FailureModeEffectsAnalysis(FMEA).pptx
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1、Failure Mode Effects Analysis(FMEA)Abbr. Version DTQS-NPQ July 20001FAILUREnWhats the failureuFailure classuFailure occurrencenWhats the reason for failure2Questions?FAILURE3Failure Mode Effects AnalysisnFMEAuA systematic group of activities intended to:lRecognize the potential failure(s) of a produ
2、ct or process and the severity of effect of that failure(s).lIdentify critical characteristics.lRank order potential design and process deficiencies.lIdentify actions that can eliminate or reduce the chance of the potential failure from occurring and reaching the customer.lDocument the process.4FMEA
3、 PurposenTo eliminate the cause of failureif this is not possiblen reduce how often the failure occursn improve the ability to detect the failure before it reaches the customer5FMEA History and TypesnHistoryu50Fighter Plane Designu60Apollo Planu70Automobile/Medical Instrumentu80Micro-electronicu90QS
4、9000, ISO9000nTypesuDFMEAuPFMEA6Process FMEA FormProcess ResponsibilityPage 1 of 1Cell SizeFMEA Due DatePrepared byCell ChemistryFMEA NumberFMEA Date (Orig.) (Rev.)Action ResultsProcessFunctionPotentialFailureModePotentialEffect(s) ofFailureSevClassPotentialcause(s) ofFailureOccCurrentControlsDetS*O
5、RPNRecommendedAction(s)Area/IndividualResponsible &Completion DateActions TakensevoccdetS*ORPNProcessProcess ResponsibilityPage 1 of 1Cell SizeFMEA Due DatePrepared byCell ChemistryFMEA NumberFMEA Date (Orig.) (Rev.)7Process FMEA FlowTeam SelectionCalculateRisk NumbersDefine ProcessDetailFailure Mod
6、eCausesEffectsBuildPareto ChartDevelopRecommendedActions8Process FMEA FlowTeam SelectionCalculateRisk NumbersDefine ProcessDetailFailure ModeCausesEffectsBuildPareto ChartDevelopRecommendedActions9Process FMEATeam SelectionnCross Functional and MultileveluOperators, Mechanics, Engineers, LeadersuTea
7、m Leader DesignatedlRecommended to be Process OwneruMust be Empowered to implement actionsuFunctional experts can be pulled in as neededuSmaller “Core” group may be useful initially to provide framework.10Process FMEA FlowTeam SelectionCalculateRisk NumbersDefine ProcessDetailFailure ModeCausesEffec
8、tsBuildPareto ChartDevelopRecommendedActions11Process FMEADefine ProcessnDevelop a Process Flow diagram that is representative of the process as it truly is.nDecide the Rating ScalesnOutline Operator, Machine, Product InteractionsOperator involvement is imperative at this step!12Severity RatingSever
9、itySeverity is a rating corresponding to the seriousness of an effect of a potential failure mode.No Effect1No effect on system or output performance or on subsequentprocesses.Very SlightEffect21Customer will probably not notice the failure. Nuisance Faultnoticed.Slight Effect3Slight effect on outpu
10、t performance. Customer slightly annoyed.Nuisance fault obvious.Minor Effect4Minor effect on output or process performance. Slight deterioration.Chronic nuisance fault.Moderate Effect54Moderate effect on performance. Customer dissatisfied. Nuisancerepair required.SignificantEffect6Performance degrad
11、ed but safe. Discomfort. Repair required.Non-vital part nonfunctional.Major Effect77Rework/Repairs necessary. Performance severely affected butsafe. Dissatisfied customer. Subsystem inoperable.Serious Effect8Equipment damaged. System inoperable but safe. Verydissatisfied customer.Very SeriousEffect9
12、9Potentially hazardous failure. Safety related but gradual failure.HazardousEffect1010Hazardous failure. Safety related sudden failure, Governmentregulation non-compliance.13OccurrenceOccurrence is a rating corresponding to the rate at which a failure mode occurs before anydetecting measures are app
13、lied.OccurrenceRatingCpkFailure RateNotesAlmostImpossible1Cpk 1.675.0 1 in1,500,000Failure unlikely. Similarprocesses or products showno failure.Remote21Cpk 1.504.51 in 150,000Remote number of failureslikely.Very Slight3Cpk 1.334.01 in 15,000Very few failures likely.Slight4Cpk 1.173.51 in 2000Few fa
14、ilures likely.Low54Cpk 1.003.01 in 400Occasional failure.Medium6Cpk 0.832.51 in 80Moderate number of failureslikely.ModeratelyHigh77Cpk 0.672.01 in 20Frequent failures likely.High8Cpk 0.511.51 in 7High number of failures likely.Very High99Cpk 0.331.01 in 3Very high number of failureslikely.AlmostCer
15、tain1010Cpk0.33 1 1 in 3Failures almost certain tooccur. Similarprocesses/products showfailures.Occurrence Rating14DetectionDetection is a rating corresponding to the likelihood that the detection methods orcurrent controls will detect the failure.Almost Certain1Reliable detection controls are known
16、 with similarprocesses or products. Controls are almost certain todetect the failure mode.Very High21History with similar processes available. Controls verylikely to detect the failure modeHigh3Controls highly likely to detect the failure mode.Moderately High4Controls likely to detect the failure mo
17、de.Medium54Controls might detect the failure mode.Low6Low likelihood that controls will detect the failuremode.Slight77Slight likelihood that controls will detect the failuremode.Very Slight8Very slight likelihood that controls will detect the failuremode.Remote99Remote likelihood that controls will
18、 detect the failuremode.AlmostImpossible1010Almost certain that controls will not detect the failuremode. No known controls available to do so.Detection Rating*Could be time based e.g. Takes x minutes or days to detect a failure.15Process FMEA FlowTeam SelectionCalculateRisk NumbersDefine ProcessDet
19、ailFailure ModeCausesEffectsBuildPareto ChartDevelopRecommendedActions16Process FMEADetailFailure ModeCausesEffectsnBrainstorm failure modes.nSelect and define failure modes that impact critical characteristics.nIdentify root causes.nDefine effects of failure mode.nDetermine how often failure modes
20、occur.nDetermine current controls ability to detect.17Process FMEA FlowTeam SelectionCalculateRisk NumbersDefine ProcessDetailFailure ModeCausesEffectsBuildPareto ChartDevelopRecommendedActions18Process FMEACalculateRisk NumbersnCalculate Risk Priority Number (RPN) for each failure mode.uRPN = sever
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