Understanding ASQ-CQA -Knowing the Ways

Knowing ASQ CQA The Quality Auditor Certification My Pre-exam Self Study Notes 4 th September 2018

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II. Audit Process (42 Questions) A. Audit Preparation and Planning

1. Elements of the audit planning process Evaluate and implement the basic steps in audit preparation and planning: Who? • verify audit authority; (?) • determine the (1) purpose, (2) scope, and (3) type of audit; • identify the requirements to audit against and the resources necessary necessary,, including the size and number of audit teams. (Evaluate) 2. Auditor selection Identify and examine various auditor selection criteria, such as education, experience, industry background, and subject matter or technical expertise. (Analyze)

4. Logistics Identify and organize audit-related logistics, including travel, safety and security considerations, the need for escorts, translators, confidentiality agreements, clear right of access, etc. (Analyze) 5. Auditing tools and working papers Identify the sampling plan or method and procedural guidelines to be used for the specific audit. Select and prepare working papers (checklists, log sheets, etc.) to document the audit. (Create) 6. Auditing strategies Identify and use various tactical methods for



























II. Audit Process (42 Questions) B. Audit Performance

1. On-site audit management Interpret situations throughout the performance of the audit to determine whether time is being managed well and when changes need to be made, such as revising planned audit team activities, reallocating resources, adjusting the audit plan, etc., and communicate with the auditee about any changes or other events related to the audit. (Analyze) 2. Opening meeting Manage the opening meeting of an audit by identifying the audit‘s purpose and scope, describing any scoring or rating criteria that will be used during the audit, creating a record of the attendees, reviewing the audit schedule, and answering questions as needed. (Apply)

3. Audit data collection and analysis Use various data collection methods to capture information: • Conducting interviews, • observing work activities, methods • taking physical measurements, • examining documents, etc. Evaluate the results to determine their importance for providing audit evidence. (Evaluate) 4. Establishment of objective evidence Identify and differentiate characteristics of objective evidence, such as observed, measured, confirmed or corroborated (Confirm/ 证实), and documented. (Analyze) 5. Organization of objective evidence



























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

Evaluate the evidence for its potential impact on  product,  process,  system,  cost of quality, etc., and determine whether additional



























Evaluate the evidence for its potential impact on  product,  process,  system, quality,, etc.,  cost of quality The etc.;  Tarnishing the Company Image.  Others?



























Evaluate the evidence for its potential impact on  product,  process,  system, quality,, etc.,  cost of quality The etc.;  Tarnishing the Company Image.  Others?





























Evaluate the evidence for its potential impact on  product,  process,  system, quality, etc.,  cost of quality, The etc.;  Tarnishing the Company Image,





























II. Audit Process (42 Questions) 6. Exit and closing meetings

Formally manage these meetings: reiterate the audit‘s purpose, scope, and scoring or rating criteria, and create a record of the attendees. Present the audit results and obtain concurrence on evidence that could lead to an adverse conclusion. Discuss the next steps in

2. Effective reports Develop and evaluate components of effective audit reports, including background information, executive summary, prioritized results (observations, findings, opportunities for improvement, etc.). Use graphical tools or other means of emphasizing conclusions, and develop





























II. Audit Process (42 Questions) D. Audit Follow-Up and Closure

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)

4. Follow-up on ineffective corrective action Develop strategies to use when corrective actions are not implemented or are not n ot effective, such as communicating to the next level of management, reissuing the corrective action request, and re-auditing. (Create)





























D. Audit Follow-Up and Closure 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)

RCA Kaoru Ishikawa Diagram





























D. Audit Follow-Up and Closure 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-

































































































































































































































































































































































































































































































































CQA- Open Book Exam! FREQUENTLY ASKED QUESTIONS Is the exam open-book? With the exception of the constructed-response constructed-response portion of the Manager of Quality/Organizational 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). 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



























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 a nalysis (FMEA), hazard analysis and critical control points (HACCP), critical to quality (CTQ) analysis, health hazard analysis (HHA), etc. Sampling methods



























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CQA- Reading II Pre-Handbook Reading, the WIKI ways. Six Sigma DMAIC phases: define, measure, analyze, improve, control.























































Six Sigma (6σ) is a set of techniques and tools for process improvement. It was introduced by engineer Bill Smith while working at Motorola M otorola 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,





























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 quality improvement requires commitment from from the entire organization, particularly from top-level management.





























The term ―six sigma‖ comes from statistics and is used in statistical quality control, which evaluates process capability capability.. Originally, 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 longterm 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. 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 im prove all processes, but not to the 3.4 DPMO DPM O level necessarily





























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





























































































































































































































































































































































































































































































































































Exercise: Calculate area under the curves: 2σ ±2σ 3σ ±3σ

= 0.0.4772 = 0.9545 = 0.4987 = 0.9973 http://onlinestatbook.com/2/cal http://onlinestatbook.com/2/calculators/normal_dist culators/normal_dist.html .html



























Exercise: Calculate area under the normal curves between LSL/USL at ±3σ, for , USL-ũ= USL-ũ= 1.5σ Areas under the curve = 0.933 http://onlinestatbook.com/2/cal http://onlinestatbook.com/2/calculators/normal_dist culators/normal_dist.html .html



























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

http://onlinestatbook.com/2/calcul http://onlinest atbook.com/2/calculators/normal_dist. ators/normal_dist.html html 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 Capability.. A simple and straightforward indicator of process capability ca pability.. USLLSL Cp= 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− 3σ

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

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Cp, upper = −ũ 3σ

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



Cpk= Process Capability Index. Adjustment of Cp for the effect of non-centered distribution. ũ− Cpk= min[ −ũ 3σ , 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+( [1+(ũ)2] σ

(The process capability indices Cp and Cpk are widely used to provide unitless measures of process potential and performance. These i ndices do no adequately address the issue of



























Interpreting C p, C pk

―C pk , Cpk= min[

−ũ ũ−

3σ , 3σ ] is an index (a simple number) which measures how close a process

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.‖





























Role of the 1.5 sigma shift Experience has shown that processes usually 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 study.. To account account for this real-life increase i ncrease 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.





























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 proces s 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





























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





























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 −ũ ũ− study determining the short-term sigma level, the long-term C pk Cpk= min[ ]

3σ

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

introduced by engineer

Sigma level

Sigma (with 1.5σ 1.5 σ shift)

DPMO

Percent defective

Percentage yield

Short-term Cpk

Long-term Cpk















































































































































































































































































Understanding ASQ-CQA -Knowing the Ways

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