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2017525 FailureModesandEffectsAnalysis(FMEA)

FailureModesandEffectsAnalysis(FMEA)

Introduction
Customersareplacingincreaseddemandsoncompaniesforhighquality,reliableproducts.Theincreasingcapabilitiesandfunctionalityofmanyproductsare
makingitmoredifficultformanufacturerstomaintainthequalityandreliability.Traditionally,reliabilityhasbeenachievedthroughextensivetestinganduseof
techniquessuchasprobabilisticreliabilitymodeling.Thesearetechniquesdoneinthelatestagesofdevelopment.Thechallengeistodesigninqualityand
reliabilityearlyinthedevelopmentcycle.

FailureModesandEffectsAnalysis(FMEA)ismethodologyforanalyzingpotentialreliabilityproblemsearlyinthedevelopmentcyclewhereitiseasiertotake
actionstoovercometheseissues,therebyenhancingreliabilitythroughdesign.FMEAisusedtoidentifypotentialfailuremodes,determinetheireffectonthe
operationoftheproduct,andidentifyactionstomitigatethefailures.Acrucialstepisanticipatingwhatmightgowrongwithaproduct.Whileanticipatingevery
failuremodeisnotpossible,thedevelopmentteamshouldformulateasextensivealistofpotentialfailuremodesaspossible.

TheearlyandconsistentuseofFMEAsinthedesignprocessallowstheengineertodesignoutfailuresandproducereliable,safe,andcustomerpleasing
products.FMEAsalsocapturehistoricalinformationforuseinfutureproductimprovement.

TypesofFMEAs
ThereareseveraltypesofFMEAs,someareusedmuchmoreoftenthanothers.FMEAsshouldalwaysbedonewheneverfailureswouldmeanpotentialharm
orinjurytotheuseroftheenditembeingdesigned.ThetypesofFMEAare:

Systemfocusesonglobalsystemfunctions
Designfocusesoncomponentsandsubsystems
Processfocusesonmanufacturingandassemblyprocesses
Servicefocusesonservicefunctions
Softwarefocusesonsoftwarefunctions

FMEAUsage
Historically,engineershavedoneagoodjobofevaluatingthefunctionsandtheformofproductsandprocessesinthedesignphase.Theyhavenotalways
donesowellatdesigninginreliabilityandquality.Oftentheengineerusessafetyfactorsasawayofmakingsurethatthedesignwillworkandprotectedthe
useragainstproductorprocessfailure.

Asdescribedinarecentarticle:

Alargesafetyfactordoesnotnecessarilytranslateintoareliableproduct.Instead,itoftenleadstoanoverdesignedproductwithreliabilityproblems.

FailureAnalysisBeatsMurpheysLaw
MechanicalEngineering,September1993

FMEAsprovidetheengineerwithatoolthatcanassistinprovidingreliable,safe,andcustomerpleasingproductsandprocesses.SinceFMEAhelpthe
engineeridentifypotentialproductorprocessfailures,theycanuseitto:

Developproductorprocessrequirementsthatminimizethelikelihoodofthosefailures.
Evaluatetherequirementsobtainedfromthecustomerorotherparticipantsinthedesignprocesstoensurethatthoserequirementsdonotintroduce
potentialfailures.
Identifydesigncharacteristicsthatcontributetofailuresanddesignthemoutofthesystemoratleastminimizetheresultingeffects.
Developmethodsandprocedurestodevelopandtesttheproduct/processtoensurethatthefailureshavebeensuccessfullyeliminated.
Trackandmanagepotentialrisksinthedesign.Trackingtheriskscontributestothedevelopmentofcorporatememoryandthesuccessoffutureproducts
aswell.
Ensurethatanyfailuresthatcouldoccurwillnotinjureorseriouslyimpactthecustomeroftheproduct/process.

