FAILURE MODES & EFFECTS ANALYSIS

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CHAPTER OBJECTIVES
WHAT IS A FMEA?
TYPES OF FMEAs
DEFINING A FAILURE MODE
TEAM CONCEPTS
FMEA FORM
HOW TO COMPLETE A FMEA
APPLICATION EXAMPLES
CLASSROOM EXERCISE

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CHAPTER OBJECTIVES
This chapter will discuss the purpose of Failure Modes & Effect
Analysis (FMEA) and the role it plays with the Six Sigma
Breakthrough Strategies. You will be provided with information
on:

What is a FMEA.
Types of FMEA.
Defining a Failure Mode.
Understanding Team Concepts for
a FMEA.
How to develop a FMEA.
Steps used in developing
a FMEA.

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WHAT IS A FMEA?
Identifies ways the product or process can fail.
Helps plan to prevent those failures.
A systematic method of identifying and preventing problems
before they occur.
Focused on preventing defects, enhancing safety and
increasing customer satisfaction.
Conducted on Product Design, Process Improvement as
well as existing processes.
Should be a living document updated for process/design
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Changes and addition of new information.

BENEFITS FROM A PROPERLY

EXECUTED FMEA
Improve product functionality and robustness.
Reduce day-to-day manufacturing problems.
Improved safety of products and processes.
Reduced business process problems.
Understand potential risks associated with revising a
process or implementing a new one.

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TYPES OF FMEAS
There are several types of FMEAs:
Service FMEA
Design FMEA
Product FMEA
Process FMEA
NOTE: Our main focus will be on Process FMEA.
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TYPES OF FMEA
Process FMEA - Focuses on Potential Failure Modes due to production or
service processes.
Process Flow/process/Sequence/Process Steps
Equipment/Machines/operator
Tooling/Fixtures/Jigs/Gauging
Significant loss to company assets.
Product FMEA - Focus on Potential Failure Modes on product itself due to
Design Process.
System
Subsystem
Sub-assemblies
Component/part
Raw Materials

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DEFINING A FAILURE MODE

Failure Mode: The manner in which a process/product can fail to meet
specification. Usually associated with defects.
All Failure modes have an effect, and some are more likely to
occur than others.
Each Failure mode has a relative risk associated with it.
FMEA process helps identify failures, effects and risks
within a process or product.
Typical Failure Modes : Bent, cracked, deformed, impure, dirty,
binding.

Cause
Cause

Failure
FailureMode
Mode
(Defect)
(Defect)

Effect
Effect

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DEFINING A FAILURE MODE

For example, a drip coffeemaker, a relatively simple household appliance
could have several things fail that would render the coffeemaker inoperable.
Here are some of the possible ways in which the coffeemaker can fail:

Heating element does not heat water to sufficient temperature to brew

coffee.
Pump does not pump water into the filter basket.
Coffeemaker does not turn on automatically by the clock.
Clock stops working or runs too fast or slow.
Calcium deposits from impure water clog up the brewing process.
Not enough or too much coffee is used.
There is a short in the electrical cord.

Discussion of failure modes during team meetings will contribute toward

identifying the effects and risks of the product or process.

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TEAM CONCEPTS
When executing an FMEA, teams work to identify potential
failure modes for design functions and/or process
requirements.
A Severity Rating, Frequency of Occurrence and Likelihood of
Detection are assigned to the effect of the failure mode.
After these numbers are determined, the Risk Priority Number
(RPN) is calculated by taking the product of the assigned
numbers.
The team then prioritizes the ranking of the RPN numbers for
focus on the areas that require process improvement efforts.

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FMEA FORM

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HOW TO COMPLETE A FMEA

Start by completing the header portion of the form that includes:
Process or Product Name
Responsible Name of process owner
Prepared By Name of Green Belt
FMEA Date - dates of initial and subsequent FMEA revisions.

