Course material for FMEA - Failure Mode and Effect Analysis

FMEA TRAINING MANUAL

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Course material for FMEA - Failure Mode and Effect Analysis

Failure Mode and Effect Analysis

FMEA

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Course material for FMEA - Failure Mode and Effect Analysis

Origin
US-Space program and defence safety system in 1960s
Common Definitions
Failure:
A Failure is that a component, assembly or system which
does not meet the requirements or function in accordance with
design intent. (Ex. Not meeting the specification, heat
treatment failure)
Failure Mode:
A Failure Mode is the manner in which a component,
assembly or system failure occurs. (Ex. How the component
could not meet the specifications, hardness high, hardness
low)

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Course material for FMEA - Failure Mode and Effect Analysis

What is FMEA?
FMEA is a systemised group of activities to:
1. recognise and evaluate the potential failure of a product /
process and its effects
2. identify actions which could eliminate or reduce the chance
of potential failure occurring
3. document the process

Why FMEA ?
1. For a company policy where continuous improvement is
emphasized for its product, process
2. FMEA is a living document

Who should do FMEA?

1. Cross Functional Team Effort with a leader
2. Team of knowledgeable individuals Ex. Expertise in Mfg.,
Assmly., Quality., etc.
3. Team should include representatives of sub-contractors
and/or customers

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Course material for FMEA - Failure Mode and Effect Analysis

When FMEA should be done ?

1. Essence is timeliness
2. Pro-Active rather than reactive
3. Before process failure mode occurs
Advantages of FMEA
1. Avoids late change crisis
2. Reduces or eliminates chance of implementing corrective
change
3. excellent technique for preventive action
4. interactive process which is never ending
Types of FMEA
1. System FMEA Power transmission system
2. Design FMEA Axle shaft
3. Process FMEA Heat treatment
QS-9000 requirements
Process FMEA shall consider special characteristics
Aiming defect prevention rather than defect detection
Use PFMEA manual & CFT approach

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Course material for FMEA - Failure Mode and Effect Analysis

Potential Process FMEA

Potential Means Anticipated
It is an analytical technique to assure that potential failure
mode and their associated causes have been considered and
addressed
Collection of teams thoughts as a process is developed

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Course material for FMEA - Failure Mode and Effect Analysis

POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)
Item.
Model.
Core Team
Process
Function

Potentia
l Failure
Mode

Potential
Effect(s) of
Failure

SEV

Process Responsibility.
Key Date
FMEA Date (Rev)

Class

Potential
Cause(s) /
mechanism
(s) of Failure

Occur

Current
process
control
prevention

Current
Process
Controls
Detectio
n

Detect

FMEA Number..
Page of .
Prepared by
R
P
N

Recommended
Action(s)

Responsibilit
y & Target
Completion
Date

Action Results

Actions
Taken

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Course material for FMEA - Failure Mode and Effect Analysis

Process
Function/Requirements
Specify the description and
Function of the process
List out Outputs of the Process

Example
Process function / description
- Manual application of wax
inside door
- Machining of outer diameter
Requirements
- To cover inner door at minimum
thickness to retard corrosion
- Outer diameter, run-out, free
from tool mark

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Potential
Failure
Mode

Potential
Effect(s) of
Failure

Course material for FMEA - Failure Mode and Effect Analysis

Potential Failure Mode

Two Assumptions are
1. Consider all inputs are acceptable
2. Consider the Design is acceptable
List the failure modes those are
possible to occur against the
requirements specified in the
previous column.
Apart from Engg. specification ,
what would a customer consider
objectionable
CUSTOMER is
- Next opn.
- Subsequent Opn.
- End user
Example
Bent, Diameter oversize, Diameter
undersize, Cracked, Deformed,
Open Circuited, Burred
OD not clear Is it a failure mode in
machining of casting / forging?

