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PROCESS FAILURE MODE AND EFFECTS ANALYSIS Rev. No. (Date) 00 (03/07/2023) Open Risk - Design 0 0
Issue No. (Date) 00 (03/07/2023) Open Risk - Lab 0 0
PFMEA Number PFMEA- 01A Key Contact / Phone FMEA Stage Department Represenative Open Risk - QA 0 0
Revision No. 0 CTO Pre-launch / Pilot / Production Quality Suraj Rawat Open Risk - Process 0 0
Revision Date NA Product Sub System Electrochemistry Shreya Open Risk - SCM 0 0
Date (Originated) 9/9/2023 Linear Cell Stack Electrode Stack Assembly - Mark 4 Open High Risk 0 0
Part Number Electrode Coating Process Responsibility: Key Date : Open Medium Risk 0 0
Part Name /
All Electrdes Manufacturing - Electro Chemistry 9/9/2023
Open Low Risk 0 0
Description Total Risks 0 0
Requirements - Inputs form PFD Failure Analysis Corrrective Actions Action Results Effectivness
Recommended Actions. [ Additional Control ] What are Other Inputs
Characteristic. Current Control Methods the recommended actions for reducing the occurrence Action Results
[ One at time ] Potential Root Cause(s) / Action
Class Potential Effect(s) of Failure of the cause or improving detection?
Mechanism(s) of Failure. DETECTI Priority.
Process No. Process [ Category as [ What is the impact if this SEVERITY OCCURREN
Description per drawing, failure is not prevented or (1 - 10) What causes the step or CE (1 - 10) ON (1 - RPN [ Hightc / Responsi Target From Team Summary of
Product Process feature to go wrong? (how Prevention Detection 10) Medium / Actions bility Date. Status Sev# OCC# DET# NEW RPN Action Priority Action Evidences / Links Members Last Updated Changes
Safety,etc ] corrected? ]
could it occur? Low ]
Parameter Covered in
Next Process : 5 3 Supplier Inspection 5 75 Low 0
Report.
Parameter Covered in
Not covered in Supplier Report / TC Supplier Inspection
IQC Report.
Not covered in IQC Report. Report available.
Training Module
Wrong Measurement Technique Inspection and
available for Inspection
Thickness out of Use of wrong / Non calibrated recording in IQC
Assembly : 5 3 Trained Inspector as 5 75 Low 0
Specification Instrument used. Report.
per skill matrix
No Deskilling for Inspection Sample Inspection
Use of Periodically
Suitable instrument not available as per Sampling
Calibrated Instruments.
Inspection sample size not adequate plan in WI
Sampling Inspection
RM Inspection of defined in Work
20A Straight and U Customer / End user : 5 3 Instruction for IQC 5 75 Low 0
Plates
Parameter Covered in
Supplier Inspection
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Wrong Measurement Technique Training Module Inspection and
Dimesnions out of Use of wrong / Non calibrated available for Inspection recording in IQC
Assembly : 5 3 Trained Inspector as 5 75 Low 0
specifications Instrument used. Report.
No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
No SOP / WI for Measurement Training Module Inspection and
RM Inspection of available for Inspection
Chemicals - Concentration less Use of wrong / Non calibrated recording in IQC
20B Assembly : 5 3 Trained Inspector as 5 75 Low 0
Sulphuric Acid than 98 % Instrument used. Report.
[ H2So4 ] No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Volumetric No SOP / WI for Measurement Training Module Inspection and
RM Inspection of Concentration less Use of wrong / Non calibrated available for Inspection recording in IQC
20C Chemical - Hydrogen Assembly : 5 3 Trained Inspector as 5 75 Low 0
than 30 % by Instrument used. Report.
Peroxide [ H2O2 ]
weight No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Wrong Measurement Technique Training Module Inspection and
TDS more than 10 Use of wrong / Non calibrated available for Inspection recording in IQC
Assembly : 5 3 Trained Inspector as 5 75 Low 0
PPM Instrument used. Report.
No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Wrong Measurement Technique Training Module Inspection and
Use of wrong / Non calibrated available for Inspection recording in IQC
RM Inspection of DI
20D Not Colorless Assembly : 5 3 Trained Inspector as 5 75 Low 0
Water Instrument used. Report.
