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aiitf Effects Analysis
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POTENTIAL
FAILURE MOD AND
EFFECTS ANALYSIS
(FMEA)
Reference Manua
Fourth Edition
Flrst Edition, February 1993 * Second Edition, February 1995 Third Edition, Juty 2001,
Fourth Edition, June 2008
Copyright 1993. 1995, 2001, 2008
Chrysler LLC, Ford Motor Company, Genera Motors Corporation
ISBN: 978-1-60534-136-1
FOREWORD
4 ,h Edition
The FMEA 4& Edition is a reference manua to be used by supplieis to Chrysler IXC, Ford Motor
Company, and Genera Motors Corporation as a guide to assist them in the development of both
Design and Process FMEAs. The manua does not define requirements; it is intended to clarify
questions concerning the technical development of FMEAs This manua is aligned with SAE
11739
Sum mary of Changes in the 4th edition FMEA Reference Manua
The DFMEA and PFMEA methods described in the 4* edition FMEA Reference Manua include
those associated with design at the system, subsystem, interface, and component level and the
process at manufactuiing and assembly opeiations
Genera Changes
The formatting used in the 4& edition is intended to provide easier reading
o An index is included
o icons are used to indicate key paiagraphs and visual cues aie used
Additional examples and veibiage have been provided to improve the utility of the
manua and to provide a closer tie into the FMEA process as it develops
Reinforcement of the need for management suppoit, inteiest, and ieview of the
FMEA process and resuits
Define and strengthen the understanding of the linkage between DFMEA and
PFMEA as well as defining the linkages to othei tools
Improvements to the Seveiity, Occunence, Detection ranking tables so that they aie
moie meaningful to real woild analysis and usage
Alternative methods are introduced that are currentiy being applied in industry
o Additional appendices which have example foims and special case application of
FMEA.
o The focus on the "standard form" has been repiaced with seveial options that
represent the current application of FMEA in industry
The suggestion that RPN not be used as the primary means for assessing risk. The
need for rmprovement has been revised including an additional method, and the use
of thiesholds on RPN is ciaiified as a practice that is not recommended
Chapter I provides genera FMEA guidelines, the need for management suppoit and having a
defined piocess fot developing and maintaining FMEAs, and the need fot continuous
impiovement
Chapter U describes the genera application of the FMEA methodology, which is common
between DFMEA and PFMEA processes This includes the planning, stiategy, action plans, and
the need for management suppoit and responsibility in FMEAs
Chapter Ifl focuses on DFMEA (Design Failure Mod Effects and Analysis), establishing the
scope of the analysis, use of bock diagrams, vaiious types of DFMEAs, formation of the teams,
basie piocedure for analysis, action plans, and follow-up, aftematives to RPN, and connection to
PFMEAs and validation plans
Chapter IV focuses on PFMEA (Piocess Failure Mod Effects and Anatysis), establishing the
scope of the anatysis, use of flow diagtams, foimation of teams, basie procedur foi analysis,
action plans, the connection to DFMEAs and the development of contro! plans
The Appendices have seveial examples of foims for DMFEA and PFMEA and addresses
different applications and piocedures for addressing design and piocess tisk.
The Suppliei Quality Requirements Task Foice would like to thank the fbllowing individuals, and
theii companies, who have contiibuted their time and eftbits to the development of this edition of
the FMEA Refeience Manua:
Michael Down, Genera Motois Coipoiation
Lawrence Biozowski, Genera Motois Corporation
Hisham Younis, Ford Motor Company
David Benedict, Chrysler LLC
JohnFcghali, Chiyslei LLC

Michael Schubert, Delphi
Rhonda Brender, Delphi
Gregory Giuska, Omnex
Glen Vallance, Contiol Planning Initiatives
Milena Krasich, Bose
William Haughey, ReliaTiain
This manua is a copyiight of Chrysler LLC, Ford Motoi Company and Genera Motois
Coiporation, with all nghts reserved. Additional copies may be obtained irom AIAG @
www.aiag.org Supply chain oiganizations of Chrysler LLC, Ford Motoi Company 01 Genera
Motois Corporation have peimission to copy foims used in this manual.
:i
TABLE OF CONTENTS
Genera Changes
Chapterl
Genera FMEA Guidelines
Intioduction
FMEA Process
Puiposeof Manua
Scope of Manua
Impact on Organization and Management
FMEA Explained
Follow-up and Continuous Improvement
Chapreill
Ovetview of FMEA Sttategy, Planning and Implementation
Intioduction
Basic Stiucture
Approach
- ...
Identify the I eam
Define the Scope
Define the Customer
Indentify Functions, Requiiements, and Specifications
Identify Potential Failure Modes
Identify Potential Effects....
Identify Potential Causes
Identify Contiols
Identifying and Assessing Risk
....
Recoramended Actions and Results
Management Responsibility
Chapterlll
DFMEA Design Failure Mod and Effects Analysis ......
mnoduction
Customei Defined
. . . .
IeamAppioach
Manufactuiing, Assembly and Seiviceability Considerations
Development of a Design FMEA
Piereuisites
Bock (Boundaiy) Diagiams
..
Parametei (P) Diagiams
Functional Requiiements.
.
Other Tools and Infoimation Resouices
Example DFMEA
Header of the Design FMEA Foim (fields A-H)
Body of the DFMEA Foim (fields a - n)
MaintainingDFMEAs
Leveraging DFMEAs
Linkages
Design Veiification Plan & Repoit (DVP&R)
PFMEA
Chaptei IV'
.. . *
PF MEA Process Failure Mod and Effects Analysis . .
Intioduction
Customer Defined
Ieam Approach .
DesignConsideiations ........
Development of a Process FMEA
iii
Prerequisites
Process Flow Diagram and Iinkage to PFMEA

Olher Tools and Infoimation Souices. ...
Reseaich Infonnation
,
ExamplePFMEAForm
Headei of the Process FMEA Form (fields A-H)
Body ofthe PFMEA Fonn(fields a-n)
Mainlaining PFMEAs
LveiagingPFMEAs
Linkages
ToDFMEA
To Conaoi Plan
APPENDICES
Appendix A; Sample Foims
DFMEAFoims
PFMEA Forms
Appendix B: System Level FMEA
Inteifaces
Inteiactions
Relationships
Multiple Levels of Design F ME As
Appendix C: Altemative Risk Assessments
AItematives to RPN
Altemative: SO (S x O)
Alteinative: SOD, SD . . . .
Appendi* D: Alternative Analyses Techniques
Failure Mod, Effect and Ciiticality Analysis (FMECA)
Design Review Based on Failure Modes (DRBFM)
Fault Iree Analysis (FTA)
Refeiences and Suggested Readings
Index
!V
TABLESandFIGTJRES
Figur III la Bock (Boundaiy) Diagram Examples
19
Figures ID. Ib, c Bock (Boundary) Diagram Examples
20
Figur IH2 Example of a Paiametei (P) Diagram foi aGeneiic Catalytic Converter
21
Table HI 1 Sample DFMEA Form with Minimal Infoimation Elemenls & Example Entries
24
labie 1H.3 Example Potential FailureModes
.
32
labie m 4 Examp!e Potential EtTects
35
labie Ci l Suggested DFMEA Severity Evaluation Criteria
37
Table III 5 Example Potential Causes
42
Table Cr2 Suggested DFMEA Occurrence Eraluation Ciiteria
46
n
Table III 6 Examples of Prevention and Detection Design Contiols ..
51
labie Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Ciiteiia
... 54
labie III.7 Examplesof Causes, ConOols and Recommended Actions
64
Figur III. 7 DFMEA Intbimation Intenelationships Flow
65
Figur IV 1 Highl_evel toDetailed ProcessMaps
.71
Figur IV.2 Example Process Flow Diagiam
72
Table IV 1 Sample PFMEA Foim with Minimal Infoimation Elements Sc Example Entries
74
labie TV 2 Example of Piocess Step/Function/Requiiements Columns on PFMEA Form including Potential
FailureModes
...
.81
IableIV3ExampleofEffects
85
Table Cr 1 Suggested PFMEA Seveiity Evaluation Ciiteiia
88
Table Cr2 Suggested PFMEA Occuirence Evaluation Ciiteria
93
Table IV.4 Examples ot Causes and Contiols
96
Table Ci 3 Suggested Process FMEA Detection Evaluation Criteria
100
Table IV.5 Examples of Causes. Controls and Actions
110
Figur 1V.S PFMEA Infoimation Inteirelationship Flow
111
DFMEAFormA
115
DFMEA FoimB
- 116
DFMEAFoimC...
117
DFMEA FoimD
118
DFMEAFormE
119
DFMEAFormF
120
PFMEAFoimA
122
PFMEA FoimB
123
PFMEAFoimC
.'
124
PFMEAFoimD
125
PFMEAFoimE
126
PFMEAFoimF
127
PFMEA Form G
128
PFMEAFoimH
129
Figur B 1 Interfaces and Inteiactions
130
F igure B 2 Item, Functions, andFailuie
132
Figur B 3 DFMEA EffectsLinkages
134
labie C 1 Contiast among RPN, SOD and SD
136
Figur D 1 ExampIeof DRBFM Elements
138
FigurD2FTA TreeStructure
139
'.
Vi
Chapter I
Geneial FMEA Guidelines
Chapter I
Genera FMEA
Guidelines
Chaptci I
Introduction
This manua introduces the topie of Potential Failure Mod and
EtTects Analysis (FMEA) and gives genera guidance in the
application of the technique
FMEA Process
FMEA is an analytical methodology used to ensuie that potentia!
problems have been considered and addiessed thioughout the
product and process development process (APQP - Advanced
Pioduct Quality Planning) Its most visible result is the
documentaiion of the coIlective knowledge of cross-functional
teams
Part of the eva!uation and analysis is the assessment of risk The
impoitant point is that a discussion is conducted regaiding the
design (pioduct or process), ieview of the functions and any
changes in application^ and the resulting risk of potential failuie.
Each FMEA should ensure that attention is given to eveiy
component within the product oi assembly Critical and safety
related components oi processes should be given a highei
priority
One of the most important factois fot the successful
implementation of an FMEA program is timeliness It is meant
to be a "before-the-event" action, not an "after-the-fact"
exercise To achieve the greatest valuc, the FMEA must be done
before the implementation of a pioduct or process in which the
failure mod potential exists Up-ftont time spem piopeily
completing an FMEA, when pioduet/process changes can be
most easily and inexpensively implemented, will minimize late
change crises Actions iesulting fiom an FMEA can leduce oi
eliminate the chance of implementing a change that would create
an even larger concern.
Ideally, the Design FMEA process should be initiated in the
early stages of the design and the Process FMEA before tooling
or manufacturing euipment is developed and purchased The
FMEA evolves throughout each stage of the design and
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
administration process or the evaluation of a safety system. In
geneial, FMEA is applied to potential failures in product design
and manufacturing processes wheie the benefits are cleai' and
potentially significant
Chapter I
Geneial FMEA Guidelines
Purpose of Manua
This manua describes the basie piinciples and iraplementalion
of the FMEA1 process and how it is integialed 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 01 a
process in its early and fuli deveiopment stage
This manua also provides descriptions and examples of alternate
and suppoiting methodologies for these analyses, their specific
advantages and limitations, guidance of how the analysis is to be
cariied out for the maximum icliability impiovement or
mitigation of potential safety risks. The manua provides
guidance on how the risk can be represented, measuied and
prioritized for cost eftective mitigation of the failure effects
As a tool in risk evaluation, FMEA is considered to be a method
to identiiy severity of potential effects of faiiuie and to provide
an input to mitigating measures to reduce iisk In many
applications, FMEA also includes an estimation of the
probability of oceunence of the causes of faiiuie and theii
tesultant faiiuie modes This broadens the analysis by providing
a measure of the failure mode's likelihood To minimize iisk, the
likelihood of failure occutience is reduced which inereases
product or ptocess reliability FMEA is a tool that is instrumental
in reliability impiovement
Theie aie three basie cases for which FMEA process is to be
applied, each with a diffeient scope 01 fbcus:
Case 1:
New designs, new technology, or new process.

The scope of the FMEA is the complete
design, technology, or process
Case 2:
Modifications to existing design 01 process

The scope of the FMEA should focus on the
modification to design or process, possible
interactions due to the modification, and field
history This can include changes in regulatory
recjuirements
Case 3:
Use of an existing design or process in a new

environment, location, applicatlon, or usage
profile (including duty cycle, regulatory
requirements, etc)
The scope of the FMEA should focus on the
impact of the new environment, location, or
application usage on the existing design or
process
The F MEA present herein also is known as a Faiiuie Modes Effects and Ciiticality Analysis (FMECA)
sice it includes a quantification of the risks
3
Chaptet I
Scopeof Manua
The analytical melhods presented in this manua are applicable
to any product or process. However, this manua will focus on
those applications pievalent within the automotive industry and
its suppliers
Impact on Organization and Management

FMEA is an impoitant activity within any company Because the
development of an FMEA is a multi-disciplined activity
affecting the entiie pioduct realization piocess, its
implementation needs to be well planned to be firlly effective
This piocess can take considetable time and a commitment of the
iequired resouices is vital. Impoitant to FMEA development is a
process ownei and senioi management commitment
Implementation apptoach will vaiy depending on the size and
stiucture of the company concemed, although the principles will
be the same:
The scope will cover FMEAs produced in house and by multitier supplieis.
Address Design and Piocess FMEAs, as applicable
Accomplish this by having the FMEA process an integral pait

of the APQP piocess
Pait of engineeiing technical reviews
Pait of the regulai sign-off and appioval of the pioduct or

process design
An FMEA is deveIoped by a multi-functional (01 crossfunctional) team The team size will depend both on the
complexity of the design and the size and organization of the
company Team members need relevant expeitise, available time
and authority sanctioned by management
A comprehensive tiaining progiam should be implemented
including:
Management Oveiview
Tiaining foi users
Supplier Training
Facilitaloi Training
Ultimately, management has the responsibility and owneiship for
development and maintenance of the FMEAs
Geaeial FMEA Guidelines
ned
FMEAs are aa integiaL part of managing iisk and supporting
continual improvement. Consequently, FMEA becomes a key
patt of Product and Process development The Advanced Product
Qua!ity Planning (APQP) process identifies five genera areas of
focus in this deve!opment process:
Plan and Define Program
Product Design and Development
Process Design and Developmenl
Product and Process Validation
Feedback, Assessment and Conective Action

The APQP Reference manua shows DFMEAs as an activity in
the Product Design and Development section of the timing chart
and PFMEAs in the Process Planning and Development section
The development of eithei DFMEA 01 PFMEA is a process that
helps to guide the tearas in developing product and process
designs that meet expectations
The FMEA analysis should not be consideied a single event, but
a long-term commitment that complements the product and
process development to ensure potential failures are evaluated
and actions are taken to icduce their iisk
One key aspect of continual improvement is the retention of
knowledge fiom past learning which often is captured in
FMEAs It is advisable for organizations to capitalize on prior
analyses of similar product and process designs for use as the
starting point for the next program and/oi application
The language used in FMEAs should be as specific as possible
when describing an item (for example, failure mod, or cause)
and not extend or extrapolate beyond the team's level of
understanding as to what the faihue effects may be
Clear statements, concise terminology and focus on the actual
effects are key to the effective identiftcation and mitigation of
iisk issues
Chaptei I
Geneial FMEA Guideliaes
Follow-up and Continuous lmprovement

The need foi taking effective pieventive/conective actions, wilh
appiopiiate follow-up on those actions, cannot be
oveiemphasized 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/conective actions.
Team leadeiship (typically the team leadei/lead engineei) is in
charge of ensuring that all iecommended actions have been
implemented 01 adeuately addressed The FMEA is a living
document and should always reflect the latest level, as well as
the latest relevant actions, including those occuuing aftei the
staitof pioduction
The team leadei/lead engineei has seveial means of assuring that

iecommended actions aie implemented They include, but are
not limited to the following:
Reviewing designs, processes, and related iecoids to ensiue

that iecommended actions have been implemented,
Confuming the incorpoiation of changes to design/assembly/

manufactuiing documentation, and,
Reviewing Design/Piocess
FMEAs,
applications, and Coratiol Plans
special
FMEA
Chaptei II
Sbategy, Planning, Implementation
Chapter I!
Overview of FMEA
Strategy, Planning and implementafaon
Chaptei II
Strategy, Planning, Implementation
Introduction
FMEA development, eithei design or piocess, usys a common
appioach to addiess:
Potential pioduct oi piocess failure to meet expectations
Potential conseueaces
Potential causes of the failure mod
Application of cuirent controls
Level of iisk
Risk reduction
Befoie the FMEA dokument is started, the team must define the
scope of the project and collect existing infoimation which is
necessaiy for an effective and efficiem FMEA development
ptocess
Basic Structure
The purpose of the recommended FMEA fbimats described in
this manua is to oiganize the collection and display of relevant
FMEA infoimation Specific formats may vaty based on the
needs of the oiganization and the requiiements of the customei
Fundamentally, the format utilized should addiess:

Functions, requirements, and deliveiables of the product 01
piocess being analyzed,
Failuie modes wheti functional reuiiements aie not met,
Effects and conseuences of the failuie mod,
Potential causes of the failure mod,
Actions and contr ols to address the causes of the failure mod,
and,
Actions to pievent lecunence of the failure mod
Approach
There is no single or unique piocess ioi FMEA development;
howevei there aie common elements as described below
Chaptei II
Sttategy, Planning, Implemenlation
Identify the Team

As pieviously mentioned, FMEA developraent is the
responsibility of a multi-disciplinaiy (or cross-functional) team
whose raembers encompass the necessary subject mattet
knowledge This should include facilitation expeitise and
knowledge of the FMEA piocess A team approach is
recommended to benefit the FMEA development piocess to
ensuie input and collaboration fiom all affected ftinctional aieas.
The FMEA team leadei should select team membeis with the
relevant expeiience and necessaiy authoiity In addition to the
design and piocess engineeis, the following aie examples of
additional resoiuces:
FMEA development topie
Scope
Relevant Resources or Expertise

