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The Certified Quality Process Analyst Handbook

Also available from ASQ Quality Press:

Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug The Quality Improvement Handbook, Second Edition ASQ Quality Management Division; John E. Bauer, Grace L. Duffy, and Russell T. Westcott, editors The Quality Toolbox, Second Edition Nancy R. Tague The Internal Auditing Pocket Guide: Preparing, Performing, Reporting, and Follow-up, Second Edition J.P. Russell Lean Kaizen: A Simplified Approach to Process Improvements George Alukal and Anthony Manos The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition Russell T. Westcott, editor Glossary and Tables for Statistical Quality Control, Fourth Edition ASQ Statistics Division The Certified Quality Technician Handbook Donald W. Benbow, Ahmad K. Elshennawy, and H. Fred Walker The Path to Profitable Measures: 10 Steps to Feedback That Fuels Performance Mark W. Morgan Everyday Excellence: Creating a Better Workplace Through Attitude, Action, and Appreciation Clive Shearer Making Change Work: Practical Tools for Overcoming Human Resistance to Change Brien Palmer Enabling Excellence: The Seven Elements Essential to Achieving Competitive Advantage Timothy A. Pine

To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http://qualitypress.asq.org.

The Certified Quality Process Analyst Handbook

Eldon H. Christensen, Kathleen M. Coombes-Betz, and Marilyn S. Stein

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203 © 2007 by ASQ All rights reserved. Published 2007 Printed in the United States of America 13 12 11 10 09 08 07 5 4 3 2 1 Library of Congress Cataloging-in-Publication Data Christensen, Eldon H., 1939­. The certified quality process analyst handbook / Eldon H. Christensen, Kathleen M. Coombes-Betz, and Marilyn S. Stein. p. cm. Includes bibliographical references and index. ISBN: 978-0-87389-709-9 (hardcover : alk. paper) 1. Quality control--Handbooks, manuals, etc. I. Coombes-Betz, Kathleen M., 1962­ II. Stein, Marilyn S., 1960­ III. Title. TS156.C533 2007 658.4'013--dc22 ISBN: 978-0-87389-709-9 No 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. Tony Acquisitions Editor: Matt T. Meinholz Project Editor: Paul O'Mara Production Administrator: Randall Benson ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange. Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, videotapes, audiotapes, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005. 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.org or http://www.asq.org/quality-press. Printed in the United States of America Printed on acid-free paper 2007012267

To Toni for her support and inspiration. Eldon H. Christensen I would like to thank my husband Kevin for giving me the time and space to write this book. I am dedicating this book to my children, Michael, Colleen, Emily, and John Thomas. Thank you for being patient and understanding . . . you will each have a book on your shelf for future reading! I would also like to thank our reviewers for taking the time to review the manuscript and lend us your comments. To my friends and colleagues at General Motors, I'm grateful to you all as it was with you that I've gained most of my practical experience. Kathleen M. Coombes-Betz To Karen, my partner, for her wisdom and encouragement, and relinquishing the computer to me during this project, I dedicate this book. I thank my boss, Ken Kees, and his predecessor, Michael N. Kelly, for their support and belief in me when I first began my career as a quality engineer, now over a decade ago. Finally, I owe a debt of gratitude to Ellis R. Ott and Edward G. Schilling for writing Process Quality Control. It was my primary reference when I first started my quality journey. Marilyn S. Stein

Table of Contents

List of Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

xiv xviii

Part I

Quality Basics

2 2 5 5 7 8 8 8 9 10 10 13 15 16 16 17 18 20 20 22 25 27 27 33 37 43 43

Chapter 1 A. ASQ Code of Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Code of Ethics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 2 B. Quality Planning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Set Goals/Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logical Steps to Reach the Goals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . An Implementation Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measures of Success . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 3 C. Cost of Quality (COQ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Cost of Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4 D. Quality Standards, Requirements, and Specifications . . . . . . . Chapter 5 E. Documentation Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Need for a Flexible and Current Documentation System . . . . . . . . . . . . . . . . . Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Configuration Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Documentation Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 6 F. Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Audit Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Audit Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 7 G. Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Types of Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Team-Building Techniques. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 8 H. Training Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Training Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Part II Problem Solving and Improvement

Chapter 9 A. Basic Quality Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Check Sheets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pareto Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scatter Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cause-and-Effect Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 10 B. Continuous Improvement Models. . . . . . . . . . . . . . . . . . . . . . . . . Plan­Do­Check­Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Kaizen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Incremental and Breakthrough Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . Six Sigma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reengineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 11 C. Basic Quality Management Tools . . . . . . . . . . . . . . . . . . . . . . . . . Affinity Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interrelationship Digraph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tree Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Matrix Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prioritization Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activity Diagram (Arrow Diagram) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process Decision Program Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 12 D. Project Management Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Principles of Project Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Some Standard Project Management Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 13 E. Taguchi Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . An Example of Robust Design via the Taguchi Method . . . . . . . . . . . . . . . . . . Classify the Variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Taguchi Loss Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signal-to-Noise Ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 14 F. Lean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setup Reduction (SUR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Kanban . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Just-in-Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous Flow Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Value Stream. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Poka-Yoke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total Preventive/Predictive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 15 G. Benchmarking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obtain a Commitment to Change the Organization's Business Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Determine Which Processes the Company Needs to Improve. . . . . . . . . . . . . 54 55 56 57 59 63 64 66 66 67 69 70 72 74 75 75 77 77 79 80 80 82 82 84 91 92 92 92 94 95 96 97 97 98 98 99 100 102 103 104 104

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Identify the Best Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Form a Benchmarking Partnership. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Study the Benchmarking Partner's Operations and Products . . . . . . . . . . . . . Create Benchmark Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compare Current Practices with the Partner's . . . . . . . . . . . . . . . . . . . . . . . . . . Develop a Plan to Change Operational Practices . . . . . . . . . . . . . . . . . . . . . . . .