No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Wrong Measurement Technique Training Module Inspection and
Use of wrong / Non calibrated available for Inspection recording in IQC
Not Odourless Assembly : 5 3 Trained Inspector as 5 75 Low 0
Instrument used. Report.
No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Wrong Measurement Technique Training Module Inspection and
RM Inspection of available for Inspection
Use of wrong / Non calibrated recording in IQC
20E Chemical - Nickel Assembly : 5 3 Trained Inspector as 5 75 Low 0
Instrument used. Report.
Chloride [ NiCl2 ] per skill matrix
No Deskilling for Inspection Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
RM Inspection of Wrong Measurement Technique Training Module Inspection and
Chemicals - Use of wrong / Non calibrated available for Inspection recording in IQC
20F Assembly : 5 3 Trained Inspector as 5 75 Low 0
Potassium Chloride Instrument used. Report.
[ KCl ] No Deskilling for Inspection per skill matrix Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
Parameter Covered in
defined in Work
Supplier Inspection
Instruction for IQC
Report.
Next Process : 5 Not covered in Supplier Report / TC 3 Parameter Covered in Supplier Inspection 5 75 Low 0
Not covered in IQC Report. IQC Report. Report available.
Wrong Measurement Technique Training Module Inspection and
RM Inspection of available for Inspection
Use of wrong / Non calibrated recording in IQC
20G Chemical -Selenium Assembly : 5 3 Trained Inspector as 5 75 Low 0
Instrument used. Report.
dioxide [ SeO2 ] per skill matrix
No Deskilling for Inspection Sample Inspection
Suitable instrument not available Use of Periodically as per Sampling
Inspection sample size not adequate Calibrated Instruments. plan in WI
Customer / End user : 5 3 Sampling Inspection 5 75 Low 0
defined in Work
Instruction for IQC
Next Process : Poor or non-uniform Under
7 3 5 105 High SOP for Solution Preparation Lab Head 11/10/2023 0
coating deposition Trained Manpower as Progress
Untrained Lab Techinician
per Skill Matrix
Parameter not defined in SOP / WI
Lab Temperature !00 % pH test by pH paper / pH
Temperature of Solution bath Under
pH Less than 2 Assembly : No Effects 5 3 Control 5 75 Low meter & recording same for every Lab Head 11/10/2023 0
Volume of Solution Progress
Calibradated pH meter batch
Improper Mixing of Solution
No Instrument to Measure
Customer / End user : Customer Reaction Plan for correction of Under
7 3 5 105 High Lab Head 11/10/2023 0
Complaint - Performace degradation bath to be made Progress
Catalyst Solution
preparation for Mixing Time Less
40A Electro-deposition [ Assembly : 5 5 5 125 Medium 0
6 electrode in 1 Ltr
than 10 Min
per batch ]
Catalyst
deposition active
Assembly : 5 5 5 125 Medium 0
area less than
30sqcm
Catalyst coating
deposition non- Assembly : 5 5 5 125 Medium 0
uniform
Dent / damage /
Scratch in coated Assembly : 5 5 5 125 Medium 0
area
Deposition time
less than 10min
Deposition time
Assembly : 5 5 5 125 Medium 0
less than 10min
Catalyst
deposition active
Assembly : 5 5 5 125 Medium 0
area less than
30sqcm
Dent / damage /
Scratch in coated Assembly : 5 5 5 125 Medium 0
area
Packaging of
60 Assembly : 5 5 5 125 Medium 0
Electrodes
Transport to Cell
80 Assembly : 5 5 5 125 Medium 0
Unit for Assembly
0
Open Risk - Design 0
Doc. No. Open Risk - Mfg 0
PROCESS FAILURE MODE AND EFFECTS ANALYSIS Rev. No. (Date) Open Risk - QA 0
Issue No. (Date) Open Risk - Process 3 2
PFMEA Number PFMEA- 01.D Key Contact / Phone FMEA Stage Team Member Deparment Open Risk - Maintenance 0
Class
Process / Functional
Requirements.