Program Management, Customer, Integiation responsible
individual(s)
Functions, iequirements and expectations
Customei, Program Management, Integiation iesponsible

individual(s), Seivice Opeiations, Safety, Manufactuiing
and Assembly, Packaging, Logistics, Materials
Potential failure mod - the way a piocess 01

pioduct might tai
Customer, Piogram Management, Integiation responsible

individual(s), Service Opeiations, Safety, Manufacturing
and Assembly, Packaging, Logistics, Materials, Quality
Effects and conseuences of the failure - to

both the organization's piocesses 01 to a
downstieam customer
Causes of the potential failure
Customer, Program Management, Integiation responsible

individual(s), Seivice Opeiations, Safety, Manufactuiing
and Assembly, Packaging, Logistics, Materials, Quality
Freuency of occunence of potential failuie
Application of cuirent controls-prevention

Application of current contiols-detection
Recommended actions requiied
Customei, Manufacturing and Assembly, Packaging,

Logistics, Materials, (ûality, Reliability, Engineering
Analysis, Equipment Manufactuier, Maintenance
Customer, Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineeiing
Analysis, Statistical Analysis, Euipment Manufactuier,
Maintenance
Manufacturing and Assembly, Packaging, Logistics,
Materials, Quality, Equipment Manufacturei, Maintenance
Customer, Manufactuiing and Assembly, Packaging,
Logistics, Materials, Quality, Maintenance
Customer, Program Management, Integiation responsible
individual(s),-Manufactuiing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineering
Analysis, Statistical Analysis, Euipment Manufactuier,
Maintenance
Chapter II
Stiategy, Planning, mplementation
Define the Scope

Scope establishes the boundaiy ofthe FMEA analysis It defines
what is included aod excluded, deteimined based on the type of
FMEA being developed, i e., system, subsystem, 01 component
Befoie the FMEA can begin, a elear undetstanding of what is to
be evaluated must be deteimined What to exclude can be just as
impoitant as what to include in the analysis The scope needs to
be established at the stait ofthe piocess to assuie consistent
diiection and focus
Ihe following raay assist the team in defining the scope ofthe
FMEA:
Function Model
Bock (Boundaiy) diagiams
Paiameter (P) diagiams
Intei face diagiams
Process flow diagiams
Inteiielationship matiices
Schematics
Bili ofMateiials (BOM)
System FMEA
A system FMEA is mad up of vaiious subsystems Examples of
systems include: Chassis System, Poweitiain System, 01 Inteiioi
System, etc The fbcus of the System FMEA is to addiess all
inteifaces and inteiactions among systems, subsystems, the
enviionment and the customei.
Subsystem FMEA
A Subsystem FMEA is a subset of a system FMEA. An example

of a subsystem is the fiont suspension subsystem, which is a
subset ofthe chassis system The focus ofthe Subsystem FMEA
is to addiess all inteifaces and inteiactions among the subsystem
components and inteiactions with othei subsystems ot systems
Component FMEA
A Component FMEA is a subset of a subsystem FMEA Foi

example, a biake pad is a component of the biake assembly,
which is a subsystem of the chassis system
NOT: Any subseuent adjustments to the scope may icuire a
modification ofthe team structiue and membeiship
10
Chaptei II
Strategy, Ptanning, Implementation
Define the Customer

There are foui major customeis to be considered in the FMEA
piocess, all need to be taken into account in the FMEA analysis:
END USER: the person or oiganization that will utilize the

pioduct The FMEA analysis affecting the End Usei could
include, for example, durability.
OEM ASSEMBLY and MANUFACTURING CENTERS

(PLANTS): the OEM locations wheie manufactuiing
opetations ( e g , stamping and poweitrain) and vehicle
assembly take place Addiessing the inteifaces between the
product and its assembly process is critical to an effective
FMEA analysis
SUPPLY CHAIN MANUFACTURING: the supplier location

wheie manufactuiing, fabiicating oi assembling of pioduction
mateiials oi parts takes place This includes fabiicating
pioduction and seivice paits and assemblies and piocesses
such as heat tieating, welding, painting, plating oi othei
finishing seivices This may be any subsequent or downstieam
opeiation or a next tier manufactuiing piocess
REGULATORS:
govemment
agencies
that
define
iequiiements and monitoi compliance to safety and
enviionmental specifications which can impact the pioduct oi
piocess
Knowledge of these customers can help to define the functions,
teuiiements and specitications moie robustly as well as aid in
deteimining the effects of related failuie modes
Indentify Functions.
Requirements, and
Specifications
Identify and undeistand the functions, reuiiements and
specifications ielevant to the defined scope. The puipose of this
activity is to claiify the item design intent or piocess puipose
This assists in the deteimination of the potential failuie mod foi
each attiibute or aspect of the function
.1
Chaptei n
Identify Potential
Failure Modes
Failure mod is defined as the way 01 mannei in which a pioduct
or piocess could fail to raeet design intent 01 piocess
ieuiiements The assumption is mad that the failure could
occur but may not necessaiily occur A concise and
undeistandable failuie definition is impoitant sice it piopeily
focuses the analysis Potential failuie modes should be desciibed
in technical teims and not as a symptom necessarily noticeable
by the customer. A laige number of failuie modes identified for
a single iequirement may indicate that the defined iequiiement is
not concise
Identify Potential
Effects
Potential effects of failuie aie defined as the effects of the failuie
mod as perceived by the customei The effects or impact of the
failure aie desciibed in teims of what the customei might notice
or expeiience The customei may be an intemal customei as
well as the End User
Deteimining potential effects includes the analysis of the
consequences of the failures and the seveiity 01 seriousness of
those conseuences
Identify Potential
Causes
Potential cause of failuie is defined as an indication of how the
failuie could occur, desciibed in teims of something that can be
conected oi can be contiolled. Potential cause of failuie may be
an indication of a design weakness, the cohsequence of which is
the failuie mod.
Theie is a diiect relation between a cause and its tesultant failuie
mod (i e , if the cause occurs, then the failuie mod occuis).
Identifying the ioot cause(s) of the failuie mod, in sufficient
detail, enables the identification of appropiiate contiols and
action plans A sepaiate, potential cause analysis is perfoimed
foi each cause if theie are multiple causes
i
1/
Chapter II
Identify Controls
Controls aie those activities that pievent oi detect the cause of
the failuie oi failure mod In deve!oping contiols it is impoitant
to identify what is going wrong, why, and how to prevent oi
detect it
Controls aie applicable to pioduct design or
manufactuiing processes. Contiols fbcused on pievention will
provide the gieatest return.
Identifying and
Assessing Risk
One oi the impoitant steps in the FMEA piocess is the
assessment of iisk This is evaluated in thiee ways, severity,
occunence, and detection:
Severity is an assessment of the level of' impact of a failiue on
the customei
Occurrence is how often the cause of a failuie may occui.
Detection is an assessment of how well the pioduct ot piocess
contiols detect the cause of the failuie oi the failuie mode.
Oiganizations need to undeistand theii customei iequiiements
for iisk assessment
Recommended
Actionsand Results
The intent of recommended actions is to reduce oveiall iisk and
likelihood that the failure mod will occur The recommended
actions address ieduction of the severity, occuirence and
detection.
The fllowing can be used to assuie that the appropiiate actions
aie taken, including but not limited to:
Ensuiing design
achieved,
reuirements
Reviewing engineering drawings and specifications,
Confirming
incorpoiation
processes, and,
Reviewing telated FMEAs, control plans and opeiations

instiuctions.
in
including
reliability
are
assembly/manufacturing
Responsibility and timing to complete the iecommended actions

should be recoided.
Once actions aie completed and results captured, the updated
iatings for seveiity, occunence and detection should also be
lecoided
13
Chapter II
Strategy, Planning, Impleraentation
Management Responsibility
Management owns the FMEA piocess Management has the

ultimate responsibility of selecting and applying iesources and
ensuiing an effective risk management piocess including timing
Management iesponsibility also includes providing diiect
suppott to the team through on-going ieviews, eliminating
loadblocks, and incoipoiating lessons leamed
14
Chapter III
Design Failuie Mod and Effects Analysis
Chapter !li
DFMEA
Design Faiiure Mod and Effects Analysis
Chapter III
Introduction
$
The Design Failuie Mod Effects Analysis, lefened to as
DFMEA, suppoits the design piocess in leducing the risk of
failures by:
Aiding in the objective evaluation of the design, including

functional ieuiiements and design alteinatives,
Evaluating the initial design for manufactuiing, assembly,

ser vice, and recycling ieuiiements,
Increasing the probability that potential failuie modes and theii

effects on system and vehicle operation have been consideted
in the design/develt>pment process,
Providing additional infoimation to aid in the planning of

thotough and efficient design, development, and validation
piograms,
Developing a ianked list of potential failuie modes accoiding

to theii effect on ihe customer, thus establishing a piioriTy
system for design impiovements, development, and validation
testing/analysis,
Pioviding an open issue format for recommending and

tracking risk-ieducing actions, and,
Pioviding mtuie refeience, ( e g , lessons learned), to aid in

addiessing field conceins, evaluating design changes, and
developing advanced designs
Ihe DFMEA is a living document and should:
Be initiated befoie design concept finateation,
Be updated as changes occui 01 additional infoimation is

obtained thioughout the phases of pioduct development,
Be fundamentally completed befoie the production design is

ieleased, and,
Be a souice of lessons learned foi futur design iteiations.
Customer Defined
The definition of "Customei" provided in Chapter U applies to
DFMEA It is important to conectly identify the customei(s)
because such knowledge diiects the development of the
DFMEA, including the impact of the function of the design
I.
16
Chapter Tli
Design Failure Mod and Effecls Analysis
Team Approach
The DFMEA is developed and maintained by a multidisciplioaiy (oi cioss-functional) team typically led by the design
responsible engineei fiom the responsible design source (e g,
OEM, Tier 1 supplier or Tiei 2 supplier and below)
The iesponsible engineei is expected to directly and actively
involve iepresentatives fiom all affected areas The areas of
expeitise and iesponsibility may include, but are not limited to,
assembly, manutacturing, design, analysis/test, reliability,
materials, quality, seivice, and supplieis, as well as the design
aiea iesponsible for the next higher or tower assembly or system,
subsystem, or component
Manufacturing,
Assembly and
Sen/iceability
Considerations
The DFMEA should include any potential failure modes and
causes that can OCCUI during the manuractuiing oi assembly
process which aie the result of the design Such failure modes
may be mitigated by design changes ( e g , a design featute which
prevents a part fiom being assembled in the wiong orientation i e., eiior-proofed) When not mitigated during the DFMEA
analysis (as noted in the action plan foi that item), theii
identification, effect, and control should be transfeired to and
coveied by the PFMEA
The DFMEA does not rely on process controls to overcome
potential design weaknesses, but it does take the technical and
physical limits of a manufacturing and assembly piocess into
consideiation, foi example:
Necessaiy mold drafts
Limited suiface finish capability
Assembling space (e g , access for tooling)
Limited haidenability of steels
Tolerances/process capability/per foi mace

The DFMEA can also take into consideiation the technical and
physical limits of produci serviceability and iecycling once the
pioduct has entered field use, foi example:
Tool access
Diagnostic capability
Materia classification symbols (foi recycling)
Materials/chemicals used in the manufacturing piocesses
17
Design Failure Mod and Effects Analysis
Chaptei III
Development of a Design FMEA

The DFMEA focuses on the design of the product that will be
delivered to the fina custoraer (End Usei). The pretequisite tasks
for an effective analysis of the product design include:
assembling a team, deteimining scope, creating bock diagiams
01 P-diagrams depicting product function and requirements. A
elear and complete deflnition of the desired product
chaiacteiistics better facilitates the identification of potential
failure modes A DFMEA foim is used to document the results
of the analysis including any recommended actions and
responsibilities (See Table III 1)
The DFMEA piocess can be mapped to the customer or
oiganization's product development piocess
Prereguisites
A DFMEA should begin with the development of information to
understand the system, subsystem, oi component being analyzed
and define their flinctional requiiements and characteristics
In ordei to determine ihe scope of the DFMEA, the team should
consider the following as applicable to component, subsystem ot
system DFMEAs:
What processes, mating components, oi systems does the

product inteiface with?
Are there functions oi features of the product that afect other

components or systems?
Aie there inputs provided by othei components or systems tha:

are needed to peifoim intended functions of the pioduct?
Do the producfs functions include the prevention or detection

of a possible failure mod in a linked component or system?
The following sections describe tools that may be applied, as
appropiiate, to assist Ihe team in developing the DFMEA
Bock (Boundary) Diagrams

The bock diagram of the pioduct shows the physical and logical
lelationships between the components of the product There aie
different appioaches and foimats to the constniction of a bock
diagiam
The bock diagiam indicates the inteiaction of components and
subsystems within the scope of the design This interaction may
include: flow of information, energy, fbice, or fluid The
objective is to understand the requirements or inputs to the
!S
Chapter HI

system, the activities acting on the inputs or function peifotmed,
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
pioduct oi a major step of the piocess. The lines coirespond to
how the pioduct components aie related to, or interface with
each other The organization needs to decide the best approach
or foimat for the bock diagram. Figur III.la, b, and c contain
examples of bock diagrams
Copies of the diagrams used in DFMEA pieparation should
accompany the DFMEA
Lift Gale Bali

Studs
LiftGate
Waadier
Strtps
Hamess
H.:nS
MFG Plant
,3J
Sttuts
Rip Glass
xxx N oad
xxx N ses| tosd
xxxN
nviT-mwni
FKp Glass
-j- U - J S - - . - . - .
Studs
Applique
TH
SCIM cc
Assembly
=Hp Glass
Stnkw
Customet
ixxxN
Wlper
.4.:5r"i-.ir
O ad
Lalch
Assembly
Koy:
Ora way action/Tunctlon:
*
TWiMWy interactionffunction:
.
Soundary Une
Cmical Meriace focus

Crtical Assembly tbcus
Numbere miale to detali on interface Analysis
Figur IH.la Bock (Boundary) Diagram Esamples
19
Chaptei III
9c
o
i?
co
-o
0)
CL
CG
CU
co
'co
iiiill
I
II
II
r>
5 j
lii
iii
n ^? c t<p * ~
u ^ a l o ouiu:
'
Figur es III Ib, c Bock (Boundaiy) Diagram Examples
20
Chaptei III
Design Failuie Mod and EfFects Analysis
Parameter (P) Diagrams

The P-Diagiam is a structuied tool to help the team undeistand
the physics related to the function(s) of the design The team
analyzes the intended inputs (signals) and outputs (responses 01
functions) for the design as well as those contiolled and
uncontrolied factois wbici can impact peifoimance.
Ihe inputs to the pioduct and outputs fiom the pioduct, i e., the
intended and unintended functions of the pioduct, are usetul in
identifying eiror states, noise factors, and control factois.
The enot states conespond to the Potential Faiiure Modes in the
DFMEA.
Chamic!
Snai: lX-:iiyr. & Ma-uriai
Mount Materia / Wire / Seals
Substrate
Wash coat Technology

Ptecious Metal toadinc/Ratto
Geometry fcontourilength)
Celi Denslty
WaJIthickness
Packaglng Location & Volume
Row Distribution
(Pip* & Cone Geometry)
Siana |
Mass
Exnaust Gas Composllion
ff^fo;
Control Factors
mm
Skt#fc
Effor States:
Functional
Output gases do not meet
emission requirernents
Non-Functionaf
Odor/Smell
Nose/Raffle
Power Loss
Excessive Heat (internal)
Excesslve Heal (extemal)
Exhaust leak
lnadvertant Chsck Engine signal
u--^
Energy
ThermaJ
Mechanical
Chemical
Pr-essure
i . - - '--'"'
Respoosa;
Y, = Regulated Emission
(HC CO NOx) [gms/mile]
Y, = Non-Regulated Emission
(H2S) [ppm/test]
Changes Ovr_Timc/Miie
Btockage / restriction
Weld cteterioration / taligue
Substrate retenlion
(Mount degradation)
Subsirale efosion / breaooe
Catatyst chemical ageing
Corrosion of sheH
Loosening of heat shield
.trnl Enyjronrnen.t
Amblent temperatur
Road load / vibralion
Off Road - debrls / rccks
Road Saltf mud/ water
Custorncr Usage
Short, Iow speed trips
High speed with Irailei tow
Fuel type & quality / sulfur tevel
Service damage
Shipping mishandling
Driving with engine errora
Noise F a c t o r s
yarialion
Materia vartalion
Substrate Wash Composftion
Cannng forces:
Clampjng farcs
Wrap tighiness
Crimping force
Assembly process
Misbiald / mtslabets
Orientation and centralny
Mount gap
IMatl/WlreJ/SheflOD
Dimension (Assembly)
Welding process
Systurn Intoractions
Heat SNeid / NVH PaCs 1
Weded Exhaust Manlfokl Leaks
Engine misfire Excessive Heat
Oli contamlnatlon
Power train load vibration
Dynamie load (engine induced)
Calibration
Backpressure
Figur III.2 Example of a Parameter (P) Diagram for a Generic Catalytic Converter
21
Chaptei III
Functional Requirements
Anothei step in the DFMEA process is a compilation of the

functional and inteiface iequirements of the design I his list may
include the following categoiies:
Geneial: This category considers the puipose of the ptoduct

and its oveiall design intent
Safety
Govemment Regulations
Reliability (Life of the Function)
Loading and Duty Cycles: Customei ptoduct usage profile
Quiet Opeiations: Noise, vibiation and hatshness (NVH)
Fluid Retention
Ergonomics
Appeaiance
Packaging and Shipping
Service
Design for Assembly
Design fot Manufactuiability
Other Tools and Information Resources

Other tools and resouices that may help the team understand and
define the design reuirements may include:
Schematics, diawingSj etc
Bill of Materials (BOM)
Intenelationship matiices
Intetface matrix
Quality Function Deployment (QFD)
Quality and Reliability Histoiy

The use of these tools, suppoited by engineenng experience and
histoiical information, can assist in deflning a comprehensive set
of ieuirements and functions
-v
Aftei considering these pteieuisites, statt filling out the fbim

(labie 111 lbelow)
22
#(
Chapter HI
This page intentionaliy left blank.
23
Chapter m
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Table 111.1 Sample DFMEA Foim with Minimal Intbiraation Elements & Example Entries
24
Chapter III
ExampleDFMEA
The example used with the saraple foim deals wilh a Fiont Door
assembly The product has several fiinctiooal requirements:
Peimit ingtess to and egress fiom vehicle
Piovide oceupant piotection &om
o
Weather (comfort)
Noise (comfort)
Side impact (safety)
Support anchoiage foi dooi hardware including

o
Minoi
Hinges
Latch
Window regulator
Provide proper surface for appeaiance items

o
Paint
Soft trim
Maintain integrity of innei dooi panel

The fina DFMEA would include analysis of all these
requirements The example includes pait of the analysis of the
requirement: "Maintain integrity of innei dooi panel"
Header of the Design FMEA Form (fields A-H)

