POTENTIAL

FAILURE MODE AND

EFFECTS ANALYSIS
(FMEA)
Reference Manual
Fourth Edition

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

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

Summary of Changes in the 4th edition FMEA Reference Manual

The DFMEA and PFMEA methods described in the 4th edition FMEA Reference Manual include
those associated with design at the system, subsystem, interface, and component level and the
process at manufacturing and assembly operations.

General Changes
• The formatting used in the 4th edition is intended to provide easier reading.
o An index is included.
o Icons are used to indicate key paragraphs and visual cues are used.
• Additional examples and verbiage have been provided to improve the utility of the
manual and to provide a closer tie into the FMEA process as it develops.
• Reinforcement of the need for management support, interest, and review of the
FMEA process and results.
• Define and strengthen the understanding of the linkage between DFMEA and
PFMEA as well as defining the linkages to other tools.
• Improvements to the Severity, Occurrence, Detection ranking tables so that they are
more meaningful to real world analysis and usage.
• Alternative methods are introduced that are currently being applied in industry.
o Additional appendices which have example forms and special case application of
FMEA.
o The focus on the “standard form” has been replaced with several 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 improvement has been revised including an additional method, and the use
of thresholds on RPN is clarified as a practice that is not recommended.

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

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

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

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

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

The Supplier Quality Requirements Task Force would like to thank the following individuals, and
their companies, who have contributed their time and efforts to the development of this edition of
the FMEA Reference Manual:

Michael Down, General Motors Corporation

Lawrence Brozowski, General Motors Corporation
Hisham Younis, Ford Motor Company
David Benedict, Chrysler LLC
John Feghali, Chrysler LLC
Michael Schubert, Delphi
Rhonda Brender, Delphi
Gregory Gruska, Omnex
Glen Vallance, Control Planning Initiatives
Milena Krasich, Bose
William Haughey, ReliaTrain

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

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TABLE OF CONTENTS
General Changes.................................................................................................................................. i
Chapter I......................................................................................................................................................... 1
General FMEA Guidelines ................................................................................................................ 1
Introduction ................................................................................................................................................ 2
FMEA Process.................................................................................................................................... 2
Purpose of Manual.................................................................................................................................. 3
Scope of Manual..................................................................................................................................... 4
Impact on Organization and Management.................................................................................................. 4
FMEA Explained........................................................................................................................................ 5
Follow-up and Continuous Improvement ................................................................................................... 6
Chapter II........................................................................................................................................................ 7
Overview of FMEA Strategy, Planning and Implementation............................................................. 7
Introduction ................................................................................................................................................ 8
Basic Structure ........................................................................................................................................... 8
Approach .................................................................................................................................................... 8
Identify the Team ................................................................................................................................... 9
Define the Scope................................................................................................................................... 10
Define the Customer............................................................................................................................. 11
Indentify Functions, Requirements, and Specifications ....................................................................... 11
Identify Potential Failure Modes .......................................................................................................... 12
Identify Potential Effects ...................................................................................................................... 12
Identify Potential Causes ...................................................................................................................... 12
Identify Controls................................................................................................................................... 13
Identifying and Assessing Risk ............................................................................................................ 13
Recommended Actions and Results ..................................................................................................... 13
Management Responsibility ..................................................................................................................... 14
Chapter III .................................................................................................................................................... 15
DFMEA Design Failure Mode and Effects Analysis ....................................................................... 15
Introduction .............................................................................................................................................. 16
Customer Defined................................................................................................................................. 16
Team Approach .................................................................................................................................... 17
Manufacturing, Assembly and Serviceability Considerations.............................................................. 17
Development of a Design FMEA ............................................................................................................. 18
Prerequisites ......................................................................................................................................... 18
Block (Boundary) Diagrams............................................................................................................. 18
Parameter (P) Diagrams.................................................................................................................... 21
Functional Requirements.................................................................................................................. 22
Other Tools and Information Resources........................................................................................... 22
Example DFMEA................................................................................................................................. 25
Header of the Design FMEA Form (fields A-H) .............................................................................. 25
Body of the DFMEA Form (fields a – n).......................................................................................... 29
Maintaining DFMEAs .......................................................................................................................... 64
Leveraging DFMEAs ........................................................................................................................... 65
Linkages ............................................................................................................................................... 65
Design Verification Plan & Report (DVP&R) ................................................................................. 66
PFMEA............................................................................................................................................. 66
Chapter IV .................................................................................................................................................... 67
PFMEA Process Failure Mode and Effects Analysis ....................................................................... 67
Introduction .............................................................................................................................................. 68
Customer Defined................................................................................................................................. 69
Team Approach .................................................................................................................................... 69
Design Considerations.......................................................................................................................... 69
Development of a Process FMEA ............................................................................................................ 70

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 Prerequisites ......................................................................................................................................... 70
Process Flow Diagram and linkage to PFMEA ................................................................................ 70
Other Tools and Information Sources............................................................................................... 73
Research Information ....................................................................................................................... 73
Example PFMEA Form........................................................................................................................ 75
Header of the Process FMEA Form (fields A-H) ............................................................................. 75
Body of the PFMEA Form (fields a – n) .......................................................................................... 77
Maintaining PFMEAs......................................................................................................................... 110
Leveraging PFMEAs .......................................................................................................................... 110
Linkages ............................................................................................................................................. 111
To DFMEA..................................................................................................................................... 111
To Control Plan .............................................................................................................................. 112
APPENDICES............................................................................................................................................ 113
Appendix A: Sample Forms ................................................................................................................... 114
DFMEA Forms................................................................................................................................... 114
PFMEA Forms.................................................................................................................................... 121
Appendix B: System Level FMEA......................................................................................................... 130
Interfaces ............................................................................................................................................ 131
Interactions ......................................................................................................................................... 131
Relationships ...................................................................................................................................... 133
Multiple Levels of Design FMEAs................................................................................................. 133
Appendix C: Alternative Risk Assessments ........................................................................................... 135
Alternatives to RPN............................................................................................................................ 135
Alternative: SO (S x O) .................................................................................................................. 136
Alternative: SOD, SD ..................................................................................................................... 136
Appendix D: Alternative Analyses Techniques...................................................................................... 137
Failure Mode, Effect and Criticality Analysis (FMECA)................................................................... 137
Design Review Based on Failure Modes (DRBFM) .......................................................................... 137
Fault Tree Analysis (FTA) ................................................................................................................. 137
References and Suggested Readings ...................................................................................................... 140
Index....................................................................................................................................................... 141

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 TABLES and FIGURES
Figure III.1a Block (Boundary) Diagram Examples .................................................................................... 19
Figures III.1b, c Block (Boundary) Diagram Examples ............................................................................... 20
Figure III.2 Example of a Parameter (P) Diagram for a Generic Catalytic Converter ................................. 21
Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries...................... 24
Table III.3 Example Potential Failure Modes............................................................................................... 32
Table III.4 Example Potential Effects .......................................................................................................... 35
Table Cr1 Suggested DFMEA Severity Evaluation Criteria ........................................................................ 37
Table III.5 Example Potential Causes .......................................................................................................... 42
Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria ................................................................... 46
Table III.6 Examples of Prevention and Detection Design Controls............................................................ 51
Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria ..................................... 54
Table III.7 Examples of Causes, Controls and Recommended Actions ....................................................... 64
Figure III.7 DFMEA Information Interrelationships Flow........................................................................... 65
Figure IV.1 High Level to Detailed Process Maps....................................................................................... 71
Figure IV.2 Example Process Flow Diagram ............................................................................................... 72
Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries ...................... 74
Table IV.2 Example of Process Step/Function/Requirements Columns on PFMEA Form including Potential
Failure Modes....................................................................................................................................... 81
Table IV.3 Example of Effects ..................................................................................................................... 85
Table Cr1 Suggested PFMEA Severity Evaluation Criteria......................................................................... 88
Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria.................................................................... 93
Table IV.4 Examples of Causes and Controls .............................................................................................. 96
Table Cr3 Suggested Process FMEA Detection Evaluation Criteria.......................................................... 100
Table IV.5 Examples of Causes, Controls and Actions.............................................................................. 110
Figure IV.5 PFMEA Information Interrelationship Flow........................................................................... 111
DFMEA Form A ........................................................................................................................................ 115
DFMEA Form B......................................................................................................................................... 116
DFMEA Form C......................................................................................................................................... 117
DFMEA Form D ........................................................................................................................................ 118
DFMEA Form E......................................................................................................................................... 119
DFMEA Form F ......................................................................................................................................... 120
PFMEA Form A ......................................................................................................................................... 122
PFMEA Form B ......................................................................................................................................... 123
PFMEA Form C ......................................................................................................................................... 124
PFMEA Form D ......................................................................................................................................... 125
PFMEA Form E.......................................................................................................................................... 126
PFMEA Form F.......................................................................................................................................... 127
PFMEA Form G ......................................................................................................................................... 128
PFMEA Form H ......................................................................................................................................... 129
Figure B.1 Interfaces and Interactions........................................................................................................ 130
Figure B.2 Item, Functions, and Failure ..................................................................................................... 132
Figure B.3 DFMEA Effects Linkages ........................................................................................................ 134
Table C.1 Contrast among RPN, SOD and SD........................................................................................... 136
Figure D.1 Example of DRBFM Elements................................................................................................. 138
Figure D.2 FTA Tree Structure .................................................................................................................. 139

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vi
Chapter I General FMEA Guidelines

Chapter I

General FMEA
Guidelines

1
Chapter I General FMEA Guidelines

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

FMEA Process
FMEA is an analytical methodology used to ensure that potential
problems have been considered and addressed throughout the
product and process development process (APQP – Advanced
Product Quality Planning). Its most visible result is the
documentation of the collective knowledge of cross-functional
teams.
Part of the evaluation and analysis is the assessment of risk. The
important point is that a discussion is conducted regarding the
design (product or process), review of the functions and any
changes in application, and the resulting risk of potential failure.
Each FMEA should ensure that attention is given to every
component within the product or assembly. Critical and safety
related components or processes should be given a higher
priority.
One of the most important factors for 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 value, the FMEA must be done
before the implementation of a product or process in which the
failure mode potential exists. Up-front time spent properly
completing an FMEA, when product/process changes can be
most easily and inexpensively implemented, will minimize late
change crises. Actions resulting from an FMEA can reduce or
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 equipment 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
general, FMEA is applied to potential failures in product design
and manufacturing processes where the benefits are clear and
potentially significant.

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Chapter I General FMEA Guidelines

Purpose of Manual
This manual describes the basic principles and implementation
of the FMEA 1 process and how it is integrated within the
product and process development cycle. This includes the
documentation of this process and how the analyses can be
applied for timely necessary improvement of a product or a
process in its early and full development stage.
This manual also provides descriptions and examples of alternate
and supporting methodologies for these analyses, their specific
advantages and limitations, guidance of how the analysis is to be
carried out for the maximum reliability improvement or
mitigation of potential safety risks. The manual provides
guidance on how the risk can be represented, measured and
prioritized for cost effective mitigation of the failure effects.
As a tool in risk evaluation, FMEA is considered to be a method
to identify severity of potential effects of failure and to provide
an input to mitigating measures to reduce risk. In many
applications, FMEA also includes an estimation of the
probability of occurrence of the causes of failure and their
resultant failure modes. This broadens the analysis by providing
a measure of the failure mode’s likelihood. To minimize risk, the
likelihood of failure occurrence is reduced which increases
product or process reliability. FMEA is a tool that is instrumental
in reliability improvement.
There are three basic cases for which FMEA process is to be
applied, each with a different scope or focus:

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 or 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
requirements.
Case 3: Use of an existing design or process in a new
environment, location, application, 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.

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

3
Chapter I General FMEA Guidelines

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

Impact on Organization and Management

FMEA is an important activity within any company. Because the
development of an FMEA is a multi-disciplined activity
affecting the entire product realization process, its
implementation needs to be well planned to be fully effective.
This process can take considerable time and a commitment of the
required resources is vital. Important to FMEA development is a
process owner and senior management commitment.
Implementation approach will vary depending on the size and
structure of the company concerned, although the principles will
be the same:
• The scope will cover FMEAs produced in house and by multi-
tier suppliers.
• Address Design and Process FMEAs, as applicable.
• Accomplish this by having the FMEA process an integral part
of the APQP process.
• Part of engineering technical reviews.
• Part of the regular sign-off and approval of the product or
process design.
An FMEA is developed by a multi-functional (or cross-
functional) 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 expertise, available time
and authority sanctioned by management.
A comprehensive training program should be implemented
including:
• Management Overview
• Training for users
• Supplier Training
• Facilitator Training
Ultimately, management has the responsibility and ownership for
development and maintenance of the FMEAs.

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Chapter I General FMEA Guidelines

FMEA Explained
FMEAs are an integral part of managing risk and supporting
continual improvement. Consequently, FMEA becomes a key
part of Product and Process development. The Advanced Product
Quality Planning (APQP) process identifies five general areas of
focus in this development process:
• Plan and Define Program
• Product Design and Development
• Process Design and Development
• Product and Process Validation
• Feedback, Assessment and Corrective Action
The APQP Reference manual 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 either DFMEA or PFMEA is a process that
helps to guide the teams in developing product and process
designs that meet expectations.
The FMEA analysis should not be considered 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 reduce their risk.
One key aspect of continual improvement is the retention of
knowledge from 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/or application.
The language used in FMEAs should be as specific as possible
when describing an item (for example, failure mode, or cause)
and not extend or extrapolate beyond the team’s level of
understanding as to what the failure effects may be.
Clear statements, concise terminology and focus on the actual
effects are key to the effective identification and mitigation of
risk issues.

