8D永久性纠正措施流程培训8D Permanent Corrective Action Process Training

8D永久性纠正措施流程培训ItisvitallyimportanttoXXthateveryoneinProcurementiswelltrainedinidentifyingproblemsandbringingthemtopromptclosure.ThemethodembracedbyXXisthe8Discipline(8D)approach.Thepurposeofthistrainingistoeducatetheuserineachofthe8Disciplineswhichleadstopermanentcorrective

actionandeliminationoftheproblem.OverviewInrelationtoXXProcurement,an8Dismostlikelyusedtosolveacustomersatisfaction,quality,orproductreliabilityissue;however,the8Dapproachcanbeimplementedinotherareassuchasadministrative,engineering,etc…Overview(cont.)The8-Dapproachshouldbeusedwhen:Asignificantsupplierattributableissue,whichhascausedXXtoissueapurgeoraFinishedGood’sproducthold.Asignificantfieldorcustomersatisfactionissuethathasbeenattributedtoasupplierissue.Failedqualityauditeitherinternal(EPIA,FPIA,CDIT,etc…)toXXorthesupplier.The8-Dapproachshouldbeusedwhen:ThesupplierattributablefalloutconsistentlyexceedstheagreedtoDPPMgoal.Adefectoccurredthatshouldhavebeencontainedwithinthesupplier'sprocess.RootCauseAnalysisandCorrectiveActionisrequiredcontractuallyorrequestedbyacriticalAccount.KeyWordsRootCause: Ultimatereason(s)forproblemorissue.Containment: Shorttermfix.Isolatesandcontainsthefailure/defectsandpreventsfurtherdefects.Doesnotaddressrootcause.CorrectiveAction: Longterm.Permanentfixthateliminatesrootcause(s).Theseexpectationsaregeneralguidelines.Each8DsituationshouldbeassessedforitscriticalityandurgencybytherespectiveCommodityManagementTeam/personwhowillthencommunicatetherequiredresponsegoalstothesupplybase.8D/CorrectiveActionExpectationsProblemidentificationandactionPLANwithin48hoursofproblemnotification.Containmentplanwithin24hoursofproblemidentification.Correctiveactionplanwithin48hoursofrootcauseidentification.ProblemclosureverificationPLANwithin24hoursofcorrectiveaction.Allactionsexecutedtoplanneddates.Allactionsdocumentedviathe8Dformat.8D/CorrectiveActionExpectationsTheOriginator:Initiatethe8DandsendtotheSupplier'sDirectorofQualityorVPofQuality.Copythe8DinternallywithinXXasappropriate.Ensureeffectiveclosure/acceptanceofthesupplier’s8DresponsebytherespectiveCommodityManagementTeam.ResponsibilitiesTheSupplier:SupplierDirectorofQualityorVPofQualityplustheirmanagementapproves8DProcesscompletionandrespondstoXXin8Dformat.Communicate8Ddetailsinternallyasnecessary.RespondwithContainment/CorrectiveActionPlansasperexpectations.ProvideupdatestoXXasdeterminedbytheoriginator.CommunicatecorrectiveactionplantoallsuppliersitesforawarenessResponsibilitiesDISCIPLINE1USETEAMAPPROACHSelectandrecordinternalandexternalteammembers.Keepteamsizebetween4-10members.Thebestteamisonemadeupofmemberswithdiversebackgrounds.OverviewofDisciplinesDISCIPLINE

2

DESCRIBETHEPROBLEMUseterminologyunderstoodbythecustomer.ProblemdescriptionshouldbedefinedintermsoftheCustomer.Describethechangeinconditionorpre-existingcondition,whichcausedtheproblem.Expresstheconditionsinmeasurable,quantifiableterms.Detailwherethefailureoccurred,i.e.EPIA,FPIA,yielddetector;XX,Supplier,ORT,fieldfailure,etc…DefineanddescribetheexposuretoXXandtheSupplier.Usethe“5W’s”and1“H”:What?,Where?,Why?,When?,Who,?andHow?Who?When?Where?What?How?Why?DISCIPLINE3

