Failure Mode Effects Analysis

(FMEA)
Failure Mode Effects Analysis

 FMEA

A systematic group of activities intended to:
 Recognize the potential failure(s) of a product or process
and the severity of effect of that failure(s).

Identify critical characteristics.
 Rank order potential design and process deficiencies.
 Identify actions that can eliminate or reduce the chance of
the potential failure from occurring and reaching the
customer.
 Document the process.

A living document.

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Failure Mode Effects Analysis

 Guided by Customer Requirements

 Customers are internal

 Customers are external

 Focus is on risk reduction with

 Design

 Manufacturing

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Failure Mode Effects Analysis

 Ideally used before a failure mode is unknowingly designed into a

product or process.
 Is also very useful with existing processes and products.
 Intended to be an interactive process that never ends. (Living
Document)
 Requires a cross functional, multi-level team approach.

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Failure Mode Effects Analysis

 FMEA Types
 System


Focus is on functions and interactions among systems.

Design
 Focus is on potential failure modes of products due to
design deficiencies and errors.
 Process
 Focus is on potential failure modes caused by process
deficiencies.

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

7
FMEA Process

Team Selection

 Cross Functional and Multilevel

 Operators, Mechanics, Engineers, Leaders


Team Leader Designated

Must be Empowered to implement actions

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

Define Process

 Develop a Process Flow diagram that is

representative of the process as it truly is.

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

Detail
Failure Mode
Causes
Effects
 Brainstorm failure modes.
 Select and define failure modes that impact
critical characteristics.
 Identify root causes.
 Define effects of failure mode.
 Detemine how often failure modes occur.
 Determine current controls ability to detect.

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

Calculate
Risk Numbers

 Calculate Risk Priority Number (RPN) for each

failure mode.
 RPN = Worst severity x most frequent

occurrence x worst ability to detect.

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

 Build Pareto’s
Build
 One for Severity
Pareto Chart

One for Severity x Occurrence
 One for RPN

 Identify “Vital Few” Failure Modes

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

Develop
Recommended
Actions

 Develop and implement actions on “Vital Few”

Failure Modes

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FMEA Process

Detail
Failure Mode
Team Selection Define Process Causes
Effects

Develop
Calculate Build
Recommended
Risk Numbers Pareto Chart
Actions

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FMEA Process

Detail
Develop
Failure Mode Calculate Build
Recommended
Causes Risk Numbers Pareto Chart
Actions
Effects

 Evaluate effect of actions taken on process in

terms of severity, occurrence and detection.
 Recalculate RPN and reassess risk number.
 Reprioritize and repeat.

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 FMEA Format
Item Process Responsibility Page 1 of 1
Model / year / vehicle FMEA Kay Date Prepared by
Core team FMEA Number FMEA Date (Orig.) (Rev.)

Process Potential Potential S C Potential O Current Current De R Recommended Area/Individua

Function Failure Effect(s) of e l cause(s) of c Controls control t P Action(s) l Responsible
Actions Taken s o d R
Mode Failure v a Failure c Prevention detectio N & Completion
e c e P
s n Date
v c t N
s

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 Severity Rating

Severity
Severity is a rating corresponding to the seriousness of an effect of a potential failure mode.
No Effect 1 No Visible effect
Very Slight Effect 2 Customer will probably not notice the failure.
Slight Effect 3 Slight effect on output performance. Customer slightly annoyed.
Minor Effect 4 Minor effect on output or process performance. Slight deterioration.
Moderate Effect 5 Moderate effect on performance. Customer dissatisfied.
Significant Effect 6 Performance degraded but safe. Discomfort. Repair required.
Major Effect 7 Rework/Repairs necessary. Performance severely affected but safe.
Dissatisfied customer. Subsystem inoperable.
Serious Effect 8 Equipment damaged. System inoperable but safe. Very dissatisfied
customer.
Very Serious 9 Potentially hazardous failure. Safety related but gradual failure.
Effect
Hazardous Effect 10 Hazardous failure. Safety related – sudden failure, Government regulation
non-compliance.

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Occurrence Rating
Occurrence
Occurrence is a rating corresponding to the rate at which a failure mode occurs before any
detecting measures are applied.
Occurrence Rating Cpk ±σ Failure Rate Notes
Almost 1 Cpk ≥1.67 5.0 <0.01 per Failure unlikely. Similar processes or
Impossible 1000 products show no failure.
Remote 2 Cpk ≥1.50 4.5 0.1 per 1000 Remote number of failures likely.
Very Slight 3 Cpk ≥1.33 4.0 0.5 per 1000 Very few failures likely.
Slight 4 Cpk ≥1.17 3.5 1 per 1000 Few failures likely.
Low 5 Cpk ≥1.00 3.0 2 per 1000 Occasional failure.
Medium 6 Cpk ≥0.83 2.5 5 per 1000 Moderate number of failures likely.
Moderately 7 Cpk ≥0.67 2.0 10 per 1000 Frequent failures likely.
High
High 8 Cpk ≥0.51 1.5 20 per 1000 High number of failures likely.
Very High 9 Cpk ≥0.33 1.0 50 per 1000 Very high number of failures likely.
Almost 10 Cpk<0.33 < > 100 per Failures almost certain to occur.
Certain 1.0 1000 Similar processes/products show
failures.

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Detection Rating

Detection
Detection is a rating corresponding to the likelihood that the detection methods or current
controls will detect the failure.
Almost Certain 1 Reliable detection controls are known with similar processes or
products. Controls are almost certain to detect the failure mode.
Very High 2 History with similar processes available. Controls very likely to
detect the failure mode
High 3 Controls highly likely to detect the failure mode.
Moderately High 4 Controls likely to detect the failure mode.
Medium 5 Controls might detect the failure mode.
Low 6 Low likelihood that controls will detect the failure mode.
Slight 7 Slight likelihood that controls will detect the failure mode.
Very Slight 8 Very slight likelihood that controls will detect the failure mode.
Remote 9 Remote likelihood that controls will detect the failure mode.
Almost 10 Almost certain that controls will not detect the failure mode. No
Impossible known controls available to do so.

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Pareto by Severity

Severity Pareto

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10
Score

0 Partial Fail to Weld - Partial Fail to Weld -

Burn Through Fails to Weld
Undetected Detected

Score 10 8 8 8

Failure Mode

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Pareto by Severity x Occurrence

Severity * Occurrence

34
32
Score

30
28 Burn Through Partial Fail to Weld - Partial Fail to Weld - Fails to Weld

Score 30 32 32 32

Failure Mode

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Pareto by Risk Priority Number
(Severity x Occurrence x Detection)

Pareto by Risk Priority Number

300
200
Score

100
0 Burn Through P artial Fail to Weld - P artial Fail to Weld - Fails to Weld

Score 120 256 128 32

Failure Mode

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Pareto of Top Failure Mode

Pareto of Partial Fail to Weld Causes by RPN

300
250
200
Score

150
100
50
0 Contaminated Poor Part Non Conforming
Damaged Parts Incorrect Settings
Parts Location in Parts

Score 256 192 128 128 64

Causes

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FMEA Summary

Identify Potential
Effect Cause
Failure Mode

Determine Determine
Severity Occurrence

Identify Calculate Risk

Current Controls Priority Number
Actions leading
to Continuous
Determine Improvement
Detectability
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