Failure Mode

and Effect Analysis

STM
Quality
Limited

TOTAL QUALITY MANAGEMENT

F.M.E.A.

Power Solutions
ABSL
STM Quality
Limited

Introduction

STM
Quality
Limited

What is an F.M.E.A.?
Why do we need it?
When do we do it?
What do we do when its finished?
STM Quality Limited

Failure Mode and Effect

Analysis?

STM
Quality
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 Limited

How Does It Work?

Identifies critical and significant

STM
Quality
Limited

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

STM Quality Limited

Purpose
Utilise individuals

STM
Quality
Limited

knowledge and skills

within a team
environment
Identify potential
failures at the earliest
possible stage of new
design/process

STM Quality Limited

Failure Mode and Effect

Analysis

STM
Quality
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 Limited

STM
Quality
Limited

F.M.E.A. - Types
System
Design
Design
FMEA
FMEA

Sub-System
Component
System

Process
Process
FMEA
FMEA

Assembly

Sub-System
Component
System

Manufacturing

Sub-System
Component
STM Quality Limited

Benefits Design F.M.E. A.

STM
Quality
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 Limited

Benefits Process F.M.E. A.

STM
Quality
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 Limited

F.M.E. A. and Control Plans

F.M.E.A

Control Plan

STM
Quality
Limited

Identifies
Risks

How Risks
are
Controlled
STM Quality Limited

STM
Quality
Limited

F.M.E.A. Model
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Failure Mode and Effect

Analysis?

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

Generating F.M.E.A.s
Who
Whoinitiates?
initiates?
Who
Whoprepares?
prepares?
Who
Whoupdates?
updates?
Who
Whois
isFMEA
FMEA
customer?
customer?

How
How is
isFMEA
FMEA
documented?
documented?

Failure
Failure
Mode
Mode
and
and
Effects
Effects
Analysis
Analysis

STM
Quality
Limited
When
When started
started
and
and updated?
updated?
When
When is
isFMEA
FMEA
complete?
complete?
When
When to
to
discard?
discard?

STM Quality Limited

Managing F.M.E.A.s

STM
Quality
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 Limited

Process F.M.E.A.s

STM
Quality
Limited

STM Quality Limited

Process Flow Chart

STM
Quality
Limited

Firstly, create a flow chart of operations

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

operation

STM Quality Limited

Process Flow Chart of

Operations

Transport
raw
materials

Op.10
Preparation

Op.20
Mould

STM
Quality
Limited
Op.30 Weld

Op.40
assemble

Store/Pack

Op.60
Inspect
& Pack

Op.50
Trim to size

Boundary for
analysis
STM Quality Limited

Boundary For Analysis

Op.50 Trim
Place part on trim machine fixture

STM
Quality
Limited

Op.50.1

Press Start
button

Op.50.2

Remove from fixture when cycle

complete

Op.50.3
STM Quality Limited

Process/Function
Requirements

STM
Quality
Limited

Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Process/Function
Requirements
From Process flow:

STM
Quality
Limited

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 Limited

Define the Process Purpose

STM
Quality
Limited

What does the process do at this

operation?
What is the process purpose?
What is its function?

STM Quality Limited

Process Purpose

Op.50 Trim
Place part on trim machine fixture

Press Start
button

Op.50.1

STM
Quality
Limited
Locate part
on
fixture - correct
orientation - fully
seated

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 Limited

Determine What Can Go

Wrong

STM
Quality
Limited

Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Failure Mode

Definition:

STM
Quality
Limited

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 nonconformance at that specific operation.
STM Quality Limited

Failure Mode

Examine process flow using:

STM
Quality
Limited

No function
Partial function
Intermittent function

STM Quality Limited

STM
Quality
Limited

Effects Of Failure Mode

Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Effects of Failure Mode

Definition:

STM
Quality
Limited

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 Limited

Effects of Failure Mode

STM
Quality
Limited

Identify potential effects on:

next user
downstream user
ultimate customer
vehicle operation
operator safety
Compliance with government regulations
machines / equipment
STM Quality Limited

Effects of Failure

Failure
mode

Next
user

STM
Quality
Limited

Downstrea Ultimate Vehicle Operato Governme

m
r
nt
custome operatio
users
r
n
safety regulation
s

STM Quality Limited

Effects of Failure
Failure mode: Incorrect Trim Programme

Failure
mode

Next
user
Incorrect to
checking
fixture

STM
Quality
Limited

Downstrea Ultimate Vehicle Operato Governme

m
r
nt
custome operatio
users
r
n
safety regulation
Packaged
Cannot
Cannot
s
None
None
in wrong
fit to
fit to
stillage

vehicle.
Stop
Production
line

vehicle

STM Quality Limited

STM
Quality
Limited

Severity
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Severity

Definition:

STM
Quality
Limited

An assessment of the seriousness of the

effect of the potential failure mode on
the customer.

