Understanding ASQ-CQA -Knowing The Ways
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<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 />
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