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FMEA- FAILURE MODE & EFFECT ANALYSIS. 1 PRESENTED BY: AJITH FRANCIS

FMEA- FAILURE MODE & EFFEC T A N A LY SI S. · FMEA provides a systematic method that allows you to organize and automate ... verify reliability of space program hardware during APOLLO

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F M E A - FA I L U R E M O D E &

E F F E C T A N A LY S I S .

1

PRESENTED BY: AJITH FRANCIS

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.

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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.

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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

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EXAMPLES

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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.

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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

OCCURRENCE RANKING

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1 Failure is unlikely

Cpk > 2.00

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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

DETECTION RANKING

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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

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SEVERITY RANKING

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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

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RISK PRIORITY NUMBER

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RISK PRIORITY NUMBER

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FMEA ANALYSIS

Process flow

Control Plan

Completed FMEA

RPN Analysis

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Process-Purchasing an oil seal from store for Car servicing.

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MY PROCESS

Collecting details

of the car.

Providing

requisition slip.

Issuing of oil seal

from store

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PROCESS FLOW

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FMEA

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RPN ANALYSIS

COMPLETED FMEA

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CONTROL PLAN

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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

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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

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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

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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

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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

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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

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Reduce the likelihood of customer complaints

Reduce maintenance and warranty costs

Reduce the possibility of safety failures

WHY IS AN FMEA IMPORTANT?

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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.

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FMEA TEAM

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Core Team

FMEA TEAM

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Core Team •FMEA experts

•Six Sigma Professionals

FMEA TEAM

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Core Team

Support Team

•FMEA experts

•Six Sigma Professionals

FMEA TEAM

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Core Team

Support Team

•FMEA experts

•Six Sigma Professionals

Representatives from:

•Production

•Development

•Design

•Sales

•Marketing

•Etc…

FMEA TEAM

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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.

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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

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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

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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

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FMEA PROCESS

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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.

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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

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BENEFITS OF FMEA

Greater customer satisfaction

Reduce product development time

Increased cooperation and teamwork between various functions

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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.

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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.

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T H A N K Y O U

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