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 2015 Annual RELIABILITY and MAINTAINABILITY Symposium

Understanding and Applying the Fundamentals of FMEAs

Carl S. Carlson

Carl S. Carlson
ReliaSoft Corporation
1450 S. Eastside Loop
Tucson, Arizona 85710 USA
e-mail: [email protected]

Tutorial Notes © 2015 AR&MS

 SUMMARY & PURPOSE
Across the globe, development times are becoming shorter, cost concerns more acute, and customers are demanding and
expecting absolute safety and high reliability. While it may have been sufficient in the past to focus on testing and analysis as
the primary methods for ensuring high reliability, this is no longer sufficient. The focus needs to be on problem prevention,
anticipating the factors that lead to failure and ensuring designs are robust. Failure Mode and Effects Analysis (FMEA) can
anticipate and prevent problems, reduce costs, shorten product development times, and achieve safe and highly reliable products
and processes. The plain truth is FMEA has the potential to be a very powerful tool to achieve high reliability in products and
processes; and when done well, it is remarkably effective. Yet in practice, FMEA does not always achieve the expected results.
It has to be done correctly: performed on the correct parts, by the correct team, during the correct timeframe, with the correct
procedure. The purpose of this tutorial is to share the fundamental concepts and procedures for effective FMEAs and highlight
the FMEA success factors.

Carl S. Carlson
Carl S. Carlson is a consultant and instructor in the areas of FMEA, reliability program planning and other reliability
engineering disciplines. He has 30 years of experience in reliability testing, engineering, and management positions, and is
currently supporting clients of ReliaSoft Corporation with reliability and FMEA training and consulting. Previous to ReliaSoft,
he worked at General Motors, most recently as senior manager for the Advanced Reliability Group. His responsibilities included
FMEAs for North American operations, developing and implementing advanced reliability methods, and managing teams of
reliability engineers. Previous to General Motors, he worked as a Research and Development Engineer for Litton Systems,
Inertial Navigation Division.
Mr. Carlson co-chaired the cross-industry team that developed the commercial FMEA standard (SAE J1739, 2002 version),
participated in the development of SAE JA 1000/1 Reliability Program Standard Implementation Guide, served for five years as
Vice Chair for the SAE's G-11 Reliability Division, and was a four-year member of the Reliability and Maintainability
Symposium (RAMS) Advisory Board. He holds a B.S. in Mechanical Engineering from the University of Michigan and
completed the 2-course Reliability Engineering sequence from the University of Maryland's Masters in Reliability Engineering
program. In 2007, he received the Alan O. Plait Award for Tutorial Excellence. He is a Senior Member of ASQ and a Certified
Reliability Engineer. His book, Effective FMEAs, was published in 2012 by John Wiley & Sons.

Table of Contents
1. Introduction .............................................................................................................................................................................. 1
2. Understanding the fundamentals and procedures of FMEAs ................................................................................................... 2
3. Selecting the right FMEA projects ........................................................................................................................................... 7
4. Preparation steps for each FMEA project ................................................................................................................................ 8
5. Applying lessons learned and quality objectives ..................................................................................................................... 9
6. Providing excellent facilitation ................................................................................................................................................ 9
7. Implementing an effective company-wide FMEA process ...................................................................................................... 9
8. Conclusions ............................................................................................................................................................................. 10
9. References .............................................................................................................................................................................. 10
10. Appendix - Problems and Solutions ..................................................................................................................................... 10
11. Tutorial Visuals ..................................................................................................................................................................... 13

