Failure Mode and Effect Analysis: F.M.E.A

STM Quality
Limited
Failure Mode
and Effect Analysis
TOTAL QUALITY MANAGEMENT
F.M.E.A.
©©ABSL Power Solutions
STM Quality Limited 2007
STM Quality
Introduction Limited
 What is an F.M.E.A.?
 Why do we need it?
 When do we do it?
 What do we do when it’s finished?

© STM Quality Limited
What is a STM Quality
Failure Mode and Effect Analysis? Limited
 F.M.E.A. is a simple way of predicting what

might go wrong.
 By using a structured method, results can be
quantified and hence compared.

STM Quality
How Does It Work? Limited
 Identifies critical and significant characteristics

 Helps engineers prioritise and focus on
eliminating product and process concerns and
help prevent problems from occurring.

STM Quality
Purpose Limited
 Utilise individuals’
knowledge and skills
within a team
environment
 Identify potential
failures at the earliest
possible stage of new
design/process

STM Quality
Failure Mode and Effect Analysis Limited
 F.M.E.A.s can be done for any design,

manufacturing or in-service activity
 F.M.E.A.s are modular and can be carried out
for single parts or large assemblies

STM Quality
F.M.E.A. - Types Limited
System
Design
Design
FMEA
FMEA
Sub-System
Component
System
Assembly Sub-System
Process
Process Component
FMEA
FMEA System
Manufacturing Sub-System
Component

STM Quality
Benefits – Design F.M.E. A. Limited
 Aids in evaluating requirements and
alternatives
 Aids in initial Design for Manufacture
 Increases probability of detecting failure
modes and their effects
 Provides additional information for testing
requirements
 Helps identify critical and significant
characteristics
 Helps validate test methods

STM Quality
Benefits – Process F.M.E. A. Limited
 Identifies potential process related failure
modes which will effect internal/external
customers
 Reduces costs of repairs due to faulty
process methodology
 Increases efficiency
 Establishes a priority system for considering
corrective actions
 Identifies confirmed critical and significant
characteristics

STM Quality
F.M.E. A. and Control Plans Limited
F.M.E.A Identifies Risks
How Risks
Control Plan are Controlled

STM Quality
F.M.E.A. Model Limited
Potential
Failure Mode and Effects Analysis
___ System FMEA Number:
Design Responsibility:
___ Subsystem Page 1 of 1
Key Date:
___ Component Prepared by:
Model Year / Vehicle(s): FMEA Date ( Orig): (Rev)
Core Team:
Action Results
Item Potential Potential S C Potential O Current D R Responsibility & S O D R
Failure Effect(s) e l Cause(s)/ c Design e P Recommended Target Actions e c e P
Mode of Failure v a Mechanisms c Controls t N Action(s) Completion Date Taken v c t N
Function s Failure u e
s r c

Why Do A STM Quality
Failure Mode and Effect Analysis? Limited
 To meet Customer Requirements – A.P.Q.P.
 To keep up with competition
 To retain current business
 Help obtain new business

STM Quality
Generating F.M.E.A.s Limited
Who
Whoinitiates?
initiates? How
Howis
isFMEA
FMEA When
Whenstarted
started
documented?
documented? and
andupdated?
updated?
Who
Whoprepares?
prepares?
Failure
Failure When
WhenisisFMEA
FMEA
Who
Whoupdates?
updates? Mode
Mode and
and complete?
complete?
Effects
Effects
Who
WhoisisFMEA
FMEA Analysis
Analysis When
Whento to
customer?
customer? discard?
discard?

STM Quality
Managing F.M.E.A.s Limited
 FM.E.A.s are living documents and are

updated when:
 Modification to a component, process or
system is planned;
 Component is to be used in new environment;
 Customer concern arises.

STM Quality
Process F.M.E.A.s Limited

STM Quality
Process Flow Chart Limited
 Firstly, create a flow chart of operations

 Then identify boundary for analysis
 Next, create a flow chart for one operation

STM Quality
Process Flow Chart of Operations Limited
Transport Op.10 Preparation Op.20 Mould Op.30 Weld

raw materials
Op.40 assemble
Op.60 Inspect Op.50

& Pack Trim to size
Store/Pack
Boundary for
analysis

STM Quality
Boundary For Analysis Limited
Op.50 Trim
Place part on trim machine fixture Op.50.1
Press ‘Start’ button Op.50.2
Remove from fixture when cycle complete Op.50.3

STM Quality
Process/Function Requirements Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Process/Function Requirements Limited
From Process flow:
 Enter a simple description of the process being

analysed i.e. Place part on trim machine fixture;
 Indicate the purpose of the process being analysed
i.e. Fully seat part in correct orientation;
 List separately other operations involved with that
process;
 Process function contains both product and process
characteristics.

STM Quality
Define the Process Purpose Limited
 What does the process do at this operation?
 What is the process purpose?
 What is its function?

