FMEA

FMEA
There are two primary flavors of FMEA:

Design FMEAs are used during process or product design and
development.
The primary objective is to uncover problems that will result
in potential failures within the new product or process.
Process FMEAs are used to uncover problems related to an
existing process.
These tend to concentrate on factors related to manpower,
systems, methods, measurements and the environment.
Although the objectives of design and process FMEAs may
appear different, both follow the same basic steps and the
approaches are often combined.
FMEA
FMEA drives systematic thinking about a product or process by
asking and attempting to answer three basic questions:
 What could go wrong (failure) with a process or system?
 How bad can it get (risks), if something goes wrong
(fails)?
 What can be done (corrective actions) to prevent things
from going wrong (failures)?
FMEA attempts to identify and prioritize potential process or
system failures. The failures are rated on three criteria:
 The impact of a failure - severity of the effects.
 The frequency of the causes of the failure - occurrence.
 How easy is it to detect the causes of a failure -
detectability.
FMEA
Notice that only the causes and effects are rated - failure
modes themselves are not directly rated in the FMEA
analysis.
FMEA is cause-and-effect analysis by another name – avoid
being hung up on the failure mode.
The failure mode simply provides a convenient model, which
allows us to link together multiple causes with multiple
effects.
It is easy to confuse failures, causes, and effects, especially since
causes and effects at one level can be failures at a lower level.
Effects are generally observable, and are the result of some
cause. Effects can be thought of as outputs.
FMEA
Effects are usually events that occur downstream that affect
internal or external customers.
Root causes are the most basic causes within the process
owner’s control. Causes, and root causes, are in the
background; they are an input resulting in an effect.
Failures are what transform a cause to an effect; they are often
unobservable.
One can think of failures, effects, and causes in terms of the
following schematic:
Root Cause Failure Effect

x f(x) y
FMEA
Note that a failure mode can have numerous distinct effects, and
that each effect has its own system of root causes.
With this in mind, another way to think of failures, effects, and

causes is:
Causes - x's
Failure - f(x) Effect - y

FMEA
Keep in mind that a single failure mode can have several effects,
and that the cause-and-effect diagram on the previous slide
should be repeated for each effect of the failure!!!
Cause Set 1 - x1's Effect 1 - y1
Cause Set 2 - x2's Effect 2 - y2
. Failure Mode - f(x) .

.
.
.
.
Cause Set n - xn's Effect n - yn
Risk Priority Numbers
The failures identified by the team in an FMEA project are
prioritized by what are called Risk Priority Numbers, or
RPN values.
The RPN values are calculated by multiplying together the
Severity, Occurrence, and Detection (SOD) values
associated with each cause-and-effect item identified for
each failure mode.
Note: The failure mode itself is not rated and only plays a
conceptual role in linking causes with their effects on the
product, process, or system.
For a given cause-and-effect pair the team assigns SOD values
to the effects and causes. Then an RPN is calculated for that
pair: RPN = Severity x Occurrence x Detection.
FMEA
Once the RPN values are assigned to each of the cause-and-
effect pairs identified by the team, the pairings are
prioritized.
The higher the RPN value, the higher the priority to work on
that specific cause-and-effect pair.
The measurement scale for the SOD values is typically a 5 or 10
point Likert scale (an ordinal rating scale).
The exact criteria associated with each level of each rating scale
is dependent upon either a company designed rating criteria
or a specified rating criteria from an industry specific
guideline.
We recommend the use of a 10 point Likert scale for each of the
three rating criteria: Severity, Occurrence, and Detection.
FMEA
Note: The 10 point scale facilitates the ability of the team to
assign ratings in a timely fashion.
Too many levels can lead to a false sense of precision and a
lot of agonizing over the exact rating to be assigned for each
item.
The rating systems used should be developed to reflect the
specific situation of interest.
Recall the example of the completed FMEA presented earlier.
The FMEA was developed by a team studying OS/390 online
systems availability to end users.
On the following slides, we will see the ratings systems agreed
upon by the team.
FMEA
Severity rates the seriousness of the effect for the potential