DEFINETHEROOTCAUSETheheartofthe8Dprocess.Withoutdeterminationofrootcause,containmentandcorrectiveactionswillnotbeeffective.Describewhythechangeinconditionoccurred,oridentifythe“hole”inthesystemwhichallowedthepre-existingconditiontogoundetected.Ask“why”untiltherealreasonisexposed.Itispossiblethattheremaybeseveralrootcausesthatcanbeattributedtotheproblem.Categorizetherootcauses: -Material -Machines -Methods -Design -Manpower -Maintenance -EnvironmentDISCIPLINE4

IMPLEMENTCONTAINMENTACTION(S)PLANImmediate!Describewho,what,when,andhowtocaptureandcontainthedefectsnowandpreventthemfromgettingtothecustomer.ConsiderthepossibilityofseparatecontainmentplansforbothXXandthesupplier.DISCIPLINE4

IMPLEMENTCONTAINMENTACTION(S)PLANConsidertheeffectofthecontainmentplanonthefollowing:Quality,e.g.willitcauseotherdefects?ReliabilityCustomerSatisfactionCostDeliveryRepair/ReworkScrapSupplierchargebackMaterialPositioningDISCIPLINE4

IMPLEMENTCONTAINMENTACTION(S)PLAN(cont.)

ConsiderimpactonXX(informationtobeprovidedbyXX):PurgeStopBuildProductHoldServiceNotificationSortAlternateMaterialPositionedWWInventoryPositionHUBMaterialPositionDISCIPLINE4

IMPLEMENTCONTAINMENTACTION(S)PLAN(cont.)ImpactonSupplier(informationtobeprovidedbySupplier):PurgeStopBuildProductHoldSortVerifiedeffectivenessofcontainmentRecoveryPlanKeeptrackofexactdateofactionimplementationDISCIPLINE

5IMPLEMENTPERMANENTCORRECTIVEACTION(S)Definechangesthatneedtobeimplementedtoeliminaterootcause.Rememberthatscreensarecontainment-NOTCorrectiveAction.Defineanddescribewho,when,andhowtoimplementchangestototallyeliminaterootcause.UpdateProcessManagementPlan(PMP)toreflectchanges.DISCIPLINE

5IMPLEMENTPERMANENTCORRECTIVEACTION(S)(cont.)Considerpermanentcorrectiveactionplanimpactupon:Quality,i.e.Willitcauseotherdefects?ReliabilityCustomerSatisfactionCostMaterialPositioningEliminationofcontainmentactivities,i.e.containmentactivitiesshouldnolongerberequired.KeeptrackofexactdateofactionimplementationDISCIPLINE6

VERIFYEFFECTIVENESSOFACTION(S)Datadrivenverification.VerificationofEffectivenessforboth

ContainmentandCorrectiveAction(s)is

requiredPerformaudittoverify.Describeverificationresultsinquantifiable

terms(e.g.:achievedCpk=1.5,ordecreased

defectoccurrencestozero,etc.).VerificationshouldbecomparedtoreflecttheproblemmagnitudebeforeandafterContainment/CorrectionAction(s)taken.Continuecontainmentactivitiesuntilpermanentcorrectiveactionsareverifiedasbeingeffective.DISCIPLINE7PREVENTRECURRENCEDescribetheinternaland/orexternalculturalorsystemicchangesthatmustbemadetoeliminate/preventsimilar

problemsfromrecurring.Theteamchampionisresponsiblefor

takingtheserecommendationsbackto

managementanddrivingimplementation.ImplementationofchangesshouldbedrivenbacktotheProcessManagementPlan.DISCIPLINE8CONGRATULATEYOURTEAMChampionandteamleaderrecognizesteammembersfortheirroleinsolvingtheproblem.Keepitshort.BesincereDetailsofeachDisciplinewithExamples1) Selectandrecordinternalandexternalteammembers.Keepteamsizebetween4-10members.Thebestteamisonemadeupofmemberswithdiversebackgrounds.2) Choosepeoplewhoworkwellinteamsandeachother.3) Teamstaystogetherforonlyaslongasneededtoaddressandsolvetheproblem.4) Selectateamchampionorsponsor(managementmemberwhowillremoveroadblocksfortheteam).5) Selectateamleader(amemberwhodirectseffortsandtakesresponsibilityforteam).Discipline

