8D报告Vishay客户纠正措施要求CAR应用指南

VishayCustomer

CorrectiveActionRequest(CAR)Guidelines

Vishay《客户纠正措施要求CAR》应用指南5/30/2023Rev.Orig8DTraining第1页WhatisaCAR/8D?

何谓CAR/8D?ACAR/8DReportisamethodtodocument,communicate,trackanddriveresolutionsforqualityissues.CAR/8D是针对品质问题而进行文献化、沟通、追踪及处理问题办法。An8DreportisFordMotorCompany’sformatforproblemsolving.Itisthepreferredmethodusedthroughoutourindustry.CAR/8D报告是福特公司处理问题格式。它是我们所有行业首选处理问题办法。5/30/2023Rev.Orig8DTraining第2页CUSTOMER8DEXPECTATION

客户应用8D盼望ImmediateContainment.

采取迅速围堵措施（短期对策）ClearidentificationofRootCause.

真正识别问题产生主线原因（真因）RobustCorrectiveActions.充足纠正措施VerifiedCorrectiveActions.验证纠正措施Systemfixes.系统化（即纠正措施标准化或文献化）100%On-timeresponse.

100%按时反应（即及时处理问题，按时回复客户）Eliminatetheproblemsthefirsttime.做到第一次就消除问题所在Preventionoffutureproblems.实现潜在问题预防5/30/2023Rev.Orig8DTraining第3页CAR/8DReportProblems

完成CAR/8D报告存在问题Notidentifyingthetrueprocesses,escape,andsystemrootcauses.

没有识别出过程、流出（逃脱）及系统主线原因（真因）Notimplementingsystemcorrectiveactions.

没有实行系统性纠正措施Notproperlycontainingentirepipelineofproduct.

没有针对产品所有流程采取正确围堵措施Unclearorambiguouswording.

对问题采取不明确或模棱两可描述Notmeetingcustomerexpectationsregardingcontentandcycletime.

不符合客户有关内容及回复时间要求5/30/2023Rev.Orig8DTraining第4页CAR/8DRequirements

CAR/8D要求Allcorrectiveactionrequestsmustbecompletedusingan8Dreport(unlessadifferentmethodisrequiredbyCustomer).

所有《纠正措施要求》必须采取8D报告形式（除非客户要求采取不一样办法MustuseCorporateformat.

必须采取Vishay公司格式Mustuse8Dchecklistasaguidelineincompletingthe8D’s.

在完成报告过程中必须采取8D检查表进行检查5/30/2023Rev.Orig8DTraining第5页8

DisciplinestoProblemSolving

处理问题8个准则D1EstablishaTeam组建问题处理小组D2DescribetheProblem描述问题D3Containtheproblem采取围堵措施（即短期对策）D4Identifytherootcauses识别/确认主线原因（真因）D5CorrectiveActions确认纠正措施D6ImplementCorrectiveActions实行纠正措施（即长期对策）D7PreventRecurrence避免再发D8CongratulatetheTeam小组庆祝5/30/2023Rev.Orig8DTraining第6页D1EstablishTeam

D1组建问题处理小组EstablishCrossFunctionalTeam.

建立跨功能小组IdentifyaChampion.确定小组长Membersshouldbefromallaffectedareas,notjustquality!i.e.Sales,Logistics,Marketing,Engineering,LineOperators,ProductionMgmt.,etc…

小组组员应来自于所有被包括区域，并非只是质量部！如销售、物流、市场、工程、生产线操作工、生产管理等等······TheTeamshouldaskthemselvesdotheyhavethecorrectskillmixtosolvetheproblem?

小组应问询自己是否具有处理问题所必需能力?5/30/2023Rev.Orig8DTraining第7页D2DescribetheProblem

D2描述问题ClearlyIdentifyandDefinetheProblem.

明确识别和定义问题InmanycasesProblemsareambiguousorimprecise.

在许多案例中，问题是模棱两可或不明确ClarityensuresthateveryoneistryingtosolvethesameProblem.

