08.10.2018 Views

Understanding ASQ-CQA -Knowing The Ways

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

<strong>Knowing</strong> <strong>ASQ</strong> <strong>CQA</strong><br />

<strong>The</strong> Quality Auditor Certification<br />

My Pre-exam Self Study Notes<br />

4 th September 2018<br />

Charlie Chong/ Fion Zhang


Aeronautical Quality Assurance<br />

Charlie Chong/ Fion Zhang


Aeronautical Quality Assurance<br />

Charlie Chong/ Fion Zhang


SR-71<br />

Charlie Chong/ Fion Zhang


SR-71<br />

Charlie Chong/ Fion Zhang


SR-71<br />

Charlie Chong/ Fion Zhang


SR-71A<br />

Charlie Chong/ Fion Zhang


闭 门 练 功<br />

Charlie Chong/ Fion Zhang


http://independent.academia.edu/CharlieChong1<br />

http://www.yumpu.com/zh/browse/user/charliechong<br />

http://issuu.com/charlieccchong<br />

Charlie Chong/ Fion Zhang


Charlie Chong/ Fion Zhang<br />

http://greekhouseoffonts.com/


<strong>The</strong> Magical Book of Tank Inspection ICP<br />

Charlie Chong/ Fion Zhang


Charlie Chong/ Fion Zhang


闭 门 练 功<br />

Charlie Chong/ Fion Zhang


闭 门 练 功<br />

Charlie Chong/ Fion Zhang


Charlie Chong/ Fion Zhang<br />

Fion Zhang at Shanghai<br />

4 th September 2018


Content:<br />

1. <strong>ASQ</strong> BOK<br />

2. Pre-read: Six Sigma 6σ-<strong>The</strong> Wikipedia<br />

Charlie Chong/ Fion Zhang


<strong>ASQ</strong> Mission:<br />

<strong>The</strong> American Society for Quality advances<br />

individual, organizational, and community<br />

excellence worldwide through learning, quality<br />

improvement, and knowledge exchange.<br />

Charlie Chong/ Fion Zhang


<strong>ASQ</strong> Mission:<br />

<strong>The</strong> American Society for Quality advances individual, organizational, and<br />

community excellence worldwide through learning, quality improvement, and<br />

knowledge exchange.<br />

• learning<br />

• knowledge<br />

exchange<br />

excellence<br />

Charlie Chong/ Fion Zhang<br />

https://asq.org/about-asq/asq-awards/deming


<strong>The</strong> Certified Quality Auditor (<strong>CQA</strong>) is a professional who understands:<br />

• the standards and<br />

• the principles of auditing and<br />

• the auditing techniques of ;<br />

examining,<br />

questioning,<br />

evaluating, and<br />

reporting<br />

to determine a quality system’s adequacy and deficiencies. <strong>The</strong> Certified<br />

Quality Auditor analyzes all elements of a quality system and judges its degree<br />

of adherence to the criteria of industrial management and quality evaluation<br />

and control systems.<br />

Charlie Chong/ Fion Zhang


• the auditing techniques of ;<br />

examining,<br />

questioning,<br />

evaluating, and<br />

reporting<br />

…appropriate techniques to<br />

gather, identify, and classify<br />

objective evidence.<br />

Charlie Chong/ Fion Zhang


<strong>The</strong> Auditing Techniques: Examining<br />

Charlie Chong/ Fion Zhang


<strong>The</strong> Auditing Techniques: Questioning<br />

Charlie Chong/ Fion Zhang


<strong>The</strong> Auditing Techniques: Evaluating & Reporting<br />

Charlie Chong/ Fion Zhang


<strong>CQA</strong><br />

Computer Delivered – <strong>The</strong> <strong>CQA</strong> examination is a one-part,165-multiplechoice-question,five-and-a-half-hour<br />

exam and is offered in English only.<br />

One hundred and fifty questions are scored and 15 are unscored. Paper and<br />

Pencil – <strong>The</strong> <strong>CQA</strong><br />

examination is a one-part,150-multiple-choice-question,five-hour exam and<br />

is offered in English only.<br />

165 – 15 Questions<br />

minus<br />

5 hours.<br />

Charlie Chong/ Fion Zhang


Minimum Expectations<br />

• Must possess the knowledge and ability to<br />

effectively conduct different types of audits, as<br />

appropriate for the method, relationship, or<br />

purpose of the audit, and must recognize the<br />

effect those audit types will have on the audit<br />

scope and outcomes.<br />

• Must be able to audit in a professional, ethical,<br />

and objective manner using and interpreting<br />

applicable standards or requirements, with an<br />

awareness of potential legal and financial<br />

ramifications 财 务 影 响 .<br />

• Must be able to effectively plan, communicate,<br />

and execute an audit within its defined scope,<br />

including scheduling resources, conducting<br />

necessary meetings in performance of the audit,<br />

and using appropriate techniques to gather,<br />

identify, and classify objective evidence.<br />

• Must be able to verify, document, and communicate<br />

audit results, develop an audit report, and evaluate the<br />

effectiveness of corrective action and follow up.<br />

• Must possess interpersonal skills to resolve conflict,<br />

conduct interviews, and make presentations while<br />

participating as an audit team member, and must<br />

possess knowledge of the unique responsibilities of<br />

the lead auditor and team facilitator.<br />

• Must understand the value that quality auditing adds<br />

to the organization and how auditing can reveal<br />

interrelationships between business processes that<br />

can influence outcomes and organizational risk.<br />

• Must be able to select appropriate quality and auditing<br />

tools and techniques, and use them effectively in a<br />

variety of practical applications.<br />

Charlie Chong/ Fion Zhang


Must possess interpersonal skills to resolve conflict.<br />

Charlie Chong/ Fion Zhang


BOK<br />

Examinations will continue to present a number of case studies. Each case<br />

study will include a brief scenario outlining critical details about an audit<br />

situation. In addition, each case study will be supported by related audit<br />

documents. <strong>The</strong> documents will be contained in a separate booklet<br />

“Confidential Audit Documents – <strong>CQA</strong> Case Studies” that will be part of the<br />

test materials distributed at the examination. Approximately 15-20 percent<br />

(25-30 questions) of the test will be devoted to these case studies.<br />

Although the questions related to these cases will use the same four-choice<br />

answer format as the rest of the test, the use of scenario details and sample<br />

documents will allow the candidates to apply their critical thinking skills in<br />

evaluating realistic situations and accompanying documents, memos, etc.<br />

Charlie Chong/ Fion Zhang


BOK<br />

Knowledge<br />

Percentage Score<br />

I. Auditing Fundamentals (27 Questions) 18%<br />

II. Audit Process (42 Questions) 28%<br />

III. Auditor Competencies (25 Questions) 17%<br />

IV. Audit Program Management and Business Applications<br />

(30 Questions)<br />

20%<br />

V. Quality Tools and Techniques (26 Questions) 17%<br />

150 Questions 100%<br />

Charlie Chong/ Fion Zhang


BOK<br />

Approximately 15-20 percent (25-30 questions) of the test will be devoted to<br />

these case studies.<br />

Charlie Chong/ Fion Zhang


BOK<br />

I. Auditing Fundamentals (27 Questions)<br />

A. Types of Quality Audits<br />

1. Method<br />

Define, differentiate, and analyze various audit<br />

types by method: product, process, desk,<br />

department, function, element, system,<br />

management. (Analyze)<br />

2. Auditor-auditee relationship<br />

Define, differentiate, and analyze various audit<br />

types by auditor-auditee relationship: first-party,<br />

second-party, third-party, internal and external.<br />

(Analyze)<br />

3. Purpose<br />

Define, differentiate, and analyze various audit<br />

types by purpose: verification of corrective<br />

action (follow-up) audits, risk audits,<br />

accreditation (registration) and compliance<br />

audits, surveillance and for-cause audits.<br />

(Analyze)<br />

4. Common elements with other audits<br />

Identify elements such as audit purpose, data<br />

gathering techniques, tracing, etc., that quality<br />

audits have in common with environmental,<br />

safety, financial, and other types of audits.<br />

(Apply)<br />

B. Purpose and Scope of Audits<br />

1. Elements of purpose and scope<br />

Describe and determine how the purpose of an<br />

audit can affect its scope. (Apply)<br />

2. Benefits of audits<br />

Analyze how audits can be used to provide an<br />

independent assessment of system<br />

effectiveness and efficiency, risks to the bottom<br />

line, and other organizational measures.<br />

(Analyze)<br />

Charlie Chong/ Fion Zhang


I. Auditing Fundamentals (27 Questions)<br />

C. Criteria to Audit Against<br />

Define and distinguish between various audit<br />

criteria, such as external (industry, national,<br />

international) standards, contracts, specifications,<br />

quality awards, policies, internal quality<br />

management system (QMS), sustainability, social<br />

responsibility, etc. (Analyze)<br />

D. Roles and Responsibilities of Audit<br />

Participants<br />

Define and describe the functions and<br />

responsibilities of various audit participants,<br />

including audit team members, lead auditor, client,<br />

auditee, etc. (Apply)<br />

2. Legal consequences<br />

Identify potential legal and financial<br />

ramifications of improper auditor actions<br />

(carelessness, negligence, etc.) in various<br />

situations, and anticipate the effect that certain<br />

audit results can have on an auditee‘s liability.<br />

(Apply)<br />

3. Audit credibility<br />

Identify and apply various factors that influence<br />

audit credibility, such as auditor independence,<br />

objectivity, and qualifications. (Apply)<br />

E. Professional Conduct and Consequences for<br />

Auditors<br />

1. Professional conduct and responsibilities<br />

Define and apply the <strong>ASQ</strong> Code of Conduct,<br />

concepts of due diligence and due care with<br />

respect to confidentiality and conflict of interest,<br />

and appropriate actions in response to the<br />

discovery of illegal activities or unsafe<br />

conditions. (Apply)<br />

Charlie Chong/ Fion Zhang


II. Audit Process (42 Questions)<br />

A. Audit Preparation and Planning<br />

1. Elements of the audit planning process<br />

Evaluate and implement the basic steps in audit<br />

preparation and planning:<br />

• verify audit authority; (?)<br />

Who?<br />

• determine the (1) purpose, (2) scope, and (3)<br />

type of audit;<br />

• identify the requirements to audit against and<br />

the resources necessary, including the size<br />

and number of audit teams. (Evaluate)<br />

2. Auditor selection<br />

Identify and examine various auditor selection<br />

criteria, such as education, experience, industry<br />

background, and subject matter or technical<br />

expertise. (Analyze)<br />

3. Audit-related documentation<br />

Identify the sources of pre-audit information and<br />

examine audit related documentation, such as<br />

audit criteria references and results from prior<br />

audits. (Analyze)<br />

4. Logistics<br />

Identify and organize audit-related logistics,<br />

including travel, safety and security<br />

considerations, the need for escorts, translators,<br />

confidentiality agreements, clear right of access,<br />

etc. (Analyze)<br />

5. Auditing tools and working papers<br />

Identify the sampling plan or method and<br />

procedural guidelines to be used for the specific<br />

audit. Select and prepare working papers<br />

(checklists, log sheets, etc.) to document the<br />

audit. (Create)<br />

6. Auditing strategies<br />

Identify and use various tactical methods for<br />

conducting an audit, such as forward and<br />

backward tracing (?), discovery, etc. (Apply)<br />

I found a good explanation of the difference between forward and backward<br />

traceability here:<br />

• Checking forward traceability: taking a batch of materials/components and tracing<br />

them through the process, including work in process, all the way to the finished<br />

products that were made with those materials/components.<br />

• Checking backward traceability – this is taking a finished product batch and tracing it,<br />

starting from the customer, back through the process including work in process, all the<br />