STM Quality Limited

Suggested Severity
Scoring
Effect

Criteria: Severity of Effect

Hazardous
without
warning

May endanger machine or assembly

operatornon compliance
government regulation without
warning
May endanger machine or assembly
operatornon compliance
government regulation without
warning

Hazardous
with
warning
Low

None

STM
Quality
Limited
Ranking
10

Minor disruption to production

line 100% of product may have
to be reworked

No Effect

STM Quality Limited

Critical or Special
Characteristic

STM
Quality
Limited

Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Identify Special
Characteristics

STM
Quality
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 Limited

STM
Quality
Limited

Cause
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

STM Quality Limited

D R
e P
t N

Cause

Definition:

STM
Quality
Limited

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 Limited

Cause

STM
Quality
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 Limited

STM
Quality
Limited

Occurrence
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Occurrence

STM
Quality
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 Limited

Suggested Occurrence
Scoring
Probability
Very high

Moderate

Remote

Possible Failure Rates

STM
Quality
Limited
Ranking

About 1 in 3

10
9

About 1 in 80

About 1 in 400
About 1 in 2000

5
4

Less than 1 in 500,000

About 1 in 2

STM Quality Limited

STM
Quality
Limited

Controls
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Controls

STM
Quality
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 Limited

Controls

STM
Quality
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 Limited

Prevention Controls

STM
Quality
Limited

Prevention: (Preferred option)

Prevent the cause / mechanism of

failure or the failure mode occurring, or

reduce their rate of occurrence

STM Quality Limited

Detection Controls

STM
Quality
Limited

Detection:
Detect the cause / mechanism of failure

or the failure mode and lead to

corrective actions

STM Quality Limited

Process Control Examples

STM
Quality
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 Limited

STM
Quality
Limited

Detection
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Detection

STM
Quality
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 Limited

Suggested Detection
Scoring
Detection
Certain

Moderate

Almost
certain

Likelihood of Detection
Process control will not and/or
cannot detect a potential cause
or there is no process control

STM
Quality
Limited
Ranking
10

Moderately high chance the process

control will detect potential cause

Process control will almost

certainly detect a potential cause

STM Quality Limited

Select and Manage Actions

To Reduce

Consider This Action

STM
Quality
Limited
To Accomplish

Change the design ... or

the process if operator
safety is involved

Eliminate failure
modes

Occurrence

Change the design or process

Prevent cause(s),
or
reduce their rate
of
occurrence

Detection

Add to or improve the control

methods

Improve ability to
detect a failure
mode

Severity

STM Quality Limited

Risk Priority Number

(R.P.N.)

STM
Quality
Limited

Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

From the answers to the three questions

we can work out a risk priority number:

Risk Priority Number

STM Quality Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

Each is given a value from 1 to 10

Lets try this out for S, O & D
For Example,

Severity =
9 10
Occurrence =
9 10
Detection =
9 10

1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
STM Quality Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

STM
Quality
Limited

Recommended Actions
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Recommended Actions

STM
Quality
Limited

The intent of any Recommended Action is

to reduce rankings in the following
order:
Severity
Occurrence
Detection

STM Quality Limited

Responsibility & Target

Date

STM
Quality
Limited

Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Responsibility

STM
Quality
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 Limited

STM
Quality
Limited

Actions Taken
Potential
Failure Mode and Effects Analysis
___ System
___ Subsystem
___ Component
Model Year / Vehicle(s):
Core Team:

FMEA Number:
Page 1 of 1
Prepared by:
FMEA Date (

Design Responsibility:
Key Date:

Orig):

(Rev)
Action Results

Item

Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
e
v

C
l
a
s
s

Potential
Cause(s)/
Mechanisms
Failure

O
c
c
u
r

Current
Design
Controls

D
e
t
e
c

R
P
N

Recommended
Action(s)

Responsibility &
Target
Completion Date

Actions
Taken

S
e
v

O
c
c

D R
e P
t N

STM Quality Limited

Actions Taken

STM
Quality
Limited

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 Limited

Actions Taken

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

Advantages of F.M.E.A.s

STM
Quality
Limited

Customer confidence
Improved quality & efficiency
Improved participation across

traditional boundaries

STM Quality Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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 Limited

Failure Mode and Effect

Analysis

STM
Quality
Limited

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!

STM Quality Limited