Process No. & Characteristic [ Category Potential Effect(s) of Failure
SEVERITY (1 -
Potential Root Cause(s) / Mechanism(s)
of Failure. OCCURRENCE
Current Control Methods
DETECTION
Recommended Actions. [ Additional Control ]
Action Priority. What are the recommended actions for reducing the occurrence of the cause or improving detection? Action Results Open Risks 4 Closed Risks 2
Name as per [ What is the impact if this failure is not RPN [ Hightc / Action Priority
[ What are the Functions, 10) What causes the step or feature to go (1 - 10) (1 - 10)
[As per PFD] drawing, prevented or corrected? ] Medium / Low ] From UL or Summary of
Features or Requirements?} Product Process wrong? (how could it occur? Prevention Detection Actions Responsibility Target Date. Status Sev# OCC# DET# NEW RPN Action Evidences / Links Last Updated
Safety,etc ] Newtrace Changes
Next Process : Electrode transfer will
6 1 2 12 Low 0
not be proper
1. Improper packaging by Supplier.
Assembly : No effect 6 2. Packaging Standard not available. 1 2 12 Low 0
1. Packaging done as per Packaging IQC Report
Free from 3. Packaging Standard not specified in
Standard. Supplier Report
Membrane Receipt 10 Scratch, Dent, PO / Drawing.
2. Packaging Standard specfied in 100% Visual Inspection of
Bend 4. No loading and Unloading Instructions
PO packaging.
Customer / End user : Performance 5. Strorage not proper
6 6. FIFO not maintained. 1 2 12 Low 0
degradation.
Anode and cathode solution 20A and 20B Customer / End User: Customer
preparation Process -
dissatisfaction - MEA lifetime will 7 1 2 14 Medium PSD to be implemented for IPA Use Open 0
Rajalaxmi
reduced. Digital hydrometer to check quality
parameter of IPA.
Assembly : Could lead to reduction of Probability of failure of motor in stirrer 1. Daily RPM is recording in
Low RPM of 6 3 1. RPM is defined in the SOP 2 36 Low 0
stack performance Malfunctioning of RPM meter. the checklist.
stirrer. (QC/F/42)
Wrong setting on the RPM meter. (QC/F/42,QC/F/41)
42002377-1 AMP -
10 A Next Process : Leeds to leakage 1. Not covered in Supplier Report
Anode Monopolar 6 2 8 96 Low
Raw material in bundles 2. Not covered in IQC Report. 1. Trained Inspector 1. Sampling Inspection and
plate.
3. Wrong Measurement Technique as per skill matrix recording in IQC Report, QC-
Feeler gap 4. Use of Wrong / Non calibrated 2. Use of Periodically F-03
Assembly : No impact 1 2 8 16 Low
(more/Less) Instrument for measurement. Calibrated Instruments 2. Sampling Inspection &
5. No Deskilling for Inspection 3. Training Module Covered Supplier Inspection
Customer / End User: Leeds to 6. Inspection sample size not adequate available for Inspection Report
6 2 8 96 Low
leakage in bundles.
Next Process : Impact 7 1. Not covered in Supplier Report 2 8 112 High Suraj Rawat 15.03.2023 Closed 7 1 8 56 Low
Trained Operator 1. Sampling Inspection and Training Module - QC acceptance of End plates, Bezel, Gasket, tie rod.docx