1

-UseTeamApproachDISCIPLINE1INTERNALMEMBERSEXTERNALMEMBERSTEAMAPPROACHEIGHTDISCIPLINEWORKSHEET8D#DLBE-499EXCGoodSupplierAmerica:JohnB.GoodGoodSupplierJapanQA:I.L.Kishi&SunYamashitaGoodSupplierJapanMfg.Eng.:LukeWarm-TeamLeaderGoodSupplierKawasakiEng.:OttoMataGoodSupplier-JapanXXP/N:123456-0019.1GBHDDHotPlugableSUPPLIERPARTNUMBERDESCRIPTIONSub-supplier:I.M.GuruGoodExampleofDiscipline:BadExampleofDiscipline:DISCIPLINE1INTERNALMEMBERSEXTERNALMEMBERSTEAMAPPROACHAABC:DerricBradfordGoodSupplier-JapanXXP/N:_______________GoodSupplier-JapanSerial#_______________SUPPLIERPARTNUMBERDESCRIPTIONDISCIPLINE1(cont.)1) Determinewhoisthecustomer.Thecustomercouldbetheendcustomer,orthenextprocessinmanufacturing.2) Useterminologyunderstoodbythecustomer,andtheproblemdescriptionshouldbedefinedintermsoftheCustomer.3) Theproblemneedstobedefinedasachangeinconditionorpre-existingcondition.Theproblemshouldbecomparedtosomepriorordesirablecondition.4)Expresstheconditioninmeasurable,quantifiableterms.5) Detailwherethefailureoccurred,I.e.EPIA,FPIA,yielddetector;XX,supplier,ORT,fieldfailure,etc…6) DefineanddescribetheexposuretoXXandtheSupplier.7) Usethe“5W’s”and“1H”:What?,Where?,Why?,When?,Who?,andHow?Discipline2

-DescribetheProblem9.1GBHDDswiththefollowingserialnumbers:52139245,52139551,52139892,and52126698arepartofthefailuresthatwerereportedon1/12/99andXXandcausedabreachinthe2,0000UpperControlLimit(UCL).Therewereatotalof6failures.Abuildof2,220occurredon1/12/99,resultingina2,703DPPM.XXreportedmultiple03/11,01/15,10/14,andDataCompareerrors.GoodSupplier-JapanperformedLevel2NondestructiveFailureAnalysistoidentifyfailuretothecomponentlever.GoodSupplier-Japanobserved4.3KHz,or1.3KHzOscillationoneachdrive.AfterTeardownanalysis,weconfirmedCrackonVCMcoiladheredareaatthecornerofE-Block.Pleaserefertotable1thatshowsfailuremode,analysissummaryandCrackinspectionresultsafterTearDown.Table1(ShownallCrackfounddrivesfromallCustomer)DISCIPLINE2DESCRIBETHEPROBLEMDATE:1/31/99GoodExampleofDiscipline:UserNameTearDownAnalysisLevel2F/ACustomerFailureModeSerialNumberAreaAAreaBAreaCAreaD1. XXEast 52139245 03/11,01/17 4.3KHzOscillation Crack C N N N 2. XXEast 52139551 01/15/01 1.3KHzOscillation HeavyCrack C N N N 3. XXEast 52139892 DataCompareError 4.3KHzOscillation Crack C N N N 4. XXEast 52126698 DataCompareError 4.3KHzOscillation Crack C N N N 5. XXHouston 52122222 HDI 1.3KHzOscillation HeavyCrack C N N N 6. XXScotland 52155565 DNR 4.3KHzOscillation Crack C N N N ``DISCIPLINE2(cont.)Remarks: C:ObservedCrack N:ObservedNoCracksInaddition:1.Theseerrorsoccurredafter200hoursrunning2.WeconfirmedCrackfailuresonABC-45MKonly.3.WehaveneverseenthisfailureonAABCdrivessofar.(Japanmanufactureddrivesonlyhadthisissue.)4.Faileddrivesweremanufacturedfrommid-Nov.toearlyJan.RefertoTable2belowwhichshowsCoiladheredDateonCustomerreturneddrivesandCrackcheckresultsinJapanonprocessreworkedHDDs.Table2DISCIPLINE2DESCRIBETHEPROBLEMDATE:1/31/99GoodExampleofDiscipline:01/16/9901/15/9901/10/9901/09/9901/08/9901/07/9901/06/9901/05/9912/20/9812/15/9812/01/9811/98Coiladhereddate0/73Crackcheckedinprocess0CustomerReturnedDrives000000000000/120/1211/6612/993/354/171/200/210/110/2830/634CheckedonlyReworkDrivesNewBuiltRework+AreaBAreaDAreaCAreaADISCIPLINE2(cont.)BadExampleofDiscipline:DISCIPLINE2DESCRIBETHEPROBLEMDATE:1/31/99Audibleoscillationduringseeking.DISCIPLINE2(cont.)Theheartofthe8Dprocess.Withoutdeterminationofrootcause,containmentandcorrectiveactionswillnotbeeffective.Describewhythechangeinconditionoccurred,oridentifythe“hole”inthesystemwhichallowedthepre-existingconditiontogoundetected.Ask“why”untiltherealreasonisexposed.Itispossiblethattheremaybeseveralrootcausesthatattributedtotheproblem.Categorizetherootcauses: -Material -Machines -Methods -Design -Manpower -Maintenance -EnvironmentDiscipline