way to the batches of materials/components received from suppliers.<br />

https://qualityinspection.org/forward-backward-traceability/<br />

Charlie Chong/ Fion Zhang


II. Audit Process (42 Questions)<br />

B. Audit Performance<br />

1. On-site audit management Interpret situations<br />

throughout the performance of the audit to determine<br />

whether time is being managed well and when changes<br />

need to be made, such<br />

as revising planned audit team activities, reallocating<br />

resources, adjusting the audit plan, etc., and<br />

communicate with the auditee<br />

about any changes or other events related to the audit.<br />

(Analyze)<br />

2. Opening meeting<br />

Manage the opening meeting of an audit by identifying<br />

the audit‘s purpose and scope, describing any scoring<br />

or rating criteria that will be used during the audit,<br />

creating a record of the attendees, reviewing the audit<br />

schedule, and answering questions as needed. (Apply)<br />

Risk= Probability x Consequences<br />

(Risk= frequency x severity?)<br />

(Risk ≡ Significant?)<br />

3. Audit data collection and analysis<br />

Use various data collection methods to capture<br />

information:<br />

• Conducting interviews,<br />

• observing work activities,<br />

methods<br />

• taking physical measurements,<br />

• examining documents, etc.<br />

Evaluate the results to determine their importance for<br />

providing audit evidence. (Evaluate)<br />

4. Establishment of objective evidence<br />

Identify and differentiate characteristics of objective<br />

evidence, such as observed, measured, confirmed or<br />

corroborated (Confirm/ 证 实 ), and documented.<br />

(Analyze)<br />

5. Organization of objective evidence<br />

Classify evidence in terms of significance, severity,<br />

frequency, and level of risk. Evaluate the evidence<br />

for its potential impact on product, process, system,<br />

cost of quality, etc., and determine whether additional<br />

investigation is required to meet the scope of the audit.<br />

(Evaluate)<br />

Charlie Chong/ Fion Zhang


5. Organization of objective evidence<br />

Classify evidence in terms of :<br />

• significance,<br />

Severity x frequency<br />

• severity,<br />

level of risk<br />

• frequency, and<br />

• level of risk.<br />

Evaluate the evidence for its potential impact on<br />

• product,<br />

• process,<br />

• system,<br />

• cost of quality, etc.,<br />

and determine whether additional<br />

investigation is required to meet<br />

the scope of the audit. (Evaluate)<br />

Charlie Chong/ Fion Zhang


Evaluate the evidence for its potential impact on<br />

• product,<br />

• process,<br />

• system,<br />

• cost of quality, etc.,<br />

<strong>The</strong> etc.;<br />

• Tarnishing the Company Image.<br />

• Others?<br />

Charlie Chong/ Fion Zhang


Evaluate the evidence for its potential impact on<br />

• product,<br />

• process,<br />

• system,<br />

• cost of quality, etc.,<br />

<strong>The</strong> etc.;<br />

• Tarnishing the Company Image.<br />

• Others?<br />

Charlie Chong/ Fion Zhang


Evaluate the evidence for its potential impact on<br />

• product,<br />

• process,<br />

• system,<br />

• cost of quality, etc.,<br />

<strong>The</strong> etc.;<br />

• Tarnishing the Company Image,<br />

• Environmental,<br />

• Others?<br />

Charlie Chong/ Fion Zhang


II. Audit Process (42 Questions)<br />

6. Exit and closing meetings<br />

Formally manage these meetings:<br />

reiterate the audit‘s purpose, scope, and scoring<br />

or rating criteria, and create a record of the<br />

attendees. Present the audit results and obtain<br />

concurrence on evidence that could lead to an<br />

adverse conclusion. Discuss the next steps in<br />

the process (follow-up audit, additional<br />

evidence-gathering, etc.), and clarify who is<br />

responsible for performing those steps. (Apply)<br />

C. Audit Reporting<br />

1. Report development and content<br />

Group observations into actionable findings of<br />

significance, and identify the severity and risk to<br />

the client and the auditee. Use appropriate steps<br />

to generate the audit report: organize and<br />

summarize details, review and finalize results,<br />

emphasize critical issues, establish unique<br />

identifiers or codes for critical issues to facilitate<br />

tracking and monitoring, etc. (Create)<br />

2. Effective reports<br />

Develop and evaluate components of effective<br />

audit reports, including background information,<br />

executive summary, prioritized results<br />

(observations, findings, opportunities for<br />

improvement, etc.). Use graphical tools or other<br />

means of emphasizing conclusions, and develop<br />

a timeline for auditee response and/or<br />

corrections. (Create)<br />

3. Final audit report steps<br />

Obtain necessary approvals for the audit report<br />

and distribute it according to established<br />

procedures. Identify the contents of the audit file<br />

and retain the file in accordance with<br />

established policies and procedures. (Apply)<br />

Charlie Chong/ Fion Zhang


II. Audit Process (42 Questions)<br />

D. Audit Follow-Up and Closure<br />

1. Elements of the corrective action process<br />

Identify and evaluate various elements:<br />

assignment of responsibility for problem<br />

identification; the performance of root cause<br />

analysis and recurrence prevention. (Evaluate)<br />

2. Review of corrective action plan<br />

Evaluate the acceptability of proposed corrective<br />

actions and schedule for completion. Identify<br />

and apply strategies for negotiating changes to<br />

unacceptable plans. (Evaluate)<br />

4. Follow-up on ineffective corrective action<br />

Develop strategies to use when corrective<br />

actions are not implemented or are not effective,<br />

such as communicating to the next level of<br />

management, reissuing the corrective action<br />

request, and re-auditing. (Create)<br />

5. Audit closure<br />

Identify and apply various elements of, and<br />

criteria for, audit closure (Apply)<br />

3. Verification of corrective action<br />

Determine the adequacy of corrective actions<br />

taken by verifying and evaluating new or<br />

updated procedures, observing revised<br />

processes, conducting follow-up audits, etc.<br />

(Evaluate)<br />

Charlie Chong/ Fion Zhang


D. Audit Follow-Up and Closure<br />

1. Elements of the corrective action process<br />

Identify and evaluate various elements:<br />

• assignment of responsibility for problem identification;<br />

• the performance of root cause analysis and<br />

• recurrence prevention. (Evaluate)<br />

RCA<br />

Kaoru Ishikawa Diagram<br />

Charlie Chong/ Fion Zhang


D. Audit Follow-Up and Closure<br />

1. Elements of the corrective action process<br />

Identify and evaluate various elements: assignment of responsibility for problem identification; the performance of root cause analysis and<br />

recurrence prevention. (Evaluate)<br />

2. Review of corrective action plan<br />

Evaluate the acceptability of proposed corrective actions and schedule for completion. Identify and apply strategies for negotiating changes to<br />

unacceptable plans. (Evaluate)<br />

Assignment of responsibility<br />

for problem identification-<br />

Aeronautical‘s SME in turbine.<br />

Charlie Chong/ Fion Zhang


Recurrence Prevention & RCA<br />

D. Audit Follow-Up and Closure<br />

1. Elements of the corrective action process<br />

Identify and evaluate various elements: assignment of responsibility for problem identification; the performance of root cause analysis and<br />

