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Potential Failure Mode and Effects Analysis: Fourth Edition

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Potential Failure Mode and Effects Analysis: Fourth Edition

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Potential Failure Mode and Effects Analysis – FMEA – Fourth Edition

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and Effects Analysis
Potential Failure Mode

FMEA
Fourth Edition
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POTENTIAL
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FAILURE MODE AND

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EFFECTS ANALYSIS
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(FMEA)
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Reference Manual
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Fourth Edition
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First Edition, February 1993 • Second Edition, February 1995 • Third Edition, July 2001,
Fourth Edition, June 2008
Copyright © 1993, © 1995, © 2001, © 2008
Chrysler LLC, Ford Motor Company, General Motors Corporation
ISBN: 978-1-60534-136-1
FOREWORD
4th Edition

The FMEA 4th Edition is a reference manual to be used by suppliers to Chrysler LLC, Ford Motor
Company, and General Motors Corporation as a guide to assist them in the development of both
Design and Process FMEAs. The manual does not define requirements; it is intended to clarify
questions concerning the technical development of FMEAs. This manual is aligned with SAE
J1739.

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co Gro
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Summary of Changes in the 4th edition FMEA Reference Manual

The DFMEA and PFMEA methods described in the 4th edition FMEA Reference Manual include

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those associated with design at the system, subsystem, interface, and component level and the

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process at manufacturing and assembly operations.

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General Changes ch

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• The formatting used in the 4th edition is intended to provide easier reading.
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o An index is included.
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o Icons are used to indicate key paragraphs and visual cues are used.
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• Additional examples and verbiage have been provided to improve the utility of the
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manual and to provide a closer tie into the FMEA process as it develops.
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• Reinforcement of the need for management support, interest, and review of the
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FMEA process and results.

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• Define and strengthen the understanding of the linkage between DFMEA and
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PFMEA as well as defining the linkages to other tools.

py en te 18 se

• Improvements to the Severity, Occurrence, Detection ranking tables so that they are
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more meaningful to real world analysis and usage.

pr n se

• Alternative methods are introduced that are currently being applied in industry.
is ocu ent er: 4 s lic

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o Additional appendices which have example forms and special case application of
FMEA.
i
an is d cum mb ent

o The focus on the “standard form” has been replaced with several options that
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represent the current application of FMEA in industry.

Th Do r Nu um

• The suggestion that RPN not be used as the primary means for assessing risk. The
need for improvement has been revised including an additional method, and the use
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of thresholds on RPN is clarified as a practice that is not recommended.

O is d

Chapter I provides general FMEA guidelines, the need for management support and having a
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defined process for developing and maintaining FMEAs, and the need for continuous
improvement.

Chapter II describes the general application of the FMEA methodology, which is common
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between DFMEA and PFMEA processes. This includes the planning, strategy, action plans, and
the need for management support and responsibility in FMEAs.

Chapter III focuses on DFMEA (Design Failure Mode Effects and Analysis), establishing the
scope of the analysis, use of block diagrams, various types of DFMEAs, formation of the teams,
basic procedure for analysis, action plans, and follow-up, alternatives to RPN, and connection to
PFMEAs and validation plans.

i
Chapter IV focuses on PFMEA (Process Failure Mode Effects and Analysis), establishing the
scope of the analysis, use of flow diagrams, formation of teams, basic procedure for analysis,
action plans, the connection to DFMEAs and the development of control plans.

The Appendices have several examples of forms for DMFEA and PFMEA and addresses
different applications and procedures for addressing design and process risk.

The Supplier Quality Requirements Task Force would like to thank the following individuals, and

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their companies, who have contributed their time and efforts to the development of this edition of

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the FMEA Reference Manual:

co Gro
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Michael Down, General Motors Corporation

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Lawrence Brozowski, General Motors Corporation
Hisham Younis, Ford Motor Company

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David Benedict, Chrysler LLC

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John Feghali, Chrysler LLC

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Michael Schubert, Delphi
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Rhonda Brender, Delphi

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Gregory Gruska, Omnex

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Glen Vallance, Control Planning Initiatives

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Milena Krasich, Bose
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William Haughey, ReliaTrain
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This manual is a copyright of Chrysler LLC, Ford Motor Company and General Motors
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Corporation, with all rights reserved. Additional copies may be obtained from AIAG @
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www.aiag.org. Supply chain organizations of Chrysler LLC, Ford Motor Company or General
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Motors Corporation have permission to copy forms used in this manual.

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ii
TABLE OF CONTENTS
General Changes.................................................................................................................................. i
Chapter I......................................................................................................................................................... 1
General FMEA Guidelines ................................................................................................................ 1
Introduction ................................................................................................................................................ 2
FMEA Process.................................................................................................................................... 2
Purpose of Manual.................................................................................................................................. 3
Scope of Manual..................................................................................................................................... 4

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Impact on Organization and Management.................................................................................................. 4

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FMEA Explained........................................................................................................................................ 5

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Follow-up and Continuous Improvement ................................................................................................... 6
Chapter II........................................................................................................................................................ 7

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Overview of FMEA Strategy, Planning and Implementation............................................................. 7
Introduction ................................................................................................................................................ 8

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Basic Structure ........................................................................................................................................... 8

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Approach .................................................................................................................................................... 8
Identify the Team ................................................................................................................................... 9

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Define the Scope................................................................................................................................... 10

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Define the Customer............................................................................................................................. 11
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Indentify Functions, Requirements, and Specifications ....................................................................... 11

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Identify Potential Failure Modes .......................................................................................................... 12

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Identify Potential Effects ...................................................................................................................... 12
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Identify Potential Causes ...................................................................................................................... 12
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Identify Controls................................................................................................................................... 13
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Identifying and Assessing Risk ............................................................................................................ 13

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Recommended Actions and Results ..................................................................................................... 13

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Management Responsibility ..................................................................................................................... 14

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Chapter III .................................................................................................................................................... 15

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DFMEA Design Failure Mode and Effects Analysis ....................................................................... 15

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Introduction .............................................................................................................................................. 16
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Customer Defined................................................................................................................................. 16
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Team Approach .................................................................................................................................... 17

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Manufacturing, Assembly and Serviceability Considerations.............................................................. 17

Development of a Design FMEA ............................................................................................................. 18
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an is d cum mb ent

Prerequisites ......................................................................................................................................... 18
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Block (Boundary) Diagrams............................................................................................................. 18

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Parameter (P) Diagrams.................................................................................................................... 21

Functional Requirements.................................................................................................................. 22
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Other Tools and Information Resources........................................................................................... 22

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Example DFMEA................................................................................................................................. 25
Header of the Design FMEA Form (fields A-H) .............................................................................. 25
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Body of the DFMEA Form (fields a – n).......................................................................................... 29

Maintaining DFMEAs .......................................................................................................................... 64
Leveraging DFMEAs ........................................................................................................................... 65
Linkages ............................................................................................................................................... 65
Design Verification Plan & Report (DVP&R) ................................................................................. 66
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PFMEA............................................................................................................................................. 66
Chapter IV .................................................................................................................................................... 67
PFMEA Process Failure Mode and Effects Analysis ....................................................................... 67
Introduction .............................................................................................................................................. 68
Customer Defined................................................................................................................................. 69
Team Approach .................................................................................................................................... 69
Design Considerations.......................................................................................................................... 69
Development of a Process FMEA ............................................................................................................ 70

iii
Prerequisites ......................................................................................................................................... 70
Process Flow Diagram and linkage to PFMEA ................................................................................ 70
Other Tools and Information Sources............................................................................................... 73
Research Information ....................................................................................................................... 73
Example PFMEA Form........................................................................................................................ 75
Header of the Process FMEA Form (fields A-H) ............................................................................. 75
Body of the PFMEA Form (fields a – n) .......................................................................................... 77
Maintaining PFMEAs......................................................................................................................... 110
Leveraging PFMEAs .......................................................................................................................... 110
Linkages ............................................................................................................................................. 111

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To DFMEA..................................................................................................................................... 111

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To Control Plan .............................................................................................................................. 112

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APPENDICES............................................................................................................................................ 113
Appendix A: Sample Forms ................................................................................................................... 114

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DFMEA Forms................................................................................................................................... 114
PFMEA Forms.................................................................................................................................... 121

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Appendix B: System Level FMEA......................................................................................................... 130

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Interfaces ............................................................................................................................................ 131

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Interactions ......................................................................................................................................... 131

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Relationships ...................................................................................................................................... 133

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Multiple Levels of Design FMEAs................................................................................................. 133
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Appendix C: Alternative Risk Assessments ........................................................................................... 135

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Alternatives to RPN............................................................................................................................ 135

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Alternative: SO (S x O) .................................................................................................................. 136
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Alternative: SOD, SD ..................................................................................................................... 136

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Appendix D: Alternative Analyses Techniques...................................................................................... 137

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Failure Mode, Effect and Criticality Analysis (FMECA)................................................................... 137

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Design Review Based on Failure Modes (DRBFM) .......................................................................... 137

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Fault Tree Analysis (FTA) ................................................................................................................. 137

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References and Suggested Readings ...................................................................................................... 140

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Index....................................................................................................................................................... 141
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iv
TABLES and FIGURES
Figure III.1a Block (Boundary) Diagram Examples .................................................................................... 19
Figures III.1b, c Block (Boundary) Diagram Examples ............................................................................... 20
Figure III.2 Example of a Parameter (P) Diagram for a Generic Catalytic Converter ................................. 21
Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries...................... 24
Table III.3 Example Potential Failure Modes............................................................................................... 32
Table III.4 Example Potential Effects .......................................................................................................... 35
Table Cr1 Suggested DFMEA Severity Evaluation Criteria ........................................................................ 37

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Table III.5 Example Potential Causes .......................................................................................................... 42

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Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria ................................................................... 46

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Table III.6 Examples of Prevention and Detection Design Controls............................................................ 51
Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria ..................................... 54

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Table III.7 Examples of Causes, Controls and Recommended Actions ....................................................... 64
Figure III.7 DFMEA Information Interrelationships Flow........................................................................... 65

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Figure IV.1 High Level to Detailed Process Maps....................................................................................... 71

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Figure IV.2 Example Process Flow Diagram ............................................................................................... 72
Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries ...................... 74

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Table IV.2 Example of Process Step/Function/Requirements Columns on PFMEA Form including Potential

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Failure Modes....................................................................................................................................... 81
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Table IV.3 Example of Effects ..................................................................................................................... 85

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Table Cr1 Suggested PFMEA Severity Evaluation Criteria......................................................................... 88

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Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria.................................................................... 93
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Table IV.4 Examples of Causes and Controls .............................................................................................. 96
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Table Cr3 Suggested Process FMEA Detection Evaluation Criteria.......................................................... 100

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Table IV.5 Examples of Causes, Controls and Actions.............................................................................. 110

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Figure IV.5 PFMEA Information Interrelationship Flow........................................................................... 111

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DFMEA Form A ........................................................................................................................................ 115

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DFMEA Form B......................................................................................................................................... 116

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DFMEA Form C......................................................................................................................................... 117

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DFMEA Form D ........................................................................................................................................ 118

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DFMEA Form E......................................................................................................................................... 119

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DFMEA Form F ......................................................................................................................................... 120

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PFMEA Form A ......................................................................................................................................... 122

PFMEA Form B ......................................................................................................................................... 123
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PFMEA Form C ......................................................................................................................................... 124

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PFMEA Form D ......................................................................................................................................... 125

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PFMEA Form E.......................................................................................................................................... 126

PFMEA Form F.......................................................................................................................................... 127
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PFMEA Form G ......................................................................................................................................... 128

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PFMEA Form H ......................................................................................................................................... 129

Figure B.1 Interfaces and Interactions........................................................................................................ 130
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Figure B.2 Item, Functions, and Failure ..................................................................................................... 132

Figure B.3 DFMEA Effects Linkages ........................................................................................................ 134
Table C.1 Contrast among RPN, SOD and SD........................................................................................... 136
Figure D.1 Example of DRBFM Elements................................................................................................. 138
Figure D.2 FTA Tree Structure .................................................................................................................. 139
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Th
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Chapter I

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Guidelines
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Chapter IC

General FMEA
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General FMEA Guidelines

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y.
Chapter I General FMEA Guidelines

Introduction
This manual introduces the topic of Potential Failure Mode and
Effects Analysis (FMEA) and gives general guidance in the
application of the technique.

FMEA Process
FMEA is an analytical methodology used to ensure that potential

in p
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y.
problems have been considered and addressed throughout the

co Gro
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product and process development process (APQP – Advanced
Product Quality Planning). Its most visible result is the

d ion
documentation of the collective knowledge of cross-functional
teams.

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Part of the evaluation and analysis is the assessment of risk. The

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important point is that a discussion is conducted regarding the

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design (product or process), review of the functions and any

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changes in application, and the resulting risk of potential failure.
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Each FMEA should ensure that attention is given to every

s mo 14
component within the product or assembly. Critical and safety
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related components or processes should be given a higher

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priority.
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One of the most important factors for the successful

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implementation of an FMEA program is timeliness. It is meant

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to be a “before-the-event” action, not an “after-the-fact”

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exercise. To achieve the greatest value, the FMEA must be done

py en te 18 se

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before the implementation of a product or process in which the

co m Si 3 en

failure mode potential exists. Up-front time spent properly

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completing an FMEA, when product/process changes can be

ht o en

most easily and inexpensively implemented, will minimize late

change crises. Actions resulting from an FMEA can reduce or

an is d cum mb ent

eliminate the chance of implementing a change that would create

an even larger concern.

Th Do r Nu um

Ideally, the Design FMEA process should be initiated in the

E- rde oc

early stages of the design and the Process FMEA before tooling
O is d

or manufacturing equipment is developed and purchased. The

FMEA evolves throughout each stage of the design and
Th

manufacturing development process and may also be used in

problem solving.
FMEA can also be applied to non-manufacturing areas. For
example, FMEA could be used to analyze risk in an
d

administration process or the evaluation of a safety system. In

general, FMEA is applied to potential failures in product design
and manufacturing processes where the benefits are clear and
potentially significant.

2
Chapter I General FMEA Guidelines

Purpose of Manual
This manual describes the basic principles and implementation
of the FMEA 1 process and how it is integrated within the
product and process development cycle. This includes the
documentation of this process and how the analyses can be
applied for timely necessary improvement of a product or a
process in its early and full development stage.
This manual also provides descriptions and examples of alternate

in p
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and supporting methodologies for these analyses, their specific

co Gro
gl
advantages and limitations, guidance of how the analysis is to be
carried out for the maximum reliability improvement or
mitigation of potential safety risks. The manual provides

d ion
guidance on how the risk can be represented, measured and

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prioritized for cost effective mitigation of the failure effects.

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ar y A
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As a tool in risk evaluation, FMEA is considered to be a method

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to identify severity of potential effects of failure and to provide
ch

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an input to mitigating measures to reduce risk. In many

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applications, FMEA also includes an estimation of the

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s mo 14 probability of occurrence of the causes of failure and their

resultant failure modes. This broadens the analysis by providing
er

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a measure of the failure mode’s likelihood. To minimize risk, the
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likelihood of failure occurrence is reduced which increases

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product or process reliability. FMEA is a tool that is instrumental

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in reliability improvement.
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There are three basic cases for which FMEA process is to be

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applied, each with a different scope or focus:

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Case 1: New designs, new technology, or new process.

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The scope of the FMEA is the complete

design, technology, or process.

an is d cum mb ent

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Case 2: Modifications to existing design or process.

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The scope of the FMEA should focus on the

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modification to design or process, possible

interactions due to the modification, and field
O is d

history. This can include changes in regulatory

requirements.
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Case 3: Use of an existing design or process in a new

environment, location, application, or usage
profile (including duty cycle, regulatory
requirements, etc.).
d

The scope of the FMEA should focus on the

impact of the new environment, location, or
application usage on the existing design or
process.

1
The FMEA present herein also is known as a Failure Modes Effects and Criticality Analysis (FMECA)
since it includes a quantification of the risks.

3
Chapter I General FMEA Guidelines

Scope of Manual
The analytical methods presented in this manual are applicable
to any product or process. However, this manual will focus on
those applications prevalent within the automotive industry and
its suppliers.

Impact on Organization and Management

in p
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y.
FMEA is an important activity within any company. Because the

co Gro
gl
development of an FMEA is a multi-disciplined activity
affecting the entire product realization process, its

d ion
implementation needs to be well planned to be fully effective.
This process can take considerable time and a commitment of the

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required resources is vital. Important to FMEA development is a

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process owner and senior management commitment.

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Implementation approach will vary depending on the size and

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structure of the company concerned, although the principles will
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be the same:

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• s mo 14
The scope will cover FMEAs produced in house and by multi-
er

tier suppliers.
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•
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Address Design and Process FMEAs, as applicable.

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• Accomplish this by having the FMEA process an integral part

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of the APQP process.

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•
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Part of engineering technical reviews.

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• Part of the regular sign-off and approval of the product or

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process design.
is ocu ent er: 4 s lic

ht o en

An FMEA is developed by a multi-functional (or cross-

functional) team. The team size will depend both on the

an is d cum mb ent

w
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complexity of the design and the size and organization of the

Th Do r Nu um

company. Team members need relevant expertise, available time

and authority sanctioned by management.
E- rde oc

A comprehensive training program should be implemented

O is d

including:
•
Th

Management Overview
• Training for users
• Supplier Training
d

• Facilitator Training
Ultimately, management has the responsibility and ownership for
development and maintenance of the FMEAs.

4
Chapter I General FMEA Guidelines

FMEA Explained
FMEAs are an integral part of managing risk and supporting
continual improvement. Consequently, FMEA becomes a key
part of Product and Process development. The Advanced Product
Quality Planning (APQP) process identifies five general areas of
focus in this development process:
• Plan and Define Program

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• Product Design and Development

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co Gro
•

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Process Design and Development
• Product and Process Validation

d ion
• Feedback, Assessment and Corrective Action

ke ct
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ac
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The APQP Reference manual shows DFMEAs as an activity in

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the Product Design and Development section of the timing chart

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and PFMEAs in the Process Planning and Development section.

wa Ind 0
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en ive 01
The development of either DFMEA or PFMEA is a process that
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helps to guide the teams in developing product and process

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designs that meet expectations.

s mo 14
er

The FMEA analysis should not be considered a single event, but

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a long-term commitment that complements the product and

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process development to ensure potential failures are evaluated

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and actions are taken to reduce their risk.

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One key aspect of continual improvement is the retention of

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knowledge from past learning which often is captured in

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FMEAs. It is advisable for organizations to capitalize on prior

co m Si 3 en

analyses of similar product and process designs for use as the

pr n se
is ocu ent er: 4 s lic

starting point for the next program and/or application.

ht o en

The language used in FMEAs should be as specific as possible

i
an is d cum mb ent

when describing an item (for example, failure mode, or cause)

w
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and not extend or extrapolate beyond the team’s level of

Th Do r Nu um

understanding as to what the failure effects may be.

E- rde oc

Clear statements, concise terminology and focus on the actual

effects are key to the effective identification and mitigation of
O is d

risk issues.
Th

5
Chapter I General FMEA Guidelines

Follow-up and Continuous Improvement

The need for taking effective preventive/corrective actions, with
appropriate follow-up on those actions, cannot be
overemphasized. Actions should be communicated to all affected
activities. A thoroughly thought-out and well-developed FMEA
will be of limited value without positive and effective
preventive/corrective actions.

in p
rd u
y.
Team leadership (typically the team leader/lead engineer) is in

co Gro
gl
charge of ensuring that all recommended actions have been
implemented or adequately addressed. The FMEA is a living

d ion
document and should always reflect the latest level, as well as
the latest relevant actions, including those occurring after the

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ac
start of production.

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The team leader/lead engineer has several means of assuring that

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recommended actions are implemented. They include, but are

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en ive 01
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not limited to the following:

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• Reviewing designs, processes, and related records to ensure

s mo 14
that recommended actions have been implemented,
er

ha to 7/
ob

• Confirming the incorporation of changes to design/assembly/

d Au n:

manufacturing documentation, and,

an e io

• Reviewing Design/Process FMEAs, special FMEA

d th at
to

applications, and Control Plans.