2. Not covered in IQC Report.
as per skill matrix recording in IQC Report, QC-
3. Wrong Measurement Technique
Parallelism F-03
(Max)
Assembly: Impact 2 4. Use of wrong / Non calibrated 2 Use of Use of 2. Sampling Inspection &
8 32 Low
Instrument used. Periodically Calibrated Covered Supplier Inspection
5. No Deskilling for Inspection Instruments
Customer / End User: Report
1 6. Inspection sample size not adequate 2 8 16 Low
Performance degradation
Next Process : Impact 7 2 8 112 High Suraj Rawat 15.03.2023 Closed 7 1 8 56 Low
1. Not covered in Supplier Report Trained Operator 1. Sampling Inspection and Training Module - QC acceptance of End plates, Bezel, Gasket, tie rod.docx
2. Not covered in IQC Report. as per skill matrix recording in IQC Report, QC-
3. Untrained Inspector F-03
Aesthetic 4. Inspection sample size not adequate Use of Use of 2. Sampling Inspection &
5. Limit Samples not available Periodically Calibrated Covered Supplier Inspection
6. Training Modules not available. Instruments Report
1. Not covered in Supplier Report Trained Operator 1. Sampling Inspection and
2. Not covered in IQC Report. as per skill matrix recording in IQC Report, QC-
3. Untrained Inspector F-03
Aesthetic Assembly: No impact 2
4. Inspection sample size not adequate
2 Use of Use of 2. Sampling Inspection &
8 32 Low
5. Limit Samples not available Periodically Calibrated Covered Supplier Inspection
Customer / End User: 6. Training Modules not available. Instruments Report
6 2 8 96 Low
Performance degradation
Next Process : Impact 7 1. Not covered in Supplier Report 2 8 112 High Suraj Rawat 15.03.2023 Closed 7 1 8 56 Low
Trained Operator 1. Sampling Inspection and Training Module - QC acceptance of End plates, Bezel, Gasket, tie rod.docx
2. Not covered in IQC Report.
as per skill matrix recording in IQC Report, QC-
3. Wrong Measurement Technique
Parallelism Assembly: assembly not F-03
(Max) possible
5 4. Use of wrong / Non calibrated 2 Use of Use of 2. Sampling Inspection &
8 80 Low
Instrument used. Periodically Calibrated Covered Supplier Inspection
5. No Deskilling for Inspection Instruments
Customer / End User: No Report
1 6. Inspection sample size not adequate 2 8 16 Low
Impact
28000120-2 [GSKT
10 L
H2 single Plenum]
1. Not covered in Supplier Report
Trained Operator 1. Sampling Inspection and
Assembly: Impact 2 2. Not covered in IQC Report. 2 8 32 Low
as per skill matrix recording in IQC Report, QC-
3. Wrong Measurement Technique
Thickness F-03
(more/Less)
4. Use of wrong / Non calibrated Use of Use of 2. Sampling Inspection &
Instrument used. Periodically Calibrated Covered Supplier Inspection
Customer: No impact 1 5. No Deskilling for Inspection 2 8 16 Low
Instruments Report
6. Inspection sample size not adequate
Gasket poor packing methods supplier inspection 100% Sampling inspection better Standard implemented
Condition(wrinkl damage during transportation Muttu M 3/31/2023 Closed
es&damage) Customer: Customer complaint 8 4 report from IQC 8 256 High Quantity reduced in one packet. 8 2 1 16 low
Hazardous
10
without warning
Hazardous With
9
Warning
8 Very high
7 High
6 Moderate
5 Low
4 Very Low
3 Minor
2 Very Minor
1 None
00000014
Severity Rating Scale
Definition (Severity of Effect)
No effect
00000015
Severity Rating Scale
Rating Description
Hazardous
10
without warning
Hazardous With
9
Warning
8 Very high
7 High
6 Moderate
5 Low
4 Very Low
3 Minor
2 Very Minor
1 None
00000016
Severity Rating Scale
Definition (Severity of Effect)
00000017
00000018
Occurrence Rating Scale
Rating Description
10 Exteremely High: Failure is almost inevitable.
Very High: Failures occur almost as often as
9
not.
8 Repeated failures.
1 Exteremely Rare
00000019
Rating Scale
Potential Failure Rate
Greater than or equal to 1 in 2
1 in 3
1 in 8
1 in 20
1 in 80
1 in 400
1 in 2,000
1 in 15,000
1 in 150,000
00000020
Design Detection Rating Scale
Rating Description
10 Absolutely impossible
9 Very remote
8 Remote
7 Very low
6 Low
5 Moderate
4 Moderately high
3 High
2 Very High
1 Almost certain
00000021
esign Detection Rating Scale
Definition
The product is not inspected or the defect caused by failure is not detectable.
An effective SPC program is in place with process capabilities (Cpk) greater than
1.33.
