FMEA Document

FMEA
Part or Process Name Facilities Affected Prepared By
Program FMEA Start Date Last Updated
Core Team Revision Level FMEA Number

Action Results
Process Step, Operation, Current Controls/

Class
Function or Potential Failure Potential Effect(s) of Potential Cause(s) Evaluation Sx Recommended Action Taken &
Requirements Mode Failure S of Failure O Method D O RPN Action(s) Assigned To Due Date Effective Date O D Diff PCT% RPN

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 FMEA Document

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 Detection Rankings
Ranking Effect Design FMEA Detection Process FMEA Detection
Absolute No chance that design control will detect No known process control to detect cause
10
uncertainty cause mechanism and subsequent failure. mechanism and subsequent failure.

Very remote chance that design control

9 Very remote will detect cause mechanism and
subsequent failure.
Remote chance that design control will Remote chance that process control to
8 Remote detect cause mechanism and subsequent detect cause mechanism and subsequent
failure. failure.
Very low chance that design control will
7 Very Low detect cause mechanism and subsequent
failure.

Low chance that design control will detect Low chance that process control to detect
6 Low
cause mechanism and subsequent failure. cause mechanism and subsequent failure.

Moderate chance that design control will

5 Moderate detect cause mechanism and subsequent
failure.
Moderately high chance that design
Moderately
4 control will detect cause mechanism and
High
subsequent failure.
very remote chance that design control
High chance that process control to detect
3 High will detect cause mechanism and
cause mechanism and subsequent failure.
subsequent failure.
Very high chance that design control will
2 Very High detect cause mechanism and subsequent
failure.

Design control will almost certainly detect Current control almost certain to detect
1 Almost Certain
cause mechanism and subsequent failure. cause mechanism and failure mode.
 Occurrence Rankings
Ranking Effect Failure Rates Percent Defective Cpk
10 Extremely High > 1 in 2 50% Cpk < 0.33
9 Very High 1 in 3 33% Cpk ~ 0.5
8 Very High 1 in 8 10-15% Cpk ~ 0.75
7 High 1 in 20 5%
6 Marginal 1 in 100 1%
5 Marginal 1 in 400 0.25% Cpk ~ 1
4 Unlikely 1 in 2000 0.05%
3 Low 1 in 15,000 0.007% Cpk > 1.33
2 Very Low 1 in 150,000 0.0007% Cpk > 1.5
1 Remote < 1 in 1,500,000 0.000007% Cpk > 1.67
 Severity Rankings
Ranking Effect Design FMEA Severity
affects safe operation without
10 Hazardous-no warning
warning
affects safe operation with
9 Hazardous- w/ warning
warning
8 Very High makes product inoperable
makes product operable at
7 High reduced performance
(customer dissatisfaction)
6 Moderate results in customer discomfort
results in comfort and
5 Low
convenience at a reduced level
results in dissatisfication by
4 Very Low
most customers.
results in dissatisfication by
3 Minor
average customer.
results in dissatisfication by few minor disruption (minimal affect
2 Very Minor
customers.
1 None No effect
Process FMEA Severity
may endanger machine or
operator without warning
may endanger machine or
operator with warning
major disruption in operations
(100% scrap)
minor disruption in operations
(may require sorting and some
scrap)
minor disruption in operations
(no sorting but some scrap)
minor disruption in operations
(portion may require rework)
minor disruption in operations
(some sorting and portion may
require rework)
minor disruption (some rework
but little affect on production
rate)
on production rate)
No effect
 FMEA Attendance Sheet
Session Date1 Date2 Date3 Date4 Date5
Hours 2 2 4 2 2
Team Members Position x x x x x
Attendee1 Facilitator x x x
Attendee2 x x x x
Attendee3 x x x
Attendee4 x
Attendee5 x x x
Attendee6 x
Attendee7 x x x x x
Attendee8 x x x x x
Attendee9 x x x
Attendee10 x x x