FailureModeandEffectsAnalysis

(FMEA)
Dr.SyedAmirIqbal
POTENTIAL FMEA Number
FAILUREMODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
Item Process Responsibility Prepared By
Model Year(s)/Vehicle(s) Key Date FMEA Date (Orig.)
Core Team
S C O D R. Action Results
Process Function Potential Failure Potential Effect(s) E L Potential Cause(s)/ C E P. Recommended Responsibility Actions S O D R.
Requirements Mode of Failure V A Mechanism(s) of C Current Process Control T N. Action(s) & Target Taken E C O P.
S Failure U E Completion Date V C T N.
S R C
1
2 3
5 6
8
9 10 11 12
13
14
15
16
17
18 9
0
1
2
4
7
1
2
3
4
5
6
7
FLOW DIAGRAM
PFMEAs
LISTS EACH OPERATION
CURRENT CONTROLS
ENHANCED CONTROLS FROM RECOMMENDED
ACTIONS
KPC's, KCC's
PER 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.
WHATISAFMEA?
TheFailureModeandEffectAnalysis(FMEA)isaPrevention
Techniqueusedtodefine,identifyandeliminatepotential
problemsfromasystem,subsystem,componentora
process.
FocusonPrevention
AnassessmentofRisk
Safety
Regulatory
CustomerSatisfaction
Program
Coordinated/Documentedteameffort
Amethodtodeterminetheneedandpriorityofactions
FAILUREMODESANDEFFECTS
ANALYSIS
Initiallydevelopedinthe1940s
UsedextensivelyinNASAApolloProgramin1960s
CarriedtootherindustriesbydisplacedApolloengineers
AdoptedbyFordengineeringinthe1980s
AdoptedbyAutomotiveIndustriesActionGroup(AIAG)
IncorporatedintoGMGVDPandPPAP
HISTORY
UNDERSTANDINGFAILUREMODE
RELATIONS
Everyproblemisprecededbytheerrorandthesourceofthe
error(cause).
Thecauseisthatwhichproducesanincorrectaction(something
donepoorly)oranomissionofarequiredaction(somethingnot
done).
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).
ValueofFMEA's
Aidsinimprovingdesignsforproductsand
process
Increasedsafety
EnhancesCustomerSatisfaction
BetterQuality
HigherReliability
Contributestocostsavings
Decreaseswarrantycosts
Decreaseswaste,nonvalueaddedoperations
7
TypesofFMEAs?
System/ Concept S/ CFMEA- (Driven by System functions) A
system is a organized set of parts or subsystems to accomplish one
or more functions. System FMEAs are typically very early, before
specific hardware has been determined.
Design DFMEA- (Driven by part or component functions) A
Design / Part is a unit of physical hardware that is considered a
single replaceable part with respect to repair. Design FMEAs are
typically done later in the development process when specific
hardware has been determined.
Process PFMEA- (Driven by process functions & part
characteristics) A Process is a sequence of tasks that is
organized to produce a product or provide a service. A
Process FMEA can involve fabrication, assembly, transactions
or services.
8
TypesofFMEAs?
System/ Concept S/ CFMEA- (Driven by System functions) A
system is a organized set of parts or subsystems to accomplish one
or more functions. System FMEAs are typically very early, before
specific hardware has been determined.
Design DFMEA- (Driven by part or component functions) A
Design / Part is a unit of physical hardware that is considered a
single replaceable part with respect to repair. Design FMEAs are
typically done later in the development process when specific
hardware has been determined.
Process PFMEA- (Driven by process functions & part
characteristics) A Process is a sequence of tasks that is
organized to produce a product or provide a service. A
Process FMEA can involve fabrication, assembly, transactions
or services.
