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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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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
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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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Sev
Occ
Det
RPN
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
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Potential
Effect(s) of
Failure
Sev
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
Severity
Class
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Potential Cause(s) /
Mechanism (s) of
Failure
Effect
Hazardous
without
warning
Hazardous
with warning
Very high
High
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.
Ranking
10
Effect
Moderate
Low
Very low
Customer Effect
Minor
Very minor
None
No discernible effect.
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Ranking
5
4
3
2
1
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.
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Occur
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
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
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Ranking
10
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
Detect RPN
Detection
RPN
not
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Recommended
Action
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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Ranking
C
X
Controls may
detect.
Controls have a
Moderately
good chance to
High
detect.
10
9
8
7
6
5
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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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.
2
1
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
Rev.03 on 01.07.01
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
Rev.03 on 01.07.01
Responsibility
& Target
Completion Date
Action
Results
RPN
De t
Occ
Actions
Taken
Sev
Rev.03 on 01.07.01
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.
Sev
Occ
Det
RPN
Rev.03 on 01.07.01