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Potential
Effect(s) of
Failure

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Course material for FMEA - Failure Mode and Effect Analysis

Potential Effect(s) of Failure

List the effects of failure in
- Next operation
- Subsequent operations
- Customer
- End user/ Environment

Describe the effects using the

terminology specified in Severity
rating table

For each failure mode, more than

one effect can be listed

Example
-

Cannot locate
Cannot face
Does not fit
Does not match
Scrap, re-work
Vehicle / item inoperable
Loss of primary function
Customer dissatisfaction

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Sev

Class

Course material for FMEA - Failure Mode and Effect Analysis

Severity

Class

Assess the seriousness of the

effect in a 1-10 scale
This rating applies to EFFECT
only (i.e. previous column)
Consider the Design FMEA
Consult subsequent Mfg./
Assembly plant
Safety related effects should be
rated in Nos.9 or 10
While giving ranking consider
only the required criteria (i.e.
next opn. / vehicle)

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Potential Cause(s) /
Mechanism (s) of
Failure

Suggested Evaluation Criteria:

(The team should agree on an evaluation criteria and ranking system, which is consistent; even if modified for individual process analysis)

Effect

Hazardous
without
warning
Hazardous
with warning
Very high

High

Criteria : Severity of Effect

This ranking results when a potential failure
mode results in final customer and / or a
manufacturing / assembly plant defect. The
final customer should always be considered
first .If both occur ,use the higher of the two
severities

Criteria : Severity of Effect

This ranking results when a potential failure
mode results in final customer and / or a
manufacturing / assembly plant defect . The
final customer should always be considered
first .If both occur ,use the higher of the two
severities

Customer Effect
Very high severity ranking when a potential
failure mode affects safe vehicle operation and/or
involves noncompliance with government
regulation without warning.
Very high severity ranking when a potential
failure mode affects safe vehicle operation and/or
involves noncompliance with government
regulation with warning.

( Manufacturing / Assembly Effect )

Vehicle/item inoperable (loss of primary

function).
Vehicle/item operable but at a reduced level of
performance. Customer very dissatisfied.

Ranking

Or may endanger operator (machine or assembly)

without warning.

10

Or may endanger operator (machine or assembly)

with warning.

Or 100% of product may have to be scrapped, or

vehicle/item repaired in repair department with a
repair time greater than one hour.
Or product may have to be sorted and a portion
(less than 100%) scrapped, or vehicle/item
repaired in repair department with a repair time
between a half-hour and an hour.

Course material for FMEA - Failure Mode and Effect Analysis

Effect

Moderate

Low
Very low

Criteria : Severity of Effect

This ranking results when a potential failure
mode results in final customer and / or a
manufacturing / assembly plant defect . The
final customer should always be considered
first .If both occur ,use the higher of the two
severities

Criteria : Severity of Effect

This ranking results when a potential failure
mode results in final customer and / or a
manufacturing / assembly plant defect . The
final customer should always be considered
first .If both occur ,use the higher of the two
severities

Customer Effect

( Manufacturing / Assembly Effect )

Or a portion (less than 100%) of the product may
have to scrapped with no sorting, or vehicle/item
repaired in repair department with a repair time
less than a half-hour.
Or 100% of product may have to be reworked, or
vehicle/item repaired off-line but does not go to
repair department.

Vehicle/item operable but Comfort/Convenience

item(s) inoperable. Customer dissatisfied.
Vehicle/item operable but Comfort/Convenience
item(s) operable at a reduced level of
performance.
Fit and Finish/Squeak and rattle item does not
conform. Defect noticed by most customers
(greater than 75%).

Minor

Fit and Finish/Squeak and Rattle item does not

conform. Defect noticed by 50% of customers.

Very minor

Fit and Finish/Squeak and Rattle item does not

conform. Defect noticed by discriminating
customers (less than 25%).

None

No discernible effect.

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Or the product may have to be sorted, with no

scrap, and a portion (less than 100%) reworked.
Or a portion (less than 100%) of the product may
have to be reworked, with no scrap, on-line but
out-of-station.
Or a portion (less than 100%) of the product may
have to be reworked, with no scrap, on-line but instation.
Or slight inconvenience to operation or operator,
or no effect.

