FAILURE MODE AND EFFECT ANALYSIS

FMEA: A General Overview

Any FMEA conducted properly and appropriately will provide
the practitioner with useful information that can reduce the risk
(work) load in the system, design, process, and service.

A good FMEA

 Identifies known and potential failure modes

 Identifies the causes and effects of each failure mode
 Prioritizes the identified failure modes according to the risk
priority number (RPN)-the product of frequency of occurrence,
severity, and detection
 Provides for problem follow-up and corrective action

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When Is the FMEA Started?

By definition the FMEA is a methodology to maximize the

satisfaction of the customer by eliminating and/or reducing
known or potential problems. To do this the FMEA must begin
as early as possible, even though all the facts and information
are not known yet. The FMEA focuses on the motto

Do the best you can, with what you have.

One should start an FMEA as soon as some information is

known (usuallv through a QFD) Practitioners should not wait for
all the information. If they do, they will never perform an FMEA
because they will never have all the data or information.
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When Is the FMEA Started?

Specifically, an FMEA program should start

 When new systems, designs, products, processes, or

services are designed
 When existing systems, designs, products, processes, or
services are about to change regardless of reason
 When new applications are found for the existing
conditions of the systems, designs, products, processes, or
service
 When improvements are considered for the existing
systems, designs, products, processes, or services

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When Is the FMEA Complete?

Is there a time when the FMEA may be considered finished or

complete? Yes. Only when the system, design, product, process,
or service is considered complete and/or discontinued.

Who conducts the FMEA?

The FMEA is a team function and cannot be done on an

individual basis.

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 FAILURE MODE AND EFFECT ANALYSIS
Interpretation of the FMEA
The essence of the FMEA is to identify and prevent known and
potential problems from reaching the customer.
There are three components that help define the priority of failures
 Occurrence (O)
 Severity (S)
 Detection (D)
Occurrence is the frequency of the failure. Severity is the
seriousness (effects) of the failure. Detection is the ability to
detect the failure before it reaches the customer.
There are many ways to define the value of these components.
The usual way is to use numerical scales (called risk criteria
guidelines). These guidelines can be qualitative and/or qualitative.
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 FAILURE MODE AND EFFECT ANALYSIS
Evaluation Criteria for OCCURRENCE

PROBABILITY OF FAILURE POSSIBLE CpK RANKING

FAILURE RATES
Very High: Failure is almost inevitable 1 in 2  0.33 10
1 in 3 0.33 9
High: Generally associated with processes 1 in 8 0.51 8
similar to previous processes that have often 0.67
1 in 20 7
failed
Moderate: Generally associated with 1 in 80 0.83 6
processes similar to previous processes which 1 in 400 1.00 5
have experienced occasional failures, but not
1 in 2000 1.17 4
in major proportions
Low: Isolated failures associated with similar 1 in 15,000 1.33 3
processes
Very Low: Only isolated failures associated 1 in 1,50,000 1.50 2
with almost identical processes
Remote: failure is unlikely. No failures ever 1 in 15,00,000 1.67 1
associated with almost identical processes

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Evaluation Criteria for SEVERITY

EFFECT CRITERIA : SEVERITY OF EFFECT RANKING

Hazardous Many endanger machine or assembly operator. Very high 10
- Without severity ranking when a potential failure mode affects safe
warning vehicle operation and/or involves noncompliance with
government regulation. Failure will occur without warning.
Hazardous Many endanger machine or assembly operator. Very high 9
- with severity ranking when a potential failure mode affects safe
warning vehicle operation and/or involves noncompliance with
government regulation. Failure will occur with warning.
Very High Major disruption to production line. 100% of product may 8
have to be scrapped. Vehicle/item inoperable, loss of
primary function. Customer very dissatisfied.
High Minor disruption to production line. Product may have to be 7
sorted and a portion (less than 100%) scrapped. Vehicle/item
operable, but at a reduced level of performance. Customer
dissatisfied.
Moderate Minor disruption to production line. A portion (less than 6
100%) of the product may have to be scrapped ( no sorting).
Vehicle/item operable, but some comfort/convenience
item(s) inoperable. Customers experiences discomfort.
Low Minor disruption to production line. 100% of product may 5
have to be reworked. Vehicle/item operable, but some
comfort/convenience item(s) operable at reduced level of
performance. Customers experiences discomfort.
Very Low Minor disruption to production line. The product may have 4
to be sorted and a portion (less than 100 %) reworked. Fit &
Finish/squeak & Rattle item does not conform. Defect
noticed by most customers.
Minor Minor disruption to production line. A portion (less than 100 3
%) of the product may have reworked on-line but out-of-
station. Fit & Finish/squeak & Rattle item does not conform.
Defect noticed by average customers.
Very Minor disruption to production line. A portion (less than 100 2
Minor %) of the product have to be reworked on-line but in-station.
Fit & Finish/squeak & Rattle item does not conform. Defect
noticed by discriminating customers.
None No effect 1

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 FAILURE MODE AND EFFECT ANALYSIS
Evaluation Criteria for DETECTION

DETECTION Criteria : Likelihood the existence of a defect will be detected RANKING

by process controls before next or subsequent process, or
before part or component leaves the manufacturing or
assembly location
Almost No known control(s) available to detect failure mode 10
Impossible
Very remote Very remote likelihood current control(s) will detect failure mode 9
Remote Remote likelihood current control(s) will detect failure mode 8
Very Low Very low likelihood current control(s) will detect failure mode 7
Low Low likelihood current control(s) will detect failure mode 6
Moderate Moderate likelihood current control(s) will detect failure mode 5
Moderately Moderately high likelihood current control(s) will detect failure 4
High mode
High High likelihood current control(s) will detect failure mode 3
Very High Very high likelihood current control(s) will detect failure mode 2
Almost Certain Current control(s) almost certain to detect the failure mode. 1
Reliable detection controls are known with similar processes

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Vocabulary of the FMEA
Function:
The task that the system, design, process, component, subsystem,
service must perform. This function is very important in
understanding the entire FMEA process. It has to be
communicated in a way that is concise, exact, and easy to
understand. It cannot be jargon.
To facilitate this, it is recommended that an active verb be found
to describe the function. The active verb defines performance, and
performance is what a function is. Examples of this may be found
in the following words.
Lubricate Position Retain Support

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 FAILURE MODE AND EFFECT ANALYSIS
Vocabulary of the FMEA
Failure: The problem, concern, error, challenge.

Failure Mode: This is the physical description of the manner in

which a failure occurs.

Examples of failure modes include the following

• Open circuit
• Leak
• Hot surface

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Vocabulary of the FMEA

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Vocabulary of the FMEA
Causes of Failure
What is the root cause of the listed failure. Next to the function,
cause of failure is perhaps the most important section of the
FMEA.
Examples of causes of failure include the following:
 System
- Item does not work
- Shorted lead to ground
 Design
- Vibration
- Shock loads

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 FAILURE MODE AND EFFECT ANALYSIS
Vocabulary of the FMEA

Current Controls

Controls that exist to prevent the cause(s) of the failure from

occurring in the design, process, or service. Some examples are

• Capability studies
• Design guidelines
• Design review
• Operator(s)training
• Durability test
• Design of Experiments

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