104 105 106 106 107 107

Part III Data Analysis

Chapter 16 A. Terms and Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Basic Statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Basic Distributions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Probability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Measurement Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 17 B. Data Types and Collection Methods . . . . . . . . . . . . . . . . . . . . . . . 1. Types of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Methods for Collecting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 18 C. Sampling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Sampling Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 19 D. Measurement Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measurement Concepts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 20 E. Statistical Process Control (SPC). . . . . . . . . . . . . . . . . . . . . . . . . . 1. Techniques and Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Control Limits and Specification Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Variables Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Attributes Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. Rational Subgroups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Process Capability Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7. Pre-Control Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Common and Special Causes of Variation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9. Data Plotting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 21 F. Regression and Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Regression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 22 G. Hypothesis Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Population Parameter versus Sample Statistic . . . . . . . . . . . . . . . . . . . . . . . . . . Point Estimate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Confidence Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Confidence Intervals in Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How Large a Sample Is Needed to Estimate a Process Average?. . . . . . . . . . . Student's t-Distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Testing a Hypothesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 110 114 118 129 132 132 133 135 135 164 167 167 168 172 172 176 178 182 188 190 195 196 198 200 200 201 205 205 205 206 209 210 211 214

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Null Hypothesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Limitations of Hypothesis Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Statistical Significance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Frequent Misunderstandings About the Use of the p-Value. . . . . . . . . . . . . . . Chapter 23 H. Design of Experiments (DOE). . . . . . . . . . . . . . . . . . . . . . . . . . . . Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sums of Squares. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blocking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main Effect and Interaction Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 24 I. Analysis of Variance (ANOVA). . . . . . . . . . . . . . . . . . . . . . . . . . . . Fixed Effects Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Random Effects Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assumptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Degrees of Freedom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

215 216 217 219 220 221 225 226 227 228 229 230 230 230 231

Part IV Customer­Supplier Relations

Chapter 25 A. Internal and External Customers and Suppliers . . . . . . . . . . . . Internal Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Improving Internal Processes and Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . Effect of Treatment of Internal Customers on That of External Customers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Methods to Energize Internal Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . External Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . External Customers' Influence on Products and Services. . . . . . . . . . . . . . . . . Chapter 26 B. Customer Satisfaction Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Complaint Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warranty and Guarantee Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Function Deployment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 27 C. Product/Process Approval Systems . . . . . . . . . . . . . . . . . . . . . . . Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Validation and Qualification Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 28 D. Reliability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Basic Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Probability Density Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bathtub Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exponential Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 29 E. Supplier Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier Management Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Key Measures of Supplier Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier Assessment Metrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234 234 235 237 238 238 241 243 244 249 253 253 259 259 261 263 263 264 264 267 270 270 271 272

Table of Contents

xiii

Chapter 30 F. Elements of Corrective and Preventive Action . . . . . . . . . . . . . . Assign Responsibility for Correcting the Situation . . . . . . . . . . . . . . . . . . . . . . Assess the Importance of the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contain the Negative Effects Resulting from the Defect. . . . . . . . . . . . . . . . . . Identify Root Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Identify Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Implement the Controls Necessary to Prevent Recurrence. . . . . . . . . . . . . . . . Dispose of Any Bad Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 31 G. Material Identification, Status, and Traceability. . . . . . . . . . . . Chapter 32 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

273 274 275 276 277 278 278 278 279 282

Part V Appendices

Appendix A Appendix B Appendix C Appendix D Quality Process Analyst Body of Knowledge . . . . . . . . . . . . . . . . Areas Under Standard Normal Curve . . . . . . . . . . . . . . . . . . . . . . . Control Limit Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factors for Control Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284 290 292 293 295 301 TK TK

Endnotes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

List of Figures and Tables

Figure 3.1 Table 5.1 Figure 7.1 Figure 7.2 Figure 7.3 Table 7.1 Table 7.2 Figure 8.1 Table 8.1 Table 8.2 Table 8.3 Figure 8.2 Figure 9.1 Figure 9.2 Figure 9.3 Figure 9.4 Figure 9.5 Figure 9.6 Figure 9.7 Figure 9.8 Figure 9.9 Figure 9.10 Figure 9.11 Figure 9.12 Figure 9.13 Figure 9.14 Figure 10.1 Figure 10.2 Table 10.1 Figure 10.3 Table 10.2

Quality costs--general description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example document traceability matrix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Guidelines for successful self-managed teams. . . . . . . . . . . . . . . . . . . . . . . . . Typical U-shaped cell layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Objectives made the S.M.A.R.T. W.A.Y. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Meeting ground rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Team roles, responsibilities, and performance attributes. . . . . . . . . . . . . . . . Considerations for selecting a training system. . . . . . . . . . . . . . . . . . . . . . . . Job training selection criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Common training delivery methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Levels of training evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Characteristics of evaluation levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The seven basic quality tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Defects table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time-related check sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pareto diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scatter diagrams depicting high degree and low degree of positive correlation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scatter diagrams depicting high degree and low degree of negative correlation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scatter diagram depicting no correlation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . Histogram worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tally and frequency distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Histogram of student SAT scores. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cause-and-effect diagram for a manufacturing problem. . . . . . . . . . . . . . . . Completed cause-and-effect diagram for a manufacturing problem. . . . . . Some common flowchart symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flowchart for calculating weekly paycheck. . . . . . . . . . . . . . . . . . . . . . . . . . . The PDCA/PDSA cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Kaizen and the PDCA cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Defects at various sigma levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . y is a function of x. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DMAIC steps with some applicable tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11 18 29 32 35 36 38 44 45 47 49 50 54 55 56 57 58 58 59 60 61 61 63 64 64 65 67 68 70 70 72

xiv

List of Figures and Tables

xv

Figure 11.1 Figure 11.2 Figure 11.3 Table 11.1 Figure 11.4 Figure 11.5 Figure 11.6 Figure 11.7 Figure 11.8 Figure 12.1 Figure 12.2 Figure 12.3 Figure 12.4 Figure 12.5 Figure 12.6 Figure 12.7 Figure 12.8 Figure 12.9 Figure 13.1 Figure 13.2 Figure 14.1 Table 14.1 Figure 14.2 Figure 14.3 Figure 14.4 Figure 16.1 Figure 16.2 Figure 16.3 Figure 16.4 Figure 16.5 Figure 16.6 Figure 16.7 Figure 18.1 Figure 18.2 Figure 18.3 Figure 18.4 Figure 18.5

Affinity diagram of "Methods to improve team performance." . . . . . . . . . . Interrelationship digraph (relations diagram) example. . . . . . . . . . . . . . . . . Tree diagram example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . When to use differently-shaped matrices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . L-shaped matrix example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Roof-shaped matrix example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prioritization matrix example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activity network diagram example (activity on node). . . . . . . . . . . . . . . . . . Process decision program chart example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . The triple constraints of project management. . . . . . . . . . . . . . . . . . . . . . . . . An example WBS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A sample Gantt chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Network diagram example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PERT chart example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CPM chart example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Network diagram example created by MS Project. . . . . . . . . . . . . . . . . . . . . . Responsibility assignment matrix (RAM) example. . . . . . . . . . . . . . . . . . . . . Line graph budget example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The four classes of variables in the Taguchi method. . . . . . . . . . . . . . . . . . . . Comparison between the traditional and the Taguchi concept for assessing the impact of product quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pull system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5S terms and descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous flow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Value stream map example--macro level (partial). . . . . . . . . . . . . . . . . . . . . Value stream map example--plant level (partial). . . . . . . . . . . . . . . . . . . . . . Standard deviation calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Binomial distribution with n = 10 and p = .20. . . . . . . . . . . . . . . . . . . . . . . . . . Histograms of error values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standard normal curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Area under the standard normal curve between z = 0 and z = 1. . . . . . . . . . Area under the standard normal curve between z = ­2 and z = 1. . . . . . . . . Area under a normal curve between 0.750 and 0.754. . . . . . . . . . . . . . . . . . . An operating characteristic (OC) curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Average outgoing quality curve for N = , n = 50, c = 3. . . . . . . . . . . . . . . . . Effect on an OC curve of changing sample size n when accept 141 number c is held constant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Effect on changing accept number c when sample size n is held constant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Effect of changing lot size N when accept number c and sample size n are held constant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

75 76 77 78 79 79 80 81 81 83 85 85 86 86 87 87 89 89 92 93 97 98 99 100 101 112 115 126 127 128 128 129 137 139 141 141 143

xvi

List of Figures and Tables

Figure 18.6 Figure 18.7 Figure 18.8 Figure 18.9 Figure 18.10 Figure 18.11 Figure 18.12 Figure 18.13 Figure 18.14 Figure 18.15

Operating characteristic curves for sampling plans having the sample size equal to 10 percent of the lot size. . . . . . . . . . . . . . . . . . . . . . . . . . Switching rules for normal, tightened, and reduced inspection. . . . . . . . . . General structure and organization of ANSI/ASQ Z1.9-2003. . . . . . . . . . . . ANSI/ASQ Z1.4-2003 Table VIII: Limit numbers for reduced inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.4-2003 Table I: Sample size code letters per inspection levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.4-2003 Table II-A: Single sampling plans for normal inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.4-2003 Table III-A: Double sampling plans for normal inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.4-2003 Table IV-A: Multiple sampling plans for normal inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.9-2003 Table A-2. Sample size code letters. . . . . . . . . . . . . . . ANSI/ASQ Z1.9-2003 Table C-1: Master table for normal and tightened inspection for plans based on variability unknown (single specification limit--form 1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.9-2003 Table B-5: Table for estimating the lot percent nonconvorming using standard deviation ethod. . . . . . . . . . . . . . . . . . . . . . . ANSI/ASQ Z1.9-2003 Table B-3: Master table for normal and tightened inspection for plans based on variability unknown (double specification limit and form 2--single specification limit). . . . . . . Factors affecting the measuring process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gauge accuracy is the difference between the measured average of the gauge and the true value, which is defined with the most accurate measurement equipment available. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measurement data can be represented by one of four possible scenarios. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example of run chart with first six points plotted. . . . . . . . . . . . . . . . . . . . . . Example of averages chart with first four points plotted. . . . . . . . . . . . . . . . Example of an average and range chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ X and R chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control chart indicators of process change. . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ X and R chart example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ­ Data for X and R chart control limit calculations. . . . . . . . . . . . . . . . . . . . . . . p chart example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example of an np chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example of a u chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Attribute data with totals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conveyor belt in chocolate making process. Possible sampling plans. . . . . Point outside control limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Seven successive points trending upward. . . . . . . . . . . . . . . . . . . . . . . . . . . .

143 146 150 154 155 156 157 158 160

161 162

Figure 18.16 Figure 18.17

163 169

Figure 19.1 Figure 19.2

170 170 173 173 174 175 176 180 181 183 184 185 186 189 197 197 197

Figure 19.3 Figure 20.1 Figure 20.2 Figure 20.3 Figure 20.4 Table 20.1 Figure 20.5 Table 20.2 Figure 20.6 Figure 20.7 Figure 20.8 Table 20.3 Figure 20.9 Figure 20.10 Figure 20.11

Figure 20.12 Seven successive points on one side of the average. . . . . . . . . . . . . . . . . . . . .

