FMEA template
InformationPotential Failure Modes and Effects
Analysis(Information Sheet)PFMEA Number:Process Name:Process
Responsibility:Prepared By:Affected Product(s):PFMEA Key Date:PFMEA
Origination Date:PFMEA Revision Date:Core Team Members:
PFMEA#Process Function (Step)Potential Failure Modes (process
defects)Potential Effect(s) of FailureSEVClassPotential Cause(s) of
FailureOCCCurrent Process ControlsDETRPNRecommend
ActionsResponsible Person & Target DateTaken
ActionsSEVOCCDETRPNCtrl + s = sort macro in RPN sequence high to
low after action12Ctrl + d = sort macro in RPN sequence high to low
before
action3456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960616263646566676869707172737475767778798081828384858687888990919293949596979899100
DFMEA#Item and FunctionPotential Failure ModePotential Effect(s)
of FailureSEVClassPotential Cause(s)/Mechanism(s) of
FailureOCCCurrent Design ControlsDETRPNRecommend ActionsResponsible
Person & Target DateTaken ActionsSEVOCCDETRPNCtrl + s = sort
macro in RPN sequence high to low after action12Ctrl + d = sort
macro in RPN sequence high to low before
action3456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960616263646566676869707172737475767778798081828384858687888990919293949596979899100
SeverityEffectCriteria: A failure could...RankingHazardous:
Without WarningInjure a customer or employee10Hazardous: With
WarningBe illegal9Very HighRender the product or service unfit for
use8HighCause extreme customer dissatisfaction7ModerateResult in
partial malfunction6LowCause a loss of performance likely to result
in a complaint5Very LowCause minor performance loss4MinorCause a
minor nuisance; can be overcome with no loss3Very MinorBe
unnoticed; minor effect on performance2NoneBe unnoticed and not
affect the performance1
OccurrenceProbability of FailureTime
PeriodProbabilityRankingVery High:More than once per day> 30
%10Failure is almost inevitableOnce every 3-4 days< 30 %9High:
Generally associated with processes similar to previousOnce per
week< 5 %8processes that have often failedOnce per month< 1
%7Moderate: Generally associated with processes similar toOnce
every 3 months< 0.03 %6previous processes which haveOnce every 6
months< 1 per 10,0005experienced occasional failures, but not in
major proportionsOnce per year< 6 per 100,0004Low: Isolated
failures associated with similar processesOnce every 1-3 years<
6 per million3Very Low: Only isolated failures associated with
almost identical processesOnce every 3-6 years< 3 per 10
million2Remote: Failure is unlikely. No failures ever associated
with almost identical processesOnce every 6-100 years< 2 per
billion1
DetectionDetectionCriteria: Liklihood the existence of a defect
will be detected by test content before product advances to next or
subsequent processRankingAlmost ImpossibleDefect caused by failure
is not detectable10Very RemoteOccasional units are checked for
defects9RemoteUnits are systematically sampled and inspected8Very
LowAll units are manually inspected7LowManual inspection with
mistake-proofing modifications6ModerateProcess is monitored via
statistical process control (SPC) and manually inspected5Moderately
HighSPC used, with an immediate reaction to out-of-control
conditions4HighSPC as above, with 100% inspection surrounding
out-of-control units3Very HighAll units are automatically
inspected2Almost CertainDefect is obvious and can be kept from
affecting customer1
DirectionsProcess FMEA StepsStepPrior to developing the PFMEA a
team should be selected and a process map developed for the process
in question1List the process steps in the first column of the PFMEA
form2For each process step brainstorm a list of the potential
failure modes - ways is which the product or service might
fail.3Identify the potential effects of each failure mode and rate
the severity of the effects4Identify the potential causes of the
failure modes and rate their likelihood of occurrence5List current
controls in place and rate the ability of the control to detect or
prevent the failure mode or cause6Multiply the three ratings to get
the Risk Priority Number (RPN)7Identify improvement actions to
reduce or eliminate the risk associated with high RPN's8Recalculate
the RPN to verify it is below the economically feasible
threshold