The following describes the infoiraation to be entered on the
foim
Ihe headei should cleaily identify the focus of the FMEA as
well as infoimation lelated to the document deve!opment and
control process. This should include an FMEA number,
identification of the scope, design lesponsibility, completion
dates, etc The header should contain the following elements2:
The letters at the end of each heading indicate the aiea referred to on the sample fbim
25
Chapler III
N,'b
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M.e-^
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mao
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Table III.I Sam ple DFMEA Form with Minima! Information Elements & Example Entries
26
FMEA Number (A)

Enter an alphanumeiic stting which is used lo identify the FMEA
document This is used foi document conool
System, Subsystem, or Cornponent Name

and Number (B)
Enter the name and number of the system, subsystem, or
cornponent which is being analyzed (See section entitled Define
the Scope)
Design Responsibiiity (C)

Entei the OEM, oiganization, and depaitment or gioup who is
design lesponsible Also entei the supply oiganization name, if
applicable
Model Year(s)/Program(s) (D)

Enter the intended model yeai(s) and piogiam(s) that will use 01
be aifected by the design being analyzed (if known)
Key Dat (E)

Entei the initial DFMEA due dat, which should not exceed the
scheduled production design ielease dat
FMEA Dates (F)

Entei the dat the oiiginal DFMEA was compieted and the latest
revision dat
Core Team (G)

Entei the team members responsible for developing the DFMEA
Contact infoimation ( e g , name, oiganization, telephone
number, and email) may be included in a leferenced
supplemental document
Prepared By (H)
Enter the name and contact infoimation including the
oiganization (company) of the engineer lesponsible for piepaiing
the DFMEA
27
- , . L _ ..._'
.'
Chapti ffl
:[--
Jos3wia
uei"WQ
' : i . . '.<
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rabie m . l Sample DFMEA Form with Minimal Inirmation Ele me im & Esample Entries
28
Chaptei HI
Body of the DFMEA Form (fields a - n)

The body of the FMEA contains the analysis of lisks idated to
the potential failuies, and impiovement action being taken 3
Item / Function / Requirements (a)

Item/Function can be sepaiated into two (or moie) columns ot
combined into a single, bridged column which encompasses
these elements Inteifaces (as "items" of analysis) can be eithei
combined or separate. Components may be listed in the
item/function column, and an additional column may be added
containing the functions or iequiiements of that item "Item",
"Function", and "Requiiements" aie desciibed below:
Item (a1)
Enter the items, inteifaces, 01 pmts which have been identified
thiough bock diagiams, P-diagiams, schematics and othei
diawings, and othei analysis conducted by the team
The teiminology used should be consistent with customei
iequirements and with those used in othei design development
documents and analysis to ensuie tiaceability.
Function (a1)
Enter the runction(s) of the item(s) 01 inteiface(s) being analyzed
which aie necessaiy to meet the design intent based on customei
iequiiements and the team's discussion. If the item(s) or
inteiface nas mor than one function with different potential
modes of failuie, it is highly lecommended that each of these
runctions and associated failure mode(s) is listed sepaiately
Function becomes a2 if Item and Function are Split
Requirements (a2)
An additional column, "Requirements", may be added to fuithei
refine the analysis of the failure mode(s) Entei the
iequirement(s) for each of the functions being analyzed (based
on customei iequirements and the team's discussion; see also
Chaptei II, Section: Pieiequisites) If the function has moie than
one iequirement with different potential modes of failure, it is
highly recommended that each of the ieuiiements and functions
are listed separately
\ Requirment becomes a3 if Item and Function are Split into
\ separate columns, e g , a1 and a2
The letters at the end of each heading indicate the area refeited to on the sample tbim
29
POTENTIAL
FAILURE MOD ANO EFFECTS ANALWIS
(DESIGN FMEA)
FMEANumber.
M o d e l Ybflf ( s y P i o j a m i s ) _
:T
-o
. Sulwytum
Componam
P9t
B
D
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l ' f ( , j ' l iv .
v
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Cote T a m _
Currenl Design
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li T 11 i
Polenlial
Failure
Cause(s) or
r
a i iiro
Racommended
Controls
Conlrols
' i n~i :
1- |-i . ! a;"i
ihmB onrtui
uccssoFkro
[be i fomei
Desgn
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JTarget
ConipteUon Data
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Potential Failure Mod (b)

Potential failure mod is defined as the manner in which a
component, subsystem, or system could potentially fail to meet
01 delivet the intended function desciibed in the item column
Identify the potential failuie mode(s) associated with the
tunction(s)/requirement(s) Potential failuie modes should be
desciibed in technical teims, and not necessaiily as a symptom
noticeable by the customei
Each function may have multiple failure modes A large numbei
of failure modes identified for a single function may indicate that
the iequirement is not well defined.
The assumption is mad that the failuie could occur, but may not
necessaiily occur, conseuently the use of the woid "potential"
i
! Potential failure modes that could occur only under certain
: operating conditions (i.e., hot, cold, dry, dusty. etc) and under
j certain usage conditions (i e., above-average mileage, rough
terrain, city driving only, etc) should be considered
After determining all the failure modes, a validation of the
completeness of the analysis can be mad through a review of
past things-gone-wrong, concems, reports, and gioup
biainstorming
The potential failure mod may also be the cause of a potential
failuie mod in a higher Ievel subsystem 01 system, or lead to the
effect of one in a lower level component
Example failuie modes, as related to diffeient requiiements, aie
shown in table III .3
31
Chaptei III
Item
Function
Disk
Brake
system
Stop vehicle on
demand
(consideiing
enviionmental
conditions such
as wet, dry, etc )
Requirement
Stop vehicle travelmg
on dry asphalt
pavement within
specified distance
within specified g's of
force
Allow unimpeded
vehicle movement on
no system demand
Biake
Rotoi
'.;'
: - '
''. .
Allows tiansfer
of force from
biake pads to
axle
Must deliver specified

toiue lesistance at axle
Failure Mod
Vehicle does not stop
Vehicle stops in excess of
specified distance
Stops vehicle with mor than xx
g's of force
Activates with no demand;
Vehicle movement is partially
impeded
ActWates with no demand
Vehicle cannot move
Insufficient torque lesistance
delivered
. ; '
Tabie ffl.3 Example Potentia! Failure Modes
32
Chapter III
This page intentionally left blank.
33
POTENTlAl
FAILUflf MOOE AND EFFECfS ANALYSIS
(DflOJ FMfAl
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Potential Effect(s) of Failure (c)

Potential effects of failuie aie defined as the effects of the failure
mod on the fiinction, as peiceived by the customei(s).
Desciibe the effects of the failuie in teims of what the customei
might notice or expeiience, iemembering that the customei may
be an internal customei as well as the ultimate End User State
clearly if the failuie mod could impact safety or noncompliance to regulations. The effects should always be stated in
teims of the specific system, subsystem, 01 component being
analyzed Remember that a hieiarchical relationship exists
between the component, subsystem, and system levels4 For
example, a pait could fiactuie, which may cause the assembly to
vibrate, resulting in an inteimittent system opeiation The
inteimittent system operation could cause peifoimance to
degiade and ultimately lead to customei dissatisfaction The
intent is to piedict the potential failure effects to the team's level
of knowledge
Typical failure effects should be stated in teims of product or
system peifoimance Table III 4 shows example effects of the
failure modes nom Table JII.3
Item
Disk Biake
System
Failure Mod
Effect
Vehicle does not

stop
Vehicle stops in
excess of specified
distance
Stops vehicle with
mor than xx g's of
foice
Vehicle control impaired; Regulatory non-compliance

Vehicle controE impahed; Regulatory non-compliance
Regulatoiy non-compliance
Activates with no
demand;
Vehicle movement is
paitially impeded
Decreased pad life; dirninished vehile control
Activates with no
demand
Vehicle cannot move
Customer unable to drive vehicle
*&JK':.-:*;;'.- ; ; '-"'''
~.":''.-1
; -.'
'
Tab!e HL4 Esample Potential Effects
See also Appendix B

35
POTENTIAL
FAILURE MOD AND EFFECTS ANALYSIS
(DESIGN FMEA)
.Syslem
_ Sgbyalom
Model
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Polential
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o i of o w a
ax<pal
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Potenlial
Cause{s) of
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*"onRi*i
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Conlrols
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Chapter 1H
Severity (S) (d)

Severily is Ihe value associated with the most seiious effect fot a
given failuie mod Seveiity is a relatiye lanking within the
scope of the individual FMEA
Suggested Evaluation Criteria
The team should agiee on evaluation criteiia and a ranking
system and apply them consistently, even if modified for
individual piocess analysis (See Table Crl below for criteiia
guidelines)
\ lt is not recommended to modify criteria ranking values of 9 and
3 10- Faiiure modes with a rank of severity 1 should not be
a analyzed further
Criteria:
Effect
Severlty of Effect on Product
Rank
(Customer Effect)_
Failurc to
Meet Safety
and/oi
Regulatory
Requh ements
Loss oiDcgradation
(lt PMTliaiy
Function
Loss o
Degiadation
of Secondaiy
function
Annoyance
No effect
Potential faiiure mod afiects safe vehicle opeiation and/oi ivolves

noncompliance with goveinment legulation without waining
10
Potential failuie mod affects safe vehicle opeiation and/oi involves

noncompliance with govemment regulation with waming
Loss of piimary function (yehicle inopeiable, does not affect sale

vehicle operation)
Degiadation of piimary function (vehicle opeiable, but at reduced

level of performance)
Loss of secondaiy function (vehicle opeiable, but comfort /

convenience functions inoperable)
Degradation of secondaiy function (vehicle opeiable, but comfoit /

convenience functions at reduced level of performance)
Appearance oi Audible Noise, vehicle opeiable, item does not

confoim and noticed by most customeis (> 75%)
Appeaiance or Audible Noise, vehicle opeiable, item does not

conform and noticed by many customeis (50%)
Appearance or Audible Noise, vehicle operable, item does not

conform and noticed by disciiminating customeis (< 25%)
No disceraible effect
Table Crl Suggested DFMEA Severity Evaluation Criteria
37
POTENTIAL
(DESIGN FMEA1
Sysiein
n
. Sobsyslejn
___Cocnponent
MoOe Yesr(aVPro9fafii(8_
B
D
FW6ANun*et_
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taiji. . . . r i n . l
Potential
Failure
FwfwWon
F M f [ t o >
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I
pana
Potential
Etfect(s) of
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Potential
Cause(s) ot
Al ' .' C.;-..<-.

R . ' . ' i . u 'I, -I
Contrds
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Design Failuie Mod and Effecls Analysis
Classification (e)
This column may be used to highlight high-piiority failuie
modes and theii associated causes
As a result of this analysis, the team may use this infoimation to
identity special chaiacteiistics
; Customer specific requirements may identify special product or
process characteristic symbols and their usage
A characteristic designated in the design record as special
; without an associated design failure mod identified in the
DFM6A is an indication of a weakness in the design process
Potential Cause(s)/Mechanism(s) of Failure

Mod (f)
This infoimation can be separated into multiple columns 01
combined into a single column
In the development of the FMEA, the identification of all
potential causes of the failuie mod is key to subsequent
analysis Although vaiied techniues (such as brainstoiming) can
be used to determine the potential cause(s) of the failuie mod, it
is recommended that the team should focus on an understanding
oitbs failure mechanizm for each failuie mod
Potentia! Mechanisrn(s) of Failure Mod (f1)

A failuie mechanism is the physical, chemical, electiical,
theimal, 01 other process that results in the failuie mod It is
impoiiant to make the distinction that a failuie mod is an
"obseived" or "extemar effect so as not to confuse failuie mod
with failuie mechanism, the actual physical phenomenon behind
the failure mod 01 the process of degradation 01 chain of events
leading to and resulting in a paiticular failuie mod
To the extent possible, list eveiy potential mechanism for each
failuie mod The mechanism should be listed as concisely and
completely as possible.
For a system, the failure mechanism is the process of enor
propagation following a component failure which leads to a
system failuie
A product or process can have several failure modes which are
: correlated to each other because of a common failure
l mechanism behind them
I Ensure that process effects are considered as part of the
. DFMEA process
39
Chapler III
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I able III-I Sample DFMEA Form with Minlmal Inoimalion Kle ments & Esample Entries
40
Potential Cause(s) of Failure Mod (f2)

Potential cause of failure is defined as an indication of how the
design process could al Iow the failuie to occur, described in
terms of something that can be corrected or can be contiolled
Potential cause of failure may be an indication of a design
weakness, the consequence of which is the failure mod
] Causes are the circumstances that induce or activate a failure
i mechanism
In identifying potential causes of failuie, use concise
desciiptions of the specific causes of failures, eg., specified bolt
plating allows for hydiogen embiittlement Ambiguous phtases
such as, pooi design or impropei design, should not be used
Investigation of causes needs to focus on the failure mod and
not on the effect(s) In deteimining the cause(s), the team should
assume the existence of Che cause under discussion will icsult in
the failuie mod (i e , the failure mod does not iequiie multiple
causes to occur)
Typically, there may be several causes each of which can result
in the failuie mod. This lesults in multiple lines (cause
bianches) for the failure mod
To the extent possible, list eveiy potential cause for each failure
mode/failuie mechanism The cause should be listed as concisely
and completely as possible Sepaiating the causes will icsult in a
focused analysis for each cause and may yield different
measuiement, contiols, and action plans
Table III 5 shows sample causes fbi the failure modes in Table
UJ 3 Although not reuiied as pait of the minimum FMEA foim
elements, the table includes the failure mechanism to show the
relationships among failuie mod, failuie mechanism, and cause
In piepaiing the DFMEA, assume that the design will be
manufactuied and assembled to the design intent Exceptions can
be mad at the teams discietion wheie histoiical data indicate
deficiencies in the manufacturing piocess
Chaptei III
Failuie Mod
Cause
Mechanisra
Mechaoical Unkage break due to inadequate corrosion

protection
Vehiciedoes not stop
Vehicle siops io exces$ of
yyfeet
Slops vehicle wilh mor

than xx g's oi force
No transfer ot lorce
from peda to pads
Reduced transfer of
force from peda to
pads
ExcessiveAapid
transfer of force from
Master cylinder vacuum lock due lo seal design

l oss of hydraulic fluid from loose hydraulic lin due to
incorrect connector torque specification
Loss of hydraulic fluid due to hydraulic lines
crimped/compressed, inappropriate tub mateiial specified
Mechanical linkage joints stiff due to inappropriate
lubrication specification
Mechanical linkage joints corroded due to inadequate
corrosion protection
Partial loss of hydraulic fluid due to hydraulic lines
crimped, inappropiiate tub materia specified
Cumulative pressure build-up rn master cylinder due to
seal design
ActWate with no demand;

Vehic!e moveraent is
impeded
Pads do not releasc
Corrosion or deposit build up on rails or pad eais due to

surface frnish not promoting adequate self cleaning and
corrosioa protection
Actfvate with no demand

Vebicle cannot raove
Hydraulic pressure
does not idease
Master cylinder vacuum lock due to sea! design
.;,V,-.:.;'.
.-
. ,'
mm&
-:.--.
Table III.5 Example Potential Causes
42
W-''--
Chaptei III
This page intentionaly left blank.
4^
Chaptei III
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Table ULI Sample DFMEA Form with Min ima I nfor mation Elements & Example Entries
44
Occurrence (O) (g)

Occunence is the likelihood ihat a specific cause/mechanism
will occur resulting in tbe failuie mod within the design life
The likelihood of occurrence ranking numbei has a ielative
raeaning iather than an absolute value (See Table Cr2).
A consistent occunence ranking system should be used to ensuie
continuity Ihe occuirence numbei is a ielative tanking within
the scope of the FMEA and may not ieflect the actual likelihood
of occunence
Suggested Eva!uation Critetia
The team should agiee on evaluation criteiia and a ranking
system and apply them consistently, even if modified foi
individual piocess analysis Occunence should be estimated
using a 1 to 10 scal using Table Cr2 as a guideline.
In deteimining this estimate, questions such as the following
should be consideied:
What is the seivice histoiy and field expeiience with similar

components, subsystems, 01 systems?
Is the item a canyover or similar to a pievious level item?
How significant aie changes fiom a pievious level item?
Is the item ladically dif feient fiom a previous level item?
Is the item completely new?
What is the application 01 what are the environmental

changes?
Has an engineenng analysis ( e g , ieliability) been used to

estimate the expected comparable occunence late for the
application?
Have preventive contr ols been put in place?
4.'
Chaptei m
Likelihood
of Failure
Criteria: O c c u r r e n c e
of C a u s e - DFMEA
Criteria: O c c u r r e n c e of C a u s e - DFMEA
( D e s i g n life/reliability of i t e m / v e h i c l e )
Rank
(Incidents per
items/vehicles)
New tecbnology/new design with no hisiory
100 per thousand
Very High
10
1 in 10
High
Failure is inevitable with new design, new application, or

change in duy cycle/operating condilions
50 per thousand
Failure is Ukcly with new design, new application, or

change in duty cycle/opetating conditions
20 per thousand
9
1 in20
'
Failure is uncenain wilh new design, new application, or

change in duy cycle/operaiing condilions
50
10 pet thousand
7
,..
Fieuent failurcs associated with sirnilai designs or in

design simulation and testing
T.
1 in 100
2 pei thousand
6
1 in500
Modetale
Occasional failuies associated with similai designs 01 in

5 pei thousand
Isolated failurcs associated with sirnilai design 01 in

I per thousand
5
1 in 2,000
4
1 in 10,000
Only isolated failures associated with almost idenlical
design or in design simulation and testing
01 per thousand
Mo observed failurcs associated with almost identical

design oi in design simulation and testing
0 0 1 pet thousand
3
1 in 100,000
2
1 in 1,000,000
Failure is eliminated through preventive contro!