STM Quality
Process Purpose Limited
Op.50 Trim • Locate part on
fixture - correct
Place part on trim machine fixture Op.50.1
orientation - fully
seated
Press ‘Start’ button Op.50.2 • Start trimming

programme
• Position in checking
fixture - fully seated
Remove from fixture when cycle complete Op.50.3 • Remove waste

before packing

STM Quality
Determine What Can Go Wrong Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Failure Mode Limited
Definition:
Potential failure mode is the manner in which

the process could potentially fail to meet the
process requirements and/or design intent.
It is a description of the non-conformance at

that specific operation.

STM Quality
Failure Mode Limited
Examine process flow using:
 No function
 Partial function
 Intermittent function

STM Quality
Effects Of Failure Mode Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Effects of Failure Mode Limited
Definition:
The effects of the failure mode on the

customer. The customer could be the next
operation, subsequent operations or the final
customer / user.

STM Quality
Effects of Failure Mode Limited
Identify potential effects on:
 next user
 downstream user
 ultimate customer
 vehicle operation
 operator safety
 Compliance with government regulations
 machines / equipment

STM Quality
Effects of Failure Limited
Failure Next Downstream Ultimate Vehicle Operator Government

mode user users customer operation safety regulations

STM Quality
Effects of Failure Limited
Failure mode: Incorrect Trim Programme
Failure Next Downstream Ultimate Vehicle Operator Government

mode user users customer operation safety regulations
Incorrect to Packaged Cannot Cannot
checking in wrong fit to fit to None None
fixture stillage vehicle. vehicle
Stop
Production
line

STM Quality
Severity Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Severity Limited
Definition:
An assessment of the seriousness of the

effect of the potential failure mode on the
customer.

STM Quality
Suggested Severity Scoring Limited
Effect Criteria: Severity of Effect Ranking
Hazardous May endanger machine or assembly 10
without operator…non compliance government
regulation without warning
warning
Hazardous May endanger machine or assembly 9

with operator…non compliance government
regulation without warning
warning
Low Minor disruption to production line 5

100% of product may have to be
reworked
None No Effect 1

STM Quality
Critical or Special Characteristic Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Identify Special Characteristics Limited
CRITICAL: Requirements that affect

compliance with government regulations or
safe vehicle / product function and require
special controls (Score = 9 or 10)
SIGNIFICANT: Product and/or test
requirements important for customer
satisfaction, summarized on Control Plan
and require special controls
(Score = 5 to 8,)

STM Quality
Cause Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Cause Limited
Definition:
Potential cause of a failure is defined as how

the failure could occur in terms of something
that can be corrected or controlled.

STM Quality
Cause Limited
 Only specific errors or malfunctions (eg.

Operator fails to remove waste) should be
listed.
 Ambiguous phrases (e.g. Operator error,

machine malfunction) should not be used.

STM Quality
Occurrence Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Occurrence Limited
 How frequently the cause is projected to
occur. Based on:
– Historical manufacturing/assembly failure

rates with similar parts
– Statistical data from similar process
– Existing process controls
– Customer concern data
– Rejects, PPM, Warranty data
STM Quality
Suggested Occurrence Scoring Limited
Probability Possible Failure Rates Ranking
Very high About 1 in 2 10
About 1 in 3 9
Moderate About 1 in 80 6
About 1 in 400 5
About 1 in 2000 4
Remote Less than 1 in 500,000 1

STM Quality
Controls Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Controls Limited
 Increasing inspection is only a temporary

measure. Permanent Corrective Action is
required.
 Emphasis must be placed on preventing

defects rather than detecting them (e.g.
S.P.C.)

STM Quality
Controls Limited
In Process Control column on FMEA:

 Prevention Controls
– Place a ‘P’ before each prevention control
listed
 Detection Controls
– Place a ‘D’ before each detection control
listed

STM Quality
Prevention Controls Limited
 Prevention: (Preferred option)
 Prevent the cause / mechanism of failure or

the failure mode occurring, or reduce their rate
of occurrence

STM Quality
Detection Controls Limited
 Detection:
 Detect the cause / mechanism of failure or the

failure mode and lead to corrective actions

STM Quality
Process Control Examples Limited
 Engineering specification tests

 Poka-yoke or error proofing
 Audible or visual warning devices
 In Process / Final inspection
 S.P.C.
 Process / Parameter audits

STM Quality
Detection Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Detection Limited
Definition:
Detection is an assessment of the probability
that:
 The process controls listed will detect a
potential cause /mechanism (process
weakness) , or
 The process controls listed will detect a
subsequent failure mode.

STM Quality
Suggested Detection Scoring Limited
Detection Likelihood of Detection Ranking
Certain Process control will not and/or cannot 10
detect a potential cause … or there is no
process control
Moderate Moderately high chance the process control 4

will detect potential cause
Almost certain Process control will almost certainly 1

detect a potential cause

STM Quality
Select and Manage Actions Limited
To Reduce Consider This Action To Accomplish
Severity Change the design ... or Eliminate failure
the process if operator modes
safety is involved
Occurrence Change the design or process Prevent cause(s), or

reduce their rate of
occurrence
Detection Add to or improve the control Improve ability to

methods detect a failure mode

STM Quality
Risk Priority Number (R.P.N.) Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
 We have seen that the F.M.E.A. asks three

questions:
What might go wrong?