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Chapter I General FMEA Guidelines

Follow-up and Continuous Improvement

The need for taking effective preventive/corrective actions, with
appropriate follow-up on those actions, cannot be
overemphasized. Actions should be communicated to all affected
activities. A thoroughly thought-out and well-developed FMEA
will be of limited value without positive and effective
preventive/corrective actions.
Team leadership (typically the team leader/lead engineer) is in
charge of ensuring that all recommended actions have been
implemented or adequately addressed. The FMEA is a living
document and should always reflect the latest level, as well as
the latest relevant actions, including those occurring after the
start of production.
The team leader/lead engineer has several means of assuring that
recommended actions are implemented. They include, but are
not limited to the following:
• Reviewing designs, processes, and related records to ensure
that recommended actions have been implemented,
• Confirming the incorporation of changes to design/assembly/
manufacturing documentation, and,
• Reviewing Design/Process FMEAs, special FMEA
applications, and Control Plans.

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Chapter II Strategy, Planning, Execution

Chapter II

Overview of FMEA
Strategy, Planning and Implementation

7
Chapter II Strategy, Planning, Execution

Introduction
FMEA development, either design or process, uses a common
approach to address:
• Potential product or process failure to meet expectations
• Potential consequences
• Potential causes of the failure mode
• Application of current controls
• Level of risk
• Risk reduction
Before the FMEA document is started, the team must define the
scope of the project and collect existing information which is
necessary for an effective and efficient FMEA development
process.

Basic Structure
The purpose of the recommended FMEA formats described in
this manual is to organize the collection and display of relevant
FMEA information. Specific formats may vary based on the
needs of the organization and the requirements of the customer.
Fundamentally, the format utilized should address:
• Functions, requirements, and deliverables of the product or
process being analyzed,
• Failure modes when functional requirements are not met,
• Effects and consequences of the failure mode,
• Potential causes of the failure mode,
• Actions and controls to address the causes of the failure mode,
and,
• Actions to prevent recurrence of the failure mode.

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

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Chapter II Strategy, Planning, Execution

Identify the Team

As previously mentioned, FMEA development is the
responsibility of a multi-disciplinary (or cross-functional) team
whose members encompass the necessary subject matter
knowledge. This should include facilitation expertise and
knowledge of the FMEA process. A team approach is
recommended to benefit the FMEA development process to
ensure input and collaboration from all affected functional areas.
The FMEA team leader should select team members with the
relevant experience and necessary authority. In addition to the
design and process engineers, the following are examples of
additional resources:

FMEA development topic Relevant Resources or Expertise

Scope Program Management, Customer, Integration responsible
individual(s)
Functions, requirements and expectations Customer, Program Management, Integration responsible
individual(s), Service Operations, Safety, Manufacturing
and Assembly, Packaging, Logistics, Materials
Potential failure mode – the way a process or Customer, Program Management, Integration responsible
product might fail individual(s), Service Operations, Safety, Manufacturing
and Assembly, Packaging, Logistics, Materials, Quality
Effects and consequences of the failure – to Customer, Program Management, Integration responsible
both the organization’s processes or to a individual(s), Service Operations, Safety, Manufacturing
downstream customer. and Assembly, Packaging, Logistics, Materials, Quality
Causes of the potential failure Customer, Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineering
Analysis, Equipment Manufacturer, Maintenance
Frequency of occurrence of potential failure Customer, Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineering
Analysis, Statistical Analysis, Equipment Manufacturer,
Maintenance
Application of current controls-prevention Manufacturing and Assembly, Packaging, Logistics,
Materials, Quality, Equipment Manufacturer, Maintenance
Application of current controls-detection Customer, Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Maintenance
Recommended actions required Customer, Program Management, Integration responsible
individual(s), Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineering
Analysis, Statistical Analysis, Equipment Manufacturer,
Maintenance

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Chapter II Strategy, Planning, Execution

Define the Scope

Scope establishes the boundary of the FMEA analysis. It defines
what is included and excluded, determined based on the type of
FMEA being developed, i.e., system, subsystem, or component.
Before the FMEA can begin, a clear understanding of what is to
be evaluated must be determined. What to exclude can be just as
important as what to include in the analysis. The scope needs to
be established at the start of the process to assure consistent
direction and focus.
The following may assist the team in defining the scope of the
FMEA:
• Function Model
• Block (Boundary) diagrams
• Parameter (P) diagrams
• Interface diagrams
• Process flow diagrams
• Interrelationship matrices
• Schematics
• Bill of Materials (BOM)

System FMEA
A system FMEA is made up of various subsystems. Examples of
systems include: Chassis System, Powertrain System, or Interior
System, etc. The focus of the System FMEA is to address all
interfaces and interactions among systems, subsystems, the
environment and the customer.

Subsystem FMEA
A Subsystem FMEA is a subset of a system FMEA. An example
of a subsystem is the front suspension subsystem, which is a
subset of the chassis system. The focus of the Subsystem FMEA
is to address all interfaces and interactions among the subsystem
components and interactions with other subsystems or systems.

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

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Chapter II Strategy, Planning, Execution

Define the Customer

There are four major customers to be considered in the FMEA
process, all need to be taken into account in the FMEA analysis:
• END USER: the person or organization that will utilize the
product. The FMEA analysis affecting the End User could
include, for example, durability.
• OEM ASSEMBLY and MANUFACTURING CENTERS
(PLANTS): the OEM locations where manufacturing
operations (e.g., stamping and powertrain) and vehicle
assembly take place. Addressing the interfaces between the
product and its assembly process is critical to an effective
FMEA analysis.
• SUPPLY CHAIN MANUFACTURING: the supplier location
where manufacturing, fabricating or assembling of production
materials or parts takes place. This includes fabricating
production and service parts and assemblies and processes
such as heat treating, welding, painting, plating or other
finishing services. This may be any subsequent or downstream
operation or a next tier manufacturing process.
• REGULATORS: government agencies that define
requirements and monitor compliance to safety and
environmental specifications which can impact the product or
process.
Knowledge of these customers can help to define the functions,
requirements and specifications more robustly as well as aid in
determining the effects of related failure modes.

Indentify Functions,
Requirements, and
Specifications
Identify and understand the functions, requirements and
specifications relevant to the defined scope. The purpose of this
activity is to clarify the item design intent or process purpose.
This assists in the determination of the potential failure mode for
each attribute or aspect of the function.

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Chapter II Strategy, Planning, Execution

Identify Potential
Failure Modes
Failure mode is defined as the way or manner in which a product
or process could fail to meet design intent or process
requirements. The assumption is made that the failure could
occur but may not necessarily occur. A concise and
understandable failure definition is important since it properly
focuses the analysis. Potential failure modes should be described
in technical terms and not as a symptom necessarily noticeable
by the customer. A large number of failure modes identified for
a single requirement may indicate that the defined requirement is
not concise.

Identify Potential
Effects
Potential effects of failure are defined as the effects of the failure
mode as perceived by the customer. The effects or impact of the
failure are described in terms of what the customer might notice
or experience. The customer may be an internal customer as
well as the End User.
Determining potential effects includes the analysis of the
consequences of the failures and the severity or seriousness of
those consequences.

Identify Potential
Causes
Potential cause of failure is defined as an indication of how the
failure could occur, described in terms of something that can be
corrected or can be controlled. Potential cause of failure may be
an indication of a design weakness, the consequence of which is
the failure mode.
There is a direct relation between a cause and its resultant failure
mode (i.e., if the cause occurs, then the failure mode occurs).
Identifying the root cause(s) of the failure mode, in sufficient
detail, enables the identification of appropriate controls and
action plans. A separate potential cause analysis is performed
for each cause if there are multiple causes.

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Chapter II Strategy, Planning, Execution

Identify Controls
Controls are those activities that prevent or detect the cause of
the failure or failure mode. In developing controls it is important
to identify what is going wrong, why, and how to prevent or
detect it. Controls are applicable to product design or
manufacturing processes. Controls focused on prevention will
provide the greatest return.
Identifying and
Assessing Risk
One of the important steps in the FMEA process is the
assessment of risk. This is evaluated in three ways, severity,
occurrence, and detection:
Severity is an assessment of the level of impact of a failure on
the customer.
Occurrence is how often the cause of a failure may occur.
Detection is an assessment of how well the product or process
controls detect the cause of the failure or the failure mode.
Organizations need to understand their customer requirements
for risk assessment.
Recommended
Actions and Results
The intent of recommended actions is to reduce overall risk and
likelihood that the failure mode will occur. The recommended
actions address reduction of the severity, occurrence and
detection.
The following can be used to assure that the appropriate actions
are taken, including but not limited to:
• Ensuring design requirements including reliability are
achieved,
• Reviewing engineering drawings and specifications,
• Confirming incorporation in assembly/manufacturing
processes, and,
• Reviewing related FMEAs, control plans and operations
instructions.
Responsibility and timing to complete the recommended actions
should be recorded.
Once actions are completed and results captured, the updated
ratings for severity, occurrence and detection should also be
recorded.

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Chapter II Strategy, Planning, Execution

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

14
Chapter III Design Failure Mode and Effects Analysis

Chapter III

DFMEA
Design Failure Mode and Effects Analysis

15
Chapter III Design Failure Mode and Effects Analysis

Introduction
The Design Failure Mode Effects Analysis, referred to as
DFMEA, supports the design process in reducing the risk of
failures by:
• Aiding in the objective evaluation of the design, including
functional requirements and design alternatives,
• Evaluating the initial design for manufacturing, assembly,
service, and recycling requirements,
• Increasing the probability that potential failure modes and their
effects on system and vehicle operation have been considered
in the design/development process,
• Providing additional information to aid in the planning of
thorough and efficient design, development, and validation
programs,
• Developing a ranked list of potential failure modes according
to their effect on the customer, thus establishing a priority
system for design improvements, development, and validation
testing/analysis,
• Providing an open issue format for recommending and
tracking risk-reducing actions, and,
• Providing future reference, (e.g., lessons learned), to aid in
addressing field concerns, evaluating design changes, and
developing advanced designs.
The DFMEA is a living document and should:
• Be initiated before design concept finalization,
• Be updated as changes occur or additional information is
obtained throughout the phases of product development,
• Be fundamentally completed before the production design is
released, and,
• Be a source of lessons learned for future design iterations.

Customer Defined
The definition of “Customer” provided in Chapter II applies to
DFMEA. It is important to correctly identify the customer(s)
because such knowledge directs the development of the
DFMEA, including the impact of the function of the design.

16
Chapter III Design Failure Mode and Effects Analysis

Team Approach
The DFMEA is developed and maintained by a multi-
disciplinary (or cross-functional) team typically led by the design
responsible engineer from the responsible design source (e.g.,
OEM, Tier 1 supplier or Tier 2 supplier and below).
The responsible engineer is expected to directly and actively
involve representatives from all affected areas. The areas of
expertise and responsibility may include, but are not limited to,
assembly, manufacturing, design, analysis/test, reliability,
materials, quality, service, and suppliers, as well as the design
area responsible for the next higher or lower assembly or system,
subsystem, or component.
Manufacturing,
Assembly and
Serviceability
Considerations
The DFMEA should include any potential failure modes and
causes that can occur during the manufacturing or assembly
process which are the result of the design. Such failure modes
may be mitigated by design changes (e.g., a design feature which
prevents a part from being assembled in the wrong orientation –
i.e., error-proofed). When not mitigated during the DFMEA
analysis (as noted in the action plan for that item), their
identification, effect, and control should be transferred to and
covered 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 process into
consideration, for example:
• Necessary mold drafts
• Limited surface finish capability
• Assembling space (e.g., access for tooling)
• Limited hardenability of steels
• Tolerances/process capability/performance
The DFMEA can also take into consideration the technical and
physical limits of product serviceability and recycling once the
product has entered field use, for example:
• Tool access
• Diagnostic capability
• Material classification symbols (for recycling)
• Materials/chemicals used in the manufacturing processes

17
Chapter III Design Failure Mode and Effects Analysis

Development of a Design FMEA

The DFMEA focuses on the design of the product that will be
delivered to the final customer (End User). The prerequisite tasks
for an effective analysis of the product design include:
assembling a team, determining scope, creating block diagrams
or P-diagrams depicting product function and requirements. A
clear and complete definition of the desired product
characteristics better facilitates the identification of potential
failure modes. A DFMEA form is used to document the results
of the analysis including any recommended actions and
responsibilities (See Table III.1).
The DFMEA process can be mapped to the customer or
organization’s product development process.

Prerequisites
A DFMEA should begin with the development of information to
understand the system, subsystem, or component being analyzed
and define their functional requirements and characteristics.
In order to determine the scope of the DFMEA, the team should
consider the following as applicable to component, subsystem or
system DFMEAs:
• What processes, mating components, or systems does the
product interface with?
• Are there functions or features of the product that affect other
components or systems?
• Are there inputs provided by other components or systems that
are needed to perform intended functions of the product?
• Do the product’s functions include the prevention or detection
of a possible failure mode in a linked component or system?
The following sections describe tools that may be applied, as
appropriate, to assist the team in developing the DFMEA.

