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<str<strong>on</strong>g>My</str<strong>on</strong>g> <str<strong>on</strong>g>Reading</str<strong>on</strong>g> <strong>on</strong> <strong>ASQ</strong> <strong>CQA</strong><br />

The Handbook <strong>Part</strong> 1~(IA-IE)<br />

<str<strong>on</strong>g>My</str<strong>on</strong>g> Pre-exam Self Study Notes<br />

6 th September 2018~9 TH September 2019<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


SR-71A<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


闭 门 练 功<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The Magical Book of <strong>CQA</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


闭 门 练 功<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang<br />

Fi<strong>on</strong> Zhang at Shanghai<br />

4 th September 2018


<strong>ASQ</strong> Missi<strong>on</strong>:<br />

The American Society for Quality advances<br />

individual, organizati<strong>on</strong>al, and community<br />

excellence worldwide through learning, quality<br />

improvement, and knowledge exchange.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


BOK<br />

Knowledge<br />

Percentage Score<br />

I. Auditing Fundamentals (30 Questi<strong>on</strong>s) 20%<br />

II. Audit Process (60 Questi<strong>on</strong>s) 40%<br />

III. Auditor Competencies (23 Questi<strong>on</strong>s) 15.3%<br />

IV. Audit Program Management and Business Applicati<strong>on</strong>s<br />

(15 Questi<strong>on</strong>s)<br />

10%<br />

V. Quality Tools and Techniques (22 Questi<strong>on</strong>s) 14.7%<br />

150 Questi<strong>on</strong>s 100%<br />

https://asq.org/cert/resource/docs/cqa_bok.pdf<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


C<strong>on</strong>tent:<br />

• <str<strong>on</strong>g>My</str<strong>on</strong>g> <str<strong>on</strong>g>Reading</str<strong>on</strong>g> <strong>on</strong> <strong>ASQ</strong> Handbook<br />

1. IA. Chapter 1<br />

2. IB. Chapter 2<br />

3. IC. Chapter 3<br />

4. ID. Chapter 4<br />

5. IE. Chapter 5<br />

6. To be c<strong>on</strong>tinues.<br />

• Thanks<br />

http://www.gbv.de/dms/zbw/728414511.pdf<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Foreword<br />

Change is the <strong>on</strong>ly c<strong>on</strong>stant, and changes to the audit professi<strong>on</strong> c<strong>on</strong>tinue in order to improve effectiveness<br />

and efficiency and to adjust to changes in technology. We are no l<strong>on</strong>ger just process and system auditors rather,<br />

members of our professi<strong>on</strong> are valued teammates, adding fresh eyes and organizati<strong>on</strong>al expertise to the<br />

wealth of tools available to management. Management system standards such as ISO 9000- based<br />

management systems are now viewed as starting points for organizati<strong>on</strong>al excellence. <strong>ASQ</strong> Audit Divisi<strong>on</strong><br />

members are no l<strong>on</strong>ger c<strong>on</strong>sidered compliance police. Rather, our membership has evolved to meet the<br />

challenges of the new millennium, just as Norm Frank predicted in his foreword to the sec<strong>on</strong>d editi<strong>on</strong> of this<br />

handbook. We are no l<strong>on</strong>ger just auditors- we are assessors, and our chosen discipline has grown to include<br />

advising management <strong>on</strong> best practices. We are teachers in the true sense of the word. This editi<strong>on</strong> of The<br />

<strong>ASQ</strong> Auditing Handbook reflects those changes. Subject- matter experts skilled in the audit professi<strong>on</strong> have<br />

grown the Body of Knowledge (BoK), working in tandem with the <strong>ASQ</strong> Certificati<strong>on</strong> Department, and this book<br />

reflects the latest revisi<strong>on</strong>. Teams of <strong>ASQ</strong> Certified Quality Auditors (<strong>CQA</strong>s), working <strong>on</strong> your behalf, met at<br />

<strong>ASQ</strong> headquarters and volunteered l<strong>on</strong>g hours to ensure that the BoK, reflected herein, represents generally<br />

accepted, world- class audit practices. C<strong>on</strong>tributors to this book, also subject- matter experts, volunteered their<br />

time to ensure that the excellence of the new BoK is scholastically available to audit professi<strong>on</strong>als the world<br />

over.<br />

The words thank you d<strong>on</strong>’t begin to express my appreciati<strong>on</strong> to the <strong>ASQ</strong> Certificati<strong>on</strong> staff, the <strong>CQA</strong>s involved<br />

in updating the BoK, the Audit Divisi<strong>on</strong> members who volunteer to manage the certificati<strong>on</strong> program, the <strong>CQA</strong>s<br />

who meet every year to write test questi<strong>on</strong>s, and the fine authors who c<strong>on</strong>tributed to the latest editi<strong>on</strong> of this<br />

book. This book has become the text of choice for candidates sitting for the <strong>CQA</strong> examinati<strong>on</strong>. The exam is<br />

written such that the handbook is a major source of informati<strong>on</strong> needed to attain the <strong>CQA</strong> credential. Enjoy our<br />

latest editi<strong>on</strong>, and use the informati<strong>on</strong> to grow your expertise. The path leading from compliance auditing to<br />

system assessing is great, but the rewards are worth the effort. I think you’ll find this book to be an invaluable<br />

resource to help you al<strong>on</strong>g that path.<br />

George Callender<br />

Chair, <strong>ASQ</strong> Audit Divisi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Notes to the Reader<br />

This handbook supports the quality auditor BoK, developed for the <strong>ASQ</strong> <strong>CQA</strong> program. The quality audit BoK<br />

was revised in 2012. The fourth editi<strong>on</strong> addresses new and expanded BoK topics, comm<strong>on</strong> auditing (quality,<br />

envir<strong>on</strong>mental, safety, and so <strong>on</strong>) methods, and process auditing. The handbook is designed to provide<br />

practical guidance for system and process auditors. Practiti<strong>on</strong>ers in the field provided c<strong>on</strong>tent, example audit<br />

situati<strong>on</strong>s, stories, and review comments as the handbook evolved. New to the fourth editi<strong>on</strong> are the topics of<br />

comm<strong>on</strong> and special causes, outliers, and risk management tools. Besides the new topics, many current topics<br />

have been expanded to reflect changes in auditing practices since 2004 and ISO 19011 guidance, and they<br />

have been rewritten to promote the comm<strong>on</strong> elements of all types of system and process audits (quality,<br />

envir<strong>on</strong>mental, safety, and health). The text is aligned with the BoK for easy cross- referencing. We hope that<br />

use of this handbook will increase your understanding of the auditing BoK.<br />

Keywords:<br />

• (1) comm<strong>on</strong>, (2) methods, and (3) process auditing<br />

• Quality tools: comm<strong>on</strong> and special causes, outliers 局 外 人 , and risk management tools<br />

• audits (quality, envir<strong>on</strong>mental, safety, and health).<br />

(1) comm<strong>on</strong>, (2)<br />

methods, and (3)<br />

process auditing<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The Use<br />

The handbook can be used by new auditors to gain an understanding of auditing. Experienced<br />

auditors will find it to be a useful reference. Audit managers and quality managers will use the<br />

handbook as a guide for leading their auditing programs.<br />

The handbook will also be used by trainers and educators as source material for teaching the<br />

fundamentals of auditing. It is not designed as a stand- al<strong>on</strong>e text to prepare for the <strong>ASQ</strong> <strong>CQA</strong><br />

exam. As with all <strong>ASQ</strong> certificati<strong>on</strong> activities, you are encouraged to work with your local secti<strong>on</strong><br />

or the Quality Audit Divisi<strong>on</strong> for preparati<strong>on</strong>.<br />

The <strong>ASQ</strong> Auditing Handbook, when used in c<strong>on</strong>juncti<strong>on</strong> with other published materials, is<br />

appropriate for refresher courses, and we hope that trainers will use it in that manner. The<br />

handbook c<strong>on</strong>tains informati<strong>on</strong> to support all aspects of the <strong>CQA</strong> BoK and is not limited to what<br />

new auditors need to know. Hence, the amount of material in each part of the handbook is not<br />

directly proporti<strong>on</strong>al to exam emphasis. The <strong>CQA</strong> exam is designed to test a candidate’s basic<br />

knowledge of quality auditing. All the informati<strong>on</strong> in the handbook is important, but those<br />

preparing for the <strong>CQA</strong> exam should spend more time <strong>on</strong> their weakest areas and <strong>on</strong> those parts<br />

of the BoK receiving more emphasis <strong>on</strong> the exam.<br />

The number of questi<strong>on</strong>s and the percentage of <strong>CQA</strong> exam questi<strong>on</strong>s are indicated at the start<br />

of each part of the handbook.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The C<strong>on</strong>tents<br />

The handbook is organized to be in alignment with the <strong>CQA</strong> BoK. We have included the BoK at the back of the<br />

handbook as an appendix. Since many c<strong>on</strong>cepts and practices of process and system auditing are still evolving,<br />

the BoK will be revised from time to time. As changes occur, the handbook must also be revised to be current.<br />

Terms and definiti<strong>on</strong>s are addressed throughout the text. Definiti<strong>on</strong>s are taken from ISO 19011:2011<br />

(Guidelines for auditing management systems ) and ISO 9000:2005, with definiti<strong>on</strong>s from the former<br />

superseding the latter. Definiti<strong>on</strong>s have underg<strong>on</strong>e extensive peer review and are accepted worldwide.<br />

However, even the definiti<strong>on</strong>s of audit terms c<strong>on</strong>tinue to evolve in order to meet the needs of the users of the<br />

standard. The <strong>ASQ</strong> Auditing Handbook represents generally accepted audit practices for both internal and<br />

external applicati<strong>on</strong>s. Thus, it may not depict 描 述 the best practice for every situati<strong>on</strong>.<br />

The handbook uses generic terms to support broad principles. For clarity, specific industry examples and<br />

stories from <strong>CQA</strong>s are sometimes used to explain a topic in the BoK. The stories, depicted as sidebars, are a<br />

way for auditors to share their experiences. Industry examples incorporated into the text and presented in the<br />

appendices are not intended to be all-inclusive and representative of all industries. We are pleased to<br />

incorporate examples shared by audit practiti<strong>on</strong>ers as a means to add value to the text. Needless to say, this<br />

work cannot address the most appropriate practice for every industry or organizati<strong>on</strong>. In some cases <strong>CQA</strong><br />

informati<strong>on</strong> needs are the same as other certified professi<strong>on</strong>al needs. Several secti<strong>on</strong>s in <strong>Part</strong> V, ―Quality Tools<br />

and Techniques,‖ are the same as similar secti<strong>on</strong>s for certified manager of quality. All secti<strong>on</strong>s and chapters are<br />

clearly marked and referenced. This publicati<strong>on</strong>, which describes audit methods and their applicati<strong>on</strong>, is not<br />

intended to be used as a nati<strong>on</strong>al or internati<strong>on</strong>al standard, although it references many existing standards.<br />

The c<strong>on</strong>venti<strong>on</strong>s for writing standards and using the term shall to mean a requirement and should to mean a<br />

guideline do not apply to The <strong>ASQ</strong> Auditing Handbook.<br />

Keywords:<br />

• Shall, should<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Who Wrote It<br />

The <strong>CQA</strong>s who supplied informati<strong>on</strong> for the handbook represent a broad spectrum of organizati<strong>on</strong>s in the<br />

United States and around the world. More than 120 individuals c<strong>on</strong>tributed material for the first, sec<strong>on</strong>d, third,<br />

and fourth editi<strong>on</strong>s. Input from members and a number of published texts were also used to create and develop<br />

The <strong>ASQ</strong> Auditing Handbook. It represents internal and external audits in a variety of product and service<br />

industries, regulated and n<strong>on</strong>-regulated. For each editi<strong>on</strong>, a developmental editor gathered material to address<br />

the BoK topics and issued a manuscript to be reviewed by audit experts and practiti<strong>on</strong>ers in the field. Extensive<br />

peer review further strengthened the manuscript. The editor sorted, culled (select from many), augmented<br />

(enlarge) , and refined the manuscript to be turned over to the publisher.<br />

Why The handbook<br />

The <strong>ASQ</strong> Audit Divisi<strong>on</strong> sp<strong>on</strong>sored the development of this<br />

handbook to promote the use of auditing as a<br />

management tool- our primary missi<strong>on</strong>. We believe that the<br />

Audit Divisi<strong>on</strong>’s members possess the greatest<br />

c<strong>on</strong>centrati<strong>on</strong> of theoretical and practical auditing<br />

knowledge in the world. In The <strong>ASQ</strong> Auditing Handbook,<br />

we have tried to give you the benefits of this collective<br />

expertise.<br />

J. P. Russell, Editor<br />

J. P. Russell, Editor<br />

Keywords:<br />

development of this handbook to promote the use of auditing as a management tool—our primary missi<strong>on</strong><br />

https://www.qualitywbt.com/library/jp-russell-library/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Keywords:<br />

• development of this handbook to promote the use of auditing as a<br />

management tool- our primary missi<strong>on</strong><br />

https://www.qualitywbt.com/library/jp-russell-library/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


JP Russell Library<br />

https://www.qualitywbt.com/library/jp-russell-library/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Acknowledgments<br />

<strong>ASQ</strong> Audit Divisi<strong>on</strong> members and experts have c<strong>on</strong>tributed to all editi<strong>on</strong>s of the handbook as c<strong>on</strong>tributors,<br />

reviewers, and handbook project leaders. For a list of our first, sec<strong>on</strong>d, and third editi<strong>on</strong> c<strong>on</strong>tributors and<br />

reviewers, please see Appendix K. For the fourth editi<strong>on</strong>, we relied <strong>on</strong> expert input from the developmental<br />

editor, other proven expert sources, and peer review. The auditing BoK has evolved since the first editi<strong>on</strong> of the<br />

handbook, published in 1997, and needs more refinement than creati<strong>on</strong>. Over the years, the quality of the<br />

feedback from day- to-day practiti<strong>on</strong>ers has significantly improved the c<strong>on</strong>tent applicability and value to users of<br />

the handbook.<br />

Reviewers of the fourth editi<strong>on</strong> of the handbook are:<br />

• Nancy Boudreau, <strong>ASQ</strong> <strong>CQA</strong>, CQPA, RABQSA QMS PA<br />

• Mary Chris Easterly, <strong>ASQ</strong> <strong>CQA</strong>, <strong>ASQ</strong> CMQ/OE<br />

• Anita McReynolds- Lidbury, <strong>ASQ</strong> <strong>CQA</strong><br />

• Lawrence Mossman, <strong>ASQ</strong> <strong>CQA</strong><br />

• Sandra Storli, <strong>ASQ</strong> CMQ/OE, CBA, <strong>CQA</strong>, RABQSA- LA<br />

J. P. Russell, Editor<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Overview<br />

This handbook is organized in the same way as the <strong>ASQ</strong> Certified Quality Auditor BoK:<br />

starting with <strong>Part</strong> I and ending with <strong>Part</strong> V. This secti<strong>on</strong> was written as an overview of auditing to better prepare<br />

readers for <strong>Part</strong> I of the handbook and is not meant to be an explanati<strong>on</strong> of the BoK.<br />

The word audit is associated with:<br />

(1) formal or methodical examining, (2) reviewing, and (3) investigating.<br />

Professi<strong>on</strong>al groups such as <strong>ASQ</strong> and the Institute of Internal Auditors (IIA) define preferred methods for<br />

c<strong>on</strong>ducting examinati<strong>on</strong>s and investigati<strong>on</strong>s (to audit). For (1) product, (2) process, and (3) system audits, the<br />

Audit Divisi<strong>on</strong> of <strong>ASQ</strong> has developed the BoK for auditing. <strong>ASQ</strong> also certifies individuals who meet the criteria<br />

for Certified Quality Auditor, Quality Auditor–HACCP (Hazard Analysis and Critical C<strong>on</strong>trol Point) Certificati<strong>on</strong>,<br />

and Quality Auditor–Biomedical. This handbook explains the topics listed in the BoK issued by <strong>ASQ</strong>. Auditing is<br />

a prescribed work practice or process. There is a preferred sequential order of activities that should be<br />

performed to c<strong>on</strong>duct a proper audit.<br />

<strong>Part</strong> II of the BoK (―Audit Process‖) follows the same preferred order. Audits must be prepared for (planning<br />

ahead), then performed (c<strong>on</strong>ducting the audit), the results reported (let every<strong>on</strong>e know what was found), and<br />

then the results resp<strong>on</strong>ded to (feedback <strong>on</strong> what is going to happen next) by the organizati<strong>on</strong> that was audited.<br />

It is comm<strong>on</strong> to refer to these as phases of an audit:<br />

1. preparati<strong>on</strong>,<br />

2. performance,<br />

3. report, and<br />

4. follow- up and<br />

5. closure.<br />

As with most service jobs, the outcome is influenced by how the service provider performs the job. That is why<br />

<strong>Part</strong> I of the handbook is about audit fundamentals, ethics, and c<strong>on</strong>duct. Auditing is c<strong>on</strong>sidered a professi<strong>on</strong>;<br />

therefore, individual auditors need to know how to c<strong>on</strong>duct themselves in a professi<strong>on</strong>al manner.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


HACCP (Hazard Analysis and Critical C<strong>on</strong>trol Point)<br />

HACCP is a management system in which food safety is addressed through the analysis and<br />

c<strong>on</strong>trol of:<br />

1. biological,<br />

2. chemical, and<br />

3. physical hazards<br />

From:<br />

1. raw material producti<strong>on</strong>,<br />

2. procurement and handling,<br />

3. to manufacturing,<br />

4. distributi<strong>on</strong> and<br />

5. c<strong>on</strong>sumpti<strong>on</strong><br />

of the finished product.<br />

<strong>ASQ</strong> also certifies individuals who meet the criteria for<br />

(1) Certified Quality Auditor,<br />

(2) Quality Auditor–HACCP (Hazard Analysis and Critical C<strong>on</strong>trol Point) Certificati<strong>on</strong>, and<br />

(3) Quality Auditor–Biomedical.<br />

https://www.fda.gov/Food/GuidanceRegulati<strong>on</strong>/HACCP/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


HACCP (Hazard Analysis and Critical C<strong>on</strong>trol Point)<br />

https://www.protrainings.eu/wiki/haccp/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Quality Auditing Technical Committee<br />

In the late 1980s the Quality Auditing Technical Committee (now the Audit Divisi<strong>on</strong> of <strong>ASQ</strong>) defined audit as:<br />

A planned, independent, and documented assessment to determine whether agreed- up<strong>on</strong><br />

requirements are being met.<br />

For now, let us think of a quality audit as an assessment to determine whether agreed- up<strong>on</strong> quality<br />

requirements are being met and will c<strong>on</strong>tinue to be met (whereas an envir<strong>on</strong>mental audit may be related to<br />

envir<strong>on</strong>mental requirements, a financial audit related to financial or accounting requirements, and so <strong>on</strong>).<br />

A distinguishing attribute of an audit is objectivity. The individuals performing audits must be able to evaluate<br />

the area being audited in an (1) objective and (2) unbiased manner. The degree of objectivity varies depending<br />

<strong>on</strong> the situati<strong>on</strong> and type of audit (purpose and scope). For example, auditors can audit within their own<br />

department, but they cannot audit their own jobs.<br />

There are several groupings or classificati<strong>on</strong>s of audits, depending <strong>on</strong> the relati<strong>on</strong>ships (external and internal),<br />

the need for objectivity, and the reas<strong>on</strong> for the audit (verificati<strong>on</strong> of product, process, or system). In Figure I.1,<br />

the circle represents an organizati<strong>on</strong>. Outside the circle are the organizati<strong>on</strong>’s customer(s) and supplier(s). All<br />

organizati<strong>on</strong>s have customer- supplier relati<strong>on</strong>ships. Any audits d<strong>on</strong>e inside the circle are internal audits, and<br />

audits d<strong>on</strong>e outside the circle are external audits. We further classify the audits as first-, sec<strong>on</strong>d-, or third- party<br />

audits based <strong>on</strong> relati<strong>on</strong>ships. First-party audits are <strong>on</strong>es within the organizati<strong>on</strong> itself (the same as internal<br />

audits or self- assessment) and are inside the circle. Sec<strong>on</strong>d party audits are audits of suppliers or of<br />

customers crossing into the circle to audit the organizati<strong>on</strong> (their supplier). Third-party audits are totally<br />

independent of the customer- supplier relati<strong>on</strong>ship and are off to the right in the diagram. Third- party audits<br />

may result in independent certificati<strong>on</strong> of a product, process, or system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Figure I.1 Types of audits.<br />

Source: J.P. Russell & Associates training materials. Used with permissi<strong>on</strong>.<br />

Customer<br />

Sec<strong>on</strong>d-<strong>Part</strong>y<br />

Customer audit your organizati<strong>on</strong><br />

External audit<br />

Sec<strong>on</strong>d-<strong>Part</strong>y<br />

You audit supplier<br />

Internal<br />

Organizati<strong>on</strong><br />

First-party<br />

Audit your own organizati<strong>on</strong><br />

First-party audits are <strong>on</strong>es<br />

within the organizati<strong>on</strong> itself (the<br />

same as internal audits or selfassessment)<br />

and are inside the<br />

circle. Sec<strong>on</strong>d party audits are<br />

audits of suppliers or of<br />

customers crossing into the circle<br />

to audit the organizati<strong>on</strong> (their<br />

supplier). Third-party audits are<br />

totally independent of the<br />

customer- supplier relati<strong>on</strong>ship<br />

and are off to the right in the<br />

diagram. Third- party audits may<br />

result in independent certificati<strong>on</strong><br />

of a product, process, or system.<br />

Supplier<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Figure I.1 Types of audits.<br />

Source: J.P. Russell & Associates training materials. Used with permissi<strong>on</strong>.<br />

Customer<br />

Sec<strong>on</strong>d-<strong>Part</strong>y<br />

Customer audit your organizati<strong>on</strong><br />

External audit<br />

Sec<strong>on</strong>d-<strong>Part</strong>y<br />

You audit supplier<br />

Internal<br />

First-party<br />

Audit your own organizati<strong>on</strong><br />

First-party audits are <strong>on</strong>es within<br />

the organizati<strong>on</strong> itself (the same<br />

as internal audits or selfassessment)<br />

and are inside the<br />

circle. Sec<strong>on</strong>d party audits are<br />

audits of suppliers or of<br />

customers crossing into the circle<br />

to audit the organizati<strong>on</strong> (their<br />

supplier). Third-party audits are<br />

totally independent of the<br />

customer- supplier relati<strong>on</strong>ship<br />

and are off to the right in the<br />

diagram. Third- party audits may<br />

result in independent certificati<strong>on</strong><br />

of a product, process, or system.<br />

Supplier<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Figure I.1 Types of audits.<br />

Source: J.P. Russell & Associates training materials. Used with permissi<strong>on</strong>.<br />

Customer<br />

Sec<strong>on</strong>d-<strong>Part</strong>y<br />

Customer audit your organizati<strong>on</strong><br />

External audit<br />

Sec<strong>on</strong>d-<strong>Part</strong>y<br />

You audit supplier<br />

Internal<br />

First-party<br />

Audit your own organizati<strong>on</strong><br />

Third-<strong>Part</strong>y<br />

Independent audit organizati<strong>on</strong> audit you<br />

First-party audits are <strong>on</strong>es within<br />

the organizati<strong>on</strong> itself (the same<br />

as internal audits or selfassessment)<br />

and are inside the<br />

circle. Sec<strong>on</strong>d party audits are<br />

audits of suppliers or of<br />

customers crossing into the circle<br />

to audit the organizati<strong>on</strong> (their<br />

supplier). Third-party audits are<br />

totally independent of the<br />

customer- supplier relati<strong>on</strong>ship<br />

and are off to the right in the<br />

diagram. Third- party audits may<br />

result in independent certificati<strong>on</strong><br />

of a product, process, or system.<br />

Supplier<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Audits:<br />

Audits<br />

First <strong>Part</strong>y<br />

Sec<strong>on</strong>d <strong>Part</strong>y<br />

Third <strong>Part</strong>y<br />

Internal Audit<br />

within your own<br />

organizati<strong>on</strong><br />

External Audit <strong>on</strong><br />

Suppliers<br />

External Audit by<br />

Customers <strong>on</strong> your<br />

organizati<strong>on</strong><br />

External<br />

Independent audit<br />

organizati<strong>on</strong> <strong>on</strong><br />

your organizati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


In the 1980s 历 史 的 回 顾<br />

http://phillips.blogs.com/goc/2014/01/current-l<strong>on</strong>g-war.html<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


1980s 历 史 的 回 顾<br />

El Salvador is <strong>on</strong>e of the smallest countries of<br />

Central America with a populati<strong>on</strong> of<br />

approximately six milli<strong>on</strong> people. In the year<br />

1980, El Salvador suffered from a bloody and<br />

l<strong>on</strong>g lasting war which lasted for a 12 year<br />

period. This war caused the deaths of 75,000<br />

people and many innocent people were<br />

separated from their families. Many of the killed<br />

were innocent children and mothers. This war<br />

was fought between the Salvadoran<br />

government and FMLN which was a left wing<br />

group that was composed of guerillas. The<br />

Nati<strong>on</strong>al Guard which was the Salvadoran<br />

military was <strong>on</strong>e of the most feared militaries<br />

and resp<strong>on</strong>sible for the deaths of many innocent<br />

individuals including M<strong>on</strong>signor Romero who<br />

was an archbishop that was politically active<br />

and would tell the U.S not to help the El<br />

Salvador’s government. They were also<br />

resp<strong>on</strong>sible for the deaths of the four American<br />

churchwomen.<br />

http://migrahackaz.leftwardthinking.com/?page_id=102<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


1980s 历 史 的 回 顾<br />

Dying for democracy: 1980 Gwangju uprising transformed South Korea<br />

https://www.japantimes.co.jp/news/2014/05/17/asia-pacific/politics-diplomacy-asia-pacific/dying-democracy-1980-gwangju-uprising-transformed-south-korea/#.W5EN0twzaUk<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


1980s 历 史 的 回 顾<br />

Mujahedeen fighters in Afghanistan during the 1980s.<br />

https://www.jacobinmag.com/2017/05/islamophobia-isis-al-qaeda-juan-cole<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Auditors can focus the audit (examinati<strong>on</strong> and investigati<strong>on</strong>) <strong>on</strong> different areas, depending <strong>on</strong> the needs.<br />

• A product or service audit determines whether product or service requirements (tangible characteristics or<br />

attributes) are being met.<br />

• The process audit determines whether process requirements (methods, procedures) are being met.<br />

• A system audit determines whether system requirements (manual, policy, standards, regulati<strong>on</strong>s) are being<br />

met.<br />

Audits<br />

Product Audits<br />

Process Audits<br />

System Audits<br />

tangible<br />

characteristics or<br />

attributes are being<br />

met<br />

methods, procedures<br />

are being met<br />

manual, policy, standards,<br />

regulati<strong>on</strong>s are being met<br />

Dict: Tangible; something that can be touched or felt, something real or substantial;<br />

Questi<strong>on</strong>: (tangible characteristic ≡ variable?)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The handbook discusses all types of audits, but most of the discussi<strong>on</strong> is focused <strong>on</strong><br />

system audits (being the most complex and having the greatest potential influence). A<br />

system can be thought of as a group of processes providing a product or service.<br />

When auditors are auditing, they are making observati<strong>on</strong>s and collecting evidence<br />

(data). They are seeking to verify that requirements are being met. They do this by<br />

collecting hard evidence, not hearsay or promises. Evidence produced as a result of<br />

the activity may be tangible objects or records, or pers<strong>on</strong>al observati<strong>on</strong>s. Auditors<br />

must be familiar with auditing techniques and the criteria they are auditing to. What<br />

auditors observe is not always straightforward or obvious, so they must be able to<br />

judge whether the intent (reas<strong>on</strong> for the requirement) is being met or addressed. The<br />

audit evidence and the method of collecting the evidence form the basis of the audit<br />

report.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The primary participants needed for c<strong>on</strong>ducting an audit are the auditor, the auditee, and the<br />

client (?).<br />

• The pers<strong>on</strong> c<strong>on</strong>ducting the audit is called the auditor, lead auditor, or audit team leader.<br />

• The organizati<strong>on</strong> being audited or investigated is called the auditee.<br />

• There is also a client, the pers<strong>on</strong> or organizati<strong>on</strong> that has requested the audit.<br />

The primary participants needed for c<strong>on</strong>ducting an audit are the auditor,<br />

the auditee, and the client. The pers<strong>on</strong> c<strong>on</strong>ducting the audit is called the auditor,<br />

lead auditor, or audit team leader. The organizati<strong>on</strong> being audited or investigated<br />

is called the auditee. There is also a client, the pers<strong>on</strong> or organizati<strong>on</strong> that has<br />

requested the audit. Audits are c<strong>on</strong>ducted <strong>on</strong>ly when some<strong>on</strong>e requests <strong>on</strong>e; they<br />

do not happen by accident. There has to be a sp<strong>on</strong>sor or client with the authority<br />

to call for an audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Audits are c<strong>on</strong>ducted <strong>on</strong>ly when some<strong>on</strong>e requests <strong>on</strong>e; they do not happen by accident. There<br />

has to be a sp<strong>on</strong>sor or client with the authority to call for an audit. Any type of organizati<strong>on</strong> can<br />

be audited against a set of standard requirements. The organizati<strong>on</strong> can produce a product or<br />

provide a service, such as government agencies or retail stores. An organizati<strong>on</strong> can be audited<br />

against almost any type of standards or set of criteria. The criteria or standards can be<br />

government regulati<strong>on</strong>s, ISO 9001 or ISO 14001 requirements, TS16949, Malcolm Baldrige<br />

Nati<strong>on</strong>al Quality Award criteria, customer requirements, and so <strong>on</strong>. If there is a set of rules,<br />

auditors can compare actual practice with the rules. While auditors are comparing actual practice<br />

with the rules or standards (determining c<strong>on</strong>formity or compliance to requirements), they may<br />

also observe that certain practices and trends are not in the best interest of the organizati<strong>on</strong><br />

being audited.<br />

Hence, auditors may report:<br />

1. compliance and n<strong>on</strong>compliance<br />

2. as well as areas that are not effective or areas that can be improved as input for<br />

management c<strong>on</strong>siderati<strong>on</strong>. (Do these go to the Auditee?)<br />

3. Auditors may also include best practices or good practices as part of an<br />

audit report so that they can be shared with other areas of the organizati<strong>on</strong><br />

(Do these go to the Auditee?)<br />

Keywords:<br />

There has to be a sp<strong>on</strong>sor or client with the authority to call for an audit.<br />

An organizati<strong>on</strong> can be audited against almost any type of standards or set of criteria.<br />

ISO/TS 16949 is an ISO technical specificati<strong>on</strong> aimed at the development of a quality management system that provides<br />

for c<strong>on</strong>tinual improvement, emphasizing defect preventi<strong>on</strong> and the reducti<strong>on</strong> of variati<strong>on</strong> and waste in the automotive industry supply chain.<br />

Are item 2 & 3 input for management<br />

c<strong>on</strong>siderati<strong>on</strong> <strong>on</strong>ly?. The<br />

recommendati<strong>on</strong>s may be subjective.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Findings are the results of the investigati<strong>on</strong>. They may be reported as n<strong>on</strong>c<strong>on</strong>formities/ c<strong>on</strong>formities, findings,<br />

n<strong>on</strong>-compliances/compliances, defects, c<strong>on</strong>cerns (?, subjective? Record as observati<strong>on</strong>s?) and so <strong>on</strong>. The<br />

audit results can include both positive and negative issues identified. It is important for every<strong>on</strong>e to agree <strong>on</strong><br />

the terminology that will be used in the audit report.<br />

Recently there has been more emphasis <strong>on</strong> looking bey<strong>on</strong>d c<strong>on</strong>ducting the audit steps, to management of the<br />

audit process. It is important to understand the objectives of the audit functi<strong>on</strong> and the potential benefits to the<br />

organizati<strong>on</strong>. This understanding and clarificati<strong>on</strong> has resulted in some audit programs being strictly limited to<br />

auditing for compliance and other audit programs seeking informati<strong>on</strong> about the effectiveness and efficiency of<br />

internal c<strong>on</strong>trols. Auditing is a management tool used to verify that systems and processes are<br />

compliant/c<strong>on</strong>formant, suitable to achieve objectives, and effective. For additi<strong>on</strong>al background informati<strong>on</strong> <strong>on</strong><br />

auditing, c<strong>on</strong>tinue <strong>on</strong> to <strong>Part</strong> I.<br />

Keywords:<br />

• The audit results can include both positive and negative issues identified.<br />

• c<strong>on</strong>cerns<br />

C<strong>on</strong>cerns?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Scenario<br />

Auditors Are Not Inspectors<br />

All too often the term audit is used to describe an inspecti<strong>on</strong> activity. Inspecti<strong>on</strong> is a tool to detect errors or<br />

defects before a product is approved for release or distributi<strong>on</strong>. It is normally part of the manufacturing or<br />

service approval process. An organizati<strong>on</strong> may form a quality c<strong>on</strong>trol department to manage and c<strong>on</strong>duct the<br />

inspecti<strong>on</strong>s. In other cases, some organizati<strong>on</strong>s may use the word inspecti<strong>on</strong> to describe an audit. Audits<br />

c<strong>on</strong>ducted by the government (such as the FDA) may be described as inspecti<strong>on</strong>s in regulatory documents.<br />

For the purposes of this handbook, we will differentiate between audits and inspecti<strong>on</strong>s <strong>on</strong> the basis of nati<strong>on</strong>al<br />

and internati<strong>on</strong>al standards such as the ISO 19011 guideline standard regarding management system audits.<br />

As organizati<strong>on</strong> sectors (other than manufacturing) attempt to apply auditing principles, they may become<br />

frustrated due to some initial misunderstandings. One of these misunderstandings is the way they use the term<br />

audit.<br />

For example, in the insurance industry, claims (such as medical, property, and liability) are processed<br />

as a case file. This file c<strong>on</strong>tains the insured party’s claim, the evidence, the adjuster’s report, the offered<br />

compensati<strong>on</strong>, the accepted compensati<strong>on</strong>, and the closing statement. All this paperwork is subject to error and<br />

omissi<strong>on</strong>. So the managers will audit these case files before they are ultimately closed. Sometimes<br />

the audit is performed before a check is cut. In reality, this is an inspecti<strong>on</strong> and not an audit.<br />

The general public associates quality with c<strong>on</strong>ducting an inspecti<strong>on</strong>. The ir<strong>on</strong>y is that using inspecti<strong>on</strong>s to<br />

ensure quality has proved to be too costly and ineffective compared to using other quality tools and techniques.<br />

For more informati<strong>on</strong> <strong>on</strong> the history of quality c<strong>on</strong>trol and auditing, see Appendix E, ―History of Quality<br />

Assurance and Auditing.‖<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Scenario<br />