明确问题可确保任何人将竭力去处理问题5/30/2023Rev.Orig8DTraining第8页D2DescribetheProblemElements

D2描述问题要素WhatistheProblem?Describethefailuremode.

问题是什么?描述失效模式Wherewasitdetected?问题是在哪里被发觉?Whenwasitdetected?问题是什么时候被发觉?Whatlots/datecodesareaffected?

被影响批次/日期码是那些?Howmanypiecesareaffected?

被影响数量是多少?IstheCustomerinformationincluded?

是否包括客户信息?5/30/2023Rev.Orig8DTraining第9页D2DescribetheProblemExamples

D2描述问题案例PoorProblemDescription差劲问题描述“Customerreceivedwrongpart.”客户接收到错误零件GoodProblemDescription完美问题描述“CustomerreceivedincorrectvalueCRCW-0603resistorson4/1/02.CustomerP.O.441960(VishayP.O.X765644-30)specifiedCRCW-0603,8.2KohmandreceivedCRCW-0603,82Kohmparts.”客户在4/1/02接收到阻值错误CRCW-63电阻。客户订单号码441960（Vishay订单号码X765644-30）指定CRCW-63电阻阻值为8.2欧姆，而收到CRCW-63电阻阻值为82欧姆。5/30/2023Rev.Orig8DTraining第10页D3Containment

D3围堵措施（短期对策）Containmentissimilartoquarantine.Quarantinedoesnotcureadisease,butitkeepsitfromspreading.

围堵相同于病人隔离。隔离虽不能医好疾病，但能够避免疾病传输FindandsegregatenonconformingproductstopreventshipmenttoCustomer.

查找和隔离不良品，避免发往客户Shutdownprocesses/equipmentthatisproducingbadproduct.

停顿正在制造不良加工或装配Makesurecontainmentactionsareeffective.

确保围堵措施是有效5/30/2023Rev.Orig8DTraining第11页D3ContainmentElements

D3围堵措施要素Hasaneffectivecontainmentmethodbeenidentifiedanddocumented?

是否有有效围堵办法已经被确定和文献化?Havedates(ordatecodes)fortemporarycontainmentactionsbeenidentified?

是否已经确定了临时围堵措施实行日期（日期码）?Haveactionsbeenverifiedwithbeforeandafterdata?

是否已经验证了围堵措施实行前后效果?Hastheentirepipelinebeencontained(production,warehouse,distributors)?

是否对产品所有流程采取了围堵措施（如生产线、仓库及发货员）?Hasdetailedinstructionsoncontainmentbeenissuedtopeopleresponsibleforcontainment?

是否给负责实行围堵措施人员发放了详细围堵作业指导书?5/30/2023Rev.Orig8DTraining第12页D3ContainmentExample

D3围堵措施案例PoorContainment差劲围堵措施“Operatorwasalertedofthefailure.”让操作工提防/注意此不良GoodContainment完美围堵措施“Productionandwarehousematerialwasinspectedon4/1/02byJ.Smith(qualityassurancepersonnel)andtherewere0lotsoutof320containingmixeddevices.”J.Smith（质量确保人员）于4/1/02检查了生产线及仓库材料5/30/2023Rev.Orig8DTraining第13页D4RootCause

D4主线原因（真因）Rootcauseisthedisease(startingpoint)thatsetsinmotionthecauseandeffectchainthatcreatestheproblemorproblems.

主线原因是产生问题或问题群原因和影响开始发作病因（发作点）BewaryofselectingsymptomsinsteadofrootcausesIfyoufixasymptomyouwon’tsolvetheproblem.

必须提防以症状替代病因，假如你仅仅关注一种症状，你将不能处理问题Poorrootcauseselectionresultsinpoorcorrectiveactions.

选择不正确主线原因将造成不正确纠正措施Usetoolssuchas5Whyanalysistoensurethattherootcausehasbeenidentified.

应用象“5个为何”分析法，确保主线原因被识别和确定5/30/2023Rev.Orig8DTraining第14页D4RootCauseElements

D4主线原因要素Hastheprocessrootcausebeenidentifiedandestablished?