Block (Boundary) Diagrams

The block diagram of the product shows the physical and logical
relationships between the components of the product. There are
different approaches and formats to the construction of a block
diagram
The block diagram indicates the interaction of components and
subsystems within the scope of the design. This interaction may
include: flow of information, energy, force, or fluid. The
objective is to understand the requirements or inputs to the

18
Chapter III Design Failure Mode and Effects Analysis

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

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

Figure III.1a Block (Boundary) Diagram Examples

19
Chapter III Design Failure Mode and Effects Analysis

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

20
Chapter III Design Failure Mode and Effects Analysis

Parameter (P) Diagrams

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

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

21
Chapter III Design Failure Mode and Effects Analysis

Functional Requirements
Another step in the DFMEA process is a compilation of the
functional and interface requirements of the design. This list may
include the following categories:
• General: This category considers the purpose of the product
and its overall design intent
• Safety
• Government Regulations
• Reliability (Life of the Function)
• Loading and Duty Cycles: Customer product usage profile
• Quiet Operations: Noise, vibration and harshness (NVH)
• Fluid Retention
• Ergonomics
• Appearance
• Packaging and Shipping
• Service
• Design for Assembly
• Design for Manufacturability

Other Tools and Information Resources

Other tools and resources that may help the team understand and
define the design requirements may include:
• Schematics, drawings, etc.
• Bill of Materials (BOM)
• Interrelationship matrices
• Interface matrix
• Quality Function Deployment (QFD)
• Quality and Reliability History
The use of these tools, supported by engineering experience and
historical information, can assist in defining a comprehensive set
of requirements and functions.
After considering these prerequisites, start filling out the form
(Table III.1 below).

22
Chapter III Design Failure Mode and Effects Analysis

This page intentionally left blank.

23
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

24
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Example DFMEA
The example used with the sample form deals with a Front Door
assembly. The product has several functional requirements:
• Permit ingress to and egress from vehicle
• Provide occupant protection from
o Weather (comfort)
o Noise (comfort)
o Side impact (safety)
• Support anchorage for door hardware including
o Mirror
o Hinges
o Latch
o Window regulator
• Provide proper surface for appearance items
o Paint
o Soft trim
• Maintain integrity of inner door panel
The final DFMEA would include analysis of all these
requirements. The example includes part of the analysis of the
requirement: “Maintain integrity of inner door panel”.

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

The following describes the information to be entered on the
form.
The header should clearly identify the focus of the FMEA as
well as information related to the document development and
control process. This should include an FMEA number,
identification of the scope, design responsibility, completion
dates, etc. The header should contain the following elements 2 :

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

25
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
over time. clogged start-up and for film thickness experiments by Limits were

26
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

FMEA Number (A)

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

System, Subsystem, or Component Name

and Number (B)
Enter the name and number of the system, subsystem, or
component which is being analyzed. (See section entitled Define
the Scope).

Design Responsibility (C)

Enter the OEM, organization, and department or group who is
design responsible. Also enter the supply organization name, if
applicable.

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

Enter the intended model year(s) and program(s) that will use or
be affected by the design being analyzed (if known).

Key Date (E)

Enter the initial DFMEA due date, which should not exceed the
scheduled production design release date.

FMEA Dates (F)

Enter the date the original DFMEA was completed and the latest
revision date.

Core Team (G)

Enter the team members responsible for developing the DFMEA.
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 including the
organization (company) of the engineer responsible for preparing
the DFMEA.

27
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

28
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Body of the DFMEA Form (fields a – n)

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

Item / Function / Requirements (a)

Item/Function can be separated into two (or more) columns or
combined into a single, bridged column which encompasses
these elements. Interfaces (as “items” of analysis) can be either
combined or separate. Components may be listed in the
item/function column, and an additional column may be added
containing the functions or requirements of that item. “Item”,
“Function”, and “Requirements” are described below:

Item (a1)
Enter the items, interfaces, or parts which have been identified
through block diagrams, P-diagrams, schematics and other
drawings, and other analysis conducted by the team.
The terminology used should be consistent with customer
requirements and with those used in other design development
documents and analysis to ensure traceability.

Function (a1)
Enter the function(s) of the item(s) or interface(s) being analyzed
which are necessary to meet the design intent based on customer
requirements and the team’s discussion. If the item(s) or
interface has more than one function with different potential
modes of failure, it is highly recommended that each of these
functions and associated failure mode(s) is listed separately.
Function becomes a2 if Item and Function are split.

Requirements (a2)
An additional column, “Requirements”, may be added to further
refine the analysis of the failure mode(s). Enter the
requirement(s) for each of the functions being analyzed (based
on customer requirements and the team’s discussion; see also
Chapter II, Section: Prerequisites). If the function has more than
one requirement with different potential modes of failure, it is
highly recommended that each of the requirements and functions
are listed separately.
Requirement becomes a3 if Item and Function are split into
separate columns, e.g., a1 and a2.

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

29
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

30
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Potential Failure Mode (b)

Potential failure mode is defined as the manner in which a
component, subsystem, or system could potentially fail to meet
or deliver the intended function described in the item column.
Identify the potential failure mode(s) associated with the
function(s)/requirement(s). Potential failure modes should be
described in technical terms, and not necessarily as a symptom
noticeable by the customer.
Each function may have multiple failure modes. A large number
of failure modes identified for a single function may indicate that
the requirement is not well defined.
The assumption is made that the failure could occur, but may not
necessarily occur, consequently the use of the word “potential”.

Potential failure modes that could occur only under certain

operating conditions (i.e., hot, cold, dry, dusty, etc.) and under
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 made through a review of
past things-gone-wrong, concerns, reports, and group
brainstorming.
The potential failure mode may also be the cause of a potential
failure mode in a higher level subsystem or system, or lead to the
effect of one in a lower level component.
Example failure modes, as related to different requirements, are
shown in table III.3.

31
Chapter III Design Failure Mode and Effects Analysis

Item Function Requirement Failure Mode

Disk Stop vehicle on
Stop vehicle traveling Vehicle does not stop
Brake demand
system (considering on dry asphalt
environmental pavement within Vehicle stops in excess of
conditions such specified distance specified distance
as wet, dry, etc.) within specified g’s of
force Stops vehicle with more than xx
g’s of force
Activates with no demand;
Allow unimpeded Vehicle movement is partially
vehicle movement on impeded
no system demand Activates with no demand
Vehicle cannot move
Brake Allows transfer Must deliver specified
Rotor of force from torque resistance at axle Insufficient torque resistance
brake pads to delivered
axle

Table III.3 Example Potential Failure Modes

32
Chapter III Design Failure Mode and Effects Analysis

This page intentionally left blank.

33
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

34
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Potential Effect(s) of Failure (c)

Potential effects of failure are defined as the effects of the failure
mode on the function, as perceived by the customer(s).
Describe the effects of the failure in terms of what the customer
might notice or experience, remembering that the customer may
be an internal customer as well as the ultimate End User. State
clearly if the failure mode could impact safety or non-
compliance to regulations. The effects should always be stated in
terms of the specific system, subsystem, or component being
analyzed. Remember that a hierarchical relationship exists
between the component, subsystem, and system levels 4 . For
example, a part could fracture, which may cause the assembly to
vibrate, resulting in an intermittent system operation. The
intermittent system operation could cause performance to
degrade and ultimately lead to customer dissatisfaction. The
intent is to predict the potential failure effects to the team’s level
of knowledge.
Typical failure effects should be stated in terms of product or
system performance. Table III.4 shows example effects of the
failure modes from Table III.3.

Item Failure Mode Effect

Disk Brake Vehicle does not
Vehicle control impaired; Regulatory non-compliance
System stop
Vehicle stops in
excess of specified Vehicle control impaired; Regulatory non-compliance
distance
Stops vehicle with
more than xx g’s of Regulatory non-compliance
force
Activates with no
demand;
Decreased pad life; diminished vehicle control
Vehicle movement is
partially impeded
Activates with no
demand Customer unable to drive vehicle
Vehicle cannot move

Table III.4 Example Potential Effects

4
See also Appendix B

35
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

36
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Severity (S) (d)

Severity is the value associated with the most serious effect for a
given failure mode. Severity is a relative ranking within the
scope of the individual FMEA.
Suggested Evaluation Criteria
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis. (See Table Cr1 below for criteria
guidelines.)
It is not recommended to modify criteria ranking values of 9 and
10. Failure modes with a rank of severity 1 should not be
analyzed further.

Criteria:
Effect Severity of Effect on Product Rank
(Customer Effect)

Failure to Potential failure mode affects safe vehicle operation and/or involves 10
Meet Safety noncompliance with government regulation without warning.
and/or
Regulatory Potential failure mode affects safe vehicle operation and/or involves
Requirements
9
noncompliance with government regulation with warning.

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

Loss or vehicle operation).
Degradation
of Primary
Degradation of primary function (vehicle operable, but at reduced 7
Function
level of performance).

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

Loss or
convenience functions inoperable).
Degradation
of Secondary
Degradation of secondary function (vehicle operable, but comfort / 5
Function
convenience functions at reduced level of performance).

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

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

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

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

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

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

No effect No discernible effect. 1

Table Cr1 Suggested DFMEA Severity Evaluation Criteria

37
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls Controls RPN Action Actions Taken
& Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
over time. clogged start-up and for film thickness experiments by Limits were

38
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Classification (e)
This column may be used to highlight high-priority failure
modes and their associated causes.
As a result of this analysis, the team may use this information to
identify special characteristics.
Customer specific requirements may identify special product or
process characteristic symbols and their usage.
A characteristic designated in the design record as special
without an associated design failure mode identified in the
DFMEA is an indication of a weakness in the design process.

Potential Cause(s)/Mechanism(s) of Failure

Mode (f)
This information can be separated into multiple columns or
combined into a single column.
In the development of the FMEA, the identification of all
potential causes of the failure mode is key to subsequent
analysis. Although varied techniques (such as brainstorming) can
be used to determine the potential cause(s) of the failure mode, it
is recommended that the team should focus on an understanding
of the failure mechanism for each failure mode.

Potential Mechanism(s) of Failure Mode (f1)

A failure mechanism is the physical, chemical, electrical,
thermal, or other process that results in the failure mode. It is
important to make the distinction that a failure mode is an
"observed" or "external" effect so as not to confuse failure mode
with failure mechanism, the actual physical phenomenon behind
the failure mode or the process of degradation or chain of events
leading to and resulting in a particular failure mode.
To the extent possible, list every potential mechanism for each
failure mode. The mechanism should be listed as concisely and
completely as possible.
For a system, the failure mechanism is the process of error
propagation following a component failure which leads to a
system failure.
A product or process can have several failure modes which are
correlated to each other because of a common failure
mechanism behind them.
Ensure that process effects are considered as part of the
DFMEA process.

39
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

40
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Potential Cause(s) of Failure Mode (f2)

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

Causes are the circumstances that induce or activate a failure

mechanism.

In identifying potential causes of failure, use concise

descriptions of the specific causes of failures, e.g., specified bolt
plating allows for hydrogen embrittlement. Ambiguous phrases
such as, poor design or improper design, should not be used.
Investigation of causes needs to focus on the failure mode and
not on the effect(s). In determining the cause(s), the team should
assume the existence of the cause under discussion will result in
the failure mode (i.e., the failure mode does not require multiple
causes to occur).
Typically, there may be several causes each of which can result
in the failure mode. This results in multiple lines (cause
branches) for the failure mode.
To the extent possible, list every potential cause for each failure
mode/failure mechanism. The cause should be listed as concisely
and completely as possible. Separating the causes will result in a
focused analysis for each cause and may yield different
measurement, controls, and action plans.
Table III.5. shows sample causes for the failure modes in Table
III.3. Although not required as part of the minimum FMEA form
elements, the table includes the failure mechanism to show the
relationships among failure mode, failure mechanism, and cause.
In preparing the DFMEA, assume that the design will be
manufactured and assembled to the design intent. Exceptions can
be made at the team’s discretion where historical data indicate
deficiencies in the manufacturing process.

41
Chapter III Design Failure Mode and Effects Analysis

Failure Mode Mechanism Cause

Mechanical linkage break due to inadequate corrosion

protection

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

Vehicle does not stop
from pedal to pads
Loss of hydraulic fluid from loose hydraulic line due to
incorrect connector torque specification
Loss of hydraulic fluid due to hydraulic lines
crimped/compressed, inappropriate tube material specified
Mechanical linkage joints stiff due to inappropriate
lubrication specification
Reduced transfer of Mechanical linkage joints corroded due to inadequate
Vehicle stops in excess of corrosion protection
force from pedal to
yy feet
pads
Partial loss of hydraulic fluid due to hydraulic lines
crimped, inappropriate tube material specified

Excessive/rapid
Stops vehicle with more Cumulative pressure build-up in master cylinder due to
transfer of force from
than xx g’s of force seal design
pedal to pads
Activate with no demand; Corrosion or deposit build up on rails or pad ears due to
Vehicle movement is Pads do not release surface finish not promoting adequate self cleaning and
impeded corrosion protection
Activate with no demand Hydraulic pressure
Master cylinder vacuum lock due to seal design
Vehicle cannot move does not release

Table III.5 Example Potential Causes

42
Chapter III Design Failure Mode and Effects Analysis

This page intentionally left blank.

