Understanding ASQ CQA Knowing The Ways

Knowing ASQ CQA
The Quality Auditor Certification

My Pre-exam Self Study Notes
4th September 2018
Charlie Chong/ Fion Zhang

Aeronautical Quality Assurance

Aeronautical Quality Assurance

SR-71

SR-71

SR-71

SR-71A

闭门练功

http://independent.academia.edu/CharlieChong1
http://www.yumpu.com/zh/browse/user/charliechong
http://issuu.com/charlieccchong

Charlie Chong/ Fion Zhang http://greekhouseoffonts.com/
The Magical Book of Tank Inspection ICP

闭门练功

闭门练功
Fion Zhang at Shanghai
4th September 2018

Content:
1. ASQ BOK
2. Pre-read: Six Sigma 6σ-The Wikipedia

ASQ Mission:
The American Society for Quality advances
individual, organizational, and community
excellence worldwide through learning, quality
improvement, and knowledge exchange.

ASQ Mission:
The American Society for Quality advances individual, organizational, and
community excellence worldwide through learning, quality improvement, and
knowledge exchange.
excellence
• learning
• knowledge
exchange
Charlie Chong/ Fion Zhang https://asq.org/about-asq/asq-awards/deming

The Certified Quality Auditor (CQA) is a professional who understands：
 the standards and
 the principles of auditing and
 the auditing techniques of ;
 examining,
 questioning,
 evaluating, and
 reporting
to determine a quality system’s adequacy and deficiencies. The Certified
Quality Auditor analyzes all elements of a quality system and judges its degree
of adherence to the criteria of industrial management and quality evaluation
and control systems.

 the auditing techniques of ; …appropriate techniques to
 examining, gather, identify, and classify
objective evidence.
 questioning,
 evaluating, and
 reporting

The Auditing Techniques: Examining

The Auditing Techniques: Questioning

The Auditing Techniques: Evaluating & Reporting

CQA
Computer Delivered – The CQA examination is a one-part,165-multiple-
choice-question,five-and-a-half-hour exam and is offered in English only.
One hundred and fifty questions are scored and 15 are unscored. Paper and
Pencil – The CQA
examination is a one-part,150-multiple-choice-question,five-hour exam and
is offered in English only.
165 – 15 Questions
minus
5 hours.

Minimum Expectations
 Must possess the knowledge and ability to  Must be able to verify, document, and communicate
effectively conduct different types of audits, as audit results, develop an audit report, and evaluate the
appropriate for the method, relationship, or effectiveness of corrective action and follow up.
purpose of the audit, and must recognize the
effect those audit types will have on the audit  Must possess interpersonal skills to resolve conflict,
scope and outcomes. conduct interviews, and make presentations while
participating as an audit team member, and must
 Must be able to audit in a professional, ethical, possess knowledge of the unique responsibilities of
and objective manner using and interpreting the lead auditor and team facilitator.
applicable standards or requirements, with an
awareness of potential legal and financial  Must understand the value that quality auditing adds
ramifications 财务影响. to the organization and how auditing can reveal
interrelationships between business processes that
 Must be able to effectively plan, communicate, can influence outcomes and organizational risk.
and execute an audit within its defined scope,
including scheduling resources, conducting  Must be able to select appropriate quality and auditing
necessary meetings in performance of the audit, tools and techniques, and use them effectively in a
and using appropriate techniques to gather, variety of practical applications.
identify, and classify objective evidence.

Must possess interpersonal skills to resolve conflict.

BOK
Examinations will continue to present a number of case studies. Each case
study will include a brief scenario outlining critical details about an audit
situation. In addition, each case study will be supported by related audit
documents. The documents will be contained in a separate booklet
“Confidential Audit Documents – CQA Case Studies” that will be part of the
test materials distributed at the examination. Approximately 15-20 percent
(25-30 questions) of the test will be devoted to these case studies.
Although the questions related to these cases will use the same four-choice
answer format as the rest of the test, the use of scenario details and sample
documents will allow the candidates to apply their critical thinking skills in
evaluating realistic situations and accompanying documents, memos, etc.

BOK
Knowledge Percentage Score
I. Auditing Fundamentals (27 Questions) 18%
II. Audit Process (42 Questions) 28%
III. Auditor Competencies (25 Questions) 17%
IV. Audit Program Management and Business Applications 20%

(30 Questions)
V. Quality Tools and Techniques (26 Questions) 17%
150 Questions 100%

BOK
Approximately 15-20 percent (25-30 questions) of the test will be devoted to
these case studies.

BOK
I. Auditing Fundamentals (27 Questions)
A. Types of Quality Audits 4. Common elements with other audits
1. Method Identify elements such as audit purpose, data
Define, differentiate, and analyze various audit gathering techniques, tracing, etc., that quality
types by method: product, process, desk, audits have in common with environmental,
department, function, element, system, safety, financial, and other types of audits.
management. (Analyze) (Apply)
2. Auditor-auditee relationship B. Purpose and Scope of Audits

Define, differentiate, and analyze various audit 1. Elements of purpose and scope
types by auditor-auditee relationship: first-party, Describe and determine how the purpose of an
second-party, third-party, internal and external. audit can affect its scope. (Apply)
(Analyze)
2. Benefits of audits
3. Purpose Analyze how audits can be used to provide an
Define, differentiate, and analyze various audit independent assessment of system
types by purpose: verification of corrective effectiveness and efficiency, risks to the bottom
action (follow-up) audits, risk audits, line, and other organizational measures.
accreditation (registration) and compliance (Analyze)
audits, surveillance and for-cause audits.
(Analyze)

I. Auditing Fundamentals (27 Questions)
C. Criteria to Audit Against 2. Legal consequences
Define and distinguish between various audit Identify potential legal and financial
criteria, such as external (industry, national, ramifications of improper auditor actions
international) standards, contracts, specifications, (carelessness, negligence, etc.) in various
quality awards, policies, internal quality situations, and anticipate the effect that certain
management system (QMS), sustainability, social audit results can have on an auditee‘s liability.
responsibility, etc. (Analyze) (Apply)
D. Roles and Responsibilities of Audit 3. Audit credibility

Participants Identify and apply various factors that influence
Define and describe the functions and audit credibility, such as auditor independence,
responsibilities of various audit participants, objectivity, and qualifications. (Apply)
including audit team members, lead auditor, client,
auditee, etc. (Apply)
E. Professional Conduct and Consequences for

Auditors
1. Professional conduct and responsibilities
Define and apply the ASQ Code of Conduct,
concepts of due diligence and due care with
respect to confidentiality and conflict of interest,
and appropriate actions in response to the
discovery of illegal activities or unsafe
conditions. (Apply)

II. Audit Process (42 Questions)
A. Audit Preparation and Planning 4. Logistics
1. Elements of the audit planning process Identify and organize audit-related logistics,
Evaluate and implement the basic steps in audit including travel, safety and security
preparation and planning: Who?
considerations, the need for escorts, translators,
• verify audit authority; (?) confidentiality agreements, clear right of access,
• determine the (1) purpose, (2) scope, and (3) etc. (Analyze)
type of audit;
• identify the requirements to audit against and 5. Auditing tools and working papers
the resources necessary, including the size Identify the sampling plan or method and
and number of audit teams. (Evaluate) procedural guidelines to be used for the specific
audit. Select and prepare working papers
2. Auditor selection (checklists, log sheets, etc.) to document the
Identify and examine various auditor selection audit. (Create)
criteria, such as education, experience, industry
background, and subject matter or technical 6. Auditing strategies
expertise. (Analyze) Identify and use various tactical methods for
conducting an audit, such as forward and
3. Audit-related documentation backward tracing (?), discovery, etc. (Apply)
Identify the sources of pre-audit information and
examine audit related documentation, such as I found a good explanation of the difference between forward and backward
traceability here:
• Checking forward traceability: taking a batch of materials/components and tracing
audit criteria references and results from prior them through the process, including work in process, all the way to the finished
audits. (Analyze) products that were made with those materials/components.
• Checking backward traceability – this is taking a finished product batch and tracing it,
starting from the customer, back through the process including work in process, all the
way to the batches of materials/components received from suppliers.
https://qualityinspection.org/forward-backward-traceability/

B. Audit Performance 3. Audit data collection and analysis
1. On-site audit management Interpret situations Use various data collection methods to capture
throughout the performance of the audit to determine information:
whether time is being managed well and when changes • Conducting interviews,
need to be made, such • observing work activities, methods
as revising planned audit team activities, reallocating • taking physical measurements,
resources, adjusting the audit plan, etc., and • examining documents, etc.
communicate with the auditee
Evaluate the results to determine their importance for
about any changes or other events related to the audit.
providing audit evidence. (Evaluate)
(Analyze)
4. Establishment of objective evidence
2. Opening meeting
Identify and differentiate characteristics of objective
Manage the opening meeting of an audit by identifying
evidence, such as observed, measured, confirmed or
the audit‘s purpose and scope, describing any scoring
corroborated (Confirm/证实), and documented.
or rating criteria that will be used during the audit,
(Analyze)
creating a record of the attendees, reviewing the audit
schedule, and answering questions as needed. (Apply)
5. Organization of objective evidence
Classify evidence in terms of significance, severity,
frequency, and level of risk. Evaluate the evidence
for its potential impact on product, process, system,
Risk= Probability x Consequences
cost of quality, etc., and determine whether additional
(Risk= frequency x severity?)
investigation is required to meet the scope of the audit.
(Risk ≡ Significant?)
(Evaluate)

5. Organization of objective evidence
Classify evidence in terms of :
 significance, Severity x frequency
 severity, level of risk

 frequency, and
 level of risk.
Evaluate the evidence for its potential impact on

 product,
 process,
 system,
 cost of quality, etc.,
and determine whether additional

investigation is required to meet
the scope of the audit. (Evaluate)

 product,
 process,
 system,
The etc.;
 Tarnishing the Company Image.
 Others?

 product,
 process,
 system,
The etc.;
 Tarnishing the Company Image.
 Others?

 product,
 process,
 system,
The etc.;
 Tarnishing the Company Image,
 Environmental,
 Others?

6. Exit and closing meetings 2. Effective reports
Formally manage these meetings: Develop and evaluate components of effective
reiterate the audit‘s purpose, scope, and scoring audit reports, including background information,
or rating criteria, and create a record of the executive summary, prioritized results
attendees. Present the audit results and obtain (observations, findings, opportunities for
concurrence on evidence that could lead to an improvement, etc.). Use graphical tools or other
adverse conclusion. Discuss the next steps in means of emphasizing conclusions, and develop
the process (follow-up audit, additional a timeline for auditee response and/or
evidence-gathering, etc.), and clarify who is corrections. (Create)
responsible for performing those steps. (Apply)
3. Final audit report steps
C. Audit Reporting Obtain necessary approvals for the audit report
1. Report development and content and distribute it according to established
Group observations into actionable findings of procedures. Identify the contents of the audit file
significance, and identify the severity and risk to and retain the file in accordance with
the client and the auditee. Use appropriate steps established policies and procedures. (Apply)
to generate the audit report: organize and
summarize details, review and finalize results,
emphasize critical issues, establish unique
identifiers or codes for critical issues to facilitate
tracking and monitoring, etc. (Create)

D. Audit Follow-Up and Closure 4. Follow-up on ineffective corrective action
1. Elements of the corrective action process Develop strategies to use when corrective
Identify and evaluate various elements: actions are not implemented or are not effective,
assignment of responsibility for problem such as communicating to the next level of
identification; the performance of root cause management, reissuing the corrective action
analysis and recurrence prevention. (Evaluate) request, and re-auditing. (Create)
2. Review of corrective action plan 5. Audit closure

Evaluate the acceptability of proposed corrective Identify and apply various elements of, and
actions and schedule for completion. Identify criteria for, audit closure (Apply)
and apply strategies for negotiating changes to
unacceptable plans. (Evaluate)
3. Verification of corrective action

Determine the adequacy of corrective actions
taken by verifying and evaluating new or
updated procedures, observing revised
processes, conducting follow-up audits, etc.
(Evaluate)

D. Audit Follow-Up and Closure
1. Elements of the corrective action process RCA
Identify and evaluate various elements: Kaoru Ishikawa Diagram
 assignment of responsibility for problem identification;
 the performance of root cause analysis and
 recurrence prevention. (Evaluate)

1. Elements of the corrective action process
Identify and evaluate various elements: assignment of responsibility for problem identification; the performance of root cause analysis and
recurrence prevention. (Evaluate)
2. Review of corrective action plan

Evaluate the acceptability of proposed corrective actions and schedule for completion. Identify and apply strategies for negotiating changes to
unacceptable plans. (Evaluate)
Assignment of responsibility
for problem identification-
Aeronautical‘s SME in turbine.