BenefitsofFMEA
FMEAisdesignedtoassisttheengineerimprovethequalityandreliabilityofdesign.ProperlyusedtheFMEAprovidestheengineerseveralbenefits.Among
others,thesebenefitsinclude:

Improveproduct/processreliabilityandquality
Increasecustomersatisfaction
Earlyidentificationandeliminationofpotentialproduct/processfailuremodes
Prioritizeproduct/processdeficiencies
Captureengineering/organizationknowledge
Emphasizesproblemprevention
Documentsriskandactionstakentoreducerisk
Providefocusforimprovedtestinganddevelopment
Minimizeslatechangesandassociatedcost
Catalystforteamworkandideaexchangebetweenfunctions

FMEATiming
TheFMEAisalivingdocument.Throughouttheproductdevelopmentcyclechangeandupdatesaremadetotheproductandprocess.Thesechangescanand
oftendointroducenewfailuremodes.Itisthereforeimportanttoreviewand/orupdatetheFMEAwhen:

Anewproductorprocessisbeinginitiated(atthebeginningofthecycle).
Changesaremadetotheoperatingconditionstheproductorprocessisexpectedtofunctionin.
Achangeismadetoeithertheproductorprocessdesign.Theproductandprocessareinterrelated.Whentheproductdesignischangedtheprocessis
impactedandviceversa.
Newregulationsareinstituted.
Customerfeedbackindicatesproblemsintheproductorprocess.

FMEAProcedure
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2017525 FailureModesandEffectsAnalysis(FMEA)
TheprocessforconductinganFMEAisstraightforward.Thebasicstepsareoutlinedbelow.

1.Describetheproduct/processanditsfunction.Anunderstandingoftheproductorprocessunderconsiderationisimportanttohaveclearlyarticulated.
Thisunderstandingsimplifiestheprocessofanalysisbyhelpingtheengineeridentifythoseproduct/processusesthatfallwithintheintendedfunctionand
whichonesfalloutside.Itisimportanttoconsiderbothintentionalandunintentionalusessinceproductfailureoftenendsinlitigation,whichcanbecostly
andtimeconsuming.
2.CreateaBlockDiagramoftheproductorprocess.Ablockdiagramoftheproduct/processshouldbedeveloped.Thisdiagramshowsmajorcomponents
orprocessstepsasblocksconnectedtogetherbylinesthatindicatehowthecomponentsorstepsarerelated.Thediagramshowsthelogical
relationshipsofcomponentsandestablishesastructurearoundwhichtheFMEAcanbedeveloped.EstablishaCodingSystemtoidentifysystem
elements.TheblockdiagramshouldalwaysbeincludedwiththeFMEAform.
3.CompletetheheaderontheFMEAFormworksheet:Product/System,Subsys./Assy.,Component,DesignLead,PreparedBy,Date,Revision(letteror
number),andRevisionDate.Modifytheseheadingsasneeded.

4.Usethediagrampreparedabovetobeginlistingitemsorfunctions.Ifitemsarecomponents,listtheminalogicalmannerundertheir
subsystem/assemblybasedontheblockdiagram.
5.IdentifyFailureModes.Afailuremodeisdefinedasthemannerinwhichacomponent,subsystem,system,process,etc.couldpotentiallyfailtomeetthe
designintent.Examplesofpotentialfailuremodesinclude:
Corrosion
Hydrogenembrittlement
ElectricalShortorOpen
TorqueFatigue
Deformation
Cracking
6.Afailuremodeinonecomponentcanserveasthecauseofafailuremodeinanothercomponent.Eachfailureshouldbelistedintechnicalterms.Failure
modesshouldbelistedforfunctionofeachcomponentorprocessstep.Atthispointthefailuremodeshouldbeidentifiedwhetherornotthefailureis
likelytooccur.Lookingatsimilarproductsorprocessesandthefailuresthathavebeendocumentedforthemisanexcellentstartingpoint.
7.Describetheeffectsofthosefailuremodes.Foreachfailuremodeidentifiedtheengineershoulddeterminewhattheultimateeffectwillbe.Afailureeffect
isdefinedastheresultofafailuremodeonthefunctionoftheproduct/processasperceivedbythecustomer.Theyshouldbedescribedintermsofwhat
thecustomermightseeorexperienceshouldtheidentifiedfailuremodeoccur.Keepinmindtheinternalaswellastheexternalcustomer.Examplesof
failureeffectsinclude:
Injurytotheuser
Inoperabilityoftheproductorprocess
Improperappearanceoftheproductorprocess
Odors
Degradedperformance
Noise
Establishanumericalrankingfortheseverityoftheeffect.Acommonindustrystandardscaleuses1torepresentnoeffectand10toindicateverysevere
withfailureaffectingsystemoperationandsafetywithoutwarning.Theintentoftherankingistohelptheanalystdeterminewhetherafailurewouldbea
minornuisanceoracatastrophicoccurrencetothecustomer.Thisenablestheengineertoprioritizethefailuresandaddresstherealbigissuesfirst.