IMPORTANCEOFPFMEA's
SystematicMethodtoAnalyzeaProcess
TheProcessPotentialFMEA:
Identifiespotentialproductrelatedprocessfailuremodes
Assessesthepotentialcustomereffectsofthefailures
Identifiesthepotentialmanufacturingorassembly
processcausesand identifiesprocessvariablesonwhich
tofocuscontrolsforoccurrencereductionordetectionof
thefailureconditions
Developsarankedlistofpotentialfailuremodes,thus
establishingaprioritysystemforcorrectiveaction
considerations
Documents theresultsofthemanufacturingorassembly
process
PFMEA
ThreeParts:
ProcessFlowDiagram(PFD)
ProcessFailureModeandEffectsAnalysis(PFMEA)
ProcessControlPlan(PCP)
PFMEA's
Focusisonpotential processrelatedFailuresandtheir
causes.
Maindriveistounderstandtheprocessthroughtheidentificationof
asmanypotentialfailuresaspossible.
e.g.Incorrectmaterialused
PFMEAtypicallyassumesthatthedesignissound.
DevelopmentofRecommendedActionsis targetedat
eliminatingthe RootCauseofthepotentialfailures
InformationFlow
OVERVIEWOFTHEFMEAPROCESS
Definethescopeofthestudy.
ScopeDefinitionWorksheet
SelecttheFMEAteam.
TeamStartUp.
TeamStartUpWorksheet.
ReviewDesignIntent/ProcessFunctionandthe
process(PFMEA)orproduct(DFMEA)tobestudied.
MRD
Process:FlowchartorTraveler
Product:BlueprintorSchematic
Identifyallfailuremodes&thecorrespondingeffects.
Ratetherelativeriskofeachfailuremodeandeffect.
Severity
Identifyallpotentialcauses
Ratetherelativeriskofeachcause.
Occurrence
Identifyallcurrentdesign/processcontrolstoprevent/detectthefailure
mode.
Ratetherelativeriskofallcontrols.
Detection/Prevention
Prioritizeforaction.
CalculatetheRPN(riskprioritynumber).
UsetheParetoPrinciple.
Takeaction.
CalculatetheresultingRPN.
OVERVIEWOFTHEFMEAPROCESS
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TheFMEATeamRoles
FMEA Core Team
Participates in team decisions
FMEA Core Team
4 6 Members
Expertise in Product / Process
Cross functional
Honest Communication
Active participation
Positive attitude
Respects other opinions
Participates in team decisions
Champion / Sponsor
Provides resources & support
Attends some meetings
Promotes team efforts
Shares authority / power with team
Kicks off team
Implements recommendations
Recorder
Keeps documentation of teams efforts
FMEA chart keeper
Coordinates meeting rooms/time
Distributes meeting rooms & agendas
Facilitator
Watchdog of the process
Keeps team on track
FMEA Process expertise
Encourages / develops team dynamics
Communicates assertively
Ensures everyone participates
Team Leader
Watchdog of the project
Good leadership skills
Respected & relaxed
Leads but doesnt dominate
Maintains full team participation
Typically lead engineer
A
Process
Flow
for
FMEA
Timing
Oneofthemostimportantfactorsforthe
successfulimplementationofanFMEA
programistimeliness.
Itismeanttobeabeforetheeventaction,
notanafterthefactexercise.
ActionsresultingfromanFMEAcanreduceor
eliminatethechanceofimplementinga
changethatwouldcreateanevenlarger
concern.
DFMEAScopeWorksheet
Product:Date:
ScopeDefinedby:
Part1:Whoisthecustomer?
Part2:Whataretheproductfeaturesandcharacteristics?
Part3:Whataretheproductbenefits?
Part4:Studytheentireproductoronlycomponentsor
subassemblies?
Part5:Includeconsiderationofrawmaterialfailures?
Part6:Includepackaging,storage,&transit?
Part7:Whatarethemanufacturingprocessrequirements&
constraints.
PFMEAScopeWorksheet
Product:Date:
ScopeDefinedby:
Part1:Whatprocesscomponentsaretobeincludedinthe
investigation?
Part2:Whoisthecustomer?
Part3:Whatprocesssupportsystemsaretobeincludedinthestudy?
Part4:Towhatextentshouldinputmaterialsbestudiedduringthe
investigation?
Part5:Whataretheproduct/processrequirements&constraints?
Part6:Shouldpackaging,storage,andtransitbeconsideredpartofthis
study?
