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FailureModeandEffectsAnalysis

(FMEA)

Dr.SyedAmirIqbal

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POTENTIAL FMEANumberFAILUREMODEAND EFFECTSANALYSIS

(PROCESSFMEA) P ag e o f

Item Process Responsibility Prepared By

Model Yea r(s )/Vehi cle( s) Ke yDate FMEA Date (Or ig.)

CoreTeam

S C O D R. Action Results

ProcessFunct ion Potent ialFai lure PotentialEffect(s) E L PotentialCause(s)/ C E P. Recommended Responsibi l ity Act ions S O D R.

R e qu i re me nt s M od e o f Fa i lu re V A M ech an ism (s )o f C C u r re nt P roce ssC o nt ro l T N . A ct io n (s ) & T arg et T ake n E C O P .

S Failure U E Completion Date V C T N.

S R C

2 3

5 6

8

9 10 11 12

13

14

5

16

7

8 9

0

1

2

1

2

3

4

5

6

7

FLOW DIAGRAM

PFMEAs

LISTS EACH OPERATION

CURRENT CONTROLS

ENHANCED CONTROLS FROM RECOMMENDED

ACTIONS

KPC's, KCC'sPER OPERATION:

INSPECTION FREQUENCY

GAGE & CHECKING DEVICES

REACTION PLANS FOR NON-

CONFORMING PRODUCT

JOB

PER OPERATION:

INSPECTION FREQUENCY

GAGE & CHECKING DEVICES

REACTION PLANS OF NON-

CONFORMING PRODUCT

PICTURE OF PROCESS

SHOWS FLOW OF PROCESS

FOUNDATION FOR PFMEA,

CONTROL PLANS, TOOL

LAYOUTS, WORK STATION

LAYOUTS, ET.

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WHATIS

A

FMEA?

TheFailureModeandEffectAnalysis(FMEA)isaPreventionTechniqueusedtodefine,identifyandeliminatepotential

problemsfrom

asystem,

subsystem,

component

or

a

process.

FocusonPrevention

AnassessmentofRisk Safety

Regulatory

CustomerSatisfaction

Program

Coordinated/Documentedteam

effort

Amethodtodeterminetheneedandpriorityofactions

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FAILUREMODESANDEFFECTSANALYSIS

Initiallydeveloped

in

the

1940s

UsedextensivelyinNASAApolloProgramin1960s

CarriedtootherindustriesbydisplacedApolloengineers

AdoptedbyFordengineeringinthe1980s

AdoptedbyAutomotiveIndustriesActionGroup(AIAG)

Incorporatedinto

GM

GVDP

and

PPAP

HISTORY

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UNDERSTANDINGFAILUREMODE

RELATIONS

Everyproblem

is

preceded

by

the

error

and

the

source

of

the

error(cause).

Thecauseisthatwhichproducesanincorrectaction(somethingdonepoorly)oranomissionofarequiredaction(somethingnotdone).

All problems have three components:

1. Frequency of occurrence of the cause.

2. The ability to detect (the problem / effect or error).3. Severity (how the problem / effect affects the customer).

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Valueof

FMEA's

Aidsinimprovingdesignsforproductsand

process

Increasedsafety

EnhancesCustomerSatisfaction

BetterQuality

HigherReliability

Contributestocostsavings

Decreaseswarranty

costs

Decreaseswaste,nonvalueaddedoperations

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7

Typesof

FMEAs

?

System/Concept S/CFMEA- (Driven by System functions)Asystem is a organized set of parts or subsystems to accomplish oneor more functions. System FMEAs are typically very early, before

specific hardware has been determined.

Design DFMEA- (Driven by part or component functions)ADesign / Part is a unit of physical hardware that is considered a

single replaceable part with respect to repair. Design FMEAs aretypically done later in the development process when specifichardware has been determined.

Process PFMEA- (Driven by process functions & part

characteristics)A Process is a sequence of tasks that isorganized to produce a product or provide a service. AProcess FMEA can involve fabrication, assembly, transactionsor services.

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8

Typesof

FMEAs

?

System/Concept S/CFMEA- (Driven by System functions)Asystem is a organized set of parts or subsystems to accomplish oneor more functions. System FMEAs are typically very early, before

specific hardware has been determined.

Design DFMEA- (Driven by part or component functions)ADesign / Part is a unit of physical hardware that is considered a

single replaceable part with respect to repair. Design FMEAs aretypically done later in the development process when specifichardware has been determined.

