Failure Mode and

Effects Analysis (FMEA)

for Small Business Owners
and Non-Engineers
Also available from ASQ Quality Press:

The ASQ Pocket Guide to Failure Mode and Effect Analysis (FMEA)
D. H. Stamatis

The ASQ Quality Improvement Pocket Guide: Basic History, Concepts, Tools, and Relationships
Grace L. Duffy, editor

The ASQ Pocket Guide to Root Cause Analysis

Bjørn Andersen and Tom Natland Fagerhaug

Quality Risk Management in the FDA-Regulated Industry

José Rodríguez-Pérez

Product Safety Excellence: The Seven Elements Essential for Product Liability Prevention
Timothy A. Pine

Achieving a Safe and Reliable Product: A Guide to Liability Prevention

E.F. “Bud” Gookins

Root Cause Analysis: Simplified Tools and Techniques, Second Edition

Bjørn Andersen and Tom Fagerhaug

Root Cause Analysis: The Core of Problem Solving and Corrective Action
Duke Okes

The Certified HACCP Auditor Handbook, Third Edition

ASQ Food Drug and Cosmetic Division

The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition

Russell T. Westcott, editor

The ASQ Auditing Handbook, Fourth Edition

J.P. Russell, 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.
 Failure Mode and
Effects Analysis (FMEA)
for Small Business Owners
and Non-Engineers

Determining and Preventing

What Can Go Wrong

Marcia M. Weeden, MS, CQE, CQT

ASQ Quality Press

Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee, WI 53203
© 2015 by ASQ.
All rights reserved. Published 2015.
Printed in the United States of America.

20  19  18  17  16  15         5  4  3  2  1

Library of Congress Cataloging-in-Publication Data

Weeden, Marcia M., 1952-
Failure mode and effects analysis (FMEA) for small business owners and non-engineers: determining and
preventing what can go wrong / by Marcia M. Weeden.
pages cm
Includes index.
ISBN 978-0-87389-918-5 (hardcover: alk. paper)
1. Small business—Management. 2. Failure mode and effects analysis. I. Title.
HD62.7.W44 2015
658.4’013—dc23

             2015031687

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: Lynelle Korte

Acquisitions Editor: Matt T. Meinholz
Managing Editor: Paul Daniel 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, 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 ASQ membership information, call 800-248-1946. Visit our Web site at
www.asq.org/quality-press.

Printed on acid-free paper

 Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Guidelines for Using FMEAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
When to Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Stages of an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Flowchart – FMEA Stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
High-Level Risk Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Graphic – Fishbone (Ishikawa) Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Planning and Design Risk Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Process Risk Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Flowchart – Tasks of an FMEA Investigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Failure Rankings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Criteria for Severity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Flowchart – Determining Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Criteria for Occurrence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Flowchart – Determining Occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Criteria for Detectability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Flowchart – Determining Detectability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Criteria for Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Flowchart – Criticality Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Processes, Stages, Tasks, and Steps Defined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

v
vi Contents

Graphic – Example of Receiving Process, Stages, Tasks, and Steps. . . . . . . . . . . . . . . . 107

How to Conduct an FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Flowchart – Conducting an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Graphic – FMEA Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Worksheet’s Structure and Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
The Value of the Worksheet Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Before Starting the FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Rating Scales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Using the FMEA Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Wrapping up the FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Appendix A – Pareto Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Appendix B – Fishbone Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Appendix C – FMEA Worksheet Examples*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
  Welding Receiving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
  Ultrasonic Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
   Ultrasonic – Part Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
   Ultrasonic – Water Cleanliness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
   Restaurant – New Seafood Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
   Cleaning Service – Commercial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

*Also available in MS Word format on accompanying CD.

 List of Figures and Tables

Table 1. The Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Table 2. Contributor Roles & Contributions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Table 3. Records Pertaining to an FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Table 4. Sampling of FMEA Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Table 5. Sampling of FMEA Guides. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Flowchart – FMEA Stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Table 6. 5Ms & 1E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Graphic – Fishbone (Ishikawa) Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Table 7. Fishbone Questions for a Design Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Flowchart – Tasks of an FMEA Investigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Table 8. Types of Operational Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Table 9a. Subjective Criteria Example for Severity as it Would Impact a Customer . . . . . . . . . . 66
Table 9b. S ubjective Criteria Example for Severity as it Would Impact the
Organization/Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Flowchart – Determining Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Table 10a. Subjective Criteria Example for Occurrence in General . . . . . . . . . . . . . . . . . . . . . . 84
Table 10b. Subjective Criteria Example for Occurrence at a Small Organization/Business . . . . . 84
Flowchart – Determining Occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Table 11a. Subjective Criteria Example for Detectability in General . . . . . . . . . . . . . . . . . . . . . 91
Table 11b. Subjective Criteria Example for Detectability at a Small Organization . . . . . . . . . . . 91
Flowchart – Determining Detectability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Table 12. Subjective Criteria Example for Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Flowchart – Criticality Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Graphic – Example of Receiving Process, Stages, Tasks, and Steps. . . . . . . . . . . . . . . . . . . . . . 107
Table 13. Completing an FMEA Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Flowchart – Conducting an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Graphic – FMEA Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Table 14. Sections of an FMEA Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

vii
viii List of Figures and Tables

Table 15. Purchasing Task – Make Purchase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Table 16. Start Purchase Request (Purchasing Task 1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Table 17. Find Supplier (Purchasing Task 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Table 18. Place Order (Purchasing Task 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Table 19. Process Header Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Table 20. Contributor Header Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Table 21. Completing the Worksheet Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Table 22. Examples of Inputs & Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Table 23. Examples of Inputs, Results, & Impacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Table 24. Examples of Inputs, Results, & Causes or Sources. . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Table 25. Examples of Inputs, Results, & Prevention Controls. . . . . . . . . . . . . . . . . . . . . . . . . . 151
Table 26. Examples of Inputs, Results, & Detection Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Table 27. Typical Monthly Expenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Table 28. Typical Monthly Expenses and Percentages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Table 29. Monthly Expenses Sorted by Percentages from Largest to Smallest. . . . . . . . . . . . . . 175
Table 30. Reorganized Monthly Expense Categories by Percentages . . . . . . . . . . . . . . . . . . . . 178
Table 31. 5Ms & 1Es. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Table 32. Ice cream stand example, potential areas for failure. . . . . . . . . . . . . . . . . . . . . . . . . 193
Table 33. Specify What to Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
 Overview

Introduction Most people take pride in the work that they do. Hand-in-hand with the
pride of job well done is work that is “done right,” meaning meeting and
satisfying expectations in a timely manner and without problems.

When setting out to establish specifications or decide what is best for an

organization, its customers, or its clients, initial efforts pursue, “What do we
want? What do our customers need?”

“Getting it right” entails more than knowing what is needed or desired. It

also entails preventing problems, because along with achieving the desirable,
it is important to know what is not wanted.

Addressing the undesirable includes avoiding minor problems as well as

worst case scenarios, such as:
• the risks that could be incurred if business, regulatory, and safety
mandates are unrecognized or overlooked, and
• the types of error possibilities in operations, process, or everyday tasks.

Once the areas at risk or the activities presenting potential problems are
identified, then it becomes possible to mitigate or eliminate
harm by:
• implementing new designs or policies
• changing current designs, work methods, processes, or policies
• clarifying workflows, responsibilities, or how to perform tasks
• designing tests that would prohibit errors from continuing through the
workflow
• designing “stops” that would shut down the process or system until
corrections can be made, or
• designing “corrections” that would automatically correct errors after they
have occurred so that the work activities can continue uninterrupted.

1
2 Overview

Contents This section contains the following topics:

Topic Page
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Why an FMEA?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
What Does an FMEA Indicate? . . . . . . . . . . . . . . . . . . . . . . 3
What Value Does an FMEA Contribute? . . . . . . . . . . . . . . . 4
When Can an FMEA be Used? . . . . . . . . . . . . . . . . . . . . . . 4
FMEA Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
FMEA Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Tolerating Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
The FMEA Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Role Contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Team Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Outside Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Purpose This book is intended for small business owners and non-engineers such
as researchers, business analysts, project managers, small non-profits,
community groups, religious organizations, and others who want an
assessment tool that can provide methods for:
• identifying the areas or actions that may be at risk for failure
• ranking the risks that they may be facing, and
• determining the degree of threat being faced.
 Overview 3

Scope While an FMEA is a tool of reliability engineering, this book is not intended to
provide the in-depth information (A–Z approach) that reliability engineering
can provide, nor does it cover all aspects and applications of an FMEA.

This book provides sufficient information about FMEAs, and how to use them
to establish specifications and for making other informed decisions without
requiring the expertise of an engineer or statistical analyst.

While there is also information given in this book that shows the broad
applicability for using FMEAs, it is not anticipated that most users will ever
find themselves in those situations. The examples are given to help the user
understand the versatility of using an FMEA.

FMEA A Failure Mode and Effects Analysis, commonly known as an FMEA

(F-M-E-A, as the letters are usually spelled out), is a formal risk assessment
tool used to identify:
• every possible way something might fail, and
• the effects (impacts) that such failures would have on a system, its owners,
or people in general.

Why an FMEA? An FMEA can be used for developing policies, specifications, and controls
that will prevent the negative consequences from happening or escalating.

What Does an By knowing ahead of time what can go wrong, as well as how severe the
FMEA Indicate? failures would be, the premise of an FMEA is:
1. design and planning can be made sufficient to prevent or mitigate these
failures, thus
2. preventing costly or irreversible harm.
4 Overview

What Value FMEAs are valuable for:

Does an FMEA • developing policies and standard operating procedures (SOPs)
Contribute?
• developing system, design, and process requirements that eliminate or
minimize the likelihood of failures
• developing designs, methods, and test systems to ensure that
– errors or failures are automatically corrected
– errors or failures are flagged for correction
– the potential for errors or failures have been eliminated, or
– risks are reduced to acceptable levels
• developing and evaluating of diagnostic systems, and
• helping with design choices (trade-off analysis)

When Can an FMEAs work on general principles and have the flexibility to be tailored to
FMEA be Used? suit a specific need, organization, or industry.

Because of this flexibility and the widespread use of FMEAs, there are
various programs and forms associated with FMEAs, but all are intended to
determine the likelihood of failure and the degree of risk.

FMEA Scope The scope, or boundaries, of an FMEA are determined by need.

Note: It is neither necessary nor advisable to delve into every possibility.

FMEA FMEAs can give a false sense of security that all risks have been addressed.
Limitations
It must be remembered that educated guesses are used in making certain
assessments. Therefore, there are no guarantees.

However, when used in conjunction with other tools, FMEAs can provide
confidence that the most important aspects have been analyzed to minimize
or eliminate risks entirely in most instances.

Note: 
An educated guess to determine the possible impact of a decision or
action is far better than a wild guess or no consideration at all.
 Overview 5

Tolerating As improbable or as astonishing as it may seem upon first being heard, there
Failures are failures that can and will be tolerated by an organization.

These types of failures include, but are not limited to, something that:
• is so minor in nature that it would be cost-prohibitive to prevent or correct it
• will be obsolete or replaced soon, making it cheaper to cull out or correct
the non-conformances for the time being
• will be rectified automatically later on in the process, and/or
• has a very low chance of occurring.

An FMEA investigation is set up to help determine those things.

The FMEA Team The FMEA team is typically drawn from a minimum of three different
departments, although who is involved will vary depending on the intent of
the FMEA and the size of the organization.

In a smaller organization, such as a small business, there may be only one or

two people involved. If the team is very small, the FMEA is still considered
from the perspectives of the roles shown in Table 1.

Those typically involved and their departments are shown in Table 1.

Note: A customer, group of customers, shareholders, and investors might

also be considered stakeholders.

ROLE DEPARTMENT
FMEA Coordinator • Quality Assurance & Reliability
• Business owner
• Engineering
Stakeholders • Have an interest or area of responsibility that would be
impacted by adverse conditions or fallout
Subject Matter Experts • Have responsibility for the tasks in the areas under the
(SMEs) FMEA’s review
• Have oversight or control of a main element under review,
e.g., databases, sales, or regulatory compliance
• May actually conduct the tasks being analyzed
Implementers • Those responsible for carrying out the recommended
improvements or changes

Table 1. The Team.

6 Overview

Role The contributions of the various roles associated with an FMEA are shown in
Contributions Table 2.

ROLE CONTRIBUTIONS

FMEA Coordinator • Identifies and assembles the team for the FMEA study
• Performs the actual FMEA study
• Calculates the FMEA figures
• Brings concerns to the appropriate individuals
• Makes the final FMEA report
• Archives the finalized report and any relevant data or
documents

Stakeholders • Give insight into the organization’s goals or plans that may
impact current operations or customer base
• Give insight into regulatory, industry, or technology changes
or trends that may impact current operations or organization’s
customer or client base
• Convey any current failure concerns of their customers, both
internal and external
• May indicate others who may have input for the investigation

Subject Matter Experts • Provide the expertise for the operations and tasks in their
(SMEs) respective areas
• May relate knowledge of past failures
• Convey any current failure concerns of their customers, both
internal and external
• Provide the expertise for preventing or resolving failures,
including workarounds, in their respective areas
• May indicate others who may have input for the investigation

Implementers • Do the hands-on work for making changes or improvements

• Alert the FMEA Coordinator of any issues that arose from
making the changes or improvements
• Report back to the FMEA Coordinator about the efficacy or
success of the changes or improvements

Table 2. Contributor Roles & Contributions.

 Overview 7

Team Constraints Because an FMEA is examining vulnerabilities and an organization typically

does not want to make its vulnerabilities public, the FMEA team is almost
always drawn from within an organization.

Outside Inputs If warranted, external stakeholders and SMEs may contribute information
as well.

There are instances when customers or regulatory representatives are asked

for input for future planning or continuous improvement efforts.

There may also be situations when collaborative efforts between different

organizations, with eliminating vulnerabilities as a major goal of a project,
that may require considerable transparency.

As a general rule, though, external contributors are usually unaware that

their comments or other information are being used in an FMEA.

Records FMEA records and supporting data are extremely important as they:
• can help to speedily identify potential problem areas if an issue arises
• eliminate the need for redundant work in a future FMEA
• help pinpoint areas that would benefit from a continuous improvement
effort, and
• contribute proof showing due diligence if a liability issues arises.

The records pertaining to an executed FMEA are shown in Table 3.

DOCUMENT TYPE DESCRIPTION LOCATION

Executed FMEA Form FMEA Template Determined by FMEA Coordinator

Supporting data & Varies Archived with executed FMEA

documents

Table 3. Records Pertaining to an FMEA.

(This page intentionally left blank.)
 Guidelines for Using FMEAs

Introduction An FMEA is about prevention, not detection, because it:

• defines what can fail
• identifies the things that most likely would cause these failures
• provides an in-depth analysis of how far a failure would have an
impact, and
• indicates where the severest risks lie so that they may be mitigated or
eliminated before they occur.

This section provides what should be taken into consideration before

performing an FMEA.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Not a Requirement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Prevention vs. Cure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Information of Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Past Experience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Is It Significant?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Statistically Significant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Pareto Principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Critical Few. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Biggest Headaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
FMEAs & 80/20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Subjectivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

9
10 Guidelines for Using FMEAs

Topic Page
Eye of the Beholder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Verify the Understanding . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Be in Agreement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Ratings Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Not a An FMEA is an investigation and risk assessment tool.

Requirement
Unless an FMEA is stipulated by a contract or a regulation, there is no
requirement to use an FMEA.

Tool An FMEA can be applied to many different kinds of situations.

With new elements, requirements, designs, or root cause investigations, it

may be a highly desirable tool.

However, it is not intended or called for in every instance regarding

specifications or processes.

Since an FMEA entails costs and time, use it when appropriate.

Common sense should prevail.

Prevention vs. An FMEA typifies “an ounce of prevention is worth a pound of cure.”
Cure

Information of As a tool, an FMEA should be used when the investigation and process will
Value provide information that is of value to an investigator or a decision maker.

“No action necessary” is a decision and does contribute value as it helps

to switch focus to what does need to be addressed, so an FMEA showing
no vulnerabilities is a worthwhile study when going through a process of
elimination.
 Guidelines for Using FMEAs 11

Past Experience It is not necessary to start from scratch with every FMEA.

Past experiences are valuable assets when performing an FMEA.

If prior work has already made certain determinations, and nothing has
changed, the work does not need to be done again.

If past experiences have shown certain vulnerabilities reoccur, the

vulnerabilities should be reconsidered.

Is It Significant? Be careful using general, vague terms such as saying that something is
“significant.”

It can be argued that if a matter is important enough to study, the matter

holds significance on some level and is therefore “significant.”

Note: This applies even if the decision is made that the matter is not
currently enough of a concern to pursue at the moment.

Significant is also a relative term, as in “significant with respect to what?”

It is possible that something holds no significance to one thing or situation,

but it is significant to something else.

When determining significance, it is important to define how the thing is

significant.

Statistically There are statistical methods that can determine if something is “statistically
Significant significant,” but these methods cannot be applied to everything.

These tools are also beyond the intention of this book.

If something is so important or critical that statistical certainty is required, an

engineer or qualified quality professional would know the tools to be able to
determine if something is statistically significant.

There are simpler tools that can be used, such as the Pareto Principle, to
separate the areas that should receive priority attention.
12 Guidelines for Using FMEAs

Pareto Principle There are simpler statistical tools that can be used, such as the Pareto
Principle, to determine the areas that need priority attention.

The origins of the Pareto Principle are found in Italy. In 1906, an Italian
economist, Vilfredo Pareto, concluded that 80% of Italian land was owned
by 20% of the population.

In 1937, quality guru Joseph M. Juran adapted the premise to show that
80% of quality problems are caused by only 20% of the factors impacting
the situation. Juran called his observation the “Pareto Principle.”

Juran named the 20% “the critical few.” The remaining 80% were initially
called “the trivial many,” but later revised to “the informative many” in
recognition that the remaining 80% are not inconsequential.

Today, the Pareto Principle is more widely known as the 80–20 rule.

Critical Few In layman’s terms, the critical few are the biggest headaches.

Modifying or eliminating the elements in the 20% that are causing the
quality issues produces the biggest returns and improvements.

Once the problems associated with the critical few are eliminated, the
remaining 80%, if desired, can be addressed. This remaining group is then
broken into the 20% comprising the critical few of that group, with the
remaining 80% set aside until addressed later.

Theoretically, the process repeats until all issues are resolved. In reality, other
issues will take priority.

By focusing on the critical few, many of the remaining of 80% will be

consequently resolved as well.

Note: See Appendix A on how to create and use a Pareto diagram.

Biggest Why the 20% are the biggest headaches varies. It could be due to:
Headaches • costs
• efforts required to remedy
• confusing, conflicting, obsolete, absent, or inadequate specifications or
instructions
• risks to the organization or humans
• impacts on the customer or user, etc., or
• the broad scope of inputs over which the organization has little or no
control.
 Guidelines for Using FMEAs 13

FMEAs and While the remaining 80% provide opportunities for improvement as well, the
80–20 best return for an improvement effort is to first concentrate on the 20%.

The remaining 80% can be resolved later and those instances may be
reduced, sometimes considerably, if the 20% are resolved first.

An FMEA takes work. To get the best return from conducting an FMEA,
consider the critical few before pursing improving the informative many.

Subjectivity Certain classifications in an FMEA are subjective. For example, what

determines if a failure is “too severe” or happens “too often?”

Since people will define these categories based on their understanding of a

term, agreement should be made with the team members and even possibly
the stakeholders as to what comprises a classification so everyone is defining
things the same way.

Eye of the The perspective of managers, supervisors, or engineers regarding frequency

Beholder of severity may differ from first-line workers for a number of reasons.

First-line workers may view issues, non-conformances, and problems

differently than other employees because they may:
• not know how report certain issues or whom to contact
• not know an issue does not exist because they
– have not personally encountered it themselves
– have not heard anyone else raise the issue
• believe the situation is tolerable because they have developed their own
personal workarounds to the problem and nobody has ever come to fix it
• believe that “this is the way things are supposed to be” and what they are
dealing with is correct
• not want to get anybody into trouble by reporting a problem
• be afraid of looking stupid or incompetent
• be afraid of saying the wrong thing, so they state what they think the
investigator wants to hear
• believe the organization wants them to give an investigator or an auditor
the impression that all is good and there are no problems, or
• simply tolerate less-than-optimal situations because “nothing’s perfect.”
14 Guidelines for Using FMEAs

Verify the Just because the words are the same, it does not follow that people mean
Understanding the words in the same way.

It may be necessary to first establish or verify that you and your audience are
talking about the same thing.

Start by stating your goals. Reassure your audience that there are no wrong
answers.

Then, if it is asked, “How bad is this?” or “Does this happen often?,” the
investigator and subject will have a better chance of being in agreement with
the answer.

Be in Agreement Above all else, when using a broadly used term that is vague or general in
nature, ensure that everyone has the same understanding regarding the
term’s meaning.

Remember: What may appear obvious or significant to one person or

department may not be obvious or may appear insignificant to
others.

Ratings Values The numerical values assigned to the ratings classifications are subjective and,
consequently, vary from one organization to another.

Therefore do not be concerned if an organization states that a Risk Priority

Number, or RPN, over a certain number is too high a risk for it but your
organization uses a different number for its own unacceptable risk point.

The values are according to what is important to, and what is specified by
the organization using them. These may not be in agreement with another
organization’s priorities.

On the other hand, if two organizations are working together regarding

risk, such as a manufacturer with a customer, it may be helpful if both
organizations synch their rating systems to be in agreement in order to
eliminate confusion and avoidable risks.
 General Information

Introduction Before starting an FMEA, it is helpful to know:

• why FMEAs are used
• what the various parts of an FMEA are used for
• a brief history of FMEAs
• where to use FMEAs, and
• who benefits from an FMEA.

Further information is found in the sections “FMEAs – When to Use” and

“How to Conduct an FMEA.” This section provides general background
information pertaining to FMEAs.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Cost Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
What If?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Three Formal Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Risk Assumption. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
How Bad is Bad?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Failure Threat Importance. . . . . . . . . . . . . . . . . . . . . . . . . . 17
Criticality Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Risk Priority Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
When to Mitigate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Root Cause Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Mil–Std–1928A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

15
16 General Information

Topic Page
Tiered Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Other Approaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
New Projects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Broad Applicability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
How Does This Apply to the Small Business?. . . . . . . . . . . . 20
The Morphing of Mil–Std–1629A. . . . . . . . . . . . . . . . . . . . 21
Sampling of FMEA Standards by Industry . . . . . . . . . . . . . . 21
Sampling of FMEA Guides. . . . . . . . . . . . . . . . . . . . . . . . . . 22

Cost Saver Since it costs far less to prevent something than detecting, analyzing, and
correcting a failure after the fact, an FMEA saves money.

When it comes to specifications, prevention is best done at the planning and

design stages.

What If? An FMEA can be useful at feasibility and conception stages because it
provides a structured method to answer questions such as “what if we did
this?” or “what if this were eliminated or added?”

Three Formal For the purposes of this book, an FMEA consists of three formal parts:
Parts 1. Identification of
a. potential failures
b. the likelihood of them occurring
c. what currently exists to prevent them
d. what needs to be developed so they can be averted, and
e. the impacts that can occur
2. Analysis of impacts and ranking their severity, should the failures occur.
3. Assessment of criticality – given all that is known after the evaluations,
a determination is made of how adversely the organization would be
impacted if the failure(s) occurred.

Knowing the criticality of the impacts determines the level of efforts needed
to avoid the failures.
 General Information 17

Risk Assumption The degree of how adverse an outcome or how much of a chance an
organization is willing to take before that outcome or chance is considered
unacceptable is known as “risk assumption.”

Because all risks can never be eliminated, and some are far less likely to occur
than others and/or are less likely to have a severe impact, risk assumption can
also be thought of as how many problems and difficulties an organization
can “live with” or is willing to absorb or assume.

How Bad is Bad? Sometimes, an organization may already know where its limits lie. Those
limits may have been set on experience, a comfortable guess, or internal or
external directives.

When risk limits are already known or established, an FMEA can show
whether a proposition or change is acceptable (e.g., we can assume this
because it falls short of the worst of what we are willing to accept), or is
unacceptable (e.g., this exceeds how far we are willing to take a chance
on something).

If something is entirely new, risk limits may not yet be established. In that
case, FMEAs can help organizations establish their risk limits by showing
potential issues and problems.

Failure Threat If no threats of failure are determined, then there is no reason to follow-up
Importance with mitigation efforts.

If failure threats are determined, the Risk Priority Number (RPN) indicates:
• what must be addressed, and
• what can be tolerated (what risks can be assumed).

Criticality A formal analysis by which each potential failure mode is ranked according to
Analysis the combined influences of severity and probability of occurrence.
18 General Information

Risk Priority The Risk Priority Number, or RPN, is the FMEA analysis figure calculated by
Number multiplying:
• Severity number – how severe the occurrence would be to the
organization, customer, system, operation, function, or a human being
• Frequency number – how often the occurrence happens, and
• Detection number – how easy it is to detect that the failure is likely to
occur or how easy it is to locate the failure after it has occurred.

The RPN is calculated at least once to determine how high a risk is present.

If mitigation or corrective action efforts are implemented, then the RPN is

calculated again to determine:
• how much the risk was lowered, and
• if the risk was lower to an acceptable level.

When to If the analysis reveals gaps, possibilities of failures, or things in need of

Mitigate corrective or preventive actions, the RPN helps to indicate what must be
corrected or prevented.

There are instances where some things are so minor or rare that the costs to
correct or prevent them outweigh any advantages gained by corrective or
preventive actions.

Root Cause If a failure happens later on, an executed FMEA is a valuable contribution to
Analysis a root cause analysis because:
• much of the work has been done already
• areas most likely to fail have already been identified
• efforts to mitigate the failures are known, and
• control and prevention gaps are easier to identify.

Many times, an executed FMEA is used as a starting point for a root cause
analysis.
 General Information 19

Mil–Std–1629A The US military’s Mil–Std–1629A, Procedures for Conducting a Failure Mode,

Effects, and Criticality Analysis, is the basis for many FMEA procedures that
have developed worldwide over the years.

Mil–Std–1629A’s foreword stresses that, while the objective of an FMEA is

to identify all modes of failure within a system design, its first purpose is:
• the early identification of all catastrophic and critical failure possibilities
so…
• they can be eliminated or minimized through design correction at the
earliest possible time.

Tiered Mid–Std–1629A takes a tiered approached, stating that the Failure Mode,
Approach Effects, and Criticality Analysis (FMECA) should be:
• initiated as soon as preliminary design information is available at the
higher system levels, and
• extended to the lower levels as more information becomes available on
the items in question.

Other Other departments within an organization are also concerned with

Approaches preventing errors and mitigating risks.

Organizations typically do this via:

• high-level policies implemented as standard practices for conducting
business
• data handling and safeguards
• computer and website security, and
• fully understanding customers’ standard practices and specifications.

FMEAs related to a project or root cause analysis typically take into

consideration or build on the above.

New Projects AN FMEA is an ideal tool when developing new programs.

20 General Information

Broad An FMEA has broad applicability.

Applicability
Mid–Std–1629A emphasizes that the use of the FMEA is called for in:
• maintainability
• safety analysis
• survivability
• vulnerability
• logistics
• support analysis
• maintenance
• plan analysis
• failure detection, and
• isolated or subsystem design.

How Does This It may be tempting to dismiss military concerns as not applying to a small
Apply to the business, but take a quick look at some examples of how the military’s
Small Business? categories can also apply to a small business:
• Maintainability – Small businesses need to keep certain operations and
equipment. What are the backup plans if something goes wrong or is
unavailable?
• Safety analysis – Safety spans from people not getting hurt on the job or
by using a product to protecting information or unauthorized access.
• Survivability – If a catastrophe hits a small business, which plans make
the most sense to ensure that the business can continue?
• Vulnerability – What exists that could harm or undermine the company?
• Logistics – Could anything be done more quickly or cheaper by other
means?
• Support analysis – Could things be done more efficiently by other means?
• Maintenance – What needs to be maintained, when, and is it affordable?
• Plan analysis – What would be needed to add a new product or service?
• Failure detection – If something fails, would we know it?
• Isolated or subsystem design – What are the special considerations a
unique system or process needs beyond “business as usual,” can we meet
them, and how will they impact what we have already?
 General Information 21

The Morphing of Mil–Std–1629A was canceled on August 4, 1998, because its use had
Mil–Std–1629A become so highly valued that different industries had adopted it to create
their own versions of the standard. In other words, its value was well-
recognized and broadly adopted beyond military applications.

The new standards provided cost savings to the military. It no longer had
to maintain the standard; the industries and publishing organizations had
assumed that. In addition to providing the next generation of risk assessment
standards, the organizations that had adopted Mil–Std–1629A conduct
periodic reviews and professional studies regarding how to improve and
apply the standards.

