FMEA Severity, Occurrence and Detection Rankings

Severity Rankings
Effect Severity of Effect Rankin
g
None No injury and client not aware of any issue. No impact on
system or processes. 1
Very Minor Failure does not result in injury of a client, but does result in
client annoyance. System operable with slight degradation of 2
performance.
Minor Failure could result in slight injury to the client with
annoyance of the client. System operable with moderate 3
degradation of performance.
Very Low Failure could result in very minor injury of client with
annoyance of the client. System operable with significant 4
degradation of performance.
Low Failure could result in minor injury of client with some
dissatisfaction. System inoperable without service 5
interruption.
Moderate Failure could result in moderate injury of client and a
moderately dissatisfied client. System inoperable with slight 6
service interruption without stopping health care delivery.
High Failure could result in significant injury of client and a highly
dissatisfied client. System inoperable with significant service 7
interruption without stopping health care delivery.
Very High Failure could result in very significant injury of client and a
very highly dissatisfied client. System inoperable with
8
significant service interruption without stopping health care
delivery.
Hazardous with warning Failure could result in permanent injury of a client. Failure
mode affects safe system operation, or completely stops 9
health care delivery, with warning.
Hazardous without warning Failure could result in death of a client. Failure mode affects
safe system operation, or completely stops health care 10
delivery, without warning.
Note:"System" can refer to a system, process or design, as applicable to the FMEA.

Probability of Failure
Remote: Failure is unlikely
Low: Relatively few failures
Occurrence/Probability Rankings
Failure Probability Rankin
g
No system failure expected. 1
One system failure expected in 0.25% of execution instances
or will result in infrastructure/component downtime of up to 2
0.5 hour per month.
One system failure expected in 0.5% of execution instances
or will result in infrastructure/component downtime of up to 1 3
hours per month.

Moderate: Occasional
failures
High: Repeated failures
Very High: Failure is almost
inevitable
One system failure expected in 1% of execution instances or
will result in infrastructure/component downtime of up to 2.5 4
hours per month.
One system failure expected in 2% of execution instances or
will result in infrastructure/component downtime of up to 4 5
hours per month.
One system failure expected in 2.5% of execution instances
or will result in infrastructure/component downtime of up to 12 6
hours per month.
Repeatable system failures expected in 5% of execution
instances or will result in infrastructure/component downtime 7
of up to 18 hours per month.
Repeatable system failures expected in 10% of execution
instances or will result in infrastructure/component downtime 8
of up to 24 hours per month.
Failures expected in 15% of execution instances or will result
in infrastructure/component downtime of up to 36 hours per 9
month.
Failures expected in 25% of execution instances or will result
in infrastructure/component downtime of up to 48 hours per 10
month.

Detectability Rankings
Detection Detectability Rankin
g
Almost Certain Design control will detect potential cause/mechanism and
subsequent failure mode. 1
Very High Very high chance the design control will detect potential
cause/mechanism and subsequent failure mode. 2
High High chance the design control will detect potential
cause/mechanism and subsequent failure mode. 3
Moderately High Moderately high chance the design control will detect
potential cause/mechanism and subsequent failure mode. 4
Moderate Moderate chance the design control will detect potential
cause/mechanism and subsequent failure mode. 5
Low Low chance the design control will detect potential
cause/mechanism and subsequent failure mode. 6
Very Low Very low chance the design control will detect potential
cause/mechanism and subsequent failure mode. 7
Remote Remote chance the design control will detect potential
cause/mechanism and subsequent failure mode. 8
Very Remote Very remote chance the design control will detect potential
cause/mechanism and subsequent failure mode. 9
Absolute certainty Design control cannot detect potential cause/mechanism and
potential failure mode. 10