Failure Mode and

6 Effect Analysis (FMEA)

This chapter has been developed to assist and instruct design, manufacturing, and
assembly engineers in the development and execution of a potential Failure Mode
and Effect Analysis (FMEA) for design considerations, manufacturing, assembly
processes, and machinery.
An FMEA is a methodology that helps identify potential failures and recom-
mends corrective action(s) for fixing these failures before they reach the customer.
A concept (system) FMEA is conducted as early as possible to identify serious
problems with the potential concept or design. A design FMEA is conducted prior
to production and involves the listing of potential failure modes and causes. An
FMEA identifies actions required to prevent defects and thus keeps products that
may fail or not be fit from reaching the customer. Its purpose is to analyze the
product’s design characteristics relative to the planned manufacturing or assembly
process to ensure that the resultant product meets customer needs and expectations.
When potential failure modes are identified, corrective action can be initiated to
eliminate them or continuously reduce their potential occurrence. The FMEA also
documents the rationale for the manufacturing or assembly process involved.
Changes in customer expectations, regulatory requirements, attitudes of the
courts, and the industry’s needs require disciplined use of a technique to identify
and prevent potential problems. That disciplined technique is the FMEA.
A process FMEA is an analytical technique that identifies potential product-
related process failure modes, assesses the potential customer effects of the failures,
identifies the potential manufacturing or assembly process causes, and identifies
significant process variables to focus controls for prevention or detection of the
failure conditions. (Also, process FMEAs can assist in developing new machine or
equipment processes. The methodology is the same; however, the machine or equip-
ment being designed would be considered the product.)
A machinery FMEA is a methodology that helps in the identification of possible
failure modes and determines the cause for and effect of these failures. The focus
of the machinery FMEA is to eliminate any safety issues and to resolve them
according to specified procedures between customer and supplier. In addition, the
purpose of this particular FMEA is to review both design and process with the intent
to reduce risk.
All FMEAs utilize occurrence and detection probability in conjunction with
severity criteria to develop a Risk Priority Number (RPN) for prioritization of
corrective action considerations. This is a major departure in methodology from the
Failure Mode and Critical Analysis (FMCA), which focuses primarily on the severity
of the failure as a priority characteristic.

223

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224 Six Sigma and Beyond

In its most rigorous form, an FMEA summarizes the engineer’s thoughts while
developing a process. This systematic approach parallels and formalizes the mental
discipline that an engineer normally uses to develop processing requirements.

DEFINITION OF FMEA
FMEA is an engineering “reliability tool” that:

1. Helps to define, identify, prioritize, and eliminate known and/or potential

failures of the system, design, or manufacturing process before they reach
the customer, with the goal of eliminating the failure modes or reducing
their risks
2. Provides structure for a cross-functional critique of a design or a process
3. Facilitates inter-departmental dialog (It is much more than a design
review.)
4. Is a mental discipline “great” engineering teams go through, when cri-
tiquing what might go wrong with the product or process
5. Is a living document that reflects the latest product and process actions
6. Ultimately helps prevent and not react to problems
7. Identifies potential product- or process-related failure modes before they
happen
8. Determines the effect and severity of these failure modes
9. Identifies the causes and probability of occurrence of the failure modes
10. Identifies the controls and their effectiveness
11. Quantifies and prioritizes the risks associated with the failure modes
12. Develops and documents action plans that will occur to reduce risk

TYPES OF FMEAS
There are many types of FMEAs (see Figure 6.1). However, the main ones are:

• System/Concept — S/CFMEA. These are driven by system functions. A

system is an organized set of parts or subsystems to accomplish one or
more functions. System FMEAs are typically done very early, before
specific hardware has been determined.
• Design — DFMEA. A design FMEA is driven by part or component
functions. A design/part is a unit of physical hardware that is considered
a single replaceable part with respect to repair. Design FMEAs are typi-
cally done later in the development process when specific hardware has
been determined.
• Manufacturing or Process — PFMEA. A process FMEA is driven by
process functions and part characteristics. A manufacturing process is a
sequence of tasks that is organized to produce a product. A process FMEA
can involve fabrication as well as assembly.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 225

Types of FMEA

Design Process
FMEA FMEA
System Component Machines
FMEA Subsystem Methods
System Material
Focus: Manpower
Machinery Minimize failure Measurement
FMEA effects on the
Environment
system
Focus:
Focus: Objective: Minimize
Design changes to Maximize system production process
lower life cycle quality, failure effects on
costs reliability cost, the system
and
Objective: maintain ability Objective:
Improve the
Maximize the
reliability and
system quality,
maintain ability of
reliability, cost,
the machinery and
maintain ability,
equipment
and productivity

FIGURE 6.1 Types of FMEA.

• Machinery — MFMEA is driven by low volume machinery and equipment

where large-scale testing is impractical prior to production and manufac-
ture of the machinery and equipment. The MFMEA focuses on design
changes to lower life cycle costs by improving the reliability and main-
tainability of the machinery and equipment.

Note: Service, software, and environmental FMEAs are additional variations.

However, in this chapter we will focus only on design, process, and machinery
FMEAs. The other FMEAs follow the same rationale as the design and process
FMEAs.

IS FMEA NEEDED?
If any answer to the following questions is positive, then you need an FMEA:

• Are customers becoming more quality conscious?

• Are reliability problems becoming a big concern?
• Are regulatory requirements harder to meet?
• Are you doing too much problem solving?
• Are you addicted to problem solving?

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226 Six Sigma and Beyond

“Addiction” to problem solving is a very important consideration in the appli-

cation of an active FMEA program. When the thrill and excitement of solving
problems become dominant, your organization is addicted to problem solving rather
than preventing the problem to begin with. A proper FMEA will help break your
addiction by:

• Reducing the percentage of time devoted to problem solving

• Increasing the percentage of time in problem prevention
• Increasing the efficiency of resource allocation

Note: The emphasis is always on reducing complexity and engineering changes.

BENEFITS OF FMEA
When properly conducted, product and process FMEAs should lead to:

1. Confidence that all risks have been identified early and appropriate actions
have been taken
2. Priorities and rationale for product and process improvement actions
3. Reduction of scrap, rework, and manufacturing costs
4. Preservation of product and process knowledge
5. Reduction of field failures and warranty cost
6. Documentation of risks and actions for future designs or processes

By way of comparison of FMEA benefits and the quality lever, Figure 6.2 may
help.
In essence, one may argue that the most important benefit of an FMEA is that
it helps identify hidden costs, which are quite often greater than visible costs. Some
of these costs may be identified through:

1. Customer dissatisfaction
2. Development inefficiencies
3. Lost repeat business (no brand loyalty)
4. High employee turnover
5. And so on

FMEA HISTORY
This type of thinking has been around for hundreds of years. It was first formalized
in the aerospace industry during the Apollo program in the 1960s. The initial
automotive adoption was in the 1970s in the area of safety issues. FMEA was
required by QS-9000 and the advanced product quality planning process in 1994
for all automotive suppliers. It has now been adopted by many other industries.

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Failure Mode and Effect Analysis (FMEA) 227

Payback: Effort
Product design fix
100:1
Process design fix
10:1
Production fix
1:1
Customer fix
1:10

Planning and
definition
Product design
and development
Mfg process
design and
development
Product and
process
validation Production

FIGURE 6.2 Payback effort.

INITIATION OF THE FMEA

Regardless of the type, all FMEAs should be conducted as early as possible. FMEA
studies can be carried out at any stage during the development of a product or
process. However, the ideal time to start the FMEA is:

• When new systems, designs, processes, or machines are being designed,

but before they are finalized
• When systems design, process, or machine modifications are being con-
templated
• When new applications are used for the systems, designs, processes, or
machines
• When quality concerns become visible
• When safety issues are of concern

Note: Once the FMEA is initiated, it becomes a living document, is updated as

necessary, and is never really complete.
Therefore:

• “FMEA-type thinking” is central to reliability and continual improvement

in products and manufacturing processes to remain competitive in our
global marketplace. It must be understood that an FMEA conducted after
production serves as a reactive tool, and the user has not taken full
advantage of the FMEA process.

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228 Six Sigma and Beyond

• A typical system FMEA should begin even before the program approval
stage. The design FMEA should start right after program approval and
continue to be updated through prototypes. A process FMEA should begin
just before prototypes and continue through pilot build and sometimes
into product launching. As for the MFMEA, it should also start at the
same time as the design FMEA. It is imperative for a user of an FMEA
to understand that sometimes information is not always available. During
these situations, users must do the best they can with what they have,
recognizing that the document itself is indeed a living document and will
change as more information becomes available.
• History has shown that a majority of product warranty campaigns and
automotive recalls could have been prevented by thorough FMEA studies.

GETTING STARTED
Just as with anything else, before the FMEA begins there are some assumptions and
preparations that must be taken care of. These are:

1. Know your customers and their needs.

2. Know the function.
3. Understand the concept of priority.
4. Develop and evaluate conceptual designs/processes based on your cus-
tomer’s needs and business strategy.
5. Be committed to continual improvement.
6. Create an effective team.
7. Define the FMEA project and scope.

1. UNDERSTAND YOUR CUSTOMERS AND THEIR NEEDS

A product or a process may perform functions flawlessly, but if the functions are
not aligned with the customer’s needs, you may be wasting your time. Therefore,
you must:

• Determine all (internal or external) relevant customers.

• Understand the customer’s needs better than the customers understand
their own needs.
• Document the customer’s needs and develop concepts. For example, cus-
tomers need:
• Chewable toothpaste
• Smokeless cigarettes
• Celery-flavored gum
• ????

In FMEA, a customer is anyone/anything that has functions/needs from your

product or manufacturing process. An easy way to determine customer needs is to
understand the Kano model — see Figure 6.3.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 229

Satisfied

Excitement needs
Performance needs

Did not do Did it

it at all very well

Time
Basic needs

Dissatisfied

FIGURE 6.3 Kano model.

The model facilitates understanding of all the customer needs, including:

Excitement needs: Generally, these are the unspoken “wants” of the customer.
Performance needs: Generally, these are the spoken “needs” of the customer.
They serve as the neutral requirements of the customer.
Basic needs: Generally, these are the unspoken “needs” of the customer. They
serve as the very minimum of requirements.

It is important to understand that these needs are always in a state of change.

They move from basic needs to performance to excitement depending on the product
or expectation, as well as value to the customer. For example:

SYSTEM customers may be viewed as: other systems, whole product, gov-
ernment regulations, design engineers, and end user.
DESIGN customers may be viewed as: higher assembly, whole product, design
engineers, manufacturing engineers, government engineers, and end user.
PROCESS customers may be viewed as: the next operation, operators, design
and manufacturing engineering, government regulations, and end user.
MACHINE customers may be viewed as: higher assembly, whole product,
design engineers, manufacturing engineers, government regulations, and
end user.

Another way to understand the FMEA customers is through the FMEA team,
which must in no uncertain terms determine:

1. Who the customers are

2. What their needs are
3. Which needs will be addressed in the design/process

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230 Six Sigma and Beyond

The appropriate and applicable response will help in developing both the function
and effects.

2. KNOW THE FUNCTION

The dictionary definition of a function is: The natural, proper, or characteristic action
of any thing. This is very useful because it implies performance. After all, it is
performance that we are focusing in the FMEA.
Specifically, a function from an FMEA perspective is the task that a system,
part, or manufacturing process performs to satisfy a customer. To understand the
function and its significance, the team conducting the FMEA must have a thorough
list of functions to evaluate. Once this is done, the rest of the FMEA process is a
mechanical task.
For machinery, the function may be analyzed through a variety of methodologies
including but not limited to:

• Describing the design intent either through a block diagram or a P-diagram

• Identifying an iterative process in terms of what can be measured
• Describing the ideal function — what the machine is supposed to do
• Identifying relationships in verb–noun statements — function tree analysis
• Considering environmental and safety conditions
• Accounting for all R & M parameters
• Accounting for the machine’s performance conditions
• Analyzing all other measurable engineering attributes

3. UNDERSTAND THE CONCEPT OF PRIORITY

One of the outcomes of an FMEA is the prioritization of problems. It is very
important for the team to recognize the temptation to address all problems, just
because they have been identified. That action, if taken, will diminish the effective-
ness of the FMEA. Rather, the team should concentrate on the most important
problems, based on performance, cost, quality, or any characteristic identified on an
a priori basis through the risk priority number.