recurrence prevention. (Evaluate)<br />

Charlie Chong/ Fion Zhang


III. Auditor Competencies (25 Questions)<br />

A. Auditor Characteristics<br />

Identify characteristics that make auditors effective:<br />

interpersonal skills, problem-solving skills, attention to<br />

detail, cultural awareness and sensitivity, ability to work<br />

independently as well as in a group or on a team, etc.<br />

(Apply)<br />

B. On-Site Audit<br />

Resource Management<br />

Identify and apply techniques for managing audit teams,<br />

scheduling audit meetings and activities, making<br />

logistical adjustments, etc. (Apply)<br />

C. Conflict Resolution<br />

Identify typical conflict situations (mild to vehement<br />

(intense) disagreements, auditee<br />

delaying tactics, interruptions, etc.) and determine<br />

appropriate techniques for resolving them:<br />

• clarifying the question or request,<br />

• reiterating ground rules,<br />

• intervention by another authority,<br />

• cool-down periods, etc.<br />

(Analyze)<br />

D. Communication and Presentation Techniques<br />

Select and use written, oral, and electronic<br />

communication techniques for presentations made<br />

during audits for opening, closing, ad-hoc meetings,<br />

etc. Use technical and managerial reporting techniques,<br />

including graphs, charts, diagrams, multimedia aids,<br />

etc., in various situations: domestic, global,<br />

in-person, virtual (e-audits), multiple sites<br />

simultaneously, etc. (Evaluate)<br />

E. Interviewing Techniques<br />

Select and use appropriate interviewing techniques and<br />

methodologies. (Apply)<br />

1. Use open-ended or closed question types<br />

2. Use active listening, paraphrasing ( 另 种 表 达 方 式 ),<br />

empathy ( 同 情 ), etc.<br />

3. Recognize and respond to non-verbal cues ( 提 示 ,<br />

暗 示 , 表 示 ): body language, the significance of<br />

pauses and their length, etc.<br />

4. Determine when and how to prompt ( 促 使 ) a<br />

response: when supervisors are present, when<br />

interviewing a group of workers, when using a<br />

translator, etc.<br />

Paraphrasing Tool to paraphrase or rewrite full length essays and<br />

articles or to find new ways to express simple phrases, sentences or<br />

single words.<br />

Empathy: the ability to understand and share the feelings of another.<br />

Charlie Chong/ Fion Zhang


III. Auditor Competencies (25 Questions)<br />

F. Team Dynamics<br />

Define, describe, and apply various<br />

aspects of team dynamics. (Apply)<br />

1. Team-building: clarifying roles and responsibilities<br />

for participants and leaders to ensure equitable<br />

treatment for all team members, providing clear<br />

direction for deliverables, identifying necessary<br />

resources and ensuring their availability, etc.<br />

Tuckman's stages of group development<br />

2. Team facilitation: providing coaching and guidance,<br />

defusing clashes between members, eliciting (bring<br />

out) input from all, cultivating objectivity,<br />

overseeing progress, encouraging diverse views<br />

and consensus, etc.<br />

3. Stages of team development: forming, storming,<br />

norming, and performing<br />

(further reading)<br />

https://en.wikipedia.org/wiki/Tuckman%27s_stages_of_group_de<br />

velopment<br />

Charlie Chong/ Fion Zhang


IV. Audit Program Management and Business Applications (30 Questions)<br />

A. Audit Program Management<br />

1. Senior management support<br />

Identify and explain management‘s<br />

role in creating and supporting the audit function.<br />

(Understand)<br />

2. Staffing and resource management<br />

Develop staffing budgets that provide adequate<br />

time for auditors to plan, conduct, and respond<br />

to scheduled audits, including time and<br />

resources that internal auditees need to<br />

participate. Identify any special equipment<br />

resources needed and ensure their adequacy<br />

and availability. Consider the use of and<br />

requirements for special audits (outsourced or<br />

contracted audits, virtual or e-audits, shared<br />

audits, etc.) as driven by costs, geography, etc.<br />

Evaluate results and adjust resources as<br />

needed on a regular basis. (Evaluate)<br />

3. Auditor training and development<br />

Identify minimum audit knowledge<br />

and skill requirements for auditors.<br />

Provide training on various aspects<br />

of the audit process such as relevant<br />

standards, regulatory influences,<br />

facilitation techniques, etc. Provide<br />

training on diversity and cultural<br />

influences (ethnicity, gender, age,<br />

organized labor, etc.) and how such<br />

factors can affect communications<br />

and other interactions among audit<br />

participants. (Create)<br />

4. Audit program evaluation<br />

Select the correct metric to evaluate<br />

the audit program, including tracking<br />

its effect on the bottom line and the<br />

risk to the organization. (Evaluate)<br />

Charlie Chong/ Fion Zhang


Special audits:<br />

• outsourced or contracted audits,<br />

• virtual or e-audits,<br />

• Shared audits, etc.<br />

Charlie Chong/ Fion Zhang


Special audits:<br />

• outsourced or contracted audits,<br />

• virtual or e-audits,<br />

• Shared audits, etc.<br />

virtual or e-audits<br />

Virtual Auditing With states facing<br />

more and more budget restrictions<br />

and travel being one area that is being<br />

cut from their budgets, state auditing<br />

departments need to come up with<br />

innovative constructive ways of<br />

continue to perform audits on Motor<br />

Fuel Accounts without the cost<br />

associated of traveling to the<br />

Taxpayers location. What are Virtual<br />

Audits? Virtual audits are paperless,<br />

electronic audits that are conducted<br />

without face to face interaction<br />

between government and industry. All<br />

data is exchanged in electronic<br />

formats such as MS Word, Excel, PDF<br />

files, text files and EDI files.<br />

https://old.taxadmin.org/fta/mf/unif_docs/<br />

white/virtualaudits.pdf<br />

Charlie Chong/ Fion Zhang


Special audits:<br />

• outsourced or contracted audits,<br />

• virtual or e-audits,<br />

• Shared audits, etc.<br />

Charlie Chong/ Fion Zhang


IV. Audit Program Management and Business Applications (30 Questions)<br />

5. Internal audit program management<br />

Develop procedures, policies,<br />

and schedules to support the<br />

organization‘s objectives. Review<br />

internal audit results to identify<br />

systemic trends. (Create)<br />

7. Best practices<br />

Analyze audit results to:<br />

• Standardize best practices and<br />

• Lessons learned,<br />

across the organization. (Analyze)<br />

6. External audit program management<br />

Develop procedures, policies, and<br />

schedules in support of the supplier<br />

management program, including:<br />

• supplier qualification surveys,<br />

• surveillance audits,<br />

• supplier improvement, etc.<br />

(Create)<br />

<strong>The</strong>re will be audit report to the<br />

Auditee and report to the management<br />

(as management review).<br />

So there will be 2 minimum reports?<br />

8. Organizational risk management<br />

Analyze how the audit program<br />

affects an organization‘s risk level<br />

and how the risk level can influence<br />

the number and frequency of audits<br />

performed. (Analyze)<br />

[Note: Tools and techniques for managing<br />

risk are covered in BoK area V.H. (?) ]<br />

9. Management review input<br />

Examine and summarize audit<br />

program results, trends, and<br />

changes in risk to provide input to<br />

management reviews. (Evaluate)<br />

Charlie Chong/ Fion Zhang


9. Management review input<br />

Examine and summarize:<br />

• audit program results,<br />

• trends, and<br />

• changes in risk<br />

to provide input to management reviews. (Evaluate)<br />

Charlie Chong/ Fion Zhang


9. Management review input<br />

Examine and summarize:<br />

• audit program results,<br />

• trends, and<br />

• changes in risk<br />

to provide input to management reviews. (Evaluate)<br />

Charlie Chong/ Fion Zhang


9. Management review input<br />

Examine and summarize:<br />

• audit program results,<br />

• trends, and<br />

• changes in risk<br />

to provide input to management reviews. (Evaluate)<br />

KPI<br />

KPI<br />

Charlie Chong/ Fion Zhang


9. Management review input<br />

Examine and summarize:<br />

• audit program results,<br />

• trends, and<br />

• changes in risk<br />

to provide input to management reviews. (Evaluate)<br />

Charlie Chong/ Fion Zhang<br />

https://www.japantimes.co.jp/news/2016/05/10/business/five-million-new-takata-recalls-ordered-japan/#.W488FNwzaUk


9. Management review input<br />

Examine and summarize:<br />

• audit program results,<br />

• trends, and<br />

• changes in risk<br />

to provide input to management reviews. (Evaluate)<br />

Charlie Chong/ Fion Zhang<br />

https://www.theatlantic.com/photo/2011/07/the-history-of-the-space-shuttle/100097/


IV. Audit Program Management and Business Applications (30 Questions)<br />

B. Business and Financial Impact<br />

1. Auditing as a management tool<br />

Use audit results to monitor:<br />

• continuous improvement,<br />

• Supplier management,<br />

• customer satisfaction, etc., and<br />

• to provide management with an independent<br />

view of the strategic plan‘s effectiveness and<br />

how well it is deployed.<br />

(Analyze)<br />

2. Interrelationships of business processes<br />

Identify how business units (receiving, product<br />

and process design, production, engineering,<br />

sales, marketing, field support, etc.) and multiple<br />

sites are interrelated, and recognize how their<br />

unique metrics and goals can be in conflict<br />

with one another. (Understand)<br />

3. Cost of quality (COQ) principles<br />

Identify, describe, and analyze<br />

the audit program‘s effect on the<br />

four COQ categories:<br />

• prevention,<br />

• Appraisal (assessment, 评 估 - 检 验 ?),<br />

• internal failure,<br />

• External failure.<br />

(Analyze)<br />

4. Emerging roles of the auditor<br />

Recognize new roles and responsibilities for<br />

auditors, such as being process consultants<br />

and facilitators who can help resolve internal<br />

issues, improve processes, and add value to<br />

the organization. (Understand)<br />

Charlie Chong/ Fion Zhang


4. Emerging roles of the auditor<br />

Recognize new roles and responsibilities for auditors, such as being:<br />

• process consultants and<br />

• facilitators<br />

who can help resolve internal issues, improve processes, and add value to the organization.<br />

(Understand)<br />

Charlie Chong/ Fion Zhang


4. Emerging roles of the auditor<br />

Recognize new roles and responsibilities for<br />

auditors, such as being:<br />

• process consultants and<br />

• facilitators<br />

who can help resolve internal issues, improve<br />

processes, and add value to the organization.<br />

(Understand)<br />

Auditor<br />

as well<br />

as SME<br />

Charlie Chong/ Fion Zhang


V. Quality Tools and Techniques (26 Questions)<br />

A. Basic Quality and Problem-solving Tools<br />

Identify, interpret, and analyze:<br />

1) Pareto charts, 2) cause and effect<br />

diagrams, 3) flowcharts, 4) statistical<br />

process control (SPC) charts,<br />

5) check sheets, 6) scatter diagrams,<br />

7) histograms, 8) root cause analysis,<br />

9) plan-do-check-act (PDCA). (Analyze)<br />

B. Process Improvement Techniques<br />

1. Six Sigma<br />

Identify, interpret, and apply the Six Sigma<br />

DMAIC phases: define, measure, analyze,<br />

improve, control. (Apply)<br />

2. Lean<br />

Identify, interpret, and apply lean<br />

Tools (?) : 5S, standard operations,<br />

kanban (pull), error-proofing, value stream<br />

mapping, etc. (Apply)<br />

C. Basic Statistics<br />

1. Measures of central tendency<br />

Identify, interpret, and use mean, median, and<br />

mode. (Apply)<br />

2. Measures of dispersion<br />

Identify, interpret, and use standard deviation<br />

and frequency distribution. (Apply)<br />

3. Qualitative and quantitative analysis<br />

Describe qualitative data in terms of the nature,<br />

type, or attribute of an observation or condition.<br />

Describe how quantitative data is used to detect<br />

patterns or trends and how such analysis can<br />

indicate whether a problem is systemic or<br />

isolated. (Understand)<br />

Charlie Chong/ Fion Zhang


V. Quality Tools and Techniques (26 Questions)<br />

D. Process Variation<br />

1. Common and special cause Identify and<br />

distinguish between common and special cause<br />

variation. (Apply)<br />

2. Process performance metrics<br />

Describe elements of Cp and Cpk process<br />

capability studies (process centering and<br />

stability, specification limits, underlying<br />

distribution, etc.), and how these studies and<br />

other performance metrics are used in relation<br />

to established goals. (Understand)<br />

E. Sampling Methods<br />

1. Acceptance sampling plans<br />

Identify and interpret these plans for attributes<br />

and variables data.<br />

(Understand)<br />

2. Types of sampling<br />

Describe and distinguish between:<br />

• random,<br />

• stratified, and<br />

• cluster sampling,<br />

and identify the uses and potential problems of<br />

non-statistical sampling. (Understand)<br />

3. Outliers<br />

Describe their significance and impact.<br />

(Understand)<br />

3. Sampling terms<br />

Define related terms including consumer and<br />

producer risk, confidence level, etc. (Understand)<br />

Charlie Chong/ Fion Zhang


V. Quality Tools and Techniques (26 Questions)<br />

F. Change Control and Configuration<br />

Management<br />

Identify the principles of change<br />

control and configuration management<br />

systems as used in various applications:<br />

hardware,<br />

software (including security considerations),<br />

product,<br />

process, and<br />

service. (Understand)<br />

G. Verification and Validation<br />

Define, distinguish between, and use various<br />

methods of verifying and<br />

validating processes. (Analyze)<br />

H. Risk Management Tools<br />

Identify methods for managing risk, including:<br />

• risk avoidance,<br />

• mitigation,<br />

• tradeoffs, etc.,<br />

and describe tools and methods for estimating<br />

and controlling risk:<br />

• failure mode and effects analysis (FMEA),<br />

• hazard analysis and critical control points<br />

(HACCP),<br />

• critical to quality (CTQ) analysis,<br />

• health hazard analysis (HHA), etc.<br />

(Understand)<br />

[Note: Organizational risk management<br />

is covered in BoK area IV.A.8.]<br />

Charlie Chong/ Fion Zhang


LEVELS OF COGNITION (awareness)<br />

Based on Bloom‘s Taxonomy—Revised (2001)<br />

In addition to content specifics, the subtext for each topic in this BoK also indicates the intended<br />

complexity level of the test questions for that topic. <strong>The</strong>se levels are based on ―Levels of Cognition‖<br />

(from Bloom‘s Taxonomy- Revised, 2001) and are presented below in rank order, from least<br />

complex to most complex.<br />

REMEMBER | Recall or recognize terms,<br />

definitions, facts, ideas, materials, patterns,<br />

sequences, methods, principles, etc.<br />

UNDERSTAND | Read and understand<br />

descriptions, communications, reports,<br />

tables, diagrams, directions, regulations, etc.<br />

APPLY | Know when and how to use<br />

ideas, procedures, methods, formulas,<br />

principles, theories, etc.<br />

ANALYZE | Break down information into<br />

its constituent parts and recognize their<br />

relationship to one another and how they<br />

are organized; identify sublevel factors or<br />

salient (conspicuous/prominent) data from a<br />

complex scenario.<br />

EVALUATE | Make judgments about the value of<br />

proposed ideas, solutions, etc., by comparing<br />

the proposal to specific criteria or standards.<br />

CREATE | Put parts or elements together in<br />

such a way as to reveal a pattern or structure<br />

not clearly there before; identify which data or<br />

information from a complex set is appropriate to<br />

examine further or from which supported<br />

conclusions can be drawn.<br />

Charlie Chong/ Fion Zhang


<strong>CQA</strong>- Open Book Exam!<br />

FREQUENTLY ASKED QUESTIONS<br />

Is the exam open-book?<br />

With the exception of the constructed-response portion of the Manager of Quality/Organizational<br />

Excellence exam, exams are open-book.<br />

All reference materials (i.e. including all forms of notes) must be bound and remain bound<br />

during the exam. Bound refers to material permanently bound by stitching or glue and materials<br />

fastened securely in its cover by fasteners, which penetrate all papers (i.e. ring binders, spiral<br />

binders, plastic snap binders, brads, or screw posts). Manually or hand stapled documents that<br />

are not securely fastened in their covers are not allowed. <strong>The</strong> size of workspace area at Prometric<br />

test centers is limited. <strong>The</strong> approximate desk dimensions are 48" in length and 24" in width.<br />

Before you enter the exam room, the Test Center Administrator (TCA) will inspect all references.<br />

"Post-Its" will be permitted as book tabs only (must be attached prior to entering the test center).<br />

Items strictly prohibited in the exam area: hand stapled or paper-clipped materials, blank writing<br />

tablets or tablets containing blank pages, unbound tablets, unbound notes, slide charts and/or<br />

wheel charts (hand-held cardboard or plastic calculating devices with rotating or sliding pieces).<br />

