FMEA (4th Edition)

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FMEA (4th Edition)

Process FMEA Table

FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)

Item……………………………………. Process Responsibility…………. FMEA Number……………………..

Model…………………………………. Key Date…………… Page …… of …….
Core Team……………………………… FMEA Date ……………(Rev)…… Prepared by…………………………

Current process
Action Results
Process step Responsibility
Potential Potential S Potential R
& Function / E Control Recommended & Target Actions
Failure Effect(s) of Class Cause(s) of D P S O D
Requirements V Control - O -Detection Action Completion RP
Mode Failure Failure
C
E N
Date Taken & E C E
Prevention T V C T N
C Completion Date

SEV – Severity OCC – Occurrence DET - Detection

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FMEA (4th Edition)

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FMEA (4th Edition)

Suggested Severity Evaluation Criteria:

Customer Effect Manufacturing / Assembly Effect

Rank
Effect Criteria Effect Criteria
Very high severity ranking when a potential
failure mode affects safe vehicle operation Failure to May endanger operator (machine
10
Failure to meet and/or involves noncompliance with meet Safety or assembly) without warning.
safety and government regulation without warning. and / or
regulatory Very high severity ranking when a potential Regulatory
requirements failure mode affects safe vehicle operation requirements May endanger operator (machine
9
and/or involves noncompliance with or assembly) with warning.
government regulation with warning.
100% of product may have to be
Loss of primary function. (Vehicle
Major scrapped. Line shutdown or stop
inoperable, but does not affect safe vehicle 8
Disruption ship.
operation)
Loss or
degradation of A portion of the production may
Primary Function Degradation of primary function. (Vehicle have to be scrapped. Deviation
operable, but at reduced level of Significant from primary process including 7
performance) Disruption decreased line speed or added man
power.

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FMEA (4th Edition)

Customer Effect Manufacturing / Assembly Effect

Rank
Effect Criteria Effect Criteria
Loss of secondary function. Vehicle operable 100% of production run may have
Loss or but Comfort/Convenience functions to be reworked off line and 6
degradation of inoperable. accepted.
Secondary Degradation of secondary function. Vehicle A portion of the production run
Function operable but Comfort/Convenience functions may have to be reworked off line 5
at reduced level of performance. Moderate and accepted.
Appearance or audible noise, vehicle Disruption 100% of production run may have
operable, item does not conform and noticed to be reworked in station before it 4
by most customers (greater than 75%). is processed.
Appearance or audible noise, vehicle A portion of the production run
Annoyance
operable, item does not conform and noticed may have to be reworked in station 3
by many customers (50%). before it is processed.
Appearance or audible noise, vehicle
Slight inconvenience to process,
operable, item does not conform and noticed Minor 2
operation, or operator
by discriminating customers (Less than 25%). Disruption

No Effect No discernible effect. No Effect No discernible effect. 1

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FMEA (4th Edition)

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FMEA (4th Edition)

Suggested Occurrence Evaluation Criteria:

Likelihood of Failure Incidents per items / vehicles Ranking

Very High > 100 per thousand 10

50 per thousand 9

High 20 per thousand 8

10 per thousand 7

2 per thousand 6

Moderate 0.5 per thousand 5

0.1 per thousand 4

0.01 per thousand 3

Low
≤ 0.001 per thousand 2

Very Low Failure is eliminated through preventive control 1

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FMEA (4th Edition)

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FMEA (4th Edition)

Suggested Detection Evaluation Criteria

Opportunity for Likelihood of detection by process control Rank Likelihood of
Detection Detection
No Detection No current process control; Cannot detect or is not analyzed Almost
10
Opportunity Impossible
Not likely to detect at Failure mode and / or error (cause) is not easily detected (e.g. random audits)
9 Very Remote
any stage
Problem Detection Failure mode detection post processing by operator through visual / tactile /
8 Remote
Post Processing audible means
Failure mode detection in-station by operator through visual / tactile / audible
Problem Detection of
means or post processing through use of attribute gauging (go / no-go, manual 7 Very Low
Source
torque check etc)
Problem Detection Failure mode detection post processing by operator through use of variable
6 Low
Post Processing gauging or in-station by operator through use of attribute gauging
Failure mode or error (cause) detection in station by operator through use of
Problem Detection of variable gauging or by automated controls in-station that will detect discrepant
5 Moderate
Source part and notify operator (light, buzzer etc). Gauging performed on setup and first
piece check (for set-up causes only)
Problem Detection Failure mode detection post processing by automated controls that will detect
4 Moderately High
Post Processing discrepant part and automatically lock part to prevent further processing
Failure mode detection in-station by automated controls that will detect
Problem Detection of
discrepant part and automatically lock part in-station to prevent further 3 High
Source
processing
Error Detection and / Error (cause) detection in station by automated controls that will detect error and
or problem prevent discrepant part from being made 2 Very High
Prevention
Detection not Error (cause) detection as a result of fixture design, machine design, or part
applicable; Error design. Discrepant part can not be made because item has been error proofed by 1 Almost Certain
prevention process / product design

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ISO/TS 16949:2009 - FMEA

Fouryes TQM Consultants

ISO/TS 16949:2009 - FMEA

Design FMEA Table

FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)

…System …Subsystem …Component Design Responsibility…………. FMEA Number……………………..

Model…………………………………. Key Date…………… Page …… of …….
Core Team……………………………… FMEA Date ………………… Prepared by…………………………

Current Design
Action Results
Item / Responsibility
Potential Potential S Potential R
Function / E Control Recommended & Target Actions
Failure Effect(s) of Class Cause(s) of D P S O D
Requirements V Control - O -Detection Action Completion RP
Mode Failure Failure
C
E N
Date Taken & E C E
Prevention T V C T N
C Completion Date

SEV – Severity OCC – Occurrence DET - Detection

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