Sampling of A sampling of current FMEA standards and the organizations which publish
FMEA Standards them are shown in Table 4.
by Industry
Note: There are many more FMEA standards besides these.

TITLE PUBLISHING ORGANIZATION

IEC 60812: Analysis techniques for system IEC – The International Electrotechnical
reliability – Procedure for failure mode and Commission is a non-profit, non-governmental
effects analysis (FMEA) international standards organization that
prepares and publishes International Standards
IEC/TR 62343-6-6:2011(E) – Dynamic for all electrical, electronic, and related
Modules – Part 6-6 – Failure Mode Effects technologies – a.k.a. “electrotechnology."
Analysis for Optical Units of Dynamic
Modules

ISO 12132:1999 – Plain bearings – Quality ISO – The International Organization for
assurance of thin-walled half bearings – Standardization is an international standard-
Design FMEA setting body composed of representatives
from various national standards organizations.
ISO 14971 – Risk Analysis and Use of a
DFMEA (Design FMEA)

SAE J 1739-2009 (SAE J1739-2009) – SAE International is a global association of

Potential Failure Mode and Effects Analysis more than 138,000 engineers and related
in Design (Design FMEA), Potential Failure technical experts in the aerospace, automotive
Mode and Effects Analysis in Manufacturing and commercial-vehicle industries.
and Assembly Processes (Process FMEA)

Table 4. Sampling of FMEA Standards.

22 General Information

Sampling of Many guides exist for using FMEAs and may be found in articles, books, and
FMEA Guides standards. Some of these are shown in Table 5.

Note: An Internet search will pull up a cornucopia of information, training,

and help.

TITLE ORGANIZATION

Failure Mode and Effect Analysis: FMEA American Society for Quality
from Theory to Execution, Stamatis, D.H

Failure Mode and Effects Analysis (FMEA) –

Training

FMEA for Beginners – Training

ISO Guide 73, Risk Management ISO – The International Organization for
Terminology, 2009 Standardization is an international standard-
setting body composed of representatives
ISO Standard 31000-2009, Risk from various national standards organizations.
Management – Principles and Guidelines,
2009

ISO Standard 31010, Risk Management

Techniques, 2009

Table 5. Sampling of FMEA Guides.

 When to Use

Introduction FMEAs provide tremendous benefits and guidance in many areas.

This section provides guidance on the general areas where an FMEA can be
utilized.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Known High Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Unknowns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
New Regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Conception & Feasibility. . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Before Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
During Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
During Modifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Before Implementing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Assisting Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
New Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Policies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
After a Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Continuous Improvement Efforts. . . . . . . . . . . . . . . . . . . . . 25
Quality Recognition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Malcolm Baldrige National Quality Award. . . . . . . . . . . . . . 26

23
24 When to Use

Known High Certain elements are known to always present high risks. These are typically
Risks controlled by policies, requirements, and standard operating procedures.

If there is any uncertainty regarding the adequacy of these controls, then an

FMEA is advisable.

However, if the organization has confidence that these controls are sufficient,
an FMEA would be a redundant and wasted effort.

Unknowns If something is introduced that is an unknown and its impact on the

organization has not been fully examined, an FMEA is an excellent tool for
determining adverse impacts.

New Regulations Systems, policies, and methods are subject to changes from outside an
organization. New regulations may alter what was previously identified at risk
and what was not.

An FMEA would help to determine if any new risks have appeared that need
to be controlled.

Conception & An FMEA can be extremely useful in conception or feasibility stages. Many
Feasibility organizations routinely utilize FMEAs at these points.

Before Design Before beginning to design something such as a product, plan, compliance
effort, or service, an FMEA can help identify how to best approach the
design.

During Design FMEA can be useful during design to evaluate a particular approach, idea, or
method from a broad, general level down to detailed specifics.

During If something is to be modified, an FMEA can help identify which

Modifications modifications would best meet the desired changes.

Before Implementing a policy, method, part, product, or service has its own sets of
Implementing risks and requirements. An FMEA can be useful here.
 When to Use 25

Assisting When responding to a customer’s or client’s inquiry, an FMEA can be used to

Customers address their concerns.

The FMEA methodology can reassure the organization that their customers’
or clients’ concerns have been heard and taken into consideration.

New Products An FMEA is recommended for all stages of new products from concept to
customer or consumer use.

Policies An FMEA may be used for assessing the adequacy of policies and manuals.

After a Failure An executed, completed FMEA can be helpful during a root cause analysis.
An executed FMEA presents previously identified risks and controls that were
in place to prevent the failures.

Continuous Many organizations seek to improve their reputations with customers or

Improvement clients via continuous improvement efforts.
Efforts
An FMEA helps to determine which investments would be the most beneficial
for enhancing the organization’s reputation in the community or with its
customers and clients.

Quality Some organizations plan on becoming recognized as industry leaders or

Recognition being the best in their fields.

An FMEA is useful for planning the most effective approaches to achieve

quality awards for excellence:
• in one’s industry or field
• given by customers or clients, or
• awarded by government agencies, such as the Malcolm Baldrige Award.
26 When to Use

Malcolm Baldrige What is the Malcolm Baldrige (as it is commonly known)?

National Quality
“The Malcolm Baldrige National Quality Award is the highest level of national
Award
recognition for performance excellence that a U.S. organization can receive.
Congress established the Baldrige Program in 1987 to recognize U.S.
companies for their achievements in quality and business performance and to
raise awareness about the importance of quality and performance excellence
in gaining a competitive edge.

“Congress originally authorized the Baldrige Award to include manufacturing,

service, and small business organizations; Congress expanded eligibility to
education and health care organizations in 1998. Nonprofit organizations,
including government agencies, became eligible for the award in 2007.

“A total of 18 awards may be given annually across the six categories—

manufacturing, service, small business, education, health care, and nonprofit.
Within the overall limit of 18, there is no limit on awards in individual
categories.

“To receive the Baldrige Award, an organization must have a role-model

organizational management system that ensures continuous improvement in
the delivery of products and/or services, demonstrates efficient and effective
operations, and provides a way of engaging and responding to customers
and other stakeholders. The award is not given for specific products or
services.

“The Baldrige Criteria for Performance Excellence provide a framework that

any organization can use to improve overall performance. The Criteria are
organized into seven categories: Leadership; Strategic Planning; Customer
Focus; Measurement, Analysis, and Knowledge Management; Workforce
Focus; Operations Focus; and Results.1”
1
National Institute of Standards and Technology’s website, “Baldrige FAQs.”
http://www.nist.gov/baldrige/about/baldrige_faqs.cfm
 Stages of an FMEA

Introduction This section provides explanations of the stages of an FMEA’s general process.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
FMEA’s Start. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Assemble the Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Verify Critical Concerns. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Identify the Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Identify Tasks & Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Identify Risks & Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Calculate Initial RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Making Improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Effectiveness of Improvements . . . . . . . . . . . . . . . . . . . . . . 30
Re-calculating the RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Control Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Control Plan Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Final Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Completing the FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

27
28 Stages of an FMEA

FMEA’s Start An FMEA starts by identifying the general area that will be examined,
analyzed, or investigated.

Among the infinite possibilities where an FMEA can be used, an FMEA

analyst may want to:
• examine what currently exists to get a better idea of what exactly is
impacting an organization or happening within it
• analyze how proposed changes may affect the organization, its customers
or clients, or any operations
• review processes, tasks, and any related steps for clarity, weaknesses, or
possible areas for improvement, or
• investigate why failures have occurred, customers are dissatisfied, or why
the organization is not making the profits or achieving the goals it had
anticipated.

Assemble the Once what the FMEA analyzed has been identified, the next stage is to
Team identify the team members, which are typically:
• stakeholders
• subject matter experts
• managers, and
• possibly customers or clients, if warranted.

Verify Critical While most organizations believe they know their critical concerns and those
Concerns belonging to their customers, systematic identification and verification of
these concerns do not always occur.

The FMEA provides the opportunity that the concerns related to regulatory
authorities, the organization, and/or its customers’ or clients’ are formally:
• identified, and
• verified as current.

Verifying the critical concerns strengths the value of conducting an FMEA and
greatly assists in knowing which areas to target.
 Stages of an FMEA 29

Identify the Once the critical concerns are verified, the next stage is to fine-tune what is
Target known up to this point in order to create a specific target.

Precisely identifying what to analyze becomes easier once it is established:

• where the analyst will begin looking
• who are the stakeholders and others involved with the area, and
• what concerns will be specifically addressed.

Identify Tasks Once the target has been identified, the next stage is to:
& Steps • break the target down into its tasks, and
• identify the steps involved within each task.

Identify Risks Once the tasks and the steps are identified, the next stage is to identify
& Rate and rate:
• any failures that can occur
• where these failures can occur
• what currently exists to prevent or detect these failures
• how severely the organization, its customers, or clients would be impacted
if these failures happened
• the frequency of how often the failures occur, and
• how easy it is to detect the failures.

Calculate Once the risks, their severity, occurrence, and the ability to detect them have
Initial RPN been identified and rated, the Risk Priority Number is calculated to determine
if the organization needs to take action.

If no action is necessary, then the FMEA is closed.

30 Stages of an FMEA

Making If the organization determines that the risks are too high to assume, then
Improvements improvements must be made to reduce or eliminate those risks.

At this point, depending on the FMEA Coordinator’s expertise and authority,

he or she may:
• make a general recommendation that improvements are necessary and
turn those efforts over to those who will determine where, how, and who
will make the improvements, and
• specify what exactly needs to be improved or changed and determine who
will make those changes.

Note: In some instances, the FMEA Coordinator may be the individual who
carries out the improvements.

Effectiveness of An FMEA does not simply identify risks and determine if improvements are
Improvements needed or not.

If improvements are required, the FMEA continues by determining if the

improvement efforts have been effective in reducing the risks.

This follow-up:
• ensures that improvements have been implemented, and
• determines if more action beyond the initial improvements is required.

Re-calculating Once the improvements have been implemented, the risks to the
the RPN organization are assumed to have been reduced.

What is still unknown is how much the improvement actions changed the
risks. It must still be determined if the risks:
• have been brought down to an acceptable level, or
• are still a threat to the organization.

The FMEA Coordinator repeats the process of identifying what risks are now
present and determining their severity, occurrence, and detectability.

Once these are known, then the RPN is re-calculated.

 Stages of an FMEA 31

Control Plan If an issue or concern being addressed is complex, a series of actions or

efforts in a number of different areas may be warranted. It may not be
enough to prevent or mitigate only one thing.

To ensure that the whole system, or process, has been addressed, a “control
plan” is established.

In order to ensure that no failure risks are involved with a final product or
project, certain industries have developed standards and procedures to make
certain all possibilities of failures have been identified and addressed. FMEAs
are often tools used in these efforts.

Note: Certain organizations and industries have established minimum

requirements to ensure that risks have been identified and addressed.
It is important to understand that “control plan” is a broad concept
and specific definitions regarding what constitutes a control plan vary.

Control Plan While beyond the scope and intention of this book, examples of several types
Examples of commonly recognized control plans for identifying and mitigating risk are:
• the US automotive industry’s
– APQP—Advanced Product Quality Planning, and
– PPAP—Production Part Approval Process, and
• the FDA’s medical device manufacturing requirements for
– I/Q—Installation Qualification
– O/Q—Operation Qualification, and
– P/Q—Process Performance (Production) Qualification.

Final Report Once the FMEA Coordinator is satisfied that the area or concern has been
fully addressed, a summary and final report is made to the appropriate
departments or individuals.

Completing The FMEA is completed after all of its relevant information is assembled and
the FMEA archived.
(This page intentionally left blank.)
 Flowchart – FMEA Stages

Identify the areas Assemble the

likely involved. FMEA team.

Identify critical
Organization’s Customers’ or Clients’
concerns.

Identify & rate Determine what

initial risks. to analyze.

Are there
risks that
Yes No FMEA completed.
need to be
controlled?

Prioritize &
select controls.

Identify & rate

new risks.

Implement
the controls.

Test & verify that

controls work.

33
(This page intentionally left blank.)
 High-Level
Risk Assessments

Introduction General information can be sufficient to decide to do or not do something,

or it can point to the direction that would be the wisest course to examine in
detail or keep under a watchful eye.

High-level risk assessments are therefore useful for brainstorming, either

when broad-range changes may occur or when considering which future
paths to take.

Examples of when high-level risk assessments are useful include, but are not
limited to:
• implementation of new laws or policies
• expanding business lines
• considering new technology, or
• changing suppliers.

This section provides guidance on what is involved with high-level risk

assessments and how to perform them.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
High-Level Matters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Fishbone Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Simple Cause and Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5Ms and 1E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Staying in Balance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Determine Investigation’s Level. . . . . . . . . . . . . . . . . . . . . . 38
Examples of High-Level Risk Questions . . . . . . . . . . . . . . . . 40

35
36 High-Level Risk Assessments

High-Level High-level risk assessments:

Matters • will be more general and less detailed than an FMEA dealing with a design
or a process, and
• may involve subject matter experts outside of the organization.

Fishbone Since a high-level use of an FMEA does not usually permit changing anything
Analysis outside of an organization, a fishbone analysis, a.k.a. Ishikawa diagram or a
fishbone diagram, is a useful tool for evaluating the situation for risks.

A fishbone analysis is called such because graphically it looks like a bony

outline of a fish. The “head” of the fish is the situation under investigation.

The “bones” of the fish are the six most common areas that quality
professionals have identified as influencing the outcome of a situation.

Note: T he “bones” are arbitrary classifications. They may be modified to suit

the situation.

As a general rule, a good place to start is with the standard categories on a

fishbone diagram:
• manpower, a.k.a. people
• machines
• methods
• materials
• measurements, and
• environment.

Simple Cause A fishbone diagram helps to visually identify in a simple, obvious way the
and Effect elements that are contributing to a situation.

For an illustration of a fishbone diagram, see the fishbone/Ishikawa graphic

following this section.

For instructions on how to create a fishbone diagram, see Appendix B.

 High-Level Risk Assessments 37

5Ms and 1E The six common fish bones are sometimes called “the 5Ms and 1E.” They are
described in Table 6.

FISH “BONE” DESCRIPTION EXAMPLES

Manpower, The people involved High level

a.k.a. “people” with the matter • Lawmakers, stockholders, board of directors
• Customers, market, general public
• Clients, patients, consumers, users
Lower level
• Trainers, sales people, customer representatives
• Operators, technicians, processors
• Contactors, temporary help

Materials The materials High level

affecting the matter • Laws
• Press releases, announcements
• Certifications, reports, audits
Lower level
• Raw materials used in manufacturing
• In-take forms, registration forms, claim forms
• Application forms, regulatory paperwork

Methods The methods High level

involved in the • Regulatory requirements
situation
• Customer requirements
Lower level
• SOPs, work instructions
• Hand assembly, computerized, voice, person-to-
person

Measurements The measurements High level

related to the • Compliance audits
matter
• Customer satisfaction surveys
Lower level
• Weights, lengths, time etc.

Table 6. 5Ms & 1E. (continued)

38 High-Level Risk Assessments

(continued)

FISH “BONE” DESCRIPTION EXAMPLES

Machines The machines High level

related to the • Computer systems
matter
• Transportation systems
Lower level
• Manufacturing equipment, office equipment

Environment The environment High level

impacting the • Government regulations
situation
• Import/export
• Political situations
• Labor disputes
Lower level
• Physical location, utilities, lighting, ventilation,
temperature
• Employee base, education, repetitive work,
training
• Work demands & safety considerations

Table 6. 5Ms & 1E.

Staying in Like a child’s mobile, if one of these elements is changed, or if one of an

Balance element’s subcategories is changed, then the whole system can be thrown
off-balance, sometimes subtly or, in a worst-case scenario, radically.

A risk assessment will help to keep an organization in balance.

Determine First, identify if the FMEA will address a high-level matter or something
Investigation’s involving a design or a process.
Level
 High-Level Risk Assessments 39

Examples of A high-level risk is something that occurs at or impacts the top of an

High-Level organization with repercussions that flow downward.
Risk Questions
High-level risks can occur externally, such as deciding against pursuing
a certain path because of the regulatory requirements associated with it and
losing a customer, or internally, such as the loss of an executive or locating
a business near an environmentally protected area.

The types of high-level questions that an FMEA can help answer are:
• If a certain law gets passed, how will that impact our organization and
what would be needed to become compliant?
• How we will be impacted if the city (or a competitor) decides to do X?
• What will be impacted if a new building or the road changes will
go through?
• What happens if we fail to do Y?
• If we choose to follow a certain path, what are the ramifications to
ourselves, our customers, and our suppliers if we do?
(This page intentionally left blank.)
 Graphic – Fishbone
(Ishikawa) Diagram

Manpower Materials Methods

Problem/situation

Measurements Machines Environment

41
(This page intentionally left blank.)
 Planning and Design
Risk Assessments

Introduction It is common for a small organization or business to say that it has plans for
the future.
When an organization plans for something to happen, it is creating a design.
These plans are not always well thought out. Sometimes, the plans are
more reactions to whatever recently happened. Little thought is given
to consequences or effectiveness of what may be regarded as knee-jerk
reactions because “action must be taken!” (In the quality field, this is known
as “firefighting.”)
Plans that are reactions often result in leading the organization as opposed to
the organization controlling the path that will be taken.
In addition to identifying, anticipating, and preventing failures, another
benefit of an FMEA is that it helps guide an organization with its planning.
This section providence guidance and examples of how design risk analyses
can be used by the small business owner.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Broad Applications of Design . . . . . . . . . . . . . . . . . . . . . . . 44
Dealing with Problems as They Occur. . . . . . . . . . . . . . . . . 44
Plan for Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Obvious and Not-So-Obvious Designs. . . . . . . . . . . . . . . . . 45
FMEAs and the Organization’s Future. . . . . . . . . . . . . . . . . 45
Organization’s Identity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Examples of Shaping an Organization’s Identity. . . . . . . . . . 46
Fishbone Diagram for Identity. . . . . . . . . . . . . . . . . . . . . . . 46

43
44 Planning and Design Risk Assessments

Broad “Design” is not necessarily limited to what is typically thought of as a creative

Applications endeavor, such as engineering effort to create a new widget or machine.
of Design
Design also applies to situations when an organization decides how it
wants to grow, what to add to its services or offerings, and even creating
its identity.

Design risk assessments are useful when addressing questions such as

“What if we did this…?” or “What if we eliminated that…?”

Design risk assessments can also take into consideration things such as
“What if that bill becomes law?” or “What if such-and-such a business
moves into our area?”

Dealing with Many small businesses start out with one or two offerings. Naturally, all
Problems as organizations would like to succeed.
They Occur
While every possible problem cannot be anticipated, assuming that the
only way to deal with problems is when they occur is not true.

Many potential pitfalls and obstacles can be identified and consequently

prevented if a risk analysis is done during the design or planning stage.

Plan for Changes Changes occur constantly in an organization.

Most changes stem from ideas, which mean somebody “designed” the ideas.

Consider using an FMEA when planning for the future or when a change is
unavoidable or desired.
 Planning and Design Risk Assessments 45

Obvious and Some design efforts are obvious, such as those that occur in Research and
Not-So-Obvious Development (R&D), product development, or design engineering.
Designs
In organizations sophisticated enough to have those departments, regulatory
requirements are usually in existence that require FMEAs or encourage
their use.

Other types of designing are not so obvious, such as creating an

organization’s reputation or its identity.

Other examples of when designs might not be obvious to a small

business include:
• changing the menu
• adding a new product
• extending or reducing the hours when the organization is open
• rearranging the floor layout
• adding or reducing personnel, and
• adopting a business trend.

FMEAs and the Many business owners have vague dreams of expanding at some point, but
Organization’s the particulars are put off for now or will be addressed later.
Future
Dreams are inspiring, but the nitty-gritty details of getting an organization
started can obscure the future, especially when resources are in short supply.

Identifying future goals helps to determine if the organization is doing what

is necessary to achieve those ends and if the actions taken today make sense
in the long run.

Organization’s An organization’s identity gets molded by its customers and how well
Identity its products and services are received. But by planning for the less-direct
influences, a pro-active organization can shape its future, reputation,
and success.

Knowing the path that an organization would like to take or intends to take
in the future is important to making decisions today.
46 Planning and Design Risk Assessments

Examples of For example, does a company want to be known as environmentally friendly

Shaping an or “green”?
Organization’s
That can influence:
Identity
• which suppliers to do business with
• which raw materials to buy
• what manufacturing processes to use
• what environmental controls would be required
• where to locate a facility, or
• which markets to target.

Other examples are organizations that may want to:

• help a particular group of people or businesses
• offer something to a specific age group, or
• be known as a leader in its field.

Whatever an organization wants to consider as a possibility for its future can

benefit from a design risk assessment.

In other words, if an organization wants to be identified in a certain way, it

can identify and better plan for what it would take to achieve that identity.

Fishbone Knowing how an organization wants to be perceived is a tremendous asset

Diagram for for guiding employees and directing internal efforts and operations.
Identity
In Table 7 are questions applied to the “bones” of a fishbone diagram that
can be useful for determining what might be needed for an organization to
achieve a certain public perception, market reputation, or identity.

Notes:
• These questions are not shown in any particular order.
• Not all the questions would apply to every organization or business.
• The questions are given as considerations; not every question needs to
be answered.
• These questions may also prompt other questions not given here.
 Planning and Design Risk Assessments 47

TITLE ORGANIZATION

Manpower, • What kind of expertise is needed?

a.k.a. “People” • When would this expertise be needed?
• Do we have the expertise already?
• Can the expertise be contracted? If so, what is the right contractor?
• Would permanent expertise be needed?
• Would it be possible to train current personnel to have the expertise?

Materials • Would we be required or restricted to using certain materials?

• Can we use the materials that we have on-hand today?
• Would certain materials be forbidden for use?
• How would our current customers be impacted if we changed our
materials?
• How much money would we need (money is a material) if we go
this route?
• Do we have sufficient funding to carry out such an effort?
• Can we secure the necessary funding?

Methods • What would we gain if we changed our method(s)?

• Do we have the methods now that are needed?
• Can our current methods be modified to achieve the desired goals?
• What kind of training would be required?
• How would our customers be impacted if we changed our methods?
• Would any of our products or offerings be adversely impacted if we
changed our methods?
• Would changes to the methods require special handling of raw
materials, byproducts, or waste?

Measurements • What measurements would show if we are being successful?

• What measurements would show if we were encountering issues?
• What would we measure to determine profits or losses?
• What measurements or data do we need to report elsewhere if we
adopt what we are proposing?
• How would we capture the information and data that is required?
• Who would analyze that information?
• Who would make the reports and at what frequencies and to whom?

Table 7. Fishbone Questions for a Design Plan. (continued)

48 Planning and Design Risk Assessments

(continued)

TITLE ORGANIZATION

Machines • Do we have the necessary machines and equipment if we make this

change?
• Would our current machines and/or equipment need to be modified?
• What additional machine or equipment would be needed?
• Would any of our current methods need to be changed or modified
because of these machines?
• Do we have the room to add new equipment or machines?
• If we opt for this machine, would we eliminate others?
• Would anything else be impacted if we eliminated machines that are
currently in use or added new ones?

Environment • Would our reputation be enhanced by making this change?

• Would our reputation be adversely impacted by making this change?
• If we ignore this matter, would our reputation be enhanced or adversely
impacted in any way?
• What is our competition doing?
• Would this change make us a leader in any way?
• If we don’t make this change, would we fall behind our competition in
any way?
• Would this change improve company morale?
• What regulatory compliance issues would factor into this change?
• Will there be added regulatory compliance issues if we make this
change or ignore it?
• Would additional licenses or certifications be required?
• Would special processes or handling be subject to regulatory reviews
or audits?
• Are our customers requiring these changes?
• In what direction is our customer moving?

Table 7. Fishbone Questions for a Design Plan.

 Process Risk
Assessments

Introduction Identifying what can go wrong and the risks that these failures present
means progressively breaking down the components of what is under
investigation.
Once the FMEA Coordinator has identified the stages in the area under
investigation, the next areas to be identified are:
• the tasks involved with each stage, and
• the steps involved with each task.

This section providence guidance on identifying the general tasks in a stage.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Determine the Process to Assess. . . . . . . . . . . . . . . . . . . . . 49
General Process Areas to Evaluate. . . . . . . . . . . . . . . . . . . . 50
High Level Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Determine If a business or organization is brand new and going through its initial
the Process development stages, performing a risk assessment of every process is
to Assess invaluable for planning and development.
For established businesses or organizations, it is usually not necessary to
evaluate every process within an organization.
As mentioned in the “Guidelines for Using FMEAs” section, the Pareto
Principle is an excellent tool for determining what is most important in terms
of needing attention or evaluation.
Within a process, the Pareto Principle can be used again to focus on what is
most important.

49
50 Process Risk Assessments

General Process The general areas in a process to evaluate typically are one or more of
Areas to the following:
Evaluate • What presently exists?
• Is everything current or has anything become obsolete?
• Will the current process be compatible with proposed changes or business
plans? If not, what impacts will the changes make?
• Where are there gaps in the process?
• Why do these gaps exist?
• Are the gaps tolerable?
• What would be achieved if we eliminated the gaps?
• What is needed in the process that is not currently present?
• Is the current process the most efficient, best way, or cheapest way that
the work or service can be done?

High-Level High-level matters:

Matters • will be more general and less detailed than an FMEA dealing with
process, and
• may involve subject matter experts outside of the organization.
 Flowchart – Tasks of an
FMEA Investigation
Something needs to What are What are What could
be assessed for the stages in the tasks of fail at
potential failures. the process? each stage? each step?

What could
cause each of
these failures?

What risks are What would the

How easy is What exists
assumed if impacts be if
it to detect now to prevent
failures were these failures
the failures? these failures?
NOT mitigated? occurred?

Can these What can be

risks be done to
No
tolerated? mitigate
these risks?

Yes
Yes

Does
anything Would any
else need to be No failures
mitigated? occur now?
FMEA completed.
No
Yes

Continue Implement
No Would any
assessing all approved
failures
stages until control
occur now?
completed. plan(s).
Develop
mitigation
actions. Yes Yes

Do other Should Obtain

Develop
stages need control plans approvals
control
to be No be considered No for control
plan if
considered? collectively. plan(s)
necessary.
if necessary.

Evaluate
control plans
Yes
as a collective
unit.

51
(This page intentionally left blank.)
 Reliability

Introduction Reliability is primary for companies. Their existence depends upon it. Without
being able to rely on procedures and equipment that produce dependable
results, an organization risks going out of business.

Reliability is often used synonymously with “dependability.”

Many methods have been developed to determine the reliability of the

various aspects and functions of an organization.

As organizations grow in size, complexity, and sophistication, full-time

reliability engineers may be employed. Reliability engineers have an
extensive set of tools available to perform their work. Which tools reliability
engineers use and apply depends on the issues that their organizations are
encountering or wish to avoid.

For a small organizations, there is no need for a full-time engineer. The

simple tools provided in this book, i.e., FMEAs, Pareto charts, and fishbone
diagrams, can provide sufficient guidance and information to ensure
reliability.

For FMEA purposes, reliability is defined as the ability of something to

perform as intended over a stated period of time.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Reliability Declines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Reliability Goals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Form, Fit, or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
One-Time Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Average Time Between Failures. . . . . . . . . . . . . . . . . . . . . . 55

53
54 Reliability

Reliability It is known that reliability declines. Nothing is static. Everything changes

Declines with time.

Even though something may be operating as intended and is in optimal

condition, reliability can still be affected or reduced due to:
• obsolescence
• changes in personnel
• introduction of outside elements, and
• new requirements, priorities, objectives, etc.

Reliability Goals The goals of reliability are evaluated against a specified time period and
include, but are not limited to:
• an item is fit for its intended first and continued use
• the capacity of a designed, produced, or maintained item to perform
as required
• the resistance to failure
• the probability that an item will perform as intended, and
• the durability of the item.

Form, Fit, or When a failure is encountered, reliability engineers typically ask if the failure
Function would affect the “form, fit, or function” of the item in question.

It is assumed that the item’s form, fit, or function are the optimal design
unless proven otherwise. Sometimes, unanticipated failures can bring about
revisions that improve the item’s form, fit, or function.

If the form, fit, or function would be affected, then the next step is to
determine if a design change or some kind of safeguard could be put in
place to prevent the impact.

One-Time A problem with determining reliability is that many times, a second failure
Failures never happens. The part is replaced or the situation is corrected.

Would the failure happen again if interventions were not made? That is
unknown.

What is known is that the failure occurred once, and certain corrective and
preventive actions were taken to prevent its reoccurrence. This information
is invaluable when creating something new that may involve this kind of
situation.
 Reliability 55

Average Time There are instances when reliability engineers perform studies to determine
Between Failures the average time between how often the same failure will occur.

These studies are known as Mean Time Between Failures studies, or as they
are more commonly known, MTBF studies.

There are established methods and formulas for conducting MTBF studies.
(This page intentionally left blank.)
 Failures

Introduction In order to know what can go wrong, it is important to know first what
constitutes a failure and what kinds of failures apply to the situation.

This section provides information on failures.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Failure Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Failure Levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
For the Want of a Nail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Hackers & Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Hind Sight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Types of General Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Types of Operational Failures. . . . . . . . . . . . . . . . . . . . . . . . 60
Failure Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Failure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Worst Case is Subjective. . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Why Worst-Case Scenario. . . . . . . . . . . . . . . . . . . . . . . . . . 61

57
58 Failures

Failure A failure is the loss of an intended function under stated conditions.

In layman’s terms, if something does not work as intended when wanted,

then there is a problem. In the user’s or owner’s eyes, the item has failed.

A failure is high-level because it is often not apparent:

• what caused the failure
• what the reason is behind the failure, and
• how far the failure’s impact has reached.

Example: If the doorbell doesn’t ring when pressed, all that is known at this
point is that the doorbell did not ring.

We do not know why the doorbell failed. We also do not know

who, what, or how something was impacted by the doorbell not
sounding its alert.

Failure Effect A failure’s effect is the immediate consequences on an operation, function

or functionality, or status of some item.

Example: The doorbell failing to ring caused the visitor not to make
the delivery.

While it is tempting to think that the only consequence of a failed delivery

is that the delivery person must return another time, there are in fact many
possible impacts and inconveniences caused by this failure.

Failure Levels It is important to investigate what else might be impacted because the
immediate impacts may seem minor in comparison to the far-reaching
consequences of a failure.

Example: The doorbell failing to ring causing the delivery person to leave
may delay the recipient receiving important power-of-attorney
papers on time, which, in turn, may cause a financial crisis due to
the recipient now being unable to provide proof that he or she
may sign and deposit a check in time to stop a foreclosure.
 Failures 59

For the Want Unknown consequences are depicted in the poem, For the Want of a Nail.
of a Nail
For want of a nail the shoe was lost.
For want of a shoe the horse was lost.
For want of a horse the rider was lost.
For want of a rider the message was lost.
For want of a message the battle was lost.
For want of a battle the kingdom was lost.
And all for the want of a horseshoe nail.

Hackers and Former hackers and other software experts conduct studies and hold
Failures convention to identify and prevent vulnerabilities.
http://news.yahoo.com/hacker-barnaby-jack-unexpectedly-dies-ahead-hacking-com

Hind Sight While some consequences of a failure may only be recognized in hindsight,
the bulk of undesirable consequences from failures are already known
and recognized.

For example, it is common knowledge that certain consequences should be

avoided. A partial list of these includes:
• loss of human life
• maiming of a person
• access to or loss of confidential information
• confidential information being sent to the wrong person or organization
• access to or loss of money, and
• lawsuits or regulatory sanctions due to failure to ensure certain safeguards.

Types of The types of general failures include:

General Failures • unanticipated
• chronic
• frequent
• noticeable
• hidden
• costly, and
• minor.
60 Failures

Types of The types of operational failures are shown in Table 8.

Operational
Failures

TYPE DESCRIPTION EXAMPLE

Binomial • Either works or it doesn’t Light bulb

• Failure is not noticed until item fails
• May be able to anticipate failure
• Regular maintenance may circumvent failure
• May be cheaper to replace than to maintain

Multinomial • Contains multiple parts Automobile

• Any part could fail
• One part failing may not be detected or noticed
• Other parts may still function despite one failure
• System capability may continue
• Multiple part failures may be required before whole
system shuts down

Continuous • Consumption may be involved Battery

• Deterioration or decline in function or ability may be
noted and/or measurable
• Lifespan is known
• Failure can be anticipated
• Maintenance and scheduled replacement can
circumvent failure

Table 8. Types of Operational Failures.

Failure FMEAs assign levels of criticality to failures.

Criticality
There are standard, recognized levels of failure criticality.

Many companies use only these while other companies may modify them to
suit their business purposes.
 Failures 61

Failure Mode The specific manner (or way) a failure occurs in the function under
investigation.

Example: The doorbell doesn’t ring when pressed because, e.g., the battery
is dead, the electricity has been cut off, a critter ate through
the wire, the wire became corroded, sticky fingers caused the
doorbell to jam, etc.

Note: A failure mode can have multiple causes.

Worst Case is The determination of a worst-case scenario is subjective.

Subjective
What may be the worst case to someone or something may be advantageous
to another person or different situation.

The worst case can be, but is not limited to:

• loss of life
• financial impact
• disruption of business, or
• upheaval of regular operations.

Why Worst- FMEAs look for the worst-case scenario because the assumption is:
Case Scenario • if one can determine the worst case that can be happen, and
• if the worst case can be prevented, then
• the other failures that are not the worst-case scenario will be prevented
as well.
(This page intentionally left blank.)
 Failure Rankings

Introduction Failure rankings are considered according to:

• the severity of impact
• the frequency of impact, and
• the ability to easily detect the failure.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Failure Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Determining Criticality . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Risk Priority Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
RPN Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Failure Criticality FMEAs assign levels of criticality to failures.

There are standard, recognized levels of failure criticality.

Many companies use only these while other companies may modify them
to suit their business purposes.

Determining In order to know how critical an effect is, the risk assessor asks:
Criticality • how severe would the impact be on the customer, people, system,
or product
• how often does something like this happen, and
• how easy is it to know if something has failed?

63
64 Failure Rankings

Risk Priority The Risk Priority Number, or RPN as it is more frequently known, is calculated
Number by multiplying the values assigned from a severity rating scale.

The values multiplied are:

• Severity
• Frequency, and
• Detectability.

RPN Threshold RPN values are guidance. Common sense must prevail to determine whether
or not action must be taken.

There is no RPN threshold that establishes when the RPN is:

• above a certain value, action must be taken, and
• below a certain value, action need not be taken.
 Criteria for Severity

Introduction The criteria against which to evaluate how severe a potential failure may be
measured against are:
• the life and safety of a person or the organization
• the financial impacts of such a failure (lost income, regulatory fines,
lawsuits, etc.)
• the financial costs to repair such a failure
• the loss of confidence by the business owners or customers with such
a failure, and
• the degree of harm inflicted.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Subjective Severity Criteria . . . . . . . . . . . . . . . . . . . . . . . . . 66
Damage Not Always Evident. . . . . . . . . . . . . . . . . . . . . . . . 67
Costs Not Always Obvious . . . . . . . . . . . . . . . . . . . . . . . . . 68
Catastrophic Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Salvageable or Not. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Major Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Salvageable for Major Failures. . . . . . . . . . . . . . . . . . . . . . . 70
Impact Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Moderate Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Moderate Failures – Ability to Repair. . . . . . . . . . . . . . . . . . 70
Minor Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Minor Failures – Ability to Repair. . . . . . . . . . . . . . . . . . . . . 71

65
66 Criteria for Severity

Subjective The severity of a failure can be measured objectively, but there are subjective
Severity Criteria failures as well.

Subjectivity typically is relative. What an organization may not hold as

noteworthy, because its process or products are not impacted, may have
considerable impact on a customer using that organization’s products or
services. (This is a major driver of configuration management.)

A sample table showing subjective criteria for evaluating the severity of an

organization’s failure on a customer is shown in Table 9a.

A sample table showing subjective criteria for evaluating the severity of an

organization’s failure on the organization/business is shown in Table 9b.

Note: There is a classification of “Significant,” but aren’t all the

classifications, with the exception of “None,” significant to one
degree or another? “Significant” needs to be defined.

EFFECT RATING CRITERIA

Extreme 6 Fails to comply with regulatory requirements

Major 5 Customer experiences downtime or excessive failure rates, and

substantial costs are incurred

Significant 4 Failure is significant and customer rejects

Moderate 3 Failure results in confrontation with customer, and additional

costs are incurred

Slight 2 Customer is dissatisfied, but still uses the products or services

None 1 Would have no effect on the customer

Table 9a. Subjective Criteria Example for Severity as it Would Impact a Customer.
 Criteria for Severity 67

EFFECT RATING CRITERIA

Extreme 6 The organization would cease to exist/go out of business.

Major 5 Major loss of market share or competition gains major

advantage

Significant 4 Significant sales lost and/or customer base; organization

develops poor reputation

Moderate 3 Reduction of sale and less repeat purchases or orders

Slight 2 Some inconvenience and increased costs to organization

None 1 Would have no effect on the organization/business

Table 9b. Subjective Criteria Example for Severity as it Would Impact the Organization/Business.

Damage Not Most people know of someone, or have heard of someone, whose car was
Always Evident in an accident and was designated “totaled” by an insurance company, but
the car looks like it could be used again with only a little repair. Some may
reason that the car is going to waste, but there are other factors to consider
besides repair.

Damage can occur on many levels. Some levels are not easily detectable and
some can never be seen. We know from experience the consequences that
can and do result from unseen damage. The reliability experts take these
into consideration.

Part of what insurance companies consider is if a component or element can

be guaranteed to operate or function as intended after repairs are made.
Rather than putting safety at risk, an insurance company will total the insured
item as opposed to letting it go back into use.

FMEAs look beyond the harm that was obviously done and consider the
possible hidden damages as well.
68 Criteria for Severity

Costs Not As with damages, the cost of a failure is not always obvious.
Always
Failure costs include the cost of not being able to conduct business, but can
Obvious
also include the costs of:
• regulatory fines
• lost or damaged reputation
• personal injury lawsuits
• competitor lawsuits
• time
• failure-to-deliver or perform-as-intended lawsuits
• sanctions, and
• loss of personnel and expertise.

Catastrophic Catastrophic failures mean the whole entity has been impacted.
Failures
When a product fails to perform as intended, resulting in the loss of a human
life, it is easy to regard that failure as catastrophic.

Businesses have also lost their “lives” due to catastrophic failures happening
to or originating within their companies.

Examples:

Acts of Nature – A tornado that physically wipes away a business that had
stood in one location for years is a catastrophe happening to a business.

Acts of People – Unethical practices, such as what happened with Enron, is

an example of a catastrophe originating within a business.

The financial costs are prohibitive, substantial, or may entail bankruptcy.

 Criteria for Severity 69

Salvageable There are some catastrophes that can be overcome. These would be
or Not considered salvageable failures.

Examples:

Acts of Nature – If an act of nature destroys the physical building of an

organization, but the organization has sufficient means to rebuild, and its
data, procedures, and other business information are stored away from the
physical location that was destroyed, it is possible to salvage that business.
The organization’s reputation has not been lost. It can still thrive.

Acts of People – Should an organization deliberately commit one or more

acts so grievous that its reputation is permanently destroyed and it no longer
has any creditability, regardless of any physical structures and information
remaining intact, the organization has, for all intents and purposes, been
wiped away. This type of catastrophic failure is typically not salvageable.

On the other hand, the loss of a major customer, perhaps caused by failing
to listen to the customer’s needs or requirements, may be catastrophic to an
organization, but possibilities exist that the organization:
• has enough resources to tide the organization over until new customers or
clients can be obtained
• learned from the incident and made enough internal changes to prevent
such a loss from happening again with other customers or clients, or
• was able to rebuild its relationship with the lost customers or clients to
eventually gain back some or all of its business.

In this case, the catastrophic failure is salvageable, but at significant costs.

Major Failures A defining line between catastrophic and major failures is the totality of
the impact:
• A catastrophic failure is complete. It impacts the total of something (the
whole thing).
• A major failure is severe, but it impacts only part of something. The loss is
not total. There are parts that were not impacted by the failure at all.
Examples:
Object – It may be necessary to replace the brake lines on a car while the
rest of the vehicle is fully operational.
Business – An organization may need to revise its confidentiality controls
while its processing system is fully functional.
As with catastrophic failures, the financial costs are prohibitive, substantial, or
may entail bankruptcy.
70 Criteria for Severity

Salvageable for As with catastrophic failures, some major failures are salvageable and some
Major Failures are not.

Impact The difference between catastrophic and major failures is how much of the
Differences organization has been impacted.

The financial costs alone may be the defining factor. Some things may cost so
much to fix that they are not worth the investment.

Moderate A moderate failure falls short of being a major failure, but is more than a
Failures minor annoyance.

Examples:

Object – It may be necessary to replace a seatbelt on a car. The part most

likely needs to be ordered, the car is out of service while the seatbelt is being
replaced, and the cost is more than simple maintenance.

Business – An organization may need to revise how a department handles

something while the rest of the departments require no changes.

Moderate Moderate failures mean:

Failures – Ability • repair is possible
to Repair
• the item or thing can be restored to its original operating state
• there is some inconvenience involved that may disrupt business, and
• the cost involved is more than would be for a minor correction.

Minor Failures A minor failure needs to be corrected, but the inconvenience and cost would
be minimal.

Examples:

Object – The windshield wipers need to be replaced on a car. The parts are
standard, in stock, can be quickly changed, and the cost is minimal.

Business – An organization may need to correct the wording on a field,

which is limited to one file and does not impact anything else.
 Criteria for Severity 71

Minor Failures – Minor failures mean:

Ability to Repair • repair is possible
• the item or issue can be resolved to its intended state
• there is little inconvenience, and
• the cost involved is negligible.
(This page intentionally left blank.)
 Flowchart –
Determining Severity
Something needs to be
assessed for severity.

Would the
failure result
in death or
non-survivable
Yes
harm?

No

Is failure
severe & does Failure is
it impact Yes catastrophic.
everything?

No
Alert company
of risk.

Are parts of
business untouched,
but impacts and Yes Failure is major.
costs to fix
considerable?

No

Are
business impacts
and costs to fix
Failure is
less than considerable, Yes Rate for severity.
moderate.
but more than
an annoyance?

No Failure is minor.

73
(This page intentionally left blank.)
 Criteria for Occurrence

Introduction Occurrence rates the likelihood of failure. When determining the likelihood of
a failure, reviewing prior failures of similar situations, processes, or products
is helpful.

The criteria for occurrence rankings fall under the categories of:
• persistency of occurrence
• frequency of occurrence, and
• likelihood of occurrence.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Situational Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Remedies for Situations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Unavoidable Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . 77
Financial Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . 77
How Often?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Tolerating Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Measuring Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Is a One-time Failure OK?. . . . . . . . . . . . . . . . . . . . . . . . . . 78
The Importance of Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Taking Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Is “Too Often” Too Much? . . . . . . . . . . . . . . . . . . . . . . . . . 80
According to Whom?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Determining Acceptability. . . . . . . . . . . . . . . . . . . . . . . . . . 81

75
76 Criteria for Occurrence

Topic Page
Guard Against Becoming Over Zealous. . . . . . . . . . . . . . . . 81
Good Enough. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Parts per Million. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
How Much Control is Enough?. . . . . . . . . . . . . . . . . . . . . . 82
Weigh the Costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Too Stringent or Too Lax. . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Subjective Frequency of Occurrence Criteria . . . . . . . . . . . . 83
Tolerable Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Situational The circumstances under which a failure occurs constitute the “situational
Occurrences occurrence.”

For example, if a tire goes flat on an automobile, that is considered a failure.

However, what were the circumstances under which the tire went flat?

Did the tire go flat because of:

• a blowout due to
– hitting an obstruction in the road
– the tire tread becoming too thin
– the tire was a re-tread
– a collision
• a slow leak due to
– picking up a nail in the tread
– the tire being improperly mounted on the rim
– the air valve was broken or dislodged
– improper maintenance of the tire, or
• a blowout or slow leak due to
– driving too fast on poor road conditions, or
– incorrect tire size, model, or style being used
 Criteria for Occurrence 77

Remedies for Identifying the situation under which the failure may occur helps to
Situations determine how to prevent or correct the occurrence.

In the above example with the automobile tires, some of the failures:
• may be unavoidable (collision, picking up a nail in the tire, or hitting an
obstruction in the road),
• could be prevented entirely (regular maintenance, using the correct
specifications), or
• could be avoided via training (don’t drive on certain types of roads, lower
speed of vehicle under certain conditions, etc.).

Unavoidable If a failure is possible, but the occurrence is unavoidable, certain preventive

Occurrences measures might be possible to safeguard against the failure, but the costs of
doing so need to be weighed.

Financial Even if it is known that a failure may occur, how the failure occurs may be so
Considerations infrequent that an organization is willing to assume the cost of replacing or
fixing the item as opposed to preventing what will cause the failure to occur.

There are a number of reasons for this, such as but not limited to:
• the organization is waiting for a new generation of the item to be released
• preventing what may cause the problem is actually more expensive than
replacement or fixing, and
• the failure is associated with something that is already designated for
retirement.

How Often? Determining how long something will run without failing is determining the
frequency of occurrence.

Studies can show that something will run as intended for X amount of hours,
weeks, years, etc.

Mean Time Between Failure (MTBF) is an engineering formula that is used

when controlled failures can be forced or studied.

When feasible, an average occurrence time can be established.

78 Criteria for Occurrence

Tolerating A common gut reaction is “one time is one time too many,” but when
Occurrences conducting an FMEA, every attempt is made to somehow quantify the
frequency of failure.

An example of a failure that is well-tolerated and would not fall under

“one time is one time too many” is the loss of power due to a circuit
breaker tripping:
• The loss of power is considered the failure.
• The circuit breaker performed as intended and therefore did not fail.
• Switching the circuit breaker off-then-on to re-establish power is
considered acceptable.

Measuring The frequency at which a failure occurs can be measured objectively. Those
Occurrences are stand-alone figures.

It is possible to determine that something will fail after so many hours,

weeks, days, months, years, etc. of operation.

The time between failures does not determine acceptability.

Is a One-Time A failure occurring once is usually one time too many. However, this is not
Failure OK? always the case.

Example:

If a light bulb goes out in a display containing many light bulbs, such as
a marquee at a movie theater, one or two failures may be aesthetically
displeasing, but the functionality of the display remains acceptable.

This partial loss of acceptability may be tolerable for a long period of time.
It is even possible that it may never be repaired.
 Criteria for Occurrence 79

The Importance An example of the importance of logs can be seen in a vehicle that
of Logs sometimes needs several attempts before it finally starts.

Once the vehicle is operational, it is common to forget about the multiple

attempts it took to get it started. If struggling to get the vehicle started
happens only once or very infrequently, most likely the failure is tolerable –
and forgettable.

Be aware, though, that a partial loss of acceptability, e.g., sometimes it takes

several attempts to get the vehicle started, can be the proverbial tip of the
iceberg and indicate serious problems elsewhere. If these are not corrected
in a timely manner, expensive repairs or complete loss of functionality may
result either temporarily or permanently.

This underscores the importance of keeping equipment logs, such as for

maintenance, calibration, and operability. Many manufacturers use shift logs
to communicate what happens from one shift to another.

A one-time incident, by definition, means that it will not happen again. It

may even be possible to forget the incident occurred.

Multiple “one-time incidents” are actually “repeat occurrences,” and when

viewed collectively may point to an underlying or more severe problem
promising a much larger, negative impact.

Taking Action Action to bring certain things back to their optimal state typically occurs
when functionality is close to being or is completely lost.

People tend to tolerate a lot until something is lost entirely. This is not
acceptable from a reliability standpoint since one of reliability’s objectives
is to continually satisfy the user.

Therefore, while a user may tolerate that something is less than optimal,
reliability seeks to:
• define what would be considered reliable on a consistent basis, and
• correct anything that might be detrimental to maintaining that state.
80 Criteria for Occurrence

Is “Too Often” Because problems are usually corrected shortly after they occur, generalities
Too Much? are often used to describe how often the failures are occurring.

Since failures are not often recorded and typically are ignored if they do not
directly impact somebody, people develop their own idea of how often they
occur.

Examples of how often failures happen, i.e., their occurrences, are usually
described as:
• “too often”
• “once in a while”
• “not that often,” and
• “sometimes.”

Generalities are not enough on which to base a decision. The investigator

next needs to determine:
• what is meant by the generalities used, and
• the conditions under which the speaker envisions them.

According to Acceptability of occurrences may vary from individual to individual simply

Whom? because one person may be affected by the failure and another is not.

The person who is not affected may assume that, since he or she is not
aware of any adverse impacts, none happened.

When it comes to reliability, this is a dangerous assumption to make.

This is why it is so critical to research the failures and the history of similar
items before assessing something as acceptable or not acceptable.

Input from multiple users and stakeholders may bring an awareness of

concerns or potential problems not otherwise known.
 Criteria for Occurrence 81

Determining So how is occurrence acceptability determined? Many factors are taken into
Acceptability consideration, including but not limited to:
• past performance
• previous downtime
• complaints, and
• customer needs or expectations.

Guard Against In a desire to be the best, some organizations become overzealous with their
Becoming stated quality goals.
Overzealous
It is not necessary for everything to be perfect. In fact, perfection can harm
an organization by imposing unnecessary costs and cutting into the profits.
Many situations and people can be satisfied with “good enough.”

“Good Enough” If a mother orders wooden pencils with her child’s name imprinted on each
pencil, and one in five pencils, or 20%, has a slight print imperfection, is this
acceptable? For most adults, yes – and a child might never notice. There is,
then, latitude within this situation to determine what is “good enough?”

On the other hand, if a parachute fails to open every 1,000 jumps, or every
0.1%, is this acceptable? Never.

Parts per There are quality programs that push for measuring defects by measuring
Million how many are found out of every million items, a.k.a. parts per million.

When it comes to a school child’s pencil, parts per million may be impractical
because it requires too much effort or costs too much to make that
achievable, and the consumer may not be willing to pay for the item with
such a failure occurrence, as a pencil tip breaking, because it is a minor
inconvenience.

When it comes to protecting against the loss of human life or ensuring

personal safety, parts per million makes sense.
82 Criteria for Occurrence

How Much The question now becomes, “What kind of control?” Again, that is relative
Control is and depends on “How important is it?”
Enough?
To determine that answer, consider how the purchaser of a custom-printed
pencil would react to a misprint that occurs one in a hundred, one in a
thousand, or one in a million pencils, and how much the purchaser would be
willing to pay for each defect level of occurrence.

For a cheap, disposable item that will be consumed, such as a pencil, the cost
for preventing defects that run in 1 per million is impractical.

Is it possible? Probably, but does it make sense for the organization or the
consumer? It could overburden an organization while the consumer might
refuse to purchase an item with the inevitable high mark-up passed along for
achieving such a low instance (occurrence) of defects.

Remember that there are always exceptions. If a parent or grandparent is

special-ordering the pencil and is expecting the child’s name to be a first
quality imprint, it might make sense to utilize some controls to ensure there
are no misprints.

Weigh the Again, the frequency of occurrence, how and when the item will be used and
Costs by whom – and quite possibly the frequency of complaints – should be taken
into consideration.

Is there any acceptable number for loss of life due to the malfunctioning of
an item? Certainly never to the deceased or those otherwise affected.

However, public transportation carriers and the agencies that oversee them,
along with the military, unofficially tolerate a certain number of lost lives.
They will focus on safety and do their best to achieve it. They do not want
any unintentional loss of life, but as we all know, it happens.

There will never be a documented value for a tolerable number of lost lives.
 Criteria for Occurrence 83

Too Stringent or A specification can be:

Too Lax • too stringent, causing unnecessary expenses and configuration impacts, or
• too lax, resulting in preventable harm.

When applying a numerical value for a tolerable or unacceptable number of

occurrences, make certain that the numerical specification is reasonable or
appropriate for the failure in question.

It is understandable to seek and use what others have done, but caution
must be executed; it is not always appropriate to implement another
organization’s scales without questioning if the scale is appropriate.

Adopting the criteria for occurrence can require modification because, for
example, some organizations may use 50,000 or even 250,000 occurrences
for a level. Since this book is intended for small business owners and non-
engineers, “too many” occurrences may be as low as 5 or 10.

There are no hard rules when it comes to knowing what to use for
“occurrence.”

To determine the appropriate number of occurrences, one must look at:

• the situation, including complaints and past failures, and
• the organization, its goals, and its policies.

Subjective Frequency of occurrences depends on the item or issue in question.

Frequency of
While it may be acceptable for a pencil point to break “every so often,” even
Occurrence
several times a day, a parachute failing to open is never acceptable.
Criteria
A sample table showing subjective criteria for rating the occurrences of
failures in general is shown in Table 10a.

A sample table showing subjective criteria for rating the occurrences of

failures at a small organization/business is shown in Table 10b.

Note: As always, the rating scale, failure rate, and descriptions are arbitrary.
For example, Table 10a could easily be modified into having only five
ratings with no more than “20” as the rating for the effect.
84 Criteria for Occurrence

EFFECT RATING FAILURE RATE CRITERIA

Almost certain 10 1 in 3 Failures almost certain to occur; history

shows many failures

Very high 9 1 in 5 Very high number of failures

High 8 1 in 10 High number of failures

Moderately high 7 1 in 20 Frequent failures

Medium 6 1 in 80 Moderate number of failures

Low 5 1 in 400 Occasional number of failures

Slight 4 1 in 2,000 A few failures

Very slight 3 1 in 4,000 Very few failures

Remote 2 1 in 10,000 Remote number of failures

Almost never 1 1 in 30,000 Failures very unlikely

Table 10a. Subjective Criteria Example for Occurrence in General.

EFFECT RATING FAILURE RATE CRITERIA

Almost certain 5 1 in 5 Failures seem to occur all the time

High 4 1 in 15 Failures occur frequently or too often

Medium 3 1 in 30 Failures occur more times than we like,

but not always

Low 2 1 in 50 Once in a while, a failure will occur

Never 1 1 in 100 A failure has never occurred with this

Table 10b. Subjective Criteria Example for Occurrence at a Small Organization/Business.

 Criteria for Occurrence 85

Tolerable There is no doubt that certain failure occurrences are tolerable.

Occurrences
If the seat of a pair of pants wears out after five years of use, chances are
good that most people will find this satisfactory. There are also individuals
who place more value on how fashionable an item is as opposed to how
long the clothing piece will last before it shows signs of wear. Since fashion is
constantly changing, five years’ use of an item may be unimaginable.

Therefore, what is tolerable depends on the item as well as the

circumstances.

In another example, nobody expects a flashlight’s batteries to last forever.

Although users do not usually define a specific time period for the life of a
battery, they do have certain expectations that battery replacements should
not to happen “too often” and the longer the batteries last, the happier the
users.

Users understand that a flashlight’s batteries will fail eventually and that there
will be a cost to replace the batteries, which are typically regarded as a minor
inconvenience.

However, if the flashlight’s batteries fail during a storm, a crisis situation,

or an electric power loss, if there are no replacement batteries present or
available, the failure is unacceptable, no matter how inexpensive it might be
to replace the batteries.
(This page intentionally left blank.)
 Flowchart –
Determining Occurrence

Something needs to be
assessed for occurence.

Can
Can
Determine when, Failure safeguards
outside
where, & how beyond control prevent or
Yes failure be Yes
often failure of system or detect the
anticipated?
happens. process? outside
failure? No

No No

Any Determine
previous how often
failures for No
failure
similar occurs.
situations?
Yes Yes

No Are
safeguards
cost effective?

Failure
Was the No element
root cause mechanical, Rate for
determined? training, Yes occurence.
etc.?
Yes
Can Yes
safeguard(s)
Yes No be
implemented?

Yes
Use root Establish
cause CAPA Is the safeguards to
as basis for failure prevent, correct,
improvement. design or detect failures.
related?

No Determine
No frequency of
failure now.

87
(This page intentionally left blank.)
 Criteria for Detectability

Introduction Knowing when, how easily, and where a failure can be detected determines
its rating for detectability.

Some failures can be anticipated, in which case, prevention controls can be

designed to prevent the failure from happening.

Some failures are tolerable and, if detected after the fact, can be easily
corrected.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Detecting When?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Detecting What?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Yes/No . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Subjective Detectability Criteria. . . . . . . . . . . . . . . . . . . . . . 91
Caution with Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Root Cause of Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

89
90 Criteria for Detectability

Detecting Detectability of failures is easier to determine than the other criteria, because
When? failures are often obvious. However, it is important to remember that
detecting a failure will not always be possible.

For example, building remodelers hoping to make a simple improvement or

repair encounter problems that were hidden beneath a surface that appeared
to be without issues or that a small repair would fix.

In cases where detecting the failure is not easy or always possible, turn to
what is the known reliability, for example, a roof will be good for 20 years, as
well as taking into consideration what is known to cause damage, such as ice
dams on a roof.

When detectability is not easy, it becomes important to maintain logs and

perform regular, recommended maintenance.

Detecting Some failures are detected by controlling and monitoring the specifications.
What?
Other times, it may be cost prohibitive or impossible to check for an actual
specifications, but it is possible to monitor or check the process which the
item is going through to ensure that it is correctly processed.