4. DEVELOP AND EVALUATE CONCEPTUAL DESIGNS/PROCESSES BASED

ON CUSTOMER NEEDS AND BUSINESS STRATEGY

There are many methods to assist in developing concepts. Some of the most common
are:

1. Brainstorming
2. Benchmarking
3. TRIZ (the theory of inventive problem solving)
4. Pugh concept selection (an objective way to analyze and select/synthesize
alternative concepts)

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Failure Mode and Effect Analysis (FMEA) 231

Eval. Criteria Razor A B C D E F G H

Stubble length D
Pain level A
Mfg. Costs T - + + + - S +
Price/Use U - S - + - S S
Etc M + S - S - S +
Etc S S - S - + -

Totals - 2 3 4 1
+ 1 1 1 2 1 2
S 1 3 2 3 1
Legend:

Evaluation Criteria: These are the criteria that we are comparing the razor
with the other approaches.

Datum: These are the basic razor characteristics that we are comparing the
other concepts to.

A: Chemical B: Electric C: Electrolysis

D: Duct tape E: Epilady F: Laser beam
G: Straight edge H: ?

+ : Better than the basic razor requirement

- : Worse than the basic razor requirement
S : Same as the basic razor requirement

FIGURE 6.4 A Pugh matrix — shaving with a razor.

Figure 6.4 shows what a Pugh matrix may look like for the concept of “shaving”
with a base that of a “razor.”

5. BE COMMITTED TO CONTINUAL IMPROVEMENT

Everyone in the organization and especially management must be committed to
continual improvement. In FMEA, that means that once recommendations have been
made to increase effectiveness or to reduce cost, defects, or any other characteristic,
a proper corrective action must be developed and implemented, provided it is sound
and it complements the business strategy.

6. CREATE AN EFFECTIVE FMEA TEAM

Perhaps one of the most important issues in dealing with the FMEA is that an FMEA
must be done with a team. An FMEA completed by an individual is only that
individual’s opinion and does not meet the requirements or the intent of an FMEA.
The elements of an effective FMEA team are:

• Expertise in subject (five to seven individuals)

• Multi-level/consensus based

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232 Six Sigma and Beyond

• Representing all relevant stakeholders (those who have ownership)

• Possible change in membership as work progresses
• Cross-functional and multidisciplinary (One person’s best effort cannot
approach the knowledge of an effective cross-functional and multidisci-
plinary team.)
• Appropriate and applicable empowerment

The structure of the FMEA team is based on:

Core team
The experts of the project and the closest to the project. They facilitate
honest communication and encourage active participation. Support
membership may vary depending on the stage of the project.
Champion/sponsor
• Provides resources and support
• Attends some meetings
• Supports team
• Promotes team efforts and implements recommendations
• Shares authority/power with team
• Kicks off team
• Higher up in management the better
Team leader
A team leader is the “watchdog” of the project. Typically, this function
falls upon the lead engineer. Some of the ingredients of a good team
leader are:
• Possesses good leadership skills
• Is respected by team members
• Leads but does not dominate
• Maintains full team participation
Recorder
Keeps documentation of team’s efforts. The recorder is responsible for co-
ordinating meeting rooms and times as well as distributing meeting
minutes and agendas.
Facilitator
The “watchdog” of the process. The facilitator keeps the team on track and
makes sure that everyone participates. In addition, it the facilitator’s re-
sponsibility to make sure that team dynamics develop in a positive en-
vironment. For the facilitator to be effective, it is imperative for the
facilitator to have no stake on the project, possess FMEA process ex-
pertise, and communicate assertively.

Important considerations for a team include:

• Continuity of members
• Receptive and open-minded
• Committed to success

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Failure Mode and Effect Analysis (FMEA) 233

• Empowered by sponsor
• Cross-functionality
• Multidiscipline
• Consensus
• Positive synergy

Ingredients of a motivated FMEA team include:

• Realistic agendas
• Good facilitator
• Short meetings
• Right people present
• Reach decisions based on consensus
• Open minded, self initiators, volunteers
• Incentives offered
• Ground rules established
• One individual responsible for coordination and accountability of the
FMEA project (Typically for the design, the design engineer is that person
and for the process, the manufacturing engineer has that responsibility.)

To make sure the effectiveness of the team is sustained throughout the project,
it is imperative that everyone concerned with the project bring useful information
to the process. Useful information may be derived due to education, experience,
training, or a combination of these.
At least two areas that are usually underutilized for useful information are
background information and surrogate data. Background information and supporting
documents that may be helpful to complete system, design, or process FMEAs are:

• Customer specifications (OEMs)

• Previous or similar FMEAs
• Historical information (warranty/recalls etc.)
• Design reviews and verification reports
• Product drawings/bill of material
• Process flow charts/manufacturing routing
• Test methods
• Preliminary control and gage plans
• Maintenance history
• Process capabilities

Surrogate data are data that are generated from similar projects. They may help
in the initial stages of the FMEA. When surrogate data are used, extra caution should
be taken.
Potential FMEA team members include:

• Design engineers
• Manufacturing engineers

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234 Six Sigma and Beyond

• Quality engineers
• Test engineers
• Reliability engineers
• Maintenance personnel
• Operators (from all shifts)
• Equipment suppliers
• Customers
• Suppliers
• Anyone who has a direct or indirect interest
• In any FMEA team effort the individuals must have interaction with
manufacturing and/or process engineering while conducting a design
FMEA. This is important to ensure that the process will manufacture
per design specification.
• On the other hand, interaction with design engineering while conduct-
ing a process or assembly FMEA is important to ensure that the design
is right.
• In either case, group consensus will identify the high-risk areas that
must be addressed to ensure that the design and/or process changes
are implemented for improved quality and reliability of the product

Obviously, these lists are typical menus to choose an appropriate team for your
project. The actual team composition for your organization will depend upon your
individual project and resources.
Once the team is chosen for the given project, spend 15–20 minutes creating a
list of the biggest (however you define “biggest”) concerns for this product or
process. This list will be used later to make sure you have a complete list of functions.

7. DEFINE THE FMEA PROJECT AND SCOPE

Teams must know their assignment. That means that they must know:

• What they are working on (scope)

• What they are not working on (scope)
• When they must complete the work
• Where and how often they will meet

Two excellent tools for such an evaluation are (1) block diagram for system, design,
and machinery and (2) process flow diagram for process. In essence, part of the respon-
sibility to define the project and scope has to do with the question “How broad is our
focus?” Another way to say this is to answer the question “How detailed do we have
to be?” This is much more difficult than it sounds and it needs some heavy discussion
from all the members. Obviously, consensus is imperative. As a general rule, the focus
is dependent upon the project and the experience or education of the team members.
Let us look at an example. It must be recognized that sometimes due to the
complexity of the system, it is necessary to narrow the scope of the FMEA. In other
words, we must break down the system into smaller pieces — see Figure 6.5.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 235

Cylinder, fluid
Master bladder, etc
cylinder
Pedal, rubber
Pedals cover, cotter pins, etc.
and
linkages Rubber hose, metal
tubing, proportioning
Hydraulics valve, fitting, etc.
Back
Brake plate and
System Back plate, springs, washer,
hardware clips, etc.

Pistons, cylinder, casting, OUR

Caliper system plate, etc. FMEA
SCOPE
Rotor hat, rotor, studs,
Rotor and studs etc.

Pads and Friction material, substrate,

hardware rivets, clip etc.

FIGURE 6.5 Scope for DFMEA — braking system.

THE FMEA FORM

There are many forms to develop a typical FMEA. However, all of them are basically
the same in that they are made up of two parts, whether they are for system, design,
process, or machinery. A typical FMEA form consists of the header information and
the main body.
There is no standard information that belongs in the header of the form, but
there are specific requirements for the body of the form.
In the header, one may find the following information — see Figure 6.7. How-
ever, one must remember that this information may be customized to reflect one’s
industry or even the organization:

• Type of FMEA study

• Subject description
• Responsible engineer
• FMEA team leader
• FMEA core team members
• Suppliers
• Appropriate dates (original issue, revision, production start, etc.)
• FMEA number
• Assembly/part/detail number
• Current dates (drawings, specifications, control plan, etc.)

The form may be expanded to include or to be used for such matters as:

Safety: Injury is the most serious of all failure effects. As a consequence, safety
is handled either with an FMEA or a fault tree analysis (FTA) or critical

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236 Six Sigma and Beyond

Yes
Good?
No No L Run, package
and ship
L
Inpect Wash board
M
print

Apply
H paste
L Load
board Our scope
M
Dispense
paste

H Set up
machine
L L L
H Load Load Load tool Develop
screen sqeegee plate program

Legend:

L: Low risk

M: Medium risk
H: High risk

Note: Just as in design FMEA, sometimes it is necessary to “narrow the scope”

of the process FMEA.

FIGURE 6.6 Scope for PFMEA — printed circuit board screen printing process.

FMEA WORKSHEET
System FMEA ____Design FMEA ____Process FMEA ____FMEA Number ____
Subject: ______________Team Leader.________________Page ____ of _____
Part/Proc. ID No. __________Date Orig. _____________Date Rev. __________
Key Date. ____________Team Members: ___________________

FIGURE 6.7 Typical FMEA header.

© 2003 by CRC Press LLC

 Failure Mode and Effect Analysis (FMEA)
Description Failure Mode Analysis Action Plan Action Results

Part name or Potential Potential S C Potential O Current D RPN Recommended Target Actual Actions S O D R Remarks
process step failure effect of L cause of controls action and finish finish taken P
and function mode failure A failure responsibility date date N
mode S mode
S

FIGURE 6.8 Typical FMEA body.

237
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238 Six Sigma and Beyond

analysis (FMCA). In the traditional FTA, the starting point is the list of
hazard or undersized events for which the designer must provide some
solution. Each hazard becomes a failure mode and thus it requires an
analysis.
Effect of downtime: The FMEA may incorporate maintenance data to study
the effects of downtime. It is an excellent tool to be used in conjunction
with total preventive maintenance.
Repair planning: An FMEA may provide preventive data to support repair
planning as well as predictive maintenance cycles.
Access: In the world of recycling and environmental conscience, the FMEA
can provide data for tear downs as well as information about how to get at
the failed component. It can be used with mistake proofing for some very
unexpected positive results.

A typical body of an FMEA form may look like Figure 6.8. The details of this
form will be discussed in the following pages. We begin with the first part of the
form; that is the description in the form of:

Part name/process step and function (verb/noun)

In this area the actual description is written in concise,

exact and simple language.

DEVELOPING THE FUNCTION

A fundamental principle in writing functions is the notion that they must be written
either in action verb format or as a measurable noun. Remember, a function is a
task that a component, subsystem, or product must perform, described in language
that everyone understands. Stay away from jargon. To identify appropriate functions,
leading questions such as the following may help:

• What does the product/process do?

• How does the product/process do that?
• If a product feature or process step is deleted, what functions disappear?
• If you were this task, what are you supposed to accomplish? Why do you
exist?

The priority of asking function questions for a system/part FMEA is:

1. A system view
2. A subsystem view
3. A component view

Typical functions are:

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Failure Mode and Effect Analysis (FMEA) 239

Primary Supporting
supporting functions Tertiary
function supporting
HOW? function
Primary Secondary
supporting supporting Tertiary
function function supporting
function
Primary
supporting
function
Task Ensure Tertiary
function dependability enhancing
Secondary function
Ensure enhancing
convenience function
Tertiary
Please senses enhancing
WHY? function
Enhancing
functions
Delight customer Tertiary
enhancing
function

FIGURE 6.9 Function tree process.