For example, in the insurance industry, claims (such as medical, property, and liability) are processed<br />

as a case file. This file c<strong>on</strong>tains the insured party’s claim, the evidence, the adjuster’s report, the offered<br />

compensati<strong>on</strong>, the accepted compensati<strong>on</strong>, and the closing statement. All this paperwork is subject to error and<br />

omissi<strong>on</strong>. So the managers will audit these case files before they are ultimately closed. Sometimes<br />

the audit is performed before a check is cut. In reality, this is an inspecti<strong>on</strong> and not an audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> I<br />

Auditing Fundamentals<br />

[27 of the <strong>CQA</strong> Exam Questi<strong>on</strong>s or 18<br />

percent]<br />

Chapter 1 Types of Quality Audits/<strong>Part</strong> IA<br />

Chapter 2 Purpose and Scope of Audits/<strong>Part</strong> IB<br />

Chapter 3 Criteria to Audit Against/<strong>Part</strong> IC<br />

Chapter 4 Roles and Resp<strong>on</strong>sibilities of Audit <strong>Part</strong>icipants/<strong>Part</strong> ID<br />

Chapter 5 Professi<strong>on</strong>al C<strong>on</strong>duct and C<strong>on</strong>sequences for Auditors/<strong>Part</strong> IE<br />

The purpose of <strong>Part</strong> I is to present audit purpose, types, and criteria as well as auditor roles and resp<strong>on</strong>sibilities.<br />

The last chapter addresses professi<strong>on</strong>al c<strong>on</strong>duct and c<strong>on</strong>sequences for auditors. Ethics affect professi<strong>on</strong>al<br />

c<strong>on</strong>duct, and professi<strong>on</strong>al c<strong>on</strong>duct affects liability and audit credibility.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Chapter 1<br />

Types of Quality Audits/<strong>Part</strong> IA<br />

__________________________________________________<br />

IA1. Method<br />

An audit is a “systematic, independent and documented process for obtaining audit<br />

evidence and evaluating it objectively to determine the extent to which audit criteria are<br />

fulfilled.”<br />

Several audit methods may be employed to achieve the audit purpose. There are three discrete<br />

types of audits: (1) product (which includes services), (2) process, and (3) system. (there is no<br />

organizati<strong>on</strong> audit!) However, other methods, such as a desk or document review audit, may be<br />

employed independently or in support of the three general types of audits. Some audits are<br />

named according to their purpose or scope. The scope of a department or functi<strong>on</strong> audit is a<br />

particular department or functi<strong>on</strong>. The purpose of a management audit relates to management<br />

interests such as assessment of area performance or efficiency.<br />

What is management audit? - management audit relates to management interests such as<br />

assessment of area performance or efficiency. (It could be either the three general type of<br />

audits?)(The management audit should not be attributed to high level ―system audit‖ type?)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Types of Quality Audits<br />

Business<br />

Performance Audit<br />

System Audit<br />

Risk Management<br />

Audit<br />

Management<br />

Audit<br />

The purpose of a management audit relates to<br />

management interests such as assessment of<br />

area performance or efficiency. <strong>HB</strong><br />

Process Audit<br />

Product Audit<br />

Compliance Audit<br />

An audit c<strong>on</strong>ducted <strong>on</strong> a management system is called a system audit. It can be<br />

described as a documented activity performed to verify, by examinati<strong>on</strong> and<br />

evaluati<strong>on</strong> of objective evidence, that applicable elements of the system are<br />

appropriate and effective and have been developed, documented, and<br />

implemented in accordance and in c<strong>on</strong>juncti<strong>on</strong> with specified requirements. A<br />

system audit looks at everything within the system (that is, the processes,<br />

products, services, and supporting groups such as purchasing, customer<br />

service, design engineering, order entry, waste management, and training).<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Types of Quality Audits<br />

Business<br />

Performance Audit<br />

System Audit<br />

Risk Management<br />

Audit<br />

Desk Audit<br />

Process Audit<br />

Compliance Audit<br />

A desk or document review audit, may be<br />

employed independently or in support of the<br />

three general types of audits.<br />

Product Audit<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product audit<br />

A product audit is an examinati<strong>on</strong> of a particular product or service (hardware, processed<br />

material, software) to evaluate whether it c<strong>on</strong>forms to requirements (that is, specificati<strong>on</strong>s,<br />

performance standards, and customer requirements). An audit performed <strong>on</strong> a service is called<br />

a service audit.<br />

Elements examined may include (1) packaging, (2) shipment preparati<strong>on</strong> and (3) protecti<strong>on</strong>, (4)<br />

user instructi<strong>on</strong>s, (5) product characteristics, (6) product performance, and (7) other customer<br />

requirements.<br />

Product audits are c<strong>on</strong>ducted when a product is in a completed stage of producti<strong>on</strong> and has<br />

passed the final inspecti<strong>on</strong>. The product auditor uses inspecti<strong>on</strong> techniques to evaluate the<br />

entire product and all aspects of the product characteristics. A product quality audit is the<br />

examinati<strong>on</strong> or test of a product that had been previously accepted or rejected for the<br />

characteristics being audited. It includes performing operati<strong>on</strong>al tests to the same requirements<br />

used by manufacturing, using the same producti<strong>on</strong> test procedure, methods, and equipment.<br />

The product audit verifies c<strong>on</strong>formance to specified standards of workmanship and performance.<br />

This audit can also measure the quality of the product going to the customer. The product audit<br />

frequently includes an evaluati<strong>on</strong> of packaging, an examinati<strong>on</strong> for cosmetics, and a check for<br />

proper documentati<strong>on</strong> and accessories, such as proper tags, stamps, process certificati<strong>on</strong>s, use<br />

of approved vendors, shipment preparati<strong>on</strong>, and security. Product audits may be performed <strong>on</strong><br />

safety equipment, envir<strong>on</strong>mental test equipment, or products to be sent to customers, or they<br />

can be the result of a service such as equipment maintenance.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit: Elements examined may include (1) packaging, (2) shipment preparati<strong>on</strong> and (3) protecti<strong>on</strong>,<br />

(4) user instructi<strong>on</strong>s, (5) product characteristics, (6) product performance, and (7) other customer requirements.<br />

Other<br />

Customer<br />

Requirements<br />

Packaging<br />

Protecti<strong>on</strong><br />

Product<br />

Performance<br />

Product Audit<br />

Shipment<br />

Preparati<strong>on</strong><br />

Product<br />

Characteristics<br />

User<br />

Instructi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit: Elements examined may include (1) packaging, (2) shipment preparati<strong>on</strong> and (3) protecti<strong>on</strong>,<br />

(4) user instructi<strong>on</strong>s, (5) product characteristics, (6) product performance, and (7) other customer requirements.<br />

Other<br />

Customer<br />

Requirements<br />

Packaging<br />

Protecti<strong>on</strong><br />

Product<br />

Performance<br />

Product Audit<br />

Shipment<br />

Preparati<strong>on</strong><br />

Product<br />

Characteristics<br />

User<br />

Instructi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA<br />

Product Audit: Elements examined may include (1) packaging, (2) shipment preparati<strong>on</strong> and (3) protecti<strong>on</strong>, (4)<br />

user instructi<strong>on</strong>s, (5) product characteristics, (6) product performance, and (7) other customer requirements.<br />

Other<br />

Customer<br />

Requirements<br />

Packaging<br />

Protecti<strong>on</strong><br />

Product<br />

Performance<br />

Product Audit<br />

Shipment<br />

Preparati<strong>on</strong><br />

Product<br />

Characteristics<br />

User<br />

Instructi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit: Elements examined may include (1) packaging, (2) shipment preparati<strong>on</strong> and (3) protecti<strong>on</strong>,<br />

(4) user instructi<strong>on</strong>s, (5) product characteristics, (6) product performance, and (7) other customer<br />

requirements.<br />

Other<br />

Customer<br />

Requirements<br />

Packaging<br />

Protecti<strong>on</strong><br />

Product<br />

Performance<br />

Product Audit<br />

or Process<br />

Audit?<br />

Shipment<br />

Preparati<strong>on</strong><br />

Product<br />

Characteristics<br />

User<br />

Instructi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit<br />

Keywords:<br />

• Product audits are c<strong>on</strong>ducted when a product is in a completed stage of producti<strong>on</strong> and has passed the<br />

final inspecti<strong>on</strong>.<br />

• A product quality audit is the examinati<strong>on</strong> or test of a product that had been previously accepted or rejected<br />

for the characteristics being audited.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

A product audit is the examinati<strong>on</strong> of the form, fit, and functi<strong>on</strong> of a completed item after final inspecti<strong>on</strong>. It is<br />

technical; it may involve special (sometimes periodic) examinati<strong>on</strong>, inspecti<strong>on</strong>, or testing of a product that<br />

previously passed final inspecti<strong>on</strong> and has been accepted for characteristics being audited to ensure that it has<br />

not degraded over time; and it can be customer oriented.<br />

The reference standard for a product quality audit is the product quality program and the product performance<br />

specificati<strong>on</strong>.<br />

One of its characteristics is a complete examinati<strong>on</strong> of a small sample of finished product. Sometimes a<br />

product audit includes the destructive test of sample products. A service audit is <strong>on</strong>e type of product audit. For<br />

many services an auditor can verify physical attributes of the service that was performed. For example:<br />

• Was the label added?<br />

• Is the area clean?<br />

• Have records been completed?<br />

• Are tools organized?<br />

For other services there are few or no traces of the service that was performed and therefore it must be verified<br />

by a process audit, for example, tuning an engine, performing repairs, receiving educati<strong>on</strong> or training, and<br />

receiving some pers<strong>on</strong>al services (a haircut can be checked and verified, but not a massage).<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit:<br />

For other services there are<br />

few or no traces of the<br />

service that was performed<br />

and therefore it must be<br />

verified by a process audit,<br />

for example, tuning an engine,<br />

performing repairs, receiving<br />

educati<strong>on</strong> or training, and<br />

receiving some pers<strong>on</strong>al<br />

services (a haircut can be<br />

checked and verified, but not<br />

a massage).<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit:<br />

For other services there are few or no traces of the service that was performed and therefore it must be verified<br />

by a process audit, for example, tuning an engine, performing repairs, receiving educati<strong>on</strong> or training, and<br />

receiving some pers<strong>on</strong>al services (a haircut can be checked and verified, but not a massage).<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Product Audit:<br />

For other services there are few or no traces of the service that was performed and therefore it must be verified<br />

by a process audit, for example, tuning an engine, performing repairs, receiving educati<strong>on</strong> or training, and<br />

receiving some pers<strong>on</strong>al services (a haircut can be checked and verified, but not a massage).<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Process audit<br />

The process audit is performed to verify that processes are working within established limits. ―The process<br />

audit examines an activity to verify that the inputs, acti<strong>on</strong>s, and outputs are in accordance with defined<br />

requirements. The boundary (scope) of a process audit should be a single process, such as marking, stamping,<br />

cooking, coating, setting up, or installing. It is very focused and usually involves <strong>on</strong>ly <strong>on</strong>e work crew.‖ A process<br />

audit covers <strong>on</strong>ly a porti<strong>on</strong> of the total system and usually takes much less time than a system audit.<br />

Keywords:<br />

The boundary (scope) of a process audit should be a single process, such as marking, stamping, cooking,<br />

coating, setting up, or installing.<br />

Questi<strong>on</strong>: Example, for refinery piping; does process audit limited to single, fit-up, welding, installati<strong>on</strong>, testing,<br />

commissi<strong>on</strong>ing, with each activity c<strong>on</strong>stitute as single independent process audit?<br />

A process audit is verificati<strong>on</strong> by<br />

evaluati<strong>on</strong> of an operati<strong>on</strong> or method<br />

against:<br />

• predetermined instructi<strong>on</strong>s or<br />

standards to measure c<strong>on</strong>formance<br />

to these standards and<br />

• the effectiveness of the instructi<strong>on</strong>s.<br />

(PDCA & Desk audit/ Document review?)<br />

A process audit is verificati<strong>on</strong> by<br />

evaluati<strong>on</strong> of an operati<strong>on</strong> or<br />

method against:<br />

• predetermined instructi<strong>on</strong>s<br />

or standards to measure<br />

c<strong>on</strong>formance to these<br />

standards and<br />

• the effectiveness of the<br />

instructi<strong>on</strong>s.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Such an audit may check c<strong>on</strong>formance to defined requirements such as:<br />

• time,<br />

• accuracy,<br />

• temperature,<br />

• pressure,<br />

• compositi<strong>on</strong>,<br />

• resp<strong>on</strong>siveness,<br />

• amperage, and<br />

• comp<strong>on</strong>ent mixture.<br />

• could be any attributes or variables?<br />

It may involve special processes such as heat- treating, soldering, plating, encapsulati<strong>on</strong>, welding, and<br />

n<strong>on</strong>destructive examinati<strong>on</strong>. A process audit examines the resources (equipment, materials, people) applied to<br />

transform the inputs into outputs, the envir<strong>on</strong>ment, the methods (procedures, instructi<strong>on</strong>s) followed, and the<br />

measures collected to determine process performance. A process audit checks the adequacy and<br />

effectiveness of the process c<strong>on</strong>trols established by procedures, work instructi<strong>on</strong>s, flowcharts, and training and<br />

process specificati<strong>on</strong>s.<br />

Auditors c<strong>on</strong>ducting process audits by their nature follow a process. The audit method of following process<br />

steps is a process audit technique. The process audit technique is an effective audit method and offers a good<br />

alternative to auditing by clause element or department or functi<strong>on</strong>. System auditors may use process audit<br />

techniques to the extent possible when auditing a management system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Process Audit Technique.<br />

Auditors c<strong>on</strong>ducting process audits by their<br />

nature follow a process. The audit method of<br />

following process steps is a process audit<br />

technique. The process audit technique is an<br />

effective audit method and offers a good<br />

alternative to auditing by clause element or<br />

department or functi<strong>on</strong>. System auditors may<br />

use process audit techniques to the extent<br />

possible when auditing a management<br />

system.<br />

No<br />

Yes<br />

Yes<br />

No<br />

Yes<br />

No<br />

Yes<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

System Audit<br />

An audit c<strong>on</strong>ducted <strong>on</strong> a management system is called a system audit. It can be described as a documented<br />

activity performed to verify, by examinati<strong>on</strong> and evaluati<strong>on</strong> of objective evidence, that:<br />

• applicable elements of the system are appropriate and effective and<br />

• have been developed, documented, and implemented in accordance and in c<strong>on</strong>juncti<strong>on</strong> with specified<br />

requirements.<br />

A quality management system audit evaluates an existing quality program to determine its c<strong>on</strong>formance to<br />

company policies, c<strong>on</strong>tract commitments, and regulatory requirements. It includes the preparati<strong>on</strong> of formal<br />

plans and checklists that are based <strong>on</strong> established requirements, the evaluati<strong>on</strong> of implementati<strong>on</strong> of detailed<br />

activities within the quality program, and the issuance of formal requests for corrective acti<strong>on</strong> where necessary.<br />

Similarly, an envir<strong>on</strong>mental system audit examines an envir<strong>on</strong>mental management system, a food safety<br />

system audit examines a food safety management system, and safety system audits examine the safety<br />

management system.<br />

Criteria c<strong>on</strong>tained in the American Society of Mechanical Engineers (ASME) codes, nuclear regulati<strong>on</strong>s, good<br />

manufacturing practices, or ISO standards, for example, may describe a management system. Normally these<br />

descripti<strong>on</strong>s state what must be d<strong>on</strong>e but do not specify how it must be d<strong>on</strong>e. The ―how‖ is left up to the<br />

organizati<strong>on</strong> being audited. An auditor looks at the management systems that c<strong>on</strong>trol all activities from the time<br />

an order comes into a company (that is, how the order is handled, processed, and passed <strong>on</strong> to operati<strong>on</strong>s,<br />

and what operati<strong>on</strong>s does in resp<strong>on</strong>se to that order) through delivery of the goods, sometimes including<br />

transportati<strong>on</strong> to the site. A system audit looks at everything within the system (that is, the processes, products,<br />

services, and supporting groups such as purchasing, customer service, design engineering, order entry, waste<br />

management, and training). It encompasses all the systems of the facility that assist in providing an acceptable<br />

product or service that is safe and c<strong>on</strong>forms to applicable local, regi<strong>on</strong>al, nati<strong>on</strong>al, and internati<strong>on</strong>al<br />

requirements.<br />

Questi<strong>on</strong>: an audit <strong>on</strong> the engineering design office, is this a process audit or a system audit?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA1<br />

Desk Audit Or Document Review<br />

A desk audit or document review is an audit of an organizati<strong>on</strong>’s documents. It can be<br />

c<strong>on</strong>ducted at a desk since people are not interviewed and activities are not observed.<br />

If auditing a new area, functi<strong>on</strong>, or organizati<strong>on</strong>, a desk audit must be c<strong>on</strong>ducted<br />

prior to a process or system audit to verify that documents meet requirements<br />

specified in the audit criteria or standards.<br />

The document review verifies that there is an adequately defined process or system<br />

prior to the full process or system audit. Findings from a desk audit or document<br />

review help ensure that audit program resources are used efficiently. It would be very<br />

costly if an audit team arrived to do a system audit, <strong>on</strong>ly to find out that the established<br />

system was not adequate. Also, a desk audit or document review may be c<strong>on</strong>ducted<br />

periodically or when documents (processes) are changed to verify the adequacy of the<br />

changes.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Types of Quality Audits/<strong>Part</strong> IA<br />

IA2. Auditor- Auditee Relati<strong>on</strong>ship<br />

Internal and external audits<br />

An audit may be classified as internal or external depending <strong>on</strong> the interrelati<strong>on</strong>ships that exist am<strong>on</strong>g the<br />

participants. Internal audits are first- party audits, while external audits can be either sec<strong>on</strong>d- or third- party<br />

audits.<br />

• Internal audits are audits of an organizati<strong>on</strong>’s product(s), processes, and systems c<strong>on</strong>ducted by employees<br />

of the organizati<strong>on</strong>.<br />

• External audits are audits of an organizati<strong>on</strong>’s product(s), processes, and systems c<strong>on</strong>ducted by individuals<br />

who are not employees of the organizati<strong>on</strong>.<br />

Figure 1.1 illustrates the classificati<strong>on</strong>s comm<strong>on</strong>ly used to differentiate between types of internal and external<br />

audits. The figure is provided as a guide to classificati<strong>on</strong>s, but there is no absolute rule, because there are<br />

excepti<strong>on</strong>s. The types of audits depicted in Figure 1.1 are not mutually exclusive. An audit can be a blend of<br />

the different types of audits. Third- party auditors (certificati<strong>on</strong>) could be joined by sec<strong>on</strong>d- party auditors<br />

(customer auditors), or internal auditors could be joined by external auditors (customer).<br />

Classificati<strong>on</strong> of Audits<br />

Internal<br />

Audits<br />

External<br />

Audits<br />

First <strong>Part</strong>y<br />

Audits<br />

Sec<strong>on</strong>d<br />

<strong>Part</strong>y Audits<br />

Third <strong>Part</strong>y<br />

Audits<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

No Absolute Rule<br />

Figure 1.1 illustrates the classificati<strong>on</strong>s comm<strong>on</strong>ly used to differentiate between types of internal and external audits. The figure is provided<br />

as a guide to classificati<strong>on</strong>s, but there is no absolute rule, because there are excepti<strong>on</strong>s. The types of audits depicted in Figure 1.1 are not<br />

mutually exclusive. An audit can be a blend of the different types of audits. Third- party auditors (certificati<strong>on</strong>) could be joined by sec<strong>on</strong>dparty<br />

auditors (customer auditors), or internal auditors could be joined by external auditors (customer).<br />

A sec<strong>on</strong>d party audit <strong>on</strong><br />

supplier could be join by the<br />

supplier auditor, similarly a<br />

sec<strong>on</strong>d party customer audit<br />

<strong>on</strong> organizati<strong>on</strong> may be join<br />

by organizati<strong>on</strong> auditor(?)<br />

Internal auditors could be<br />

joined by external auditors<br />

(customer).<br />

Third- party auditors<br />

(certificati<strong>on</strong>) could be<br />

joined by sec<strong>on</strong>d- party<br />

auditors (customer<br />

auditors)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

First-, sec<strong>on</strong>d-, and Third- <strong>Part</strong>y audits<br />

First-<strong>Part</strong>y Audit<br />

A first-party audit is performed within an organizati<strong>on</strong> to measure its strengths and weaknesses<br />

against its own procedures or methods and/or against external standards adopted by (voluntary)<br />

or imposed <strong>on</strong> (mandatory) the organizati<strong>on</strong>. A first- party audit is an internal audit c<strong>on</strong>ducted by<br />

auditors who are employed by the organizati<strong>on</strong> being audited but who have no vested<br />

(inalienable) interest in the audit results of the area being audited. The auditing management<br />

systems standard ISO 19011 states that the independence of the audit team members from the<br />

activities to be audited should be c<strong>on</strong>sidered, and to avoid c<strong>on</strong>flicts of interest when selecting<br />

audit team members. Companies may have a separate audit group c<strong>on</strong>sisting of full- time<br />

auditors, or the auditors may be trained employees from other areas of the company who<br />

perform audits as needed <strong>on</strong> a part- time basis in additi<strong>on</strong> to their other duties. One of the<br />

benefits of using part- time auditors is that the auditor learns the requirements by evaluating the<br />

objective evidence to determine c<strong>on</strong>formance with the requirement bey<strong>on</strong>d their normal work<br />

assignment. In some cases an organizati<strong>on</strong> may hire (outsource) an audit organizati<strong>on</strong> to<br />

c<strong>on</strong>duct its internal audits. The benefits of hiring an external auditing organizati<strong>on</strong> are that<br />

internal employees do not have to take time from their day- to-day jobs, auditors may be more<br />

objective and impartial, and the organizati<strong>on</strong> may benefit from employing more experienced<br />

auditors.<br />

A multisite company’s audit of another of its divisi<strong>on</strong>s or subsidiaries, whether it is local, nati<strong>on</strong>al,<br />

or internati<strong>on</strong>al, is often c<strong>on</strong>sidered an internal audit. If, however, the other locati<strong>on</strong>s functi<strong>on</strong><br />

primarily as suppliers to the main operati<strong>on</strong> or locati<strong>on</strong>, audits of those sites would be<br />

c<strong>on</strong>sidered sec<strong>on</strong>d-party (external?) audits.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Brainstorming is a group creativity technique by which efforts are made to find a c<strong>on</strong>clusi<strong>on</strong> for a specific<br />

problem by gathering a list of ideas sp<strong>on</strong>taneously c<strong>on</strong>tributed by its members. In other words, brainstorming is<br />

a situati<strong>on</strong> where a group of people meet to generate new ideas and soluti<strong>on</strong>s around a<br />

specific domain of interest by removing inhibiti<strong>on</strong>s. People are able to think more freely and they suggest<br />

many sp<strong>on</strong>taneous new ideas as possible. All the ideas are noted down and are not critic<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

First-<strong>Part</strong>y Audit- The Auditor Selecti<strong>on</strong>s<br />

Independent<br />

• A first- party audit is an internal audit c<strong>on</strong>ducted by auditors who are employed by the organizati<strong>on</strong> being<br />

audited but who have no vested (inalienable) interest in the audit results of the area being audited.<br />

• The auditing management systems standard ISO 19011 states that the independence of the audit team<br />

members from the activities to be audited should be c<strong>on</strong>sidered, and to avoid c<strong>on</strong>flicts of interest when<br />

selecting audit team members.<br />

Source of Auditors<br />

• Companies may have a separate audit group c<strong>on</strong>sisting of full- time auditors, or<br />

• the auditors may be trained employees from other areas of the company who perform audits as needed <strong>on</strong><br />

a part- time basis in additi<strong>on</strong> to their other duties.<br />

One of the benefits of using part- time auditors is that the auditor learns the requirements by evaluating<br />

the objective evidence to determine c<strong>on</strong>formance with the requirement bey<strong>on</strong>d their normal work<br />

assignment.<br />

• In some cases an organizati<strong>on</strong> may hire (outsource) an audit organizati<strong>on</strong> to c<strong>on</strong>duct its internal audits.<br />

The benefits of hiring an external auditing organizati<strong>on</strong> are (1) that internal employees do not have to<br />

take time from their day- to-day jobs, (2) auditors may be more objective and impartial, and (3) the<br />

organizati<strong>on</strong> may benefit from employing more experienced auditors.<br />

First <strong>Part</strong>y or Sec<strong>on</strong>d <strong>Part</strong>y Audit within Own Organizati<strong>on</strong>?<br />

• A multisite company’s audit of another of its divisi<strong>on</strong>s or subsidiaries, whether it is local, nati<strong>on</strong>al, or<br />

internati<strong>on</strong>al, is often c<strong>on</strong>sidered an internal audit. If, however, the other locati<strong>on</strong>s functi<strong>on</strong> primarily as<br />

suppliers to the main operati<strong>on</strong> or locati<strong>on</strong>, audits of those sites would be c<strong>on</strong>sidered sec<strong>on</strong>d-party<br />

(external?) audits.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Sec<strong>on</strong>d-<strong>Part</strong>y Audit<br />

A sec<strong>on</strong>d-party audit is an external audit performed <strong>on</strong> a supplier by a customer or<br />

by a c<strong>on</strong>tracted organizati<strong>on</strong> <strong>on</strong> behalf of a customer. A c<strong>on</strong>tract is in place, and the<br />

goods or service is being, or will be, delivered.<br />

Note: If the c<strong>on</strong>tract is not in place the survey, assessment can not be termed as<br />

―Sec<strong>on</strong>d-<strong>Part</strong>y or external ―audit‖?<br />

Sec<strong>on</strong>d- party audits are subject to the rules of c<strong>on</strong>tract law, as they are providing<br />

c<strong>on</strong>tractual directi<strong>on</strong> from the customer to the supplier. Sec<strong>on</strong>d- party audits tend to be<br />

more formal than first- party audits because audit results could influence the (future?)<br />

customer’s purchasing decisi<strong>on</strong>s.<br />

A survey, sometimes called an assessment or examinati<strong>on</strong>, is a comprehensive<br />

evaluati<strong>on</strong> that analyzes such things as facilities, resources, ec<strong>on</strong>omic stability,<br />

technical capability, pers<strong>on</strong>nel, producti<strong>on</strong> capabilities, and past performance, as well<br />

as the entire management system. In general, a survey is performed prior to the<br />

award of a c<strong>on</strong>tract to a prospective supplier to ensure that the proper capabilities,<br />

c<strong>on</strong>trols, and systems are in place. The scope of the survey may be limited to<br />

specified management systems such as quality, envir<strong>on</strong>mental, or safety systems, or<br />

it may include the entire organizati<strong>on</strong> management system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Sec<strong>on</strong>d <strong>Part</strong>y Audit and Survey/ Assessment<br />

2nd <strong>Part</strong>y Audit by<br />

Client<br />

Awarded Supplier<br />

C<strong>on</strong>tract<br />

2nd <strong>Part</strong>y Audit by<br />

C<strong>on</strong>tracted<br />

Organizati<strong>on</strong>.<br />

Prospective Supplier<br />

(C<strong>on</strong>tract not Awarded)<br />

Survey/ Assessment<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

A survey, sometimes called an assessment or examinati<strong>on</strong>, is a comprehensive<br />

evaluati<strong>on</strong> that analyzes such things as:<br />

1. facilities,<br />

2. resources,<br />

3. ec<strong>on</strong>omic stability,<br />

4. technical capability,<br />

5. pers<strong>on</strong>nel,<br />

6. producti<strong>on</strong> capabilities, and<br />

7. past performance,<br />

8. as well as the entire management system.<br />

In general, a survey is performed prior to the award of a c<strong>on</strong>tract to a prospective<br />

supplier to ensure that the proper capabilities, c<strong>on</strong>trols, and systems are in place. The<br />

scope of the survey may be limited to specified management systems such as quality,<br />

envir<strong>on</strong>mental, or safety systems, or it may include the entire organizati<strong>on</strong><br />

management system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

A survey, sometimes called an assessment or examinati<strong>on</strong>, is a comprehensive evaluati<strong>on</strong> that analyzes such things as:<br />

1. facilities,<br />

2. resources,<br />

3. ec<strong>on</strong>omic stability,<br />

4. technical capability,<br />

5. pers<strong>on</strong>nel,<br />

6. producti<strong>on</strong> capabilities, and<br />

7. past performance,<br />

8. as well as the entire management system.<br />

In general, a survey is performed prior to the award of a c<strong>on</strong>tract to a prospective supplier to ensure that the proper capabilities,<br />

c<strong>on</strong>trols, and systems are in place. The scope of the survey may be limited to specified management systems such as quality,<br />

envir<strong>on</strong>mental, or safety systems, or it may include the entire organizati<strong>on</strong> management system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

A survey, sometimes called an<br />

assessment or examinati<strong>on</strong>, is a<br />

comprehensive evaluati<strong>on</strong> that<br />

analyzes such things as:<br />

1. facilities,<br />

2. resources,<br />

3. ec<strong>on</strong>omic stability,<br />

4. technical capability,<br />

5. pers<strong>on</strong>nel,<br />

6. producti<strong>on</strong> capabilities, and<br />

7. past performance,<br />

8. as well as the entire management<br />

system.<br />

In general, a survey is performed prior to the<br />

award of a c<strong>on</strong>tract to a prospective supplier to<br />

ensure that the proper capabilities, c<strong>on</strong>trols,<br />

and systems are in place. The scope of the<br />

survey may be limited to specified management<br />

systems such as quality, envir<strong>on</strong>mental, or<br />

safety systems, or it may include the entire<br />

organizati<strong>on</strong> management system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Third-<strong>Part</strong>y Audit<br />

A third-party audit is performed by an audit organizati<strong>on</strong> independent of the<br />

customer- supplier relati<strong>on</strong>ship and is free of any c<strong>on</strong>flict of interest.<br />

Independence of the audit organizati<strong>on</strong> is a key comp<strong>on</strong>ent of a third- party audit.<br />

Third- party audits may result in:<br />

• certificati<strong>on</strong>,<br />

• registrati<strong>on</strong>,<br />

• recogniti<strong>on</strong>,<br />

• an award,<br />

• license approval,<br />

• a citati<strong>on</strong>,<br />

• a fine, or<br />

• a penalty<br />

issued by the third- party organizati<strong>on</strong> or an interested party.<br />

Third- party audits may be performed <strong>on</strong> behalf of an auditee’s potential customers<br />

who cannot afford to survey or audit external organizati<strong>on</strong>s themselves or who<br />

c<strong>on</strong>sider a third- party audit to be a more cost- effective alternative. Government<br />

representatives perform mandatory audits <strong>on</strong> regulated industries such as nuclear<br />

power stati<strong>on</strong>s, airlines, and medical device manufacturers to provide assurances of<br />

safety to the public.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

• A third-party audit is performed by an audit organizati<strong>on</strong> independent of<br />

the customer- supplier relati<strong>on</strong>ship and is free of any c<strong>on</strong>flict of interest.<br />

• Third- party audits may be performed <strong>on</strong> behalf of an auditee’s potential<br />

customers who cannot afford to survey or audit external organizati<strong>on</strong>s<br />

themselves or who c<strong>on</strong>sider a third- party audit to be a more cost- effective<br />

alternative.<br />

Keywords: Potential customer<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Third-<strong>Part</strong>y Audit<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Government representatives perform mandatory audits <strong>on</strong> regulated industries such as nuclear<br />

power stati<strong>on</strong>s, airlines, and medical device manufacturers to provide assurances of safety to the public.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA<br />

Government representatives (USNRC) perform mandatory audits <strong>on</strong> regulated industries<br />

such as nuclear power stati<strong>on</strong>s, airlines, and medical device manufacturers to provide assurances of safety to<br />

the public.<br />

https://www.nrc.gov/insp-gen.html<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Government representatives perform mandatory audits <strong>on</strong> regulated industries such as nuclear<br />

power stati<strong>on</strong>s, airlines, and medical device manufacturers to provide assurances of safety to the public.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA<br />

Government representatives perform mandatory audits <strong>on</strong> regulated industries such as nuclear<br />

power stati<strong>on</strong>s, airlines, and medical device manufacturers to provide assurances of safety to the public.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

An auditor told of <strong>on</strong>e case in which an organizati<strong>on</strong> wanted to acknowledge a supplier for the perfect product it<br />

had been receiving. However, during the award process it was discovered that the supplier had absolutely no<br />

quality system in place! The supplier was able to ship an acceptable product simply because its employees<br />

were good sorters.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA2<br />

Wild Boar Hunting<br />

http://www.<strong>on</strong>linehuntingaucti<strong>on</strong>s.com/7-Day-Anatolian-Wild-Boar-Hunt-for-One-Hunter-and-One-N<strong>on</strong>-Hunter-in-Turkey-Includes-Trophy-Fee_i23666588<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Types of Quality Audits/<strong>Part</strong> IA/<br />

3. Purpose<br />

It is also comm<strong>on</strong> to refer to an audit according to its purpose or objectives. An auditor may specialize in types<br />

of audits based <strong>on</strong> the audit purpose, such as to verify:<br />

• compliance,<br />

• c<strong>on</strong>formance, or<br />

• performance.<br />

Questi<strong>on</strong>: Compliance ≡ C<strong>on</strong>formance<br />

Some audits have special administrative purposes such as auditing:<br />

• documents,<br />

• risk, or<br />

• performance or<br />

• following up <strong>on</strong> completed corrective acti<strong>on</strong>s.<br />

Audit Authority<br />

1<br />

VP<br />

Keywords:<br />

purpose or objectives<br />

purpose ≡ objectives<br />

Purpose<br />

2<br />

Compliance<br />

3<br />

Scope Producti<strong>on</strong> Line #<br />

Type<br />

Audit Against:<br />

4<br />

5<br />

Process Audit (internal)<br />

Specific Company Procedures<br />

Identifying Resources<br />

Auditor selecti<strong>on</strong> size/ numbers and<br />

qualificati<strong>on</strong> of auditors, documentati<strong>on</strong>, logistic,<br />

tools, strategies.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Purpose or Objective of Audit<br />

It is also comm<strong>on</strong> to refer to an audit according to its purpose or objectives. An auditor may<br />

specialize in types of audits based <strong>on</strong> the audit purpose, such as to verify:<br />

• compliance,<br />

• c<strong>on</strong>formance, or<br />

• performance.<br />

• documents,<br />

• risk, or<br />

• following up <strong>on</strong> completed corrective acti<strong>on</strong>s.<br />

Audit Authority<br />

Purpose<br />

Type<br />

Audit Against:<br />

1<br />

2<br />

3<br />

Scope Producti<strong>on</strong> Line #<br />

4<br />

5<br />

VP<br />

Compliance<br />

Process Audit (internal)<br />

Specific Company Procedures<br />

Identifying Resources<br />

6<br />

Auditor selecti<strong>on</strong> size/ numbers and qualificati<strong>on</strong><br />

of auditors, documentati<strong>on</strong>, logistic, tools,<br />

strategies.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Certificati<strong>on</strong> Purposes<br />