Process PFMEA- (Driven by process functions & part

characteristics)A Process is a sequence of tasks that isorganized to produce a product or provide a service. AProcess FMEA can involve fabrication, assembly, transactionsor services.

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IMPORTANCEOF

PFMEA's

SystematicMethodtoAnalyzeaProcess

TheProcess

Potential

FMEA:

Identifiespotentialproductrelatedprocessfailuremodes Assessesthepotentialcustomereffectsofthefailures Identifiesthepotentialmanufacturingorassembly

process

causes

and identifies

process

variables

on

which

tofocus

controls

for

occurrence

reduction

or

detection

of

thefailureconditions Developsarankedlistofpotentialfailuremodes,thus

establishingaprioritysystemforcorrectiveaction

considerations Documents theresultsofthemanufacturingorassemblyprocess

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PFMEA

ThreeParts:

ProcessFlow

Diagram

(PFD)

ProcessFailureModeandEffectsAnalysis(PFMEA)

ProcessControlPlan(PCP)

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PFMEA's Focusisonpotential processrelatedFailuresandtheir

causes. Maindriveistounderstandtheprocessthroughtheidentificationof

asmanypotentialfailuresaspossible.

e.g.Incorrectmaterialused

PFMEAtypically

assumes

that

the

design

is

sound.

DevelopmentofRecommendedActionsis targetedat

eliminatingthe RootCauseof thepotentialfailures

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InformationFlow

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OVERVIEWOF

THE

FMEA

PROCESS

Definethescopeofthestudy.

ScopeDefinition

Worksheet

SelecttheFMEAteam.

TeamStartUp.

Team

Start

Up

Worksheet. ReviewDesignIntent/ProcessFunctionandthe

process(PFMEA)orproduct(DFMEA)tobestudied.

MRD

Process:Flowchart

or

Traveler

Product:BlueprintorSchematic

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Identifyallfailuremodes&thecorrespondingeffects.

Ratetherelativeriskofeachfailuremodeandeffect.

Severity Identifyallpotentialcauses

Ratetherelativeriskofeachcause. Occurrence

Identifyallcurrentdesign/processcontrolstoprevent/detectthefailuremode.

Ratetherelativeriskofallcontrols. Detection/Prevention

Prioritizeforaction.

Calculate

the

RPN

(risk

priority

number). UsetheParetoPrinciple.

Takeaction.

CalculatetheresultingRPN.

OVERVIEWOF

THE

FMEA

PROCESS

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15

TheFMEATeamRoles

FMEA Core Team4 6 Members

Expertise in Product / ProcessCross functional

Honest CommunicationActive participation

Positive attitudeRespects other opinions

Participates in team decisions

Champion / SponsorProvides resources & support

Attends some meetingsPromotes team efforts

Shares authority / power with teamKicks off teamImplements recommendations

RecorderKeeps documentation of teams efforts

FMEA chart keeperCoordinates meeting rooms/time

Distributes meeting rooms & agendas

FacilitatorWatchdog of the process

Keeps team on trackFMEA Process expertise

Encourages / develops team dynamicsCommunicates assertively

Ensures everyone participates

Team LeaderWatchdog of the project

Good leadership skillsRespected & relaxed

Leads but doesnt dominateMaintains full team participation

Typically lead engineer

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A

Process

Flow

for

FMEA

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Timing Oneofthemostimportantfactorsforthe

successfulimplementation

of

an

FMEA

programistimeliness.

Itismeanttobeabeforetheeventaction,

notan

after

the

fact

exercise.

ActionsresultingfromanFMEAcanreduceoreliminatethechanceofimplementinga

changethat

would

create

an

even

larger

concern.

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DFMEAScope

Worksheet

Product:Date:

ScopeDefined

by:

Part1:Whoisthecustomer?

Part2:Whataretheproductfeaturesandcharacteristics?

Part3:Whataretheproductbenefits?

Part4:Studytheentireproductoronlycomponentsorsubassemblies?

Part5:Includeconsiderationofrawmaterialfailures?

Part6:

Include

packaging,

storage,

&

transit?

Part7:Whatarethemanufacturingprocessrequirements&constraints.

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PFMEAScope

Worksheet

Product:Date:

ScopeDefined

by:

Part1:Whatprocesscomponentsaretobeincludedinthe

investigation?

Part2:Whoisthecustomer?