Veiy 1 ow
Failure is eliminated
through preventive
control.
Table Ci2 Suggested DFMEA Occurrence Evaluation Criteria
Chapter IIT
Design Pailure Mod and Effects Analysis
47
Chapter III
i.
^L'.J.U-:: -
: .:. i;=c
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Table III-I Sample DFMEA Form with Minimai Iniormation Elements & Example Entiies
48
Current Design Controls (h)

Cunent Design Controls aie those activities conducted as part of
tbe design process that have been completed 01 committed to and
that will assuie the design adeuacy for the design functional and
reliability leuirements under consideiation.
Theie aie two types of design controls to consider:
PreventioD:
Eliminate (prevent) the cause of the mechanism of failuie or the
failuie mod fiom occuning, oneduce its tat of occurrence.
Detection:
Identify (detect) the existence of a cause, the lesulting
mechanism of failuie or the failure mod, eithei by analytical or
physical methods, beibie the item is released foi pioduction.
: The preferred approach is to first use prevention controls, if
j possible The initial occurrence rankings will be affected by the
l prevention controls provided they are integrated as part of the
design intent
Detection contro! should include identification of those activities
which detect the failure mod as well as those that detect the
cause.
The team should consider analysis, testing, ieviews, and othei
activities that will assure the design adeuacy such as:
Prevention Controls
Benchmaiking studies
Pail-safe designs
Design and Mateiial standards (interna! and exteinal)
Documentation - records of best piactices, lessons Iearaed, etc

fiom similar designs
Simulation studies - analysis of concepts to establish design

reuirements
Eiioi-proofing
Detection controls
Design reviews
Prototype testing
VaIidation testing
Simulation studies - validation of design
Design of Expeiiments; including reliability testing
Mock-up using similai parts
49
POTENTIAL
iDtSKti FMEA1
. SvsMm
FMEANumbar
toOsi Y*ai(3yprogram(a)_
B
D
Paot-
_5..:'.v.;-.;i-r
.Componsnl
Design RssponsiDMIf
Kv Ctai
FMADato (Ora.!
H
F
Coio Team
->.'... r
i .nit
Polenlial
Failure
Mecie
Polenlial
Eect(s) of
irBeyt* Offaii
Cii .!..> I t i . .
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Failure
d o c (13*19 101
UawtaiMicn
p p c r a c o cbe tal
mei tnnkmii para
Polenlial
Cause(s) ol
failirr
Currenl Design
Atuen Rc&tus
Conlrols
Controls
r-iu-oi.... i
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columns for the design controls (i.e, separate columns foi
Prevention Contiols and Deteclion Controls) lo assist the team in
cleaily distinguishing between these two types of design
contiols. This allows fo-i a quick visual deteimination that both
types of design contiols have been considered
If a one-column (foi design contiols) foim is used, then the
following prefixes should be used For prevention contiols, place
a 'P' befoie each pieventon contiol listed Foi deteclion contiols,
place a 'D' befoie each deteclion contiol listed
Preventing the causes of the failuie mod through a design
change 01 design piocess change is the only way a reduction in
the occunence ianking can be effected
Table III 6 shows example pievention and detection contiols for
the causes identified in Table III.5.
Failure
Mod
Vehicle
does not
stop
Cause
Prevention
controls
Mechanical linkage
bieak due to inadeuale
conosion piotection
Master cylinder vacuum
lock due to seal design
Designed per
mateiial standard
MS-845
Carry-ovei design
with same duty
cycle leuiiements
Designed per
torue
reuirements 3993
Loss of hydraulic fluid

trom loose hydiaulic
Iine due to incoirect
connectoi torue
specification
Loss of hydiaulic fluid
due to hydiaulic lines
ciimped/compressed,
inappropriate tub
materia specified
,-,:..'
Designed pei
materia standaid
MS-1178
Detection
controls
Enviionmental
stress test 03-9963
Pressure vaiiabiiity
testing - system
level
Vibiation stepstiesstest 18-1950
Design of
Expeiiments (DOE)
-tubeiesiliency
../:
^mm'-y'
Table III.6 Esamples ol Prevention and Detection Design Controls
5;
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Detection (D) (i)

Detection is the iank associated with the best detection conttol
listed in the Cuiient Design Con&ol Detection column When
mor than one control is identified, it is recommended that the
detection ranking of each control be included as pait of the
description of the control Record the lowest ianking value in the
Detection column
A suggested appioach to Cuirent Design Control Detection is to
assume the failure has occuned and then assess the capabilities
of the cunent design contr ols to detect this failure mod
Do not automatically presume that the detection ranking is Iow
because the occuiience is Iow It is impoitant to assess the
capability of the design contiols to detect Iow fieuency failure
modes 01 reduce the risk of them going futther in the design
releaseprocess
Detection is a relative ianking within the scope of the individual
FMEA In order to achieve a lower ranking, geneially the design
control (analysis or verification activities) has to be improved
Suggested Evaluaticn Criteria
The team should agiee on evaluation criteria and a ranking
system and apply them consistently, even tf modified lor
individual piocess analysis. Detection should be estimated using
Table Cr 3 as a guideline
The ranking value of one (1) is reserved for failure prevention
: through proven design solutions
53
Chaptei III
Opportunity
for
Detection
Criteria:
Likefihood of Detection by Design Control
Ltkeiihood
m
Rank
-.of
..;,
Detection
'.I J.iiwii.i!'.
No detection
opportunity
No cuirenl design control; Cannot detect ot is not analyzed
Not likely to
detect at any
stage
Design anaiysis/detection contiols have a weak detection

capabilily; Virtual Analysis (e g , CAE, FEA, etc ) is not
cprrclau-d ;o expeeted aciual operating conditions
Product verification/validation aftei design freeze and prioi to

launch with pass/fail testing (Subsystem or system testing with
acceptance criteria such as nde and handling, shipping
evaluaiion, etc)
Post Design
Freeze and
prior to launch
, Alm ust
10
Very,.'
Rumu te
Ws&M.
Pioduct veiification/validation after design fieeze and prior to

launch with test to falure testing (Subsystem ex system testing
until failure oceurs, testing of system inteiactions. etc)
Pioduct vetification/validaIion after design fieeze and prior to

launch with riegradation testing (Subsystem or system testing
after durability test. e g , function check)
Product validation (ieliability testing, development or
validation tests) prior to design freeze using pass/fali testing
(e g , acceptance ctiteiia for performance, function checks,
etc)
Prioi to Design
Fjeeze
Product validation (reliability testing, dcvclopment ot

validation tests) prioi to design freeze using test to failure
(e g , until leaks, yields, cracks. etc )
Moderatply-
Product validation (reliability tesling, development or

validation tests) prior to design freeze using degradation
testing (e g , data trends, before/aftet values, etc)
Viitual
Analysis Correlaled
Design anaiysis/detection contiols have a stiong detection

capability Virtual analysis (e g , CAE, FEA, etc ) is hihlv
corretated with actual 01 expected operating conditions prioi
to design fieeze
Detection not
applicable;
Failuie
Prevention
Failure cause ot failure mod can not occui because it is fully

prevented through design solutions (c g , prowen design
standard, best praclice or common materia, etc)
- Almost
Cci
Table C t 3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria
v-
Chaptei III
Thls page inteotionally left blank
55
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56
Determining Action Priorities

Once the team has completed the initial identification of failuie
modes and effects, causes and controls, including lankings foi
sevexity, occuiience, and detection, they must decide if fuithei
efforts are needed to ieduce the risk Due to the inherent
limitations on tesouices, time, technology, and other factots,
they must choose how to best piioritize these eflbrts
The initial focus ofthe team should be oiiented towards failuie
modes with the highest seveiity iankings When the sevetity is 9
01 10, it is impeiative that the team must ensuie that the risk is
addiessed thiough existing design contiols or recommended
actions (as documented in the FMEA).
For failure modes with severities 8 or below the team should
considei causes having highest occuiience oi detection iankings
It is the team*s lesponsibility to look at ihe infoimation
identified, decide upon an approach, and deteimine how to best
piioritize the risk reduction effoits that best serve theii
organization and customeis
Risk Evaluation;
Risk Priority Number {RPN) Q)
One appioach to assist in action prioiitization has been to use the
Risk Piioiity Numbei:
RPN - Sevetity (S) x Occuiience (O) x Detection (D)
Within the scope of the individual FMEA, this value can rang
between 1 and 1000
The use oj an RPN rhreshold te NOT a recommended ptactice
fot determining the needfor actwm
Applying thiesholds assumes that RPNs are a measuie of ielative
risk (which they often are not) and that continuous improvement
is not iequired (which it is)
Foi examp!e, if the customei applied an arbitrary thieshold of
100 to the following, the suppliei would be reuiied to take
action on the chaiactestic B with the RPN of 112.
Item
Severity
Occuiience
9
7
2
4
57
Detection
5
4
RPN
90
l:2
POTENTIA
FAILURE MOD ANO EfFECTS ANALYSlS
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In this exaraple, the RPN is higher foi chaiacteristic B, but the

priority should be to woik on A with the highei severity of 9,
although the RPN is 90 which is lower and below the thieshold.
Another concern with using the threshold approach is that theie
is no specific RPN value that reauiies mandatory action.
Unfoitunately, establishing such thiesholds may promote the
wiong behavior causing team membeis to spend time trying to
justify a lowei occurtence ot detection ranking value to ieduce
RPN This type of behavioi avoids addressing the teal problem
that underlies the cause of the failure mod and merely keeps the
RPN below the thieshold It is impoitant to recognize that while
determining "acceptable" risk at a particulai program milestone
( e g , vehicle launch) is desiiable, it should be based on an
analysis of severity, occunence and detection and not thiough
the application of RPN thresholds
: Use of the RPN index in the discussions of the team can be a

i useful tool The limitations of the use of RPN need to be
understood However, the use of RPN thresholds to detetmine
l action priority is not recommended
Recomrnended Action(s) (k)

In genera, prevention actions (i e , reducing the occunence) are
preferable to detection actions An example of this is the use of
proven design standard or best practice rather than product
verification/vaIidation after design fieeze
The intent of recommended actions is to improve the design
fdentifying these actions should consider reducing rankings in
the following order: severity, occunence, and detection
Example approaches to ieduce these are explained below:
To Re duce Severity (S) Ranking; Only a design ievision can

bring about a leduction in the seveiity lanking
\ High severity rankings can sometimes be reduced by making

| design revisions that compensate or mitigate the resultant
severity of failure For example: The requirement for a tire is to
i "retain applied air pressure under use" The severity of the effect
- of the failure mod "rapid loss of air pressure" would be lower for
.- a "run fiat" tire
\ A design change, in and of itself, does not imply that the severity
I will be reduced Any design change should be reviewed by the
l team to determine the effect to the product functionality and
j process
59
Chaptei III
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60

Foi maximum effectiveness and efficiency of this appioach,
changes to the pioduct and piocess design should be
implemented early in the development piocess Foi example,
altemate materials may need to be consideied eaily in the
development cycle to eliminate conosion seveiity.
To Reduce Occurrence (O) Ranking: A reduction in the
occunence ianking can be effecied by removing 01 controlling
one oi mor of the causes 01 mechanisms of the failure mod
through a design ievision Actions such as, but not limited to,
the following should be consideied:
o
Enot proof the design to eliminate the faihue mod
Revised design geometry and toleiances
Revised design to lowei the stiesses ot replace weak

(high failure piobability) components
Add redundancy
Revised mateiial specifkation
To Reduce Deteetion (D) Ranking: The piefened method is

the use of eiroi/mistake prooflng An increase in design
validation/venfication actions should result in a leduction of
the deteetion ianking only In some cases, a design change to a
specific pait may be iequired to increase the likelihood of
deteetion (i e , reduce the deteetion ianking) Additionally, the
following should be consideied:
o
Design of Experiments (particularly when multiple

oi interactive causes of a failuie mod aie piesent)
Revised test plan
If the assessment leads to no recommended actions foi a specific

failure mode/cause/contiol combination, indicate this by enteiing
"Non" in this column. It may be useful to also include a
rationale if "Non" is enteied, especially in case of high severity
For design actions consider using the following:
Results of design DOE oi reliability testing
Design analysis (ieliabilify, structural oi physics of failuie)
that would confum that the solution is effective and does not
introduce new potential faihue modes
Diawing, schematics, ot model to confirm physical change of
taigetedfeature
Results fi om a design review
Changes to a given Engineering Standard or Design Guidelines
Reliability analysis lesults
61
Chaptet III
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62

Table III .7 below provides an example of the application of
causes (Column f), controls (Column h) and recommended
actions (Column k)
Rssponsibility & Target Completion Dat (I)

Entei the name of the individual and organization responsible for
completing each lecommended action including the taiget
completion dat The deslgn-responsible engineei/team leader is
responsible for ensuiing that all actions iecommended have been
implemented or adequately addiessed
Action Results (m-n)

Ihis section identifies the results of any completed actions and
their effect on S, O, D rankings and RPN
Action(s) Taken and Completion Dat (m)

After the action has been implemented, entei a bfief description
of the action taken and actual completion dale
Severity, Occurrence, Detection and RPN (n)

Aftei die preventivev'conective action has been completed,
determine and lecord the resulting seveiity, occuirence, and
detection rankings
Calculate and record the resulting action (lisk) priority indicatoi
( e g , RPN)
All ievised rankings should be reviewed. Actions alone do not
guaiantee that the problem was solved ( i e , cause addtessed),
thus an appropriate analysis or test should be completed as
verification If finthei action is considered necessary, repeat the
analysis The focus should always be on continuous
impiovement
63
Design Failure Mod and Efiects Analysis
Preventfon
Controls
Item
Failure
Mod
Cause
Disk
Brakc
system
Vebictc
doesnot
stop
Mechamcal linkage
break, due lo
inadequate coirosion
proteclion
" '
'.:'
Detection
Controls
Recommended
Actions
Designed pet
materia
standaid MS845
Environraental stress
test 03-9963
Change materia to
stainless steel
Maslet cylinder
vacuum lock due to
seal design
Carry-over
design with
same dury cycle
reuiieraents.
Pressure variability
testing - system leve!
Use carry-over aeal

design
Lossof hydraulic
fluid from loose
hydiaulic lin due to
incoirect coiwectoi
rorue specificalioo
Designed per
loiue
leuirements 3993
Vibiation step-stiess
test 18-1950
Modtfy connector
&om bolt-style to
quick-connect
Loss of hydiaulic
fluid due to hydraulic
lines
ci imped;corapiessed,
inappropriate tub
materia! specified
Designed per
materia
standaid MS1178
DOE-tube
resiliency
Modify hose
design &om MS1178 to MS-2025
toincreasestiength
'"
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Maintaining DFMEAs
The DFMEA is a lLving document and should be reviewed
whenevei there is a pioduct design change and updated. as
iequiied. Recommended actions updates should be included into
a subseuent DF MEA along with the fina lesults (what wotked
and what did not wotk)
Anothei element of on-going maintenance of DFMEAs should
include a peiiodic ieview of the rankings used in the DFMEA
Specific focus should be given to Occunence and Detection
rankings This is paiticularly impoitant where impiovements
have been mad eithet thiough pioduct changes oi impiovements
in design controls Additionally, in cases wheie field issues have
occmred, the lankings should be ievised accordingly
Chaptei III
Design Failute Mod and Effects Analysis
Leveraging DFMEAs
If a new pioject or application is functionally similai to the
existing product, a single DFMEA may be used with customer
concurrence Using a fundamentally sound baseline DFMEA as
the staiting point piovides the gieatest opportunity to leverage
past expeiience and knowledge If there are slight differences,
the team should identify and focus on the effects of these
differences
Linkages
The DFMEA is not a "stand-alone" document. Foi example, the
output of the DFMEA can be used as input foi subsequent
product development processes It is the summaiy of the team's
discussions and analysis Figur III 7 shows the linkages of

some of the commonly used documents
Boundary (Biock) Diagram,

P - Diagram, etc.
DFMEA
Design Verification
Plan& Report (DVP&R),
PRv1EA:etc.
Figur I H 7 DFMEA Information Inteirelationships Flow
65
Chapter Iii
Design Verification Plan & Report (DVP&R)

DFMEA and DVP&R have an impoitant Iinkage The DFMEA
identifies and documents the cunent design prevention and
detection contiols which become input to the test desciiption
included within the DVP&R The DFMEA identifies "what" the
contiols are while the DVP&R provides the "how" such as
acceptance ciitetia, proceduie and sample size
PFMEA
Anothei impoitant Iinkage is between the DFMEA and PFMEA
For example, a Piocess (PFMEA) failuie mod oi a Design
(DFMEA) failuie mod can iesult in the same potential pioduct
effect In this case, the effects of the design failuie mod should
be ieflected in the effects and seveiity rankings of the DFMEA
and PFMEA.
66
Chaptet IV
Piocess Failuie Mod and Effccts Analysis
PFMEA
Process Faiiure Mod and Effects Analysis
67
n->
Piocess Failuie Mod and Effects Analysis
The piocess FMEA, leferred to as PFMEA, supports

manufactuiing piocess development in reducing the risk of
failures by:
Identifying and evaluating the piocess functions

reuiiemems,
Identifying and evaluating potential pioduct and piocessrelated failure modes, and the effects of the potential failures
on the piocess and customeis,
Identifying the potential manufactuiing oi assembly process

causes,
Identifying piocess variables on which to focus process

contiols for occunence reduction or incieased detection of the
failuie conditions, and
Enabling the establishment of a piioiity

pteventive/conective action and controls
system
and
foi
The PFMEA is a living document and should:
Be initiated before ot at the feasibility stage,
Be initiated piior to tooling for production,
Take into account all manufactuiing

individual components to assemblies, and
Include all piocesses within the plant that can impact the
manufactuiing and assembly opeiations, such as shipping,
receiving, transporting of materia, storage, conveyors or
labeling
opeiations
fiom
Eaily review and analysis of new oi ievised piocesses is advised

to anticipate, resolve, or monitoi potential process concerns
duiing the manufactuiing planning stages of a new model ot
component ptogram
The PFMEA assumes the product as designed will meet the
design intent Potential failuie modes that can occur because of a
design weakness may be included in a PFMEA Theii effect and
avoidance is covered by the Design FMEA
The PFMEA does not rely on pioduct design changes to
overcome limitations in the process Howevei, it does take into
consideiation a pioducfs design chaiacteiistics relative to the
planned manufacturing oi assembly process to assure that, to the
extent possible, the resultant pioduct meets customer needs and
expectations. Foi example, the PFMEA development generally
assumes that the machines and euipment will meet their design
intent and therefoie aie excluded frorn the scope Control
mechanisms for incorning paits and mateiials may need to be
considered based on histoiical data
68
Chaptei r v
Customer Defined
The definition of "Customer" for a PFMEA should normally be
the "End User" However, the customer can aiso be a subseuent
oi downstream raanufacturing oi assembly opeiation, a seivice
opeiation, oi regulator5
Team Approach
The Pf MEA is developed and maintained by a mulri-disciplinaiy
(or cross-functional) team typically led by tire responsible
engineer During the initial development of the PFMEA, the
lesponsible engineei/team leadei is expected to directly and
actively involve repiesentatives from all affected aieas These
aieas should include but are not limited to design, assembly,
manufactuiing, materials, quality, service, and supplieis, as well
as the aiea responsible for the next assembly The PFMEA
should be a catayst to stimulate the inteichange of ideas between
the aieas affected and thus promote a team approach
Design Considerations
The team should assume the pioduct as designed will meet the
design intent
During the development of a PFMEA, the team may identify
design oppoitunities which, if implemented, would either
eliminate or reduce the occurrence of a piocess failuie mod For
example, adding a feature to a part and a matching featute to a
fixtuie will eliminate the possibility of an operator placing a part
in the wtong orientation Such infoimation must be piovided to
the responsible design engineer as well as the tooling /
equipment / fixture design-iesponsible individual for
consideration and possible implementation
See discussion in Chapter IT, Customer Defined