制程主线原因是否已经被识别和确定?Hastheescaperootcausebeenidentifiedandestablished?

流出（逃脱）主线原因是否已经被识别和确定?Hasthesystemrootcausebeenidentifiedandestablished?

系统主线原因是否被识别和确定?Dothethreerootcausesexplainallweknowabouttheproblem(timing,failuremode,failureamount,etc…)?

三种主线原因是否能够解说我们所懂得问题所有方面（如时间、失效模式、失效数量等等）?Wastherootcauseanalysisperformedusingthe5whytechnique?

主线原因分析是否使用了“5个为何”办法?5/30/2023Rev.Orig8DTraining第15页D4RootCauseExamples

D4主线原因案例PoorRootCauseStatement差劲主线原因“OperatorplacedwronglabelonPackage.ItwasanOperatorError.”操作工在包装箱上贴错了标签，是操作工错。

GoodRootCauseStatement完美主线原因“ProcessRootCause:Anincorrectlabelwasplacedonthepackagebecausethecurrentsystemallowsformultiplelotstobeprocessed(batchprinting)atoneworkstation.”制程主线原因：目前系统允许在同一种岗位加工种类不一样批次，导致错误标签被贴在包装箱上“EscapeRootCause:Themis-labeledproductescapedbecausetherewasnoverificationstepatorafterthelabelprocess.”

流出主线原因：贴错标签产品流出是由于在该岗位或后续过程没有标签验证步骤5/30/2023Rev.Orig8DTraining第16页D5CorrectiveActions

D5纠正措施Correctiveactionsshouldfixthediseaseorrootcause.

纠正措施必须是针对病因或主线原因（真因）Correctiveactionsshouldaddressprocess,escape,andsystemrootcauses.

纠正措施必须致力于制程、流出（逃脱）及系统主线原因（真因）Negativeeffectsofcorrectiveactionsshouldbeconsidered.

必须考虑纠正措施带来负面影响（即边界效应）Retrainingofoperatorsisnotacorrectiveaction.

操作工再教育不属于纠正措施范围Increasedinspectionisnotacorrectiveaction.

增加检查（人员、数量、频次等）也不属于纠正措施范围5/30/2023Rev.Orig8DTraining第17页D5CorrectiveActionsElements

D5纠正措施要素Haveprimaryandalternativecorrectiveactionsbeenidentified?

是否已识别和确定首选及多项选择纠正措施Docorrectiveactionsaddressprocess,escape,andsystemrootcauses?

纠正措施是否是针对制程、流出（逃脱）及系统根本原因Havenegativeeffectsofcorrectiveactionsbeenconsidered?

是否考虑了纠正措施负面影响（即边界效应）5/30/2023Rev.Orig8DTraining第18页D5CorrectiveActionExamples

D5纠正措施案例PoorCorrectiveAction差劲纠正措施“Re-trainoperator.”操作工再培训GoodCorrectiveAction

完美纠正措施“ProcessCorrectiveAction:Changeworkflowtoaserialprocesswherebyonlyonelotisattheprintingstationatalltimes.Thiswilleliminatethechanceofmixingtheproductlabels.”制程纠正措施：变更流程，在任何时间标签印刷岗位只加工单一批次“EscapeCorrectiveAction:Implementabarcodeverificationsteptoensurethatcustomerlabelmatchesthefactorylabel.”流出（逃脱）纠正措施：实行标签验证步骤，确保工厂标签和客户标签一致5/30/2023Rev.Orig8DTraining第19页D6ImplementCorrectiveActions

D6实行纠正措施（长期对策）Stepwherewemonitor/validatethatthecorrectiveactionshaveeliminatedtherootcause(s).

确定我们监控/验证纠正措施是否已经消除了主线原因步骤Datesforthestartandcompletionofthecorrectiveactionshouldbeidentifiedalongwiththeresponsibleperson.

和纠正措施实行责任人一起确定纠正措施开始实行和完成日期5/30/2023Rev.Orig8DTraining第20页D6ImplementCorrectiveActionsElements

纠正措施实行要素Havecorrectiveactiondatesalongwithresponsibleindividualbeenidentified?