43
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

44
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Occurrence (O) (g)

Occurrence is the likelihood that a specific cause/mechanism
will occur resulting in the failure mode within the design life.
The likelihood of occurrence ranking number has a relative
meaning rather than an absolute value (See Table Cr2).
A consistent occurrence ranking system should be used to ensure
continuity. The occurrence number is a relative ranking within
the scope of the FMEA and may not reflect the actual likelihood
of occurrence.
Suggested Evaluation Criteria
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis. Occurrence should be estimated
using a 1 to 10 scale using Table Cr2 as a guideline.
In determining this estimate, questions such as the following
should be considered:
• What is the service history and field experience with similar
components, subsystems, or systems?
• Is the item a carryover or similar to a previous level item?
• How significant are changes from a previous level item?
• Is the item radically different from a previous level item?
• Is the item completely new?
• What is the application or what are the environmental
changes?
• Has an engineering analysis (e.g., reliability) been used to
estimate the expected comparable occurrence rate for the
application?
• Have preventive controls been put in place?

45
Chapter III Design Failure Mode and Effects Analysis

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

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

Very High 10
≥ 1 in 10
Failure is inevitable with new design, new application, or 50 per thousand
change in duty cycle/operating conditions. 9
1 in 20
Failure is likely with new design, new application, or 20 per thousand
High change in duty cycle/operating conditions. 8
1 in 50
Failure is uncertain with new design, new application, or 10 per thousand
change in duty cycle/operating conditions. 7
1 in 100
Frequent failures associated with similar designs or in 2 per thousand
design simulation and testing. 6
1 in 500
Occasional failures associated with similar designs or in .5 per thousand
Moderate design simulation and testing. 5
1 in 2,000
Isolated failures associated with similar design or in .1 per thousand
design simulation and testing. 4
1 in 10,000
Only isolated failures associated with almost identical .01 per thousand
design or in design simulation and testing. 3
Low 1 in 100,000
No observed failures associated with almost identical ≤.001 per thousand
design or in design simulation and testing. 2
1 in 1,000,000
Failure is eliminated through preventive control. Failure is eliminated
Very Low through preventive 1
control.

Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria

46
Chapter III Design Failure Mode and Effects Analysis

This page intentionally left blank.

47
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

48
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Current Design Controls (h)

Current Design Controls are those activities conducted as part of
the design process that have been completed or committed to and
that will assure the design adequacy for the design functional and
reliability requirements under consideration.
There are two types of design controls to consider:
Prevention:
Eliminate (prevent) the cause of the mechanism of failure or the
failure mode from occurring, or reduce its rate of occurrence.
Detection:
Identify (detect) the existence of a cause, the resulting
mechanism of failure or the failure mode, either by analytical or
physical methods, before the item is released for production.

The preferred approach is to first use prevention controls, if

possible. The initial occurrence rankings will be affected by the
prevention controls provided they are integrated as part of the
design intent.

Detection control should include identification of those activities

which detect the failure mode as well as those that detect the
cause.
The team should consider analysis, testing, reviews, and other
activities that will assure the design adequacy such as:
Prevention Controls
• Benchmarking studies
• Fail-safe designs
• Design and Material standards (internal and external)
• Documentation – records of best practices, lessons learned, etc.
from similar designs
• Simulation studies – analysis of concepts to establish design
requirements
• Error-proofing
Detection controls
• Design reviews
• Prototype testing
• Validation testing
• Simulation studies – validation of design
• Design of Experiments; including reliability testing
• Mock-up using similar parts

49
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

50
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

The example Design FMEA form in this manual has two

columns for the design controls (i.e., separate columns for
Prevention Controls and Detection Controls) to assist the team in
clearly distinguishing between these two types of design
controls. This allows for a quick visual determination that both
types of design controls have been considered.
If a one-column (for design controls) form is used, then the
following prefixes should be used. For prevention controls, place
a 'P' before each prevention control listed. For detection controls,
place a 'D' before each detection control listed.
Preventing the causes of the failure mode through a design
change or design process change is the only way a reduction in
the occurrence ranking can be effected.
Table III.6 shows example prevention and detection controls for
the causes identified in Table III.5.

Failure Cause Prevention Detection

Mode controls controls
Vehicle Mechanical linkage Designed per Environmental
does not break due to inadequate material standard stress test 03-9963
stop corrosion protection MS-845
Master cylinder vacuum Carry-over design Pressure variability
lock due to seal design with same duty testing – system
cycle requirements level
Loss of hydraulic fluid Designed per Vibration step-
from loose hydraulic torque stress test 18-1950
line due to incorrect requirements -
connector torque 3993
specification
Loss of hydraulic fluid Designed per Design of
due to hydraulic lines material standard Experiments (DOE)
crimped/compressed, MS-1178 – tube resiliency
inappropriate tube
material specified

Table III.6 Examples of Prevention and Detection Design Controls

51
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

52
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Current Design Control Detection column. When
more than one control is identified, it is recommended that the
detection ranking of each control be included as part of the
description of the control. Record the lowest ranking value in the
Detection column.
A suggested approach to Current Design Control Detection is to
assume the failure has occurred and then assess the capabilities
of the current design controls to detect this failure mode.
Do not automatically presume that the detection ranking is low
because the occurrence is low. It is important to assess the
capability of the design controls to detect low frequency failure
modes or reduce the risk of them going further in the design
release process.
Detection is a relative ranking within the scope of the individual
FMEA. In order to achieve a lower ranking, generally the design
control (analysis or verification activities) has to be improved.

Suggested Evaluation Criteria

The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis. Detection should be estimated using
Table Cr3 as a guideline.

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

through proven design solutions.

53
Chapter III Design Failure Mode and Effects Analysis

Opportunity Criteria: Likelihood

for Rank of
Detection Likelihood of Detection by Design Control Detection

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

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

Very
detect at any capability; Virtual Analysis (e.g., CAE, FEA, etc.) is not 9
stage correlated to expected actual operating conditions. Remote

Product verification/validation after design freeze and prior to

launch with pass/fail testing (Subsystem or system testing with
acceptance criteria such as ride and handling, shipping
8 Remote
evaluation, etc.).

Post Design
Freeze and Product verification/validation after design freeze and prior to
prior to launch launch with test to failure testing (Subsystem or system testing 7 Very Low
until failure occurs, testing of system interactions, etc.).

Product verification/validation after design freeze and prior to

launch with degradation testing (Subsystem or system testing 6 Low
after durability test, e.g., function check).

Product validation (reliability testing, development or

validation tests) prior to design freeze using pass/fail testing
(e.g., acceptance criteria for performance, function checks,
5 Moderate
etc.).

Prior to Design Product validation (reliability testing, development or Moderately

Freeze validation tests) prior to design freeze using test to failure 4
(e.g., until leaks, yields, cracks, etc.). High

Product validation (reliability testing, development or

validation tests) prior to design freeze using degradation 3 High
testing (e.g., data trends, before/after values, etc.).

Design analysis/detection controls have a strong detection

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

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

Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria

54
Chapter III Design Failure Mode and Effects Analysis

This page intentionally left blank.

55
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

56
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Determining Action Priorities

Once the team has completed the initial identification of failure
modes and effects, causes and controls, including rankings for
severity, occurrence, and detection, they must decide if further
efforts are needed to reduce the risk. Due to the inherent
limitations on resources, time, technology, and other factors,
they must choose how to best prioritize these efforts.
The initial focus of the team should be oriented towards failure
modes with the highest severity rankings. When the severity is 9
or 10, it is imperative that the team must ensure that the risk is
addressed through existing design controls or recommended
actions (as documented in the FMEA).
For failure modes with severities 8 or below the team should
consider causes having highest occurrence or detection rankings.
It is the team’s responsibility to look at the information
identified, decide upon an approach, and determine how to best
prioritize the risk reduction efforts that best serve their
organization and customers.

Risk Evaluation;
Risk Priority Number (RPN) (j)
One approach to assist in action prioritization has been to use the
Risk Priority Number:
RPN = Severity (S) x Occurrence (O) x Detection (D)
Within the scope of the individual FMEA, this value can range
between 1 and 1000.
The use of an RPN threshold is NOT a recommended practice
for determining the need for actions.
Applying thresholds assumes that RPNs are a measure of relative
risk (which they often are not) and that continuous improvement
is not required (which it is).
For example, if the customer applied an arbitrary threshold of
100 to the following, the supplier would be required to take
action on the characteristic B with the RPN of 112.

Item Severity Occurrence Detection RPN

A 9 2 5 90
B 7 4 4 112

57
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

58
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

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

priority should be to work on A with the higher severity of 9,
although the RPN is 90 which is lower and below the threshold.
Another concern with using the threshold approach is that there
is no specific RPN value that requires mandatory action.
Unfortunately, establishing such thresholds may promote the
wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce
RPN. This type of behavior avoids addressing the real problem
that underlies the cause of the failure mode and merely keeps the
RPN below the threshold. It is important to recognize that while
determining “acceptable” risk at a particular program milestone
(e.g., vehicle launch) is desirable, it should be based on an
analysis of severity, occurrence and detection and not through
the application of RPN thresholds.

Use of the RPN index in the discussions of the team can be a

useful tool. The limitations of the use of RPN need to be
understood. However, the use of RPN thresholds to determine
action priority is not recommended.

Recommended Action(s) (k)

In general, prevention actions (i.e., reducing the occurrence) are
preferable to detection actions. An example of this is the use of
proven design standard or best practice rather than product
verification/validation after design freeze.
The intent of recommended actions is to improve the design.
Identifying these actions should consider reducing rankings in
the following order: severity, occurrence, and detection.
Example approaches to reduce these are explained below:
• To Reduce Severity (S) Ranking: Only a design revision can
bring about a reduction in the severity ranking.

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

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

59
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

60
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

For maximum effectiveness and efficiency of this approach,

changes to the product and process design should be
implemented early in the development process. For example,
alternate materials may need to be considered early in the
development cycle to eliminate corrosion severity.
• To Reduce Occurrence (O) Ranking: A reduction in the
occurrence ranking can be effected by removing or controlling
one or more of the causes or mechanisms of the failure mode
through a design revision. Actions such as, but not limited to,
the following should be considered:
o Error proof the design to eliminate the failure mode
o Revised design geometry and tolerances
o Revised design to lower the stresses or replace weak
(high failure probability) components
o Add redundancy
o Revised material specification
• To Reduce Detection (D) Ranking: The preferred method is
the use of error/mistake proofing. An increase in design
validation/verification actions should result in a reduction of
the detection ranking only. In some cases, a design change to a
specific part may be required to increase the likelihood of
detection (i.e., reduce the detection ranking). Additionally, the
following should be considered:
o Design of Experiments (particularly when multiple
or interactive causes of a failure mode are present)
o Revised test plan
If the assessment leads to no recommended actions for a specific
failure mode/cause/control combination, indicate this by entering
“None” in this column. It may be useful to also include a
rationale if “None” is entered, especially in case of high severity.
For design actions consider using the following:
• Results of design DOE or reliability testing
• Design analysis (reliability, structural or physics of failure)
that would confirm that the solution is effective and does not
introduce new potential failure modes
• Drawing, schematics, or model to confirm physical change of
targeted feature
• Results from a design review
• Changes to a given Engineering Standard or Design Guidelines
• Reliability analysis results

61
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
Core Team G
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

62
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

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

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

Responsibility & Target Completion Date (l)

Enter the name of the individual and organization responsible for
completing each recommended action including the target
completion date. The design-responsible engineer/team leader is
responsible for ensuring that all actions recommended have been
implemented or adequately addressed.

Action Results (m-n)

This section identifies the results of any completed actions and
their effect on S, O, D rankings and RPN.

Action(s) Taken and Completion Date (m)

After the action has been implemented, enter a brief description
of the action taken and actual completion date.

Severity, Occurrence, Detection and RPN (n)

After the preventive/corrective action has been completed,
determine and record the resulting severity, occurrence, and
detection rankings.
Calculate and record the resulting action (risk) priority indicator
(e.g., RPN).
All revised rankings should be reviewed. Actions alone do not
guarantee that the problem was solved (i.e., cause addressed),
thus an appropriate analysis or test should be completed as
verification. If further action is considered necessary, repeat the
analysis. The focus should always be on continuous
improvement.

63
Chapter III Design Failure Mode and Effects Analysis

Item Failure Cause Prevention Detection Recommended

Mode Controls Controls Actions
Disk Vehicle Mechanical linkage Designed per Environmental stress Change material to
Brake does not break due to material test 03-9963 stainless steel
system stop inadequate corrosion standard MS-
protection 845
Master cylinder Carry-over Pressure variability Use carry-over seal
vacuum lock due to design with testing – system level design
seal design same duty cycle
requirements
Loss of hydraulic Designed per Vibration step-stress Modify connector
fluid from loose torque test 18-1950 from bolt-style to
hydraulic line due to requirements - quick-connect
incorrect connector 3993
torque specification
Loss of hydraulic Designed per DOE – tube Modify hose
fluid due to hydraulic material resiliency design from MS-
lines standard MS- 1178 to MS-2025
crimped/compressed, 1178 to increase strength
inappropriate tube
material specified

Table III.7 Examples of Causes, Controls and Recommended Actions

Maintaining DFMEAs
The DFMEA is a living document and should be reviewed
whenever there is a product design change and updated, as
required. Recommended actions updates should be included into
a subsequent DFMEA along with the final results (what worked
and what did not work).
Another element of on-going maintenance of DFMEAs should
include a periodic review of the rankings used in the DFMEA.
Specific focus should be given to Occurrence and Detection
rankings. This is particularly important where improvements
have been made either through product changes or improvements
in design controls. Additionally, in cases where field issues have
occurred, the rankings should be revised accordingly.