69
Chapter IV
Development of a Process FMEA

The process-iesponsibie engineer/team leader has at his or her
disposal a number of documents that will be useful in pieparing
the Pf MEA. 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.,
thepiocess intent
The PFMEA should begin with a flow chait of the genera
process This flow chart should identify the pioduct/process
chaiacteristics associated with each opeiation Identification of
product effects ftom the corresponding DFMEA should be
included Copies of the flow chart used in the PFMEA
prepaiation should accompany it
In ordei to facilitate documentation of the analysis of potential
failures and theii conseuences, example PFMEA forms have
been developed and aie piovided in Appendix A The minimum
infoimation content ieuired foi a PFMEA is discussed below
(AlsoseeTablelYl)
Prerequisites
A PFMEA should begin with the development of infoimation to
understand the manufactuiing and assembly opeiations being
analyzed and define theii reuiiements.
The process flow diagiam is a piimaiy input to the PFMEA The
flow diagiam is used as a tool to help establish the scope of
analysis duiing manufactuiing system design
Process Flow Diagram and linkage to PFMEA

A process flow diagiam6 describes the flow of the pioduct
through the process - fiom incoming to outgoing This should
include each stp in a manufactuiing or assembly piocess as well
as theii related outputs (pioduct chaiacteristics, teuirements,
deliveiables, etc) and inputs (process characteiistics, souices of
vaiiation, etc) The detail of the process flow depends on the
stage of piocess development discussion Ihe initial flow
diagiam is generally considered a high level piocess map It
needs mor detailed analysis to identify the potential failure
modes.
The Process Flow Diagram is also refeired to as a Process Flow Chart

70
Chapter IV
Piocess Failwe Mod and Effects Analysis
High Level Process Map
B-B-S-0
Detailed Process Flow Diagram
Figur IV 1 High Level to Detailed Process Maps
The PFMEA should be consistent with the information in the

process flow diagram The scope of the piocess flow diagram
should include all manufactuiing operations ftom processing of
individual components to assemblies including shipping,
ieceiving, transportation of materia, stoiage, conveyois,
labeling, etc A pieliminary tisk assessmenl using the process
flow diagram may be peifbimed to identify which of these
operations or individual steps can have an impact on the pioduct
manufactuiing and assembly and should be included in the
PFMEA
The PFMEA development continues by identifying the
iequiiement(s) for each process/function Requiiements aie the
outputs of each operation/step and relate to the reuirements for
the producl The Requirements provide a desciiption of what
should be achieved at each operation/step The Reuirements
provide the team with a basis to identify potential failure modes
In order lo assure continuity, it is highly recommended that the
same cioss-functional team develop the Process Flow Diagiam,
PFMEA, and Contiol Plan
See Figur IV 2 foi an example process flow diagram
71
Piocess Failuie Mod and Effecls Analysis
Chaptei IV
Deprtment:
Prod/Svc*
Page
_ xxxxxxxxxxx
Belt Drive C o m
Pon6'nt
Sources of Variation
(Experience-based)
ID N u m b e r
of
xxxxxxxxxx
Dat:. 09/24/08
Process Flow
Spillage, rough handiing

Materia Hardness, Structure,
and Dirnensions
Coolant Contaminalion and
Pressure
Tool setup by preset
Maintenance
Tool (insert) consistency
Lack of maintenance
Materia consistency
Tool (insert) consistency
Improper setup
Poof chip remova (ie Iow
coolant pressure
Improper setup
Toollng consistency
Cootant flow
Dress/compensation
consistency & accuracy
Dirty/oily parts
Poor gage maintenance
Consistency of maintenance
Operation f \
100%
St
orActivityV^lnspection|
|
~
OperatiorÂctivity with Inspection
V7
f\
Delay
V
' U
Transportation
: * ' '
Operator
(Fulltime)
^.
(PartTime)^)
I985-I9W ilu ilrind nistiwilcw. Iw
Figuie IV.2 Example Process Flow Diagram
72
Chapter IV
Process Failuie Mod and Effects Analysis
Other Tools and Information Sources

Othei sources of infoimation that aie useful in pioviding the
team with ways to focus and captuie discussions on the
ieuirements of the piocess include:
DFMEA
Diawings and design recoids
Bill of Process
Inteiielationship (Characteiistic) matiix
Intemal and extemal (customer) nonconfoimances (i e , known
failute modes based on histoiical data)
Quality and Reliability Histoty
Research Information
Aftei establishing the scope of the analysis effoit, the team
should begin by ieviewing histoiical information. The areas to
ievie\v should include:
Lessons that have been learned from pievious product and

piocess design implementation, and
Any information available that establishes best piactices
including items such as guidelines and standards, standard pait
identification, or enor-pioofiiig methods
Quality peifoimance infoimation available from similar,
pievious product and process designs, including items such as:
process yield7, first time capability (both end of lin and at each
opeiation), Paits pei Million (PPM), piocess capability indices
(Cpi; and PPk), and wananty metiics
The infoimation can be useful input for deteimination of
seveiity, occunence and detection rankings
After consideiing these pieiequisites, siait filling out the form
f Table IV 1 below)
Fiist Time Qualiry (f TQ); First Time Ihiough (FTT)

73
POTENTIAL
FAILURE MOD AND EFFECTS ANALYS1S
(PROCESS FMEA)
Het,,.
Wodd Vat(&JiPfOflfany*.
"
i _
Prcwas
B
3
G
Potential
Failure
Mod
Roinnii*^nl
"indlori
PflJCBS
KwDate
Poteniial
E f f e c t l s i of
Failure
Polential
Cause(s) of
Failure
k-eitttacrii w c
Mttij
h
F
FMEAOswiOiio.i
C u r r e n l Process
V;'M-.
RfrcotnmeiKled
Conlrols
Controis
Pwvnl">n
V i . '
-I
of
Pretora) Bv:
RB8poisibilIiv
& Targ i
Comj^boo Data
"'/' i
.,1
I,::..
C 0 V O K M OW
Aclions Taken
A i k l po-Jl.ic
* f * a v n&a
ud
UntrtaJbr
haOitO
UiKtrecs
Piae_
ft5p0fl!*IW
FMEANwtm
l-0X01S
Ccmx)B4 ***<
.... ' i i . , n
com;tr-MW<il
îcitmolEd
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ScfailwM
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ul winili c i
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V t > w 4 t t l e o nigh
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autt pievrrfai).<t
AiUctoi dwoi
'.... 1. I I n u jjn G
titûwnig
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lar tiir> i t a t n & t

0 X ' 0 01
tnKM'*ilia.a
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1'trnai c h e t
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:veut*i
SAM PLE
a1
a2
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1 . 1
w
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llMIll*
M.ii I i , i . . n : o
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ifcr*. K a U t o D cifoloi a m i
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Ci
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artrol-Cffc-3.06
-:
Chapter IV
Piocess Failure Mod and Effects Analysis
Example PFMEA Form

The foim used in the examples in this refeience manua is a
guide to document the team*s discussions and analysis ot the
PFMEA elements It contains the minimum content that is
noimally expected by the OEMs
Column oider can be modified and columns can be added to this
foim depending on the oiganization and customer needs and
expectations. In any case, any form submitted must be
acceptable to the customci.
Headerof the Process FMEA Form (fields A-H)

The following desciibes the infoimation to be entered on the
foim
The PFMEA headei should cleaily identify the focus of the
PFMEA as well as infoimation telated to the document
development and contiol process This should inelude an FMEA
number, identification of the scope, design iesponsibility,
completion dates, etc The headei should contain the following
elements8:
FMEA Number (A)

Entei an alphanumeiic stiing which is used to identify the
PFMEA document This is used foi document control
Itern (B)
Entei the name and number of the system, subsystem 01
component for which the piocess is being analyzed.
Process Responsibility (C)

Entei the OEM, oiganization, and depaitment 01 gioup who is
piocess design lesponsible Also entei the supply oiganization
name, if applicabte
Model Year(s)/Program(s) (D)

Entei the intended model year(s) and progiam(s) that will use 01
be atfected by the process being analyzed (if known)
The letters at the end oi each heading indicate the aiea refeired to on the sample foim
75
POTENTIAL
-1
FUEANdltier-
FAILURE MOOt ANO EFFECTS ANALYSIS

(PROCESS FMEA1
lm.
Mmet YssilsyPiograinis).
Co-e Teatr
D
G
(repai^d Bv:.
KevDale
fU6ADale(Owj.!-
ACIO- Nasilili
Currenl Procsss
Polential
Rwtwieniistl
Feiluro
Mod
Potential
Potentlal
Effectfs) of
r
Cause(s) ot
vli:Ll-f:
Failure
FuftCWill
Cb'0:
ReGonwifinded
Contrds
Conlrols
Pfevwttto<i
pr-\
CompkUofiDale
Cowtf In nor *U".
Minwnia
".(.'.H W I J <:'.
. , - . , . . - II--..
AHTMIH
Acbons Taken
Mig B t f n i a t n g
Uy CX 10 1S
v nm I W A M I
merterflu'
Co*rod wlaior
KMW Docr pum
ConipleKiA Oate
Stp acual,
"Hi Eiflif iMiUifl

DV0X 12 IS
GiiW*?:: IIOD
UoiWUiit*<v
., .... : .-
cnertmt.
in>paid wonni,
ot itieitoi 0oo>
.,:
IBSJ>SV
ilart-MG * - d
i y fint otosiow
*H*n1ainiii;
1>uf> oiut P r o s
i- - : : i . "
Ot* Mo w*lf
ws.*
IW
UHI rtrtt w i t
ant
I * COCflfllt
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C o * ni don*
h'cw Burwi i In
CglHjl C i " " i t
OMlUIBKU
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umili
Pr*nirt*iM*
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lutim.aicmM
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al
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r-
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'HiUCOiJif
Chaptei IV
Process Fjriluie Mod and Effects Analysis
Key Dat (E)

Enter the initial PFMEA due dat, which should not exceed the
scheduled start of production dat In case of a supply
oiganization, this dat should not exceed the customer reuiied
Production Pait Approval Process (PPAP) submission dat
FMEA Dat (Original) (F)

Entei the dat the original PFMEA was completed and the (atest
revision dat
Core Team (G)

Enter the team members responsible for developing the PFMEA
Contact information ( e g , name, organization, telephone
number, and email) may be included in a referenced
supplemental document
Prepared By (H)
Enter the name and contact information inciuding the
organization (company) of the engineei/team leader responsible
for pieparing the PFMEA
Body of the PFMEA Form (fields a
n)
Ihe body of the PFMEA contains the analysis of risks related to

the potential failures and impiovement action being taken 9
Process Step / Process Function /

Requirements (a)
Process Step/Function can be sepaiated rnio two (or mor)
columns or combined rnto a single, biidged column which
encompasses these elements Piocess Steps may be listed in the
Piocess Step/Function column ot additional column(s) may be
added containing the functions 01 iequiiements of that piocess
step
"Process Step", "Function", and "Requirements" are
desciibedbelow:
The letters al ihe end of each heading indicate the area releiied to on the sample fbim
POTENTtAl
f A1LURE MOC* AND EFFECTS ANALYSIS
IPROCESS FMEA1
SI
B.
Horn:,
MoflH Ye(syPiogram(sL
Ptwtm
fttefl
Resitoratilliy
Key D a l e
N jnfter.
F|.1EAD3iOrtg._
3
"a
T
Rqncmenl
g
3
& l i f t e m - a .
uwiai
cpposoncJ
Dat: turistrs
l i t Mit u>
AtfOnResuUs
Re*iin>ende<l
Conlrols
Conlrols
Pre*Mlon
,vl,.:l.:.
Acttons TaKen
. 'N
i-..
.'... . : . i i ' - ; i .
& Targei
C a r J r l i c o Dale
.. i i
EtMdt Dl m e r
I
^
kfraicr chcOicd
i c
'.-.i:.
>>
.':.
uniptt>4i0i
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ruit UwCjjh p j r t
C~Ui linii.
Incnitrd lurrwin
S U &V l i i i !
t * L't'H*iH n a
- '(
- immilut "o
- .
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Teilmar*
t t W K j iiifl
IM
IDOElon
P^sujie Ko O -
CompleUon D a l e
.-.
*pinstae<o
fcnltiKUue
f w i e i t tai
Respon&fcility
EtetEiwrWoB i Insi
iloof h w * * 9 l a
-UjBjlcijraoY
DO
Ra
Crmnl I''<:;::;;,;;
Potential
Cause(s) ot
Failure
u-i---,
I
I
Potenlial
Effect(s) of
Failure
Ul .1l--
.L.7.
Polenllal
Failure
proâm to
* I I I r^jos
SpJBV llMUf
......
0XV)01
<h4miK4ind
I m cunuit l * v a
Dan n&aioaCeMtci O n t t
i i psi * n
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y.
"(
w
-Tl
iw**anl<Ml)
- 1
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i . ' . I ..i '.-,
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:<
I m i r u ; IWra
SAM
U4iamt*rg
. . . . . li--. .
YWtgSOI
c u f t t f t OM-ofl
tttirtul clmna
U N W p c w a a ID
(onite - CpW.OS
ao
rr
r;
a1
a2
ni
E
- ^ ' ~
ProcessStep (a1)
Entet the identiiicalion of the piocess step ot opetation being
analyzed, based on the numbering piocess and teiminology Foi
example, entei the numbei and identifier (eg., name) Piocess
numbei ing scheme, seuencing, and teiminology used should be
consistent with those used in the process flow diagiam to ensure
tiaceability and lelationships to othei documents (Control Plans,
operator instiuctions, etc) Repaii and iewotk opeiations should
also be included.
Process Function (a1)

List the piocess function that coiresponds to each piocess step 01
opeiation being analyzed. The piocess function desciibes the
puipose ot intent of the opeiation A lisk analysis is
recommended in oidei to limit the numbei of steps to be
included to only those that add value 01 othei wise aie seen as
likely to have a negative impact on the pioduct If theie aie
multiple process functions being analyzed with iespect to a given
opeiation, each should be aligned on the foim with its iespective
"Requiiements" to aid in the development of the associated
failuie modes
Process Function becomes a2 if Process Step and Process

Function are split
Requirements (a2)
List the ieuiiements foi each piocess function of the piocess
step ot operation being analyzed Reuiiements aie the inputs to
the process specified to meet design intent and othei customei
iequirements If theie aie multiple ieuiiements with iespect to a
given ninction, each should be aligned on the foim with the
respective associated failuie modes in oidei to facilitate the
analysis
Requirements become a3 if Process Step and Process Function

are split into separate columns, e g , a1 and a2
79
poreNriAL
FW-AhuniMf.
FAILURE MOD AND Eff ECTS ANALYSIS

(PROCESS FMEA)
Iient.
Model
Y#siiWtaQiom{s)
B
D
Piocess
ResoorwJitl^
PrepsrW Bv;
Ke.Dae
FMEA Dato (Ortfl.j.
Cuncnl Proccss
Potential
jur^meu
Failure
Potential
Effecl(s) of
Potentlal
Cause(s) ot
Moce
Failure
Fallute
WCflrlty
Mcoch Ol IlWf
itaayhesa not
Controls
Descttc
\u-a
utfst* d n a
;->
Conlrols
FutKUon
CV 7 1
aersulKM
Mdittut
nwa-ojBow
pitej w c *
Acfton ResuiC?
;,.,,-, : m : < rot. -i
Aclion
Resposibiltly
STargel
Conipleton Date
A - M <yi>l><*
Acbons Taken
Contpleton
Dale
SUpSOWtA
b > Q X 1 0 IS
sera.*
'. i i
1'uuoi ciioefc
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Tompcaturc Itf"
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aiiefKieiWai*
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7.:
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a
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mrtuomrn
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o
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S AMPLE
Vgmr
U u w L i s ^ i i , In
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jpodtod Bunin-
al
a2
-II-
"Si
Chaptei IV
Piocess Failure Mod and Effecls Analysis
Potential Failure Mod (b)

Potential failure mod is defined as Ihe manner in which the
piocess could potentially fail to meet the piocess icuiiements
(including the design intent)
In prepaiing the FMEA, assume that the incoming
part(s)/mateiial(s) aie correct Exceptions can be mad by the
FMEA team where histoiical data indicate deficiencies in
incoming part uality
The team should also assume that the
basie design of the product is coirect; howevet, if there are
design issues which result in ptocess conceins, those issues
shouid be communicated to the design team foi resolution
List the potential failuie mode(s) foi the patticular opeiation in
teims of the piocess iequiiement(s) ( e g , as documented in the
piocess flow diagiam) Assume that the failure could occui but
may not necessarily oceur Potential failure modes should be
desciibed in technical teirns, not as a symptom noticeable by the
customer See the example table below.
Process
Step/Function
Operation 20:
Requirement
Artach seat cushion

to track using a
toique gun
*& ;
Potential Failure Mod
Four sciews
Specified screws
Assembly sequence: Fiist
screw in right front hole
Fewer than four sciews

