Guidelines For Auditing FMEA
Guidelines For Auditing FMEA
Guidelines For Auditing FMEA
(Source: Potential Failure Mode and Effects Analysis (FMEA) Reference Manual (AIAG): (Feb, 1996))
Note: A QS-9000 auditor may only audit the FMEA process. They may not question the content of the
FMEA.
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Severity, Occurrence, and Detection Criteria for Design FMEA
Very high severity ranking when a potential failure mode affects safe vehicle
Hazardous -
operation and/or involves noncompliance with government regulation without 10
without warning
warning
Very high severity ranking when a potential failure mode affects safe vehicle
Hazardous - with
operation and/or involves noncompliance with government regulation with 9
warning
warning
Fit & finish/Squeak & Rattle item does not conform. Defect noticed by
Very Low 4
average customers.
Fit & finish/Squeak & Rattle item does not conform. Defect noticed by most
Minor 3
customers.
Fit & finish/Squeak & Rattle item does not conform. Defect noticed by
Very Minor 2
discriminating customers.
None No effect. 1*
*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed
8 > 0.51 1 in 8
High: Repeated failures
7 > 0.67 1 in 20
6 > 0.83 1 in 80
*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed
Absolute Design Control will not and/or cannot detect a potential cause/ mechanism and
10
Uncertainty subsequent failure mode; or there is no Design Control.
Remote chance the Design Control will detect a potential cause/ mechanism
Remote 8
and subsequent failure mode.
Very Low chance the Design Control will detect a potential cause/ mechanism
Very Low 7
and subsequent failure mode.
Low chance the Design Control will detect a potential cause/mechanism and
Low 6
subsequent failure mode.
Moderately Moderately High chance the Design Control will detect a potential
4
High cause/mechanism and subsequent failure mode.
High chance the Design Control will detect a potential cause/mechanism and
High 3
subsequent failure mode.
Very High chance the Design Control will detect a potential cause/mechanism
Very High 2
and subsequent failure mode.
*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed