Product safety excellence : the seven elements essential for product liability prevention

135 Pages·2012·1.652 MB·English

by  Timothy A. Pine

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
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Product Safety
Excellence
The Seven Elements Essential for
Product Liability Prevention
Timothy A. 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
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To Pat, a remarkable and lovely wife, friend,
patriot, Christian, and mother of our children.
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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
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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
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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
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