The defect is obvious or there is 100% automatic inspection with regular calibration
and preventive maintenance of the inspection equipment.
00000022
00000023
Severity Occurrence Detection Action Priority
3-1 9-10 8-10 Medium
4-7 Medium
1-3 Medium
7-8 8-10 Medium
4-7 Low
1-3 Low
5-6 8-10 Low
4-7 Low
1-3 Low
3-4 8-10 Low
4-7 Low
1-3 Low
1-2 8-10 Low
4-7 Low
1-3 Low
Critical
High
Medium
Severity Occurrence Detection Action Priority Low
1 1 1 Low
2 1 1 Low
1 2 1 Low
1 1 2 Low
3 1 1 Low
1 3 1 Low
1 1 3 Low
4 1 1 Low
2 2 1 Low
1 4 1 Low
2 1 2 Low
1 2 2 Low
1 1 4 Low
5 1 1 Low
1 5 1 Low
1 1 5 Low
6 1 1 Low
3 2 1 Low
2 3 1 Low
1 6 1 Low
3 1 2 Low
1 3 2 Low
2 1 3 Low
1 2 3 Low
1 1 6 Low
1 7 1 Low
00000024
1 1 7 Low
4 2 1 Low
2 4 1 Low
1 8 1 Low
4 1 2 Low
2 2 2 Low
1 4 2 Low
2 1 4 Low
1 2 4 Low
1 1 8 Low
3 3 1 Low
3 1 3 Low
1 3 3 Low
1 1 9 Low
5 2 1 Low
2 5 1 Low
5 1 2 Low
1 5 2 Low
2 1 5 Low
1 2 5 Low
1 1 10 Low
6 2 1 Low
4 3 1 Low
3 4 1 Low
2 6 1 Low
6 1 2 Low
3 2 2 Low
2 3 2 Low
1 6 2 Low
4 1 3 Low
2 2 3 Low
1 4 3 Low
3 1 4 Low
1 3 4 Low
2 1 6 Low
1 2 6 Low
2 7 1 Low
1 7 2 Low
2 1 7 Low
1 2 7 Low
5 3 1 Low
5 1 3 Low
1 5 3 Low
3 1 5 Low
1 3 5 Low
4 4 1 Low
2 8 1 Low
00000025
4 2 2 Low
2 4 2 Low
1 8 2 Low
4 1 4 Low
2 2 4 Low
1 4 4 Low
2 1 8 Low
1 2 8 Low
6 3 1 Low
3 3 2 Low
6 1 3 Low
3 2 3 Low
2 3 3 Low
1 6 3 Low
3 1 6 Low
1 3 6 Low
2 1 9 Low
1 2 9 Low
5 4 1 Low
5 2 2 Low
2 5 2 Low
5 1 4 Low
1 5 4 Low
4 1 5 Low
2 2 5 Low
1 4 5 Low
2 1 10 Low
1 2 10 Low
3 7 1 Low
1 7 3 Low
3 1 7 Low
1 3 7 Low
1 8 3 Low
1 6 4 Low
1 4 6 Low
1 3 8 Low
2 6 2 Low
2 4 3 Low
2 3 4 Low
2 2 6 Low
3 8 1 Low
3 4 2 Low
3 2 4 Low
3 1 8 Low
4 3 2 Low
4 2 3 Low
4 1 6 Low
00000026
6 4 1 Low
6 2 2 Low
6 1 4 Low
5 1 5 Low
1 5 5 Low
3 9 1 Low
3 3 3 Low
3 1 9 Low
1 3 9 Low
4 7 1 Low
2 7 2 Low
1 7 4 Low
4 1 7 Low
2 2 7 Low
1 4 7 Low
1 6 5 Low
1 5 6 Low
1 3 10 Low
2 5 3 Low
2 3 5 Low
3 10 1 Low
3 2 5 Low
3 1 10 Low
5 3 2 Low
5 2 3 Low
5 1 6 Low
6 1 5 Low
4 8 1 Low
4 4 2 Low
2 8 2 Low
4 2 4 Low
2 4 4 Low
1 8 4 Low
4 1 8 Low
2 2 8 Low
1 4 8 Low
1 7 5 Low
5 1 7 Low
1 5 7 Low
4 9 1 Low
6 3 2 Low
6 2 3 Low
4 3 3 Low
3 4 3 Low
2 6 3 Low
3 3 4 Low