• Position
• Support
• Seal in, out
• Retain
• Lubricate

ORGANIZING PRODUCT FUNCTIONS

After the brainstorming is complete, a function tree — see Figure 6.9 — can be used
to organize the functions. This is a simple tree structure to document and help
organize the functions, as follows:

Purposes of the function tree

a. To document all the functions
b. To improve team communication
c. To document complexity and improve team understanding of all the
functions
Steps
a. Brainstorm all the functions.
b. Arrange functions into function tree.
c. Test for completeness of function (how/why).
Building the function tree
Ask:
What does the product/process do?
Which component/process step does that?

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240 Six Sigma and Beyond

How does it do that?

• Primary functions provide a direct answer to this question with-
out conditions or ambiguity.
• Secondary functions explain how primary functions are per-
formed.
• Continue until the answer to “how” requires using a part name,
labor operation, or activity.
• Ask “why” in the reverse direction.
• Add additional functions as needed.

The function tree process can be summarized as follows:

1. Identify the task function.

Place on the far left side of a chart pad.
2. Identify the supporting functions.
Place on the top half of the pad.
3. Identify enhancing functions.
Place on the bottom half of the pad.
4. Build the function tree.
Include the secondary/tertiary functions.
Place these to the right of the primary functions.
5. Verify the diagram: Ask how and why.

For an example of a function tree for a ball point pen (tip), see Figure 6.10.

FAILURE MODE ANALYSIS

The second portion of the FMEA body form deals with the failure mode analysis.
A typical format is shown in Figure 6.11.

Understanding Failure Mode

Failure mode (a specific loss of a function) is the inability of a component/sub-

system/system/process/part to perform to design intent. In other words, it may
potentially fail to perform its function(s). Design failure mode is a technical descrip-
tion of how the system, subsystem, or part may not adequately perform its function.
Process failure mode is a technical description of how the manufacturing process
may not perform its function, or the reason the part may be rejected.

Failure Mode Questions

The process of brainstorming failure modes may include the following questions:

DFMEA
• Considering the conditions in which the product will be used, how can
it fail to perform its function?
• How have similar products failed in the past?

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Failure Mode and Effect Analysis (FMEA) 241

Super pen makes marks on varied surfaces

User grasps barrel and moves pen axially while

simultaneously pressing down on the tip at
a vector to the 180 degree plane

Axial Force Function Vector Force Function

The inside diameter of the The end of the barrel and
barrel tip end transmits axial the barrel I.D. (tip end)
force to the tip system simultaneously apply force
housing sheath O.D. to the tip system housing
end and sheath.

The tip system housing tip The tip assembly housing

retainer I.D. transmits axial transmits the vector force to
force to the ball housing the O.D. of the ball housing

The ball housing transmits

The ball housing I.D. (ball) the vector force to the ball,
transmits axial force the ball moves up into the
on the ball ball housing creating a gap
between the ball and ball
housing
The ball transmits axial force
to the marking surface,
however, the marking surface The ink flows through the
is stationary, which causes ink tube contacting the ball
the ball rotational motion surface

The ball rotates through the

ink supply, picking up a film
of ink on the ball surface

The ink is transferred from the

ball surface to the marking
surface

The ink remains on the

marking surface (3mm width)
area, drying in 3 seconds

FIGURE 6.10 Example of ballpoint pen.

PFMEA
• Considering the conditions in which the process will be used, what
could possibly go wrong with the process?
• How have similar processes failed in the past?
• What might happen that would cause a part to be rejected?

© 2003 by CRC Press LLC

242 Six Sigma and Beyond

Potential Potential S C Potential O Current D Risk Priority

Failure Effects of E L Causes of C Controls E Number
V A C T
Mode Failure S Failure Mode U E (RPN)
E
Mode R S R C
R T
I E
T I
N O
Y C N
E
Identify
the
Potential
Failure

FIGURE 6.11 FMEA body.

Determining Potential Failure Modes

Failure modes are when the function is not fulfilled in five major categories. Some
of these categories may not apply. As a consequence, use these as “thought provok-
ers” to begin the process and then adjust them as needed:

1. Absence of function
2. Incomplete, partial, or decayed function
3. Related unwanted “surprise” failure mode
4. Function occurs too soon or too late
5. Excess or too much function
6. Interfacing with other components, subsystems or systems. There are four
possibilities of interfacing. They are (a) energy transfer, (b) information
transfer, (c) proximity, and (d) material compatibility.

Failure mode examples using the above categories and applied to the pen case
include:

1. Absence of function:
• DFMEA: Make marks
• PFMEA: Inject plastic
2. Incomplete, partial or decayed function:
• DFMEA: Make marks
• PFMEA: Inject plastic
3. Related unwanted “surprise” failure mode
• DFMEA: Make marks
• PFMEA: Inject plastic
4. Function occurs too soon or too late
• DFMEA: Make marks
• PFMEA: Inject plastic
5. Excess or too much function
• DFMEA: Make marks
• PFMEA: Inject plastic

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 243

General examples of failure modes include:

Design FMEA:
No power Failed to open
Water leaking Partial insulation
Open circuit Loss of air
Releases too early No spark
Noise Insufficient torque
Vibration Paper jams
Does not cut And so on

Process FMEA:
Four categories of process failures:

1. Fabrication failures
2. Assembly failures
3. Testing failures
4. Inspection failures

Typical examples of these categories are:

• Warped
• Too hot
• RPM too slow
• Rough surface
• Loose part
• Misaligned
• Poor inspection
• Hole too large
• Leakage
• Fracture
• Fatigue
• And so on

Note: At this stage, you are ready to transfer the failure modes in the FMEA
form — see Figure 6.12.

FAILURE MODE EFFECTS

A failure mode effect is a description of the consequence/ramification of a system,
part, or manufacturing process failure. A typical failure mode may have several
effects depending on which customer(s) are considered. Consider the effects/conse-
quences on all the “customers,” as they are applicable, as in the following FMEAs:

SFMEA
• System
• Other systems

© 2003 by CRC Press LLC

244 Six Sigma and Beyond

Potential Potential S C Potential O Current D Risk Priority

Failure Effects E L Causes of C Controls E Number
V A C T
Mode of S Failure U E (RPN)
E
Failure R S Mode R C
Mode R T
I E
T I
N O
Y C
E N
Does Not
Transfer Ink
Partial Ink
and so on

FIGURE 6.12 Transferring the failure modes to the FMEA form.

• Whole product
• Government regulations
• End user
DFMEA
• Part
• Higher assembly
• Whole product
• Government regulations
• End user
PFMEA
• Part
• Next operation
• Equipment
• Government regulations
• Operators
• End user

Effects and Severity Rating

Effects and severity are very related items. As the effect increases, so does the
severity. In essence, two fundamental questions have to be raised and answered:

1. What will happen if this failure mode occurs?

2. How will customers react if these failures happen?
• Describe as specifically as possible what the customer(s) might notice
once the failure occurs.
• What are the effects of the failure mode?
• How severe is the effect on the customers?

The progression of function, cause, failure mode, effect, and severity can be
illustrated by the following series of questions:

In function: What is the individual task intended by design?

In failure mode: What can go wrong with this function?
© 2003 by CRC Press LLC
Failure Mode and Effect Analysis (FMEA) 245

In cause: What is the “root cause” of the failure mode?

In effect: What are the consequences of this failure mode?
In severity: What is the seriousness of the effect?

The following are some examples of DFMEA and PFMEA effects:

Customer gets wet Loss of performance

System failure Scrap
Loss of efficiency Rework
Reduced life Becomes loose
Degraded performance Hard to load in next operation
Cannot assemble Operator injury
Violate Gov. Reg. XYZ Noise, rattles
Damaged equipment And so on

Special Note: Please note that the effect remains the same for both DFMEA and
PFMEA.

Severity Rating (Seriousness of the Effect)

Severity is a numerical rating — see Table 6.1 for design and Table 6.2 for process —
of the impact on customers. When multiple effects exist for a given failure mode,
enter the worst-case severity on the worksheet to calculate risk. (This is the excepted
method for the automotive industry and for the SAE J1739 standard. In cases where
severity varies depending on timing, use the worst-case scenario.
Note: There is nothing special about these guidelines. They may be changed to
reflect the industry, the organization, the product/design, or the process. For example,
the automotive industry has its own version and one may want to review its guidelines
in the AIAG (2001). To modify these guidelines, keep in mind:

1. List the entire range of possible consequences (effects).

2. Force rank the consequences from high to low.
3. Resolve the extreme values (rating 10 and rating 1).
4. Fill in the other ratings.
5. Use consensus.

At this point the information should be transferred to the FMEA form — see
Figure 6.13. The column identifying the “class” is the location for the placement of
the special characteristic. The appropriate response is only “Yes” or “No.” A Yes in
this column indicates that the characteristic is special, a No indicates that the
characteristic is not special. In some industries, special characteristics are of two
types: (a) critical and (b) significant. “Critical” refers to characteristics associated
with safety and/or government regulations, and “significant” refers to those that
affect the integrity of the product. In design, all special characteristics are potential.
In process they become critical or significant depending on the numerical values of
severity and occurrence combinations.

© 2003 by CRC Press LLC

246 Six Sigma and Beyond

TABLE 6.1
DFMEA — Severity Rating
Effect Description Rating

None No effect noticed by customer; the failure will not have any 1
perceptible effect on the customer
Very minor Very minor effect, noticed by discriminating customers; the 2
failure will have little perceptible effect on discriminating
customers
Minor Minor effect, noticed by average customers; the failure will have 3
a minor perceptible effect on average customers
Very low Very low effect, noticed by most customers; the failure will have 4
some small perceptible effect on most customers
Low Primary product function operational, however at a reduced level 5
of performance; customer is somewhat dissatisfied
Moderate Primary product function operational, however secondary 6
functions inoperable; customer is moderately dissatisfied
High Failure mode greatly affects product operation; product or 7
portion of product is inoperable; customer is very dissatisfied
Very high Primary product function is non-operational but safe; customer 8
is very dissatisfied.
Hazard with warning Failure mode affects safe product operation and/or involves 9
nonconformance with government regulation with warning
Hazard with no warning Failure mode affects safe product operation and/or involves 10
nonconformance with government regulation without warning

FAILURE CAUSE AND OCCURRENCE

The analysis of the cause and occurrence is based on two questions:

1. What design or process choices did we already make that may be respon-
sible for the occurrence of a failure?
2. How likely is the failure mode to occur because of this?

For each failure mode, the possible mechanism(s) and cause(s) of failure are
listed. This is an important element of the FMEA since it points the way toward
preventive/corrective action. It is, after all, a description of the design or process
deficiency that results in the failure mode. That is why it is important to focus on
the “global” or “root” cause. Root causes should be specific and in the form of a
characteristic that may be controlled or corrected. Caution should be exerted not to
overuse “operator error” or “equipment failure” as a root cause even though they
are both tempting and make it easy to assign “blame.”
You must look for causes, not symptoms of the failure. Most failure modes have
more than one potential cause. An easy way to probe into the causes is to ask:
What design choices, process variables, or circumstances could result in the failure
mode(s)?

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 247

TABLE 6.2
PFMEA — Severity Rating
Effect Description Rating

None No effect noticed by customer; the failure will not have any effect 1
on the customer
Very minor Very minor disruption to production line; a very small portion 2
of the product may have to be reworked; defect noticed by
discriminating customers
Minor Minor disruption to production line; a small portion (much <5%) 3
of product may have to be reworked on-line; process up but
minor annoyances
Very low Very low disruption to production line; a moderate portion 4
(<10%) of product may have to be reworked on-line; process
up but minor annoyances
Low Low disruption to production line; a moderate portion (<15%) 5
of product may have to be reworked on-line; process up but
minor annoyances
Moderate Moderate disruption to production line; a moderate portion 6
(>20%) of product may have to be scrapped; process up but
some inconveniences
High Major disruption to production line; a portion (>30%) of product 7
may have to be scrapped; process may be stopped; customer
dissatisfied
Very high Major disruption to production line; close to 100% of product 8
may have to be scrapped; process unreliable; customer very
dissatisfied
Hazard with warning May endanger operator or equipment; severely affects safe 9
process operation and/or involves noncompliance with
government regulation; failure will occur with warning
Hazard with no warning May endanger operator or equipment; severely affects safe 10
process operation and/or involves noncompliance with
government regulation; failure occurs without warning

DFMEA failure causes are typically specific system, design, or material char-
acteristics.
PFMEA failure causes are typically process parameters, equipment characteris-
tics, or environmental or incoming material characteristics.