Examples:

A Social Security Number (SS#) has a specific format, XXX-XX-XXXX. When

setting up a field for a SS#, the field can be:
• limited to accept only numerical characters
• set-up to test for the presence of nine characters, and
• set-up to test for certain numbers in certain placements that are never
used by Social Security.

When processing a member’s eligibility, one factor alone (a specification)

does not determine if the member is eligible or not. Multiple requirements
must be entered and if all of these test “true” as a collective unit, then
eligibility is established.

Yes/No Detectability of failure is often a simple case of yes or no:

• Yes – something is present, something works as intended, etc., or
• No – something is not present, something is not permitted, or something
is not working as intended, etc.
 Criteria for Detectability 91

Subjective A sample table showing subjective criteria for rating the occurrences of
Detectability failures in general is shown in Table 11a.
Criteria
A sample table showing subjective criteria for rating the occurrences of
failures at a small organization/business is shown in Table 11b.

Note: As always, the rating scale, failure rate, and descriptions are arbitrary.

EFFECT RATING CRITERIA

Almost 5 We have no controls in place to detect a failure.

impossible

Low 4 We have some controls in place that can detect certain types of
failures.

Medium 3 We constantly monitor what we know has the potential to fail.

High 2 We have controls in place that will detect most potential

problems so we can stop them from happening.

Almost 1 We know exactly what needs to be controlled; our prevention

certain efforts eliminate the need to detect.

Table 11a. Subjective Criteria Example for Detectability in General.

EFFECT RATING CRITERIA

Almost 5 We don’t detect failures; when they happen, we deal with them;
impossible they’re a part of life.

Low 4 If a customer complains, we respond, but we don’t change how

we normally do things.

Medium 3 We usually notice when problems keep repeating and go

looking for why the problems keep happening in order to make
them stop.

High 2 Employees are trained to identify potential issues and log them
in so we can respond swiftly.

Almost 1 We have systematically looked at all our processes, corrected

certain potential problem areas, and implemented controls to alert us of
any problems.

Table 11b. Subjective Criteria Example for Detectability at a Small Organization.

92 Criteria for Detectability

Caution with Table 11a illustrates another problem with subjective criteria for detectability.
Definitions
Note that in the “Almost Impossible” category (rating 10), the definition
states, “No controls in place to detect the failure.” This implies that controls,
had they been in place, could have detected the failure.

Situations can exist where no controls are possible, which is different from
the above. In quality engineering, a “closed system” is one example of this.

Note: A closed system is a process within a machine where there is no

way to determine if the item undergoing processing is changing as
it should. Proper processing can only be determined after the item
has been completed process (after the fact). Examples of a closed
system would be plating or pottery baked in a kiln. While there may
be no way to detect how the item is responding in a closed-system
process, it is possible to control the elements/variables controlling
that process. Other controls include ensuring that the raw materials
or pro-processing of the item are correct and optimal before the item
entered the closed-system.

“Almost impossible” can also include events or actions beyond the realm of,
or control of, the item in question.

Root Cause of If something fails due to being impacted by an unanticipated unknown

Failure outside of its intended use, there would be no way that controls could have
been in place to detect that failure.

Rather, the failure is due to the unknown being able to reach or impact the
item. Therefore, the failure is not actually due to the item.

Example:

If my fully functional automobile gets crushed by a meteorite falling from the

sky and is no longer operational, the failure is not due to the car.

Furthermore, no vehicle is ever going to be equipped with controls to detect

falling meteorites.

A better definition would be, “Failure is beyond the scope of the item.”
 Flowchart –
Determining Detectability

Something needs to be
assessed for detectability.

Identify where Does this apply Identify where

failures can occur. Design to design Process failures can occur.
or process?

Could design
modifications No
eliminate
failure?

Yes Do controls Could design

detect if a failure No modifications
occurs? detect failure?

Modify design to Yes

eliminate failure.
Yes
Yes

Could design
Modify design to
modifications
detect failure.
correct failure?
Any remaining Yes
failure risks?

Modify design to
correct failure.

No

No No

Rate for detectability risk.

93
(This page intentionally left blank.)
 Criteria for Criticality

Introduction “Criticality” is a word with multiple meanings and is often interchanged

with “critical.”

How critical something is to an organization is a relative consideration.

An issue or a concern can be critical at one point and yet, at another point,
not critical at all. For example, what is critical in a start-up phase differs from
what is critical in the design or operational phases.

Critical can be arbitrary, such as when an organization has designated its

reputation as critical; a business owner may decide that the organization
will be known as best in its city or for providing 24-hour service, friendly
customer service, on-time delivery, etc.

Critical can also be subjective, as when people go with a gut feeling, such as,
“I don’t like the sound of that,” or “something isn’t right here.” There may
or may not be any hard evidence backing these conclusions, but individuals
will pursue them until they are satisfied no risk exists. A gut feeling is not
necessarily unreliable. People can intuitively and accurately respond to
something based on their training, skills, and experience.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Standard Critical Classifications. . . . . . . . . . . . . . . . . . . . . . 96
Critical is Subjective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Criticality is Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Once Can be Enough. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Moving Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Conformance to Requirements. . . . . . . . . . . . . . . . . . . . . . 97

95
96 Criteria for Criticality

Topic Page
Not that Important. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Doing It Right the First Time. . . . . . . . . . . . . . . . . . . . . . . . 98
Short-Sightedness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Preventive Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Sample Subjective Criticality Table. . . . . . . . . . . . . . . . . . . . 99

Standard Critical Many organizations have adopted some version of the US Department of
Classifications Defense’s classifications for criticality.

Without applying these classifications to a specific industry or organization,

they are generally regarded as follows:
• Category I: Catastrophic – Involves loss of life or renders something so
useless that it is beyond any recovery or repair
• Category II: Critical – Involves severe personal injury, major property
damage, or major system or functional damage that will cause significant
downtime to the organization or company
• Category III: Marginal – Involves minor injury, minor property damage, or
minor system damage that would result in delays or loss of availability
• Category IV: Minor – No personal injuries, property damage, nor system
damage, but does cause unscheduled maintenance or requires minor
repairs.

Critical is Certain things are always important to an organization and would therefore
Subjective be considered critical. For example, not violating laws and being in regulatory
compliance. Making money would be another as companies exist to be
profitable.

What is critical to an organization, individual, or a customer is determined by

those entities, and, therefore, is subjective.
 Criteria for Criticality 97

Criticality is “Criticality” is more objective. It is not arbitrary.

Objective
It pertains more to “either it is or it isn’t.”

Criticality is concerned about:

• continued functionality
• low risk, and
• probability of occurrence.

Once Can be A one-time determination of criticality can be enough and it may not
Enough necessarily take a formal study to conclude that. For example, ordering
the wrong components, sub-standard raw materials, or processing a claim
incorrectly.

A one-time formal study to determine the effect of something may be

desired in certain cases, such as “if we pursue this route, what negative
impacts would doing X have on Y?”

Moving Target Since what is critical or important can be a moving target, it is important
to verify that anything that is considered critical at the time of the FMEA
assessment is:
• identified
• still current, and
• sufficiently defined to prevent misinterpretations.

Conformance to For reliability professionals, quality is conformance to requirements, not

Requirements “goodness,” “nice to have,” or something that might be considered
superior.

In order to have conformance to requirements, one must first have the

requirements. While that sounds simple and obvious, the fact is that often
guesses and “good enough” are used for requirements.

Requirements often deal only with “what we want” as opposed to also

considering “what we don’t want.”
98 Criteria for Criticality

Not that There is a mindset that certain things are just “not that important.” This is
Important sometimes interchanged with certain aspects being “not that critical.”

It can happen that the classification “not that critical” is applied because
looking into the matter would require some effort as well as delays.

However, if dismissal ultimately costs an organization a loss of products,

services, deadline adherence, reputation, customer satisfaction, or market
share, or results in fines or sanctions, what was once considered “not that
important” or “not that critical” is elevated, in hindsight, as something that
should not have been overlooked.

It is the lack of understanding of what is required, and failing to prevent the

failures or failing to ensure that the desirable will happen, which adversely
impacts an organization financially.

The time, money, and effort that goes into correcting an unacceptable
development far exceeds any time, money, or effort that would have gone
into studying and designing to avoid such developments.

Doing It Right Quality guru Phil Crosby dryly noted that, “There is never enough time to do
the First Time it right the first time, but there is always enough time to do it over.”

His book, Quality is Free, was based on the premise that if you know the
risks, the needs, and concerns, you can design to prevent failures from
happening and thus eliminate the costs of repair, delays, warranties, product
failures, or dissatisfied customers.

Crosby advocated that it is not good (the desired) quality that adversely
impacts an organization financially; it is the cost of correcting and regaining
ground lost by poor quality. These costs are unnecessary and avoidable.

Short- While no organization has unlimited resources and time, dismissing

Sightedness something because it would require effort is short-sighted.

Short-sighted thinking has resulted in avoidable costs and loss of business

reputations. Phil Crosby called the short-sighted thinking “the cost of
poor quality.”
 Criteria for Criticality 99

Preventive As an organization initially adjusts to routinely conducting in-depth analyses,

Efforts because that type of analysis was not routinely done before, there is a
demand on time and resources.

Fortunately, most companies offer standardized products and services. Once

standardized policies, products, and services are in place, future preventive
efforts can reliably draw off of previous work. It will not be necessary to
“re-invent the wheel” every time. The demands on research and
development are reduced.

The preventive efforts that ensure the good and prevent the bad are why
Crosby said that “quality is free.”

Sample Subjective criteria that could be used for a criticality table are shown in
Subjective Table 12. In this example, the organization is considering a new product line.
Criticality Table

EFFECT RATING CRITERIA

Severe 4 Cannot effectively compete in the market

Undesirable 3 A significant advantage has not been identified

Moderate 2 Would equalize standing with competitors

Minor 1 Slight advantage over current offerings

Table 12. Subjective Criteria Example for Criticality.

(This page intentionally left blank.)
 Flowchart –
Criticality Assessments

Something needs to be
assessed for criticality.

Assessing Identify
Identify what
Failure for failure where
failures Reliability
impact impact or failures
can occur.
reliablility? can occur.

Determine What is the

Is failure easily What are the
how far the probability
detected? current controls?
failure impacts of occurrence?
can reach.

Determine Is risk
severity of No
tolerable?
impacts.

Can cost
effective
No
controls be
Yes created?
Yes

Alert company
Any of risk.
remaining
Yes
failure risks?

No FMEA completed.

101
(This page intentionally left blank.)
 Processes, Stages,
Tasks, and Steps Defined

Introduction In order to effectively perform an FMEA investigation, it is important to be

able to identify the main process involved and then break the process down
into its stages and tasks, and then the steps that compose each task.

Process, stage, task, and step all can be defined in multiple ways.

The section defines process, stage, task, and step, as well as provides
guidance on how to distinguish them from each other.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Process Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Stage Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Task Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Step Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Drilling Down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Outline Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Stages, Tasks, and Steps Examples. . . . . . . . . . . . . . . . . . . . 105

Process For the purposes of this book, process is a noun defined as a series of high-
Definition level actions grouped into stages, also known as “phases,” directed toward
achieving a general goal or objective.

Stage For the purposes of this book, stage is a noun defined as a group of actions
Definition within one high-level phase of a process.

103
104 Processes, Stages, Tasks, and Steps Defined

Task Definition For the purposes of this book, task is a noun defined as one of a series of
specific or clearly defined jobs or work efforts within one stage of a process.

Step Definition For the purposes of this book, step is a noun defined as one action in a
sequence of consecutive actions to accomplish a specific task.

Drilling Down Moving from process to stages to tasks to steps is a “drilling down” effort.

In other words, the FMEA investigator is moving from general, high-level

information to specific activities in a progressive, more-detailed manner.

Outline One way to view how a process, stages, tasks, and steps relate to each is in
Structure an outline structure, as depicted below.

Process
1. Stage 1
a. Task 1
i. Step 1
ii. Step 2
iii. Step 3 etc.
b. Task 2
i. Step 1
ii. Step 2
iii. Step 3 etc.
2. Stage 2
a. Task 1
i. Step 1
ii. Step 2
iii. Step 3 etc.
b. Task 2
i. Step 1
ii. Step 2
iii. Step 3 etc.
3. Stage 3 (continue by sequential stage with tasks and steps as appropriate)
 Processes, Stages, Tasks, and Steps Defined 105

Stages, Tasks, Examples of the stages of a process, such as receiving a shipment, and some
and Steps of its related tasks and steps are given below.
Examples
Process – Receiving a Shipment

Receiving Stages
1) Verify
2) Unload
3) Break apart
4) Re-palletize
5) Route
6) Stock

Tasks in Verifying Shipment

a. Verify the shipping destination is correct (if multiple delivery points)
b. Items’ descriptions match items on purchase order
c. Amount received matches amount indicated as delivered
d. Cartons are inspected for obvious damage
e. Sign for the shipment

Steps in Signing for the Shipment

1. Amount delivered matches amount ordered
2. Carton labeling is correct and properly placed on cartons
3. Purchase order is indicated on paperwork
4. Sign & date
5. Route paperwork to Accounts Payable
(This page intentionally left blank.)
 Graphic – Example of Receiving
Process, Stages, Tasks, and Steps

Introduction A graphical depiction of a receiving process’ stages, tasks, and steps is

shown below.

• Verify shipment
• Unload
Receiving • Break shipment apart by need
(Stages in a process) • Re-pallatize by need
• Route according to need
• Stock any surplus inventory

• Verify shipping destination is correct

(if multiple locations)
Verify shipment • Items’ description matches purchase order
(Tasks in a stage) • Amount received matches delivery papers
• Items inspected for damage
• Sign for items

• Verify delivered amount matches amount ordered

• Verify carton labeling & positioning are correct
Signs for Items • Verify purchase order is indicated on paperwork
(Steps within a task) • Sign & date
• Route paperwork to Accounts Payable

107
(This page intentionally left blank.)
 How to Conduct an FMEA

Introduction This section provides general guidance on how to conduct an FMEA.

The flowchart following the section gives an illustrated breakdown of the

main stages of an FMEA.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Identify What to Analyze. . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Identify the Stakeholders. . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Assemble the Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Verify Critical Concerns. . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Determine What to Analyze . . . . . . . . . . . . . . . . . . . . . . . . 111
Past Efforts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
FMEA Stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Advising Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Implemented Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Final RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Archive FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

109
110 How to Conduct an FMEA

Identify What Determine specifically what needs to be analyzed; in other words, identify the
to Analyze scope of the investigation. It should not be too broad, but detailed enough
to provide information on which to base reasoned decisions.

An FMEA can be used for an entire process or just certain elements of it.

Also, there is no need to repeat a whole effort if a satisfactory investigation

into something quite similar has been done previously and the information is
still current. If an FMEA is still desired, consider limiting the FMEA to the area
that adds new information to the study.

If a scope has been examined and its limits have been reached, questions
may still remain or new concerns may have arisen. In these cases, it is better
to generate a new FMEA than to broaden the scope of the present one.

Identify the Determine who has oversight of the areas that might be adversely impacted
Stakeholders should a failure occur.

Inform them of the proposed study and ask if they can assign someone to be
the point person for the FMEA.

Assemble The team typically is comprised of:

the Team • the FMEA Coordinator (the person actually conducting the FMEA)
• stakeholders or their designated representatives, and
• subject matter experts.

Verify Critical While certain concerns or requirements may have already been stipulated,
Concerns certain things may have been overlooked.

Before going further, verify that the following have been identified:
• Product- or service-specific requirements
• Departments, operations, personnel, etc., involved in the process
• Any concerns, needs, and expectations of the above
• Any security requirements
• Any confidentiality requirements
• Any other organization policies that might apply
• Any other corporate policies that might apply
• Customer needs, concerns, and expectations as appropriate, and
• Any outside governances such as regulatory requirements.
 How to Conduct an FMEA 111

Determine What After taking the critical concerns into consideration and meeting with the
to Analyze FMEA team, determine exactly what needs to be analyzed.

Past Efforts Once the FMEA’s target has been identified, research and collect any
information regarding past failures or efforts that relate to the matter or are
similar in nature.

Sources of information include:

• Complaint records
• Operational logs
• Maintenance records
• Gap analyses
• Root cause analyses
• CAPAs, and
• Executed FMEAs.

FMEA Stages The stages of an FMEA are shown in Table 13.

STAGE DESCRIPTION
1 Identify what will be analyzed and why.
2 Identify the stakeholders, subject matter experts, and approvers.
3 Identify the tasks and their respective steps involved.
4 Identify the inputs/actions that can go wrong.
5 Identify the ways the failures can affect other things.
6 Identify the potential causes or sources of the failures.
7 Identify any controls in place to prevent failures.
8 Identify any controls currently in place to detect the failures.
9 Calculate the initial RPN and determine if improvement actions are desired.
10 If no improvements are required, the FMEA is closed; otherwise, recommendations
follow.
11 Recommend needed changes and identify the individual(s) responsible for
addressing the recommendations.
12 Identify the mitigation efforts and implemented controls.
13 Recalculate the RPN after the mitigation controls are in place.

Table 13. Completing an FMEA Template.

112 How to Conduct an FMEA

Advising Advising needed changes are recommendations.

Changes
Specific changes will be made by the appropriate subject experts in
accordance with their policies and methods.

Implemented Implementing changes will improve the RPN.

Changes
Recalculate the RPN after the prevention and detection controls have been
implemented.

Final RPN The final RPN is either:

• the RPN determined when no changes are required, or
• the recalculated RPN after changes have been implemented.

Archive FMEA Archive the completed FMEA along with its related materials, e.g.,
documents, policies, etc.
 Flowchart –
Conducting an FMEA

Identify the areas Identify Assemble the

likely involved. stakeholders. FMEA team

Organization’s Verify critical Customers’ or Clients’

concerns.

Identify any
Complete
related executed Determine
investigation
FMEAs, root cause what to
section on FMEA
investigations, analyze.
worksheet.
& CAPAs.

Calculate Make report(s)

initial RPN. as appropriate.

Are there
Make Complete FMEA form &
risks that need
recommendation Yes No archive FMEA-related
to be
for changes. documents.
controlled?

Identify individuals
responsible for
developing and/or
making changes.

Ensure
mitigations Recalculate
& controls RPN after
have been implementations.
implemented.

113
(This page intentionally left blank.)
 Graphic –
FMEA Worksheet
Failure Mode & Effects Analysis Worksheet
FMEA # Task Name Facility Project ID # SME #1 / Department Customer

Start Date Total Steps Department Manager SME #2 / Department Completed By

Process Name Step # Design Rev # Design SME #3 / Department Approved by

Process Stage – Describe the process stage under development

or study.
Potential Failure Mode – In what ways can the key input(s)/ 1.
actions go wrong? 2.
3.
4.
Potential Failure Effects – In what ways can the above failures 1.
affect other things? 2.
3.
4.
Cause or Source of Potential Failure – Indicate (C) for Cause 1.
or (S) for Source. Cause means the cause of the potential failure
has been identified as located in the area under investigation and 2.
will be addressed under this FMEA. Source means the source of 3.
failure must be located outside the area under review and there is
a need for further investigation independent of this FMEA. 4.
Current Prevention Controls – What are the existing controls 1.
and procedures (inspection and test) that prevent either the cause 2.
or the Failure Mode? State procedure (number) that exists or
note if there are no controls. 3.
4.
Current Detection Controls – What are the existing controls 1.
and procedures (inspection and test) that detect the Failure 2.
Mode? State procedure (number) that exists or note if there are
no controls. 3.
4.
Initial Rating – Create & use rating scales Severity (S) – measure of the possible consequences of a failure to a
user, customer, process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring.
Detectability (D) – The probability that the failure mode will be
detected before used internally or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D
Recommended Changes – What are the recommended 1.
improvements? 2.
3.
4.
Responsibility – Who is responsible for the recommended 1.
action(s)? 2.
Mitigation Action/Control Implemented – What were the 1.
actions for reducing the occurrence of the cause or improving 2.
detection?
3.
4.
Updated Rating – Use the rating scales Severity (S) – measure of the possible consequences of a failure to a user,
customer, the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Detectability (D) – The probability that the failure mode will be
detected before used internally or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D
Criticality Comments 1.
2.
3.

115
(This page intentionally left blank.)
 Worksheet’s Structure
and Purpose

Introduction The FMEA worksheet’s objective is to capture as much information as

possible relevant to an FMEA analysis.

This section describes:

• how an FMEA worksheet is laid out
• the differences between worksheet orientations
• the importance of dating information
• how to handle attachments and supplemental information, and
• the main sections of an FMEA worksheet.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
The Layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Worksheet’s Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Worksheet’s Orientation. . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Preferred Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
All the Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Beyond the Worksheet – Attachments &
Supplemental Information. . . . . . . . . . . . . . . . . . . . . . . . . . 119
Types of Attachments & Supplemental Information. . . . . . . 119
Important. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Historical Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Preserving as Much as Possible. . . . . . . . . . . . . . . . . . . . . . 120
How Much to Preserve. . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Worksheet Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

117
118 Worksheet’s Structure and Purpose

The Layout The FMEA worksheet is laid out in the logical progression of an FMEA
investigation and analysis.

In other words, the worksheet starts with the initial information and works
through to the end of the study.

Worksheet’s The worksheet’s objective is to ensure that all steps in the study have
Purpose been addressed.

Worksheet’s FMEA worksheet samples often show a worksheet laid out in a landscape
Orientation (horizontal) format, which can be cumbersome if the user does not normally
scan for information from left-to-right, but from top-to-down instead.

Some assume that a left-to-right, horizontal orientation is the only way that
an FMEA worksheet may be laid out.

Since most English-speaking readers are used to documents being in a

portrait (vertical) orientation, and scan for information from the top down,
a vertical orientation is often an easier way to determine one’s progress
through an FMEA, which is why the worksheet is presented vertically.

Preferred A worksheet set up with a horizontal orientation means the reader must read
Orientation long rows of information. Certainly, this is possible, but it is not the norm for
most people, which can make the reader uncomfortable.

An uncomfortable reader may miss important information or find it difficult

to locate information previously read.

None of these obstacles are so large that they preclude using a horizontal
orientation if that is what is desired.

Use the orientation that:

• suits (matches) the formats of the materials associated with the
analysis, and
• is easier for those who will be reading the FMEA analysis.

In the end, it is irrelevant for the success of an FMEA analysis if the worksheet
information is laid out horizontally or vertically.

It often comes down to personal preference.

 Worksheet’s Structure and Purpose 119

All the A worksheet is a summary sheet of the information used in an FMEA

Information situation.

It may not be possible or practical to include all the information relevant to

an FMEA analysis on the worksheet, especially when that information:
• contains one or more databases
• are policies belonging to a customer or an outside authority, or
• is published on a website or in a book.

Beyond the Attachments or supplemental information may make up a part of an FMEA

Worksheet – investigation.
Attachments &
The attachments or supplemental information typically show:
Supplemental
Information • what provided direction for the FMEA analysis
• what the FMEA conclusions were based on, and
• what information and/or policies were relevant at the time of the
investigation.

Types of Types of attachments or supplemental information may include:

Attachments & • hard copies of the relevant data (remember that data may be constantly
Supplemental update or fields revised – the objective is to capture the data that was
Information used for the FMEA analysis)
• links to databases
• links to internal or Internet websites
• screenshots of relevant information
• blueprints or drawings
• hard copies of policies, and
• other documents.

Important Always provide a date, revision (if applicable), view (if applicable), and source
for every attachment or supplemental information used in the FMEA.

Historical Particularly for gap analyses or liability issues, an FMEA’s file demonstrates
Accuracy what was relevant and considered at the time of the FMEA analysis.

Therefore, it is critical to cite, usually by date or/or revision, exactly what was
valid at the time of, or used for, the analysis.
120 Worksheet’s Structure and Purpose

Preserving as Keep in mind that policies and methods change over time, sometimes
Much as Possible frequently.

Websites and databases can be in a continuous state of flux.

Websites, databases, and any links can eventually disappear entirely.

The FMEA investigator will understand that it will be impossible to capture

everything that might be relevant or used in an FMEA, and it is also
impossible to anticipate every future need for the information.

Therefore, the FMEA investigator might want to:

• create documents with the most pertinent information, e.g., screenshots
pasted into Word documents and then saved, or
• write up as a separate report what was found and record the sources of
that information.

How Much to How much to preserve depends on the scope and purpose of the FMEA.
Preserve
Preserve enough so that anyone needing to review a completed FMEA will
conclude that “due diligence” was exercised.

Those who would determine what needs to be preserved may be:

• the FMEA investigator
• the FMEA’s approver
• the customer requesting the FMEA, or
• legal counsel.

Worksheet The main sections of the FMEA worksheet and their contents are shown in
Sections Table 14.
 Worksheet’s Structure and Purpose 121

NO. SECTION CONTENTS

1 Header Identification of:

• what is being investigated
• where investigation is being conducted
• who contributed to the investigation, and
• who conducted the investigation

2 Descriptions of Descriptions of:

Current Situation • what can go wrong
• how things can go wrong
• the sources of the potential failures, and
• what is currently in place to prevent failures from
happening (detection controls)

3 Rankings of Fields to enter the rankings of the:

Current Situation • severity of the impacts should the failures occur
• frequency of failures occurring, and
• the ease of detecting the possible failures

4 Recommendations Initial recommendations for the:

for Improvements • controls or changes to reduce or eliminate the failures,
and
• individuals, roles, or departments responsible for making
these improvements

5 Actual changes Description of what actually was done to mitigate or

eliminate the possible failures

6 Rankings after Fields to re-assess (rank again) the:

Improvements • severity of the impacts should the failures occur
• frequency of failures occurring, and
• the ease of detecting the possible failures

Table 14. Sections of an FMEA Worksheet.

(This page intentionally left blank.)
 The Value of the
Worksheet Header

Introduction The FMEA worksheet header contains a goldmine of information for the
FMEA investigator, quality professionals, developers, managers, auditors, and
other interested parties.

In order to understand the value of what the worksheet header offers, this
section explains:
• the importance of the header information
• the differences between tasks and steps
• why the information is so important, and
• how future users may benefit from the information.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Completing the Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
N/A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Optional Header Information . . . . . . . . . . . . . . . . . . . . . . . 124
Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
High Process Levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Operational Processes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Operational Task Examples . . . . . . . . . . . . . . . . . . . . . . . . . 126
Task Steps Example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Header Process Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Process Header Information . . . . . . . . . . . . . . . . . . . . . . . . 128
Header Contributor Information. . . . . . . . . . . . . . . . . . . . . 130
Contributor Header Information. . . . . . . . . . . . . . . . . . . . . 130

123
124 The Value of the Worksheet Header

Completing the Completing the header thoroughly and accurately is important for a number
Header of reasons, including but not limited to:
• efforts will not be unnecessarily repeated in future FMEA studies
• the decision makers, i.e., the individuals involved, are readily identified
• there is a record that all steps identified in the area under investigation
were addressed and not inadvertently overlooked, and
• in the case of a liability issue or major failure, a record of mitigation efforts
exists.

N/A To show that the field was taken into consideration and not overlooked,
do not leave it blank. Instead, enter “N/A” (not applicable) in the field to
indicate that particular field does not apply to the FMEA.

Optional Header The header contains fields for entering information, but those fields may not
Information apply to a particular FMEA investigation.

The individual conducting the FMEA analysis must determine the appropriate
optional fields to complete.

The optional fields are:

• Customer – the situation may not pertain to one particular customer or
any customers at all
• Design – sometimes a specific design is being assessed, but other times, a
design may not be involved at all – complete as appropriate
• Design Rev # – a design and its revision number may not be involved
• Project ID # – sometimes an FMEA is part of a project that has its own
ID number; if that is the case, include the number here for traceability
purposes
• Process Step & Process Name – A process may not be involved; for
example, the situation may involve “what would happen to our market
reputation if we did X or did not do Y”
• Design Rev # – Applies only if a specific design and its revision are involved
• SME #2 & SME #3 – It may not be necessary to involve a second or third
subject matter expert or department
 The Value of the Worksheet Header 125

Header Below is the header on the FMEA worksheet.

It is divided into two main sections:

• Process section
• Contributor section

The process section identifies the process undergoing the FMEA analysis.

The contributor section contains fields for the responsible job function or
department contributing the FMEA.

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer

Start Date Total Steps Department Manager SME #2 / Department Completed By

Process Name Step # Design Rev # Design SME #3 / Department Approved by

High Process If the issue under the FMEA investigation is very high level, it may be
Levels regarded as an action, or inaction, as opposed to a process.

Examples of high-level impacts would be, but are not limited to:
• if X becomes law, how would that impact the organization
• failing to disclose known hazards, or
• offering a discount at a certain time of the year.