Recurrence Prevention & RCA
1. Elements of the corrective action process
Identify and evaluate various elements: assignment of responsibility for problem identification; the performance of root cause analysis and
recurrence prevention. (Evaluate)

III. Auditor Competencies (25 Questions)
A. Auditor Characteristics D. Communication and Presentation Techniques
Identify characteristics that make auditors effective: Select and use written, oral, and electronic
interpersonal skills, problem-solving skills, attention to communication techniques for presentations made
detail, cultural awareness and sensitivity, ability to work during audits for opening, closing, ad-hoc meetings,
independently as well as in a group or on a team, etc. etc. Use technical and managerial reporting techniques,
(Apply) including graphs, charts, diagrams, multimedia aids,
etc., in various situations: domestic, global,
B. On-Site Audit in-person, virtual (e-audits), multiple sites
Resource Management simultaneously, etc. (Evaluate)
Identify and apply techniques for managing audit teams,
scheduling audit meetings and activities, making E. Interviewing Techniques
logistical adjustments, etc. (Apply) Select and use appropriate interviewing techniques and
methodologies. (Apply)
C. Conflict Resolution 1. Use open-ended or closed question types
Identify typical conflict situations (mild to vehement 2. Use active listening, paraphrasing (另种表达方式),
(intense) disagreements, auditee empathy (同情), etc.
delaying tactics, interruptions, etc.) and determine 3. Recognize and respond to non-verbal cues (提示,
appropriate techniques for resolving them: 暗示,表示): body language, the significance of
 clarifying the question or request, pauses and their length, etc.
 reiterating ground rules, 4. Determine when and how to prompt (促使) a
 intervention by another authority, response: when supervisors are present, when
 cool-down periods, etc. interviewing a group of workers, when using a
(Analyze) translator, etc.
Paraphrasing Tool to paraphrase or rewrite full length essays and
articles or to find new ways to express simple phrases, sentences or
single words.
Empathy: the ability to understand and share the feelings of another.

III. Auditor Competencies (25 Questions)
F. Team Dynamics Tuckman's stages of group development
Define, describe, and apply various
aspects of team dynamics. (Apply)
1. Team-building: clarifying roles and responsibilities
for participants and leaders to ensure equitable
treatment for all team members, providing clear
direction for deliverables, identifying necessary
resources and ensuring their availability, etc.
2. Team facilitation: providing coaching and guidance,

defusing clashes between members, eliciting (bring
out) input from all, cultivating objectivity,
overseeing progress, encouraging diverse views
and consensus, etc.
3. Stages of team development: forming, storming, https://en.wikipedia.org/wiki/Tuckman%27s_stages_of_group_de

velopment
norming, and performing
(further reading)

IV. Audit Program Management and Business Applications (30 Questions)
A. Audit Program Management 3. Auditor training and development
1. Senior management support Identify minimum audit knowledge
Identify and explain management‘s and skill requirements for auditors.
role in creating and supporting the audit function. Provide training on various aspects
(Understand) of the audit process such as relevant
standards, regulatory influences,
2. Staffing and resource management facilitation techniques, etc. Provide
Develop staffing budgets that provide adequate training on diversity and cultural
time for auditors to plan, conduct, and respond influences (ethnicity, gender, age,
to scheduled audits, including time and organized labor, etc.) and how such
resources that internal auditees need to factors can affect communications
participate. Identify any special equipment and other interactions among audit
resources needed and ensure their adequacy participants. (Create)
and availability. Consider the use of and
requirements for special audits (outsourced or 4. Audit program evaluation
contracted audits, virtual or e-audits, shared Select the correct metric to evaluate
audits, etc.) as driven by costs, geography, etc. the audit program, including tracking
Evaluate results and adjust resources as its effect on the bottom line and the
needed on a regular basis. (Evaluate) risk to the organization. (Evaluate)

Special audits:
 outsourced or contracted audits,
 virtual or e-audits,
 Shared audits, etc.

Special audits:
virtual or e-audits
Virtual Auditing With states facing
more and more budget restrictions
and travel being one area that is being
cut from their budgets, state auditing
departments need to come up with
innovative constructive ways of
continue to perform audits on Motor
Fuel Accounts without the cost
associated of traveling to the
Taxpayers location. What are Virtual
Audits? Virtual audits are paperless,
electronic audits that are conducted
without face to face interaction
between government and industry. All
data is exchanged in electronic
formats such as MS Word, Excel, PDF
files, text files and EDI files.
https://old.taxadmin.org/fta/mf/unif_docs/
white/virtualaudits.pdf

Special audits:

5. Internal audit program management 7. Best practices
Develop procedures, policies, Analyze audit results to:
and schedules to support the • Standardize best practices and
organization‘s objectives. Review • Lessons learned,
internal audit results to identify
across the organization. (Analyze)
systemic trends. (Create)
8. Organizational risk management
6. External audit program management
Analyze how the audit program
Develop procedures, policies, and
affects an organization‘s risk level
schedules in support of the supplier
and how the risk level can influence
management program, including:
the number and frequency of audits
• supplier qualification surveys,
performed. (Analyze)
• surveillance audits,
[Note: Tools and techniques for managing
• supplier improvement, etc.
risk are covered in BoK area V.H. (?) ]
(Create)
There will be audit report to the
9. Management review input
Auditee and report to the management Examine and summarize audit
(as management review).
So there will be 2 minimum reports?
program results, trends, and
changes in risk to provide input to
management reviews. (Evaluate)

Examine and summarize:
 audit program results,
 trends, and
 changes in risk
to provide input to management reviews. (Evaluate)

 trends, and
 changes in risk

 trends, and
 changes in risk
KPI
KPI

 trends, and
 changes in risk
Charlie Chong/ Fion Zhang https://www.japantimes.co.jp/news/2016/05/10/business/five-million-new-takata-recalls-ordered-japan/#.W488FNwzaUk

 trends, and
 changes in risk
Charlie Chong/ Fion Zhang https://www.theatlantic.com/photo/2011/07/the-history-of-the-space-shuttle/100097/

B. Business and Financial Impact 3. Cost of quality (COQ) principles
1. Auditing as a management tool Identify, describe, and analyze
Use audit results to monitor: the audit program‘s effect on the
• continuous improvement, four COQ categories:
• Supplier management, • prevention,
• customer satisfaction, etc., and • Appraisal (assessment,评估-检验?),
• to provide management with an independent • internal failure,
view of the strategic plan‘s effectiveness and • External failure.
how well it is deployed.
(Analyze)
(Analyze)
4. Emerging roles of the auditor
2. Interrelationships of business processes Recognize new roles and responsibilities for
Identify how business units (receiving, product auditors, such as being process consultants
and process design, production, engineering, and facilitators who can help resolve internal
sales, marketing, field support, etc.) and multiple issues, improve processes, and add value to
sites are interrelated, and recognize how their the organization. (Understand)
unique metrics and goals can be in conflict
with one another. (Understand)

Recognize new roles and responsibilities for auditors, such as being:
• process consultants and
• facilitators
who can help resolve internal issues, improve processes, and add value to the organization.
(Understand)

Recognize new roles and responsibilities for
auditors, such as being:
• process consultants and
• facilitators
who can help resolve internal issues, improve
processes, and add value to the organization.
(Understand)
Auditor
as well
as SME