Popular Ways (Techniques) to Determine Causes

Ways to determine failure causes include the following:

• Brainstorm
• Whys
• Fishbone diagram

© 2003 by CRC Press LLC

248 Six Sigma and Beyond

Potential Potential S C Potential O Current D Risk Priority

Failure Effects E L Causes of C Controls E Number
Mode of V A Failure Mode C T (RPN)
Failure E S U E
Mode R S R C
I R T
T E I
Y N O
C N
E
Does not Pan does 8 N
transfer ink not work;
customer
tries and
eventually
tears
paper
and
scraps
the pen
Old pen
stops
writing,
Partial ink customer 7 N
scraps
pen
Customer
has to
retrace
and so on Writing
or
drawing
looks bad

and so on

FIGURE 6.13 Transferring severity and classification to the FMEA form.

• Fault Tree Analysis (FTA; a model that uses a tree to show the cause-and-
effect relationship between a failure mode and the various contributing
causes. The tree illustrates the logical hierarchy branches from the failure
at the top to the root causes at the bottom.)
• Classic five-step problem-solving process
a. What is the problem?
b. What can I do about it?
c. Put a star on the “best” plan.
d. Do the plan.
e. Did your plan work?
• Kepner Trego (What is, what is not analysis)
• Discipline GPS – see Volume II
• Experience
• Knowledge of physics and other sciences
• Knowledge of similar products

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 249

TABLE 6.3
DFMEA — Occurrence Rating
Occurrence Description Frequency Rating

Remote Failure is very unlikely < 1 in 1,500,000 1

Low Relatively few failures 1 in 150,000 2
1 in 15,000 3
Moderate Occasional failures 1 in 2000 4
1 in 400 5
1 in 80 6
High Repeated failures 1 in 20 7
1 in 8 8
Very high Failure is almost inevitable 1 in 3 9
>1 in 2 10

• Experiments — When many causes are suspect or specific cause is

unknown
• Classical
• Taguchi methods

Occurrence Rating

The occurrence rating is an estimated number of frequencies or cumulative number

of failures (based on experience) that will occur in our design concepts for a given
cause over the intended life of the design. For example: cause of staples falling out
= soft wood. The likelihood of occurrence is a 9 if we pick balsa wood but a 2 if
we choose oak.
Just as with severity, there are standard tables for occurrence — see Table 6.3
for design and Table 6.4 for process — for each type of FMEA. The ratings on these
tables are estimates based on experience or similar products or processes. Non-
standard occurrence tables may also be used, based on specific characteristics.
However, reliability expertise is needed to construct occurrence tables. (Typical
characteristics may be historical failure frequencies, Cpks, theoretical distributions,
and reliability statistics.)
At this point the data for causes and their ratings should be transferred to the
FMEA form — see Figure 6.14.

Current Controls and Detection Ratings

Design and process controls are the mechanisms, methods, tests, procedures, or
controls that we have in place to prevent the cause of the failure mode or detect the
failure mode or cause should it occur. (The controls currently exist.)

Design controls prevent or detect the failure mode prior to engineering release.
Process controls prevent or detect the failure mode prior to the part or assembly
leaving the area.

© 2003 by CRC Press LLC

250 Six Sigma and Beyond

TABLE 6.4
PFMEA — Occurrence Rating
Occurrence Description Frequency Cpk Rating

Remote Failure is very unlikely; no failures associated <1 in 1,500,000 >1.67 1

with similar processes
Low Few failures; isolated failures associated with 1 in 150,000 1.50 2
like processes 1 in 15,000 1.33 3
Moderate Occasional failures associated with similar 1 in 2,000 1.17 4
processes, but not in major proportions 1 in 400 1.00 5
1 in 80 0.83 6
High Repeated failures; similar processes have often 1 in 20 0.67 7
failed 1 in 8 8
Very high Process failure is almost inevitable 1 in 3 0.51 9
>1 in 2 0.33 10

A good control prevents or detects causes or failure modes.

• As early as possible (ideally before production or prototypes)
• As early as possible
• Using proven methods

So, the next step in the FMEA process is to:

• Analyze planned controls for your system, part, or manufacturing process

• Understand the effectiveness of these controls to detect causes or failure
modes

Detection Rating

Detection rating — see Table 6.5 for design and Table 6.6 for process — is a numer-
ical rating of the probability that a given set of controls will discover a specific cause
or failure mode to prevent bad parts from leaving the operation/facility or getting
to the ultimate customer. Assuming that the cause of the failure did occur, assess
the capabilities of the controls to find the design flaw or prevent the bad part from
leaving the operation/facility. In the first case, the DFMEA is at issue. In the second
case, the PFMEA is of concern.
When multiple controls exist for a given failure mode, record the best (lowest)
to calculate risk. In order to evaluate detection, there are appropriate tables for
both design and process. Just as before, however, if there is a need to alter them,
remember that the change and approval must be made by the FMEA team with
consensus.
At this point, the data for current controls and their ratings should be transferred
to the FMEA form — see Figure 6.15. There should be a current control for every
cause. If there is not, that is a good indication that a problem might exist.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 251

Potential Potential S C Potential O Current D Risk Priority

Failure Effects E L Causes of C Controls E Number
Mode of V A Failure Mode C T (RPN)
Failure E S U E
Mode R S R C
I R T
T E I
Y N O
C N
E
Does not Pan does 8 N Ball housing 2
transfer ink not work; I.D. deform
customer
tries and Ink viscosity 9
eventually too high
tears
paper Debris build- 5
and up
scraps
the pen

Old pen
stops
Partial ink writing, 7 N Inconsistent 2
customer ball rolling
scraps due to
pen deformed
housing
Customer 7 Ball does not 7
has to always pick
retrace up ink due to
ink viscosity
Writing
or Housing I.D. 1
drawing variation due
looks bad to mfg
and so on and so on

and so on

FIGURE 6.14 Transferring causes and occurrences to the FMEA form.

UNDERSTANDING AND CALCULATING RISK

Without risk, there is very little progress. Risk is inevitable in any system, design,
or manufacturing process. The FMEA process aids in identifying significant risks,
then helps to minimize the potential impact of risk. It does that through the risk
priority number or as it is commonly known, the RPN index. In the analysis of the
RPN, make sure to look at risk patterns rather than just a high RPN. The RPN is
the product of severity, occurrence, and detection or:

© 2003 by CRC Press LLC

252 Six Sigma and Beyond

TABLE 6.5
DFMEA Detection Table
Detection Description Rating

Almost certain Design control will almost certainly detect the potential cause of 1
subsequent failure modes
Very high Very high chance the design control will detect the potential cause of 2
subsequent failure mode
High High chance the design control will detect the potential cause of 3
subsequent failure mode
Moderately high Moderately high chance the design control will detect the potential cause 4
of subsequent failure mode
Moderate Moderate chance the design control will detect the potential cause of 5
subsequent failure mode
Low Low chance the design control will detect the potential cause of 6
subsequent failure mode
Very low Very low chance the design control will detect the potential cause of 7
subsequent failure mode
Remote Remote chance the design control will detect the potential cause of 8
subsequent failure mode
Very remote Very remote chance the design control will detect the potential cause 9
of subsequent failure mode
Very uncertain There is no design control or control will not or cannot detect the 10
potential cause of subsequent failure mode

Risk = RPN = S × O × D

Obviously the higher the RPN the more the concern. A good rule-of-thumb
analysis to follow is the 95% rule. That means that you will address all failure modes
with a 95% confidence. It turns out the magic number is 50, as indicated in this
equation: [(S = 10 × O = 10 × D = 10) – (1000 × .95)]. This number of course is
only relative to what the total FMEA is all about, and it may change as the risk
increases in all categories and in all causes.
Special risk priority patterns require special attention, through specific action
plans that will reduce or eliminate the high risk factor. They are identified through:

1. High RPN
2. Any RPN with a severity of 9 or 10 and occurrence > 2
3. Area chart

The area chart — Figure 6.16 — uses only severity and occurrence and therefore
is a more conservative approach than the priority risk pattern mentioned previously.
At this stage, let us look at our FMEA project and calculate and enter the RPN —
see Figure 6.17. It must be noted here that this is only one approach to evaluating
risk. Another possibility is to evaluate the risk based on the degree of severity first,

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 253

TABLE 6.6
PFMEA Detection Table
Detection Description Rating

Almost certain Process control will almost certainly detect or prevent the potential cause 1
of subsequent failure mode
Very high Very high chance process control will detect or prevent the cause of 2
subsequent failure mode
High High chance the process control will detect or prevent the potential cause 3
of subsequent failure mode.
Moderately high Moderately high chance the process control will detect or prevent the 4
potential cause of subsequent failure mode
Moderate Moderate chance the process control will detect or prevent the potential 5
cause of subsequent failure mode
Low Low chance the process control will detect or prevent the potential cause 6
of subsequent failure mode
Very low Very low chance the process control will detect or prevent the potential 7
cause of subsequent failure mode
Remote Remote chance the process control will detect or prevent the potential 8
cause of subsequent failure mode
Very remote Very remote chance the process control will detect or prevent the potential 9
cause of subsequent failure mode
Very uncertain There is no process control or control will not or cannot detect the potential 10
cause of subsequent failure mode

in which case the engineer tries to eliminate the failure; evaluate the risk based on
a combination of severity (values of 5–8) and occurrence (>3) second, in which case
the engineer tries to minimize the occurrence of the failure through a redundant
system; and to evaluate the risk through the detection of the RPN third, in which
case the engineer tries to control the failure before the customer receives it.

ACTION PLANS AND RESULTS

The third portion of the FMEA form deals with the action plans and results analysis.
A typical format is shown in Figure 6.18.
The idea of this third portion of the FMEA form is to generate a strategy that
reduces severity and occurrence and makes the detection effective to reduce the total
RPN:

Reducing the severity rating (or reducing the severity of the failure mode effect)
• Design or manufacturing process changes are necessary.
• This approach is much more proactive than reducing the detection
rating.
Reducing the occurrence rating (or reducing the frequency of the cause)
• Design or manufacturing process changes are necessary.
• This approach is more proactive than reducing the detection rating.

© 2003 by CRC Press LLC

254 Six Sigma and Beyond

Potential Potential S C Potential O Current D Risk Priority

Failure Effects E L Causes of C Controls E Number
Mode of V A Failure Mode C T (RPN)
Failure E S U E
Mode R S R C
I R T
T E I
Y N O
C N
E
Does not Pan does 8 N Ball housing 2 Life test 2
transfer ink not work; I.D. deform Test # X
customer
tries and Ink viscosity 9 Test # X 10
eventually too high
tears
paper Debris build- 5 Design review 7
and up Prototype test #
scraps XY
the pen

Old pen
stops
Partial ink writing, 7 N Inconsistent 2 Test # X 10
customer ball rolling
scraps due to
pen deformed
Customer housing
has to 7 Ball does not 7 None 10
retrace always pick
up ink due to
ink viscosity
Writing Housing I.D. 1 None 10
or variation due
drawing to mfg
looks bad
and so on and so on and so on

and so on

FIGURE 6.15 Transferring current controls and detection to the FMEA form.

Reducing the detection rating (or increasing the probability of detection)

• Improving the detection controls is generally costly, reactive, and does
not do much for quality improvement, but it does reduce risk.
• Increased frequency of inspection, for example, should only be used
as a last resort. It is not a proactive corrective action.

