2015.11.30.

Failure Mode and Effect Analysis

Objectives

 What is FMEA?
 Why is an FMEA important?
 History of FMEA
 Benefits of FMEA
 Limitations of FMEA
 How to conduct an FMEA?

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Who is in Attendance?

 Anyone conducted an FMEA before?

 Anyone completed a Risk Analysis
Procedure?

What is FMEA?
Failure Mode and Effect Analysis

 A systemized group of activities designed

to:
▪ recognize and evaluate the potential
failure of a product/process and its effects
▪ identify actions which could eliminate or
reduce the chance of potential failure
▪ document the process

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Failure Mode and Effect Analysis

 Simply put FMEA is:

a process that identifies all the possible
types of failures that could happen to a
product and potential consequences of
those failures.

FMEA Terms

 Failure mode - the way in which

something might fail

 Effects analysis – studying the

consequences of the various failure
modes to determine their severity to
the customer.

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Why do an FMEA?

 Preventing problems is cheaper and

easier than cleaning them up.
 Some things are too risky or costly to
incur mistakes.

The Reasons for FMEA

 Get it right the first time
 Indentifies any inadequacies in the development
of the product
 Tests and trials may be limited to a few products
 Regulatory reasons
 Continuous improvement
 Preventive approach
 Team building
 Required procedures

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FMEA Provides the Potential to:

 Reduce the likelihood of customer

complaints
 Reduce the likelihood of campaign changes
 Reduce maintenance and warranty costs
 Reduce the possibility of safety failures
 Reduce the possibility of extended life or
reliability failures
 Reduce the likelihood of product liability
claims

Benefits
 Identify potential and known failures
 Reduce the number of engineering
changes
 Reduce product development time
 Lower start-up costs
 Greater customer satisfaction
 Increased cooperation and teamwork
between various functions
 Continuous improvement

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History
 An offshoot of Military Procedure MIL-P-1629, titled
Procedures for Performing a Failure Mode, Effects
and Criticality Analysis, dated November 9, 1949.
 Used as a reliability evaluation technique to
determine the effect of system and equipment
failures.
 Failures were classified according to their impact on
mission success and personnel/equipment safety.
 Formally developed and applied by NASA in the
1960’s to improve and verify reliability of space
program hardware.

Concept 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.

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Design FMEA

 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 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

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Types of FMEA

Resources Needed

 Commitment of top management

 Knowledgeable individuals
 Individuals attentive to FMEA timelines
 People resources may be internal or
external to the business or a
combination of both

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FMEA Timing

 FMEA should be updated:

▪at the conceptual stage
▪when changes are made to the design
▪when new regulations are instituted
▪when customer feedback indicates a
problem

Advantages

 Enhance design and manufacturing

efficiencies
 Alleviate late change crises
 Minimize exposure to product failures
 Augment business records
 Improve “bottom line” results
 Add to customer satisfaction

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Limitations

 Employee training requirements

 Initial impact on product and
manufacturing schedules
 Financial impact required to upgrade
design, manufacturing, and process
equipment and tools

▪These limitations should be recognized and treated as short term and minimal
interruptions to a business.

Risk Assessment Factors

Severity (S): A number from 1 to 5, depending on the
severity of the potential failure mode’s effect
1 = no effect
5 = maximum severity

Probability of occurrence (O): A number from 1 to 5,

depending on the likelihood of the failure mode’s
occurrence
1 = very unlikely to occur
5 = almost certain to occur

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Risk Assessment Factors

Probability of detection (D): A number from 1 to 5,
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
5 = impossible to detect

Risk Priority Number (RPN): The failure mode’s risk is

found by the formula RPN = S x O x D. RPN =
Severity x Probability of Occurrence x Probability of
Detection. RPN will be a number between 1
(virtually no risk) and 125 (extreme risk).

Risk Priority Number

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Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on
bread

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Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB
bread

Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB Jelly Sandwich

bread

13
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Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB Jelly Sandwich 5/5

bread

Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB Jelly Sandwich 5/5 Out of Stock

bread
Past
Expiration

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Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB Jelly Sandwich 5/5 Out of Stock 2/5

bread
Past
Expiration

Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB Jelly Sandwich 5/5 Out of Stock 2/5 10

bread
Past
Expiration

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Procedures for FMEA

Necessity Problem Effects How bad Causes How Likely? Score Steps to
is it? Prevent
“Process “Failure “Occurrence”
Function” Mode” “Severity”

Put PB on No PB Jelly Sandwich 5/5 Out of Stock 2/5 10 Check

bread Pantry
Past
Expiration Check
Expiration
Date

Conduct an FMEA

 Conduct a process FMEA on a paper

airplane
 Build a paper airplane
 Conduct a design FMEA on your paper
airplane
 Paper Airplane Competition

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Conclusion

 What is FMEA?
 Why is an FMEA important?
 History of FMEA
 Benefits of FMEA
 Limitations of FMEA
 How to conduct an FMEA?

References
 Lean Six Sigma - http://www.leansixsigma.com/
 Stunell Technology - http://www.stunell.com/images/fmea.jpg

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