Wiong screw used (laiger dia)
Sctew placed in any othei hole
Sciews fully seated
Screw not fully seated
Screws torued to dynamie

toique specification
Screw toiqued too high
wm::.
Screw toiqued too Iow
. : ; , ' : ; ;
Table IV.2 Example of Ptocess Step/Fu nction/Req u irements Columns on PFMEA Form
including Potential Failure Modes
If the requirements have been well defined, then the potential
failure mod is ieadily identifiable by deteimining the condition
when a specific leuiiement is not met Each iequirement may
have multiple failure modes A laige number of failure modes
identified foi a single iequirement usually indicates that the
iequirement is not weil defined
The assumption is mad that the failure could oceur but may not
necessarily oceur - consequent!y the use of the woid "potential".
Veiification of completeness of the potential failuie modes can
be mad thiough a review of past things-gone-wTong, concerns,
81
POTINTIAL
FA1LURE MOOE AND EFFECTC ANALYSli
(PROCESS FMEAJ
':'..
M o d e l Y e a ^ & J f r ogram<s)_
B
D
P f o c c r a RetpoitiibJKy
FfcifcANturtw.
PiwaI M BK.
KeyDate
FMEAOaisIOrtjt.
CceTeam
Rai(ueii*<u
Potential
Failure
Funciiofi
cnie* i nnor da:

: w r l i t JM
opro
Uiul
!:. ii:tti-: ....
Potenlial
Eflecl(s) of
Failure
Potenlial
Cause(s) ol
Fgilure
' .,
ManuUifinsaM
9 a v hisd u l
HHttttiM W
OlDiKC
i ...lv
dx<iuiui
ai f a m
!:;
1:1.- : .
Current Procuss
Adian P a *
RecommenCed
Conlrols
Conlrols
1PK
Acbon
ResponsibillIV
Slargel
CftrnplaOn P a w
-II::
M:l.
Ol i m Hk'iH
fUMpo-llp
6JIH 'luft la
prave>
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reject 01 scrap lepoils, and group biainstoiming Souices for this

should aiso include a compaiison of similai pfocesses and a
review of customei (End Usei and subseuent opeiation) claims
relating to similar components
Potential Effect(s) o f Failure (c)

Potential effects of failure are defined as the effects of the failure
mod as peiceived by the customer(s)
The effects of the failure should be desciibed in teims of what
the customei might notice or expetience, iemembeiing that the
customei may be an inteinal customei as wdl as the ultimate
End Usei The customei(s) in this context could be the next
opeiation, subsequent opeiations oi locations, the dealer, and/or
the vehicle owner Each must be consideied when assessing the
potential effect of a failure The pioduct effects in the PFMEA
should be consistent with those in the coiresponding DFMEA
If the failure mod could impact safety oi cause noncompliance
to regularions, this should be cleaiiy identifled in the PFMEA
For the End Usei, the effects should be stated in teims of pioduct
or system performance If the customei is the next opeiation or
subsequent operation(s) / Iocation(s), the effects should be stated
in terms of piocess / operation peifoimance See Table IV 3
Example ot Effects
In ordei to determine the Potential Effect(s), the following
questions should be asked:
1. Does the Potential Failure Mod physically prevent
downstteam processing or cause potential harm to
equipment or operator s?
This includes an inability to assemble or join to a mating
component at any subseuent customeis facility If so, then
assess the manufacturing impact No further analysis is iequired
If not, then go to uestion 2 Examples could include:
Unable to assemble at opeiation x
Unable to attach at customei facility
Unable to connect at customei facility
Cannot bor at operation x
Causes excessive tool weai at opeiation x
Damages equipment at opeiation x
Endangeis opeiator at customei facility
S3

!
3 Not: The location, station or operation at which the effect occurs
] should be identified. (f at a customer's facility, this should be
i stated.
2. What is the potential impact on the End Usei ?
Independent of any controls planned or implemented including
error 01 mistake-proofing, consider what the End User would
notice 01 expeiience This infbimation may be available within
the DFMEA. Once determined, go to uestion 3 Examples
could include:
Noise
High effoit
Unpleasant odoi
Intermittent opei ation
Watei leak
Rough idle
Unable to adjust
Difficult to contiol
Poor appeaiance
3. What would happen if an effect was detected prior to
reaching the End User?
The potential effect at the cunent oi receiving locations also
needs to be consideied Examples could include:
Lin shutdown
Stop shipment
Yaidhold
100% of product sciapped
Decreased lin speed
Added manpower to maintain reuiied lin iate
I
i
|
i
:
Not: If mor 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
Piocess Failute Mod and Effects Analysis
Example of Effects
Reuirement
Failure Mod
Effect
Fotu screws
Fewer than foui sciews
EndUuser Loose seat

cushion and noise
Afanufacturing and
A$sembly Stop shipment
and additional soit and
rework due to affected
portion.
Afanufacturing and
Assembly Unableto
install sciew in station
Specified screws
Wrong sciew used

(largei dia)
Assembly seuence:
Fiist sciew iitright
fiont hole
Screw placed in any othei

hole
Afanufactur ing and

Assembly Difficult to
install iemaining screws
in station
Screws fully seated
Screw not fully seated
Sciews toiqued to
dynamie toiue
specification
Sciew torqued too high
End User Loose seat

cushion and noise
Afanufacturing and
Assembly Soitand
rewoik due to affected
poition.
End User Loose seat
cushion due to subseuent
fmctuie of sciew and
noise
Afanufacturing and
Assembly Sottand
rewoik due to affected
poition.
End User Loose seat
cushion due to giadual
loosening of screw and
noise
Afanufacturing and
Assembly Soit and
iewoik due to affected
portion.
Screw torqued too Iow
'
< ' " ' ' '
* ''** * *
! * "
Table IV.3 Example of Effects
85
POTENTIAL
FAILURE MOD A N D EFF ECTS ANAlYSiS
IPROCESS f MEA1
Pfocs RospanaUrilif
Hem.
MtxJel YeaftBj/Prociram(s)_
K.N
n.!
Pt
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Piopaiwl 8y:
FMEADale (Ofia.l-
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FS
H
F
G
!
ReouHfanenl
Potenlial
Failure
Polentia!
Cause{s) of
Failure
Potential
Effect(s) of
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Current Process
Controls
Conltols
pfewntlco
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ResponsiMKy
& Targa
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Severity (S) (d)

Severity is Ihe value associated with the most seiious effect for a
given failuie mod Seveiily is a ie!ative lanking within the
scope of the individual PMEA
Suggested Evaluation Criteria
The team should agree on evaluation ciiteiia and a lanking
system and apply them consistently, even if modified fot
individual piocess analysis (See Table O l fot criteria
guidelines)
It is not recommended to modify criteria for ranking values 9 and

10. Failure modes with a rank of 1 should not be analyzed
further.
S7
Chaptei IV
1
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58
fi
III
labie Crl Suggested PFMEA Severity EvaIuation Ciiteiia
>N
Chapter IV
Process Faiiure Mod and Effects Analysis
Chaptei IV
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Table IV 1 Sample PFMEA Fotm with Minima) Information Elcmcnts & Example Entries
90
Chaptet IV
Process Failure Mod and Effects Analysis
Classification (e)
This column may be used to highlight high piiority faiiute modes
ot causes that may teuire additional engineering assessment
Ihis column may also be used to classiry any special pioduct oi
piocess chaiacteristics ( e g , critical, key, major, significant) foi
components, subsystems, or systems that may require additionaf
ptocess controls
i Customer specific requirements may identify special product or

| process characteristic symbols and their usage
Wheie a special characteiistic is identified with a seveiity of 9 or

10 in the PFMEA, the design lesponsibie engineer should be
notified sice this may affect the engineering documents.
Potential Cause(s) of Failure Moda (f)

Potential cause of failure is defined as an indication of how the
failure could occur, and is described in teims of something that
can be coirected 01 can be conttolled Potential cause of failuie
may be an indication of a design or piocess weakness, the
conseuence of which is the failure mod
To the extent possible, identify and document eveiy potential
cause for each failure mod The cause should be detailed as
concisely and completely as possible Sepaiating the causes will
result in a focused analysis for each and may yield different
measurement, controls, and action plans There may be one ot
moie causes that can result in the failure mod being analyzed
This tesults in multiple lines for each cause in the table or
form.10
In preparing the PFMEA, the team should assume that the
incoming pait(s)/material(s) ate correct. Exceptions can be
mad at the team's discietion wheie histoiical data indicate
deficiencies in incoming part quality
Only specific enors ot maltunctions ( e g , seal not installed oi
seal installed inveited) should be listed Ambiguous phiases
( e g , opeiatoi enoi oi seal mis-installed, etc) should not be
used See Table TV 4 Example of Causes and Controls
In preparing the PFMEA, the team needs to ensure that any limitations of the design that may iesult in a
potential process failure mod aie communicated to the design function
0;
Chapter IV
Process Failure Mod and Eiiects Analysis
Occurrence (O) (g)

OccuueDce is the likelihood that a specific cause of failuie will
occui. The likelihood of occunence ianking numbei has a
relative meaning iathei tham an absolute vaiue (See Table Cr2)
Estimate ihe likelihood of occunence of a polential cause of
failuie on a 1 lo 10 scal A consistent occunence ianking
system should be used to ensuie continuity The occunence
ianking numbei1 is a ielative ianking within the scope of the
FMEA and may not leflect the actual likelihood of occunence
The "Incident pei items/vehicles" is used to indicate the numbei
of failuies thal aie anticipated duiing the piocess execution. If
statistical data aie available ftom a similat piocess, the data
should be used to deteimine the occunence ianking In othei
cases, a subjeciive assessment can be mad by using the woid
desciiptions in the left hand column of the table, along with input
ftom the appropiiate process knowledge souice to estimate the
ianking
Suggested EvaIuation Ctiteria
The team should agree on eva!uation criteiia and a ianking
system and appiy them consistently, even it modified for
individual piocess analysis Occunence should be estimated
using a 1 to 10 scal based upon Table Ci2 as a guideline.
92
Chapler IV
i
Likelihood
of Failure
Very High
Criteria: Occurrence of C a u s e - PFMEA

(Incidents per items/vehicles)
> lOOperthousand
10
a 1 in 10
50 per thousand
l i n 20
High
20 per thousand
1 in50
lOpei thousand
1 in 100
2 per thousand
1 in 500
Moderate
5 pei thousand
i
'.
l i n 2,000
1 per thousand
1 in 10,000
.01 per thousand
1 in 100,000
.001 per thousand
1
' ' ' '
l i n 1,000,000
Very Low
Failuie is eliminated thiough pieventive control

Table Cr2 Suggested PFMEA Occuirence Evaluation Ciiteria
93
-;
'
Low
''.
.'-
POTENTIAL
FAILURE MODC ANO EFFECTS ANALYSIS
(PROCFSS f MEAI
I
IW".
CiUrtTBWii
Piocess
':.,i
,.>' i'
B
D
G
Potential
Failure
Mad';
Proces
K c y Dala
Potential
Effec(s) of
Failure
Potential
Cause(s) or
Failure
I
i
Cowt tnns * o - .
innr-oni w u
inv.ut>
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F
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- -'|;,i
Reconwiiended
Contros
Controls
PfOVeilltl]
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& Tatgel
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--tn-
Chapter IV
Current Process Controls (h)

Cunent Process Conti ols are desciiptions of the contiols that can
either prevent to the ex.tent possible, the cause of failure fiom
occuning oi detect the failuie mod or cause of failuie should it
occui
Thete aie two types of Piocess Contiols to consider:
Prevention:
Eliminate (pievent) the cause of the failure oi the failuie mod
fiom occutring, oi leduce its tat of occurrence
Detection:
Identify (detect) the cause of failure ot the failure mod, leading
to the development of associated corrective action(s) oi countermeasuies.
J The preferred approach is to first use prevention controls, if

j possible The initial occurrence rankings will be affected by the
i prevention controls provlded they are integrated as part of the
j process The initial detection rankings will be based on process
] controls that either detect the cause of failure, or detect the
\ failure mod
j Because statistical charting methods ( i e , Statistical Process
| Control)11 typically use sampling to assess process stability and
| detect out-of-control conditions they should not be considered
;! when evaluating the effectiveness of specific Detection Controls
i SPC may, however, be considered as a Prevention Control for
j specific causes whose trends are identifiable in advance of an
| actual non-conformance being produced, such as tool wear
The example PFMBA form in this manua has two sepaiate

columns foi Pievention Contiols and Detection Contiols to assist
the team in cleaily disttnguishing between these two types of
contiols This allows foi a quick visual determination that both
types of piocess contiols have been considered
If a one-column (foi piocess contiols) foim is used, then the
following piefixes should be used For prevention contiols, place
a 'P' befoie or aftei each pievention contiol listed Foi detection
contiols, place a 'D' before oi aftei each detection contiol listed
(see labie IV 4 Example of Causes and Contiols)
See Chryslei, Foid, GM; SPC Manua, AIAG

95
Chaptei IV"
Piocess Failute Mod and hffects Analysis
Failute
Mod
Screw not
fiilly scated
Reuirement
Screws torued
until fuLly seated
Screws torued
io dynamie
torue
specification
Screw
torqucd ioo
high
Pievention
Conti ul
Cause
Detection Conti oi
Nut runner not

held perpendiculai
to work surface by
opetatoi
Operator training
Angle sensor included in nut

iunner to detect cross-threading
not allowing part to be removed
fiom fixture until value is
satisfied
Toruc setting set

ioo high by nonset-up personnel
Password
protected contiol
panel (only set-up
peisonnel have
access)
Torque validation box included

in set-up procedur to validate
setting por to running
Torue setting set

too high by set-up
personnel
Training of set-up
personnel
Torue validation box included

in set-up piocedure to validate
setting pnoi to running
Senings added to
set-up instructions
Screw
toiued too
Iow
Torue setting set

Ioo Iow by nonset-up personnel
Password
piotected contro!
panel (only set-up
personnel have
access)

setting piioi to running
Torue setting sel

too Iow by set-up
peisonnel
Training of set-up
personne!

setting piior to running
Settings added to
set-up instructions
"
" " ' - '
- ' : ' - - '
'
':
labie IV4 Esamples of Causes and Conti ols
96
Chaptei IV
This page inientionaly left blank
97
Chapiei TV
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Hi ii*
i IIII
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III
3 a
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8
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III 11
LO
i 5
S-th
co
Table IV..l Sample PFMEA Form wih Minfmal Information Elements & Exarnple Eotries
98
Piocess Faituie Mod and Effecis Analysis
Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Detection Conttols column Detection is a telative
ranking within the scope of the individual FMEA In oidei to
achieve a lower ranking, geneially the planned detection control
has to be improved
When mor than one control is identified, it is recommended that
the detection ranking of each control be included as part of the
desciiption of the control Record the Iowest ranking value in the
Detection column.
Assume the failure has occirrred and then assess the capabilities
of all "Cunent Process Controls" to pievent shipment of the part
having this failure mod Do not automatically presume that the
detection ranking is low because the occurrence is low, but do
assess the ability of the process controls to detect low fiequency
failure modes or prevent them from going further in the piocess
j Random qualily checks are unlikely to detect the existencs of an

i isolated problem and should not influence the detection ranking
Suggested Evaluation Cnteria
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual product analysis Detection should be estimated using
Table Ci 3 as a guideline
a
I The ranking value of one (1) is reserved for failure prevention

j through proven process design solutions
99
Chapter IV
.
1 O p p o r t u n i t y for
Detection
No detection
opportunity
Criteria:
Rank
Ukelhood
of D e t e c t i o n
10
^ZL
Likelihood of Detection by P r o c e s s C o n t r o l
No cuirent process contiol; Cannot detect or is not
analyzed
Not likely to detect

at any stage
Failure Mod and/oi Error (Cause) is not easily detected

( e g , iandom audits)
Problem Detection
Post Piocessing
Failure Mod detection post-piocessing by

opeiator through visual/tactile/audible means.
Problem Detection
at Souice
Failure Mod detection in-station by operator through

visual/tactile/audible means or post-piocessing through
use of ataibute gauging (go/no-go, manua toiue
check/clicker wiench, etc)
Problem Detection
Post Processing
Failure Mod detection post-processing by operator

through use ot vaiiable gauging oi in-station by operator
through use of ataibute gauging (go/no-go, manua
toiue check/clicker wiench, etc).
Problem Detection
at Souice
Failure Mod or Error (Cause) detection in-station by

operator through use of variable gauging or by
automated controls in-station that will detect disciepant
part and notiiy operator (light, buzzer, etc) Gauging
performed on setup and first-piece check (for set-up
causesonly)
Pioblem Detection
Post Processing
Failute Mod detection post-piocessing by automated

controls that will detect discrepant part and lock part to
prevent iurthei processing
Pioblem Detection
at Souice
Failute Mod detection in-station by automated controls

that will detect discrepant pait and automatically lock
pait in station to pievent turther processing
1
i s
-Very Rcnifte
Re.no,
l - Y e n t L o w
,;',
^::;^../:;v,::'
6
>%%'*
-:/
>
1
1
Modcrati*
j
4
Moderatcly;
''"> o
i*
''*
1
3
f" $$&.
> ery High.
Eitor Detection
and/oi Pioblem
Pievention
Enor (Cause) detection in-station by automated controls _that will detect enor and pievent disciepant pait fiom
being mad
Detection not
applicable; Enor
Pievention
Error (Cause) pievention as a result of fixture design,

machin design or pait design Disciepant paits cannot be '%
mad because item has been enor-proofed by
piocess/product design
Table Cr3 Suggested Process FMEA Detection Evaluation Criteria
100
AimOStr;;
C&rtai' '- ""-
Chaptei IV
i
This page intentionaly lett blank
I
101
POTENTIAL
FAILURE MOD AND EFFECTS ANALYSlS
(PROCESS FMEA1
Kem
D
G
CcreTam.
Redurentertl
Key D a l e
Polential
Failure
Mod
Potential
EffGCl(S) of
Failure
^ _ _ _
Potenlial
Causeis) of
Ir
I
I
li
-.
..:
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Determining Action Priorities