What effect would this have?
What caused the problem?

STM Quality
 From the answers to the three questions

we can work out a risk priority number:
Risk Priority Number

STM Quality
 How do we calculate the R.P.N.?
 We simply use the scoring criteria easily
remembered by:
Severity of the problem

Occurrence of the problem
Detection of the problem

STM Quality
 Each is given a value from 1 to 10

 Let’s try this out for S, O & D
 For Example,
Severity = 1 2 3 4 5 6 7 8 9 10
Occurrence = 1 2 3 4 5 6 7 8 9 10
Detection = 1 2 3 4 5 6 7 8 9 10
Each of these could be assessed in a rating
from 1 to 10.
STM Quality
 How can we use these values to give an

overall risk?
 We multiply the three figures together:

 e.g. 7 x 4 x 3 = 84.
 So the R.P.N. is 84.

STM Quality
 From the R.P.N. we can now see the

areas of greatest concern
 i.e. Those failures with the highest risk

priority numbers

STM Quality
 We can now focus our attention on the
worst problems – those with the highest
R.P.N.
 With limited resources, this must be a
good idea
 We can now eliminate or
reduce the potential failure

STM Quality
Recommended Actions Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Recommended Actions Limited
The intent of any Recommended Action is to

reduce rankings in the following order:
 Severity
 Occurrence
 Detection

STM Quality
Responsibility & Target Date Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
Responsibility Limited
 Each action must be assigned to a specific

individual and not a dept. / organisation
 If the individual is not in the team a team

member should be assigned responsibility for
communication and feedback of action with a
target date.

STM Quality
Actions Taken Limited
Potential
Key Date:
Core Team:
Action Results
s r c

STM Quality
 After the corrective action has been identified,

estimate and record the resulting severity,
occurrence and detection rankings
 Calculate and record the resulting R.P.N.
 P.F.M.E.A. team must review the revised
R.P.N.s to determine if further action is
necessary.
 If no action write ‘None’.

STM Quality
 Once the actions have been implemented,

the estimated values, ‘the future’, becomes
‘the present’ and can be incorporated into the
LHS of the form on the next F.M.E.A.

STM Quality
 Advantages of F.M.E.A.s
Customer confidence
Improved quality & efficiency
Improved participation across traditional
boundaries

STM Quality
 More advantages of F.M.E.A.s
Uses extensive & untapped

personnel/process knowledge to improve
new & existing work
Provides a vehicle for continuous
improvement
Supports product liability

STM Quality
 There are drawbacks for F.M.E.A.s:
Must be adequate time & resources for

F.M.E.A.s
Product Liability
Need for in-depth product & process or
design knowledge

STM Quality
 Remember - F.M.E.A. is a practical activity and
there will be differing interpretations regarding
to the failure modes and rankings - this does
not matter, provided that the team does not get
bogged down in this way!

STM Quality
 Keep the meetings short and the tempo
sharp!
 Design F.M.E.A. team - Chairman,

Production, Service, Quality Personnel
 Process F.M.E.A. team - YOU CHOOSE!

Failure Mode and Effect Analysis: F.M.E.A

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STM Quality

TOTAL QUALITY MANAGEMENT

 Why do we need it?

 What do we do when it’s finished?

 F.M.E.A. is a simple way of predicting what

© STM Quality Limited

 Identifies critical and significant characteristics

© STM Quality Limited

© STM Quality Limited

 F.M.E.A.s can be done for any design,

© STM Quality Limited

© STM Quality Limited

© STM Quality Limited

© STM Quality Limited

F.M.E.A Identifies Risks

© STM Quality Limited

© STM Quality Limited

 To meet Customer Requirements – A.P.Q.P.

 To keep up with competition

 To retain current business

 Help obtain new business

© STM Quality Limited

© STM Quality Limited

 FM.E.A.s are living documents and are

© STM Quality Limited

© STM Quality Limited

 Firstly, create a flow chart of operations

© STM Quality Limited

Transport Op.10 Preparation Op.20 Mould Op.30 Weld

Op.60 Inspect Op.50

© STM Quality Limited

Press ‘Start’ button Op.50.2

Remove from fixture when cycle complete Op.50.3

© STM Quality Limited

© STM Quality Limited

 Enter a simple description of the process being

© STM Quality Limited

 What does the process do at this operation?

 What is the process purpose?

 What is its function?

© STM Quality Limited

Press ‘Start’ button Op.50.2 • Start trimming

Remove from fixture when cycle complete Op.50.3 • Remove waste

© STM Quality Limited

© STM Quality Limited

Potential failure mode is the manner in which

It is a description of the non-conformance at

© STM Quality Limited

© STM Quality Limited

© STM Quality Limited

The effects of the failure mode on the

© STM Quality Limited

© STM Quality Limited

Failure Next Downstream Ultimate Vehicle Operator Government

© STM Quality Limited

Failure Next Downstream Ultimate Vehicle Operator Government

© STM Quality Limited

© STM Quality Limited

An assessment of the seriousness of the

© STM Quality Limited

Hazardous May endanger machine or assembly 9

Low Minor disruption to production line 5

© STM Quality Limited