List of Figures and Tables xvii

Figure 20.13 Figure 20.14 Figure 21.1 Figure 21.2 Figure 22.1 Figure 22.2 Table 22.1 Table 23.1 Table 23.2 Table 23.3 Table 23.4 Table 23.5 Table 23.6 Figure 23.1 Figure 25.1 Table 26.1 Table 26.2 Figure 26.1 Table 26.3 Figure 26.2 Figure 26.3 Figure 26.4 Figure 27.1 Figure 28.1 Figure 28.2 Table 28.1 Table 29.1

Nonrandom pattern. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nonrandom patterns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example of linear correlation as demonstrated by a series of scatter diagrams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Some frequently occurring patterns of data that lead to seriously misleading values of r and are not recognized as a consequence. . . . . . . . . Fifty realizations of a 95 percent confidence interval for m. . . . . . . . . . . . . . Density of the t-distribution for 1, 2, 3, 5, 10, and 30 df compared to the normal distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . t-table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Experimental plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Experimental results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The 22 configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signs of interaction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment combination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis of variance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main effect and interaction plots for the 22 design in Table 23.2. . . . . . . . . . The customer­supplier value chain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Survey types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Survey mediums. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Customer complaint form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test to identify organization's attitude toward complaints. . . . . . . . . . . . . . Quality function deployment matrix house of quality. . . . . . . . . . . . . . . . . . Voice of the customer deployed through an iterative QFD process. . . . . . . QFD house of quality matrix example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stages of the product development cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bathtub curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reliability can be modeled by the exponential distribution. . . . . . . . . . . . . Relationship between each bathtub phase, its a probability distribution, and failure causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier performance assessment metrics. . . . . . . . . . . . . . . . . . . . . . . . . . . .

198 198 203 204 208 212 212 221 222 224 224 225 226 227 236 245 247 251 252 254 255 257 260 264 266 266 272

Introduction

T

his handbook is designed as a reference for the Certified Quality Process Analyst Body of Knowledge (BoK), providing the basic information needed to prepare for the CQPA examination. There are four main sections in the CQPA Body of Knowledge, further subdivided into related subsections. These sections are: · Quality Basics · Problem Solving and Improvement · Data Analysis · Customer­Supplier Relations The first part of the handbook, Quality Basics, begins with the quality principles embodied by the ASQ Code of Ethics. The fundamental elements of a quality system are described in this section. The second part focuses on problem solving and improvement, including such tools as Pareto charts, scatter diagrams, the plan­do­check­act (PDCA) cycle, quality management, project management, the Taguchi loss function, and Taguchi's signal-to-noise ratios, concluding with lean tools. To support any effective problem solving and improvement endeavors Part III, Data Analysis, provides the analytical methods to interpret and compare data sets and model processes. Basic statistics, probability, sampling methods, statistical process control (SPC), basic statistical decision tools, regression and correlation, and design of experiments (DOE) are explained in this section. Finally, any successful enterprise must understand its Customer­Supplier Relations, the last section of the BoK. Effective customer­supplier relations are key to high customer satisfaction, the ultimate measure of a company's worth. The relevant portion of the CQPA Body of Knowledge is excerpted at the beginning of each handbook chapter as a guide for the reader.

xviii

Part I

Quality Basics

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 A. ASQ Code of Ethics B. Quality Planning C. Cost of Quality (COQ) D. Quality Standards, Requirements, and Specifications E. Documentation Systems F. Audits G. Teams H. Training Components

Part I

1

Chapter 1

Part I.A

A. ASQ Code of Ethics

Identify appropriate behaviors for situations requiring ethical decisions. (Apply) Body of Knowledge I.A

CODE OF ETHICS

Fundamental Principles

ASQ requires its members and certification holders to conduct themselves ethically by: I. Being honest and impartial in serving the public, their employers, customers, and clients. II. Striving to increase the competence and prestige of the quality profession, and III. Using their knowledge and skill for the enhancement of human welfare. Members and certification holders are required to observe the tenets set forth below:

Relations with the Public

Article 1--Hold paramount the safety, health, and welfare of the public in the performance of their professional duties.

Relations with Employers and Clients

Article 2--Perform services only in their areas of competence. Article 3--Continue their professional development throughout their careers and provide opportunities for the professional and ethical development of others. 2

Chapter 1: A. ASQ Code of Ethics

3

Article 4--Act in a professional manner in dealings with ASQ staff and each employer, customer, or client. Article 5--Act as faithful agents or trustees and avoid conflict of interest and the appearance of conflicts of interest.

Part I.A

Relations with Peers

Article 6--Build their professional reputation on the merit of their services and not compete unfairly with others. Article 7--Assure that credit for the work of others is given to those to whom it is due.

As a Certified Quality Process Analyst, you will be expected to perform your process analysis duties as a professional, which includes acting in an ethical manner. The ASQ Code of Ethics has been carefully drafted to serve as a guide for ethical behavior of its members and those individuals who hold certifications in its various disciplines. Specifically, the Code of Ethics requires that CQPAs are honest and impartial and serve the interests of their employers, clients, and the public with dedication. CQPAs should join with other quality process analysts to increase the competence and prestige of the profession. CQPAs should use their knowledge and skill for the advancement of human welfare and to promote the safety and reliability of products for public use. They should earnestly strive to aid the work of the American Society for Quality in its efforts to advance the interests of the quality process analyst profession. Performing your duties in an ethical manner is not always easy. Ethical choices are often not clear-cut and the right course of action is not always obvious. The ASQ Code of Ethics is not meant to be the one final answer to all ethical issues you may encounter. In fact, the Code has been revised and will continue to be revised from time to time in order to keep it current as new perspectives and challenging dilemmas arise. To improve relations with the public, CQPAs should do whatever they can to promote the reliability and safety of all the products that fall within their jurisdiction. They should endeavor to extend public knowledge of the work of ASQ and its members as it relates to the public welfare. They should be dignified and modest in explaining quality process analysis work and its merit. CQPAs should preface any public statements they make by clearly indicating on whose behalf they are made. An example of the CQPA's obligation to serve the public at large arose when a process analyst found that her manufacturing facility was disposing of hazardous waste materials in an illegal fashion. Naturally, she wrote up the violation and sent her report to the director of manufacturing. Her manager told her a few days later to "just forget about" the report she had written. This CQPA considered the incident a significant violation of her personal ethics and she told her boss that she felt the larger public interest outweighed the company's practice in this case.