Companies in certain high- risk categories—such as toys, pressure vessels, elevators,<br />

gas appliances, and electrical and medical devices—wanting to do business in Europe must comply with<br />

C<strong>on</strong>formité Europeene Mark (CE Mark) requirements.<br />

One way for organizati<strong>on</strong>s to comply is to have their management system certified by a third- party audit<br />

organizati<strong>on</strong> to management system requirement criteria (such as ISO 9001). Customers may suggest or<br />

require that their suppliers c<strong>on</strong>form to ISO 9001, ISO 14001, or safety criteria. The U.S. Federal Acquisiti<strong>on</strong><br />

Regulati<strong>on</strong>s (FARs) 48 CFR 46.202-4 (48 CFR 46 - Quality Assurance) replaced references to government<br />

specificati<strong>on</strong>s with higher- level c<strong>on</strong>tract quality requirements. Cited higher- level c<strong>on</strong>tract quality requirements<br />

include ISO 9001, AS9100, ANSI/<strong>ASQ</strong>C E4, and ANSI/ASME NQA-1. However, this does not preclude other<br />

federal government entities, such as the Department of Energy (DOE) or the Department of Defense (DOD),<br />

from having additi<strong>on</strong>al requirements for the specific work they do (for example, nuclear facility standards/<br />

regulati<strong>on</strong>s such as Federal Register 10 CFR 830 Subpart A). Many nati<strong>on</strong>al standards have been canceled,<br />

and users have been referred to the U.S.-adopted ISO 9001 standard. A third- party audit normally results in<br />

the issuance of a certificate stating that the auditee organizati<strong>on</strong> management system complies with the<br />

requirements of a pertinent (relevant, appropriate) standard or regulati<strong>on</strong>.<br />

Third-party audits for system certificati<strong>on</strong> should be performed by organizati<strong>on</strong>s that have been evaluated and<br />

accredited by an established accreditati<strong>on</strong> board, such as the ANSI- <strong>ASQ</strong> Nati<strong>on</strong>al Accreditati<strong>on</strong> Board (ANAB).<br />

As the U.S. accreditati<strong>on</strong> body for management systems, ANAB accredits certificati<strong>on</strong> bodies for ISO 9001,<br />

ISO 13485, ISO/TS 16949 QMSs, and ISO 14001 EMSs, as well as for several other c<strong>on</strong>formity requirements<br />

standards.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

C<strong>on</strong>formité Europeene Mark<br />

Companies in certain high- risk categories—such as toys, pressure vessels, elevators,<br />

gas appliances, and electrical and medical devices—wanting to do business in Europe must comply with C<strong>on</strong>formité Europeene Mark (CE<br />

Mark) requirements.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

C<strong>on</strong>formité Europeene Mark<br />

Companies in certain high- risk categories—such as<br />

toys, pressure vessels, elevators,<br />

gas appliances, and electrical and medical devices—<br />

wanting to do business in Europe must comply with<br />

C<strong>on</strong>formité Europeene Mark (CE Mark) requirements.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Accredited Third <strong>Part</strong>y (ANAB-accredited certificati<strong>on</strong> body-CB)<br />

Third-party audits for system certificati<strong>on</strong> should be performed by organizati<strong>on</strong>s that have been evaluated and<br />

accredited by an established accreditati<strong>on</strong> board, such as:<br />

• the ANSI- <strong>ASQ</strong> Nati<strong>on</strong>al Accreditati<strong>on</strong> Board (ANAB). As the U.S. accreditati<strong>on</strong> body for management<br />

systems, ANAB accredits certificati<strong>on</strong> bodies for ISO 9001, ISO 13485, ISO/TS 16949 QMSs, and ISO<br />

14001 EMSs, as well as for several other c<strong>on</strong>formity requirements standards.<br />

• How many other US Nati<strong>on</strong>al Accreditati<strong>on</strong> Board?<br />

How many other US<br />

Nati<strong>on</strong>al Accreditati<strong>on</strong><br />

Board?<br />

Quality Systems - Aerospace - Model for Quality Assurance in Design, Development, Producti<strong>on</strong>,<br />

Installati<strong>on</strong> and Servicing AS9100<br />

Standard AS9100 includes <strong>ASQ</strong> 9001:2000 quality system requirements and specifies additi<strong>on</strong>al requirements<br />

for the quality system of the aerospace industry. For those not involved in design activities (Ref. <strong>ASQ</strong> 9002), 4.4<br />

is not applicable. It is emphasized that the quality system requirements specified in AS9100 are complementary<br />

(not alternative) to the c<strong>on</strong>tractual and applicable law and regulatory requirements. If you require the most<br />

recent versi<strong>on</strong> of this standard, please refer to AS9100A.<br />

SAE Internati<strong>on</strong>al, initially established as the Society of Automotive<br />

Engineers, is a U.S.-based, globally active professi<strong>on</strong>al associati<strong>on</strong> and<br />

standards developing organizati<strong>on</strong> for engineering professi<strong>on</strong>als in<br />

various industries. Principal emphasis is placed <strong>on</strong> transport industries<br />

such as automotive, aerospace, and commercial vehicles.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

What’s the difference between certificati<strong>on</strong>, registrati<strong>on</strong>, and<br />

accreditati<strong>on</strong>?<br />

• The terms (1) certificati<strong>on</strong> and (2) registrati<strong>on</strong> are used interchangeably to refer to verifying<br />

the c<strong>on</strong>formance of an organizati<strong>on</strong>’s management systems to a standard or other<br />

requirements.<br />

• The term accreditati<strong>on</strong> is used when validating or verifying the c<strong>on</strong>formance of a<br />

certificati<strong>on</strong> body to the requirements of nati<strong>on</strong>al and/or internati<strong>on</strong>al criteria.<br />

• Certificati<strong>on</strong> also refers to the process of validating and verifying the credentials of<br />

individuals such as auditors.<br />

• A certificati<strong>on</strong> body, also known as a registrar, is a third- party company c<strong>on</strong>tracted to<br />

evaluate the c<strong>on</strong>formance of an organizati<strong>on</strong>’s management systems to the requirements<br />

of the appropriate standard(s) and issue a certificate of c<strong>on</strong>formance when warranted.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

What’s the difference between certificati<strong>on</strong>, registrati<strong>on</strong>, and<br />

accreditati<strong>on</strong>?<br />

Certificati<strong>on</strong>/Registrati<strong>on</strong> (Awarded to Organizati<strong>on</strong>/Individual by CB)<br />

• The terms (1) certificati<strong>on</strong> and (2) registrati<strong>on</strong> are used interchangeably to refer to verifying<br />

the c<strong>on</strong>formance of an organizati<strong>on</strong>’s management systems to a standard or other<br />

requirements.<br />

• Certificati<strong>on</strong> also refers to the process of validating and verifying the credentials of<br />

individuals such as auditors.<br />

Accreditati<strong>on</strong> (Awarded to CB/ Registrar by Nati<strong>on</strong>al Accreditati<strong>on</strong> Board)<br />

• The term accreditati<strong>on</strong> is used when validating or verifying the c<strong>on</strong>formance of a<br />

certificati<strong>on</strong> body to the requirements of nati<strong>on</strong>al and/or internati<strong>on</strong>al criteria.<br />

• A certificati<strong>on</strong> body, also known as a registrar, is a third- party company c<strong>on</strong>tracted to<br />

evaluate the c<strong>on</strong>formance of an organizati<strong>on</strong>’s management systems to the requirements<br />

of the appropriate standard(s) and issue a certificate of c<strong>on</strong>formance when warranted.<br />

6<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

What’s the difference between certificati<strong>on</strong>, registrati<strong>on</strong>, and<br />

accreditati<strong>on</strong>?<br />

Nati<strong>on</strong>al Accreditati<strong>on</strong><br />

Board (UKAS/ ANAB..)<br />

Certificati<strong>on</strong> Third <strong>Part</strong>y<br />

(Either accredited of Not).<br />

Individual or Organizati<strong>on</strong><br />

being Certified.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Accreditati<strong>on</strong> Certificates from UKAS (Inspecti<strong>on</strong>/ Certificati<strong>on</strong> Body)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Accreditati<strong>on</strong> Certificates from CNAS & UKAS<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Certificati<strong>on</strong>/Registrati<strong>on</strong> by Accredited Third <strong>Part</strong>y Certificati<strong>on</strong> Body<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Certificati<strong>on</strong>/Registrati<strong>on</strong> by Accredited Third <strong>Part</strong>y Certificati<strong>on</strong> Body<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


UKAS The United Kingdom Accreditati<strong>on</strong> Service (UKAS) is the sole nati<strong>on</strong>al<br />

accreditati<strong>on</strong> body recognized by the British government to assess the competence of<br />

organizati<strong>on</strong>s that provide (1) certificati<strong>on</strong>, (2) testing, (3) inspecti<strong>on</strong> and (4) calibrati<strong>on</strong><br />

services. It evaluates these c<strong>on</strong>formity assessment bodies and then accredits them<br />

where they are found to meet the internati<strong>on</strong>ally specified standard.<br />

Were the competencies of the appointed so called BINDTs’ ―AQB‖, ―AEC‖, especially<br />

―AQB‖ individually assesses by UKAS? or the BINDT had provide positive evidence that<br />

their suppliers ―AQB‖ were audited and assessed to be satisfied UKAS competency<br />

requirement. Is it is correct for BINDT to authorized the ―AQB‖ to administrate the BINDT<br />

certificati<strong>on</strong> activities <strong>on</strong> behalf independently?<br />

<strong>Part</strong> IA3<br />

BINDT AEC & AQB (Case Study)<br />

AEC & AQB<br />

Authorized Examinati<strong>on</strong> Centre and<br />

Authorized Qualifying Body<br />

AEC – Authorised Examinati<strong>on</strong> Centre – is a locati<strong>on</strong>,<br />

approved by BINDT, where PCN examinati<strong>on</strong>s are<br />

c<strong>on</strong>ducted.<br />

AQB – Authorised Qualifying Body – is a body, independent<br />

of any single predominant interest, satisfying the criteria<br />

detailed in PCN document reference CP9 and authorised by<br />

the British Institute of NDT to prepare and administer PCN<br />

examinati<strong>on</strong>s to qualify NDT pers<strong>on</strong>nel.<br />

Document CP9 prescribes the requirements that aspirant<br />

and existing BINDT AQBs are to satisfy in order to gain and<br />

maintain authorisati<strong>on</strong> to c<strong>on</strong>duct qualificati<strong>on</strong> examinati<strong>on</strong>s<br />

leading to the award by BINDT of PCN certificati<strong>on</strong>. Such<br />

requirements cover the facilities, resources, quality systems,<br />

staff and records to be maintained.<br />

http://www.bindt.org/What-is-NDT/Index-of-acr<strong>on</strong>yms/A/AEC-and-AQB/<br />

UKAS The United Kingdom Accreditati<strong>on</strong> Service (UKAS) is the sole nati<strong>on</strong>al accreditati<strong>on</strong> body<br />

recognized by the British government to assess the competence of organizati<strong>on</strong>s that provide (1)<br />

certificati<strong>on</strong>, (2) testing, (3) inspecti<strong>on</strong> and (4) calibrati<strong>on</strong> services. It evaluates these c<strong>on</strong>formity<br />

assessment bodies and then accredits them where they are found to meet the internati<strong>on</strong>ally specified<br />

standard.<br />

Were the competencies of the appointed so called BINDTs’ ―AQB‖, ―AEC‖, (especially ―AQB‖) individually<br />

assesses by UKAS? or the BINDT had provide positive evidence that their suppliers ―AQB‖ were audited<br />

and assessed to be satisfied UKAS competency requirement. Is it is correct for BINDT to authorized the<br />

―AQB‖ to administrate the BINDT certificati<strong>on</strong> activities <strong>on</strong> behalf totally and independently?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Certificati<strong>on</strong>/Registrati<strong>on</strong> by Accredited Third <strong>Part</strong>y Certificati<strong>on</strong> Body<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

UKAS The United Kingdom Accreditati<strong>on</strong> Service (UKAS) is the sole nati<strong>on</strong>al<br />

accreditati<strong>on</strong> body recognised by the British government to assess the competence of organisati<strong>on</strong>s that<br />

provide (1) certificati<strong>on</strong>, (2) testing, (3) inspecti<strong>on</strong> and (4) calibrati<strong>on</strong> services. It evaluates these c<strong>on</strong>formity<br />

assessment bodies and then accredits them where they are found to meet the internati<strong>on</strong>ally specified standard.<br />

An organisati<strong>on</strong> accredited by UKAS can dem<strong>on</strong>strate competence, impartiality and reliability in its ability to<br />

deliver results. Accreditati<strong>on</strong> ensures that every<strong>on</strong>e from specifiers, purchasers, and suppliers (?) to c<strong>on</strong>sumers<br />

can have c<strong>on</strong>fidence in the quality of goods and in the provisi<strong>on</strong> of services throughout the supply chain. It was<br />

set up in 1995 under a memorandum of understanding with the British government (between UKAS and the<br />

Secretary of State for Business Innovati<strong>on</strong> and Skills). It resulted from the merger in 1995 of NAMAS (Nati<strong>on</strong>al<br />

Measurement Accreditati<strong>on</strong> Service) and NACCB (Nati<strong>on</strong>al Accreditati<strong>on</strong> Council for Certificati<strong>on</strong> Bodies).<br />

NAMAS was itself the result of a merger in 1985 of NATLAS (Nati<strong>on</strong>al Testing Laboratory Accreditati<strong>on</strong> Scheme)<br />

formed in 1981 and BCS (British Calibrati<strong>on</strong> Service) formed in 1966.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Performance versus Compliance/C<strong>on</strong>formance audits<br />

There has been increased emphasis <strong>on</strong> how audits can add value. Various authors use the following terms to<br />

describe an audit purpose bey<strong>on</strong>d compliance and c<strong>on</strong>formance:<br />

• value- added assessments,<br />

• management audits,<br />

• added value auditing,<br />

• and c<strong>on</strong>tinual improvement assessment.<br />

Value-Added-Auditing: it's "a systematic, disciplined approach to<br />

evaluate and improve the effectiveness of risk management, c<strong>on</strong>trol and<br />

governance processes."<br />

https://www.qualitydigest.com/oct02/articles/04_article.shtml<br />

The purpose of these audits goes bey<strong>on</strong>d traditi<strong>on</strong>al compliance and c<strong>on</strong>formance audits. The audit purpose<br />

relates to organizati<strong>on</strong> performance. Audits that determine compliance and c<strong>on</strong>formance are not focused <strong>on</strong><br />

good or poor performance. Yet performance is an important c<strong>on</strong>cern for most organizati<strong>on</strong>s.<br />

A key difference between compliance/c<strong>on</strong>formance audits and audits designed to promote improvement is the<br />

collecti<strong>on</strong> of: ―audit evidence related to organizati<strong>on</strong> performance versus evidence to verify c<strong>on</strong>formance<br />

or compliance to a standard or procedure.”<br />

An organizati<strong>on</strong> may c<strong>on</strong>form to its procedures for taking orders, but if every order is subsequently changed<br />

two or three times, management may have cause for c<strong>on</strong>cern and want to rectify the inefficiency. All types of<br />

audits—including product, process, and system and first-, sec<strong>on</strong>d-, and third- party audits—can include a<br />

purpose to identify and report performance observati<strong>on</strong>s.<br />

However, audits with an objective to identify risks and opportunities for improvement are more likely to be firstparty,<br />

process, or system audits. If an organizati<strong>on</strong>’s audit program has an objective for audits to be a<br />

management tool for improvement, performance may be included in the audit purpose.<br />

The missi<strong>on</strong> of the <strong>ASQ</strong> Audit Divisi<strong>on</strong> is ―to develop the expectati<strong>on</strong>s of the audit professi<strong>on</strong> and auditors. To<br />

promote to stakeholders auditing as a management tool to achieve c<strong>on</strong>tinuous improvement and to increase<br />

customer satisfacti<strong>on</strong>.‖<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

The missi<strong>on</strong> of the <strong>ASQ</strong> Audit Divisi<strong>on</strong> is<br />

“to develop the expectati<strong>on</strong>s of the audit professi<strong>on</strong> and<br />

auditors. To promote to stakeholders auditing as a<br />

management tool to achieve c<strong>on</strong>tinuous improvement and<br />

to increase customer satisfacti<strong>on</strong>.”<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

CAPA: The analytical aspects of both corrective and preventive acti<strong>on</strong>s also harken<br />

back to PDCA. The comp<strong>on</strong>ent of preventive acti<strong>on</strong> that encourages documentati<strong>on</strong><br />

and company educati<strong>on</strong> <strong>on</strong> innovati<strong>on</strong>s and less<strong>on</strong>s learned is similar to Yokaten in<br />

lean manufacturing.<br />

https://www.smartsheet.com/corrective-and-preventive-acti<strong>on</strong><br />

Customer<br />

satisfacti<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

CAPA: The analytical aspects of both corrective and preventive acti<strong>on</strong>s also harken back<br />

to PDCA. The comp<strong>on</strong>ent of preventive acti<strong>on</strong> that encourages documentati<strong>on</strong> and company<br />

educati<strong>on</strong> <strong>on</strong> innovati<strong>on</strong>s and less<strong>on</strong>s learned is similar to Yokaten in lean manufacturing.<br />

https://www.smartsheet.com/corrective-and-preventive-acti<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Follow-up audit<br />

A product, process, or system audit may have findings that require correcti<strong>on</strong> and<br />

corrective acti<strong>on</strong>. Since most corrective acti<strong>on</strong>s cannot be performed at the time of<br />

the audit, the audit program manager may require a follow- up audit to verify that<br />

correcti<strong>on</strong>s were made and corrective acti<strong>on</strong>s were taken. Due to the high cost of a<br />

single- purpose follow- up audit, it is normally combined with the next scheduled<br />

audit of the area. However, this decisi<strong>on</strong> should be based <strong>on</strong> the importance and<br />

risk of the finding. An organizati<strong>on</strong> may not be willing to risk a fine due to a repeat<br />

sampling equipment failure or risk sending customers a n<strong>on</strong>c<strong>on</strong>forming product.<br />

An organizati<strong>on</strong> may also c<strong>on</strong>duct follow-up audits to verify preventive acti<strong>on</strong>s<br />

were taken as a result of performance issues that may be reported as opportunities<br />

for improvement.<br />

Other times organizati<strong>on</strong>s may forward identified performance issues to management<br />

for follow- up.<br />

Keywords:<br />

.. preventive acti<strong>on</strong>s were taken as a result of performance issues that may be<br />

reported as opportunities for improvement.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA3<br />

Preventive Acti<strong>on</strong><br />

.. preventive acti<strong>on</strong>s were taken as a result of performance issues that may be<br />

reported as opportunities for improvement.<br />

Definiti<strong>on</strong>: Preventive Acti<strong>on</strong><br />

A preventive acti<strong>on</strong> is a change implemented to address a weakness (opportunities<br />

for improvement) in a management system that is not yet resp<strong>on</strong>sible for causing<br />

n<strong>on</strong>c<strong>on</strong>forming product or service.<br />

https://en.wikipedia.org/wiki/Preventive_acti<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA4<br />

Types of Quality Audits/<strong>Part</strong> IA<br />

4. Comm<strong>on</strong> Elements With Other Audits<br />

Regardless of the scope of a system or process audit, they all have some comm<strong>on</strong> elements.<br />

ISO 19011:2011 defines an audit as a ―systematic, independent and documented process for obtaining audit<br />

evidence [records, statements of fact, or other informati<strong>on</strong> relevant to the audit criteria and verifiable] and<br />

evaluating it objectively to determine the extent to which audit criteria [set of policies, procedures, or<br />

requirements] are fulfilled.‖<br />

Audits can address almost any topic of interest where activities or outputs result from defined plans. The scope<br />

of the audit might be product or service quality; envir<strong>on</strong>mental, marketing, or promoti<strong>on</strong>al claims; financial<br />

results and statements; health and safety c<strong>on</strong>diti<strong>on</strong>s; equal opportunity compliance; internal c<strong>on</strong>trols for<br />

operati<strong>on</strong>s (Sarbanes-Oxley); postproducti<strong>on</strong> sales and service with feedback for improvement; and the like.<br />

Basically, if an activity or status is subject to planning or reporting, it can be audited.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA4<br />

Audits can address almost any topic of interest where activities or outputs result from<br />

defined plans. The scope of the audit might be product or service quality; envir<strong>on</strong>mental, marketing, or<br />

promoti<strong>on</strong>al claims; financial results and statements; health and safety c<strong>on</strong>diti<strong>on</strong>s; equal opportunity<br />

compliance; internal c<strong>on</strong>trols for operati<strong>on</strong>s (Sarbanes-Oxley); postproducti<strong>on</strong> sales and service with feedback<br />

for improvement; and the like. Basically, if an activity or status is subject to planning or reporting, it can be<br />

audited.<br />

https://www.gizmodo.com.au/2012/10/how-kids-using-machines-today-compare-with-kids-using-machines-100-years-ago/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA4<br />

Evaluati<strong>on</strong> & Assessment<br />

Audit-like inquiries that do not fulfill all the technical requirements of an audit (such as an audit plan or avoiding<br />

c<strong>on</strong>flicts of interest) are known as:<br />

• an evaluati<strong>on</strong> or<br />

• an assessment.<br />

• a survey?<br />

Evaluati<strong>on</strong> (Compare)<br />

Comm<strong>on</strong>ly, evaluati<strong>on</strong>s are fairly subjective audit- like activities that compare current performance with some<br />

potential status, like theoretical capacity or capability of a system or process, for example. Evaluati<strong>on</strong>s are<br />

judgments. Similarly, assessments are activities that more closely align with the definiti<strong>on</strong> of an audit but lack<br />

satisfying some known and identified requirement.<br />

Assessment (Estimate)<br />

Assessments are estimates or determinati<strong>on</strong>s of significance or importance.<br />

Audit (Processes)<br />

The key c<strong>on</strong>cept is that audits, regardless of form or name, are processes. Processes c<strong>on</strong>sist of a set of<br />

resources (materials, labor, finance, and so <strong>on</strong>) called the inputs being transformed through interacti<strong>on</strong>s to<br />

create outputs. Outputs of processes are typically not just the desired product or service but also the<br />

n<strong>on</strong>c<strong>on</strong>forming product or service, waste, polluti<strong>on</strong>, and worn equipment or tooling. In most cases, unless<br />

management specifically requests the associated negative or less positive results, <strong>on</strong>ly the desired positive<br />

outputs are emphasized, and management is provided with less than the total available data or informati<strong>on</strong><br />

necessary to manage the organizati<strong>on</strong> and avoid risks. For the audit process, we have inputs of competent<br />

auditors; an authorizing, supportive client; cooperative auditee pers<strong>on</strong>nel; defined auditee plans and<br />

procedures for satisfying requirements and accomplishing objectives (purpose) ; an identified audit purpose<br />

and scope; reference documents; and appropriate administrative and infrastructure support. These inputs,<br />

al<strong>on</strong>g with a planned sequence of audit activities, provide an output of accumulated data that are transformed<br />

into useful acti<strong>on</strong>able informati<strong>on</strong> and presented to the auditee and the client in a formal report. Appropriate<br />

follow- up corrective and preventive acti<strong>on</strong>s are implemented to support improvements and mutual benefits.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA4<br />

Input & Output<br />

Input<br />

Audit Authority<br />

1<br />

VP<br />

Purpose<br />

2<br />

Compliance<br />

3<br />

Scope Producti<strong>on</strong> Line #<br />

Type<br />

Audit Against:<br />

4<br />

5<br />

Process Audit (internal)<br />

Specific Company Procedures<br />

Identifying Resources<br />

6<br />

Auditor selecti<strong>on</strong> size/ numbers and qualificati<strong>on</strong><br />

of auditors, documentati<strong>on</strong>, logistic, tools,<br />

strategies.<br />

Output<br />

provide an output of accumulated data<br />

that are transformed into useful<br />

acti<strong>on</strong>able informati<strong>on</strong> and presented<br />

to the auditee and the client in a<br />

formal report. Appropriate follow- up<br />

corrective and preventive acti<strong>on</strong>s are<br />

implemented to support improvements<br />

and mutual benefits.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA4<br />

Some comm<strong>on</strong> elements of audits include:<br />

1. Purpose and scope: ―Why are we doing this?‖ The answer will provide the purpose of the audit and lead to<br />

the proper scope (extent) of inquiry.<br />

2. Document review: Documents are reviewed during the audit preparati<strong>on</strong> phase to determine whether the<br />

auditee has developed a suitable (adequate and appropriate) set of comprehensive documents for the<br />

audited area or activities to satisfy all relevant goals and requirements. (Desk Audit to be performed during<br />

audit preparati<strong>on</strong> phase)<br />

3. Preparati<strong>on</strong> for review: Details of who will be interviewed (not until advise by the auditee organizati<strong>on</strong><br />

during entry meeting?) , at what locati<strong>on</strong>, and which aspects of the operati<strong>on</strong>s should be scheduled. Data<br />

collecti<strong>on</strong> plans are finalized.<br />

4. On-site or remote data collecti<strong>on</strong> (the audit): Actual data collecti<strong>on</strong> activities may vary somewhat (for<br />

example, a shorter opening meeting) in internal and external audits due to the familiarity of auditor(s) and<br />

auditee, and auditor’s knowledge of auditee’s processes, products, services, and infrastructure. External<br />

audits are generally more formal. Collecti<strong>on</strong> of data, however, is the same for both internal and external<br />

audits.<br />

5. Formal audit report: While most audit reports follow a prescribed format, sometimes the client (or an<br />

applicable standard) may require a unique format for the audit. Audit reports normally include an<br />

introducti<strong>on</strong>, an overall summary, findings, and c<strong>on</strong>clusi<strong>on</strong>s.<br />

6. Audit follow- up: The auditee is resp<strong>on</strong>sible for implementati<strong>on</strong> of the corrective acti<strong>on</strong> and its verificati<strong>on</strong>.<br />

An auditor may be assigned to perform a follow- up audit (an independent verificati<strong>on</strong> that the corrective<br />

acti<strong>on</strong> was implemented and effective).<br />

The auditing community c<strong>on</strong>tinues to move toward establishing comm<strong>on</strong> audit practices. The ISO 19011<br />

provides guidance <strong>on</strong> all management system audit types, such as quality, envir<strong>on</strong>mental, and occupati<strong>on</strong>al<br />

safety and health. The main differences am<strong>on</strong>g audits are the standards against which the organizati<strong>on</strong> is<br />

audited and the emphasis <strong>on</strong> certain techniques over others, depending <strong>on</strong> whether it is a quality,<br />

envir<strong>on</strong>mental, or safety audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IA4<br />

Corrective Acti<strong>on</strong> And Its Verificati<strong>on</strong><br />

6. Audit follow- up: The auditee is resp<strong>on</strong>sible for implementati<strong>on</strong> of the corrective acti<strong>on</strong> and its verificati<strong>on</strong>.<br />

An auditor may be assigned to perform a follow- up audit (an independent verificati<strong>on</strong> that the corrective<br />

acti<strong>on</strong> was implemented and effective).<br />

The auditee is resp<strong>on</strong>sible<br />

for implementati<strong>on</strong> of the<br />

corrective acti<strong>on</strong> and its<br />

verificati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Chapter 2<br />

Purpose and Scope of Audits/<strong>Part</strong> IB<br />

The type of audit to be performed may be described by its scope or purpose.<br />

An auditor may c<strong>on</strong>duct system audits of a department or functi<strong>on</strong> such as<br />

manufacturing, operati<strong>on</strong>s, or a laboratory. Process audits can be described<br />

as machining, cutting, testing, extinguishing, welding, loading, packaging, and<br />

sealing audits. Similarly, product or service audits can be described by the name<br />

of the product or service, such as X cable, ready room, package, and tire audits. An<br />

audit may also be described by its purpose, such as a verificati<strong>on</strong>, management,<br />

or compliance audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Audit Reas<strong>on</strong><br />

An audit can provide management with unbiased facts that can be used to:<br />

• Provide input to management so that they can make informed decisi<strong>on</strong>s<br />

• Keep management informed of actual or potential risks<br />

• Identify areas of opportunity for improvement<br />

• Assess pers<strong>on</strong>nel training effectiveness and equipment capability<br />

• Provide visible management support of the quality, envir<strong>on</strong>mental, safety, and other<br />

programs<br />

• Ensure <strong>on</strong>going compliance and c<strong>on</strong>formity to regulati<strong>on</strong>s and standards<br />

• Determine system and process effectiveness<br />

• Identify system and process efficiencies<br />

The purpose of most audits is to determine compliance or c<strong>on</strong>formity of a system,<br />

process, or product to requirements.<br />

An auditor may determine whether the documented system c<strong>on</strong>forms to requirements<br />

and whether it has been implemented by the users. Auditors can also determine<br />

effectiveness based <strong>on</strong> the ability of the organizati<strong>on</strong> to achieve stated objectives.<br />

Management has a need to ensure <strong>on</strong>going compliance and c<strong>on</strong>formance.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Management also needs factual informati<strong>on</strong> to stay competitive and to allocate resources. The need for<br />

system and process audits may also include:<br />

• M<strong>on</strong>itoring risk treatments<br />

• Identifying risks<br />

• Improving organizati<strong>on</strong> performance<br />

The words effectiveness, efficiency, and performance are related because they are linked to<br />

management’s interests to stay competitive and achieve budgetary goals. Public sector organizati<strong>on</strong>s<br />

are interested in effectiveness, efficiency, and performance so that they can meet budget requirements<br />

and use resources efficiently, whereas determinati<strong>on</strong> of compliance and c<strong>on</strong>formity is more closely<br />

linked to meeting requirements and maintaining the status quo. Experts state that if a process is<br />

meeting output objectives, it is an effective process. Management determines the goals and objectives.<br />

Audit evidence should indicate whether the process owners are measuring results against the stated<br />

objectives/ goals. They should know whether the process objectives are being achieved. A first- party<br />

audit may be needed by management to ensure that procedures are adequate and utilized, and to<br />

provide for early detecti<strong>on</strong> of a problem, which gives management the opportunity to identify root<br />

causes of problems and take corrective acti<strong>on</strong>.<br />

The tasks of management at whatever level in the organizati<strong>on</strong> are to identify possible sources of<br />

problems, to plan preventive acti<strong>on</strong> in order to forestall (act <strong>on</strong> advance) the problems, and to solve<br />

them should they arise. If this were not the case, managers would not be needed. When reduced to<br />

fundamentals, the vast majority of the problems are, in essence, quality problems. They are problems<br />

c<strong>on</strong>cerning the quality of work being performed, the quality of work that has been performed, the<br />

quality of items being received, the quality of informati<strong>on</strong> being communicated, the quality of available<br />

equipment, the quality of decisi<strong>on</strong>s made. All quality problems have a cost associated with them. It,<br />

therefore, follows that the avoidance, preventi<strong>on</strong>, and resoluti<strong>on</strong> of these problems equates to the<br />

preventi<strong>on</strong> and reducti<strong>on</strong> of unnecessary costs.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Sec<strong>on</strong>d-party supplier audits may be needed to help eliminate the shipping of n<strong>on</strong>c<strong>on</strong>forming<br />

products and reduce costs and waste. Audits of suppliers may promote:<br />

• partnerships that ensure a better understanding of customer expectati<strong>on</strong>s or<br />

• provide a means for technology transfer between the customer and the supplier.<br />

Sec<strong>on</strong>d- party quality audits help ensure a better final product by verifying that there are<br />

appropriate c<strong>on</strong>trols for inputs into the system. Sec<strong>on</strong>d- party envir<strong>on</strong>mental or safety audits are<br />

not the norm; however, if a customer-supplier relati<strong>on</strong>ship included envir<strong>on</strong>mental and safety<br />

requirements, they could be audited as well.<br />

The reas<strong>on</strong> for most third-party audits is to verify compliance or c<strong>on</strong>formance to specified<br />

regulati<strong>on</strong>s or standards. The regulati<strong>on</strong>s and standards may be required by law, such as in the<br />

FAA, FDA, and Department of Energy (DOE) regulati<strong>on</strong>s, or they may be voluntary, such as ISO<br />

9001, TS 16949, or AS9100. Some organizati<strong>on</strong>s seek third- party audits to improve their<br />

competitive positi<strong>on</strong>, for recogniti<strong>on</strong> in the form of a certificate, or for an award.<br />

Audit Type<br />

First-party audits<br />

Sec<strong>on</strong>d- party audits<br />

third- party audits<br />

Purpose<br />

to measure its strengths and weaknesses against its own procedures or<br />

methods and/or against external standards adopted by (voluntary) or<br />

imposed <strong>on</strong> (mandatory) the organizati<strong>on</strong>. (IA2)<br />

help ensure a better final product by verifying that there are appropriate<br />

c<strong>on</strong>trols for inputs into the system. (IB2)<br />

is to verify compliance or c<strong>on</strong>formance to specified regulati<strong>on</strong>s or standards,<br />

to improve their competitive positi<strong>on</strong>, for recogniti<strong>on</strong> in the form of a<br />

certificate, or for an award. (IB2)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

DOT 49 CFR 192<br />

Pipeline and Hazardous Materials Safety Administrati<strong>on</strong><br />

The reas<strong>on</strong> for most third- party audits is to verify compliance or c<strong>on</strong>formance to specified regulati<strong>on</strong>s or standards. The regulati<strong>on</strong>s and standards may be<br />

required by law, such as in the FAA, FDA, and Department of Energy (DOE) regulati<strong>on</strong>s, or they may be voluntary, such as ISO 9001, TS 16949, or<br />

AS9100.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IB1. Elements Of Purpose And Scope<br />

Audit Purpose<br />

It is the client’s resp<strong>on</strong>sibility to determine the purpose of an audit. Usually, this statement is specific. However,<br />

a client may state the purpose in general terms with the understanding that the lead auditor will specify the<br />

particulars to fit the situati<strong>on</strong>. In the case of an audit performed <strong>on</strong> a regular basis, the purpose may have been<br />

defined and known well in advance of the audit by all parties. First-party audits may be performed to assure<br />

management that the audited area is in compliance with particular standards and that the goals and strategies<br />

of the organizati<strong>on</strong> are being met. The following list provides example purpose statements for first- party audits.<br />

Audit Authority<br />

Purpose/ Objective<br />

1<br />

2<br />

VP<br />

Compliance<br />

3<br />

Scope Producti<strong>on</strong> Line #<br />

Type<br />

4<br />

Process Audit (internal)<br />

Purpose<br />

And Scope<br />

Audit Against:<br />

6<br />

5<br />

Specific Company Procedures<br />

Identifying Resources<br />

Auditor selecti<strong>on</strong> size/ numbers and qualificati<strong>on</strong> of<br />

auditors, documentati<strong>on</strong>, logistic, tools, strategies.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