V. Quality Tools and Techniques (26 Questions)
A. Basic Quality and Problem-solving Tools C. Basic Statistics
Identify, interpret, and analyze: 1. Measures of central tendency
1) Pareto charts, 2) cause and effect Identify, interpret, and use mean, median, and
diagrams, 3) flowcharts, 4) statistical mode. (Apply)
process control (SPC) charts, 2. Measures of dispersion
5) check sheets, 6) scatter diagrams, Identify, interpret, and use standard deviation
7) histograms, 8) root cause analysis, and frequency distribution. (Apply)
9) plan-do-check-act (PDCA). (Analyze) 3. Qualitative and quantitative analysis
Describe qualitative data in terms of the nature,
B. Process Improvement Techniques type, or attribute of an observation or condition.
1. Six Sigma Describe how quantitative data is used to detect
Identify, interpret, and apply the Six Sigma patterns or trends and how such analysis can
DMAIC phases: define, measure, analyze, indicate whether a problem is systemic or
improve, control. (Apply) isolated. (Understand)
2. Lean
Identify, interpret, and apply lean
Tools (?) : 5S, standard operations,
kanban (pull), error-proofing, value stream
mapping, etc. (Apply)

D. Process Variation E. Sampling Methods
1. Common and special cause Identify and 1. Acceptance sampling plans
distinguish between common and special cause Identify and interpret these plans for attributes
variation. (Apply) and variables data.
(Understand)
2. Process performance metrics 2. Types of sampling
Describe elements of Cp and Cpk process Describe and distinguish between:
capability studies (process centering and • random,
stability, specification limits, underlying • stratified, and
distribution, etc.), and how these studies and • cluster sampling,
other performance metrics are used in relation and identify the uses and potential problems of
to established goals. (Understand) non-statistical sampling. (Understand)
3. Outliers 3. Sampling terms

Describe their significance and impact. Define related terms including consumer and
(Understand) producer risk, confidence level, etc. (Understand)

F. Change Control and Configuration H. Risk Management Tools
Management Identify methods for managing risk, including:
Identify the principles of change • risk avoidance,
control and configuration management • mitigation,
systems as used in various applications: • tradeoffs, etc.,
hardware,
software (including security considerations), and describe tools and methods for estimating
product, and controlling risk:
process, and • failure mode and effects analysis (FMEA),
service. (Understand) • hazard analysis and critical control points
(HACCP),
G. Verification and Validation • critical to quality (CTQ) analysis,
Define, distinguish between, and use various • health hazard analysis (HHA), etc.
methods of verifying and
validating processes. (Analyze) (Understand)
[Note: Organizational risk management

is covered in BoK area IV.A.8.]

LEVELS OF COGNITION (awareness)
Based on Bloom‘s Taxonomy—Revised (2001)
In addition to content specifics, the subtext for each topic in this BoK also indicates the intended
complexity level of the test questions for that topic. These levels are based on ―Levels of Cognition‖
(from Bloom‘s Taxonomy- Revised, 2001) and are presented below in rank order, from least
complex to most complex.
REMEMBER | Recall or recognize terms, ANALYZE | Break down information into

definitions, facts, ideas, materials, patterns, its constituent parts and recognize their
sequences, methods, principles, etc. relationship to one another and how they
UNDERSTAND | Read and understand are organized; identify sublevel factors or
descriptions, communications, reports, salient (conspicuous/prominent) data from a
tables, diagrams, directions, regulations, etc. complex scenario.
APPLY | Know when and how to use EVALUATE | Make judgments about the value of
ideas, procedures, methods, formulas, proposed ideas, solutions, etc., by comparing
principles, theories, etc. the proposal to specific criteria or standards.
CREATE | Put parts or elements together in
such a way as to reveal a pattern or structure
not clearly there before; identify which data or
information from a complex set is appropriate to
examine further or from which supported
conclusions can be drawn.

CQA- Open Book Exam!
FREQUENTLY ASKED QUESTIONS
Is the exam open-book?
With the exception of the constructed-response portion of the Manager of Quality/Organizational
Excellence exam, exams are open-book.
All reference materials (i.e. including all forms of notes) must be bound and remain bound
during the exam. Bound refers to material permanently bound by stitching or glue and materials
fastened securely in its cover by fasteners, which penetrate all papers (i.e. ring binders, spiral
binders, plastic snap binders, brads, or screw posts). Manually or hand stapled documents that
are not securely fastened in their covers are not allowed. The size of workspace area at Prometric
test centers is limited. The approximate desk dimensions are 48" in length and 24" in width.
Before you enter the exam room, the Test Center Administrator (TCA) will inspect all references.
"Post-Its" will be permitted as book tabs only (must be attached prior to entering the test center).
Items strictly prohibited in the exam area: hand stapled or paper-clipped materials, blank writing
tablets or tablets containing blank pages, unbound tablets, unbound notes, slide charts and/or
wheel charts (hand-held cardboard or plastic calculating devices with rotating or sliding pieces).
Absolutely no collections of questions and answers or weekly refresher-course quizzes are
permitted. Reference sources that contain such copy are not allowed unless the questions are
removed.
Examinees are responsible for abiding by applicable copyright laws.
https://asq.org/cert/faq/open-book-exam

CQA
More to read
• Six Sigma DMAIC phases: define, measure, analyze, improve, control.
• Process capability Cp and Cpk
• Lean Tools (?) : 5S, standard operations, kanban (pull), error-proofing, value stream mapping,
etc.
• Risk Management Tools
• failure mode and effects analysis (FMEA),
• hazard analysis and critical control points (HACCP),
• critical to quality (CTQ) analysis,
• health hazard analysis (HHA), etc.
• Sampling methods

CQA
Star War Dead Star

CQA- Reading II
Pre-Handbook Reading, the WIKI ways.
Six Sigma DMAIC phases: define, measure, analyze, improve, control.
https://en.wikipedia.org/wiki/Six_Sigma Charlie Chong/ Fion Zhang

Six Sigma (6σ) is a set of techniques and tools for process improvement. It was
introduced by engineer Bill Smith while working at Motorola in 1986. Jack Welch made
it central to his business strategy at General Electric in 1995.
Six Sigma strategies seek to improve the quality of the output of a process by
identifying and removing the causes of defects and minimizing variability in
manufacturing and business processes. It uses a set of quality management methods,
mainly empirical, statistical methods, and creates a special infrastructure of people
within the organization who are experts in these methods. Each Six Sigma project
carried out within an organization follows a defined sequence of steps and has specific
value targets, for example: reduce process cycle time, reduce pollution, reduce costs,
increase customer satisfaction, and increase profits.
The term Six Sigma (capitalized because it was written that way when registered as a
Motorola trademark on December 28, 1993) originated from terminology associated
with statistical modeling of manufacturing processes. The maturity of a manufacturing
process can be described by a sigma rating indicating its yield or the percentage of
defect-free products it creates. A six sigma process is one in which 99.99966% (?) of
all opportunities to produce some feature of a part are statistically expected to be free
of defects (3.4 defective features per million opportunities). Motorola set a goal of "six
sigma" for all of its manufacturing.