Once the team has corapleted the initial identification of failure
modes and effects, causes and contiols, including rankings for
sevetity, occuiieoce and detection, they must decide if further
efforts aie needed to icduce the iisk Due to the inherent
limitations on resouices, time, technology, and other factors,
they must choose how to best piioiitize these efforts
The initial focus of the team should be oiiented towards failure
modes with the highest sevetity rankings When the seveiity is 9
oi 10, it is imperative that the team ensuie that the iisk is
addressed through exisring design controls or tecommended
actions (as documented in the FMEA)
For failure modes with seveiities of 8 oi below the team should
consider causes having ihe highest occurrence or detection
iankings It is the team's lesponsibility to look at the
infoimation, decide upon an approach, and determine how to
best prioritize their iisk leduction effoils which best seive their
organization and customers
Risk Evaluation;
Risk Priority Number (RPN) (j)
One approach to assist in action piioiitization has been to use the
Risk Prioiity Numbei:
RPN - Seveiity (S) x Occuirence (O) x Detection (D)
Within the scope of the individual FMEA, this value can rang
between 1 and 1000
The use of an RP>\ thtes/toid is NOT a tecommendedpractice
fot determining the need for actions
Applying thresholds assumcs that RPNs are a measuie of ielative
risk (which they often aie not) and that continuous improvement
is not requiied (which it is)
For example, if the customei applied an aibitraiy thieshold of
100 to the following, the supplier would be requiied to take
action on the characteiistic B with the RPN of 112
Item
A
B
Severity
9
7
Occunence
2
4
Detection
5
4
RPN
90
112
In this example, the RPN is higher for characteiistic B than

chaiacteiistic A. Howevei, the piioiity should be lo woik on A
with the higher severity of 9, although its RPN is 90 which is
lower and below the threshold
103
POTENTIAL
f AILURE MOD AND EFf ECTS ANALYSlS
IPROCESS FMEA1
Modal Yaat<s|>fogran>ls)_
B
D
Dttalhm.
IWlK.
ftajmenteiit
Potentia)
Failure
P<epaiM B Y :
Kv Dole
FMCA Dale ( O l g . ; .
Potentlal
Cause(s) ot
Failure
iKilittt l i ! i*t
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Another concem with using the Ihieshold approach is that there
is no specific RPN value ihat requires mandatory action
Unfoitunately, establishing such thiesholds may piomote rhe
wiong behavioi causing team members to spend time tiying to
justify a lower occunence ot detection lanking value to teduce
the RPN This type of behavioi avoids addressing the ieal
problem that underlies the cause of the failure mod and meiely
keeps the RPN belo w the thieshold. It is impoitant to recognize
that while deteimining "acceptable" risk at a particular program
milestone (e g , vehicle launch) is desiiable, it shouid be based
on an analysis of seveiity, occunence and detection and not
thiough the application of RPN thiesholds
Use of the RPN index in the discussions of the team can be a
1 useful tool The limitalions of the use of RPN need to be
1 understood However, the use of RPN thresholds to determine
action priorfty is not recommended
Recommended Action(s) (k)

In genera, pievention actions (i.e , reducing the occunence) are
piefetable to detection actions An example of this is the use of
piocess design enoi pioofing tather than landom uality checks
oi associated inspection
The intent of any recommended action is to reduce iankings in
the following order: seveiity, occunence, and detection.
Example approaches to icduce these are explained below:
j
j
I
|
To Reduce Sevetity (S) Ranking; Only a design or process

ievision can bring about a reduction in the severity ranking
A product/process design change, in and of itself, does not imply

that the severity will be reduced Any product/process design
change shouid be reviewed by the team to determine the effect
on the product functionality and process
j For maximum effectiveness and efficiency of this approach,

J changes to the product and process design shouid be
I implemented eatly in the development process For example,
I process technology needs to be considered very early in the
j process development if severity is to be reduced
To Reduce Occunence (O) Ranking: To reduce occunence,

process and design tevisions may be reuired A reduction in
the occunence lanking can be effected by iemovrng or
contiolling one oi mor of the causes of the failuie mod
through a product oi process design revision
Studies to undeistand the souices of vaiiation of the piocess

using statistical methods may be implemented These studies
105
H
BD
POTENTtAL
FAILURE MOD A N D FFFECT5 ANALYSIS
(PROCESS FMEA)
Hem.
Cro T o o m
Re*il(emaiW
B
D
G
Potentiai
Failure
Proceto
Data
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.
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Re?ponikify
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Cause(s) ot
i-n lure
Potential
Etfecl(s) of
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FMEA N U i t i M f -
Acilwis Taken
CompkHion D a U
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Chapter IV

may lesult in aclions that reduce occunence Fuither, the
knowledge gained may assist in the identification of suitable
contiols including ongoing feedback of infbrmation to the
appropiiate operations for continuous improvement and problem
ptevention
To Reduce Detection (D) Ranking: The prefened method is

the use of enor/mistake proofing
A redesign of the
detection methodology may result in a reduction of the
detection ranking In sonie cases, a design change to a
process step may be requiied to increase the likelihood of
detection (i.e, ieduce the detection ranking) Generally,
improving detection contiols iequires the knowledge and
undeistanding of the dominant causes of process vaiiation
and any special causes Incieasing the fiequency of
inspection is usually not an effective action and should only
be used as a tempoiaiy measuie to collect additional
infoimation on the piocess so that peimanent
preventive/conective action can be implemented12
If the assessment leads to no recommended actions fot a specific

failure mode/cause/contioi combination, indicate this by enteiing
"Non" in this column It may be useful to also include a
rationale if "Non" is enteied, especially in case of high severity
For ptocess actions, the evaluation may include but is not limited
to a rt:view of:
Results of piocess DOE 01 othei testing when applicable
Modified process flow diagram, flooi plan, work instiuctions

or preventive maintenance plan
Review of equipment, fixtuies or machineiy specifications
New or modified sensing/detection device

Table IV 5 below provides an example of the application of
causes (Column f), controls (Column h) and iecommended
actions (Column k)
Responsibility & Target Complstion Dat (I)

Enter the name of the indvidual and oiganization responsible foi
completing each iecommended action including the target
completion dat The piocess-tesponsible engineei/team leader is
responsible for ensuiing that all actions recommended have been
implemented or adequately addressed
)
12
See Chiysier, Ford, GM; SPC Manua, AlAG

107
er
POTENTIAl
FAJLUftE M0D6 AND EFFECTS ANALYSlS
IPROCSS FMEA1
Ihm.
Pto&as
Rnpoiii
Kev Dale
FtEADaWOtkn
H
F
Caro T -
.''..' Al K t i . . -
Cunei)! Piocess
*~,V.
i-mci;
Polentlal
Potenlial
Potenlial
Failute
Effecf(s) o t
Cause(s) of
Modo
Failure
r a i ure
Controls
Contros
F!-econifnr)odetl
A..:i' i
R- .
Preveiiln)ii
ResponsibillIv
A c t i o n s Tefcen
STatgel
Ccmptaoon D&e
Comp*e&dr> D a m
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Action Results (m-n)

I his section identifies the results of any completed actions and
their effect on S, O, D lankings and RPN
Action(s) Taken and Compietion Dat (rn)

After the action has beea implemented, enter a biief desctiption
of the action taken and actual compietion dat
Severity, Occurrence, Detection and RPN (n)

After the pieventive/coirective action has been completed,
deteimine and tecord the lesulting seveiity, occurrence, and
detection iankings
Calculate and recoid the lesulting action (iisk) piioiity indicatoi
( e g , RPN)
AU revised iankings should be reviewed Actions alone do not
guaiantee that the problem was so!ved (i e , cause addressed),
thus an appropriate analysis 01 test should be completed as
verification If furthei action is considered necessary, repeat the
analysis The focus should always be on continuous
improvement
Chaptei IV
Process
Step/Function
Op 20(attach
seat cushion to
tiack using a
torue gun)
Sclect four
screws
Reuiiemem
Four screws
Failuie
Mode
Fewer than
foui screws
Cause
Too few
screws
inadvertently
installed
Prcvention
Conti ols
Visual aids
illusttating
correct
uantity
Detection
Contiols
Recommended
Actfons
Visual
Inspection
in station
In-station torue
monitoiing;
Linelockout if
fewei dian foui
Visual
inspection
in slation
In-station torue
angie monitoring;
L irrc lockout if
angle not met
Operator
training
Specified
screws
Wrong
screw used
(latgct dia)
Similar
screws
availab!e at
station
Visual aids
illustiating
correcl
screw
Operator
iraining
Erroi proof by
design: use one
type screw for
-i-.i -::/riL.iLac:
bole
llll
Assembly
seuence:
First screw
in nght front
iili
Op 20(attach
seat cushion to
track using a
tOique gun)
Bcginning with
right fiont hole,
lorue cach sctcw
to thereuired
torue
Visuai aids
identifying
location of
first screw
Visuai
inspection
in station
Operator
training
Add posifion
sensor to nut
runner not
aliowing too! to
opciate unless
runner is aligned
with correct hole
labie I V 5 Esamples oiCauses, Contr ols and Actions
Maintaining PFIVlEAs
The PFMEA is a living document and should be ieviewed
whenevei theie is a pioduct oi piocess design change and
updated, as iequiied.
Anothei element of on-going maintenance of PFMEAs should
include a peiiodic revie\v Specific focus should be given to
Occuirence and Detection iankings
This is particulaity
impoitant wheie theie have been pioduct oi process changes oi
impiovements in process conttols Additionaily, in cases wheie
either field issues oi pioduction issues, such as dismptions, have
occuned, the iankings shoitld be ievised accordingly
Lyraging PFMEAs
The use of a fundamentally sound PFMEA is the staiting point
that provides the gieatest oppoitunity to !everage the use ofj>ast
expeiience and knowledge
110
Chaplei IV

If a new project or application is functionally similar to the
existing pioduct and the piocess to be used is similar; a single
PFMEA may be used with customer concunence If there are
differences, the team should identify and focus on the effects of
these diffeiences
Linkages
Ihe PFMEA is not a "stand-alone" document Figur IV 5 shows
some common linkages
DFMEA, Process Flow

Diagram, etc.
Process Control Plans

Figur IV.5 PFMEA Infbrmaiion Inteirelationship Flow
To DFMEA
In the development of a PFMEA it is impoitant to utilize the
infoimation and knowledge gained in the creation of me
DFMEA However, the link between the two documents is not
always obvious The difftculty occuis because the focus of each
FMEA is diffeient
The DFMEA focuses on pait function
whereas the PFMEA focuses on the manufactuiing steps 01
process Infoimation in the columns of each foim is not directly
aligned For example, Item/Function-Design does not equal
Piocess Functions/Reuirements; potential design failure mod
does not equal potential piocess failure mod; potential design
cause of failuie does not eûal potential process cause of failure
However, by comparing the oveiall analysis ol design and
process, a connection can be mad. One such connection is
between the chaiacteiistics identified duiing the DFMEA and
PFMEA analysis
Another connection is the lelationship between potential design
cause of failure (DFMEA) and potential process failuie mod
(PFMEA) For example, the design of a feature such as a hole
can cause a particular failuie mod The conesponding piocess
lii
Chaptei IV
Piocess Faiiuie Mod and Effects Analysis

faiiuie mod is rhe inability of the piocess to manufacture the
same featuie as designed In this example, the potential design
cause of faiiuie (hole diameter designed too laige) would appeai
to be similai to the potential piocess faiiuie mod (hole drilled
too laige) The potential effect of the failure mod foi both
design and process may be identical if' theie weie no additional
piocess ielated effects In other words, the end iesult (effect) of
the failure mod is the same, but there are rwo distinct causes
While developing the PFMEA, it is the team's iesponsibiliry to
ensure that all piocess reJated potential faiiuie modes which Iead
to pioduct ielated effects are consistent between the DFMEA
and the PFMEA
To Control Plan
In addition to the list of Recommended Actions and their
subsequent follow-up as a iesult of the PFMEA activity, a
Control Plan should be developed13 Some organizations may
elect not to specifically identify the ielated pioduct and piocess
charactetistics" in the PFMEA In this siruation, the "Pioduct
Chaiacteiistics" poition of the Control Plan may be deiived fiorn
the
"Reuirements"
poition
of
the
"Piocess
Function/Requiiements"
column
and
the
"Piocess
Chaiacteiistics" poition may be derived ftom the "Potential
Cause(s) of Failure Mod" column
When the team develops the Control Plan, they need to assuie
that the PFMEA cunent controls aie consistent with the connol
methods specified in the Control Plan
13
Guidelines for Conttol Plan developmem aie included in Chiyslei, Foid, GM; Advanted P>oduct Quality
Planning and Conttol Plan (APQP), AIAG.
112
APPENDICES
113
Appendix A
Saraple Forms
Appendix A: Sample Forms

DFMEA Forms
Foim A: Basic form (with minimal information)14

o
Foim B: Foim with. Item/Function and Reuirements in

sepaiate columns
o
To assist in the deteimination of failure modes
Foim C: Form A with Pievention Contiols column to the left

of the Occunence column
o
To better show the relationship between pievention

contiols and occurrence ianking
Form D: Fotm B and C combined
Form E: Form D with sepaiate columns for Cunent

Detection Design Contiols (Cause and Failuie Mod)
o
To highlight the need to consider cause-ielated

contiols
Form F: Foim B with separate columns foi Responsibility

and Taiget Complelion Dat and Actions Taken and
Completion Dat
o
15
With Ptevention and Detection Contiols as sepaiate

columns15
To allow soiting by dates
Ihis form was provided in the Chiyslei, Ford, and GM; FMA Manua 3* Ediiton, AIAG
Pieventive and Detective Contiols may be in the same column if each control is identified with a "P"
oi "D" iespectively
114
Appendix A
Sample Foims
NdH
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115
Appendix A
Sample Forms
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116
Appendix A
Sample Foirtis
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117
Sample Foims
ixA
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118
Appendix A
Sample Borms
DFMEA Form E
119
Appendix A
Sample Foims
Nd a
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120
Appendix A
Sample Forms
PFMEA Forms
Foim A: Basic form (with minima! information)16
o
With Prevention and Detection Contiols as sepaiate

columns'7
Foim B: Foim A with Process Step/Function and

Requiiements as sepaiate columns
o
To assist in the deteimination of failure modes
Foim C: Form A with Prevention Contiols Column to the

left ot the Occurrence column
o
To better show the telationship between pievention

conttols to occunence ianking
FoimD: Form B and C combined

Foim E: Foim D with sepaiate columns for Cunent
Detection Piocess Contiols (Cause and Failure Mod)
o
To highlight the need to consider cause ielated

controls
Form F: Foim B with sepaiate columns for Responsibility

and Taiget Complerion Dat and Actions Taken and
Completion Dat
o
To allow soiting by dates
Form G: Form B with ID, Product and Piocess within a

bridged Reuiieroents column
o
To piovide consistency among the Piocess Flow,

PFMEA and Contiol Plan
Form H: Foim D and G combined
16
17
This foim was adapted from that provided in ihe Chiyslei, Foid, and GM; FMEA Manua .$"* Edition, AlAG.
Preventive and Deiective Contiols may be in the same column if each control is identified with a "P" 01 "D"
respectively
121
Appendix A
Sample Forms
Nd&
mi......
ssuuroso
'
gg
- I
3
M
"'
Ndd
uoipsiea
7C= <c-
P
93"19Jjn3DQ
lii
uoiie3j|isse|Q
'f.,La-\3g
III
x
PFMEA Form A
122
Appendix A
Sample Fonns
NdH
. - , - - .-~<G
^-"-'S
|2
Ndti
-J l!l
< U.
<
Uli
C u-
5
**
J <
0. o,
UJ
1
8
-
3C.I3JJI M O
UJ
.;
3
_j
S
:
U0;13C!JSSB O
U8MS
1"
IJJ
! I
1'FMEAFormB
123
Appendix A
Sample Foims
o.
iii
&
o-o
aci.sjinKio
313
i
twjeoyissaio
.luOAog
JJ
PFMKAFormC
124
Appendix A
Sample Foims
Ndb
!'
>M;~Q
^0!^XIJ!Q
pwas
a s
Nd*
innwtan
w -.
m
l,
UJ w.
ggS
2 <Ul
Q9
HU
JO-JOJJI
,'.;(;.
Iii!
m ui c
L^tycjisssjo
AjUOAOg
m
?
W
PFMEA Form D
125
Appendix A
Sample Forms
MdH
*jipasa
*!3U^r-33Q
c 2
P
i ?1 i
^
\dcl
noipaiaa
_ ' ' .1
<Q 5
| " (U vi
< o:
LU &
D ~
O
11
O o.
:;
:OL:O.J"OOO
111
:'
LLl
':
<
Sil
0-0*5
uoiieoyisseio
AiuaAeg
li
lii
3
o. cc
PFMEA Form E
126
Appendk A
Sample Fornis
i?!.-' ';
<IUJ.'JS
II
.', -".I- :..!:,.,>,
s 3
Nua
jorcajea
lip
i
35
acuaunoco
83
uc;|ec[|issnio
tl3A0$
III
lii
i
II
PFMEA J: ui rnF
127
Appendix A
Sample Forms
Nch
uopajaa
Ktrajmao
SilWii^
<3
Ndi:
uoii=ywci
-j w _
5 S
Oa
Jll!
ui}|;cj:jissr;|;j
Ajus,\as
Iii
-
a
a
>-
E
o.
S
I
.1
PFMEA Form G
128
Appendix A
Sampie Foims
O133J30
iUC!IEQQ
Soomt
II
NriB
uC;iCS)3a
o.,' ^
esiraunMO
ta w
3 2 I
uoiuraarasep
MuiMog
lii
"
1
6
PFMEAFoimH
129
Appendix B
System Level FMEA
Appendix B: System Level

The piocess for a System FMEA is geneially the same as the
deveIopment of other FMEAs The majoi 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 lowei levels) The System level
FMEA includes failure modes associated with inteifaces and
interactions in addition to consideiing single point failuies which
is the primaiy focus of product level FMEAs
Io help illustiate the meaning of System, Subsystem, and
Component FMEAs, two examples have been constiucted below
in Figuie B 1 (for Inteifaces and Interactions) and in Figur B 2
(foi Item, Function, and Failure Modes.)
:_-
'
IYIIIIUI
Indirect interface with

other subsystems
Subsystems
** Jr
D
*-
"\
u--^?
/W
/
*-"""
'
Major
Subsystems
'-.":''.'':.:
'
, , ' . - , "
' . i
' ' ; '
[A
X
-
Minor
Si. hcvctorn<:
Interface with the

Environment
Figur B.l Interfaces and Interactions

The FMEA team is responsible for specifying the scope of its
respective FMEAs The example in Figur B i shows that the
team has specified Subsystems A, B, C, and D along with the
suiiounding enviionment as compiising the System that must be
considered while completing the System FMEA.
130
Appendix B
System L evel FMEA
interfaces
In Figur B 1, intetiaces between subsystems aie 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 lin The Enviionment also touches each
of the subsystems listed in Figuie B 1, which reuires the
"Environmental Inteifaces" be consideied when completing the
FMEA Also, the inteifaces to major and minoi subsystems,
whethei direct or indiiect, should be included
The interfaces which are identified in the System FMEA should

be included in the respective Subsystem FMEA
Figur B.2 shows a system and its intenelationships in a