3-DefinetheRootCauseTherootcauseisthecombinationoffollowingtwofactors:1. VCMcoiladhesionmethodimplementedonOct.16,1998.Extendedadhesivecoatarea. AreasAandBareverysensitivetothermaltransfer.2. VCMcoilduringprocessvariationduetoincreasedproductionvolume. E-Blockassembliescuringprocessoutofcontrol.DuringOct.-Dec.,ABC-45MKproductvolumewasincreasedwithrequiredtheoperatorstoopenthecurechamberdoororefrequentlywhiletheadhesivewasnotfullycured.Thefrequentopeningofthechamberdoorchangedthecureprofileoftheadhesive,therebyincreasingitsresidualstress.HistoryandbackgroundofVCMcoildesignchange1.PreviousVCMcoilshadasmalleradhesiveattachmentareathanthenewdesign.Thereasonforthedesignchangewastoeliminatein-process800Hzseekvibrationfailures.2. Twodesignchangeswereconsidered:1)adhesivecoatextensionand2)DSPmicrocodechange.DISCIPLINE3DESCRIBETHEROOTCAUSEDATE:1/31/99GoodExampleofDiscipline:DISCIPLINE3(cont.)DISCIPLINE3(cont.)HistoryandbackgroundofVCMcoildesignchange,cont..3. ExperimentationconfirmedtheDSPmicrocodechangewasmosteffectiveascompared totheadhesivecoatextension.However,theextendedVCMcoiladhesionareashowedsignificantreductionon800Hzvibrationreductionandwaseasiertoimplementthanthemicrocodechange.Therefore,weimplementedtheextendedadhesiveareafortheVCMcoil.4. Sincenotificationofthefailures,DesignEngineeringhasmodeledtheadhesiveresidualstressontheVCMcoilassemblyunderdifferenttemperatureconditions(25Cto120C).Themodelingshowshigherresiduastressatthecorner(AreaA)ofE-Blockarm.DISCIPLINE3DESCRIBETHEROOTCAUSEDATE:1/31/99GoodExampleofDiscipline:DifferencesbetweenUSAbuiltandJapanbuiltHDDsTheVCMsoiladhesionprocessisthesameatbothlocations.TherearenoVCMcoilcrackfailurereportedfromUSAmanufacturedHDDs.TheUSAfactoryhadmorecuringchambersandtoolsascomparedtheJapanfactory,whichallowuninterrupted,lowstressadhesivecuringoftheVCMcoils.TherootcauseofthisproblemwasloosenscrewofretractplatebynoUVglueadhesionsupport.AoperatordidnotprovideUVgluebymistake.DISCIPLINE3DESCRIBETHEROOTCAUSEDATE:1/31/99BadExampleofDiscipline:DISCIPLINE3(cont.)Discipline4ImplementContainmentAction(s)PlansContainmentactionsarethosethatstoptheproblemNOW!Theyarequicktoinvokeandwillresultindrasticreductionoreliminationoftheproblem.Remember,containmentactionsDONOTattackrootcause.Rather,theyarescreensintheprocesswhicheffectivelyallowcaptureofthedefectsfromgettingtothecustomer.Unfortunately,manycontainmentscreensactlike“sledgehammers”totheprocess,inthattheywillscreenouttheconcernedpartsaswellasmanygoodproductsaswell.Itemstoconsiderwheninvokingacontainmentactionare:a) Williteliminatetheproblemfromgettingtothecustomer?b) Whatwillitcostintime,money,andresourcestoimplement?c) Willitresultinsuchareductioninthrough-putthatitwilleffectfurthershipments?d) Doesitcauseotherdefectsthatcouldgettothecustomer?DISCIPLINE4(cont.)1) Immediate!Describewho,what,when,andhowtocaptureandcontainthedefectsnowandpreventthemfromgettingtothecustomer.ConsiderthepossibilityofseparatecontainmentplansforbothXXandthesupplier.2) Considertheeffectofthecontainmentplanonthefollowing:Quality,i.e.willitcauseotherdefects?ReliabilityCustomerSatisfactionCostDeliveryRepair/ReworkScrapSupplierchargebackMaterialPositioningAgoodcontainmentactionplanwillhavedatesanddetailsoftheactionssothattheproblemsolvingprocesscanbecomeahistoricaldocument.DISCIPLINE4(cont.)