• Who determine the purpose of audit?<br />

The Client.<br />

• Who is the Client?<br />

There is also a client, the pers<strong>on</strong> or organizati<strong>on</strong> that has requested the audit.<br />

Audits are c<strong>on</strong>ducted <strong>on</strong>ly when some<strong>on</strong>e requests <strong>on</strong>e; they do not happen<br />

by accident. There has to be a sp<strong>on</strong>sor or client with the authority<br />

to call for an audit. (<strong>HB</strong> page xx)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

First- <strong>Part</strong>y Audit<br />

The purpose of the first- party audit is to:<br />

• Ensure c<strong>on</strong>tinued compliance or c<strong>on</strong>formance (readiness) of the management<br />

system, to evaluate the effectiveness of the system in meeting the stated goals<br />

and objectives, and to identify opportunities for improvement in the product,<br />

process, and system<br />

• Review the mechanical assembly area’s compliance with procedures and to<br />

evaluate the procedures for opportunities for improvement<br />

• C<strong>on</strong>firm that project engineering, document c<strong>on</strong>trol, and procurement activities<br />

performed in support of basic design are being accomplished in accordance with<br />

the Quality Assurance Manual, selected integrated executi<strong>on</strong> procedures, and<br />

governing project procedures, including, as appropriate, client requirements<br />

• Assess the progress of the management system toward meeting the requirements<br />

of a management system standard such as ISO 9001, ISO 13485, ISO/TS 16949,<br />

ISO 22000, and ISO 14001<br />

• Identify opportunities for improved system/process effectiveness to achieve<br />

objectives<br />

• Identify process efficiencies for the delivery of products and services<br />

• Report organizati<strong>on</strong>al risks to management for evaluati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The Management Standards<br />

Assess the progress of the management system toward meeting the requirements of a management system standard such as ISO 9001,<br />

ISO 13485, ISO/TS 16949, ISO 22000, and ISO 14001<br />

The Standards<br />

Descripti<strong>on</strong>s<br />

ISO 9001<br />

ISO 13485<br />

ISO/TS 16949<br />

ISO 22000<br />

ISO 14001<br />

ISO 90001 is a set of Internati<strong>on</strong>al Standards for management and verificati<strong>on</strong> of<br />

good quality management practices.<br />

ISO 13485 is an Internati<strong>on</strong>al Organizati<strong>on</strong> for Standardizati<strong>on</strong> (ISO) standard,<br />

published in 2003, that represents the requirements for a comprehensive quality<br />

management system for the design and manufacture of medical devices.<br />

ISO/TS 16949 is an ISO technical specificati<strong>on</strong> aimed at the development of a<br />

quality management system that provides for c<strong>on</strong>tinual improvement, emphasizing<br />

defect preventi<strong>on</strong> and the reducti<strong>on</strong> of variati<strong>on</strong> and waste in the automotive<br />

industry supply chain.<br />

ISO 22000 is a Food Safety Management System that can be applied to any<br />

organizati<strong>on</strong> in the food chain, farm to fork.<br />

ISO 14000 is a family of standards related to envir<strong>on</strong>mental management that<br />

exists to help organizati<strong>on</strong>s (a) minimize how their operati<strong>on</strong>s (processes, etc.)<br />

negatively affect the envir<strong>on</strong>ment (i.e. cause adverse changes to air, water, or land);<br />

(b) comply with applicable laws, regulati<strong>on</strong>s, and other envir<strong>on</strong>mentally oriented<br />

requirements; and (c) c<strong>on</strong>tinually improve in the above.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The Management Standards<br />

The Standards<br />

ISO 9001<br />

TL 9000<br />

AS9100<br />

ISO 13485<br />

Descripti<strong>on</strong>s<br />

ISO 90001 is a set of Internati<strong>on</strong>al Standards for management and verificati<strong>on</strong> of good quality management<br />

practices.<br />

TL 9000 is a quality management practice designed by the QuEST Forum in 1998. It was created to focus <strong>on</strong><br />

supply chain directives throughout the internati<strong>on</strong>al telecommunicati<strong>on</strong>s industry, including the USA. As with<br />

ISO/TS 16949 for the automotive industry and AS9000 for the aerospace industry, TL 9000 specializes the<br />

generic ISO 9001 to meet the needs of <strong>on</strong>e industrial sector, which for TL 9000 is the informati<strong>on</strong> and<br />

communicati<strong>on</strong>s technology (ICT)—extending from service providers through ICT equipment manufacturers<br />

through the suppliers and c<strong>on</strong>tractors and subc<strong>on</strong>tractors that provide electr<strong>on</strong>ic comp<strong>on</strong>ents and software<br />

comp<strong>on</strong>ents to those ICT equipment manufacturers.<br />

AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was<br />

released in October, 1999, by the Society of Automotive Engineers and the European Associati<strong>on</strong> of Aerospace<br />

Industries.<br />

ISO 13485 Medical devices -- Quality management systems -- the requirements for a comprehensive quality<br />

management system for the design and manufacture of medical devices.<br />

ISO/TS 16949<br />

ISO 22000<br />

ISO 14001<br />

ISO/TS 16949 is an ISO technical specificati<strong>on</strong> aimed at the development of a quality management system that<br />

provides for c<strong>on</strong>tinual improvement, emphasizing defect preventi<strong>on</strong> and the reducti<strong>on</strong> of variati<strong>on</strong> and waste in the<br />

automotive industry supply chain.<br />

ISO 22000 is a Food Safety Management System that can be applied to any organizati<strong>on</strong> in the food chain, farm<br />

to fork.<br />

ISO 14000 is a family of standards related to envir<strong>on</strong>mental management that exists to help organizati<strong>on</strong>s (a)<br />

minimize how their operati<strong>on</strong>s (processes, etc.) negatively affect the envir<strong>on</strong>ment (i.e. cause adverse changes to<br />

air, water, or land); (b) comply with applicable laws, regulati<strong>on</strong>s, and other envir<strong>on</strong>mentally oriented requirements;<br />

and (c) c<strong>on</strong>tinually improve in the above.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

What Does TS in ISP/TS<br />

16949 means?<br />

https://ciiaas.files.wordpress.com/2007/11/iso-ts-16949-2002.pdf<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Meal Time<br />

今 天 晚 餐 吃 金 陵 烤 鸭<br />

金 陵 烤 鸭 是 苏 菜 菜 谱 之 一 , 以 鸭 皮 为 制 作 主 料 , 金 陵 烤 鸭 的<br />

烹 饪 技 巧 以 烤 菜 为 主 。 鸭 皮 金 红 、 香 脆 酥 松 , 油 润 光 亮 , 肉<br />

嫩 鲜 香 , 食 之 满 口 留 香 。 堪 为 色 、 香 、 味 三 绝 。 四 、 山 珍 野<br />

味 菜 烹 。<br />

20180911-1822hrs<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

As auditing has evolved, management also expects management risks to be identified. Risk<br />

exists in all processes; however, the kind and degree of risk must be managed. There may be<br />

safety (worker or customer injury), envir<strong>on</strong>mental (polluti<strong>on</strong>, fines), financial (loss of revenue,<br />

excessive cost), and customer goodwill (loss of future sales) risks. Management needs to be<br />

informed of risks to the organizati<strong>on</strong> as input into the decisi<strong>on</strong>- making process. Example<br />

objectives of a process performance audit may be to:<br />

• Determine if the system design is adequate to achieve organizati<strong>on</strong> objectives<br />

• Identify performance weaknesses and strengths<br />

• Verify process resp<strong>on</strong>siveness to customer and organizati<strong>on</strong> needs<br />

• Identify process risks and areas to be optimized<br />

Internal<br />

Process<br />

Performance<br />

Audit<br />

if the system design is adequate to<br />

achieve organizati<strong>on</strong> objectives<br />

Identify performance weaknesses<br />

and strengths<br />

Verify process resp<strong>on</strong>siveness to<br />

customer and organizati<strong>on</strong> needs<br />

C<strong>on</strong>tinuous<br />

improvement and to<br />

increase customer<br />

satisfacti<strong>on</strong><br />

(The missi<strong>on</strong> of the <strong>ASQ</strong> Audit Divisi<strong>on</strong>)<br />

Identify process risks and areas to be<br />

optimized<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Risk- Based Auditing<br />

Some audit programs may allocate resources specifically to areas that have been problematic or<br />

that are high risk. This could include product characteristics, product or process hazards,<br />

pers<strong>on</strong>nel or process safety, and envir<strong>on</strong>mental c<strong>on</strong>trols. This is often called risk- based auditing.<br />

A starting point for risk- based auditing is for the organizati<strong>on</strong> to identify and quantify its risks.<br />

Risk-based auditing is a style of auditing which focuses up<strong>on</strong> the analysis and management of risk.<br />

In the UK, the 1999 Turnbull Report <strong>on</strong> corporate governance required directors to provide a<br />

statement to shareholders of the significant risks to the business. This then encouraged the audit<br />

activity of studying these risks rather than just checking compliance with existing c<strong>on</strong>trols.[1]<br />

Standards for risk management have included the COSO guidelines and the first internati<strong>on</strong>al<br />

standard, AS/NZS 4360. The latter is now the basis for a family of internati<strong>on</strong>al standards for risk<br />

management - ISO 31000.<br />

A traditi<strong>on</strong>al audit would focus up<strong>on</strong> the transacti<strong>on</strong>s which would make up financial statements such<br />

as the balance sheet. A risk-based approach will seek to identify risks with the greatest potential<br />

impact. Strategic risk analysis will then include political and social risks such as the potential effect of<br />

legislati<strong>on</strong> and demographic change. An experiment suggested that managers might resp<strong>on</strong>d to riskbased<br />

auditing by transferring activity to accounts which are ostensibly low risk. Auditors would need<br />

to anticipate such attempts to game the process.<br />

https://en.wikipedia.org/wiki/Risk-based_auditing<br />

Internal auditors and some external auditors should be aware of the existence of risk and that<br />

effectiveness, efficiency, performance, and risk are important factors when determining the<br />

purpose of the audit or when planning the annual audit schedule. In this secti<strong>on</strong> we have<br />

discussed organizati<strong>on</strong>al risk as a purpose of an audit. Later we will discuss audit program risk<br />

and audit process risk.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The Client in Sec<strong>on</strong>d <strong>Part</strong>y Audits<br />

For a sec<strong>on</strong>d- party audit, the audit program, the engineering and technology departments, or the<br />

purchasing department normally determines the purpose of the audit and communicates it to the<br />

auditee.<br />

The primary purpose of a sec<strong>on</strong>d- party audit is to either assess a supplier to verify that c<strong>on</strong>tract<br />

requirements are being followed or assess a potential supplier’s capability of meeting specific<br />

requirements for a product or service. By determining that the supplier is meeting the<br />

requirements specified in a c<strong>on</strong>tract, the purchaser gains c<strong>on</strong>fidence in the quality of goods and<br />

services being delivered. The following list provides example purpose statements for sec<strong>on</strong>dparty<br />

audits.<br />

Sec<strong>on</strong>dparty<br />

Audit<br />

Purchaser<br />

Customer<br />

Engineering<br />

Department<br />

Client<br />

Purchasing<br />

Dept.<br />

Client<br />

Technological<br />

Dept.<br />

Client<br />

QA,QC and<br />

other Dept.<br />

Client<br />

Supplier 1<br />

Auditee<br />

Supplier 2<br />

Auditee<br />

Supplier 3<br />

Auditee<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

• Who determine the purpose of audit?<br />

The Client.<br />

• Who is the Client?<br />

There is also a client, the pers<strong>on</strong> or organizati<strong>on</strong> that has requested the audit.<br />

- Organizati<strong>on</strong> management higher in hierarchy than the department to be<br />

audited in first party audits.<br />

- Engineering or other c<strong>on</strong>cern departments audit <strong>on</strong> supplier in sec<strong>on</strong>d<br />

party audit<br />

Audits are c<strong>on</strong>ducted <strong>on</strong>ly when some<strong>on</strong>e requests <strong>on</strong>e; they do not happen<br />

by accident. There has to be a sp<strong>on</strong>sor or client with the authority<br />

to call for an audit. (<strong>HB</strong> page xx)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The purpose of the sec<strong>on</strong>d- party audit is to:<br />

• Assess the capability of XYZ Company to meet c<strong>on</strong>tract requirements by a review of the available<br />

resources and by obtaining objective evidence of management’s commitment to the quality requirements of<br />

its product<br />

• Verify that the materials, equipment, and work being performed under C<strong>on</strong>tract 12345-P-001 are in<br />

accordance with the procurement documents, as specified in Secti<strong>on</strong> 6 of this c<strong>on</strong>tract, and that the work is<br />

being executed by qualified pers<strong>on</strong>nel<br />

• Identify the possible cause of recent n<strong>on</strong>c<strong>on</strong>formities by c<strong>on</strong>ducting a comprehensive assessment of the<br />

tasks, procedures, records, and system documentati<strong>on</strong> related to the producti<strong>on</strong> of the wireless widget<br />

• Verify that the supplier has an active envir<strong>on</strong>mental abatement (reducti<strong>on</strong>) and safety improvement program<br />

that meets customer requirements<br />

External<br />

Sec<strong>on</strong>d <strong>Part</strong>y<br />

Supplier Audit<br />

Assess the capability to meet c<strong>on</strong>tract requirements<br />

Obtaining objective evidence of management’s<br />

commitment to the quality requirements of its product<br />

Verify that the materials, equipment, and work being<br />

performed are in accordance with the c<strong>on</strong>tract req.<br />

Identify the possible cause of recent n<strong>on</strong>c<strong>on</strong>formities,<br />

RCA and CAPA.<br />

C<strong>on</strong>tinuous<br />

improvement and to<br />

increase customer<br />

satisfacti<strong>on</strong><br />

(The missi<strong>on</strong> of the <strong>ASQ</strong> Audit Divisi<strong>on</strong>)<br />

Verify that the supplier has an active envir<strong>on</strong>mental<br />

abatement (reducti<strong>on</strong>) and safety improvement program<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Most third-party audits are performed by auditing organizati<strong>on</strong>s to determine the<br />

compliance or c<strong>on</strong>formance of the auditee’s systems with agreed- up<strong>on</strong> criteria. In the<br />

case of an audit for certificati<strong>on</strong>, an auditor examines an auditee’s systems for<br />

c<strong>on</strong>formity with a specific standard (for example, ISO 9001 or ISO 14001) or current<br />

good manufacturing practices. The purpose statement for most third-party audits is<br />

very specific, as shown in the following examples.<br />

Some organizati<strong>on</strong>s seek<br />

third- party audits to improve<br />

their competitive positi<strong>on</strong>, for<br />

recogniti<strong>on</strong> in the form of a<br />

certificate, or for an award.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The purpose of the third- party audit is to:<br />

• Determine the degree of c<strong>on</strong>formity to the requirements of the standard (ISO 9001,<br />

ISO 14001, AS9100) for the purposes of certificati<strong>on</strong> of the company management<br />

system<br />

• Assess the c<strong>on</strong>formity of the system to all requirements of the internati<strong>on</strong>al<br />

standard (ISO 9001, TL9000, ISO/TS 16949) for the purpose of recommending the<br />

organizati<strong>on</strong> for certificati<strong>on</strong> to the standard or approval of a license<br />

• Assess the compliance of the organizati<strong>on</strong> to all requirements of Regulati<strong>on</strong> 123 for<br />

the purpose of recommending approval or disapproval as a supplier<br />

Third-party audits performed for regulatory purposes determine the compliance of the<br />

auditee’s systems with regulati<strong>on</strong>s or laws. These audits have penalties associated<br />

with them (fines, jail, or both), so they are very serious. The purpose of the audit is<br />

determined by the regulatory agency and is normally specified in the regulati<strong>on</strong> or law.<br />

These audits focus <strong>on</strong> detailed compliance with regulati<strong>on</strong>s or laws to ensure that<br />

companies are protecting the envir<strong>on</strong>ment, the public, and their employees.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The Purpose Of The Third- <strong>Part</strong>y Audit<br />

External<br />

Third <strong>Part</strong>y<br />

Audit<br />

Determine the degree of c<strong>on</strong>formity to the<br />

requirements of the standard for the purposes of<br />

certificati<strong>on</strong> of the company management system<br />

Assess the compliance of the organizati<strong>on</strong> to<br />

all requirements of Customer requirement for<br />

the purpose of recommending approval as a<br />

supplier. (Shell, BP, Aramco..)<br />

Certificati<strong>on</strong> for better<br />

business opportunity/<br />

Mandatory Regulatory<br />

Compliances<br />

Third-party audits performed for regulatory<br />

purposes determine the compliance of the<br />

auditee’s systems with regulati<strong>on</strong>s or laws.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Audit Scope<br />

According to ISO 19011 the audit scope is the extent and boundaries of an audit.<br />

The audit scope normally includes a descripti<strong>on</strong> of the physical locati<strong>on</strong>s, organizati<strong>on</strong>al units,<br />

activities and processes, and the time period covered. The audit scope indicates or fixes a limit<br />

or extent of the audit. The scope has been described as the breadth of the audit and may<br />

specify areas not to be included in the audit.<br />

The scope or criteria of an audit can include:<br />

• Physical locati<strong>on</strong>s<br />

• Departments, areas, or units<br />

• Products, processes, or systems<br />

• Areas excluded from the audit<br />

• Timeline for audit activities or events<br />

• Relevant system and process policies, procedures, instructi<strong>on</strong>s, and plans<br />

• Applicable standards, c<strong>on</strong>tracts, regulati<strong>on</strong>s, codes, and other legal documents<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The following list provides examples of audit scope.<br />

The scope of the audit includes:<br />

• Processes performed in the raw material storage, fermentati<strong>on</strong> and purificati<strong>on</strong><br />

suites, bulk filling area, final product storage, and the product testing laboratory.<br />

• Policies and procedures for IT security for financial computer systems. Qualityrelated<br />

computer systems will not be addressed during this audit.<br />

• The c<strong>on</strong>fined space entry and lockout/ tagout safety systems for process vessels.<br />

• C<strong>on</strong>trols in place at supplier XXX C<strong>on</strong>tainer Company for the manufacture, testing,<br />

and release of bottles and caps during the past two years.<br />

If the scope or audit criteria must be changed before or during the audit, the audit<br />

participants should be informed of the change and it should be documented in the<br />

audit plan. If two or more management systems of different areas or disciplines (e.g.,<br />

quality, safety, envir<strong>on</strong>mental) are audited together (a combined or integrated audit), it<br />

is important that the audit objectives, scope, and criteria be compatible with the<br />

objectives of the relevant audit programs.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IA-Gossip<br />

An auditor told of <strong>on</strong>e case in which an organizati<strong>on</strong> wanted to<br />

acknowledge a supplier for the perfect product it had been receiving.<br />

However, during the award process it was discovered that the supplier<br />

had absolutely no quality system in place! The supplier was able<br />

to ship an acceptable product simply because its employees were<br />

good sorters.<br />

Comments:<br />

The good sorter system was indeed a good quality system?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IA-Gossip<br />

What’s the difference between certificati<strong>on</strong>, registrati<strong>on</strong>, and accreditati<strong>on</strong>?<br />

The terms certificati<strong>on</strong> and registrati<strong>on</strong> are used interchangeably to refer to verifying the<br />

c<strong>on</strong>formance of an organizati<strong>on</strong>’s management systems to a standard or other requirements. The<br />

term accreditati<strong>on</strong> is used when validating or verifying the c<strong>on</strong>formance of a certificati<strong>on</strong> body to the<br />

requirements of nati<strong>on</strong>al and/or internati<strong>on</strong>al criteria. Certificati<strong>on</strong> also refers to the process of<br />

validating and verifying the credentials of individuals such as auditors. A certificati<strong>on</strong> body, also<br />

known as a registrar, is a third- party company c<strong>on</strong>tracted to evaluate the c<strong>on</strong>formance of an<br />

organizati<strong>on</strong>’s management systems to the requirements of the appropriate standard(s) and issue a<br />

certificate of c<strong>on</strong>formance when warranted.<br />

Comments:<br />

This a fact not gossiping? Why some certificati<strong>on</strong> bodies or registrars are using their suppliers ―AQB<br />

(Authorized Qualificati<strong>on</strong> Body)‖ to fully administrate their own functi<strong>on</strong>s? https://www.ndt.net/search/docs.php3?id=21282&c<strong>on</strong>tent=1<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IA-Gossip<br />

The universality of auditing extends to most sectors of our society,<br />

including the American Civil Liberties Uni<strong>on</strong> (ACLU), local building<br />

or fire inspectors, the Envir<strong>on</strong>mental Protecti<strong>on</strong> Agency (EPA),<br />

the Occupati<strong>on</strong>al Safety and Health Administrati<strong>on</strong> (OSHA), uni<strong>on</strong><br />

representatives, critical customers, and the Internal Revenue Service<br />

(IRS), to assess and report how well the organizati<strong>on</strong> is performing.<br />

Comments:<br />

An audit universe represents the potential range of all audit activities and is comprised of a<br />

number of auditable entities. These entities generally include a range of programs, activities,<br />

functi<strong>on</strong>s, structures and initiatives which collectively c<strong>on</strong>tribute to the achievement of the<br />

department’s strategic objectives.<br />

https://www.nrcan.gc.ca/audit/reports/1100<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IA-Gossip- Learn from<br />

https://www.nrcan.gc.ca/audit/reports/1100<br />

The Planning Process<br />

The starting point for the risk-based selecti<strong>on</strong> process is NRCan’s internal audit universe. The audit universe represents a potential<br />

range of all audit activities and is comprised of a number of auditable entities. The Audit Branch uses the departmental Program<br />

Activity Architecture (PAA) to help assess completeness of the audit universe.<br />

The next stage is to prioritize the audit universe based <strong>on</strong> a risk assessment. This is a two step process and involves preliminary and<br />

final prioritizati<strong>on</strong>. This includes management c<strong>on</strong>sultati<strong>on</strong>s, review and c<strong>on</strong>siderati<strong>on</strong> of available departmental risk informati<strong>on</strong>,<br />

including the Corporate Risk Profile (CRP), the latest Management Accountability Framework assessment, strategic review, business<br />

planning, the Report <strong>on</strong> Plans and Priorities (RPP), departmental and government priorities, the most recent tabled financial<br />

statements, and other c<strong>on</strong>siderati<strong>on</strong>s such as previous audit results (both internal and external).<br />

C<strong>on</strong>siderati<strong>on</strong> is given to other factors such as senior management requests; the Departmental Audit Committee (DAC) advice and<br />

recommendati<strong>on</strong>s; mandated audits such as Office of the Comptroller General’s horiz<strong>on</strong>tal directed audits; audits resulting from the<br />

Budget 2009 Ec<strong>on</strong>omic Acti<strong>on</strong> Plan; planned audits by other assurance providers.<br />

Finally the draft audit plan is distributed to Departmental Audit Committee for review and recommended to the Deputy Minister for<br />

approval.<br />

The following diagram highlights the four key phases used in the selecti<strong>on</strong> process for the development of a robust risk-based audit<br />

plan.<br />

https://www.nrcan.gc.ca/audit/reports/1100<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IT Risk Universes<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IA-Gossip<br />

A comm<strong>on</strong> type of assessment is termed ―statutory and regulatory compliance audit.‖ While the<br />

auditors may be trained and informed in the relevant materials and documents, they need to be<br />

careful to avoid going bey<strong>on</strong>d their competence in their reporting. For statutory issues,<br />

interpretati<strong>on</strong> of laws is often required and can be viewed as the domain of lawyers who are<br />

members of the bar. Typically, determinati<strong>on</strong> of regulatory compliance lies solely in the domain of<br />

pers<strong>on</strong>s who are formally recognized by the regulatory agency as being competent to interpret<br />

regulati<strong>on</strong>s developed by statutory authorities, for example, OSHA, the EPA, the Department of<br />

Transportati<strong>on</strong> (DOT), the Federal Aviati<strong>on</strong> Administrati<strong>on</strong> (FAA), and the Food and Drug<br />

Administrati<strong>on</strong> (FDA). Auditors may be qualified as technical subject matter experts (SMEs) but<br />

lack appropriate recogniti<strong>on</strong>s by interested bodies.<br />

Comments: Send a Lawyer to the pipeline c<strong>on</strong>structi<strong>on</strong> area to deals <strong>on</strong> the Department of<br />

Transportati<strong>on</strong> (DOT), 46CFR 192 compliances issues? https://www.gpo.gov/fdsys/granule/CFR-2011-title49-vol3/CFR-2011-title49-vol3-part192<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

…For statutory issues, interpretati<strong>on</strong> of laws is often required and can be viewed as the domain of lawyers who<br />

are members of the bar. Typically, determinati<strong>on</strong> of regulatory compliance lies solely in the domain of pers<strong>on</strong>s<br />

who are formally recognized by the regulatory agency as being competent to interpret regulati<strong>on</strong>s developed<br />

by statutory authorities…<br />

http://slideshare.net/charliech<strong>on</strong>g/api-1169-part-49-cfr-195transportati<strong>on</strong>-of-hazardous-liquids-by-pipeline<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IB2. Benefits Of Audits<br />

The benefits of an audit are numerous. Audits can verify <strong>on</strong>going c<strong>on</strong>formance to requirements<br />

and promote improvement of the organizati<strong>on</strong>’s effectiveness and efficiency. Management can<br />

utilize the objective data to make informed decisi<strong>on</strong>s regarding the achievement of organizati<strong>on</strong><br />

objectives. Auditing benefits include:<br />

• Verificati<strong>on</strong> of c<strong>on</strong>formance to requirements such as:<br />

(a) a management system,<br />

(b) regulatory and<br />

(c) c<strong>on</strong>tractual<br />

• Identificati<strong>on</strong> of risks and m<strong>on</strong>itoring of risk treatments<br />

• Identificati<strong>on</strong> of opportunities for improvement<br />

• Verificati<strong>on</strong> that projects were implemented according to plan<br />

• Determinati<strong>on</strong> of readiness of new products and processes<br />

• Verificati<strong>on</strong> of system effectiveness<br />

• Identificati<strong>on</strong> of inefficiencies and ineffective c<strong>on</strong>trols<br />

• Verificati<strong>on</strong> of corrective acti<strong>on</strong>s and their effectiveness<br />

• Identificati<strong>on</strong> and reporting of best practices<br />

• Advancing the achievement of organizati<strong>on</strong> objectives<br />

Auditors have a broad perspective of an organizati<strong>on</strong> and analyze evidence reported to<br />

management. Management can use this informati<strong>on</strong> to evaluate the organizati<strong>on</strong> and implement<br />

measures necessary to meet its objectives.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Auditing Benefits<br />

Identificati<strong>on</strong><br />

and reporting<br />

of best<br />

practices<br />

Verificati<strong>on</strong> of<br />

c<strong>on</strong>formance<br />

to<br />

requirements<br />

Identificati<strong>on</strong><br />

of risks and<br />

m<strong>on</strong>itoring of<br />

risk<br />

treatments<br />

Verificati<strong>on</strong> of<br />

corrective<br />

acti<strong>on</strong>s and<br />

their<br />

effectiveness<br />

Identificati<strong>on</strong><br />

of<br />

inefficiencies<br />

and<br />

ineffective<br />

c<strong>on</strong>trols<br />

Advancing the<br />

achievement<br />

of<br />

organizati<strong>on</strong><br />

objectives<br />

Identificati<strong>on</strong><br />

of<br />

opportunities<br />

for<br />

improvement<br />

Verificati<strong>on</strong><br />

that projects<br />

were<br />

implemented<br />

according to<br />

plan<br />

Verificati<strong>on</strong> of<br />

system<br />

effectiveness<br />

Determinati<strong>on</strong><br />

of readiness<br />

of new<br />

products and<br />

processes<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Management review should c<strong>on</strong>sider recurring n<strong>on</strong>c<strong>on</strong>formities (for example, at a particular locati<strong>on</strong> or with a<br />

particular procedure) as possible evidence that the plans and procedures should be changed.<br />

Even more useful is a management review of potential inefficiencies. When audit results are being viewed as<br />

added system informati<strong>on</strong>, auditing starts to provide the informati<strong>on</strong> needed for the ―Check‖ step in the Deming<br />

(also known as ―Shewhart‖) Plan- Do-Check-Act (PDCA; also known as the PDSA: Plan- Do-Study-Act) cycle.<br />

With the kind of informati<strong>on</strong> that process and system audits provide, management is better prepared to move<br />

forward with more- informed decisi<strong>on</strong>s. Elevati<strong>on</strong> of n<strong>on</strong>c<strong>on</strong>formity resoluti<strong>on</strong> to the PDCA paradigm (modal)<br />

requires the use of more c<strong>on</strong>temporary tools for problem solving, improvement, and overall management. The<br />

universe of opportunities expands as new knowledge and theories are developed. System and process<br />

auditing can provide this new knowledge, if understood and properly applied.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

The Shewhart c<strong>on</strong>trol chart has a baseline and upper and lower limits, shown as dashed lines,<br />

that are symmetric about the baseline. Measurements are plotted <strong>on</strong> the chart versus a time line.<br />

Measurements that are outside the limits are c<strong>on</strong>sidered to be out of c<strong>on</strong>trol.<br />

The baseline for the c<strong>on</strong>trol chart is the<br />

accepted value, an average of the<br />

historical check standard values. A<br />

minimum of 100 check standard values is<br />

required to establish an accepted value.<br />

The upper (UCL) and lower (LCL) c<strong>on</strong>trol<br />

limits are:<br />

UCL = Accepted value + k*process<br />

standard deviati<strong>on</strong><br />

LCL = Accepted value - k*process<br />

standard deviati<strong>on</strong><br />

where the process standard deviati<strong>on</strong> is<br />

the standard deviati<strong>on</strong> computed from the<br />

check standard database.<br />

18 March 1891 – 11March 1967<br />

https://www.itl.nist.gov/div898/handbook/mpc/secti<strong>on</strong>2/mpc221.htm<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

IB-Gossip<br />

A new auditor received lots of complimentary feedback from an auditee who was very close to<br />

the process he managed. A staff auditor had coached the new internal system auditor to ask<br />

reporter- type questi<strong>on</strong>s, explaining that the ―why‖ questi<strong>on</strong> was not philosophical. The answer to<br />

―why‖ gives the reas<strong>on</strong> or driver for an activity. After the audit, the manager said that he had<br />

learned more from attempting to answer and document the driver for the activity than from any<br />

previous audit experience. It reinforced the acti<strong>on</strong>s needed for an activity and surfaced<br />

unnecessary acti<strong>on</strong>s.<br />

Comments:<br />

The 5-Why did works to improve quality as a means for root cause analysis?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

5 Whys is an iterative interrogative technique used to explore the cause-and-effect relati<strong>on</strong>ships underlying a particular<br />

problem. The primary goal of the technique is to determine the root cause of a defect or problem by repeating the questi<strong>on</strong><br />

"Why?" Each answer forms the basis of the next questi<strong>on</strong>. The "5" in the name derives from an anecdotal observati<strong>on</strong> <strong>on</strong> the<br />

number of iterati<strong>on</strong>s needed to resolve the problem. Not all problems have a single root cause. If <strong>on</strong>e wishes to uncover<br />

multiple root causes, the method must be repeated asking a different sequence of questi<strong>on</strong>s each time. The method provides<br />

no hard and fast rules about what lines of questi<strong>on</strong>s to explore, or how l<strong>on</strong>g to c<strong>on</strong>tinue the search for additi<strong>on</strong>al root causes.<br />

Thus, even when the method is closely followed, the outcome still depends up<strong>on</strong> the knowledge and persistence of the<br />

people involved.<br />

The technique was originally developed by Sakichi Toyoda and was used within the Toyota Motor Corporati<strong>on</strong> during the<br />

evoluti<strong>on</strong> of its manufacturing methodologies. It is a critical comp<strong>on</strong>ent of problem-solving training, delivered as part of the<br />

inducti<strong>on</strong> into the Toyota Producti<strong>on</strong> System. The architect of the Toyota Producti<strong>on</strong> System, Taiichi Ohno, described the 5<br />

Whys method as "the basis of Toyota's scientific approach . . . by repeating why five times, the nature of the problem as well<br />

as its soluti<strong>on</strong> becomes clear." The tool has seen widespread use bey<strong>on</strong>d Toyota, and is now used within Kaizen, lean<br />

manufacturing, and Six Sigma. In other companies, it appears in other forms. Under Ricardo Semler, Semco practices "three<br />

whys" and broadens the practice to cover goal setting and decisi<strong>on</strong> making.<br />

https://en.wikipedia.org/wiki/5_Whys<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

American Society for Quality<br />

600 N Plankint<strong>on</strong> Ave, Milwaukee, WI 53203<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IB<br />

Milwaukee<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Chapter 3<br />

Criteria to Audit Against/<strong>Part</strong> IC<br />

Discussi<strong>on</strong><br />

Audit criteria is a universal term that describes the reference used by an auditor against which the evidence<br />

collected during the audit can be compared.<br />

(the others informal terms are; assessment, survey, examinati<strong>on</strong>).<br />

In the late 1980s the Quality Auditing Technical Committee (now the Audit Divisi<strong>on</strong> of <strong>ASQ</strong>)<br />

defined audit as:<br />

(<strong>ASQ</strong>) audit<br />

A planned, independent, and documented assessment to determine whether agreed- up<strong>on</strong><br />

requirements are being met. (<strong>HB</strong>)<br />

3.1 audit<br />

systematic, independent and documented process for obtaining audit evidence (3.3) and<br />

evaluating it objectively to determine the extent to which the audit criteria (3.2) are fulfilled<br />

Guidelines for auditing management systems (ISO 19011:2011)<br />

http://qic-eg.com/wp-c<strong>on</strong>tent/uploads/2015/08/BS-EN-ISO-19011-2011.pdf<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Audit Divisi<strong>on</strong> of <strong>ASQ</strong> versus ISO<br />

Definiti<strong>on</strong> <strong>on</strong> Audit (Compare)<br />

A planned, independent, and<br />

documented assessment to<br />

determine whether agreedup<strong>on</strong><br />

requirements are being<br />

met. (<strong>HB</strong>)<br />

systematic, independent and<br />

documented process for obtaining<br />

audit evidence (3.3) and evaluating<br />

it objectively to determine the<br />

extent to which the audit criteria<br />

(3.2) are fulfilled. (ISO)<br />

Assessment to determine<br />

agreed- up<strong>on</strong><br />

requirements are being<br />

met.<br />

Process for obtaining audit<br />

evidence and evaluating it<br />

objectively to determine<br />

determine the extent to<br />

which the audit criteria<br />

are fulfilled<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Audit Criteria<br />

The ISO 19011, clause 3.2 states that audit criteria are:<br />

• a set of policies,<br />

• procedures, or<br />

• requirements<br />

used as a reference against which audit evidence is compared.<br />

audit criteria (ISO 19011:2011(E))<br />

set of policies, procedures or requirements used as a reference against which audit evidence (3.3) is compared<br />