64
Chapter III Design Failure Mode and Effects Analysis

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

Linkages
The DFMEA is not a “stand-alone” document. For example, the
output of the DFMEA can be used as input for subsequent
product development processes. It is the summary of the team’s
discussions and analysis. Figure III.7 shows the linkages of
some of the commonly used documents.

Boundary (Block) Diagram,

P – Diagram, etc.

DFMEA

Design Verification
Plan & Report (DVP&R),
PFMEA, etc.

Figure III.7 DFMEA Information Interrelationships Flow

65
Chapter III Design Failure Mode and Effects Analysis

Design Verification Plan & Report (DVP&R)

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

PFMEA
Another important linkage is between the DFMEA and PFMEA.
For example, a Process (PFMEA) failure mode or a Design
(DFMEA) failure mode can result in the same potential product
effect. In this case, the effects of the design failure mode should
be reflected in the effects and severity rankings of the DFMEA
and PFMEA.

66
Chapter IV Process Failure Mode and Effects Analysis

Chapter IV

PFMEA
Process Failure Mode and Effects Analysis

67
Chapter IV Process Failure Mode and Effects Analysis

Introduction
The process FMEA, referred to as PFMEA, supports
manufacturing process development in reducing the risk of
failures by:
• Identifying and evaluating the process functions and
requirements,
• Identifying and evaluating potential product and process-
related failure modes, and the effects of the potential failures
on the process and customers,
• Identifying the potential manufacturing or assembly process
causes,
• Identifying process variables on which to focus process
controls for occurrence reduction or increased detection of the
failure conditions, and
• Enabling the establishment of a priority system for
preventive/corrective action and controls.
The PFMEA is a living document and should:
• Be initiated before or at the feasibility stage,
• Be initiated prior to tooling for production,
• Take into account all manufacturing operations from
individual components to assemblies, and
• Include all processes within the plant that can impact the
manufacturing and assembly operations, such as shipping,
receiving, transporting of material, storage, conveyors or
labeling.
Early review and analysis of new or revised processes is advised
to anticipate, resolve, or monitor potential process concerns
during the manufacturing planning stages of a new model or
component program.
The PFMEA assumes the product as designed will meet the
design intent. Potential failure modes that can occur because of a
design weakness may be included in a PFMEA. Their effect and
avoidance is covered by the Design FMEA.
The PFMEA does not rely on product design changes to
overcome limitations in the process. However, it does take into
consideration a product’s design characteristics relative to the
planned manufacturing or assembly process to assure that, to the
extent possible, the resultant product meets customer needs and
expectations. For example, the PFMEA development generally
assumes that the machines and equipment will meet their design
intent and therefore are excluded from the scope. Control
mechanisms for incoming parts and materials may need to be
considered based on historical data.

68
Chapter IV Process Failure Mode and Effects Analysis

Customer Defined
The definition of “Customer” for a PFMEA should normally be
the “End User.” However, the customer can also be a subsequent
or downstream manufacturing or assembly operation, a service
operation, or regulator. 5
Team Approach
The PFMEA is developed and maintained by a multi-disciplinary
(or cross-functional) team typically led by the responsible
engineer. During the initial development of the PFMEA, the
responsible engineer/team leader is expected to directly and
actively involve representatives from all affected areas. These
areas should include but are not limited to design, assembly,
manufacturing, materials, quality, service, and suppliers, as well
as the area responsible for the next assembly. The PFMEA
should be a catalyst to stimulate the interchange of ideas between
the areas affected and thus promote a team approach.

Design Considerations
The team should assume the product as designed will meet the
design intent.
During the development of a PFMEA, the team may identify
design opportunities which, if implemented, would either
eliminate or reduce the occurrence of a process failure mode. For
example, adding a feature to a part and a matching feature to a
fixture will eliminate the possibility of an operator placing a part
in the wrong orientation. Such information must be provided to
the responsible design engineer as well as the tooling /
equipment / fixture design-responsible individual for
consideration and possible implementation.

5
See discussion in Chapter II, Customer Defined

69
Chapter IV Process Failure Mode and Effects Analysis

Development of a Process FMEA

The process-responsible engineer/team leader has at his or her
disposal a number of documents that will be useful in preparing
the PFMEA. The PFMEA begins by developing a list of what the
process is expected to do and what it is expected not to do, i.e.,
the process intent.
The PFMEA should begin with a flow chart of the general
process. This flow chart should identify the product/process
characteristics associated with each operation. Identification of
product effects from the corresponding DFMEA should be
included. Copies of the flow chart used in the PFMEA
preparation should accompany it.
In order to facilitate documentation of the analysis of potential
failures and their consequences, example PFMEA forms have
been developed and are provided in Appendix A. The minimum
information content required for a PFMEA is discussed below.
(Also see Table IV.1)
Prerequisites
A PFMEA should begin with the development of information to
understand the manufacturing and assembly operations being
analyzed and define their requirements.
The process flow diagram is a primary input to the PFMEA. The
flow diagram is used as a tool to help establish the scope of
analysis during manufacturing system design.

Process Flow Diagram and linkage to PFMEA

A process flow diagram 6 describes the flow of the product
through the process – from incoming to outgoing. This should
include each step in a manufacturing or assembly process as well
as their related outputs (product characteristics, requirements,
deliverables, etc.) and inputs (process characteristics, sources of
variation, etc.). The detail of the process flow depends on the
stage of process development discussion. The initial flow
diagram is generally considered a high level process map. It
needs more detailed analysis to identify the potential failure
modes.

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

70
Chapter IV Process Failure Mode and Effects Analysis

Figure 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 process flow diagram
should include all manufacturing operations from processing of
individual components to assemblies including shipping,
receiving, transportation of material, storage, conveyors,
labeling, etc. A preliminary risk assessment using the process
flow diagram may be performed to identify which of these
operations or individual steps can have an impact on the product
manufacturing and assembly and should be included in the
PFMEA.
The PFMEA development continues by identifying the
requirement(s) for each process/function. Requirements are the
outputs of each operation/step and relate to the requirements for
the product. The Requirements provide a description of what
should be achieved at each operation/step. The Requirements
provide the team with a basis to identify potential failure modes.

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

same cross-functional team develop the Process Flow Diagram,
PFMEA, and Control Plan.
See Figure IV.2 for an example process flow diagram.

71
Chapter IV Process Failure Mode and Effects Analysis

Figure IV.2 Example Process Flow Diagram

72
Chapter IV Process Failure Mode and Effects Analysis

Other Tools and Information Sources

Other sources of information that are useful in providing the
team with ways to focus and capture discussions on the
requirements of the process include:
• DFMEA
• Drawings and design records
• Bill of Process
• Interrelationship (Characteristic) matrix
• Internal and external (customer) nonconformances (i.e., known
failure modes based on historical data)
• Quality and Reliability History

Research Information
After establishing the scope of the analysis effort, the team
should begin by reviewing historical information. The areas to
review should include:
• Lessons that have been learned from previous product and
process design implementation, and
• Any information available that establishes best practices
including items such as guidelines and standards, standard part
identification, or error-proofing methods.
Quality performance information available from similar,
previous product and process designs, including items such as:
process yield 7 , first time capability (both end of line and at each
operation), Parts per Million (PPM), process capability indices
(Cpk and Ppk), and warranty metrics.
The information can be useful input for determination of
severity, occurrence and detection rankings.
After considering these prerequisites, start filling out the form
(Table IV.1 below).

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

73
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

74
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Example PFMEA Form

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

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

The following describes the information to be entered on the
form.
The PFMEA header should clearly identify the focus of the
PFMEA as well as information related to the document
development and control process. This should include an FMEA
number, identification of the scope, design responsibility,
completion dates, etc. The header should contain the following
elements 8 :

FMEA Number (A)

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

Item (B)
Enter the name and number of the system, subsystem or
component for which the process is being analyzed.

Process Responsibility (C)

Enter the OEM, organization, and department or group who is
process design responsible. Also enter the supply organization
name, if applicable.

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

Enter the intended model year(s) and program(s) that will use or
be affected by the process being analyzed (if known).

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

75
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

76
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Key Date (E)

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

FMEA Date (Original) (F)

Enter the date the original PFMEA was completed and the latest
revision date.

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 including the
organization (company) of the engineer/team leader responsible
for preparing the PFMEA.

Body of the PFMEA Form (fields a – n)

The body of the PFMEA contains the analysis of risks related to
the potential failures and improvement action being taken. 9

Process Step / Process Function /

Requirements (a)
Process Step/Function can be separated into two (or more)
columns or combined into a single, bridged column which
encompasses these elements. Process Steps may be listed in the
Process Step/Function column or additional column(s) may be
added containing the functions or requirements of that process
step. “Process Step”, “Function”, and “Requirements” are
described below:

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

77
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

78
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Process Step (a1)

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

Process Function (a1)

List the process function that corresponds to each process step or
operation being analyzed. The process function describes the
purpose or intent of the operation. A risk analysis is
recommended in order to limit the number of steps to be
included to only those that add value or otherwise are seen as
likely to have a negative impact on the product. If there are
multiple process functions being analyzed with respect to a given
operation, each should be aligned on the form with its respective
“Requirements” to aid in the development of the associated
failure modes.

Process Function becomes a2 if Process Step and Process

Function are split.

Requirements (a2)
List the requirements for each process function of the process
step or operation being analyzed. Requirements are the inputs to
the process specified to meet design intent and other customer
requirements. If there are multiple requirements with respect to a
given function, each should be aligned on the form with the
respective associated failure modes in order to facilitate the
analysis.

Requirements become a3 if Process Step and Process Function

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

79
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

80
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Potential Failure Mode (b)

Potential failure mode is defined as the manner in which the
process could potentially fail to meet the process requirements
(including the design intent).
In preparing the FMEA, assume that the incoming
part(s)/material(s) are correct. Exceptions can be made by the
FMEA team where historical data indicate deficiencies in
incoming part quality. The team should also assume that the
basic design of the product is correct; however, if there are
design issues which result in process concerns, those issues
should be communicated to the design team for resolution.
List the potential failure mode(s) for the particular operation in
terms of the process requirement(s) (e.g., as documented in the
process flow diagram.) Assume that the failure could occur but
may not necessarily occur. Potential failure modes should be
described in technical terms, not as a symptom noticeable by the
customer. See the example table below.

Process
Requirement Potential Failure Mode
Step/Function
Operation 20: Four screws Fewer than four screws
Specified screws Wrong screw used (larger dia)
Attach seat cushion
Assembly sequence: First Screw placed in any other hole
to track using a
screw in right front hole
torque gun
Screws fully seated Screw not fully seated
Screws torqued to dynamic Screw torqued too high
torque specification Screw torqued too low

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

including Potential Failure Modes

If the requirements have been well defined, then the potential

failure mode is readily identifiable by determining the condition
when a specific requirement is not met. Each requirement may
have multiple failure modes. A large number of failure modes
identified for a single requirement usually indicates that the
requirement is not well defined.
The assumption is made that the failure could occur but may not
necessarily occur – consequently the use of the word “potential”.
Verification of completeness of the potential failure modes can
be made through a review of past things-gone-wrong, concerns,

81
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

82
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

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

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

Potential Effect(s) of Failure (c)

Potential effects of failure are defined as the effects of the failure
mode as perceived by the customer(s).
The effects of the failure should be described in terms of what
the customer might notice or experience, remembering that the
customer may be an internal customer as well as the ultimate
End User. The customer(s) in this context could be the next
operation, subsequent operations or locations, the dealer, and/or
the vehicle owner. Each must be considered when assessing the
potential effect of a failure. The product effects in the PFMEA
should be consistent with those in the corresponding DFMEA.
If the failure mode could impact safety or cause noncompliance
to regulations, this should be clearly identified in the PFMEA.
For the End User, the effects should be stated in terms of product
or system performance. If the customer is the next operation or
subsequent operation(s) / location(s), the effects should be stated
in terms of process / operation performance. See Table IV.3
Example of Effects.
In order to determine the Potential Effect(s), the following
questions should be asked:
1. Does the Potential Failure Mode physically prevent
downstream processing or cause potential harm to
equipment or operators?
This includes an inability to assemble or join to a mating
component at any subsequent customer’s facility. If so, then
assess the manufacturing impact. No further analysis is required.
If not, then go to question 2. Examples could include:
• Unable to assemble at operation x
• Unable to attach at customer facility
• Unable to connect at customer facility
• Cannot bore at operation x
• Causes excessive tool wear at operation x
• Damages equipment at operation x
• Endangers operator at customer facility

83
Chapter IV Process Failure Mode and Effects Analysis

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

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

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

Independent of any controls planned or implemented including
error or mistake-proofing, consider what the End User would
notice or experience. This information may be available within
the DFMEA. Once determined, go to question 3. Examples
could include:
• Noise
• High effort
• Unpleasant odor
• Intermittent operation
• Water leak
• Rough idle
• Unable to adjust
• Difficult to control
• Poor appearance

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

reaching the End User?
The potential effect at the current or receiving locations also
needs to be considered. Examples could include:
• Line shutdown
• Stop shipment
• Yard hold
• 100% of product scrapped
• Decreased line speed
• Added manpower to maintain required line rate

Note: If more than one potential effect is identified when

considering questions 2 and 3, all may be listed, but for purposes
of the analysis, only consider the worst case when documenting
the resulting Severity ranking.