6 1 6 Low
00000027
3 2 6 Low
2 3 6 Low
1 6 6 Low
4 1 9 Low
2 2 9 Low
1 4 9 Low
4 10 1 Low
5 4 2 Low
5 2 4 Low
2 5 4 Low
4 2 5 Low
2 4 5 Low
1 8 5 Low
5 1 8 Low
1 5 8 Low
4 1 10 Low
2 2 10 Low
1 4 10 Low
3 7 2 Low
2 7 3 Low
1 7 6 Low
6 1 7 Low
3 2 7 Low
2 3 7 Low
1 6 7 Low
5 3 3 Low
3 3 5 Low
5 1 9 Low
1 5 9 Low
6 4 2 Low
3 8 2 Low
4 4 3 Low
2 8 3 Low
6 2 4 Low
4 3 4 Low
3 4 4 Low
2 6 4 Low
4 2 6 Low
2 4 6 Low
1 8 6 Low
6 1 8 Low
3 2 8 Low
2 3 8 Low
1 6 8 Low
1 7 7 Low
5 2 5 Low
2 5 5 Low
00000028
5 1 10 Low
1 5 10 Low
3 9 2 Low
6 3 3 Low
3 3 6 Low
6 1 9 Low
3 2 9 Low
2 3 9 Low
1 6 9 Low
4 7 2 Low
2 7 4 Low
4 2 7 Low
2 4 7 Low
1 8 7 Low
3 10 2 Low
5 4 3 Low
5 3 4 Low
6 2 5 Low
4 3 5 Low
3 4 5 Low
2 6 5 Low
5 2 6 Low
2 5 6 Low
6 1 10 Low
3 2 10 Low
2 3 10 Low
1 6 10 Low
3 7 3 Low
3 3 7 Low
4 8 2 Low
4 4 4 Low
2 8 4 Low
4 2 8 Low
2 4 8 Low
2 7 5 Low
5 2 7 Low
2 5 7 Low
4 9 2 Low
6 4 3 Low
3 8 3 Low
6 3 4 Low
6 2 6 Low
4 3 6 Low
3 4 6 Low
2 6 6 Low
4 2 9 Low
2 4 9 Low
00000029
5 3 5 Low
4 10 2 Low
5 4 4 Low
4 4 5 Low
2 8 5 Low
5 2 8 Low
2 5 8 Low
4 2 10 Low
2 4 10 Low
3 9 3 Low
4 7 3 Low
2 7 6 Low
6 2 7 Low
4 3 7 Low
3 4 7 Low
2 6 7 Low
3 10 3 Low
6 3 5 Low
5 3 6 Low
5 2 9 Low
2 5 9 Low
4 8 3 Low
6 4 4 Low
4 4 6 Low
2 8 6 Low
6 2 8 Low
2 6 8 Low
2 7 7 Low
5 4 5 Low
5 2 10 Low
2 5 10 Low
5 3 7 Low
4 9 3 Low
6 3 6 Low
6 2 9 Low
2 6 9 Low
4 4 7 Low
2 8 7 Low
4 10 3 Low
6 4 5 Low
5 4 6 Low
6 2 10 Low
2 6 10 Low
6 3 7 Low
5 4 7 Low
6 4 6 Low
6 4 7 Low
00000030
Notes:
This is a general movement in the indsutry to go away from using the RPN as a method of
Prioritizing which item to work on, and move an Action Priority Level, consisisting of 3, 4 or 5
levels.
In this case 4 seperate levels were identified: Critical, High, Medium, Low.
Why was the change made?
Some quality professionals have pointed out (for many years) that using the RPN to determine the
priority of potential risks to tackle is a flawed approach.
The RPN is determined by multiplying the "Severity x Occurrence x Detection (or S x O x D)"
rankings; while this methodology has 1000 possible values there is only 120 unique values for the
RPN value.