3) ConsiderimpactonXX(informationtobeprovidedbyXX):PurgeStopBuildProductHoldServicenotificationSortAlternateMaterialPositionedWWInventoryPositionHubMaterialPositionDISCIPLINE4(cont.)4) ImpactonSupplier(informationtobeprovidedbySupplier):PurgeStopBuildProductHoldSortVerifiedeffectivenessofcontainmentRecoveryPlanKeeptrackofexactdateofactionimplementationRiskAssessment: -Incomingfailure(XX) :4/273,840drives;14.6DPPM -FieldFailure :01. TotalDPPMis488asofDecember1998.2. NosimilarincidentshavebeenreportedfromotherCustomers.3. NoORT,48hrsAudit,OBA,orevenin-processrelatedfailureswerereportedforthisfailure.4. PurgeallexistingJapanmanufacturedinventoryworldwide.5. SerialNumberofthesuspectdriveswillbeprovidedby2-02.6. SubsequentpurgewilltakeplaceatallGoodSupplierinventorysites.7. Asof1-31.9.1GBHDDsareonStopBuildandStopShip.DISCIPLINE4CONTAINMENTPLANDATE:1/31/99GoodExampleofDiscipline:Weissuedtechnicalinformationtofactory,whichindicatesfollowingitems.1. AddedretractplatescrewinspectionprocesstoidentifyUVglueproperlycoatedandscrewtighten.2. Re-trainedalloperatorstorecognizethisparts(retractplate)isrequiredUVglueadhesionsupportandproperlyfollowingworkinstruction.DISCIPLINE4CONTAINMENTPLANDATE:1/31/99BadExampleofDiscipline:DISCIPLINE4(cont.)Discipline