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REVIEW THE PROCESS

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BRAINSTORM POTENTIAL
FAILURE MODES

Once everyone on the team has an understanding of the process or

product, team members can begin thinking about potential failure modes
that could affect the manufacturing process or product quality.
Brainstorming sessions are an ideal vehicle for producing viable ideas that
contribute toward the FMEA.
Because of the complexity of most manufactured products and
manufacturing processes, it is best to conduct a series of brainstorming
sessions; each focused on a different element of the product or process.
Focusing on the elements one at a time will result in a more thorough list
of potential failure modes.

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BRAINSTORM POTENTIAL
FAILURE MODES
Once the brainstorming is complete, the ideas should be organized into
like categories.
Group them by like failures, such as by process or product failure or
seriousness of failure.
Without the grouping step, the team invests a lot of energy jumping from
one aspect to a completely different aspect of the product or process and
then back again.
Grouping also gives the team a chance to consider whether some of the
failures should be combined, because they are similar to each other.
Once the failure modes have been grouped and combined, transfer them
onto the FMEA worksheet under the column heading Potential Failure
Modes (process defects).

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LIST POTENTIAL EFFECTS

ON EACH FAILURE MODE

With the failure modes listed on the FMEA form, the FMEA team then
reviews each failure mode and identifies the potential effects of the failure,
should it occur.
For some of the failure modes, there may be only one effect while there
may be several effects for other failure modes.
This step must be thorough, because this information will feed into the
assignment of risk ratings for each of the failures.
It is helpful to think of this step as an if-then process: If the failure occurs,
then what are the consequences.
Transfer this information to the FMEA form under column heading
Potential Failure Effects.

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ASSIGN A SEVERITY RATING

FOR EACH FAILURE MODE
The severity rating is an estimation of how serious the effects would be if a
given failure did occur.
Utilize past experience to predict how serious the problem would be.
In other cases, it is necessary to estimate the severity based on the knowledge
and expertise of the team members.
Because each failure may have several different effects, and each effect can
have a different level of severity, it is the effect, not the failure, which is rated.
Therefore, each effect should be given its own severity rating, even if there are
several effects for a single failure mode.
After the severity rating(s) are determined, transfer it to the FMEA form under
the column heading SEV.

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SEVERITY EVALUATION
CRITERIA FOR PROCESS FMEA

LIST POTENTIAL CAUSES OF

FAILURE AND CURRENT
PROCESS CONTROLS

Once the failure modes and potential effects are listed on the FMEA form,
the potential causes of failures are listed.
These are the descriptions of how the failure could occur, described in
terms of something that can be corrected or controlled.
Current controls are a list of process controls that either prevent, to the
extent possible, the failure mode from occurring, or detecting the failure
mode should it occur.
Examples of Current Process Controls are sensors, probes, hard gages,
visual, etc.
Transfer the information to the FMEA form under the column heading
potential Causes of Failure.

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ASSIGN AN OCCURRENCE RATING

FOR EACH FAILURE MODE
The best method for determining the occurrence rating is to use actual data
from the process such as failure logs or even process capability data.
When actual failure data is not available, the team must estimate how often a
failure mode may occur.
Once the potential causes have been identified for all the failure modes, an
occurrence rating can be assigned.
Transfer the occurrence rating to the FMEA form under the column heading
OCC.
The following table outlines the evaluation criteria for determining the
occurrence for each process step.

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OCCURRENCE EVALUATION
CRITERIA

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ASSIGN DETECTION RATING

FOR EACH FAILURE MODE
AND/OR EFFECT
The detection rating looks at how likely we are to detect a failure or
the effect of a failure.
Start this step by identifying current controls that may detect a
failure or effect of a failure.
If there are no current controls, the likelihood of detection will be
low, and the item would receive a high rating, such as a 9 or 10 as
indicated on the following table.