Absolutely no collections of questions and answers or weekly refresher-course quizzes are<br />

permitted. Reference sources that contain such copy are not allowed unless the questions are<br />

removed.<br />

Examinees are responsible for abiding by applicable copyright laws.<br />

https://asq.org/cert/faq/open-book-exam<br />

Charlie Chong/ Fion Zhang


<strong>CQA</strong><br />

More to read<br />

• Six Sigma DMAIC phases: define, measure, analyze, improve, control.<br />

• Process capability Cp and Cpk<br />

• Lean Tools (?) : 5S, standard operations, kanban (pull), error-proofing, value stream mapping,<br />

etc.<br />

• Risk Management Tools<br />

• failure mode and effects analysis (FMEA),<br />

• hazard analysis and critical control points (HACCP),<br />

• critical to quality (CTQ) analysis,<br />

• health hazard analysis (HHA), etc.<br />

• Sampling methods<br />

Charlie Chong/ Fion Zhang


<strong>CQA</strong><br />

Star War Dead Star<br />

Charlie Chong/ Fion Zhang


<strong>CQA</strong>- Reading II<br />

Pre-Handbook Reading, the WIKI ways.<br />

Six Sigma DMAIC phases: define, measure, analyze, improve, control.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Six Sigma (6σ) is a set of techniques and tools for process improvement. It was<br />

introduced by engineer Bill Smith while working at Motorola in 1986. Jack Welch made<br />

it central to his business strategy at General Electric in 1995.<br />

Six Sigma strategies seek to improve the quality of the output of a process by<br />

identifying and removing the causes of defects and minimizing variability in<br />

manufacturing and business processes. It uses a set of quality management methods,<br />

mainly empirical, statistical methods, and creates a special infrastructure of people<br />

within the organization who are experts in these methods. Each Six Sigma project<br />

carried out within an organization follows a defined sequence of steps and has specific<br />

value targets, for example: reduce process cycle time, reduce pollution, reduce costs,<br />

increase customer satisfaction, and increase profits.<br />

<strong>The</strong> term Six Sigma (capitalized because it was written that way when registered as a<br />

Motorola trademark on December 28, 1993) originated from terminology associated<br />

with statistical modeling of manufacturing processes. <strong>The</strong> maturity of a manufacturing<br />

process can be described by a sigma rating indicating its yield or the percentage of<br />

defect-free products it creates. A six sigma process is one in which 99.99966% (?) of<br />

all opportunities to produce some feature of a part are statistically expected to be free<br />

of defects (3.4 defective features per million opportunities). Motorola set a goal of "six<br />

sigma" for all of its manufacturing.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Six Sigma doctrine asserts:<br />

Continuous efforts to achieve stable and predictable process results (e.g. by reducing<br />

process variation) are of vital importance to business success.<br />

Manufacturing and business processes have characteristics that can be DMAIC<br />

―defined, measured, analyzed, improved, and controlled.‖<br />

Achieving sustained quality improvement requires commitment from the entire<br />

organization, particularly from top-level management.<br />

Features that set Six Sigma apart from previous quality-improvement initiatives<br />

include:<br />

• A clear focus on achieving measurable and quantifiable financial returns from any<br />

Six Sigma project.<br />

• An increased emphasis on strong and passionate (enthusiastic) management<br />

leadership and support.<br />

• A clear commitment to making decisions on the basis of verifiable data and<br />

statistical methods, rather than assumptions and guesswork.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


<strong>The</strong> term ―six sigma‖ comes from statistics and is used in statistical quality control,<br />

which evaluates process capability. Originally, it referred to the ability of manufacturing<br />

processes to produce a very high proportion of output within specification. Processes<br />

that operate with ―six sigma quality‖ over the short term are assumed to produce longterm<br />

defect levels below 3.4 defects per million opportunities (DPMO). <strong>The</strong> 3.4 dpmo<br />

is based on a ―shift‖ of +/- 1.5 sigma created by the psychologist Dr Mikel Harry. He<br />

created this figure based on the tolerance in the height of a stack of discs. Six Sigma‗s<br />

implicit goal is to improve all processes, but not to the 3.4 DPMO level necessarily.<br />

Organizations need to determine an appropriate sigma level for each of their most<br />

important processes and strive to achieve these. As a result of this goal, it is<br />

incumbent ( 有 义 务 的 ) on management of the organization to prioritize areas of<br />

improvement.<br />

"Six Sigma" was registered June 11, 1991 as U.S. Service Mark 1,647,704. In 2005<br />

Motorola attributed over US$17 billion in savings to Six Sigma.[5]<br />

Other early adopters of Six Sigma include Honeywell and General Electric, where<br />

Jack Welch introduced the method. By the late 1990s, about two-thirds of the Fortune<br />

500 organizations had begun Six Sigma initiatives with the aim of reducing costs and<br />

improving quality.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


In recent years, some practitioners have combined Six Sigma ideas with lean<br />

manufacturing to create a methodology named Lean Six Sigma. <strong>The</strong> Lean Six Sigma<br />

methodology views lean manufacturing, which addresses process flow and waste<br />

issues, and Six Sigma, with its focus on variation and design, as complementary<br />

disciplines aimed at promoting "business and operational excellence". Companies<br />

such as GE, Accenture, Verizon, GENPACT, and IBM use Lean Six Sigma to focus<br />

transformation efforts not just on efficiency but also on growth. It serves as a<br />

foundation for innovation throughout the organization, from manufacturing and<br />

software development to sales and service delivery functions.<br />

<strong>The</strong> International Organization for Standardization (ISO) has published in 2011 the<br />

first standard "ISO 13053:2011" defining a Six Sigma process. Other "standards" are<br />

created mostly by universities or companies that have so-called first-party certification<br />

programs for Six Sigma.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


is a set of techniques and tools for process improvement. It was introduced by<br />

engineer<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Six Sigma Difference from lean management<br />

Lean management and Six Sigma are two concepts which share similar<br />

methodologies and tools. Both programs are Japanese-influenced, but they are two<br />

different programs:<br />

• Lean management is focused on eliminating waste and ensuring efficiency while<br />

• Six Sigma's focus is on eliminating defects and reducing variability.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Methodologies<br />

Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-<br />

Study-Act Cycle. <strong>The</strong>se methodologies, composed of five phases each, bear the<br />

acronyms DMAIC and DMADV.<br />

• DMAIC is used for projects aimed at improving an existing business process.<br />

• DMADV is used for projects aimed at creating new product or process designs.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


DMAIC<br />

<strong>The</strong> DMAIC project methodology has five phases:<br />

1. Define the system, the voice of the customer and their requirements, and the<br />

project goals, specifically.<br />

2. Measure key aspects of the current process and collect relevant data; calculate<br />

the 'as-is' Process Capability.<br />

3. Analyze the data to investigate and verify cause-and-effect relationships.<br />

Determine what the relationships are, and attempt to ensure that all factors have<br />

been considered. Seek out root cause of the defect under investigation.<br />

4. Improve or optimize the current process based upon data analysis using<br />

techniques such as design of experiments, poka yoke or mistake proofing, and<br />

standard work to create a new, future state process. Set up pilot runs to establish<br />

process capability.<br />

5. Control the future state process to ensure that any deviations from the target are<br />

corrected before they result in defects. Implement control systems such as<br />

statistical process control, production boards, visual workplaces, and continuously<br />

monitor the process. This process is repeated until the desired quality level is<br />

obtained.<br />

Some organizations add a Recognize step at the beginning, which is to recognize the<br />

right problem to work on, thus yielding an RDMAIC methodology.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Poka-yoke or Mistake Proofing<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


DMADV or DFSS<br />

<strong>The</strong> five steps of DMADV<br />

<strong>The</strong> DMADV project methodology, known as DFSS ("Design For Six Sigma"), features<br />

five phases:<br />

1. Define design goals that are consistent with customer demands and the enterprise<br />

strategy.<br />

2. Measure and identify CTQs (characteristics that are Critical To Quality), measure<br />

product capabilities, production process capability, and measure risks.<br />

3. Analyze to develop and design alternatives<br />

4. Design an improved alternative, best suited per analysis in the previous step<br />

5. Verify the design, set up pilot runs, implement the production process and hand it<br />

over to the process owner(s).<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


DMAIC- Define, Measure, Analuze, Improve, Control<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


DMADV (DFSS)- Define, Measure, Analyze, Design, Verify<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Quality management tools and methods<br />

Within the individual phases of a DMAIC or DMADV project, Six Sigma utilizes many<br />

established quality-management tools that are also used outside Six Sigma. <strong>The</strong><br />

following table shows an overview of the main methods used.<br />

• 5 Whys<br />

• Statistical and fitting tools<br />

• Analysis of variance<br />

• General linear model<br />

• ANOVA Gauge R&R<br />

• Regression analysis<br />

• Correlation<br />

• Scatter diagram<br />

• Chi-squared test<br />

• Axiomatic design<br />

• Business Process<br />

Mapping/Check sheet<br />

• Cause & effects diagram<br />

(also known as fishbone or<br />

Ishikawa diagram)<br />

• Control chart/Control plan<br />

(also known as a swimlane<br />

map)/Run charts<br />

• Cost-benefit analysis<br />

• CTQ tree<br />

• Design of<br />

experiments/Stratification<br />

• Histograms/Pareto<br />

analysis/Pareto chart<br />

• Pick chart/Process<br />

capability/Rolled<br />

throughput yield<br />

• Quality Function<br />

Deployment (QFD)<br />

• Quantitative marketing<br />

research through use of<br />

Enterprise Feedback<br />

Management (EFM)<br />

systems<br />

• Root cause analysis<br />

• SIPOC analysis (Suppliers,<br />

Inputs, Process, Outputs,<br />

Customers)<br />

• COPIS analysis (Customer<br />

centric version/perspective<br />

of SIPOC)<br />

• Taguchi methods/Taguchi<br />

Loss Function<br />

• Value stream mapping<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Implementation roles<br />

One key innovation of Six Sigma involves the absolute "professionalizing" of quality management<br />

functions. Prior to Six Sigma, quality management in practice was largely relegated to the<br />

production floor and to statisticians in a separate quality department. Formal Six Sigma programs<br />

adopt a kind of elite ranking terminology (similar to some martial arts systems, like judo) to define<br />

a hierarchy (and special career path) that includes all business functions and levels. Six Sigma<br />

identifies several key roles for its successful implementation.<br />

1. Executive Leadership includes the CEO and other members of top management. <strong>The</strong>y are responsible for<br />

setting up a vision for Six Sigma implementation. <strong>The</strong>y also empower the other role holders with the<br />

freedom and resources to explore new ideas for breakthrough improvements by transcending departmental<br />

barriers and overcoming inherent resistance to change.<br />

2. Champions take responsibility for Six Sigma implementation across the organization in an integrated<br />

manner. <strong>The</strong> Executive Leadership draws them from upper management. Champions also act as mentors<br />

to Black Belts.<br />

3. Master Black Belts, identified by Champions, act as in-house coaches on Six Sigma. <strong>The</strong>y devote 100% of<br />

their time to Six Sigma. <strong>The</strong>y assist Champions and guide Black Belts and Green Belts. Apart from<br />

statistical tasks, they spend their time on ensuring consistent application of Six Sigma across various<br />

functions and departments.<br />

4. Black Belts operate under Master Black Belts to apply Six Sigma methodology to specific projects. <strong>The</strong>y<br />

devote 100% of their valued time to Six Sigma. <strong>The</strong>y primarily focus on Six Sigma project execution and<br />

special leadership with special tasks, whereas Champions and Master Black Belts focus on identifying<br />

projects/functions for Six Sigma.<br />

5. Green Belts are the employees who take up Six Sigma implementation along with their other job<br />

responsibilities, operating under the guidance of Black Belts.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


According to proponents ( 建 议 者 ) of the system, special training is needed for all of<br />

these practitioners to ensure that they follow the methodology and use the data-driven<br />

approach correctly. Some organizations use additional belt colours, such as Yellow<br />