是否已经确定纠正措施实行日期和责任人?Havecorrectiveactionsbeenvalidatedtoeliminaterootcause(s)?

对纠正挫伤是否进行了验证，它能否消除主线原因?5/30/2023Rev.Orig8DTraining第21页D6ImplementCorrectiveActionsExamples

D6纠正措施实行案例PoorCorrectiveAction差劲纠正措施“Complete.”已完成GoodCorrectiveAction完美纠正措施“CorrectiveactionsstatedinD5werecompletedon4/1/02byJ.Smith.Postlabelinginspectionhasdiscovered0failuresoutof400lotsinspectedasof5/1/02.”

J.Smith已于4/1/02完成了D%中描述纠正措施。5/1/02在标签检查岗位共检查了400个批次，没有发觉一批标签不良5/30/2023Rev.Orig8DTraining第22页D7PreventRecurrence

D7避免再发Preventtheproblemfromreturningbyaddressingproduction,business,management,orengineeringprocesses.

通过向生产、业务、管理层、工程传达，以避免问题再发5/30/2023Rev.Orig8DTraining第23页D7PreventRecurrenceElements

D7避免再发要素Dopreventiveactionsaddressbasicsystemissues?

预防措施论述是否基于基本系统问题HaveFMEA’s,controlplans,and/orproceduresbeenupdatedtoensurethatthesystemswillpreventissuesfromre-occurring?

FMEA、控制计划及/或程序是否已经被更新，以确保系统能够避免问题再发Havepreventiveactionsbeenagreeduponbyallaffectedareas?

预防措施是否已经征得被影响区域认可Dounfinishedpreventiveactionshaveachampionandaprojectedcompletiondate?

未完成预防措施是否确定了组长和其完成日期

5/30/2023Rev.Orig8DTraining第24页D7PreventRecurrenceExamples

D7避免再发案例PoorPreventiveAction差劲预防措施“Sameascorrectiveactions.”预防措施同于纠正措施GoodPreventiveActions完美预防措施“Workinstructionandcontrolplanhavebeenchangedon4/1/02toeliminatebatchprocessingandtoaddbarcodeverificationprocesses”作业指导书及控制计划已于4/1/02进行变更，以消除批次处理问题及增加标签验证过程“CorrectiveandPreventiveactionswerealsoappliedtoVishay’ssisterfactoriesinChinaon4/1/02.”纠正/预防措施已于4/1/02应用于Vishay在中国弟兄工厂“Auditchecklistwasmodifiedon4/1/02toincludemonthlycheckstoensuresinglelotprocessing.”检查表已于4/1/02修订，包括月检以确保单一批次被加工5/30/2023Rev.Orig8DTraining第25页D8CongratulateTeam

D8小组庆祝Variesbyfacilitybutmostoftenoverlooked.

5/30/2023Rev.Orig8DTraining第26页OtherComments

其他内容8Dshouldsupplyfactsnotemotions.

8D应当提供事实，不应带有感情色彩Avoidusinginternalacronyms.

避免使用公司内部缩写Becompleteinyourdescriptions.

论述应当完整ItisourresponsibilitytofixVishayproblemsevenifwedonothavetraceabilityinformation.

虽然没有可追溯信息，但关注Vishay问题是我们责任5/30/2023Rev.Orig8DTraining第27页8DExampleHeartInc,amanufacturerofHeartdefibulators,returned25shortedpartswithmultipledatecodeson5/1/02.Heartstatedthatthe25partsfailedattherefinaltest.Heart’sfailurerateis10PPM.Theyexpressedconcernthatfaileddefibulatorsmightreachtheircustomers.

