失效模式及其影響分析英文教材

HInnovation

&

Industrial

SupportPhilips

CFT

Asia

Pacific

CFT)FAILURE

MODE

and

EFFECTS

ANALYSIS失效模式及其影響分析Philips

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PacificInnovation

&

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TANHInnovation

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16

三月2023

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2FMEACourse

ScheduleDay

29.00Real-lifeP-FMEA

exercise-co’tn’Review10.30Tea-break10.45D-FMEA12.00Lunch1.00Organization

Aspectof

FMEA3.00Tea-break3.30Maturity

GridDay

19.00IntroductionIntroto

FMEAProcessFMEA10.30Tea-break10.45Process

-FMEA(con’t)12.00Lunch1.00Real-lifeP-FMEA

exercise3.30Tea-break3.45Real-lifeP-FMEAexercise

-con’tPhilips

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31INTRODUCTIONTOFMEAPhilips

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16

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4Car

2:No

Major

Breakdowns非主要的破損Few

failures很少的失效Car

1:FrequentBreakdowns頻繁地破損Manyminorcomponentsfailures許多的小部件失效A

reliability

program

?Why

necessary?一個(gè)可靠性的計(jì)劃？為什么必須？Philips

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PacificCZB698-00-0006|

16

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5Customer

Satisfaction－顧客滿意HInnovation

&

Industrial

SupportCustomer

satisfaction

means:Neverhavingtosayyou’resorry!

P顧hilips

C客FT

Asi滿a

Paci意fic意味著：決不要說(shuō)對(duì)不起！Philips

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PacificCZB698-00-0006|

16

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6QUALITY

ENGINEERINGTOOLSTOOLSntDesignReview7QC

ToolsNew

7

QCToolsStatisticalProcess

ControlDesignof

ExperimentsQualityFunctionDeploymeFailureModeandEffectsAnalysisAPPLICATIONHInnovation

&

Industrial

SupportDesign

QualityAssuranceDataanalysis/Problem-solvingBusiness

Process

Mgt,

QFPHolding

the

improvementQuality

breakthroughsMeetingcustomerrequirementFool-proofDesign&processesHInnovation

&

Industrial

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16

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7WhatisaFMEA?Philips

CFT

Asia

PacificAstructured,disciplinedprocesstosystematicallyandcomprehensively,identifyanddocumentpotentialproblemsandweaknessesinadesignorprocesssothatdesignchangescanbemadeorothercorrectiveactionstakentopreventactualoccurrenceoffailure一個(gè)結(jié)構(gòu)化和專業(yè)化的過(guò)程，它能系統(tǒng)和綜合地找出并記錄在設(shè)設(shè)計(jì)和工藝過(guò)程中潛在的問(wèn)題和缺點(diǎn)并由此作出設(shè)計(jì)改變或采取取其它的改正措施以防止失效的實(shí)際發(fā)生HInnovation

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8EffectofFMEAonProcessandDesignchangesDesignStartPhilips

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Production

ProductionReleaseTimeNoofEngineeringChangesFMEAapproachTraditionalapproachHInnovation

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16

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9TYPESofFMEATYPEALIASESDESCRIPTIONProductDesignFMEA*Focusontheproductitself,reviewFMEAD-FMEAsystems,parts&componentsProcessProductionFMEA*Focusonthemanufacturingprocess,FMEAP-FMEArevieweachprocessstepApplicationDownstreamcustome’sr*’

Focusoncustome’srp’rocessFMEAManufacturingFMEA*Primarilyinterestedincompatibilitybetweenyourproduct&custome’srp’

rocessService*

Focuson

field

serviceFMEA*

Concerned

with

reliability,

productapplication,

maintainabilityPhilips

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10Objective

of

FMEAFailureMode

&EffectAnalysis

(FMEA)

is

used

toimprovePhilips

CFT

Asia

Pacificproductreliability(considering

usage,

environment,lifetimeetc.)qualityof

(purchased)

parts(inc‘hl.‘idde’nf’unctions

ofa

part)reproducibility

of

the

product(reduction

offall

off

&

repairsinassembly)reproducibility

of

the

production

process(handling,transportetc.)Focus

on

technical

problemsLink

withMaturity

GridandRisk

Management!

