Product safety excellence : the seven elements essential for product liability prevention PDF
Preview Product safety excellence : the seven elements essential for product liability prevention
Product Safety Excellence The Seven Elements Essential for Product Liability Prevention 2 1 Concept Evaluation Technical Collaboration 3 Design Qualification 5 4 Product Qualification Supplier Qualification 6 Supplier Quality Process 7 Strategic Auditing Timothy A. Pine Product Safety Excellence H1432_Pine_pi_114.indd 1 5/2/12 4:32 PM Also available from ASQ Quality Press: Achieving a Safe and Reliable Product: A Guide to Liability Prevention E.F. “Bud” Gookins Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition Elaine Whitmore HALT, HASS, and HASA Explained: Accelerated Reliability Techniques, Revised Edition Harry W. McLean Medical Device Design and Regulation Carl T. 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Pine ASQ Quality Press Milwaukee, Wisconsin H1432_Pine_pi_114.indd 3 5/2/12 4:32 PM American Society for Quality, Quality Press, Milwaukee 53203 © 2012 by ASQ All rights reserved. Printed in the United States of America 17 16 15 14 13 12 5 4 3 2 1 Library of Congress Cataloging-in-Publication Data Pine, Timothy A., 1949– Product safety excellence : the seven elements essential for product liability prevention / Timothy A. Pine. p. cm. ISBN 978-0-87389-842-3 (alk. paper) 1. Product safety. 2. Product design. 3. Consumer protection. 4. Products liability. I. Title. TS175.P56 2012 363.19—dc23 2012013749 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 Meinholz Project Editor: Paul Daniel O’Mara Production Administrator: Randall Benson ASQ Mission: The American Society for Quality advances individual, organiza- tional, and community excellence worldwide through learning, quality improve- ment, and knowledge exchange. Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, 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, visit our website at http://www.asq.org/quality-press. Printed on acid-free paper H1432_Pine_pi_120.indd 4 5/10/12 11:08 AM To Pat, a remarkable and lovely wife, friend, patriot, Christian, and mother of our children. H1432_Pine_pi_114.indd 5 5/2/12 4:32 PM H1432_Pine_pi_114.indd 6 5/2/12 4:32 PM Contents List of Figures ................................. xi Preface ...................................... xiii Acknowledgments .............................. xv Chapter 1 Introduction ...................... 1 Excellence vs. Perfection ............. 2 Invest in Prevention ................. 4 Design Defects and Recalls ........... 5 Voluntary and Regulatory Requirements and Recalls ..................... 5 Comprehension vs. Commitment. . . . . . . 6 The Seven Vital Elements ............ 6 Chapter 2 Technical Collaboration ............ 9 Discovering Needed Knowledge ....... 9 NEISS Information ................. 11 CPSC Recall History ................ 12 Trade Associations .................. 12 Medical Expertise and Academia ...... . 13 Laboratories and Consulting Firms ..... 14 Partner Supplier Input ............... 15 vii H1432_Pine_pi_114.indd 7 5/2/12 4:32 PM viii Contents Benchmarking and Competition ....... 15 Summary ......................... 16 Chapter 3 Concept Evaluation ................ 17 Early Safety Influence ............... 18 Hazard Identification Checklists ....... 18 Energy-Hazard Relationship .......... 20 Foreseeable Use and Misuse .......... 20 Human Factors ..................... 25 Technical Collaboration Input ......... 28 Warning Label Problems ............. 29 Concept Risk Assessment ............ 31 Chapter 4 Design Qualification ............... 35 Design Review ..................... 35 Safety Checklist .................... 37 Reliability ......................... 39 Process Capability Analysis ........... 43 Safety Specification Development ...... 46 Claim Substantiation ................ 47 Summary ......................... 47 Chapter 5 Supplier Qualification .............. 49 Quality Systems Audit ............... 49 Management Commitment ............ 51 Supplier Capabilities and Capacities .... 52 Manufacturing Agreement ........... . 53 Change Control .................... 54 Strategic Partnership ................ 56 Chapter 6 Product Qualification .............. 59 Production Process Documentation .... . 60 Production-Representative Samples for Test ........................... 61 H1432_Pine_pi_114.indd 8 5/2/12 4:32 PM Contents ix Testing to Failure ................... 61 Factor of Safety .................... 64 Test Documentation ................. 66 Chapter 7 Supplier Quality Process ............ 69 Verifying Process Performance ........ 69 Precontrol and Positrol ............... 70 Certifications ...................... 73 Error Avoidance (Poka-Yoke) ......... 74 Performance Metrics and Trends ....... 79 Management Reviews ............... 82 Chapter 8 Strategic Auditing ................. 83 Auditing Supplier Performance ....... . 83 Consumer Complaints ............... 84 Defect Analysis .................... 86 Knowledge Database ................ 87 Converting Data into Wisdom ......... 88 Summary ......................... 89 Chapter 9 Conclusion ....................... 91 Error-Prevention Process ............. 91 Product Liability Prevention .......... 94 Product Safety Excellence ............ 95 Appendix A Quiz: Twenty Questions to Test Your Product Safety Savvy ............... 97 Appendix B Answers to the Quiz ... ............. 101 Index ........................................ 109 H1432_Pine_pi_114.indd 9 5/2/12 4:32 PM
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