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
Bjrn Andersen and Tom Natland Fagerhaug
Quality Risk Management in the FDA-Regulated Industry
Jos Rodrguez-Prez
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
Bjrn 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.
20191817161554321
Library of Congress Cataloging-in-Publication Data
Weeden, Marcia M., 1952Failure 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 businessManagement. 2. Failure mode and effects analysis. I. Title.
HD62.7.W44 2015
658.4013dc23
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 OMara
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ASQMission: The American Society for Quality advances individual, organizational, and community
excellence worldwide through learning, quality improvement, and knowledge exchange.
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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

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
Worksheets 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.

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 (AZ 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
FMEA Indicate?

By knowing ahead of time what can go wrong, as well as how severe the
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
Does an FMEA
Contribute?

FMEAs are valuable for:

developing policies and standard operating procedures (SOPs)
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
FMEA be Used?

FMEAs work on general principles and have the flexibility to be tailored to

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
Limitations

FMEAs can give a false sense of security that all risks have been addressed.
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
Failures

As improbable or as astonishing as it may seem upon first being heard, there

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
FMEA Coordinator

DEPARTMENT
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

(SMEs)

Have responsibility for the tasks in the areas under the

FMEAs 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
Table 1. The Team.

Those responsible for carrying out the recommended

improvements or changes

6 Overview

Role
Contributions

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

ROLE
FMEA Coordinator

CONTRIBUTIONS
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 organizations 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 organizations
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

(SMEs)

Provide the expertise for the operations and tasks in their

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 &

documents

Varies

Archived with executed FMEA

Table 3. Records Pertaining to an FMEA.

(This page intentionally left blank.)

Index

Page numbers in italics refer to figures or tables.

criticality
arbitrary nature of, 95
assessment flowchart, 101f
conformance to requirements, 97
defined, 95
as a moving target, 97
not that critical (classification), 98
objective nature of, 97
one-time determination of, 97
preventive efforts, 99
standard classifications, 96
subjective nature of, 95, 96, 99t
criticality analysis, 17
Crosby, Phil, 98, 99
customer assistance, 25
customers, 163

acts of nature, 68, 69

acts of people, 69
American Society for Quality, 22t
average time between failures, 55. See also Mean Time
Between Failures (MTBF)

Baldrige Award, 26
Baldrige Criteria for Performance Excellence, 26
binomial failure, 60t

CAPA (Corrective Action and Preventive Action), 162,

163, 166
catastrophic failure, 6870, 96
cause FMEA, 162
change, plan for, 44
closed systems, 92, 162
conception phase, 24
configuration management, 163
conformance to requirements, 97
consumers, 163
continuous failure, 60t
continuous improvement efforts, 25
control plan, 31
corrective action, 18, 156, 162, 163, 166
Corrective Action (CA) and Preventive Action (PA),
162, 163, 166
cost of poor quality, 98
cost of quality, 98, 99
cost savings, 16
criteria subjectivity, 138t
critical concerns, verification of, 28, 29
the critical few, 12

damages, hidden, 67
design, defined, 44
design phase, 24
design plan, 45, 4748f
detectability
flowchart, 93f
root cause of failure, 92
RPN value, 64
specifications, 90
subjective criteria, 91t, 92
timing, 90
yes/no, 90
detection number, 18
drilling down, 104, 163, 165, 190
due diligence, 163

207

208 Index

8020 rule, 12, 13, 169

end effect, 163
environment, 38t, 48f
equipment logs, 79
external customers, 164
external stakeholders, 7

failure
acceptability of, 80, 81
acts of nature, 68, 69
acts of people, 69
average time between, 55
catastrophic, 6870, 96
consequences of, 59
cost of, 68
criticality, 60, 63
defined, 58, 164
detection, 20
frequency of, 77, 79, 80
in hindsight, 59
major, 69
Mean Time Between Failures (MTBF), 55, 77, 165
minor, 70, 71
moderate, 70
one-time, 54, 78, 79
operational, 60t
parts per million, 81
rating scales, 137141
RPN threshold, 64
salvageable, 69, 70
specification criteria, 83
threat assessment, 17
tolerating, 5
types of, 59
worst-case scenarios, 1, 61
failure cause, 164
failure effect, 58, 164
failure levels, 58
failure mode, 60, 164
Failure Mode, Effects, and Criticality Analysis
(FMECA), 19
Failure Mode and Effects Analysis. See FMEA
failure rankings, 6364
feasibility phase, 24
firefighting, 43, 165
first-line workers, 13
fishbone analysis, 36, 185
fishbone diagrams
5Ms and 1E, 37t, 186, 189t
appearance, 184, 190, 191f, 192f
bones, 190, 191f
cause and effect, 185
consistency, 194