CLASSIFICATION AND CHARACTERISTICS

Different industries have different criteria for classification. However, in all cases
the following characteristics must be classified according to risk impact:

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 255

10
9
High
8 Priority
7
Occurrence 6
Medium
5
Priority
4
3
2 Low
Priority
1
Severity
1 2 3 4 5 6 7 8 9 10

FIGURE 6.16 Area chart.

• Severity 9, 10: Highest classification (critical)

These product- or process-related characteristics:
• May affect compliance with government or federal regulations
(EPA, OSHA, FDA, FCC, FAA, etc.)
• May affect safety of the customer
• Require specific actions or controls during manufacturing to ensure
100% compliance
• Severity between 5 and 8 and occurrence greater than 3: Secondary clas-
sification (significant)
These product- or process-related characteristics:
• Are non-critical items that are important for customer satisfaction
(e.g., fit, finish, durability, appearance)
• Should be identified on drawings, specifications, or process instruc-
tions to ensure acceptable levels of capability
• High RPN: Secondary classification (see Table 6.7)

Product Characteristics/“Root Causes”

Examples include size, form, location, orientation, or other physical properties such
as color, hardness, strength, etc.

Process Parameters/“Root Causes”

Examples include pressure, temperature, current, torque, speeds, feeds, voltage,

nozzle diameter, time, chemical concentrations, cleanliness of incoming part, ambi-
ent temperature, etc.

DRIVING THE ACTION PLAN

For each recommended action, the FMEA team must:

© 2003 by CRC Press LLC

256 Six Sigma and Beyond

Potential Potential S C Potential O Current D Risk Priority

Failure Effects E L Causes C Controls E Number
V A C T (RPN)
Mode of of U
E S E
Failure R S Failure Mode R C
Mode I R T
T E I
N
Y C O
E N
Does not Pan does 8 N Ball housing 2 Life test 2 32
transfer ink Pan does I.D. deform Test # X
not work;
customer Ink viscosity 9 Test # X 10 720
tries and too high
eventually Design review
tears Debris build- 5 Prototype test # 7 280
paper up XY
and
scraps
the pen
Old pen
stops
writing,
Partial ink customer 7 N Inconsistent 2 Test # X 10 140
scraps ball rolling
pen due to
deformed
housing
Customer
7 Ball does not 7 None 10 490
has to
retrace always pick
up ink due to
ink viscosity
Writing 1 None 10 70
Housing I.D.
or variation due
drawing to mfg
looks bad
and so on and so on and so on and so on

and so on

FIGURE 6.17 Transferring the RPN to the FMEA form.

• Plan for implementation of recommendations

• Make sure that recommendations are followed, demonstrate improvement,
and are completed

Implementation of action plans requires answering the classic questions…

• WHO … (will take the lead)

• WHAT… (specifically is to be done)

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 257

Action Plan Action Results

Recommended Target Actual Actions S O D RPN Remarks
Actions and Finish Finish Taken
Responsibility Date Date

FIGURE 6.18 Action plans and results analysis.

TABLE 6.7
Special Characteristics for Both Design and Process
FMEA Type Classification Purpose Criteria Control

Design YC A potential critical Severity = 9–10 Does not apply

characteristic
(Initiate PFMEA)
Design YS A potential significant Severity = 5–8 Does not apply
characteristic Occurrence = 4–10
(Initiate PFMEA)
Design Blank Not a potential critical or Severity < 5 Does not apply
significant characteristic
Process Inverted delta A critical characteristic Severity = 9–10 Required
Process SC A significant characteristic Severity = 5–8 Required
Occurrence = 4–10
Process HI High impact Severity = 5–8 Emphasis
Occurrence = 4–10
Process OS Operator safety Severity = 9–10 Safety sign-off
Process Blank Not a special characteristic Other Does not apply

• WHERE … (will the work get done)

• WHY… (this should be obvious)
• WHEN… (should the actions be done)
• HOW… (will we start)

Additional points concerning the action plan include the following:

• Accelerate implementation by getting buy-in (ownership).

• It is important to draw out and address objections.
• When plans address objections in a constructive way, stakeholders feel own-
ership in plans and actions. Ownership aids in successful implementation.

© 2003 by CRC Press LLC

258 Six Sigma and Beyond

• Typical questions that begin a fruitful discussion are:

• Why are we…?
• Why not this…?
• What about this…?
• What if…?
• Timing and actions must be reviewed on a regular basis to:
• Maintain a sense of urgency
• Allow for ongoing facilitation
• Ensure work is progressing
• Drive team members to meet commitments
• Surface new facts that may affect plans
• Fill in the actions taken.
• The “Action Taken” column should not be filled out until the actions
are totally complete.
• Record final outcomes in the Action Plan and Action Results sections
of the FMEA form. Remember, because of the actions you have taken
you should expect changes in severity, occurrence, detection, RPN, and
new characteristic designations. Of course, these changes may be indi-
vidual or in combination. The form will look like Figure 6.19.

LINKAGES AMONG DESIGN AND PROCESS FMEAS

AND CONTROL PLAN
FMEAs are not islands unto themselves. They have continuity, and the information
must be flowing throughout the design and process FMEAs as well as to the control
plan. A typical linkage is shown in Figure 6.20.
In addition to the control plan, the FMEA is also linked with robustness. To
appreciate these linkages in FMEA, we must recall that design for six sigma (DFSS)
must be a robust process. In fact, to see the linkages of this robustness we may begin
with a P diagram (see Volume V) and identify its components. It turns out that the
robustness in the FMEA usage is to make sure that the part, subsystem, or system
is going to perform its intended function, in spite of problems in both manufacturing
and environment. Of particular interest are the error states, control factors, and noise
factors. Error states may help in identifying the failures, noise factors may help us
in identifying causes, and control factors may help us in identifying the recommen-
dations. The signal and response become the functions or the starting point of the
FMEA.
The linkages then help generate the inputs and outputs of the FMEA. Typical
inputs are:

System (concept) inputs

P diagram
Boundary diagram
Interface matrix
Potential design verification tests

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 259

Description Failure Action Action

Mode Plan Results
Analysis
RPN Recommended Target Actual Action SO DR R Remarks
Action and Finish Finish Taken P
Responsibility Date Date N
32 No action 8 2 2 32 None
required
720 DOE - Taguchi 3/22/99 2/15/99 Optimize 8 1 10 80
ink
formula
280 Develop accel. 2/18/99 2/3/99 Test 8 5 1 40
test (thermal procedure
vibration) revised
D. Robins 4/3/99

2/2/99 2/2/99 Test

140 Develop new imple- 7 1 4 28
test # ABC mented
2/2/99

490 5/3/99 4/30/99 Optimized

DOE - Taguchi ink 7 1 10 70
optimize formula
viscosity on
C. Abrams 4/30/99
70 Evaluate TBD 7
machining
process
and so
on and so on

FIGURE 6.19 Transferring action plans and action results on the FMEA form.

Surrogate data for reliability and robustness considerations

Corporate requirements
Benchmarking results
Customer functionality in terms of engineering specifications
Regulatory requirements review
Design inputs
P diagram
Boundary diagram
Interface matrix
Customer functionality in terms of engineering specifications
Regulatory requirements review
Process inputs
P diagram
Process flow diagram
Special characteristics from the DFMEA
Process characteristics
Regulatory requirements review

© 2003 by CRC Press LLC

260 Six Sigma and Beyond

Design FMEA
Quality
Function
Deployment Function Failure Effect Severity Class Cause Controls Rec. Action

System
Design
Specifications

Sign-Off Report
Design Verification
Plan and Report
Process FMEA
Part C
Characteristic Function Failure Effect Controls L Cause Controls Reaction
1 Normal A S Special
2 S
3
4
etc. Remove the
classification
symbol

Dynamic Control Part Drawing

Plan (Inverted Delta
and Special
Characteristics)

FIGURE 6.20 FMEA linkages.

Machinery inputs
P diagram
Boundary diagram
Interface matrix
Customer functionality in terms of engineering specifications
Regulatory requirements review

GETTING THE MOST FROM FMEA

Common team problems that may make it difficult to get the most from FMEA
include:
• Poor team composition (not cross-functional or multidisciplinary)
• Low expertise in FMEA
• Not multi-level

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 261

• Low experience/expertise in product

• One-person FMEA
• Lack of management support
• Not enough time
• Too detailed, could go on forever
• Arguments between team members (Opinions should be based on facts
and data.)
• Lack of team enthusiasm/motivation
• Difficulty in getting team to start and stay with the process
• Proactive vs. reactive (a “before the event” not “after the fact” exercise)
• Doing it for the wrong reason

Common procedural problems include:

• Confusion about, poorly defined or incomplete functions, failure modes,

effects, or causes
• Subgroup discussion
• Using symptoms or superficial causes instead of root causes
• Confusion about ratings as estimates and not absolutes (It will take time
to be consistent.)
• Confusion about the relationship between causes, failure modes, and
effects
• Using “customer dissatisfied” as failure effect
• Shifting design concerns to manufacturing and vice-versa
• Doing FMEAs by hand
• Dependent on the engineers’ “printing skills”
• RPNs or criticality cannot be ranked easily
• Hard to update
• Much space taken up by complicated FMEAs
• Time consuming
• Resistance to being the “recorder” when done manually
• Inefficient means of storing and retrieving info
Note: With FMEA software these are all eliminated.
• Working non-systematically on the form (It is suggested that the failure
analysis should progress from left to right, with each column being com-
pleted before the next is begun.)
• Resistance of individuals to taking responsibility for recommended
actions
• Doing a reactive FMEA as opposed to a proactive FMEA (FMEAs are
best applied as a problem prevention tool, not problem solving tool,
although one may use them for both. However, the value of a reactive
FMEA is much less.)
• Not having robust FMEA terminology (A robust communication pro-
cess is one that delivers its “function” [imparting knowledge and under-
standing] without being affected by “noise factors” [varying degrees
of training]. Simply stated, the process should be as clear as possible
with minimum possibility for misunderstanding.)
© 2003 by CRC Press LLC
262 Six Sigma and Beyond

Stages of Learning Stages of FMEA Maturity

Unconscious incompetence Never heard of FMEA

Conscious incompetence We talked about it

Conscious competence Customer made us do it

Unconscious competence Some small successes

Proper and regular use

FIGURE 6.21 The learning stages.

Institutionalizing FMEA in your company is challenging, and its success is

largely dependent upon the culture in the organization as well as the reason it is
being utilized. Below are some main considerations:

• Selecting pilot projects (Start small and build successes.)

• Identifying team participants
• Developing and promoting FMEA successes
• Developing templates (databases of failure modes, functions, controls,
etc.)
• Addressing training needs

Figure 6.21 shows the learning stages (the direction of the arrows indicates the
increasing level) in a company that is developing maturity in the use of FMEA.

SYSTEM OR CONCEPT FMEA

A concept FMEA is used to analyze concepts at very early stages with new ideas.
Concept FMEAs can be design, process, or even machinery oriented. However, in
practical terms, most of them are done on a system or subsystem level.
The process of the system or concept FMEA is practically the same as that of
a design FMEA. In fact, the evaluation guidelines are exactly the same as those of
DFMEA. The difference is that in the system FMEA a great effort is made to identify
gross failures with high severities. If these problems cannot be overcome, then the
project most likely will be killed. If the failures can be fixed through reasonable
design changes, then the project moves to a second stage and the design FMEA
takes over.

DESIGN FAILURE MODE AND EFFECTS ANALYSIS

(DFMEA)
The Design Failure Mode and Effects Analysis (Design FMEA) is a method for iden-
tifying potential or known failure modes and providing follow-up and corrective actions.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 263

OBJECTIVE
The design FMEA is a disciplined analysis of the part design with the intent to
identify and correct any known or potential failure modes before the manufacturing
stage begins. Once these failure modes are identified and the cause and effects are
determined, each failure mode is then systematically ranked so that the most severe
failure modes receive priority attention. The completion of the design FMEA is the
responsibility of the individual product design engineer. This individual engineer is
the most knowledgeable about the product design and can best anticipate the failure
modes and their corrective actions.

