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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:

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Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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90

Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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100

Process
Function
(Step)

Potential Failure
Modes (process
defects)

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) of
Failure

O
C
C

Current
Process
Controls

D
E
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

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Item and
Function

Potential Failure
Mode

Potential
Effect(s) of
Failure

S
E
V

C
l
a
s
s

Potential
O
Cause(s)/Mecha
C
nism(s) of
C
Failure

D
Current Design
E
Controls
T

R
P
N

Recommend
Actions

Responsible
Person &
Target Date

Taken
Actions

S
E
V

O
C
C

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

D
E
T

R
P
N

Effect
Hazardous:
Without Warning
Hazardous: With
Warning
Very High
High
Moderate
Low
Very Low
Minor
Very Minor
None

Criteria: A failure could...

Ranking

Injure a customer or employee

10

Be illegal

Render the product or service unfit for use


Cause extreme customer dissatisfaction
Result in partial malfunction
Cause a loss of performance likely to result in a complaint
Cause minor performance loss
Cause a minor nuisance; can be overcome with no loss
Be unnoticed; minor effect on performance
Be unnoticed and not affect the performance

8
7
6
5
4
3
2
1

Probability of Failure

Time Period

Probability

Ranking

More than once per day

> 30 %

10

Once every 3-4 days

< 30 %

High: Generally associated with


processes similar to previous

Once per week

<5%

processes that have often failed

Once per month

<1%

Moderate: Generally associated


with processes similar to

Once every 3 months

< 0.03 %

previous processes which have

Once every 6 months

< 1 per 10,000

experienced occasional failures,


but not in major proportions

Once per year

< 6 per 100,000

Low: Isolated failures associated


with similar processes

Once every 1-3 years

< 6 per million

Very Low: Only isolated failures


associated with almost identical
processes

Once every 3-6 years

< 3 per 10 million

Once every 6-100 years

< 2 per billion

Very High:
Failure is almost inevitable

Remote: Failure is unlikely. No


failures ever associated with almost
identical processes

Detection

Criteria: Liklihood the existence of a defect will be


detected by test content before product advances to
next or subsequent process

Ranking

Almost Impossible

Defect caused by failure is not detectable

10

Very Remote

Occasional units are checked for defects

Remote

Units are systematically sampled and inspected

Very Low

All units are manually inspected

Low

Manual inspection with mistake-proofing modifications

Moderate

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 outof-control units
All units are automatically inspected

Defect is obvious and can be kept from affecting


customer

Moderately High
High
Very High
Almost Certain

4
3
2

Process FMEA Steps


Step
1
2
3
4
5
6
7
8

Prior to developing the PFMEA a team should be selected and a process map
developed for the process in question
List the process steps in the first column of the PFMEA form
For each process step brainstorm a list of the potential failure modes - ways is
which the product or service might fail.
Identify the potential effects of each failure mode and rate the severity of the effects
Identify the potential causes of the failure modes and rate their likelihood of
occurrence
List current controls in place and rate the ability of the control to detect or prevent
the failure mode or cause
Multiply the three ratings to get the Risk Priority Number (RPN)
Identify improvement actions to reduce or eliminate the risk associated with high
RPN's
Recalculate the RPN to verify it is below the economically feasible threshold

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