HInnovation

&

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11Types

of

RisksMarketRiskshavingthe

rightproductonthe

right

timeTechnical

Risksachievingtheproductspecquality,reproducibilityProjectRisksprojectorganisation,teamaspects,resourcesMarketRisksPhilips

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PacificTechnicalRisksProjectRisksPlanningSpecificationKnow-how,capacityHInnovation

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12Use

ofFMEAPhilips

CFT

Asia

PacificA.ReliabilityEngineering-

Reliabilityimprovements.B.

Producibility

AnalysisLessrepairsand

scrap

during

manufacturing.Improvementof

theZero-

Hour

Quality.C.ProductionProcessAnalysisLessrepairsand

scrap.Determination

of

process

controlpoints.Processrelease.AandBduringdevelopment

phase.Cduringworkpreparation

phase.HInnovation

&

Industrial

SupportCZB698-00-0006|

12

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13100

:

110

:

11

:

1IMPROVEPRODUCTPAYBACKSLOWVISIBILITY/REWARDHIGHVISIBILITY/REWARDTIME500

:

1Philips

CFT

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PacificCONCEPTDESIGNPRODUCTDESIGNPROCESSDESIGNPRODUCTIONQualityLeverHInnovation

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12

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14Reliability

Investigation

byMeansof

FMEAPhilips

CFT

Asia

PacificPremises:The

normal

functioning

of

the

productQuestion:What

isthe

influenceof

:

use

-

timeandenvironment

oneach

componentPossibilities:a.

wear,b.

rust,c.

material

fatigue,d.contamination, e.deformation

under

load

(creep)f.

ageing,cessfailures.What

isthe

effect

onproduct

functions

?HInnovation

&

Industrial

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15ProducibilityAnalysis

by

Means

ofFMEAPhilips

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Asia

PacificPremises:Measuring

toolis:

egFOR/ppmActions:Actionsas

outcome

oftheProcessQuality

Control

(P.Q.C.)Analysis:Focusedon

failures

which

are

madeand

noticedduringthe

productionprocess.HInnovation

&

Industrial

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12

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162PROCESSFMEAPhilips

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17FMEA

for

the

Production

ProcessPhilips

CFT

Asia

PacificSubjectfor

Analysis:-

flowchart

and

scenario

oftheproduction

processFocusedon:-

manipulations

of

the

operatorwrong(deviations)materialprocessequipmenttransportstorageHInnovation

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12

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18FailuremodeRPN2=

SO2D2ControlsCause

1RPNn=

SOnDnControlsCause

1Development

ofa

Process

FMEA

:

AnOverviewProcessstepPurposeRPN1=

SO1D1ControlsCause

1EffectsSeverity,

SPhilips

CFT

Asia

PacificOccurrence,

OnDetection,

DnHPhilips

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19HPhilips

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20ProcessFMEA

Procedure5Steps:Establish

theProcessFlowAnalyzethe

ProcessEstablish

purpose

ofeach

operationand

the

possible

failuremodesDefinethe

weak

points

of

the

ProcessEstablish

actions

andresponsibilitiesHInnovation

&

Industrial

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12

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21PMhilipas

CkFTeAsiaoPafcitfihcStep

1-Establish

Process

FlowTake

into

account

the:Specificationfor

manufacturingSystemStructure:manufacturing

strategy(manual/automatic

etc)technologies,

processes&

equipment-line

&factory

layoutsuppliers,transport,

materialflowSystemoperation,

control

and

maintenanceSystemenvironmentalconditionsTesting&

quality

controle

assemblyprocessa:PROCESSFLOWCHARTHInnovation

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Industrial

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22ProcessFlow

Chart

(eg)Handling

processGluepartAdjustment

processTestingMount

subassyHandling

processMount

partTestingStation1Philips

CFT

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PacificStation2Mount

partStation3Station4HInnovation

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23ProcessFlow

Chart

(eg)EquipmentsLightpen

carrierPress-on

toolLDGU

cutting/insertion

machineLightpen

carrierMounting

fixtureElectric

screwdriverScrewdispenserLightpen

carrierSoldering

equipmentGratingadjustmentmachineGlue

dispenserandcuringunitLightpen

carrierMount

actuatr&installspringclipMount

&secureflexassemblyCut

LDGU

leads&mount

LDGU

intoLightpen

housingSolderactuator

andLDGU

toflex

assyGrating&

glueing

ofLDGUMount

rack

&

wirespringAssembly

processPhilips

CFT

Asia

PacificHInnovation

&

Industrial

SupportFailureMode

and

Effect

Analysis

Chart

CZB698-00-0006|

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24Philips

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25Step

2-

Analysis

ofthe

ProcessPhilips

CFT

Asia

PacificExaminationof:How

thepurpose

of

the

process/operation

are

realisedbythe

designers/engineers.What

are

the

workingconditionsstaticdynamicHInnovation

&

Industrial

SupportCZB698-00-0006|

12

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26Step3-Establish

purpose

ofeach

operation

and

thepossible

failure

modesPhilips

CFT

Asia

PacificWhat

isthe

purpose

of

the

processstep

?Which

deviations

arepossible

?

(FAILUREMODE)What

isthe

effect

ofthat

deviation

on

the

producibility?(EFFECT)What

isthe

cause

ofthat

deviation?

(CAUSE)HInnovation

&

Industrial

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27MATERIALMANMACHINEMETHODENVIRONMENTMEASUREMENTPROCESSProductFunctionsProductFunctionsProductFunctionsProcessCause-EffectInvestigationPOTENTIALCAUSEPhilips

CFT

Asia

PacificPOTENTIALEFFECTPOTENTIALFAILUREHIn*novatuions&

eIndbustrriaalSuipnposrt

tormingtoensurecompletenessCZB698-00-0006|

12

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28PotentialFailureModesPhilips

CFT

Asia

PacificFailuremeansanyoneormoreofthefollowing…-failuretoperform/deliverfunction-failuretomeetdesignintent-failuretomeetcustomerexpectations-somethingundesirable,e.g.anoisyprojector-applicationproblem,e.g.wrongapplicationfailurecouldoccur,butwillnotnecessarilyoccur*

describei“np“hysical”ortechnicalterms,notas

asymptomrecognisablebythecustomer

Examples:corrodedcrackeddeformedoxidisedleakingfracturedmalformedflattenednon-stickingcontaminatedHInnovation

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29FailureModeandEffectAnalysisChartPhilips

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30Effects(ProcessFMEA)Philips

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PacificEachfailuremodemayhaveundesirablesideeffectsonsomeorallthefollowing:End-user(product)Down-streamprocess(nextoperation)3.LocalprocessAll3effectsshouldbeconsideredinanyprocessFMEAHInnovation

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31Severity(Process-FMEA)~SeverityistheassessmentoftheseriousnessoftheeffectRatingDegreeEffectsonEffectondownEndUserStream/Localprocess1Minor*notnoticeable*noeffect2low*slightlynoticeable*noimpact/limitedeffect3*limitedimpactonboth4Moderate*custdissatisfaction*mayrequireminorrework5*reducedperformance*mayreq.unscheduledrework6*perform.Deterioration*maycausedamagetoequip.7High*highdeg.ofcustdissatisfaction*maycauseseriousdisruption8*lossofsub-systemfunction,*mayrequiremajorreworkmayendangermachine/operator9Veryhigh*safety-related*productionlineshutdown10*non-compliancewith*saftetyofprodpersonnelthreatenedgovernmentregulationsPhilips

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32FailureModeandEffectAnalysisChartPhilips

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33PotentialCause(s)ofFailurePhilips

CFT

Asia

PacificHowthefailuremodecouldoccur,describedintermsofsomethingcorrectableorcontrollablelist,usingbrainstormingorFaultTreeAnalysis(FTA),everyconceivablefailurecauseassignabletoeachfailuremodecausesshouldbespecific,e.g“o.“peratorerro”ro“”rm“

achineproblem”areexamplesofcauseswhicharenotspecificenoughcausesmayormaynotbemutuallyexclusive-iferadicatingacausehasadirectimpactonthefailuremode,then,thecauseissaidtobeexclusivetothefailuremode-whencausesarenotmutuallyexclusive,DesignofExperimentsmaybeusetoidentifytherootcauses(minorcontributors)orthosewhichcanbemosteasilycontrolledHInnovation

