BIQS审核检查表中英文

BIQSAuditPg1 Supplier: AuditDate: Location: BIQSScore: ERROR:#DIV/0! AuditorName: DUNS: TotalElements: 0 NumberofGreen: 0 NumberofYellow: 0 NumberofRed: 0 PROBLEMSOLVINGCLOSUREEFFECTIVENESS: QUALITYISSUE# FASTRESPONSEPROCESSUSED PROBLEMSOLVINGFORMCOMPLETE QUALITYALERTPOSTED DEPTCONTAINMENTWORKSHEETUSED FMEAUPDATED(NEWRPN) CONTROLPLANUPDATED STANDARDIZEDWORKUPDATED TRAININGCOMPLETED ERRORPROOFED ERRORPROOFINGVERIFICATIONCOMPLETE ADDEDTOCARE/GP12 ADDEDTOLAYEREDAUDIT GENERALAREATAGGING/NCMATLSEGREGATION CORRECTIVEACTIONEFFECTIVENESSMONITORED ENGINEERINGCHANGEREQUEST/PROCESSCHANGEREQUEST PTRCONDUCTED READACROSSTOSIMILARLINES/PROCESSES CHANCESOFRECURRENCE ISSUEDESCRIPTION *Instructions-Get3ClosedProblemSolvingIssuesfromtheSupplier(differentplant/product)andrevieweachwiththeabovechecklisttomeasuretheeffectivenessoftheproblemsolving. *Supplier:Bepreparedtoshowdocumentation/evidencethatsupportscompletionofthekeycomponentsofeffectiveproblemsolvingidentifiedinthechartabove. X=Noncompliant O=Compliant&"Arial,BoldItalic"GMCONFIDENTIAL Revision:03/10/15 BIQSAuditPg2 BIQSItem# BIQSRequirementBIQS要求 BIQSCalibratorGuidelines(LookFor)审核指引 Score Comments评价 *HowtoScore-Green:Amature,well-defined,qualitysystemorprocessisinplace,beingfollowed/utilizedasdirected,andthesystemorprocessdoesnotplaceGMatunnecessaryrisk.Yellow:Qualitysystemorprocessisinplace,butisnotfollowed/utilizedasintended.Red:Qualitysystemorprocessisnotevident,orthecurrentsystemorprocessinplaceputsGMatsignificantrisk. NonconformingMaterial/MaterialIdentification不合格物料/物料标识管理 BIQS-1 NonconformingMaterial/MaterialIdentificationTeammembershavestandardizedworkandunderstandwhattodowithnonconforming/suspectmaterial.Conformingmaterialishandled,storedandidentifiedappropriately.Nonconforming/suspectmaterialisclearlyidentifiedand/orsegregatedforreview/disposition(i.e.appropriatecolorcodingforfootprinting–red,yellow,green).Acontainmentmethodisinplacetoensurethataneffectivebreakpointhasbeenestablished.Containmentactivitiesandresultsaredocumented.Traceabilityisappliedaccordingtothetraceabilitymethodsofthefinishedproduct.1.有不合格零件的处理，员工理解如何处理不合格/可疑零件。2.合格物料得到正确的处理，存储和识别。3.对不合格/可疑品进行清晰的标识/隔离，以进行评价和处理。（例如红/黄/绿颜色）4.有相应的遏制来确认有效的断点已经被建立，遏制行动和结果要保留记录。5.零部件的追溯要求 Sampleaudittoverifythatteammembersunderstandwhattodowithnonconforming/suspectmaterial.Confirmthatconformingmaterialishandled,storedandidentifiedappropriately.Confirmthatnonconforming/suspectmaterialisclearlyidentifiedand/orsegregated.Red,Yellow,Greenstoplightapproachisadheredtoforfootprinting,containerization,tablemarkingandtagging.Auditthatallpartsremovedfromtheprocessareidentified,accountedfor(FTQ),andreconciledtoeliminatemishandlingofmaterial.VerifyuseofDepartmentContainmentWorksheets,withpotentialpartslocationsbyoperationidentifiedtoensurenopartsaremissedduringacontainmentandallpartsarereconciled.Thecontainmentworksheetsmustcoverfromtheincomingmaterial,processandshipment.ScraporSuspectparts/containersclearlysegregatedfromotherparts.AutoRejectstationswithLockedrejectbins,withcontrolsonhowbinsareemptiedtoensureallpartsarereconciled.Partsshouldbephysicallytaggedorpaintedforidentificationpurposesandtodriveaphysicalactduringhandling,whichwillreducethechancesofmishandlingparts.OverallWPOuse5S LayeredAudit BIQS-2 LayeredAuditLayeredauditsareinplacetoassesscompliancetostandardizedprocesses,identifyopportunitiesforcontinuousimprovement,andprovidescoachingopportunities.LayeredauditprocessisownedbyManagement.AuditplanshallincludemultiplelevelsofManagement.Auditsaretrackedandtheirresultsrecorded.Followuptoaddressnoncomplianceisinplace.1.