Risk Management Using Failure Mode and Effect Analysis (FMEA)

Dean H. Stamatis

Description

Risk is everywhere. It does not matter where we are or what we do. It affects us on a personal level, but it also affects us in our world of commerce and our business.
This indispensable summary guide is for everyone who wants some fast information regarding failures and how to deal with them.
It explores the evaluation process of risk by utilizing one of the core methodologies available: failure modes and effects analysis (FMEA). The intent is to make the concepts easy to understand and explain why FMEA is used in many industries with positive results to either eliminate or mitigate risk.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Contrôle des processus
• Automatisation
• Automate
• Analyse des modes de défaillance, de leurs effets et de leur criticité
• Engineering
• Technology
• FMEA
• risk management
• Sciences et techniques
• Quality Control

Informations

• Publié par: ASQ Quality Press
• Date de parution: 18 janvier 2019
• Nombre de lectures: 0
• EAN13: 9781951058692
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

Risk Management Using Failure Mode and Effect Analysis (FMEA)

Also available from ASQ Quality Press:

Failure Mode and Effect Analysis: FMEA from Theory to Execution, Second Edition D.H. Stamatis Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement, and Data Analysis Lance B. Coleman Sr. The Certified Supplier Quality Professional Handbook Mark Allen Durivage, editor The ASQ Auditing Handbook, Fourth Edition J.P. Russell, editor Proactive Supplier Management in the Medical Device Industry James B. Shore and John A. Freije Quality Risk Management in the FDA-Regulated Industry, Second Edition José Rodríguez-Pérez The ISO 9001:2015 Implementation Handbook: Using the Process Approach to Build a Quality Management System Milton P. Dentch The Certified Six Sigma Yellow Belt Handbook Govindarajan Ramu Handbook of Investigation and Effective CAPA Systems, Second Edition José Rodríguez-Pérez Practical Design of Experiments (DOE): A Guide for Optimizing Designs and Processes Mark Allen Durivage The Certified Pharmaceutical GMP Professional Handbook Second Edition FDC Division and Mark Allen Durivage, editor The Quality Toolbox, Second Edition Nancy R. Tague

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

Risk Management Using Failure Mode and Effect Analysis (FMEA)

D. H. Stamatis

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203 © 2019 by ASQ. Printed in 2018. All rights reserved. Printed in the United States of America. 23 22 21 20 19 18 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

Names: Stamatis, D. H., 1947–author. Title: Risk management using failure mode and effect analysis (FMEA) / D.H. Stamatis. Milwaukee, Wisconsin : ASQ Quality Press, 2018. | Includes bibliographical references and index. Identifiers: LCCN 2018053259 | ISBN 9780873899789 (pbk. : alk. paper) Subjects: LCSH: Failure analysis (Engineering) | Reliability (Engineering) | Quality control. | Risk management. Classification: LCC TS176 .S75174 2018 | DDC 620/.00452—dc23 LC record available at https://lccn.loc.gov/2018053259

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TableofContents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1 Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . In ISO 9001:2015 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . In IATF 16949 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VDA (New FMEA Proposed Standard of 2018) . . . . . . . . . . . . Method or Process of Conducting Any Risk Assessment . . . . . General Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 2 Reliability and FMEA . . . . . . . . . . . . . . . . . . . . . . . . Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Need to Understand the Concept of Failure . . . . . . . . . . . . . . . . Design for Reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 3 Prerequisites of FMEA . . . . . . . . . . . . . . . . . . . . . . . Creating an Effective Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Structure of the FMEA Team . . . . . . . . . . . . . . . . . . . . . . . Ingredients of a Motivated FMEA Team . . . . . . . . . . . . . . . . . . Potential FMEA Team Members . . . . . . . . . . . . . . . . . . . . . . . . Mind-set of Minimizing Failures . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4 What Is an FMEA?. . . . . . . . . . . . . . . . . . . . . . . . . . . Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Is FMEA Needed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benefits of FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Process of Conducting an FMEA . . . . . . . . . . . . . . . . . . . . Understanding Your Customers and Their Needs . . . . . . . . . . .