Part3:Whatprocesssupportsystemsaretobeincludedinthestudy?

Part4:Towhatextentshouldinputmaterialsbestudiedduringthe

investigation?

Part5:

What

are

the

product/process

requirements

&

constraints?

Part6:Shouldpackaging,storage,andtransitbeconsideredpartofthis

study?

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PFMEA

Overview Assumesthatthedesignissound

Analysesmanufacturing

&

assembly

processes

at

the

system,subsystemorcomponentlevels

Focussesonpotentialfailuremodesoftheprocesses

thatare

caused

by

manufacturing

or

assembly

processdeficiencies.

Recommendsactionstargetedateliminatingtheroot

causesof

the

potential

failures

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PFMEA

Assumptions

Thedesignisvalid

Failurescanbutwillnotnecessarilyoccur

Allincoming

product

is

to

design

specifications

Designfailuresarecoveredaspartofthe

designFMEA.

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PFMEA Process

Steps

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PFMEA Failure

Categories

Completefailure

Partialfailure

IntermittentFailure

Failureovertime

Overperformanceoffunction

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PFMEA Process

Controls

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ProcessControl

Plans

IdentifywhichcontrolsrelatetoProductand

Processes

Noteany

special

characteristics

Identifyevaluationmethods,frequencyand

controlmethods.

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PFMEA

Benefits

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DesignFMEA

LedbyDesignResponsibleEngineer

Customerincludes

End

User,

Other

Design

TeamsandManufacturing

Does

not

rely

on

process

controls

to

overcomepotentialweaknessesinthedesign

Doestakeintoaccountthetechnical/physical

limitsof

amanufacturing/assembly

process

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ProcessFMEA

ItisinitiatedbyamemberfromtheOperations

orEngineering.

RepresentativesfromDesign,Assembly,

Manufacturing,

Materials,Quality,

Service

and

the

Area

Responsibleforthenextassemblyshouldbe

involved.

The

Process

FMEA

assumes

the

product/process

asdesignedwillmeetthedesignintent.

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DesignIntent

and

Process

Function

Definesthefunctionoftheproductorthe

processNameofitemorsystem

Functionofitemperdesignintent

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PotentialFailures

D)Mannerinwhichacomponent,subsystem

orsystem

could

fail

to

meet

design

intent

(P)Mannerinwhichtheprocesscouldfailto

meettheprocessrequirementsand/ordesign

intent

Usingthisdefinitionafailuredoesnotneedto

bereadily

detectable

by

acustomer

to

still

be

consideredafailure.

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PotentialEffects

Determinetheeffectsofpotentialfailures.

Effectsofthefailuremodeonthecustomer

(internal

or

external)

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SeverityRanking

Ratingof1to10with10beingthemost

severeimpact.

Useascale.

Usethesamescalethroughout.

Toassignthisrating,mustassumethefailuremodehasoccurred.

Assignseverity

rating

for

every

possible

effect.

Mayhavetoestimaterating.

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Process

Severity

Evaluation

CriteriaEffect Severityofeffect Ranking

Hazardous,without warning Mayendangerpersonnel.Involvesnoncompliance with

govt.regulationwithoutwarning.

10

Hazardous,with

warning Same

as

above

only

with

warning 9

VeryHigh Majordisruptiontoproductionline;100%of

productscrapped

8

High Minordisruptiontoproductionline;customer

dissatisfied

7

Moderate Productoperable;notcosmeticallysatisfactory 6

Low 100%ofproductmayhavetobereworked;some

customerdissatisfaction

5

VeryLow Fit/finishdefectsnoticedbymostcustomers 4

Minor Sameasabove,but,defectnoticedbyaverage

customer

3

VeryMinor Sameasabove,but,defectnoticedonlybythe

discriminatingcustomer

2

None Noeffect 1

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ClassificationThiscolumnmaybeusedtoclassifyanyspecial

productcharacteristics

(e.g.,

critical,

key,

major,

significant)forcomponents,subsystems,or

systemsthatmayrequireadditionaldesignor

processcontrols.

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Potential

CausesWhatarethepotentialcausesofthefailuremode?

Acause

and

effect

(fishbone)

diagram

may

be

helpfulhere.

(D)An

indication

of

adesign

weakness

resulting

in

thefailuremode

(P)Howthefailurecouldoccur

Typicalfailure

causes:

Improper

torque,

Inadequate

gating,inadequateornolubrication,partmislocated

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Occurrence

Ranking Howoftenwilleachcauseoccur?