Ranking

5
4
3
2
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Course material for FMEA - Failure Mode and Effect Analysis

Potential Cause(s) /
Mechanism (s) of
Failure

Classification
Classify special process
characteristics (e.g. critical,
key, major)

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Occur

Potential Cause(s) /
Mechanism (s) of Failure
List the first level potential causes
such as
-

man
machine
tool
process parameter
fixture etc.

List the root causes under the first

level causes using WHY? WHY?
Analysis
Describe the causes in such a way
that can be eliminated or controlled
Dont use ambiguous statements such
as
- operator mal-functioning
- fixture problem etc.
Use the cause and effect diagram, if
required
Consider input materials in last
iteration of cause analysis
Contd..

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Occur

Course material for FMEA - Failure Mode and Effect Analysis

Current
Process
Controls
Prevention

Current
Process
Controls
Detection

Potential Cause(s) /
Mechanism (s) of Failure
Example
Under Man
-

Fails to clean
Fails to assemble
Fails to tight
Mis-locate

Under machine
- inadequate lubrication
- excessive vibration
- excessive spindle run-out
Under process
- improper time / temperature
- inadequate gating / venting
Under design
- symmetric design
- difficult to assemble
Under Raw Material
-

mixed material
new source
alternate material
excessive hardness

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Occur

Course material for FMEA - Failure Mode and Effect Analysis

Current
Process
Controls
Prevention

Current
Process
Controls
Detection

Current
Process
Controls
Prevention

Occurrence
Estimate the probability of occurrence on
a 1-10 scale
Rate against each causes
Use existing or past data as a basis
(Cpk / rejection %) for ranking
Document the basis of occurrence ranking
For a new processes, if there is no
previous experience, use team judgement
Dont consider failure detecting measures
while giving ranking (100% inspection)

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Current
Process
Controls
Detection

Detect

Course material for FMEA - Failure Mode and Effect Analysis

Course material for FMEA - Failure Mode and Effect Analysis

Suggested Evaluation Criteria:
(The team should agree on an evaluation criteria and ranking system, which is consistent, even if modified for individual process
analysis)
Probability of Failure

Very High: Persistent Failures

High: Frequent Failures

Moderate: Occasional Failures

Low: Relatively Few Failures

Remote: Failure is Unlikely

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Possible Failure Rates

Ranking

> 100 per thousand pieces

10

50 per thousand pieces

20 per thousand pieces

10 per thousand pieces

5 per thousand pieces

2 per thousand pieces

1 per thousand pieces

0.5 per thousand pieces

0.1 per thousand pieces

0.01 per thousand pieces

Current Process Controls

Type of Controls
There are two types of controls to consider :
Prevention : Prevent the cause / mechanism of failure or the failure
mode from occurring or reduce the rate of occurrence.
Detection : Detect the cause / mechanism of failure or the failure
mode and lead to corrective actions

Level

Type

Prevention of causes
Detection of causes & leading
to corrective actions

2
3

Detection of defect

Examples
Mistake Proofing
SPC, visual control
etc.,
100% inspection,
patrol inspection

List the existing controls, which can detect

the causes or failure mode
While listing, specify the frequency of
detection measures
Examples
- Visual Check, one per shift for film thickness
- SPC chart five pieces in an hour
- On-line monitoring of crimping force
- Auto-control of temperature
- 100% on-line inspection
- Visual monitoring of Ammeter

Detect RPN

Course material for FMEA - Failure Mode and Effect Analysis

Detection

RPN

Assess the probability of controls

listed in the previous process
control column, which will detect
the cause or failure mode
While giving ranking, assume the
failure is occurred
Dont assume ranking is low
because the occurrence is low
Random controls should
influence detection ranking

not

One detection ranking can be

assigned to multiple controls
Sampling done on statistical basis
is valid detection control.
INSPECTION TYPES ARE
A : Error Proofed
B : Gauging
C : Manual Inspection

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Recommended
Action

Course material for FMEA - Failure Mode and Effect Analysis

Suggested Evaluation Criteria
(The team should agree on an evaluation criteria and ranking system which is consistent, even if modified for individual
process analysis)

Detection

Inspection
Types

Criteria

A
Almost
Impossible
Very
Remote
Remote
Very Low
Low
Moderate

Absolute certainty
of non-detection
Controls will
probably not detect.
Controls have poor
chance of detection.
Controls have poor
chance of detection.
Controls may
detect.