v

ix xi xiii 1 1 3 7 7 10 14 18 19 19 20 21 23 23 23 25 26 27 29 29 30 31 32 36

vi Table of Contents

What Happens after Completion of the FMEA? . . . . . . . . . . . . Vocabulary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 5 Robustness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Boundary Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interface Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P-Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 6 The FMEA Form and Rankings . . . . . . . . . . . . . . . . Severity Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Occurrence Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Detection Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Classification and Characteristics . . . . . . . . . . . . . . . . . . . . . . . Understanding and Calculating Risk . . . . . . . . . . . . . . . . . . . . . Driving the Action Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 7 Types of FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FMEA Challenges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 8 The Common Types of FMEAs . . . . . . . . . . . . . . . . . Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 9 Health FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Comparison of Root-Cause Analysis and HFMEA . . . . . . . . . . The Process of the HFMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . Forms and Rankings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 10 Failure Mode Effects and Criticality Analysis (FMECA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Possible Sources for Identifying Functions . . . . . . . . . . . . . . . . The Process of Conducting an FMECA . . . . . . . . . . . . . . . . . . . Qualitative Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quantitative Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 11 Control Plans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Content of a Control Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FMEA/Control Plan Linkage . . . . . . . . . . . . . . . . . . . . . . . . . . .

37 38 45 45 46 47 49 50 51 51 52 53 54 57 58 59 59 61 66 75 85 86 87 91

97 97 98 99 101 101 108

113 113 114 114 115

Table of Contentsvii

Chapter 12 Linkages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DFMEA to PFMEA to Process Flow Diagram to Control Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 13 Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of Typical Tools Used in FMEA . . . . . . . . . . . . . . . . Chapter 14 Troubleshooting an FMEA . . . . . . . . . . . . . . . . . . . AfterFMEA........................................ Chapter 15 Typical Concerns When Conducting an FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Common Team Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Common Procedural Problems. . . . . . . . . . . . . . . . . . . . . . . . . . Institutionalizing FMEA in Your Company. . . . . . . . . . . . . . . . Chapter 16 FMEAs Used in Selected Specific Industries . . . . . Automotive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aerospace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chemical/Pharmaceutical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 17 Warranty, Six Sigma, Lean, and FMEA . . . . . . . . Automotive Perception of Warranty . . . . . . . . . . . . . . . . . . . . . . Six Sigma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . After Improvements Are Made . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selected Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

119

119 123 123 141 141

147 147 147 149

151 151 152 152 152 155 155 158 159 159 161 163 165

List of Figures and Tables

Figure 1.1 Table 1.1

Figure 4.1 Figure 4.2 Table 5.1 Figure 5.1 Table 5.2 Figure 5.2 Figure 6.1

Figure 6.2 Table 7.1 Table 8.1

Table 8.2 Table 8.3 Figure 8.1 Table 8.4 Table 8.5

Table 8.6 Table 8.7 Figure 8.2

VDA-proposed FMEA form . . . . . . . . . . . . . . . . . . . . . . . . . . A typical risk register for a project that includes four steps: identify, analyze, plan response, monitor and control . . . . . . . Overview of a DFMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of a PFMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Robustness focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A typical boundary diagram . . . . . . . . . . . . . . . . . . . . . . . . . . Interface matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A typical P-diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A typical FMEA form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Area chart showing priority levels . . . . . . . . . . . . . . . . . . . . . . Types of FMEAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DFMEA—severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DFMEA—occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DFMEA—detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A typical PFMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PFMEA—severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PFMEA—occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PFMEA—detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A typical control matrix for a manufacturing process. . . . . . . Explanation of the EFMEA form. . . . . . . . . . . . . . . . . . . . . . .

ix

13

16 34 35 46 46 47 48 50 53 58 63 64 65 68 69 70 71 72 79