defined, 184
design plan questions, 4748f
example, 192f
failure prevention, 196
focus on the positive, 195, 196t
graphic, 41f
ice cream stand example, 192f, 193t
for identity, 46
layers, 186, 187f, 188
as a map, 186
money drainers, 195
other considerations, 192
parts of, 185
priority reinforcement, 198
roadmap to success, 198
time wasters, 194
value of, 185
five whys, 165
5Ms and 1E, 37t, 186, 189t
FMEA (Failure Mode and Effects Analysis)
administrative preparation, 133136
applicability, 20
approaches to, 19
completion of, 31
critical concerns, 110
defined, 3, 10
final steps, 159160
guidelines for using, 915
guides sampling, 22t
limitations, 4
no action necessary, 10
numbering system, 135, 138
past efforts, 111
process, 109112, 113f
purposes of, 3
ratings classifications, 13, 14
requirement for use, 10
role contributions, 5, 6t
scope and flexibility, 4, 110
stages, 2731, 33f, 111t
stakeholders, 110
standards by industry, 21t
three formal parts of, 16
value of, 4
FMEA coordinator, 5, 6, 30, 49
FMEA investigation flowchart, 51f
FMEA log/database, 134, 135
FMEA methodology, uses of, 2425
FMEA team, 5, 28, 110
FMEA template, 111t
FMEA worksheet
archiving step, 160
audits, 160
authority for change, 156
cause, 149
consistency, 153

Index 209
contributor information, 130, 131132t
criticality comments, 157
detection controls, 152
drivers, 147
examples, 199205
failures, 147
format, 144145
header, 123131, 126t, 127t, 128t, 129t, 132t, 145
high process levels, 125
improvements, 155
inputs, results, and causes/sorces, 150t
inputs, results, and detection controls, 152t
inputs, results, and impacts, 148t
inputs, results, and prevention controls, 151t
inputs and outputs, 147t
Internet links, 160
investigation section, 145
numbered lists, 146
operational processes, 126
outcomes, 154
potential failure causes or sources, 149
potential failure effects, 148
potential failure mode, 147, 148
preliminary information, 149
prevention controls, 151
procedure identification, 152
process header information, 128, 129t
purpose, 153
ranking criteria, 153
rankings, 153
RPN decisions, 154
RPN recalculation and comparison, 156
scope, 146
source, 149
structure and purpose, 117120, 121t
supplemental information, 160
tasks, 126, 127t, 128t
FMECA (Failure Mode, Effects, and Criticality
Analysis), 19
For the Want of a Nail (poem), 59
form, fit, or function, 54, 165
frequency, of problems, 13, 14, 64
frequency number, 18
future goals, 45

good enough, 81

hackers, 59
hindsight, 59

identity, organizational, 45, 46

IEC (International Electrotechnical Commission
Standardization), 21t
implementers, 5, 6
improvements, effectiveness of, 30
the informative many, 12
internal customers, 165
Ishikawa diagram, 36, 41f, 184. See also fishbone
diagrams
ISO (International Organization for Standardization),
22t
isolated design, 20

Juran, Joseph M., 12, 169

knee-jerk reactions, 43
known risks, 24

logistics, 20

machines, 38t, 48f

maintainability, 20
maintenance, 20
maintenance logs, 79
major failure, 69
Malcolm Baldrige National Quality Award, 26
manpower (people), 37t, 47f
materials, 37t, 47f
Mean Time Between Failures (MTBF), 55, 77, 165
measurements, 37t, 47f
methods, 37t, 47f
MilStd1629A, 19, 20, 21
minor failure, 70, 71
mitigation, RPN and, 18
moderate failure, 70
modification phase, 24
multinomial failure, 60t

new product design, 25

new regulations, 24
normal use-and-abuse, 166
not that critical (classification), 98