4

Part I: Quality Basics

Her arguments were persuasive and eventually the company reversed its former practice of disposing of the hazardous materials in an illegal manner. To advance relations with employers and clients, CQPAs should act in professional matters as faithful agents or trustees of each employer or client. They should inform each client or employer of any business connections, interests, and affiliations that might influence the CQPA's judgment or impair the equitable character of his or her services. CQPAs should indicate to his or her employer or client the adverse consequences to be expected if his or her judgment is overruled. CQPAs should not disclose information concerning the business affairs or technical processes of any present or former employer or client without formal consent. CQPAs should not accept compensation from more than one party for the same service without the consent of all parties. For example, if the CQPA is employed, he or she should not engage in supplementary employment in consulting practice without first gaining the consent of the employer. Another example of an ethical issue concerning loyalty to employers and clients occurred when a quality consultant was asked to give another client in a competing firm a short description of the first client's product. The information that the second company was requesting was readily available on the Internet, but this CQPA felt that he should not be the source of information about a competitor's project since that information was obtained while engaged by the competitor. To improve relations with peers, CQPAs should give credit for the work of others to those to whom it is due. CQPAs should endeavor to aid the professional development and advancement of those in his or her employ or under his or her supervision. Finally, CQPAs must not compete unfairly with others. They should extend friendship and confidence to all associates and to those with whom he or she has business relations. An example of a potential violation of the ASQ Code of Ethics as it relates to dealing with peers occurred when a consulting quality process analyst was asked to do a job that required more work than she could do on her own. She properly enlisted the support of a peer, a highly qualified and very senior Certified Quality Engineer. The CQE so impressed the client that they asked him to take the lead on the engagement. The CQE, however, chose not to violate the Code of Ethics. Instead, he discussed the situation openly with the CQPA and the client and it was agreed to keep the leadership for this engagement in the CQPA's domain.

Part I.A

Index

A

acceptable quality level (AQL), 138 acceptance number, in sampling, 140­42 acceptance sampling, 135­36 by attributes, 137­42 acceptance stamp, 279 accuracy, in measurement, 169 achieved availability, 269 activity diagram, 80 activity network diagram (AND), 80 ad hoc teams, 30 affinity diagram, 75 alpha testing, 262 analysis of variance (ANOVA), 229­32 ANSI/ASQ Z1.4-2003 standard, for attributes sampling, 144­48 tables, 154­59 ANSI/ASQ Z1.9-2003 standard, for variables sampling, 149­53 tables, 160­63 appraisal costs, 11 areas under the standard normal curve, 126­29 Appendix B, 290­91 arrow diagram, 80 ASQ Code of Ethics, 2­4 assignable cause variation, 196 assumptions, in ANOVA, 230­31 attributes charts, 182­88 attributes data, 132 attributes sampling plans, types, 142­44 audit(s), 20­26 process, 22­24 roles and responsibilities, 25­26 types, 20­22 audit process, 22­24 audit team member, 23 audit team leader, responsibilities, 25 auditee, responsibilities, 26 auditor, responsibilities, 26 automatic gauging, 133 availability, in reliability, 269 average outgoing quality limit (AOQL), 139­40

average outgoing quality (AOQ), 138­39 average quality protection sampling, versus lot-by-lot, 136 ­ averages and range (X and R) chart, 174 ­ averages (X ) chart, 172­74

B

basic quality management tools, 74­81 basic quality tools, 54­65 bathtub curve, 264­66 benchmarking, 103­7 benefits-to-cost ratio (BCR), for training evaluation, 50 best practices, 103, 104­5 beta testing, 262 bias, in measurement, 171 bimodal distribution, 62­63 binomial distribution, 115­17 blocking, in DOE, 220, 226 Body of Knowledge, Quality Process Analyst (Appendix A), 284­89 breakthrough improvement, versus incremental improvement, 69

C

c charts, 184 capability, 190­95 categorical data, 132 cause-and-effect diagram, 63­64 cellular teams, 32 central tendency, measures of, 110­11 check sheets, 55­56 Code of Ethics, ASQ, 2­4 combinations, probability, 122­24 common cause variation, 196 companywide quality control, 13 Ishikawa's definition, 6 complaint forms, 249­52 complaint management system (CMS), 250 complementation rule, probability, 118 conditional probability, 120­21

391

392 Index

confidence interval, 206­9 in measurement, 209­10 configuration management (CM) program, 17­18 consensus, decision-making method, 36 constructive feedback, guidelines, 41­42 consumer's risk (b ), 138 containment activities, in corrective action, 276­77 contingency tables, 119­20 continuous data, versus discrete, 114, 115 continuous flow manufacturing, 98­99 continuous improvement models, 66­73 incremental and breakthrough improvement, 69 kaizen, 67­68 plan­do­check­act, 66­67 reengineering, 72­73 Six Sigma, 70­72 control charts, 174­76, 176­78 constants for (Appendix D), 293 control limits formulas (Appendix C), 292 for p charts, 185­87 versus specification limits, 176­78 for u charts, 187­88 ­ for X and R charts, 178­79 ­ for X and s charts, 179 control marking, 279 convenience sampling, 166 corrective action, 273­78 steps, 274 corrective action board, 274­75 corrective action team, 277 corrective maintenance, 268 correlation, of data, 58­59, 201­4 correlation coefficient (r), 58­59, 201­2 cost of quality (COQ), 10­12 count data, 182 Cp, calculating, 193­94 Cpk, calculating, 191­93 CR, calculating, 194 critical defect, 145, 276, 280 critical path method (CPM), 80, 86­88 customer feedback, 243­44 customer requirements, 13­14 customer satisfaction analysis, 243­58 complaint forms, 249­52 quality function deployment, 253­58 surveys, 244­49 voice of the customer, 243 warranty and guarantee analysis, 253 customer segmentation, 241 customers, external, 238­42 influence on products and services, 241­42 customers, intermediate, 240­41