NOTE 1 Adapted from ISO 9000:2005, definiti<strong>on</strong> 3.9.3.<br />

NOTE 2 If the audit criteria are legal (including statutory or regulatory) requirements, the terms ―compliant‖ or<br />

―n<strong>on</strong>compliant‖ are often used in an audit finding (3.4).<br />

The ISO 9000 vocabulary standard explains that requirements may be generated by various stakeholders or<br />

interested parties. Requirements may be specified or they may be generally implied, such as customs or<br />

comm<strong>on</strong> practice. This definiti<strong>on</strong> recognizes that not all requirements can be specified. For example, we<br />

expect new products to arrive clean, services to be performed in a timely manner, reports to be legible, and<br />

service pers<strong>on</strong>s to practice good hygiene, even though such requirements may not be specified in a document,<br />

c<strong>on</strong>tract, or standard. The audit criteria may be referred to as system or process requirements, rules that the<br />

auditee follows, or a specific named standard or regulati<strong>on</strong>. The audit principle is that auditors audit against<br />

criteria, a set of rules or specified c<strong>on</strong>trols, and not their own opini<strong>on</strong> of what the auditee should be doing. The<br />

evidence collected, which is used as a basis for findings and the audit report, should be relevant to the audit<br />

criteria. Assigned auditors must be knowledgeable of the audit criteria, document, or standard that the<br />

organizati<strong>on</strong> is being evaluated against. Auditors must be competent, and part of that competency is<br />

knowledge of the audit criteria and their interpretati<strong>on</strong>s.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Criteria<br />

The audit principle is that auditors audit<br />

against criteria, a set of rules or specified<br />

c<strong>on</strong>trols, and not their own opini<strong>on</strong> of what the<br />

auditee should be doing.<br />

https://hubpages.com/politics/George-W-Bush-<br />

and-the-Missing-Weap<strong>on</strong>s-of-Mass-<br />

Destructi<strong>on</strong>-The-Great-Lie-of-the-Last-Century<br />

https://www.brookings.edu/events/the-interrogati<strong>on</strong>-of-saddam-hussein-and-u-s-policy-in-iraq/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Audit Requirements<br />

Audits of programs (such as quality or envir<strong>on</strong>mental programs) normally require reference standards against<br />

which to judge the adequacy of the plans. These are normally external documents that may include:<br />

• Nati<strong>on</strong>al and internati<strong>on</strong>al standards<br />

• Customer and corporate specificati<strong>on</strong>s<br />

• C<strong>on</strong>tract and customer requirements<br />

• Local and nati<strong>on</strong>al statutes and regulati<strong>on</strong>s<br />

• Industry codes and standards<br />

• Guides, handbooks, and so <strong>on</strong><br />

Standards, codes, and regulati<strong>on</strong>s . . . are issued by related industrial or professi<strong>on</strong>al associati<strong>on</strong>s, by nati<strong>on</strong>al<br />

standards writing organizati<strong>on</strong>s c<strong>on</strong>cerned with the intended market place, by local/state/nati<strong>on</strong>al legislative<br />

bodies and by internati<strong>on</strong>al bodies.<br />

Questi<strong>on</strong>:<br />

Customer and corporate specificati<strong>on</strong>s; do these include company quality manual and alike?<br />

Answer: See keyword; ―external document‖<br />

Keywords:<br />

external documents<br />

Customer and corporate<br />

specificati<strong>on</strong>s, do these<br />

include company quality<br />

manual and alike?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Performance Standards<br />

Performance standards are the documents that c<strong>on</strong>tain the norms or criteria against which an activity is<br />

measured. There are four levels of performance standards:<br />

1. Policies:<br />

Examples include corporate policy statements, internati<strong>on</strong>al and nati<strong>on</strong>al quality system standards,<br />

regulatory standards, and business sector standards.<br />

2. Manuals:<br />

Examples are corporate manuals and plant manuals. One may exist for each functi<strong>on</strong>, department, or<br />

divisi<strong>on</strong>.<br />

3. Procedural documents:<br />

These include the step- by-step requirements for doing a job.<br />

4. Detailed documents:<br />

These documents, such as drawings, purchase orders, product specificati<strong>on</strong>s, and inspecti<strong>on</strong> plans,<br />

c<strong>on</strong>tain specific requirements or instructi<strong>on</strong>s.<br />

Policies<br />

Manuals<br />

Procedural<br />

documents<br />

Detailed documents<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Performance Standards<br />

(Internal documents?)<br />

Policies<br />

Manuals<br />

Procedures<br />

Detailed<br />

Documents<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Audit Basis (C<strong>on</strong>fusi<strong>on</strong> Term?)<br />

To perform an audit, an auditor must be aware of the audit basis, sometimes called reference standards, audit<br />

criteria, or performance standards. The compliance or adequacy of a system cannot be measured until those<br />

requirements are defined. Regardless of the requirements, an audit must be performed against a basis for<br />

reference (for example, organizati<strong>on</strong> performance standards and/or nati<strong>on</strong>al standards such as ISO 9001).<br />

These reference documents may include the following:<br />

(1) management system, product, or process standards, (2) c<strong>on</strong>tracts, (3) specificati<strong>on</strong>s,<br />

(4) organizati<strong>on</strong> policies and objectives, and (5) laws or regulati<strong>on</strong>s.<br />

Dicti<strong>on</strong>ary:<br />

• Basis: foundati<strong>on</strong>, base<br />

• Criteria: criteri<strong>on</strong>, standard against which something is measured<br />

Comment <strong>on</strong> audit basis:<br />

The impartiality of<br />

auditor characteristic<br />

could be a good audit<br />

basis.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Standards (Audit against…)<br />

Certain internati<strong>on</strong>al, nati<strong>on</strong>al, and industry standards are mandated for many organizati<strong>on</strong>s. Audits verify<br />

compliance/c<strong>on</strong>formance with the applicable management system standard, whether it be ISO 9001, AS9100,<br />

TL 9000, or ISO 14001.<br />

The Standards<br />

ISO 9001<br />

TL 9000<br />

AS9100<br />

ISO 13485<br />

ISO/TS 16949<br />

ISO 22000<br />

ISO 14001<br />

Descripti<strong>on</strong>s<br />

ISO 90001 is a set of Internati<strong>on</strong>al Standards for management and verificati<strong>on</strong> of good quality management practices.<br />

TL 9000 is a quality management practice designed by the QuEST Forum in 1998. It was created to focus <strong>on</strong> supply<br />

chain directives throughout the internati<strong>on</strong>al telecommunicati<strong>on</strong>s industry, including the USA. As with ISO/TS 16949<br />

for the automotive industry and AS9000 for the aerospace industry, TL 9000 specializes the generic ISO 9001 to meet<br />

the needs of <strong>on</strong>e industrial sector, which for TL 9000 is the informati<strong>on</strong> and communicati<strong>on</strong>s technology (ICT)—<br />

extending from service providers through ICT equipment manufacturers through the suppliers and c<strong>on</strong>tractors and<br />

subc<strong>on</strong>tractors that provide electr<strong>on</strong>ic comp<strong>on</strong>ents and software comp<strong>on</strong>ents to those ICT equipment manufacturers.<br />

AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released<br />

in October, 1999, by the Society of Automotive Engineers and the European Associati<strong>on</strong> of Aerospace Industries.<br />

ISO 13485 Medical devices -- Quality management systems - the requirements for a comprehensive quality<br />

management system for the design and manufacture of medical devices.<br />

ISO/TS 16949 is an ISO technical specificati<strong>on</strong> aimed at the development of a quality management system that<br />

provides for c<strong>on</strong>tinual improvement, emphasizing defect preventi<strong>on</strong> and the reducti<strong>on</strong> of variati<strong>on</strong> and waste in the<br />

automotive industry supply chain.<br />

ISO 22000 is a Food Safety Management System that can be applied to any organizati<strong>on</strong> in the food chain, farm to<br />

fork.<br />

ISO 14000 is a family of standards related to envir<strong>on</strong>mental management that exists to help organizati<strong>on</strong>s (a) minimize<br />

how their operati<strong>on</strong>s (processes, etc.) negatively affect the envir<strong>on</strong>ment (i.e. cause adverse changes to air, water, or<br />

land); (b) comply with applicable laws, regulati<strong>on</strong>s, and other envir<strong>on</strong>mentally oriented requirements; and (c)<br />

c<strong>on</strong>tinually improve in the above.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

An organizati<strong>on</strong> may voluntarily adopt certain standards by incorporating them into c<strong>on</strong>tracts or<br />

policies even though there is no requirement to do so. An organizati<strong>on</strong> may adopt certain<br />

standards because it is in its best interests, such as for external marketing or providing an<br />

internal structure for managing the organizati<strong>on</strong>.<br />

C<strong>on</strong>tracts (Audit against…)<br />

In a sec<strong>on</strong>d- party audit, the purchase order or other c<strong>on</strong>tract between two parties states the<br />

specific requirements that must be met, and an audit is performed to verify that the supplier is<br />

meeting those requirements. A c<strong>on</strong>tract may include references to a specific standard, such as<br />

American Nati<strong>on</strong>al Standards Institute (ANSI), American Society for Testing and Materials<br />

(ASTM) Internati<strong>on</strong>al, FAA, DOE, or FDA standards.<br />

C<strong>on</strong>tracts may specify that a supplier establish and maintain a management system standard<br />

such as ISO 9001 or ISO 13485. A third party may verify that the supplier c<strong>on</strong>forms to the<br />

management system standard.<br />

However, the customer may have additi<strong>on</strong>al requirements, referring to them as ―ISO 9001 plus‖<br />

audits.<br />

Other suppliers may not have a management system in place and may be subject to an ―ISO<br />

9001 minus‖ audit (not all ISO 9001 c<strong>on</strong>trols are required).<br />

Keywords:<br />

―ISO 9001 plus‖ audits<br />

―ISO 9001 minus‖ audit<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Specificati<strong>on</strong>s (Audit against…)<br />

Specificati<strong>on</strong>s are normally used when c<strong>on</strong>ducting product or service audits. An auditor examines<br />

physical dimensi<strong>on</strong>s, placement or arrangement of items, or chemical compositi<strong>on</strong>s, for example,<br />

to see if they are in compliance with the specified requirements.<br />

Policies and objectives (Audit against…)<br />

Internally, many companies regularly assess compliance/c<strong>on</strong>formance and effectiveness with<br />

their own policies or policy statements. These policies are often stated in manuals and are the<br />

basis for a quality, envir<strong>on</strong>mental, or safety program. Most companies publish specified<br />

objectives. Objectives may relate to cost, safety, stewardship, health, efficiency, effectiveness,<br />

optimum use of resources, and so <strong>on</strong>. Auditors can verify the progress of departments, functi<strong>on</strong>s,<br />

and projects toward the achievement of objectives.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

Laws and Regulati<strong>on</strong>s (Audit against…)<br />

Many companies perform internal audits to ensure that they are meeting all the requirements imposed by<br />

various laws and regulati<strong>on</strong>s, whether general or industry-specific.<br />

Third- party auditors within a regulatory agency use the laws and regulati<strong>on</strong>s, case law, and their internal<br />

requirements/guidelines as the basis for the audit. Auditors verify mandatory governmental standards such as<br />

FDA current good manufacturing practices (cGMPs), FAA, 10CFR 830, or Sarbanes-Oxley.<br />

The audit criteria must be stipulated as part of the audit plan. There is no minimum or maximum limit to the<br />

amount or kinds of audit criteria. However, for an audit to be performed, there must be audit criteria. If there are<br />

no criteria to compare the organizati<strong>on</strong> with, the investigati<strong>on</strong> may be called a survey or review.<br />

Keywords:<br />

survey or review<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IC<br />

What is the 'Sarbanes-Oxley Act Of 2002 - SOX'<br />

The U.S. C<strong>on</strong>gress passed the Sarbanes-Oxley Act of 2002 <strong>on</strong> July 30, 2002 to protect investors from the<br />

possibility of fraudulent accounting activities by corporati<strong>on</strong>s. The SOX Act of 2002, also known as the<br />

Corporate Resp<strong>on</strong>sibility Act of 2002, mandated strict reforms to improve financial disclosures from<br />

corporati<strong>on</strong>s and prevent accounting fraud.<br />

The Act was in resp<strong>on</strong>se to accounting malpractice in the early 2000s when public scandals such as Enr<strong>on</strong><br />

Corporati<strong>on</strong>, Tyco Internati<strong>on</strong>al plc and WorldCom shook investor c<strong>on</strong>fidence in financial statements and<br />

demanded an overhaul of regulatory standards.<br />

L<strong>on</strong>g title: An Act To protect investors by improving the accuracy and reliability of corporate disclosures made<br />

pursuant to the securities laws, and for other purposes.<br />

Read more: Sarbanes-Oxley Act Of 2002 (SOX)<br />

https://www.investopedia.com/terms/s/sarbanesoxleyact.asp#ixzz5QsrIqK4l<br />

Follow us: Investopedia <strong>on</strong> Facebook<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Chapter 4<br />

Roles and Resp<strong>on</strong>sibilities of Audit<br />

<strong>Part</strong>icipants<br />

/<strong>Part</strong> ID<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Audit <strong>Part</strong>icipants<br />

An audit involves three key participants who may interrelate in a number of ways. Described by<br />

functi<strong>on</strong>, these participants are the client, the auditor, and the auditee.<br />

• The client is the pers<strong>on</strong> or organizati<strong>on</strong> that has requested or commissi<strong>on</strong>ed the audit. The<br />

client is usually a member of senior management, and the audit is typically c<strong>on</strong>ducted of an<br />

organizati<strong>on</strong>al unit under the client’s jurisdicti<strong>on</strong>, of independent suppliers, or to support an<br />

applicati<strong>on</strong> for third- party certificati<strong>on</strong>.<br />

• The auditor is the pers<strong>on</strong> who plans and carries out the audit. An auditing organizati<strong>on</strong>, which<br />

employs auditors to carry out audits, may be internal to a company or an independent<br />

organizati<strong>on</strong>, such as the auditing group of a quality or envir<strong>on</strong>mental program certificati<strong>on</strong><br />

body or c<strong>on</strong>sulting organizati<strong>on</strong>.<br />

• The auditee is the organizati<strong>on</strong> to be audited. The auditee may be a divisi<strong>on</strong> of the client’s<br />

organizati<strong>on</strong> or an entirely separate entity, such as a supplier. In internal audits, the client is<br />

the top management and the auditee is the functi<strong>on</strong> or area to be audited.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

External Audit<br />

The following are examples of external audits:<br />

External Audit (Third-<strong>Part</strong>y Audit)<br />

• Situati<strong>on</strong>: Organizati<strong>on</strong> desires recogniti<strong>on</strong> or approval of its capability to meet a particular<br />

standard such as ISO 9001<br />

• Client: The top management of an organizati<strong>on</strong> desiring certificati<strong>on</strong>/ registrati<strong>on</strong><br />

• Auditee: The organizati<strong>on</strong> desiring certificati<strong>on</strong>/registrati<strong>on</strong><br />

• Auditing organizati<strong>on</strong>: The organizati<strong>on</strong> granting certificati<strong>on</strong>/registrati<strong>on</strong> using an auditor<br />

employed by the auditing organizati<strong>on</strong> or hired to c<strong>on</strong>duct the audit<br />

External Audit (Sec<strong>on</strong>d-<strong>Part</strong>y Audit)<br />

• Situati<strong>on</strong>: Customer organizati<strong>on</strong> desires to evaluate a supplier<br />

• Client: The interested purchasing agent, purchasing manager, or engineer<br />

• Auditee: The potential or existing supplier<br />

• Auditing organizati<strong>on</strong>: Member(s) of the customer organizati<strong>on</strong> staff or auditors under c<strong>on</strong>tract<br />

to the customer organizati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

External Audit (Regulatory Audit?)<br />

• Situati<strong>on</strong>: Regulatory organizati<strong>on</strong> verifies that supplier or operator is in compliance with requirements<br />

• Client: The regulatory agency<br />

• Auditee: The potential supplier or operator (Organizati<strong>on</strong> operating under jurisdicti<strong>on</strong> of regulatory agency?)<br />

• Auditing organizati<strong>on</strong>: Employee(s) of the regulatory agency or auditors under c<strong>on</strong>tract to the agency<br />

Internal Audit<br />

The following is an example of an internal audit:<br />

• Situati<strong>on</strong>: Organizati<strong>on</strong> desires to determine the degree of c<strong>on</strong>formity of its own organizati<strong>on</strong> elements to a<br />

predefined management system<br />

(Other objective? – Effectiveness, opportunity of improvements, risk etc.)<br />

• Client: Upper-management team of the organizati<strong>on</strong> desiring to use auditing as a management tool<br />

• Auditee: The department/functi<strong>on</strong>(s) of the organizati<strong>on</strong> to be evaluated<br />

• Auditing organizati<strong>on</strong>: Employee(s) of the organizati<strong>on</strong> or individuals hired to c<strong>on</strong>duct the audit<br />

In the internal audit example, the client can be the organizati<strong>on</strong>’s own top management.<br />

The origin of the term audit client comes from the very first applicati<strong>on</strong> of audits in the United States (external<br />

financial audits). After the Great Depressi<strong>on</strong>, laws were passed requiring a financial audit of the books of<br />

companies subject to securities and exchange regulati<strong>on</strong>s. In order for the audit results to be creditable, the<br />

audits had to be performed by outside certified public accountants (CPAs). These CPA auditors were hired by a<br />

client. Today, we call them the auditee. The CPAs delivered their report to the client, who gave it to the audit<br />

committee <strong>on</strong> the board of directors.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

The Great Depressi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

The Great Depressi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

The Great Depressi<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Roles And Resp<strong>on</strong>sibilities<br />

The audit process involves several participants. By its nature, an audit can cause<br />

stress between participants. Therefore, it is in every<strong>on</strong>e’s best interest if the<br />

participants work together to ensure a successful and effective audit. The more<br />

c<strong>on</strong>tentious (belligerent, argumentative, c<strong>on</strong>troversial) the relati<strong>on</strong>ship between<br />

participants (such as the auditor and the auditee), the more difficult it will be to<br />

achieve compliance, c<strong>on</strong>formity, or improvement.<br />

The following are audit process participants:<br />

• Client: Pers<strong>on</strong> or organizati<strong>on</strong> that requested the audit<br />

• Auditor: Pers<strong>on</strong> carrying out the audit<br />

• Lead auditor or audit team leader: Auditor resp<strong>on</strong>sible for managing the audit<br />

• Auditee: Pers<strong>on</strong> or organizati<strong>on</strong> to be audited<br />

- Escort: Pers<strong>on</strong> assigned to escort the audit team members<br />

- Coordinator: Pers<strong>on</strong> in c<strong>on</strong>tact with the lead auditor or the audit program manager<br />

in order to arrange for the audit<br />

• Audit program manager: Pers<strong>on</strong> resp<strong>on</strong>sible for the audit program<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Audit Process <strong>Part</strong>icipants<br />

The following are audit process participants:<br />

• Client: Pers<strong>on</strong> or organizati<strong>on</strong> that requested the audit<br />

• The Auditor Team: Pers<strong>on</strong>(s) carrying out the audit<br />

Audit program manager: Pers<strong>on</strong> resp<strong>on</strong>sible for the audit program<br />

Lead auditor or audit team leader: Auditor resp<strong>on</strong>sible for managing the audit<br />

Auditor: Pers<strong>on</strong> carrying out the audit<br />

• Auditee: Pers<strong>on</strong> or organizati<strong>on</strong> to be audited<br />

- Coordinator: Pers<strong>on</strong> in c<strong>on</strong>tact with the lead auditor or the audit program manager<br />

in order to arrange for the audit<br />

- Escort: Pers<strong>on</strong> assigned to escort the audit team members<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

List of Resp<strong>on</strong>sibilities and duties<br />

• Client<br />

a. Determines the need for an audit<br />

b. Determines the audit organizati<strong>on</strong> to be used<br />

c. Determines the audit purpose<br />

d. Determines overall audit scope and may c<strong>on</strong>fer with the audit program manager or<br />

lead auditor to define specifics<br />

e. Addresses budget issues<br />

f. May determine the audit team leader or delegate the resp<strong>on</strong>sibility to the audit<br />

program manager<br />

g. May choose to attend audit process meetings such as the exit meeting<br />

h. Receives the audit report<br />

i. Determines and directs the distributi<strong>on</strong> of the audit report<br />

j. Determines the need for follow-up acti<strong>on</strong>s<br />

k. Supports the audit initiative<br />

l. Follows organizati<strong>on</strong>al procedures regarding the audit process<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

List of Resp<strong>on</strong>sibilities and duties<br />

• Client<br />

Resp<strong>on</strong>sibilities<br />

Determines the need for an audit<br />

Determines the audit organizati<strong>on</strong> to be used<br />

Determines the audit purpose<br />

Determines overall audit scope and may c<strong>on</strong>fer with (ask advice from) the audit program manager or lead<br />

auditor to define specifics<br />

Addresses budget issues<br />

May determine the audit team leader or delegate the resp<strong>on</strong>sibility to the audit program manager<br />

May choose to attend audit process meetings such as the exit meeting (entry meeting?)<br />

Receives the audit report<br />

Determines and directs the distributi<strong>on</strong> of the audit report<br />

Determines the need for follow-up acti<strong>on</strong>s<br />

Supports the audit initiative<br />

Follows organizati<strong>on</strong>al procedures regarding the audit process<br />

KIV<br />

Overall Scope<br />

Team Leader<br />

Selecti<strong>on</strong><br />

Follow-up<br />

acti<strong>on</strong><br />

Organizati<strong>on</strong><br />

procedure<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The guidance given in Clauses 5 to 7 is based <strong>on</strong> the six principles outlined below.<br />

a) Integrity: the foundati<strong>on</strong> of professi<strong>on</strong>alism<br />

Auditors and the pers<strong>on</strong> managing an audit programme should:<br />

— perform their work with h<strong>on</strong>esty, diligence, and resp<strong>on</strong>sibility;<br />

— observe and comply with any applicable legal requirements;<br />

— dem<strong>on</strong>strate their competence while performing their work;<br />

— perform their work in an impartial manner, i.e. remain fair and unbiased in all their dealings;<br />

— be sensitive to any influences that may be exerted <strong>on</strong> their judgement while carrying out an audit.<br />

b) Fair presentati<strong>on</strong>: the obligati<strong>on</strong> to report truthfully and accurately<br />

Audit findings, audit c<strong>on</strong>clusi<strong>on</strong>s and audit reports should reflect truthfully and accurately the audit<br />

activities. Significant obstacles encountered during the audit and unresolved diverging opini<strong>on</strong>s between<br />

the audit team and the auditee should be reported. The communicati<strong>on</strong> should be truthful, accurate,<br />

objective, timely, clear and complete.<br />

c) Due professi<strong>on</strong>al care: the applicati<strong>on</strong> of diligence and judgement in auditing<br />

Auditors should exercise due care in accordance with the importance of the task they perform and the<br />

c<strong>on</strong>fidence placed in them by the audit client and other interested parties. An important factor in carrying<br />

out their work with due professi<strong>on</strong>al care is having the ability to make reas<strong>on</strong>ed judgements in all audit<br />

situati<strong>on</strong>s.<br />

d) C<strong>on</strong>fidentiality: security of informati<strong>on</strong><br />

Auditors should exercise discreti<strong>on</strong> in the use and protecti<strong>on</strong> of informati<strong>on</strong> acquired in the course of<br />

their duties. Audit informati<strong>on</strong> should not be used inappropriately for pers<strong>on</strong>al gain by the auditor or the<br />

audit client, or in a manner detrimental to the legitimate interests of the auditee. This c<strong>on</strong>cept includes the<br />

proper handling of sensitive or c<strong>on</strong>fidential informati<strong>on</strong>.<br />

e) Independence: the basis for the impartiality of the audit and objectivity of the audit c<strong>on</strong>clusi<strong>on</strong>s<br />

Auditors should be independent of the activity being audited wherever practicable, and should in all<br />

cases act in a manner that is free from bias and c<strong>on</strong>flict of interest. For internal audits, auditors should<br />

be independent from the operating managers of the functi<strong>on</strong> being audited. Auditors should maintain <strong>on</strong> the audit evidence.<br />

For small organizati<strong>on</strong>s, it may not be possible for internal auditors to be fully independent of the activity<br />

being audited, but every effort should be made to remove bias and encourage objectivity.<br />

f) Evidence-based approach: the rati<strong>on</strong>al method for reaching reliable and reproducible audit c<strong>on</strong>clusi<strong>on</strong>s<br />

in a systematic audit process<br />

Audit evidence should be verifiable. It will in general be based <strong>on</strong> samples of the informati<strong>on</strong> available,<br />

since an audit is c<strong>on</strong>ducted during a finite period of time and with finite resources. An appropriate use of<br />

sampling should be applied, since this is closely related to the c<strong>on</strong>fidence that can be placed in the audit<br />

c<strong>on</strong>clusi<strong>on</strong>s.<br />

<strong>Part</strong> ID<br />

Auditor<br />

a. Understands the purpose and scope of the audit<br />

b. Understands the audit criteria being audited against<br />

c. Prepares for the audit<br />

d. Performs the audit to collect evidence to verify c<strong>on</strong>formance or n<strong>on</strong>c<strong>on</strong>formance to the audit<br />

criteria<br />

e. Records the results of the investigati<strong>on</strong> (perhaps <strong>on</strong> a checklist)<br />

f. Attends the opening and exit meetings<br />

g. Reports findings to the lead auditor<br />

h. Cooperates with the lead auditor<br />

i. Verifies the correcti<strong>on</strong> of previous n<strong>on</strong>c<strong>on</strong>formities if directed to do so<br />

j. Provides input to the formal report if directed to do so by the lead auditor or client<br />

k. Maintains c<strong>on</strong>fidentiality of the audit informati<strong>on</strong><br />

l. Reports c<strong>on</strong>flicts of interest to the lead auditor<br />

m. Is ethical and adheres to an organizati<strong>on</strong> code of c<strong>on</strong>duct or the principles of auditing as<br />

listed in ISO 19011, secti<strong>on</strong> 4<br />

4 Principles of auditing<br />

Auditing is characterized by reliance <strong>on</strong> a number of principles. These principles should help to make the audit<br />

an effective and reliable tool in support of management policies and c<strong>on</strong>trols, by providing informati<strong>on</strong> <strong>on</strong> which<br />

an organizati<strong>on</strong> can act in order to improve its performance. Adherence to these principles is a prerequisite for<br />

providing audit c<strong>on</strong>clusi<strong>on</strong>s that are relevant and sufficient and for enabling auditors, working independently<br />

from <strong>on</strong>e another, to reach similar c<strong>on</strong>clusi<strong>on</strong>s in similar circumstances……<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

7.2.2 Pers<strong>on</strong>al behavior<br />

Auditors should possess the necessary qualities to enable them to act in accordance with the<br />

principles of auditing as described in Clause 4.<br />

Auditors should exhibit professi<strong>on</strong>al behavior during the performance of audit activities,<br />

including being:<br />

•ethical, i.e. fair, truthful, sincere, h<strong>on</strong>est and discreet;<br />

•open-minded, i.e. willing to c<strong>on</strong>sider alternative ideas or points of view;<br />

•diplomatic, i.e. tactful in dealing with people;<br />

•observant, i.e. actively observing physical surroundings and activities;<br />

•perceptive, i.e. aware of and able to understand situati<strong>on</strong>s;<br />

•versatile, i.e. able to readily adapt to different situati<strong>on</strong>s;<br />

•tenacious, i.e. persistent and focused <strong>on</strong> achieving objectives;<br />

•decisive, i.e. able to reach timely c<strong>on</strong>clusi<strong>on</strong>s based <strong>on</strong> logical reas<strong>on</strong>ing and analysis;<br />

•self-reliant, i.e. able to act and functi<strong>on</strong> independently whilst interacting effectively with others;<br />

•acting with fortitude, i.e. able to act resp<strong>on</strong>sibly and ethically, even though these acti<strong>on</strong>s may<br />

not always be popular and may sometimes result in disagreement or c<strong>on</strong>fr<strong>on</strong>tati<strong>on</strong>;<br />

•open to improvement, i.e. willing to learn from situati<strong>on</strong>s, and striving for better audit results;<br />

•culturally sensitive, i.e. observant and respectful to the culture of the auditee;<br />

•collaborative, i.e. effectively interacting with others, including audit team members and the<br />

auditee’s pers<strong>on</strong>nel.<br />

ISO19011:2011<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Lead Auditor/Audit Team Leader<br />

a. Is resp<strong>on</strong>sible for communicati<strong>on</strong> with the client, auditor program management,<br />

and the auditee representative<br />

b. Provides audit team selecti<strong>on</strong> input if requested to do so (?)<br />

c. Communicates audit plan and requirements to auditee<br />

d. Ensures that necessary resources are available to audit team<br />

e. Ensures the team has the appropriate working papers<br />

f. Plans the audit and directs the audit team<br />

g. C<strong>on</strong>ducts audit process meetings<br />

h. Prepares audit report<br />

i. Manages the audit process and resolves c<strong>on</strong>flicts of interest or other pers<strong>on</strong>nel<br />

issues<br />

j. Ensures reports and records are properly filed and safeguarded<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Auditee<br />

a. Coordinates audit with the lead auditor<br />

b. Informs employees of the pending audit purpose and scope<br />

c. Addresses logistical issues with the lead auditor<br />

d. Provides adequate space and privacy for the opening and exit meetings<br />

e. Attends the opening and exit meetings<br />

f. Provides area for auditors to work and meet if requested<br />

g. Cooperates with the auditors<br />

h. Provides access to areas included in the audit scope<br />

i. Acknowledges audit results<br />

j. Takes corrective acti<strong>on</strong> <strong>on</strong> audit findings<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> ID<br />

Audit Program Manager<br />

a. Assigns auditors (not lead author unless delegated) to scheduled audits<br />

b. Ensures availability of resources (budgeting)<br />

c. Establishes a reporting relati<strong>on</strong>ship that ensures objective and impartial audits<br />

d. Qualifies auditors (knowledge, experience, and skills) (Teacher?)<br />

e. Establishes c<strong>on</strong>trols (procedures, criteria, plans, and objectives) for an effective<br />

and efficient audit program<br />

f. Creates, distributes, and maintains audit program schedules<br />

g. Reports audit program progress to management<br />

h. M<strong>on</strong>itors auditor performance<br />

i. Determines audit program objectives and creates plans to accomplish the<br />

objectives<br />

j. Keeps and safeguards audit program informati<strong>on</strong><br />

k. Promotes ethical behavior <strong>on</strong> the part of auditors and those involved in managing<br />

the audit program<br />

The audit participant’s role and involvement will be discussed further as topics are<br />

presented.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE<br />

Chapter 5<br />

Professi<strong>on</strong>al C<strong>on</strong>duct and C<strong>on</strong>sequences<br />

for Auditors/<strong>Part</strong> IE<br />

Ethics affect professi<strong>on</strong>al c<strong>on</strong>duct, and professi<strong>on</strong>al c<strong>on</strong>duct affects credibility. Ethics are basic<br />

philosophical c<strong>on</strong>clusi<strong>on</strong>s about whether c<strong>on</strong>duct and behavior are right or wr<strong>on</strong>g. Ethics are also<br />

moral principles by which an individual is guided. It is imperative (necessity, obligati<strong>on</strong>; command,<br />

order; ) that auditors be ethical (objective and impartial) and behave appropriately (with<br />

professi<strong>on</strong>al c<strong>on</strong>duct) in carrying out their resp<strong>on</strong>sibilities.<br />

• Professi<strong>on</strong>al c<strong>on</strong>duct is the manner in which auditors c<strong>on</strong>duct themselves. Objectivity,<br />

courtesy, h<strong>on</strong>esty, and many other character attributes combine to make up the particular<br />

c<strong>on</strong>duct of any auditor during an audit.<br />

• Liability is the degree of legal resp<strong>on</strong>sibility an individual or company has in a given situati<strong>on</strong>.<br />

Liability issues are beginning to surface with the increase in third- party auditing and<br />

certificati<strong>on</strong>/registrati<strong>on</strong>. The audit participants must provide the audit service in such a<br />

manner as not to cause harm or injury, for which the law gives a remedy to the auditee (as<br />

damages, restituti<strong>on</strong> (reparati<strong>on</strong>, compensati<strong>on</strong>, reimbursement) ,specific performance, or injuncti<strong>on</strong>).<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Professi<strong>on</strong>al c<strong>on</strong>duct is the manner in which auditors<br />

c<strong>on</strong>duct themselves. Objectivity, courtesy, h<strong>on</strong>esty, and<br />

many other character attributes combine to make up the<br />

particular c<strong>on</strong>duct of any auditor during an audit.<br />

<strong>Part</strong> IE1<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

IE1. Professi<strong>on</strong>al C<strong>on</strong>duct And Resp<strong>on</strong>sibilities<br />

Codes of ethics<br />

A code of ethics is a standard for c<strong>on</strong>duct. An auditor’s ethical and moral principles should be compatible with a<br />

formal set of ethical standards. The American Society for Quality (<strong>ASQ</strong>) developed a code of ethics that each<br />

<strong>ASQ</strong> certified individual must pledge to uphold. The c<strong>on</strong>tent of the <strong>ASQ</strong> code of ethics is included in certificati<strong>on</strong><br />

examinati<strong>on</strong>s. Acceptance of the code of ethics by the examinee is required prior to certificati<strong>on</strong>. <strong>ASQ</strong>’s code of<br />

ethics is shown in Figure 5.1.<br />

Many companies and professi<strong>on</strong>al organizati<strong>on</strong>s have developed a code of ethics to guide them in the<br />

performance of their work. The Institute of Internal Auditors (IIA) developed its code of ethics in 1974. The IIA<br />

took a slightly different approach than <strong>ASQ</strong> in the c<strong>on</strong>tent of its code of ethics. Although these codes of ethics<br />

represent different perspectives, they both have the same basic principles described in their standards of<br />

c<strong>on</strong>duct. Figure 5.2 presents the IIA code of ethics. A code of ethics serves as a guideline for performance for<br />

both the auditor and the auditee.<br />

According to Charles A. Mills: A formal code of ethics allows quality auditors to approach audit performance<br />

uniformly. A formal code provides a benchmark against which an auditee and client can measure an auditor’s<br />

activities, establish an auditor’s independence, and recognize potential c<strong>on</strong>flicts of interest. Ethical standards<br />

serve as a general behavioral guide for auditors. Auditors often rely <strong>on</strong> pers<strong>on</strong>al judgments and past<br />

experiences to determine ethical c<strong>on</strong>duct in specific situati<strong>on</strong>s, however. Auditors’ pers<strong>on</strong>alities, temperaments,<br />

auditing styles, and basic percepti<strong>on</strong>s can vary tremendously. By incorporating a set of ethical principles into<br />

their daily audit activities, auditors can maintain the high standards of c<strong>on</strong>duct, h<strong>on</strong>or, and character needed for<br />

audit results to be received as an unbiased and accurate product.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Codes of ethics<br />