ii – Carlson 2015 AR&MS Tutorial Notes

 1. INTRODUCTION to:
• Identify and fully understand potential failure modes and
1.1 Brief history of FMEA
their causes, and the effects of failure on the system or end
FMEA was formalized in 1949 by the US Armed Forces users, for a given product or process.
by the introduction of Mil-P 1629 Procedure for performing a • Assess the risk associated with the identified failure
failure mode effect and criticality analysis.. The objective was modes, effects and causes, and prioritize issues for
to classify failures “according to their impact on mission corrective action.
success and personnel/equipment safety.” [1] It was later • Identify and carry out corrective actions to address the
adopted in the Apollo space program to mitigate risk due to most serious concerns.
small sample sizes. The use of FMEA gained momentum An FMEA is an engineering analysis done by a cross-
during the 1960s, with the push to put a man on the moon and functional team of subject matter experts that thoroughly
return him safely to earth. In the late 1970s the Ford Motor analyzes product designs or manufacturing processes, early in
Company introduced FMEA to the automotive industry for the product development process. Its objective is finding and
safety and regulatory consideration after the Pinto affair. They correcting weaknesses before the product gets into the hands
also used it to improve production and design. In the 1980s, of the customer. [3]
the automotive industry began implementing FMEA by An FMEA should be the guide to the development of a
standardizing the structure and methods through the complete set of actions that will reduce risk associated with the
Automotive Industry Action Group. Although developed by system, subsystem, and component or manufacturing/assembly
the military, the FMEA method is now extensively used in a process to an acceptable level. [3]
variety of industries including semiconductor processing, Performing an FMEA just to fill a checkbox in the
foodservice, plastics, software, aeronautics, automotive, and Product Development Process and then filing it away, never to
healthcare, to name a few. [2] be seen again, is a waste of time and adds no value. If not for
use as guidance through the development process, why waste
1.2 FMEA Standards
the time and resources to do it in the first place? If effectively
There are many standards and guidelines published that used throughout the product life cycle, it will result in
cover the scope and general procedure for doing FMEAs or significant improvements to reliability, safety, quality,
FMECAs. Some of the more common and relevant are: delivery, and cost. [3]
• SAE J1739, Potential Failure Mode and Effects Analysis The primary objective of an FMEA is to improve the
in Design (Design FMEA), Potential Failure Mode and design. For System FMEAs, the objective is to improve the
Effects Analysis in Manufacturing and Assembly design of the system. For Design FMEAs, the objective is to
Processes (Process FMEA) [2009] improve the design of the subsystem or component. For
• AIAG, Potential Failure Mode and Effects Analysis Process FMEAs, the objective is to improve the design of the
(FMEA) Reference Manual Fourth Edition [2008] manufacturing process. [3]
• MIL-STD-1629A, Procedures for Performing a Failure There are many other objectives for doing FMEAs, such
Mode Effects and Criticality Analysis (Cited for as: [3]
cancelation in 1994, but still used in some military and • identify and prevent safety hazards
other applications) • minimize loss of product performance or performance
• SAE ARP5580, Recommended Failure Modes and Effects degradation
Analysis (FMEA) Practices for Non-Automobile • improve test and verification plans (in the case of System
Applications [2001] or Design FMEAs)
• IEC 60812, Analysis techniques for system reliability – • improve Process Control Plans (in the case of Process
Procedure for failure mode and effects analysis (FMEA) FMEAs)
[2006] • consider changes to the product design or manufacturing
process
1.3 Why do FMEAs?
• identify significant product or process characteristics
There are a number of business reasons to implement an • develop Preventive Maintenance plans for in-service
effective FMEA Process. When done well, FMEA is a proven machinery and equipment
tool to reduce life cycle warranty costs. When done well, • develop online diagnostic techniques
FMEAs will reduce the number of “oops” during product
1.5 Types of FMEAs
development. It is far less expensive to prevent problems early
in product development than fix problems after launch. The most common types of FMEAs are System FMEA,
FMEAs can identify and address safety issues before a Design FMEA and Process FMEA.
potential catastrophe. System FMEA is the highest-level analysis of an entire
system, made up of various subsystems. The focus is on
1.4 Definition and purpose of FMEA
system-related deficiencies, including system safety, system
Failure Mode and Effects Analysis is a method designed integration, interfaces or interactions between subsystems or