customers, internal, 234­38 effect of treatment of on external customers, 237­38 methods to energize, 238 customer­supplier relations, 234­81 corrective and preventive action, 273­78 customer satisfaction analysis, 243­58 internal and external customers and suppliers, 234­42 material identification, status, and traceability, 279­81 product/process approval systems, 259­62 reliability, 263­69 supplier management, 270­72 customer­supplier value chain, 235

D

data correlation, with scatter charts, 58­59 methods for collecting, 133­34 plotting, 198­99 types, 132­33 data analysis, 109­232 analysis of variance (ANOVA), 229­32 data types and collection methods, 132­34 design of experiments (DOE), 220­28 hypothesis testing, 205­19 measurement terms, 167­71 regression and correlation, 200­204 sampling, 135­66 statistical process control (SPC), 172­99 terms and definitions, 110­31 data coding, 133­34 data plotting, 198­99 defect under ANSI/ASQ Z1.4-2003, 144­45 classifications, 276, 280 versus defective, 114 defect concentration diagram, 56 defective charting, 182­84 versus defect, 114 define­measure­analyze­design­verify (DMADV) methodology, 71­72 define­measure­analyze­improve­control (DMAIC) methodology, 71­72 definitions, data analysis. See data analysis, terms and definitions degrees of freedom, in ANOVA, 231­32 design of experiments (DOE), 220­32 blocking, 226 effects, 221­24 main effect and interaction plots, 227­28 sums of squares, 225­26

Index 393

discount buyer, 239 discrete data, versus continuous, 114, 115 dispersion, measures of, 111­14 distributions, basic, terms and definitions, 114­18 binomial distribution, 115­17 normal distribution, 114 Poisson distribution, 117 Weibull distribution, 117­18 distributor, 240 documentation control (DC) system, 18­19 Dodge-Romig tables, 148­49 documentation systems, 15­19 configuration management, 17­18 document control, 18­19 document library, 16­17 ISO 9001:2000 requirements, 16, 19 double sampling plans, 144 double-peaked distribution, 62­63

general multiplication rule, probability, 121 goals and objectives, in quality planning, 7­8 group marking, 279 guarantee analysis, 253

H

histograms, 59­63 shapes, 62­63 house of quality, 253­56 hypothesis testing, 205­19 confidence interval, 206­9 confidence interval in measurement, 209­10 limitations of, 216­17 misunderstandings about use of p-value, 219 null hypothesis, 215­16 point estimate, 205 population parameter versus sample statistic, 205 process average estimation, 210­11 statistical significance, 217­19 Student's t-distribution, 211­14 testing a hypothesis, 214­15

E

effects, in DOE, 221­24 empirical rule, in measurement, 209 employee buyer, 239 end users, types, 238­39 error, measurement, 168­69 ethics, in quality work, 3­4 exponential distribution, in reliability, 267­69 external audit, 21 external failure costs, 11­12

I

improvement models, continuous. See continuous improvement models incremental improvement, versus breakthrough improvement, 69 independence, statistical, 121 and special multiplication rule, 121­22 infant mortality period, in product lifecycle, 265 inferential statistics, 205 inherent availability, 269 inspection, 100 percent, versus sampling, 135­36 interaction plots, in DOE, 227­28 intermediate customers, 240­41 internal audit, 20 internal failure costs, 11 internal processes and services, improving, 235­37 interrelationship digraph, 76­77 interval measurement, 130­31 Ishikawa diagram, 63­64 ISO 9001:2000 documentation requirements, 16, 19 and nonconforming material, 281 ISO/TS 16949, requirements for nonconforming material, 281

F

F distribution, 211, 229 factor sparsity, 226 factorial experiments, in DOE, 220 failure costs, 11­12 feedback constructive, guidelines, 41­42 customer, 243­44 final customers, types, 238­39 first-article testing, 262 fishbone diagram, 63­64 5S methodology, 98 fixed effects model, of ANOVA, 230 fixed sampling, 165­66 flowcharts, 64

G

Gantt chart, 85­86 general addition rule, probability, 119

394 Index

J

just-in-time methodology, 97­98

K

kaizen, 28, 67­68 kaizen blitz, 28, 68 kaizen event, 28, 68 kanban system, 97

L

lead auditor, 25 lean methodology, 95­102 continuous flow manufacturing, 98­99 5S, 98 just-in-time, 97­98 kanban, 97 poka-yoke, 100­102 setup reduction (SUR), 96­97 total preventive/predictive maintenance, 102 value stream, 99­100 learner-controlled instruction (LCI), 46­47 learning, types of, 48­49 legal metrology, 167 levels of inspection, under ANSI/ASQ Z1.42003, 145 library, document, 16­17 Likert scale, 248 linear regression, 200­201 linearity, in measurement, 171 lot marking, 279 lot size, in sampling, 140­42 lot tolerance percent defective (LTPD), 138 lot-by-lot sampling, versus average quality protection, 136 L-shaped matrix, 78

mean time between maintenance actions, 268 mean time to failure, 267­68 mean time to repair, 268 measles chart, 56 measurement concepts, terms, 168­71 confidence interval in, 209­10 terms, 167 measurement scales, terms and definitions, 129­31 classifications, debate on, 131 interval measurement, 130­31 nominal measurement, 129­30 ordinal measurement, 130 ratio measurement, 131 measures of successful quality planning, 9 of supplier performance, 271­72 median, 111 minimum sensitivity design, 92 minor defect, 145, 276, 280 mistake-proofing (poka-yoke), 100­102 mode, 111 muda, eight types of, 95­96 multiple linear regression, 200 multiple sampling plans, 144 mutual exclusivity, 119, 122