5ImplementPermanentCorrectiveAction(s)Permanentcorrectiveaction(s)eliminatetherootcauseoftheproblemtherebyeliminatingtheproblemandusuallyresultinabasicchangeinthedesignoftheproductormanufacturingprocessPermanentcorrectiveaction(s)areNOTpermanentscreenssorts,orcontinuouscontainmentactionsInmostcases,thepermanentcorrectiveactions(s)willrequiretimetoimplement.Theteamshouldexercisediligenceinidentifyingandpermanentlysolvingtheproblemwithoutcreatinganotherproblemlater.Therefore,thekeyissuesinimplementingpermanentcorrectiveactionsare:a)Theseactionseliminatetherootcauseoftheproblemb) Theseactionsarenotextensionsofthecontainmentactionsc) Caremustbetakennottosolveoneproblemandcreateanother.1) Definechangesthatneedtobeimplementedtoeliminaterootcause.2) Rememberthatscreensarecontainment-NOTCorrectiveAction.3) Defineanddescribewho,when,andhowtoimplementchangestototallyeliminaterootcause.4) UpdateProcessManagementPlan(PMP)toreflectchanges.5) Considerpermanentcorrectiveactionplanimpactupon:Quality,I.e.Willitcauseotherdefects?ReliabilityCustomerSatisfactionCostMaterialPositioningEliminationofcontainmentactivities,i.e.containmentactivitiesshouldnolongerberequired.6) KeeptrackofexactdateofactionimplementationDISCIPLINE5(cont’d.)1. ImplementpreviousprocessofVCMCoiladhesion-Immediateimplementation.2. Inspect100%ofcuredadhesiveunderblacklightfordetectionresidualstress-Immediateimplementation.3. Automatecuringprocessthatlocksthecuringchambersooperatorcannotopenthechamberuntilafterthecuringprocessiscomplete-Newautomatedchambersdueon-line2-28-99DISCIPLINE5PERMANENTC/APLANDATE:1/31/99GoodExampleofDiscipline:DISCIPLINE5(cont’d.)WeissuedtechnicalinformationtoAABC,whichindicatesfollowingitems.1. AddedretractplatescrewinspectionprocesstoidentifyUVglueproperlycoatedandscrewtighten.2. Re-trainedalloperatorstorecognizethisparts(retractplate)isrequiredUVglueadhesionsupportandproperlyfollowingworkinstruction.AllitemsindicatedabovehasappliedsinceJune29,1999asapermanentcorrectiveactionDISCIPLINE5PERMANENTC/APLANDATE:1/31/99BadExampleofDiscipline:NOTETHATTHISDISCIPLINEISTHESAMEASDISCIPLINE4Discipline

6-VerifyEffectivenessofAction(s)Thisisaveryimportantstepsinceitwillconvincetheteamandthecustomer,thatthepermanentcorrectiveactionshavehadapositiveoutcomeontheproblem.Eachactionthathasbeentakenshouldbeverifiedinquantifiabletermsastohoweffectivetheactionwas.Thegoalisfor100%effectivenessforeveryaction;however,inmostcases,lessthan100%isachieved,Thismayleadtheteamtodetermineifacontinuedeffortwillberequiredoriftheactionstakenhavereducedtheconcernenoughthatadditionalresourceswouldbebetterspendonsomethingelse.Itisagoodideatocontinuethecontainmentaction(s)untilthepermanentaction(s)havebeenverified,atwhichtimethecontainmentactioncanbediscontinued.1) Datadrivenverification.2) VerificationofEffectivenessforbothcontainmentandcorrectiveaction(s)is

requiredPerformaudittoverify.3) Describeverificationresultsinquantifiableterms(e.g.:achievedCpk=1.5,or

decreaseddefectoccurrencestozero,etc.).4) VerificationshouldbecomparedtoreflecttheproblemmagnitudebeforeandafterContainment/CorrectionAction(s)taken.5) Continuecontainmentactivitiesuntilpermanentcorrectiveactionsareverifiedasbeingeffective.DISCIPLINE6(cont’d.)1. Since1-31-99,noORTfailuresrelatedVCMadhesion(0/122HDDstested).2. Since1-31-99,noOBAfailuresrelatedtoVCMadhesion(0/20,960HDDsaudited).3. Since1-31-99,nofailuresatXXattributedtoVCMadhesion(2/249,156HDDsdelivered).4. Thenewautomatedcurechambersareoperatingcorrectlybynotallowi