X
X

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Cannot detect or is not checked

Control is achieved with indirect or random
checks only.
Control is achieved with visual inspection only.

Control is achieved with double visual inspection

only.
Control is achieved with charting methods, such
X
as SPC {Statistical Process Control}.
Control is based on variable gauging after parts
have left the station, or Go/No Go gauging
performed on 100% of the parts after parts have
left the station.
Error detection in subsequent operations, OR
gauging performed on setup and first -piece check
(for set - up causes only)
X

Ranking

C
X

Controls may
detect.

Controls have a
Moderately
good chance to
High
detect.

Suggested Range of Detection Methods

10
9
8
7
6
5

Course material for FMEA - Failure Mode and Effect Analysis

Detection

Inspection
Types

Criteria

Controls have a
good chance detect.

Very High

Controls almost
certain to detect.

Very High

Controls certain to
detect.

High

Inspection Types :
A. Error - proofed
B. Gauging
C. Manual Inspection

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Suggested Range of Detection Methods

Ranking

C
Error detection in-station, or error detection in
subsequent operations by multiple layers of
acceptance: supply, select, install, verify, cannot
accept discrepant part.
Error detection in-station (automatic gauging with
automatic stop feature). Cannot pass discrepant
part.
Discrepant parts cannot be because item has been
error - proofed by process / product design.

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Failure Mode and Effects Analysis ( 3rd Edition)

RPN
Risk Priority Number is
the multiplication of
severity x occurrence x
detection.
While calculating RPN,
consider only highest
severity rating of each
failure mode

Nathan & Nathan Consultants Pvt. Ltd.

Rev.03 on 01.07.01

Recommended Responsibility &

Target
Action
Completion Date

Failure Mode and Effects Analysis ( 3rd Edition)

Recommended Action
Policy for RPN to take action
- define a target RPN and anything
above that can be considered for
action.
For Ex. It can be 50.
Considering 95% of the failures
are attended
- consider only high priority no.
for take action and review
periodically

As a first priority, take action

on
causes
to
reduce
occurrence ranking
The next priority is to consider
action on controls to reduce
detection ranking by use of
mistake proofing methods

Emphasis must be given in

preventing the defect rather than
detection by use of SPC/ Process
improvements rather than quality
inspection.

severity ranking can be

reduced by
-elimination of failure mode by

change in processes or design

Nathan & Nathan Consultants Pvt. Ltd.

Rev.03 on 01.07.01

Responsibility
& Target
Completion Date

Action
Results

Failure Mode and Effects Analysis ( 3rd Edition)

Specify the responsibility and

target completion date for
every actions identified
During APQP, the FMEA
completion dates should be
prior to production run

Nathan & Nathan Consultants Pvt. Ltd.

RPN

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Actions
Taken

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Responsibility & Target

Completion Date

Rev.03 on 01.07.01

Failure Mode and Effects Analysis ( 3rd Edition)

Rev.03 on 01.07.01

Action Results
Actions Taken
Describe the verification results on
the actual actions implemented & the
effective date
Where effectiveness measure is
required, specify the target date
accordingly
After the assessment of the actions
taken, re-assess the values of severity,
occurrence, detection and RPN.
The revised ratings are to be
reviewed and if further action is
considered necessary repeat the
analysis.
The focus should be on continual
improvement
FOLLOW UP ACTIONS
- Responsible process Engineer is
responsible for ensuring that all
actions recommended have been
implemented
or
adequately
addressed.
Nathan & Nathan Consultants Pvt. Ltd.

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Failure Mode and Effects Analysis ( 3rd Edition)

Nathan & Nathan Consultants Pvt. Ltd.

Rev.03 on 01.07.01