Six Sigma doctrine asserts:
Continuous efforts to achieve stable and predictable process results (e.g. by reducing
process variation) are of vital importance to business success.
Manufacturing and business processes have characteristics that can be DMAIC
―defined, measured, analyzed, improved, and controlled.‖
Achieving sustained quality improvement requires commitment from the entire
organization, particularly from top-level management.
Features that set Six Sigma apart from previous quality-improvement initiatives
include:
 A clear focus on achieving measurable and quantifiable financial returns from any
Six Sigma project.
 An increased emphasis on strong and passionate (enthusiastic) management
leadership and support.
 A clear commitment to making decisions on the basis of verifiable data and
statistical methods, rather than assumptions and guesswork.

The term ―six sigma‖ comes from statistics and is used in statistical quality control,
which evaluates process capability. Originally, it referred to the ability of manufacturing
processes to produce a very high proportion of output within specification. Processes
that operate with ―six sigma quality‖ over the short term are assumed to produce long-
term defect levels below 3.4 defects per million opportunities (DPMO). The 3.4 dpmo
is based on a ―shift‖ of +/- 1.5 sigma created by the psychologist Dr Mikel Harry. He
created this figure based on the tolerance in the height of a stack of discs. Six Sigma‗s
implicit goal is to improve all processes, but not to the 3.4 DPMO level necessarily.
Organizations need to determine an appropriate sigma level for each of their most
important processes and strive to achieve these. As a result of this goal, it is
incumbent (有义务的) on management of the organization to prioritize areas of
improvement.
"Six Sigma" was registered June 11, 1991 as U.S. Service Mark 1,647,704. In 2005
Motorola attributed over US$17 billion in savings to Six Sigma.[5]
Other early adopters of Six Sigma include Honeywell and General Electric, where
Jack Welch introduced the method. By the late 1990s, about two-thirds of the Fortune
500 organizations had begun Six Sigma initiatives with the aim of reducing costs and
improving quality.

In recent years, some practitioners have combined Six Sigma ideas with lean
manufacturing to create a methodology named Lean Six Sigma. The Lean Six Sigma
methodology views lean manufacturing, which addresses process flow and waste
issues, and Six Sigma, with its focus on variation and design, as complementary
disciplines aimed at promoting "business and operational excellence". Companies
such as GE, Accenture, Verizon, GENPACT, and IBM use Lean Six Sigma to focus
transformation efforts not just on efficiency but also on growth. It serves as a
foundation for innovation throughout the organization, from manufacturing and
software development to sales and service delivery functions.
The International Organization for Standardization (ISO) has published in 2011 the
first standard "ISO 13053:2011" defining a Six Sigma process. Other "standards" are
created mostly by universities or companies that have so-called first-party certification
programs for Six Sigma.

is a set of techniques and tools for process improvement. It was introduced by
engineer

Six Sigma Difference from lean management
Lean management and Six Sigma are two concepts which share similar
methodologies and tools. Both programs are Japanese-influenced, but they are two
different programs:
 Lean management is focused on eliminating waste and ensuring efficiency while
 Six Sigma's focus is on eliminating defects and reducing variability.

Methodologies
Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-
Study-Act Cycle. These methodologies, composed of five phases each, bear the
acronyms DMAIC and DMADV.
 DMAIC is used for projects aimed at improving an existing business process.
 DMADV is used for projects aimed at creating new product or process designs.

DMAIC
The DMAIC project methodology has five phases:
1. Define the system, the voice of the customer and their requirements, and the
project goals, specifically.
2. Measure key aspects of the current process and collect relevant data; calculate
the 'as-is' Process Capability.
3. Analyze the data to investigate and verify cause-and-effect relationships.
Determine what the relationships are, and attempt to ensure that all factors have
been considered. Seek out root cause of the defect under investigation.
4. Improve or optimize the current process based upon data analysis using
techniques such as design of experiments, poka yoke or mistake proofing, and
standard work to create a new, future state process. Set up pilot runs to establish
process capability.
5. Control the future state process to ensure that any deviations from the target are
corrected before they result in defects. Implement control systems such as
statistical process control, production boards, visual workplaces, and continuously
monitor the process. This process is repeated until the desired quality level is
obtained.
Some organizations add a Recognize step at the beginning, which is to recognize the
right problem to work on, thus yielding an RDMAIC methodology.

Poka-yoke or Mistake Proofing

DMADV or DFSS
The five steps of DMADV
The DMADV project methodology, known as DFSS ("Design For Six Sigma"), features
five phases:
1. Define design goals that are consistent with customer demands and the enterprise
strategy.
2. Measure and identify CTQs (characteristics that are Critical To Quality), measure
product capabilities, production process capability, and measure risks.
3. Analyze to develop and design alternatives
4. Design an improved alternative, best suited per analysis in the previous step
5. Verify the design, set up pilot runs, implement the production process and hand it
over to the process owner(s).

DMAIC- Define, Measure, Analuze, Improve, Control

DMADV (DFSS)- Define, Measure, Analyze, Design, Verify

Quality management tools and methods
Within the individual phases of a DMAIC or DMADV project, Six Sigma utilizes many
established quality-management tools that are also used outside Six Sigma. The
following table shows an overview of the main methods used.
• 5 Whys • Cause & effects diagram • Quality Function
• Statistical and fitting tools (also known as fishbone or Deployment (QFD)
• Analysis of variance Ishikawa diagram) • Quantitative marketing
• General linear model • Control chart/Control plan research through use of
• ANOVA Gauge R&R (also known as a swimlane Enterprise Feedback
• Regression analysis map)/Run charts Management (EFM)
• Correlation • Cost-benefit analysis systems
• Scatter diagram • CTQ tree • Root cause analysis
• Chi-squared test • Design of • SIPOC analysis (Suppliers,
• Axiomatic design experiments/Stratification Inputs, Process, Outputs,
• Business Process • Histograms/Pareto Customers)
Mapping/Check sheet analysis/Pareto chart • COPIS analysis (Customer
• Pick chart/Process centric version/perspective
capability/Rolled of SIPOC)
throughput yield • Taguchi methods/Taguchi
Loss Function
• Value stream mapping

Implementation roles
One key innovation of Six Sigma involves the absolute "professionalizing" of quality management
functions. Prior to Six Sigma, quality management in practice was largely relegated to the
production floor and to statisticians in a separate quality department. Formal Six Sigma programs
adopt a kind of elite ranking terminology (similar to some martial arts systems, like judo) to define
a hierarchy (and special career path) that includes all business functions and levels. Six Sigma
identifies several key roles for its successful implementation.
1. Executive Leadership includes the CEO and other members of top management. They are responsible for
setting up a vision for Six Sigma implementation. They also empower the other role holders with the
freedom and resources to explore new ideas for breakthrough improvements by transcending departmental
barriers and overcoming inherent resistance to change.
2. Champions take responsibility for Six Sigma implementation across the organization in an integrated
manner. The Executive Leadership draws them from upper management. Champions also act as mentors
to Black Belts.
3. Master Black Belts, identified by Champions, act as in-house coaches on Six Sigma. They devote 100% of
their time to Six Sigma. They assist Champions and guide Black Belts and Green Belts. Apart from
statistical tasks, they spend their time on ensuring consistent application of Six Sigma across various
functions and departments.
4. Black Belts operate under Master Black Belts to apply Six Sigma methodology to specific projects. They
devote 100% of their valued time to Six Sigma. They primarily focus on Six Sigma project execution and
special leadership with special tasks, whereas Champions and Master Black Belts focus on identifying
projects/functions for Six Sigma.
5. Green Belts are the employees who take up Six Sigma implementation along with their other job
responsibilities, operating under the guidance of Black Belts.