The purpose of the American Society for Quality (<strong>ASQ</strong>) Code of Ethics is to establish global standards of c<strong>on</strong>duct and behavior for its members, certificati<strong>on</strong><br />

holders, and any<strong>on</strong>e else who may represent or be perceived to represent <strong>ASQ</strong>. In additi<strong>on</strong> to the code, all applicable <strong>ASQ</strong> policies and procedures should<br />

be followed. Violati<strong>on</strong>s to the Code of Ethics should be reported. Differences in work style or pers<strong>on</strong>alities should be first addressed directly with others<br />

before escalating to an ethics issue. The <strong>ASQ</strong> Professi<strong>on</strong>al Ethics and Qualificati<strong>on</strong>s Committee, appointed annually by the <strong>ASQ</strong> Board of Directors, is<br />

resp<strong>on</strong>sible for interpreting this code and applying it to specific situati<strong>on</strong>s, which may or may not be specifically called out in the text. Disciplinary acti<strong>on</strong>s will<br />

be commensurate with the seriousness of the offense and may include permanent revocati<strong>on</strong> of certificati<strong>on</strong>s and/or expulsi<strong>on</strong> from the society.<br />

Fundamental Principles<br />

<strong>ASQ</strong> requires its representatives to be h<strong>on</strong>est and transparent. Avoid c<strong>on</strong>flicts of interest and plagiarism. Do not harm others. Treat them with respect,<br />

dignity, and fairness. Be professi<strong>on</strong>al and socially resp<strong>on</strong>sible. Advance the role and percepti<strong>on</strong> of the Quality professi<strong>on</strong>al.<br />

Expectati<strong>on</strong>s of a Quality Professi<strong>on</strong>al<br />

• Act with Integrity and H<strong>on</strong>esty<br />

Strive to uphold and advance the integrity, h<strong>on</strong>or, and dignity of the Quality professi<strong>on</strong>.<br />

Be truthful and transparent in all professi<strong>on</strong>al interacti<strong>on</strong>s and activities.<br />

Execute professi<strong>on</strong>al resp<strong>on</strong>sibilities and make decisi<strong>on</strong>s in an objective, factual, and fully informed manner.<br />

Accurately represent and do not mislead others regarding professi<strong>on</strong>al qualificati<strong>on</strong>s, including educati<strong>on</strong>, titles, affiliati<strong>on</strong>s, and certificati<strong>on</strong>s.<br />

Offer services, provide advice, and undertake assignments <strong>on</strong>ly in your areas of competence, expertise, and training.<br />

• Dem<strong>on</strong>strate Resp<strong>on</strong>sibility, Respect, and Fairness<br />

Hold paramount the safety, health, and welfare of individuals, the public, and the envir<strong>on</strong>ment.<br />

Avoid c<strong>on</strong>duct that unjustly harms or threatens the reputati<strong>on</strong> of the Society, its members, or the Quality professi<strong>on</strong>.<br />

Do not intenti<strong>on</strong>ally cause harm to others through words or deeds. Treat others fairly, courteously, with dignity, and without prejudice or<br />

discriminati<strong>on</strong>.<br />

Act and c<strong>on</strong>duct business in a professi<strong>on</strong>al and socially resp<strong>on</strong>sible manner.<br />

Allow diversity in the opini<strong>on</strong>s and pers<strong>on</strong>al lives of others.<br />

• Safeguard Proprietary Informati<strong>on</strong> and Avoid C<strong>on</strong>flicts of Interest<br />

Ensure the protecti<strong>on</strong> and integrity of c<strong>on</strong>fidential informati<strong>on</strong>.<br />

Do not use c<strong>on</strong>fidential informati<strong>on</strong> for pers<strong>on</strong>al gain.<br />

Fully disclose and avoid any real or perceived c<strong>on</strong>flicts of interest that could reas<strong>on</strong>ably impair objectivity or independence in the service of clients,<br />

customers, employers, or the Society.<br />

Give credit where it is due.<br />

Do not plagiarize. Do not use the intellectual property of others without permissi<strong>on</strong>. Document the permissi<strong>on</strong> as it is obtained<br />

https://asq.org/about-asq/code-of-ethics<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Codes of ethics<br />

The purpose of the American Society for Quality (<strong>ASQ</strong>) Code of Ethics is to establish global standards of c<strong>on</strong>duct and behavior for its members, certificati<strong>on</strong> holders, and<br />

any<strong>on</strong>e else who may represent or be perceived to represent <strong>ASQ</strong>. In additi<strong>on</strong> to the code, all applicable <strong>ASQ</strong> policies and procedures should be followed. Violati<strong>on</strong>s to the<br />

Code of Ethics should be reported. Differences in work style or pers<strong>on</strong>alities should be first addressed directly with others before escalating to an ethics issue. The <strong>ASQ</strong><br />

Professi<strong>on</strong>al Ethics and Qualificati<strong>on</strong>s Committee, appointed annually by the <strong>ASQ</strong> Board of Directors, is resp<strong>on</strong>sible for interpreting this code and applying it to specific<br />

situati<strong>on</strong>s, which may or may not be specifically called out in the text. Disciplinary acti<strong>on</strong>s will be commensurate with the seriousness of the offense and may include permanent<br />

revocati<strong>on</strong> of certificati<strong>on</strong>s and/or expulsi<strong>on</strong> from the society.<br />

Fundamental Principles<br />

<strong>ASQ</strong> requires its representatives to be h<strong>on</strong>est and transparent. Avoid c<strong>on</strong>flicts of interest and plagiarism. Do not harm others. Treat them with respect, dignity, and fairness. Be<br />

professi<strong>on</strong>al and socially resp<strong>on</strong>sible. Advance the role and percepti<strong>on</strong> of the Quality professi<strong>on</strong>al.<br />

Expectati<strong>on</strong>s of a Quality Professi<strong>on</strong>al<br />

• Act with Integrity and H<strong>on</strong>esty<br />

Strive to uphold and advance the integrity, h<strong>on</strong>or, and dignity of the Quality professi<strong>on</strong>.<br />

Be truthful and transparent in all professi<strong>on</strong>al interacti<strong>on</strong>s and activities.<br />

Execute professi<strong>on</strong>al resp<strong>on</strong>sibilities and make decisi<strong>on</strong>s in an objective, factual, and fully informed manner.<br />

Accurately represent and do not mislead others regarding professi<strong>on</strong>al qualificati<strong>on</strong>s, including educati<strong>on</strong>, titles, affiliati<strong>on</strong>s, and certificati<strong>on</strong>s.<br />

Offer services, provide advice, and undertake assignments <strong>on</strong>ly in your areas of competence, expertise, and training.<br />

• Dem<strong>on</strong>strate Resp<strong>on</strong>sibility, Respect, and Fairness<br />

Hold paramount the safety, health, and welfare of individuals, the public, and the envir<strong>on</strong>ment.<br />

Avoid c<strong>on</strong>duct that unjustly harms or threatens the reputati<strong>on</strong> of the Society, its members, or the Quality professi<strong>on</strong>.<br />

Do not intenti<strong>on</strong>ally cause harm to others through words or deeds. Treat others fairly, courteously, with dignity, and without prejudice or<br />

discriminati<strong>on</strong>.<br />

Act and c<strong>on</strong>duct business in a professi<strong>on</strong>al and socially resp<strong>on</strong>sible manner.<br />

Allow diversity in the opini<strong>on</strong>s and pers<strong>on</strong>al lives of others.<br />

• Safeguard Proprietary Informati<strong>on</strong> and Avoid C<strong>on</strong>flicts of Interest<br />

Ensure the protecti<strong>on</strong> and integrity of c<strong>on</strong>fidential informati<strong>on</strong>.<br />

Do not use c<strong>on</strong>fidential informati<strong>on</strong> for pers<strong>on</strong>al gain.<br />

Fully disclose and avoid any real or perceived c<strong>on</strong>flicts of interest that could reas<strong>on</strong>ably impair objectivity or independence in the service of clients,<br />

customers, employers, or the Society.<br />

Give credit where it is due.<br />

Do not plagiarize. Do not use the intellectual property of others without permissi<strong>on</strong>. Document the permissi<strong>on</strong> as it is obtained<br />

https://asq.org/about-asq/code-of-ethics<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Codes of ethics<br />

The purpose of the American Society for Quality (<strong>ASQ</strong>) Code of Ethics is to establish global standards of c<strong>on</strong>duct and behavior for its members, certificati<strong>on</strong> holders, and any<strong>on</strong>e else who may represent or be<br />

perceived to represent <strong>ASQ</strong>. In additi<strong>on</strong> to the code, all applicable <strong>ASQ</strong> policies and procedures should be followed. Violati<strong>on</strong>s to the Code of Ethics should be reported. Differences in work style or pers<strong>on</strong>alities<br />

should be first addressed directly with others before escalating to an ethics issue. The <strong>ASQ</strong> Professi<strong>on</strong>al Ethics and Qualificati<strong>on</strong>s Committee, appointed annually by the <strong>ASQ</strong> Board of Directors, is resp<strong>on</strong>sible for<br />

interpreting this code and applying it to specific situati<strong>on</strong>s, which may or may not be specifically called out in the text. Disciplinary acti<strong>on</strong>s will be commensurate with the seriousness of the offense and may include<br />

permanent revocati<strong>on</strong> of certificati<strong>on</strong>s and/or expulsi<strong>on</strong> from the society.<br />

<strong>Part</strong> IE1<br />

Fundamental Principles<br />

<strong>ASQ</strong> requires its representatives to be h<strong>on</strong>est and transparent. Avoid c<strong>on</strong>flicts of interest and plagiarism. Do not harm others. Treat them with respect, dignity, and fairness. Be professi<strong>on</strong>al and socially resp<strong>on</strong>sible.<br />

Advance the role and percepti<strong>on</strong> of the Quality professi<strong>on</strong>al.<br />

Expectati<strong>on</strong>s of a Quality Professi<strong>on</strong>al<br />

• Act with Integrity and H<strong>on</strong>esty<br />

Strive to uphold and advance the integrity, h<strong>on</strong>or, and dignity of the Quality professi<strong>on</strong>.<br />

Be truthful and transparent in all professi<strong>on</strong>al interacti<strong>on</strong>s and activities.<br />

Execute professi<strong>on</strong>al resp<strong>on</strong>sibilities and make decisi<strong>on</strong>s in an objective, factual, and fully informed manner.<br />

Accurately represent and do not mislead others regarding professi<strong>on</strong>al qualificati<strong>on</strong>s, including educati<strong>on</strong>, titles, affiliati<strong>on</strong>s, and certificati<strong>on</strong>s.<br />

Offer services, provide advice, and undertake assignments <strong>on</strong>ly in your areas of competence, expertise, and training.<br />

• Dem<strong>on</strong>strate Resp<strong>on</strong>sibility, Respect, and Fairness<br />

Hold paramount the safety, health, and welfare of individuals, the public, and the envir<strong>on</strong>ment.<br />

Avoid c<strong>on</strong>duct that unjustly harms or threatens the reputati<strong>on</strong> of the Society, its members, or the Quality professi<strong>on</strong>.<br />

Do not intenti<strong>on</strong>ally cause harm to others through words or deeds. Treat others fairly, courteously, with dignity, and without prejudice or discriminati<strong>on</strong>.<br />

Act and c<strong>on</strong>duct business in a professi<strong>on</strong>al and socially resp<strong>on</strong>sible manner.<br />

Allow diversity in the opini<strong>on</strong>s and pers<strong>on</strong>al lives of others.<br />

• Safeguard Proprietary Informati<strong>on</strong> and Avoid C<strong>on</strong>flicts of Interest<br />

Ensure the protecti<strong>on</strong> and integrity of c<strong>on</strong>fidential informati<strong>on</strong>.<br />

Do not use c<strong>on</strong>fidential informati<strong>on</strong> for pers<strong>on</strong>al gain.<br />

Fully disclose and avoid any real or perceived c<strong>on</strong>flicts of interest that could reas<strong>on</strong>ably impair objectivity or independence in the service of clients, customers, employers, or<br />

the Society.<br />

Give credit where it is due.<br />

Do not plagiarize. Do not use the intellectual property of others without permissi<strong>on</strong>. Document the permissi<strong>on</strong> as it is obtained<br />

https://asq.org/about-asq/code-of-ethics<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Codes of ethics<br />

The purpose of the American Society for Quality (<strong>ASQ</strong>) Code of Ethics is to establish global standards of c<strong>on</strong>duct and behavior for its members, certificati<strong>on</strong> holders, and any<strong>on</strong>e else who may represent or be<br />

perceived to represent <strong>ASQ</strong>. In additi<strong>on</strong> to the code, all applicable <strong>ASQ</strong> policies and procedures should be followed. Violati<strong>on</strong>s to the Code of Ethics should be reported. Differences in work style or pers<strong>on</strong>alities<br />

should be first addressed directly with others before escalating to an ethics issue. The <strong>ASQ</strong> Professi<strong>on</strong>al Ethics and Qualificati<strong>on</strong>s Committee, appointed annually by the <strong>ASQ</strong> Board of Directors, is resp<strong>on</strong>sible for<br />

interpreting this code and applying it to specific situati<strong>on</strong>s, which may or may not be specifically called out in the text. Disciplinary acti<strong>on</strong>s will be commensurate with the seriousness of the offense and may include<br />

permanent revocati<strong>on</strong> of certificati<strong>on</strong>s and/or expulsi<strong>on</strong> from the society.<br />

<strong>Part</strong> IE1<br />

Fundamental Principles<br />

<strong>ASQ</strong> requires its representatives to be h<strong>on</strong>est and transparent. Avoid c<strong>on</strong>flicts of interest and plagiarism. Do not harm others. Treat them with respect, dignity, and fairness. Be professi<strong>on</strong>al and socially resp<strong>on</strong>sible.<br />

Advance the role and percepti<strong>on</strong> of the Quality professi<strong>on</strong>al.<br />

Expectati<strong>on</strong>s of a Quality Professi<strong>on</strong>al<br />

• Act with Integrity and H<strong>on</strong>esty<br />

Strive to uphold and advance the integrity, h<strong>on</strong>or, and dignity of the Quality professi<strong>on</strong>.<br />

Be truthful and transparent in all professi<strong>on</strong>al interacti<strong>on</strong>s and activities.<br />

Execute professi<strong>on</strong>al resp<strong>on</strong>sibilities and make decisi<strong>on</strong>s in an objective, factual, and fully informed manner.<br />

Accurately represent and do not mislead others regarding professi<strong>on</strong>al qualificati<strong>on</strong>s, including educati<strong>on</strong>, titles, affiliati<strong>on</strong>s, and certificati<strong>on</strong>s.<br />

Offer services, provide advice, and undertake assignments <strong>on</strong>ly in your areas of competence, expertise, and training.<br />

• Dem<strong>on</strong>strate Resp<strong>on</strong>sibility, Respect, and Fairness<br />

Hold paramount the safety, health, and welfare of individuals, the public, and the envir<strong>on</strong>ment.<br />

Avoid c<strong>on</strong>duct that unjustly harms or threatens the reputati<strong>on</strong> of the Society, its members, or the Quality professi<strong>on</strong>.<br />

Do not intenti<strong>on</strong>ally cause harm to others through words or deeds. Treat others fairly, courteously, with dignity, and without prejudice or discriminati<strong>on</strong>.<br />

Act and c<strong>on</strong>duct business in a professi<strong>on</strong>al and socially resp<strong>on</strong>sible manner.<br />

Allow diversity in the opini<strong>on</strong>s and pers<strong>on</strong>al lives of others.<br />

• Safeguard Proprietary Informati<strong>on</strong> and Avoid C<strong>on</strong>flicts of Interest<br />

Ensure the protecti<strong>on</strong> and integrity of c<strong>on</strong>fidential informati<strong>on</strong>.<br />

Do not use c<strong>on</strong>fidential informati<strong>on</strong> for pers<strong>on</strong>al gain.<br />

Fully disclose and avoid any real or perceived c<strong>on</strong>flicts of interest that could reas<strong>on</strong>ably impair objectivity or independence in the service of clients, customers, employers, or<br />

the Society.<br />

Give credit where it is due.<br />

Do not plagiarize. Do not use the intellectual property of others without permissi<strong>on</strong>. Document the permissi<strong>on</strong> as it is obtained<br />

https://asq.org/about-asq/code-of-ethics<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Codes of ethics<br />

The purpose of the American Society for Quality (<strong>ASQ</strong>) Code of Ethics is to establish global standards of c<strong>on</strong>duct and behavior for its members, certificati<strong>on</strong> holders, and any<strong>on</strong>e else who may represent or be<br />

perceived to represent <strong>ASQ</strong>. In additi<strong>on</strong> to the code, all applicable <strong>ASQ</strong> policies and procedures should be followed. Violati<strong>on</strong>s to the Code of Ethics should be reported. Differences in work style or pers<strong>on</strong>alities<br />

should be first addressed directly with others before escalating to an ethics issue. The <strong>ASQ</strong> Professi<strong>on</strong>al Ethics and Qualificati<strong>on</strong>s Committee, appointed annually by the <strong>ASQ</strong> Board of Directors, is resp<strong>on</strong>sible for<br />

interpreting this code and applying it to specific situati<strong>on</strong>s, which may or may not be specifically called out in the text. Disciplinary acti<strong>on</strong>s will be commensurate with the seriousness of the offense and may include<br />

permanent revocati<strong>on</strong> of certificati<strong>on</strong>s and/or expulsi<strong>on</strong> from the society.<br />

Fundamental Principles<br />

<strong>ASQ</strong> requires its representatives to be h<strong>on</strong>est and transparent. Avoid c<strong>on</strong>flicts of interest and plagiarism. Do not harm others. Treat them with respect, dignity, and fairness. Be professi<strong>on</strong>al and socially resp<strong>on</strong>sible.<br />

Advance the role and percepti<strong>on</strong> of the Quality professi<strong>on</strong>al.<br />

Expectati<strong>on</strong>s of a Quality Professi<strong>on</strong>al<br />

• Act with Integrity and H<strong>on</strong>esty<br />

Strive to uphold and advance the integrity, h<strong>on</strong>or, and dignity of the Quality professi<strong>on</strong>.<br />

Be truthful and transparent in all professi<strong>on</strong>al interacti<strong>on</strong>s and activities.<br />

Execute professi<strong>on</strong>al resp<strong>on</strong>sibilities and make decisi<strong>on</strong>s in an objective, factual, and fully informed manner.<br />

Accurately represent and do not mislead others regarding professi<strong>on</strong>al qualificati<strong>on</strong>s, including educati<strong>on</strong>, titles, affiliati<strong>on</strong>s, and certificati<strong>on</strong>s.<br />

Offer services, provide advice, and undertake assignments <strong>on</strong>ly in your areas of competence, expertise, and training.<br />

• Dem<strong>on</strong>strate Resp<strong>on</strong>sibility, Respect, and Fairness<br />

Hold paramount the safety, health, and welfare of individuals, the public, and the envir<strong>on</strong>ment.<br />

Avoid c<strong>on</strong>duct that unjustly harms or threatens the reputati<strong>on</strong> of the Society, its members, or the Quality professi<strong>on</strong>.<br />

Do not intenti<strong>on</strong>ally cause harm to others through words or deeds. Treat others fairly, courteously, with dignity, and without prejudice or discriminati<strong>on</strong>.<br />

Act and c<strong>on</strong>duct business in a professi<strong>on</strong>al and socially resp<strong>on</strong>sible manner.<br />

Allow diversity in the opini<strong>on</strong>s and pers<strong>on</strong>al lives of others.<br />

• Safeguard Proprietary Informati<strong>on</strong> and Avoid C<strong>on</strong>flicts of Interest<br />

Ensure the protecti<strong>on</strong> and integrity of c<strong>on</strong>fidential informati<strong>on</strong>.<br />

Do not use c<strong>on</strong>fidential informati<strong>on</strong> for pers<strong>on</strong>al gain.<br />

Fully disclose and avoid any real or perceived c<strong>on</strong>flicts of interest that could reas<strong>on</strong>ably impair objectivity or independence in the service of clients, customers, employers, or<br />

the Society.<br />

Give credit where it is due.<br />

Do not plagiarize. Do not use the intellectual property of others without permissi<strong>on</strong>. Document the permissi<strong>on</strong> as it is obtained<br />

https://asq.org/about-asq/code-of-ethics<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

https://asq.org/about-asq/code-of-ethics<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

The Institute of Internal Auditors code of Ethics<br />

The Code of Ethics states the principles and expectati<strong>on</strong>s governing the behavior of individuals and organizati<strong>on</strong>s in the c<strong>on</strong>duct<br />

of internal auditing. It describes the minimum requirements for c<strong>on</strong>duct, and behavioral expectati<strong>on</strong>s rather than specific activities.<br />

Code of Ethics—Principles<br />

Internal auditors are expected to apply and uphold the following principles:<br />

1. Integrity<br />

The integrity of internal auditors establishes trust and thus provides the basis for reliance <strong>on</strong> their judgment.<br />

2. Objectivity<br />

Internal auditors exhibit the highest level of professi<strong>on</strong>al objectivity in gathering, evaluating, and communicating informati<strong>on</strong> about the activity or process<br />

being examined. Internal auditors make a balanced assessment of all the relevant circumstances and are not unduly influenced by their own interests or by<br />

others in forming judgments.<br />

3. C<strong>on</strong>fidentiality<br />

Internal auditors respect the value and ownership of informati<strong>on</strong> they receive and do not disclose informati<strong>on</strong> without appropriate authority unless there is a<br />

legal or professi<strong>on</strong>al obligati<strong>on</strong> to do so.<br />

4. Competency<br />

Internal auditors apply the knowledge, skills, and experience needed in the performance of internal audit services.<br />

Rules of C<strong>on</strong>duct<br />

1. Integrity—Internal auditors:<br />

1.1. Shall perform their work with h<strong>on</strong>esty, diligence, and resp<strong>on</strong>sibility.<br />

1.2. Shall observe the law and make disclosures expected by the law and the professi<strong>on</strong>.<br />

1.3. Shall not knowingly be a party to any illegal activity, or engage in acts that are discreditable to the professi<strong>on</strong> of internal auditing or to the organizati<strong>on</strong>.<br />

1.4. Shall respect and c<strong>on</strong>tribute to the legitimate and ethical objectives of the organizati<strong>on</strong>.<br />

2. Objectivity—Internal auditors:<br />

2.1. Shall not participate in any activity or relati<strong>on</strong>ship that may impair or be presumed to impair their unbiased assessment. This participati<strong>on</strong> includes those<br />

activities or relati<strong>on</strong>ships that may be in c<strong>on</strong>flict with the interests of the organizati<strong>on</strong>.<br />

2.2. Shall not accept anything that may impair or be presumed to impair their professi<strong>on</strong>al judgment.<br />

2.3. Shall disclose all material facts known to them that, if not disclosed, may distort the reporting of activities under review.<br />

3. C<strong>on</strong>fidentiality—Internal auditors:<br />

3.1. Shall be prudent in the use and protecti<strong>on</strong> of informati<strong>on</strong> acquired in the course of their duties.<br />

3.2. Shall not use informati<strong>on</strong> for any pers<strong>on</strong>al gain or in any manner that would be c<strong>on</strong>trary to the law or detrimental to the legitimate and ethical objectives<br />

of the organizati<strong>on</strong>.<br />

4. Competency—Internal auditors:<br />

4.1. Shall engage <strong>on</strong>ly in those services for which they have the necessary knowledge, skills, and experience.<br />

4.2. Shall perform internal audit services in accordance with the Internati<strong>on</strong>al Standards for the Professi<strong>on</strong>al Practice of Internal Auditing (Standards).<br />

4.3. Shall c<strong>on</strong>tinually improve their proficiency and the effectiveness and quality of their services.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

The Institute of Internal Auditors code of Ethics<br />

1.3. Shall not knowingly be a party to any illegal activity,<br />

or engage in acts that are discreditable to the professi<strong>on</strong> of internal auditing or to the organizati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

The Institute of Internal Auditors code of Ethics<br />

1.3. Shall not knowingly be a party to any illegal activity,<br />

or engage in acts that are discreditable to the professi<strong>on</strong> of internal auditing or to the organizati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

The Institute of Internal Auditors code of Ethics<br />

1.3. Shall not knowingly be a party to any illegal activity,<br />

or engage in acts that are discreditable to the professi<strong>on</strong> of internal auditing or to the organizati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The Institute of Internal<br />

Auditors code of Ethics<br />

1.3. Shall not knowingly be a party to any illegal activity, or<br />

engage in acts that are discreditable to the professi<strong>on</strong> of internal<br />

auditing or to the organizati<strong>on</strong>.<br />

<strong>Part</strong> IE1<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


The Institute of Internal<br />

Auditors code of Ethics<br />

1.3. Shall not knowingly be a party to any illegal activity, or<br />

engage in acts that are discreditable to the professi<strong>on</strong> of internal<br />

auditing or to the organizati<strong>on</strong>.<br />

<strong>Part</strong> IE1<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>flict of Interest<br />

The subject of c<strong>on</strong>flict of interest often arises during audits. C<strong>on</strong>flict-of-interest situati<strong>on</strong>s sometimes<br />

encountered prior to and during audits include:<br />

• Previous employment of the auditor (or close relative) by the auditee or a major competitor of the auditee,<br />

regardless of the reas<strong>on</strong> for separati<strong>on</strong><br />

• Holding of significant amounts of stocks or b<strong>on</strong>ds in the auditee’s business or that of a major competitor<br />

• Previous or current close working relati<strong>on</strong>ship (for example, teaming partner, major supplier) with the<br />

organizati<strong>on</strong><br />

• Prior involvement by the auditor in developing the quality program or procedures used by the group being<br />

audited<br />

• Desire to be hired by the group being audited<br />

• Close friendships within the group being audited<br />

• Offer by auditee of m<strong>on</strong>ey, goods, or services in the nature of a bribe, kickback, or secret commissi<strong>on</strong><br />

• Acceptance of a gift (m<strong>on</strong>ey, gratuity, or other thing of value) with more than a nominal value, or<br />

involvement in auditee- sp<strong>on</strong>sored sales promoti<strong>on</strong>s or other activities that may represent or be c<strong>on</strong>strued<br />

as a c<strong>on</strong>flict of interest<br />

• Performance of outside work for the auditee that might adversely affect the auditor’s performance or<br />

judgment <strong>on</strong> the job<br />

The auditor should be aware of the different types of c<strong>on</strong>flicts of interest. Prior to accepting an audit, auditors<br />

should examine their activities and relati<strong>on</strong>ship with the auditee and determine whether an actual or potential<br />

c<strong>on</strong>flict of interest exists. For example, if after the start of an audit an auditor realizes that <strong>on</strong>e of the department<br />

managers of the auditee organizati<strong>on</strong> is a past pers<strong>on</strong>al friend or mentor, the auditor should immediately report<br />

(to whom?) a potential c<strong>on</strong>flict of interest even though the audit of the <strong>on</strong>-site activities has already started.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>flict of Interest Exists<br />

(am<strong>on</strong>g other obvious situati<strong>on</strong>s)<br />

Previous employment of<br />

the auditor by Auditee or<br />

Competitor.<br />

regardless of the reas<strong>on</strong> for<br />

separati<strong>on</strong><br />

Close<br />

friendships<br />

within the<br />

group<br />

Holding of<br />

significant<br />

amounts of<br />

stocks<br />

Desire to<br />

be hired<br />

Previous or<br />

current close<br />

working<br />

relati<strong>on</strong>ship<br />

Prior involvement<br />

by the auditor in<br />

developing the<br />

quality program<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>flict of Interest Exists<br />

(am<strong>on</strong>g other obvious situati<strong>on</strong>s)<br />

Auditee<br />

Ex-Girl Friend<br />

Auditee<br />

Friend<br />

Yet to be GF<br />

Jack Ma<br />

Daughter<br />

Auditor<br />

Auditee<br />

Ex-Colleague<br />

Previous<br />

employment of the<br />

auditor by Auditee or<br />

Competitor.<br />

Close<br />

friendships<br />

within the<br />

group<br />

Holding of<br />

significant<br />

amounts of<br />

stocks<br />

C<strong>on</strong>flicts<br />

Desire to<br />

be hired<br />

Previous or<br />

current close<br />

working<br />

relati<strong>on</strong>ship<br />

Prior involvement<br />

by the auditor in<br />

developing the<br />

quality program<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

• When a C<strong>on</strong>flict of Interest Exists<br />

When there is an actual or potential c<strong>on</strong>flict of interest with the organizati<strong>on</strong> or people<br />

being audited, the auditor must relay this informati<strong>on</strong> to audit program management<br />

or decline to c<strong>on</strong>duct the audit, whichever is more appropriate.<br />

Acti<strong>on</strong>s that management and the audit team leader can take include:<br />

• Ensuring that sufficient time has passed to eliminate the c<strong>on</strong>flict (?)<br />

• Assigning a different auditor to cover the specific area of c<strong>on</strong>flict<br />

• Removing the auditor or the audit team leader from the team<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

When a C<strong>on</strong>flict<br />

of Interest<br />

Exists<br />

Acti<strong>on</strong>s that management<br />

and the audit team leader<br />

can take include:<br />

• Ensuring that<br />

sufficient time has<br />

passed to eliminate<br />

the c<strong>on</strong>flict.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>fidentiality<br />

With processes, formulas, and equipment being developed by individual companies, the questi<strong>on</strong> of<br />

c<strong>on</strong>fidentiality of proprietary informati<strong>on</strong> has become a major c<strong>on</strong>cern during audits. Businesses could suffer<br />

great financial loss if customers or competitors were to gain access to proprietary processing knowledge,<br />

formulas, and trade secrets.<br />

The auditor must maintain c<strong>on</strong>fidentiality (How the c<strong>on</strong>fidentiality is maintain?), but not to the point of<br />

performing an inadequate audit. Each auditor needs to be prepared to sign agreements or utilize techniques<br />

for working around a proprietary area.<br />

• C<strong>on</strong>fidentiality and Security C<strong>on</strong>cerns<br />

Auditees can use a c<strong>on</strong>fidentiality agreement or a n<strong>on</strong>disclosure agreement to protect<br />

their interests. Both serve the same purpose- to keep proprietary informati<strong>on</strong><br />

within the c<strong>on</strong>trol of the auditee.<br />

• C<strong>on</strong>fidentiality Agreement<br />

An auditor is often expected to sign a c<strong>on</strong>fidentiality or n<strong>on</strong>disclosure agreement<br />

before an audit begins. In general, these agreements require that the auditor not disclose<br />

any proprietary informati<strong>on</strong> gained during the audit. They may be extended<br />

to the auditor’s company, family, assigns, and so <strong>on</strong>, through legal language. Some<br />

c<strong>on</strong>fidentiality agreements that auditees expect the auditor to sign before being<br />

allowed to perform an audit of proprietary areas have become particularly <strong>on</strong>erous<br />

(burdensome, laborious; oppressive;). Often these are written in legal language<br />

and are understandable <strong>on</strong>ly by some<strong>on</strong>e familiar with the legal definiti<strong>on</strong>s<br />

of the words used. Auditors are normally not authorized to obligate their organizati<strong>on</strong>s.<br />

Agreements should c<strong>on</strong>tain a release that takes effect if proprietary informati<strong>on</strong> becomes public.<br />

An auditor should receive the agreement in advance so that it can be reviewed and approved<br />

by the auditing organizati<strong>on</strong>’s legal counsel or designated authority before the auditor signs it.<br />

The auditor must maintain c<strong>on</strong>fidentiality<br />

(How the c<strong>on</strong>fidentiality is maintain?), but<br />

not to the point of performing an<br />

inadequate audit. Each auditor needs to<br />

be prepared to sign agreements or utilize<br />

techniques for working around a<br />

proprietary area.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>fidentiality<br />

Often these are written in legal language and are understandable <strong>on</strong>ly by<br />

some<strong>on</strong>e familiar with the legal definiti<strong>on</strong>s of the words used.<br />

• Auditors are normally not authorized to obligate their organizati<strong>on</strong>s.<br />

• Agreements should c<strong>on</strong>tain a release that takes effect if proprietary<br />

informati<strong>on</strong> becomes public.<br />

• An auditor should receive the agreement in advance so that it can be<br />

reviewed and approved by the auditing organizati<strong>on</strong>’s legal counsel or<br />

designated authority before the auditor signs it.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

IE2-Gossip<br />

An auditor was asked to sign a four- page c<strong>on</strong>fidentiality agreement<br />

before being allowed to perform an audit of a supplier. The agreement<br />

was written in legal language and obligated the auditor, the<br />

auditor’s heirs, the auditor’s assigns, and the auditor’s company to<br />

pay for any damages that might come about if the informati<strong>on</strong> was<br />

obtained by the supplier’s competitors. There was no time frame for<br />

the agreement, so if the informati<strong>on</strong> was disclosed at any time and by<br />

any pers<strong>on</strong>, they were all liable for the damages. The audit organizati<strong>on</strong>’s<br />

attorney advised against signing this agreement, and the audit<br />

team used alternate techniques to determine whether the process was<br />

adequate.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>duct<br />

Discussing proprietary informati<strong>on</strong> with others destroys the integrity of the audit functi<strong>on</strong>. While it is acceptable<br />

for an auditor to discuss actual audit experiences with other auditors, the discussi<strong>on</strong> should be generic so that<br />

the auditee cannot be identified. Proprietary informati<strong>on</strong> should never be divulged (act of revealing) in a sharing<br />

situati<strong>on</strong> with other auditors.<br />

Even body language could disclose proprietary informati<strong>on</strong>. For example, when asked a questi<strong>on</strong> about a<br />

proprietary process, auditors who shrug their shoulders, roll their eyes, or raise their eyebrows could signal the<br />

answer even if no words are spoken.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>duct<br />

Discussing proprietary informati<strong>on</strong> with others destroys<br />

the integrity of the audit functi<strong>on</strong>. While it is acceptable<br />

for an auditor to discuss actual audit experiences with<br />

other auditors, the discussi<strong>on</strong> should be generic so that<br />

the auditee cannot be identified. Proprietary informati<strong>on</strong><br />

should never be divulged (act of revealing) in a sharing<br />

situati<strong>on</strong> with other auditors.<br />

Even body language could disclose proprietary<br />

informati<strong>on</strong>. For example, when asked a questi<strong>on</strong> about<br />

a proprietary process, auditors who shrug their<br />

shoulders, roll their eyes, or raise their eyebrows could<br />

signal the answer even if no words are spoken.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>duct<br />

Discussing proprietary informati<strong>on</strong> with others destroys the<br />

integrity of the audit functi<strong>on</strong>. While it is acceptable for an auditor<br />

to discuss actual audit experiences with other auditors, the<br />

discussi<strong>on</strong> should be generic so that the auditee cannot be<br />

identified. Proprietary informati<strong>on</strong> should never be divulged (act of<br />

revealing) in a sharing situati<strong>on</strong> with other auditors.<br />

Even body language could disclose proprietary informati<strong>on</strong>. For<br />

example, when asked a questi<strong>on</strong> about a proprietary process,<br />

auditors who shrug their shoulders, roll their eyes, or raise their<br />

eyebrows could signal the answer even if no words are spoken.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>duct<br />

