FMEA

FAILURE MODES
EFFECTS ANALYSIS

FMEA is an Engineering Reliability Tool

Why is FMEA ?
Identifies Design or process related Failure
Modes before they happen.
Determines the Effect & Severity of these failure
modes
Identifies the Causes and probability of
Occurrence of the Failure Modes.
Identifies the Controls and their Effectiveness.
Quantifies and prioritizes the Risksassociated with
the Failure Modes.
Develops & documents Action Plans that will occur
to reduce risk.

Definitions
Failure Mode

The way in which the product or process could

fail to perform its intended function.
Failure modes may be the result of upstream
operations or inputs, or may cause downstream
operations or outputs to fail.

Failure Effects

The outcome of the occurrence of the failure

mode on the system, product, or process.
Failure effects define the impact on the customer.
Ranking is translated into Severity score

Definitions
Failure Causes

Potential causes or reasons the failure mode

could occur
Likelihood of the cause creating the failure
mode is translated into an Occurrence
score

Current Controls

Mechanisms currently in place that will

detect or prevent the failure mode from
occurring
Ability to detect the failure before it reaches
the customer is translated in Delectability
score

History of the FMEA

1940s - First developed by the US
military in 1949 to determine the
effect of system and equipment
failures
1960s - Adopted and refined by
NASA (used in the Apollo Space
program)
1970s Ford Motor Co.
introduces FMEA after the Pinto
affair. Soon adopted across
automotive industry
Today FMEA used in both
manufacturing and service
industries

Quality
Control

Risk
Assesment

FMEA

continuous
Improvement

Knowledge
Base

CONCEPT of FMEA
Used to analyze concepts in the early
stages before hardware is defined (most
often at system and subsystem)
Focuses on potential failure modes
associated with the proposed functions of
a concept proposal
Includes the interaction of multiple
systems and interaction between the
elements of a system at the concept
stages.

DESIGN
Aid in the objective evaluation of design
requirements and design alternatives
Aid in the initial design for manufacturing
and assembly
Increase the probability that potential
failure modes have been considered
Provide additional information to aid in
the planning of efficient design testing

PROCESS OF FMEA
Indentify potential product related process
failure modes
Assess the potential customer effects of
the failures
Indentify the potential manufacturing
causes on which to focus on
Develop a ranked list of potential failure
modes
Document the results of the
manufacturing

Risk Assesment Criteria

There are a wide variety of scoring
anchors, both quantitative or qualitative
Two types of scales are 1-5 or 1-10
The 1-5 scale makes it easier for the teams
to decide on scores
But usually 1-10 scale is used

Severity (S): A number from 1 to 10,

depending on the severity of the potential
failure modes effect
1 = no effect
10 = maximum severity

Risk Guidelines
Effect

Rank

Criteria

None

No effect

Very Slight

Negligible effect on Performance. Some users may notice.

Slight

Slight effect on performance. Non vital faults will be noticed

by many users

Minor

Minor effect on performance. User is slightly dissatisfied.

Moderate

Reduced performance with gradual performance degradation.

User dissatisfied.

Severe

Degraded performance, but safe and usable. User dissatisfied.

High Severity

Very poor performance. Very dissatisfied user.

Very High Severity

Inoperable but safe.

Extreme Severity

Probable failure with hazardous effects. Compliance with

regulation is unlikely.

Maximum Severity

10

Unpredictable failure with hazardous effects almost certain.

Non-compliant with regulations.

Probability of occurrence (O): A number

from 1 to 10, depending on the likelihood
of the failure modes occurrence
1 = very unlikely to occur
10 = almost certain to occur

Occurrence Ranking
Occurrence

Rank

Criteria

Extremely Unlikely

Less than 0.01 per thousand

Remote Likelihood

0.1 per thousand rate of occurrence

Very Low Likelihood

0.5 per thousand rate of occurrence

Low Likelihood

1 per thousand rate of occurrence

Moderately Low
Likelihood

2 per thousand rate of occurrence

Medium Likelihood

5 per thousand rate of occurrence

Moderately High
Likelihood

10 per thousand rate of occurrence

Very High Severity

20 per thousand rate of occurrence

Extreme Severity

50 per thousand rate of occurrence

Maximum Severity

10

100 per thousand rate of occurrence

Probability of detection (D): A number

from 1 to 10, depending on how unlikely
it is that the fault will be detected by the
system responsible (design control
process, quality testing, etc.)
1 = nearly certain detention
10 = impossible to detect

Detection Ranking
Detection

Rank

Criteria

Extremely Likely

Can be corrected prior to prototype/ Controls will almost certainly

detect

Very High Likelihood

Can be corrected prior to design release/Very High probability of

detection

High Likelihood

Likely to be corrected/High probability of detection

Moderately High
Likelihood

Design controls are moderately effective

Medium Likelihood

Design controls have an even chance of working

Moderately Low
Likelihood

Design controls may miss the problem

Low Likelihood

Design controls are likely to miss the problem

Very Low Likelihood

Design controls have a poor chance of detection

Remote Likelihood

Unproven, unreliable design/poor chance for detection

Extremely Unlikely

10

No design technique available/Controls will not detect

Risk Priority Number (RPN)

is defined as the product of the three
independently assessed factors:
RPN = (S) * (O) * (D)
where

Severity = (S),
Occurrence = (O),
and Detection = (D).

Sample FMEA Form

Describe
the impact

Process
Step

Describe how the

process step could
go wrong

What could
What actions
cause the
will you take?
failure?
Is there anything in place to
detect or stop this from
happening?

Rankings (1-10)

FMEA / fMECA

20

FMEA / fMECA

CALCULATE THE RISK PRIORITY NUMBER FOR EACH FAILURE MODE

PRIORITIZE THE THE FAILURE MODES FOR ACTION

TAKE ACTION TO ELEMINATE OR REDUCE THE HIGH RISK FAILURE

MODES

CALCULATE THE RESULTING RPN AFTER ACTIONS

21

FMEA / fMECA

22

FMEA / fMECA

23

Feed results back into design

process
Corrective actions developed on a priority
basis
Assign Responsibility for Implementation
of corrective action
Scheduling of corrective action items is
key to product development and
improvement

Implementation into Design Process

Methodology

FMEA Tips
No absolutes rules for what is a high RPN
number. Rather, FMEA often are viewed on
relative scale (i.e., highest RPN addressed first)
It is a team effort
Motivate the team members
Ensure cross-functional representation on the
team
Treat as a living document, reflect the latest
changes
Develop prioritization with the process owners!
Assign an owner to the FMEA; ensure it is
periodically reviewed and updated

TYPES OF FMEA

TEAM OF FMEA
A team approach is necessary.
Team should be led by the Process

Owner
who is the responsible manufacturing
engineer or technical person, or other similar
individual familiar with FMEA.
The following should be considered for team
members:
Design Engineers
Process Engineers
Materials Suppliers
Customers

Operators
Reliability
Suppliers

FMEA & Other Risk Analysis Tools

FMEA
Bottoms-up approach to
failure analysis
Systematic method for
identifying all the potential
failure modes of a process
or product
Creates prioritized
ranking of failure modes
within a system

Cause & Effect Diagram

Fault Tree Analysis

Examines a certain failure

mode or event and
identifies all the possible
causes

Top-down approach to

Causes are grouped into

several logical categories

failure analysis
Starting point is a failure
or undesired state
Drill down into lower
level events leading up to
the undesired state
Similar to the 5 Whys
method