In cases such as these, the intent is simply to determine the impacts and the
possible risks if such events happened or failed to happen. There would be
no process involved, and consequently, there would be no need for any tasks
or steps.
126 The Value of the Worksheet Header

Operational All companies have their ways of conducting business, which are their
Processes “operational processes.”

Note: T hese should not be confused with “Operations,” which is concerned

with how the organization maintains itself apart from the production
or services the organization provides to its customers.

All operations have at least three tasks:

• receiving the work
• doing the work, and
• handling the completed work.

Each of these tasks has at least three steps, activities that:

1. start the task
2. perform the task work, and
3. finish and route the work to the next task.

Note: Section “Processes, Tasks, & Steps” provides detailed information on

the above.

Operational Task An example of an operational task is needing to purchase something. The

Examples example of Engineering needing a certain type of software is shown in
Table 15.

STEP ACTION

1 Verify purchase request information is complete and accurate

2 Find supplier to make purchase from

3 Complete purchase form

4 Route purchase order to designated locations

Table 15. Purchasing Task – Make Purchase.

 The Value of the Worksheet Header 127

Task Steps In the above examples, Purchasing would not have only three tasks involved.
Example Within each task would be a series of steps that would need to be followed
to complete the task.

The steps are the detailed activities. For the above example tasks, Purchasing
may use the steps as shown in Tables 16, 17, and 18.

STEP ACTION

1 Ensure that the purchase request has been approved.

2 Ensure that the information regarding what to buy and how much is accurate
and complete.

3 Verify the “needed by” date.

Table 16. Start Purchase Request (Purchasing Task 1).

STEP ACTION

1 Determine if there is anything unique about the item that it can only be
purchased from one source, a.k.a. “sole supplier.”

2 Determine if any of the organization’s approved suppliers offer the item for sale
at a price that meets the approved expense.

3 If approved suppliers offer the item, determine which supplier is offering the
best terms for purchasing.

4 If no approved suppliers exist, find a supplier which would meet the

organization’s purchasing policies, a.k.a. qualifying as a supplier.*
*Qualifying a supplier has its own set of tasks, each with its own set of steps.

5 Select supplier based on the best matches determined from above appropriate
steps.

Table 17. Find Supplier (Purchasing Task 2).

128 The Value of the Worksheet Header

STEP ACTION

1 Obtain supplier’s ordering information for item.

2 Complete information on purchase order.

3 Send purchase order to supplier.

4 Route copy to Accounts Payable.

5 Upload purchase order into system so Receiving can access it when shipment
is received.

Table 18. Place Order (Purchasing Task 3).

Header Process Below is the section of the header that pertains to the process under the
Section FMEA investigation. These are grouped together for ease of reference.

FMEA # Task Name

Start Date Total Steps

Process Name Step #

Process Header The fields for the process header information, and the reasons why this
Information information is provided, are shown in Table 19.
 The Value of the Worksheet Header 129

FIELD NAME INFORMATION REASONS FOR INFORMATION

FMEA # The number assigned to • Every FMEA study should be assigned its own
the FMEA study unique number as part of document control
• Serves as a quality control that the correct
FMEA was obtained for a reference
• A unique Identification number makes it easy to
track down the information at a later date
• Consider using two digits to identify the year
in which the study was conducted in the
identification number

Start Date The date the FMEA was • FMEAs always have a start date, but they are
started not always completed
• Be consistent with dating things – people can
interpret dates differently
• Without a date, FMEA study is meaningless
because one cannot determine what time
period the information applies to

Process Identifies the name of • Identifies what process this applies to, e.g.,
Name the process where FMEA Receiving, Assembly, Claims, Finishing etc.
applies • A process may have risks or needs for controls
that other processes do not require

Task Name Identifies the task within • Processes usually contain multiple tasks
the process • Serves as a quality control that ensures that all
tasks were identified
• A separate worksheet should be used for each
task in a process
• Serves as a quality control that ensures that all
tasks are addressed
• Identifies if only one or a limited number of
tasks were investigated

Table 19. Process Header Information. (continued)

130 The Value of the Worksheet Header

(continued)

FIELD NAME INFORMATION REASONS FOR INFORMATION

Total Steps Identifies how many • Identifies how many steps there are in a task
steps in the task • One task may be under investigation, but it
is conceivable it is, for example, the fourth or
another task in the overall process

Step # Identifies which step is • Depending on the issue, it make be necessary

being investigated to investigate every step in a task; this ensures
each step is accounted for
• Depending on the issue, it may necessary to
investigate only one step in task; this identifies
which step was investigated and help to ensure
the correct step received the investigation

Table 19. Process Header Information.

Header Below are the fields in the header that contribute in some way to the FMEA.
Contributor These are grouped together for ease of reference.
Information

Facility Project ID # SME #1 / Department Customer

Department Manager SME #2 / Department Completed By

Design Rev # Design SME #3 / Department Approved by

Contributor Certain factors and individuals provide parameters for or contribute to an

Header FMEA analysis. The fields for the contributor header information, and the
Information reasons why this information is provided, are shown in Table 20.
 The Value of the Worksheet Header 131

FIELD NAME INFORMATION REASONS FOR INFORMATION

Facility The name of the facility • An organization may own multiple facilities
involved with the FMEA • An organization may move its facility to a new
location – a change of location can alter or
increase risks
• A process can be spread across multiple facilities
• Certain steps may be outsourced
• The FMEA may be conducted off-site, such as
at a supplier’s or customer’s facility

Department Name of the department • Steps can flow through multiple departments
the step belongs to • Serves as a quality control that the step was
associated with the correct department

Design Rev # Input the design’s • Designs are sometimes repeatedly assessed
revision number by revision
• A revision to a design can significantly
increase, mitigate, or eliminate a risk; it is
paramount to know which design revision
was used

Project ID# The ID number relevant • Some companies keep track of efforts by
to the FMEA project ID numbers
• There may be concerns or situations unique to
one project only

Manager Name of the manager • Identifies the decision maker in the area under
responsible for area the FMEA investigation
under investigation • Provides the go-to person if any questions
arise or if improvements are to be
implemented

Design Name of the design • An FMEA can be used to evaluate a single,

being assessed specific design
• FMEAs can be used to evaluate a series of
different designs
• Sometimes, the design and its revision are
critical contributors to the FMEA

Table 20. Contributor Header Information. (continued)

132 The Value of the Worksheet Header

(continued)

FIELD NAME INFORMATION REASONS FOR INFORMATION

SME #1 & Name of the second • The person conducting the FMEA may be the
Department Subject Matter only subject matter expert involved with the FMEA
Expert and/or the • Readily identifies who contributed the most
department involved information to the FMEA
• Sometimes the name of the department is
more valuable than the name of the individual
– for example, the name of a government
representative who answered a question may not
matter, but government agency that provided the
information is

SME #2 Name of the second • Readily identifies who contributed the second
or 3 & and third SME and/or and third most information to the FMEA
Departments the department respectively
involved • As with SME #1, identifying the department, as
opposed to an individual, may be the significant
information

Customer Name of the customer • Sometimes, because of liability risks the customer
for whom the FMEA may be facing, it may request an FMEA to be
is being conducted included as proof that it being diligent
• Sometimes, a customer may have a request so
out of the norm of the organization’s regular
activities that the organization might wish to
see what kind of risks the customer’s needs
may impose

Completed Name of who entered • The individual conducting the FMEA is almost
by the information on always the person who completes the FMEA form
the FMEA form • Sometimes, a person might be assigned to
complete an FMEA on behalf of somebody else

Approved by Name of the • An FMEA may be requested by someone who

individual responsible does not conduct the FMEA
for approving the • Identifies who took responsibility for the risks
conclusions of the determined by the FMEA and any subsequent
FMEA mitigation or improvement efforts

Table 20. Contributor Header Information.

 Before Starting
the FMEA

Introduction Before starting the FMEA, it must be set up administratively.

This section covers what must done before conducing an FMEA.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Tracking FMEAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Information Will Get Lost. . . . . . . . . . . . . . . . . . . . . . . . . . 134
FMEA Unique Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
FMEA Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Departments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Responsibilities & Activities Change. . . . . . . . . . . . . . . . . . . 136

133
134 Before Starting the FMEA

Tracking FMEAs The easiest way to track FMEAs is by creating an FMEA log or database. A log
or database allows for fast information retrieval when researching historical
FMEA activities.

Include in the log or database information:

• the unique number assigned to each FMEA
• a brief description of the FMEA’s study
• synopsis of the results, and
• start and end dates

More fields for information may be added if deemed helpful, such as:
• main determinations from the study
• actions that were taken
• when the implementations were concluded, and
• comments.

Information When involved with an FMEA, it may seem impossible to forget what was
Will Get Lost done, how, when, or why, but as time goes on and other things demand
attention, details become blurred and it does become easy to forget.

Memory is not the only concern.

The individuals involved may leave the company, for any number of reasons,
or may be unavailable when information is needed. Responsibilities change
as well.

Save yourself headaches, time, and unnecessary costs by keeping a log of

the FMEAs.
 Before Starting the FMEA 135

FMEA Unique The easiest way to assign an FMEA number is by using an established format
Number that changes sequentially.

An example would be FMEA-YY-XXX, where:

• FMEA indicates that the matter pertains to an FMEA analysis and helps
to ensure the information will get filed correctly
• YY is a two-digit number for the year, and
• XXX is the sequential number.

Thus, the respective numbers for first three FMEAs conducted in 2015
would be:
• FMEA-15-001
• FMEA-15-002, and
• FMEA-15-003.

FMEA Log An example of how an FMEA log may appear is shown below.

The main purpose is to establish a system for keeping track of FMEAs

by assigning each one a unique number.

What else is included and how much detail depends on the needs of
the organization.

FMEA Log
FMEA # Description Start Date Determinations Implemented Actions Completed
FMEA-15-001 Evaluate FDA revision 1/16/2015 Update XYZ policy Revision B, training, and release 3/21/2015
FMEA-15-002 New product proposal 1/20/2015 Market receptive Recommend development 2/17/2015
FMEA-15-003 Difficulty processing orders 1/23/2015 New field required Modify program 2/4/2015
FMEA-15-004
136 Before Starting the FMEA

Departments Because job responsibilities and employees change, it is usually wisest to

identify a department rather than an individual or specific job title.

For example, Accounting identifies what job must be done, for example,
reconciling an account, but who is responsible for performing the actual job,
e.g., cost accountant, accounts payable clerk, may change for any number of
reasons.

When a job title is unlikely to change, e.g., design engineer, use the title
instead of the name of the person.

A side benefit to using a job title or department instead of specifying a

particular individual is the elimination of the situation becoming personal.

Note: T he name of the individual may be recorded as a subject matter

expert or in the FMEA’s notes.

Responsibilities As a company grows or changes, responsibilities emerge or others are

& Activities assigned to new or different job functions.
Change
Activities and even departments will change or can be eliminated entirely.
Workflows may be expanded or reduced.

Sometimes, work is outsourced. Payroll may have originally been done

in-house, but later transferred to an external organization.

It is important to remember that whatever is being investigated at the time

that an FMEA is being conducted, it may change considerably later on,
may no longer exist at all, or new elements may have been added since its
conclusion.

An FMEA needs to be regarded as a snapshot in time. It is good to know

what happened before because sometimes companies return to what they
eliminated or reduced earlier.

Records of FMEAs save time and reduce the need to repeat efforts.
 Rating Scales

Introduction Rating scales can be:

• adopted from elsewhere
• imposed upon the organization, or
• developed internally.

Regardless of where a rating scale is obtained from, keep in mind that the
scales are arbitrary and were created by humans. People can be intimidated
or overwhelmed by the scales. Rating scales are customizable and should
make sense to the user. There is nothing infallible about a rating scale
obtained elsewhere.

This section provides guidance for creating rating scales for FMEAs.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Numbers Making Sense . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Applying Percentages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Revisiting Table 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Rate Numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Less is More . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Worth the Effort?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Address Gaps in the Ratings. . . . . . . . . . . . . . . . . . . . . . . . 140
Test for the ROI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Beware of Hair-Splitting . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
If Hair-Splitting is Necessary. . . . . . . . . . . . . . . . . . . . . . . . . 141

137
138 Rating Scales

Numbers Making People often use 3, 5, and 10 without much regard to the impact these
Sense numbers have on the item in question. Odd numbers have an appeal because
it is simpler to find the middle than if even numbers were used.
Why is this done? Because it is easy.
Does it make sense? Not necessarily. It depends.
What’s the problem? There are quite a number of issues involved, which
are beyond the scope of this book. Suffice it to say that arbitrarily assigning
numbers can result in avoidable costs because something is based on “an
educated guess” as opposed to having research and data to back up the
decision.

Applying It is not uncommon for companies to arbitrarily assign numbers to designate

Percentages classifications, such as 1 in 3 or 10%.
Applying a percent is dangerous because as the population size changes,
so does the number of unacceptable events, which can easily become
statistically significant.

Revisiting Below is Table 10a, which is also found in the section on Occurrence.
Table 10a
This table is being revisited here because it illustrates some of the potential
issues associated with rating scales.

EFFECT RATING FAILURE RATE CRITERIA

Almost certain 10 1 in 3 Failures almost certain to occur; history
shows many failures
Very high 9 1 in 5 Very high number of failures
High 8 1 in 10 High number of failures
Moderately high 7 1 in 20 Frequent failures

Medium 6 1 in 80 Moderate number of failures

Low 5 1 in 400 Occasional number of failures
Slight 4 1 in 2,000 A few failures
Very slight 3 1 in 4,000 Very few failures
Remote 2 1 in 10,000 Remote number of failures
Almost never 1 1 in 30,000 Failures very unlikely

Table 10a. Subjective Criteria Example for Occurrence in General.

 Rating Scales 139

Rate Numbers The range of the failure rate numbers in Table 10a is 1 to 30,000.

For some organizations, especially certain manufacturing environments,

30,000 is a reasonable number. In other organizations, 30,000 would never
be reached and is illogical to use in the scale.

Whatever rating scales are created, ensure that they are relative to the
organization.

For example, in Table 10a, 1 in 30,000 and “failures very unlikely” may
sound acceptable, but if the information refers to fatal hospital surgeries, the
occurrences are unacceptable.

Less is More Table 10a illustrates the good intentions of attempting to rate occurrence,
but there is usually very little perceptible difference between:
• “very high” and “high” (ratings 9 & 8), and
• “moderately high” and “medium” (ratings 7 & 6).

In a case such as Table 10a, a better approach would be:

• grouping together, instead of breaking out into more categories, the
definitions that people would have difficulty easily distinguishing from one
and other, and
• using fewer categories.

Worth the If people end up struggling over what something means, or cannot define it
Effort? among themselves, these are indications that the differences are insignificant.

A test for “would it help to split this further” would be to determine:

• what would be gained by more refinements
• can these be easily defined, and
• can the differences be easily understood.

If nothing or very little is gained, or if the knowledge does not contribute to

notable improvements, the effort expended into breaking the information
down into more categories brings little for the effort.

Remember: 
An FMEA is not an exact science; it is an approximation. Do not
get hung up squabbling over minor details when the objective
is an educated guess.
140 Rating Scales

Address Gaps in There are gaps in Table 10a.

the Ratings
If an occurrence is determined to be other than exactly as stated, how is it
classified? A better way of presenting these failure rates, rather than “1 in
X,” is to provide a range, e.g., 1-3 failures is “almost certain,” 4-10 failures
is “very high.”

Test for the ROI Every time somebody must deal with something that is unclear, difficult, or
providing little value, the organization is incurring costs that can be avoided.

Another test for the value returned is simply to ask, “What would the
organization gain by investing in attempting to achieve this knowledge?”

If something is not worth the effort, i.e., the return on the investment (ROI)
of time and manpower gains very little, do not expend the effort.

Note: That does not mean the issue in question does not need to be
addressed; it simply means that particular method for addressing the
issue does not give a good return for the effort involved.

Beware of Resist the temptation to “split hairs” when creating categories, especially at
Hair-Splitting the beginning of a study.

When people “split hairs” to an extreme degree, there is often a mistaken

belief that they have done a better job or have gained more information.

In Table 10a, where 1 in 3 is “almost certain” and 1 in 5 is “very high,”

but 1 in 30,000 is “almost never,” the difference between 1 and 30,000
is extremely broad; therefore, two categories of 1 in 3 and 1 in 5,
comparatively, are so close together that they would most likely add
very little value to the information studied.

While hair-splitting can promote a warm, fuzzy sense of a job well-done and
that everything was addressed, in practical terms, it often wastes resources
and money.

Beware of “hair-splitting.” If the information gained has little or no value, do

not waste the money or manpower to define it or chase it down.
 Rating Scales 141

If Hair-Splitting The initial question to ask is, “How much would many categories add to the
is Necessary information desired by conducting the study?”

Sometimes many categories serve a good purpose and can contribute much
to understanding the study. It depends on what the purpose of the study is;
what are the seekers attempting to know? There is nothing that excludes
many categories.

However, there is no reason to add more categories than necessary as that

results in using more labor and time to produce information that adds no or
very little value to the study.

If it becomes evident that more information would be helpful, then that is

the time to refine the study. For starters, start simply.
(This page intentionally left blank.)
 Using the
FMEA Worksheet

Introduction The FMEA worksheet is a tool used to guide an FMEA investigation. It cannot
anticipate all possible situations.

This section:
• provides guidance on how to complete a worksheet
• indicates what to do with certain types of supplemental information
• indicates the optional fields on an FMEA worksheet
• provides guidance on creating ranking scales, and
• shows how to calculate the RPN.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Completing the Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . 144
Sections of the Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . 145
Completing the Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Investigation Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Numbered Lists. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
FMEA Drivers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Potential Failure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Potential Failure Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
CAUTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Cause. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

143
144 Using the FMEA Worksheet

Topic Page
Preliminary Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Potential Failure Causes or Sources. . . . . . . . . . . . . . . . . . . 149
Current Prevention Controls. . . . . . . . . . . . . . . . . . . . . . . . 151
Current Detection Controls. . . . . . . . . . . . . . . . . . . . . . . . . 152
Identifying Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Criteria for Rankings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Be Consistent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Initial & Updated Rankings . . . . . . . . . . . . . . . . . . . . . . . . . 153
Remember the Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
RPN Decisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Eliminating Possibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
No Improvements Necessary. . . . . . . . . . . . . . . . . . . . . . . . 154
Improvement Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
FMEA Efforts Not Shown . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Follow the Trail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Authority for Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Recalculating the RPN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Comparing the RPNs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Criticality Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Completing The purpose of the FMEA, i.e., the intent of the study, is the driving factor of
the Worksheet the FMEA, not the worksheet. The worksheet is a document to record and
guide the activities of the FMEA.

The format of the FMEA worksheet can be modified to fit the organization’s
needs as well as the study’s scope.

Unfortunately, an FMEA worksheet’s format found in a book or online may

be as unchangeable. The worksheet’s layout is not what makes the FMEA.

While it is important to complete certain steps in an FMEA, if it suits the

purposes of the study or the organization, it is permissible to:
• not to include certain information
• supplement information, and
• even change the format of the worksheet.
 Using the FMEA Worksheet 145

Sections of The worksheet is divided into six main sections that are arranged
the Worksheet progressively from start-to-finish.

These sections are:

1. header
2. investigation section
3. initial rating
4. improvement section
5. final rating, and
6. criticality comments.

Completing Review “The Value of the Worksheet Header” presented previously and
the Header complete the header using the steps shown in Table 21.

STEP ACTION

1 Verify purchase request information is complete and accurate

2 Find supplier to make purchase from

3 Complete purchase form

4 Route purchase order to designated locations

Table 21. Completing the Worksheet Header.

146 Using the FMEA Worksheet

Investigation After the header, the next section to complete on the FMEA worksheet is the
Section process stage and its relevant information, as shown below.

Process Stage – Describe the process stage under development

or study.
Potential Failure Mode – In what ways can the key input(s)/ 1.
actions go wrong? 2.
3.
4.
Potential Failure Effects – In what ways can the above failures 1.
affect other things? 2.
3.
4.
Cause or Source of Potential Failure – Indicate (C) for Cause 1.
or (S) for Source. Cause means the cause of the potential failure
has been identified as located in the area under investigation and 2.
will be addressed under this FMEA. Source means the source of 3.
failure must be located outside the area under review and there is
a need for further investigation independent of this FMEA. 4.
Current Prevention Controls – What are the existing controls 1.
and procedures (inspection and test) that prevent either the cause 2.
or the Failure Mode? State procedure (number) that exists or
note if there are no controls. 3.
4.
Current Detection Controls – What are the existing controls 1.
and procedures (inspection and test) that detect the Failure 2.
Mode? State procedure (number) that exists or note if there are
no controls. 3.
4.

Numbered Lists While the worksheet has numbered lists of 1-4 available for completion, the
blank areas are provided for convenience.

At least one line in each category will be completed. When nothing applies,
enter “N/A” on the first line. The remaining lines, 2-4, may be left blank.

When more than four responses are in order, continue the list elsewhere and
indicate where that continued list is found.

Scope Before starting the FMEA, it is important to determine the limits of the
investigation – just how much needs to be investigated by the team.

FMEAs can:
• get bogged down by being too detailed
• miss important factors by being “too light,” that is, not digging deeply
enough into the matter, or
• be “just right,” by digging as deeply as needed without overloading or
distracting from the objective with too much information.
 Using the FMEA Worksheet 147

FMEA Drivers Enter a description of the area under analysis, which is determined by the
scope. Remember:
• the purpose of the FMEA drives the worksheet
• the scope determines how far the investigation will go, and
• the FMEA may require subsequent FMEAs based on the conclusion(s) from
the present study.

Failures The potential failure mode describes what can go wrong. There may be
multiple:
• things that can go wrong, e.g., wrong data is uploaded, wrong
calculations result, wrong fields are populated
• ways that a failure can occur, e.g., information is not relayed to
departments A, B, and C, or
• locations where failures can occur, such as in a cascading or domino effect.

Potential Describe the ways that things can go wrong.

Failure Mode
Since the key inputs or actions are under investigation, there needs to be an
A (input) and a B (result.)

Examples of inputs and results are shown in Table 22.

Remember: A
 n input can result in multiple failures and these failures can
occur in multiple locations.

A – INPUT B – RESULT

Pressed “On” • Nothing happens

Entered Data • Field will not accept information

Entered figures • Calculation is incorrect

• Incorrect calculation is uploaded
• Final monthly figures are incorrect

Clicked on link • Directed to wrong location

Response time not specified • Customer angry

Paperwork not filed • Fined for non-compliance

Table 22. Examples of Inputs & Results.

148 Using the FMEA Worksheet

Potential After identifying what can go wrong, next determine the failures’ impacts.
Failure Effects
Examples of impacts are shown in Table 23.

A – INPUT B – RESULT C – IMPACT(S)

Pressed “On” • Nothing happens • Manufacturing process shuts down
• Costs added – In-process goods must be
reworked or scrapped
• Deliveries are not made on time
Entered data • Field will not • Work cannot proceed any further
accept information
Entered figures • Calculation is • Cost estimates are too high or too low
incorrect • The organization faces financial hardships
Clicked on link • Directed to wrong • Wrong information is uploaded
location • Cascade of problems result
Response time • Customers angry • The organization is regarded as not caring
not specified about its customers
• Customers take business elsewhere
• Employees think the organization does not
know what it is doing
Paperwork • Fined for non- • Investors pull their money out of the
not filed compliance organization
• The organization prohibited from bidding

Table 23. Examples of Inputs, Results, & Impacts.

CAUTION While the potential failure mode and the potential failure effects may
seem straightforward, in terms of correcting or preventing failures, analysts
sometimes confuse the impacts with the results.

By preventing or correcting the results in column B, the impacts of column C

do not occur or are mitigated.

It is highly unlikely that the impacts in column C can be mitigated if no

actions are taken to remedy the results in column B.

In short, B leads to C, and most likely, something can be done about B.

 Using the FMEA Worksheet 149

Source As stated on the FMEA worksheet, “Source” means that the failure occurred
due to something outside of the area under investigation. In other words, the
“source” of the failure lies elsewhere.

Examples of failures occurring elsewhere include, but are not limited to:
• electrical transformer blew up
• supplier changed formula of a raw material, and
• manufacturer mislabeled part.

Cause As stated on the FMEA worksheet, “cause” means that the failure occurred
in the area under analysis, has been identified, and the problem can be
addressed by the FMEA.

Examples of failures occurring in the area under investigation include, but are
not limited to:
• parameters were never identified
• an impact was overlooked, and
• a specification was omitted.

Preliminary At this point, the analyst is gathering preliminary information that will be
information used to determine the severity, occurrence, and detection rankings.

In-depth investigations into why the failures could occur is done after the
RPN has been calculated and the risk has been deemed unacceptable.

The in-depth investigations will determine the recommended improvement

actions.

Potential Failure After determining the impacts, next determine if the area under analysis
Causes or caused the failure or if the source of the failure occurred elsewhere.
Sources
A failure can have:
• a cause, but not a source,
• a source, but not a cause, or
• multiple causes and sources.

Examples of causes and sources are shown in Table 24.

150 Using the FMEA Worksheet

A – INPUT B – RESULT CAUSE OR SOURCE

Pressed “On” • Nothing happens • Cause – the wrong switch was installed
• Cause – the correct switch was installed
incorrectly
• Source – the wrong switch was ordered
• Source – the wrong switch was shipped

Entered data • Field will not • Cause – field size is too small
accept information • Source – field size previously not a
requirement

Entered figures • Calculation is • Cause – formula was entered incorrectly

incorrect • Source – developer given wrong formula
• Cause or Source – formula was never
validated

Clicked on link • Directed to wrong • Source – application has software glitch

location • Source – link is no longer valid

Response time • Customers angry • Source – response time never considered

not specified important enough to specify

Paperwork • Fined for non- • Cause – work overload; insufficient time for
not filed compliance filing
• Cause – no central location to route
paperwork
• Cause – access to files is not restricted
• Cause – release of documents is not
controlled
• Source – external requirements not routinely
reviewed for new filing requirements

Table 24. Examples of Inputs, Results, & Causes or Sources.

 Using the FMEA Worksheet 151

Current Preventative controls may already be in place to address failures that are
Prevention known to be likely, or presumed likely, to occur. The FMEA study usually
Controls includes research to determine the preventive measures that guard against
failures from occurring.

For instance, an organization may use a checklist to ensure that each

preventive measure is in place and working. Such a checklist can be regarded
as a prevention control.

Examples of prevention controls are shown in Table 25.

A – INPUT B – RESULT PREVENTION CONTROLS

Pressed “On” • Nothing happens • Machine is verified as functional at the start
of each shift
Entered data • Field will not • Minimum field size must be determined
accept information when developing applications
Entered figures • Calculation is • Calculation formulas are copied and pasted
incorrect from validated formulas instead of manually
inputted
• Formulas are tested before application goes
“live”
Clicked on link • Directed to wrong • SOPs are reviewed annually to ensure that
location their links are still current
• Links are tested on an annual basis to ensure
that they are still “live”
Response time • Customers angry Confirmation email:
not specified • Is immediately sent that communique was
received
• Includes name and contact information
of employee or department that will
respond within a stipulated timeframe, e.g.,
24-hours, two business days, etc.
• Further contact information is provided if
customer’s matter is urgent
Paperwork • Fined for non- • The organization maintains internal website
not filed compliance with procedures, updates, and changes in
customer or regulatory areas

Table 25. Examples of Inputs, Results, & Prevention Controls.

152 Using the FMEA Worksheet

Current Sometimes, detection controls are in place that indicate a failure has
Detection occurred. This could be due to prevention not being possible. In many
Controls instances, however, detection is a quick, “firefighting” response because
time and effort were not put into examining whether prevention is possible.

Examples of detection controls that could be used are shown in Table 26.

A – INPUT B – RESULT DETECTION CONTROLS

Pressed “On” • Nothing happens When pressing “on” is successful:
• a green light comes on, and/or
• an operating bell sounds
Entered data • Field will not • Software can detect if information does not
accept information meet certain parameters, and
• A pop-up screen says information is invalid
Entered figures • Result will not • Program can detect if math formula is
calculate improper
Clicked on link • Directed to wrong • Program that alerts when link is no longer
location valid
Response time • Customers angry • Sales people or customer service
not specified representative receive complaints
• Satisfaction surveys have low ratings
Paperwork not • Fined for non- • Calendar is set up to warn that filing is due
filed compliance in 30 days
• Calendar is set up with progressive warnings
that action is needed

Table 26. Examples of Inputs, Results, & Detection Controls.

Identifying If there are procedures applicable to either the prevention or detection

Procedures controls, make sure that these are stated in the FMEA.