2015 Annual RELIABILITY and MAINTAINABILITY Symposium Carlson – 1

with other systems, interactions with the surrounding 5. Providing excellent facilitation
environment, human interaction, service, and other issues that 6. Implementing an effective company-wide FMEA process.
could cause the overall system not to work as intended. In Implementing these FMEA success factors will help
System FMEAs, the focus is on functions and relationships ensure FMEAs achieve safe, reliable and economical products
that are unique to the system as a whole (i.e., do not exist at and processes.
lower levels). Included are failure modes associated with
2. UNDERSTANDING THE FUNDAMENTALS AND
interfaces and interactions, in addition to considering single-
PROCEDURES OF FMEAS
point failures (where a single component failure can result in
complete failure of the entire system). Some practitioners It is important to begin with an understanding of the basic
separate out human interaction and service into their own definitions of FMEAs. Time spent toward understanding the
respective FMEAs. fundamental concepts and definitions of FMEAs will shorten
Design FMEA focuses on product design, typically at the the time in meetings and help ensure high quality results.
subsystem or component level. The focus is on design-related There is no substitute for having a thorough knowledge and
deficiencies, with emphasis on improving the design and understanding of the FMEA definitions and concepts.
ensuring product operation is safe and reliable during the Figure 1 is an example of a Generic FMEA Worksheet,
useful life of the equipment. The scope of the Design FMEA truncated after the “Recommended Actions” column. The
includes the subsystem or component itself, as well as the numbers in the illustration correspond to the subsections in this
interfaces between adjacent components. Design FMEA paper. The definitions are presented in the sequence they are
usually assumes the product will be manufactured according to normally developed in an FMEA project.
specifications.
Process FMEA focuses on the manufacturing or
assembly process, emphasizing how the manufacturing process
can be improved to ensure that a product is built to design
requirements in a safe manner, with minimal downtime, scrap
and rework. The scope of a Process FMEA can include
manufacturing and assembly operations, shipping, incoming
parts, transporting of materials, storage, conveyors, tool
maintenance, and labeling. Process FMEAs most often assume
the design is sound. Figure 1. Generic FMEA Worksheet, up through
Failure Mode Effects and Criticality Analysis (FMECA) is “Recommended Actions”
similar to FMEA, with the added step of a more formal
2.1 Item
Criticality Analysis. This added step commonly requires
objective data to support the criticality calculation. It is An “item” (1) is the focus of the FMEA project. For a
recommended for practitioners who are required to perform a System FMEA this is the system itself. For a Design FMEA,
FMECA analysis to understand the basics of FMEA first, and this is the subsystem or component under analysis. For a
then to learn the FMECA procedure. Process FMEA, this is usually one of the specific steps of the
Some other types of FMEAs include Concept FMEA, a manufacturing or assembly process under analysis, as
short version of FMEA to aid in selecting optimum concept represented by an operation description. Figure 2 is an
alternatives or to determine changes to system design example of an “Item” for a Design FMEA. Figure 3 is an
specifications; Maintenance FMEA, in support of Reliability example of an “Item” for a Process FMEA.
Centered Maintenance projects; Hazard Analysis, which
focuses on identifying and addressing potential hazards
associated with the use of a product; and Software FMEA,
which identifies system weaknesses, and evaluates the
effectiveness of the software architecture and software
specifications.
1.6 FMEA Success Factors
There are six broad success factors that are critical to
uniformity of success in the application of FMEA in any
company. The six success factors are listed here, and will be
elaborated on later in this tutorial.
1. Understanding the fundamentals and procedures of
FMEAs, including the concepts and definitions.
2. Selecting the right FMEA projects Figure 2. Example of an “Item” for Design FMEA [3]
3. Preparation steps for each FMEA project
4. Applying lessons learned and quality objectives

2 – Carlson 2015 AR&MS Tutorial Notes

 Dictionary defines the word “failure” as the act of ceasing to
function or the state of not functioning. “Mode” is defined as a
way in which something occurs. Figure 6 is an example of a
“Failure Mode” for a Design FMEA. Figure 7 is an example of
a “Failure Mode” for a Process FMEA.

Figure 3. Example of an “Item” for a Process FMEA [3]

2.2 Function
A “function” (2) is what the item or process is intended to Figure 5. Example of a “Function” for Process FMEA [3]
do, usually to a given standard of performance or requirement.
For Design FMEAs, this is the primary purpose or design
intent of the item. For Process FMEAs, this is the primary
purpose of the manufacturing or assembly operation.
Functions are typically described in a verb-noun format. It is
essential to include the standard of performance as part of the
function statement in order to help describe the failure mode.
There can be many functions for each item or operation.
Figure 4 is an example of example of a “Function” for a
Design FMEA [3]. Figure 5 is an example of a “Function” for a
Process FMEA. Note, in the case of Process FMEAs, the
“function” can be similar to the “item”, as described in the
operation description for the manufacturing or assembly
process.
Figure 6. Example of a “Failure Mode” for Design FMEA [3]

Figure 4. Example of a “Function” for a Design FMEA [3] Figure 7. Example of “Failure Mode” for Process FMEA [3]
2.3 Failure Mode 2.4 Effect
A “failure mode” (3) is the manner in which the item or An “effect” (4) is the consequence of the failure on the
operation potentially fails to meet or deliver the intended system or end user. This can be a single description of the
function and associated requirements. It may include failure to effect on the top-level system and/or end user, or three levels
perform a function within defined limits, inadequate or poor of effects (local, next-higher level, and end effect). For Process
performance of the function, intermittent performance of a FMEAs, consider the effect at the manufacturing or assembly
function, and/or performing an unintended or undesired level, as well as at the system or end user. There can be more
function. The term “failure mode” combines two words that than one effect for each failure mode. However, typically the
both have unique meanings. The Concise Oxford English FMEA team will use the most serious of the end effects for the

2015 Annual RELIABILITY and MAINTAINABILITY Symposium Carlson – 3

analysis. Figure 8 is an example of an “Effect” for a Design “Cause” for a Process FMEA.
FMEA. Figure 9 is an example of an “Effect” for a Process
FMEA.
2.5 Severity
“Severity” (5) is a ranking number associated with the
most serious effect for a given failure mode, based on the
criteria from a severity scale. It is a relative ranking within the
scope of the specific FMEA determined without regard to the
likelihood of occurrence or detection. Figure 10 is an example
of a Severity scale for Design FMEAs. Figure 11 is an
example of a Severity scale for Process FMEAs. Note, when
applying the severity scale for Process FMEAs, the team
assesses the severity of the effect on both product and process
and uses the worst case.