According to proponents (建议者) of the system, special training is needed for all of
these practitioners to ensure that they follow the methodology and use the data-driven
approach correctly. Some organizations use additional belt colours, such as Yellow
Belts, for employees that have basic training in Six Sigma tools and generally
participate in projects and "White belts" for those locally trained in the concepts but do
not participate in the project team. "Orange belts" are also mentioned to be used for
special cases.
Defining roles and responsibilities
for: Top management, Champion,
Master Black Belt, Black Belt and
Green Belt.

Formal Six Sigma programs adopt a kind of elite ranking terminology
(Key to define each roles and responsibilities)

Certification
General Electric and Motorola developed certification programs as part of their Six
Sigma implementation, verifying individuals' command of the Six Sigma methods at
the relevant skill level (Green Belt, Black Belt etc.). Following this approach, many
organizations in the 1990s started offering Six Sigma certifications to their employees.
Criteria for Green Belt and Black Belt certification vary; some companies simply
require participation in a course and a Six Sigma project. There is no standard
certification body, and different certification services are offered by various quality
associations and other providers against a fee. The American Society for Quality for
example requires Black Belt applicants to pass a written exam and to provide a signed
affidavit stating that they have completed two projects or one project combined with
three years' practical experience in the body of knowledge
https://en.wikipedia.org/wiki/Six_Sigma

Etymology*of "six sigma process"
The term "six sigma process" comes from the notion that if one has six standard
deviations between the process mean and the nearest specification limit, as shown in
the graph, practically items will fail to meet specifications. This is based on the
calculation method employed in process capability studies.
* Etymology- a study of origin of a word

Graph of the normal distribution, which underlies the statistical assumptions of the Six Sigma
model. In the centre at 0, the Greek letter µ (mu) marks the mean, with the horizontal axis
showing distance from the mean, marked in standard deviations and given the letter σ (sigma).
The greater the standard deviation, the greater is the spread of values encountered. For the
green curve shown above, µ = 0 and σ = 1. The upper and lower specification limits (marked USL
and LSL) are at a distance of 6σ from the mean. Because of the properties of the normal
distribution, values lying that far away from the mean are extremely unlikely: approximately 1 in a
billion too low, and the same too high. Even if the mean were to move right or left by 1.5σ at
some point in the future (1.5 sigma shift, coloured red and blue), there is still a good safety
cushion. This is why Six Sigma aims to have processes where the mean is at least 6σ away from
the nearest specification limit.

Graph of the normal distribution, which underlies the statistical assumptions of the Six Sigma
model. In the centre at 0, the Greek letter µ (mu) marks the mean, with the horizontal axis
showing distance from the mean, marked in standard deviations and given the letter σ (sigma).
The greater the standard deviation, the greater is the spread of values encountered. For the
green curve shown above, µ = 0 and σ = 1. The upper and lower specification limits (marked USL
and LSL) are at a distance of 6σ from the mean. Because of the properties of the normal
distribution, values lying that far away from the mean are extremely unlikely: approximately 1 in a
billion too low, and the same too high.

Even if the mean were to move right or left by 1.5σ at some point in the future (1.5 sigma shift,
coloured red and blue), there is still a good safety cushion. This is why Six Sigma aims to have
processes where the mean is at least 6σ away from the nearest specification limit.

Even if the mean were to move right or left by 1.5σ at some point in the future (1.5 sigma shift,
coloured red and blue), there is still a good safety cushion. This is why Six Sigma aims to have
processes where the mean is at least 6σ away from the nearest specification limit.

Exercise:
Calculate area under the curves:
2σ = 0.0.4772
±2σ = 0.9545
3σ = 0.4987
±3σ = 0.9973
http://onlinestatbook.com/2/calculators/normal_dist.html

Exercise:
Calculate area under the normal curves
between LSL/USL at ±3σ, for, USL-ũ= 1.5σ
Areas under the curve = 0.933

Exercise:
Calculate area under the normal curves
between LSL/USL at ±3σ, for, USL-ũ= 1.5σ
Areas under the curve = 0.933
3 sigma process: Note due to the limitation of online statistical calculator 3σ process was used to
illustrate the scenario

Knowing: Process capability index
Definitions
 Cp= Process Capability. A simple and straightforward indicator of process capability.
Cp= USL−LSL
6σ
(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
distributed.)
 Cp, lower= ũ−LSL

3σ
(Estimates process capability for specifications that consist of a lower limit only (for example, concentration). Assumes process output is approximately normally distributed.)
 Cp, upper= USL−ũ

3σ
(Estimates process capability for specifications that consist of a upper limit only (for example, strength). Assumes process output is approximately normally distributed.)
 Cpk= Process Capability Index. Adjustment of Cp for the effect of non-centered distribution.
Cpk= min[ USL−ũ
3σ
,
ũ−LSL
3σ
]
(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
overestimates process capability.) Cpk<0, if the process mean falls outside of the specification limits. Assumes process output is approximately normally distributed.)
 Cpm = Taguchi Capability Index

Cpm= √[1+(𝐶ũ−T)2] 𝑝
σ
(The process capability indices Cp and Cpk are widely used to provide unitless measures of process potential and performance. These indices do no adequately address the issue of
process centering. An alternative definition of Cp advocated by Taguchi addresses this issue directly. Later authors introduced the name C pm for the Taguchi index and examined statistical
properties of an inefficient estimator under the assumption that the process mean coincides with the target value. http://asq.org/qic/display-item/?item=11328 )
 Cpkm = Taguchi Capability Index

Cpkm= √[1+(𝐶 ũ−T)2] 𝑝𝑘
σ
(Estimates process capability around a target, T, and accounts for an off-center process mean. Assumes process output is approximately normally distributed.. http://asq.org/qic/display-
item/?item=11328 )
 Pp= Process Performance. A simple and straightforward indicator of process performance.