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34FaultTreeexampleProblemCause

ACause

BCause

CA1A2B1B2Philips

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&

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Support10inevitable1in2(50.0%)CZB698-00-0006|

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35Occurrence(P-FMEA)7HighNotinStatistical1in40(2.5%08control1in20(5.0%)9VeryhighFailurealmost1in8(12.5%)~canbethoughtastheprobabilityofoccurrenceofthefailuremodeRatingDegreeBasedonSPCBaseonfailurerate1RemoteCpK>1.67<1ppm2VerylowCpK>1.3350ppm3LowCpK>1.00250ppm41000ppm5ModerateCpK<0.832500ppm61in80(1.25%)Philips

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36FailureModeandEffectAnalysisChartPhilips

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37CurrentcontrolsCurrentcontrolsaredescriptions

ofcontrols

that:(a)preventthefailuremodefrom

occurringor(b)detectsthefailuremodeshouldit

occurExamplesofprocesscontrols:fixture

fool-proofingSPCinspectioneither

at

the

subject

operationtestingoratthesubsequent

operationsgaugeR

&Rpreventivemaintenanceoperator

trainingGMP

(goodmanufacturing

practice)-

ISO

9000SOP

(standardoperating

procedures)humidity

/pressure

/tempcontrolsfiniteelementanalysiscalibrationPhilips

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PacificHCZB698-00-0006|

12

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38Detection

(P-FMEA)Inn1ova0tioNn

&

iInldCustroial

Snuptprorotlwillnotdetectfailure~Assume

the

failure

has

occur,

assesstheprobabilitythatthe

controls

willdetect

the

failure

modebefore

shippingoutRatingDegreeDescription1VeryHighProcessautomatically

detects

failure2Controlwillalmostcertainly

detectfailure3HighControlhavegood

chanceofdetecting

failure45ModerateControlmaydetect

failure67LowControlhavelowchanceof

detectingfailure8

9VeryLowControlprobablywill

not

detectfailure

Philips

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39FailureModeandEffectAnalysisChartPhilips

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40Step4-

DefinetheWeak

PointsDefine

the

severityof

the

failure

(=S)EffectRating

:1.........10Define

the

probability

of

occurrenceofthefailure(=O)CauseRating

:1

........

10Define

the

likelihood

ofdetection

of

the

failure(=D)TimeEffectRating

:1

........

10Philips

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41RiskPriority

Number:

(RPN)=

>Severity

xOccurrence

xDetection=> RPN

=S

xO

xD1<RPN<1000In

themselves

,absoluteRPNnumbershavenosignificance.Theyareonlyforrankingthefailurecauses,forcorrect

iveactions

Philips

CFT

Asia

PacificCZB698-00-0006|

12

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42SODDescriptionAction?1011101101110111010101FailFrequMin1Ser1010ure

unlikelyto

reachuserentMinor,

detectable

failureordefectreachesuserinfrequentlyiousandfrequentfailureFrequent

minor

defectreaches

useSerious

defect

reachesuserrPhil1ips0CFT

Asia

Pa1cif0ic

10

INTROUBLE!!!RPN:

AcceptancethresholdS

=5

(reduced

performance

+degradation)O

=5

(approximately0.25%)D

=5

(may

detect

priorto

shipment)Generally,

RPN

125

may

be

agoodthreshold

touseie

for

RPN

>125=>corrective

action

isneeded.Butthere

are

exceptions;SxOxDHInnovation

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SupportRPN125HInnovation

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43Step

5-

EstablishActions

andResponsibilitiesPhilips

CFT

Asia

PacificWhat

has

tobe

improved:change

ofdesignlifetestcontact

with

suppliercontrol

point

build

in,

in

production

processetc.Whois

responsibleWhen

is

itfinishedHInnovation

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44RPNacceptable?Corrective

actionsDONew

RPN1YesNoNo

Acceptable?YesEndRPNacceptable?Corrective

actionsDONew

RPNnYesNoNo

Acceptable?YesEndPhilips

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45Choiceof

Corrective

ActionsPhilips

CFT

Asia

PacificUnlikely

tobe

effectivePreferredchoicesIncrease

inspection

*Poka-Additionaltest*

ProcesAdditionalcheck*

designRe-train

operators

*Re-write

SOP

*Roboticsyoke

(fool-proofing)s

changechangeAutomationComputerisationHPhilips

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PacificInnovation

&

Industrial

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46HInnovation

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47Corrective

ActionPreference

HierarchyPhilips

CFT

Asia

PacificThe

intent

of

anyrecommendedcorrective

actionis

toimprove

theRPN

rating

byreducingSeverity,

Occurrence,

Detectionor

all3

together.Emphasis

should

beon

prevention,

i.e.