Belts, for employees that have basic training in Six Sigma tools and generally<br />

participate in projects and "White belts" for those locally trained in the concepts but do<br />

not participate in the project team. "Orange belts" are also mentioned to be used for<br />

special cases.<br />

Defining roles and responsibilities<br />

for: Top management, Champion,<br />

Master Black Belt, Black Belt and<br />

Green Belt.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Formal Six Sigma programs adopt a kind of elite ranking terminology<br />

(Key to define each roles and responsibilities)<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Certification<br />

General Electric and Motorola developed certification programs as part of their Six<br />

Sigma implementation, verifying individuals' command of the Six Sigma methods at<br />

the relevant skill level (Green Belt, Black Belt etc.). Following this approach, many<br />

organizations in the 1990s started offering Six Sigma certifications to their employees.<br />

Criteria for Green Belt and Black Belt certification vary; some companies simply<br />

require participation in a course and a Six Sigma project. <strong>The</strong>re is no standard<br />

certification body, and different certification services are offered by various quality<br />

associations and other providers against a fee. <strong>The</strong> American Society for Quality for<br />

example requires Black Belt applicants to pass a written exam and to provide a signed<br />

affidavit stating that they have completed two projects or one project combined with<br />

three years' practical experience in the body of knowledge<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Etymology*of "six sigma process"<br />

<strong>The</strong> term "six sigma process" comes from the notion that if one has six standard<br />

deviations between the process mean and the nearest specification limit, as shown in<br />

the graph, practically items will fail to meet specifications. This is based on the<br />

calculation method employed in process capability studies.<br />

* Etymology- a study of origin of a word<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Graph of the normal distribution, which underlies the statistical assumptions of the Six Sigma<br />

model. In the centre at 0, the Greek letter µ (mu) marks the mean, with the horizontal axis<br />

showing distance from the mean, marked in standard deviations and given the letter σ (sigma).<br />

<strong>The</strong> greater the standard deviation, the greater is the spread of values encountered. For the<br />

green curve shown above, µ = 0 and σ = 1. <strong>The</strong> upper and lower specification limits (marked USL<br />

and LSL) are at a distance of 6σ from the mean. Because of the properties of the normal<br />

distribution, values lying that far away from the mean are extremely unlikely: approximately 1 in a<br />

billion too low, and the same too high. Even if the mean were to move right or left by 1.5σ at<br />

some point in the future (1.5 sigma shift, coloured red and blue), there is still a good safety<br />

cushion. This is why Six Sigma aims to have processes where the mean is at least 6σ away from<br />

the nearest specification limit.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Graph of the normal distribution, which underlies the statistical assumptions of the Six Sigma<br />

model. In the centre at 0, the Greek letter µ (mu) marks the mean, with the horizontal axis<br />

showing distance from the mean, marked in standard deviations and given the letter σ (sigma).<br />

<strong>The</strong> greater the standard deviation, the greater is the spread of values encountered. For the<br />

green curve shown above, µ = 0 and σ = 1. <strong>The</strong> upper and lower specification limits (marked USL<br />

and LSL) are at a distance of 6σ from the mean. Because of the properties of the normal<br />

distribution, values lying that far away from the mean are extremely unlikely: approximately 1 in a<br />

billion too low, and the same too high.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Even if the mean were to move right or left by 1.5σ at some point in the future (1.5 sigma shift,<br />

coloured red and blue), there is still a good safety cushion. This is why Six Sigma aims to have<br />

processes where the mean is at least 6σ away from the nearest specification limit.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Even if the mean were to move right or left by 1.5σ at some point in the future (1.5 sigma shift,<br />

coloured red and blue), there is still a good safety cushion. This is why Six Sigma aims to have<br />

processes where the mean is at least 6σ away from the nearest specification limit.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Exercise:<br />

Calculate area under the curves:<br />

2σ = 0.0.4772<br />

±2σ = 0.9545<br />

3σ = 0.4987<br />

±3σ = 0.9973<br />

http://onlinestatbook.com/2/calculators/normal_dist.html<br />

Charlie Chong/ Fion Zhang


Exercise:<br />

Calculate area under the normal curves<br />

between LSL/USL at ±3σ, for, USL-ũ= 1.5σ<br />

Areas under the curve = 0.933<br />

http://onlinestatbook.com/2/calculators/normal_dist.html<br />

Charlie Chong/ Fion Zhang


Exercise:<br />

Calculate area under the normal curves<br />

between LSL/USL at ±3σ, for, USL-ũ= 1.5σ<br />

Areas under the curve = 0.933<br />

http://onlinestatbook.com/2/calculators/normal_dist.html<br />

3 sigma process: Note due to the limitation of online statistical calculator 3σ process was used to<br />

illustrate the scenario<br />

Charlie Chong/ Fion Zhang


<strong>Knowing</strong>: Process capability index<br />

Definitions<br />

• C p = Process Capability. A simple and straightforward indicator of process capability.<br />

C p = USL−LSL<br />

6σ<br />

(Estimates what the process is capable of producing if the process mean were to be centered between the specification limits. Assumes process output is approximately normally<br />

distributed.)<br />

• C p, lower = ũ−LSL<br />

3σ<br />

(Estimates process capability for specifications that consist of a lower limit only (for example, concentration). Assumes process output is approximately normally distributed.)<br />

• C p, upper = USL−ũ<br />

3σ<br />

(Estimates process capability for specifications that consist of a upper limit only (for example, strength). Assumes process output is approximately normally distributed.)<br />

• C pk = Process Capability Index. Adjustment of Cp for the effect of non-centered distribution.<br />

C pk = min[ USL−ũ<br />

, ũ−LSL<br />

3σ<br />

3σ<br />

]<br />

(Estimates what the process is capable of producing, considering that the process mean may not be centered between the specification limits. (If the process mean is not centered, Cp<br />

overestimates process capability.) Cpk


Interpreting C p , C pk<br />

―C pk , C pk = min[ USL−ũ<br />

, ũ−LSL<br />

] is an index (a simple number) which measures how close a process<br />

3σ 3σ<br />

is running to its specification limits, relative to the natural variability of the process. <strong>The</strong> larger the<br />

index, the less likely it is that any item will be outside the specs.‖<br />

https://www.isixsigma.com/tools-templates/capability-indices-process-capability/process-capability-cp-cpk-and-process-performance-pp-ppk-what-difference/#defs<br />

Charlie Chong/ Fion Zhang


Role of the 1.5 sigma shift<br />

Experience has shown that processes usually do not perform as well in the long term as they do in the short term. As a result, the<br />

number of sigmas that will fit between the process mean and the nearest specification limit may well drop over time, compared to<br />

an initial short-term study. To account for this real-life increase in process variation over time, an empirically based 1.5 sigma shift<br />

is introduced into the calculation. According to this idea, a process that fits 6 sigma between the process mean and the nearest<br />

specification limit in a short-term study will in the long term fit only 4.5 sigma – either because:<br />

• the process mean will move over time, or<br />

• because the long-term standard deviation of the process will be greater than that observed in the short term,<br />

• or both.<br />

Hence the widely accepted definition of a six sigma process is a process that<br />

produces 3.4 defective parts per million opportunities (DPMO). This is based on the<br />

fact that a process that is normally distributed will have 3.4 parts per million outside<br />

the limits, when the limits are six sigma from the "original" mean of zero and the<br />

process mean is then shifted by 1.5 sigma (and therefore, the six sigma limits are no<br />

longer symmetrical about the mean).<br />

3 sigma process<br />

<strong>The</strong> former six sigma distribution, when under the effect of the 1.5 sigma shift, is<br />

commonly referred to as a 4.5 sigma process. <strong>The</strong> failure rate of a six sigma<br />

distribution with the mean shifted 1.5 sigma is not equivalent to the failure rate of a<br />

4.5 sigma process with the mean centered on zero. This allows for the fact that<br />

special causes may result in a deterioration in process performance over time and is<br />

designed to prevent underestimation of the defect levels likely to be encountered in<br />

real-life operation.<br />

0<br />

<strong>The</strong> role of the sigma shift is mainly academic. <strong>The</strong> purpose of six sigma is to<br />

generate organizational performance improvement. It is up to the organization to<br />

determine, based on customer expectations, what the appropriate sigma level of a<br />

process is. <strong>The</strong> purpose of the sigma value is as a comparative figure to determine<br />

whether a process is improving, deteriorating, stagnant or non-competitive with others<br />

in the same business. Six sigma (3.4 DPMO) is not the goal of all processes.<br />

http://onlinestatbook.com/2/calculators/normal_dist.html<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


<strong>The</strong> failure rate of a six sigma distribution with the mean shifted 1.5 sigma is not equivalent to the<br />

failure rate of a 4.5 sigma process with the mean centered on zero. This allows for the fact that<br />

special causes may result in a deterioration in process performance over time and is designed to<br />

prevent underestimation of the defect levels likely to be encountered in real-life operation.<br />

3 sigma process 3 sigma process<br />

mean shifted<br />

1.5 sigma<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


A control chart depicting a<br />

process that experienced a<br />

1.5 sigma drift in the<br />

process mean toward the<br />

upper specification limit<br />

starting at midnight. Control<br />

charts are used to maintain<br />

6 sigma quality by signaling<br />

when quality professionals<br />

should investigate a process<br />

to find and eliminate<br />

special-cause variation.<br />

A control chart depicting a process that experienced a<br />

1.5 sigma drift in the process mean toward the upper<br />

specification limit starting at midnight. Control charts are<br />

used to maintain 6 sigma quality by signaling when<br />

quality professionals should investigate a process to find<br />

and eliminate special-cause variation.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Sigma levels<br />

<strong>The</strong> table below gives long-term DPMO values corresponding to various short-term<br />

sigma levels.<br />

<strong>The</strong>se figures assume that the process mean will shift by 1.5 sigma toward the side<br />

with the critical specification limit. In other words, they assume that after the initial<br />

study determining the short-term sigma level, the long-term C pk , C pk = min[ USL−ũ<br />

3σ 3σ<br />

or C pk = min[ USL−ũ<br />

, ũ−LSL<br />

] ? value will turn out to be 0.5 less than the short-term C<br />

6σ 6σ<br />

pk<br />

value.<br />

, ũ−LSL<br />

]<br />

So, now for example, the DPMO figure given for 1 sigma assumes that the long-term<br />

process mean will be 0.5 sigma beyond the specification limit<br />

• (Cpk = –0.17) [C pk = σ -0.5], rather than 1 sigma within it,<br />

3σ<br />

• (Cpk = 0.33) [C pk = σ ] as it was in the short-term study.<br />

3σ<br />

Sigma levels<br />

<strong>The</strong> table below gives long-term DPMO values corresponding to various short-term sigma levels.<br />

<strong>The</strong>se figures assume that the process mean will shift by 1.5 sigma toward the side with the critical<br />

specification limit. In other words, they assume that after the initial study determining the short-term sigma<br />

level, the long-term C pk, C pk= min[ USL−ũ , ũ−LSL ] or C<br />

3σ 3σ pk= min[ USL−ũ , ũ−LSL ] ? value will turn out to be 0.5 less<br />

6σ 6σ<br />

than the short-term C pk value.<br />

So, now for example, the DPMO figure given for 1 sigma assumes that the long-term process mean will be 0.5<br />

sigma beyond the specification limit<br />

• (Cpk = –0.17) [C σ pk= -0.5], rather than 1 sigma within it,<br />

3σ<br />

• (Cpk = 0.33) [C σ pk= ] as it was in the short-term study.<br />

3σ<br />

Note that the defect percentages indicate only defects exceeding the specification limit to which the process<br />

mean is nearest. Defects beyond the far specification limit are not included in the percentages. <strong>The</strong> formula<br />

used here to calculate the DPMO is thus:<br />

DPMO = 1000000 x (1-Φ(level-1.5))<br />

Note that the defect percentages indicate only defects exceeding the specification limit<br />

to which the process mean is nearest. Defects beyond the far specification limit are<br />

not included in the percentages. <strong>The</strong> formula used here to calculate the DPMO is thus:<br />