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

6
Th
O is d
E- rde oc
Chapter II

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at

7
an e io os
d Au n: ch
ha to 7/ LL
s mo 14 C
Chapter II
be t /2

Overview of FMEA
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
Strategy, Planning and Implementation
d ion
ac
co Gro
rd u
in p
Strategy, Planning, Implementation

gl
y.
Chapter II Strategy, Planning, Implementation

Introduction
FMEA development, either design or process, uses a common
approach to address:
• Potential product or process failure to meet expectations
• Potential consequences
• Potential causes of the failure mode

in p
• Application of current controls

rd u
y.
co Gro
•

gl
Level of risk
• Risk reduction

d ion
Before the FMEA document is started, the team must define the

ke ct
C

ac
scope of the project and collect existing information which is

ar y A
LL
necessary for an effective and efficient FMEA development
process.

rm tr
ch

wa Ind 0
te us
en ive 01
os
Basic Structure
be t /2
tB

s mo 14
er

The purpose of the recommended FMEA formats described in

ha to 7/
ob

this manual is to organize the collection and display of relevant

d Au n:

FMEA information. Specific formats may vary based on the

an e io

needs of the organization and the requirements of the customer.

d th at
to

Fundamentally, the format utilized should address:

te by xpir
rig t is Lic 11 d

• Functions, requirements, and deliverables of the product or

py en te 18 se

ot ed E

process being analyzed,

co m Si 3 en

pr n se

• Failure modes when functional requirements are not met,

is ocu ent er: 4 s lic

ht o en

• Effects and consequences of the failure mode,

i
an is d cum mb ent

• Potential causes of the failure mode,

w
ec

• Actions and controls to address the causes of the failure mode,

Th Do r Nu um

and,
E- rde oc

• Actions to prevent recurrence of the failure mode.

O is d
Th

Approach
There is no single or unique process for FMEA development;
however there are common elements as described below.
d

8
Chapter II Strategy, Planning, Implementation

Identify the Team

As previously mentioned, FMEA development is the
responsibility of a multi-disciplinary (or cross-functional) team
whose members encompass the necessary subject matter
knowledge. This should include facilitation expertise and
knowledge of the FMEA process. A team approach is
recommended to benefit the FMEA development process to

in p
rd u
y.
ensure input and collaboration from all affected functional areas.

co Gro
gl
The FMEA team leader should select team members with the
relevant experience and necessary authority. In addition to the

d ion
design and process engineers, the following are examples of
additional resources:

ke ct
C

ac
ar y A
LL
FMEA development topic Relevant Resources or Expertise

rm tr
ch

wa Ind 0
te us
Scope Program Management, Customer, Integration responsible

en ive 01
os
individual(s)

be t /2
tB

Functions, requirements and expectations

s mo 14 Customer, Program Management, Integration responsible
er

individual(s), Service Operations, Safety, Manufacturing

ha to 7/
ob

and Assembly, Packaging, Logistics, Materials

d Au n:
:R

Potential failure mode – the way a process or Customer, Program Management, Integration responsible
an e io

product might fail individual(s), Service Operations, Safety, Manufacturing

d th at
to

and Assembly, Packaging, Logistics, Materials, Quality

te by xpir
rig t is Lic 11 d

Effects and consequences of the failure – to Customer, Program Management, Integration responsible
py en te 18 se

both the organization’s processes or to a individual(s), Service Operations, Safety, Manufacturing

ot ed E
co m Si 3 en

downstream customer. and Assembly, Packaging, Logistics, Materials, Quality

pr n se
is ocu ent er: 4 s lic

Causes of the potential failure Customer, Manufacturing and Assembly, Packaging,

ht o en

Logistics, Materials, Quality, Reliability, Engineering

Analysis, Equipment Manufacturer, Maintenance

an is d cum mb ent

w
ec

Frequency of occurrence of potential failure Customer, Manufacturing and Assembly, Packaging,

Th Do r Nu um

Logistics, Materials, Quality, Reliability, Engineering

Analysis, Statistical Analysis, Equipment Manufacturer,
E- rde oc

Maintenance
O is d

Application of current controls-prevention Manufacturing and Assembly, Packaging, Logistics,

Materials, Quality, Equipment Manufacturer, Maintenance
Th

Application of current controls-detection Customer, Manufacturing and Assembly, Packaging,

Logistics, Materials, Quality, Maintenance
Recommended actions required Customer, Program Management, Integration responsible
individual(s), Manufacturing and Assembly, Packaging,
d

Logistics, Materials, Quality, Reliability, Engineering

Analysis, Statistical Analysis, Equipment Manufacturer,
Maintenance

9
Chapter II Strategy, Planning, Implementation

Define the Scope

Scope establishes the boundary of the FMEA analysis. It defines
what is included and excluded, determined based on the type of
FMEA being developed, i.e., system, subsystem, or component.
Before the FMEA can begin, a clear understanding of what is to
be evaluated must be determined. What to exclude can be just as
important as what to include in the analysis. The scope needs to
be established at the start of the process to assure consistent

in p
direction and focus.

rd u
y.
co Gro
gl
The following may assist the team in defining the scope of the
FMEA:

d ion
• Function Model

ke ct
•

C
Block (Boundary) diagrams

ac
ar y A
LL
• Parameter (P) diagrams

rm tr
ch

wa Ind 0
•

te us
Interface diagrams

en ive 01
os
• Process flow diagrams

be t /2
tB

•
s mo 14
Interrelationship matrices
er

ha to 7/

•
ob

Schematics
d Au n:

•
:R

Bill of Materials (BOM)

an e io
d th at
to

te by xpir

System FMEA
rig t is Lic 11 d
py en te 18 se

A system FMEA is made up of various subsystems. Examples of

ot ed E
co m Si 3 en

systems include: Chassis System, Powertrain System, or Interior

pr n se

System, etc. The focus of the System FMEA is to address all

is ocu ent er: 4 s lic

ht o en

interfaces and interactions among systems, subsystems, the

environment and the customer.
i
an is d cum mb ent

w
ec

Subsystem FMEA
Th Do r Nu um

A Subsystem FMEA is a subset of a system FMEA. An example

E- rde oc

of a subsystem is the front suspension subsystem, which is a

O is d

subset of the chassis system. The focus of the Subsystem FMEA

is to address all interfaces and interactions among the subsystem
Th

components and interactions with other subsystems or systems.

Component FMEA
d

A Component FMEA is a subset of a subsystem FMEA. For

example, a brake pad is a component of the brake assembly,
which is a subsystem of the chassis system.
NOTE: Any subsequent adjustments to the scope may require a
modification of the team structure and membership.

10
Chapter II Strategy, Planning, Implementation

Define the Customer

There are four major customers to be considered in the FMEA
process, all need to be taken into account in the FMEA analysis:
• END USER: the person or organization that will utilize the
product. The FMEA analysis affecting the End User could
include, for example, durability.
• OEM ASSEMBLY and MANUFACTURING CENTERS

in p
(PLANTS): the OEM locations where manufacturing

rd u
y.
operations (e.g., stamping and powertrain) and vehicle

co Gro
gl
assembly take place. Addressing the interfaces between the
product and its assembly process is critical to an effective

d ion
FMEA analysis.

ke ct
•

C
SUPPLY CHAIN MANUFACTURING: the supplier location

ac
ar y A
LL
where manufacturing, fabricating or assembling of production
materials or parts takes place. This includes fabricating

rm tr
ch

wa Ind 0
te us
production and service parts and assemblies and processes

en ive 01
os
such as heat treating, welding, painting, plating or other

be t /2
tB

finishing services. This may be any subsequent or downstream

s mo 14
operation or a next tier manufacturing process.
er

ha to 7/
• REGULATORS: government agencies that define
ob

d Au n:

requirements and monitor compliance to safety and

an e io

environmental specifications which can impact the product or

d th at
to

process.
te by xpir
rig t is Lic 11 d

Knowledge of these customers can help to define the functions,

py en te 18 se

requirements and specifications more robustly as well as aid in

ot ed E
co m Si 3 en

determining the effects of related failure modes.

pr n se
is ocu ent er: 4 s lic

ht o en

Indentify Functions,
i

Requirements, and
an is d cum mb ent

w
ec

Specifications
Th Do r Nu um
E- rde oc

Identify and understand the functions, requirements and

specifications relevant to the defined scope. The purpose of this
O is d

activity is to clarify the item design intent or process purpose.

This assists in the determination of the potential failure mode for

each attribute or aspect of the function.
d

11
Chapter II Strategy, Planning, Implementation

Identify Potential
Failure Modes
Failure mode is defined as the way or manner in which a product
or process could fail to meet design intent or process
requirements. The assumption is made that the failure could
occur but may not necessarily occur. A concise and

in p
understandable failure definition is important since it properly

rd u
y.
focuses the analysis. Potential failure modes should be described

co Gro
gl
in technical terms and not as a symptom necessarily noticeable
by the customer. A large number of failure modes identified for

d ion
a single requirement may indicate that the defined requirement is
not concise.

ke ct
C

ac
ar y A
LL
Identify Potential

rm tr
ch

wa Ind 0
te us
Effects

en ive 01
os

be t /2
tB

Potential effects of failure are defined as the effects of the failure

s mo 14
mode as perceived by the customer. The effects or impact of the
er

ha to 7/
failure are described in terms of what the customer might notice
ob

or experience. The customer may be an internal customer as

d Au n:
:R

well as the End User.

an e io
d th at
to

Determining potential effects includes the analysis of the

te by xpir
rig t is Lic 11 d

consequences of the failures and the severity or seriousness of

py en te 18 se

those consequences.
ot ed E
co m Si 3 en

pr n se

Identify Potential
is ocu ent er: 4 s lic

ht o en

Causes
i
an is d cum mb ent

w
ec

Potential cause of failure is defined as an indication of how the

Th Do r Nu um

failure could occur, described in terms of something that can be

corrected or can be controlled. Potential cause of failure may be
E- rde oc

an indication of a design weakness, the consequence of which is

O is d

the failure mode.

There is a direct relation between a cause and its resultant failure
Th

mode (i.e., if the cause occurs, then the failure mode occurs).
Identifying the root cause(s) of the failure mode, in sufficient
detail, enables the identification of appropriate controls and
action plans. A separate potential cause analysis is performed
d

for each cause if there are multiple causes.

12
Chapter II Strategy, Planning, Implementation

Identify Controls
Controls are those activities that prevent or detect the cause of
the failure or failure mode. In developing controls it is important
to identify what is going wrong, why, and how to prevent or
detect it. Controls are applicable to product design or
manufacturing processes. Controls focused on prevention will
provide the greatest return.

in p
Identifying and

rd u
y.
co Gro
gl
Assessing Risk

d ion
One of the important steps in the FMEA process is the
assessment of risk. This is evaluated in three ways, severity,

ke ct
C

ac
occurrence, and detection:

ar y A
LL
Severity is an assessment of the level of impact of a failure on

rm tr
ch

wa Ind 0
the customer.

te us
en ive 01
os
Occurrence is how often the cause of a failure may occur.

be t /2
tB

s mo 14
Detection is an assessment of how well the product or process
er

controls detect the cause of the failure or the failure mode.

ha to 7/
ob

Organizations need to understand their customer requirements

d Au n:
:R

for risk assessment.

an e io

Recommended
d th at
to

te by xpir

Actions and Results

rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

The intent of recommended actions is to reduce overall risk and

pr n se

likelihood that the failure mode will occur. The recommended

is ocu ent er: 4 s lic

ht o en

actions address reduction of the severity, occurrence and

detection.
i
an is d cum mb ent

The following can be used to assure that the appropriate actions

w
ec

are taken, including but not limited to:

Th Do r Nu um

• Ensuring design requirements including reliability are

E- rde oc

achieved,
O is d

• Reviewing engineering drawings and specifications,

• Confirming incorporation in assembly/manufacturing

processes, and,
• Reviewing related FMEAs, control plans and operations
instructions.
d

Responsibility and timing to complete the recommended actions

should be recorded.
Once actions are completed and results captured, the updated
ratings for severity, occurrence and detection should also be
recorded.

13
Chapter II Strategy, Planning, Implementation

Management Responsibility
Management owns the FMEA process. Management has the
ultimate responsibility of selecting and applying resources and
ensuring an effective risk management process including timing.
Management responsibility also includes providing direct
support to the team through on-going reviews, eliminating
roadblocks, and incorporating lessons learned.

in p
rd u
y.
co Gro
gl
d ion
ke ct
C

ac
ar y A
LL

rm tr
ch

wa Ind 0
te us
en ive 01
os

be t /2
tB

s mo 14
er

ha to 7/
ob

d Au n:
:R

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

14
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

15
an e io ch
d Au n:

DFMEA
ha to 7/ LL
s mo 14 C
be t /2
en ive 01 Chapter III
wa Ind 0
te us
rm tr
ar y A
ke ct
Design Failure Mode and Effects Analysis
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

gl
y.
Chapter III Design Failure Mode and Effects Analysis

Introduction
The Design Failure Mode Effects Analysis, referred to as
DFMEA, supports the design process in reducing the risk of
failures by:
• Aiding in the objective evaluation of the design, including
functional requirements and design alternatives,
• Evaluating the initial design for manufacturing, assembly,

in p
service, and recycling requirements,

rd u
y.
co Gro
•

gl
Increasing the probability that potential failure modes and their
effects on system and vehicle operation have been considered

d ion
in the design/development process,
•

ke ct
Providing additional information to aid in the planning of

ac
ar y A
thorough and efficient design, development, and validation

LL
programs,

rm tr
ch

wa Ind 0
•

te us
Developing a ranked list of potential failure modes according

en ive 01
os
to their effect on the customer, thus establishing a priority

be t /2
tB

system for design improvements, development, and validation

s mo 14
testing/analysis,
er

ha to 7/
•
ob

Providing an open issue format for recommending and

d Au n:

tracking risk-reducing actions, and,

an e io

• Providing future reference, (e.g., lessons learned), to aid in

d th at
to

addressing field concerns, evaluating design changes, and

te by xpir
rig t is Lic 11 d

developing advanced designs.

py en te 18 se

ot ed E

The DFMEA is a living document and should:

co m Si 3 en

pr n se

• Be initiated before design concept finalization,

is ocu ent er: 4 s lic

ht o en

• Be updated as changes occur or additional information is

obtained throughout the phases of product development,

an is d cum mb ent

w
ec

• Be fundamentally completed before the production design is

Th Do r Nu um

released, and,
E- rde oc

• Be a source of lessons learned for future design iterations.

O is d

Customer Defined
Th

The definition of “Customer” provided in Chapter II applies to

DFMEA. It is important to correctly identify the customer(s)
because such knowledge directs the development of the
d

DFMEA, including the impact of the function of the design.

16
Chapter III Design Failure Mode and Effects Analysis

Team Approach
The DFMEA is developed and maintained by a multi-
disciplinary (or cross-functional) team typically led by the design
responsible engineer from the responsible design source (e.g.,
OEM, Tier 1 supplier or Tier 2 supplier and below).
The responsible engineer is expected to directly and actively
involve representatives from all affected areas. The areas of
expertise and responsibility may include, but are not limited to,

in p
rd u
y.
assembly, manufacturing, design, analysis/test, reliability,

co Gro
gl
materials, quality, service, and suppliers, as well as the design
area responsible for the next higher or lower assembly or system,
subsystem, or component.

d ion
Manufacturing,

ke ct
C

ac
Assembly and

ar y A
LL
Serviceability

rm tr
ch

wa Ind 0
te us
Considerations

en ive 01
os

be t /2
tB

The DFMEA should include any potential failure modes and

s mo 14
causes that can occur during the manufacturing or assembly
er

ha to 7/
process which are the result of the design. Such failure modes
ob

may be mitigated by design changes (e.g., a design feature which

d Au n:
:R

prevents a part from being assembled in the wrong orientation –

an e io

i.e., error-proofed). When not mitigated during the DFMEA

d th at
to

analysis (as noted in the action plan for that item), their
te by xpir
rig t is Lic 11 d

identification, effect, and control should be transferred to and

py en te 18 se

covered by the PFMEA.

ot ed E
co m Si 3 en

pr n se

The DFMEA does not rely on process controls to overcome

is ocu ent er: 4 s lic

potential design weaknesses, but it does take the technical and

ht o en

physical limits of a manufacturing and assembly process into

consideration, for example:

an is d cum mb ent

w
ec

• Necessary mold drafts

Th Do r Nu um

• Limited surface finish capability

E- rde oc

• Assembling space (e.g., access for tooling)

O is d

• Limited hardenability of steels

• Tolerances/process capability/performance
The DFMEA can also take into consideration the technical and
physical limits of product serviceability and recycling once the
d

product has entered field use, for example:

• Tool access
• Diagnostic capability
• Material classification symbols (for recycling)
• Materials/chemicals used in the manufacturing processes

17
Chapter III Design Failure Mode and Effects Analysis

Development of a Design FMEA

The DFMEA focuses on the design of the product that will be
delivered to the final customer (End User). The prerequisite tasks
for an effective analysis of the product design include:
assembling a team, determining scope, creating block diagrams
or P-diagrams depicting product function and requirements. A
clear and complete definition of the desired product

in p
characteristics better facilitates the identification of potential

rd u
y.
failure modes. A DFMEA form is used to document the results

co Gro
gl
of the analysis including any recommended actions and
responsibilities (See Table III.1).

d ion
The DFMEA process can be mapped to the customer or

ke ct
C
organization’s product development process.

ac
ar y A
LL
Prerequisites

rm tr
ch

wa Ind 0
te us
en ive 01
os
A DFMEA should begin with the development of information to

be t /2
tB

understand the system, subsystem, or component being analyzed

s mo 14
er

and define their functional requirements and characteristics.

ha to 7/
ob

In order to determine the scope of the DFMEA, the team should

d Au n:
:R

consider the following as applicable to component, subsystem or

an e io

system DFMEAs:
d th at
to

•
te by xpir

What processes, mating components, or systems does the

rig t is Lic 11 d
py en te 18 se

product interface with?

ot ed E
co m Si 3 en

• Are there functions or features of the product that affect other

pr n se

components or systems?
is ocu ent er: 4 s lic

ht o en

• Are there inputs provided by other components or systems that

are needed to perform intended functions of the product?

an is d cum mb ent

w
ec

• Do the product’s functions include the prevention or detection

Th Do r Nu um

of a possible failure mode in a linked component or system?

E- rde oc

The following sections describe tools that may be applied, as

O is d

appropriate, to assist the team in developing the DFMEA.

Block (Boundary) Diagrams

The block diagram of the product shows the physical and logical
relationships between the components of the product. There are
d

different approaches and formats to the construction of a block

diagram
The block diagram indicates the interaction of components and
subsystems within the scope of the design. This interaction may
include: flow of information, energy, force, or fluid. The
objective is to understand the requirements or inputs to the

18
Chapter III Design Failure Mode and Effects Analysis

system, the activities acting on the inputs or function performed,

and the deliverables or output.
The diagram may be in the form of boxes connected by lines,
with each box corresponding to a major component of the
product or a major step of the process. The lines correspond to
how the product components are related to, or interface with
each other. The organization needs to decide the best approach
or format for the block diagram. Figure III.1a, b, and c contain
examples of block diagrams.

in p
rd u
y.
Copies of the diagrams used in DFMEA preparation should

co Gro
gl
accompany the DFMEA.

d ion
ke ct
C

ac
ar y A
LL

rm tr
ch

wa Ind 0
te us
en ive 01
os

be t /2
tB

s mo 14
er

ha to 7/
ob

d Au n:
:R

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

Figure III.1a Block (Boundary) Diagram Examples

19
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

20
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr

Figures III.1b, c Block (Boundary) Diagram Examples

ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

gl
y.
Chapter III Design Failure Mode and Effects Analysis

Parameter (P) Diagrams

The P-Diagram is a structured tool to help the team understand
the physics related to the function(s) of the design. The team
analyzes the intended inputs (signals) and outputs (responses or
functions) for the design as well as those controlled and
uncontrolled factors which can impact performance.
The inputs to the product and outputs from the product, i.e., the
intended and unintended functions of the product, are useful in

in p
identifying error states, noise factors, and control factors.

rd u
y.
co Gro
gl
The error states correspond to the Potential Failure Modes in the
DFMEA.

d ion
ke ct
C

ac
ar y A
LL

rm tr
ch

wa Ind 0
te us
en ive 01
os

be t /2
tB

s mo 14
er

ha to 7/
ob

d Au n:
:R

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

Figure III.2 Example of a Parameter (P) Diagram for a Generic Catalytic Converter

21
Chapter III Design Failure Mode and Effects Analysis

Functional Requirements
Another step in the DFMEA process is a compilation of the
functional and interface requirements of the design. This list may
include the following categories:
• General: This category considers the purpose of the product
and its overall design intent
• Safety

in p
• Government Regulations

rd u
y.
co Gro
gl
• Reliability (Life of the Function)
• Loading and Duty Cycles: Customer product usage profile

d ion
• Quiet Operations: Noise, vibration and harshness (NVH)

ke ct
C

ac
ar y A
•

LL
Fluid Retention
•

rm tr
Ergonomics
ch

wa Ind 0
te us
en ive 01
•
os
Appearance

be t /2
tB

• Packaging and Shipping

s mo 14
er

• Service
ha to 7/
ob

• Design for Assembly

d Au n:
:R

an e io

• Design for Manufacturability

d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

Other Tools and Information Resources

ot ed E
co m Si 3 en

pr n se

Other tools and resources that may help the team understand and
is ocu ent er: 4 s lic

define the design requirements may include:

ht o en

• Schematics, drawings, etc.

i
an is d cum mb ent

•
ec

Bill of Materials (BOM)

Th Do r Nu um

• Interrelationship matrices
E- rde oc

• Interface matrix
O is d

• Quality Function Deployment (QFD)

• Quality and Reliability History

The use of these tools, supported by engineering experience and
historical information, can assist in defining a comprehensive set
of requirements and functions.
d

After considering these prerequisites, start filling out the form

(Table III.1 below).