For example, when asked a questi<strong>on</strong> about a<br />

proprietary process, auditors who shrug their shoulders,<br />

roll their eyes, or raise their eyebrows could signal the<br />

answer even if no words are spoken.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

C<strong>on</strong>duct<br />

For example, when asked a questi<strong>on</strong> about a proprietary process, auditors who shrug their shoulders, roll their eyes, or raise their eyebrows could<br />

signal the answer even if no words are spoken.<br />

Discussing proprietary informati<strong>on</strong> with others destroys the integrity of the audit functi<strong>on</strong>.<br />

While it is acceptable for an auditor to discuss actual audit experiences with other<br />

auditors, the discussi<strong>on</strong> should be generic so that the auditee cannot be identified.<br />

Proprietary informati<strong>on</strong> should never be divulged (act of revealing) in a sharing situati<strong>on</strong><br />

with other auditors. Even body language could disclose proprietary informati<strong>on</strong>. For<br />

example, when asked a questi<strong>on</strong> about a proprietary process, auditors who shrug their<br />

shoulders, roll their eyes, or raise their eyebrows could signal the answer even if no<br />

words are spoken.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Techniques<br />

Several techniques are available to the auditor to ensure that proprietary informati<strong>on</strong> remains proprietary.<br />

• No Note, Only Memory<br />

When auditing in an undisclosed area (The area could be intellectual or physical area?) , the auditor can rely<br />

<strong>on</strong> memory and not write audit notes. Any notes could become accessible to the public and would be<br />

discoverable in litigati<strong>on</strong>. An auditor can ―audit around‖ an undisclosed area. The auditor needs to be very<br />

flexible to be able to accomplish audit objectives when the auditee erects barriers.<br />

• Check Input<br />

A company may be in the process of getting a patent <strong>on</strong> a new method, for example, and may flatly refuse to<br />

allow the auditor to view a certain porti<strong>on</strong> of that system. In these instances, the auditor must respect the<br />

auditee’s wishes and audit around the undisclosed area. If the inputs going into the undisclosed area appear to<br />

be correct and the outputs are likewise acceptable, then the auditor may assume that the undisclosed process<br />

is doing its job correctly.<br />

• Interview Pers<strong>on</strong>nel Away From Undisclosed Area (physical area?)<br />

Another technique is to remove pers<strong>on</strong>nel from the undisclosed area for interviews.<br />

• <strong>Part</strong>ial Review of Document or Auditee Certify Relevant Document in Place<br />

The auditor can view parts of a document or have the auditee certify it. A company sometimes will refuse to<br />

allow an auditor to look at the procedure for a certain process even though a written procedure is required. To<br />

verify that the procedure exists, the auditor can ask the auditee to certify that the procedure does exist and that<br />

it covers the relevant process. The auditee may allow the auditor to view n<strong>on</strong>-c<strong>on</strong>fidential secti<strong>on</strong>s of the<br />

document. The auditor may never actually view all the details but should do as much as practical to ensure that<br />

a procedure does exist and is approved for use.<br />

Such situati<strong>on</strong>s often resolve themselves <strong>on</strong> subsequent audits involving the same parties. As an auditee<br />

becomes more comfortable with the audit team and places greater trust in the ethics of the team members, the<br />

need to limit access to certain areas often becomes n<strong>on</strong>existent.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Greater Trust In The Ethics Of The Team Members<br />

(Acquaintances?)<br />

Such situati<strong>on</strong>s often resolve themselves <strong>on</strong> subsequent audits involving the same parties. As an auditee<br />

becomes more comfortable with the audit team and places greater trust in the ethics of the team members, the<br />

need to limit access to certain areas often becomes n<strong>on</strong>existent.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Techniques<br />

Several techniques are available to the auditor to ensure that proprietary informati<strong>on</strong> remains proprietary.<br />

• No Note, Only Memory<br />

When auditing in an undisclosed area (The area could be intellectual or physical area?), the auditor can rely <strong>on</strong><br />

memory and not write audit notes. Any notes could become accessible to the public and would be discoverable<br />

in litigati<strong>on</strong>. An auditor can ―audit around‖ an undisclosed area. The auditor needs to be very flexible to be able<br />

to accomplish audit objectives when the auditee erects barriers.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Security<br />

Companies in certain highly sensitive industries, such as<br />

those involved in nati<strong>on</strong>al defense, may require that<br />

auditors have or obtain security clearances. This<br />

requirement should be determined well in advance of the<br />

audit to permit sufficient time for processing the request.<br />

Without the proper security clearance, an auditor may be<br />

restricted from certain areas of a company.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Security<br />

Companies in certain highly<br />

sensitive industries, such as those<br />

involved in nati<strong>on</strong>al defense, may<br />

require that auditors have or obtain<br />

security clearances. This<br />

requirement should be determined<br />

well in advance of the audit to<br />

permit sufficient time for processing<br />

the request. Without the proper<br />

security clearance, an auditor may<br />

be restricted from certain areas of a<br />

company.<br />

Our business<br />

is life itself<br />

孙 红 雷<br />

HL.Sun<br />

https://www.thenewec<strong>on</strong>omy.com/business/chinese-merger-set-to-create-worlds-sec<strong>on</strong>d-largest-steelmaker<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Security<br />

Companies in certain highly sensitive industries, such as those involved in<br />

nati<strong>on</strong>al defense, may require that auditors have or obtain security<br />

clearances. This requirement should be determined well in advance of the<br />

audit to permit sufficient time for processing the request. Without the proper<br />

security clearance, an auditor may be restricted from certain areas of a<br />

company.<br />

https://www.thenewec<strong>on</strong>omy.com/business/chinese-merger-set-to-create-worlds-sec<strong>on</strong>d-largest-steelmaker<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Trust<br />

The auditee must be c<strong>on</strong>fident that the auditor will<br />

c<strong>on</strong>duct the audit professi<strong>on</strong>ally and that the auditor<br />

possesses the integrity and technical knowledge to<br />

successfully complete the audit. Auditors are expected to<br />

exercise due care while performing their activities. This<br />

means that an auditor should be sufficiently competent to<br />

arrive at c<strong>on</strong>clusi<strong>on</strong>s similar to those that another auditor<br />

would reach in the same or similar circumstances. Since<br />

an audit <strong>on</strong>ly samples a particular product, process, or<br />

system at a particular point in time, an auditor cannot be<br />

held resp<strong>on</strong>sible if an audit fails to recognize all<br />

deficiencies or irregularities in a system, as l<strong>on</strong>g as that<br />

auditor has used:<br />

• theoretically sound sampling techniques,<br />

• has complied with applicable standards, and<br />

• has adhered to the code of ethics.<br />

In additi<strong>on</strong> to the usual resp<strong>on</strong>sibilities, an auditor may<br />

need to address difficult situati<strong>on</strong>s that require careful<br />

handling for successful resoluti<strong>on</strong>. Possible c<strong>on</strong>flicts of<br />

interest should be recognized and rec<strong>on</strong>ciled before an<br />

audit begins.<br />

The detecti<strong>on</strong> of unsafe, unethical, or even illegal<br />

practices during an audit may rapidly change the planned<br />

course of the audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Trust<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Trust<br />

The detecti<strong>on</strong> of unsafe,<br />

unethical, or even illegal<br />

practices during an audit<br />

may rapidly change the<br />

planned course of the<br />

audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

IE1-Gossip<br />

One way to work through the lack of a security clearance is to be<br />

c<strong>on</strong>stantly escorted, with classified areas, equipment, and activities<br />

shielded from view. This way, the auditor can evaluate part of the<br />

process and interview the people <strong>on</strong> the line.<br />

Some products may<br />

be adversely impacted by the presence of auditors<br />

or by the auditor’s health. For example, some pharmaceutical<br />

products may be sensitive to people with certain medical c<strong>on</strong>diti<strong>on</strong>s.<br />

Medical tests may need to be performed and results evaluated<br />

before the auditor is permitted to enter the processing facility. Wearing<br />

appropriate pers<strong>on</strong>al protective equipment such as gowning to<br />

limit human exposure may be sufficient to protect the product from<br />

humans.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

IE1-Gossip<br />

Some products may be adversely impacted by the<br />

presence of auditors or by the auditor’s health. For<br />

example, some pharmaceutical products may be<br />

sensitive to people with certain medical c<strong>on</strong>diti<strong>on</strong>s.<br />

Medical tests may need to be performed and<br />

results evaluated before the auditor is permitted to<br />

enter the processing facility. Wearing appropriate<br />

pers<strong>on</strong>al protective equipment such as gowning<br />

to limit human exposure may be sufficient to protect<br />

the product from humans.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

IE1-Gossip<br />

Some products may be adversely impacted by the<br />

presence of auditors or by the auditor’s health. For<br />

example, some pharmaceutical products may be<br />

sensitive to people with certain medical c<strong>on</strong>diti<strong>on</strong>s.<br />

Medical tests may need to be performed and<br />

results evaluated before the auditor is permitted to<br />

enter the processing facility. Wearing appropriate<br />

pers<strong>on</strong>al protective equipment such as gowning<br />

to limit human exposure may be sufficient to protect<br />

the product from humans.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Discovery Of Illegal Or Unsafe C<strong>on</strong>diti<strong>on</strong>s Or Activities<br />

Auditors are in a unique positi<strong>on</strong> to observe illegal or unsafe c<strong>on</strong>diti<strong>on</strong>s during the course of an audit because<br />

of their access to almost any area necessary for successful completi<strong>on</strong> of the audit. Auditors must know what to<br />

do when these activities are observed.<br />

When Unsafe Activities Are Observed<br />

In some industries, an auditor may need to access potentially hazardous areas in a company during the course<br />

of an audit. Auditors are usually provided with pers<strong>on</strong>al protective equipment such as goggles or hard hats.<br />

Normally, auditors face no physical danger as l<strong>on</strong>g as regulati<strong>on</strong>s are enforced and the process is functi<strong>on</strong>ing<br />

properly. Sometimes, however, negligence or inexperience <strong>on</strong> the part of the auditee’s employees, a deficiency<br />

or malfuncti<strong>on</strong> of equipment or a process, or a combinati<strong>on</strong> of these may result in potentially dangerous<br />

situati<strong>on</strong>s. When an unsafe practice (such as open c<strong>on</strong>tainers of hazardous chemicals near work areas,<br />

release of c<strong>on</strong>trolled chemicals, or flammable materials near a welding stati<strong>on</strong>) is observed, whether within or<br />

outside the scope of an audit, an auditor must not ignore it.<br />

• In an internal audit, an auditor should immediately inform an auditee representative and the audit team<br />

leader, who will inform the auditee manager so that the problem can be resolved.<br />

• In an external audit (sec<strong>on</strong>d or third- party audit), the auditor must immediately inform the auditee and<br />

create a record of the situati<strong>on</strong>. (and inform the audit team leader?)<br />

If any<strong>on</strong>e <strong>on</strong> the audit team is endangered, the audit must be stopped and the auditors returned to a safe area.<br />

In most situati<strong>on</strong>s, management welcomes informati<strong>on</strong> about liability risks or other potential dangers.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

When an unsafe practice is observed (Internal Audit)<br />

When an unsafe practice is observed (such as open c<strong>on</strong>tainers of hazardous chemicals near work areas,<br />

release of c<strong>on</strong>trolled chemicals, or flammable materials near a welding stati<strong>on</strong>), whether within or outside the<br />

scope of an audit, an auditor must not ignore it.<br />

• In an internal audit, an auditor should immediately inform an auditee representative and the audit team<br />

leader, who will inform the auditee manager so that the problem can be resolved.<br />

Unsafe Act Observed by<br />

Auditor<br />

Inform Auditee<br />

Representative<br />

(Coordinator?)<br />

Inform Auditor Team<br />

Leader<br />

Inform<br />

Program Manager<br />

Problem Resolved<br />

(Safety situati<strong>on</strong> or<br />

audit interrupti<strong>on</strong>?)<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

When an unsafe practice is observed (External Audit)<br />

When an unsafe practice is observed (such as open c<strong>on</strong>tainers of hazardous chemicals near work areas,<br />

release of c<strong>on</strong>trolled chemicals, or flammable materials near a welding stati<strong>on</strong>), whether within or outside the<br />

scope of an audit, an auditor must not ignore it.<br />

• In an external audit (sec<strong>on</strong>d or third- party audit), the auditor must immediately inform the auditee and<br />

create a record of the situati<strong>on</strong>. (and inform the auditor team leader?)<br />

Problem Resolved<br />

Unsafe Act Observed by<br />

Auditor<br />

Inform Auditee<br />

Representative<br />

(Coordinator?)<br />

Inform Auditor Team<br />

Leader?<br />

Inform<br />

Program Manager?<br />

create a record of the<br />

situati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

When Illegal or Unethical Activities Are Detected<br />

An auditor finding evidence of wr<strong>on</strong>gdoing, whether within or outside the scope of an audit assignment, has an<br />

ethical duty to bring the matter to the attenti<strong>on</strong> of the client and appropriate management for acti<strong>on</strong>. The auditor<br />

should keep a record of such matters, safeguard the evidence, and obtain copies of pertinent documents and<br />

records (if necessary). The auditor must be aware of and apply the ethics of the professi<strong>on</strong> and the law in this<br />

regard. An auditor may ask the client about the company’s ethics policy and ethics department prior to<br />

accepting the audit. If an ethics department exists, it may be a valuable resource if potentially unethical<br />

situati<strong>on</strong>s surface before, during, or after an audit.<br />

Management will take appropriate acti<strong>on</strong> <strong>on</strong> illegal or unethical activities within the company. This may involve<br />

legal acti<strong>on</strong> of some type and the involvement of the auditor. Auditors should be aware of their legal<br />

resp<strong>on</strong>sibilities and rights under the law, including whistle- blower laws.<br />

If management sp<strong>on</strong>sors allegedly illegal activities, either internally or externally, the auditor’s employment may<br />

be threatened. An auditor should have access to legal counsel to resolve questi<strong>on</strong>able issues. Often that legal<br />

counsel is best if it comes from outside the company. The U.S. C<strong>on</strong>gress and various states have passed laws<br />

protecting people who report incidents of wr<strong>on</strong>gdoing, including waste, fraud, and abuse (see a list of these<br />

laws at http://www.ncsl.org/issues-research/labor/state-whistleblower-laws.aspx ). These whistle- blower<br />

statutes (see Figure 5.3 for examples) protect auditors and others. Questi<strong>on</strong>s about specific laws should be<br />

directed to the appropriate federal, state, or local authorities (see Figure 5.4 for an example of a local<br />

regulati<strong>on</strong>). Please note that Figures 5.3 and 5.4 are provided as examples and may be dated. An auditor faced<br />

with a potential whistle- blower situati<strong>on</strong> should seek the latest informati<strong>on</strong> available. It is sufficient to say that<br />

whistle- blowers have some protecti<strong>on</strong> under both federal and some state laws; however, the amount of<br />

protecti<strong>on</strong> and how it is applied depend <strong>on</strong> each situati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

whistle- blower laws.<br />

A whistleblower (also written as whistle-blower or whistle blower) is<br />

a pers<strong>on</strong> who exposes any kind of informati<strong>on</strong> or activity that is<br />

deemed illegal, unethical, or not correct within an organizati<strong>on</strong> that<br />

is either private or public. The informati<strong>on</strong> of alleged wr<strong>on</strong>gdoing<br />

can be classified in many ways: violati<strong>on</strong> of company policy/rules,<br />

law, regulati<strong>on</strong>, or threat to public interest/nati<strong>on</strong>al security, as well<br />

as fraud, and corrupti<strong>on</strong>.[3] Those who become whistleblowers can<br />

choose to bring informati<strong>on</strong> or allegati<strong>on</strong>s to surface either internally<br />

or externally. Internally, a whistleblower can bring his/her<br />

accusati<strong>on</strong>s to the attenti<strong>on</strong> of other people within the accused<br />

organizati<strong>on</strong> such as an immediate supervisor. Externally, a<br />

whistleblower can bring allegati<strong>on</strong>s to light by c<strong>on</strong>tacting a third<br />

party outside of an accused organizati<strong>on</strong> such as the media,<br />

government, law enforcement, or those who are c<strong>on</strong>cerned.<br />

Whistleblowers, however, take the risk of facing stiff reprisal and<br />

retaliati<strong>on</strong> from those who are accused or alleged of wr<strong>on</strong>gdoing.<br />

Because of this, a number of laws exist to protect whistleblowers.<br />

Some third party groups even offer protecti<strong>on</strong> to whistleblowers, but<br />

that protecti<strong>on</strong> can <strong>on</strong>ly go so far. Whistleblowers face legal acti<strong>on</strong>,<br />

criminal charges, social stigma, and terminati<strong>on</strong> from any positi<strong>on</strong>,<br />

office, or job. Two other classificati<strong>on</strong>s of whistleblowing are private<br />

and public. The classificati<strong>on</strong>s relate to the type of organizati<strong>on</strong>s<br />

some<strong>on</strong>e chooses to whistle-blow <strong>on</strong>: private sector, or public<br />

sector. Depending <strong>on</strong> many factors, both can have varying results.<br />

However, whistleblowing in the public sector organizati<strong>on</strong> is more<br />

likely to result in criminal charges and possible custodial sentences.<br />

A whistleblower who chooses to accuse a private sector<br />

organizati<strong>on</strong> or agency is more likely to face terminati<strong>on</strong> and legal<br />

and civil charges.<br />

https://en.wikipedia.org/wiki/Whistleblower<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

An auditor may encounter illegal or unethical situati<strong>on</strong>s during the course of an audit, such as:<br />

• when an auditee is knowingly shipping defective products,<br />

• exposing pers<strong>on</strong>nel to unsafe c<strong>on</strong>diti<strong>on</strong>s or<br />

• dumping waste.<br />

The auditor should verify the situati<strong>on</strong> and then inform the audit team leader, who will inform the auditee.<br />

If the problem is caused by an oversight, it should be corrected immediately.<br />

Internal Audit<br />

• However, an auditee who knowingly ships a defective product, bypasses safety rules, or allows<br />

unauthorized discharges of polluti<strong>on</strong> may be unwilling to correct the problem. In this case, the auditing<br />

organizati<strong>on</strong> should refuse to return to that company or internal group.<br />

Third-<strong>Part</strong>y Audit<br />

• If a third- party audit is being performed, the auditor should immediately report the situati<strong>on</strong> to the client.<br />

External Supplier Audit<br />

If the auditee is a supplier,<br />

• the auditing organizati<strong>on</strong> may delay or stop shipments (if given the authority to do so) until the appropriate<br />

management functi<strong>on</strong> can resolve the issue.<br />

• The auditing organizati<strong>on</strong> may advise its management to cancel any existing c<strong>on</strong>tracts or agreements and<br />

find more reputable and socially resp<strong>on</strong>sible sources for the item or service.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

An auditor may encounter illegal or unethical situati<strong>on</strong>s<br />

during the course of an audit, such as:<br />

• when an auditee is knowingly shipping defective<br />

products,<br />

• exposing pers<strong>on</strong>nel to unsafe c<strong>on</strong>diti<strong>on</strong>s or<br />

• dumping waste.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

An auditor may encounter illegal<br />

or unethical situati<strong>on</strong>s during the<br />

course of an audit, such as:<br />

• Human Organs Trafficking?.<br />

https://bigthink.com/philip-perry/what-you-need-to-know-about-human-organ-trafficking<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

An auditor may encounter illegal<br />

or unethical situati<strong>on</strong>s during the<br />

course of an audit, such as:<br />

• Human Organs Trafficking?.<br />

https://bigthink.com/philip-perry/what-you-need-to-know-about-human-organ-trafficking<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

An auditor who detects illegal or unethical activities within the auditing organizati<strong>on</strong> must tell the audit team<br />

leader, who will inform the manager. If the same or similar illegal or unethical activities recur often, the auditor’s<br />

principles are probably not compatible with those of the organizati<strong>on</strong>, and new employment should be<br />

c<strong>on</strong>sidered.<br />

Unethical activity that is in violati<strong>on</strong> of internal company policy should be reported directly to management,<br />

whether it is unethical behavior of another employee, a customer, or a supplier. Illegal or unethical behavior <strong>on</strong><br />

the part of an <strong>ASQ</strong> member that violates the <strong>ASQ</strong> code of ethics should be reported to the <strong>ASQ</strong> Ethics<br />

Committee at ethics@asq.org.<br />

Although not comm<strong>on</strong>place, bribery is another example of an illegal or unethical<br />

situati<strong>on</strong> that an auditor may encounter. An auditor encountering obvious<br />

bribery should flatly refuse the offer and stop the audit. The client and auditing<br />

organizati<strong>on</strong> management must be alerted and give the matter immediate<br />

attenti<strong>on</strong>. Gift- giving could be a less obvious form of bribery. Many public<br />

agencies and private companies have specific regulati<strong>on</strong>s and policies <strong>on</strong><br />

ethical behavior. For example, a limited dollar amount may be specified for gifts<br />

that the auditor may ethically accept. An auditor has an obligati<strong>on</strong> to refuse or<br />

return any gift that exceeds the stated amount, al<strong>on</strong>g with the opti<strong>on</strong> of<br />

refusing any item. Many auditors will accept an offer of an inexpensive meal<br />

since they feel that both parties benefit from the rapport established in a casual<br />

setting, while others will refuse even the offer of a soft drink.<br />

Meaning: Rapport<br />

a close and harm<strong>on</strong>ious relati<strong>on</strong>ship in which the people or groups c<strong>on</strong>cerned<br />

understand each other's feelings or ideas and communicate well.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


C<strong>on</strong>sidering New<br />

Employment.<br />

An auditor who detects illegal or unethical<br />

activities within the auditing organizati<strong>on</strong><br />

must tell the audit team leader, who will<br />

inform the manager. If the same or similar<br />

illegal or unethical activities recur often, the<br />

auditor’s principles are probably not<br />

compatible with those of the organizati<strong>on</strong>,<br />

and new employment should be c<strong>on</strong>sidered.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Gifts and Meals<br />

An auditor has an obligati<strong>on</strong> to refuse or return any gift that exceeds the stated<br />

amount, al<strong>on</strong>g with the opti<strong>on</strong> of refusing any item. Many auditors will accept<br />

an offer of an inexpensive meal since they feel that both parties benefit from the<br />

rapport established in a casual setting, while others will refuse even the offer of<br />

a soft drink.<br />

.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE1-Gossip<br />

One example of an unethical practice was noted during a supplier<br />

audit. A check of the material certificati<strong>on</strong> provided by the supplier<br />

revealed some similarities to another certificati<strong>on</strong> received from<br />

another supplier. The certificates were identical, including the names<br />

of the people and the dates signed, except that the supplier’s logo<br />

and name were now at the top. Further investigati<strong>on</strong> found that the<br />

supplier simply pasted its logo and name over the logo and name of<br />

another company, made a copy, and sent it out as its own material<br />

certificati<strong>on</strong>. The company was caught <strong>on</strong>ly because the auditor had<br />

seen both certificati<strong>on</strong>s.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE1-Gossip<br />

An auditor reported that <strong>on</strong>e of the most blatantly unethical activities<br />

he observed was by a supplier who knowingly shipped empty<br />

outer casings for a particular device. The casing had a sticker over<br />

the edge stating, ―Warranty void if sticker broken.‖ The sticker would<br />

be broken if the customer opened the casing to look inside. After<br />

verifying what he had discovered, he discussed the situati<strong>on</strong> with the<br />

audit manager, who in turn discussed it with auditee management.<br />

The auditor’s company ended up pulling its order from the supplier.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE1-Gossip<br />

During the course of an audit, an auditor happened to menti<strong>on</strong> that<br />

she was an avid tennis player. Several weeks later she received a case<br />

of tennis balls from the auditee. She wrote a polite note and sent it to<br />

the auditee, al<strong>on</strong>g with the case of tennis balls.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Social and Cultural C<strong>on</strong>siderati<strong>on</strong>s<br />

In the internati<strong>on</strong>al auditing arena, an auditor must be familiar with local customs so that potentially unethical<br />

situati<strong>on</strong>s can be interpreted correctly and resp<strong>on</strong>ded to appropriately.<br />

For example, in the United States it is c<strong>on</strong>sidered a breach of ethics for an auditor to accept a gift or favor from<br />

a pers<strong>on</strong> in the audited organizati<strong>on</strong>. The custom in Japan is that gifts are given to visitors from foreign<br />

countries as a sign of friendship or as a memento of their visit to the factory. However, accepting gifts is not<br />

permitted for auditors.<br />

Government auditors in Japan are strictly prohibited from accepting any gift or meal. Some companies allow<br />

acceptance of gifts to avoid offending the auditee but require the pers<strong>on</strong> to turn in the gift (for possible d<strong>on</strong>ati<strong>on</strong><br />

to a charity).<br />

As quality auditing becomes increasingly global, organizati<strong>on</strong>s and individuals must be aware of such<br />

differences to prevent serious cultural misunderstandings from undermining the audit process. The need to be<br />

familiar with different cultures and norms is not limited to internati<strong>on</strong>al auditing. Auditors should also be aware<br />

of cultural differences and expectati<strong>on</strong>s in each individual workplace where the audit is being c<strong>on</strong>ducted. The<br />

auditor’s awareness and willingness to work with different cultures will help avoid misunderstandings and<br />

ensure the effectiveness of the audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Overcoming Language And Literacy Barriers<br />

Audit pers<strong>on</strong>nel must either be fluent in the language in which the audit is to be c<strong>on</strong>ducted or have the support<br />

of a technical expert with the necessary technical language skills. When necessary, the auditing organizati<strong>on</strong><br />

should employ a skilled interpreter to assist with the audit. Even if all primary participants in an audit speak the<br />

same language, the auditor may encounter language or literacy barriers when attempting to interview individual<br />

employees. These same barriers may prevent the employee from understanding or performing assigned tasks.<br />

A written procedure may solve the problem, but if the employees are unable to read or understand the<br />

procedure, then the problem has not been addressed.<br />

If an auditor understands the physical process before going into an audit and then focuses <strong>on</strong> the work, some<br />

of the literacy issues may be overcome with:<br />

• the aid of flowcharts and (for auditor or employee?)<br />

• other simple diagrams. (for auditor or employee?)<br />

At times, an auditor may need to ask extremely simple questi<strong>on</strong>s to overcome a lack of language skills. If it is<br />

necessary for pers<strong>on</strong>nel to be able to follow procedures and complete records to perform their job and they are<br />

not able to do so, they may not be competent. Competency issues may lead an auditor to determine how<br />

pers<strong>on</strong>nel were trained and competency needs addressed.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE1-Gossip<br />

One technique that can be used when the auditor does not speak<br />

the language of the auditee is for the auditor to observe the process,<br />

take detailed notes, and then have some<strong>on</strong>e in the audit room walk<br />

the auditor through the related procedure (even if it is in the native<br />

language) so that he or she can compare it with his or her notes. This<br />

practice can highlight issues with following the written procedure.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE1-Gossip<br />

An auditor was shown documented instructi<strong>on</strong>s that were available<br />

to guide the operators in their work. The instructi<strong>on</strong>s were<br />

written in English. However, the auditor noticed that a number of<br />

the operators were unable to read or speak English, and no translated<br />

instructi<strong>on</strong>s were available for this porti<strong>on</strong> of the workforce.<br />

Were the n<strong>on</strong>- English-speaking operators more competent than the<br />

English- speaking operators, and therefore instructi<strong>on</strong>s were unnecessary?<br />

Or, did the instructi<strong>on</strong>s include pictures and diagrams to<br />

overcome the language barrier? Literacy questi<strong>on</strong>s or understanding<br />

documentati<strong>on</strong> in another language can be very sensitive issues. The<br />

auditor should be very cautious in phrasing questi<strong>on</strong>s <strong>on</strong> these topics.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

Avoiding Internal C<strong>on</strong>flict- Of-interest Problems<br />

Selecting an auditor from within an organizati<strong>on</strong> (for a first- party audit) can cause problems, especially in the<br />

case of a <strong>on</strong>e- site operati<strong>on</strong>. The objectivity of an auditor working in an area of previous employment may be<br />

questi<strong>on</strong>ed. Former peers may be intimidated or uncooperative, or they may use the auditor as a sounding<br />

board for complaints, making it difficult for the auditor to obtain objective informati<strong>on</strong>. They also may think that<br />

the auditor will not report procedural violati<strong>on</strong>s. Furthermore, the auditor’s knowledge of how a product, process,<br />

or system functi<strong>on</strong>s may be outdated, and time may be wasted as the auditor follows the wr<strong>on</strong>g path using<br />

incorrect criteria. Ideally, an auditor will not be assigned to audit an area of previous employment. For internal<br />

audits, though, such assignments cannot always be avoided, especially for small organizati<strong>on</strong>s. The negative<br />

effects must be weighed against the benefits that selecting an auditor from within the organizati<strong>on</strong> may offer.<br />

Such benefits may include a superior understanding of the organizati<strong>on</strong>’s product or service and the processes<br />

involved in producti<strong>on</strong>, al<strong>on</strong>g with a str<strong>on</strong>g familiarity with the applicable quality requirements or standards.<br />

Negative effects may include hidden agendas, perceived bias <strong>on</strong> the part of the auditee, and the possibility that<br />

the auditor will try to solve problems using past knowledge rather than auditing the current system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE1<br />

• Remedial Acti<strong>on</strong>/ C<strong>on</strong>tainment Acti<strong>on</strong>/ Correcti<strong>on</strong><br />

During an audit, some auditees will request to be notified of n<strong>on</strong>c<strong>on</strong>formances so that they can<br />

take immediate acti<strong>on</strong>. In many cases, immediate acti<strong>on</strong> would be remedial acti<strong>on</strong> (also called<br />

c<strong>on</strong>tainment acti<strong>on</strong> or correcti<strong>on</strong>) and not corrective acti<strong>on</strong>.<br />

Remedial acti<strong>on</strong> addresses <strong>on</strong>ly the symptom and does not eliminate the underlying cause of the<br />

problem as corrective acti<strong>on</strong> would.<br />

The auditor may discuss with the auditee the pitfalls of taking <strong>on</strong>ly remedial acti<strong>on</strong>. The auditor<br />

should also explain that even though remedial acti<strong>on</strong> was taken, it would be unethical not to<br />

include the observed n<strong>on</strong>c<strong>on</strong>formance in the final report.<br />

• Maintaining Audit C<strong>on</strong>fidence<br />

Besides acting professi<strong>on</strong>ally at all times, the auditor must maintain the c<strong>on</strong>fidence of the auditing<br />

organizati<strong>on</strong>:<br />

• by never divulging proprietary informati<strong>on</strong> to the auditee,<br />

• by refraining from speaking negatively about the auditing organizati<strong>on</strong> or previous auditees, and<br />

• by refraining from discussing the performance of previous auditees with people in the<br />

organizati<strong>on</strong> currently being audited.<br />

When facing <strong>on</strong>e of these problems or other more difficult <strong>on</strong>es, the auditor must remain focused<br />

and in c<strong>on</strong>trol of the audit process.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

IE2. Legal C<strong>on</strong>sequences<br />

Pers<strong>on</strong>al and Corporate Liability<br />

This handbook is not a primer <strong>on</strong> law as applied to auditing and should not be c<strong>on</strong>sidered a source of legal<br />

advice. If questi<strong>on</strong>s arise, auditors must c<strong>on</strong>sult their own lawyers for informati<strong>on</strong>. Liability issues have become<br />

more apparent with the advent of the quality management system (QMS) and envir<strong>on</strong>mental management<br />

system (EMS) registrati<strong>on</strong>/certificati<strong>on</strong> programs. Each company and each auditor accepts liability for the<br />

decisi<strong>on</strong>s made regarding whether to grant registrati<strong>on</strong>/certificati<strong>on</strong>. There are appeal processes, but in the end,<br />

a court of law could be called in for the final decisi<strong>on</strong>. A key liability c<strong>on</strong>siderati<strong>on</strong> is whether a company relies<br />

<strong>on</strong> audit informati<strong>on</strong> as the basis for making a decisi<strong>on</strong>.<br />

Illegal Activities<br />

As an auditor collects informati<strong>on</strong> throughout the audit process, the auditee may disclose certain kinds of<br />

informati<strong>on</strong>. This informati<strong>on</strong> can lead to illegal activities by the auditor, unless the auditor is aware that the use<br />

of this informati<strong>on</strong> is illegal. Figure 5.5 provides a general explanati<strong>on</strong> of each type of informati<strong>on</strong> and the illegal<br />

activity that the auditor can inadvertently engage in.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

Figure 5.5 Illegal auditor activities.<br />

Source: <strong>ASQ</strong>’s Foundati<strong>on</strong>s in Quality: Certified Quality Auditor, Module 1: Ethics, Professi<strong>on</strong>al C<strong>on</strong>duct, and Liability Issues (Milwaukee, WI: <strong>ASQ</strong> Quality<br />

Press, 1998), pp. 1–16.<br />

Liability Explanati<strong>on</strong> Auditor example<br />

Violati<strong>on</strong> of securities laws<br />

If some<strong>on</strong>e learns informati<strong>on</strong> that is important to<br />

investors but not available to the public and proceeds to<br />

act <strong>on</strong> it or tells some<strong>on</strong>e who then acts <strong>on</strong> it, it is a<br />

violati<strong>on</strong> of securities laws.<br />

During an audit interview, a senior manager accidentally reveals<br />

acquisiti<strong>on</strong> plans to an auditor. The auditor uses the informati<strong>on</strong><br />

to make pers<strong>on</strong>al investments in the stock market.<br />

What is Securities Law?<br />

Securities law represents the multiple federal laws and regulati<strong>on</strong>s that govern the sale, purchase, and creati<strong>on</strong> of security interests. These rules derive from a<br />

simple and straightforward c<strong>on</strong>cept: all investors, whether large instituti<strong>on</strong>s or private individuals, should have access to certain basic facts about an investment<br />

prior to buying it. Only through the steady flow of timely, comprehensive and accurate informati<strong>on</strong> can people make sound investment decisi<strong>on</strong>s.<br />

Securities Law Violati<strong>on</strong>s<br />

Each year the SEC brings between 400-500 civil enforcement acti<strong>on</strong>s against individuals and companies that break the securities laws. Typical infracti<strong>on</strong>s<br />

include insider trading, accounting fraud, and providing false or misleading informati<strong>on</strong> about securities and the companies that issue them. Securities law<br />

violati<strong>on</strong>s are also serious criminal infracti<strong>on</strong>s that can result into both incarcerati<strong>on</strong> (impris<strong>on</strong>ment) and substantial fines.<br />

