QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
1. OBJECTIVE: - To consider all possible failure modes, effect of failure in a particular process/design and
related action. FMEA procedure made with reference to AIAG –IV Addition Manual.
2. SCOPE: - The PFMEA is applicable for dealing all possible failure modes during NPD, initial control and mass
production.
3. PROCESS OWNER: - Functional Head/ QA is over all responsible to ensure the effectiveness of FMEA.
Guidelines as per FMEA AIAG 4th edition Manual.
4. DESCRIPTION: Sl. No.
4.1
4.2
4.3
4.4
4.5
4.6
Activity
Review the process:
Formation of CFT accordingly
Assuring all team members are familiar with the process
Identify the function of components
FMEA to be prepared with the help of FMEA input as given below
Consider the defects faced in past in similar parts.
Consider the defects expected in the part under development
Consider the defects which can't be captured at customer end.
Consider the defects which may leads to field failure (Warranty failure).
Consider the defects which are difficult to repair.
Customer feedback
Drawing
Brainstorming potential failure:
CFT have to consider potential failure mode corresponding to the function
of parts.
Failure mode represents process characteristics and product
characteristics.
Potential effect of failure :
Define the effect if a failure occurred.
Some failure can effect to customer, next process, operator, environment
& process itself.
Assign Severity ranking:
Assign severity ranking to each effect.
Severity Ranking scale is 1 to 10.
Refer the severity ranking scale for each effect (attached).
Assign occurrence ranking:
Study the failure mechanism and define the occurrence ranking.
The occurrence ranking should be based on frequency of failure that will
occur.
Occurrence ranking scale is 1 to 10.
Refer the occurrence ranking scale as attached.
Prepared By:
Approved By:
Resp.
Reference
CFT
(F02NPD03)
DEFECT MATRIX
F01NPD02
CFT
PAST DEFECT
HISTORY
F14 NPD 01
CFT
F15 NPD01
CFT
F15 NPD01
CFT
F15 NPD01
CFT
F15 NPD01
QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
4.7
4.8
4.9
Assign Detection Ranking:
Identify the controls available in process.
Assign Detection Ranking to each control.
Control can relate to failure mode or cause of failure or effect of failure
mode.
Refer the Detection ranking scale as attached.
Calculate RPN:
RPN is risk priority Number that is Detection*occurrence*severity.
The higher the Severity, the higher the risk.
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
CFT
F15 NPD01
CFT
F15 NPD01
CFT
F15NPD01
CFT
F03NPD02
CFT
(F02NPD03)
Decide the Action Plan & Implementation in following conditions:
1- If priority level found 1 in any process, then take recommended action.
2- If no priority level 1 found then take action on priority level 2.
3- If no priority level 2 found and only 3 level is found then take action.
NOTE:- 1- Priority level to be calculated through severity zone & detection
zone intersection also detection zone & severity to be calculated as per
sheet (AN-NPD-02).
2- Action result to be calculated after 6 month of action recommended
during FMEA review.
4.10
R. PFMEA review criteria are following
1)In case of any change in process sequence/ECN/NPD part
2)In case of any modification in defect detection method
3)In case of any implementation of Poka Yoke
4) in case of customer complaints ,If necessary
5) In case of major in house rejection, repeated defect, If necessary
6) In case of any requirement generated by customer.
7) After any quality improvement activity
NOTE:- FMEA review to be conducted on yearly basis as per FMEA
review plan ( F03NPD02)
4.11
FMEA to be prepared by Core team:
Coordinator- Tool Room
Head- Operation, Design & purchase
Head- QA
Engineer – QA
Head- NPD
Head- Production
5. FMEA Ranking Criteria
5.1 PFMEA Severity Evaluation Criteria
Prepared By:
Approved By:
QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
Effect
Failure to
Meet Safety
and/or
Regulatory
Requirements
Loss or
Degradation
of Primary
Function
Loss or
Degradation
of Secondary
Function
Annoyance
No Effect
Prepared By:
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
Criteria :
Severity of Effect on Product
(Customer Effect)
Rank
Potential failure mode affects safe
vehicle operation and/or involves
noncompliance with government
regulation without warning.
10
Potential failure mode affects safe
vehicle operation and/or involves
noncompliance with government
regulation with warning.
9
Loss of primary function (vehicle
inoperable but does not affect safe
vehicle operation)
8
Major
Disruption
100% of product may have to be
scrapped. Line shutdown or stop ship
Degradation of primary function
(vehicle operable, but a reduced
level of performance).
7
Significant
Disruption
A portion of the product may have to
be scrapped. Deviation form primary
process including decreased line
speed or added manpower.
Loss of secondary function (vehicle
operable, but comfort / convenience
functions inoperable).
6
Degradation of secondary function
(vehicle operable but comfort /
convenience functions at a reduced
level of performance).
Effect
Criteria :
Severity of Effect on Process
(Manufacturing/Assembly Effect)
May endanger operator (machine or
Failure to Meet assembly) without warning.