22
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

23
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
This page intentionally left blank.

wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

gl
y.
Th
POTENTIAL
______ System A FMEA Number
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C H Design Responsibility ______________________________________ Prepared By:
Chapter III

Th DBo r Nu um
c e
Model Year(s)/Program(s)_________________________________
an is dD um mb nt E F Key Date ________________________________________________ FMEA Date (Orig.)

Core Team
d Goc en er is
is Action Results
Item
Current Design
cPotential Potential Potential Responsibility
um t S : 4 lice
Requirement
o
Failure e i 3 n Recommended
Actions Taken
p Effect(s) of te Cause(s) RPN Action & Target
RPN

Severity
Mode y
n
Failure Failure
18 of sControls Controls
Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
t

Occurrence
Occurrence

L
Based on test
rig is ic 11 ed
Front Door L.H. Maintain integrity Integrity breach Corroded interior 5 Upper edge of Design 3 Vehicle 7 105 Laboratory A. Tate 5 2 3 30
allows environ. results (test no.
H8HX-0000-A of inner door
to protective wax requirements accelerated
lower door panels durability test. Body Engineer
panel access of inner (#31268) and 1481) upper edge
ht o en
application specified T-118 (7) corrosion test
w
door panel
:R
for inner door panels best practice 0X 09 03 spec raised 125
Deteriorated life of is too low (BP 3455) 0X 09 30
pr n se
door leading to:
• Unsatisfactory Test results (Test 5 2 3 30
Insufficient wax A. Tate
ob
Laboratory
ot ed E
appearanc e due to Design 3 Vehicle 7 105
thickness specified accelerated Body Engineer No. 1481) show
rust through paint requirements durability test.
specified thickness
ec
T-118 (7) corrosion test
er
over time. (#31268) and 0X 09 03 is adequate.
• Impaired function best practice
te by xpir
0X 09 30
tB
of interior door (BP 3455)
hardware Design of J. Smythe DOE shows 25% 5 2 3 30
d th at
Experiments Body Engineer variation in specified
os

24
an e io
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
d Au n: ch
0X 10 25

Physical and
ha to 7/
Inappropriate wax Industry 2 5 50 None
LL
C formulation specified standard Chemical Lab
MS-1893 test - Report
s mo 14
No. 1265 (5)
be t /2
Vehicle
durability test.
T-118 (7)
en ive 01
Corner design 5 Design aid 7 175 Team T. Edwards Based on test: 5 1 1 5
prevents spray equip with non- evaluation using Body Engineer 3 additional vent
wa Ind 0
from reaching all functioning production spray and Assy Ops holes provided in
areas spray head (8) equipment and affected areas
te us
specified wax 0X 11 15 (error-proofed)
Vehicle
rm tr
durability test. 0X 12 15
T-118 (7)
ar y A
Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40
Body Engineer
between panels evaluation of evaluation using adequate access
and Assy Ops
ke ct
SAMPLE for spray head
access
spray head
access (4)
design aid buck
and spray head 0X 12 15
0X 11 15
d ion
Vehicle
ac
durability test.
T-118 (7)
co Gro
rd u
in p
a1 a2 b c de f h g h i j k ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

l gly m
.
Chapter III Design Failure Mode and Effects Analysis

Example DFMEA
The example used with the sample form deals with a Front Door
assembly. The product has several functional requirements:
• Permit ingress to and egress from vehicle
• Provide occupant protection from
o Weather (comfort)

in p
o Noise (comfort)

rd u
y.
co Gro
gl
o Side impact (safety)
• Support anchorage for door hardware including

d ion
o Mirror

ke ct
C

ac
o Hinges

ar y A
LL
o Latch

rm tr
ch

wa Ind 0
te us
o Window regulator

en ive 01
os
•
be t /2
Provide proper surface for appearance items
tB

s mo 14 o Paint
er

ha to 7/
ob

o Soft trim
d Au n:
:R

• Maintain integrity of inner door panel

an e io
d th at
to

The final DFMEA would include analysis of all these

te by xpir

requirements. The example includes part of the analysis of the

rig t is Lic 11 d
py en te 18 se

requirement: “Maintain integrity of inner door panel”.

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en

Header of the Design FMEA Form (fields A-H)

The following describes the information to be entered on the

an is d cum mb ent

w
ec

form.
Th Do r Nu um

The header should clearly identify the focus of the FMEA as

E- rde oc

well as information related to the document development and

control process. This should include an FMEA number,
O is d

identification of the scope, design responsibility, completion

dates, etc. The header should contain the following elements 2 :
Th

2
The letters at the end of each heading indicate the area referred to on the sample form.

25
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Th Do Br Nu um
c e
Model Year(s)/Program(s)_________________________________
an is d Dum mb nt E Key Date ________________________________________________ FMEA Date (Orig.) F
Core Team
d G i
Current Design Action Results
Item
is ocu ent er: 4 s lic
m Potential e Recommended
Responsibility
Requirement
co Potential n of Actions Taken
e Si 3 Potential
pFailure RPN Action & Target
tofe 1Cause(s)
RPN

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

yr nEffect(s) L
Front Door L.H. Maintain integrity Integrity breach 5 7 105 Based on test 5 2 3 30
Corroded interior Upper edge of Design 3 Vehicle Laboratory A. Tate
ig is ic 1 d t
H8HX-0000-A of inner door allows environ. requirements results (test no.
lower door panels protective wax durability test. accelerated Body Engineer
panel access of inner (#31268) and 1481) upper edge
ht o en
application specified corrosion test
o:
T-118 (7) 0X 09 03 spec raised 125
door panel for inner door panels best practice
Deteriorated life of is too low (BP 3455) 0X 09 30
pr wn se
door leading to:
Ro
• Unsatisfactory Test results (Test 5 2 3 30
Insufficient wax Laboratory A. Tate
ot ed E
appearanc e due to Design 3 Vehicle 7 105
thickness specified accelerated Body Engineer No. 1481) show
be
durability test.
ec b x rust through paint requirements corrosion test specified thickness
T-118 (7)
te y p over time.
rt (#31268) and 0X 09 03 is adequate.
• Impaired function best practice
i r 0X 09 30
of interior door (BP 3455)
hardware
Bo
Design of J. Smythe DOE shows 25% 5 2 3 30
d th at
Experiments Body Engineer variation in specified

26
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

FMEA Number (A)

Enter an alphanumeric string which is used to identify the FMEA
document. This is used for document control.

System, Subsystem, or Component Name

and Number (B)

in p
rd u
y.
Enter the name and number of the system, subsystem, or

co Gro
gl
component which is being analyzed. (See section entitled Define
the Scope).

d ion
Design Responsibility (C)

ke ct
C

ac
ar y A
LL
Enter the OEM, organization, and department or group who is
design responsible. Also enter the supply organization name, if

rm tr
ch

wa Ind 0
te us
applicable.

en ive 01
os

be t /2
tB

Model Year(s)/Program(s) (D)

s mo 14
er

ha to 7/
Enter the intended model year(s) and program(s) that will use or
ob

be affected by the design being analyzed (if known).

d Au n:
:R

an e io
d th at
to

Key Date (E)

te by xpir
rig t is Lic 11 d

Enter the initial DFMEA due date, which should not exceed the
py en te 18 se

scheduled production design release date.

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

FMEA Dates (F)

ht o en
i

Enter the date the original DFMEA was completed and the latest
an is d cum mb ent

w
ec

revision date.
Th Do r Nu um

Core Team (G)

E- rde oc
O is d

Enter the team members responsible for developing the DFMEA.

Contact information (e.g., name, organization, telephone
Th

number, and email) may be included in a referenced

supplemental document.

Prepared By (H)
d

Enter the name and contact information including the

organization (company) of the engineer responsible for preparing
the DFMEA.

27
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

28
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Body of the DFMEA Form (fields a – n)

The body of the FMEA contains the analysis of risks related to
the potential failures, and improvement action being taken. 3

Item / Function / Requirements (a)

Item/Function can be separated into two (or more) columns or
combined into a single, bridged column which encompasses

in p
these elements. Interfaces (as “items” of analysis) can be either

rd u
y.
co Gro
combined or separate. Components may be listed in the

gl
item/function column, and an additional column may be added
containing the functions or requirements of that item. “Item”,

d ion
“Function”, and “Requirements” are described below:

ke ct
C

ac
ar y A
LL
Item (a1)

rm tr
ch

wa Ind 0
Enter the items, interfaces, or parts which have been identified

te us
en ive 01
os
through block diagrams, P-diagrams, schematics and other

be t /2
drawings, and other analysis conducted by the team.
tB

s mo 14 The terminology used should be consistent with customer

ha to 7/
requirements and with those used in other design development
ob

documents and analysis to ensure traceability.

d Au n:
:R

an e io
d th at
to

Function (a1)
te by xpir
rig t is Lic 11 d

Enter the function(s) of the item(s) or interface(s) being analyzed

py en te 18 se

ot ed E

which are necessary to meet the design intent based on customer

co m Si 3 en

requirements and the team’s discussion. If the item(s) or

pr n se
is ocu ent er: 4 s lic

interface has more than one function with different potential

ht o en

modes of failure, it is highly recommended that each of these

functions and associated failure mode(s) is listed separately.

an is d cum mb ent

w
ec

Function becomes a2 if Item and Function are split.

Th Do r Nu um
E- rde oc

Requirements (a2)
O is d

An additional column, “Requirements”, may be added to further

refine the analysis of the failure mode(s). Enter the
Th

requirement(s) for each of the functions being analyzed (based

on customer requirements and the team’s discussion; see also
Chapter II, Section: Prerequisites). If the function has more than
one requirement with different potential modes of failure, it is
d

highly recommended that each of the requirements and functions

are listed separately.
Requirement becomes a3 if Item and Function are split into
separate columns, e.g., a1 and a2.

3
The letters at the end of each heading indicate the area referred to on the sample form.

29
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

30
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Potential Failure Mode (b)

Potential failure mode is defined as the manner in which a
component, subsystem, or system could potentially fail to meet
or deliver the intended function described in the item column.
Identify the potential failure mode(s) associated with the
function(s)/requirement(s). Potential failure modes should be
described in technical terms, and not necessarily as a symptom

in p
rd u
y.
noticeable by the customer.

co Gro
gl
Each function may have multiple failure modes. A large number
of failure modes identified for a single function may indicate that

d ion
the requirement is not well defined.

ke ct
C
The assumption is made that the failure could occur, but may not

ac
ar y A
LL
necessarily occur, consequently the use of the word “potential”.

rm tr
ch

wa Ind 0
te us
en ive 01
os
Potential failure modes that could occur only under certain
operating conditions (i.e., hot, cold, dry, dusty, etc.) and under

be t /2
tB

certain usage conditions (i.e., above-average mileage, rough

s mo 14
er

terrain, city driving only, etc.) should be considered.

ha to 7/
ob

d Au n:
:R

After determining all the failure modes, a validation of the

an e io

completeness of the analysis can be made through a review of

d th at
to

past things-gone-wrong, concerns, reports, and group

te by xpir
rig t is Lic 11 d

brainstorming.
py en te 18 se

ot ed E
co m Si 3 en

The potential failure mode may also be the cause of a potential

pr n se

failure mode in a higher level subsystem or system, or lead to the

is ocu ent er: 4 s lic

ht o en

effect of one in a lower level component.

Example failure modes, as related to different requirements, are

an is d cum mb ent

shown in table III.3.

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

31
Chapter III Design Failure Mode and Effects Analysis

Item Function Requirement Failure Mode

Disk Stop vehicle on
Stop vehicle traveling Vehicle does not stop
Brake demand
system (considering on dry asphalt
environmental pavement within Vehicle stops in excess of
conditions such specified distance specified distance

in p
as wet, dry, etc.) within specified g’s of

rd u
y.
force Stops vehicle with more than xx

co Gro
gl
g’s of force
Activates with no demand;

d ion
Allow unimpeded Vehicle movement is partially
impeded

ke ct
vehicle movement on

ac
ar y A
LL
no system demand Activates with no demand
Vehicle cannot move

rm tr
ch

wa Ind 0
te us
Brake Allows transfer Must deliver specified

en ive 01
os
Rotor of force from torque resistance at axle Insufficient torque resistance

be t /2
tB

brake pads to
s mo 14 delivered
axle
er

ha to 7/
ob

d Au n:
:R

Table III.3 Example Potential Failure Modes

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

32
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

33
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
This page intentionally left blank.

wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

gl
y.
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

34
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Potential Effect(s) of Failure (c)

Potential effects of failure are defined as the effects of the failure
mode on the function, as perceived by the customer(s).
Describe the effects of the failure in terms of what the customer
might notice or experience, remembering that the customer may
be an internal customer as well as the ultimate End User. State
clearly if the failure mode could impact safety or non-

in p
rd u
y.
compliance to regulations. The effects should always be stated in

co Gro
gl
terms of the specific system, subsystem, or component being
analyzed. Remember that a hierarchical relationship exists
between the component, subsystem, and system levels 4 . For

d ion
example, a part could fracture, which may cause the assembly to

ke ct
C
vibrate, resulting in an intermittent system operation. The

ac
ar y A
LL
intermittent system operation could cause performance to
degrade and ultimately lead to customer dissatisfaction. The

rm tr
ch

wa Ind 0
intent is to predict the potential failure effects to the team’s level

te us
en ive 01
os
of knowledge.

be t /2
tB

s mo 14 Typical failure effects should be stated in terms of product or

system performance. Table III.4 shows example effects of the
er

ha to 7/
failure modes from Table III.3.
ob

d Au n:
:R

an e io

Item Failure Mode Effect

d th at
to

te by xpir

Disk Brake Vehicle does not

rig t is Lic 11 d

Vehicle control impaired; Regulatory non-compliance

py en te 18 se

System stop
ot ed E

Vehicle stops in
co m Si 3 en

pr n se

excess of specified Vehicle control impaired; Regulatory non-compliance

is ocu ent er: 4 s lic

distance
ht o en

Stops vehicle with

more than xx g’s of Regulatory non-compliance

an is d cum mb ent

w
ec

force
Th Do r Nu um

Activates with no
E- rde oc

demand;
Decreased pad life; diminished vehicle control
Vehicle movement is
O is d

partially impeded
Th

Activates with no
demand Customer unable to drive vehicle
Vehicle cannot move
d

Table III.4 Example Potential Effects

4
See also Appendix B

35
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

36
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Severity (S) (d)

Severity is the value associated with the most serious effect for a
given failure mode. Severity is a relative ranking within the
scope of the individual FMEA.
Suggested Evaluation Criteria
The team should agree on evaluation criteria and a ranking

in p
system and apply them consistently, even if modified for

rd u
y.
individual process analysis. (See Table Cr1 below for criteria

co Gro
gl
guidelines.)
It is not recommended to modify criteria ranking values of 9 and

d ion
10. Failure modes with a rank of severity 1 should not be

ke ct
analyzed further.

ac
ar y A
LL
Criteria:

rm tr
ch

wa Ind 0
Effect Rank

te us
Severity of Effect on Product

en ive 01
os
(Customer Effect)

be t /2
tB

Failure to
s mo 14
Potential failure mode affects safe vehicle operation and/or involves 10
er

noncompliance with government regulation without warning.

ha to 7/
Meet Safety
ob

and/or
d Au n:
:R

Regulatory Potential failure mode affects safe vehicle operation and/or involves
an e io

Requirements
9
noncompliance with government regulation with warning.
d th at
to

te by xpir
rig t is Lic 11 d

Loss of primary function (vehicle inoperable, does not affect safe 8

py en te 18 se

Loss or vehicle operation).

ot ed E

Degradation
co m Si 3 en

pr n se

of Primary
Degradation of primary function (vehicle operable, but at reduced
is ocu ent er: 4 s lic

Function 7
ht o en

level of performance).
i
an is d cum mb ent

Loss of secondary function (vehicle operable, but comfort / 6

w
ec

Loss or
convenience functions inoperable).
Degradation
Th Do r Nu um

of Secondary
Degradation of secondary function (vehicle operable, but comfort / 5
Function
E- rde oc

convenience functions at reduced level of performance).

O is d

Appearance or Audible Noise, vehicle operable, item does not 4

conform and noticed by most customers (> 75%).

Appearance or Audible Noise, vehicle operable, item does not 3

Annoyance
conform and noticed by many customers (50%).
d

Appearance or Audible Noise, vehicle operable, item does not 2

conform and noticed by discriminating customers (< 25%).

No effect No discernible effect. 1

Table Cr1 Suggested DFMEA Severity Evaluation Criteria

37
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

38
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Classification (e)
This column may be used to highlight high-priority failure
modes and their associated causes.
As a result of this analysis, the team may use this information to
identify special characteristics.
Customer specific requirements may identify special product or

in p
process characteristic symbols and their usage.

rd u
y.
co Gro
A characteristic designated in the design record as special

gl
without an associated design failure mode identified in the
DFMEA is an indication of a weakness in the design process.

d ion
ke ct
C
Potential Cause(s)/Mechanism(s) of Failure

ac
ar y A
LL
Mode (f)

rm tr
ch

wa Ind 0
This information can be separated into multiple columns or

te us
en ive 01
os
combined into a single column.

be t /2
tB

In the development of the FMEA, the identification of all

s mo 14
potential causes of the failure mode is key to subsequent
er

ha to 7/
analysis. Although varied techniques (such as brainstorming) can
ob

be used to determine the potential cause(s) of the failure mode, it

d Au n:
:R

is recommended that the team should focus on an understanding

an e io

of the failure mechanism for each failure mode.

d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

Potential Mechanism(s) of Failure Mode (f1)

ot ed E
co m Si 3 en

A failure mechanism is the physical, chemical, electrical,

pr n se
is ocu ent er: 4 s lic

thermal, or other process that results in the failure mode. It is

ht o en

important to make the distinction that a failure mode is an

"observed" or "external" effect so as not to confuse failure mode

an is d cum mb ent

with failure mechanism, the actual physical phenomenon behind

the failure mode or the process of degradation or chain of events

Th Do r Nu um

leading to and resulting in a particular failure mode.

E- rde oc

To the extent possible, list every potential mechanism for each

O is d

failure mode. The mechanism should be listed as concisely and

completely as possible.
Th

For a system, the failure mechanism is the process of error

propagation following a component failure which leads to a
system failure.
d

A product or process can have several failure modes which are

correlated to each other because of a common failure
mechanism behind them.
Ensure that process effects are considered as part of the
DFMEA process.