N

natural teams, 30­31 network diagram, 86­88 next operation as customer, 234 nominal measurement, 129­30 nonconforming material, 275, 280­81 nonlinear regression models, 200 normal curve, standard, areas under, 126­29 Appendix B, 290­91 normal distribution, 62, 114 np charts, 182­83 null hypothesis, 215­16

M

machine capability, 195 main effect plots, in DOE, 227­28 maintainability, in reliability, 268 major defect, 145 Malcolm Baldrige National Quality Award (MBNQA), and benchmarking, 104­5 material identification, status, and traceability, 279­81 material review board, 274­75 matrix diagrams, 78­79 mean, 110­11 mean time between failures, 268

O

off-the-job training, 43­46 one-piece flow, 98 on-the-job training, 43­46 operating characteristic (OC) curve, 136­37, 140­42 operational availability, 269 ordinal measurement, 130 organization buyer, 239 organizational benchmarking, 106 orthogonality, in DOE, 220 out of statistical control, 177, 182

Index 395

P

p charts, control limits for, 185­87 Pareto charts, 56­57 Pareto principle, 56 performance benchmarking, 106 permutations, probability, 124­25 philosophy, Six Sigma, 70 pilot run, 262 plan, organizational, requirements, 5 plan­do­check­act methodology, 13 in complaint handling, 250­52 steps, 66­67 planning, quality, 5­9 point estimate, 205 Poisson distribution, 117 poka-yoke, 100­102 population parameter, versus sample statistic, 205 pp , calculating, 195 Ppk , calculating, 194 precision, in measurement, 169 pre-control chart, 195­96 predictor variables, 201 prevention costs, 11 preventive action, 273­74 preventive maintenance, 268 prioritization matrix, 79­80 probability, terms and definitions, 118­29 areas under a normal curve, 126­29 basic probability rules, 118­19 combinations, 122­24 conditional probability, 120­21 contingency tables, 119­20 general multiplication rule, 121 independence and the special multiplication rule, 121­22 permutations, 124­25 probability density functions, 264 problem identification, 55 problem solving and improvement, 53­107 basic quality management tools, 74­81 basic quality tools, 54­65 benchmarking, 103­7 continuous improvement models, 66­73 lean, 95­102 project management tools, 82­90 Taguchi concepts, 91­94 problems, team process, 40­41 process approval systems, 259­62 process audit, 21­22 process average estimation, and sample size, 210­11 process benchmarking, 106 process capability, measures, 190­95 process control, 225 process decision program chart, 80­81

process improvement teams, 28 producer's risk (a ), 138 product approval systems, 259­62 product audit, 21 production part approval process (PPAP), 262 program evaluation and review technique (PERT), 80, 86 project benchmarking, 106­7 project budget, 88­89 project charter, 84 project constraints, 83 project management, principles of, 82­84 project management tools, 82­90 Gantt chart, 85­86 network diagram, 86­88 principles of project management, 82­84 project budget, 88­89 project charter, 84 project progress review, 90 project variance analysis, 90 responsibility assignment matrix (RAM), 88 work breakdown structure (WBS), 84 project progress review, 90 project variance analysis, 90 pull system, 97, 99 p-value, misunderstandings about use of, 219

Q

qualification, in product/process approval, 261­62 qualitative data, 132 quality, basics, 1­51 ASQ Code of Ethics, 2­4 audits, 20­26 cost of quality (COQ), 10­12 documentation systems, 15­19 quality planning, 5­9 quality standards, requirements, and specifications, 13­14 teams, 27­42 training components, 43­51 quality assurance (QA), 14 function, 13 quality control, companywide, Ishikawa's definition, 6 quality control, total, Feigenbaum's definition, 5­6 quality council, 6 quality function deployment, 253­58 benefits, 258 steps, 256­58 quality level agreements, 236­37 quality management tools, seven basic, 74­81 activity diagram (arrow diagram), 80

396 Index

affinity diagram, 75 interrelationship digraph, 76­77 matrix diagrams, 78­79 prioritization matrix, 79­80 process decision program chart, 80­81 tree diagram, 77 quality manual, 17 quality plan, 8, 9 quality planning, 5­9 goals and objectives, 7­8 implementation approach, 8 measures of success, 9 resources, 8 responsibilities, 5­6 quality process analyst (QPA) Body of Knowledge (Appendix A), 284­89 function on team, 28­29 quality requirements, 13­14 quality specifications, 13­14 quality standards, 13­14 quality tools, seven basic, 54­65 cause-and-effect diagram, 63­64 check sheets, 55­56 flowcharts, 64 histograms, 59­63 nonquantitative, 54 Pareto charts, 56­57 quantitative, 54 scatter diagram, 57­59 quantitative data, 132­33 quick changeover, 96 quid pro quo, in benchmarking, 106

repeatability, in measurement, 170 replication, in DOE, 220 reproducibility, in measurement, 170 requirements, quality, 13­14 resources, quality planning, 8 response, in DOE, 221 responsibilities and roles in auditing, 25­26 of team members, 37­42 responsibility assignment matrix (RAM), 88 retail buyer, 239 retail chain buyer, 240 return on training investment (ROTI), for training evaluation, 50 robust design, via Taguchi method, 92 roles and responsibilities in auditing, 25­26 of team members, 37­42 roof-shaped matrix, 78­79 root cause analysis, 63, 66, 275, 277 root cause identification, 277 run chart, 172­76

