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Certified quality engineer handbook 3rd.1.The Certified QualityEngineer HandbookThird Edition.Also available from ASQ Quality Press:The Certified Six Sigma Black Belt Handbook, Second EditionT. Kubiak and Donald W. BenbowThe Certified Quality Inspector HandbookH. Fred Walker, Ahmad K. Elshennawy, Bhisham C. Gupta, and MaryMcShane VaughnThe Certified Reliability Engineer HandbookDonald W. Benbow and Hugh W.

BroomeThe Certified Software Quality Engineer HandbookLinda Westfall, editorThe Metrology HandbookJay Bucher, editorThe Certified Six Sigma Green Belt HandbookRoderick A. Munro, Matthew J. Maio, Mohamed B. Nawaz, Govindarajan Ramu,and Daniel J. ZrymiakThe Quality Calibration Handbook: Developing and Managing a Calibration ProgramJay L.

BucherDesign of Experiments with MINITABPaul MathewsThe Certified Manager of Quality/Organizational Excellence Handbook, Third EditionRussell T. Westcott, editorThe Certified Quality Technician HandbookDonald W. Benbow, Ahmad K. Elshennawy, and H.

Fred WalkerThe Weibull Analysis Handbook, Second EditionBryan DodsonStatistical Engineering: An Algorithm for Reducing Variation in Manufacturing ProcessesStefan H. Steiner and R. Jock MacKayLean Kaizen: A Simplified Approach to Process ImprovementsGeorge Alukal and Anthony ManosTo request a complimentary catalog of ASQ Quality Press publications,call 800-248-1946, or visit our Web site at Quality PressMilwaukee, WisconsinThe Certified QualityEngineer HandbookThird EditionConnie M. Borror, Editor.American Society for Quality, Quality Press, Milwaukee 53203© 2009 by ASQAll rights reserved.

Published 2008Printed in the United States of America14 13 12 11 10 09 08 5 4 3 2 1Library of Congress Cataloging-in-Publication DataThe certified quality engineer handbook / Connie M. Borror, editor.—3rd ed.p.

Cm.Includes bibliographical references and index.ISBN 978-0-87389-745-7 (hard cover: alk. Swiss gear wireless mouse drivers. Production management—Quality control. Reliability (Engineering).I. Borror, Connie M.TS156.C4.4'013—dc494ISBN: 978-0-87389-745-7No part of this book may be reproduced in any form or by any means, electronic, mechanical,photocopying, recording, or otherwise, without the prior written permission of the publisher.Publisher: William A.

TonyAcquisitions Editor: Matt T. MeinholzProject Editor: Paul O’MaraProduction Administrator: Randall BensonASQ Mission: The American Society for Quality advances individual, organizational, andcommunity excellence worldwide through learning, quality improvement, and knowledgeexchange.Attention Bookstores, Wholesalers, Schools and Corporations: ASQ Quality Press books,videotapes, audiotapes, and software are available at quantity discounts with bulk purchasesfor business, educational, or instructional use. For information, please contact ASQ QualityPress at 800-248-1946, or write to ASQ Quality Press, P.O.

Box 3005, Milwaukee, WI.To place orders or to request a free copy of the ASQ Quality Press Publications Catalog,including ASQ membership information, call 800-248-1946. Visit our Web site at www.asq.orgor in the United States of AmericaPrinted on acid-free paper.vTable of ContentsCD-ROM Contents. XiiList of Figures and Tables. XiiiPreface to the Third Edition. XxPreface to the Second Edition.

XxiiPreface to the First Edition. XxiiiHow to Use This Book.

XxviiiPart I Management and Leadership. 1Chapter 1 A. Quality Philosophies and Foundations. 2History of Quality. 2What Is Quality?. 7Chapter 2 B. The Quality Management System.

Strategic Planning. Deployment Techniques. Quality Information System.

33Chapter 3 C. ASQ Code of Ethics for Professional Conduct. 41Ethical Dilemmas. 42Chapter 4 D. Leadership Principles and Techniques. 45Developing, Building, and Organizing Teams. 46Leading Quality Initiatives.

