The Quality Calibration Handbook

Jay L. Bucher

Description

If a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers. This can only be accomplished with test equipment that produces repeatable, accurate, and traceable measurements and/or outputs. Without a quality calibration system in place, this cannot and will not happen. This book is about how to design, implement, maintain, and continuously improve a quality calibration system, with all the required documentation, traceability, and known uncertainty for each and every item of test equipment owned and used by any company, large or small. It will benefit companies that want to implement a program and also those that already have one in place. Some industries have tighter requirements than others on how they treat calibration; some are more specific about how their standards are read, while being vague about what is needed to meet calibration. Is there one tried-and-true quality calibration system that every organization can use as a foundation for its personalized program? There certainly is, and The Quality Calibration Handbook describes it. By using the quality calibration system outlined and demonstrated, any organization can put together its own version to meet its specific requirements and/or regulations. Quality calibration systems are the very foundation for improving research and development (R&D), production, and quality assurance arenas through accurate, reliable, and traceable calibrations of their test equipment. By ensuring the calibration of test equipment used in the production of genetic identity kits used by law enforcement at crime scenes, the guilty are often caught and the innocent exonerated. Calibrated test equipment used in support of the airline and automotive industries helps prevent disasters. At pharmaceutical companies, calibration technicians quietly lay the foundation for quality treatments that help keep us healthy, cure diseases, and sometimes prevent death. This book explains why a quality calibration system can be the difference between life and death, success and failure, andmost important to shareholders and boards of directorsprofit and loss. COMMENTS FROM OTHER CUSTOMERS Average Customer Rating (5 of 5 based on 4 reviews) "This book offers me the information I need to upgrade the quality of the service I provide to customers. It makes the quantum leap between the theory and practice in calibration. I needed this applicable and practical information a long time ago." A reader in Anchorage, Alaska "This book is a great and simple reference guide for developing a world class calibration system. If you are thinking about revamping your calibration system or developing one, this book is a must. This book is written by a person sharing his practical experience to less experienced people." A reader in Austin, Texas "Excellent reference for setting up a calibration program or improving your current operations. This book is a must read for anyone working in the metrology field." A reader in Springboro, Ohio "This book is for anyone who wants to learn more about the requirements of a good calibration program. It gives easy to understand guidelines and practical advice to help you make your calibration program world class." A reader in Putnam, Connecticut

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Total Quality Management
• Gestion et management
• Metrology
• Economics

Informations

• Publié par: ASQ Quality Press
• Date de parution: 26 juillet 2006
• Nombre de lectures: 0
• EAN13: 9780873890656
• Langue: English
• Poids de l'ouvrage: 2 Mo

