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Certified Quality Process Analyst Handbook PDF

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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 2007012267 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 Table of Contents List of Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii Part I Quality Basics Chapter 1 A. ASQ Code of Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Code of Ethics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Chapter 2 B. Quality Planning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Set Goals/Objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Logical Steps to Reach the Goals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 An Implementation Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Measures of Success . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Chapter 3 C. Cost of Quality (COQ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 The Cost of Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Chapter 4 D. Quality Standards, Requirements, and Specifications . . . . . . . 13 Chapter 5 E. Documentation Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Need for a Flexible and Current Documentation System . . . . . . . . . . . . . . . . . 16 Library. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Configuration Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Documentation Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Chapter 6 F. Audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 1. Audit Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 2. Audit Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3. Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Chapter 7 G. Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 1. Types of Teams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 2. Team-Building Techniques. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 3. Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Chapter 8 H. Training Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Training Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 ix x Table of Contents Part II Problem Solving and Improvement Chapter 9 A. Basic Quality Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Check Sheets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Pareto Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Scatter Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Histograms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Cause-and-Effect Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Chapter 10 B. Continuous Improvement Models. . . . . . . . . . . . . . . . . . . . . . . . . 66 Plan–Do–Check–Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Kaizen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Incremental and Breakthrough Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Six Sigma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Reengineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Chapter 11 C. Basic Quality Management Tools . . . . . . . . . . . . . . . . . . . . . . . . . 74 Affinity Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Interrelationship Digraph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Tree Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Matrix Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Prioritization Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Activity Diagram (Arrow Diagram). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Process Decision Program Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Chapter 12 D. Project Management Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Principles of Project Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Some Standard Project Management Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Chapter 13 E. Taguchi Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 An Example of Robust Design via the Taguchi Method . . . . . . . . . . . . . . . . . . 92 Classify the Variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 The Taguchi Loss Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Signal-to-Noise Ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Chapter 14 F. Lean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Setup Reduction (SUR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Kanban . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Just-in-Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 5S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Continuous Flow Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Value Stream. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 Poka-Yoke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Total Preventive/Predictive Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Chapter 15 G. Benchmarking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Obtain a Commitment to Change the Organization’s Business Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Determine Which Processes the Company Needs to Improve. . . . . . . . . . . . . 104 Table of Contents xi Identify the Best Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Form a Benchmarking Partnership. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Study the Benchmarking Partner’s Operations and Products . . . . . . . . . . . . . 106 Create Benchmark Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Compare Current Practices with the Partner’s . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Develop a Plan to Change Operational Practices. . . . . . . . . . . . . . . . . . . . . . . . 107 Part III Data Analysis Chapter 16 A. Terms and Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 1. Basic Statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 2. Basic Distributions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 3. Probability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 4. Measurement Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Chapter 17 B. Data Types and Collection Methods. . . . . . . . . . . . . . . . . . . . . . . 132 1. Types of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 2. Methods for Collecting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Chapter 18 C. Sampling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 1. Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 2. Sampling Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Chapter 19 D. Measurement Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Measurement Concepts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 Chapter 20 E. Statistical Process Control (SPC). . . . . . . . . . . . . . . . . . . . . . . . . . 172 1. Techniques and Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 2. Control Limits and Specification Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 3. Variables Charts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 4. Attributes Charts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 5. Rational Subgroups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 6. Process Capability Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 7. Pre-Control Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195 8. Common and Special Causes of Variation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 196 9. Data Plotting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198 Chapter 21 F. Regression and Correlation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 Regression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 Chapter 22 G. Hypothesis Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205 Population Parameter versus Sample Statistic . . . . . . . . . . . . . . . . . . . . . . . . . . 205 Point Estimate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205 Confidence Interval. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206 Confidence Intervals in Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 How Large a Sample Is Needed to Estimate a Process Average?. . . . . . . . . . . 210 Student’s t-Distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211 Testing a Hypothesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214 xii Table of Contents Null Hypothesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 Limitations of Hypothesis Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 Statistical Significance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 Frequent Misunderstandings About the Use of the p-Value. . . . . . . . . . . . . . . 219 Chapter 23 H. Design of Experiments (DOE). . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221 Sums of Squares. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225 Blocking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226 Main Effect and Interaction Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228 Chapter 24 I. Analysis of Variance (ANOVA). . . . . . . . . . . . . . . . . . . . . . . . . . . . 229 Fixed Effects Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 Random Effects Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 Assumptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 Degrees of Freedom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231 Part IV Customer–Supplier Relations Chapter 25 A. Internal and External Customers and Suppliers . . . . . . . . . . . . 234 Internal Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234 Improving Internal Processes and Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235 Effect of Treatment of Internal Customers on That of External Customers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237 Methods to Energize Internal Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238 External Customers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238 External Customers’ Influence on Products and Services. . . . . . . . . . . . . . . . . 241 Chapter 26 B. Customer Satisfaction Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . 243 Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244 Complaint Forms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249 Warranty and Guarantee Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253 Quality Function Deployment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253 Chapter 27 C. Product/Process Approval Systems . . . . . . . . . . . . . . . . . . . . . . . 259 Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259 Validation and Qualification Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261 Chapter 28 D. Reliability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263 Basic Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263 Probability Density Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264 Bathtub Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264 Exponential Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267 Chapter 29 E. Supplier Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270 Supplier Management Processes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270 Key Measures of Supplier Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271 Supplier Assessment Metrics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272 Table of Contents xiii Chapter 30 F. Elements of Corrective and Preventive Action . . . . . . . . . . . . . . 273 Assign Responsibility for Correcting the Situation . . . . . . . . . . . . . . . . . . . . . . 274 Assess the Importance of the Problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275 Contain the Negative Effects Resulting from the Defect. . . . . . . . . . . . . . . . . . 276 Identify Root Causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277 Identify Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278 Implement the Controls Necessary to Prevent Recurrence. . . . . . . . . . . . . . . . 278 Dispose of Any Bad Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278 Chapter 31 G. Material Identification, Status, and Traceability. . . . . . . . . . . . 279 Chapter 32 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282 Part V Appendices Appendix A Quality Process Analyst Body of Knowledge. . . . . . . . . . . . . . . . 284 Appendix B Areas Under Standard Normal Curve. . . . . . . . . . . . . . . . . . . . . . . 290 Appendix C Control Limit Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 Appendix D Factors for Control Charts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 Endnotes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295 Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TK Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TK Part I Quality Basics P a r t Chapter 1 A. ASQ Code of Ethics I Chapter 2 B. Quality Planning Chapter 3 C. Cost of Quality (COQ) Chapter 4 D. Quality Standards, Requirements, and Specifications Chapter 5 E. Documentation Systems Chapter 6 F. Audits Chapter 7 G. Teams Chapter 8 H. Training Components 1 Chapter 1 A. ASQ Code of Ethics A . I t r a P 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 e thically 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 P the appearance of conflicts of interest. a r t I Relations with Peers . A 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 pro- cess 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 vari- ous 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 prod- ucts 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 ana- lyst 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 juris- diction. 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 hazard- ous 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.

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This new Handbook was developed to assist those preparing for the Certified Quality Process Analyst certification. It covers the certification’s Body of Knowledge explicitly and comprehensively. The book and certification are aimed at the paraprofessional who, in support of and under the direction
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