Safety and/or
Regulatory
Requirements May endanger operator (machine or
assembly) with warning.
100% of the production run may have
to be reworked off line and accepted.
Moderate
Disruption
5
A portion of the production run may
have to be reworked off line and
accepted
Appearance or Audible Noise,
vehicle operable, items does not
conform and noticed by most
customers (>75%)
4
100% of the production run may have
to be reworked in-station before it is
processed.
Appearance or Audible Noise,
vehicle operable, items does not
conform and noticed by many
customers (50%)
3
Appearance or Audible Noise,
vehicle operable, items does not
conform and noticed by
discriminating customers (<25%)
2
Very Minor
Slight inconvenience to process,
operation, or operator
No discernible effect.
1
No Effect
No discernible effect.
Moderate
Disruption
A portion of the production run may
have to be reworked in-station before it
is processed.
Approved By:
QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
5.2 PFMEA Occurrence Evaluation Criteria
Likelihood
of Failure
Criteria: Occurrence of Cause-PFMEA
(Incidents per items / vehicles)
PPM
(Consider:IHR+CR+VR)
Rank
Very High
≥ 100 per thousand
≥ 1 in 10
>50,001
10
50 per thousand
1 in 20
<50,000
9
20 per thousand
1 in 50
<20,000
8
10 per thousand
1 in 100
<10,000
7
2 per thousand
1 in 500
<2000
6
0.5 per thousand
1 in 2,000
<500
5
0.1 per thousand
1 in 10,000
<100
4
0.01 per thousand
1 in 100,000
<10
3
≤ 0.001 per thousand
1 in 1,000,000
<1
2
Failure is eliminated through preventive control
0
1
High
Moderate
Low
Very Low
Prepared By:
Approved By:
QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
5.3 PFMEA Detection Evaluation Criteria
Opportunity for
Detection
Criteria:
Likelihood of Detection by Process Control
Rank
Likelihood of
Detection
No Detection
opportunity
No current process control; Cannot detect or is not analyzed
10
Almost
Impossible
Not likely to detect
at any stage
Failure Mode and / or Effect (Cause) is not easily detected (e.g.
random audits).
9
Very Remote
Problem Detection
Post Processing
Failure Mode detection post-processing by operator through visual /
tactile / audible means
8
Remote
Problem Detection
at Source
Failure Mode detection in-station by operator through visual / tactile /
audible means or post- processing through use of attribute gauging
(go/no-go, manual torque check/clicker wrench, etc.)
7
Very Low
Problem Detection
Post Processing
Failure Mode detection post- processing by operator through use of
variable gauging or in-station by operator through use of attribute
gauging (go/no-go, manual torque check/clicker wrench, etc.)
6
Low
Problem Detection
at Source
Failure Mode or Error (Cause) detection in-station by operator
through use of variable gauging or by automated controls in-station
that will detect discrepant part and notify operator (light, buzzer, etc).
Gauging performed on setup and
first-piece check (for set-up causes only).
5
Moderate
Problem Detection
Post Processing
Failure Mode detection post-processing by automated controls that
will detect discrepant part and automatically lock to prevent further
processing
4
Moderately
High
Problem Detection
at Source
Failure Mode detection in-station by automated controls that will
detect discrepant part and automatically lock part in station to
prevent further processing
3
High
Error Detection
and/or Problem
Prevention
Error (Cause) detected in-station by automated controls that will
detect error and prevent discrepant part from being made
2
Very High
Detection not
applicable; Error
Prevention
Error (Cause) prevention as a result of fixture design, machine
design or part design. Discrepant parts cannot be made because
item has been error proofed by process / product design.
1
Almost Certain
Prepared By:
Approved By:
QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
6. RECORDS:S. N.
Description
Reference
1
Process flow and Control plan
F10 NPD-01
2
Defect matrix
F01NPD01
3
Occurrence matrix
F02NPD01
4
Past defect history
F07 NPD-01
5
FMEA WI (Severity, Occurrence & Detection)
(AN-NPD-01)
6
CFT
(F02NPD03)
REV.NO
REV. DATE
00
-------
01
Prepared By
Approved by
Initial Issue
Krishna Kumar
Jitender Kumar
01.04.19
Procedure Revised as per Mace Requirements
Krishna Kumar
Jitender Kumar
02
14.08.19
Company logo Change
Krishna Kumar
Jitender Kumar
03
22.12.23
Procedure Revised as per Mace Requirements
Krishna Kumar
Pooja Kushwah
04
14.10.24
Procedure Revised as per IATF Requirements
Krishna Kumar
Pooja Kushwah
Prepared By:
DESCRIPTION
Approved By:
QUALITY SYSTEM PROCEDURE
PROCEDURE FOR FMEA
Prepared By:
Approved By:
Doc. No. : PC-NPD-02
Rev. No. : 04
Rev.Date : 14.10.24
Page: 1 of 6
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