Figure 10.Example of a Severity scale for Design FMEAs [4]

Figure 8. Example of an “Effect” for a Design FMEA [3]

Figure 11. Example of a Severity scale for Process FMEAs [4]

Figure 9. Example of an “Effect” for a Process FMEA [3]

2.6 Cause
A “cause” (6) is the specific reason for the failure,
preferably found by asking “why” until the root cause is
determined. For Design FMEAs, the cause is the design
deficiency that results in the failure mode. For Process
FMEAs, the cause is the manufacturing or assembly deficiency
that results in the failure mode. At the component level, cause
should be taken to the level of failure mechanism. If a cause Figure 12. Example of a “Cause” for a Process FMEA [3]
occurs, the corresponding failure mode occurs. There can be
many causes for each failure mode. Figure12 is an example of
a “Cause” for a Design FMEA. Figure 13 is an example of a

4 – Carlson 2015 AR&MS Tutorial Notes

 development, or actions to detect a problem during service
before it becomes catastrophic. There can be many controls for
each cause.

Figure 13. Example of a “Cause” for a Process FMEA [3]

2.7 Occurrence
“Occurrence” (7) is a ranking number associated with the
likelihood that the failure mode and its associated cause will
be present in the item being analyzed. For System and Design
FMEAs, consider the likelihood of occurrence during the
design life of the product. For Process FMEAs consider the
likelihood of occurrence during production. It is based on the
criteria from the corresponding occurrence scale, and has a
relative meaning rather than absolute value, determined
without regard to the severity or likelihood of detection. Figure Figure 15. Example of an Occurrence scale for Process
14 is an example of an Occurrence scale for Design FMEAs. FMEAs [4]
Figure 15 is an example of an Occurrence scale for Process
For System or Design FMEAs, prevention-type design
FMEAs.
controls describe how a cause, failure mode, or effect in the
product design is prevented based on current or planned
actions. They are intended to reduce the likelihood that the
problem will occur, and are used as input to the occurrence
ranking. Only those prevention-type controls that are currently
planned, or are already in place, should be entered onto the
FMEA worksheet. Detection-type design controls describe
how a failure mode or cause in the product design is detected,
based on current or planned actions before the product design
is released to production, and are used as input to the detection
ranking. They are intended to increase the likelihood that the
problem will be detected before it reaches the end user. Only
those detection-type controls that are currently planned, or are
already in place, should be entered onto the FMEA
worksheet. [3]
Figure 16 is an example of “Design Controls” for a
Design FMEA.
For Process FMEAs, prevention-type process controls
describe how a cause, failure mode or effect in the
manufacturing or assembly process is prevented, based on
Figure 14. Example of an Occurrence scale for Design current or planned actions. Detection-type process controls
FMEAs [4] describe how a failure mode or cause in the manufacturing or
assembly process is detected, based on current or planned
2.8 Controls
action, before the item is shipped from the manufacturing or
“Controls” (8) are the methods or actions currently assembly plant, and are used as an input to the detection
planned, or already in place, to reduce or eliminate the risk ranking. [3]
associated with each potential cause. Controls can be the Figure 17 is an example of “Process Controls” for a
methods to prevent or detect the cause during product Process FMEA.

2015 Annual RELIABILITY and MAINTAINABILITY Symposium Carlson – 5

 Figure 16. Example of “Design Controls” for a Design
FMEA: [3]

Figure 18. Example of Detection scale for Design FMEAs [4]

