FMEA PROCESS TEMPLATE
20
(Information Sheet) PFMEA Number: Process Name: Process Responsibility: Prepared By: Affected Product(s): PFMEA Key Date: PFMEA Origination Date: PFMEA Revision Date: Core Team Members: Potential Failure Modes and Effects Analysis
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FMEA PROCESS TEMPLATE SAMPLE FOR WORKOUT
Transcript of FMEA PROCESS TEMPLATE
(Information Sheet)
PFMEA Number:
Process Name:
Process Responsibility:
Prepared By:
Affected Product(s):
PFMEA Key Date:
PFMEA Origination Date:
PFMEA Revision Date:
Core Team Members:
Potential Failure Modes and Effects Analysis
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Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
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#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
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#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
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#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
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#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
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#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Failure Effects (KPOVs)
SEV
Class
Potential Causes of
Failure (KPIVs)
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
DET
RPN
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Effect Criteria: Severity of Effect Defined Ranking
10
9
Very High 8
High 7
Moderate 6
Low 5
Very Low 4
Minor 3
Very Minor 2
None No effect. 1
Hazardous: Without Warning
May endanger operator. Failure mode affects safe vehicle operation and / or involves noncompliance with government regulation. Failure will occur WITHOUT warning.
Hazardous: With Warning
May endanger operator. Failure mode affects safe vehicle operation and / or involves noncompliance with government regulation. Failure will occur WITH warning.
Major disruption to production line. 100% of product may have to be scrapped. Vehicle / item inoperable, loss of primary function. Customer very dissatisfied.
Minor disruption to production line. Product may have to be sorted and a portion (less than 100%) scrapped. Vehicle operable, but at a reduced level of performance. Customer dissatisfied.
Minor disruption to production line. A portion (less than 100%) may have to be scrapped (no sorting). Vehicle / item operable, but some comfort / convenience item(s) inoperable. Customers experience discomfort.
Minor disruption to production line. 100% of product may have to be reworked. Vehicle / item operable, but some comfort / convenience item(s) operable at reduced level of performance. Customer experiences some dissatisfaction.
Minor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked. Fit / finish / squeak / rattle item does not conform. Defect noticed by most customers.
Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but out-of-station. Fit / finish / squeak / rattle item does not conform. Defect noticed by average customers.
Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but in-station. Fit / finish / squeak / rattle item does not conform. Defect noticed by discriminating customers.
Probability of Failure Possible Failure Rates Cpk Ranking
Very High: < 0.33 10
Failure is almost inevitable 1 in 3 9
1 in 8 8
processes that have often failed 1 in 20 7
1 in 80 6
previous processes which have 1 in 400 5
1 in 2,000 4
1 in 15,000 3
1 in 150,000 2
1
³ 1 in 2
³ 0.33
High: Generally associated with processes similar to previous
³ 0.51
³ 0.67
Moderate: Generally associated with processes similar to
³ 0.83
³ 1.00
experienced occasional failures, but not in major proportions
³ 1.17
Low: Isolated failures associated with similar processes
³ 1.33
Very Low: Only isolated failures associated with almost identical processes
³ 1.5
Remote: Failure is unlikely. No failures ever associated with almost identical processes
£ 1 in 1,500,000 ³ 1.67
Detection Ranking
Almost Impossible Test content detects < 80 % of failures 10
Very Remote Test content must detect 80 % of failures 9
Remote Test content must detect 82.5 % of failures 8
Very Low Test content must detect 85 % of failures 7
Low Test content must detect 87.5 % of failures 6
Moderate Test content must detect 90 % of failures 5
Moderately High Test content must detect 92.5 % of failures 4
High Test content must detect 95 % of failures 3
Very High Test content must detect 97.5 % of failures 2
Almost Certain Test content must detect 99.5 % of failures 1
Criteria: Liklihood the existence of a defect will be detected by test content before product advances to
next or subsequent process
Steps in the FMEA Process1. Select the Process FMEA
team2. Develop a Process Map and
identify all process steps3. List all the Key Process
Outputs to satisfy internal and external customer requirements
4. For each Process Step, list Key Process Inputs
5. For the Process Define matrix relating Product Outputs to Process Variables
6. Rank the inputs according to importance
7. Start the process FMEA
8. For each Process Input, List ways that it can vary (causes) and identify associated Failure Modes and Effects
9. List all other Causes (sources of variability) and associated FM’s and Effects
10.Assign Severity, Occurrence and Detection rating to each Cause
11.Calculate the risk priority number (RPN) for each potential failure mode scenario
12.Determine recommended actions to reduce all RPNs
13. Take appropriate actions14.Re-calculate all RPNs
Note: When doing a Process FMEA, first assume the material is good, but the process is bad. Then assume the process is good, but the material is bad. Last, assume the process is
unsafe.
Note: When doing a Process FMEA, first assume the material is good, but the process is bad. Then assume the process is good, but the material is bad. Last, assume the process is
unsafe.
Steps in the FMEA Process1. Select the Process FMEA
team2. Develop a Process Map and
identify all process steps3. List all the Key Process
Outputs to satisfy internal and external customer requirements
4. For each Process Step, list Key Process Inputs
5. For the Process Define matrix relating Product Outputs to Process Variables
6. Rank the inputs according to importance
7. Start the process FMEA
8. For each Process Input, List ways that it can vary (causes) and identify associated Failure Modes and Effects
9. List all other Causes (sources of variability) and associated FM’s and Effects
10.Assign Severity, Occurrence and Detection rating to each Cause
11.Calculate the risk priority number (RPN) for each potential failure mode scenario
12.Determine recommended actions to reduce all RPNs
13. Take appropriate actions14.Re-calculate all RPNs
Note: When doing a Process FMEA, first assume the material is good, but the process is bad. Then assume the process is good, but the material is bad. Last, assume the process is
unsafe.
Note: When doing a Process FMEA, first assume the material is good, but the process is bad. Then assume the process is good, but the material is bad. Last, assume the process is
unsafe.
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