DPMO = 1000000 x (1-Φ(level-1.5))<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Six Sigma (6σ) is a set of techniques and tools for process improvement. It was<br />

introduced by engineer<br />

Sigma<br />

level<br />

Sigma (with<br />

1.5σ shift)<br />

DPMO<br />

Percent<br />

defective<br />

Percentage<br />

yield<br />

Short-term<br />

C pk<br />

Long-term<br />

C pk<br />

1 −0.5 691,462 69% 31% 0.33 −0.17<br />

2 0.5 308,538 31% 69% 0.67 0.17<br />

3 1.5 66,807 6.7% 93.3% 1.00 0.5<br />

4 2.5 6,210 0.62% 99.38% 1.33 0.83<br />

5 3.5 233 0.023% 99.977% 1.67 1.17<br />

6 4.5 3.4 0.00034% 99.99966% 2.00 1.5<br />

7 5.5 0.019 0.0000019% 99.9999981% 2.33 1.83<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Application<br />

Six Sigma mostly finds application in large organizations. An important factor in the<br />

spread of Six Sigma was GE's 1998 announcement of $350 million in savings thanks<br />

to Six Sigma, a figure that later grew to more than $1 billion. According to industry<br />

consultants like Thomas Pyzdek and John Kullmann, companies with fewer than 500<br />

employees are less suited to Six Sigma implementation or need to adapt the standard<br />

approach to make it work for them. Six Sigma however contains a large number of<br />

tools and techniques that work well in small to mid-size organizations. <strong>The</strong> fact that an<br />

organization is not big enough to be able to afford Black Belts does not diminish its<br />

abilities to make improvements using this set of tools and techniques. <strong>The</strong><br />

infrastructure described as necessary to support Six Sigma is a result of the size of<br />

the organization rather than a requirement of Six Sigma itself.<br />

Although the scope of Six Sigma differs depending on where it is implemented, it can<br />

successfully deliver its benefits to different applications.<br />

https://en.wikipedia.org/wiki/Six_Sigma<br />

Charlie Chong/ Fion Zhang


Recommended values<br />

Process capability indices are constructed to express more desirable capability with increasingly higher values.<br />

Values near or below zero indicate processes operating off target (ũ far from T) or with high variation.<br />

(<strong>The</strong> target process mean is T, the estimated mean of the process is ũ and the estimated variability of the process (expressed as a standard deviation) σ. )<br />

Fixing values for minimum "acceptable" process capability targets is a matter of personal opinion, and what<br />

consensus exists varies by industry, facility, and the process under consideration. For example, in the<br />

automotive industry, the Automotive Industry Action Group sets forth guidelines in the Production Part Approval<br />

Process, 4th edition for recommended Cpk minimum values C pk = min[ USL−ũ<br />

, ũ−LSL<br />

] for critical-to-quality CTQ<br />

3σ 3σ<br />

process characteristics. However, these criteria are debatable and several processes may not be evaluated for<br />

capability just because they have not properly been assessed.<br />

Since the process capability is a function of the specification, the Process Capability Index is only as good as<br />

the specification. For instance, if the specification came from an engineering guideline without considering the<br />

function and criticality of the part, a discussion around process capability is useless, and would have more<br />

benefits if focused on what are the real risks of having a part borderline out of specification. <strong>The</strong> loss function of<br />

Taguchi better illustrates this concept.<br />

At least one academic expert recommends the following:<br />

(cont. ………)<br />

Charlie Chong/ Fion Zhang


At least one academic expert recommends the following:<br />

Situation<br />

Recommended minimum<br />

process capability for twosided<br />

specifications<br />

C pk = min[ USL−ũ<br />

, ũ−LSL<br />

]<br />

3σ 3σ<br />

Recommended minimum<br />

process capability for onesided<br />

specification<br />

Existing process 1.33 1.25<br />

New process 1.50 1.45<br />

Safety or critical parameter<br />

for existing process<br />

Safety or critical parameter<br />

for new process<br />

1.50 1.45<br />

1.67 1.60<br />

Six Sigma quality process 2.00 2.00<br />

However where a process produces a characteristic with a capability index greater than 2.5, the unnecessary<br />

precision may be expensive.<br />

Charlie Chong/ Fion Zhang


Relationship to measures of process fallout<br />

<strong>The</strong> mapping from process capability indices, such as Cpk, to measures of process fallout is straightforward.<br />

Process fallout quantifies how many defects a process produces and is measured by DPMO or PPM. Process<br />

yield is the complement of process fallout and is approximately equal to the area under the probability density<br />

function, if the process output is approximately normally distributed.<br />

Φ(σ) =<br />

1<br />

2π<br />

σ<br />

e −t2 /2<br />

−σ<br />

dt<br />

In the short term ("short sigma"), the relationships are:<br />

C pk<br />

Sigma level (σ)<br />

Area under the<br />

probability<br />

density curve Φ(σ)<br />

Process yield<br />

Process fallout(in<br />

terms of<br />

DPMO/PPM)<br />

0.33 1 0.6826894921 68.27% 317311<br />

0.67 2 0.9544997361 95.45% 45500<br />

1.00 3 0.9973002039 99.73% 2700<br />

1.33 4 0.9999366575 99.99% 63<br />

1.67 5 0.9999994267 99.9999% 1<br />

2.00 6 0.9999999980 99.9999998% 0.002<br />

Charlie Chong/ Fion Zhang


C pk<br />

Sigma level (σ)<br />

Area under the<br />

probability<br />

density curve Φ(σ)<br />

Process yield<br />

Process fallout(in<br />

terms of<br />

DPMO/PPM)<br />

0.33 1 0.6826894921 68.27% 317311<br />

0.67 2 0.9544997361 95.45% 45500<br />

1.00 3 0.9973002039 99.73% 2700<br />

1.33 4 0.9999366575 99.99% 63<br />

1.67 5 0.9999994267 99.9999% 1<br />

2.00 6 0.9999999980 99.9999998% 0.002<br />

4 sigma σ level<br />

Charlie Chong/ Fion Zhang


C pk<br />

Adjusted Sigma<br />

level (σ)<br />

Area under the<br />

probability<br />

density curve Φ(σ)<br />

Process yield<br />

Process fallout(in<br />

terms of<br />

DPMO/PPM)<br />

0.33 1 0.3085375387 30.85% 691462<br />

0.67 2 0.6914624613 69.15% 308538<br />

1.00 3 0.9331927987 93.32% 66807<br />

1.33 4 0.9937903347 99.38% 6209<br />

1.67 5 0.9997673709 99.9767% 232.6<br />

2.00 6 0.9999966023 99.99966% 3.40<br />

4 sigma σ level,<br />

with 1.5σ shift<br />

In the long term, processes can shift or drift significantly (most control<br />

charts are only sensitive to changes of 1.5σ or greater in process<br />

output). If there was a 1.5 sigma shift 1.5σ off of target in the processes<br />

(see Six Sigma), it would then produce the above relationships.<br />

Because processes can shift or drift significantly long term, each<br />

process would have a unique sigma shift value, thus process capability<br />

indices are less applicable as they require statistical control.<br />

Charlie Chong/ Fion Zhang


Example<br />

Consider a quality characteristic with target of 100.00 μm and upper and lower specification limits of (±4μm)<br />

106.00μm and 94.00μm respectively. If, after carefully monitoring the process for a while, it appears that the<br />

process is in control and producing output predictably (as depicted in the run chart below), we can meaningfully<br />

estimate its mean and standard deviation.<br />

If ũ and σ are<br />

estimated to be<br />

98.94 μm and<br />

1.03 μm,<br />

respectively,<br />

then<br />

Charlie Chong/ Fion Zhang


If ũ and σ are estimated to be 98.94 μm and 1.03 μm, respectively, then<br />

C p = USL−LSL<br />

6σ<br />

= 106.00−94.00<br />

6 x 1.03<br />

= 1.94<br />

Index<br />

C pk = min[ USL−ũ , ũ−LSL ] = min[ 106.00−98.94 , 98.94−94.00<br />

3σ 3σ<br />

] = 1.6<br />

3 x 1.03 3 x 1.03<br />

C<br />

C pm =<br />

p<br />

√[1+( ũ−T<br />

σ )2 ] = 1.94<br />

√[1+( 98.94−100.00<br />

1.03 )2 ] = 1.35<br />

C pkm =<br />

C pk<br />

√[1+( ũ−T<br />

σ )2 ] = 1.6<br />

√[1+( 98.94−100.00<br />

1.03 )2 ] = 1.11<br />

<strong>The</strong> fact that the process is running off-center (about 1σ below its target) is reflected in<br />

the markedly different values for C p , C pk , C pm , and C pkm .<br />

C pk = min[ USL−ũ<br />

3σ , ũ−LSL<br />

3σ<br />

C pkm =<br />

] = min[ 106.00−98.94<br />

, 98.94−94.00<br />

3 x 1.03 3 x 1.03<br />

C pk<br />

√[1+( ũ−T<br />

σ )2 ] = 1.6<br />

√[1+( 98.94−100.00<br />

1.03 )2 ] = 1.11<br />

] = 1.6<br />

Charlie Chong/ Fion Zhang


Charlie Chong/ Fion Fion Zhang Zhang


Good Luck!<br />

Charlie Chong/ Fion Zhang


Good Luck!<br />

Charlie Chong/ Fion Zhang


<strong>CQA</strong><br />

CERTIFIED<br />

QUALITY AUDITOR<br />

Quality excellence to enhance your career<br />

and boost your organization’s bottom line<br />

asq.org/cert


Certification from <strong>ASQ</strong> is considered a mark of quality<br />

excellence in many industries. It helps you advance your<br />

career, and boosts your organization’s bottom line through<br />

your mastery of quality skills. Becoming certified as a<br />

Quality Auditor confirms your commitment to quality and<br />

the positive impact it will have on your organization.<br />

Examination<br />

Each certification candidate<br />

is required to pass a written<br />

examination that consists of<br />

multiple-choice questions that<br />

measure comprehension of<br />

the body of knowledge.<br />

2 Certified Quality Auditor


INFORMATION<br />

Certified Quality Auditor<br />

<strong>The</strong> Certified Quality Auditor (<strong>CQA</strong>) is a professional who understands<br />

the standards and principles of auditing and the auditing techniques of<br />

examining, questioning, evaluating, and reporting to determine a quality<br />

system’s adequacy and deficiencies. <strong>The</strong> Certified Quality Auditor analyzes<br />

all elements of a quality system and judges its degree of adherence to the<br />

criteria of industrial management and quality evaluation and control systems.<br />