reducingOccurrence.Shouldpreventionbe

impossible,

thefollowingHierarchy

ofpreferenceshouldbe

used:Prevention,

orpotential

cause

eliminationDetection,

as

early

in

theproduct

lifecycleas

possible:best………at

thedesign

stagenext

best………

prior

to

massproductionthen………priorto

shipmentand,

as

lastresort ………in

the

field,

prior

tocatastrophicfailureImpact

reduction,

i.e.

reduce

SeverityGenerally,

to

reduce

anyof

the

three

rating -O,

D,S-processand/ordesignchanges/modification

arerequiredHInnovation

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48FMEAisis

not

structured*

a

show-piecesystematic*

a

numbergamerigorous *a

guessinggamecomprehensive *a

documentation

exercisescientific*

a

self-consolationexercisea

discipline

..preventive..customer-focused..a

teameffort

..a

cross-functional

exercise..a

living

document

..a

continuous

process *a

one-offexercisePhilips

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49Real

LifeFMEAExercisePhilips

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503PRODUCT

D-FMEAPhilips

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51Process

FMEAvs

ProductD-FMEA*P-FMEAdoesnot

relyon

productdesign

changesto

overcomeprocessweaknesses,

but

itdoestakeintoconsiderationaproduct’sdesign

characteristics*

D-FMEAdoesnot

relyon

processcontrolsto

overcome

designweaknesses,butitdoestakethe

technical/physical

limitationsofthe

manufacturingprocess

(i.e.the

process

capability)

intoconsideration.ProcessstepPurposeor

sub-assyFunctionProduct

FMEAPiece-partPhilips

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FMEAHInnovation

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52Process

FMEA

vsProduct

D-FMEA*Hencecauses

such

a“so“peratornotinsertingresistor

properly”“&s“uppliershippingwrongparts”

may

notbe

of

concernin

aD-FMEA,

but

iftherearedesign-relatedfactors

thataffectinsertion,orwhichcausetransportation/shippingproblems.,thentheymustbe

considered.ProcessstepPurposeor

sub-assyFunctionProduct

FMEAPiece-partPhilips

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FMEAHInnovation

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53Design

FMEAPhilips

CFT

Asia

PacificAD-FMEAstartsfromaBill-of-Material

orFunctionalBlock

DiagramDesign

FMEA

cantakeeither

of2

approaches:1.

ComponentsBottom-up

ApproachThisapproach

is

possibleonlywhena

designalready

exists.It

servesto

justifyeverycomponentin

the

design.HInnovation

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54Design

FMEAPhilips

CFT

Asia

Pacific2.FunctionalBlock

Approach(Top-down)Thisapproach

helpsdesignerspickthe

optimal

sub-systems

orsub-assemblies.

Itplays

a

part

in

thedesigndecision-makingprocessIn

the

caseofbig,complicatedsystems,theSelectiveFunctionalBlockApproach

may

beused--at

each

level

of

theFunctional

BlockDiagrampickthemostsusceptiblesub-assy

of

sub-systemtoFMEAHInnovation

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55Product

FunctionsPhilips

CFT

Asia

PacificTakeintoaccount

the:SpecificationSystem

Structure:-differentelements

with

theircharacteristics,

performancerolesand

functions- connectionsbetween

elementsSystem

operation,

controlandmaintenanceSystem

environmentalconditionsUserspatternMakeof

the

functions,

subsystems

and

components

:==>FUNCTION

TREEHInnovation

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56Product

Function

TreeProduct

basicfunctionFunction

AFunction

BFunction

CFunction

DFunctionAaFunctionAbFunctionCaFunctionCbFunctionFunctionAba

AbcFunctionFunctionFunctionCaa

Cab

CacPhilips

CFT

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PacificHInnovation

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57Effects

(D-FMEA)3levels

ofeffects

must

beconsidered:2.

