Process Failure Modes and Effec

FMEA Process Leader:

Participants:

Origin Date: Last Revised:

Risk Priorit
Severity of Effect Probability of Occurrence

S O
Function Potential Effects of Potential Causes of
Potential Failure Mode E C
(Requirements) Failure Mode Failure
V C

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Failure Modes and Effects Analysis
Functional Group:
Description:

Risk Priority Number

A Action Results
Ability to Detect C
T S O D
I
D R O E C E
Current Design Controls E P Recommended Actions
N
Resp. Due Date Action Taken V C T
T N #

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 0

Version 1 (20-Jul-2010)
 R
R
P
N

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 FMEA Step-by-Step Instructions

Step 1: Review the Process

To ensure that everyone on the FMEA team has the same understanding of the process that is being worked on, the
team should review a detailed flowchart of the operation for a Process FMEA or blueprint for a Design FMEA. If a
flowchart/blueprint is not available, the team will need to create one prior to starting the FMEA process. With the
blueprint/flowchart, the team should familiarize themselves with the process or product. For a process FMEA, the
team members should physically walk through the process.

Step 2: Brainstorm Potential Failure Modes

Once every team member understands the process/product, team members can begin thinking about potential
failure modes that could affect the process or the product quality. Team members should come to the brainstorming
meeting with a list of their ideas. More ideas will be generated as a result of the synergy of the group brainstorming
process. Document the potential failure modes on the FMEA worksheet.

Once the ideas have been generated, the ideas may be generated into categories, such as where the failure occurs
in the process or by failure mode.

Step 3: List Potential Effects of Each Failure Mode

Review each failure mode and list the potential effects of the failure should it occur, i.e. If the failure occurs, then
what are the consequences?

Steps 4, 5, and 6: Assigning the Severity, Occurrence, and Detection Ratings

Each rating is based on a 10-point scale, with 1 being the lowest rating and 10 being the highest, as defined on the
FMEA Rankings worksheet.

Step 4: Assign a Severity Rating for Each Effect

The severity rating is an estimation of how serious the effects would be if a given failure did occur. A particular
failure mode may have several different effects, and each effect may have a different severity rating, so each effect
should be given its own severity rating.

Step 5: Assign an Occurrence Rating for Each Failure Mode

The best method for determining the occurrence rating is to use actual data. If actual data is not available, the team
must estimate how often a failure mode may occur.

Step 6: Assign a Detection Rating for Each Failure Mode and/or Effect
The detection rating is based on how likely we are to detect a failure or the effect of a failure. The first step is to
identify current controls that are in place to detect a failure or the effect of a failure, then a detection rating can be
determined. For example, if there are no controls, the ability to detect is very low and the item would receive a high
rating, such as 9 or 10.

Step 7: Calculate the Risk Priority Number for Each Failure Mode
Severity x Occurrence x Detection = Risk Priority Number. The total risk priority number is calculated by adding all
the risk priority numbers. Note that this number alone is meaningless, because all FMEAs have a different number
of failure modes. However, it will serve as a gauge to compare the revised total RPN against the original RPN once
the recommended actions have been implemented.

Page 7 of 10, FMEA Instructions

Step 8: Prioritize the Failure Modes for Action
Failure modes can be prioritized by ranking them in order of highest RPN to lowest RPN. A Pareto diagram is a
useful tool to visualize the differences between the various ratings. At this point, the team must decide which items
to work on. Typically, a set cut-off RPN is determined and any failure modes about the cut-off RPN are attended to
first. Actions may still be taken to address other potential failure modes with RPNs below the cut-off.

Step 9: Take Action to Eliminate or Reduce the High-Risk Failure Modes

Identify and implement actions to eliminate or reduce the high-risk failure modes. Where a failure mode cannot be
completely eliminated take action to reduce the severity, minimize the likelihood of occurrence and increase
detectability, as applicable. Reducing severity is important, especially in situations that may result in injuries.

Step 10: Calculate the Resulting RPN as the Failure Modes are Reduced
Once action has been taken to eliminate or reduce the high-risk failure modes, new ratings for severity, occurrence
and detection should be determined and a new RPN calculated. For the failure modes where actions were taken,
there should be a significant reduction in the RPN.

Reference:
McDermott, R. E., & Mikulak, R. J., & Beauregard, M.R. (1996). The Basics of FMEA. Resource Engineering, Inc.

Page 8 of 10, FMEA Instructions

 FMEA Severity, Occurrence and Detection Rankings

Severity Rankings
Effect Severity of Effect Ranking
None No injury and client not aware of any issue. No impact on system
1
or processes.
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 degradation of 3
performance.
Very Low Failure could result in very minor injury of client with annoyance of
the client. System operable with significant degradation of 4
performance.
Low Failure could result in minor injury of client with some
5
dissatisfaction. System inoperable without service interruption.
Moderate Failure could result in moderate injury of client and a moderately
dissatisfied client. System inoperable with slight service 6
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 significant 8
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 health care 9
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 delivery, without 10
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
Moderate: Occasional failures
Occurrence/Probability Rankings
Failure Probability Ranking
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 0.5 hour 2
per month.
One system failure expected in 0.5% of execution instances or will
result in infrastructure/component downtime of up to 1 hours per 3
month.
One system failure expected in 1% of execution instances or will
result in infrastructure/component downtime of up to 2.5 hours per 4
month.
One system failure expected in 2% of execution instances or will
result in infrastructure/component downtime of up to 4 hours per 5
month.
One system failure expected in 2.5% of execution instances or will
result in infrastructure/component downtime of up to 12 hours per 6
month.

Page 9 of 10, FMEA Rankings


High: Repeated failures
Repeatable system failures expected in 5% of execution instances
or will result in infrastructure/component downtime of up to 18 7
hours per month.
Repeatable system failures expected in 10% of execution
instances or will result in infrastructure/component downtime of up 8
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 month. 9

Very High: Failure is almost Failures expected in 25% of execution instances or will result in
inevitable infrastructure/component downtime of up to 48 hours per month. 10

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

Page 10 of 10, FMEA Rankings