39
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

40
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Potential Cause(s) of Failure Mode (f2)

Potential cause of failure is defined as an indication of how the
design process could allow the failure to occur, described in
terms of something that can be corrected or can be controlled.
Potential cause of failure may be an indication of a design
weakness, the consequence of which is the failure mode.

in p
rd u
y.
Causes are the circumstances that induce or activate a failure

co Gro
gl
mechanism.

d ion
In identifying potential causes of failure, use concise

ke ct
C

ac
descriptions of the specific causes of failures, e.g., specified bolt

ar y A
LL
plating allows for hydrogen embrittlement. Ambiguous phrases
such as, poor design or improper design, should not be used.

rm tr
ch

wa Ind 0
te us
en ive 01
Investigation of causes needs to focus on the failure mode and
os
not on the effect(s). In determining the cause(s), the team should

be t /2
tB

assume the existence of the cause under discussion will result in

s mo 14
er

the failure mode (i.e., the failure mode does not require multiple
ha to 7/
ob

causes to occur).
d Au n:
:R

Typically, there may be several causes each of which can result

an e io

in the failure mode. This results in multiple lines (cause

d th at
to

branches) for the failure mode.

te by xpir
rig t is Lic 11 d
py en te 18 se

To the extent possible, list every potential cause for each failure
ot ed E

mode/failure mechanism. The cause should be listed as concisely

co m Si 3 en

pr n se

and completely as possible. Separating the causes will result in a

is ocu ent er: 4 s lic

focused analysis for each cause and may yield different

ht o en

measurement, controls, and action plans.

i
an is d cum mb ent

Table III.5. shows sample causes for the failure modes in Table
w
ec

III.3. Although not required as part of the minimum FMEA form

Th Do r Nu um

elements, the table includes the failure mechanism to show the

relationships among failure mode, failure mechanism, and cause.
E- rde oc

In preparing the DFMEA, assume that the design will be

O is d

manufactured and assembled to the design intent. Exceptions can

be made at the team’s discretion where historical data indicate

deficiencies in the manufacturing process.
d

41
Chapter III Design Failure Mode and Effects Analysis

Failure Mode Mechanism Cause

Mechanical linkage break due to inadequate corrosion

protection

No transfer of force Master cylinder vacuum lock due to seal design

Vehicle does not stop
from pedal to pads

in p
rd u
y.
Loss of hydraulic fluid from loose hydraulic line due to

co Gro
incorrect connector torque specification

gl
Loss of hydraulic fluid due to hydraulic lines
crimped/compressed, inappropriate tube material specified

d ion
Mechanical linkage joints stiff due to inappropriate
lubrication specification

ke ct
C

ac
Reduced transfer of Mechanical linkage joints corroded due to inadequate

ar y A
Vehicle stops in excess of

LL
force from pedal to corrosion protection
yy feet
pads

rm tr
ch
Partial loss of hydraulic fluid due to hydraulic lines

wa Ind 0
te us
crimped, inappropriate tube material specified

en ive 01
os

be t /2
Excessive/rapid
tB

Stops vehicle with more Cumulative pressure build-up in master cylinder due to
transfer of force from
s mo 14
than xx g’s of force seal design
pedal to pads
er

ha to 7/
Activate with no demand; Corrosion or deposit build up on rails or pad ears due to
ob

Vehicle movement is Pads do not release surface finish not promoting adequate self cleaning and
d Au n:
:R

impeded corrosion protection

an e io

Activate with no demand Hydraulic pressure

d th at
to

Master cylinder vacuum lock due to seal design

Vehicle cannot move does not release
te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se

Table III.5 Example Potential Causes

is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

42
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

43
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
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wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

44
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Occurrence (O) (g)

Occurrence is the likelihood that a specific cause/mechanism
will occur resulting in the failure mode within the design life.
The likelihood of occurrence ranking number has a relative
meaning rather than an absolute value (See Table Cr2).
A consistent occurrence ranking system should be used to ensure
continuity. The occurrence number is a relative ranking within
the scope of the FMEA and may not reflect the actual likelihood

in p
rd u
y.
of occurrence.

co Gro
gl
Suggested Evaluation Criteria

d ion
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for

ke ct
C
individual process analysis. Occurrence should be estimated

ac
ar y A
LL
using a 1 to 10 scale using Table Cr2 as a guideline.

rm tr
In determining this estimate, questions such as the following
ch

wa Ind 0
te us
en ive 01
should be considered:
os
•
be t /2
What is the service history and field experience with similar
tB

s mo 14
components, subsystems, or systems?
er

ha to 7/
• Is the item a carryover or similar to a previous level item?
ob

d Au n:

•
:R

How significant are changes from a previous level item?

an e io

•
d th at
to

Is the item radically different from a previous level item?

te by xpir

•
rig t is Lic 11 d

Is the item completely new?

py en te 18 se

•
ot ed E

What is the application or what are the environmental

co m Si 3 en

pr n se

changes?
is ocu ent er: 4 s lic

ht o en

• Has an engineering analysis (e.g., reliability) been used to

estimate the expected comparable occurrence rate for the
i
an is d cum mb ent

application?
w
ec

•
Th Do r Nu um

Have preventive controls been put in place?

E- rde oc
O is d
Th

45
Chapter III Design Failure Mode and Effects Analysis

Criteria: Occurrence
Likelihood Criteria: Occurrence of Cause - DFMEA of Cause - DFMEA
Rank
of Failure (Design life/reliability of item/vehicle) (Incidents per
items/vehicles)

New technology/new design with no history. ≥ 100 per thousand

Very High 10
≥ 1 in 10

in p
rd u
y.
Failure is inevitable with new design, new application, or 50 per thousand

co Gro
gl
change in duty cycle/operating conditions. 9
1 in 20

d ion
Failure is likely with new design, new application, or 20 per thousand
High change in duty cycle/operating conditions. 8
1 in 50

ke ct
C

ac
ar y A
LL
Failure is uncertain with new design, new application, or 10 per thousand
change in duty cycle/operating conditions. 7

rm tr
1 in 100
ch

wa Ind 0
te us
en ive 01
Frequent failures associated with similar designs or in
os
2 per thousand
design simulation and testing. 6

be t /2
tB

1 in 500
s mo 14
er

Occasional failures associated with similar designs or in .5 per thousand

ha to 7/
Moderate design simulation and testing. 5
ob

1 in 2,000
d Au n:
:R

Isolated failures associated with similar design or in .1 per thousand

an e io

design simulation and testing. 4

d th at
to

1 in 10,000
te by xpir
rig t is Lic 11 d

Only isolated failures associated with almost identical .01 per thousand
py en te 18 se

design or in design simulation and testing. 3

ot ed E

1 in 100,000
co m Si 3 en

Low
pr n se

No observed failures associated with almost identical ≤.001 per thousand

is ocu ent er: 4 s lic

design or in design simulation and testing. 2

ht o en

1 in 1,000,000
i

Failure is eliminated through preventive control. Failure is eliminated

an is d cum mb ent

w
ec

Very Low through preventive 1

Th Do r Nu um

control.
E- rde oc

Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria

O is d
Th

46
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

47
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
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wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

48
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Current Design Controls (h)

Current Design Controls are those activities conducted as part of
the design process that have been completed or committed to and
that will assure the design adequacy for the design functional and
reliability requirements under consideration.
There are two types of design controls to consider:
Prevention:
Eliminate (prevent) the cause of the mechanism of failure or the

in p
rd u
y.
failure mode from occurring, or reduce its rate of occurrence.

co Gro
gl
Detection:
Identify (detect) the existence of a cause, the resulting

d ion
mechanism of failure or the failure mode, either by analytical or
physical methods, before the item is released for production.

ke ct
C

ac
ar y A
LL
The preferred approach is to first use prevention controls, if

rm tr
ch

wa Ind 0
te us
possible. The initial occurrence rankings will be affected by the

en ive 01
os
prevention controls provided they are integrated as part of the

be t /2
design intent.
tB

s mo 14
er

ha to 7/
Detection control should include identification of those activities
ob

which detect the failure mode as well as those that detect the
d Au n:
:R

cause.
an e io
d th at
to

The team should consider analysis, testing, reviews, and other

te by xpir
rig t is Lic 11 d

activities that will assure the design adequacy such as:

py en te 18 se

Prevention Controls
ot ed E
co m Si 3 en

pr n se

• Benchmarking studies
is ocu ent er: 4 s lic

ht o en

• Fail-safe designs
i

•
an is d cum mb ent

Design and Material standards (internal and external)

w
ec

• Documentation – records of best practices, lessons learned, etc.

Th Do r Nu um

from similar designs

E- rde oc

• Simulation studies – analysis of concepts to establish design

O is d

requirements
•
Th

Error-proofing
Detection controls
• Design reviews
d

• Prototype testing
• Validation testing
• Simulation studies – validation of design
• Design of Experiments; including reliability testing
• Mock-up using similar parts

49
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

50
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

The example Design FMEA form in this manual has two

columns for the design controls (i.e., separate columns for
Prevention Controls and Detection Controls) to assist the team in
clearly distinguishing between these two types of design
controls. This allows for a quick visual determination that both
types of design controls have been considered.
If a one-column (for design controls) form is used, then the
following prefixes should be used. For prevention controls, place

in p
a 'P' before each prevention control listed. For detection controls,

rd u
y.
place a 'D' before each detection control listed.

co Gro
gl
Preventing the causes of the failure mode through a design
change or design process change is the only way a reduction in

d ion
the occurrence ranking can be effected.

ke ct
C

ac
Table III.6 shows example prevention and detection controls for

ar y A
LL
the causes identified in Table III.5.

rm tr
ch

wa Ind 0
te us
en ive 01
os
Failure Cause Prevention Detection

be t /2
Mode controls controls
tB

Vehicle
s mo 14
Mechanical linkage Designed per Environmental
er

ha to 7/
does not break due to inadequate material standard stress test 03-9963
ob

stop corrosion protection MS-845

d Au n:
:R

Master cylinder vacuum Carry-over design Pressure variability

an e io

lock due to seal design with same duty testing – system

d th at
to

cycle requirements level

te by xpir
rig t is Lic 11 d
py en te 18 se

Loss of hydraulic fluid Designed per Vibration step-

ot ed E

from loose hydraulic torque stress test 18-1950

co m Si 3 en

pr n se

line due to incorrect requirements -

is ocu ent er: 4 s lic

connector torque 3993

ht o en

specification
i

Loss of hydraulic fluid Designed per Design of

an is d cum mb ent

w
ec

due to hydraulic lines material standard Experiments (DOE)

Th Do r Nu um

crimped/compressed, MS-1178 – tube resiliency

inappropriate tube
E- rde oc

material specified
O is d
Th

Table III.6 Examples of Prevention and Detection Design Controls

51
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

52
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Current Design Control Detection column. When
more than one control is identified, it is recommended that the
detection ranking of each control be included as part of the
description of the control. Record the lowest ranking value in the
Detection column.
A suggested approach to Current Design Control Detection is to

in p
assume the failure has occurred and then assess the capabilities

rd u
y.
of the current design controls to detect this failure mode.

co Gro
gl
Do not automatically presume that the detection ranking is low

d ion
because the occurrence is low. It is important to assess the
capability of the design controls to detect low frequency failure

ke ct
C
modes or reduce the risk of them going further in the design

ac
ar y A
LL
release process.

rm tr
ch
Detection is a relative ranking within the scope of the individual

wa Ind 0
te us
en ive 01
FMEA. In order to achieve a lower ranking, generally the design
os
control (analysis or verification activities) has to be improved.

be t /2
tB

s mo 14
er

ha to 7/
Suggested Evaluation Criteria
ob

d Au n:

The team should agree on evaluation criteria and a ranking

an e io

system and apply them consistently, even if modified for

d th at
to

individual process analysis. Detection should be estimated using

te by xpir
rig t is Lic 11 d

Table Cr3 as a guideline.

py en te 18 se

ot ed E
co m Si 3 en

pr n se

The ranking value of one (1) is reserved for failure prevention

is ocu ent er: 4 s lic

through proven design solutions.

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

53
Chapter III Design Failure Mode and Effects Analysis

Opportunity Criteria: Likelihood

for Rank of
Detection Likelihood of Detection by Design Control Detection

No detection Almost
opportunity
No current design control; Cannot detect or is not analyzed. 10
Impossible

Not likely to Design analysis/detection controls have a weak detection

Very
detect at any capability; Virtual Analysis (e.g., CAE, FEA, etc.) is not 9

in p
Remote

rd u
y.
stage correlated to expected actual operating conditions.

co Gro
gl
Product verification/validation after design freeze and prior to

d ion
launch with pass/fail testing (Subsystem or system testing with
acceptance criteria such as ride and handling, shipping
8 Remote

ke ct
C
evaluation, etc.).

ac
ar y A
LL
Post Design

rm tr
ch

wa Ind 0
Freeze and Product verification/validation after design freeze and prior to

te us
en ive 01
prior to launch launch with test to failure testing (Subsystem or system testing 7 Very Low
os
until failure occurs, testing of system interactions, etc.).

be t /2
tB

s mo 14
er

Product verification/validation after design freeze and prior to

ha to 7/
ob

launch with degradation testing (Subsystem or system testing 6 Low

d Au n:

after durability test, e.g., function check).

an e io
d th at
to

Product validation (reliability testing, development or

te by xpir

validation tests) prior to design freeze using pass/fail testing

rig t is Lic 11 d

(e.g., acceptance criteria for performance, function checks,

5 Moderate
py en te 18 se

etc.).
ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

Product validation (reliability testing, development or

ht o en

Prior to Design Moderately

Freeze validation tests) prior to design freeze using test to failure 4
High
i

(e.g., until leaks, yields, cracks, etc.).

an is d cum mb ent

w
ec
Th Do r Nu um

Product validation (reliability testing, development or

validation tests) prior to design freeze using degradation 3 High
E- rde oc

testing (e.g., data trends, before/after values, etc.).

O is d
Th

Design analysis/detection controls have a strong detection

Virtual
capability. Virtual analysis (e.g., CAE, FEA, etc.) is highly
Analysis -
correlated with actual or expected operating conditions prior
2 Very High
Correlated
to design freeze.
d

Detection not
Failure cause or failure mode can not occur because it is fully Almost
applicable;
Failure
prevented through design solutions (e.g., proven design 1
standard, best practice or common material, etc.). Certain
Prevention

Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria

54
Th
O is d
E- rde oc
Chapter III

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

55
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
This page intentionally left blank.

wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Design Failure Mode and Effects Analysis

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

56
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

Determining Action Priorities

Once the team has completed the initial identification of failure
modes and effects, causes and controls, including rankings for
severity, occurrence, and detection, they must decide if further
efforts are needed to reduce the risk. Due to the inherent
limitations on resources, time, technology, and other factors,
they must choose how to best prioritize these efforts.
The initial focus of the team should be oriented towards failure

in p
modes with the highest severity rankings. When the severity is 9

rd u
y.
or 10, it is imperative that the team must ensure that the risk is

co Gro
gl
addressed through existing design controls or recommended
actions (as documented in the FMEA).

d ion
For failure modes with severities 8 or below the team should

ke ct
C
consider causes having highest occurrence or detection rankings.

ac
ar y A
LL
It is the team’s responsibility to look at the information
identified, decide upon an approach, and determine how to best

rm tr
ch

wa Ind 0
prioritize the risk reduction efforts that best serve their

te us
en ive 01
os
organization and customers.

be t /2
tB

s mo 14
Risk Evaluation;
er

ha to 7/
ob

Risk Priority Number (RPN) (j)

d Au n:
:R

One approach to assist in action prioritization has been to use the

an e io

Risk Priority Number:

d th at
to

te by xpir
rig t is Lic 11 d

RPN = Severity (S) x Occurrence (O) x Detection (D)

py en te 18 se

Within the scope of the individual FMEA, this value can range
ot ed E
co m Si 3 en

between 1 and 1000.

pr n se
is ocu ent er: 4 s lic

The use of an RPN threshold is NOT a recommended practice

ht o en

for determining the need for actions.

i
an is d cum mb ent

Applying thresholds assumes that RPNs are a measure of relative

w
ec

risk (which they often are not) and that continuous improvement
Th Do r Nu um

is not required (which it is).

E- rde oc

For example, if the customer applied an arbitrary threshold of

O is d

100 to the following, the supplier would be required to take

action on the characteristic B with the RPN of 112.
Th

Item Severity Occurrence Detection RPN

A 9 2 5 90
d

B 7 4 4 112

57
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

58
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

In this example, the RPN is higher for characteristic B, but the

priority should be to work on A with the higher severity of 9,
although the RPN is 90 which is lower and below the threshold.
Another concern with using the threshold approach is that there
is no specific RPN value that requires mandatory action.
Unfortunately, establishing such thresholds may promote the
wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce

in p
RPN. This type of behavior avoids addressing the real problem

rd u
y.
co Gro
that underlies the cause of the failure mode and merely keeps the

gl
RPN below the threshold. It is important to recognize that while
determining “acceptable” risk at a particular program milestone

d ion
(e.g., vehicle launch) is desirable, it should be based on an

ke ct
analysis of severity, occurrence and detection and not through

ac
ar y A
the application of RPN thresholds.

rm tr
ch

wa Ind 0
te us
en ive 01
Use of the RPN index in the discussions of the team can be a
os
useful tool. The limitations of the use of RPN need to be

be t /2
tB

understood. However, the use of RPN thresholds to determine

s mo 14
action priority is not recommended.
er

ha to 7/
ob

d Au n:

Recommended Action(s) (k)

an e io
d th at

In general, prevention actions (i.e., reducing the occurrence) are

te by xpir

preferable to detection actions. An example of this is the use of

rig t is Lic 11 d

proven design standard or best practice rather than product

py en te 18 se

ot ed E

verification/validation after design freeze.

co m Si 3 en

pr n se

The intent of recommended actions is to improve the design.

is ocu ent er: 4 s lic

ht o en

Identifying these actions should consider reducing rankings in

the following order: severity, occurrence, and detection.
i
an is d cum mb ent

Example approaches to reduce these are explained below:

w
ec

• To Reduce Severity (S) Ranking: Only a design revision can

Th Do r Nu um

bring about a reduction in the severity ranking.

E- rde oc
O is d

High severity rankings can sometimes be reduced by making

design revisions that compensate or mitigate the resultant
Th

severity of failure. For example: The requirement for a tire is to

“retain applied air pressure under use”. The severity of the effect
of the failure mode “rapid loss of air pressure” would be lower for
a “run flat” tire.
d

A design change, in and of itself, does not imply that the severity
will be reduced. Any design change should be reviewed by the
team to determine the effect to the product functionality and
process.

59
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

60
an e io
(DOE) on Wax thickness is
sc
h Thickness 0X 10 18 acceptable
d Au n:
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

gl l
y.
Chapter III Design Failure Mode and Effects Analysis

For maximum effectiveness and efficiency of this approach,

changes to the product and process design should be
implemented early in the development process. For example,
alternate materials may need to be considered early in the
development cycle to eliminate corrosion severity.
• To Reduce Occurrence (O) Ranking: A reduction in the
occurrence ranking can be effected by removing or controlling
one or more of the causes or mechanisms of the failure mode
through a design revision. Actions such as, but not limited to,

in p
the following should be considered:

rd u
y.
co Gro
gl
o Error proof the design to eliminate the failure mode
o Revised design geometry and tolerances

d ion
o Revised design to lower the stresses or replace weak

ke ct
C

ac
(high failure probability) components

ar y A
LL
o Add redundancy

rm tr
ch

wa Ind 0
te us
o Revised material specification

en ive 01
os
• To Reduce Detection (D) Ranking: The preferred method is
be t /2
tB

the use of error/mistake proofing. An increase in design

s mo 14
er

validation/verification actions should result in a reduction of

ha to 7/
ob

the detection ranking only. In some cases, a design change to a

d Au n:

specific part may be required to increase the likelihood of

an e io

detection (i.e., reduce the detection ranking). Additionally, the

d th at
to

following should be considered:

te by xpir
rig t is Lic 11 d

o Design of Experiments (particularly when multiple

py en te 18 se

or interactive causes of a failure mode are present)

ot ed E
co m Si 3 en

pr n se

o Revised test plan

is ocu ent er: 4 s lic

ht o en

If the assessment leads to no recommended actions for a specific

failure mode/cause/control combination, indicate this by entering
i
an is d cum mb ent

“None” in this column. It may be useful to also include a

w
ec

rationale if “None” is entered, especially in case of high severity.

Th Do r Nu um

For design actions consider using the following:

E- rde oc

• Results of design DOE or reliability testing

O is d

• Design analysis (reliability, structural or physics of failure)

that would confirm that the solution is effective and does not
introduce new potential failure modes
• Drawing, schematics, or model to confirm physical change of
targeted feature
d

• Results from a design review

• Changes to a given Engineering Standard or Design Guidelines
• Reliability analysis results

61
Th
POTENTIAL
______ System FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
E- rde oc
______Component; _____________________________________ C Design Responsibility ______________________________________ Prepared By: H
Chapter III

Th DoB r Nu um
c e
Model Year(s)/Program(s)_________________________________
an is d Dum mb nt E Key Date ________________________________________________ FMEA Date (Orig.) F
Core Team
d G i
Current Design Action Results
Item
is ocu ent er: 4 s lic
Responsibility
Requirement
coPotentialm Potential e Recommended
Failure of n Actions Taken
e Si 3 Potential
Controls Controls RPN Action & Target
te 1Cause(s) ofs
RPN

Severity
Mode
nFailure
py Effect(s) Failure
8 Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

L
Based on test
rig is ic 1 ed
Front Door L.H. Maintain integrity Integrity breach Corroded interior 5 Upper edge of Design 3 Vehicle 7 105 Laboratory A. Tate 5 2 3 30
results (test no.
H8HX-0000-A of inner door allows environ.
to protective wax requirements accelerated
lower door panels durability test. Body Engineer
panel access of inner (#31268) and 1481) upper edge
ht o en
application specified T-118 (7) corrosion test
w
door panel
:R
for inner door panels best practice 0X 09 03 spec raised 125
Deteriorated life of is too low (BP 3455) 0X 09 30
pr n se
door leading to:
• Unsatisfactory Test results (Test 5 2 3 30
Insufficient wax A. Tate
ob
Laboratory
ot ed E
appearanc e due to Design 3 Vehicle 7 105
thickness specified accelerated Body Engineer No. 1481) show
rust through paint requirements durability test.
specified thickness
ec
T-118 (7) corrosion test
er
over time. (#31268) and 0X 09 03 is adequate.
• Impaired function best practice
te by xpir
0X 09 30
tB
of interior door (BP 3455)
hardware Design of J. Smythe DOE shows 25% 5 2 3 30
d th at
Experiments Body Engineer variation in specified
os

62
an e io
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
d Au n: ch
0X 10 25

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

lgly
.
Chapter III Design Failure Mode and Effects Analysis

Table III.7 below provides an example of the application of

causes (Column f), controls (Column h) and recommended
actions (Column k).