8.Identifythecausesforeachfailuremode.Afailurecauseisdefinedasadesignweaknessthatmayresultinafailure.Thepotentialcausesforeach
failuremodeshouldbeidentifiedanddocumented.Thecausesshouldbelistedintechnicaltermsandnotintermsofsymptoms.Examplesofpotential
causesinclude:
Impropertorqueapplied
Improperoperatingconditions
Contamination
Erroneousalgorithms
Improperalignment
Excessiveloading
Excessivevoltage
9.EntertheProbabilityfactor.Anumericalweightshouldbeassignedtoeachcausethatindicateshowlikelythatcauseis(probabilityofthecause
occuring).Acommonindustrystandardscaleuses1torepresentnotlikelyand10toindicateinevitable.
10.IdentifyCurrentControls(designorprocess).CurrentControls(designorprocess)arethemechanismsthatpreventthecauseofthefailuremodefrom
occurringorwhichdetectthefailurebeforeitreachestheCustomer.Theengineershouldnowidentifytesting,analysis,monitoring,andothertechniques
thatcanorhavebeenusedonthesameorsimilarproducts/processestodetectfailures.Eachofthesecontrolsshouldbeassessedtodeterminehow
wellitisexpectedtoidentifyordetectfailuremodes.Afteranewproductorprocesshasbeeninusepreviouslyundetectedorunidentifiedfailuremodes
mayappear.TheFMEAshouldthenbeupdatedandplansmadetoaddressthosefailurestoeliminatethemfromtheproduct/process.

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2017525 FailureModesandEffectsAnalysis(FMEA)
11.DeterminethelikelihoodofDetection.DetectionisanassessmentofthelikelihoodthattheCurrentControls(designandprocess)willdetecttheCauseof
theFailureModeortheFailureModeitself,thuspreventingitfromreachingtheCustomer.BasedontheCurrentControls,considerthelikelihoodof
Detectionusingthefollowingtableforguidance.
12.ReviewRiskPriorityNumbers(RPN).TheRiskPriorityNumberisamathematicalproductofthenumericalSeverity,Probability,andDetectionratings:
RPN=(Severity)x(Probability)x(Detection)
TheRPNisusedtoprioritizeitemsthanrequireadditionalqualityplanningoraction.
13.DetermineRecommendedAction(s)toaddresspotentialfailuresthathaveahighRPN.Theseactionscouldincludespecificinspection,testingorquality
proceduresselectionofdifferentcomponentsormaterialsderatinglimitingenvironmentalstressesoroperatingrangeredesignoftheitemtoavoidthe
failuremodemonitoringmechanismsperformingpreventativemaintenanceandinclusionofbackupsystemsorredundancy.
14.AssignResponsibilityandaTargetCompletionDatefortheseactions.Thismakesresponsibilityclearcutandfacilitatestracking.
15.IndicateActionsTaken.Aftertheseactionshavebeentaken,reassesstheseverity,probabilityanddetectionandreviewtherevisedRPNs.Areany
furtheractionsrequired?
16.UpdatetheFMEAasthedesignorprocesschanges,theassessmentchangesornewinformationbecomesknown.

RelatedLinks
ProductDevelopmentforum(http://www.npdsolutions.com/pdforum.html)
NPDBodyOfKnowledge(http://www.npdsolutions.com/bok.html)
FailureModesandEffectsAnalysisWorkshop(http://www.npdsolutions.com/fmeaws.html)
ProductDevelopmentToolkit(http://www.npdsolutions.com/npdsoftwaretools/pdtoolkit)

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