Extrait

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The Quality Calibration HandbookFM_Bucher_7x10.qxd 9/26/06 1:56 PM Page ii
Also Available from ASQ Quality Press:
The Metrology Handbook
Jay L. Bucher, editor
Make Your Destructive, Dynamic, and Attribute Measurement System Work for You
William D. Mawby
ANSI/ISO/IEC 17025-2005: General requirements for the competence of testing and calibration
laboratories
ANSI/ISO/IEC
ANSI/ISO/ASQ Q10012-2003: Measurement management systems—Requirements for
measurement processes and measuring equipment
ANSI/ISO/ASQ
The Uncertainty of Measurements: Physical and Chemical Metrology: Impact and Analysis
S. K. Kimothi
Managing the Metrology System, Third Edition
C. Robert Pennella
Get It Right: A Guide to Strategic Quality Systems
Ken Imler
Integrating Inspection Management into Your Quality Improvement System
William D. Mawby
Failure Mode and Effect Analysis: FMEA from Theory to Execution, Second Edition
D. H. Stamatis
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
The Certified Manager of Quality/Organizational Excellence Handbook: Third Edition
Russell T. Westcott, editor
Leadership for Results: Removing Barriers to Success for People, Projects, and Processes
Tom Barker
To request a complimentary catalog of ASQ Quality Press publications,
call 800-248-1946 or visit our Web site at http://qualitypress.asq.org.FM_Bucher_7x10.qxd 9/26/06 1:56 PM Page iii
The Quality Calibration Handbook
Developing and Managing a Calibration Program
Jay L. Bucher
ASQ Quality Press
Milwaukee, WisconsinFM_Bucher_7x10.qxd 9/26/06 1:56 PM Page iv
American Society for Quality, Quality Press, Milwaukee 53203
© 2007
All rights reserved. Published 2006
Printed in the United States of America
12 11 10 09 08 07 06 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Bucher, Jay L., 1949–
The quality calibration handbook : developing and managing a calibration program / Jay L.
Bucher. – 1st ed.
p. cm.
Includes bibliographical references and index.
ISBN 0-87389-704-8 (casebound : alk. paper)
1. Mensuration—Handbooks, manuals, etc. 2. Calibration—Handbooks, manuals, etc.
3. Quality assurance—Handbooks, manuals, etc. I. Title.
T50.B75 2006
658.4'013-dc22 2006027515
ISBN–10: 0–87389–704–8
ISBN–13: 978–0–87389–704–4
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 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://qualitypress.asq.org.
Printed on acid-free paperFM_Bucher_7x10.qxd 9/26/06 1:56 PM Page v
Contents
List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Part I Why Calibration Is Critical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chapter 1 Preventing the Next Great Train Wreck . . . . . . . . . . . . . 3
Chapter 2 Requirements and Standards—What They Really Say . . 9
Part II The Basics of a Quality Calibration System . . . . . . . . . . . . . . . . . . 23
Chapter 3 The Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Chapter 4 Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Chapter 5 Calibration Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Chapter 6 It’s Out of Tolerance—Now What? . . . . . . . . . . . . . . . . 49
Chapter 7 Calibration Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Chapter 8 Traceability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
NIST Policy on Traceability . . . . . . . . . . . . . . . . . . . . 81
Chapter 9 Uncertainty 85
Measurement System Analysis—MSA . . . . . . . . . . . . 86
Uncertainty Calculator . . . . . . . . . . . . . . . . . . . . . . . . 92
System File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
What Does the Crystal Ball Show for the Future? . . . 96
Chapter 10 Calibration Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Part III Developing a Quality Calibration Program . . . . . . . . . . . . . . . . . . . 105
Chapter 11 Meeting Your Needs and Requirements . . . . . . . . . . . . . 107
Chapter 12 Calibration Environment . . . . . . . . . . . . . . . . . . . . . . . . 113
Chapter 13 Calibration Scheduling . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Chapter 14 Calibration Software . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Chapter 15 Calibration Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Part IV Managing a Quality Calibration Program . . . . . . . . . . . . . . . . . . . . 131
Chapter 16 Continuous Process Improvement . . . . . . . . . . . . . . . . . 133
Chapter 17 Ethics . . . The Last Frontier . . . . . . . . . . . . . . . . . . . . . 139
Chapter 18 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
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vi Contents
Chapter 19 The Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Chapter 20 Keeping Your Program Ahead of an
EverChanging World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Index 183
About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189FM_Bucher_7x10.qxd 9/26/06 1:56 PM Page vii
Figures and Tables
Figure 5.1 Sample calibration system computer folder. . . . . . . . . . . . . . . . . . . . 40
Figure 5.2 Sample calibration form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Figure 5.3 44
Figure 5.4 Using routers or hubs to set up a system. . . . . . . . . . . . . . . . . . . . . . 45
Figure 5.5 Julian date calendar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Figure 5.6 Julian date calendar for leap years. . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Figure 6.1 Sample out-of-tolerance notification form. . . . . . . . . . . . . . . . . . . . 51
Figure 6.2 Out-of-tolerance tracking database. . . . . . . . . . . . . . . . . . . . . . . . . . 52
Figure 6.3 12-month alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Table 7.1 SI derived units. 62
Table 7.2 SI prefixes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Table 7.3 Definitions of various types of standards. . . . . . . . . . . . . . . . . . . . . 64
Figure 8.1 Traceability pyramid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Figure 8.2 T 81
Table 9.1 Confidence interval values and associated k values. . . . . . . . . . . . . 86
Figure 9.1 Accuracy versus precision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Table 9.2 Weight requirements to meet prescribed tolerances. 89
Table 9.3 Example for finding the lowest mass that can be weighed. . . . . . . . 89
Figure 9.2 Opening screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Figure 9.3 First-time user screen 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Figure 9.4 First-time user screen 2. 94
Figure 10.1 Samples of calibration labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Figure 10.2 Samples of limited calibration labels. . . . . . . . . . . . . . . . . . . . . . . . . 100
Figure 10.3 Samples of Do Not Use labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Figure 10.4Calibration Not Required labels. . . . . . . . . . . . . . . . . . . 101
Figure 10.5 Sample Standardize Before Use and Calibrate Before
Use labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Table 12.1 General-purpose calibration laboratories. . . . . . . . . . . . . . . . . . . . . . 114
Table 12.2 Standards calibration laboratories, or higher-accuracy
requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Table 15.1 Sample acceptable limit range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Table 15.2 Five-year average pass rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Figure 16.1 Adjustable pipettes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Figure 18.1 Workload forecast. 150
Figure 18.2 Short-cycled workload forecast. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
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Preface
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