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Process For Process Failure Mode & Effect Analysis (PFMEA)

1. The document describes a process for conducting a Process Failure Mode and Effects Analysis (PFMEA) to identify potential failures, their causes and effects. 2. A cross-functional team is formed to collect historical data, identify potential failure modes and rank their severity, occurrence and detection. 3. The PFMEA process results in actions to address high risk failures and control plans to prevent defects impacting customers.

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Gourav Saini
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0% found this document useful (0 votes)
557 views

Process For Process Failure Mode & Effect Analysis (PFMEA)

1. The document describes a process for conducting a Process Failure Mode and Effects Analysis (PFMEA) to identify potential failures, their causes and effects. 2. A cross-functional team is formed to collect historical data, identify potential failure modes and rank their severity, occurrence and detection. 3. The PFMEA process results in actions to address high risk failures and control plans to prevent defects impacting customers.

Uploaded by

Gourav Saini
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 11

QUALITY SYSTEM PROCESS DOC. No.

: IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

Revision History

Change
Approved Affected Revision
Date Changes Made Made By
By (HOD) Section No.
(MR)
20.11.15 Review NPD Plant Head All 00

01.08.21 AIAG 4th Edition NPD Plant Head All 01

16.01.23 PFMEA Review Point Added NPD Plant Head All 02

19.01.23 About Special Characteristics and NPD Plant Head All 03


its categories detail added

Document Ownership and Timelines

Title PFMEA Date of Origin 20.11.15


Bhanu
Document Prepared By
Lovneet
Document Issued By

Document Approved By R.K.Dubey

Document Classification " Internal document"

Prepared By: Issued By: Approved By:

1. TURTLE DIAGRAM:-

Page 1 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

Process Owner
PROCESS INPUT PROCESS OUTPUT
HOD- NEW PRODUCT
 Risk Analysis & Opportunity DEVELOPMENT  List of actions to prevent causes
 CSR or detect failure modes
 Process Flow Diagram  Product special characteristics
 In-house Past Problem History control
 Special Characteristics  Defect rate control
 List of expected problems  PFMEA
 Customer Complaints  Control plan /Work Instruction
 List of part difficult to repair standardization
 List of problems that are
difficult to capture at customer PROCESSPROCE
end. SS FAILURE MODE &
 Occurrence data EFFECT ANALYSIS
 Customer Effects of failure (PFMEA)
 At development stage

Team Members

 CFT Members

With what Methods? With what Key Criteria?


 Form CFT for the identified process
 Collect history of product/process  No. of problems occurred that not covered in
 For each failure mode, determine effects. PFMEA.
Select a severity level for each effect  No of error proofing introduced
 List current controls for each effect
 Develop recommended actions,

Page 2 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

2. PROCESS SCOPE:-

This process is applicable to all process of new and existing products. Which provide guideline for
the preparation of PFMEA to identify the potential failure modes and their associated causes in
order to initiate preventive actions.

3. PROCESS OWNER: - HOD-DEVELOPMENT

4. DEFINITIONS/ABBREVIATION:- PFMEA- PROCESS FAILURE MODE & EFFECT ANALYSIS


SOD- SEVERITY, OCCURRENCE, DETECTION
CFT- CROSS FUNCTIONAL TEAM
SD- SEVERITY, DETECTION

5. PROCESS DESCRIPTION:-

Sr.
Activity Responsibility Ref. Doc.
No.

5.1 Prepared list of CFT Team and PFMEA is to be carried out for all PFD-IF/QA/15
processes as identified in the Process Flow Diagrams.
PFMEA- IF/QA/20
CFT
CFT-IF/QA/40

5.2 AIAG FMEA manual 4th edition is used as guideline standard for
FMEA preparation
CFT

5.3 Refer to all historical data (e.g. Customer Complaint , In-house Expected
Rejection ,expected problem, defect item unable to capture at Defect:-IF/NPD /15
customer end, defect item difficult to repair/rework etc) before
conducting any PFMEA. CUSTOMER
COMPLAINT
REGISTER
CFT :-IF/QA/07

RED BIN ANALYSIS


REPORT:-

IF/QA/14

Page 3 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

5.4 Form CFT team for carrying out PFMEA


1:-Production
2:-Quality
3:-Engineering,
4:-Store CFT
5:-Marketing
6:- Maintenance

5.5 Identify the potential failure mode of each characteristics of part


in PFMEA. Find out the effect of each potential failure mode at
CFT
the next operation(s), customer end and at end user.

5.6 Based on the effects of failure mode, identify the severity of the
failure mode by using severity-ranking chart given in AIAG
CFT
Manuals.

5.7 Based on the identified effects of failure mode, identify the Customer
potential cause(s) or mechanism(s) of failure. By considering the Complaints:-IF/QA/0
7
failures such as customer complaints, in-house rejection level due
to particular causes; rank the occurrence rating by using CFT RED BIN ANALYSIS
REPORT:-
Occurrence rating.
IF/QA/14

5.8 For the identified potential causes or mechanism of failure


identify the current controls (prevention type and detection
type). Based on the same, ranking of the detections is given by CFT
using “Detection Ranking Chart” given in AIAG Manual.