Responsibility & Target Completion Date (l)

Enter the name of the individual and organization responsible for
completing each recommended action including the target
completion date. The design-responsible engineer/team leader is

in p
responsible for ensuring that all actions recommended have been

rd u
y.
implemented or adequately addressed.

co Gro
gl
d ion
Action Results (m-n)

ke ct
This section identifies the results of any completed actions and

ac
ar y A
their effect on S, O, D rankings and RPN.

rm tr
ch

wa Ind 0
te us
Action(s) Taken and Completion Date (m)

en ive 01
os

be t /2
After the action has been implemented, enter a brief description
tB

s mo 14
of the action taken and actual completion date.
er

ha to 7/
ob

Severity, Occurrence, Detection and RPN (n)

d Au n:
:R

an e io

After the preventive/corrective action has been completed,

d th at
to

determine and record the resulting severity, occurrence, and

te by xpir
rig t is Lic 11 d

detection rankings.
py en te 18 se

ot ed E

Calculate and record the resulting action (risk) priority indicator

co m Si 3 en

(e.g., RPN).
pr n se
is ocu ent er: 4 s lic

ht o en

All revised rankings should be reviewed. Actions alone do not

guarantee that the problem was solved (i.e., cause addressed),
i
an is d cum mb ent

thus an appropriate analysis or test should be completed as

w
ec

verification. If further action is considered necessary, repeat the

Th Do r Nu um

analysis. The focus should always be on continuous

improvement.
E- rde oc
O is d
Th

63
Chapter III Design Failure Mode and Effects Analysis

Item Failure Cause Prevention Detection Recommended

Mode Controls Controls Actions
Disk Vehicle Mechanical linkage Designed per Environmental stress Change material to
Brake does not break due to material test 03-9963 stainless steel
system stop inadequate corrosion standard MS-
protection 845
Master cylinder Carry-over Pressure variability Use carry-over seal
vacuum lock due to design with testing – system level design
seal design same duty cycle

in p
requirements

rd u
y.
co Gro
gl
Loss of hydraulic Designed per Vibration step-stress Modify connector
fluid from loose torque test 18-1950 from bolt-style to
hydraulic line due to requirements - quick-connect

d ion
incorrect connector 3993
torque specification

ke ct
C

ac
Loss of hydraulic Designed per DOE – tube Modify hose

ar y A
LL
fluid due to hydraulic material resiliency design from MS-
lines standard MS- 1178 to MS-2025

rm tr
ch
crimped/compressed, 1178 to increase strength

wa Ind 0
te us
en ive 01
inappropriate tube
os
material specified

be t /2
tB

s mo 14
er

ha to 7/
Table III.7 Examples of Causes, Controls and Recommended Actions
ob

d Au n:
:R

an e io
d th at
to

Maintaining DFMEAs
te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E

The DFMEA is a living document and should be reviewed

co m Si 3 en

pr n se

whenever there is a product design change and updated, as

is ocu ent er: 4 s lic

required. Recommended actions updates should be included into

ht o en

a subsequent DFMEA along with the final results (what worked

and what did not work).

an is d cum mb ent

w
ec

Another element of on-going maintenance of DFMEAs should

Th Do r Nu um

include a periodic review of the rankings used in the DFMEA.

Specific focus should be given to Occurrence and Detection
E- rde oc

rankings. This is particularly important where improvements

O is d

have been made either through product changes or improvements

in design controls. Additionally, in cases where field issues have
Th

occurred, the rankings should be revised accordingly.

64
Chapter III Design Failure Mode and Effects Analysis

Leveraging DFMEAs
If a new project or application is functionally similar to the
existing product, a single DFMEA may be used with customer
concurrence. Using a fundamentally sound baseline DFMEA as
the starting point provides the greatest opportunity to leverage
past experience and knowledge. If there are slight differences,
the team should identify and focus on the effects of these
differences.

in p
rd u
y.
co Gro
Linkages

gl
d ion
The DFMEA is not a “stand-alone” document. For example, the
output of the DFMEA can be used as input for subsequent

ke ct
C
product development processes. It is the summary of the team’s

ac
ar y A
LL
discussions and analysis. Figure III.7 shows the linkages of
some of the commonly used documents.

rm tr
ch

wa Ind 0
te us
en ive 01
os

be t /2
tB

s mo 14
er

Boundary (Block) Diagram,

ha to 7/
ob

P – Diagram, etc.
d Au n:
:R

an e io
d th at
to

te by xpir

DFMEA
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

Design Verification
ht o en

Plan & Report (DVP&R),

i
an is d cum mb ent

PFMEA, etc.
ec
Th Do r Nu um
E- rde oc

Figure III.7 DFMEA Information Interrelationships Flow

O is d
Th

65
Chapter III Design Failure Mode and Effects Analysis

Design Verification Plan & Report (DVP&R)

DFMEA and DVP&R have an important linkage. The DFMEA
identifies and documents the current design prevention and
detection controls which become input to the test description
included within the DVP&R. The DFMEA identifies “what” the
controls are while the DVP&R provides the “how” such as
acceptance criteria, procedure and sample size.

in p
rd u
y.
PFMEA

co Gro
gl
Another important linkage is between the DFMEA and PFMEA.
For example, a Process (PFMEA) failure mode or a Design

d ion
(DFMEA) failure mode can result in the same potential product

ke ct
effect. In this case, the effects of the design failure mode should

ac
ar y A
be reflected in the effects and severity rankings of the DFMEA

LL
and PFMEA.

rm tr
ch

wa Ind 0
te us
en ive 01
os

be t /2
tB

s mo 14
er

ha to 7/
ob

d Au n:
:R

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

66
Th
O is d
E- rde oc
Chapter IV

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

67
an e io ch
d Au n:

PFMEA
ha to 7/ LL
s mo 14 C
be t /2
en ive 01 Chapter IV
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
Process Failure Mode and Effects Analysis
ac
co Gro
rd u
in p
Process Failure Mode and Effects Analysis

gl
y.
Chapter IV Process Failure Mode and Effects Analysis

Introduction
The process FMEA, referred to as PFMEA, supports
manufacturing process development in reducing the risk of
failures by:
• Identifying and evaluating the process functions and
requirements,
• Identifying and evaluating potential product and process-

in p
related failure modes, and the effects of the potential failures

rd u
y.
on the process and customers,

co Gro
gl
• Identifying the potential manufacturing or assembly process

d ion
causes,
•

ke ct
Identifying process variables on which to focus process

ac
ar y A
controls for occurrence reduction or increased detection of the

LL
failure conditions, and

rm tr
ch

wa Ind 0
•

te us
Enabling the establishment of a priority system for

en ive 01
os
preventive/corrective action and controls.

be t /2
tB

The PFMEA is a living document and should:

s mo 14
er

• Be initiated before or at the feasibility stage,

ha to 7/
ob

•
d Au n:

Be initiated prior to tooling for production,

an e io

• Take into account all manufacturing operations from

d th at
to

individual components to assemblies, and

te by xpir
rig t is Lic 11 d

•
py en te 18 se

Include all processes within the plant that can impact the
ot ed E

manufacturing and assembly operations, such as shipping,

co m Si 3 en

pr n se

receiving, transporting of material, storage, conveyors or

is ocu ent er: 4 s lic

labeling.
ht o en

Early review and analysis of new or revised processes is advised

i
an is d cum mb ent

to anticipate, resolve, or monitor potential process concerns

w
ec

during the manufacturing planning stages of a new model or

Th Do r Nu um

component program.
E- rde oc

The PFMEA assumes the product as designed will meet the

O is d

design intent. Potential failure modes that can occur because of a

design weakness may be included in a PFMEA. Their effect and
Th

avoidance is covered by the Design FMEA.

The PFMEA does not rely on product design changes to
overcome limitations in the process. However, it does take into
consideration a product’s design characteristics relative to the
d

planned manufacturing or assembly process to assure that, to the

extent possible, the resultant product meets customer needs and
expectations. For example, the PFMEA development generally
assumes that the machines and equipment will meet their design
intent and therefore are excluded from the scope. Control
mechanisms for incoming parts and materials may need to be
considered based on historical data.

68
Chapter IV Process Failure Mode and Effects Analysis

Customer Defined
The definition of “Customer” for a PFMEA should normally be
the “End User.” However, the customer can also be a subsequent
or downstream manufacturing or assembly operation, a service
operation, or regulator. 5
Team Approach

in p
The PFMEA is developed and maintained by a multi-disciplinary

rd u
y.
(or cross-functional) team typically led by the responsible

co Gro
gl
engineer. During the initial development of the PFMEA, the
responsible engineer/team leader is expected to directly and

d ion
actively involve representatives from all affected areas. These
areas should include but are not limited to design, assembly,

ke ct
C

ac
ar y A
manufacturing, materials, quality, service, and suppliers, as well

LL
as the area responsible for the next assembly. The PFMEA

rm tr
ch
should be a catalyst to stimulate the interchange of ideas between

wa Ind 0
te us
en ive 01
the areas affected and thus promote a team approach.
os

be t /2
tB

Design Considerations
s mo 14
er

ha to 7/
ob

The team should assume the product as designed will meet the
d Au n:
:R

design intent.
an e io
d th at
to

During the development of a PFMEA, the team may identify

te by xpir

design opportunities which, if implemented, would either

rig t is Lic 11 d

eliminate or reduce the occurrence of a process failure mode. For

py en te 18 se

ot ed E

example, adding a feature to a part and a matching feature to a

co m Si 3 en

fixture will eliminate the possibility of an operator placing a part

pr n se
is ocu ent er: 4 s lic

in the wrong orientation. Such information must be provided to

ht o en

the responsible design engineer as well as the tooling /

equipment / fixture design-responsible individual for

an is d cum mb ent

consideration and possible implementation.

ec
Th Do r Nu um
E- rde oc
O is d
Th

5
See discussion in Chapter II, Customer Defined

69
Chapter IV Process Failure Mode and Effects Analysis

Development of a Process FMEA

The process-responsible engineer/team leader has at his or her
disposal a number of documents that will be useful in preparing
the PFMEA. The PFMEA begins by developing a list of what the
process is expected to do and what it is expected not to do, i.e.,
the process intent.

in p
The PFMEA should begin with a flow chart of the general

rd u
y.
process. This flow chart should identify the product/process

co Gro
gl
characteristics associated with each operation. Identification of
product effects from the corresponding DFMEA should be

d ion
included. Copies of the flow chart used in the PFMEA
preparation should accompany it.

ke ct
C

ac
ar y A
In order to facilitate documentation of the analysis of potential

LL
failures and their consequences, example PFMEA forms have

rm tr
ch

wa Ind 0
been developed and are provided in Appendix A. The minimum

te us
en ive 01
os
information content required for a PFMEA is discussed below.
(Also see Table IV.1)
be t /2
tB

Prerequisites s mo 14
er

ha to 7/
ob

A PFMEA should begin with the development of information to

d Au n:

understand the manufacturing and assembly operations being

an e io

analyzed and define their requirements.

d th at
to

The process flow diagram is a primary input to the PFMEA. The

te by xpir
rig t is Lic 11 d

flow diagram is used as a tool to help establish the scope of

py en te 18 se

analysis during manufacturing system design.

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en

Process Flow Diagram and linkage to PFMEA

A process flow diagram 6 describes the flow of the product

an is d cum mb ent

w
ec

through the process – from incoming to outgoing. This should

Th Do r Nu um

include each step in a manufacturing or assembly process as well

as their related outputs (product characteristics, requirements,
E- rde oc

deliverables, etc.) and inputs (process characteristics, sources of

O is d

variation, etc.). The detail of the process flow depends on the

stage of process development discussion. The initial flow
Th

diagram is generally considered a high level process map. It

needs more detailed analysis to identify the potential failure
modes.
d

6
The Process Flow Diagram is also referred to as a Process Flow Chart.

70
Chapter IV Process Failure Mode and Effects Analysis

in p
rd u
y.
co Gro
gl
d ion
Figure IV.1 High Level to Detailed Process Maps

ke ct
C

ac
ar y A
LL

rm tr
ch
The PFMEA should be consistent with the information in the

wa Ind 0
te us
en ive 01
process flow diagram. The scope of the process flow diagram
os
should include all manufacturing operations from processing of

be t /2
tB

individual components to assemblies including shipping,

s mo 14
er

receiving, transportation of material, storage, conveyors,

ha to 7/
labeling, etc. A preliminary risk assessment using the process
ob

d Au n:

flow diagram may be performed to identify which of these

an e io

operations or individual steps can have an impact on the product

d th at
to

manufacturing and assembly and should be included in the

te by xpir

PFMEA.
rig t is Lic 11 d
py en te 18 se

The PFMEA development continues by identifying the

ot ed E
co m Si 3 en

requirement(s) for each process/function. Requirements are the

pr n se

outputs of each operation/step and relate to the requirements for

is ocu ent er: 4 s lic

ht o en

the product. The Requirements provide a description of what

should be achieved at each operation/step. The Requirements
i
an is d cum mb ent

provide the team with a basis to identify potential failure modes.

w
ec
Th Do r Nu um

In order to assure continuity, it is highly recommended that the

E- rde oc

same cross-functional team develop the Process Flow Diagram,

PFMEA, and Control Plan.
O is d

See Figure IV.2 for an example process flow diagram.

71
Th
O is d
E- rde oc
Chapter IV

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

72
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
wa Ind 0

Figure IV.2 Example Process Flow Diagram

te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Process Failure Mode and Effects Analysis

gl
y.
Chapter IV Process Failure Mode and Effects Analysis

Other Tools and Information Sources

Other sources of information that are useful in providing the
team with ways to focus and capture discussions on the
requirements of the process include:
• DFMEA
• Drawings and design records

in p
rd u
y.
• Bill of Process

co Gro
gl
• Interrelationship (Characteristic) matrix

d ion
• Internal and external (customer) nonconformances (i.e., known
failure modes based on historical data)

ke ct
C

ac
ar y A
•

LL
Quality and Reliability History

rm tr
ch

wa Ind 0
te us
en ive 01
os
Research Information

be t /2
tB

s mo 14 After establishing the scope of the analysis effort, the team

should begin by reviewing historical information. The areas to

ha to 7/
review should include:
ob

d Au n:

•
:R

Lessons that have been learned from previous product and

an e io

process design implementation, and

d th at
to

•
te by xpir

Any information available that establishes best practices

rig t is Lic 11 d
py en te 18 se

including items such as guidelines and standards, standard part

ot ed E

identification, or error-proofing methods.

co m Si 3 en

pr n se

Quality performance information available from similar,

is ocu ent er: 4 s lic

ht o en

previous product and process designs, including items such as:

process yield 7 , first time capability (both end of line and at each
i
an is d cum mb ent

operation), Parts per Million (PPM), process capability indices

w
ec

(Cpk and Ppk), and warranty metrics.

Th Do r Nu um

The information can be useful input for determination of

E- rde oc

severity, occurrence and detection rankings.

O is d

After considering these prerequisites, start filling out the form

(Table IV.1 below).
Th

7
First Time Quality (FTQ); First Time Through (FTT)

73
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Th Do Br Nu um
c e
Model Year(s)/Program(s)_________________________________
an is d Dum mb nt E Key Date __________________________________________________ FMEA Date (Orig.) F
Core Team
d G i
Process Current Process Action Results
is ocu ent er: 4 s lic
Step
m Potential e Recommended
Responsibility
Requirement
co Potential n of Actions Taken
e Si 3 Potential
pFailure RPN Action & Target
tofe 1Cause(s)
RPN

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

yr nEffect(s)
ig is ic 1 d t L
Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner
ht o en
spray head not depth stop to by 0X 10 15 sprayer checked
o:
for film thickness
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
pr wn se
door panel thickness Visual check
Ro
Corroded interior for coverage.
lower door panels
ot ed E
Automate Mfg Engineering Rejected due to
x be
spraying by 0X 12 15 complexity of
ec b
te y p Deteriorated life of
rt different doors on
door leading to:
i r the same line
• Unsatisfactory
appearanc e due to
d th at Bo
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35

74
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Example PFMEA Form

The form used in the examples in this reference manual is a
guide to document the team’s discussions and analysis of the
PFMEA elements. It contains the minimum content that is
normally expected by the OEMs.
Column order can be modified and columns can be added to this
form depending on the organization and customer needs and

in p
rd u
y.
expectations. In any case, any form submitted must be

co Gro
gl
acceptable to the customer.

d ion
Header of the Process FMEA Form (fields A-H)

ke ct
C

ac
The following describes the information to be entered on the

ar y A
LL
form.

rm tr
ch
The PFMEA header should clearly identify the focus of the

wa Ind 0
te us
en ive 01
PFMEA as well as information related to the document
os
development and control process. This should include an FMEA
be t /2
tB

s mo 14 number, identification of the scope, design responsibility,

completion dates, etc. The header should contain the following

ha to 7/

elements 8 :
ob

d Au n:
:R

an e io

FMEA Number (A)

d th at
to

te by xpir

Enter an alphanumeric string which is used to identify the

rig t is Lic 11 d
py en te 18 se

PFMEA document. This is used for document control.

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

Item (B)
ht o en

Enter the name and number of the system, subsystem or

i
an is d cum mb ent

component for which the process is being analyzed.

w
ec
Th Do r Nu um

Process Responsibility (C)

E- rde oc

Enter the OEM, organization, and department or group who is

O is d

process design responsible. Also enter the supply organization

name, if applicable.
Th

Model Year(s)/Program(s) (D)

Enter the intended model year(s) and program(s) that will use or
d

be affected by the process being analyzed (if known).

8
The letters at the end of each heading indicate the area referred to on the sample form.

75
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

76
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Key Date (E)

Enter the initial PFMEA due date, which should not exceed the
scheduled start of production date. In case of a supply
organization, this date should not exceed the customer required
Production Part Approval Process (PPAP) submission date.

in p
rd u
y.
FMEA Date (Original) (F)

co Gro
gl
Enter the date the original PFMEA was completed and the latest

d ion
revision date.

ke ct
C

ac
ar y A
Core Team (G)

rm tr
Enter the team members responsible for developing the PFMEA.
ch

wa Ind 0
te us
Contact information (e.g., name, organization, telephone

en ive 01
os
number, and email) may be included in a referenced

be t /2
tB

s mo 14 supplemental document.
er

Prepared By (H)
ha to 7/
ob

d Au n:

Enter the name and contact information including the

organization (company) of the engineer/team leader responsible

an e io
d th at

for preparing the PFMEA.

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E

Body of the PFMEA Form (fields a – n)

co m Si 3 en

pr n se
is ocu ent er: 4 s lic

The body of the PFMEA contains the analysis of risks related to

ht o en

the potential failures and improvement action being taken. 9

i
an is d cum mb ent

w
ec

Process Step / Process Function /

Th Do r Nu um

Requirements (a)
E- rde oc

Process Step/Function can be separated into two (or more)

O is d

columns or combined into a single, bridged column which

encompasses these elements. Process Steps may be listed in the
Th

Process Step/Function column or additional column(s) may be

added containing the functions or requirements of that process
step. “Process Step”, “Function”, and “Requirements” are
described below:
d

9
The letters at the end of each heading indicate the area referred to on the sample form.

77
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

78
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Process Step (a1)

Enter the identification of the process step or operation being
analyzed, based on the numbering process and terminology. For
example, enter the number and identifier (e.g., name). Process
numbering scheme, sequencing, and terminology used should be
consistent with those used in the process flow diagram to ensure
traceability and relationships to other documents (Control Plans,

in p
operator instructions, etc). Repair and rework operations should

rd u
y.
also be included.

co Gro
gl
d ion
Process Function (a1)

ke ct
List the process function that corresponds to each process step or

ac
ar y A
operation being analyzed. The process function describes the

LL
purpose or intent of the operation. A risk analysis is

rm tr
ch
recommended in order to limit the number of steps to be

wa Ind 0
te us
en ive 01
included to only those that add value or otherwise are seen as
os
likely to have a negative impact on the product. If there are

be t /2
tB

multiple process functions being analyzed with respect to a given

s mo 14
er

operation, each should be aligned on the form with its respective

ha to 7/
ob

“Requirements” to aid in the development of the associated

d Au n:

failure modes.
:R

an e io
d th at
to

te by xpir

Process Function becomes a2 if Process Step and Process

rig t is Lic 11 d

Function are split.

py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

Requirements (a2)
ht o en

List the requirements for each process function of the process

i
an is d cum mb ent

step or operation being analyzed. Requirements are the inputs to

w
ec

the process specified to meet design intent and other customer

Th Do r Nu um

requirements. If there are multiple requirements with respect to a

given function, each should be aligned on the form with the
E- rde oc

respective associated failure modes in order to facilitate the

O is d

analysis.
Th

Requirements become a3 if Process Step and Process Function

are split into separate columns, e.g., a1 and a2.
d

79
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

80
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Potential Failure Mode (b)

Potential failure mode is defined as the manner in which the
process could potentially fail to meet the process requirements
(including the design intent).
In preparing the FMEA, assume that the incoming
part(s)/material(s) are correct. Exceptions can be made by the
FMEA team where historical data indicate deficiencies in

in p
rd u
y.
incoming part quality. The team should also assume that the

co Gro
gl
basic design of the product is correct; however, if there are
design issues which result in process concerns, those issues

d ion
should be communicated to the design team for resolution.
List the potential failure mode(s) for the particular operation in

ke ct
C

ac
terms of the process requirement(s) (e.g., as documented in the

ar y A
LL
process flow diagram.) Assume that the failure could occur but

rm tr
may not necessarily occur. Potential failure modes should be
ch

wa Ind 0
te us
en ive 01
described in technical terms, not as a symptom noticeable by the
os
customer. See the example table below.

be t /2
tB

s mo 14
er

Process
ha to 7/
Requirement Potential Failure Mode
ob

Step/Function
d Au n:
:R

Operation 20: Four screws Fewer than four screws

an e io
d th at
to

Specified screws Wrong screw used (larger dia)

Attach seat cushion
te by xpir
rig t is Lic 11 d

Assembly sequence: First Screw placed in any other hole

to track using a
py en te 18 se

screw in right front hole

torque gun
ot ed E
co m Si 3 en

Screws fully seated Screw not fully seated

pr n se
is ocu ent er: 4 s lic

ht o en

Screws torqued to dynamic Screw torqued too high

torque specification
i

Screw torqued too low

an is d cum mb ent

w
ec
Th Do r Nu um

Table IV.2 Example of Process Step/Function/Requirements Columns on PFMEA Form

E- rde oc

including Potential Failure Modes

O is d

If the requirements have been well defined, then the potential

failure mode is readily identifiable by determining the condition

when a specific requirement is not met. Each requirement may
have multiple failure modes. A large number of failure modes
identified for a single requirement usually indicates that the
d

requirement is not well defined.