有分层审核流程以确认标准化作业的实施，识别持续改善机会，并对员工提供现场指导2.领导层负责分层审核的实施，分层审核计划应该包含每一级管理层。3.跟踪分层审核的实施并记录审核结果。4.对审核发现的不符合项需要改进对策。 LayeredAuditisaneffectivetooltoconfirmtheprocessesareoperatingatstandard,andenhancecontinuousimprovement.Leadershiputilizesanauditprocessbygoingandseeingontheshopfloortocheckprocesscompliance,employeebehaviorandknowledge.LeadershipusesLayeredAuditasanopportunityforcoaching.Recognitionisusedtoreinforcetherightbehaviors.AskLeadershiphowLayeredAuditworksintheorganization,whoisinvolvedinthelayeredauditprocess,whatisthefrequencyoflayeredaudits.Isthelayeredauditsheetcontentrelevantfortheuser(haveeachprinciplecalibratorreviewrespectivepartoftheauditsheet)?Layeredauditquestionsarereviewedfromtimetotimetofocusontheplantweaknesses.Checkthatallfindingsarerecordedontheauditsheetandthosenotsolvedwithintheshiftaretransferredtocountermeasuresheets. 0 ManagingRisk BIQS-3 PFMEAsAlloperationshavebeenanalyzedforriskusingaPFMEA.PFMEAworkshopsmustbedonebycrossfunctionalteams,includingmanufacturingteammemberinput.RiskPriorityNumber(RPN)valuesmustbeconsistentlyappliedusingSeverity,OccurrenceandDetectionrankingtables.FailuremodesarecomprehendedinthePFMEA(i.e.wrongparts,mixedparts,containmentcontrol,etc.).1.运用PFMEA来辨识所有操作存在的风险。PFMEAworkshop应由跨功能小组完成，包括制造团队的输入，严重度，频度和探测度打分严格遵循SOD表要求。2.FMEA中的失效模式要完整（比如装错件，混料等） LookforPFMEAstobeavailableforalloperationswithintheplant.ConfirmPFMEAworkshopsaredonebycrossfunctionalteams,includingmfg.teammemberinput.ConfirmRPNvaluesareconsistentlyappliedusingSeverity,OccurrenceandDetectionrankingtables.ConfirmmaterialhandlingfailuremodesarecomprehendedinthePFMEA(i.e.wrongparts,mixedparts,containmentcontrol,etc.) 0 BIQS-4 PFMEAs-RiskReduction&AnnualReviewMonthlyRPNriskreductionreviewsbyproductfocusedonpreventingdefectsfromleavingtheworkstationareheldtodrivecontinuousimprovement.Actionplansfortopissuesmustinclude:1.Recommendedactions,2.Responsibility,3.Timing.ReversePFMEAprocessisinplacetoidentifynewpotentialfailuremodeintheshopfloor1.按照产品类别定期开展PFMEA风险降低评审，预防缺陷离开加工工位，进行持续改善。对高风险项要有风险降低对策，对策包含建议措施，责任人，完成时间。2.实施主动风险降低活动（反向PFMEA）以识别新的过程失效模式。 Lookforevidenceofmonthlycrossfunctionalriskreductionreviewsfocusedonpreventingdefectsfromleavingtheworkstation.Confirmactionplansfortopissuesinclude:1.Recommendedactions,2.Responsibility,3.Timing.PlantManagementshallbeincludedintopriskreportingandapprovalofcountermeasures.VerifyifReversePFMEA(On-stationreviews)findingsaredrivenbackintotheProcessFlow,PFMEA,ControlPlan,andWorkInstructionsasapplicableBestpracticecrossfunctionallinesitereviewforRPNreductions 0 BIQS-5 Bypass/DeviationManagementTheplantshallidentifymanufacturingprocessesanderrorproofingdeviceswhichcanbebypassedorplacedindeviation.RiskPriorityNumber(RPN)forallapprovedBypass/deviationprocessesareevaluatedandrisksarereviewed.StandardworkinstructionsareavailableforeachBypass/deviationprocess.Implementedbypasses/deviationsarereviewedindailyLeadershipMeetingwiththegoaltoreduceoreliminatebypassed/deviatedoperations.Processes/devicesinbypass/deviationmusthaveaqualityfocusedauditsperformed.Supplierlocationsthathaveaprocessinbypass/deviationshallhavethebypass/deviationprocesscheckedonthedailyLPA.Restartverificationisdocumentedfordefinedperiod.Itshouldbe100%checkedforallfeatures1.