PFMEA Overview
Assumesthatthedesignissound
Analysesmanufacturing&assemblyprocessesatthe
system,subsystemorcomponentlevels
Focussesonpotentialfailuremodesoftheprocesses
thatarecausedbymanufacturingorassembly
processdeficiencies.
Recommendsactionstargetedateliminatingtheroot
causesofthepotentialfailures
PFMEA Assumptions
Thedesignisvalid
Failurescanbutwillnotnecessarilyoccur
Allincomingproductistodesignspecifications
Designfailuresarecoveredaspartofthe
designFMEA.
PFMEA ProcessSteps
PFMEA FailureCategories
Completefailure
Partialfailure
IntermittentFailure
Failureovertime
Over performanceoffunction
PFMEA InterfaceProcesses
PFMEA ProcessControls
ProcessControlPlans
IdentifywhichcontrolsrelatetoProductand
Processes
Noteanyspecialcharacteristics
Identifyevaluationmethods,frequencyand
controlmethods.
PFMEA Benefits
DesignFMEA
LedbyDesignResponsibleEngineer
CustomerincludesEndUser,OtherDesign
TeamsandManufacturing
Doesnotrelyonprocesscontrolsto
overcomepotentialweaknessesinthedesign
Doestakeintoaccountthetechnical/physical
limitsofamanufacturing/assemblyprocess
ProcessFMEA
ItisinitiatedbyamemberfromtheOperations
orEngineering.
RepresentativesfromDesign,Assembly,
Manufacturing,
Materials,Quality,ServiceandtheArea
Responsibleforthenextassemblyshouldbe
involved.
TheProcessFMEAassumestheproduct/process
asdesignedwillmeetthedesignintent.
DesignIntentandProcessFunction
Definesthefunctionoftheproductorthe
process
Nameofitemorsystem
Functionofitemperdesignintent
PotentialFailures
D)Mannerinwhichacomponent,subsystem
orsystemcouldfailtomeetdesignintent
(P)Mannerinwhichtheprocesscouldfailto
meettheprocessrequirementsand/ordesign
intent
Usingthisdefinitionafailuredoesnotneedto
bereadilydetectablebyacustomertostillbe
consideredafailure.
TypesofQuestionstoAsk
Howcantheprocess/partfailtomeet
specifications/requirements?
Regardlessoftheengineering/requirement
specs.,whatwouldthecustomerconsider
objectionable?
Whenthisoperationisbeingdone,what
couldgowrong?Or,whattendstogowrong?
PotentialEffects
Determinetheeffectsofpotentialfailures.
Effectsofthefailuremodeonthecustomer
(internalorexternal)
SeverityRanking
Ratingof1to10with10beingthemost
severeimpact.
Useascale.
Usethesamescalethroughout.
Toassignthisrating,mustassumethefailure
modehasoccurred.
Assignseverityratingforeverypossibleeffect.
Mayhavetoestimaterating.
ProcessSeverityEvaluationCriteria
Effect Severityofeffect Ranking
Hazardous,without warning Mayendangerpersonnel.Involvesnoncompliance with
govt.regulationwithoutwarning.
10
Hazardous,withwarning Sameasaboveonlywithwarning 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
Classification
Thiscolumnmaybeusedtoclassifyanyspecial
productcharacteristics(e.g.,critical,key,major,
significant)forcomponents,subsystems,or
systemsthatmayrequireadditionaldesignor
processcontrols.
PotentialCauses
Whatarethepotentialcausesofthefailuremode?
Acauseandeffect(fishbone)diagrammaybe
helpfulhere.
(D)Anindicationofadesignweaknessresultingin
thefailuremode
(P)Howthefailurecouldoccur
Typicalfailurecauses:Impropertorque,Inadequate
gating,inadequateornolubrication,partmislocated
OccurrenceRanking
Howoftenwilleachcauseoccur?
Ignoretheseverityoftheeffectandanypossibility
thatitwillbedetected.
Ratingona1to10scalewith10beingthemost
frequent.
Definerootcausesofeachfailuremode
Usedatawherepossible
Customercomplaints.
