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8/10/2019 FMEA-BPR
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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
cause/mechanismandsubsequentfailuremode.
7
Low LowchancetheDesignControlwilldetectapotential
cause/mechanism
andsubsequent
failure
mode.
6
Moderate ModeratechancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
5
Moderately
High
ModeratelyhighchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
4
High HighchancetheDesignControlwilldetectapotentialcause/mechanism andsubsequentfailuremode.
3
VeryHigh VeryhighchancetheDesignControlwilldetectapotential
cause/mechanismandsubsequentfailuremode.
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