Ignorethe

severity

of

the

effect

and

any

possibility

thatitwillbedetected.

Ratingona1to10scalewith10beingthemostfrequent.

Definerootcausesofeachfailuremode

Usedatawherepossible

Customercomplaints.

Defectanalysis.

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Occurrence

Evaluation

Criteria

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Current

Controls Whatarethecurrentdesignorprocess

controlsto

prevent

or

detect

the

potential

failuremode?

Preventionofcauseoffailuremodeor

reductionin

occurrence.

Detectionofcauseoffailuremodeleadingto

Corrective

Actions

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Detection

/

Prevention

Rating Theassessmentoftheabilityofthe

design/processcontrols

to

identify

apotentialcauseordesignweaknessbeforethe

componentorsystemisreleasedfor

production/shippedto

the

customer.

RatetheDetectionfrom1to10with10being

nochanceofdetectingthefailuremodeorits

effect(s).

DETECTION(D)EvaluationCriteria

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Detection Criteria:LikelihoodofDETECTIONbyDesignControl Ranking

Absolute

Uncertainty Design

Control

will

not

and/or

can

not

detect

a

potential

cause/mechanism andsubsequentfailuremode;orthereisnoDesign

Control

10

VeryRemote VeryremotechancetheDesignControlwilldetectapotential

cause/mechanismandsubsequentfailuremode.

9

Remote Remotechance

the

Design

Control

will

detect

apotential

cause/mechanism andsubsequentfailuremode.8

VeryLow VerylowchancetheDesignControlwilldetectapotential


7

Low LowchancetheDesignControlwilldetectapotential

cause/mechanism

andsubsequent

failure

mode.

6

Moderate ModeratechancetheDesignControlwilldetectapotential


5

Moderately

High

ModeratelyhighchancetheDesignControlwilldetectapotential


4

High HighchancetheDesignControlwilldetectapotentialcause/mechanism andsubsequentfailuremode.

3

VeryHigh VeryhighchancetheDesignControlwilldetectapotential


2

Almost

Certain Design

Control

will

almost

certainly

detect

a

potential

cause/mechanismandsubsequentfailuremode. 1

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Process

Detection

Evaluation

Criteria

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Risk

AssessmentSeverity

Theimpact(s)

of

failure

Occurrence

The

likelihood

of

a

failure

occurrence

from

an

identifiedcauseundercurrentcontrols

Detection

Howdetectable

is

the

failure

at

any

point?

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Risk

Priority

Number

(RPN) Severity

1

10none hazardous

Occurrence

1

10remote veryhighfrequency

Detection1 10

verydetectable extremelyundetectable

RPN=SX

O

X

D

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Why

do

we

need

to

calculate

the

RPNs?BygivingeveryFailureModeaRPNrating,we

cannow

prioritize

which

failure

modes

to

addressnowandwhichfailuremodeswe

addresslater.

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REDUCING

THE

POTENTIAL

RISK:Firstlineofdefense

Eliminatecauses

of

failure

so

that

it

does

not

OCCURImplementpreventiontechniques

Secondlineofdefense

Reduceprobability

of

OCCURRENCE

Thirdlineofdefense

Improve

DETECTION

of

the

failure

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Disagreements

on

Ratings? Usedatawherepossible.

Tryto

come

to

consensus.

Ifconsensusfails:

Teammayelecttodefertooneofitsmembers.

Averageindividualratings.

Onlyaverageifratingsareclose(spreadof2or3

points

maximum).Gettheprocessexpertinvolved.

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FMEA

Reduce

Future

Liability FMEAcanbealegaldocument

Courtscan

take

afavorable

view

of

the

liability

ifproperFMEAwasconductedandriskswere

analyzed/actedupon

Punitivedamages

can

be

eliminated

and/or

reduced

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FMEA

Pitfalls

A

review CrossfunctionalityoftheTeam

LeadershipoftheTeam

ScopeDefinition

DataAvailability

NOCustomerInvolvement

MeetingManagement

problems

S,O,Dcriteriadecisions(toolong!)

Nosupplierinvolvement

Committed

resources ManagementCommitment&Support

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In

Conclusion FMEAdoestaketimeandeffort

Itdoes

reduce

the

risk

to

your

customer

Itdoesreducetherisktoyou

It

does

save

time

to

product

launch ItdoeshelpwithContinuousImprovement

FMEA-BPR

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