Defectanalysis.
OccurrenceEvaluationCriteria
CurrentControls
Whatarethecurrentdesignorprocess
controlstopreventordetectthepotential
failuremode?
Preventionofcauseoffailuremodeor
reductioninoccurrence.
Detectionofcauseoffailuremodeleadingto
CorrectiveActions
Detection/PreventionRating
Theassessmentoftheabilityofthe
design/processcontrolstoidentifya
potentialcauseordesignweaknessbeforethe
componentorsystemisreleasedfor
production/shippedtothecustomer.
RatetheDetectionfrom1to10with10being
nochanceofdetectingthefailuremodeorits
effect(s).
Detection Criteria:LikelihoodofDETECTIONbyDesignControl
Ranking
Absolute
Uncertainty
DesignControlwillnotand/orcannotdetectapotential
cause/mechanismandsubsequentfailuremode;orthereisnoDesign
Control
10
VeryRemote VeryremotechancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
9
Remote RemotechancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
8
VeryLow VerylowchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
7
Low LowchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
6
Moderate ModeratechancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
5
Moderately
High
ModeratelyhighchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
4
High HighchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
3
VeryHigh VeryhighchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
2
Almost
Certain
DesignControlwillalmostcertainlydetectapotential
cause/mechanismandsubsequentfailuremode.
1
DETECTION(D)EvaluationCriteria
ProcessDetectionEvaluationCriteria
RiskAssessment
Severity
Theimpact(s)offailure
Occurrence
Thelikelihoodofafailureoccurrencefroman
identifiedcauseundercurrentcontrols
Detection
Howdetectableisthefailureatanypoint?
RiskPriorityNumber(RPN)
Severity
1 10
nonehazardous
Occurrence
1 10
remoteveryhighfrequency
Detection
1 10
verydetectable extremelyundetectable
RPN=SXOXD
WhydoweneedtocalculatetheRPNs?
BygivingeveryFailureModeaRPNrating,we
cannowprioritizewhichfailuremodesto
addressnowandwhichfailuremodeswe
addresslater.
REDUCINGTHEPOTENTIALRISK:
Firstlineofdefense
Eliminatecausesoffailuresothatitdoesnot
OCCUR Implementpreventiontechniques
Secondlineofdefense
ReduceprobabilityofOCCURRENCE
Thirdlineofdefense
ImproveDETECTIONofthefailure
PriorityforAction
InvolveManagementtoassignresources
(human/financial)foractionitemstoreducetheRPN.
CreateaWhat,Who,HowandWhenMatrixinorderto
monitoractionitems.
TheFMEATeamLeaderwillcheckthestatusofthe
FMEAfollowupandschedulereviewmeetingsas
necessary.
RecalculatetheRPNasactionitemsarecompleted
andvalidated.Calculatesavings($$$)ifpossiblebased
onthereductionofthepotentialrisk.
FMEAISALIVINGDOCUMENT!!!
DisagreementsonRatings?
Usedatawherepossible.
Trytocometoconsensus.
Ifconsensusfails:
Teammayelecttodefertooneofitsmembers.
Averageindividualratings.
Onlyaverageifratingsareclose(spreadof2or3
pointsmaximum).
Gettheprocessexpertinvolved.
FMEA ReduceFutureLiability
FMEAcanbealegaldocument
Courtscantakeafavorableviewoftheliability
ifproperFMEAwasconductedandriskswere
analyzed/actedupon
Punitivedamagescanbeeliminatedand/or
reduced
FMEAPitfalls Areview
CrossfunctionalityoftheTeam
LeadershipoftheTeam
ScopeDefinition
DataAvailability
NOCustomerInvolvement
MeetingManagementproblems
S,O,Dcriteriadecisions(toolong!)
Nosupplierinvolvement
Committedresources
ManagementCommitment&Support
InConclusion
FMEAdoestaketimeandeffort
Itdoesreducetherisktoyourcustomer
Itdoesreducetherisktoyou
Itdoessavetimetoproductlaunch
ItdoeshelpwithContinuousImprovement