"haidware" oriented appioach
Interactions
A change in one subsystem or component may cause a change in
anothei subsystem or component
In Figuie B I , inteiactions between subsystems and components
can occui among any of the interfacing systems For example,
Subsystem A heats up, lesulting in Subsystem B and D gaining
heat through their respective inteifaces, as well as Subsystem A
giving ot? heat to the enviionment Interactions might also occur
among 'nofl-contacting' systems via transfer through the
'ero/iionmenl' For example, if the environment is composed of
high humidity and Subsystems A and C are dissimilai metals
sepaiated by a non-metal composing Subsystem B, Subsystem A
and C can still have an electrolytic reaction due to the moisture
ftom the enviionment. Thus, inteiactions among non-contacting
subsystems can be ielatively difficult to piedict but aie impoitant
and should be consideied
131
System Level
r
OJ
to
I
I
I
3)
Accommodales mae adidls

comtortably h) Ihe 99.5lh
percentile
Frame
Upper Frame
Potential Failure Mode(s):

-Structural failure of seat support
-Excesstve ceflection ot seat
support
,
Function:
-Provides pleasing appearance
...etc....
Bicycie

-Finish (shlne) detenorates
-Paint chips
Function:
-Ease of use
Potuntial Failure Mode(s|:
-DifflcuU lo sleer
Diflicufl lo peda
Front Wheel Assembly
-PfOYide reliable Iransportalion
\ i
\'
Rear Wheei Assembly

-Structural failure
-Excessive deflection
Function:
-Provides dimensional control (or
correct firushed frame geometry
-Length of frame mounling poinls
toolong
-length of frame mounling points
too short
Lower Front Tub

Lower Rear Tub
Sprocket Tub
Sprocket
Function:
-Provide comtortabie Iransportation
Function:
-Provides structural support
Handle Bar
Function:
Potential Failure Modelsj:
Chan breaks ffequenUy
Tires require freuent Mamlenance
Component Levei
Function:
-Provide slabie attachmenl for
seat support
Design Objscllvos1)
Minimum 3000 hours of rlding
wilhoul Ihe need (oc mamtenance
and 10,000 hours o l rkJing i w Ihe
design Hfe.
2}
Subsystem Level
Seat
Poiential Failure Mode{s)

-Sealing posrlion is not comfortabte
Cham Assembly
i
cc
Appendix B
Sys(em L e v d F M E A
Relationships
Multiple Levels of Design FMEAs
Moie 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 hieiarchy (i e , system, subsystem and component) aie
linked tbiough the cause -> failure mod -> effect ot failure
lelationships This is a two way linkage (see Figuie B 3):
Ftom Lower to ffighei Levei: The effect of a failure mod at a
given level is a failure mod at the next highei level
Fot example, the effect of a part 2 failuie mod would be a
failure mod of module 3 eithei diiectly or indirectly by causing
another pajt to fail The effect of a module 4 failure mod is a
failuie mod of subsystem 4 Conseuently, the effect of a
failure mod at any sublevel may ultimately become a system
tailure mod with its customer/ user related effects.
Ftom Highei to Lower level: The linkage ftom a higher level to
the next lowet Ievel is iclated to the physics of failure lather than
a pure cause and effect relationship sice in the development of a
DFMEA, the causes identified at any level deal with the design
piocess and only indirectly with the failure mechanisms.
Undeistanding these relationships will piovide a consistency of
analysis and an economy of etfoit in the development of
DFMEAs
133
System Level f MEA
Effect on the end user
System
Subsystem
5
4
The effect of a
! Subsystem 4 Failure Mod is a
V
System Failure Mod
j ; SubsystemJ|
.Module
1
Module
2
Module
The effect of a
Module 3 Failure Mod is a
- Subsystem 4 Failure Mod
Design Process
Causes Y1, Y2, ..... Yn
Figuie B 3 DFMEA Effects Linkages
134
The effect of a
sublevel Failure Mod
is ultimately a
System Failure Mod
and its customer effect
HJaÊSI^^SEEfflffW
Appendk C
Altemative Risk Assessments
Appendix G: A!ternative Risk Assessments

Alternatives to RPN
The risk piiority numbei is the product of the severity (S),
occuirence (O), and detection (D) iankings
(S) x (O) x (D) = RPN
Wirhin the scope of the individual FMEA, this value (between 1
and 1000) can be used to assist the team in ianking the concems
in the design of the pioduct and process.
Ihe table below, however, illustiates how differenl Seveiity (S),
Occuiience (O) & Detection (D) scenaiios result in eual RPN
values 18
Upon ieview of each scenario, priorities would not be
established by the team based on the RPN alone
Fifteen Different Situations with an RPN=360
1
2
3
4
5
6
7
3
9
10
-1
12
:3
14
15
Severity of
Problem
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
High
High
Moderate
Moderate
Moderate
Moderate
Moderate
Moderate
1C
1C
1C
9
9
9
9
8
8
6
6
5
5
4
4
Likelihood of
Ccci; rrerice
High
Moderate
Moderate
Very High
High
Moderate
Moderate
9
6
4
10
8
5
4
High
Moderate
Very High
Moderate
High
High
Very High
High
5
10
6
9
s
1C
9
Likelihood of
Detection
Moderate
Low
V97 Rcrô:o
Mod High
Moderate
Remote
fmpossible
Moderate
Very Remote
Low
Impossible
Remote
Very Remote
\Zery Remote
Impossible
4
6
9
4
5
8
'0
5
9
6
10
8
9
9
10
The ease of calculation and soiting of this index has led many to
use it exclusively and without consideiation to what may be a
more appioptiate means of piioiitizing Examples of some such
altematives follow
Used wilh peimission ftom Whiilpool Coipoialion, 2005, 2006

135
Altemative Risk Assessmenls
Appendbc C
Alternative: SO (S x O)
Some organizations may choose to piimaiily focus on Seveiity
and Occurrence The SO index is the pioduct of the Seveiity, and
Occuirence rankings In using this index, the otganization may
focus on how to ieduce SO by leducing the value of "O" thiough
preventive actions Fuitheimoie this may lead to subseuent
detection impiovements for those with the highest SO value
Alternatfoe: SOD, SD
Some organizations have chosen to use SOD 01 SD as a
piioiitization tool SOD is the non-arithmetic combination of the
Seveiity, Occunence and Detection iankings SD is the nonarithmetic combination of the Seveiity and Detection rankings
Example (SOD):
Severity,
S=7
Occunence,
O- 3
Detection,
D=5
The resulting SOD is 735

Esample (SD):
Seveiity,
S =7
Detection,
D=5
The resulting SD is 75
The SOD, when soited in numeiical, descending oidet, will
piioiitize the scenaiios fitst by severity, second by occunence

and lastly by detection
s
7
7
3
O
7
D
3
RPN
147
3
7
7
7
147
147
SOD
773
737
SD ,
377
37
73
77
al
Veiy
Diffeient
Scenaiios
Equal RPN Values

Table C l Contrast among RPN, SOD and SD
1 Just as with RPN. use of the SOD/SD index should be used in
1 context of team discussion Defining priorities simply based on
j the SOD has limitations just as with the RPN For example, a
i failure mod with a SOD of 711 would be ranked higher (i.e.,
j have to be considered before) a failure mod with 599
136
Appendix D
Alteinative Analysis Techniues
Appendix D: AIternative Analyses Techniques

Failure Mod and EfFects Analysis is one of many lechniques
used to evaluate and analyze design risk Other methods have
beeii deve!oped fot specillc aieas and can be used to complement
the analysis in the FMEA piocess They raay be used as a
ieplacement foi an FMEA with authoiization by the customei
These aie only a few of the examples.
Failure Mod, Effect

and Criticality
Analysis (FMECA)
FMCA is similar to FMEA The C in FMECA indicates that the
ciiticality (01 sevetity) of the various failuie effects aie
consideied and ianked Today, FMEA is often used as a
synonym foi FMECA
Design Review Based

on Failure Modes
(DRBFIM)
Design Review Based on Failuie Modes is a cause and effect
analysis of conceins related to a design change It is a tool used
to guide and manage good discussion in relation to the change
DRBFM fbcuses on the impact of the change on design,
evaluation piocedures, and manufactuiing systems with the
intent of anticipating and preventing problems A design ieview
by subject mattei expeits to evaluate the change{s) and related
impiovements is an integial pait of DRBFM. (Reference Figuie
Dl)
Fault Tree Analysis

(FTA)
FTA is a techniue fot system analysis wheie system faults are
analyzed 6om a single potential failuie to identily all possible
causes FTA consideis combinations of inteidependent as well as
independent causes In addition to the structute of the fault tree
and all of the logie inteidependencies, the FTA noimally
inciudes the failuie piobabilities identification This allows the
calculation of system reliability given the component
leliabilities [9 (Reference Figuie D 2).
19
References: IEC 61025; QICID (ASQ-20352)
137
Appendix D
AIteinative Anaiysis Techniques
Action Status
'"'riap.".: .- - I! "'
Target Cwrptlon
Dato
3 _
o OJ
Manufacturing
Targe Compelion
Data
c_
Evaluation
cc
3
8
LI
CO
O
s
()
"O
o
<y
ii
r;
cc
o o .
Responsib*ty a
i?
8S
a:
Taccjet Complelion
Dale
;.r.
Design
ci
Design Actions to
elimtnate concerns
c
o
(provitfe deaits and

best practices used)
"O
_^2
fc u)
V)
go
co
CO
5
<
Severity
r^
Effect Cody
Li
Customer and
System or
Subsystem Effeci
a
E
co
ia
Other Causes
QL
(Review)
II
a U
C;'
o:
c
.??
"w
;ro
Other Concerns
(Review)
CC
6
L e s s o f Functlon
or Va)ue
to Customer
Part Function
Change to Design
or Environment
I-Iguie D-! Example of DRBFM Elements
138
Appendix D
Alternative Analysis lechniues
CODECand
anatog m t 8 2 not
oparaflooal
I
One or Bom
'
IC Faisd: No er
noisy yffliage
s:.ppy
analog tnputs r.ot |

avaitebe
Comocnents
&iling - any fajre
CD
ICfatlsd i * to
random faiiure
Cne or mora pins

shorted due to
CeDns on bcord
Ccnnecton(s)
openofshortt
du to m(g defect
5V analog not
awfciaHo
Voltjge nas high

or tow freuertey
n.oise
IC (Ms due to
manufacTunog
Cold or insufnaent
sodsr on ora er
mor pins
One or mor pins

snerted du to
cxcessve scJdcr
IC damaged t y
ESD dunng
assemblyor test
IC erackad Cunnp
assemWy
T
[
Solder A
l short_G13 J
Figur D.2 FTA Tree S t i u c t u r e
139
[Brc*en_C13 j
Refeiences and Suggested Readings
References and Suggested Readings

IEC 60300-3-1, Dependability management - Pan 3-1 Apphcatlon guide - Analysis techniues for
dependabiity - Guide on merhodology
LEC 60812, Edilion 2; Failure modes andeffects analysis, lanuaiy 2006
IEC 61025, Edition 2; Fault ttee analysis, lanuary 2007
QICID (ASQ-20352) "System Reliability Thtough Fault Ttee Analysis"
SAE ARP 5580, Recommended Faiute Modes and Ejfects Analysis (FMEA) Practices for NonAutomotive AppHcations (Repiaceraent for MIL-SID-1629A, 1998 (withdrawn))
SAE 11739:2002, Potential Failure Mod and Ejfects Analysis in Design (Design FMEA) and Potentia
Failure Mod andEffects Analysis in Manufactutmg and Assembly Processes (Process FMEA)
Alfledo, H S Ang and Wilson, H Tang (1990). "Ptobability Concepts in EngineeringPlanningand
Design, Volume II ~ Decision Risk and Reliability", WUey Publications
Bowles, J (2003) "An Assessment of RPN Piioritization in a Failure Modes Effects and Ciiticality
Analysis", Ptoceedings Annual Reliability and Maintainability Symposium, pp 380-386; aiso in Joutnal oj
the IEST, Imtitute ofEnvitonmental Sciences and Technology, Vol47, 2004, pp 51-56
Krasich, M (2007) "Physics of Failure Appioach to FMEA", Tutorial Ptoteedings Reliability and
Maintainability Symposium
Kjasich, M (2005) "Fault Tree Analysis in Pioduct Reliability Improvernent", Tutonal Ptoceedings
Reliability and Maintainability Symposium
0'Connei, PD.T,(2002) Piactical Reliability Engineeiing 4thedition, (Wiley)
Shu-Ho Dai and Ming-0 Wang (1992), Reliability Analysis m Engmeetmg Apphcations, Van Nostiand
Reinhold
Wheelei, D J (2005) The SixSigma Ptactitioner'% Guide to Data Analysis, SPC Piess, Knoxvi!le, pp 311315
Rausand, M (2004) System Reliability Theoty (2nd ed), Wiley, 2004
140
Ind es
lnex
APQP (Advanced Pioduct Quality Planning), 2,
5
bock diagiam, 18, 19,29
classification, 39, 91
continuous impiovement, 6, 57,63, 103,107,
109
contro! plans, 6,13,111
cioss-functional, 2, 9,17, 69,71
cunent design contiols, 49, 53
design improvements, 16
design intent, 11,12,22,29,41,49, 68, 79
design life, 45
detection, 13, 18,49, 51, 57-64, 68,73,95,99110,135,136
detection contiols, 49,66,99,107
DFMEA (Design Failure Mod and Effccts
Analysis), 5, 16-19,22,25,29, 39,41, 64-66,
70,73,83,84,111,133
DOE (Design of Expeiiments), 61, 107
DRBFM (Design Review by Failure Mod), 137,
enoi proofing, 73,105
evaluation critetia, 37,45, 53, 87,92,99
flow diagiam, 70, 71,81, 107
FMECA (Failuie Mod, Effect and Ciitical
Analysis), 3,137
Follow-up, 6
F1A (Fauli Ilee Analysis), 137,139
iunction, 16,18,19,21 , 29 ,31, 35, 71, 79,111
fiinctional requiiements, 8,16,18,25
inteiactions.3,10,130, 131
inteifaces, 10, 11,29, 130,131
item,73, 75, Ul, 133
linkages, 65,111,134
mistake pioofmg, 61, 107
occunence 3 13,45,46,49,53,57,59,61,63,
64,68, 69, 92, 93,95,99,103, 105,107,109,
110,135,136
OEM (GM, Foid, Chrysler), 11, 17,27, 75
PFMEA (Process Failure Mod and Effects
Analysis), 5, 17,66, 68-71, 75, 77, 83, 91,95.
110,111
potential cause, 12,39,41,91,92
potential failuie mod, 11,16-18, 31, 61, 70-71,
81, 112
preventive contiols, 45
process step, 77, 79, 107
recommended actions, 6, 13,18, 57, 59, 61,103,
L07
responsible engineei, 17, 63, 69, 70,91,107
RPN (Risk Priority Numbei), 57,59,63,103,
105,109,135,136
scope, 3,4, 8,10,11,18,25,68,70,71, 73, 75,
130
SD (Ranking by Seveiity and Detection), 136
Seveiity, 13, 37, 57, 59,63, 84, 87,103,109,
135,136
SO (Ranking by Seveiity and Occunence), 136
SOD (Ranking based on Seveiity, Occunence
and Detection), 136
SPC (Statistical Piocess Contiol), 95, 107
special chaiacteristic, 39, 91
specification, 11,13, 61,107
team, 2,4,5, 8, 9,10,14,17,18,21,22,27, 29,
35, 37,41,45,49,53,57,59,69, 71, 73,81,
87,91,95,99,103,105,11!
team leadei, 6, 9, 69, 70,107
thresholds, 57, 59,103,105
va!idation, 16, 31,49,59,61
141

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aiitf Effects Analysis

JohnFcghali, Chiyslei LLC

Process Flow Diagram and Iinkage to PFMEA

Geneial FMEA Guidelines

Genera FMEA Guidelines

FMEA can also be applied to non-manufacturing areas. For

Geneial FMEA Guidelines

New designs, new technology, or new process.

Modifications to existing design 01 process

Use of an existing design or process in a new

Genera FMEA Guidelines

Impact on Organization and Management

Address Design and Piocess FMEAs, as applicable

Accomplish this by having the FMEA process an integral pait

Pait of engineeiing technical reviews

Pait of the regulai sign-off and appioval of the pioduct or

Tiaining foi users

Geaeial FMEA Guidelines

Plan and Define Program

Product Design and Development

Process Design and Developmenl

Product and Process Validation

Feedback, Assessment and Conective Action

Geneial FMEA Guideliaes

Follow-up and Continuous lmprovement

The team leadei/lead engineei has seveial means of assuring that

Reviewing designs, processes, and related iecoids to ensiue

Confuming the incorpoiation of changes to design/assembly/

Sbategy, Planning, Implementation

Strategy, Planning, Implementation

Potential pioduct oi piocess failure to meet expectations

Potential causes of the failure mod

Application of cuirent controls

Fundamentally, the format utilized should addiess:

Sttategy, Planning, Implemenlation

Identify the Team

Relevant Resources or Expertise

Functions, iequirements and expectations

Customei, Program Management, Integiation iesponsible

Potential failure mod - the way a piocess 01

Customer, Piogram Management, Integiation responsible

Effects and conseuences of the failure - to

Customer, Program Management, Integiation responsible

Freuency of occunence of potential failuie

Application of cuirent controls-prevention

Customei, Manufacturing and Assembly, Packaging,

Stiategy, Planning, mplementation

Define the Scope

Bock (Boundaiy) diagiams

Paiameter (P) diagiams

Intei face diagiams

Process flow diagiams

Bili ofMateiials (BOM)

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

A Component FMEA is a subset of a subsystem FMEA Foi

Strategy, Ptanning, Implementation

Define the Customer

END USER: the person or oiganization that will utilize the

OEM ASSEMBLY and MANUFACTURING CENTERS

SUPPLY CHAIN MANUFACTURING: the supplier location

Strategy, Planning, Implementation

Strategy, Planning, Implementation

Reviewing engineering drawings and specifications,