Since a procedure can relate to only one or more controls, there are
configuration management concerns related to procedures.

Consequently, verify that the procedure is still applicable to a particular

control.
 Using the FMEA Worksheet 153

Criteria for If ranking classifications have not already been established for severity,
Rankings occurrence, and detection, now is the time to create them.

Refer to the previous sections entitled “Criteria for Severity,” “Criteria for
Occurrence,” and “Criteria for Detection” for guidance on how to establish
these ranking classifications.

Be Consistent As a reminder, criteria rankings are subjective and the numbers assigned to
the classifications vary by organization.

For the sake of consistency, use the same ranking classifications for all
FMEAs.

Initial & Updated The purpose of using initial and updated rankings to provide an assessment
Rankings method is to determine how the implemented changes have mitigated
the risks.

There may be instances where the implemented changes indicate that more
changes are needed to reduce the risks to an acceptable level. In such a
case, a second FMEA may be required with the second FMEA using the
implemented changes from the first.

Remember the Avoid the temptation to reduce paperwork by simply going straight to the
Purpose final implemented changes and not recording the efforts that came before.

An engineer or quality professional may need to know what did not work
to the degree desired, particularly when working on a future project. There
may be information in the progression of efforts that they would find helpful.
Since procedures, software, equipment, and parts are continuously changing,
it is helpful to the engineer or quality professional to know what was in place
related to the prevention and detection controls at the time of an FMEA.

If a liability issue arises, records of efforts that failed to mitigate the risk show
the organization recognized the risk and due diligence was taken to reduce
or eliminate the risk.

In other words, multiple FMEAs required to ultimately eliminate or mitigate a

risk show that the organization “did its job.”
154 Using the FMEA Worksheet

RPN Decisions Enter the S, F, and D rankings, and calculate the RPN using the formula
shown.

Initial Rating – Create & use rating scales Severity (S) – measure of the possible consequences of a failure to a
user, customer, process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring.
Detectability (D) – The probability that the failure mode will be
detected before used internally or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D

Determine if the RPN number is low enough to close the FMEA or if more
effort is required.

Again, the decision to close or put in more effort is arbitrary and may require
input from others before a final decision is made.

Eliminating A series of FMEAs systematically identifies possible problem areas and does
Possibilities so in a progressive fashion.

One of the possible outcomes of an FMEA is the indication that something in

question no longer needs to be considered; the FMEA has shown it is not an
area of concern.

When initial or revised RPN numbers indicate that no further efforts are
required, the FMEA can be closed.

If applicable, the investigation can proceed to the next area or stage in

question.

No Improvements The improvement section is used only if the initial RPN indicates that
Necessary improvement efforts are required.

If no improvements are necessary, complete the FMEA by:

• indicating N/A in the improvement section’s fields
• including any final notes, if applicable
• completing the log or tracking sheet from which the FMEA’s number
was assigned
• forwarding the FMEA final report to the appropriate individuals, and
• filing or archiving the FMEA’s relevant documents.
 Using the FMEA Worksheet 155

Improvement When the RPN indicates the need for improvements, the FMEA worksheet’s
Section improvement section follows the initial RPN determination and is shown
below.

Recommended Changes – What are the recommended 1.

improvements? 2.
3.
4.

The improvement section:

• records the recommended changes
• indicates who is responsible for ensuring that these changes have been
implemented, and
• reports what was ultimately done to eliminate or mitigate the risks.

FMEA Efforts If a decision is made, based on the RPN, that there is a need for an
Not Shown improvement effort, the bulk of an FMEA effort, which is typically an
in-depth investigation, occurs at this point.

It is at this time that the analyst will begin delving into why things do or do
not happen.

Extensive research may go into finding the causes of the potential failures,
or efforts may be applied to finding how to stay abreast with changes
happening at the sources of failures.

To ensure that the FMEA file is as complete as possible, some kind of record
must be included showing what was researched and how the conclusions
were reached.

Follow the Trail How far to go with these investigative efforts depends on what is involved
with the issue.

The analyst needs to follow the trail wherever it leads.

At this point, a root cause analysis is being conducted because in order to

prevent, mitigate, or eliminate a risk, the root cause of the potential failure
must be determined.
156 Using the FMEA Worksheet

Authority for Depending on who is conducting the FMEA, the recommended changes may:
Changes • simply be recommendations, or
• the analyst may have the expertise to determine what must be changed as
well as have the authority to require that the changes be made.

Recalculating If the initial RPN determined an unacceptable risk that warranted mitigation
the RPN or corrective action, it is logical to recalculate the RPN after the improvements
have been implemented to determine if the improvements were effective
enough to bring the risks down to an acceptable risk level.

The worksheet provides an area to calculate the second RPN in the area
entitled “Updated Rating,” as shown below.

Updated Rating – Use the rating scales Severity (S) – measure of the possible consequences of a failure to a user,
customer, the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Detectability (D) – The probability that the failure mode will be
detected before used internally or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D

Comparing In most cases, the improvements will lower the RPN to an acceptable
the RPNs risk level.

If not, as stated above, further decisions will be required. Possibilities are

the organization may:
• decide to scrap the idea, or
• require that more improvement efforts be taken.

In either case, the current FMEA is closed.

 Using the FMEA Worksheet 157

Criticality When addressing a matter over a length of time, it can seem like the details
Comments will never be forgotten. However, as new demands replace current ones,
memories fade. Almost everyone has encountered a situation where they
have wondered why something was done or questioned what people were
thinking when a past decision was made.

What is critical, important, or vital to an organization can change over time,

and often does. Sometimes a decision seems foolish or illogical, but almost
always it was the best or a very good decision based on what was known or
happening at the time the decision was made.

At the bottom of the FMEA worksheet is an area to record what was critically
important at the time of the FMEA investigation. Recording what is known
while working on the FMEA increases its historical value.

Be sure to complete this section if:

• the details or contributions are unique in some way that they elevated
the matter to a critical level, e.g., the organization received notice from a
federal authority that something was amiss, or
• a change elsewhere could change the conclusions drawn from the FMEA
(e.g., the customer or client is requiring a modification).

Criticality Comments 1.
2.
3.
(This page intentionally left blank.)
 Wrapping up the FMEA

Introduction Just as there were initial things to be done before starting an FMEA, there are
activities associated with completing an FMEA.

This section provides guidance on:

• closing the FMEA
• dealing with supplemental information
• how to handle links internally and to the Internet
• archiving the FMEA, and
• what might be encountered from an audit.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Closing the FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Supplemental Information. . . . . . . . . . . . . . . . . . . . . . . . . . 160
Internet Links. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Archiving the FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Closing the Close the FMEA by:

FMEA • completing the FMEA worksheet
• completing the log or tracking sheet from which the FMEA’s number was
assigned
• completing a summary report of the FMEA efforts
• forwarding the FMEA’s final report to the appropriate individuals, and
• filing or archiving the FMEA’s relevant documents.

159
160 Wrapping up the FMEA

Supplemental If at any time there is insufficient space to document information or it is

Information deemed important to include information not asked for on the worksheet,
attach more sheets with this information.

Remember to indicate somewhere on the front of the worksheet, in a readily

observable location, that:
• more information is available
• what type of information is available, e.g., data, chart, graphic, blueprint,
report, and
• where that information is found or filed.

To the extent possible, all information relevant to an FMEA is archived with

the FMEA report.

Internet Links While it may seem logical to copy and paste in a link to an Internet source of
information, links change and websites disappear.

If the information is critical to understanding the FMEA investigation or its

conclusions, then:
• take as many screen shots as necessary
• paste them into Word documents, and
• save them for archiving purposes.

Note: K
 eep in mind that even internal links may change if an organization
upgrades its system or applications, or is bought out by another
organization.

Archiving the Archive the completed FMEA along with its copies of related materials and
FMEA information, e.g., documents, policies etc.

Audits The worksheet is not the FMEA investigation. It is a tool used to record
information pertaining to the FMEA.

For the FMEA investigator and quality assurance professional, it is important

that:
• all relevant information is supplied, and
• traceability in terms of dates, people, designs, policies, and revisions are
included.

Auditors are concerned that the information is complete and correct and that
the FMEA was conducted properly.
 Definitions

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
a.k.a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
CAPA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Cause – FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Closed System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Configuration Management. . . . . . . . . . . . . . . . . . . . . . . . 163
Consumers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Drill Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Due Diligence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
End Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
External Customer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Failure Cause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Failure Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Failure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Firefighting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Five Whys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Form, Fit, or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Internal Customer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
MTBF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

161
162 Definitions

Topic Page
Normal Use-and-Abuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Pareto Principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Probability of Occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Qualitative Criticality Analysis. . . . . . . . . . . . . . . . . . . . . . . 166
Quantitative Criticality Analysis. . . . . . . . . . . . . . . . . . . . . . 167
Reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Reliability Engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Required/Shall/Must . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Risk Assumption. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Risk Tolerance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Robust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Root Cause. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Severity Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Source – FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

a.k.a. Also known as

CAPA Corrective Action (CA) and Preventive Action (PA) – Two specific, independent
investigations that determine the root cause (the initiating cause) that
resulted in a string of events that led to the undesired outcome followed
by efforts to both correct the immediate problem as well as prevent it from
happening again, or if impossible to prevent the problem entirely, then to
mitigate any potential negative impacts. The separate investigations ensure
that efforts have addressed all possible negative outcomes.

Cause – FMEA The failure occurs in the area under review in the FMEA, has been definitively
identified, and will be addressed under the FMEA.

Closed System A process where what is happening internally cannot be observed.

 Definitions 163

Configuration The systematic evaluation of the relationships between parts, subsystems,

Management and systems for effectively controlling the impacts of changes and to
minimize any adverse effects they may impose on themselves or things
dependent upon them, e.g., finished products used by consumers.

For an FMEA, the impacts include those affecting the customer.

Consumers Ultimate recipients of finished product or work efforts.

Corrective 1. When part of a CAPA, corrective action (CA) is one part of a three-part
Action investigation and remedy to correct whatever initiated the string of events
that ultimately resulted in an undesirable outcome or situation and is done
in conjunction with preventive action, which investigates where further
occurrences of the undesired outcome can occur.
Note: T he other two parts of a CAPA is determining the root cause and
preventive action (PA.)
When CA and PA are done in response to an undesirable outcome that
has already occurred, and are not part of an FMEA, they are known as a
CAPA.
2. When they are done in an FMEA, they are known as corrective and
preventive actions and not as a CAPA.
Note: A
 n FMEA can be used in multiple ways so an undesirable outcome
may or may not have occurred. If an undesirable outcome has not
occurred, it is possible to make corrections and/or take preventive
action to prevent or mitigate the undesired outcome.

Customers Recipients of work efforts or products that are still in-process.

Drill Down Digging deeper into a matter or investigation to determine what else might
be present or contributing to the situation.

Due Diligence The attempt made to validate something based on its unique characteristics.

End Effect The consequence(s) of a failure mode on the operation, function, or status of
the highest indenture level.
164 Definitions

External Anyone who receives a product or service who is not directly related to the
Customer organization or a organization department.

Example 1: A organization or individual to whom a product or service is

directly sold.

Example 2: A department that receives for further handling something that
was partially completed or processed in a previous department.

Note: The definition depends on the context in which the term is used.

Failure The loss of an intended function under stated conditions. The loss of
ability of a system, device, or process to perform a required function. The
manifestation of a fault.

Example: The doorbell doesn’t ring when pressed.

Failure Cause The defect(s) which is/are the underlying cause or sequence of causes that
lead(s) to a failure mode over a certain time.

Causes typically stem from, but are not limited to, requirements, design,
process, quality, handling, application, or use.

Example: The doorbell doesn’t ring when pressed because it is not

protected from the elements; normal-use-and-abuse was also not
taken into account.

Note: A failure may have multiple causes.

Failure Effect The immediate consequences of a failure on operation, function, or

functionality, or status of whatever is under investigation.

Example: 
The doorbell failing to ring caused the visitor not to make the
delivery.

Failure Mode The specific manner (or way) a failure occurs in the function under
investigation.

Example: T he doorbell doesn’t ring when pressed because, e.g., the battery
is dead, the electricity has been cut off, a critter ate through the
wire, the wire became corroded, or sticky fingers caused the
doorbell to jam etc.

Note: A failure mode can have multiple causes.

 Definitions 165

Firefighting The quality term for responding to a problem by fixing or repairing what
occurred, i.e., “putting out the fire,” without looking into the underlying
factors and ultimately discovering and correcting the root cause of the
issue; it is regarded as an ineffective, short-term fix that provides immediate
satisfaction that “something was done,” but ultimately does not fix anything
in the long run because the root cause of the problem was not identified
nor addressed.

Five Whys A drill-down quality investigative technique that identifies a problem then
asks a series of five iterative “whys” as to “why did this occur” to determine
a possible root cause.

Example: P roblem X occurred – why? Because of A. Why did A occur?

Because of B. Why did B occur? Because of C. Why did C occur?
Because of D. Why did D occur? Because of E.

Form, Fit, or Three areas reliability experts independently address when ensuring the
Function adequacy or robustness of an item, part, or system, i.e., how does something
affect the form, fit, or function of what is being evaluated?

Internal Anyone who receives a product or service who is directly related to the
Customer organization or an organization department.

Example 1: A department or individual within the same organization to

whom a product or service is relayed for further handling.

Example 2: An individual within a department who receives for further

handling something that was partially completed or processed
within the same department.

Note: The definition depends on the context in which the term is used.

MTBF Mean Time Between Failures – The average time something will function
between failures.

MTBF is sometimes predicted

• based on experience, or
• by analyzing known factors such as raw data supplied by manufacturers.

MTBF is meaningless if the

• definition of failure is not clear, or
• assumptions are unrealistic or misinterpreted.
166 Definitions

Normal Use- The generally anticipated, recognized ways that something may be used,
and-Abuse properly and improperly, under normal or typical conditions or situations.

Examples: Sticky, dirty fingers causing a doorbell to jam would fall under

normal use-and-abuse; taking a sledge hammer to a doorbell to
ring it would not.

Pareto Principle Quality guru Joseph M. Juran’s determination that 80% of quality problems
are caused by only 20% of the factors impacting the situation. Juran called
his observation the “Pareto Principle.” Today, the Pareto Principle is more
widely known as the 80–20 rule.

Preventive 1. If done as part of a CAPA, preventive action (PA) is the effort taken to
Action prevent or mitigate reoccurrence of the root cause of the events that
ultimately resulted in a specific undesirable outcome or situation which has
already occurred.
Note: In a CAPA, PA investigates further to determine where else in the
system the same type of problem, based on the root cause, could
occur and ensures the root cause correct is effective enough to
prevent occurrences elsewhere. PA can reveal more areas which
need correcting. These new discoveries can indicate that the
original corrective action (CA) was not robust enough and needs to
be modified.
2. If done in conjunction with an FMEA, it is whatever actions or controls are
implemented to prevent a known or potential problem from occurring.

Probability of The likelihood that something will occur after factoring together the
Occurrence frequency of occurrence and the level of detectability.

Qualitative The analysis used to determine risks and prioritize corrective action by rating:
Criticality • the severity of the potential effects of failures, and
Analysis
• the likelihood of occurrence for each potential failure mode.
 Definitions 167

Quantitative The analysis conducted to determine:

Criticality • the reliability/unreliability for each item at a given operating time
Analysis
• the portion of the item’s unreliability that can be attributed to each
potential failure mode, and
• the probability that each failure mode will result in a system failure.

Reliability The ability of something to perform its required functions under stated
conditions for a stated period of time.

Reliability The evaluation and prediction of performance to improve the safety,

Engineering reliability, and maintainability of products and/or systems.

Required/ Indicates organization policy with which associates must comply.

Shall/Must

Risk The feasible detrimental outcome of an activity or action subject to hazards.

Risk The amount of risk a company is willing to assume, a.k.a. risk tolerance.
Assumption

Risk Tolerance The amount of risk a company is willing to tolerate, a.k.a. risk assumption.

Robust An effort that is effective enough, or has sufficient impact, that it addresses
all concerns.

Root Cause The initiating cause that started a series of events or action that led to an
undesirable outcome.

RPN Risk Priority Number – The calculated risk figure determined by multiplying
the FMEA values assigned to Severity, Frequency, and Detectability.
168 Definitions

Severity Effect The consequences of a failure mode. Severity considers the worst potential
consequence (worst case scenario) of a failure, determined by the degree of:
• personal injury
• business damage
• property damage
• system damage
• confidentiality damage
• financial damage
• time lost, and/or
• costs to repair the failure.

Source – FMEA The failure did not occur in the area under review in the FMEA and further
investigation is needed beyond the current FMEA study.
 Appendix A –
Pareto Charts

Introduction As was discussed in the section Guidelines for Using FMEAs, Joseph M. Juran
introduced the Pareto Principle when he realized that 80% of quality issues
were caused by 20% of the factors impacting or contributing to them. This
80:20 ratio is now accepted as a business maxim.

Note: Another way that this is expressed is 20% of whatever an

organization is dealing with is causing 80% of its headaches
(problems.)

The important point to remember is that problems are not distributed evenly.
Most of what an organization is providing is happening as intended, which
means it is wasting money to keep focusing on these areas to improve them.
Since the main issues are concentrated in a few small areas, and manpower
and financial resources are limited, the best return on the investment is
identifying the most troublesome areas.

This section provides guidance on:

• what goes into to creating a Pareto chart, and
• how to use a Pareto chart when performing an FMEA.

169
170 Appendix A – Pareto Charts

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
Pareto Charts & FMEAs. . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Budget as the Driver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Identify What to Examine. . . . . . . . . . . . . . . . . . . . . . . . . . 171
Monthly Expenses Example. . . . . . . . . . . . . . . . . . . . . . . . . 171
Creating a Pareto Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
First Calculations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Initial Data Plotted in a Chart . . . . . . . . . . . . . . . . . . . . . . . 174
First Glance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Next Step. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Largest to Smallest %. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Regrouping the Categories. . . . . . . . . . . . . . . . . . . . . . . . . 176
Clustering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Reducing Category Groups. . . . . . . . . . . . . . . . . . . . . . . . . 178
Pareto with New Categories. . . . . . . . . . . . . . . . . . . . . . . . 179
Charting the Percentages. . . . . . . . . . . . . . . . . . . . . . . . . . 180
Omissions Become Apparent. . . . . . . . . . . . . . . . . . . . . . . . 180
Transportation Example. . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Using with an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Pareto Charts A Pareto chart is an excellent tool for identifying which problems are having
& FMEAs the biggest negative impacts on a business and its products, systems, or
services.

A Pareto chart can also be used to identify which:

• employee is having the most… (difficulties, sales, sick days, overtime, etc.)
• department is having the most… (turnover, delays, complaints, etc.), and
• costs might benefit from a closer examination.

Note: P areto charts can also identify what is working, where the most
praise is received, and what customers like the best. Sometimes
solutions to problems in one area can be found in the areas
demonstrating success.
 Appendix A – Pareto Charts 171

Budget as It is rare that an organization has unlimited funds to address problems.

the Driver
Budgets rule most organizations so it makes sense, when seeking to address
what to improve, to identify the area(s) or issue(s) that will provide the most
benefit for the efforts expended.

Identify What The first objective when creating a Pareto diagram is to pick an area or topic
to Examine to examine. This can be anything, such as:
• how many errors on invoices
• sales per department or salesperson
• returns by product category
• products or services that receive complaints, or
• the distances that the delivery trucks drive.

Suggestion: If you do not know where to start, try an informal poll. Ask
your employees, customers, even friends or families, where
they think problems or issues may lay.

Now that you have identified a tentative area, begin by writing down the
main topics that keep repeating.

Monthly In order to present an example that most people can relate to, consider your
Expenses personal income and expenses. Chances are you will readily agree that 80%
Example of your income (and perhaps even more) goes out to paying 20% of your
bills, such as the rent and your transportation.

Without regard to any particular order, or who might be contributing to the

income, Table 27 depicts how an income might be spent.
172 Appendix A – Pareto Charts

AREA AMOUNT

Rent (mortgage) $1,500

Car payment $250

Food $600

Electricity $105

Clothing $50

Personal expenses $125

Entertainment $240

Heat and/or A/C $350

Cable & internet $150

Cell phone $100

Savings $300

Total $3,770

Table 27. Typical Monthly Expenses.

Creating a Pareto charts can be created by hand or by using a software program.

Pareto Chart Steps on How to Create a Pareto Chart in MS Excel 2010 can be found at
www.wikihow.com. In Microsoft’s Excel program, clicking on the question
mark (?) for help and searching for “Pareto Chart” provides instructions for
installing the add-in, Analysis ToolPak, and creating a Pareto chart.

The charts in this section were created in Excel, although they could have also
been created by hand by:
• using simple mathematical formulas for addition and percentage, and
• sorting from the largest percent to the smallest.

Note: P areto charts are frequently depicted with a line showing the
cumulative percentages. A cumulative line is optional and not
required.
 Appendix A – Pareto Charts 173

First After assembling the initial data, the next step in a Pareto diagram to
Calculations determine the percentage (x%) each category represents out of the whole
(100%).

Using the above expenses, tally up all the costs, which in this case comes to
$3,770. Then, figure out what percentage each category constitutes out of
that 100%, i.e., the $3,770.

Note: Percentage is calculated by dividing the dollar amount for each

category by the total dollar amount, in this case $3,770, and
multiplying by 100. To double-check if your calculations are correct,
the individual percentages should add up to a total of 100%.

Table 28 shows the percentage value of each category out of the total.

CATEGORY AMOUNT PERCENTAGE

Rent (mortgage) $1,500 40%

Car payment $250 7%

Food $600 16%

Electricity $105 3%

Clothing $50 1%

Personal expenses $125 3%

Entertainment $240 6%

Heat and/or A/C $350 9%

Cable & internet $150 4%

Cell phone $100 3%

Savings $300 8%

Total $3,770 100%

Table 28. Typical Monthly Expenses and Percentages.

174 Appendix A – Pareto Charts

Initial Data If we were to plot the above data in a bar chart, either by hand or using a
Plotted in computer program, it would appear such as below.
a Chart

Initial Information
100%
100%
90%
80%
70%
60%
50%
40%
40%
30%
20% 16%
10% 9% 7% 8% 6% 4%
3% 3% 3%
1%
0%
e)

od

ng

gs

et

al
en

se

en
cit

on
A/

t
ag

rn
vin
Fo

hi

To
en
m

m
tri

ph
or

te
tg

ot

Sa
ay

in
xp
ec

d/

in
or

Cl

ll

rta
rp

le
El

an

Ce
(m

&
te
na
Ca

e
at
nt

En

bl
rso
He

Ca
Re

Pe

Note: The tall bar on the right, showing 100% of the costs by percentage,
it to put the individual categories into perspective when compared
against the whole.

First Glance At first glance, it may not be obvious how 80% can be found in the above.
After all, the largest category is only 40% and most categories are only in the
single digits.

Immediately, there are two things to consider:

1. Is there another way that the information could be grouped (categorized?)
2. Has everything been taken into consideration?

Which two of these questions is considered first is the investigator’s choice.

We will begin by seeing if grouping the many specific areas into smaller,
more general areas will produce the 80%.
 Appendix A – Pareto Charts 175

Next Step It is easiest to evaluate data when it is presented in a logical sequence, so the
next step is to order the categories by percentages, which is done in Table 29
below. Here, the categories are grouped from the largest percent (40%) to
the smallest (1%).

CATEGORY AMOUNT PERCENTAGE

Rent (mortgage) $1,500 40%

Food $600 16%

Heat and/or A/C $350 9%

Savings $300 8%

Car payment $250 7%

Entertainment $240 6%

Cable & Internet $150 4%

Electricity $105 3%

Personal expenses $125 3%

Cell phone $100 3%

Clothing $50 1%

Total $3,770 100%

Table 29. Monthly Expenses Sorted by Percentages from Largest to Smallest.

176 Appendix A – Pareto Charts

Largest to How does this data compare to the original set? The easiest way is to now
Smallest % arrange the above data in a bar chart, from largest to smallest percent.
Again, this can be done by hand or by using a computer program.

Sorted from Highest Percentage to Lowest

100%
100%
90%
80%
70%
60%
50%
40%
40%
30%
20% 16%
10% 9% 8% 7% 6% 4% 3% 3% 3% 1%
0%
e)

od

gs

et

ng

al
en

en

se
cit

on
A/

t
ag

rn
vin
Fo

hi

To
en
m

tri

ph
or

te
tg

ot
Sa

ay

in

xp
ec
d/

in
or

Cl
ll
rta
rp

le
El
an

Ce
(m

&
te

na
Ca

e
at
nt

En

bl

rso
He

Ca
Re

Pe

Regrouping the We are keeping in mind that a Pareto provides opportunities to look at
Categories situations from multiple perspectives – and the 80:20 rule has not yet
appeared. We can reach that point, but more steps are required.
Notice in the above categories that some of them can be grouped into larger
categories, such as housing and utilities (“housing” for short,) entertainment,
and “other.” We have been certain that “transportation” must be absorbing
an appreciable amount of the income, so we will add that category as well.
Opening our minds to possibilities that we had not considered is one of the
benefits of a Pareto study. Therefore, keeping in mind that more might be
learned, try grouping the categories in new ways to see if a pattern or a
certain picture might begin to emerge.
By regrouping the categories, we may discover that, much to our surprise:
• we had overlooked or forgotten to include other categories or costs
• an area that we felt sure was substantial turned out to be not so
significant when compared with the other categories, or
• some costs can be attributed to more than one category.
 Appendix A – Pareto Charts 177

Clustering Assembling the expenses into broader categories, i.e., clustering the groups,
helps to identify the 80:20 ratio.

Exception: The 80:20 ratio is not always found in one category. Sometimes,

it appears in the two highest percentages (or in rare cases, the
top three.)

Looking at the monthly expenses categories, it is possible to group them into:

• Housing
• Transportation
• Entertainment, and
• Other.

Reducing By clustering the old categories (now called “Area” below) into new
Category categories, the percentages for each area in the new category are added
Groups together (subtotaled) and the percentages are now based on these new
subtotals, as shown in Table 30.
178 Appendix A – Pareto Charts

NEW
AREA AMOUNT
CATEGORY PERCENTAGE
Rent (mortgage) $1,500 Housing
Electricity $105 Housing
52%
Heat and/or A/C $350 Housing
Subtotal $1,955 Housing
Car payment $250 Transportation
7%
Subtotal $250 Transportation
Food $600 Other
Clothing $50 Other
Personal expenses $125 Other
31%
Cell Phone $100 Other
Savings $300 Other
Subtotal $1,175 Other
Entertainment $240 Entertainment 10%
Cable & internet $150 Entertainment
Subtotal $390 Entertainment
Total $3,770 All 100%

Table 30. Reorganized Monthly Expense Categories by Percentages.

Pareto with The new groupings, of which there are now only four, are next arranged
New Categories from highest percent to the lowest, and would appear in a Pareto chart as
below.

Note: It is not mandatory to add the 100% column. However, many prefer it
because of the reference it provides.
 Appendix A – Pareto Charts 179

New Categories and Percentages

100%
100%
90%
80%
70%
60%
52%
50%
40%
31%
30%
20%
10%
10% 7%

0%
Housing Other Entertainment Transportation All

Charting the Pareto percentages are often displayed in a chart, although this is not
Percentages necessary if one is comfortable with looking at percentage numbers alone.

Plotting percentages in a chart, also known as a Pareto chart, is helpful

to obtain a visual grasp of what the numbers mean. In presentations
particularly, a slide containing a Pareto chart is a dramatic means to drive
home certain points.

Percentages are arranged from highest-to-lowest, from left-to-right.

In addition, many overlay a line showing the percentages as they accumulate

to 100%. This line curves upwards to 100% and is optional, although it is
frequently used.

In the above chart, which was created with the information from the initial
re-grouping, the 80:20 rule is still not apparent if we were looking for only
one category to equal 80%. Certainly there are instance where it is only one
category, but chances are the first two (less rarely, the first three) categories,
when grouped together, reach or exceed 80%.

Since Housing equals 52% and Other equals 31%, these two categories
add up to 83%.

The next step is to determine if any categories (the category could be

anything, such as defects, complaints, missed calls, returns, etc.) could be
modified or enlarged.

Note: It might also make sense to add more categories due to information
being overlooked or omitted, as shown on the following pages.
180 Appendix A – Pareto Charts

Omissions Re-grouping helps to point to areas, in this case, expenses, that were
Become omitted.
Apparent
After regrouping the categories into broader ones, it becomes evident that:
• certain expenses were overlooked, or
• it may be better to move an expense to a different (broader) category.

Examples of what could have been omitted, should have been included, or
point to moving an expense to another category, are given below.