 Ppk= Process Performance Index. Adjustment of Pp for the effect of non-centered distribution.
The 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.
https://www.isixsigma.com/tools-templates/capability-indices-process-capability/process-capability-cp-cpk-and-process-performance-pp-ppk-what-difference/#defs Charlie Chong/ Fion Zhang

Interpreting Cp, Cpk
USL−ũ ũ−LSL
―Cpk , Cpk= min[ , ] is an index (a simple number) which measures how close a process
3σ 3σ
is running to its specification limits, relative to the natural variability of the process. The larger the
index, the less likely it is that any item will be outside the specs.‖
https://www.isixsigma.com/tools-templates/capability-indices-process-capability/process-capability-cp-cpk-and-process-performance-pp-ppk-what-difference/#defs Charlie Chong/ Fion Zhang

Role of the 1.5 sigma shift
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
number of sigmas that will fit between the process mean and the nearest specification limit may well drop over time, compared to
an initial short-term study. To account for this real-life increase in process variation over time, an empirically based 1.5 sigma shift
is introduced into the calculation. According to this idea, a process that fits 6 sigma between the process mean and the nearest
specification limit in a short-term study will in the long term fit only 4.5 sigma – either because:
 the process mean will move over time, or

 because the long-term standard deviation of the process will be greater than that observed in the short term,
 or both.
Hence the widely accepted definition of a six sigma process is a process that 3 sigma process
produces 3.4 defective parts per million opportunities (DPMO). This is based on the
fact that a process that is normally distributed will have 3.4 parts per million outside
the limits, when the limits are six sigma from the "original" mean of zero and the
process mean is then shifted by 1.5 sigma (and therefore, the six sigma limits are no
longer symmetrical about the mean).
The former six sigma distribution, when under the effect of the 1.5 sigma shift, is
commonly referred to as a 4.5 sigma process. The failure rate of a six sigma
distribution with the mean shifted 1.5 sigma is not equivalent to the failure rate of a 0
4.5 sigma process with the mean centered on zero. This allows for the fact that
special causes may result in a deterioration in process performance over time and is
designed to prevent underestimation of the defect levels likely to be encountered in
real-life operation.
The role of the sigma shift is mainly academic. The purpose of six sigma is to
generate organizational performance improvement. It is up to the organization to
determine, based on customer expectations, what the appropriate sigma level of a
process is. The purpose of the sigma value is as a comparative figure to determine
whether a process is improving, deteriorating, stagnant or non-competitive with others
in the same business. Six sigma (3.4 DPMO) is not the goal of all processes.

The failure rate of a six sigma distribution with the mean shifted 1.5 sigma is not equivalent to the
failure rate of a 4.5 sigma process with the mean centered on zero. This allows for the fact that
special causes may result in a deterioration in process performance over time and is designed to
prevent underestimation of the defect levels likely to be encountered in real-life operation.
3 sigma process 3 sigma process

mean shifted
1.5 sigma

A control chart depicting a
process that experienced a
1.5 sigma drift in the
process mean toward the
upper specification limit
starting at midnight. Control
charts are used to maintain
6 sigma quality by signaling
when quality professionals
should investigate a process
to find and eliminate
special-cause variation.
A control chart depicting a process that experienced a
1.5 sigma drift in the process mean toward the upper
specification limit starting at midnight. Control charts are
used to maintain 6 sigma quality by signaling when
quality professionals should investigate a process to find
and eliminate special-cause variation.

Sigma levels
The table below gives long-term DPMO values corresponding to various short-term
sigma levels.
These figures assume that the process mean will shift by 1.5 sigma toward the side
with the critical specification limit. In other words, they assume that after the initial
USL−ũ ũ−LSL
study determining the short-term sigma level, the long-term Cpk, Cpk= min[ , ]
3σ 3σ
USL−ũ ũ−LSL
or Cpk= min[ , ] ? value will turn out to be 0.5 less than the short-term Cpk
6σ 6σ
value.
So, now for example, the DPMO figure given for 1 sigma assumes that the long-term
process mean will be 0.5 sigma beyond the specification limit
σ
 (Cpk = –0.17) [Cpk= -0.5], rather than 1 sigma within it,
Sigma levels
The table below gives long-term DPMO values corresponding to various short-term sigma levels.
3σ
These figures assume that the process mean will shift by 1.5 sigma toward the side with the critical
specification limit. In other words, they assume that after the initial study determining the short-term sigma
USL−ũ ũ−LSL USL−ũ ũ−LSL
level, the long-term Cpk, Cpk= min[ , ] or Cpk= min[ , ] ? value will turn out to be 0.5 less
3σ 3σ 6σ 6σ
σ
than the short-term Cpk value.
So, now for example, the DPMO figure given for 1 sigma assumes that the long-term process mean will be 0.5
sigma beyond the specification limit
σ
 (Cpk = –0.17) [Cpk=
 (Cpk = 0.33) [Cpk=

-0.5], rather than 1 sigma within it,
3σ
σ
] as it was in the short-term study.

 (Cpk = 0.33) [Cpk= ] as it was in the short-term study.
3σ
3σ
Note that the defect percentages indicate only defects exceeding the specification limit to which the process
mean is nearest. Defects beyond the far specification limit are not included in the percentages. The formula
used here to calculate the DPMO is thus:
DPMO = 1000000 x (1-Φ(level-1.5))
Note that the defect percentages indicate only defects exceeding the specification limit
to which the process mean is nearest. Defects beyond the far specification limit are
not included in the percentages. The formula used here to calculate the DPMO is thus:
DPMO = 1000000 x (1-Φ(level-1.5))

Six Sigma (6σ) is a set of techniques and tools for process improvement. It was
introduced by engineer
Sigma Sigma (with Percent Percentage Short-term Long-term

DPMO
level 1.5σ shift) defective yield Cpk Cpk
1 −0.5 691,462 69% 31% 0.33 −0.17

2 0.5 308,538 31% 69% 0.67 0.17
3 1.5 66,807 6.7% 93.3% 1.00 0.5
4 2.5 6,210 0.62% 99.38% 1.33 0.83
5 3.5 233 0.023% 99.977% 1.67 1.17
6 4.5 3.4 0.00034% 99.99966% 2.00 1.5
7 5.5 0.019 0.0000019% 99.9999981% 2.33 1.83

Application
Six Sigma mostly finds application in large organizations. An important factor in the
spread of Six Sigma was GE's 1998 announcement of $350 million in savings thanks
to Six Sigma, a figure that later grew to more than $1 billion. According to industry
consultants like Thomas Pyzdek and John Kullmann, companies with fewer than 500
employees are less suited to Six Sigma implementation or need to adapt the standard
approach to make it work for them. Six Sigma however contains a large number of
tools and techniques that work well in small to mid-size organizations. The fact that an
organization is not big enough to be able to afford Black Belts does not diminish its
abilities to make improvements using this set of tools and techniques. The
infrastructure described as necessary to support Six Sigma is a result of the size of
the organization rather than a requirement of Six Sigma itself.
Although the scope of Six Sigma differs depending on where it is implemented, it can
successfully deliver its benefits to different applications.