84
Chapter IV Process Failure Mode and Effects Analysis

Example of Effects

Requirement Failure Mode Effect

Four screws Fewer than four screws EndUuser: Loose seat
cushion and noise.
Manufacturing and
Assembly: Stop shipment
and additional sort and
rework due to affected
portion.
Specified screws Wrong screw used Manufacturing and
(larger dia.) Assembly: Unable to
install screw in station.
Assembly sequence: Screw placed in any other Manufacturing and
First screw in right hole Assembly: Difficult to
front hole install remaining screws
in station.
Screws fully seated Screw not fully seated End User: Loose seat
cushion and noise.
Manufacturing and
Assembly: Sort and
rework due to affected
portion.
Screws torqued to Screw torqued too high End User: Loose seat
dynamic torque cushion due to subsequent
specification fracture of screw and
noise.
Manufacturing and
Assembly: Sort and
rework due to affected
portion.
Screw torqued too low End User: Loose seat
cushion due to gradual
loosening of screw and
noise.
Manufacturing and
Assembly: Sort and
rework due to affected
portion.

Table IV.3 Example of Effects

85
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

86
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Severity (S) (d)

Severity is the value associated with the most serious effect for a
given failure mode. Severity is a relative ranking within the
scope of the individual FMEA.
Suggested Evaluation Criteria
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis (See Table Cr1 for 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.

87
 Criteria: Rank Criteria:
Effect Severity of Effect on Product Effect Severity of Effect on Process
Chapter IV

(Customer Effect) (Manufacturing/Assembly Effect)

Potential failure mode affects safe vehicle operation and/or 10 May endanger operator (machine or assembly) without
involves noncompliance with government regulation without warning.
Failure to Meet Failure to Meet
warning.
Safety and/or Safety and/or
Regulatory Regulatory
Requirements Potential failure mode affects safe vehicle operation and/or 9 Requirements May endanger operator (machine or assembly) with
involves noncompliance with government regulation with warning.
warning.

Loss of primary function (vehicle inoperable, does not affect 8 100% of product may have to be scrapped. Line
Major Disruption
Loss or safe vehicle operation). shutdown or stop ship.
Degradation of
Primary Degradation of primary function (vehicle operable, but at 7 A portion of the production run may have to be
Function Significant
reduced level of performance). scrapped. Deviation from primary process including
Disruption
decreased line speed or added manpower.

Loss of secondary function (vehicle operable, but comfort / 6 100% of production run may have to be reworked off
Loss or convenience functions inoperable). Moderate line and accepted.
Degradation of Disruption
Secondary Degradation of secondary function (vehicle operable, but 5 A portion of the production run may have to be

88
Function comfort / convenience functions at reduced level of reworked off line and accepted.
performance).

Appearance or Audible Noise, vehicle operable, item does 4 100% of production run may have to be reworked in
not conform and noticed by most customers (> 75%). station before it is processed.
Moderate
Appearance or Audible Noise, vehicle operable, item does 3 Disruption A portion of the production run may have to be
not conform and noticed by many customers (50%). reworked in-station before it is processed.
Annoyance

Appearance or Audible Noise, vehicle operable, item does 2 Slight inconvenience to process, operation, or operator.
not conform and noticed by discriminating customers Minor Disruption
(< 25%).

No effect No discernible effect. 1 No effect No discernible effect.

Table Cr1 Suggested PFMEA Severity Evaluation Criteria

Process Failure Mode and Effects Analysis
Chapter IV Process Failure Mode and Effects Analysis

This page intentionally left blank.

89
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

90
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Classification (e)

This column may be used to highlight high priority failure modes

or causes that may require additional engineering assessment.
This column may also be used to classify any special product or
process characteristics (e.g., critical, key, major, significant) for
components, subsystems, or systems that may require additional
process controls.

Customer specific requirements may identify special product or

process characteristic symbols and their usage.

Where a special characteristic is identified with a severity of 9 or

10 in the PFMEA, the design responsible engineer should be
notified since this may affect the engineering documents.

Potential Cause(s) of Failure Mode (f)

Potential cause of failure is defined as an indication of how the
failure could occur, and is described in terms of something that
can be corrected or can be controlled. Potential cause of failure
may be an indication of a design or process weakness, the
consequence of which is the failure mode.
To the extent possible, identify and document every potential
cause for each failure mode. The cause should be detailed as
concisely and completely as possible. Separating the causes will
result in a focused analysis for each and may yield different
measurement, controls, and action plans. There may be one or
more causes that can result in the failure mode being analyzed.
This results in multiple lines for each cause in the table or
form. 10
In preparing the PFMEA, the team should assume that the
incoming part(s)/material(s) are correct. Exceptions can be
made at the team’s discretion where historical data indicate
deficiencies in incoming part quality.
Only specific errors or malfunctions (e.g., seal not installed or
seal installed inverted) should be listed. Ambiguous phrases
(e.g., operator error or seal mis-installed, etc.) should not be
used. See Table IV.4 Example of Causes and Controls.

10
In preparing the PFMEA, the team needs to ensure that any limitations of the design that may result in a
potential process failure mode are communicated to the design function.

91
Chapter IV Process Failure Mode and Effects Analysis

Occurrence (O) (g)

Occurrence is the likelihood that a specific cause of failure will
occur. The likelihood of occurrence ranking number has a
relative meaning rather than an absolute value (See Table Cr2).
Estimate the likelihood of occurrence of a potential cause of
failure on a 1 to 10 scale. A consistent occurrence ranking
system should be used to ensure continuity. The occurrence
ranking number is a relative ranking within the scope of the
FMEA and may not reflect the actual likelihood of occurrence.
The “Incident per items/vehicles” is used to indicate the number
of failures that are anticipated during the process execution. If
statistical data are available from a similar process, the data
should be used to determine the occurrence ranking. In other
cases, a subjective assessment can be made by using the word
descriptions in the left hand column of the table, along with input
from the appropriate process knowledge source to estimate the
ranking.
Suggested Evaluation Criteria
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis. Occurrence should be estimated
using a 1 to 10 scale based upon Table Cr2 as a guideline.

92
Chapter IV Process Failure Mode and Effects Analysis

Likelihood Criteria: Occurrence of Cause - PFMEA

Rank
of Failure (Incidents per items/vehicles)

≥ 100 per thousand

Very High 10
≥ 1 in 10
50 per thousand
9
1 in 20
20 per thousand
High 8
1 in 50
10 per thousand
7
1 in 100
2 per thousand
6
1 in 500
.5 per thousand
Moderate 5
1 in 2,000
.1 per thousand
4
1 in 10,000
.01 per thousand
3
Low 1 in 100,000
≤.001 per thousand
2
1 in 1,000,000
Very Low Failure is eliminated through preventive control. 1

Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria

93
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

94
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Current Process Controls (h)

Current Process Controls are descriptions of the controls that can
either prevent to the extent possible, the cause of failure from
occurring or detect the failure mode or cause of failure should it
occur.
There are two types of Process Controls to consider:
Prevention:
Eliminate (prevent) the cause of the failure or the failure mode
from occurring, or reduce its rate of occurrence.
Detection:
Identify (detect) the cause of failure or the failure mode, leading
to the development of associated corrective action(s) or counter-
measures.

The preferred approach is to first use prevention controls, if

possible. The initial occurrence rankings will be affected by the
prevention controls provided they are integrated as part of the
process. The initial detection rankings will be based on process
controls that either detect the cause of failure, or detect the
failure mode.
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.
SPC may, however, be considered as a Prevention Control for
specific causes whose trends are identifiable in advance of an
actual non-conformance being produced, such as tool wear.

The example PFMEA form in this manual has two separate

columns for Prevention Controls and Detection Controls to assist
the team in clearly distinguishing between these two types of
controls. This allows for a quick visual determination that both
types of process controls have been considered.
If a one-column (for process controls) form is used, then the
following prefixes should be used. For prevention controls, place
a 'P' before or after each prevention control listed. For detection
controls, place a 'D' before or after each detection control listed
(see Table IV.4 Example of Causes and Controls).

11
See Chrysler, Ford, GM; SPC Manual, AIAG.

95
Chapter IV Process Failure Mode and Effects Analysis

Failure Prevention
Requirement Cause Detection Control
Mode Control
Screws torqued Screw not Nut runner not Operator training Angle sensor included in nut
until fully seated fully seated held perpendicular runner to detect cross-threading
to work surface by not allowing part to be removed
operator from fixture until value is
satisfied

Screws torqued Screw Torque setting set Password Torque validation box included
to dynamic torqued too too high by non- protected control in set-up procedure to validate
torque high set-up personnel panel (only set-up setting prior to running
specification personnel have
access)
Torque setting set Training of set-up Torque validation box included
too high by set-up personnel in set-up procedure to validate
personnel setting prior to running
Settings added to
set-up instructions

Screw Torque setting set Password Torque validation box included

torqued too too low by non- protected control in set-up procedure to validate
low set-up personnel panel (only set-up setting prior to running
personnel have
access)

Torque setting set Training of set-up Torque validation box included

too low by set-up personnel in set-up procedure to validate
personnel setting prior to running
Settings added to
set-up instructions

Table IV.4 Examples of Causes and Controls

96
Chapter IV Process Failure Mode and Effects Analysis

This page intentionally left blank.

97
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

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

98
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Detection Controls column. Detection is a relative
ranking within the scope of the individual FMEA. In order to
achieve a lower ranking, generally the planned detection control
has to be improved.
When more than one control is identified, it is recommended that
the detection ranking of each control be included as part of the
description of the control. Record the lowest ranking value in the
Detection column.
Assume the failure has occurred and then assess the capabilities
of all "Current Process Controls" to prevent shipment of the part
having this failure mode. 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 frequency
failure modes or prevent them from going further in the process.

Random quality checks are unlikely to detect the existence of an

isolated problem and should not influence the detection ranking.

Suggested Evaluation Criteria

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 Cr3 as a guideline.

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

through proven process design solutions.

99
 Chapter IV Process Failure Mode and Effects Analysis

Opportunity for Criteria: Likelihood

Rank
Detection Likelihood of Detection by Process Control of Detection

No detection No current process control; Cannot detect or is not Almost

opportunity analyzed.
10
Impossible
Not likely to detect Failure Mode and/or Error (Cause) is not easily detected
at any stage (e.g., random audits).
9 Very Remote

Problem Detection Failure Mode detection post-processing by

Post Processing operator through visual/tactile/audible means.
8 Remote

Failure Mode detection in-station by operator through

Problem Detection visual/tactile/audible means or post-processing through
at Source use of attribute gauging (go/no-go, manual torque
7 Very Low
check/clicker wrench, etc.).

Failure Mode detection post-processing by operator

Problem Detection through use of variable gauging or in-station by operator
Post Processing through use of attribute gauging (go/no-go, manual
6 Low
torque check/clicker wrench, etc).

Failure Mode or Error (Cause) detection in-station by

operator through use of variable gauging or by
Problem Detection automated controls in-station that will detect discrepant
at Source part and notify operator (light, buzzer, etc.). Gauging
5 Moderate
performed on setup and first-piece check (for set-up
causes only).

Failure Mode detection post-processing by automated

Problem Detection Moderately
Post Processing
controls that will detect discrepant part and lock part to 4
prevent further processing. High

Failure Mode detection in-station by automated controls

Problem Detection
at Source
that will detect discrepant part and automatically lock 3 High
part in station to prevent further processing.
Error Detection Error (Cause) detection in-station by automated controls
and/or Problem that will detect error and prevent discrepant part from 2 Very High
Prevention being made.
Error (Cause) prevention as a result of fixture design,
Detection not
machine design or part design. Discrepant parts cannot be Almost
applicable; Error
made because item has been error-proofed by
1
Prevention Certain
process/product design.

Table Cr3 Suggested Process FMEA Detection Evaluation Criteria

100
Chapter IV Process Failure Mode and Effects Analysis

This page intentionally left blank

101
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
over time. clogged start-up and for film thickness experiments by Limits were

102
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Determining Action Priorities

Once the team has completed the initial identification of failure
modes and effects, causes and controls, including rankings for
severity, occurrence and detection, they must decide if further
efforts are needed to reduce the risk. Due to the inherent
limitations on resources, time, technology, and other factors,
they must choose how to best prioritize these efforts.
The initial focus of the team should be oriented towards failure
modes with the highest severity rankings. When the severity is 9
or 10, it is imperative that the team ensure that the risk is
addressed through existing design controls or recommended
actions (as documented in the FMEA).
For failure modes with severities of 8 or below the team should
consider causes having the highest occurrence or detection
rankings. It is the team’s responsibility to look at the
information, decide upon an approach, and determine how to
best prioritize their risk reduction efforts which best serve their
organization and customers.

Risk Evaluation;
Risk Priority Number (RPN) (j)
One approach to assist in action prioritization has been to use the
Risk Priority Number:
RPN = Severity (S) x Occurrence (O) x Detection (D)
Within the scope of the individual FMEA, this value can range
between 1 and 1000.
The use of an RPN threshold is NOT a recommended practice
for determining the need for actions.
Applying thresholds assumes that RPNs are a measure of relative
risk (which they often are not) and that continuous improvement
is not required (which it is).
For example, if the customer applied an arbitrary threshold of
100 to the following, the supplier would be required to take
action on the characteristic B with the RPN of 112.