Figure 17. Example of “Process Controls” for a Process

FMEA [3]
2.9 Detection
“Detection” (9) is a ranking number associated with the
best control from the list of detection-type controls, based on
the criteria from the detection scale. It considers the likelihood
Figure 19. Example of a Detection scale for Process
of detection of the failure mode/cause, according to defined FMEAs [4]
criteria. It is a relative ranking within the scope of the specific
FMEA, and is determined without regard to the severity or Example: If the effect of a failure mode has a severity
likelihood of occurrence. Figure 18 is an example of a ranking of 10, and the cause of the failure mode has an
Detection scale for Design FMEAs. Figure 19 is an example of occurrence ranking of 6 and detection ranking of 4, then the
a Detection scale for Process FMEAs. RPN will be 240 (severity 10 x occurrence 6 x detection 4)
Caution is advised when using a Detection scale. The 2.10.1 RPN Limitations
examples in figures 18 and 19 attempt to integrate three types
of detection risk into one scale: risk due to the likelihood that RPN has a number of limitations and is not a perfect
the detection-type controls will detect the cause of the failure, representation of the risk associated with a failure mode and
risk due to the timing of the detection-type controls, and risk associated cause. Practitioners who use RPN should be aware
due to the type of detection controls. Practitioners need to be of the inherent limitations and take measures to be sure
aware of the criteria inherent in detection scales and ensure product and process risks are properly characterized and
they are properly used. addressed. Examples of limitations to RPN include:
1. It is subjective, not objective
2.10 Risk Priority Number (RPN) 2. The potential values of RPN are not continuous
“RPN” (10) is a numerical ranking of the risk of each 3. The Detection scale has its own limitations
potential failure mode/cause, made up of the arithmetic 4. There are many duplicate RPN values, representing
product of the three elements: severity of the effect, likelihood different combinations of severity, occurrence and
of occurrence of the cause, and likelihood of detection of the detection rankings
cause. 5. The practice of using RPN thresholds is not advised.

6 – Carlson 2015 AR&MS Tutorial Notes

 When RPN is used high severity must be considered
regardless of RPN value.
Many companies use alternatives to RPN, such as severity
and occurrence. For example, FMECA (FMEA, with the added
step of Criticality Analysis) uses severity and occurrence risk
rankings as input to the criticality risk, without the use of a
detection risk ranking.
When severity and occurrence risk rankings are used by
themselves, care must be taken to understand potential risk due
to inability to detect failure modes and their causes, and
properly characterize and address this risk.
2.10.2 Use of Risk-Ranking Scales
If the risk-ranking scales are not mandated and the team Figure 20. Example of “Recommended Actions” for a Design
has the flexibility to establish their own scales, the risk- FMEA [3]
ranking criteria can be tailored, along with the worksheet
columns, to satisfy company-specific applications. Regarding
the number of scale ranking levels, there is a simple rule to
follow: use the minimum number of ranking levels for each
scale that adequately differentiates the risk criteria. In other
words, if the team can manage with five ranking levels and the
needed differentiation of risk for a given application is
adequately defined, then use ranking scales with five levels. If
ten ranking levels are needed to adequately differentiate and
define the risk, use scales that have ten ranking levels.
2.11 Recommended Actions Figure 21. Example of “Recommended Actions” for a Process
FMEA [3]
“Recommended actions” (11) are the tasks recommended
by the FMEA team to reduce or eliminate the risk associated
with potential causes of failure. They should consider existing
controls, relative importance (prioritization) of the issue, and
the cost and effectiveness of the corrective action. There can
be many recommended actions for each cause. In practice, it
usually takes more than one, and sometimes many actions to
address high risk issues.
The FMEA team must adequately address all high-
severity as well as high-RPN issues. Every task the FMEA
team recommends (that is different from what is already
planned or in place) shows up in the Recommended Actions
column. Figure 20 is an example of “Recommended Actions”
for a Design FMEA. Figure 21 is an example of
“Recommended Actions” for a Process FMEA.
Completing the FMEA worksheet, “Actions Taken” is the Figure 22. The Logical Relationship Between FMEA
specific action that is implemented to reduce risk to an Elements [3]
acceptable level. It should correlate to the specific 3. SELECTING THE RIGHT FMEA PROJECTS
recommended action, and is assessed as to effectiveness by a
revised severity, occurrence, detection ranking, and FMEAs take time and cost money. They should be done
corresponding revised RPN. when a certain level of risk can be effectively addressed by the
Figure 22 shows the logical relationship between the FMEA procedure. New product designs can include hundreds
various elements of FMEAs. or even thousands of subsystems and components. Few
companies have the resources to properly do FMEAs on
everything. New or modified designs usually require a System
FMEA. Lower level FMEA projects can be identified based on
well-defined selection criteria.
Companies can identify important criteria for selecting
FMEA projects.