50Chapter 5 E. Facilitation Principles and Techniques. 52Facilitator Roles and Responsibilities in the Team Environment. 52Idea Processing and Decision Making.

55Chapter 6 F. Communication Skills. 59The Need for Communication Skills. 59Creating a Shared Vision. 59Communication Process.

60Chapter 7 G. Customer Relations. 64Customer Needs and Wants. 64Quality Function Deployment.

65Customer-Driven Quality. 70.vi Table of ContentsChapter 8 H. Supplier Management. 72Procurement Standards and Specifications.

72Survey versus Audit versus Sampling Inspection. 73Surveying the Supplier.

74Supplier Rating and Evaluation. 77Chapter 9 I. Overcoming Barriers to Quality Improvement. 80Twelve Obstacles to Implementing Quality. 80Summary of Part I. 82Part II The Quality System.

85Chapter 10 A. Elements of the Quality System. 86Chapter 11 B. Documentation of the Quality System. 90Chapter 12 C. Quality Standards and Other Guidelines.

93National versus International Standards. 93The ISO 9000 Family. 94Some Other Quality Standards.

98Malcolm Baldrige National Quality Award. 98Chapter 13 D.

Quality Audits. Types of Audits. Roles and Responsibilities in Audits. Audit Planning and Implementation. Audit Reporting and Follow-Up. 103Chapter 14 E.

Cost of Quality. 105The Economics of Quality. 105Goal of a Quality Cost System. 107Management of Quality Costs. 107Quality Cost Categories. 108Quality Cost Collection. 111Quality Cost Summary and Analysis.

112Quality Cost Reporting. 113Using Quality Costs.

113Quality Improvement and Reducing Quality Costs. 114Quality Cost Principles and Lessons. 114Chapter 15 F. Quality Training. 116Developing a Training Program.

117Needs Analysis. 118Developing Curricula and Materials.

118Determine Effectiveness. 119A Final Thought. 122Summary of Part II. 122.Table of Contents viiPart III Product and Process Design. 123Chapter 16 A. Classification of Quality Characteristics. 124Measurement of Variables Data.

124Measurement of Attributes Data. 124Chapter 17 B. Design Inputs and Review. 126Design Background and Definition.

126The Product/Process Development Lifecycle. 126Design Review. 128Design Inputs. 129Chapter 18 C. Technical Drawings and Specifications. 131Dimensioning and Tolerancing.

131Chapter 19 D. Design Verification. 135Chapter 20 E. Reliability and Maintainability. Predictive and Preventive Maintenance Tools. System Reliability and Maintainability Indices.

The Bathtub Curve and Other Failure Models. Reliability, Safety, and Hazard Assessment Tools.

156Summary of Part III. 178Part IV Product and Process Control. 179Chapter 21 A. 180Control Plans. 180Work Instructions. 182Chapter 22 B.

Material Control. Material Identification, Status, and Traceability. Material Segregation. Classification of Defects.

Material Review Board (MRB). 191Chapter 23 C.

Acceptance Sampling. 193Sampling Inspection versus 100 Percent Inspection. Sampling Concepts. Sampling Standards and Plans. 205Variables Sampling Plans. 215Sequential Sampling Plans.

Sample Integrity. 224Chapter 24 D. Measurement and Test.

227The Measurement Process. Measurement Tools.

Destructive and Nondestructive Tests. 242.viii Table of ContentsChapter 25 E. 245Introduction and Scope. 245Context of Measurements. 245Concepts in Metrology. 253Chapter 26 F.

Measurement System Analysis. 256Terms and Definitions.

256Gage Repeatability and Reproducibility. 258Summary of Part IV.

271Part V Continuous Improvement. 273Chapter 27 A. Quality Control Tools.

275Pareto Chart. 276Cause-and-Effect Diagrams. 278Check Sheets. 282Scatter Diagrams. 284Run Charts. 285Control Charts. 288Summary of the Graphical Tools.

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288Chapter 28 B. Quality Management and Planning Tools. 289Affinity Diagrams.