Next

higherleveleffects1.

End-usereffects3.

Local

effectsThe

following

example

will

help

todistinguish

the3

typesofeffevactlvse:Philips

CFT

Asia

Pacificengine

system

powersystemcarcomponentnexthigherend-userunderreviewlevelEffectDescriptionExampleEnd-usereffects

whatthe

customer

wouldand/or

experienceNexthigher

level

effectseLocaleffectseffectson

car

performance;noisy;observeffects

on

theengineeffects

onthe

valveitselfjerky;

cannotrunat

highspeedover-heated;vibrationdeteriorationHInnovation

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58MATERIAL

ENVIRONMENTSPECIFICATIONUSEDESIGNCOMPONENTPRODUCTPOTENTIALCAUSEPhilips

CFT

Asia

PacificPOTENTIALEFFECTPOTENTIALFAILUREProduct

Cause

-Effect

InvestigationProductFunctionsProductFunctionsProductFunctionsHInnovation

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59Severity

(D-FMEA)RatingDegreeEffects1Minor*

no

perceptible

effect

on

productperformance*

userwill

probablynot

notice

thefailure3low*

customer

notices

slight

deterioration

inperformance*

causes

slight

customerannoyance5Moderate*

causes

somecustomer

dissatisfactioncustomer

notices

reduced

productperformancegradual

performancedeterioration7High*

highdegreeof

customer

dissatisfaction*

lossof

sub-systemfunction,

eg.enginefail10Very

high*safety-related*

non-compliance

withgovernment

regulationsPhilips

CFT

Asia

PacificHPhilips

CFT

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60Occurrence

(D-FMEA)RatingDescriptionProbability

offailureDesignlifefailurerate1RemoteFailureunlikely <1ppm3LowRelatively

lowfailure

rate200ppm1000

ppm5ModerateOccasional

failures2500

ppm1

in

80(1.25%)7HighRepeated

failures 1in

40(2.5%01

in

20(5.0%)10Very

highFailurealmostinevitable1

in

8(12.5%)1

in

2(50.0%)HInnovation

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61DetectionApproach

DescriptionApplicationTime-tableHow

earlyin

product

life

cycleD-FMEAfrom

design

start

toField

failure?Fixed-gate What’stheprobabilityofdetectionD-FMEAat

anypoint

(gate)

in

the

cycle

?Philips

CFT

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62Detection

(D-FMEA)Philips

CFT

Asia

PacificTime-tableapproachRatingProbability

of

detection1Will

be

detectedprior

to

Production

Release3Very

likely

to

bedetected

prior

to

Final

Release4Detectableafterreleasebut

before

Mass

Production5Detectablepriorto

Shipment7Will

be

detectedbeforeoccurrence

inthe

field10Undetectable

until

failure

occurs

inthe

fieldHInnovation

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63Detection

(D-FMEA)Philips

CFT

Asia

PacificFixed

Gate

approachRatingProbability

of

detection1Willbe

detected

in

design

evaluations3

Highchanceof

detectionin

design

evaluations5

Moderate

chance

ofdetection

indesignevaluations7

Lowchanceof

detection

during

design

evaluations10

Undetectable

until

failure

occurs

in

the

fieldHInnovation

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644ORGANIZATIONALASPECTS

OFFMEAPhilips

CFT

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65OrganisationalAspects

of

FMEAPhilips

CFT

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PacificGeneralPointsParticipantsPreparationsReportingHInnovation

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66FMEA

isa

teameffortcovering

allrelevant

disciplinesFMEA

sessionsshouldnot

last

longer

thanhalfadayThe

product

FMEA

should

be

focusedon:-reliability

(normal

functioning)-producibilityThe

process

FMEA

should

be

focusedon:-processflow-

manipulations

of

operator-

deviations

inmaterial -

transport-

storagePhilips

CFT

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PacificGeneralPointsHInnovation

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67FMEA

:Critical

Success

FactorsPhilips

CFT

Asia

Pacific*BehonestBepositiveBeth