Fmea Process Template

Potential Failure Modes and Effects Analysis (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:
Process Function (Step)
C S O Potential Failure Potential Potential Failure l E C Modes (process s Causes of Effects (KPOVs) a V defects) Failure (KPIVs) C s
0 0
Current Process Controls
D E T
0
R P N
Recommend Actions
Responsible Person & Target Date
Taken Actions
S E V
O D C E C T
10
11
12
13
14
15
16
D E T
R P N
Recommend Actions
Taken Actions
S E V
O D C E C T
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
D E T
R P N
Recommend Actions
Taken Actions
S E V
O D C E C T
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
D E T
R P N
Recommend Actions
Taken Actions
S E V
O D C E C T
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
D E T
R P N
Recommend Actions
Taken Actions
S E V
O D C E C T
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
D E T
R P N
Recommend Actions
Taken Actions
S E V
O D C E C T
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
D E T
R P N
Recommend Actions
Taken Actions
S E V
O D C E C T
97
98
99
100
R P N
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R P N
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Effect
Criteria: Severity of Effect Defined
Ranking 10
May endanger operator. Failure mode affects safe vehicle operation and / or Hazardous: involves noncompliance with government regulation. Failure will occur WITHOUT Without Warning warning. May endanger operator. Failure mode affects safe vehicle operation and / or Hazardous: With involves noncompliance with government regulation. Failure will occur WITH Warning warning. Very High 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. No effect.
High
Moderate
Low
Very Low
Minor
Very Minor None
2 1
Probability of Failure Very High: Failure is almost inevitable High: Generally associated with processes similar to previous processes that have often failed Moderate: Generally associated with processes similar to previous processes which have experienced occasional failures, but not in major proportions Low: Isolated failures associated with similar processes Very Low: Only isolated failures associated with almost identical processes Remote: Failure is unlikely. No failures ever associated with almost identical processes
Possible Failure Rates 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
Cpk < 0.33 0.33 0.51 0.67 0.83 1.00 1.17 1.33 1.5 1.67
Ranking 10 9 8 7 6 5 4 3
1 in 150,000
1 in 1,500,000
Detection
Criteria: Liklihood the existence of a defect will be detected by test content before product advances to next or subsequent process Test content detects < 80 % of failures Test content must detect 80 % of failures Test content must detect 82.5 % of failures Test content must detect 85 % of failures Test content must detect 87.5 % of failures Test content must detect 90 % of failures Test content must detect 92.5 % of failures Test content must detect 95 % of failures Test content must detect 97.5 % of failures Test content must detect 99.5 % of failures
Ranking
Almost Impossible Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
10 9 8 7 6 5 4 3 2 1
Steps in the FMEA Process
1. Select the Process FMEA 8. For each Process In team that it can vary (cau identify associated F 2. Develop a Process Map and and Effects identify all process steps 9. List all other Cause 3. List all the Key Process variability) and asso Outputs to satisfy internal and and Effects external customer requirements 10. Assign Severity, Oc Detection rating to e 4. For each Process Step, list Key Process Inputs 11. Calculate the risk pr (RPN) for each pote 5. For the Process Define matrix mode scenario relating Product Outputs to Process Variables 12. Determine recomme to reduce all RPNs 6. Rank the inputs according to importance 13. Note: When doing aaProcess FMEA, first assume theTake appropriate Note: When doing Process FMEA, first assume thematerial is good, bu material is good, b 7. Then assume the process is good, but the 14. Re-calculate all RPN bad. Start the process FMEAgood, but the material is bad. Last, assum bad. Then assume the process is material is bad. Last, assum
unsafe. unsafe.
A Process
For each Process Input, List ways that it can vary (causes) and identify associated Failure Modes and Effects List all other Causes (sources of variability) and associated FMs and Effects Assign Severity, Occurrence and Detection rating to each Cause Calculate the risk priority number (RPN) for each potential failure mode scenario Determine recommended actions to reduce all RPNs theTake appropriate actions thematerial is good, but the process is material is good, but the process is Re-calculate all RPNstheprocess is ial is bad. Last, assume the process is erial is bad. Last, assume

Fmea Process Template

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Potential Failure Modes and Effects Analysis (Information Sheet)

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Process Function (Step)

Current Process Controls

Responsible Person & Target Date

Criteria: Severity of Effect Defined

Very Minor None

Possible Failure Rates 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

Steps in the FMEA Process

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