Embed Size (px)
Citation preview
(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
#
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
#Process Function
(Step)
Potential Failure Modes (process
defects)
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s) of
Failure
OCC
Current Process Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
91
92
93
94
95
96
97
98
99
100
DET
RPN
DET
RPN
DET
RPN
DET
RPN
DET
RPN
DET
RPN
DET
RPN
#
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
# Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
# Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
# Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
# Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
# Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
# Item and Function
Potential Failure Mode
Potential Effect(s) of
Failure
SEV
Class
Potential Cause(s)/Mecha
nism(s) of Failure
OCC
Current Design Controls
DET
RPN
Recommend Actions
Responsible Person &
Target Date
Taken Actions
SEV
OCC
91
92
93
94
95
96
97
98
99
100
DET
RPN
DET
RPN
DET
RPN
DET
RPN
DET
RPN
DET
RPN
DET
RPN
Effect Criteria: A failure could... Ranking
Injure a customer or employee 10
Be illegal 9
Very High Render the product or service unfit for use 8High Cause extreme customer dissatisfaction 7
Moderate Result in partial malfunction 6Low Cause a loss of performance likely to result in a complaint 5
Very Low Cause minor performance loss 4Minor Cause a minor nuisance; can be overcome with no loss 3
Very Minor Be unnoticed; minor effect on performance 2None Be unnoticed and not affect the performance 1
Hazardous: Without WarningHazardous: With
Warning
Probability of Failure Time Period Probability Ranking
Very High: More than once per day > 30 % 10
Failure is almost inevitable Once every 3-4 days < 30 % 9
Once per week < 5 % 8
processes that have often failed Once per month < 1 % 7
Once every 3 months < 0.03 % 6
previous processes which have Once every 6 months < 1 per 10,000 5
Once per year < 6 per 100,000 4
Once every 1-3 years < 6 per million 3
Once every 3-6 years < 3 per 10 million 2
Once every 6-100 years < 2 per billion 1
High: Generally associated with processes similar to previous
Moderate: Generally associated with processes similar to
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
Detection Ranking
Almost Impossible Defect caused by failure is not detectable 10
Very Remote Occasional units are checked for defects 9
Remote Units are systematically sampled and inspected 8
Very Low All units are manually inspected 7
Low Manual inspection with mistake-proofing modifications 6
Moderate 5
Moderately High 4
High 3
Very High All units are automatically inspected 2
Almost Certain 1
Criteria: Liklihood the existence of a defect will be detected by test content before product advances to
next or subsequent process
Process is monitored via statistical process control (SPC) and manually inspected
SPC used, with an immediate reaction to out-of-control conditions
SPC as above, with 100% inspection surrounding out-of-control units
Defect is obvious and can be kept from affecting customer
Process FMEA Steps
Step
1 List the process steps in the first column of the PFMEA form2
3Identify the potential effects of each failure mode and rate the severity of the effects
4
5
6 Multiply the three ratings to get the Risk Priority Number (RPN)7
8 Recalculate the RPN to verify it is below the economically feasible threshold
Prior to developing the PFMEA a team should be selected and a process map developed for the process in question
For each process step brainstorm a list of the potential failure modes - ways is which the product or service might fail.
Identify the potential causes of the failure modes and rate their likelihood of occurrenceList current controls in place and rate the ability of the control to detect or prevent the failure mode or cause
Identify improvement actions to reduce or eliminate the risk associated with high RPN's
