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OBJECTIVES
What is FMEA?
Why is an FMEA important?
History of FMEA
Benefits of FMEA
Limitations of FMEA
How to conduct an FMEA?
Examples. 2
WHAT IS FMEA?
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
FMEA provides a systematic method that allows you to organize and automate
the process.
3
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.
4
WHAT IS FMEA?
OPERATION
FUNCTION
FAILURE MODE
EFFECT
CAUSE CURRENT
CONTROL
Failure Mode : Moisture content inside the compressor.
Effect : Compressor gets damaged.
Cause : Installation of AC system went wrong
Control : Follow the procedure.
5
EXAMPLES
Failure Mode : Too many spelling errors.
Effect :Customer dissatisfied, not understandable.
Cause : Typing error.
Control : Spell check.
6
EXAMPLES
EXAMPLES
Failure Mode :Undersized cast product.
Effect :Unfit for use.
Cause :Shrinkage allowance not provided.
Control :Awareness on the shrinkage on cooling or solidification.
7
Failure Mode :Frequent power failure.
Effect :Production delay.
Cause :Generator malfunctioning.
Control :Maintenance.
8
EXAMPLES
Failure Mode : No raw materials.
Effect : Delay in production.
Cause :Re order point wasn’t calculated.
Control :Use of inventory control system.
9
EXAMPLES
EXAMPLES
Failure Mode : Under inflated tyre-pressure below the required unit.
Effect : Difficulty in controlling the vehicle.
Cause : Unaware of pressure changes with climate variations
Control : Pressure check based on the climate.
10
Failure Mode :Candidate recruited to a wrong field.
Effect :Inefficient work, less output from the candidate.
Cause :Not aware of the candidate’s qualification.
Control :QFD
11
EXAMPLES
12
Failure Mode :Insufficient planning
Effect :Target not met.
Cause :Forecasting error.
Control :Improved forecasting technique
EXAMPLES
13
Failure Mode :Very high RPN/ Zero RPN
Effect :Confusion among the FMEA team.
Cause :Ranking error.
Control : Training and analysis.
EXAMPLES
KEY TERMS
FAILURE MODE –
A failure mode is the root through which the failure has happened.
This can also be mentioned as the deviation that has caused the effect.
14
15
KEY TERMS
CAUSE -The causes are related to the mode and is the reason why the
deviation (failure Mode) has happened and hence the effect.
Probability of occurrence (O): A number from 1 to 10, depending on the
likelihood of the failure mode’s occurrence
1 = very unlikely to occur
10 = almost certain to occur
17
KEY TERMS
CURRENT CONTROL - The immediate tasks that prevent causes from
occurring or which detect the failure before it reaches the customer
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
EFFECT - The consequences of a failure mode. Severity considers the worst
case outcome of a failure as determined by the degree of injury, property
damage, or harm that could ultimately occur
Severity (S): A number from 1 to 10, depending on the severity of the
potential failure mode’s effect
1 = no effect
10 = maximum severity
KEY TERMS
19
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.
RISK ASSESSMENT FACTORS
21
Process-Purchasing an oil seal from store for Car servicing.
25
MY PROCESS
Collecting details
of the car.
Providing
requisition slip.
Issuing of oil seal
from store
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
Operation :Patient Check Up
PROCEDURE FOR FMEA
31
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
PROCEDURE FOR FMEA
32
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
PROCEDURE FOR FMEA
33
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
10
PROCEDURE FOR FMEA
34
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
10 Outside
food.
PROCEDURE FOR FMEA
35
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
10 Outside
food.
7
PROCEDURE FOR FMEA
36
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
10 Outside
food.
7 Cooking
PROCEDURE FOR FMEA
37
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
10 Outside
food.
7 Cooking
5
PROCEDURE FOR FMEA
38
Operation :Patient Check Up
Function
/Require
ment
Failure
mode
Effect Severity
(How
bad is
it?)
Causes Occurren
ce
(How
often?)
Control
method
Detectio
n
RPN
Diagnose
the
disease.
High
bacteria
level.
Tempera
ture
(fever)
10 Outside
food.
7 Cooking
5 10*7*5=
350
PROCEDURE FOR FMEA
39
Operation :Patient Check Up
WHY IS AN FMEA IMPORTANT?
Preventing problems is cheaper and easier than cleaning them up.
Some things are too risky or costly to incur mistakes.
Regulatory reasons
40
Reduce the likelihood of customer complaints
Reduce maintenance and warranty costs
Reduce the possibility of safety failures
WHY IS AN FMEA IMPORTANT?
41
HISTORY OF FMEA
Formally developed and applied by NASA in the 1960’s to improve and
verify reliability of space program hardware during APOLLO missions.
In 1974, the NAVY developed the MIL-STD-1629 regarding the use of
FMEA.
42
FMEA TEAM
46
Core Team
Support Team
•FMEA experts
•Six Sigma Professionals
Representatives from:
•Production
•Development
•Design
•Sales
•Marketing
•Etc…
FMEA TEAM
47
Core Team
Support Team
•FMEA experts
•Six Sigma Professionals
Representatives from:
•Production
•Development
•Design
•Sales
•Marketing
•Etc…
WHEN IS AN FMEA CARRIED OUT?
When a process, product or service is being designed or redesigned,
after quality function deployment.
When improvement goals are planned for an existing process, product
or service.
When analyzing failures of an existing process, product or service.
48
If the high level design issues can be known and analyzed during the early
stages, then the more detailed and in-depth analysis can be programmed and
achieved before time constraints intervene.
FMEA must, therefore, be initiated at as early a stage in the design process
as possible, and at a time when there is something to analyze. It should then
continue to run in parallel but slightly lagging the design effort.
FMEA IN DESIGN PROCESS
49
HOW OFTEN SHOULD THE FMEA BE
UPDATED?
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
50
FMEA Team
Client’s Focal Point
(Design/Operations))
Designers
• The team of designers and the FMEA team should
operate as parts of an overall team and not operate in an
isolated manner.
•Criticism of a design by the FMEA analysts
should not be accepted with bad grace by the
designers.
REPORTING PROCEDURE IN FMEA
51
STANDARDS IN FMEA
It is important to specify the standard to which the FMEA is to be carried
out.
The use of a clearly defined methodology for carrying out the FMEA will
allow the required in-depth study to be attained without the uncertainty and
indiscipline that a less structured approach would bring.
Increased confidence that all parties will accept the FMEA.
53
Standard that is usually referred to when carrying out an FMEA :
US Department of Defense MIL-STD-1629A,(Used by the Government,
Military and other organizations world wide.)
STANDARDS IN FMEA
54
BENEFITS OF FMEA
Greater customer satisfaction
Reduce product development time
Increased cooperation and teamwork between various functions
55
LIMITATIONS OF FMEA
Employee training requirements.
Initial impact on product and manufacturing schedules.
Financial impact required to upgrade design, manufacturing, and process
equipment and tools.
56
COMMON MISTAKES
Could not separate Failure Mode, Cause & Effect.
Ranking criteria too loose.
Only identifying the problems but not the solutions.
Do once, then keep in file.
Lack of consistency.
57