2015 Annual RELIABILITY and MAINTAINABILITY Symposium Carlson – 7

 Selection criteria may include: projects. Other tasks may be unique for each project.
• New technology
• New designs where risk is a concern
• New applications of existing technology
• Potential for safety issues
• History of significant field problems
• Potential for important regulation issues
• Mission Critical applications
• Supplier Capability
The risk criteria can each be assessed on a variable scale
for the items being considered for FMEAs. Preliminary Risk
Assessment criteria can be tailored to the unique needs of any
company.
Figure 23 shows an example of preliminary risk Figure 24. FMEA and Stage Gate Process – High Level [3]
assessment done on a bicycle system. This example only
Each selected FMEA project requires thorough
shows the bicycle subsystems. The same process can be
preparation. The following are the high level preparation tasks.
applied to all of the bicycle components to select FMEA
Each of these tasks must be done thoroughly. Short cutting
projects.
FMEA preparation time will significantly increase the amount
of time to do FMEAs and jeopardize quality of results.
• Determine the scope of the FMEA project
• Make the scope visible and get consensus on boundaries
(such as FMEA Block Diagram or Process Flow diagram)
• Assemble the right FMEA team (not done by one or two
people)
• Establish ground rules and assumptions
• Gather information
• Prepare for the FMEA meetings
An example of an FMEA Block Diagram is shown in
Figure 25. It is a System FMEA Block Diagram for a bicycle
Figure 23. Preliminary Risk Assessment on Bicycle system, showing only the major subsystems and interfaces. For
Subsystems [3] self-study, you may be able to identify a few interface
3.1 Timing criteria for FMEAs elements that were intentionally omitted from the diagram.

In general, FMEAs should be done early in the product

development process, where design and process changes can
be most easily implemented. Concept FMEAs should be
performed during the time when concept alternatives are being
considered and before design or process concepts have been
selected. System FMEA should be started as soon as the
system configuration is determined and completed before the
system configuration freeze-date. Design FMEAs should be
started as soon as the design concept is determined and
completed before the design freeze date. Process FMEAs
should be started as soon as the manufacturing or assembly
process is determined at the concept level, and completed
before the manufacturing or assembly process freeze date.
The high level timing for FMEAs is shown in Figure 24.
4. PREPARING FOR FMEA PROJECTS Figure 25. All Terrain System FMEA Block Diagram [3]

The importance of good preparation for FMEA projects Selecting the right FMEA team is necessary for getting
cannot be emphasized enough. All of the preparation steps are high quality results. FMEA is a cross-functional team activity.
essential for the FMEA project to be successful and completed Some companies try to perform FMEAs with only 1 or 2
in a timely manner. Some tasks, such as selecting FMEA people, which is not acceptable. An example core team for a
software, selecting or modifying FMEA standards and scales, Design FMEA includes representation from systems
FMEA team training, meeting logistics, and defining the engineering, design engineering, manufacturing engineering,
system hierarchy, need doing only once, for all of the FMEA test engineering, field service, and quality or reliability. An
example core team for a Process FMEA includes

8 – Carlson 2015 AR&MS Tutorial Notes

representation from : manufacturing engineering, plant develop expert facilitation skills, including brainstorming,
assembly, product engineering, supplier quality, end-of-lineencouraging participation, active listening, controlling
test, maintenance, and quality or reliability. Recommend discussion, making decisions, conflict management, managing
between 4 and 8 team members. level of detail, managing time, and unleashing team creativity.
Examples and checklists for ground rules and Facilitators must be well trained in effective meeting
assumptions, gather information, and FMEA meeting facilitation techniques, know the FMEA procedure, and know
readiness are available on www.effectivefmeas.com. how to effectively use FMEA software. FMEA team members
need to be trained in an overview of FMEA procedure. Good
5. APPLYING LESSONS LEARNED AND QUALITY
facilitation is essential to prevention of high-risk problems
OBJECTIVES
without wasting time.
Much is learned by observing the mistakes companies Figure 27 shows the FMEA Roadmap, which outlines at a
have made in doing FMEAs. Based on the experience of over high-level the steps for performing effective FMEAs.
two thousand FMEAs and working with hundreds of
companies in a wide variety of applications, certain common
mistakes show up repeatedly. What are the primary ways that
FMEAs can be done wrongly (mistakes made). What are the
leading factors that make for effective FMEAs (quality
objectives)?
Figure 26 shows common FMEA mistakes converted into
Quality Objectives.

Figure 27. FMEA Roadmap – High Level [3]

7. IMPLEMENTING AN EFFECTIVE FMEA PROCESS
A company-wide FMEA process is the entire set of
systems and tasks essential to support development of high-
reliability products and processes through timely
accomplishment of well-done FMEAs. Key elements of this
process include management support for strategy and
resources, well-defined roles and responsibilities, management
review of high risk issues on an ongoing basis, FMEA quality
audits, execution of FMEA recommended actions, and a
feedback loop to incorporate lessons learned. Figure 28 shows
an effective FMEA process.