TIMING
The design FMEA is initiated during the early planning stages of the design and is
continually updated as the program develops. The design FMEA must be totally
completed prior to the first production run.

REQUIREMENTS
The requirements for a design FMEA include:

1. Forming a team
2. Completing the design FMEA form
3. FMEA risk ranking guidelines

DISCUSSION
The effectiveness of an FMEA is dependent on certain key steps in the analysis
process, as follows:

Forming the Appropriate Team

A typical team for conducting a design FMEA is the following:

• Design engineer(s)
• Test/development engineer
• Reliability engineer
• Materials engineer
• Field service engineer
• Manufacturing/process engineer
• Customer

A design and a manufacturing engineer are required to be team members. Others

may participate as needed or as the project calls for their knowledge or experience.
The leader for the design FMEA is typically the design engineer.

© 2003 by CRC Press LLC

264 Six Sigma and Beyond

Describing the Function of the Design/Product

There are three types of functions:

1. Task functions: These functions describe the single most important reason
for the existence of the system/product. (Vacuum cleaner? Windshield
wiper? Ballpoint pen?)
2. Supporting functions: These are the “sub” functions that are needed in
order for the task function to be performed.
3. Enhancing functions: These are functions that enhance the product and
improve customer satisfaction but are not needed to perform the task
function.

After computing the function tree or a block diagram, transfer functions to the
FMEA worksheet or some other form of a worksheet to retain. Add the extent of
each function (range, target, specification, etc.) to test the measurability of the
function.

Describing the Failure Mode Anticipated

The team must pose the question to itself, “How could this part, system or design
fail? Could it break, deform, wear, corrode, bind, leak, short, open, etc.?” The team
is trying to anticipate how the design being considered could possibly fail; at this
point, it should not make the judgment as to whether it will fail but should concentrate
on how it could fail.
The purpose of a design FMEA (DFMEA) is to analyze and evaluate a design on
its ability to perform its functions. Therefore, the initial assumption is that parts are
manufactured and assembled according to plan and in compliance with specifications.
Once failure modes are determined under this assumption, then determine
other failure modes due to purchased materials, components, manufac-
turing processes, and services.

Describing the Effect of the Failure

The team must describe the effect of the failure in terms of customer reaction or in
other words, e.g., “What does the customer experience as a result of the failure mode
of a shorted wire?” Notice the specificity. This is very important, because this will
establish the basis for exploratory analysis of the root cause of the function. Would
the shorted wire cause the fuel gage to be inoperative or would it cause the dome
light to remain on?

Describing the Cause of the Failure

The team anticipates the cause of the failure. Would poor wire insulation cause the
short? Would a sharp sheet metal edge cut through the insulation and cause the
short? The team is analyzing what conditions can bring about the failure mode. The
more specific the responses are, the better the outcome of the FMEA.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 265

The purpose of a design FMEA (DFMEA) is to analyze and/or evaluate a design

on its ability to perform its functions (part characteristics). Therefore, the initial
assumption in determining causes is that parts are made and assembled according
to plan and in compliance with specifications, including purchased materials, com-
ponents, and services. Then and only then, determine causes due to purchased
materials, components, and services.
Some cause examples include:

Brittle material
Weak fastener
Corrosion
Low hardness
Too small of a gap
Wrong bend angle
Stress concentration
Ribs too thin
Wrong material selection
Poor stitching design
High G forces
Part interference
Tolerance stack-up
Vibration
Oxidation
And so on

Estimating the Frequency of Occurrence of Failure

The team must estimate the probability that the given failure is going to occur. The
team is assessing the likelihood of occurrence, based on its knowledge of the system,
using an evaluation scale of 1 to 10. A 1 would indicate a low probability of
occurrence whereas a 10 would indicate a near certainty of occurrence.

Estimating the Severity of the Failure

In estimating the severity of the failure, the team is weighing the consequence
of the failure. The team uses the same 1 to 10 evaluation scale. A 1 would indicate
a minor nuisance, while a 10 would indicate a severe consequence such as “loss of
brakes” or “stuck at wide open throttle” or “loss of life.”

Identifying System and Design Controls

Generally, these controls consist of tests and analyses that detect failure modes or
causes during early planning and system design activities. Good system controls
detect faults or weaknesses in system designs. Design controls consist of tests and
analyses that detect failure causes or failure modes during design, verification, and
validation activities. Good design controls detect faults or weaknesses in component
designs.

© 2003 by CRC Press LLC

266 Six Sigma and Beyond

Special notes:

• Just because there is a current control in place that does not mean that it
is effective. Make sure the team reviews all the current controls, especially
those that deal with inspection or alarms.
• To be effective (proactive), system controls must be applied throughout
the pre-prototype phase of the Advanced Product Quality Planning
(APQP) process.
• To be effective (proactive), design controls must be applied throughout
the pre-launch phase of the APQP process.
• To be effective (proactive), process controls should be applied during the
post-pilot build phase of APQP and continue during the production phase.
If they are applied only after production begins, they serve as reactive
plans and become very inefficient.

Examples of system and design controls include:

Engineering analysis
• Computer simulation
• Mathematical modeling/CAE/FEA
• Design reviews, verification, validation
• Historical data
• Tolerance stack studies
• Engineering reviews, etc.
System/component level physical testing
• Breadboard, analog tests
• Alpha and beta tests
• Prototype, fleet, accelerated tests
• Component testing (thermal, shock, life, etc.)
• Life/durability/lab testing
• Full scale system testing (thermal, shock, etc)
• Taguchi methods
• Design reviews

Estimating the Detection of the Failure

The team is estimating the probability that a potential failure will be detected before
it reaches the customer. Again, the 1 to 10 evaluation scale is used. A 1 would
indicate a very high probability that a failure would be detected before reaching the
customer. A 10 would indicate a very low probability that the failure would be
detected, and therefore, be experienced by the customer. For instance, an electrical
connection left open preventing engine start might be assigned a detection number
of 1. A loose connection causing intermittent no-start might be assigned a detection
number of 6, and a connection that corrodes after time causing no start after a period
of time might be assigned a detection number of 10.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 267

Detection is a function of the current controls. The better the controls, the more
effective the detection. It is very important to recognize that inspection is not a very
effective control because it is a reactive task.

Calculating the Risk Priority Number

The product of the estimates of occurrence, severity, and detection forms a risk
priority number (RPN). This RPN then provides a relative priority of the failure
mode. The higher the number, the more serious is the mode of failure considered.
From the risk priority numbers, a critical items summary can be developed to
highlight the top priority areas where actions must be directed.

Recommending Corrective Action

The basic purpose of an FMEA is to highlight the potential failure modes so that
the responsible engineer can address them after this identification phase. It is imper-
ative that the team provide sound corrective actions or provide impetus for others
to take sound corrective actions. The follow-up aspect is critical to the success of
this analytical tool. Responsible parties and timing for completion should be desig-
nated in all corrective actions.
Strategies for Lowering Risk: (System/Design) — High Severity or Occurrence
To reduce risk, you may change the product design to:

• Eliminate the failure mode cause or decouple the cause and effect
• Eliminate or reduce the severity of the effect
• Make the cause less likely or impossible to occur
• Eliminate function or eliminate part (functional analysis)

Some “tools” to consider:

• Quality Function Deployment (QFD)

• Fault Tree Analysis (FTA)
• Benchmarking
• Brainstorming
• TRIZ, etc.

Evaluate ideas using Pugh concept selection. Some specific examples:

• Change material, increase strength, decrease stress

• Add redundancy
• Constrain usage (exclude features)
• Develop fail safe designs, early warning system

Strategies for Lowering Risk: (System/Design) — High Detection Rating

Change the evaluation/verification/tests to:

© 2003 by CRC Press LLC

268 Six Sigma and Beyond

• Make failure mode easier to perceive

• Detect causes prior to failure

Some “tools” to consider:

• Benchmarking
• Brainstorming
• Process control (automatic corrective devices)
• TRIZ, etc.

Evaluate ideas using Pugh concept selection. Some specific examples:

• Change testing and evaluation procedures

• Increase failure feedback or warning systems
• Increase sampling in testing or instrumentation
• Increase redundancy in testing

PROCESS FAILURE MODE AND

EFFECTS ANALYSIS (FMEA)
The Process Failure Mode and Effects Analysis (process FMEA) is a method for
identifying potential or known processing failure modes and providing problem
follow-up and corrective actions.

OBJECTIVE
The process FMEA is a disciplined analysis of the manufacturing process with the
intent to identify and correct any known or potential failure modes before the first
production run occurs. Once these failure modes are identified and the cause and
effects are determined, each failure mode is then systematically ranked so that the
most severe failure modes receive priority attention. The completion of the process
FMEA is the responsibility of the individual product process engineer. This individ-
ual process engineer is the most knowledgeable about the process structure and can
best anticipate the failure modes and their effects and address the corrective actions.

TIMING
The process FMEA is initiated during the early planning stages of the process before
machines, tooling, facilities, etc., are purchased. The process FMEA is continually
updated as the process becomes more clearly defined. The process FMEA must be
totally completed prior to the first production run.

REQUIREMENTS
The requirements for a process FMEA are as follows:

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 269

1. Form team
2. Complete the process FMEA form
3. FMEA risk ranking guidelines

DISCUSSION
The effectiveness of an FMEA on a process is dependent on certain key steps in the
analysis, including the following:

Forming the Team

A typical team for the process/assembly FMEA is the following:

• Design engineer
• Manufacturing or process engineer
• Quality engineer
• Reliability engineer
• Tooling engineer
• Responsible operators from all shifts
• Supplier
• Customer

A design engineer, a manufacturing engineer, and representative operators are

required to be team members. Others may participate as needed or as the project
calls for their knowledge or experience. The leader for the process FMEA is typically
the process or manufacturing engineer.

Describing the Process Function

The team must identify the process or machine and describe its function. The team
members should ask of themselves, “What is the purpose of this operation?” State
concisely what should be accomplished as a result of the process being performed.
Typically, there are three areas of concern. They are:

1. Creating/constructing functions: These are the functions that add value to

the product. Examples include cutting, forming, painting, drying, etc.
2. Improving functions: These are the functions that are needed in order to
improve the results of the creating function. Examples include deburring,
sanding, cleaning, etc.
3. Measurement functions: These are functions that measure the success of
the other functions. Examples include SPC, gauging, inspections, etc.

Manufacturing Process Functions

Just as products have functions, manufacturing processes also have functions. The
goal is to concisely list the function(s) for each process operation. The first step in
improving any process is to make the current process visible by developing a process

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270 Six Sigma and Beyond

flow diagram (a sequential flow of operations by people and/or equipment). This

helps the team understand, agree, and define the scope. Three important questions
exist for any existing process:

1. What do you think is happening?

2. What is actually happening?
3. What should be happening?

Special reminder for manufacturing process functions: Remember, if the process

flow diagram is too extensive for a “timely” FMEA, a risk assessment may be done
on each process operation to narrow the scope.
The PFMEA Function Questions
Each manufacturing step typically has one or more functions. Determine what
functions are associated with each manufacturing process step and then ask:

1. What does the process step do to the part?

2. What are you doing to the part/assembly?
3. What is the goal, purpose, or objective of this process step?

For example, consider the pen assembly process (see Figure 6.22), which involves
the following steps:

1. Inject ink into ink tube (0.835 cc)

2. Insert ink tube into tip assembly housing (12 mm)
3. Insert tip assembly into tip assembly housing (full depth until stop)
4. Insert tip assembly housing into barrel (full depth until stop)
5. Insert end cap into barrel (full depth until stop)
6. Insert barrel into cap (full depth until stop)
7. Move to dock (to dock within 8 seconds)
8. Package and ship (12 pens per box)

Note: At the end of this function analysis you are ready to transfer the informa-
tion to the FMEA form.
Remember that another way to reduce the complexity or scope of the FMEA is
to prioritize the list of functions and then take only the ones that the team collectively
agrees are the biggest concerns.