290Interrelationship Digraphs. 292Tree Diagrams. 294Process Decision Program Charts.

298Matrix Diagrams. 299Prioritization Matrices. 303Activity Network Diagram and Arrow Diagram. 304Process Maps.

308Process Value Chain (PVC) Diagrams. 311Value Stream Mapping. 311SIPOC Diagrams. 313Summary of Quality Management and Planning Tools. 316Chapter 29 C. Continuous Improvement Techniques.

318Total Quality Management (TQM). 319PDSA or PDCA. 320Six Sigma. 321Sustaining and Communicating Change. 332The DMAIC Process.

333Theory of Constraints. 334.Table of Contents ixLean Enterprise. 334Chapter 30 D. Corrective Action. 346Phase 1: Identify the Opportunity (Problem Identification).

347Phase 2: Analyze the Current Process. 349Phase 3: Develop the Optimal Solution(s) (Correction). 350Phase 4: Implement Changes. 351Phase 5: Study the Results.

352Phase 6: Standardize the Solution (Recurrence Control). 352Phase 7: Plan for the Future (Effectiveness Assessment). 354Chapter 31 E. Preventive Action.

355Verifying the Effectiveness of Preventive Actions. 356Robust Design. 356Summary of Part V. 357Part VI Quantitative Methods and Tools.

359Chapter 32 A. Collecting and Summarizing Data. Types of Data. Measurement Scales. Data Collection Methods. Data Accuracy.

Descriptive Statistics. Graphical Methods for Depicting Relationships. Graphical Methods for Depicting Distributions.

374Chapter 33 B. Quantitative Concepts. Drawing Statistical Conclusions. Probability Terms and Concepts. 381Chapter 34 C.

Probability Distributions. Continuous Distributions. Discrete Distributions. 408General Form of Expected Value and Variance. 414Central Limit Theorem Revisited.

415Chapter 35 D. Statistical Decision Making.

Point Estimates and Confidence Intervals. Hypothesis Testing. Paired-Comparison Tests. Goodness-of-Fit Tests. Analysis of Variance (ANOVA). Contingency Tables.

469Chapter 36 E. Relationships Between Variables. Linear Regression.

Simple Linear Correlation. Time-Series Analysis. 488.x Table of ContentsChapter 37 F. Statistical Process Control (SPC). Objectives and Benefits. Common and Special Causes.

Selection of Variable. Rational Subgrouping. Control Charts. Control Chart Analysis. Pre-Control Charts. Short-Run Statistical Process Control. 524Chapter 38 G.

Process and Performance Capability. Process Capability Studies. Calculating Process Performance versus Specifications. Process Capability Indices.

Process Performance Indices. 532Chapter 39 H. Design and Analysis of Experiments. Planning and Organizing Experiments. Design Principles. One-Factor Experiments.

Full-Factorial Experiments. Two-Level Fractional Factorial Experiments. 566Summary of Part VI. 574Part VII Appendices. 575Appendix A ASQ Certified Quality Engineer (CQE) Bodyof Knowledge. 576Levels of Cognition Based on Bloom’s Taxonomy—Revised (2001).

584Appendix B Control Limit Formulas. 585Variables Charts. 585Attributes Charts.

585Appendix C Constants for Control Charts. 586Appendix D Statistical Tolerance Factors for at Least 99 Percent ofthe Population (“k-Values”). 587Appendix E Standard Normal Distribution for Selected Z-Values. 588Appendix F Areas under Standard Normal Distribution to the Leftof Z-Values. 590Appendix G F Distribution F0.10. 593Appendix H F Distribution F0.05.

597Appendix I F Distribution F0.01. 601Appendix J Binomial Distribution. 605Appendix K Chi-Square Distribution. 607.Table of Contents xiAppendix L Exponential Distribution. 609Appendix M Poisson Distribution.

611Appendix N Median Ranks. 613Appendix O Normal Scores. 615Appendix P Values of t Distribution. 617Appendix Q Selected National and International Quality SystemStandards.