Figure 26. FMEA Quality Objectives [3]

Make these FMEA Quality Objectives part of FMEA team
training. Review them at each FMEA meeting. Conduct
FMEA Quality audits based on these quality objectives. Keep
FMEAs open until Quality Objectives are met.
6. PROVIDING EXCELLENT FMEA FACILITATION
FMEA facilitation is a different subject than FMEA
Figure 28. An Effective FMEA Process [3]
methodology. Poorly led FMEA teams will not achieve
excellent results. To be successful, FMEA leaders need to The importance of broad support from management in

2015 Annual RELIABILITY and MAINTAINABILITY Symposium Carlson – 9

implementing an effective FMEA process cannot be satisfied and loyal customers. When done correctly, FMEA
overstated. Management provides agreement on strategy and can anticipate and prevent problems, reduce costs, shorten
supports needed resources, assists in integrating FMEA with product development times, and achieve safe and highly
other business processes, provides effective reviews of high reliable products and processes. Using the FMEA success
risk failure modes and recommended actions, and mandates factors will help ensure the success of FMEA projects.
attendance of expert FMEA team members.
REFERENCES
7.1 FMEA Linkages
1. United States Military, 1949, Mil-P 1629 “Procedure for
FMEAs can provide important input for other processes. performing a failure mode effect and criticality analysis”
System/Design FMEAs input to Design Verification Plans, 2. Fadlovich, Erik. Performing Failure Mode and Effect
Process FMEAS input to Process Control Plans, and Design Analysis [Online] 2007 [cited 2010; Available from:
FMEAs input to Process FMEAs. In addition, FMEA must be http://www.embeddedtechmag.com/component/content/ar
fully integrated with the Product Development Process. ticle/6134, Embedded Technology
Although FMEA can be implemented as a stand-alone process 3. Carl S. Carlson, Effective FMEAs: Achieving Safe,
and make significant design or process improvements, Reliable, and Economical Products and Processes using
properly linking FMEAs to other processes results in Failure Mode and Effects Analysis, John Wiley & Sons,
efficiencies, and can greatly enhance the effectiveness of Wiley Series in Quality & Reliability Engineering, 2012
individual FMEAs. 4. AIAG, Potential Failure Mode and Effects Analysis
(FMEA) Reference Manual Fourth Edition [2008]; note,
8. CONCLUSIONS
the scales in this tutorial have been re-formatted,
Everyone wants to support the accomplishment of safe abbreviated and/or shortened for readability
and trouble-free products and processes while generating

APPENDIX - PROBLEMS AND SOLUTIONS

The following FMEA problems and solutions are excerpted from the book Effective FMEAs.[3] The book, along with the
companion Solutions Manual, has over 100 problems and solutions, ranging from fundamentals of FMEAs to all aspects of
FMEA applications, including case studies, quality audits, FMEA facilitation, FMECA, Design Review Based on Failure Mode
(DRBFM), Fault Tree Analysis (FTA), Reliability Centered Maintenance (RCM), Hazard Analysis, and Software FMEA. A
few have been selected to introduce FMEA practitioners to this form of self-study. Answers to problems 1 to 5 are at the end of
the paper. Problems 6 and 7, along with their respective solutions can be found on the website www.effectivefmeas.com.
Problem 1
Which of the following are true statements about FMEA? (Select all that apply)
1. An FMEA is an engineering analysis done by the most knowledgeable person on the engineering team.
2. Part of the FMEA is to identify and carry out corrective actions to address the most serious concerns.
3. The primary objective of an FMEA is to understand the design.
4. Risk assessment is not part of the FMEA procedure.
Problem 2
Indicate whether each statement about the application of FMEA is true or false.
1. One of the uses of FMEA is to improve the reliability of the product.
2. One of the uses of FMEA is to improve the safety of the product.
3. FMEAs can be used to improve the quality of the manufacturing process.
4. One of the primary applications of FMEA is to fix field problems.
Problem 3
In an FMEA, which of the following is true about a “function”? (Select all that apply)
1. A “function” is what the item is intended to do, without respect to any standard of performance.
2. A “function” is what the item is intended to do, usually to a given standard of performance.
3. There is one function for each item in an FMEA.
4. The function description in an FMEA must include the consequence or impact on the end user.
Problem 4
In an FMEA, which of the following is true about a “failure mode”? (Select all that apply)
1. A “failure mode” is the specific reason for the failure.
2. A “failure mode” is the manner in which the item or assembly could fail to meet the intended function and its requirements