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Detection

DETECTION EVALUATION
CRITERIA

Almost
Impossible
Very remote

Remote

Very Low

Low

Moderate

Moderately
High

Criteria: Likelihood that the Existence of a Defect will

be Detected by Process Controls Before Next or
Subsequent Process, or Before a Part or Component
Leaves the Manufacturing or Assembly Location

Ranking

No known control(s) available to detect failure mode.

10

Very remote likelihood that current control(s) will detect failure

mode.

Remote likelihood that current control(s) will detect failure mode.

Very low likelihood that current control(s) will detect failure mode.

Low likelihood that current control(s) will detect failure mode.

Moderate likelihood that current control(s) will detect failure mode.

Moderately high likelihood that current control(s) will detect failure

mode.

High likelihood that current control(s) will detect failure mode.

Very high likelihood that the current control(s) will detect failure
mode.

Current control(s) is almost certain to detect the failure mode.

Reliable detection controls are known with similar processes.

High

Very High

Almost
Certain

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CALCULATE THE RISK PRIORITY

NUMBER FOR EACH EFFECT
The risk priority number (RPN) is simply calculated by taking the product of
the severity rating, occurrence rating and detection rating,
Risk Priority Number =
Severity x Occurrence x Detection
The total risk priority number should be calculated by adding all the risk
priority numbers. This number alone is meaningless, because each FMEA
has a different number of failure modes and effects. However, it will serve as
a gauge to compare the revised total RPN against the original RPN once the
recommended actions have been instituted. Transfer the RPN number to the
FMEA table under the column heading RPN.

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PRIORITIZE THE FAILURE FOR

ACTION
Rank the RPN numbers from highest to lowest on the FMEA form. If
necessary, a Pareto diagram can help visualize the differences between the
various RPNs.
Next, determine which Process Function Steps with the highest RPNs to
address first by setting a cut-off RPN.
This is achieved by including only the top RPNs with the greatest values.
The lower RPNs are left alone and are addressed at a later time once the
higher RPNs are reduced or eliminated.
For example, the team may decide to set a cut-off RPN at 200 since
anything above that number may create unacceptable risk.

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TAKE ACTION TO ELIMINATE OR

REDUCE THE HIGH-RISK
FAILURE MODES
Using an organized problem solving process, identify and implement actions to
eliminate or reduce the high-risk failure modes.
This is accomplished by lowering the occurrence, severity, and/or detection
rankings of the highest RPN failure modes.
The team should focus on activities that lead to the prevention of defects (i.e.,
occurrence ranking reduction) rather than solely focusing on the improvement
of detection methodologies (i.e., detection ranking reduction).
Enter the information of the FMEA under Recommended Actions.
Make sure to assign individual(s) (team and/or facility personnel) responsible
for completion of the recommended actions along with a target date.
This provides accountability and documentation for all actions required.

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CALCULATE THE RESULTING RPN AS THE

FAILURE MODES ARE REDUCED OR
ELIMINATED
Once action has been taken to improve the product or
process, new ratings for severity, occurrence, and detection
should be determined, and the resulting RPN calculated.
The resulting RPNs can be organized on a Pareto diagram
and compared with the original RPNs.
You should expect at least a 50% or greater reduction in the
total after recalculating the RPN for effective corrective action.
Further reduction in the RPN may require additional team
meetings/brainstorming sessions and the implementation of
corrective action(s).

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FMEA MANUFACTURING
EXAMPLE

Open-up FMEA.mfg.xls located in GBdata.

Camargo Six Sigma project Cat. 37477 (Incandescent
lampholder; Javier Serna, Green Belt).
Used to identify potential failure modes and defects in the
eyeletting/bodine operations.
After taking action, total RPN decreased by 31%.

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FMEA TRANSACTIONAL
EXAMPLE

Open-up FMEA.TRANSACTIONAL.xls located in

GBdata.
Voice and Data Six Sigma project focused on reducing
processing time of finished goods and components
through the facility.
Used to identify problems and process defects in the
Receiving Inspection function.
Also used to identify and implement improvements to the
process defects.

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FMEA EXERCISE

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