Omissions
• Transportation – Expenses for gasoline, car maintenance, parking fees, and
car insurance were not included
• Food/Dining Out – Lunch is bought daily at work and at school, five days
per week – Dining out on the weekends happens as well – How much
does that add up to? If paying for a child’s school lunches, where would
be the better place to assign that cost – Food/Dining Out or Child Care?
• Child care costs – Daycare, babysitting, activities (sports, music, etc.)
• Medical costs – Co-payments, medical supplies and equipment, lab fees,
prescriptions, dental, vision
• Taxes – Taxes do not appear as a separate category. Were they included as
part of the mortgage? Are there additional taxes, such as a vehicle excise
tax, that would be included under Transportation?
• Other fees – Are there other fees, such as sewer fees or community or
maintenance dues?
• Donations – Are donations, such as to a religious organization or favorite
cause, made on a predictable basis?

Change Categories
• Cable and Internet – The Internet has become a necessity in many homes
today, especially if working from home or when related to school work –
Would it be better to move that category under “Housing”?
• Dining Out – Dining out has become less of an entertainment function
and more of a way of eating due to convenience, scheduling, and time
demands. Maybe it should be grouped together with Food?
 Appendix A – Pareto Charts 181

Transportation Under Transportation, we could revise that category to include the following:
Example • Gasoline: $60/week * 4 weeks. . . . . . . . . . . . . . = $240
• Maintenance:
– Oil change at ($30*4/year) ÷ 12. . . . . . . . . . . = $10/month
– Tires, wipers, etc. ~ $360/year ÷ 12. . . . . . . . = $30/month
• Parking: $15/day * 20 days/month. . . . . . . . . . . = $300
• Car insurance: $1,380/year ÷ 12. . . . . . . . . . . . . = $115/month
• Registration: $60/year ÷ 12. . . . . . . . . . . . . . . . . = $5/month
• Motor vehicle excise tax: $120/year ÷ 12 . . . . . . = $10/month

Additions to Transportation = $710

Car payment = $250
New total for Transportation = $960

Using with A Pareto chart is not a required element for an FMEA. It is a tool that aids
an FMEA with determining where to apply efforts.

Assembling the information into a Pareto chart reinforces where the biggest
issues lay. Once you are satisfied that all the variables have been identified
and included, the investigator now has a better idea of where to apply an
FMEA.

Remember that for an FMEA, a Pareto chart is simply a starting point, even
if the only issue is to identify quantity. Even so, one incident or event that is
severe enough to put an organization out of business is not going to show
up as a high percentage on a Pareto, if at all.
A Pareto chart does have its limitations and is not appropriate for all
situations.

This is why FMEAs also deal with severity, detectability, and criticality.
(This page intentionally left blank.)
 Appendix B –
Fishbone Diagrams

Introduction This section provides guidance on:

• what a fishbone diagram is
• how a fishbone diagram is structured
• how to construct a fishbone diagram, and
• the benefits of a fishbone diagram.

Contents The topics given in this section and the page numbers on which they are
found are:

Topic Page
What is a Fishbone Diagram. . . . . . . . . . . . . . . . . . . . . . . . 184
Diagram’s Appearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Cause and Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Value of a Fishbone Analysis. . . . . . . . . . . . . . . . . . . . . . . . 185
Fishbone Diagram as a Map . . . . . . . . . . . . . . . . . . . . . . . . 186
5Ms and 1E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Layered Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Omitting Layers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Higher and Lower Layers. . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Adding the Bones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
Bones with Specific Examples. . . . . . . . . . . . . . . . . . . . . . . 191
Wealth of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Other Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Consistency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Time Wasters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Money Drainers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

183
184 Appendix B – Fishbone Diagrams

Topic Page
Determine What is Wanted . . . . . . . . . . . . . . . . . . . . . . . . 195
Preventing Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
If It is Not on the List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Not Enough Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Time to Do It Over . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Reinforcing Your Priorities. . . . . . . . . . . . . . . . . . . . . . . . . . 198
Roadmap to Success. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

What is a A fishbone diagram, also known as simply as a “fishbone,” is a graphical tool

Fishbone that helps to break down and sort of the various elements that either make
Diagram up and/or contribute to a situation or a problem.

The term “fishbone” comes from the skeletal appearance of a fish that the
diagram presents.

Note: A
 fishbone can also be called an Ishikawa diagram after Kaoru
Ishikawa, who developed the technique.

Diagram’s The term “fishbone” comes from the skeletal appearance of a fish that the
Appearance diagram presents.

Manpower Machines Methods

Investigation
Area

Materials Measurements Environment

 Appendix B – Fishbone Diagrams 185

The “skeleton” is comprised of three main parts:

• The head – where the problem or situation under investigation is
summarized in a few words
• The spine – which links the head with the main categories, and
• The ribs – which are the main categories, often referred to as the 5Ms
and 1E.
The “ribs” are arbitrary classifications; they may be modified to suit the
situation. There is no particular order in which the categories are presented.
Often, these are arranged because of space considerations. The investigation
builds on the ribs with the subcategories being added to them. The ribs and
their subcategories are sometimes collectively known as the “bones” of a
fishbone diagram.
Typically, only the head, spine, and the bones are depicted. The head is
usually found on the right, although this is not mandatory.
The actual shape of the fish is understood to be present, but is usually not
shown except possibly once, when initially when presenting the concept to
those who may not be familiar with it.

Cause and A fishbone diagram is a starting point. It is a springboard that prompts ideas
Effect and other factors to consider.
Once the main elements and subcategories have been identified, further
analysis is performed to determine what is potentially or actually impacting,
either significantly or negatively, the situation or matter under investigation.
This “digging deeper” to find out what is actually going on, or where
the gaps may be, amounts to discovering the causes that are creating the
undesirable effects; hence, fishbone diagrams are also known as cause-and-
effect diagrams.

Value of a When performing an FMEA, the goal is to identify the root cause(s) of
Fishbone potential failures. Often what appears to be the “obvious” reason why
Analysis something failed or is not functioning as desired is not the reason at all.
A fishbone diagram is an excellent tool for determining the root cause(s).
A fishbone diagram’s value lies in its ability to break down the factors that
could possibly be:
• contributing to less-than-optimal conditions, i.e., failures, or
• impacting a small organization that would require vigilance or some kind
of response.
By separating out the various elements that make up a situation, it becomes
easier to see the other factors that are contributing to it.
186 Appendix B – Fishbone Diagrams

Fishbone A fishbone diagram can be thought of as a map giving a general overview of

Diagram the landscape. Subcategories provide landmarks for further investigation.
as a Map
The investigator explores these areas to find the details. Once an investigator
starts digging, what becomes obvious is that there are many possibilities and
factors contributing to the situation.

5Ms and 1E The “ribs” of the fish are the six most common areas that quality
professionals have identified as influencing the outcome of a situation.

As a general rule, a good place to start is with the standard categories on a

fishbone diagram:
• manpower, a.k.a. people
• machines
• methods
• materials
• measurements, and
• environment.

Layered It is helpful to also consider the fishbone as having multiple layers along the
Considerations lines of a stacked pancake effect.

The higher-layer requirements often, although not always, drive the lower-
layer requirements.

For example, federal requirements for worker safety may be the basis for
equipment selection or operator qualification.

There may be instances where the lower layer requirements must sync with
the higher layers, such as a facility may have a union present which creates its
requirements, but under state law, these requirements must be in alignment
with the state’s labor and training laws. If there were no union, the state’s
requirements would not apply.

The graphic on the following page, Tiered Environmental Considerations,

shows how the Environment category on a fishbone may actually have
multiple layers that impact that category.
 Appendix B – Fishbone Diagrams 187

Tiered Environmental Considerations

Federal Regulations
Example:
OSHA (Occupational Safety and Layer 1
Health Administration)

State and / or City

Regulations & Licenses
Examples: Layer 2
Toxic Waste Disposal, Certified Welder

Plant or Shop
Examples: Layer 3
Utilities, Warehousing, Waste Handling

Customer Requirements & Needs

Examples:
Customer-specific Raw Materials, Skidding
Layer 4
Department
Examples:
Location, Accessibility

Operation
Examples: Layer 5
Ventilation, Lighting, Power

Employee
Examples: Layer 6
Tools, Safety, Fatigue, Comfort, Union
188 Appendix B – Fishbone Diagrams

Omitting Layers Layers may be omitted if they do not apply, but you might want to make
note that you took them into consideration and found them to be “not
applicable.”

If liability issues are a potential concern, consider documenting why you

deemed them not applicable. A few sentences noting that the requirements
were considered and deemed not applicable may be sufficient to prove due
diligence in the event of a lawsuit.

Failure to provide records that you knew about the requirements may
amount to neglect or failure to demonstrate due diligence. Protect yourself
and your organization.

Higher and Any layer may be considered the “top” layer, but remember that the
Lower Layers placement is relational only and does not indicate priority in terms of cause.

For the purpose of a fishbone, all layers have priority, but which dominates in
terms of possible causes varies. What the business owner can control typically
lies within the organization.

The differences between layers are that they have different considerations
and they typically require different types of responses.

If it is easier, think of the layers as being a higher or lower to each other.

Separating the requirements into different layers makes it easier to identify

where the requirements are coming from and how to respond effectively
to them.

For complicated matters, drawing a fishbone for each layer can help to
ensure that everything was taken into consideration and this might be
something the investigator chooses to do; however, this is not required.
Fishbone diagrams are tools meant to assist so use them when they make
sense.

Table 31, 5Ms and 1E, which is represented on the next page, provides
examples for the six common categories that could be considered “higher
level” and “lower level.”
 Appendix B – Fishbone Diagrams 189

FISH “BONE” DESCRIPTION EXAMPLES

Manpower, The people involved High level

a.k.a. “people” with the matter • Lawmakers, stockholders, board of directors
• Customers, markets, general public
• Clients, patients, consumers, users
Lower level
• Trainers, sales people, customer representatives
• Operators, technicians, processors
• Contractors, temporary help

Materials The materials High level

affecting the matter • Laws
• Press releases, announcements
• Certifications, reports, audits
Lower level
• Raw materials used in manufacturing
• In-take forms, registration forms, claim forms
• Application forms, regulatory paperwork

Methods The methods High level

involved in the • Regulatory requirements
situation
• Customer requirements
Lower level
• SOPs, work instructions
• Hand assembly, computerized, voice, person-to-
person

Measurements The measurements High level

related to the • Compliance audits
matter
• Customer satisfaction surveys
Lower level
• Weights, lengths, time, etc.

Table 31. 5Ms & 1Es. (continued)

190 Appendix B – Fishbone Diagrams

(continued)

FISH “BONE” DESCRIPTION EXAMPLES

Machines The machines High level

related to the • Computer systems
matter
• Transportation systems
Lower level
• Manufacturing equipment, office equipment

Environment The environment High level

impacting the • Government regulations
situation
• Import/export
• Political situations
• Labor disputes
Lower level
• Physical location, utilities, lighting, ventilation,
temperature
• Employee base, education, repetitive work,
training
• Work demands & safety considerations

Table 31. 5Ms & 1Es.

Adding the Adding the “bones” to the “ribs” of a fishbone diagram is essentially a
Bones “drilling down” exercise.

The bones simply reflect what is going on in a particular area. There are no
minimum or maximum requirements of what must be present.

Without showing the specifics, the structure would appear along the lines of
the following figure.

Note: S ome categories may have nothing or very little indicated while other
categories might appear overloaded with information.
 Appendix B – Fishbone Diagrams 191

Manpower Machines Methods

Subcategory Subcategory
Subcategory
Side Consideration 1 Subcategory
Side Consideration 2 Subcategory

Major Consideration

Investigation
Area

Subcategory
Subcategory
Subcategory

Side consideration 1
Major Consideration 1

Major Consideration 2 Sideconsideration 2

Materials Measurements Environment Major Consideration 1

Bones with The fishbone below shows an example of an ice cream stand with some
Specific specifics that may pertain to it.
Examples
Note that:
• not every possible consideration is shown, and
• one category can act as the springboard for identifying other elements or
contributors.
192 Appendix B – Fishbone Diagrams

Dish

Manpower Machines Methods Paper

Waffle Bowl
Maintenance
Uniform Display Freezer Hand Scoop
Weekly
Server Storage Freezer Monthly
Sugar
Seasonal
Soft Serve Dispensing Waffle
Experienced Shut Down
Each Use
Start-Up Soft Cone
Inexperienced Cleaning
Frequency Order Payments
Training Scheduling 1-Flavor
End of Day
Paychecks 2-Flavor
Seasonal
Machine Ice Cream
Most Popular Stand
Small Medium Store
Flavors
Appearance
Sizes
Manager Customers
Seasonal
Kiddie Cones Servers
Walk-Up Window
Large Bowls Cleaners
Sundays
Products Dining Room
Prices
Drinks Staff Promptness
Drinks Drive Through
Sales Sundaes

Location
Materials Measurements Environment

Wealth of While the above fishbone did not capture every possibility for potential
Information failures at a restaurant that specializes in short order food and ice cream,
what is present are landmarks to identify other areas to investigate so, if
possible, failures can be averted.

Other It is difficult to recall everything when one has multiple tasks to perform
Considerations and/or when dealing with multiple individuals, each with his or her own
concerns and needs. One or more categories may bring to mind other
elements to consider.

Table 32 provides examples of considerations that an owner may

undoubtedly be well aware of, but might not have delved into deeply in
order to set up policies, systems, or instructions to prevent potential problems
or ensure repeated success.
 Appendix B – Fishbone Diagrams 193

CATEGORY SUB-CATEGORY ELEMENTS CONSIDERATIONS

Manpower Uniform • Hair • Neatness
• Apron • Cleanliness
• Name Tag
Scheduling • Store hours • Duties – opening and
• Staff availability closing, peak hours,
slow periods
Payroll • Tracking employee • Approvals
hours • Cutting checks
• Pay rates • Direct deposit
Machines Operating • Safety • Dismantling
• Hygiene • Reassembling
• Cleaning • Repairing
Methods Soft Serve • Number of twists • Dips
• Toppings
Order Payments • Cash register • Payment entry
• Credit & debit • Accounting method
cards
Measurements Flavors • Supplier • Hold times
• Made-on-site • Freezer temperatures
• Seasonal • Rotating stock
• Specialties • Reordering – lead time
Sundaes • Elements • Amount to use
• Toppings – flavors • Order of addition
• Whipped cream • Toppings – heated, room
• Options temp, chilled
• Equipment – set-up,
running, safety, hygiene,
cleaning
Drinks • Elements • Amount to use
• Flavors • Order of addition
• Options • Cup size
• Equipment – set-up,
running, safety, hygiene,
cleaning
Table 32. Ice cream stand example, potential areas for failure. (continued)
194 Appendix B – Fishbone Diagrams

(continued)

CATEGORY SUB-CATEGORY ELEMENTS CONSIDERATIONS

Machines Sizes • Cones • How measured – scale,
• Bowls twists, spoon count,
spoon size
• Sundaes
• Pricing product by size
• Drinks
Environment Appearance • Furniture • Cleanliness
• Counter • Certifications &
• Staff inspections
• Handling customers

Table 32. Ice cream stand example, potential areas for failure.

Consistency Simply by sitting down to rough out what else to consider or specify,
an owner is in a much better position to create consistency within the
organization.

Even something as simple as “how to wear a name tag” is a specification, as

in “the name tag is always worn while on duty, is positioned horizontally, and
is centered across the top of the left breast pocket.”

By roughing out what else to consider, an owner is in a much better position

to identify where policies are needed and what needs to be specified.

Time Wasters Examples of what wastes time, slows down delivery, and impairs customer
satisfaction, include:
• not having clear policies
• not having any policies at all
• not establishing priorities
• giving only partial instructions
• not specifying locations, and
• expecting an experienced person to remember everything when training a
new hire.
 Appendix B – Fishbone Diagrams 195

Money Drainers Examples of what ultimately result in avoidable errors and consequently use
money that does not need to be wasted include:
• not having clear policies
• not having any policies at all
• expecting people to know
• believing what is obvious to you is obvious to everybody else
• expecting people to use common sense
• giving only partial instructions
• expecting memories to never fail and that an experienced person will
remember everything when training a new hire

Determine The kinds of problems that can arise are limitless. Therefore, it is futile to
What is Wanted attempt to specify everything that should be avoided.

People often speak in negative generalities, but achieving the negative is

difficult if not impossible. Instead, concentrate on what is desired.

INSTEAD OF DETERMINE
EXAMPLES
SAYING… DESIRED SPECIFICS
Never ignore What constitutes • Saying hello
the customer “giving the customer • Smiling
attention”?
• Greeting the party within one minute
• Seating the customers with menus
• Immediately asking if they would like water
or coffee
• Repeating their orders once taken
Don’t forget to What exactly is the “X” needs to be done:
do “X” issue with “X”? • before the end of closing, within the next
half hour, before punching out
• because “Y” is backing up
• a customer complained
• it needs to be ready when so-and-so comes
in tomorrow

Table 33. Specify What to Do. (continued)

196 Appendix B – Fishbone Diagrams

(continued)

INSTEAD OF DETERMINE
EXAMPLES
SAYING… DESIRED SPECIFICS
Don’t overload Why do we want this? • We need room for other items
the shelves • Too much weight and the shelf will fall down
How do we achieve it?
• Keep a maximum of ten on the shelf and
store the rest underneath
Don’t let it get What is clean? • Dirty to the eye?
too dirty • Dirty to the touch?
• Is it washed? Washed with what? How
often? Is it rinsed as well?
• Is it replaced on a regular basis with a new
one? How frequently?
Don’t use toxic What is non-toxic? • X may cause burns or explosions
materials • Label must state “non-toxic”
• Use only specified materials
• Ensure material is within its expiration date

Table 33. Specify What to Do.

Preventing It is far easier for employees to follow one or two things that are required
Failures than to remember a list of all the things that they should not do.

For example, for an ice cream shop:

• customers should be acknowledged within one minute of appearing at the
store
• tables should be cleared and washed down within five minutes of the
customers leaving
• the manager or supervisor notes when servers are busy and attends to the
customers themselves
• serving customers takes priority over refilling sugar containers and salt-
and-pepper shakers, or
• a state-certified food handler must be present on every shift.
 Appendix B – Fishbone Diagrams 197

If It is Not Getting back to the list of “what not to do,” direct the attention back to
on the List what is required.

If a situation appears that is not covered by the policy or specifications, then

it is:
• not applicable
• the business does not do this, or
• someone in authority decides how it needs to be handled.

Since it is not possible to anticipate all possibilities, management should be

made aware of the matter. It will decide how to proceed from there.

Not Enough Frequently, supervisors and other individuals in authority claim that they are
Time too busy to draw up a table or a diagram.

It may be easier to verbally answer questions as they arise, but this:

• permits opinions to replace policies
• feeds into laziness, and
• guarantees that there will misunderstandings, incorrect information, or
omissions.

Time to Do There is an adage in the quality assurance field that “there is never enough
It Over time to do it right the first time, but there is always enough time to do it
over.”

If you have time to do a task over, or correct an error or problem, or address

an unhappy customer, you have time to do it correctly in the first place.

Remember that a fishbone diagram does not need to be completed in one

sitting. Put it aside and work on it as time permits, but get it completed.
198 Appendix B – Fishbone Diagrams

Reinforcing Your If you find yourself doing the same things repeatedly and are lacking
Priorities opportunities for accomplishing your other goals, make the time for a hard
look at what you are doing so you can get policies and procedures down in
writing. Then, should questions arise, answer them with, “What does the
(manual, worksheet, SOP, etc.) say?” and by directing the employees to come
back to you with that information.

This teaches the employees what needs to be done and how, as well as
reinforces that:
• policies and procedures do exist
• policies and procedures do not change on somebody’s whim
• employees are expected to take initiative and be responsible
• the answers are available whenever employees need them
• memories are not the best sources of information, and
• a manager or supervisor will be available to answer questions after things
are first done “the right way.”

Roadmap to Whether used as part of an FMEA or independently to determine exactly

Success what is happening within an organization, a fishbone diagram provides an
immense amount of information.

A fishbone diagram is a very inexpensive investment that goes far to

contributing to an organization’s success.

You owe it to your peace of mind to utilize this most valuable tool.
 Appendix C –
FMEA Worksheet Examples

The worksheets on the following pages are available in MS Word format on the
accompanying CD.

199
200 Appendix C – FMEA Worksheet Examples

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer
FMEA-15-001 Receipt of Kits Plant A N/A John Anderson – Welding N/A
Start Date Total Steps Department Manager SME #2 / Department Completed By
6/1/15 7 Welding John Anderson Bethany Trask – Engineering Nick Jenkins
Process Name Step # Design Rev # Design SME #3 / Department Approved by
Welding 1 N/A Bethany Trask Matt Hudson – Welder Patrick Mercier

Kits are received from outside of the welding department.

Process Stage – Describe the process stage under
Kits are usually assembled from parts located in the stock room.
development or study.
Sometimes, the kits come into Welding directly from the production floor.

1. Parts may be mixed either on floor or in stock room.

2. The count is incorrect.

Potential Failure Mode – In what ways can the key
input(s)/actions go wrong?
3. Parts may be dirty due to long storage or frequent handling.

4. The paperwork does not match the parts.

1. The parts are unusable due to damage or incomplete processing prior to Welding’s receipt.

2. Incorrect number of parts creates a “short” lot.

Potential Failure Effects – In what ways can the
above failures affect other things?
3. Parts incorrect cleaned or not cleaned at all.

4. Downtime may result in delayed shipment.

Cause or Source of Potential Failure – Indicate (C)
1. S – Miscount, dirt, and broken parts occur prior to the kits entering Welding.
for Cause or (S) for Source. Cause means the cause
of the potential failure has been identified as located in
2. S – Incorrect part selection occurs prior to the kits being received by Welding.
the area under investigation and will be addressed
under this FMEA. Source means the source of failure
3.
must be located outside the area under review and
there is a need for further investigation independent of
4.
this FMEA.
1. Traveler contains part numbers, count numbers, customer, and delivery date.
Current Prevention Controls – What are the existing
controls and procedures (inspection and test) that 2. Cleaned parts are protected in plastic bags.
prevent either the cause or the Failure Mode? State
procedure (number) that exists or note if there are no 3. Kitters trained to identify parts, dirty and broken parts and how to count correctly.
controls.
4. Welders verify kit contents with paperwork – non-conforming parts put on hold.

1. Employees handling are trained to ID and isolate broken and dirty parts.
Current Detection Controls – What are the existing
2. Kitters are trained on how to verify the kit’s contents and counts before submitting to Welding.
controls and procedures (inspection and test) that
detect the Failure Mode? State procedure (number) 3. Welders check each kit for correct paperwork, correct count, undamaged parts, and clean
that exists or note if there are no controls. parts.
4.
Severity (S) – measure of the possible consequences of a hazard to a user, customer,
5
process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring. 2
Initial Rating – Create & use rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
1
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D 10

1. None at this time

2. System appears sufficient to catch any discrepancies

Recommended Changes – What are the
recommended improvements?
3. May revise determination after further investigation into other areas

4.

1. Quality assurance
Responsibility – Who is responsible for the
recommended action(s)?
2.

1.

Mitigation Action/Control Implemented – What 2.

were the actions for reducing the occurrence of the
cause or improving detection? 3.

4.
Severity (S) – measure of the possible consequences of a failure to a user, customer,
the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Updated Rating – Use the rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D
1. Failure to detect incorrect parts may mean parts assembled incorrectly, creates waste of
materials and labor, and need to do-over.
Criticality Comments 2. Need to do-over entails avoidable costs at company’s expense.
3. Need to do-over delays shipment – customer’s production hindered by incorrect or delayed
parts – potential loss for future sales.
 Appendix C – FMEA Worksheet Examples 201

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer
FMEA-15-022 Ultrasonic Cleaning Plant A N/A Cindy McGuirl N/A
Start Date Total Steps Department Manager SME #2 / Department Completed By
8/17/15 8 Cleaning Rachel Harris Steve Patel – QA Nick Jenkins
Process Name Step # Design Rev # Design SME #3 / Department Approved by
Ultrasonic Overall Process N/A N/A N/A Patrick Mercier
Parts are received for ultrasonic cleaning
Process Stage – Describe the process stage under Parts are assembled on trays for cleaning
development or study. Parts undergo three washes, one rinse, and one dry
Parts released from department

1. Part orientation on trays prevents proper cleaning or creates pockets that hold water.

2. Detergent – amount incorrect or not used at all.

Potential Failure Mode – In what ways can the key
input(s)/actions go wrong?
3. Tank fluids too dirty or not replenished frequently enough.

4. Calibration results are not understood – failure to properly respond.

1. Parts may be improperly cleaned or air dried.

2. Improperly cleaned parts may leave department.

Potential Failure Effects – In what ways can the
above failures affect other things?
3. Poor sonic operation will not clean sufficiently.

4. Drying may not be sufficient if there are pockets of water on parts.

Cause or Source of Potential Failure – Indicate (C)
1. C – Proper orientation of parts not identified prior to cleaning.
for Cause or (S) for Source. Cause means the cause
of the potential failure has been identified as located in
2. C – Tank water cleanliness is based on experience of operators.
the area under investigation and will be addressed
under this FMEA. Source means the source of failure
3. C – Management not alerted the sonic equipment is not operating sufficiently
must be located outside the area under review and
there is a need for further investigation independent of
4. C – Studies have not been performed to determine optimal drying.
this FMEA.
1. Training for part orientation is one employee showing another.
Current Prevention Controls – What are the existing
controls and procedures (inspection and test) that 2. Only authorized personnel are permitted to operate cleaning system.
prevent either the cause or the Failure Mode? State
procedure (number) that exists or note if there are no 3. Tank water must be changed after three lots – earlier if the water appears excessively dirty.
controls.
4. Detergent amounts are weighed – Washing and drying have minimum time controls.
1. Operators using subjective (eyesight) assessment of how dirty the water is, when tank water
needs replenishing, and if parts are sufficiently dried.
Current Detection Controls – What are the existing
controls and procedures (inspection and test) that 2. Training relies on memory and people remembering to show new hires what to look for or do.
detect the Failure Mode? State procedure (number)
3. Sonic calibration is performed, but operators do not know how to interpret the foil results.
that exists or note if there are no controls.
4.
Severity (S) – measure of the possible consequences of a hazard to a user, customer,
5
process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring. 3
Initial Rating – Create & use rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
1
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D 15

1. Develop training program for calibrating ultrasonic performance – develop if/then action plan.
2. Perform study to determine if current (subjective) assessments of dirty water and need to
Recommended Changes – What are the replenish the tank water are reliable.
recommended improvements? 3. Develop a standard training program (PowerPoint?) that includes visual examples of how to
orient parts and how to handle tank water and detergents.
4. Develop a standard training program (PowerPoint?) that includes visual examples of how to
orient parts and instructions for handling water, detergents, drying, and sonic calibrations.
1. Quality assurance
Responsibility – Who is responsible for the
recommended action(s)?
2.

1.

Mitigation Action/Control Implemented – What 2.

were the actions for reducing the occurrence of the
cause or improving detection? 3.

4.
Severity (S) – measure of the possible consequences of a failure to a user, customer,
the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Updated Rating – Use the rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D

1. Unclean parts can cause customer dissatisfaction and loss of sales.

Criticality Comments 2. Unclean part can impact patient health or cause death.

3.
202 Appendix C – FMEA Worksheet Examples

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer
FMEA-15-024 Part Orientation Plant A N/A Cindy McGuirl N/A
Start Date Total Steps Department Manager SME #2 / Department Completed By
8/17/15 8 Cleaning Rachel Harris Steve Patel – QA Nick Jenkins
Process Name Step # Design Rev # Design SME #3 / Department Approved by
Ultrasonic Cleaning 3 N/A N/A N/A Patrick Mercier

Process Stage – Describe the process stage under Parts are assembled on trays for cleaning.
development or study. Parts undergo three washes, one rinse, and one dry.

1. Part orientation on trays prevents proper cleaning or creates pockets that hold water.

2. Detergent – amount incorrect or not used at all.

Potential Failure Mode – In what ways can the key
input(s)/actions go wrong?
3. Tank fluids too dirty or not replenished.

4. Calibration results are not understood – failure to properly respond.

1. Parts may be improperly cleaned, rinse, or dried.

2. Machine oil and dirt can remain on parts.

Potential Failure Effects – In what ways can the
above failures affect other things?
3. Improperly cleaned parts may leave department.

4.
Cause or Source of Potential Failure – Indicate (C)
1. C – Proper orientation of parts not identified prior to cleaning.
for Cause or (S) for Source. Cause means the cause
of the potential failure has been identified as located in
2. C – Tank water cleanliness is based on subjective analysis and experience of operators.
the area under investigation and will be addressed
under this FMEA. Source means the source of failure
3. C – Formal training on ultrasonic cleaning never occurred.
must be located outside the area under review and
there is a need for further investigation independent of
4. C – No follow-up ever occurred to see if initial part orientation instructions were adequate.
this FMEA.
1. Training for part orientation is one employee showing another.