Recommended values
Process capability indices are constructed to express more desirable capability with increasingly higher values.
Values near or below zero indicate processes operating off target (ũ far from T) or with high variation.
(The 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. )
Fixing values for minimum "acceptable" process capability targets is a matter of personal opinion, and what
consensus exists varies by industry, facility, and the process under consideration. For example, in the
automotive industry, the Automotive Industry Action Group sets forth guidelines in the Production Part Approval
USL−ũ ũ−LSL
Process, 4th edition for recommended Cpk minimum values Cpk= min[ 3σ , 3σ ] for critical-to-quality CTQ
process characteristics. However, these criteria are debatable and several processes may not be evaluated for
capability just because they have not properly been assessed.
Since the process capability is a function of the specification, the Process Capability Index is only as good as
the specification. For instance, if the specification came from an engineering guideline without considering the
function and criticality of the part, a discussion around process capability is useless, and would have more
benefits if focused on what are the real risks of having a part borderline out of specification. The loss function of
Taguchi better illustrates this concept.
At least one academic expert recommends the following:

(cont. ………)

At least one academic expert recommends the following:
Cpk= min[ USL−ũ

3σ
,
ũ−LSL
3σ
]
Situation Recommended minimum Recommended minimum
process capability for two- process capability for one-
sided specifications sided specification
Existing process 1.33 1.25
New process 1.50 1.45
Safety or critical parameter
1.50 1.45
for existing process
Safety or critical parameter
1.67 1.60
for new process
Six Sigma quality process 2.00 2.00
However where a process produces a characteristic with a capability index greater than 2.5, the unnecessary
precision may be expensive.

Relationship to measures of process fallout
The mapping from process capability indices, such as Cpk, to measures of process fallout is straightforward.
Process fallout quantifies how many defects a process produces and is measured by DPMO or PPM. Process
yield is the complement of process fallout and is approximately equal to the area under the probability density
function, if the process output is approximately normally distributed.
1 σ −𝑡2/2
Φ(σ) = 𝑒 dt
2π −σ
In the short term ("short sigma"), the relationships are:
Area under the Process fallout(in

Cpk Sigma level (σ) probability Process yield terms of
density curve Φ(σ) DPMO/PPM)
0.33 1 0.6826894921 68.27% 317311
0.67 2 0.9544997361 95.45% 45500
1.00 3 0.9973002039 99.73% 2700
1.33 4 0.9999366575 99.99% 63
1.67 5 0.9999994267 99.9999% 1
2.00 6 0.9999999980 99.9999998% 0.002

Cpk Sigma level (σ) probability Process yield terms of
0.33 1 0.6826894921 68.27% 317311
0.67 2 0.9544997361 95.45% 45500
1.00 3 0.9973002039 99.73% 2700
1.33 4 0.9999366575 99.99% 63
1.67 5 0.9999994267 99.9999% 1
2.00 6 0.9999999980 99.9999998% 0.002
4 sigma σ level

Adjusted Sigma
Cpk probability Process yield terms of
level (σ)
0.33 1 0.3085375387 30.85% 691462
0.67 2 0.6914624613 69.15% 308538
1.00 3 0.9331927987 93.32% 66807
1.33 4 0.9937903347 99.38% 6209
1.67 5 0.9997673709 99.9767% 232.6
2.00 6 0.9999966023 4 sigma σ level,3.40
99.99966%
with 1.5σ shift
In the long term, processes can shift or drift significantly (most control
charts are only sensitive to changes of 1.5σ or greater in process
output). If there was a 1.5 sigma shift 1.5σ off of target in the processes
(see Six Sigma), it would then produce the above relationships.
Because processes can shift or drift significantly long term, each

process would have a unique sigma shift value, thus process capability
indices are less applicable as they require statistical control.

Example
Consider a quality characteristic with target of 100.00 μm and upper and lower specification limits of (±4μm)
106.00μm and 94.00μm respectively. If, after carefully monitoring the process for a while, it appears that the
process is in control and producing output predictably (as depicted in the run chart below), we can meaningfully
estimate its mean and standard deviation.
If ũ and σ are
estimated to be
98.94 μm and
1.03 μm,
respectively,
then

If ũ and σ are estimated to be 98.94 μm and 1.03 μm, respectively, then
Index
USL−LSL 106.00−94.00
Cp= = = 1.94
6σ 6 𝑥 1.03
USL−ũ ũ−LSL 106.00−98.94 98.94−94.00
Cpk= min[ , ] = min[ , ] = 1.6
3σ 3σ 3 𝑥 1.03 3 𝑥 1.03
𝐶𝑝 1.94
Cpm= ũ−T 2 = 98.94−100.00 2 = 1.35
√[1+( √[1+( )]
σ)] 1.03
𝐶𝑝𝑘 1.6
Cpkm= ũ−T 2 = 98.94−100.00 2 = 1.11
√[1+( √[1+( )]
σ)] 1.03
The fact that the process is running off-center (about 1σ below its target) is reflected in
the markedly different values for Cp, Cpk, Cpm, and Cpkm.
USL−ũ ũ−LSL 106.00−98.94 98.94−94.00
Cpk= min[ , ] = min[ , ] = 1.6
3σ 3σ 3 𝑥 1.03 3 𝑥 1.03
𝐶𝑝𝑘 1.6
Cpkm= ũ−T 2 = 98.94−100.00 2 = 1.11
√[1+(
σ) ] √[1+(
1.03
)]

Charlie Chong/
Charlie Chong/ Fion
Fion Zhang
Zhang
Good Luck!

Good Luck!

Understanding ASQ CQA Knowing The Ways

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Understanding ASQ CQA Knowing The Ways

Uploaded by

Copyright:

Available Formats

Knowing ASQ CQA

The Quality Auditor Certification

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang https://asq.org/about-asq/asq-awards/deming

to determine a quality system’s adequacy and deficiencies. The Certified

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

II. Audit Process (42 Questions) 28%

III. Auditor Competencies (25 Questions) 17%

IV. Audit Program Management and Business Applications 20%

V. Quality Tools and Techniques (26 Questions) 17%

150 Questions 100%

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

2. Auditor-auditee relationship B. Purpose and Scope of Audits

Charlie Chong/ Fion Zhang

D. Roles and Responsibilities of Audit 3. Audit credibility

E. Professional Conduct and Consequences for

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

 severity, level of risk

Evaluate the evidence for its potential impact on

and determine whether additional

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

2. Review of corrective action plan 5. Audit closure

3. Verification of corrective action

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

2. Review of corrective action plan

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

2. Team facilitation: providing coaching and guidance,

3. Stages of team development: forming, storming, https://en.wikipedia.org/wiki/Tuckman%27s_stages_of_group_de

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang

Charlie Chong/ Fion Zhang