Describing the Failure Mode Anticipated

The team must pose the question to itself, “How could this process fail to complete
its intended function? Could the resulting workpiece be oversize, undersize, rough,
eccentric, misassembled, deformed, cracked, open, shorted, leaking, porous, dam-
aged, omitted, misaligned, out of balance, etc.?” The team members are trying to
anticipate how the workpiece might fail to meet engineering requirements; at this
point in their analysis they should stress how it could fail and not whether it will fail.

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 271

Ink

Ink Inject ink

tube into ink tube

Insert ink tube

Tip
into tip
assembly
assembly
housing
Insert tip
assembly into tip
Tip assembly
assembly housing

Insert tip
Barrel
assembly housing

Insert end cap into

End cap
barrel

Insert barrel into cap Cap

Move to dock

Package and ship

FIGURE 6.22 Pen assembly process.

The purpose of a process FMEA (PFMEA) is to analyze and evaluate a process

on its ability to perform its functions. Therefore, the initial assumptions are:

1. The design intent meets all customer requirements.

2. Purchased materials and components comply with specifications.

Once failure modes are determined under these assumptions, then determine
other failure modes due to:

1. Design flaws that cause or lead to process problems

2. Problems with purchased materials, components, or services

Describing the Effect(s) of the Failure

The team must describe the effect of the failure on the component or assembly. What
will happen as a result of the failure mode described? Will the component or

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272 Six Sigma and Beyond

assembly be inoperative, intermittently operative, always on, noisy, inefficient, surg-

ing, not durable, inaccurate, etc.? After considering the failure mode, the engineer
determines how this will manifest itself in terms of the component or assembly
function. The open circuit causes an inoperative gage. The rough surface will cause
excessive bushing wear. The scratched surface will cause noise. The porous casting
will cause external leaks. The cold weld will cause reduced strength, etc. In some
cases the process engineer (the leader) must interface with the product design
engineer to correctly describe the effect(s) of a potential process failure on the
component or total assembly.

Describing the Cause(s) of the Failure

The engineer anticipates the cause of the failure. The engineer is describing what
conditions can bring about the failure mode. Locators are not flat and parallel. The
handling system causes scratches on a shaft. Inadequate venting and gaging can
cause misruns, porosity, and leaks. Inefficient die cooling causes die hot spots.
Undersize condition can be caused by heat treat shrinkage, etc.
The purpose of a process FMEA (PFMEA) is to analyze or evaluate a process
on its ability to perform its functions (part characteristics). Therefore, the initial
assumptions in determining causes are:

• The design intent meets all customer requirements.

• Purchased materials, components, and services comply with specifications.

Then and only then, determine causes due to:

• Design flaws that cause or lead to process problems

• Problems with purchased materials, components, or services

Typical causes associated with process FMEA include:

Fatigue
Poor surface preparation
Improper installation
Low torque
Improper maintenance
Inadequate clamping
Misuse
High RPM
Abuse
Inadequate venting
Unclear instructions
Tool wear
Component interactions
Overheating
And so on

© 2003 by CRC Press LLC

Failure Mode and Effect Analysis (FMEA) 273

Estimating the Frequency of Occurrence of Failure

The team must estimate the probability that the given failure mode will occur. This
team is assessing the likelihood of occurrence, based on their knowledge of the
process, using an evaluation scale of 1 to 10. A 1 would indicate a low probability
of occurrence, whereas a 10 would indicate a near certainty of occurrence.

Estimating the Severity of the Failure

In estimating the severity of the failure, the team is weighing the consequence (effect)
of the failure. The team uses the same 1 to 10 evaluation scale. A 1 would indicate
a minor nuisance, while a 10 would indicate a severe consequence such as “motor
inoperative, horn does not blow, engine seizes, no drive, etc.”

Identifying Manufacturing Process Controls

Manufacturing process controls consist of tests and analyses that detect causes or
failure modes during process planning or production. Manufacturing process controls
can occur at the specific operation in question or at a subsequent operation. There
are three types of process controls, those that:

1. Prevent the cause from happening

2. Detect causes then lead to corrective actions
3. Detect failure modes then lead to corrective actions

Manufacturing process controls should be based on process dominance factors.

Dominance factors are process elements that generate significant process variation.
Dominance factors are the predominant factors that contribute to problems in a
process. Most processes have one or two dominant sources of variation. Depending
on the source, there are tools that may be used to track these as well as monitor
them. Table 6.8 gives a cross reference of the dominance factors and the tools that
may be used for tracking them. The following list provides some very common
dominance factors:

• Setup
• Machine
• Operator
• Component or material
• Tooling
• Preventive maintenance
• Fixture/pallet/work holding
• Environment

Special note: Controls should target the dominant sources of variation.

Manufacturing process control examples include:

© 2003 by CRC Press LLC

274 Six Sigma and Beyond

TABLE 6.8
Manufacturing Process Control Matrix
Dominance Factor Attribute Data Variable Date

Setup Check sheet X-bar/R chart

Checklist X-MR chart
Machine p or c chart Run chart
Check sheet X-bar/R chart
X-MR chart
Operator Check sheet X-bar/R chart
Run chart X-MR chart
Component/material Check sheet Check sheet
Supplier information Supplier information
Tool Tool logs Tool logs
Check sheet Capability study
p or c chart X-MR chart
Preventive maintenance Time to failure chart Time to failure chart
Supplier information Supplier information
X-MR chart

Fixture/pallet/work holding Time to failure chart Time to failure chart

Check sheet X-bar/R chart
p or c chart X-MR chart
Environment Check sheet Run chart
X-MR chart

Statistical Process Control (SPC)

• X-bar/R control charts (variable data)
• Individual X-moving range charts (variable data)
• p; n; u; c charts (attribute data)
Non-statistical control
• Check sheets, checklists, setup procedures, operational definitions/
instruction sheets
• Preventive maintenance
• Tool usage logs/change programs (PM)
• Mistake proofing/error proofing/Poka Yoke
• Training and experience
• Automated inspection
• Visual inspection

It is very important to recognize that inspection is not a very effective control

because it is a reactive task.

Estimating the Detection of the Failure

The detection is directly related to the controls available in the process. So the better
the controls, the better the detection. The team in essence is estimating the probability
© 2003 by CRC Press LLC
Failure Mode and Effect Analysis (FMEA) 275

that a potential failure will be detected before it reaches the customer. The team
members use the 1 to 10 evaluation scale. A 1 would indicate a very high probability
that a failure would be detected before reaching the customer. A 10 would indicate
a very low probability that the failure would be detected, and therefore, be experi-
enced by the customer. For instance, a casting with a large hole would be readily
detected and would be assessed as a 1. A casting with a small hole causing leakage
between two channels only after prolonged usage would be assigned a 10. The team
is assessing the chances of finding a defect, given that the defect exists.

Calculating the Risk Priority Number

The product of the estimates of occurrence, severity, and detection forms a risk
priority number (RPN). This RPN then provides a relative priority of the failure
mode. The higher the number, the more serious is the mode of failure considered.
From the risk priority numbers, a critical items summary can be developed to
highlight the top priority areas where actions must be directed.

Recommending Corrective Action

The basic purpose of an FMEA is to highlight the potential failure modes so that
the engineer can address them after this identification phase. It is imperative that
the engineer provide sound corrective actions or provide impetus for others to take
sound corrective actions. The follow-up aspect is critical to the success of this
analytical tool. Responsible parties and timing for completion should be designated
in all corrective actions.
Strategies for Lowering Risk: (Manufacturing) — High Severity or Occurrence
Change the product or process design to:

• Eliminate the failure cause or decouple the cause and effect

• Eliminate or reduce the severity of the effect (recommend changes in
design)

Some “tools” to consider:

• Benchmarking
• Brainstorming
• Mistake proofing
• TRIZ, etc.

Evaluate ideas using Pugh concept selection. Some specific examples:

• Developing a robust design (insensitive to manufacturing variations)

• Changing process parameters (time, temperature, etc.)
• Increasing redundancy, adding process steps
• Altering process inputs (materials, components, consumables)
• Using mistake proofing (Poka Yoke), reducing handling

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276 Six Sigma and Beyond

Strategies for Lowering Risk: (Manufacturing) — High Detection Rating

Change the process controls to:

• Make failure mode easier to perceive

• Detect causes prior to failure mode

Some “tools” to consider:

• Benchmarking
• Brainstorming, etc.

Evaluate ideas using Pugh concept selection. Some specific examples:

• Change testing and inspection procedures/equipment.

• Improve failure feedback or warning systems.
• Add sensors/feedback or feed forward systems.
• Increase sampling and/or redundancy in testing.
• Alter decision rules for better capture of causes and failures (i.e., more
sophisticated tests).

At this stage, now you are ready to enter a brief description of the recommended
actions, including the department and individual responsible for implementation, as
well as both the target and finish dates, on the FMEA form. If the risk is low and
no action is required write “no action needed.”
For each entry that has a designated characteristic in the class[ification] column,
review the issues that impact cause/occurrence, detection/control, or failure mode.
Generate recommended actions to reduce risk. Special RPN patterns suggest that certain
characteristics/root causes are important risk factors that need special attention.

Guidelines for process control system:

1. Select the process.

2. Conduct the FMEA on the process.
3. Conduct gage system analysis.
4. Conduct process potential study.
5. Develop control plan.
6. Train operators in control methods.
7. Implement control plan.
8. Determine long-term process capability.
9. Review the system for continual improvement.
10. Develop audit system.
11. Institute improvement actions.

After FMEA:

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Failure Mode and Effect Analysis (FMEA) 277

1. Review the FMEA.

2. Highlight the high-risk areas based on the RPN.
3. Identify the critical and major characteristics based on your classification
criteria.
4. Ensure that a control plan exists and is being followed.
5. Conduct capability studies.
6. Work on processes that have Cpk of less or equal to 1.33.
7. Work on processes that have Cpk greater than 1.33 to reduce variation and
reach a Cpk of greater or equal to 2.0.

MACHINERY FMEA (MFMEA)

A machinery FMEA is a systematic approach that applies the traditional tabular
method to aid the thought process used by simultaneous engineering teams to identify
the machine’s potential failure modes, potential effects, and potential causes of the
potential failure modes and to develop corrective action plans that will remove or
reduce the impact of the potential failure modes. Generally, the delivery of a MFMEA
is the responsibility of the supplier who generates a functional MFMEA for system
and subsystem levels. This is in contrast to a DFMEA where the responsibility is
still on the supplier but now the focus is to generate transfer mechanisms, spindles,
switches, cylinders, exclusive of assembly-level equipment.
A typical MFMEA follows a hierarchical model in that it divides the machine
into subsystems, assemblies, and lowest replaceable units. For example:

Level 1: System level — generic machine

Level 2: Subsystem level — electrical, mechanical, controls
Level 3: Assembly level — fixtures/tools, material handling, drives
Level 4: Component level
And so on

IDENTIFY THE SCOPE OF THE MFMEA

Use the boundary diagram. Once the diagram has been completed, you can focus
the MFMEA on the low MTBF and reliability values.

IDENTIFY THE FUNCTION

Define the function in terms of an active verb and a noun. Use a functional diagram
or the P diagram to find the ideal function. Always focus on the intent of the system,
subsystem, or component under investigation.