<strong>CQA</strong><br />

Computer Delivered – <strong>The</strong> <strong>CQA</strong><br />

examination is a one-part,<br />

165-multiple-choice-question,<br />

five-and-a-half-hour exam and<br />

is offered in English only. One<br />

hundred and fifty questions are<br />

scored and 15 are unscored.<br />

Paper and Pencil – <strong>The</strong> <strong>CQA</strong><br />

examination is a one-part,<br />

150-multiple-choice-question,<br />

five-hour exam and is offered<br />

in English only.<br />

For comprehensive exam information on Quality Auditor certification,<br />

visit asq.org/cert.<br />

Certified Quality Auditor<br />

3


Education and/or Experience<br />

You must have eight years of on-thejob<br />

experience in one or more of the<br />

areas of the Certified Quality Auditor<br />

Body of Knowledge. A minimum of<br />

three years of this experience must<br />

be in a decision-making position.<br />

“Decision-making” is defined as<br />

the authority to define, execute, or<br />

control projects/processes and to be<br />

responsible for the outcome. This may<br />

or may not include management or<br />

supervisory positions.<br />

If you were ever certified by <strong>ASQ</strong><br />

as a Quality Engineer, Reliability<br />

Engineer, Software Quality Engineer,<br />

Supplier Quality Professional, or<br />

Manager of Quality/Organizational<br />

Excellence, experience used to qualify<br />

for certification in these fields applies<br />

to certification as a Quality Auditor.<br />

If you have completed a degree*<br />

from a college, university, or technical<br />

school with accreditation accepted<br />

by <strong>ASQ</strong>, part of the eight-year<br />

experience requirement will be<br />

waived as follows (only one of these<br />

waivers may be claimed):<br />

• Diploma from a technical<br />

or trade school–one year<br />

will be waived.<br />

• Associate’s degree–<br />

two years waived.<br />

• Bachelor’s degree–<br />

four years waived.<br />

• Master’s or doctorate–<br />

five years waived.<br />

*Degrees or diplomas from<br />

educational institutions outside<br />

the United States must be<br />

equivalent to degrees from<br />

U.S. educational institutions.<br />

4 Certified Quality Auditor


Minimum Expectations<br />

• Must possess the knowledge<br />

and ability to effectively conduct<br />

different types of audits, as<br />

appropriate for the method,<br />

relationship, or purpose of the<br />

audit, and must recognize the<br />

effect those audit types will have<br />

on the audit scope and outcomes.<br />

• Must be able to audit in a<br />

professional, ethical, and<br />

objective manner using<br />

and interpreting applicable<br />

standards or requirements, with<br />

an awareness of potential legal<br />

and financial ramifications.<br />

• Must be able to effectively plan,<br />

communicate, and execute an<br />

audit within its defined scope,<br />

including scheduling resources,<br />

conducting necessary meetings<br />

in performance of the audit, and<br />

using appropriate techniques<br />

to gather, identify, and classify<br />

objective evidence.<br />

• Must be able to verify, document,<br />

and communicate audit results,<br />

develop an audit report, and<br />

evaluate the effectiveness of<br />

corrective action and follow up.<br />

• Must possess interpersonal skills to<br />

resolve conflict, conduct interviews,<br />

and make presentations while<br />

participating as an audit team<br />

member, and must possess knowledge<br />

of the unique responsibilities of the<br />

lead auditor and team facilitator.<br />

• Must understand the value that<br />

quality auditing adds to the<br />

organization and how auditing<br />

can reveal interrelationships<br />

between business processes that<br />

can influence outcomes and<br />

organizational risk.<br />

• Must be able to select appropriate<br />

quality and auditing tools and<br />

techniques, and use them effectively<br />

in a variety of practical applications.<br />

Certified Quality Auditor<br />

5


BODY OF KNOWLEDGE<br />

Certified Quality Auditor (<strong>CQA</strong>)<br />

Topics in this body of knowledge (BoK) include additional detail in<br />

the form of subtext explanations and cognitive level. <strong>The</strong>se details<br />

will be used by the Exam Development Committee as guidelines for<br />

writing test questions, and are designed to help candidates prepare<br />

for the exam by identifying specific content within each topic that may<br />

be tested. <strong>The</strong> subtext is not intended to limit the subject matter or be<br />

all-inclusive of what might be covered in an exam, but is intended<br />

to clarify how the topics relate to a Quality Auditor’s role. <strong>The</strong> descriptor<br />

in parentheses at the end of each entry refers to the maximum cognitive<br />

level at which the topic will be tested. A more comprehensive description<br />

of cognitive levels is provided at the end of this document.<br />

Examinations will continue to present a number of case studies. Each<br />

case study will include a brief scenario outlining critical details about an<br />

audit situation. In addition, each case study will be supported by related<br />

audit documents. <strong>The</strong> documents will be contained in a separate booklet<br />

“Confidential Audit Documents – <strong>CQA</strong> Case Studies” that will be part<br />

of the test materials distributed at the examination. Approximately 15-20<br />

percent (25-30 questions) of the test will be devoted to these case studies.<br />

Although the questions related to these cases will use the same four-choice<br />

answer format as the rest of the test, the use of scenario details and sample<br />

documents will allow the candidates to apply their critical thinking skills in<br />

evaluating realistic situations and accompanying documents, memos, etc.<br />

I. Auditing Fundamentals<br />

(27 Questions)<br />

A. Types of Quality Audits<br />

1. Method<br />

Define, differentiate, and<br />

analyze various audit types by<br />

method: product, process, desk,<br />

department, function, element,<br />

system, management. (Analyze)<br />

2. Auditor-auditee relationship<br />

Define, differentiate, and analyze<br />

various audit types by auditorauditee<br />

relationship: first-party,<br />

second-party, third-party, internal<br />

and external. (Analyze)<br />

3. Purpose<br />

Define, differentiate, and analyze<br />

various audit types by purpose:<br />

verification of corrective action<br />

(follow-up) audits, risk audits,<br />

accreditation (registration) and<br />

compliance audits, surveillance<br />

and for-cause audits. (Analyze)<br />

6 Certified Quality Auditor


4. Common elements<br />

with other audits<br />

Identify elements such as<br />

audit purpose, data gathering<br />

techniques, tracing, etc., that<br />

quality audits have in common with<br />

environmental, safety, financial,<br />

and other types of audits. (Apply)<br />

B. Purpose and Scope of Audits<br />

1. Elements of purpose and scope<br />

Describe and determine how the<br />

purpose of an audit can affect its<br />

scope. (Apply)<br />

2. Benefits of audits<br />

Analyze how audits can be<br />

used to provide an independent<br />

assessment of system effectiveness<br />

and efficiency, risks to the bottom<br />

line, and other organizational<br />

measures. (Analyze)<br />

C. Criteria to Audit Against<br />

Define and distinguish between<br />

various audit criteria, such as external<br />

(industry, national, international)<br />

standards, contracts, specifications,<br />

quality awards, policies, internal quality<br />

management system (QMS), sustainability,<br />

social responsibility, etc. (Analyze)<br />

D. Roles and Responsibilities<br />

of Audit Participants<br />

Define and describe the functions<br />

and responsibilities of various audit<br />

participants, including audit team<br />

members, lead auditor, client,<br />

auditee, etc. (Apply)<br />

E. Professional Conduct and<br />

Consequences for Auditors<br />

1. Professional conduct<br />

and responsibilities<br />

Define and apply the <strong>ASQ</strong><br />

Code of Conduct, concepts<br />

of due diligence and due care<br />

with respect to confidentiality<br />

and conflict of interest, and<br />

appropriate actions in response<br />

to the discovery of illegal activities<br />

or unsafe conditions. (Apply)<br />

2. Legal consequences<br />

Identify potential legal and financial<br />

ramifications of improper auditor<br />

actions (carelessness, negligence,<br />

etc.) in various situations, and<br />

anticipate the effect that certain<br />

audit results can have on an<br />

auditee’s liability. (Apply)<br />

3. Audit credibility<br />

Identify and apply various factors<br />

that influence audit credibility, such<br />

as auditor independence, objectivity,<br />

and qualifications. (Apply)