5.9 Calculate RPN values based on Severity, Occurrence and


Detection ranking.
CFT

5.10 Recommended Action


 If severity is 9 and 10, then severity should be
considered for recommended action.
 If severity is <8, then highest occurrence no is >4 should
be considered for recommended action
CFT
 If severity is <8 & occurrence is <4, then detection no >8
should be considered for recommended action.
 Else, Take action for top Two values of RPN

Page 4 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

5.11 PFMEA REVIEW


PFMEA Review at given situation :-
1:-PFMEA will be reviewed at least once in year with the existing
process inputs to improve the process performance and reduce
the defects / customer complaints.
2:-Customer Complain
3:-In House raised DCR ,
4: At any ECN change
5:-PCN change
IF/WI/157
CFT
IF/WI/158
PFMEA Review as per define WI
Note- 1) For occurrence rating take minimum 6 month Rejection
data before any PFMEA Review. For PFMEA review without any
problem.
2) But PFMEA review during Customer Complain, In House
raised DCR, At any ECN change ,PCN change depend on action
taken.

Page 5 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

5.12 About Special Characteristics


 Special Characteristics is written as per define process
and critical dimension, customer effected dimension,
next operation effective dimension, assembly effective
dimension, customer line stoppage situation.
Critical Characteristics Point (Cr)
 Customer Specific requirement
 Written on drawing.
 During development time feasible study given
dimension by Customer.
Major Special Characteristics (Ma)
 Process parameters
 RM Grade
 Finish Dimension which is affected to customer
fitment.
 Crack
 Minimum Qty dispatch to customer.
Minor Special Characteristics (Mn)
 Process appearance characteristics Instead of crack.
 Product parameters which is control in Next
Operation.

 Calculation of RPN Value

The Risk Priority Number is multiplication of severity, occurrence and detection.

RPN = S x O x D

 Calculation of SOD
SOD is not based on calculation. It is the non-arithmetic combination of the Severity,
Occurrence & Detection rankings.

 Calculation of SD
SD is not based on calculation. It is the non-arithmetic combination of the Severity &
Detection rankings.

The use of an RPN for a recommended action is not a good practice Instead,
please follow the instructions below.

Page 6 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

Example: 1.
Item Severity Occurrence Detection RPN SOD SD

A 9 2 5 90 925 95

B 7 4 4 112 744 74

In this example, the RPN is higher for characteristics B than characteristics A. However, the
priority should be to work on A with the higher severity of 9, although RPN is 90 which is
lower. So to decide actions consider SOD & SD value with RPN.

Example: 2.
S O D RPN SOD SD

7 7 3 147 773 73

7 3 7 147 737 77

3 7 7 147 377 37

In this example RPN value 147 is same and top SOD value is 773 and top SD value is 77 hence we will
take action on top SD.

Hence, CFT should consider all three values (RPN, SOD and SD) and decide for initiation of
recommended actions.

Situation where severity is 6 ~8, installation of Poka-yoke is recommended. Wherever installation of


Poka-yoke is not feasible and 100% inspection is also not possible (E.g. Destructive testing like Welding,
Heat Treatment etc.) the controls shall be ensured through activities such as (but not limited to):
1. Set up Verification
2. Process Parameter Control
3. Control charts
4. 100% Visual Check

Annexure -I

PFMEA Severity Evaluation Criteria

Page 7 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

Criteria : Criteria :
Effect Severity of Effect on Product Rank Effect Severity of Effect on Process
(Customer Effect) (Manufacturing/Assembly Effect)

Potential failure mode affects safe vehicle


operation and/or involves noncompliance May endanger operator (machine or assembly)
10
Failure to Meet with government regulation without Failure to Meet without warning.
Safety and/or warning. Safety and/or
Regulatory Regulatory
Requirements Potential failure mode affects safe vehicle Requirements
May endanger operator (machine or assembly)
operation and/or involves noncompliance 9
with warning.
with government regulation with warning.

Loss of primary function (vehicle inoperable 100% of product may have to be scrapped.
8 Major Disruption
but does not affect safe vehicle operation) Line shutdown or stop ship
Loss or
Degradation of
A portion of the product may have to be
Primary Function Degradation of primary function (vehicle
Significant scrapped. Deviation form primary process
operable, but a reduced level of 7
Disruption including decreased line speed or added
performance).
manpower.

Loss of secondary function (vehicle operable,


100% of the production run may have to be
but comfort / convenience functions 6
Loss or reworked off line and accepted.
inoperable).
Degradation of Moderate
Secondary Disruption
Degradation of secondary function (vehicle
Function A portion of the production run may have to
operable but comfort / convenience 5
be reworked off line and accepted
functions at a reduced level of performance).