Current Prevention Controls – What are the existing 2. Only authorized personnel are permitted to operate cleaning system.
controls and procedures (inspection and test) that
prevent either the cause or the Failure Mode? State 3. Machining origin area, including solvents and oils used, are noted on traveler.
procedure (number) that exists or note if there are no
controls. 4. Detergent amounts require weighing – Washing and drying have minimum time controls.

5. Tank water is changed after three lots – earlier if the water appears excessively dirty.

1. Operators using subjective (eyesight) assessment of how dirty the water is.
Current Detection Controls – What are the existing
controls and procedures (inspection and test) that 2. Training on part orientation relies on memory.
detect the Failure Mode? State procedure (number) 3.
that exists or note if there are no controls.
4.
Severity (S) – measure of the possible consequences of a hazard to a user, customer,
5
process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring. 3
Initial Rating – Create & use rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
1
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D 15

1. Develop a training program (PowerPoint?) that includes visual examples of how to orient parts.

2. Perform studies – determine if subjective assessments of dirty water and drying are reliable.
Recommended Changes – What are the
recommended improvements?
3. Enforce operator-only use of system.

4. Determine if more specialized racks are need to properly orient parts for cleaning.

1. Engineering & QA – training and studies.

Responsibility – Who is responsible for the
recommended action(s)?
2. Management – improper use of equipment – must demonstrate support for operators.

1.

Mitigation Action/Control Implemented – What 2.

were the actions for reducing the occurrence of the
cause or improving detection? 3.

4.
Severity (S) – measure of the possible consequences of a failure to a user, customer,
the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Updated Rating – Use the rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D
1. Floor managers bypass cleaning operators and process steps to clean parts “their way”, i.e.,
walk-in, hand-dunk parts in tanks, give quick, hand-dunk rinses, and shake off water.
Criticality Comments 2. Understanding of process is not understood by operators and floor personnel.

3. Operators and process are disrespected – process criticality not enforced by management.
 Appendix C – FMEA Worksheet Examples 203

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer
FMEA-15-025 Water Cleanliness Plant A N/A Cindy McGuirl N/A
Start Date Total Steps Department Manager SME #2 / Department Completed By
8/17/15 8 Cleaning Rachel Harris Steve Patel – QA Nick Jenkins
Process Name Step # Design Rev # Design SME #3 / Department Approved by
Ultrasonic 3 N/A N/A N/A Patrick Mercier

Process Stage – Describe the process stage under

Loaded trays are lifted and moved from one tank to another for cleaning
development or study.

1. Detergent is not weighed – the amount is measured by volume (cup) or by eyeballing amount

2. Some parts dirtier than others – the kinds of dirt can vary – dirt contaminates the water
Potential Failure Mode – In what ways can the key
input(s)/actions go wrong?
3. Back-up of lots to be cleaned may temp operators to overload the trays

4. The draining method and time, from tank-to-tank, varies by operator

1. “Drag” can occur (dirty water is carried from one tank to the next for a variety of reasons)

2. Insufficient detergent hampers cleaning

Potential Failure Effects – In what ways can the
above failures affect other things?
3. Excessive detergent hampers rinsing

4. Contaminants may not be visible to the naked eye

Cause or Source of Potential Failure – Indicate (C)
1. C – Water changed according to the “magical” number of “3” – not scientific basis for “3”
for Cause or (S) for Source. Cause means the cause
of the potential failure has been identified as located in
2. C – Tank water cleanliness is based on subjective analysis and experience of operators
the area under investigation and will be addressed
under this FMEA. Source means the source of failure
3. C – Tray draining time is not specified.
must be located outside the area under review and
there is a need for further investigation independent of
4. C – Instructions (SOP) written five years ago – have not been revised
this FMEA.
1. Training consists of one employee showing another.
Current Prevention Controls – What are the existing
controls and procedures (inspection and test) that 2. Experienced operators rely on “what they know works”.
prevent either the cause or the Failure Mode? State
procedure (number) that exists or note if there are no 3. Volume (cups) are used instead of weight – volume measuring methods vary by operator.
controls.
4. Custom-made racks are used on trays to help orient pieces in optimal positions for cleaning

1. Operators using subjective (eyesight) assessment of how dirty the water is.
Current Detection Controls – What are the existing
2. Operators using subjective (eyesight) assessment to determining sufficient draining.
controls and procedures (inspection and test) that
detect the Failure Mode? State procedure (number) 3. Travelers cite prior machining methods – operators know that certain machining methods
that exists or note if there are no controls. require different types of cleaning solvents.
4.
Severity (S) – measure of the possible consequences of a hazard to a user, customer,
5
process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring. 3
Initial Rating – Create & use rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
3
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D 45

1. Establish minimum draining time and minimum frequency for changing tank water.
2. Determine if all machining processes have their cleaning methods specified. Correlate
Recommended Changes – What are the cleaning methods with prior machining steps. Implement as step for future travelers.
recommended improvements?
3. Determine suitability of SOP – incorporate operator experience & knowledge as appropriate.
4. Perform studies to determine type and amount of contaminants that remain on the parts after
cleaning, if any.
1. Quality assurance – all.
Responsibility – Who is responsible for the
recommended action(s)?
2. Engineering – all.

1.

Mitigation Action/Control Implemented – What 2.

were the actions for reducing the occurrence of the
cause or improving detection? 3.

4.
Severity (S) – measure of the possible consequences of a failure to a user, customer,
the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Updated Rating – Use the rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D
1. Not all dirt and oil are visible to the eye – water may be too dirty to clean despite appearance;
contaminants may remain on parts despite being visually clean.
Criticality Comments 2. Ultrasonic cleaning depends on accessibility to all nooks and crannies of the parts.

3.
204 Appendix C – FMEA Worksheet Examples

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer
FMEA-16-002 New Food Line Restaurant N/A Kyle Richards – Chef N/A
Start Date Total Steps Department Manager SME #2 / Department Completed By
1/24/16 N/A Kitchen Joe Muniz N/A Phil Twombly
Process Name Step # Design Rev # Design SME #3 / Department Approved by
Menu N/A N/A N/A N/A Phil Twombly

Process Stage – Describe the process stage under

Considering adding new seafood food line to menu.
development or study.

1. Customer interest will be low, not a big seafood area – recipes will not appeal to customers.

2. Chef/cooks will not know how to properly prepare and cook.

Potential Failure Mode – In what ways can the key
input(s)/actions go wrong?
3. Will lack equipment and supplier for fresh seafood.

4. Will lack safe seafood handling methods.

1. Food will not move – food will not taste good or will go bad – will need to throw out.

2. New equipment needs space to operate – will cramp or slow down current kitchen operations.
Potential Failure Effects – In what ways can the
above failures affect other things?
3. May need to qualify personnel on safe seafood handling.

4. Customer might get sick if seafood is not prepared properly.

Cause or Source of Potential Failure – Indicate (C)
1. C – Cooks need training in seafood preparation and safe handling.
for Cause or (S) for Source. Cause means the cause
of the potential failure has been identified as located in
2. C – Restaurant lacks space for new equipment – refrigeration and cooking.
the area under investigation and will be addressed
under this FMEA. Source means the source of failure
3. S – Seafood supplier is not local – extra charge for delivery – raw seafood may not be fresh.
must be located outside the area under review and
there is a need for further investigation independent of
4. C – Unknown customer preferences for seafood.
this FMEA.
1. Chef - culinary school graduate – knows seafood – certified in safe seafood handling.
Current Prevention Controls – What are the existing
controls and procedures (inspection and test) that 2. Kitchen already has refrigerator capacity.
prevent either the cause or the Failure Mode? State
procedure (number) that exists or note if there are no 3. Kitchen has room for preparation area for raw seafood.
controls.
4. Cooking equipment has flexibility for new cooking temperatures and methods.

1. Recipes are taste-tested and assessed against current menu prior to adoption.
Current Detection Controls – What are the existing
2. Have rough/general idea of customers’ interest in seafood.
controls and procedures (inspection and test) that
detect the Failure Mode? State procedure (number) 3. Recipes assessed for needed equipment and ingredients as well as prep and serving
that exists or note if there are no controls. methods.
4. Chef has broad experience in using different types of seafood – can ID seafood issues.
Severity (S) – measure of the possible consequences of a hazard to a user, customer,
50
process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring. 1
Initial Rating – Create & use rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
2
or served to the customer
Risk Priority Number (RPN) = S x F x D 100

1. Assess seafood restaurant competition within 3-mile radius

2. Find local seafood supplier

Recommended Changes – What are the
recommended improvements? 3. If seafood line is a go, need to develop training methods for kitchen staff & selling points for
servers
4. Determine if seafood sells better on certain days than others

1. Chef – locate local seafood supplier & make recommendations for recipes & presentations
Responsibility – Who is responsible for the
2. Owner – determine local competition – decide if restaurant should offer special seafood dishes
recommended action(s)?
3. Manager – determine selling points for servers, if seafood sells better on some days than
others, & how new line will impact operations and serving
1.
Mitigation Action/Control Implemented – What
were the actions for reducing the occurrence of the 2.
cause or improving detection?
3.
Severity (S) – measure of the possible consequences of a failure to a user, customer,
the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Updated Rating – Use the rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D

1. Bad seafood, handling, or preparation can illness, death, or waste money.

2. May be little or no market if area is already saturated with seafood restaurants or there is no
Criticality Comments
demand.
3. May not sell dishes if customer traffic is not interested in the menu or dislikes offerings.
 Appendix C – FMEA Worksheet Examples 205

Failure Mode & Effects Analysis Worksheet

FMEA # Task Name Facility Project ID # SME #1 / Department Customer
FMEA-16-008 Expansion Commercial Facilities N/A N/A N/A
Start Date Total Steps Department Manager SME #2 / Department Completed By
2/3/16 N/A Varies Rachel Plover N/A Matt O’Reilly
Process Name Step # Design Rev # Design SME #3 / Department Approved by
Commercial Line N/A N/A N/A N/A Matt O’Reilly

Process Stage – Describe the process stage under

Considering expanding cleaning line from residential into commercial facilities.
development or study.

1. Commercial facilities may have hazardous materials (hazmats).

2. Commercial facilities may have confidentiality issues – access, client information etc.
Potential Failure Mode – In what ways can the key
input(s)/actions go wrong?
3. Current equipment and/or staff may be insufficient to clean large commercial areas.

4. Current staff may not be able to work off-hours.

1. Protective clothing or special equipment may be required – cleaning products may require
special handling – potential for toxic or undesirable reactions.
2. Bonded employees and/or proof of work eligibility may be required.
Potential Failure Effects – In what ways can the
above failures affect other things? 3. Company may not be able to accept work due to equipment limitations – may lack capability to
adequately clean due to restricted areas.
4. May need to add staff and/or let go current employees due to workload or scheduling conflicts.
Cause or Source of Potential Failure – Indicate (C) 1. S – Hazmats located at commercial facilities.
for Cause or (S) for Source. Cause means the cause
of the potential failure has been identified as located in
2. S – Restricted areas and confidentiality issues vary by facility.
the area under investigation and will be addressed
under this FMEA. Source means the source of failure
3. C – Cleaning solutions may adversely react with materials onsite at commercial facilities.
must be located outside the area under review and
there is a need for further investigation independent of
4. C or S – Waste disposal requirements may vary or require special handling.
this FMEA.
1. Employees are trained to read labels before use.
Current Prevention Controls – What are the existing
2. Prior to signing contract, clients show areas that need to be cleaned and specify type of
controls and procedures (inspection and test) that
cleaning (vacuuming, washing, dusting etc.) – Specific needs and requests are obtained.
prevent either the cause or the Failure Mode? State
3. Clients specify hours permitted to be on-site and how to access building and areas and lock-
procedure (number) that exists or note if there are no
up.
controls.
4. Client’s on-call and emergency contact information are obtained prior to starting contract.
1. Company provides own cleaning products and equipment. Cleaning trucks have standardized
equipment and cleaning materials.
Current Detection Controls – What are the existing 2. Cleaning crew is trained on handling cleaning products, equipment, and client’s needs and
controls and procedures (inspection and test) that expectations.
detect the Failure Mode? State procedure (number)
3. Set-up and clean-up areas, electric, and water are identified before starting contract.
that exists or note if there are no controls.
4. Crews receive written instructions for each client – must complete before and after checklists
for each assignment.
Severity (S) – measure of the possible consequences of a hazard to a user, customer,
50
process, sub-process, or finished output.
Frequency (F) – The probability of the cause of the failure mode occurring. 10
Initial Rating – Create & use rating scales
Detect (D) – The probability that the failure mode will be identified before occurring. 10
Risk Priority Number (RPN) = S x F x D 5,000

1. Determine type of facilities able to current clean – size, type of business etc.
2. Create a client interview checklist for hazmats, waste, and confidentiality issues with standard
Recommended Changes – What are the questions – types, locations, handling.
recommended improvements? 3. Create training program for employees – determine method for conveying precautions and
restrictions.
4. Determine types of equipment and cleaning products needed for adequate and safe cleaning.
Determine safe waste handling and disposal methods.
1. Owner
Responsibility – Who is responsible for the
recommended action(s)?
2.

1.
Mitigation Action/Control Implemented – What
were the actions for reducing the occurrence of the 2.
cause or improving detection?
3.
Severity (S) – measure of the possible consequences of a failure to a user, customer,
the organization, sub-assembly, process, task, or finished item.
Frequency (F) – The probability of the cause of the failure mode occurring.
Updated Rating – Use the rating scales
Detect (D) – The probability that the failure mode will be identified before used internally
or dispatched to the customer.
Risk Priority Number (RPN) = S x F x D

1. Employees may not be able to read English – unable to read labels, procedures, or restrictions.

Criticality Comments 2. Employees may inadvertently cause damage or harm to clients’ facilities.

3. Business insurance must be adequate to cover new locations and clients.

(This page intentionally left blank.)
 Index

Page numbers in italics refer to figures or tables.

A criticality
acts of nature, 68, 69 arbitrary nature of, 95
acts of people, 69 assessment flowchart, 101f
American Society for Quality, 22t conformance to requirements, 97
average time between failures, 55. See also Mean Time defined, 95
Between Failures (MTBF) as a moving target, 97
“not that critical” (classification), 98
objective nature of, 97
B one-time determination of, 97
Baldrige Award, 26 preventive efforts, 99
Baldrige Criteria for Performance Excellence, 26 standard classifications, 96
binomial failure, 60t subjective nature of, 95, 96, 99t
criticality analysis, 17
Crosby, Phil, 98, 99
C customer assistance, 25
CAPA (Corrective Action and Preventive Action), 162, customers, 163
163, 166
catastrophic failure, 68–70, 96
cause – FMEA, 162 D
change, plan for, 44 damages, hidden, 67
closed systems, 92, 162 design, defined, 44
conception phase, 24 design phase, 24
configuration management, 163 design plan, 45, 47–48f
conformance to requirements, 97 detectability
consumers, 163 flowchart, 93f
continuous failure, 60t root cause of failure, 92
continuous improvement efforts, 25 RPN value, 64
control plan, 31 specifications, 90
corrective action, 18, 156, 162, 163, 166 subjective criteria, 91t, 92
Corrective Action (CA) and Preventive Action (PA), timing, 90
162, 163, 166 yes/no, 90
cost of poor quality, 98 detection number, 18
cost of quality, 98, 99 drilling down, 104, 163, 165, 190
cost savings, 16 due diligence, 163
criteria subjectivity, 138t
critical concerns, verification of, 28, 29
“the critical few,” 12

207
208 Index

E defined, 184
80–20 rule, 12, 13, 169 design plan questions, 47–48f
end effect, 163 example, 192f
environment, 38t, 48f failure prevention, 196
equipment logs, 79 focus on the positive, 195, 196t
external customers, 164 graphic, 41f
external stakeholders, 7 ice cream stand example, 192f, 193t
for identity, 46
layers, 186, 187f, 188
F as a map, 186
failure money drainers, 195
acceptability of, 80, 81 other considerations, 192
acts of nature, 68, 69 parts of, 185
acts of people, 69 priority reinforcement, 198
average time between, 55 roadmap to success, 198
catastrophic, 68–70, 96 time wasters, 194
consequences of, 59 value of, 185
cost of, 68 five “whys,” 165
criticality, 60, 63 5Ms and 1E, 37t, 186, 189t
defined, 58, 164 FMEA (Failure Mode and Effects Analysis)
detection, 20 administrative preparation, 133–136
frequency of, 77, 79, 80 applicability, 20
in hindsight, 59 approaches to, 19
major, 69 completion of, 31
Mean Time Between Failures (MTBF), 55, 77, 165 critical concerns, 110
minor, 70, 71 defined, 3, 10
moderate, 70 final steps, 159–160
one-time, 54, 78, 79 guidelines for using, 9–15
operational, 60t guides sampling, 22t
parts per million, 81 limitations, 4
rating scales, 137–141 “no action necessary,” 10
RPN threshold, 64 numbering system, 135, 138
salvageable, 69, 70 past efforts, 111
specification criteria, 83 process, 109–112, 113f
threat assessment, 17 purposes of, 3
tolerating, 5 ratings classifications, 13, 14
types of, 59 requirement for use, 10
worst-case scenarios, 1, 61 role contributions, 5, 6t
failure cause, 164 scope and flexibility, 4, 110
failure effect, 58, 164 stages, 27–31, 33f, 111t
failure levels, 58 stakeholders, 110
failure mode, 60, 164 standards by industry, 21t
Failure Mode, Effects, and Criticality Analysis three formal parts of, 16
(FMECA), 19 value of, 4
Failure Mode and Effects Analysis. See FMEA FMEA coordinator, 5, 6, 30, 49
failure rankings, 63–64 FMEA investigation flowchart, 51f
feasibility phase, 24 FMEA log/database, 134, 135
firefighting, 43, 165 FMEA methodology, uses of, 24–25
first-line workers, 13 FMEA team, 5, 28, 110
fishbone analysis, 36, 185 FMEA template, 111t
fishbone diagrams FMEA worksheet
5Ms and 1E, 37t, 186, 189t archiving step, 160
appearance, 184, 190, 191f, 192f audits, 160
bones, 190, 191f authority for change, 156
cause and effect, 185 cause, 149
consistency, 194 consistency, 153
 Index 209

contributor information, 130, 131–132t I

criticality comments, 157 identity, organizational, 45, 46
detection controls, 152 IEC (International Electrotechnical Commission
drivers, 147 Standardization), 21t
examples, 199–205 implementers, 5, 6
failures, 147 improvements, effectiveness of, 30
format, 144–145 “the informative many,” 12
header, 123–131, 126t, 127t, 128t, 129t, 132t, 145 internal customers, 165
high process levels, 125 Ishikawa diagram, 36, 41f, 184. See also fishbone
improvements, 155 diagrams
inputs, results, and causes/sorces, 150t ISO (International Organization for Standardization),
inputs, results, and detection controls, 152t 22t
inputs, results, and impacts, 148t isolated design, 20
inputs, results, and prevention controls, 151t
inputs and outputs, 147t
Internet links, 160 J
investigation section, 145 Juran, Joseph M., 12, 169
numbered lists, 146
operational processes, 126
outcomes, 154 K
potential failure causes or sources, 149 knee-jerk reactions, 43
potential failure effects, 148 known risks, 24
potential failure mode, 147, 148
preliminary information, 149 L
prevention controls, 151
logistics, 20
procedure identification, 152
process header information, 128, 129t
purpose, 153 M
ranking criteria, 153 machines, 38t, 48f
rankings, 153 maintainability, 20
RPN decisions, 154 maintenance, 20
RPN recalculation and comparison, 156 maintenance logs, 79
scope, 146 major failure, 69
source, 149 Malcolm Baldrige National Quality Award, 26
structure and purpose, 117–120, 121t manpower (people), 37t, 47f
supplemental information, 160 materials, 37t, 47f
tasks, 126, 127t, 128t Mean Time Between Failures (MTBF), 55, 77, 165
FMECA (Failure Mode, Effects, and Criticality measurements, 37t, 47f
Analysis), 19 methods, 37t, 47f
“For the Want of a Nail” (poem), 59 Mil–Std–1629A, 19, 20, 21
form, fit, or function, 54, 165 minor failure, 70, 71
frequency, of problems, 13, 14, 64 mitigation, RPN and, 18
frequency number, 18 moderate failure, 70
future goals, 45 modification phase, 24
multinomial failure, 60t
G
“good enough,” 81 N
new product design, 25
H new regulations, 24
normal use-and-abuse, 166
hackers, 59
“not that critical” (classification), 98
hindsight, 59
210 Index

O performance recognition, 26
occurrence plan analysis, 20
acceptability of, 80, 81 planning and design, risk assessment in, 43–48
action taken, 79 policy development, 25
control and, 82 prevention, timing of, 16
criteria subjectivity, 83, 84t preventive action, 166
financial considerations, 77 preventive efforts, 99
flowchart, 87f probability of occurrence, 166
frequency and cost, 82 Procedures for Conducting a Failure Mode, Effects,
frequency of, 77, 80, 83 and Criticality Analysis (Mil–Std–1629A), 19
“good enough,” 81 process
logs, 79 defined, 103
Mean Time Between Failures (MTBF), 77 outline structure, 104
measuring, 78 risk assessment, 49–50, 51f
one-time, 78 stages, tasks, and steps, 105, 107f
overzealousness, 81
parts per million, 81 Q
ranking criteria, 75
qualitative criticality analysis, 166
rating scales, 137–141
Quality is Free (Crosby), 98
reliability and, 79, 80
quality recognition, 25
ROI and, 140
quantitative criticality analysis, 167
situational, 76
questions, high-risk, 39
specification criteria, 83
tolerable numbers, 78, 82, 83, 84t, 85
unavoidable, 77 R
one-time occurrence, 78, 79 rating scales, 137–141, 138t
operational failure, 60t ratings classifications, 13, 14
organizational identity, 45, 46 records, 7
outside inputs, 7 regulatory requirements, 45
overzealousness, 81 reliability, 54–55, 167
reliability engineering, 167
P remedies, for situations, 77
repeat occurrences, 79
Pareto charts
required/shall/must, 167
budgets as drivers, 171
risk, defined, 167
category changes, 180
risk assessment
category reconfiguration, 178
5Ms and 1E, 37t
category reduction, 177
brainstorming, 35
category regrouping, 176
fishbone analysis, 36
clustering, 177
fishbone analysis diagram, 41f
and FMEAs, 170, 181
high-level, 35–41
focus selection, 171
high-level questions, 39
initial data and calculations, 172, 174
organizational balance, 38
introduction, 169
planning and design, 43–48
manual or software preparation, 172
process, 49–50, 51f
monthly expense example, 171, 172t, 173t, 174t,
simple cause and effect, 36
175t, 176t, 178t, 179
risk assumption, 17, 30, 167
omissions, 180
risk identification, 29
percentages, 179
risk limits, 17
Pareto Principle
risk priority number (RPN), 18, 29, 30, 167
Juran and, 166
risk questions, high-level, 39
origins, 11–12
risk tolerance, 167
in process risk assessment, 49
robustness, 167
reliability and, 53
root cause, 167
parts per million, 81
root cause analysis, 18, 25
past experience, 11
root cause of failure, 92
 Index 211

RPN (risk priority number) T

calculation, 29 target identification, 29
defined, 18, 167 task, defined, 104
re-calculating, 30 task identification, 29
RPN threshold, 64 team constraints, 7
terminology, 11, 13
S tiered approach, 19
Tiered Environmental Considerations diagram, 186,
SAE International, 21t
187f
safety analysis, 20
“the trivial many,” 12
salvageable failure, 69–70
severity
catastrophic failures, 68–70, 96 U
cost of, 68 undesirable outcomes, addressing, 1
flowchart, 73f unknowns, 24, 92
hidden damages, 67
major, 69, 70
minor, 70, 71 V
moderate, 70 vague terminology, 11
of problems, 13, 14, 64 vehicle logs, 79
salvageable, 69–70 vulnerability, 20
subjective criteria, 66, 66t, 67t
severity effect, 168
severity number, 18 W–Z
“significant” (term of use), 11 “what if” questions, 16, 44
situational occurrence, 76 worst-case scenarios, 1, 61
small business, FMEA applicability and, 2, 5, 20, 26,
43–45, 83
software vulnerabilities, 59
source – FMEA, 168
specification criteria, 83
splitting hairs, 140–141
stage, defined, 103
stakeholders, 5, 6, 28
“statistically significant” (term of use), 11
step, defined, 104
subject matter experts (SMEs), 5, 6, 7, 28
subjectivity, 13, 14
subsystem design, 20
support analysis, 20
supporting data, 7
survivability, 20
(This page intentionally left blank.)
The Knowledge Center
www.asq.org/knowledge-center
Learn about quality. Apply it. Share it.

ASQ’s online Knowledge Center is the place to:

• Stay on top of the latest in quality with Editor’s Picks and Hot Topics.

• Search ASQ’s collection of articles, books, tools, training, and more.

• Connect with ASQ staff for personalized help hunting down the knowledge you
need, the networking opportunities that will keep your career and organization
moving forward, and the publishing opportunities that are the best fit for you.

Use the Knowledge Center Search to quickly sort through hundreds of books, articles,
and other software-related publications.

www.asq.org/knowledge-center

TRAINING CERTIFICATION CONFERENCES MEMBERSHIP PUBLICATIONS

Ask a Librarian

Did you know?

• The ASQ Quality Information Center • ASQ members receive free ­internal
contains a wealth of knowledge and information searches and reduced rates
information available to ASQ members for article purchases
and non-members
• You can also contact the Q ­ uality
• A librarian is available to answer Information Center to request ­permission
research requests using ASQ’s to reuse or reprint ASQ copyrighted
ever-expanding library of relevant, material, i­ncluding journal articles and
credible quality resources, including book excerpts
journals, conference proceedings, case
studies and Quality Press publications • For more information or
to submit a question, visit
http://asq.org/knowledge-center/
ask-a-librarian-index

Visit www.asq.org/qic for more information.

TRAINING CERTIFICATION CONFERENCES MEMBERSHIP PUBLICATIONS

Belong to the Quality Community!

Established in 1946, ASQ is a global ASQ is…

community of quality experts in all fields
and industries. ASQ is dedicated to the • More than 90,000 individuals and
promotion and advancement of quality 700 companies in more than 100
tools, principles, and practices in the countries
workplace and in the community.
• The world’s largest organization
The Society also serves as an advocate ­dedicated to promoting quality
for quality. Its members have informed
and advised the U.S. Congress, • A community of professionals
government agencies, state legislatures, striving to bring quality to their work
and other groups and individuals and their lives
worldwide on quality-related topics.
• The administrator of the Malcolm
­Baldrige National Quality Award
Vision
• A supporter of quality in all sectors
By making quality a global priority, an including manufacturing, ­service,
organizational imperative, and a personal healthcare, government, and
ethic, ASQ becomes the ­community of education
choice for everyone who seeks quality
technology, concepts, or tools to improve • YOU
themselves and their world.

Visit www.asq.org for more information.

TRAINING CERTIFICATION CONFERENCES MEMBERSHIP PUBLICATIONS

ASQ Membership
Research shows that people who join associations experience increased job satisfaction,
earn more, and are generally happier*. ASQ membership can help you achieve this while
providing the tools you need to be successful in your industry and to distinguish yourself
from your competition. So why wouldn’t you want to be a part of ASQ?

Networking Solutions
Have the opportunity to meet, Find answers to all your quality p
­ roblems,
communicate, and collaborate with big and small, with ASQ’s Knowledge
your peers within the quality community Center, mentoring program, various
through conferences and local ASQ section e-newsletters, Quality Progress magazine,
meetings, ASQ forums or divisions, ASQ and industry-specific p
­ roducts.
Communities of Quality discussion boards,
and more. Access to Information
Learn classic and current quality principles
Professional Development
and theories in ASQ’s Quality Information
Access a wide variety of professional Center (QIC), ASQ Weekly e-newsletter,
development tools such as books, training, and product offerings.
and certifications at a discounted price.
Also, ASQ certifications and the ASQ Advocacy Programs
Career Center help enhance your quality
ASQ helps create a better community,
knowledge and take your career to the
government, and world through i­nitiatives
next level.
that include social r­ esponsibility,
Washington advocacy, and Community
Good Works.

Visit www.asq.org/membership for more information on ASQ membership.

*2008, The William E. Smith Institute for Association Research

TRAINING CERTIFICATION CONFERENCES MEMBERSHIP PUBLICATIONS