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3. In an FMEA, there is one failure mode for each function.
4. The failure mode description in an FMEA must include the consequence or impact on the end user.
Problem 5
In an FMEA, which of the following is true about a “control”? (Select all that apply)
1. A “control” is the specific recommendation by the FMEA team to control the risk associated with the cause of failure.
2. A “control” needs to be taken to the level of root cause of the failure.
3. There are often two types of controls identified in an FMEA: prevention-type controls and detection-type controls.
4. “Controls” are the methods or actions that are not currently planned, but need to be done to reduce or eliminate the design-
related risk associated with the cause of failure.
5. “Controls” are the methods or actions that are planned or currently in place to reduce or eliminate the design-related risk
associated with the cause of failure.
Problem 6
• Study the “Pencil Problem” on the website www.effectivefmeas.com (click on link “FMEA Links and Articles”, click on
“Pencil Problem”)
• Perform problems 1 through 9. Compare answers to Solutions at the end of the Pencil Problem.
Problem 7
• Study the “Projector Lamp Problem” on the website www.effectivefmeas.com (click on link “FMEA Links and Articles”,
click on “Projector Lamp Problem”)
• Perform problems 1 through 9. Compare answers to Solutions at the end of the Projector Lamp Problem.
Solutions to Self-study Problems
Solution 1
Which of the following are true statements about FMEA? (Select all that apply.)
1. An FMEA is an engineering analysis done by the most knowledgeable person on the engineering team. (False. An FMEA
is an engineering analysis done by a cross-functional team of subject-matter experts.)
2. Part of the FMEA is to identify and carry out corrective actions to address the most serious concerns. (True)
3. The primary objective of an FMEA is to understand the design. (False. The primary objective of an FMEA is to improve
the design.)
4. Risk assessment is not part of the FMEA procedure. (False. Risk assessment is an integral part of the FMEA procedure.)
Solution 2
Indicate whether each statement about the application of FMEA is true or false.
1. One of the uses of FMEA is to improve the reliability of the product. (True)
2. One of the uses of FMEA is to improve the safety of the product. (True)
3. FMEAs can be used to improve the quality of the manufacturing process. (True)
4. One of the primary applications of FMEA is to fix field problems. (False)
Solution 3
In an FMEA, which of the following is true about a “function”? (Select all that apply)
1. A “function” is what the item is intended to do, without respect to any standard of performance. (False. A function
description needs to include the standard of performance.)
2. A “function” is what the item is intended to do, usually to a given standard of performance. (True)
3. There is one function for each item in an FMEA. (False. There can be many functions for an item.)
4. The function description in an FMEA must include the consequence or impact on the end user. (False. An effect must
include the consequence or impact on the end user, not a function.)
Solution 4
In an FMEA, which of the following is true about a “failure mode”? (Select all that apply)
1. A “failure mode” is the specific reason for the failure. (False. A “failure mode” is the manner in which the item or
assembly could fail to meet the intended function and its requirements.)
2. A “failure mode” is the manner in which the item or assembly could fail to meet the intended function and its
requirements. (True)
3. In an FMEA, there is one failure mode for each function. (False. There can be many failure modes for each function.)
4. The failure mode description in an FMEA must include the consequence or impact on the end user. (False. An effect must
2015 Annual RELIABILITY and MAINTAINABILITY Symposium Carlson – 11
 include the consequence or impact on the end user, not a failure mode.)
Solution 5
In an FMEA, which of the following is true about a “control”? (Select all that apply)
1. A “control” is the specific recommendation by the FMEA team to control the risk associated with the cause of failure.
(False. Controls are the methods or actions that are planned or currently in place to reduce or eliminate the design-related
risk associated with the cause of failure. Recommendations need to be in the Recommended Actions column of the
FMEA.)
2. A “control” needs to be taken to the level of root cause of the failure. (False. Causes in the FMEA need to be taken to the
level of root cause, not controls.)
3. There are often two types of controls identified in an FMEA: prevention-type controls and detection-type controls. (True)
4. “Controls” are the methods or actions that are not currently planned, but need to be done to reduce or eliminate the design-
related risk associated with the cause of failure. (False. Controls are methods or actions that are planned or currently in
place.)
5. “Controls” are the methods or actions that are planned or currently in place to reduce or eliminate the design-related risk
associated with the cause of failure. (True)
Solution 6
The solution to the “Pencil Problem” can be found on the website www.effectivefmeas.com (click on link “FMEA Links and
Articles”, click on “Pencil Problem”)
Solution 7
The solution to the “Projector Lamp Problem” can be found on the website www.effectivefmeas.com (click on link “FMEA
Links and Articles”, click “Projector Lamp Problem”)

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