II. Audit Process<br />

(42 Questions)<br />

A. Audit Preparation and Planning<br />

1. Elements of the<br />

audit planning process<br />

Evaluate and implement the basic<br />

steps in audit preparation and<br />

planning: verify audit authority;<br />

determine the purpose, scope,<br />

and type of audit; identify the<br />

requirements to audit against and<br />

the resources necessary, including<br />

the size and number of audit<br />

teams. (Evaluate)<br />

2. Auditor selection<br />

Identify and examine various<br />

auditor selection criteria, such as<br />

education, experience, industry<br />

background, and subject matter<br />

or technical expertise. (Analyze)<br />

3. Audit-related documentation<br />

Identify the sources of pre-audit<br />

information and examine auditrelated<br />

documentation, such as<br />

audit criteria references and results<br />

from prior audits. (Analyze)<br />

4. Logistics<br />

Identify and organize audit-related<br />

logistics, including travel, safety<br />

and security considerations, the<br />

need for escorts, translators,<br />

confidentiality agreements, clear<br />

right of access, etc. (Analyze)<br />

5. Auditing tools and working papers<br />

Identify the sampling plan or<br />

method and procedural guidelines<br />

to be used for the specific audit.<br />

Select and prepare working<br />

papers (checklists, log sheets, etc.)<br />

to document the audit. (Create)<br />

6. Auditing strategies<br />

Identify and use various tactical<br />

methods for conducting an audit,<br />

such as forward and backward<br />

tracing, discovery, etc. (Apply)<br />

B. Audit Performance<br />

1. On-site audit management<br />

Interpret situations throughout<br />

the performance of the audit<br />

to determine whether time is<br />

being managed well and when<br />

changes need to be made, such<br />

as revising planned audit team<br />

activities, reallocating resources,<br />

adjusting the audit plan, etc., and<br />

communicate with the auditee<br />

about any changes or other events<br />

related to the audit. (Analyze)<br />

2. Opening meeting<br />

Manage the opening meeting of<br />

an audit by identifying the audit’s<br />

purpose and scope, describing any<br />

scoring or rating criteria that will be<br />

used during the audit, creating a<br />

record of the attendees, reviewing<br />

the audit schedule, and answering<br />

questions as needed. (Apply)<br />

8 Certified Quality Auditor


3. Audit data collection and analysis<br />

Use various data collection methods<br />

to capture information: conducting<br />

interviews, observing work activities,<br />

taking physical measurements,<br />

examining documents, etc.<br />

Evaluate the results to determine<br />

their importance for providing<br />

audit evidence. (Evaluate)<br />

4. Establishment of objective evidence<br />

Identify and differentiate<br />

characteristics of objective<br />

evidence, such as observed,<br />

measured, confirmed or<br />

corroborated, and documented.<br />

(Analyze)<br />

5. Organization of objective evidence<br />

Classify evidence in terms of<br />

significance, severity, frequency, and<br />

level of risk. Evaluate the evidence<br />

for its potential impact on product,<br />

process, system, cost of quality, etc.,<br />

and determine whether additional<br />

investigation is required to meet the<br />

scope of the audit. (Evaluate)<br />

6. Exit and closing meetings<br />

Formally manage these meetings:<br />

reiterate the audit’s purpose, scope,<br />

and scoring or rating criteria, and<br />

create a record of the attendees.<br />

Present the audit results and obtain<br />

concurrence on evidence that could<br />

lead to an adverse conclusion.<br />

Discuss the next steps in the<br />

process (follow-up audit, additional<br />

evidence-gathering, etc.), and<br />

clarify who is responsible for<br />

performing those steps. (Apply)<br />

C. Audit Reporting<br />

1. Report development and content<br />

Group observations into actionable<br />

findings of significance, and identify<br />

the severity and risk to the client and<br />

the auditee. Use appropriate steps to<br />

generate the audit report: organize<br />

and summarize details, review and<br />

finalize results, emphasize critical<br />

issues, establish unique identifiers or<br />

codes for critical issues to facilitate<br />

tracking and monitoring, etc. (Create)<br />

2. Effective reports<br />

Develop and evaluate components<br />

of effective audit reports,<br />

including background information,<br />

executive summary, prioritized<br />

results (observations, findings,<br />

opportunities for improvement,<br />

etc.). Use graphical tools or other<br />

means of emphasizing conclusions,<br />

and develop a timeline for auditee<br />

response and/or corrections. (Create)<br />

3. Final audit report steps<br />

Obtain necessary approvals for<br />

the audit report and distribute<br />

it according to established<br />

procedures. Identify the contents<br />

of the audit file and retain the file<br />

in accordance with established<br />

policies and procedures. (Apply)<br />

D. Audit Follow-Up and Closure<br />

1. Elements of the<br />

corrective action process<br />

Identify and evaluate various<br />

elements: assignment of responsibility<br />

for problem identification; the<br />

performance of root cause analysis<br />

and recurrence prevention. (Evaluate)<br />

2. Review of corrective action plan<br />

Evaluate the acceptability of<br />

proposed corrective actions<br />

and schedule for completion.<br />

Identify and apply strategies<br />

for negotiating changes to<br />

unacceptable plans. (Evaluate)<br />

3. Verification of corrective action<br />

Determine the adequacy of<br />

corrective actions taken by<br />

verifying and evaluating new or<br />

updated procedures, observing<br />

revised processes, conducting<br />

follow-up audits, etc. (Evaluate)<br />

4. Follow-up on<br />

ineffective corrective action<br />

Develop strategies to use<br />

when corrective actions are<br />

not implemented or are not<br />

effective, such as communicating<br />

to the next level of management,<br />

reissuing the corrective action<br />

request, and re-auditing. (Create)<br />

5. Audit closure<br />

Identify and apply various elements<br />

of, and criteria for, audit closure<br />

(Apply)<br />

Certified Quality Auditor<br />

9


III. Auditor Competencies<br />

(25 Questions)<br />

A. Auditor Characteristics<br />

Identify characteristics that make<br />

auditors effective: interpersonal skills,<br />

problem-solving skills, attention to detail,<br />

cultural awareness and sensitivity, ability<br />

to work independently as well as in a<br />

group or on a team, etc. (Apply)<br />

B. On-Site Audit<br />

Resource Management<br />

Identify and apply techniques for<br />

managing audit teams, scheduling<br />

audit meetings and activities, making<br />

logistical adjustments, etc. (Apply)<br />

C. Conflict Resolution<br />

Identify typical conflict situations (mild<br />

to vehement disagreements, auditee<br />

delaying tactics, interruptions, etc.)<br />

and determine appropriate techniques<br />

for resolving them: clarifying the<br />

question or request, reiterating ground<br />

rules, intervention by another authority,<br />

cool-down periods, etc. (Analyze)<br />

D. Communication and<br />

Presentation Techniques<br />

Select and use written, oral, and<br />

electronic communication techniques<br />

for presentations made during audits<br />

for opening, closing, ad-hoc meetings,<br />

etc. Use technical and managerial<br />

reporting techniques, including graphs,<br />

charts, diagrams, multimedia aids, etc.,<br />

in various situations: domestic, global,<br />

in-person, virtual (e-audits), multiple sites<br />

simultaneously, etc. (Evaluate)<br />

E. Interviewing Techniques<br />

Select and use appropriate interviewing<br />

techniques and methodologies. (Apply)<br />

1. Use open-ended<br />

or closed question types<br />

2. Use active listening,<br />

paraphrasing, empathy, etc.<br />

3. Recognize and respond to<br />

non-verbal cues: body language,<br />

the significance of pauses and<br />

their length, etc.<br />

4. Determine when and how<br />

to prompt a response: when<br />

supervisors are present, when<br />

interviewing a group of workers,<br />

when using a translator, etc.<br />

F. Team Dynamics<br />

Define, describe, and apply various<br />

aspects of team dynamics. (Apply)<br />

1. Team-building: clarifying roles<br />

and responsibilities for participants<br />

and leaders to ensure equitable<br />

treatment for all team members,<br />

providing clear direction for<br />

deliverables, identifying necessary<br />

resources and ensuring their<br />

availability, etc.<br />

2. Team facilitation: providing<br />

coaching and guidance, defusing<br />

clashes between members, eliciting<br />

input from all, cultivating objectivity,<br />

overseeing progress, encouraging<br />

diverse views and consensus, etc.<br />

3. Stages of team development:<br />

forming, storming, norming,<br />

and performing<br />

IV. Audit Program Management<br />

and Business Applications<br />

(30 Questions)<br />

A. Audit Program Management<br />

1. Senior management support<br />

Identify and explain management’s<br />

role in creating and supporting the<br />

audit function. (Understand)<br />

2. Staffing and resource management<br />

Develop staffing budgets that<br />

provide adequate time for auditors<br />

to plan, conduct, and respond to<br />

scheduled audits, including time<br />

and resources that internal auditees<br />

need to participate. Identify any<br />

special equipment resources<br />

needed and ensure their adequacy<br />

and availability. Consider the use<br />

of and requirements for special<br />

audits (outsourced or contracted<br />

audits, virtual or e-audits, shared<br />

audits, etc.) as driven by costs,<br />

geography, etc. Evaluate results<br />

and adjust resources as needed<br />

on a regular basis. (Evaluate)<br />

10 Certified Quality Auditor


3. Auditor training and development<br />

Identify minimum audit knowledge<br />

and skill requirements for auditors.<br />

Provide training on various aspects<br />

of the audit process such as relevant<br />

standards, regulatory influences,<br />

facilitation techniques, etc. Provide<br />

training on diversity and cultural<br />

influences (ethnicity, gender, age,<br />

organized labor, etc.) and how such<br />

factors can affect communications<br />

and other interactions among audit<br />

participants. (Create)<br />

4. Audit program evaluation<br />

Select the correct metric to evaluate<br />

the audit program, including tracking<br />

its effect on the bottom line and the<br />

risk to the organization. (Evaluate)<br />

5. Internal audit<br />

program management<br />

Develop procedures, policies,<br />

and schedules to support the<br />

organization’s objectives. Review<br />

internal audit results to identify<br />

systemic trends. (Create)<br />

6. External audit<br />

program management<br />

Develop procedures, policies, and<br />

schedules in support of the supplier<br />

management program, including<br />

supplier qualification surveys,<br />

surveillance audits, supplier<br />

improvement, etc. (Create)<br />

7. Best practices<br />

Analyze audit results to standardize<br />

best practices and lessons learned<br />

across the organization. (Analyze)<br />

8. Organizational risk management<br />

Analyze how the audit program<br />

affects an organization’s risk level<br />

and how the risk level can influence<br />

the number and frequency of audits<br />

performed. (Analyze) [Note: Tools<br />

and techniques for managing risk<br />

are covered in BoK area V.H.]<br />

9. Management review input<br />

Examine and summarize audit<br />

program results, trends, and<br />

changes in risk to provide input to<br />

management reviews. (Evaluate)<br />

B. Business and Financial Impact<br />

1. Auditing as a management tool<br />

Use audit results to monitor<br />

continuous improvement, supplier<br />

management, customer satisfaction,<br />

etc., and to provide management<br />

with an independent view of the<br />

strategic plan’s effectiveness and<br />

how well it is deployed. (Analyze)<br />

12 Certified Quality Auditor


2. Interrelationships of<br />

business processes<br />

Identify how business units<br />

(receiving, product and process<br />

design, production, engineering,<br />

sales, marketing, field support, etc.)<br />

and multiple sites are interrelated,<br />

and recognize how their unique<br />

metrics and goals can be in conflict<br />

with one another. (Understand)<br />

3. Cost of quality (COQ) principles<br />

Identify, describe, and analyze<br />

the audit program’s effect on the<br />

four COQ categories: prevention,<br />

appraisal, internal failure, external<br />

failure. (Analyze)<br />

4. Emerging roles of the auditor<br />

Recognize new roles and<br />

responsibilities for auditors,<br />

such as being process consultants<br />

and facilitators who can help<br />

resolve internal issues, improve<br />

processes, and add value to<br />

the organization. (Understand)<br />

V. Quality Tools and Techniques<br />

(26 Questions)<br />

A. Basic Quality and<br />

Problem-solving Tools<br />

Identify, interpret, and analyze:<br />

1) Pareto charts, 2) cause and effect<br />

diagrams, 3) flowcharts, 4) statistical<br />

process control (SPC) charts,<br />

5) check sheets, 6) scatter diagrams,<br />

7) histograms, 8) root cause analysis,<br />

9) plan-do-check-act (PDCA). (Analyze)<br />

B. Process Improvement Techniques<br />

1. Six Sigma<br />

Identify, interpret, and apply the<br />

Six Sigma DMAIC phases: define,<br />

measure, analyze, improve, control.<br />

(Apply)<br />

2. Lean<br />

Identify, interpret, and apply lean<br />

tools: 5S, standard operations,<br />

kanban (pull), error-proofing, valuestream<br />

mapping, etc. (Apply)<br />

C. Basic Statistics<br />

1. Measures of central tendency<br />

Identify, interpret, and use mean,<br />

median, and mode. (Apply)<br />

2. Measures of dispersion<br />

Identify, interpret, and use standard<br />

deviation and frequency distribution.<br />

(Apply)<br />

3. Qualitative and<br />

quantitative analysis<br />

Describe qualitative data in terms<br />

of the nature, type, or attribute<br />

of an observation or condition.<br />

Describe how quantitative data<br />

is used to detect patterns or trends<br />

and how such analysis can indicate<br />

whether a problem is systemic or<br />

isolated. (Understand)<br />

D. Process Variation<br />

1. Common and special cause<br />

Identify and distinguish between<br />

common and special cause<br />

variation. (Apply)<br />

2. Process performance metrics<br />

Describe elements of Cp and<br />

Cpk process capability studies<br />

(process centering and stability,<br />

specification limits, underlying<br />

distribution, etc.), and how these<br />

studies and other performance<br />

metrics are used in relation to<br />

established goals. (Understand)<br />

3. Outliers<br />

Describe their significance<br />

and impact. (Understand)<br />

E. Sampling Methods<br />

1. Acceptance sampling plans<br />

Identify and interpret these plans<br />

for attributes and variables data.<br />

(Understand)<br />

2. Types of sampling<br />

Describe and distinguish between<br />

random, stratified, and cluster<br />

sampling, and identify the uses<br />

and potential problems of nonstatistical<br />

sampling. (Understand)<br />

3. Sampling terms<br />

Define related terms including<br />

consumer and producer risk,<br />

confidence level, etc. (Understand)<br />

Certified Quality Auditor<br />

13


F. Change Control and<br />

Configuration Management<br />

Identify the principles of change<br />

control and configuration management<br />

systems as used in various applications:<br />

hardware, software (including security<br />

considerations), product, process, and<br />

service. (Understand)<br />

G. Verification and Validation<br />

Define, distinguish between, and<br />

use various methods of verifying and<br />

validating processes. (Analyze)<br />

H. Risk Management Tools<br />

Identify methods for managing risk,<br />

including risk avoidance, mitigation,<br />

tradeoffs, etc., and describe tools<br />

and methods for estimating and<br />

controlling risk: failure mode and<br />

effects analysis (FMEA), hazard<br />

analysis and critical control points<br />

(HACCP), critical to quality (CTQ)<br />

analysis, health hazard analysis<br />

(HHA), etc. (Understand) [Note:<br />

Organizational risk management<br />

is covered in BoK area IV.A.8.]<br />

14 Certified Quality Auditor


LEVELS OF COGNITION<br />

Based on Bloom’s Taxonomy—Revised (2001)<br />

In addition to content specifics, the subtext for each topic in this BoK also<br />

indicates the intended complexity level of the test questions for that topic.<br />

<strong>The</strong>se levels are based on “Levels of Cognition” (from Bloom’s Taxonomy—<br />

Revised, 2001) and are presented below in rank order, from least complex<br />

to most complex.<br />

REMEMBER | Recall or recognize terms,<br />

definitions, facts, ideas, materials, patterns,<br />

sequences, methods, principles, etc.<br />

UNDERSTAND | Read and understand<br />

descriptions, communications, reports,<br />

tables, diagrams, directions, regulations, etc.<br />

APPLY | Know when and how to use<br />

ideas, procedures, methods, formulas,<br />

principles, theories, etc.<br />

ANALYZE | Break down information into<br />

its constituent parts and recognize their<br />

relationship to one another and how they<br />

are organized; identify sublevel factors or<br />

salient data from a complex scenario.<br />

EVALUATE | Make judgments about the<br />

value of proposed ideas, solutions, etc.,<br />

by comparing the proposal to specific<br />

criteria or standards.<br />

CREATE | Put parts or elements together<br />

in such a way as to reveal a pattern or<br />

structure not clearly there before; identify<br />

which data or information from a complex<br />

set is appropriate to examine further or<br />

from which supported conclusions can<br />

be drawn.<br />

Visit asq.org/cert for comprehensive exam information.


Enhance your career<br />

with <strong>ASQ</strong> certification today!<br />

Visit asq.org/cert for additional<br />

certification information including:<br />

• Applications<br />

• Available certifications and<br />

international language options<br />

• Reference materials<br />

• Study guides and test-taking tips<br />

• Comprehensive exam information<br />

• <strong>ASQ</strong> sections<br />

• International contacts<br />

• Endorsements<br />

Item B0020

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!