The assumption is made that the failure could occur but may not
necessarily occur – consequently the use of the word “potential”.
Verification of completeness of the potential failure modes can
be made through a review of past things-gone-wrong, concerns,

81
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Th DoB r Nu um
c e
Model Year(s)/Program(s)_________________________________
an is d Dum mb nt E Key Date __________________________________________________ FMEA Date (Orig.) F
Core Team
d G i
Process Current Process Action Results
is ocu ent er: 4 s lic
Step Responsibility
Requirement
coPotentialm Potential e Recommended
Failure of n Actions Taken
e Si 3 Potential
Controls Controls RPN Action & Target
te 1Cause(s) ofs
RPN

Severity
Mode
nFailure
py Effect(s) Failure
8 Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

rig is ic 1 ed L
Op 70: Cover inner door, Insufficient wax Allows integrity 7 None 5 280 7 2 5 70
to Manually inserted 8 Variables check Add positive Mfg Engineering Stop added,
Manual lower surfaces coverage over breach of inner
ht o en
spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to
w
specified surface door panel
:R
inserted far sprayer online
wax inside specification enough
pr n se
door panel thickness Visual check
Corroded interior for coverage.
ob
lower door panels
ot ed E
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
ec er
Deteriorated life of different doors on
door leading to: the same line
te by xpir tB
• Unsatisfactory
appearanc e due to
d th at
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
os

82
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
ch
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

lgly
.
Chapter IV Process Failure Mode and Effects Analysis

reject or scrap reports, and group brainstorming. Sources for this

should also include a comparison of similar processes and a
review of customer (End User and subsequent operation) claims
relating to similar components.

Potential Effect(s) of Failure (c)

Potential effects of failure are defined as the effects of the failure
mode as perceived by the customer(s).

in p
rd u
y.
The effects of the failure should be described in terms of what

co Gro
gl
the customer might notice or experience, remembering that the
customer may be an internal customer as well as the ultimate

d ion
End User. The customer(s) in this context could be the next
operation, subsequent operations or locations, the dealer, and/or

ke ct
C

ac
the vehicle owner. Each must be considered when assessing the

ar y A
LL
potential effect of a failure. The product effects in the PFMEA

rm tr
should be consistent with those in the corresponding DFMEA.
ch

wa Ind 0
te us
en ive 01
os
If the failure mode could impact safety or cause noncompliance

be t /2
to regulations, this should be clearly identified in the PFMEA.
tB

s mo 14
For the End User, the effects should be stated in terms of product
er

ha to 7/
or system performance. If the customer is the next operation or
ob

subsequent operation(s) / location(s), the effects should be stated

d Au n:
:R

in terms of process / operation performance. See Table IV.3

an e io

Example of Effects.
d th at
to

te by xpir

In order to determine the Potential Effect(s), the following

rig t is Lic 11 d
py en te 18 se

questions should be asked:

ot ed E
co m Si 3 en

1. Does the Potential Failure Mode physically prevent

pr n se
is ocu ent er: 4 s lic

downstream processing or cause potential harm to

ht o en

equipment or operators?
i

This includes an inability to assemble or join to a mating

an is d cum mb ent

w
ec

component at any subsequent customer’s facility. If so, then

Th Do r Nu um

assess the manufacturing impact. No further analysis is required.

If not, then go to question 2. Examples could include:
E- rde oc

• Unable to assemble at operation x

O is d

• Unable to attach at customer facility

• Unable to connect at customer facility

• Cannot bore at operation x
• Causes excessive tool wear at operation x
d

• Damages equipment at operation x

• Endangers operator at customer facility

83
Chapter IV Process Failure Mode and Effects Analysis

Note: The location, station or operation at which the effect occurs

should be identified. If at a customer’s facility, this should be
stated.

2. What is the potential impact on the End User?

Independent of any controls planned or implemented including
error or mistake-proofing, consider what the End User would
notice or experience. This information may be available within

in p
the DFMEA. Once determined, go to question 3. Examples

rd u
y.
could include:

co Gro
gl
• Noise

d ion
• High effort

ke ct
C
•

ac
Unpleasant odor

ar y A
LL
• Intermittent operation

rm tr
ch

wa Ind 0
•

te us
Water leak

en ive 01
os
• Rough idle
be t /2
tB

•
s mo 14
Unable to adjust
er

ha to 7/

•
ob

Difficult to control
d Au n:
:R

• Poor appearance
an e io
d th at
to

te by xpir
rig t is Lic 11 d

3. What would happen if an effect was detected prior to

py en te 18 se

reaching the End User?

ot ed E
co m Si 3 en

pr n se

The potential effect at the current or receiving locations also

is ocu ent er: 4 s lic

needs to be considered. Examples could include:

ht o en

•
i

Line shutdown
an is d cum mb ent

w
ec

• Stop shipment
Th Do r Nu um

• Yard hold
E- rde oc

• 100% of product scrapped

O is d

• Decreased line speed

• Added manpower to maintain required line rate

Note: If more than one potential effect is identified when

considering questions 2 and 3, all may be listed, but for purposes

of the analysis, only consider the worst case when documenting
the resulting Severity ranking.

84
Chapter IV Process Failure Mode and Effects Analysis

Example of Effects

Requirement Failure Mode Effect

Four screws Fewer than four screws EndUuser: Loose seat
cushion and noise.
Manufacturing and
Assembly: Stop shipment

in p
and additional sort and

rd u
y.
co Gro
gl
rework due to affected
portion.
Specified screws Wrong screw used Manufacturing and

d ion
(larger dia.) Assembly: Unable to

ke ct
C
install screw in station.

ac
ar y A
LL
Assembly sequence: Screw placed in any other Manufacturing and

rm tr
First screw in right hole Assembly: Difficult to
ch

wa Ind 0
te us
front hole install remaining screws

en ive 01
os
in station.

be t /2
tB

Screws fully seated Screw not fully seated

s mo 14 End User: Loose seat
er

cushion and noise.

ha to 7/
ob

Manufacturing and
d Au n:

Assembly: Sort and

an e io

rework due to affected

d th at
to

portion.
te by xpir

Screws torqued to Screw torqued too high End User: Loose seat
rig t is Lic 11 d
py en te 18 se

dynamic torque cushion due to subsequent

ot ed E

specification fracture of screw and

co m Si 3 en

pr n se

noise.
is ocu ent er: 4 s lic

Manufacturing and
ht o en

Assembly: Sort and

rework due to affected

an is d cum mb ent

w
ec

portion.
Th Do r Nu um

Screw torqued too low End User: Loose seat

cushion due to gradual
E- rde oc

loosening of screw and

O is d

noise.
Manufacturing and
Th

Assembly: Sort and

rework due to affected
portion.
d

Table IV.3 Example of Effects

85
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

86
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Severity (S) (d)

in p
system and apply them consistently, even if modified for

rd u
y.
individual process analysis (See Table Cr1 for criteria

co Gro
gl
guidelines).

d ion
It is not recommended to modify criteria for ranking values 9 and

ke ct
C

ac
10. Failure modes with a rank of 1 should not be analyzed

ar y A
LL
further.

rm tr
ch

wa Ind 0
te us
en ive 01
os

be t /2
tB

s mo 14
er

ha to 7/
ob

d Au n:
:R

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

87
Th
O is d
E- rde oc Criteria: Criteria: Rank
Effect Effect Severity of Effect on Process
D r u
Chapter IV

(Customer Effect) (Manufacturing/Assembly Effect)

Th o Nu mSeverity of Effect on Product
c
Potential failure mode affects safe vehicle operation and/or 10 May endanger operator (machine or assembly) without
an is d um mb ent
involves noncompliance with government regulation without warning.
d i Failure to Meet Failure to Meet
warning.
Safety and/or Safety and/or
Regulatory Regulatory
is ocu ent er: 4 s lic
Requirements Potential failure mode affects safe vehicle operation and/or 9 Requirements May endanger operator (machine or assembly) with
involves noncompliance with government regulation with warning.
co m Si 3 en
warning.
py en te 18 se
Loss of primary function (vehicle inoperable, does not affect 8 100% of product may have to be scrapped. Line
rig t is Lic 11 d
Major Disruption
Loss or safe vehicle operation). shutdown or stop ship.
to
Degradation of
ht o en
w
Primary Degradation of primary function (vehicle operable, but at 7 A portion of the production run may have to be
:R
Significant
pr n se
Function reduced level of performance). scrapped. Deviation from primary process including
Disruption
decreased line speed or added manpower.
ot ed E ob
ec er
Loss of secondary function (vehicle operable, but comfort / 6 100% of production run may have to be reworked off
convenience functions inoperable). line and accepted.
te by xpir
Loss or
tB
Moderate
Degradation of Disruption
d th at
Secondary Degradation of secondary function (vehicle operable, but 5 A portion of the production run may have to be
os

88
an e io
Function comfort / convenience functions at reduced level of reworked off line and accepted.
ch
performance).
d Au n:
ha to 7/ LL
Appearance or Audible Noise, vehicle operable, item does
C 4 100% of production run may have to be reworked in
not conform and noticed by most customers (> 75%). station before it is processed.
s mo 14
Moderate
be t /2
Appearance or Audible Noise, vehicle operable, item does 3 Disruption A portion of the production run may have to be
not conform and noticed by many customers (50%). reworked in-station before it is processed.
en ive 01
Annoyance wa Ind 0
Appearance or Audible Noise, vehicle operable, item does 2 Slight inconvenience to process, operation, or operator.
not conform and noticed by discriminating customers Minor Disruption
te us
(< 25%).
rm tr
No effect No discernible effect. 1 No effect No discernible effect.
ar y A

Table Cr1 Suggested PFMEA Severity Evaluation Criteria

ke ct
d ion
ac
co Gro
rd u
in p
Process Failure Mode and Effects Analysis

gl
y.
Th
O is d
E- rde oc
Chapter IV

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

89
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
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wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Process Failure Mode and Effects Analysis

gl
y.
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Th DoB r Nu um
c e
Model Year(s)/Program(s)_________________________________
an is d Dum mb nt E Key Date __________________________________________________ FMEA Date (Orig.) F
Core Team
d G i
Process Current Process Action Results
is ocu ent er: 4 s lic
Step Responsibility
Requirement
coPotentialm Potential e Recommended
Failure of n Actions Taken
e Si 3 Potential
Controls Controls RPN Action & Target
te 1Cause(s) ofs
RPN

Severity
Mode
nFailure
py Effect(s) Failure
8 Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

90
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
ch
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

lgly
.
Chapter IV Process Failure Mode and Effects Analysis

Classification (e)

This column may be used to highlight high priority failure modes

or causes that may require additional engineering assessment.
This column may also be used to classify any special product or
process characteristics (e.g., critical, key, major, significant) for
components, subsystems, or systems that may require additional

in p
process controls.

rd u
y.
co Gro
gl
Customer specific requirements may identify special product or

d ion
process characteristic symbols and their usage.

ke ct
C

ac
ar y A
LL
Where a special characteristic is identified with a severity of 9 or

rm tr
ch
10 in the PFMEA, the design responsible engineer should be

wa Ind 0
te us
en ive 01
notified since this may affect the engineering documents.
os

be t /2
tB

s mo 14 Potential Cause(s) of Failure Mode (f)

ha to 7/
ob

Potential cause of failure is defined as an indication of how the

d Au n:

failure could occur, and is described in terms of something that

an e io

can be corrected or can be controlled. Potential cause of failure

d th at
to

may be an indication of a design or process weakness, the

te by xpir

consequence of which is the failure mode.

rig t is Lic 11 d
py en te 18 se

To the extent possible, identify and document every potential

ot ed E
co m Si 3 en

cause for each failure mode. The cause should be detailed as

pr n se
is ocu ent er: 4 s lic

concisely and completely as possible. Separating the causes will

ht o en

result in a focused analysis for each and may yield different

measurement, controls, and action plans. There may be one or
i
an is d cum mb ent

more causes that can result in the failure mode being analyzed.
w
ec

This results in multiple lines for each cause in the table or

Th Do r Nu um

form. 10
E- rde oc

In preparing the PFMEA, the team should assume that the

O is d

incoming part(s)/material(s) are correct. Exceptions can be

made at the team’s discretion where historical data indicate
Th

deficiencies in incoming part quality.

Only specific errors or malfunctions (e.g., seal not installed or
seal installed inverted) should be listed. Ambiguous phrases
(e.g., operator error or seal mis-installed, etc.) should not be
d

used. See Table IV.4 Example of Causes and Controls.

10
In preparing the PFMEA, the team needs to ensure that any limitations of the design that may result in a
potential process failure mode are communicated to the design function.

91
Chapter IV Process Failure Mode and Effects Analysis

Occurrence (O) (g)

Occurrence is the likelihood that a specific cause of failure will
occur. The likelihood of occurrence ranking number has a
relative meaning rather than an absolute value (See Table Cr2).
Estimate the likelihood of occurrence of a potential cause of
failure on a 1 to 10 scale. A consistent occurrence ranking
system should be used to ensure continuity. The occurrence

in p
rd u
y.
ranking number is a relative ranking within the scope of the

co Gro
gl
FMEA and may not reflect the actual likelihood of occurrence.
The “Incident per items/vehicles” is used to indicate the number

d ion
of failures that are anticipated during the process execution. If
statistical data are available from a similar process, the data

ke ct
C

ac
should be used to determine the occurrence ranking. In other

ar y A
LL
cases, a subjective assessment can be made by using the word

rm tr
descriptions in the left hand column of the table, along with input
ch

wa Ind 0
te us
en ive 01
from the appropriate process knowledge source to estimate the
os
ranking.

be t /2
tB

s mo 14
Suggested Evaluation Criteria
er

ha to 7/
The team should agree on evaluation criteria and a ranking
ob

system and apply them consistently, even if modified for

d Au n:
:R

individual process analysis. Occurrence should be estimated

an e io

using a 1 to 10 scale based upon Table Cr2 as a guideline.

d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

92
Chapter IV Process Failure Mode and Effects Analysis

Likelihood Criteria: Occurrence of Cause - PFMEA

Rank
of Failure (Incidents per items/vehicles)

≥ 100 per thousand

Very High 10
≥ 1 in 10

in p
rd u
y.
50 per thousand

co Gro
gl
9
1 in 20

d ion
20 per thousand
High 8

ke ct
1 in 50

ac
ar y A
LL
10 per thousand
7

rm tr
ch

wa Ind 0
1 in 100

te us
en ive 01
os
2 per thousand
be t /2
tB

s mo 14 6
1 in 500
er

ha to 7/
ob

.5 per thousand
d Au n:

Moderate 5
:R

1 in 2,000
an e io
d th at
to

.1 per thousand
te by xpir

4
rig t is Lic 11 d

1 in 10,000
py en te 18 se

ot ed E
co m Si 3 en

.01 per thousand

pr n se

3
is ocu ent er: 4 s lic

1 in 100,000
ht o en

Low
≤.001 per thousand
i
an is d cum mb ent

2
w
ec

1 in 1,000,000
Th Do r Nu um

Very Low Failure is eliminated through preventive control. 1

E- rde oc
O is d

Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria

93
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

94
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Current Process Controls (h)

Current Process Controls are descriptions of the controls that can
either prevent to the extent possible, the cause of failure from
occurring or detect the failure mode or cause of failure should it
occur.
There are two types of Process Controls to consider:

in p
Prevention:

rd u
y.
Eliminate (prevent) the cause of the failure or the failure mode

co Gro
gl
from occurring, or reduce its rate of occurrence.
Detection:

d ion
Identify (detect) the cause of failure or the failure mode, leading

ke ct
C
to the development of associated corrective action(s) or counter-

ac
ar y A
LL
measures.

rm tr
ch

wa Ind 0
te us
en ive 01
os
The preferred approach is to first use prevention controls, if
possible. The initial occurrence rankings will be affected by the

be t /2
tB

s mo 14 prevention controls provided they are integrated as part of the

process. The initial detection rankings will be based on process

ha to 7/
controls that either detect the cause of failure, or detect the
ob

failure mode.
d Au n:
:R

an e io

Because statistical charting methods (i.e., Statistical Process

Control) 11 typically use sampling to assess process stability and
d th at
to

te by xpir

detect out-of-control conditions they should not be considered

rig t is Lic 11 d

when evaluating the effectiveness of specific Detection Controls.

py en te 18 se

SPC may, however, be considered as a Prevention Control for

ot ed E
co m Si 3 en

specific causes whose trends are identifiable in advance of an

pr n se

actual non-conformance being produced, such as tool wear.

is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

The example PFMEA form in this manual has two separate

w
ec

columns for Prevention Controls and Detection Controls to assist

Th Do r Nu um

the team in clearly distinguishing between these two types of

controls. This allows for a quick visual determination that both
E- rde oc

types of process controls have been considered.

O is d

If a one-column (for process controls) form is used, then the

following prefixes should be used. For prevention controls, place

a 'P' before or after each prevention control listed. For detection
controls, place a 'D' before or after each detection control listed
(see Table IV.4 Example of Causes and Controls).
d

11
See Chrysler, Ford, GM; SPC Manual, AIAG.

95
Chapter IV Process Failure Mode and Effects Analysis

Failure Prevention
Requirement Cause Detection Control
Mode Control
Screws torqued Screw not Nut runner not Operator training Angle sensor included in nut
until fully seated fully seated held perpendicular runner to detect cross-threading
to work surface by not allowing part to be removed
operator from fixture until value is
satisfied

in p
rd u
y.
Screws torqued Screw Torque setting set Password Torque validation box included

co Gro
gl
to dynamic torqued too too high by non- protected control in set-up procedure to validate
torque high set-up personnel panel (only set-up setting prior to running
specification personnel have

d ion
access)
Torque setting set Training of set-up Torque validation box included

ke ct
C

ac
too high by set-up personnel in set-up procedure to validate

ar y A
LL
personnel setting prior to running

rm tr
Settings added to
ch

wa Ind 0
te us
set-up instructions

en ive 01
os
Screw Torque setting set Password Torque validation box included

be t /2
tB

torqued too
s mo 14 too low by non- protected control in set-up procedure to validate
low set-up personnel panel (only set-up setting prior to running
er

ha to 7/
personnel have
ob

access)
d Au n:
:R

an e io

Torque setting set Training of set-up Torque validation box included

too low by set-up personnel in set-up procedure to validate
d th at
to

personnel setting prior to running

te by xpir
rig t is Lic 11 d

Settings added to
py en te 18 se

set-up instructions
ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en

Table IV.4 Examples of Causes and Controls

i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

96
Th
O is d
E- rde oc
Chapter IV

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os

97
an e io ch
d Au n:
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
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wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Process Failure Mode and Effects Analysis

Th DoB r Nu um
c e
Model Year(s)/Program(s)_________________________________
an is d Dum mb nt E Key Date __________________________________________________ FMEA Date (Orig.) F
Core Team
d G i
Process Current Process Action Results
is ocu ent er: 4 s lic
Step Responsibility
Requirement
coPotentialm Potential e Recommended
Failure of n Actions Taken
e Si 3 Potential
Controls Controls RPN Action & Target
te 1Cause(s) ofs
RPN

Severity
Mode
nFailure
py Effect(s) Failure
8 Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

98
over time.
an e io
clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
ch
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

lgly
.
Chapter IV Process Failure Mode and Effects Analysis

Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Detection Controls column. Detection is a relative
ranking within the scope of the individual FMEA. In order to
achieve a lower ranking, generally the planned detection control
has to be improved.
When more than one control is identified, it is recommended that

in p
rd u
y.
the detection ranking of each control be included as part of the

co Gro
gl
description of the control. Record the lowest ranking value in the
Detection column.

d ion
Assume the failure has occurred and then assess the capabilities
of all "Current Process Controls" to prevent shipment of the part

ke ct
C

ac
having this failure mode. Do not automatically presume that the

ar y A
LL
detection ranking is low because the occurrence is low, but do

rm tr
assess the ability of the process controls to detect low frequency
ch

wa Ind 0
te us
en ive 01
failure modes or prevent them from going further in the process.
os

be t /2
tB

s mo 14
Random quality checks are unlikely to detect the existence of an
er

ha to 7/
isolated problem and should not influence the detection ranking.
ob

d Au n:
:R

an e io

Suggested Evaluation Criteria

d th at
to

te by xpir

The team should agree on evaluation criteria and a ranking

rig t is Lic 11 d
py en te 18 se

system and apply them consistently, even if modified for

ot ed E

individual product analysis. Detection should be estimated using

co m Si 3 en

pr n se

Table Cr3 as a guideline.

is ocu ent er: 4 s lic

ht o en
i

The ranking value of one (1) is reserved for failure prevention

an is d cum mb ent

through proven process design solutions.