Unfortunately, these 120 unique values are not evenly distributed across the range of 0-1000.
Some RPN scores will group up to 24 different (posssibly widely varying )scenarios into the same
score.
159 The discrimination can distort the importance of one potential risk relative to another.
252 And additionally, when the RPN is used to determine a rank order of action plans, some "severe"
280 potential risks (with a Severity ranking of 9 or 10) may not get the attention that they should
because low Occurrence and Detection rankings may drop the RPN below an actionable level.
308
FALSE The Automotive Industry Action Group (AIAG) and the Verband der Automobilindustrie (VDA)
FALSE jointly released an updated FMEA handbook on April 2, 2019. One of the major changes with the
FALSE new AIAG-VDA FMEA process is the use of the RPN has been eliminated. The RPN has been
replaced by an action priority (AP) table.
FALSE
FALSE The AIAG-VDA Manual states that the RPN method overlooks "rational logic" thereby
FALSE allowing some combinations of S, O and D to be overlooked when mitigation action plans should
FALSE have been initiated.
FALSE
Don Wheeler, author, statistician and well-respected legend in the Quality field wrote about the
FALSE shortcomings of the RPN in Quality Digest in 2011.
FALSE
FALSE --------------
FALSE The general table (to the right) is a rough cut to categorize the risk levels for different RPN values.
Use, modify, adapt it to fit your company's FMEA and/or the product you make.
FALSE
FALSE Unfortunately the General table and the table for Vlooup are not linked. If you want to update the
FALSE Vlook up Table, use the filters to quickly sort according to the preferred category and change the
FALSE Action Priority in the Vlookup Table.
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
00000031
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
FALSE
00000032
he RPN as a method of
el, consisisting of 3, 4 or 5
m, Low.
relative to another.
of action plans, some "severe"
attention that they should
below an actionable level.
Automobilindustrie (VDA)
of the major changes with the
nated. The RPN has been
00000033
FMEA Procedure
Starting with Step 1: One can summarize the FMEA procedure
• Identify all Functions within scope. 1 Review all subsystems to do a list of the
• Identify how each Function can fail (Failure Modes). 2 Brainstorm potential failure modes asso
• Identify a group of associated Effects for each Failure Mode.
• Identify a Severity rating for each Effect group that prioritizes the 3 List the probable failure effects of each c
Failure Mode(s).
For each failure mode:
Step 1 of the Working Model is completed by considering appropriate 4 Assign an Occurrence rating using the Ta
Recommended Actions to:
• Eliminate the Failure Mode 5 Assign a Detection Rating using the Table
• Mitigate the Effect 6 Assign a Severity rating using the Table
Special emphasis on possible actions is required when Severity is 9 or 7 Calculate the failure mode RPN. RPN = S
10. Lower Severities may also be considered for actions. 8 Develop an action plan to address the hi
To eliminate failure mode(s), consider this action:
• Change the design (e.g., geometry, material) if related to a product 9 Take corrective action, and;
characteristic. 10 Reevaluate the RPN number after the ac
If the Failure Mode cannot be eliminated, continue with the Working
Model Step 2.
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summarize the FMEA procedure in 10 main steps. They are:
ll subsystems to do a list of the main items and their components;
m potential failure modes associated with each component;
robable failure effects of each component to each subsystem;
failure mode:
n Occurrence rating using the Table
Detection Rating using the Table
Severity rating using the Table
the failure mode RPN. RPN = Severity X Occurrence X Detection
an action plan to address the highest RPN;
rective action, and;
te the RPN number after the actions are completed.
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PFMEA REVISION HISTORY
Part Name:- Customer :-
Part No & Rev - Model :-
Sign
Sr No Last Rev Latest Rev Review Date Revision History / Description Remarks
Engg QA Prod
01 ----- 00 05.11.2023 Initial FMEA made
July 2023 Status
Risk Count Status New Risk Status
Sections
Total Open Closed % Risk Total Open Closed % Risk
High Medium Low Design Mfg Quality Process Maintenance Tooling NPI Stores
2 2 0 0 0 0 3 0 1 0 0
0 0 0 0 0 0 0 0 0 0 0
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