FAILURE MODE
A failure is an event when the equipment/machinery is not capable of producing
parts at specific conditions when scheduled or is not capable of producing parts or

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278 Six Sigma and Beyond

performing scheduled operations to specifications. Machinery failure modes can

occur in three ways:

• Component defect (hard failure)

• Failure observation (potential)
• Abnormality of performance (constitutes the equipment as failed)

POTENTIAL EFFECTS
The consequence of a failure mode on the subsystem is described in terms of safety
and the big seven losses. (The big seven losses may be identified through warranty
or historical data.)
Describe the potential effects in terms of downtime, scrap, and safety issues. If
a functional approach is used, then list the causes first before developing the effects
listing. Associated with the potential effects is the severity, which is a rating corre-
sponding to the seriousness of the effect of a potential machinery failure mode.
Typical descriptions are:

Downtime
• Breakdowns: Losses that are a result of a functional loss or function
reduction on a piece of machine requiring maintenance intervention.
• Setup and adjustment: Losses that are a result of set procedures. Adjust-
ments include the amount of time production is stopped to adjust
process or machine to avoid defect and yield losses, requiring operator
or job setter intervention.
• Startup losses: Losses that occur during the early stages of production
after extended shutdowns (weekends, holidays, or between shifts),
resulting in decreased yield or increased scrap and defects.
• Idling and minor stoppage: Losses that are a result of minor interrup-
tions in the process flow, such as a process part jammed in a chute or
a limit switch sticking, etc., requiring only operator or job setter inter-
vention. Idling is a result of process flow blockage (downstream of the
focus operation) or starvation (upstream of the focus operation). Idling
can only be resolved by looking at the entire line/system.
• Reduced cycle: Losses that are a result of differences between the ideal
cycle time of a piece of machinery and its actual cycle time.
Scrap
• Defective parts: Losses that are a result of process part quality defects
resulting in rework, repair, or scrap.
• Tooling: Losses that are a result of tooling failures/breakage or dete-
rioration/wear (e.g., cutting tools, fixtures, welding tips, punches, etc.).
Safety
• Safety considerations: Immediate life or limb threatening hazard or
minor hazard.

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Failure Mode and Effect Analysis (FMEA) 279

SEVERITY RATING
Severity is comprised of three components:

• Safety of the machinery operator (primary concern)

• Product scrap
• Machinery downtime

A rating should be established for each effect listed. Rate the most serious effect.
Begin the analysis with the function of the subsystem that will affect safety, gov-
ernment regulations, and downtime of the equipment. A very important point here
is the fact that a reduction in severity rating may be accomplished only through a
design change. A typical rating is shown in Table 6.9.
It should be noted that these guidelines may be modified to reflect specific
situations. Also, the basis for the criteria may be changed to reflect the specificity
of the machine and its real world usage.

CLASSIFICATION
The classification column is not typically used in the MFMEA process but should
be addressed if related to safety or noncompliance with government regulations.
Address the failure modes with a severity rating of 9 or 10. Failure modes that affect
worker safety will require a design change. Enter “OS” in the class column. OS
(operator safety) means that this potential effect of failure is critical and needs to
be addressed by the equipment supplier. Other notations can be used but should be
approved by the equipment user.

POTENTIAL CAUSES
The potential causes should be identified as design deficiencies. These could translate as:

• Design variations, design margins, environmental, or defective components

• Variation during the build/install phases of the equipment that can be
corrected or controlled

Identify first level causes that will cause the failure mode. Data for the devel-
opment of the potential causes of failure can be obtained from:

• Surrogate MFMEA
• Failure logs
• Interface matrix (focusing on physical proximity, energy transfer, material,
information transfer)
• Warranty data
• Concern reports (things gone wrong, things gone right)
• Test reports
• Field service reports

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TABLE 6.9
Machinery Guidelines for Severity, Occurrence, and Detection
Alternate
Probability Criteria for Criteria for
Effect Criteria Severity Rank of Failure Occurrence Rank Occurrence Detection Criteria for Detection Rank

Hazardous Very high severity: affects operator, 10 Failure occurs R(t) < 1 or some 10 1 in 1 Very low Present design controls 10
without plant, or maintenance personnel every hour MTBF cannot detect potential
warning safety and/or effects cause or no design control
noncompliance with government available
regulations without warning
Hazardous High severity: affects operator, 9 Failure occurs R(t) = 5% 9 1 in 8 Team’s discretion depending 9
with warning plant or maintenance personnel every shift on machine and situation
safety and/or effects
noncompliance with government
regulations with warning
Very high Downtime of 8+ hours or the 8 Failure occurs R(t) = 20% 8 1 in 24 Team’s discretion depending 8

Six Sigma and Beyond

production of defective parts for every day on machine and situation
over 2 hours
High Downtime of 2–4 hours or the 7 Failure occurs R(t) 37% 7 1 in 80 Low Machinery control will 7
production of defective parts for every week isolate the cause and failure
up to 2 hours mode after the failure has
occurred, but will not
prevent the failure from
occurring

© 2003 by CRC Press LLC

 Alternate
Probability Criteria for Criteria for
Effect Criteria Severity Rank of Failure Occurrence Rank Occurrence Detection Criteria for Detection Rank

Failure Mode and Effect Analysis (FMEA)

Moderate Downtime of 60–120 min or the 6 Failure occurs R(t) = 60% 6 1 in 350 Team’s discretion depending 6
production of defective parts for every month on machine and situation
up to 60 min
Low Downtime of 30–60 min with no 5 Failure occurs R(t) = 78% 5 1 in 1000 Medium Machinery controls will 5
production of defective parts or the every 3 months provide an indicator of
production of defective parts for imminent failure
up to 30 min
Very low Downtime of 15–30 min with no 4 Failure occurs R(t) = 85% 4 1 in 2500 Team’s discretion depending 4
production of defective parts every 6 months on machine and situation
Minor Downtime up to 15 min with no 3 Failure occurs R(t) = 90% 3 1 in 5000 High Machinery controls will 3
production of defective parts every year prevent an imminent failure
and isolate the cause
Very minor Process parameter variability not 2 Failure occurs R(t) = 95% 2 1 in 10,000 Team’s discretion depending 2
within specification limits. every 2 years on machine and situation
Adjustments may be done during
production; no downtime and no
defects produced
None Process parameter variability 1 Failure occurs R(t) = 98% 1 1 in 25,000 Very high Machinery controls not 1
within specification limits; every 5 years required; design controls
adjustments may be performed will detect a potential cause
during normal maintenance and subsequent failure
almost every time

281
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282 Six Sigma and Beyond

OCCURRENCE RATINGS
Occurrence is the rating corresponding to the likelihood of the failure mode occurring
within a certain period of time — see Table 6.8. The following should be considered
when developing the occurrence ratings:

• Each cause listed requires an occurrence rating.

• Controls can be used that will prevent or minimize the likelihood that the
failure cause will occur but should not be used to estimate the occurrence
rating.

Data to establish the occurrence ratings should be obtained from:

• Service data
• MTBF data
• Failure logs
• Maintenance records

SURROGATE MFMEAS
Current Controls

Current controls are described as being those items that will be able to detect the
failure mode or the causes of failure. Controls can be either design controls or
process controls.
A design control is based on tests or other mechanisms used during the design
stage to detect failures. Process controls are those used to alert the plant personnel
that a failure has occurred. Current controls are generally described as devices to:

• Prevent the cause/mechanism failure mode from occurring

• Reduce the rate of occurrence of the failure mode
• Detect the failure mode
• Detect the failure mode and implement corrective design action

Detection Rating
Detection rating is the method used to rate the effectiveness of the control to detect
the potential failure mode or cause. The scale for ranking these methods is based
on a 1 to 10 scale — see Table 6.8.

RISK PRIORITY NUMBER (RPN)

The RPN is a method used by the MFMEA team to rank the various failure modes
of the equipment. This ranking allows the team to attack the highest probability of
failure and remove it before the equipment leaves the supplier floor.
The RPN typically:

• Has no value or meaning (Ratings and RPNs in themselves have no value

or meaning. They should be used only to prioritize the machine’s potential

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Failure Mode and Effect Analysis (FMEA) 283

design weakness [failure mode] for consideration of possible design

actions to eliminate the failures or make them maintainable.)
• Is used to prioritize potential design weaknesses (root causes) for consid-
eration of possible design actions
• Is the product of severity, occurrence and detection (RPN = S × O × D)

Special note on risk identification: Whereas it is true that most organizations

using FMEA guidelines use the RPN for identifying the risk priority, some do not
follow that path. Instead, they use a three path approach based on:

Step 1: severity
Step 2: criticality
Step 3: detection

This means that regardless of the RPN, the priority is based on the highest
severity first, especially if it is a 9 or a 10, followed by the criticality, which is the
product of severity and occurrence, and then the RPN.

RECOMMENDED ACTIONS
• Each RPN value should have a recommended action listed.
• The actions are designed to reduce severity, occurrence, and detection
ratings.
• Actions should address in order the following concerns:
• Failure modes with a severity of 9 or 10
• Failure mode/cause that has a high severity occurrence rating
• Failure mode/cause/design control that has a high RPN rating
• When a failure mode/cause has a severity rating of 9 or 10, the design
action must be considered before the engineering release to eliminate
safety concerns.

DATE, RESPONSIBLE PARTY

• Document the person, department, and date for completion of the recom-
mended action.
• Always place the responsible party’s name in this area.

ACTIONS TAKEN/REVISED RPN

• After each action has been taken, document the action.
• Results of an effective MFMEA will reduce or eliminate equipment down-
time.
• The supplier is responsible for updating the MFMEA. The MFMEA is a
living document. It should reflect the latest design level and latest design
actions.
• Any equipment design changes need to be communicated to the MFMEA
team.

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284 Six Sigma and Beyond

REVISED RPN
• Recalculate S, O, and D after the action taken has been completed. Always
remember that only a change in design can change the severity. Occurrence
may be changed by a design change or a redundant system. Detection
may be changed by a design change or better testing or better design
control.
• MFMEA — A team needs to review the new RPN and determine if
additional design actions are necessary.

SUMMARY
In summary, the steps in conducting the FMEA are as follows:

1. Select a project and scope.

2. If DFMEA, construct a block diagram.
3. If PFMEA, construct a process flow diagram.
4. Select an entry point based on the block or process flow diagram.
5. Collect the data.
6. Analyze the data.
7. Calculate results (results must be data driven).
8. Evaluate/confirm/measure the results.
• Better off
• Worse off
• Same as before
9. Do it all over again.

SELECTED BIBLIOGRAPHY
Chrysler Corporation, Ford Motor Company, and General Motors Corporation, Potential
Failure Mode and Effect Analysis (FMEA) Reference Manual, 2nd ed., distributed by
the Automotive Industry Action Group (AIAG), Southfield, MI, 1995.
Chrysler Corporation, Ford Motor Company, and General Motors Corporation, Advanced
Product Quality Planning and Control Plan, distributed by the Automotive Industry
Action Group (A.I.A.G.), Southfield, MI, 1995.
Chrysler Corporation, Ford Motor Company, and General Motors Corporation, Potential
Failure Mode and Effect Analysis (FMEA) Reference Manual, 32nd ed., Chrysler
Corporation, Ford Motor Company, and General Motors Corporation. Distributed by
the Automotive Industry Action Group (AIAG), Southfield, MI, 2001.
The Engineering Society for Advancing Mobility Land Sea Air and Space, Potential Failure
Mode and Effects Analysis in Design FMEA and Potential Failure Mode and Effects
Analysis in Manufacturing and Assembly Processes (Process FMEA) Reference Man-
ual, SAE: J1739, The Engineering Society for Advancing Mobility Land Sea Air and
Space, Warrendale, PA, 1994.

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Failure Mode and Effect Analysis (FMEA) 285

The Engineering Society for Advancing Mobility Land Sea Air and Space, Reliability and
Maintainability Guideline for Manufacturing Machinery and Equipment, SAE Prac-
tice Number M-110, The Engineering Society for Advancing Mobility Land Sea Air
and Space, Warrendale, PA, 1999.
Ford Motor Company, Failure Mode Effects Analysis: Training Reference Guide, Ford Motor
Company — Ford Design Institute. Dearborn, MI, 1998.
Kececioglu, D., Reliability Engineering Handbook, Vol. 1–2, Prentice Hall, Englewood Cliffs,
NJ, 1991.
Stamatis, D.H., Advanced Quality Planning, Quality Resources, New York, 1998.
Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from Theory to Execution, Quality
Press, Milwaukee, 1995.

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