210 Index

occurrence
acceptability of, 80, 81
action taken, 79
control and, 82
criteria subjectivity, 83, 84t
financial considerations, 77
flowchart, 87f
frequency and cost, 82
frequency of, 77, 80, 83
good enough, 81
logs, 79
Mean Time Between Failures (MTBF), 77
measuring, 78
one-time, 78
overzealousness, 81
parts per million, 81
ranking criteria, 75
rating scales, 137141
reliability and, 79, 80
ROI and, 140
situational, 76
specification criteria, 83
tolerable numbers, 78, 82, 83, 84t, 85
unavoidable, 77
one-time occurrence, 78, 79
operational failure, 60t
organizational identity, 45, 46
outside inputs, 7
overzealousness, 81

Pareto charts
budgets as drivers, 171
category changes, 180
category reconfiguration, 178
category reduction, 177
category regrouping, 176
clustering, 177
and FMEAs, 170, 181
focus selection, 171
initial data and calculations, 172, 174
introduction, 169
manual or software preparation, 172
monthly expense example, 171, 172t, 173t, 174t,
175t, 176t, 178t, 179
omissions, 180
percentages, 179
Pareto Principle
Juran and, 166
origins, 1112
in process risk assessment, 49
reliability and, 53
parts per million, 81
past experience, 11

performance recognition, 26
plan analysis, 20
planning and design, risk assessment in, 4348
policy development, 25
prevention, timing of, 16
preventive action, 166
preventive efforts, 99
probability of occurrence, 166
Procedures for Conducting a Failure Mode, Effects,
and Criticality Analysis (MilStd1629A), 19
process
defined, 103
outline structure, 104
risk assessment, 4950, 51f
stages, tasks, and steps, 105, 107f

qualitative criticality analysis, 166

Quality is Free (Crosby), 98
quality recognition, 25
quantitative criticality analysis, 167
questions, high-risk, 39

rating scales, 137141, 138t

ratings classifications, 13, 14
records, 7
regulatory requirements, 45
reliability, 5455, 167
reliability engineering, 167
remedies, for situations, 77
repeat occurrences, 79
required/shall/must, 167
risk, defined, 167
risk assessment
5Ms and 1E, 37t
brainstorming, 35
fishbone analysis, 36
fishbone analysis diagram, 41f
high-level, 3541
high-level questions, 39
organizational balance, 38
planning and design, 4348
process, 4950, 51f
simple cause and effect, 36
risk assumption, 17, 30, 167
risk identification, 29
risk limits, 17
risk priority number (RPN), 18, 29, 30, 167
risk questions, high-level, 39
risk tolerance, 167
robustness, 167
root cause, 167
root cause analysis, 18, 25
root cause of failure, 92

Index 211

RPN (risk priority number)

calculation, 29
defined, 18, 167
re-calculating, 30
RPN threshold, 64

SAE International, 21t

safety analysis, 20
salvageable failure, 6970
severity
catastrophic failures, 6870, 96
cost of, 68
flowchart, 73f
hidden damages, 67
major, 69, 70
minor, 70, 71
moderate, 70
of problems, 13, 14, 64
salvageable, 6970
subjective criteria, 66, 66t, 67t
severity effect, 168
severity number, 18
significant (term of use), 11
situational occurrence, 76
small business, FMEA applicability and, 2, 5, 20, 26,
4345, 83
software vulnerabilities, 59
source FMEA, 168
specification criteria, 83
splitting hairs, 140141
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

target identification, 29
task, defined, 104
task identification, 29
team constraints, 7
terminology, 11, 13
tiered approach, 19
Tiered Environmental Considerations diagram, 186,
187f
the trivial many, 12

undesirable outcomes, addressing, 1

unknowns, 24, 92

vague terminology, 11
vehicle logs, 79
vulnerability, 20

WZ

what if questions, 16, 44

worst-case scenarios, 1, 61