failure mode - how serious is the effect if the failure did
occur?
The more critical the effect, the higher the severity rating.
FMEA
Severity ratings for the online systems availability FMEA.
Severity Rank Criterion
None 1 No effect
Very Minor 2 No noticeable effect on production
Minor 3 Minor effect on production
Very Low 4 Very low effect on production
Low 5 Low effect on production
Moderate 6 Moderate effect on production
Significant 7 Noticeable effect on production
High 8 Production nearly halted
Very High 9 Production halted
Disaster 10 Implement Hotsite recovery
FMEA
Occurrence, or frequency of occurrence, is a rating that
describes the chances that a given cause of failure will occur
over the life of product, design, or system.
Actual data from the process or design is the best method for
determining the rate of occurrence. If actual data is not
available, the team must estimate rates for the failure mode.
Examples:
 The number of data entry errors per 1000 entries, or
 The number of errors per 1000 calculations.
An occurrence value must be determined for every potential
cause of the failure listed in the FMEA form.
FMEA
The higher the likelihood of occurrence, the higher the
occurrence value.
Once again, occurrence guidelines can be developed and should

reflect the situation of interest.
FMEA
Occurrence guidelines for the system availability FMEA:
Occurrence Rank Criterion Possible failure rate
Remote 1 Unklikely that cause occurs  1 in 15,00,000
Very low 2 Very low chance that cause occurs 1 in 1,50,000
Low 3 Few occurrences of cause likely 1 in 15,000
4 1 in 2000
Moderate 5 Medium number of occurences of cause 1 in 400
6 1 in 80
7 1 in 20
High High number of occurrences of cause
8 1 in 8
9 1 in 3
Very High Very high number of occurrences of cause
10  1 in 2
FMEA
The detection rating describes the likelihood that we will detect
a cause for a specific failure mode.
An assessment of process controls gives an indication of the
likelihood of detection.
Process controls are methods for ensuring that potential
causes are detected before failures take place.
For example, process controls can include:
• Required fields or limited fields in electronic forms,
• Process and/or system audits, and
• “Are you sure” dialog boxes in computer programs.
If there are no current controls, the detection rating will be high.
If there are controls, the detection rating will be low.
FMEA
The higher a detection rating, the lower the likelihood we
will detect a specific cause if it were to occur.
Detection guidelines developed for the system availability FMEA:
Detection Rank Criterion
Almost certain 1 Cause obvious and easy to detect
Very High 2 Very high chance of detecting the cause
High 3 High chance of detecting the cause
Moderately High 4 Cause easily detected by inspection
Moderate 5 Moderate likelihood of detection
Low 6
Low likelihood of detection
Very Low 7
Very low likelihood of detection
Remote 8 Cause is hard to identif y
Very Remote 9 Cause is very hard to identif y
Almost impossible 10 Cause usually not detectable

FMEA
Conducting an FMEA: Basic Steps
1. Define the scope of the FMEA.
2. Develop a detailed understanding of the current process.
3. Brainstorm potential failure modes.
4. List potential effects of failures and causes of failures.
5. Assign severity, occurrence and detection ratings.
6. Calculate the risk priority number (RPN) for each cause.
7. Rank or prioritize causes.
8. Take action on high risk failure modes.
9. Recalculate RPN numbers.

FMEA

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FMEA

There are two primary flavors of FMEA:

Root Cause Failure Effect

With this in mind, another way to think of failures, effects, and

Failure - f(x) Effect - y

Cause Set 1 - x1's Effect 1 - y1

Cause Set 2 - x2's Effect 2 - y2

. Failure Mode - f(x) .

Severity rates the seriousness of the effect for the potential

Once again, occurrence guidelines can be developed and should

Occurrence Rank Criterion Possible failure rate

Remote 1 Unklikely that cause occurs  1 in 15,00,000

Very low 2 Very low chance that cause occurs 1 in 1,50,000

Low 3 Few occurrences of cause likely 1 in 15,000

Moderate 5 Medium number of occurences of cause 1 in 400

Almost certain 1 Cause obvious and easy to detect

Very High 2 Very high chance of detecting the cause

High 3 High chance of detecting the cause

Moderately High 4 Cause easily detected by inspection

Moderate 5 Moderate likelihood of detection

Very Remote 9 Cause is very hard to identif y

Almost impossible 10 Cause usually not detectable

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