Item Severity Occurrence Detection RPN

A 9 2 5 90
B 7 4 4 112

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

characteristic A. However, the priority should be to work on A
with the higher severity of 9, although its RPN is 90 which is
lower and below the threshold.

103
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
over time. clogged start-up and for film thickness experiments by Limits were

104
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Another concern with using the threshold approach is that there

is no specific RPN value that requires mandatory action.
Unfortunately, establishing such thresholds may promote the
wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce
the RPN. This type of behavior avoids addressing the real
problem that underlies the cause of the failure mode and merely
keeps the RPN below the threshold. It is important to recognize
that while determining “acceptable” risk at a particular program
milestone (e.g., vehicle launch) is desirable, it should be based
on an analysis of severity, occurrence and detection and not
through the application of RPN thresholds.

Use of the RPN index in the discussions of the team can be a

useful tool. The limitations of the use of RPN need to be
understood. However, the use of RPN thresholds to determine
action priority is not recommended.

Recommended Action(s) (k)

In general, prevention actions (i.e., reducing the occurrence) are
preferable to detection actions. An example of this is the use of
process design error proofing rather than random quality checks
or associated inspection.
The intent of any recommended action is to reduce rankings in
the following order: severity, occurrence, and detection.
Example approaches to reduce these are explained below:
• To Reduce Severity (S) Ranking: Only a design or process
revision 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 should be reviewed by the team to determine the effect
on the product functionality and process.
For maximum effectiveness and efficiency of this approach,
changes to the product and process design should be
implemented early in the development process. For example,
process technology needs to be considered very early in the
process development if severity is to be reduced.

• To Reduce Occurrence (O) Ranking: To reduce occurrence,

process and design revisions may be required. A reduction in
the occurrence ranking can be effected by removing or
controlling one or more of the causes of the failure mode
through a product or process design revision.
Studies to understand the sources of variation of the process
using statistical methods may be implemented. These studies

105
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
over time. clogged start-up and for film thickness experiments by Limits were

106
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

may result in actions that reduce occurrence. Further, the

knowledge gained may assist in the identification of suitable
controls including ongoing feedback of information to the
appropriate operations for continuous improvement and problem
prevention.
• To Reduce Detection (D) Ranking: The preferred method is
the use of error/mistake proofing. A redesign of the
detection methodology may result in a reduction of the
detection ranking. In some cases, a design change to a
process step may be required to increase the likelihood of
detection (i.e., reduce the detection ranking.) Generally,
improving detection controls requires the knowledge and
understanding of the dominant causes of process variation
and any special causes. Increasing the frequency of
inspection is usually not an effective action and should only
be used as a temporary measure to collect additional
information on the process so that permanent
preventive/corrective action can be implemented 12 .
If the assessment leads to no recommended actions for a specific
failure mode/cause/control combination, indicate this by entering
“None” in this column. It may be useful to also include a
rationale if “None” is entered, especially in case of high severity.
For process actions, the evaluation may include but is not limited
to a review of:
• Results of process DOE or other testing when applicable
• Modified process flow diagram, floor plan, work instructions
or preventive maintenance plan
• Review of equipment, fixtures or machinery 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 recommended
actions (Column k).

Responsibility & Target Completion Date (l)

Enter the name of the individual and organization responsible for
completing each recommended action including the target
completion date. The process-responsible engineer/team leader is
responsible for ensuring that all actions recommended have been
implemented or adequately addressed.

12
See Chrysler, Ford, GM; SPC Manual, AIAG.

107
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of

Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
Core Team G
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35
over time. clogged start-up and for film thickness experiments by Limits were

108
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too and preventative Visual check viscosity vs. limit controls have
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85

Spray head Preventative 2 Variables check 5 70 None

deformed due to maintenance for film thickness
impact programs to
maintain heads Visual check
for coverage.

Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
Excessive wax
coverage over
specified surface

a1 a2 b c de f h g h i j k l m ----n----

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

Action Results (m-n)

This section identifies the results of any completed actions and
their effect on S, O, D rankings and RPN.

Action(s) Taken and Completion Date (m)

After the action has been implemented, enter a brief description
of the action taken and actual completion date.

Severity, Occurrence, Detection and RPN (n)

After the preventive/corrective action has been completed,
determine and record the resulting severity, occurrence, and
detection rankings.
Calculate and record the resulting action (risk) priority indicator
(e.g., RPN).
All revised rankings should be reviewed. Actions alone do not
guarantee that the problem was solved (i.e., cause addressed),
thus an appropriate analysis or test should be completed as
verification. If further action is considered necessary, repeat the
analysis. The focus should always be on continuous
improvement.

109
Chapter IV Process Failure Mode and Effects Analysis

Process Failure Prevention Detection Recommended

Step/Function Requirement Cause
Mode Controls Controls Actions
Op. 20 (attach Four screws Fewer than Too few Visual aids Visual In-station torque
seat cushion to four screws screws illustrating Inspection monitoring;
track using a inadvertently correct in station Line lockout if
torque gun) installed quantity fewer than four
Select four
Operator
screws
training

Specified Wrong Similar Visual aids Visual In-station torque

screws screw used screws illustrating inspection angle monitoring;
(larger dia.) available at correct in station Line lockout if
station screw angle not met
Operator
training Error proof by
design: use one
type screw for
station/product
Op. 20 (attach Assembly Screw More than Visual aids Visual Add position
seat cushion to sequence: placed in one hole identifying inspection sensor to nut
track using a First screw any other available to location of in station runner not
torque gun) in right front hole operator first screw allowing tool to
Beginning with hole operate unless
right front hole, Operator runner is aligned
torque each screw training with correct hole
to the required
torque

Table IV.5 Examples of Causes, Controls and Actions

Maintaining PFMEAs
The PFMEA is a living document and should be reviewed
whenever there is a product or process design change and
updated, as required.
Another element of on-going maintenance of PFMEAs should
include a periodic review. Specific focus should be given to
Occurrence and Detection rankings. This is particularly
important where there have been product or process changes or
improvements in process controls. Additionally, in cases where
either field issues or production issues, such as disruptions, have
occurred, the rankings should be revised accordingly.

Leveraging PFMEAs
The use of a fundamentally sound PFMEA is the starting point
that provides the greatest opportunity to leverage the use of past
experience and knowledge.

110
Chapter IV Process Failure Mode and Effects Analysis

If a new project or application is functionally similar to the

existing product and the process to be used is similar, a single
PFMEA may be used with customer concurrence. If there are
differences, the team should identify and focus on the effects of
these differences.

Linkages
The PFMEA is not a “stand-alone” document. Figure IV.5 shows
some common linkages.

DFMEA, Process Flow

Diagram, etc.

PFMEA

Process Control Plans

Figure IV.5 PFMEA Information Interrelationship Flow

To DFMEA
In the development of a PFMEA it is important to utilize the
information and knowledge gained in the creation of the
DFMEA. However, the link between the two documents is not
always obvious. The difficulty occurs because the focus of each
FMEA is different. The DFMEA focuses on part function
whereas the PFMEA focuses on the manufacturing steps or
process. Information in the columns of each form is not directly
aligned. For example, Item/Function-Design does not equal
Process Functions/Requirements; potential design failure mode
does not equal potential process failure mode; potential design
cause of failure does not equal potential process cause of failure.
However, by comparing the overall analysis of design and
process, a connection can be made. One such connection is
between the characteristics identified during the DFMEA and
PFMEA analysis.
Another connection is the relationship between potential design
cause of failure (DFMEA) and potential process failure mode
(PFMEA). For example, the design of a feature such as a hole
can cause a particular failure mode. The corresponding process

111
Chapter IV Process Failure Mode and Effects Analysis

failure mode is the inability of the process to manufacture the

same feature as designed. In this example, the potential design
cause of failure (hole diameter designed too large) would appear
to be similar to the potential process failure mode (hole drilled
too large). The potential effect of the failure mode for both
design and process may be identical if there were no additional
process related effects. In other words, the end result (effect) of
the failure mode is the same, but there are two distinct causes.
While developing the PFMEA, it is the team’s responsibility to
ensure that all process related potential failure modes which lead
to product related 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 result of the PFMEA activity, a
Control Plan should be developed 13 . Some organizations may
elect not to specifically identify the related product and process
characteristics” in the PFMEA. In this situation, the “Product
Characteristics” portion of the Control Plan may be derived from
the “Requirements” portion of the “Process
Function/Requirements” column and the “Process
Characteristics” portion may be derived from the “Potential
Cause(s) of Failure Mode” column.
When the team develops the Control Plan, they need to assure
that the PFMEA current controls are consistent with the control
methods specified in the Control Plan.

13
Guidelines for Control Plan development are included in Chrysler, Ford, GM; Advanced Product Quality
Planning and Control Plan (APQP), AIAG.

112
APPENDICES

113
Appendix A Sample Forms

Appendix A: Sample Forms

DFMEA Forms
• Form A: Basic form (with minimal information) 14
o With Prevention and Detection Controls as separate
columns 15
• Form B: Form with Item/Function and Requirements in
separate columns
o To assist in the determination of failure modes
• Form C: Form A with Prevention Controls column to the left
of the Occurrence column
o To better show the relationship between prevention
controls and occurrence ranking
• Form D: Form B and C combined
• Form E: Form D with separate columns for Current
Detection Design Controls (Cause and Failure Mode)
o To highlight the need to consider cause-related
controls
• Form F: Form B with separate columns for Responsibility
and Target Completion Date and Actions Taken and
Completion Date
o To allow sorting by dates

14
This form was provided in the Chrysler, Ford, and GM; FMEA Manual 3rd Edition, AIAG.
15
Preventive and Detective Controls may be in the same column if each control is identified with a “P”
or “D” respectively.

114
 POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number
(DESIGN FMEA) Page of
______ Subsystem

______Component; _____________________________________ Design Responsibility ______________________________________ Prepared By:

Appendix A

Model Year(s)/Program(s)_________________________________ Key Date ________________________________________________ FMEA Date (Orig.)

Core Team

Item / Action Results

Current Current
Function Potential Potential Responsibility
Potential Design Design
Failure Effect(s) of Cause(s) Controls Recommended & Target Actions Taken
Controls Action

RPN
Completion Date
RPN

Mode Failure

Severity
& Effective Date
Severity

of Failure Prevention Detection

Detection

Detection

Occurrence
Occurance

Requirements

Classification

115
DFMEA Form A
Sample Forms
Appendix A Sample Forms

DFMEA Form B

116
Appendix A Sample Forms

DFMEA Form C

117
Appendix A Sample Forms

DFMEA Form D

118
Appendix A Sample Forms

DFMEA Form E

119
Appendix A Sample Forms

DFMEA Form F

120
Appendix A Sample Forms

PFMEA Forms
• Form A: Basic form (with minimal information) 16
o With Prevention and Detection Controls as separate
columns 17
• Form B: Form A with Process Step/Function and
Requirements as separate columns
o To assist in the determination of failure modes
• Form C: Form A with Prevention Controls Column to the
left of the Occurrence column
o To better show the relationship between prevention
controls to occurrence ranking
• Form D: Form B and C combined
• Form E: Form D with separate columns for Current
Detection Process Controls (Cause and Failure Mode)
o To highlight the need to consider cause related
controls
• Form F: Form B with separate columns for Responsibility
and Target Completion Date and Actions Taken and
Completion Date
o To allow sorting by dates
• Form G: Form B with ID, Product and Process within a
bridged Requirements column
o To provide consistency among the Process Flow,
PFMEA and Control Plan
• Form H: Form D and G combined

16
This form was adapted from that provided in the Chrysler, Ford, and GM; FMEA Manual 3rd Edition, AIAG.
17
Preventive and Detective Controls may be in the same column if each control is identified with a “P” or “D”
respectively.

121
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number
(PROCESS FMEA) Page of

Item: _________________________________________________ Process Responsibility ______________________________________ Prepared By:

Appendix A

Model Year(s)/Program(s)_________________________________ Key Date __________________________________________________ FMEA Date (Orig.)

Core Team

Action Results
Process Step Current Current
/ Function Potential Potential Responsibility
Potential
Failure Effect(s) of Process Process Recommended
Cause(s) Controls & Target Actions Taken
Controls Action

RPN
Completion Date
RPN

Mode Failure

Severity
of Failure & Effective Date
Severity
Detection

Detection

Occurrence
Occurance

Classification
Requirements

122
PFMEA Form A
Sample Forms
Appendix A Sample Forms

PFMEA Form B

123
Appendix A Sample Forms

PFMEA Form C

124
Appendix A Sample Forms

PFMEA Form D

125
 POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number
(PROCESS FMEA) Page of

Item: _________________________________________________ Process Responsibility ______________________________________ Prepared By:

Appendix A

Model Year(s)/Vehicle(s )__________________________________ Key Date __________________________________________________ FMEA Date (Orig.)

Core Team

Action Results
Process Current Current Detection
Potential Potential Responsibility
Step Potential Process
Failure Effect(s) of Cause(s) Process Controls Recommended
Requirements Controls & Target Actions Taken
Action

RPN
Completion Date
RPN

Mode Failure Prevention

Severity
of Failure & Effective Date
Severity

Cause Failure Mode

Detection

Detection

Occurrence
Occurance

Classification
Function

126
PFMEA Form E
Sample Forms
Appendix A Sample Forms

PFMEA Form F

127
Appendix A Sample Forms

PFMEA Form G

128
Appendix A Sample Forms

PFMEA Form H

129
Appendix B System Level FMEA

Appendix B: System Level FMEA

The process for a System FMEA is generally the same as the
development of other FMEAs. The major differences between
System level FMEAs and other types of FMEAs is the focus on
functions and relationships that are unique to the system as a
whole (i.e., do not exist at lower levels). The System level
FMEA includes failure modes associated with interfaces and
interactions in addition to considering single point failures which
is the primary focus of product level FMEAs.

To help illustrate the meaning of System, Subsystem, and

Component FMEAs, two examples have been constructed below
in Figure B.1 (for Interfaces and Interactions) and in Figure B.2
(for Item, Function, and Failure Modes.).

Figure B.1 Interfaces and Interactions

The FMEA team is responsible for specifying the scope of its

respective FMEAs. The example in Figure B.1 shows that the
team has specified Subsystems A, B, C, and D along with the
surrounding environment as comprising the System that must be
considered while completing the System FMEA.

130
Appendix B System Level FMEA

Interfaces
In Figure B.1, interfaces between subsystems are shown where
Subsystem A touches and (connects with) Subsystem B, B
touches or connects with C, and a clearance between D and B,
signified by the dashed line. The Environment also touches each
of the subsystems listed in Figure B.1, which requires the
“Environmental Interfaces” be considered when completing the
FMEA. Also, the interfaces to major and minor subsystems,
whether direct or indirect, should be included.

The interfaces which are identified in the System FMEA should

be included in the respective Subsystem FMEA.

Figure B.2 shows a system and its interrelationships in a

“hardware” oriented approach.

Interactions
A change in one subsystem or component may cause a change in
another subsystem or component.
In Figure B.1, interactions between subsystems and components
can occur among any of the interfacing systems. For example,
Subsystem A heats up, resulting in Subsystem B and D gaining
heat through their respective interfaces, as well as Subsystem A
giving off heat to the environment. Interactions might also occur
among ‘non-contacting’ systems via transfer through the
‘environment’. For example, if the environment is composed of
high humidity and Subsystems A and C are dissimilar metals
separated by a non-metal composing Subsystem B, Subsystem A
and C can still have an electrolytic reaction due to the moisture
from the environment. Thus, interactions among non-contacting
subsystems can be relatively difficult to predict but are important
and should be considered.

131
Appendix B System Level FMEA

Figure B.2 Item, Functions, and Failure

132
Appendix B System Level FMEA

Relationships
Multiple Levels of Design FMEAs
More likely than not, the focus of a DFMEA is an item which is
a subset of a larger system. The FMEAs at the different levels of
the design hierarchy (i.e., system, subsystem and component) are
linked through the cause Æ failure mode Æ effect of failure
relationships. This is a two way linkage (see Figure B.3):
From Lower to Higher Level: The effect of a failure mode at a
given level is a failure mode at the next higher level.
For example, the effect of a part 2 failure mode would be a
failure mode of module 3 either directly or indirectly by causing
another part to fail. The effect of a module 4 failure mode is a
failure mode of subsystem 4. Consequently, the effect of a
failure mode at any sublevel may ultimately become a system
failure mode with its customer / user related effects.
From Higher to Lower level: The linkage from a higher level to
the next lower level is related to the physics of failure rather than
a pure cause and effect relationship since in the development of a
DFMEA, the causes identified at any level deal with the design
process and only indirectly with the failure mechanisms.
Understanding these relationships will provide a consistency of
analysis and an economy of effort in the development of
DFMEAs.

133
Appendix B System Level FMEA

Figure B.3 DFMEA Effects Linkages

134
Appendix C Alternative Risk Assessments

Appendix C: Alternative Risk Assessments

Alternatives to RPN
The risk priority number is the product of the severity (S),
occurrence (O), and detection (D) rankings.

(S) x (O) x (D) = RPN

Within the scope of the individual FMEA, this value (between 1
and 1000) can be used to assist the team in ranking the concerns
in the design of the product and process.
The table below, however, illustrates how different Severity (S),
Occurrence (O) & Detection (D) scenarios result in equal RPN
values. 18
Upon review of each scenario, priorities would not be
established by the team based on the RPN alone.

Fifteen Different Situations with an RPN=360

Severity of Likelihood of Likelihood of
Problem Occurrence Detection
1 Hazardous 10 High 9 Moderate 4
2 Hazardous 10 Moderate 6 Low 6
3 Hazardous 10 Moderate 4 Very Remote 9
4 Hazardous 9 Very High 10 Mod High 4
5 Hazardous 9 High 8 Moderate 5
6 Hazardous 9 Moderate 5 Remote 8
7 Hazardous 9 Moderate 4 Impossible 10
8 High 8 High 9 Moderate 5
9 High 8 Moderate 5 Very Remote 9
10 Moderate 6 Very High 10 Low 6
11 Moderate 6 Moderate 6 Impossible 10
12 Moderate 5 High 9 Remote 8
13 Moderate 5 High 8 Very Remote 9
14 Moderate 4 Very High 10 Very Remote 9
15 Moderate 4 High 9 Impossible 10

The ease of calculation and sorting of this index has led many to
use it exclusively and without consideration to what may be a
more appropriate means of prioritizing. Examples of some such
alternatives follow.

18
Used with permission from Whirlpool Corporation, ©2005, 2006

135
Appendix C Alternative Risk Assessments

Alternative: SO (S x O)
Some organizations may choose to primarily focus on Severity
and Occurrence. The SO index is the product of the Severity, and
Occurrence rankings. In using this index, the organization may
focus on how to reduce SO by reducing the value of “O” through
preventive actions. Furthermore this may lead to subsequent
detection improvements for those with the highest SO value.
Alternative: SOD, SD
Some organizations have chosen to use SOD or SD as a
prioritization tool. SOD is the non-arithmetic combination of the
Severity, Occurrence and Detection rankings. SD is the non-
arithmetic combination of the Severity and Detection rankings.
Example (SOD):
Severity, S=7
Occurrence, O=3
Detection, D=5
The resulting SOD is 735

Example (SD):
Severity, S=7
Detection, D=5
The resulting SD is 75

The SOD, when sorted in numerical, descending order, will

prioritize the scenarios first by severity, second by occurrence
and lastly by detection.

S O D RPN SOD SD
7 7 3 147 773 73
Very
7 3 7 147 737 77 Different
3 7 7 147 377 37 Scenarios
Equal RPN Values

Table C.1 Contrast among RPN, SOD and SD

Just as with RPN, use of the SOD/SD index should be used in

context of team discussion. Defining priorities simply based on
the SOD has limitations just as with the RPN. For example, a
failure mode with a SOD of 711 would be ranked higher (i.e.,
have to be considered before) a failure mode with 599.

136
Appendix D Alternative Analysis Techniques

Appendix D: Alternative Analyses Techniques

Failure Mode and Effects Analysis is one of many techniques
used to evaluate and analyze design risk. Other methods have
been developed for specific areas and can be used to complement
the analysis in the FMEA process. They may be used as a
replacement for an FMEA with authorization by the customer.
These are only a few of the examples.
Failure Mode, Effect
and Criticality
Analysis (FMECA)
FMECA is similar to FMEA. The C in FMECA indicates that the
criticality (or severity) of the various failure effects are
considered and ranked. Today, FMEA is often used as a
synonym for FMECA.
Design Review Based
on Failure Modes
(DRBFM)
Design Review Based on Failure Modes is a cause and effect
analysis of concerns related to a design change. It is a tool used
to guide and manage good discussion in relation to the change.
DRBFM focuses on the impact of the change on design,
evaluation procedures, and manufacturing systems with the
intent of anticipating and preventing problems. A design review
by subject matter experts to evaluate the change(s) and related
improvements is an integral part of DRBFM. (Reference Figure
D.1).
Fault Tree Analysis
(FTA)
FTA is a technique for system analysis where system faults are
analyzed from a single potential failure to identify all possible
causes. FTA considers combinations of interdependent as well as
independent causes. In addition to the structure of the fault tree
and all of the logic interdependencies, the FTA normally
includes the failure probabilities identification. This allows the
calculation of system reliability given the component
reliabilities. 19 (Reference Figure D.2).

19
References: IEC 61025; QICID (ASQ-20352).

137
Appendix D Alternative Analysis Techniques

Figure D.1 Example of DRBFM Elements

138
Appendix D Alternative Analysis Techniques

Figure D.2 FTA Tree Structure

139
References and Suggested Readings

References and Suggested Readings

IEC 60300-3-1, Dependability management – Part 3-1: Application guide – Analysis techniques for
dependability – Guide on methodology.
IEC 60812, Edition 2; Failure modes and effects analysis, January 2006.
IEC 61025, Edition 2; Fault tree analysis, January 2007.
QICID (ASQ-20352) “System Reliability Through Fault Tree Analysis”.
SAE ARP 5580, Recommended Failure Modes and Effects Analysis (FMEA). Practices for Non-
Automotive Applications. (Replacement for MIL-STD-1629A, 1998 (withdrawn)).
SAE J1739:2002, Potential Failure Mode and Effects Analysis in Design (Design FMEA) and Potential
Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA).
Alfredo, H.S. Ang and Wilson, H. Tang (1990). “Probability Concepts in Engineering Planning and
Design, Volume II -- Decision Risk and Reliability”, Wiley Publications.
Bowles, J. (2003). “An Assessment of RPN Prioritization in a Failure Modes Effects and Criticality
Analysis”, Proceedings Annual Reliability and Maintainability Symposium, pp 380-386; also in Journal of
the IEST, Institute of Environmental Sciences and Technology, Vol 47, 2004, pp. 51-56.
Krasich, M. (2007). “Physics of Failure Approach to FMEA”, Tutorial Proceedings Reliability and
Maintainability Symposium.
Krasich, M. (2005). “Fault Tree Analysis in Product Reliability Improvement”, Tutorial Proceedings
Reliability and Maintainability Symposium.
O’Conner, P.D.T., (2002). Practical Reliability Engineering. 4th edition, (Wiley).
Shu-Ho Dai and Ming-O Wang (1992), Reliability Analysis in Engineering Applications, Van Nostrand
Reinhold.
Wheeler, D. J. (2005). The Six Sigma Practitioner's Guide to Data Analysis, SPC Press, Knoxville, pp.311-
315.
Rausand, M. (2004). System Reliability Theory (2nd ed), Wiley, 2004.

140
Index

Index
APQP (Advanced Product Quality Planning), 2, occurrence, 3, 13, 45, 46, 49, 53, 57, 59, 61, 63,
5 64, 68, 69, 92, 93, 95, 99, 103, 105, 107, 109,
block diagram, 18, 19, 29 110, 135, 136
classification, 39, 91 OEM (GM, Ford, Chrysler), 11, 17, 27, 75
continuous improvement, 6, 57, 63, 103, 107, PFMEA (Process Failure Mode and Effects
109 Analysis), 5, 17, 66, 68-71, 75, 77, 83, 91, 95,
control plans, 6, 13, 111 110, 111
cross-functional, 2, 9, 17, 69, 71 potential cause, 12, 39, 41, 91, 92
current design controls, 49, 53 potential failure mode, 11, 16-18, 31, 61, 70-71,
design improvements, 16 81, 112
design intent, 11, 12, 22, 29, 41, 49, 68, 79 preventive controls, 45
design life, 45 process step, 77, 79, 107
detection, 13, 18, 49, 51, 57-64, 68, 73, 95, 99- recommended actions, 6, 13, 18, 57, 59, 61, 103,
110, 135, 136 107
detection controls, 49, 66, 99, 107 responsible engineer, 17, 63, 69, 70, 91, 107
DFMEA (Design Failure Mode and Effects RPN (Risk Priority Number), 57, 59, 63, 103,
Analysis), 5, 16-19, 22, 25, 29, 39, 41, 64-66, 105, 109, 135, 136
70, 73, 83, 84, 111, 133 scope, 3, 4, 8, 10, 11, 18, 25, 68, 70, 71, 73, 75,
DOE (Design of Experiments), 61, 107 130
DRBFM (Design Review by Failure Mode), 137, SD (Ranking by Severity and Detection), 136
error proofing, 73, 105 Severity, 13, 37, 57, 59, 63, 84, 87, 103, 109,
evaluation criteria, 37, 45, 53, 87, 92, 99 135, 136
flow diagram, 70, 71, 81, 107 SO (Ranking by Severity and Occurrence), 136
FMECA (Failure Mode, Effect and Critical SOD (Ranking based on Severity, Occurrence
Analysis), 3, 137 and Detection), 136
Follow-up, 6 SPC (Statistical Process Control), 95, 107
FTA (Fault Tree Analysis), 137, 139 special characteristic, 39, 91
function, 16, 18, 19 ,21 , 29 , 31, 35, 71, 79, 111 specification, 11, 13, 61, 107
functional requirements, 8,16,18, 25 team, 2, 4, 5, 8, 9, 10, 14, 17, 18, 21, 22, 27, 29,
interactions, 3,10, 130, 131 35, 37, 41, 45, 49, 53, 57, 59, 69, 71, 73, 81,
interfaces, 10, 11, 29, 130,131 87, 91, 95, 99, 103, 105, 111
item, 73, 75, 111, 133 team leader, 6, 9, 69, 70, 107
linkages, 65, 111, 134 thresholds, 57, 59, 103, 105
mistake proofing, 61, 107 validation, 16, 31, 49, 59, 61

141
142