Insider Trading<br />

Insider trading refers to transacti<strong>on</strong>s in securities of publicly held corporati<strong>on</strong>s by pers<strong>on</strong>s with inside or advance informati<strong>on</strong> <strong>on</strong> which the trading is based.<br />

Usually, the trader is an "insider" with an employment or other relati<strong>on</strong>ship of trust with the corporati<strong>on</strong>. For example, if an employee of a corporati<strong>on</strong> learns that<br />

her company will enter a merger agreement with a rival competitor, and with this knowledge purchases shares of stock with the expectati<strong>on</strong> that the value will<br />

increase after the merger agreement becomes public knowledge, the employee is abusing her insider status and has engaged in insider trading.<br />

https://www.legalmatch.com/law-library/article/securities-law.html<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

Figure 5.5 Illegal auditor activities.<br />

Source: <strong>ASQ</strong>’s Foundati<strong>on</strong>s in Quality: Certified Quality Auditor, Module 1: Ethics, Professi<strong>on</strong>al C<strong>on</strong>duct, and Liability Issues (Milwaukee, WI: <strong>ASQ</strong> Quality<br />

Press, 1998), pp. 1–16.<br />

Liability Explanati<strong>on</strong> Auditor example<br />

Violati<strong>on</strong> of antitrust laws<br />

反 垄 断<br />

(Who violate the antitrust law?<br />

The competitor?)<br />

If some<strong>on</strong>e learns informati<strong>on</strong> and uses it to restrict<br />

competiti<strong>on</strong> in a particular market, it is a violati<strong>on</strong> of<br />

antitrust laws.<br />

An auditor comments to the auditee that another supplier with<br />

the same quality system realizes far fewer gains. The auditee<br />

uses the informati<strong>on</strong> to produce negative advertisements<br />

against the supplier.<br />

United States antitrust law is a collecti<strong>on</strong> of federal and state government laws that regulates the c<strong>on</strong>duct and organizati<strong>on</strong> of business corporati<strong>on</strong>s, generally<br />

to promote fair competiti<strong>on</strong> for the benefit of c<strong>on</strong>sumers. (The c<strong>on</strong>cept is called competiti<strong>on</strong> law in other English-speaking countries.) The main statutes are the<br />

Sherman Act of 1890, the Clayt<strong>on</strong> Act of 1914 and the Federal Trade Commissi<strong>on</strong> Act of 1914. These Acts, first, restrict the formati<strong>on</strong> of cartels and prohibit<br />

other collusive practices regarded as being in restraint of trade. Sec<strong>on</strong>d, they restrict the mergers and acquisiti<strong>on</strong>s of organizati<strong>on</strong>s that could substantially<br />

lessen competiti<strong>on</strong>. Third, they prohibit the creati<strong>on</strong> of a m<strong>on</strong>opoly and the abuse of m<strong>on</strong>opoly power.[1]<br />

The Federal Trade Commissi<strong>on</strong>, the U.S. Department of Justice, state governments and private parties who are sufficiently affected may all bring acti<strong>on</strong>s in the<br />

courts to enforce the antitrust laws. The scope of antitrust laws, and the degree to which they should interfere in an enterprise's freedom to c<strong>on</strong>duct business,<br />

or to protect smaller businesses, communities and c<strong>on</strong>sumers, are str<strong>on</strong>gly debated. One view, mostly closely associated with the "Chicago School of<br />

ec<strong>on</strong>omics" suggests that antitrust laws should focus solely <strong>on</strong> the benefits to c<strong>on</strong>sumers and overall efficiency, while a broad range of legal and ec<strong>on</strong>omic<br />

theory sees the role of antitrust laws as also c<strong>on</strong>trolling ec<strong>on</strong>omic power in the public interest.<br />

https://en.wikipedia.org/wiki/United_States_antitrust_law<br />

Definiti<strong>on</strong> of Sherman Antitrust Act<br />

Noun: A federal statute that prohibits companies from engaging in unfair business practices.<br />

https://legaldicti<strong>on</strong>ary.net/sherman-antitrust-act/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

Figure 5.5 Illegal auditor activities.<br />

Source: <strong>ASQ</strong>’s Foundati<strong>on</strong>s in Quality: Certified Quality Auditor, Module 1: Ethics, Professi<strong>on</strong>al C<strong>on</strong>duct, and Liability Issues (Milwaukee, WI: <strong>ASQ</strong> Quality<br />

Press, 1998), pp. 1–16.<br />

Liability Explanati<strong>on</strong> Auditor example<br />

Violati<strong>on</strong> of due care<br />

If some<strong>on</strong>e fails to exercise reas<strong>on</strong>able care or<br />

competency in the course of providing guidance for<br />

others in their business transacti<strong>on</strong>s, it is a violati<strong>on</strong> of<br />

due care.<br />

An auditor grants a supplier ISO 9001 certificati<strong>on</strong> despite the<br />

audit team’s failure to follow correct accrediting<br />

procedure (not exercising due care) during the audit. Based <strong>on</strong><br />

the certificati<strong>on</strong>, a company purchases faulty<br />

product from the supplier for commercial<br />

distributi<strong>on</strong>.<br />

Due care is a level of resp<strong>on</strong>sibility that a pers<strong>on</strong> in a particular situati<strong>on</strong> is expected to practice. For example, due care is practiced when a pers<strong>on</strong> drives his<br />

car safely. He is expected to adhere to the rules of the road so as to prevent injury to himself and to others. When he makes it from point A to point B, while<br />

following all of the rules that are expected of him, he has practiced due care in operating his vehicle. In law, determining some<strong>on</strong>e’s due care is determining to<br />

what extent, if any, he was negligent in the situati<strong>on</strong> at hand.<br />

https://legaldicti<strong>on</strong>ary.net/due-care/<br />

Aiding and abetting (encourage<br />

or help some<strong>on</strong>e to do<br />

something (especially<br />

something illegal))<br />

If some<strong>on</strong>e willfully causes an act to be d<strong>on</strong>e and the<br />

same act would be an offense against the United States<br />

if directly performed by him or her, it c<strong>on</strong>stitutes aiding<br />

and abetting.<br />

An auditor discovers that an auditee is using materials against<br />

c<strong>on</strong>tractual requirements but does not include the informati<strong>on</strong> in<br />

the final audit report.<br />

Definiti<strong>on</strong> of Aiding and Abetting<br />

Noun: The act of helping, encouraging, or supporting some<strong>on</strong>e in the commissi<strong>on</strong> of a crime.<br />

Verb: To actively encourage, to assist, or to support the commissi<strong>on</strong> of a criminal act.<br />

Example of Aiding and Abetting<br />

When Della’s boyfriend Rob, and his friend Steve, begin holding ―private‖ meetings in the couple’s basement, she knows something is up. A few weeks later,<br />

Rob comes home in a rush, hauling a couple of heavy bags down the basement steps. Worried, Della follows him down, to see a huge amount of cash in the<br />

bags, as Rob worked frantically to stuff it all into a hole in the wall behind the heating unit. Deciding she doesn’t want to know, Della just pushes it out of her<br />

mind. A couple of weeks later, the police come to Della’s door, wanting to talk to her. When they tell her they have evidence that Rob committed a bank<br />

robbery recently, she acts shocked, and denies knowing anything about it. The truth is, she has suspected as much the day he brought the cash home, but has<br />

been reluctant to say something. Rob has ensured her a $100,000 cut of the m<strong>on</strong>ey, and she would hate for the authorities to carry it all away.<br />

Throughout the investigati<strong>on</strong>, in this example of aiding and abetting, Della denies any involvement with, or even knowledge of the crime. Della, by her acti<strong>on</strong>s<br />

(or failure to tell what she knows), is aiding and abetting her boyfriend’s crime. https://legaldicti<strong>on</strong>ary.net/aiding-and-abetting/<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

The Auditor as an Agent<br />

As a representative of a company, an individual auditor can unknowingly acquire legal liability in<br />

several areas.<br />

• Auditor Making Empty Statement (refrain from)<br />

First, the auditor might make statements that an auditee uses to make decisi<strong>on</strong>s. If these<br />

statements are later shown to be untrue, the auditee might have recourse against the auditor’s<br />

company for damages. For example, if a third- party auditor told the auditee that the auditee’s<br />

company would get a discount <strong>on</strong> insurance if it were compliant with ISO 9001, and the auditee<br />

used that informati<strong>on</strong> as a reas<strong>on</strong> for deciding to implement ISO 9001, then the auditee might<br />

recover damages if no discount was forthcoming.<br />

• Telling Auditee How to Do His Work (refrain from)<br />

An auditor also has to be careful not to tell the auditee how to do his or her work or what<br />

decisi<strong>on</strong>s to make. If an auditee relies <strong>on</strong> the auditor’s words and subsequently fails to provide a<br />

good product or service, ensure compliance to governmental regulati<strong>on</strong>s, or obtain registrati<strong>on</strong>,<br />

the auditee might recover damages. Also, if an auditor provides guidance, even if the guidance<br />

fixes the problem, the auditor still owns the soluti<strong>on</strong>. If the recommended soluti<strong>on</strong> is not the best,<br />

there may be malicious compliance that will reflect back <strong>on</strong> the auditor.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

The Auditor as an Agent<br />

As a representative of a company, an individual auditor can<br />

unknowingly acquire legal liability in several areas.<br />

• Auditor Making Empty Statement (refrain from)<br />

First, the auditor might make statements that an auditee uses to<br />

make decisi<strong>on</strong>s. If these statements are later shown to be<br />

untrue, the auditee might have recourse against the auditor’s<br />

company for damages. For example, if a third- party auditor told<br />

the auditee that the auditee’s company would get a discount <strong>on</strong><br />

insurance if it were compliant with ISO 9001, and the auditee<br />

used that informati<strong>on</strong> as a reas<strong>on</strong> for deciding to implement ISO<br />

9001, then the auditee might recover damages if no discount<br />

was forthcoming.<br />

• Telling Auditee How to Do His Work (refrain from)<br />

An auditor also has to be careful not to tell the auditee how to<br />

do his or her work or what decisi<strong>on</strong>s to make. If an auditee relies<br />

<strong>on</strong> the auditor’s words and subsequently fails to provide a good<br />

product or service, ensure compliance to governmental<br />

regulati<strong>on</strong>s, or obtain registrati<strong>on</strong>, the auditee might recover<br />

damages. Also, if an auditor provides guidance, even if the<br />

guidance fixes the problem, the auditor still owns the soluti<strong>on</strong>. If<br />

the recommended soluti<strong>on</strong> is not the best, there may be<br />

malicious compliance that will reflect back <strong>on</strong> the auditor.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

Registrar/certificati<strong>on</strong> organizati<strong>on</strong>s and their auditors face a special liability during the audit and after<br />

registrati<strong>on</strong>/certificati<strong>on</strong>. An organizati<strong>on</strong> certifying that others meet a set of standards must use reas<strong>on</strong>able<br />

care or competency in certifying. The auditor must follow the procedures of the certificati<strong>on</strong> body during the<br />

audit process and base the certificati<strong>on</strong> recommendati<strong>on</strong> <strong>on</strong> the results of the audit.<br />

The certificati<strong>on</strong> body must have specific procedures and requirements for certificati<strong>on</strong>, and these must be<br />

equally applied to all companies.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE2-Gossip<br />

An auditor discovers that the auditee is shipping defective products.<br />

After verifying and investigating the incident, the auditor records<br />

10 product deficiencies that should be corrected before shipping<br />

resumes. The audit team prioritizes the deficiencies and includes<br />

them in the final report.<br />

The fact that the audit team prioritized the deficiencies means<br />

that it accepted partial resp<strong>on</strong>sibility for the soluti<strong>on</strong>. This makes the<br />

audit team and its company at least partially liable should a problem<br />

involving the defective products surface in the future.<br />

Comments: Aiding and abetting or Violati<strong>on</strong> of Due-Care?<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

Proprietary Informati<strong>on</strong><br />

Disclosure of proprietary informati<strong>on</strong> can come about because of the legal process itself. An<br />

auditor completes audit checklists, makes notes of the results of the audit, and often makes<br />

copies of informati<strong>on</strong> supporting the findings of the audit. These notes, completed checklists,<br />

and copies find their way into the audit record and are kept for a specified period of time. If a<br />

lawsuit is initiated during that time, the c<strong>on</strong>tents of the file may become available for ―discovery‖<br />

by the parties to the lawsuit. Records of both internal and external audits are subject to<br />

discovery by parties in a lawsuit. For example, if a supplier to your organizati<strong>on</strong> is party to a<br />

lawsuit and your organizati<strong>on</strong> c<strong>on</strong>ducted an audit (external) of the supplier, your records are<br />

subject to discovery. The same rights of discovery are true for both civil and criminal legal<br />

proceedings. Through discovery, these records can become public. This is <strong>on</strong>e of the main<br />

reas<strong>on</strong>s an auditor should not make copies of or take notes <strong>on</strong> proprietary informati<strong>on</strong> when<br />

auditing a company. It is also a major reas<strong>on</strong> for keeping extraneous comments out of the audit<br />

record. Such comments can come back to haunt an auditor at the most inappropriate time.<br />

Keywords:<br />

an auditor should not make copies of or take notes <strong>on</strong> proprietary informati<strong>on</strong> when auditing a<br />

company.<br />

Meaning: Discovery, in the law of comm<strong>on</strong> law jurisdicti<strong>on</strong>s, is a pre-trial procedure in a lawsuit in which each party, through<br />

the law of civil procedure, can obtain evidence from the other party or parties by means of discovery devices such as a request for<br />

answers to interrogatories, request for producti<strong>on</strong> of documents, request for admissi<strong>on</strong>s and depositi<strong>on</strong>s. Discovery can be<br />

obtained from n<strong>on</strong>-parties using subpoenas ( 法 院 传 票 ). When a discovery request is objected to, the requesting party may seek<br />

the assistance of the court by filing a moti<strong>on</strong> to compel discovery. https://en.wikipedia.org/wiki/Discovery_%28law%29<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE2-Gossip<br />

During an FAA audit of an organizati<strong>on</strong>, the FAA regulator asked to<br />

review the completed internal audit checklists. On <strong>on</strong>e checklist, an<br />

auditor had written ―This procedure is terrible‖ in the margin. The<br />

auditor and the lead auditor spent the next three hours explaining<br />

why the comment was <strong>on</strong> the checklist even though the auditor evaluated<br />

the procedure as satisfactory.<br />

FAA- Federal Aviati<strong>on</strong> Administrati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE2<br />

Audit Record Disclosure<br />

Because most management systems require records indicating that each step is performed by following<br />

documented procedures or methods, there are many documents and records available for both the defense<br />

and the prosecuti<strong>on</strong> in the event of a lawsuit.<br />

• Audit Report<br />

Copies of the audit report must be sent to the client. Clients either designate other organizati<strong>on</strong>s and individuals<br />

to receive copies or do the distributi<strong>on</strong> themselves. In most cases, it is agreed that the auditee will receive a<br />

copy of the audit report.<br />

• Audit Records<br />

The audit records should be treated as c<strong>on</strong>fidential informati<strong>on</strong> and should not be disclosed to internal or<br />

outside entities without prior approval of the client and the auditee.<br />

Accidental or deliberate disclosure of negative audit informati<strong>on</strong> that other companies can use as a basis for<br />

making decisi<strong>on</strong>s that adversely affect the auditee may make the auditor and the auditor’s company liable for<br />

damages. These damages can be c<strong>on</strong>siderable if a major c<strong>on</strong>tract is canceled or awarded to another company<br />

<strong>on</strong> the basis of the audit informati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE2-Gossip<br />

Discovery is a pretrial device used by <strong>on</strong>e party to obtain facts and<br />

informati<strong>on</strong> about the case from the other party (who is this other party or parties) in order to help<br />

prepare for trial. Under federal rules of civil procedure and in states that have adopted similar<br />

rules, tools of discovery include depositi<strong>on</strong> to oral and written questi<strong>on</strong>s, written interrogatories,<br />

producti<strong>on</strong> of documents, permissi<strong>on</strong> to enter land or other property, physical and mental<br />

examinati<strong>on</strong>s, and requests for admissi<strong>on</strong>. In criminal proceedings, discovery emphasizes the<br />

right of the defense to obtain access to evidence necessary to prepare its own case.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


IE2-Gossip<br />

For FDA audits of organizati<strong>on</strong>s, the FDA typically will not request to<br />

see internal audit reports but will ask to see evidence that scheduled<br />

audits were performed. In some cases where there is a serious issue,<br />

the FDA may require review of the internal audit report c<strong>on</strong>tent to<br />

evaluate whether the issue had been found during internal audits.<br />

The potential audiences of the reports should be kept in mind when the<br />

reports are written.<br />

FDA: US Food and Drug Administrati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

IE3. Audit Credibility<br />

Auditor C<strong>on</strong>duct<br />

Professi<strong>on</strong>alism is defined as the aims and qualities that characterize a professi<strong>on</strong> or a professi<strong>on</strong>al pers<strong>on</strong>.<br />

Auditors must comply with high standards of h<strong>on</strong>esty, integrity, work ethic, diligence, loyalty, and commitment.<br />

Auditing is a professi<strong>on</strong> that requires individuals to c<strong>on</strong>form to certain behaviors for maximum job proficiency.<br />

The book Standards for the Professi<strong>on</strong>al Practice of Internal Auditing, published by the IIA, defines and<br />

amplifies five general standards:<br />

1. Independence<br />

Internal auditors should be independent of the activities they audit<br />

2. Professi<strong>on</strong>al proficiency<br />

Internal audits should be performed with proficiency and due professi<strong>on</strong>al care<br />

3. Scope of work<br />

The scope of the internal audit should encompass the examinati<strong>on</strong> and evaluati<strong>on</strong> of the adequacy and<br />

effectiveness of the organizati<strong>on</strong>’s system of internal c<strong>on</strong>trol and the quality of performance in carrying out<br />

assigned resp<strong>on</strong>sibilities<br />

4. Performance of audit work<br />

Audit work should include planning the audit, examining and evaluating informati<strong>on</strong>, c<strong>on</strong>ducting interviews,<br />

communicating results, and following up<br />

5. Management of the internal auditing department<br />

The director of internal auditing should properly manage the internal auditing department<br />

These general standards could also apply to product, process, and system auditing. People in the auditing field<br />

should be aware of standards of performance in other professi<strong>on</strong>s. A broader knowledge allows the auditor to<br />

quickly understand different and difficult situati<strong>on</strong>s as they arise.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

Communicating with the Auditee<br />

An auditor’s temperament is often the key to a successful audit. A sullen ( 阴 沉 沉 ) or<br />

unfriendly attitude could lead to resistance or malicious compliance.<br />

Overly friendly or garrulous ( 啁 啾 不 休 的 ) behavior could lead to the impressi<strong>on</strong> that the<br />

audit is not serious. The auditor should find an acceptable balance. By approaching an<br />

auditee in a diplomatic and objective manner, the auditor can set a t<strong>on</strong>e of success<br />

for an audit. The auditor must be aware that each auditee views the audit process<br />

differently, <strong>on</strong> the basis of individual management style, culture, pers<strong>on</strong>ality, and<br />

opini<strong>on</strong>s. Many auditees are reluctant to welcome auditors into their world.<br />

Resentment, fear, and anxiety are obstacles that must be overcome. By diplomatically<br />

presenting and maintaining the audit program, the auditor can influence the auditee’s<br />

percepti<strong>on</strong> of the audit functi<strong>on</strong> as well as the overall success of individual audits.<br />

Meaning:<br />

Malicious compliance is the behavior of intenti<strong>on</strong>ally inflicting harm by strictly following<br />

the orders of a superior knowing that compliance with the orders will not have the<br />

intended result. The term usually implies the following of an order in such a way that<br />

ignores the order's intent but follows it to the letter. It is usually d<strong>on</strong>e to injure or harm<br />

a superior while maintaining a sense of legitimacy. A specific form of industrial acti<strong>on</strong><br />

that utilizes this behavior is work-to-rule.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

The auditor can establish good rapport with an auditee early in the audit by being<br />

respectful, courteous, and appreciative of any special arrangements made for the<br />

auditor’s comfort and c<strong>on</strong>venience. By dem<strong>on</strong>strating that the audit has been<br />

adequately planned and prepared for, and by making every effort to maintain the audit<br />

schedule, the auditor projects an image of efficiency and professi<strong>on</strong>alism. Maintaining<br />

open communicati<strong>on</strong> channels throughout an audit is essential. An auditor must listen<br />

attentively during interviews, allow the interviewee adequate resp<strong>on</strong>se time, and<br />

refrain from asking leading questi<strong>on</strong>s. Frequent and timely communicati<strong>on</strong> of findings,<br />

questi<strong>on</strong>s, and c<strong>on</strong>cerns gives both the auditor and the auditee opportunities to<br />

request clarificati<strong>on</strong>s, address corrective acti<strong>on</strong>, examine the scope of the situati<strong>on</strong>,<br />

and discuss the progress of the audit. Additi<strong>on</strong>ally, an auditor can set a positive t<strong>on</strong>e<br />

for an audit by highlighting commendable findings and observati<strong>on</strong>s.<br />

The auditor’s ability to communicate effectively with management sets the t<strong>on</strong>e for the<br />

entire audit and may influence the auditee’s resp<strong>on</strong>se to the audit findings. Auditors<br />

should avoid naming names and should emphasize the purpose of the assessment<br />

of the product, process, or system.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

• Grievances<br />

However, exemplary ( 可 仿 效 ) c<strong>on</strong>duct by an auditor does not prevent an auditee from<br />

making false claims of theft, discriminati<strong>on</strong>, sexual misc<strong>on</strong>duct, or other forms of<br />

unprofessi<strong>on</strong>alism. No <strong>on</strong>e is immune from false accusati<strong>on</strong>s, but disgruntled ( 不 开 心 )<br />

auditees may target auditors who issue unfavorable reports.<br />

Grievance procedures can be abused by the auditee to ―get even‖ with the auditor for<br />

finding problems in the auditee’s area of resp<strong>on</strong>sibility.<br />

• Grievance Or Complaint Procedures<br />

All audit organizati<strong>on</strong>s should have grievance or complaint procedures. The<br />

procedures should include the protecti<strong>on</strong> of the rights of the accuser and the accused.<br />

For audits that represent a high risk of false claims, or when the auditor feels<br />

uncomfortable with a situati<strong>on</strong>, <strong>on</strong>e of the following opti<strong>on</strong>s should be c<strong>on</strong>sidered:<br />

1. A sec<strong>on</strong>d pers<strong>on</strong> should be scheduled to work with the auditor<br />

2. The auditor should use some type of recording device (for example, a digital voice<br />

recorder)<br />

3. An escort should be present to witness interviews between the auditor and the<br />

auditee<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

Audit Ethics<br />

Audit ethics is perhaps the area that demands the most skill from an auditor. Training is<br />

available for enhancing skills in checklist development, interviewing techniques, audit<br />

documentati<strong>on</strong>, follow- up methods, and almost all other phases of an audit. On the other<br />

hand, very little informati<strong>on</strong> is available <strong>on</strong> the topic of audit ethics. An auditor’s use of<br />

questi<strong>on</strong>able or unethical methods during or following an audit can quickly erase any<br />

favorable impressi<strong>on</strong>s and be detrimental to the auditor and the auditing organizati<strong>on</strong> as a<br />

whole.<br />

ISO 19011 c<strong>on</strong>tains six principles of auditing that are:<br />

―prerequisite for providing audit c<strong>on</strong>clusi<strong>on</strong>s that are relevant and sufficient for enabling<br />

auditors working independently from <strong>on</strong>e another to reach similar c<strong>on</strong>clusi<strong>on</strong>s in similar<br />

circumstances.‖<br />

These principles are:<br />

1. Integrity: the foundati<strong>on</strong> of professi<strong>on</strong>alism<br />

Auditors and the pers<strong>on</strong> managing an audit program should:<br />

■ Perform their work with h<strong>on</strong>esty, diligence, and resp<strong>on</strong>sibility;<br />

■ Observe and comply with any applicable legal requirements;<br />

■ Dem<strong>on</strong>strate their competence while performing their work;<br />

■ Perform their work in an impartial manner, i.e. remain fair and unbiased in all their dealings;<br />

■ Be sensitive to any influences that may be exerted <strong>on</strong> their judgment while carrying<br />

out an audit.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

2. Fair presentati<strong>on</strong>: the obligati<strong>on</strong> to report truthfully and accurately<br />

Audit findings, audit c<strong>on</strong>clusi<strong>on</strong>s and audit reports should reflect truthfully and<br />

accurately the audit activities. Significant obstacles encountered during the audit and<br />

unresolved diverging opini<strong>on</strong>s between the audit team and the auditee should be<br />

reported. The communicati<strong>on</strong> should be truthful, accurate, objective, timely, clear and<br />

complete.<br />

3. Due professi<strong>on</strong>al care: the applicati<strong>on</strong> of diligence and judgment in auditing<br />

Auditors should exercise due care in accordance with the importance of the task they<br />

perform and the c<strong>on</strong>fidence placed in them by the audit client and other interested<br />

parties. An important factor in carrying out their work with due professi<strong>on</strong>al care is<br />

having the ability to make reas<strong>on</strong>ed judgments in all audit situati<strong>on</strong>s.<br />

4. C<strong>on</strong>fidentiality: security of informati<strong>on</strong><br />

Auditors should exercise discreti<strong>on</strong> in the use and protecti<strong>on</strong> of informati<strong>on</strong> acquired<br />

in the course of their duties. Audit informati<strong>on</strong> should not be used inappropriately for<br />

pers<strong>on</strong>al gain by the auditor or the audit client, or in a manner detrimental to the<br />

legitimate interests of the auditee. This c<strong>on</strong>cept includes the proper handling of<br />

sensitive or c<strong>on</strong>fidential informati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

5.Independence:<br />

the basis for the impartiality of the audit and objectivity of the audit c<strong>on</strong>clusi<strong>on</strong>s .<br />

Auditors should be independent of the activity being audited wherever practicable, and<br />

should in all cases act in a manner that is free from bias and c<strong>on</strong>flict of interest. For<br />

internal audits, auditors should be independent from the operating managers of the<br />

functi<strong>on</strong> being audited. Auditors should maintain objectivity throughout the audit<br />

process to ensure that the audit findings and c<strong>on</strong>clusi<strong>on</strong>s are based <strong>on</strong>ly <strong>on</strong> the audit<br />

evidence. For small organizati<strong>on</strong>s, it may not be possible for internal auditors to be<br />

fully independent of the activity being audited, but every effort should be made to<br />

remove bias and encourage objectivity.<br />

6. Evidence-based approach: the rati<strong>on</strong>al method for reaching reliable and<br />

reproducible audit c<strong>on</strong>clusi<strong>on</strong>s in a systematic audit process<br />

Audit evidence should be verifiable. It will in general be based <strong>on</strong> samples of the<br />

informati<strong>on</strong> available, since an audit is c<strong>on</strong>ducted during a finite period of time and<br />

with finite resources. An appropriate use of sampling should be applied, since this is<br />

closely related to the c<strong>on</strong>fidence that can be placed in the audit c<strong>on</strong>clusi<strong>on</strong>s.<br />

These principles should help make the audit an effective, credible, and reliable tool in<br />

support of management policies and c<strong>on</strong>trols by providing informati<strong>on</strong> <strong>on</strong> which an<br />

organizati<strong>on</strong> can act in order to improve its performance. The principles provide a<br />

foundati<strong>on</strong> for the c<strong>on</strong>duct of auditors and pers<strong>on</strong>s managing an audit program.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

AUDIT Functi<strong>on</strong> Credibility<br />

A credible audit is a meaningful audit. Competent individuals who gather and handle all<br />

informati<strong>on</strong> pertaining to the audit in an unbiased and ethical manner provide a credible audit. An<br />

audit group should be structured so that it does not report directly to the manager of the functi<strong>on</strong><br />

being audited. Management must use the audit results appropriately to establish and maintain<br />

the credibility of the program. The misuse of audit results or failure to initiate corrective acti<strong>on</strong>s<br />

will erode the credibility of the audit program, regardless of the performance of the auditors.<br />

Misuse of audit results includes:<br />

• using results as the sole basis for disciplinary acti<strong>on</strong> against individuals in a department,<br />

• evaluating pers<strong>on</strong>nel performance against goals and objectives,<br />

• and deciding pay raise, b<strong>on</strong>us, or perk ( 额 外 补 贴 ) .<br />

Using a knowledgeable, experienced, skilled, capable, and well-trained auditor is the most<br />

effective way to enhance the credibility of the audit functi<strong>on</strong>. Becoming an <strong>ASQ</strong> Certified Quality<br />

Auditor is <strong>on</strong>e way for an auditor to dem<strong>on</strong>strate knowledge. Many organizati<strong>on</strong>s have their own<br />

auditor qualificati<strong>on</strong> and/or certificati<strong>on</strong> process to ensure auditors are knowledgeable and<br />

capable. The use of unqualified auditors who possess little knowledge or who do not have the<br />

ability to assist management in making good decisi<strong>on</strong>s or improving a process can discredit the<br />

entire audit process.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

A good auditor does not have to be an expert in the area being audited, but the auditor does<br />

need to be knowledgeable in the discipline of auditing. The auditor needs to have an<br />

understanding of what is being observed.<br />

At times, an auditor must be able to grasp that understanding in minutes. When auditors need<br />

help, they should ask another member of the audit team to verify an observati<strong>on</strong> or to assist in<br />

other ways. Auditors need to be able to communicate effectively, both orally and in writing. A<br />

large part of the job c<strong>on</strong>sists of interviewing. A good auditor must ask intelligent, proper<br />

questi<strong>on</strong>s and listen attentively. An auditor needs to be tactful and offer feedback in a positive,<br />

n<strong>on</strong>-intimidating manner. An auditor needs to be especially c<strong>on</strong>siderate of an auditee’s<br />

employees. The audit process is disruptive to daily operati<strong>on</strong>s and can inc<strong>on</strong>venience<br />

employees. The auditor shows respect for and sensitivity to those being audited by sticking to<br />

the proposed audit schedule and not retaining employees through their meal or refreshment<br />

breaks. If people see the audit process as a nuisance, they are less likely to cooperate, and the<br />

auditor runs the risk of being unable to complete the assignment well or <strong>on</strong> time.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

An auditor aims to keep the credibility of the audit functi<strong>on</strong> <strong>on</strong> a high plane. The<br />

auditor does this by looking at informati<strong>on</strong> objectively and avoiding ethical c<strong>on</strong>flicts.<br />

An auditee must trust that an auditor will not divulge proprietary informati<strong>on</strong> to<br />

competitors or other outsiders who can use it to their benefit. Even internally, auditors<br />

must be careful to maintain c<strong>on</strong>fidentiality. This is especially true when the locati<strong>on</strong>s or<br />

departments report to different management. Following a code of ethics is not the sole<br />

resp<strong>on</strong>sibility of the auditor. Every<strong>on</strong>e involved in the process must practice and<br />

promote ethics. Audit program managers and audit functi<strong>on</strong>s/departments should be<br />

resp<strong>on</strong>sible for promoting and m<strong>on</strong>itoring ethical behavior throughout the audit<br />

functi<strong>on</strong> and requiring auditors to adhere to a code of ethics.<br />

Higher levels of ethical c<strong>on</strong>duct can be achieved <strong>on</strong>ly when management actively<br />

promotes this c<strong>on</strong>duct and when auditors are supported instead of being left to fend<br />

for themselves. The credibility of the audit functi<strong>on</strong> is enhanced when the role of the<br />

audit functi<strong>on</strong> is communicated and understood by all stakeholders, when the auditors<br />

act professi<strong>on</strong>ally, and when the program is professi<strong>on</strong>ally managed. Fear of the audit<br />

functi<strong>on</strong> will reduce its credibility. The audit functi<strong>on</strong> should be managed and made<br />

accountable in the same way as other functi<strong>on</strong>s within the organizati<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

IE3-Gossip<br />

In a closing meeting at a supplier audit, the auditee asked the name<br />

of the pers<strong>on</strong> involved with every negative finding. These individuals<br />

were brought to the meeting room by the auditee management. It was<br />

a very uncomfortable situati<strong>on</strong> for the auditor and for those being singled<br />

out as having caused the n<strong>on</strong>c<strong>on</strong>formances, some of which were<br />

minor issues. The auditor should make every effort to emphasize that<br />

a negative finding is not meant to point fingers at a specific pers<strong>on</strong> but<br />

to identify a gap in c<strong>on</strong>formance with a requirement.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

IE3-Gossip<br />

While performing an audit, an auditor found several points where<br />

a specific auditee was not following procedures. The auditee was<br />

informed during the interview that these would show up in the audit<br />

report. Unknown to the auditor, the auditee immediately filed a formal<br />

written complaint against the auditor, claiming unprofessi<strong>on</strong>al<br />

c<strong>on</strong>duct and lack of objectivity. After an extensive investigati<strong>on</strong> (<strong>on</strong>e<br />

that was not kept c<strong>on</strong>fidential and that damaged the auditor’s professi<strong>on</strong>al<br />

reputati<strong>on</strong>), the end result was that there was no basis for<br />

the complaint, and so it was dismissed. Because of this investigati<strong>on</strong>,<br />

n<strong>on</strong>e of the auditor’s c<strong>on</strong>cerns were allowed to be included in the<br />

audit report.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

IE3-Gossip<br />

I am familiar with the attitude of <strong>on</strong>e company in choosing members<br />

for its internal audit group. Rather than selecting its best employees<br />

and training them as auditors, this company uses the audit group as<br />

a means of relieving its worst employees from critical areas in the<br />

organizati<strong>on</strong>. These people are completely wr<strong>on</strong>g for this positi<strong>on</strong>.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> IE3<br />

IE3-Gossip<br />

As an auditee, I had received an audit agenda for a third- party audit.<br />

The first item <strong>on</strong> the agenda was a quick plant tour. However, as we<br />

started the tour, the auditor requested to see a certain area of the plant<br />

not scheduled for that audit. As we were about to leave the area, he<br />

said, ―I know it’s not <strong>on</strong> the agenda, but I would like to ask a couple<br />

of questi<strong>on</strong>s here. It w<strong>on</strong>’t take l<strong>on</strong>g; I d<strong>on</strong>’t want to get off schedule,<br />

but I’d like to start here.‖ A day and a half later, the auditor was still<br />

in that area asking questi<strong>on</strong>s. He never audited another department<br />

in the entire facility.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


<strong>Part</strong> II<br />

Audit Process<br />

[42 of the <strong>CQA</strong> Exam Questi<strong>on</strong>s or 28 percent]<br />

Chapter 6 Audit Preparati<strong>on</strong> and Planning/<strong>Part</strong> IIA<br />

Chapter 7 Audit Performance/<strong>Part</strong> IIB<br />

Chapter 8 Audit Reporting/<strong>Part</strong> IIC<br />

Chapter 9 Audit Follow- up and Closure/<strong>Part</strong> IID<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang


Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Fi<strong>on</strong> Zhang Zhang


t least <strong>on</strong>e academic expert recommends[3] the following:<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang

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