InternalanalysisbyVishayindicatesthatthe25partsareindeedshortedandtheyarenotthedevicetype(PN#V123)thatVishaysellstoHeartInc.Infact,the25partsareamixtureofdifferentVishaydevicesspanningthelast3monthsofproduction(February,March,andApril).AllreturneddeviceshadalowerpowerratingthanwhatissuppliedtoHeart,whichiswhytheyshortedinHeart’sapplication.Additionalanalysis,pointstothefactthatthepartsweremixedatmarking.Themarkingequipmenthasaknowndefectinwhichthelastfewpartsmightgetstuckinthetrackduetorandombutfrequentstickingofthepushpinmechanismwhenthebowlfeederbecomesempty.Tocombatthisissue,theengineerduringtheinitialdiscoveryoftheissueinstructedtheoperatorstoinspectthetrackpriortostartinganewlot.Intheeventthatpartswereleftovertheoperatorwastoremovethedevicesandcallthetechniciantorepairthepushpin.Inadditiontothechangeinprocedure,productionimplementedasampleoutgoingelectricaltest(200piecesper20,000piecelot)toeliminatemixedlots.Theoperatoronthemarkingequipmentwasnew(approximatelyworkingforVishayfor3months)andwasnotperformingtheinspectionasrequiredbytheprocedure.5/30/2023Rev.Orig8DTraining第28页8DExample8D案例

D1EstablishTeamD1建立小组5/30/2023Rev.Orig8DTrainingNameFunctionChampionJ.SmithProductEngManagerTeamLeaderJ.DoeQualityEngineerMembersR.NeilProductionSupervisorB.DellProductionEngineerV.ChambersLogisticSupervisorA.MayMaintenanceEngineerN.PhillipsTrainingSupervisorS.RobinSales第29页8DExample8D案例

D2DescribeProblemD2描述问题HeartInc.returned25V123partson5/1/02withthefollowingdatecodesthatfailedshortattheirfinaltest.Heart公司在5/1/02返回25个V123产品，产品日期码如下，这些产品是其产品终检时发觉短路#ofPartsDateCode10 0202 10 020350204Theestimatedfailurerateis10PPMandthecustomerisconcernedaboutfieldreliability.估计失效率为10PPM，并且客户非常担心已流入市场5/30/2023Rev.Orig8DTraining第30页8DExample8D案例

D3ContainmentActionsD3围堵措施AllproductinproductionandinVishay’swarehouseswasquarantined(byV.Chamberson5/2/02)and100%electricallytested(byB.Dellon5/4/02)toeliminatethemixedproduct.12mixedpartswereremovedoutof60,000partstested.Allretestedlotswillbemarkedwitha“green”stickertoidentifythattheyhavebeenretested.所有在线及在库品所有隔离（V.Chambers已于5/2/02完成），并进行100%电性测试以消除混入产品（B.Dell已于5/4/02完成），从60,000个中剔除出12个异类产品。所有重测产品批均用“绿色”标签标识以示重测。5/30/2023Rev.Orig8DTraining第31页8DExample8D案例

D4ProcessRootCauseD4制程主线原因Problem:ShortedParts问题：短路Why?WrongpartsweresenttoCustomerandthepartswereunderratedfortheapplication.为何：错误元件发给客户及其用途被低估Why?Residualpartswereleftinthemarkingequipmentcausingthesubsequentlottocontainmixedparts.为何：残留元件被遗留在打标机上造成其混入后续批次Why?Thepushpinfailedtocleartheresidualparts.为何：推针失效而无法清除残留元件5/30/2023Rev.Orig8DTraining第32页8DExample8D案例

D4SystemRootCauseD4系统主线原因Problem:ShortedParts问题描述：短路Why?WrongpartsweresenttoCustomerandthepartswereunderratedfortheApp.为何：错误元件发给客户及其用途被低估Why?Residualpartswereleftinthemarkingequipmentcausingthesubsequentlottocontainmixedparts.为何：残留元件被遗留在打标机上造成其混入后续批次Why?Thepushpinfailedtocleartheresidualparts.为何：推针失效而无法清除残留元件Why?Theactuatorsonthepushpinareoldandneedtobereplaced.为何：推针执行器老化而需要更换Why?Wedonothaveadetailpreventivemaintenanceplanforreplacementofworn-out/oldequipment.为何：我们没有一种详细针对替代破损/老化设备维护计划5/30/2023Rev.Orig8DTraining第33页8DExample8D案例