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

99
Chapter IV Process Failure Mode and Effects Analysis

Opportunity for Criteria: Likelihood

Rank
Detection Likelihood of Detection by Process Control of Detection

No detection No current process control; Cannot detect or is not Almost

opportunity analyzed.
10
Impossible

in p
Not likely to detect Failure Mode and/or Error (Cause) is not easily detected

rd u
y.
9 Very Remote

co Gro
at any stage (e.g., random audits).

gl
Problem Detection Failure Mode detection post-processing by

d ion
Post Processing operator through visual/tactile/audible means.
8 Remote

ke ct
C

ac
ar y A
LL
Failure Mode detection in-station by operator through
Problem Detection visual/tactile/audible means or post-processing through

rm tr
7 Very Low
ch

wa Ind 0
at Source use of attribute gauging (go/no-go, manual torque

te us
en ive 01
os
check/clicker wrench, etc.).

be t /2
tB

s mo 14
Failure Mode detection post-processing by operator
er

ha to 7/
Problem Detection through use of variable gauging or in-station by operator
ob

Post Processing through use of attribute gauging (go/no-go, manual

6 Low
d Au n:
:R

torque check/clicker wrench, etc).

an e io
d th at
to

Failure Mode or Error (Cause) detection in-station by

te by xpir
rig t is Lic 11 d

operator through use of variable gauging or by

py en te 18 se

Problem Detection automated controls in-station that will detect discrepant

ot ed E

5 Moderate
co m Si 3 en

at Source part and notify operator (light, buzzer, etc.). Gauging

pr n se
is ocu ent er: 4 s lic

performed on setup and first-piece check (for set-up

ht o en

causes only).
i
an is d cum mb ent

Failure Mode detection post-processing by automated

w
ec

Problem Detection Moderately

controls that will detect discrepant part and lock part to 4
Th Do r Nu um

Post Processing High

prevent further processing.
E- rde oc

Failure Mode detection in-station by automated controls

Problem Detection
O is d

at Source
that will detect discrepant part and automatically lock 3 High
part in station to prevent further processing.
Th

Error Detection Error (Cause) detection in-station by automated controls

and/or Problem that will detect error and prevent discrepant part from 2 Very High
Prevention being made.
Error (Cause) prevention as a result of fixture design,
d

Detection not
machine design or part design. Discrepant parts cannot be Almost
applicable; Error
made because item has been error-proofed by
1
Prevention Certain
process/product design.

Table Cr3 Suggested Process FMEA Detection Evaluation Criteria

100
Th
O is d
E- rde oc
Chapter IV

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

101
d Au n: ch
ha to 7/ LL
s mo 14
be t /2 C
en ive 01
This page intentionally left blank

wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
Process Failure Mode and Effects Analysis

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

102
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Determining Action Priorities

Once the team has completed the initial identification of failure
modes and effects, causes and controls, including rankings for
severity, occurrence and detection, they must decide if further
efforts are needed to reduce the risk. Due to the inherent
limitations on resources, time, technology, and other factors,
they must choose how to best prioritize these efforts.
The initial focus of the team should be oriented towards failure

in p
modes with the highest severity rankings. When the severity is 9

rd u
y.
or 10, it is imperative that the team ensure that the risk is

co Gro
gl
addressed through existing design controls or recommended
actions (as documented in the FMEA).

d ion
For failure modes with severities of 8 or below the team should

ke ct
C
consider causes having the highest occurrence or detection

ac
ar y A
LL
rankings. It is the team’s responsibility to look at the
information, decide upon an approach, and determine how to

rm tr
ch

wa Ind 0
best prioritize their risk reduction efforts which best serve their

te us
en ive 01
os
organization and customers.

be t /2
tB

s mo 14
Risk Evaluation;
er

ha to 7/
ob

Risk Priority Number (RPN) (j)

d Au n:
:R

One approach to assist in action prioritization has been to use the

an e io

Risk Priority Number:

d th at
to

te by xpir
rig t is Lic 11 d

RPN = Severity (S) x Occurrence (O) x Detection (D)

py en te 18 se

Within the scope of the individual FMEA, this value can range
ot ed E
co m Si 3 en

between 1 and 1000.

pr n se
is ocu ent er: 4 s lic

The use of an RPN threshold is NOT a recommended practice

ht o en

for determining the need for actions.

i
an is d cum mb ent

Applying thresholds assumes that RPNs are a measure of relative

w
ec

risk (which they often are not) and that continuous improvement
Th Do r Nu um

is not required (which it is).

E- rde oc

For example, if the customer applied an arbitrary threshold of

O is d

100 to the following, the supplier would be required to take

action on the characteristic B with the RPN of 112.
Th

Item Severity Occurrence Detection RPN

A 9 2 5 90
B 7 4 4 112
d

In this example, the RPN is higher for characteristic B than

characteristic A. However, the priority should be to work on A
with the higher severity of 9, although its RPN is 90 which is
lower and below the threshold.

103
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

104
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Another concern with using the threshold approach is that there

is no specific RPN value that requires mandatory action.
Unfortunately, establishing such thresholds may promote the
wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce
the RPN. This type of behavior avoids addressing the real
problem that underlies the cause of the failure mode and merely
keeps the RPN below the threshold. It is important to recognize
that while determining “acceptable” risk at a particular program

in p
milestone (e.g., vehicle launch) is desirable, it should be based

rd u
y.
co Gro
on an analysis of severity, occurrence and detection and not

gl
through the application of RPN thresholds.

d ion
Use of the RPN index in the discussions of the team can be a

ke ct
C
useful tool. The limitations of the use of RPN need to be

ac
ar y A
LL
understood. However, the use of RPN thresholds to determine
action priority is not recommended.

rm tr
ch

wa Ind 0
te us
en ive 01
os
Recommended Action(s) (k)
be t /2
tB

s mo 14
In general, prevention actions (i.e., reducing the occurrence) are
er

preferable to detection actions. An example of this is the use of

ha to 7/
ob

process design error proofing rather than random quality checks

d Au n:
:R

or associated inspection.
an e io

The intent of any recommended action is to reduce rankings in

d th at
to

the following order: severity, occurrence, and detection.

te by xpir
rig t is Lic 11 d

Example approaches to reduce these are explained below:

py en te 18 se

ot ed E

•
co m Si 3 en

To Reduce Severity (S) Ranking: Only a design or process

pr n se

revision can bring about a reduction in the severity ranking.

is ocu ent er: 4 s lic

ht o en
i

A product/process design change, in and of itself, does not imply

an is d cum mb ent

that the severity will be reduced. Any product/process design

w
ec

change should be reviewed by the team to determine the effect

Th Do r Nu um

on the product functionality and process.

E- rde oc

For maximum effectiveness and efficiency of this approach,

changes to the product and process design should be
O is d

implemented early in the development process. For example,

process technology needs to be considered very early in the
Th

process development if severity is to be reduced.

• To Reduce Occurrence (O) Ranking: To reduce occurrence,

process and design revisions may be required. A reduction in

the occurrence ranking can be effected by removing or
controlling one or more of the causes of the failure mode
through a product or process design revision.
Studies to understand the sources of variation of the process
using statistical methods may be implemented. These studies

105
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

106
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

may result in actions that reduce occurrence. Further, the

knowledge gained may assist in the identification of suitable
controls including ongoing feedback of information to the
appropriate operations for continuous improvement and problem
prevention.
• To Reduce Detection (D) Ranking: The preferred method is
the use of error/mistake proofing. A redesign of the
detection methodology may result in a reduction of the
detection ranking. In some cases, a design change to a

in p
process step may be required to increase the likelihood of

rd u
y.
co Gro
gl
detection (i.e., reduce the detection ranking.) Generally,
improving detection controls requires the knowledge and
understanding of the dominant causes of process variation

d ion
and any special causes. Increasing the frequency of

ke ct
inspection is usually not an effective action and should only

ac
ar y A
LL
be used as a temporary measure to collect additional
information on the process so that permanent

rm tr
ch
preventive/corrective action can be implemented 12 .

wa Ind 0
te us
en ive 01
os
If the assessment leads to no recommended actions for a specific

be t /2
tB

s mo 14 failure mode/cause/control combination, indicate this by entering

“None” in this column. It may be useful to also include a
er

ha to 7/
rationale if “None” is entered, especially in case of high severity.
ob

d Au n:

For process actions, the evaluation may include but is not limited
:R

an e io

to a review of:
d th at
to

• Results of process DOE or other testing when applicable

te by xpir
rig t is Lic 11 d
py en te 18 se

• Modified process flow diagram, floor plan, work instructions

ot ed E
co m Si 3 en

or preventive maintenance plan

pr n se

•
is ocu ent er: 4 s lic

Review of equipment, fixtures or machinery specifications

ht o en

• New or modified sensing/detection device

i
an is d cum mb ent

w
ec
Th Do r Nu um

Table IV.5 below provides an example of the application of

causes (Column f), controls (Column h) and recommended
E- rde oc

actions (Column k).

O is d

Responsibility & Target Completion Date (l)

Enter the name of the individual and organization responsible for

completing each recommended action including the target
completion date. The process-responsible engineer/team leader is
d

responsible for ensuring that all actions recommended have been

implemented or adequately addressed.

12
See Chrysler, Ford, GM; SPC Manual, AIAG.

107
Th
POTENTIAL
FMEA Number A
O is d
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
E- rde oc
Item: _________________________________________________ C Process Responsibility ______________________________________ Prepared By: H
Chapter IV

Severity
Mode Failure
8Failure Prevention Detection Completion Date Completion Date
Severity

se Controls Controls
Function
Detection

Detection

Classification
t

Occurrence
1
Occurrence

108
sc
• Impaired function h - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative viscosity vs. limit controls have
d Au n:
Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
ha to 7/ LL
C clean heads show process is in
control Cpk=1.85
s mo 14
be t /2
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
en ive 01
maintain heads Visual check
for coverage.
wa Ind 0
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
te us
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
rm tr
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
ar y A
critical areas show process is in
control – Cpk=2.05
ke ct
SAMPLE d ion
ac
Excessive wax
coverage over
specified surface
co Gro
rd u
in p
a1 a2 b c de f h g h i j k m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

gl l
y.
Chapter IV Process Failure Mode and Effects Analysis

Action Results (m-n)

This section identifies the results of any completed actions and
their effect on S, O, D rankings and RPN.

Action(s) Taken and Completion Date (m)

After the action has been implemented, enter a brief description
of the action taken and actual completion date.

in p
rd u
y.
co Gro
Severity, Occurrence, Detection and RPN (n)

gl
After the preventive/corrective action has been completed,

d ion
determine and record the resulting severity, occurrence, and
detection rankings.

ke ct
C

ac
ar y A
LL
Calculate and record the resulting action (risk) priority indicator
(e.g., RPN).

rm tr
ch

wa Ind 0
te us
All revised rankings should be reviewed. Actions alone do not

en ive 01
os
guarantee that the problem was solved (i.e., cause addressed),

be t /2
tB

thus an appropriate analysis or test should be completed as

s mo 14
verification. If further action is considered necessary, repeat the
er

ha to 7/
analysis. The focus should always be on continuous
ob

improvement.
d Au n:
:R

an e io
d th at
to

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

109
Chapter IV Process Failure Mode and Effects Analysis

Process Failure Prevention Detection Recommended

Step/Function Requirement Cause
Mode Controls Controls Actions
Op. 20 (attach Four screws Fewer than Too few Visual aids Visual In-station torque
seat cushion to four screws screws illustrating Inspection monitoring;
track using a inadvertently correct in station Line lockout if
torque gun) installed quantity fewer than four
Select four
Operator
screws
training

Specified Wrong Similar Visual aids Visual In-station torque

in p
screws screw used screws illustrating inspection angle monitoring;

rd u
y.
co Gro
(larger dia.) available at correct in station Line lockout if

gl
station screw angle not met
Operator

d ion
training Error proof by
design: use one

ke ct
type screw for

ac
ar y A
station/product

LL
Op. 20 (attach Assembly Screw More than Visual aids Visual Add position
seat cushion to sequence: placed in one hole identifying inspection sensor to nut

rm tr
ch

wa Ind 0
te us
track using a First screw any other available to location of in station runner not

en ive 01
os
torque gun) in right front hole operator first screw allowing tool to
Beginning with hole operate unless

be t /2
tB

right front hole, s mo 14 Operator runner is aligned

torque each screw training with correct hole
er

ha to 7/
to the required
ob

torque
d Au n:
:R

an e io
d th at
to

Table IV.5 Examples of Causes, Controls and Actions

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se

Maintaining PFMEAs
is ocu ent er: 4 s lic

ht o en

The PFMEA is a living document and should be reviewed

i
an is d cum mb ent

whenever there is a product or process design change and

w
ec

updated, as required.
Th Do r Nu um

Another element of on-going maintenance of PFMEAs should

E- rde oc

include a periodic review. Specific focus should be given to

O is d

Occurrence and Detection rankings. This is particularly

important where there have been product or process changes or
Th

improvements in process controls. Additionally, in cases where

either field issues or production issues, such as disruptions, have
occurred, the rankings should be revised accordingly.
d

Leveraging PFMEAs
The use of a fundamentally sound PFMEA is the starting point
that provides the greatest opportunity to leverage the use of past
experience and knowledge.

110
Chapter IV Process Failure Mode and Effects Analysis

If a new project or application is functionally similar to the

existing product and the process to be used is similar, a single
PFMEA may be used with customer concurrence. If there are
differences, the team should identify and focus on the effects of
these differences.

Linkages
The PFMEA is not a “stand-alone” document. Figure IV.5 shows

in p
rd u
y.
some common linkages.

co Gro
gl
d ion
DFMEA, Process Flow
Diagram, etc.

ke ct
C

ac
ar y A
LL

rm tr
ch

wa Ind 0
PFMEA

te us
en ive 01
os

be t /2
tB

s mo 14
er

ha to 7/
ob

Process Control Plans

d Au n:
:R

an e io
d th at
to

Figure IV.5 PFMEA Information Interrelationship Flow

te by xpir
rig t is Lic 11 d
py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

To DFMEA
ht o en

In the development of a PFMEA it is important to utilize the

i
an is d cum mb ent

information and knowledge gained in the creation of the

w
ec

DFMEA. However, the link between the two documents is not

Th Do r Nu um

always obvious. The difficulty occurs because the focus of each

FMEA is different. The DFMEA focuses on part function
E- rde oc

whereas the PFMEA focuses on the manufacturing steps or

O is d

process. Information in the columns of each form is not directly

aligned. For example, Item/Function-Design does not equal
Th

Process Functions/Requirements; potential design failure mode

does not equal potential process failure mode; potential design
cause of failure does not equal potential process cause of failure.
However, by comparing the overall analysis of design and
d

process, a connection can be made. One such connection is

between the characteristics identified during the DFMEA and
PFMEA analysis.
Another connection is the relationship between potential design
cause of failure (DFMEA) and potential process failure mode
(PFMEA). For example, the design of a feature such as a hole
can cause a particular failure mode. The corresponding process

111
Chapter IV Process Failure Mode and Effects Analysis

failure mode is the inability of the process to manufacture the

same feature as designed. In this example, the potential design
cause of failure (hole diameter designed too large) would appear
to be similar to the potential process failure mode (hole drilled
too large). The potential effect of the failure mode for both
design and process may be identical if there were no additional
process related effects. In other words, the end result (effect) of
the failure mode is the same, but there are two distinct causes.
While developing the PFMEA, it is the team’s responsibility to

in p
ensure that all process related potential failure modes which lead

rd u
y.
co Gro
to product related effects are consistent between the DFMEA

gl
and the PFMEA.

d ion
To Control Plan

ke ct
C
In addition to the list of Recommended Actions and their

ac
ar y A
LL
subsequent follow-up as a result of the PFMEA activity, a
Control Plan should be developed 13 . Some organizations may

rm tr
ch

wa Ind 0
elect not to specifically identify the related product and process

te us
en ive 01
os
characteristics” in the PFMEA. In this situation, the “Product

be t /2
Characteristics” portion of the Control Plan may be derived from
tB

s mo 14 the “Requirements” portion of the “Process

Function/Requirements” column and the “Process

ha to 7/
ob

Characteristics” portion may be derived from the “Potential

d Au n:
:R

Cause(s) of Failure Mode” column.

an e io
d th at

When the team develops the Control Plan, they need to assure
to

that the PFMEA current controls are consistent with the control
te by xpir
rig t is Lic 11 d

methods specified in the Control Plan.

py en te 18 se

ot ed E
co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

13
Guidelines for Control Plan development are included in Chrysler, Ford, GM; Advanced Product Quality
Planning and Control Plan (APQP), AIAG.

112
Th
O is d
E- rde oc
Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

113
d Au n: ch
ha to 7/ LL
s mo 14
be t /2 C

APPENDICES
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
in p
gl
y.
Appendix A Sample Forms

Appendix A: Sample Forms

DFMEA Forms
• Form A: Basic form (with minimal information) 14
o With Prevention and Detection Controls as separate
columns 15

in p
• Form B: Form with Item/Function and Requirements in

rd u
y.
co Gro
separate columns

gl
o To assist in the determination of failure modes

d ion
• Form C: Form A with Prevention Controls column to the left

ke ct
of the Occurrence column

ac
ar y A
LL
o To better show the relationship between prevention
controls and occurrence ranking

rm tr
ch

wa Ind 0
te us
en ive 01
• Form D: Form B and C combined
os

be t /2
•
tB

s mo 14 Form E: Form D with separate columns for Current

Detection Design Controls (Cause and Failure Mode)
er

ha to 7/
ob

o To highlight the need to consider cause-related

d Au n:

controls
:R

an e io

• Form F: Form B with separate columns for Responsibility

d th at
to

and Target Completion Date and Actions Taken and

te by xpir
rig t is Lic 11 d

Completion Date
py en te 18 se

ot ed E

o To allow sorting by dates

co m Si 3 en

pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

14
This form was provided in the Chrysler, Ford, and GM; FMEA Manual 3rd Edition, AIAG.
15
Preventive and Detective Controls may be in the same column if each control is identified with a “P”
or “D” respectively.

114
POTENTIAL
FMEA Number
Th
______ System FAILURE MODE AND EFFECTS ANALYSIS
(DESIGN FMEA) Page of
______ Subsystem
O is d
______Component; _____________________________________ Design Responsibility ______________________________________ Prepared By:
E- rde oc
Appendix A

Model Year(s)/Program(s)_________________________________
Th Do r Nu um Key Date ________________________________________________ FMEA Date (Orig.)