Appearance or Audible Noise, vehicle


100% of the production run may have to be
operable, items does not conform and noticed 4
reworked in-station before it is processed.
by most customers (>75%)
Moderate
Disruption
Appearance or Audible Noise, vehicle
A portion of the production run may have to
Annoyance operable, items does not conform and noticed 3
be reworked in-station before it is processed.
by many customers (50%)

Appearance or Audible Noise, vehicle


Slight inconvenience to process, operation, or
operable, items does not conform and noticed 2 Very Minor
operator
by discriminating customers (<25%)

No Effect No discernible effect. 1 No Effect No discernible effect.

Annexure –II
PFMEA Occurrence Evaluation Criteria

Page 8 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

PPM
Likelihood Criteria: Occurrence of Cause-PFMEA
Rank
of Failure (Incidents per items / vehicles) (Consider:- Cpk
IHR+CR+WR)

≥ 100 per thousand


Very High >50,001 10
≥ 1 in 10
<0.65

50 per thousand
<50,000 9
1 in 20
>0.65~<0.69

20 per thousand
High <20,000 8
1 in 50
>0.69~<0.86

10 per thousand
<10,000 7
1 in 100
>0.86~<1.03

2 per thousand
<2000 6
1 in 500
>1.03~<1.10

0.5 per thousand


Moderate <500 5
1 in 2,000
>1.10~<1.30

0.1 per thousand


<100 4
1 in 10,000
>1.30~<1.47

0.01 per thousand


<10 3
1 in 100,000
>1.47~<1.63
Low
≤ 0.001 per thousand
<1 2
1 in 1,000,000
>1.63

Not
Very Low Failure is eliminated through preventive control 0 Applicable 1

IHR:-Inhouse Rejection, CR:- Customer Return, WR:- Warranty Return

Annexure III

PFMEA Detection Evaluation Criteria

Opportunity for Criteria: Rank Likelihood of


Detection Likelihood of Detection by Process Control Detection

Page 9 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

No Detection Almost
No current process control; Cannot detect or is not analyzed 10
opportunity Impossible

Not likely to detect at Failure Mode and / or Effect (Cause) is not easily detected (e.g. random
9 Very Remote
any stage audits).

Problem Detection Failure Mode detection post-processing by operator through visual / tactile /
8 Remote
Post Processing audible means

Failure Mode detection in-station by operator through visual / tactile / audible


Problem Detection at
means or post- processing through use of attribute gauging (go/no-go, manual 7 Very Low
Source
torque check/clicker wrench, etc)

Failure Mode detection post- processing by operator through use of variable


Problem Detection
gauging or in-station by operator through use of attribute gauging (go/no-go, 6 Low
Post Processing
manual torque check/clicker wrench, etc)

Failure Mode or Error (Cause) detection in-station by operator through use of


Problem Detection at variable gauging or by automated controls in-station that will detect discrepant
5 Moderate
Source part and notify operator (light, buzzer, etc). Gauging performed on setup and
first-piece check (for set-up causes only).

Problem Detection Failure Mode detection post-processing by automated controls that will detect Moderately
4
Post Processing discrepant part and automatically lock to prevent further processing High

Failure Mode detection in-station by automated controls that will detect


Problem Detection at
discrepant part and automatically lock part in station to prevent further 3 High
Source
processing

Error Detection
Error (Cause) detected in-station by automated controls that will detect error
and/or Problem 2 Very High
and prevent discrepant part from being made
Prevention

Detection not Error (Cause) prevention as a result of fixture design, machine design or part
applicable; Error design. Discrepant parts cannot be made because item has been error proofed 1 Almost Certain
Prevention by process / product design.

6. KEY PERFORMANCE INDICATORS:-

No. of problems occurred that not covered in PFMEA.


 No of error proofing introduced

7. REFERENCE DOCUMENTS & RECORDS:-

Sr. Format/ Doc. No.


No. Description Responsibility
(if any)

01 Process FMEA IF/QA/20 CFT

Page 10 of 11
QUALITY SYSTEM PROCESS DOC. No. : IF/QMS/02
REV. No.& Date : 03&
TITLE: PROCESS FOR PROCESS FAILURE MODE & EFFECT ANALYSIS 19.01.23
Efft. Date :-01/04/15
(PFMEA)

02 List of expected Problem IF/NPD/15 CFT

03 RED BIN ANALYSIS REPORT r IF/QA/14 CFT

04 COHERENCE SHEET IF/WI/158 CFT

05 External origin documents: AIAG FMEA Manual ------------ -------------


4th Edition

06 PFMEA REVIEW WORK INSTRUCTION IF/WI/157 CFT

07 CFT TEAM FOR PFMEA IF/QA/40 CFT

08 CUSTOMER COMPLAINT REGISTER IF/QA/07 CFT

Page 11 of 11

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