S

sample size in process average estimation, 210­11 in sampling, 140­42 sample statistic, versus population parameter, 205 sampling, 135­66 acceptance, by attributes, 137­42 ANSI/ASQ Z1.4-2003, 144­48 ANSI/ASQ Z1.9-2003, 149­53 characteristics, 135­63 Dodge-Romig tables, 148­49 lot-by-lot versus average quality protection, 136 methods, 164­66 versus 100 percent inspection, 135­36 operating characteristic (OC) curve, 136­37 rational subgroups, 188­90 types of, under ANSI/ASQ Z1.4-2003, 147­48 variables sampling plans, 149 sampling methods, 164­66 sampling plans, 136 variables, 149 attributes, types of, 142­44 scatter diagram, 57­59 in linear correlation, 202­4 scientific metrology, 167 "scope creep" in auditing, 23 in project management, 82­83

R

random effects model, of ANOVA, 230 random errors, 168 random failure period, in product lifecycle, 265 random sampling, 164­65 randomization, in DOE, 220 range, 111­12 rapid exchange of tooling and dies (RETAD), 96 ratio measurement, 131 rational subgroups, 188­90 rectifying sampling, 135­36 recurrence prevention, 273, 274, 278 reengineering, for improvement, 72­73 regression analysis, 200­201 relationship diagram, 76­77 reliability, 263­69 basic concepts, 263­64 bathtub curve, 264­66 exponential distribution, 267­69 probability density functions, 264

Index 397

self-directed learning, 46­47 self-managed teams, 29­30 senior management, auditing responsibilities, 25 sequential sampling, 165 service buyer, 239 service providers, 240­41 service user, 239 setup reduction (SUR), 96­97 seven basic quality tools. See quality tools, seven basic seven basic quality management tools. See quality management tools, seven basic sigma (s ), standard deviation, 69 signal-to-noise ratio, Taguchi concept, 94 simple linear regression, 200 single minute exchange of die (SMED), 96­97 single sampling plans, 142­44 Six Sigma methodology, 71­72 philosophy, 70 requirements for success, 72 tools, 70­71 skewed distribution, 62 S.M.A.R.T. quality goals, 7 S.M.A.R.T. W.A.Y., of setting team goals and objectives, 35 sparsity of effects, 226 special addition rule, probability, 118 special cause variation, 196 special project teams, 32­33 special multiplication rule, probability, 121 and statistical independence, 121­22 specification limits, versus control limits, 176­78 specifications customer, 14 quality, 13­14 spread, 111 squares of the deviations from the mean, 112­13 standard deviation, 112­14 standard error, 209 standard normal curve areas under, 126­29, (Appendix B) 290­91 properties, 126­27 standardized work, 99 standards, quality, 13­14 statistical process control (SPC), 172­99 applications, 172­76 attributes charts, 182­88 common and special cause variation, 196 control limits, 176­78 data plotting, 198­99 pre-control chart, 195­96 process capability measures, 190­95

rational subgroups, 188­90 specification limits, 176­78 techniques, 172­76 variables charts, 178­79 statistical significance, 217­19 statistics, basic, terms and definitions, 110­14 mean, 110­11 median, 111 mode, 111 range, 111­12 standard deviation, 112­14 statistics, inferential, 205 status, material, 279­81 status stamp, 279 stoplight control, 195 stratified sampling, 165 Student's t-distribution, 211­14 sum of the squares of the deviations from the mean, 112­13 sums of squares, in DOE, 225­26 supplier, internal, 235 supplier assessment, metrics, 272 supplier management, 270­72 supplier performance, key measures, 271­72 surveys, 244­49 design, 247­48 question design, 248­49 types, 244 switching procedures, under ANSI/ASQ Z1.4-2003, 145­47 system audit, 22 systematic errors, 168 systematic sampling, 165­66

T

Taguchi concepts, 91­94 Taguchi loss function, 92­93 takt time, 99 tally sheet, 55­56 t-distribution, Student's, 211­14 team development, stages, 36­37 team processes, task type versus maintenance type, 34 team-building techniques, 33­37 teams, 37­42 roles and responsibilities, 37­42 team-building techniques, 33­37 temporary, 30 types of, 27­33 virtual, 33 technical metrology, 167 temporary teams, 30 third-party audit, 21 tools project management, 82­90

398 Index

quality, seven basic, 54­65 quality management, seven basic, 74­81 Six Sigma, 70­71 total preventive/predictive maintenance (TPM), 102 total quality control, 14 Feigenbaum's definition, 5­6 Juran's requirements, 8 traceability, material, 279­81 training, 43­51 effectiveness, 48­51 reasons for failure, 50­51 methods, 43­48 training effectiveness, 48­51 training methods, 43­48 treatment combinations, in DOE, 223 tree diagram, 77 trends, control chart patterns, 196­97

Taguchi classification, 92 variables charts, 178­79 variables sampling plans, 149 variance, 113 variation common cause, 196 dispersion, 111 special cause, 196 verification, in product/process approval, 259­61 virtual teams, 33 voice of the customer, 243 volume buyers, miscellaneous, 240

W

warranty analysis, 253 waste (muda), eight types of, 95­96 wearout period, in product lifecycle, 265 Weibull distribution, 117­18 and product failure rate, 265­66 wholesale buyer, 240 work breakdown structure (WBS), 84 work groups, 30­31

U

u charts, control limits for, 187­88

V

validation, in product/process approval, 261­62 value stream map (VSM), 100 value stream mapping, 99­100 value-added activities, 236 variability unknown--range method, variables sampling, 151­52 variability unknown--standard deviation method, variables sampling, 152­53 variables predictor, 201

X

­ X (averages) chart, 172­74 ­ X and R (averages and range) chart, 174 ­ control limits for, 178­79 X and s charts, control limits for, 179

Z

z score, 207

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