Core Team an is d cum mb ent

Action Results
Item /
d Current Current
Function Responsibility
o en er is
iPotential
s cuPotential t Design Design
lic
Recommended
: 4Potential
Failure e Controls Controls & Target Actions Taken
Action

RPN
3 Completion Date
RPN

co Effect(s)

Severity
& Effective Date
Severity

m of Si Cause(s)
Prevention Detection
e
Detection

Detection

Occurrence
Occurance

Requirements
Mode p

Classification
18 ns
yr Failurent te L of Failure
ig is ic 11 ed t
ht o en o:
pr wn se Ro
ot ed E be
ec
te y b x p rt
d th at i r Bo
an e io

115
sc
d Au n:
ha to 7/ h
LL

DFMEA Form A
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

116
d Au n: ch
ha to 7/ LL

DFMEA Form B
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

117
d Au n: ch
ha to 7/ LL

DFMEA Form C
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

118
d Au n: ch
ha to 7/ LL

DFMEA Form D
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

119
d Au n: ch
ha to 7/ LL

DFMEA Form E
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

120
d Au n: ch
ha to 7/ LL

DFMEA Form F
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Appendix A Sample Forms

PFMEA Forms
• Form A: Basic form (with minimal information) 16
o With Prevention and Detection Controls as separate
columns 17
• Form B: Form A with Process Step/Function and
Requirements as separate columns
o To assist in the determination of failure modes

in p
rd u
y.
• Form C: Form A with Prevention Controls Column to the

co Gro
gl
left of the Occurrence column

d ion
o To better show the relationship between prevention
controls to occurrence ranking

ke ct
C

ac
•

ar y A
Form D: Form B and C combined

LL
• Form E: Form D with separate columns for Current

rm tr
ch

wa Ind 0
te us
Detection Process Controls (Cause and Failure Mode)

en ive 01
os
o To highlight the need to consider cause related

be t /2
tB

s mo 14 controls
er

• Form F: Form B with separate columns for Responsibility

ha to 7/
ob

and Target Completion Date and Actions Taken and

d Au n:
:R

Completion Date
an e io
d th at
to

o To allow sorting by dates

te by xpir

•
rig t is Lic 11 d

Form G: Form B with ID, Product and Process within a

py en te 18 se

bridged Requirements column

ot ed E
co m Si 3 en

To provide consistency among the Process Flow,

pr n se

o
is ocu ent er: 4 s lic

PFMEA and Control Plan

ht o en

• Form H: Form D and G combined

i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

16
This form was adapted from that provided in the Chrysler, Ford, and GM; FMEA Manual 3rd Edition, AIAG.
17
Preventive and Detective Controls may be in the same column if each control is identified with a “P” or “D”
respectively.

121
POTENTIAL
FMEA Number
Th
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
O is d
Item: _________________________________________________ Process Responsibility ______________________________________ Prepared By:
E- rde oc
Appendix A

Model Year(s)/Program(s)_________________________________
Th Do r Nu um Key Date __________________________________________________ FMEA Date (Orig.)

Core Team

Action Results
an is d cum mb ent
Process Step
d Current Current Responsibility
/ Function Potential Potential
en er is
Process Process Recommended
is ocuPotential
Failure Effect(s)
t
of
lic
: 4Cause(s)
& Target Actions Taken
Action

RPN
c m Completion Date
RPN

Severity
& Effective Date
Severity

Mode o
Detection

Detection

Occurrence
en Controls Controls
Occurance

Classification
Requirements s
en Site of31Failure
py Failure
rig t is Lic 811 ed
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

122
d Au n: ch
ha to 7/ LL

PFMEA Form A
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
pr n se :R
ot ed E ob
ec er
te by xpir tB
d th at os
an e io

123
d Au n: ch
ha to 7/ LL

PFMEA Form B
s mo 14
be t /2 C
en ive 01
wa Ind 0
te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
rd u
Sample Forms

in p
gl
y.
Th
O is d
E- rde oc
Appendix A

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
ht o en to
w
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Sample Forms

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Th
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Sample Forms

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POTENTIAL
FMEA Number
Th
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
O is d
Item: _________________________________________________ Process Responsibility ______________________________________ Prepared By:
E- rde oc
Appendix A

Model Year(s)/Vehicle(s )__________________________________

Th Do r Nu um Key Date __________________________________________________ FMEA Date (Orig.)

Core Team an is d cum mb ent

Action Results
d Current
Process Current Detection Responsibility
oc en er is
Potential
is Potential
u
Step t Process Controls
lic Process
: 4 Potential
Requirements
cFailure m S of Recommended & Target Actions Taken
e Controls Action

RPN
Completion Date
RPN

Mode Prevention

Severity
3ofCause(s)
Failure
n & Effective Date
i
Severity

Cause
eFailure 1 Failure Mode
Detection

Detection

Occurrence
Occurance

op Effect(s)

Classification
Function yr nt e L 81 sed
ig is ic 1 to
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PFMEA Form E
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Sample Forms

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Th
O is d
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Sample Forms

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Th
O is d
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Appendix A

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PFMEA Form G
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Sample Forms

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Th
O is d
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Appendix A

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PFMEA Form H
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Sample Forms

in p
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Appendix B System Level FMEA

Appendix B: System Level FMEA

The process for a System FMEA is generally the same as the
development of other FMEAs. The major differences between
System level FMEAs and other types of FMEAs is the focus on
functions and relationships that are unique to the system as a
whole (i.e., do not exist at lower levels). The System level
FMEA includes failure modes associated with interfaces and

in p
rd u
y.
interactions in addition to considering single point failures which

co Gro
gl
is the primary focus of product level FMEAs.

d ion
To help illustrate the meaning of System, Subsystem, and
Component FMEAs, two examples have been constructed below

ke ct
C

ac
in Figure B.1 (for Interfaces and Interactions) and in Figure B.2

ar y A
LL
(for Item, Function, and Failure Modes.).

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er

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an e io
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pr n se
is ocu ent er: 4 s lic

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

Figure B.1 Interfaces and Interactions

The FMEA team is responsible for specifying the scope of its

respective FMEAs. The example in Figure B.1 shows that the
team has specified Subsystems A, B, C, and D along with the
surrounding environment as comprising the System that must be
considered while completing the System FMEA.

130
Appendix B System Level FMEA

Interfaces
In Figure B.1, interfaces between subsystems are shown where
Subsystem A touches and (connects with) Subsystem B, B
touches or connects with C, and a clearance between D and B,
signified by the dashed line. The Environment also touches each
of the subsystems listed in Figure B.1, which requires the
“Environmental Interfaces” be considered when completing the

in p
rd u
y.
FMEA. Also, the interfaces to major and minor subsystems,

co Gro
gl
whether direct or indirect, should be included.

d ion
The interfaces which are identified in the System FMEA should

ke ct
be included in the respective Subsystem FMEA.

ac
ar y A
LL

rm tr
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Figure B.2 shows a system and its interrelationships in a

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“hardware” oriented approach.
os

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Interactions
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A change in one subsystem or component may cause a change in

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another subsystem or component.

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In Figure B.1, interactions between subsystems and components

te by xpir

can occur among any of the interfacing systems. For example,

rig t is Lic 11 d
py en te 18 se

Subsystem A heats up, resulting in Subsystem B and D gaining

ot ed E

heat through their respective interfaces, as well as Subsystem A

co m Si 3 en

pr n se

giving off heat to the environment. Interactions might also occur

is ocu ent er: 4 s lic

among ‘non-contacting’ systems via transfer through the

ht o en

‘environment’. For example, if the environment is composed of

high humidity and Subsystems A and C are dissimilar metals

an is d cum mb ent

w
ec

separated by a non-metal composing Subsystem B, Subsystem A

Th Do r Nu um

and C can still have an electrolytic reaction due to the moisture

from the environment. Thus, interactions among non-contacting
E- rde oc

subsystems can be relatively difficult to predict but are important

O is d

and should be considered.

131
Th
O is d
E- rde oc
Appendix B

Th Do r Nu um
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132
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Figure B.2 Item, Functions, and Failure

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System Level FMEA

gl
y.
Appendix B System Level FMEA

Relationships
Multiple Levels of Design FMEAs
More likely than not, the focus of a DFMEA is an item which is
a subset of a larger system. The FMEAs at the different levels of
the design hierarchy (i.e., system, subsystem and component) are
linked through the cause Æ failure mode Æ effect of failure
relationships. This is a two way linkage (see Figure B.3):

in p
From Lower to Higher Level: The effect of a failure mode at a

rd u
y.
co Gro
given level is a failure mode at the next higher level.

gl
For example, the effect of a part 2 failure mode would be a

d ion
failure mode of module 3 either directly or indirectly by causing
another part to fail. The effect of a module 4 failure mode is a

ke ct
C

ac
failure mode of subsystem 4. Consequently, the effect of a

ar y A
LL
failure mode at any sublevel may ultimately become a system
failure mode with its customer / user related effects.

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From Higher to Lower level: The linkage from a higher level to
os
the next lower level is related to the physics of failure rather than

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a pure cause and effect relationship since in the development of a

s mo 14
er

DFMEA, the causes identified at any level deal with the design
ha to 7/
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process and only indirectly with the failure mechanisms.

d Au n:
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Understanding these relationships will provide a consistency of

an e io

analysis and an economy of effort in the development of

d th at
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DFMEAs.
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Th

133
Th
O is d
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Appendix B

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Figure B.3 DFMEA Effects Linkages

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System Level FMEA

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Appendix C: Alternative Risk Assessment

Appendix C: Alternative Risk Assessments

Alternatives to RPN
The risk priority number is the product of the severity (S),
occurrence (O), and detection (D) rankings.

(S) x (O) x (D) = RPN

in p
Within the scope of the individual FMEA, this value (between 1

rd u
y.
and 1000) can be used to assist the team in ranking the concerns

co Gro
gl
in the design of the product and process.

d ion
The table below, however, illustrates how different Severity (S),
Occurrence (O) & Detection (D) scenarios result in equal RPN

ke ct
values. 18

ac
ar y A
LL
Upon review of each scenario, priorities would not be

rm tr
established by the team based on the RPN alone.
ch

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Fifteen Different Situations with an RPN=360
tB

s mo 14
Severity of Likelihood of Likelihood of
er

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Problem Occurrence Detection
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1 Hazardous 10 High 9 Moderate 4

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2 Hazardous 10 Moderate 6 Low 6

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3 Hazardous 10 Moderate 4 Very Remote 9

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4 Hazardous 9 Very High 10 Mod High 4

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5 Hazardous 9 High 8 Moderate 5

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6 Hazardous 9 Moderate 5 Remote 8

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7 Hazardous 9 Moderate 4 Impossible 10

ht o en

8 High 8 High 9 Moderate 5

9 High 8 Moderate 5 Very Remote 9

an is d cum mb ent

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10 Moderate 6 Very High 10 Low 6

Th Do r Nu um

11 Moderate 6 Moderate 6 Impossible 10

E- rde oc

12 Moderate 5 High 9 Remote 8

13 Moderate 5 High 8 Very Remote 9
O is d

14 Moderate 4 Very High 10 Very Remote 9

15 Moderate 4 High 9 Impossible 10

The ease of calculation and sorting of this index has led many to
d

use it exclusively and without consideration to what may be a

more appropriate means of prioritizing. Examples of some such
alternatives follow.

135
Appendix C: Alternative Risk Assessment

Alternative: SO (S x O)
Some organizations may choose to primarily focus on Severity
and Occurrence. The SO index is the product of the Severity, and
Occurrence rankings. In using this index, the organization may
focus on how to reduce SO by reducing the value of “O” through
preventive actions. Furthermore this may lead to subsequent
detection improvements for those with the highest SO value.
Alternative: SOD, SD

in p
rd u
y.
Some organizations have chosen to use SOD or SD as a

co Gro
gl
prioritization tool. SOD is the non-arithmetic combination of the
Severity, Occurrence and Detection rankings. SD is the non-

d ion
arithmetic combination of the Severity and Detection rankings.

ke ct
Example (SOD):

ac
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Severity, S=7

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Occurrence, O=3

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Detection, D=5

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s mo 14 The resulting SOD is 735

Example (SD):
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Severity, S=7
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Detection, D=5
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The resulting SD is 75
rig t is Lic 11 d
py en te 18 se

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co m Si 3 en

The SOD, when sorted in numerical, descending order, will

pr n se
is ocu ent er: 4 s lic

prioritize the scenarios first by severity, second by occurrence

ht o en

and lastly by detection.

i
an is d cum mb ent

w
ec

S O D RPN SOD SD
Th Do r Nu um

7 7 3 147 773 73
E- rde oc

Very
7 3 7 147 737 77 Different
O is d

3 7 7 147 377 37 Scenarios

Equal RPN Values

Table C.1 Contrast among RPN, SOD and SD

Just as with RPN, use of the SOD/SD index should be used in

context of team discussion. Defining priorities simply based on
the SOD has limitations just as with the RPN. For example, a
failure mode with a SOD of 711 would be ranked higher (i.e.,
have to be considered before) a failure mode with 599.

136
Appendix D Alternative Analysis Techniques

Appendix D: Alternative Analyses Techniques

Failure Mode and Effects Analysis is one of many techniques
used to evaluate and analyze design risk. Other methods have
been developed for specific areas and can be used to complement
the analysis in the FMEA process. They may be used as a
replacement for an FMEA with authorization by the customer.
These are only a few of the examples.

in p
Failure Mode, Effect

rd u
y.
co Gro
gl
and Criticality
Analysis (FMECA)

d ion
ke ct
C
FMECA is similar to FMEA. The C in FMECA indicates that the

ac
ar y A
LL
criticality (or severity) of the various failure effects are
considered and ranked. Today, FMEA is often used as a

rm tr
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wa Ind 0
synonym for FMECA.

te us
en ive 01
Design Review Based
os

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on Failure Modes s mo 14
er

(DRBFM)
ha to 7/
ob

d Au n:

Design Review Based on Failure Modes is a cause and effect

an e io

analysis of concerns related to a design change. It is a tool used

d th at
to

to guide and manage good discussion in relation to the change.

te by xpir
rig t is Lic 11 d

DRBFM focuses on the impact of the change on design,

py en te 18 se

evaluation procedures, and manufacturing systems with the

ot ed E
co m Si 3 en

intent of anticipating and preventing problems. A design review

pr n se

by subject matter experts to evaluate the change(s) and related

is ocu ent er: 4 s lic

ht o en

improvements is an integral part of DRBFM. (Reference Figure

D.1).
i

Fault Tree Analysis

an is d cum mb ent

w
ec

(FTA)
Th Do r Nu um
E- rde oc

FTA is a technique for system analysis where system faults are

analyzed from a single potential failure to identify all possible
O is d

causes. FTA considers combinations of interdependent as well as

independent causes. In addition to the structure of the fault tree

and all of the logic interdependencies, the FTA normally
includes the failure probabilities identification. This allows the
calculation of system reliability given the component
reliabilities. 19 (Reference Figure D.2).
d

19
References: IEC 61025; QICID (ASQ-20352).

137
Th
O is d
E- rde oc
Appendix D

Th Do r Nu um
an is d cum mb ent
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138
d Au n: ch
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wa Ind 0

Figure D.1 Example of DRBFM Elements

te us
rm tr
ar y A
ke ct
d ion
ac
co Gro
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in p
Alternative Analysis Techniques

gl
y.
Th
O is d
E- rde oc
Appendix D

Th Do r Nu um
an is d cum mb ent
d i
is ocu ent er: 4 s lic
co m Si 3 en
py en te 18 se
rig t is Lic 11 d
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139
d Au n: ch
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s mo 14
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en ive 01

Figure D.2 FTA Tree Structure

wa Ind 0
te us
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ar y A
ke ct
d ion
ac
co Gro
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in p
Alternative Analysis Techniques

gl
y.
References and Suggested Readings

References and Suggested Readings

IEC 60300-3-1, Dependability management – Part 3-1: Application guide – Analysis techniques for
dependability – Guide on methodology.
IEC 60812, Edition 2; Failure modes and effects analysis, January 2006.
IEC 61025, Edition 2; Fault tree analysis, January 2007.
QICID (ASQ-20352) “System Reliability Through Fault Tree Analysis”.

in p
rd u
y.
SAE ARP 5580, Recommended Failure Modes and Effects Analysis (FMEA). Practices for Non-

co Gro
gl
Automotive Applications. (Replacement for MIL-STD-1629A, 1998 (withdrawn)).
SAE J1739:2002, Potential Failure Mode and Effects Analysis in Design (Design FMEA) and Potential

d ion
Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA).
Alfredo, H.S. Ang and Wilson, H. Tang (1990). “Probability Concepts in Engineering Planning and

ke ct
C

ac
Design, Volume II -- Decision Risk and Reliability”, Wiley Publications.

ar y A
LL
Bowles, J. (2003). “An Assessment of RPN Prioritization in a Failure Modes Effects and Criticality

rm tr
ch
Analysis”, Proceedings Annual Reliability and Maintainability Symposium, pp 380-386; also in Journal of

wa Ind 0
te us
en ive 01
the IEST, Institute of Environmental Sciences and Technology, Vol 47, 2004, pp. 51-56.
os

be t /2
Krasich, M. (2007). “Physics of Failure Approach to FMEA”, Tutorial Proceedings Reliability and
tB

s mo 14
Maintainability Symposium.
er

ha to 7/
Krasich, M. (2005). “Fault Tree Analysis in Product Reliability Improvement”, Tutorial Proceedings
ob

Reliability and Maintainability Symposium.

d Au n:
:R

an e io

O’Conner, P.D.T., (2002). Practical Reliability Engineering. 4th edition, (Wiley).

d th at
to

Shu-Ho Dai and Ming-O Wang (1992), Reliability Analysis in Engineering Applications, Van Nostrand
te by xpir
rig t is Lic 11 d

Reinhold.
py en te 18 se

Wheeler, D. J. (2005). The Six Sigma Practitioner's Guide to Data Analysis, SPC Press, Knoxville, pp.311-
ot ed E
co m Si 3 en

315.
pr n se
is ocu ent er: 4 s lic

Rausand, M. (2004). System Reliability Theory (2nd ed), Wiley, 2004.

ht o en
i
an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

140
Index

Index
APQP (Advanced Product Quality Planning), 2, occurrence, 3, 13, 45, 46, 49, 53, 57, 59, 61, 63,
5 64, 68, 69, 92, 93, 95, 99, 103, 105, 107, 109,
block diagram, 18, 19, 29 110, 135, 136
classification, 39, 91 OEM (GM, Ford, Chrysler), 11, 17, 27, 75
continuous improvement, 6, 57, 63, 103, 107, PFMEA (Process Failure Mode and Effects
109 Analysis), 5, 17, 66, 68-71, 75, 77, 83, 91, 95,
control plans, 6, 13, 111 110, 111
cross-functional, 2, 9, 17, 69, 71 potential cause, 12, 39, 41, 91, 92

in p
current design controls, 49, 53 potential failure mode, 11, 16-18, 31, 61, 70-71,

rd u
y.
co Gro
design improvements, 16 81, 112

gl
design intent, 11, 12, 22, 29, 41, 49, 68, 79 preventive controls, 45
design life, 45 process step, 77, 79, 107

d ion
detection, 13, 18, 49, 51, 57-64, 68, 73, 95, 99- recommended actions, 6, 13, 18, 57, 59, 61, 103,
110, 135, 136 107

ke ct
C

ac
detection controls, 49, 66, 99, 107 responsible engineer, 17, 63, 69, 70, 91, 107

ar y A
LL
DFMEA (Design Failure Mode and Effects RPN (Risk Priority Number), 57, 59, 63, 103,
Analysis), 5, 16-19, 22, 25, 29, 39, 41, 64-66, 105, 109, 135, 136

rm tr
ch

wa Ind 0
70, 73, 83, 84, 111, 133 scope, 3, 4, 8, 10, 11, 18, 25, 68, 70, 71, 73, 75,

te us
en ive 01
os
DOE (Design of Experiments), 61, 107 130
DRBFM (Design Review by Failure Mode), 137, SD (Ranking by Severity and Detection), 136

be t /2
tB

error proofing, 73, 105 s mo 14 Severity, 13, 37, 57, 59, 63, 84, 87, 103, 109,
evaluation criteria, 37, 45, 53, 87, 92, 99 135, 136
er

ha to 7/
flow diagram, 70, 71, 81, 107 SO (Ranking by Severity and Occurrence), 136
ob

FMECA (Failure Mode, Effect and Critical SOD (Ranking based on Severity, Occurrence
d Au n:
:R

Analysis), 3, 137 and Detection), 136

an e io

Follow-up, 6 SPC (Statistical Process Control), 95, 107

d th at
to

FTA (Fault Tree Analysis), 137, 139 special characteristic, 39, 91

te by xpir
rig t is Lic 11 d

function, 16, 18, 19 ,21 , 29 , 31, 35, 71, 79, 111 specification, 11, 13, 61, 107
py en te 18 se

functional requirements, 8,16,18, 25 team, 2, 4, 5, 8, 9, 10, 14, 17, 18, 21, 22, 27, 29,
ot ed E

interactions, 3,10, 130, 131 35, 37, 41, 45, 49, 53, 57, 59, 69, 71, 73, 81,
co m Si 3 en

pr n se

interfaces, 10, 11, 29, 130,131 87, 91, 95, 99, 103, 105, 111
is ocu ent er: 4 s lic

item, 73, 75, 111, 133 team leader, 6, 9, 69, 70, 107
ht o en

linkages, 65, 111, 134 thresholds, 57, 59, 103, 105

mistake proofing, 61, 107 validation, 16, 31, 49, 59, 61

an is d cum mb ent

w
ec
Th Do r Nu um
E- rde oc
O is d
Th

141
Th
O is d
E- rde oc
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