Failure Mode and Effect Analysis

Dr. Shaymaa Elsawaby

 What is FMEA?
Failure Mode and Effect Analysis

⚫ A systemized group of activities designed to:

1. recognize and evaluate the potential failure of a
product/process and its effects
2. identify actions which could eliminate or reduce
the chance of potential failure
3. document the process
 What is FMEA?

⚫ An FMEA is a rigorous, step by step

process, to figure out everything that could
go wrong and what can be done to keep
those things from happening.

⚫ It is not something we don’t do everyday.

⚫ There are risky things that people do.

 What is FMEA?

⚫ For example when we get into a car we

know that we could have a car accident so
we put on a seatbelt.

⚫ It’sa way of thinking what could go wrong

ahead of time and preventing that from
happening
Failure Mode and Effect Analysis

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

⚫ For example, a car’s tire might fail by

1- puncture from a sharp object.
⚫ 2- blowout resulting from wear.
(Puncture and blowout are two of the
many tire failure modes.)
 FMEA Terms

⚫ Effects analysis – studying the

consequences of the various
failure modes to determine their
severity to the customer.
 Effects analysis
⚫ 1- the blowout is likely to have the most serious
consequence, since when a tire suddenly explodes the
speeding car usually goes out of control, often with
dire consequences.

⚫ 2-a puncture problem usually allows the tire pressure

to decrease gradually, allowing the driver time to
sense the problem before he looses control.((Neither
failure mode is something the driver wants but
of the two the puncture is preferred.))
 Why do an FMEA?

⚫ Preventing problems is cheaper and easier than

cleaning them up.

⚫ Some things are too risky or costly to incur

mistakes.
 Example
⚫ Healthcare is a good example of this because
we have very costly and risky procedures.

⚫ FMEA is critical for healthcare procedures

because preventative medicine is less costly
than curative medicine.

⚫ We want to prevent problems before they

happen and that is exactly what an FMEA does
 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
 The main reason to do FMEA

is to identify any inadequacies in

the product and to get it right
the first time so that there are no
costly mistakes later.
 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
 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.
 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
Types of FMEA
 Types of FMEA
⚫ The main difference between the two is
that:

⚫ A Design FMEA is done during the design

phase of a product to ensure failure modes
have been addressed

⚫ A Process FMEA is done to a process (like a

factory) to ensure failure modes have been
addressed.
 FMEA needs the following
resources:
1- Commitment of top management

2- Knowledgeable individuals with

expertise in: Design Manufacturing,
Assembly, Service, Quality,
Reliability
 FMEA needs the following
resources:
3- Individuals attentive to FMEA timelines
because you want to achieve the greatest
value. These individuals want to identify
failure modes before a design or process
failure mode has been unknowingly
designed into the product
4- People resources may be internal or
external to the business or a combination of
both
 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
⚫ ease late change crises
⚫ Minimize exposure to product failures
⚫ enhance business records
⚫ Improve “bottom line” results
⚫ Add to customer satisfaction
 Limitations
⚫ Employee training requirements
⚫ Initial impact on product and manufacturing
schedules
⚫ Financial impact required to upgrade design,
manufacturing, and process equipment and
tools
 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
 Risk Assessment Factors

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
 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 Assessment Factors

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
 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
 Procedures for FMEA

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

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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
 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
 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
 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
It is the name of the component which is
analyzed
Identifies the name and ID of the systems
or subsystems
Contains names of the responsible
individuals that have the authority to
perform task
Identifies the team responsible for this
design
Used for document tracking purposes
Contains the original date and revised date
Contains the name and Id of item being
analyzed as well as one specific function of
the item
Contains methods
1.May fail to meet design criteria
2.May cause potential failure in high level
systems and low level system
Severity(S)
Used to specify any additional controls
Reasons for failure
Occurrence(O)
Prevention measures
Risk priority number(RPN)=S*O*D
Corrective actions examined by the team
Target completion dates
After an action has been taken, the actual
action and the effective date should be
entered in this colums
S, O, D values should be re-estimated
and RPN should be recalculated
`

S, O, D values should be re-estimated

and RPN should be recalculated