D4EscapeRootCauseD4流出主线原因Problem:MixedPartsEscapedtoCustomer问题描述：混入产品流到客户Why?SampletestpostmarkingwillnotalwaysdetectPPMissues.为何：抽样检查岗位无法发觉PPM级缺陷Why?Samplesizeistoosmall.为何：抽样量非常少5/30/2023Rev.Orig8DTraining第34页8DExample8D案例

D5RootCauseD5主线原因Analysis:Vishayverifiedthatthepartsareshorted.ItwasdeterminedthattheshortedpartsweremixeddevicesthathadlowerpowerratingsthantheonessuppliedtoHeart.ThemixoccurredatVishay'smarkingoperationduetoresidualunitsleftonthemarkingmachineduringFebruary,MarchandApril.Vishayhadaprocedureinplacefortheoperatortoverifythetrackwasemptypriortothestartofanewlot.Theprocedurewasnotfollowed.分析：Vishay确认产品是短路，最后原因被确定为被发给Heart公司额定功率低产品混入到设备中，混入现象发生在Vishay打标岗位，是在2月、三月份及四月份残留元件被遗留在打标岗位所致。Vishay在操作岗位有作业程序，要求在开始打标新批次时须检查轨道是洁净，但程序没有被执行。ProcessRootCause:Theactuatorinthepushpinmechanismusedtoflushresidualunitsfromthetrackstopworking.制程主线原因：推针执行器被用来剔除轨道停滞工作时残留元件EscapeRootCause:ThesamplesizeforthepostmarkingtestisnotsufficientenoughtodetectPPMmixturelevels.流出主线原因：在打标岗位抽样检查数对混入水平在PPM级不良来说是不足SystemRootCause1:Theactuatorsarenotincludedonapreventivemaintenanceschedulethusallowingactuatortodegradeandbecomedefective.系统主线原因1：执行器没有被纳入保养计划，这样允许执行器劣化及没有效力SystemRootCause2:Currenttrainingplandoesnotrequiretrainingverificationthereforeitwasnotknownthattheoperatorwasnotfollowingtheoperatingprocedure.系统主线原因1：目前培训计划中没有要求进行培训效果验证，因此并不懂得操作工没有遵守作业程序要求5/30/2023Rev.Orig8DTraining第35页8DExample8D案例

D5CorrectiveActionsD5纠正措施ProcessRootCause:Replaceactuatorsonallmarkingequipmenttoeliminateresidualparts.制程根原因：在打标机上替代执行器以除去残留部件EscapeRootCause:Implement100%qualitytestpostmarkingtoensurethatmixedpartswillnotbeshippedtoHeart.流出主线原因：在打标岗位实行100%检查确保混入部件不被发送Heart公司SystemRootCause1:Incorporateapartreplacement/refurbishprogramintotheexistingpreventivemaintenancescheduletoensurethatpartsarereplacebeforetheycauseaproblem.系统主线原因1：在现有检修计划中增加部件置换/刷新项目，以确保部件产生问题时被置换SystemRootCause2:Modifytrainingprogramtoincludeaverificationsteppriortograntingcertification.系统主线原因2：修订培训程序，包括在同意合格前有一种检查步骤5/30/2023Rev.Orig8DTraining第36页8DExample8D案例

D6ImplementCorrectiveActions

D6实行纠正措施ProcessRootCause:CompletedbyA.Mayon5/10/02.Severallotswereprocessedthroughthemarkingmachineandthepushpinproperlyremovedtheresidualparts.制程主线原因：A.May于5/10/02完成打标机打标多种批次时，推针可正确推离残留部件EscapeRootCause:CompletedbyB.Bellon5/10/02.Severalmixeddeviceswereplacedthroughthetestertoverifythatthetestprogramwouldremovealldefectiveunits.Allincorrectdeviceswereremoved.流出主线原因：B.Bell于5/10/02完成多台混料装置被安顿在检查仪上以验证检查程序能够剔除不良品，所有不好测量仪已被移走SystemRootCause1:Projectedcompletion6/1/02byA.May.系统主线原因1：A