工厂应识别可屏蔽的制造过程和防错装置.对所有批准的屏蔽过程，要评估替代的RPN值和风险.每一个屏蔽过程的替代方案都应有相应的标准化作业指导书(JES/TIS)。2.对正在实施的屏蔽应在每日分层审核中进行质量关注评审，并在管理层会议上进行回顾以减少或者消除屏蔽。屏蔽解除或正常工序重启时，要按照规定频次对重启工序进行验证.(例如：对于连续缺陷重启时要连续确认5件/对间歇性缺陷在一定时间内进行100%检查） Lookfortheplantlistofmanufacturingprocessesanderrorproofingdeviceswhichcanbebypassedorplacedindeviation.ConfirmthatRiskPriorityNumber(RPN)forallapprovedbypass/deviationprocessesareevaluatedandthatStandardizedWorkisavailableforeachbypass/deviationprocess.Supplierlocationsshallhaveawrittenandapprovedbypass/deviationprocedurethatincludescustomernotification.Ensureimplementedbypasses/deviationsarereviewedinFastResponsewiththegoaltoreduceoreliminatebypassed/deviatedoperations.Lookforevidenceofthebypass/deviationchecklistbeingusedforprocesses/devicesinbypass. 0 ErrorProofing BIQS-6 ErrorproofingVerificationAllErrorProofingDevicesarecheckedforfunction(failureorsimulatedfailure)atthebeginningoftheshift.Otherwiseaccordingtotheprocesscontrolplan.ErrorProofingMasters/Challengeparts(whenused)areclearlyidentified.Recordsofverificationareavailable.Whenapplicabletherabbitspartarecalibrated.所有防错设备在开班前(或者按控制计划规定的频次）要进行功能确认（失效或者模拟失效），以确认防错有效。防错验证用样件要有清晰标识。要保留防错验证的记录。在有些情况下验证用的好件或坏件也要进行定期校准。 Confirmthatalistoferrorproofingdevicesisavailable.Confirmthatthemethodoftheerrorproofingverificationisdefinedanddocumentedinthestandardizedwork.Verifythatallerrorproofingdevicesarecheckedforfunction(failureorsimulatedfailure)atthebeginningoftheshift.Otherwiseaccordingtotheprocesscontrolplan.Looktoseethaterrorproofingmasters(whenused)areclearlyidentified.Confirmrecordsofverificationareavailable.Verifythatareactionplanisavailableintheeventoferrorproofingdevicefailureandisunderstoodbytheteammember. 0 GageControl BIQS-7 GageCalibration/MeasurementSystemAnalysisGagecapability(e.g.gageR&R,bias,linearity,stability,etc.)ofmonitoringandmeasuringequipmentisdeterminedandtheequipmentiscertified/calibratedatascheduledfrequency.对监控或者测量设备的能力（如测量设备的R&R，偏移，线性，稳定性等等）进行了计算，并且量检具根据规定的周期进行定期校准。 EvidenceGageR&Randcertificationsarecompletedontimeperlocalprocedure.Checkthatnogagesarepastdueforcalibration.Writedown3gagenumbersatrandomandverifytheyareinthegagecontrolsystemandonsomecalibrationschedule. 0 FastResponse BIQS-8 FastResponseProblemSolvingProcessMinimumcriteriaforinitiatingFastResponseismet.PlantManagerensurestheapplicabilityandthetimelycompletionoftheitemsbeingtracked.PlantStafflevelpersonnelactivelyparticipateindailymeeting.Requireddocumentsarereviewed(FastResponseTrackingSheet,ProblemSolvingDocument,PFMEA,Processcontrolplan,standardizedwork,Layeredauditsetc.).Exitcriteriawithappropriatetimingaredefinedforclosingissues.Thereisreadacrossofcorrectiveactionstolikeoperations.达到实施快速响应的最低标准。工厂经理确保被跟踪项目的适时完成情况。工厂管理层积极参与到每日例会中来。要求的文件得到回顾（快速相应跟踪表，问题解决文件，PFMEA，PCP，JES等等），在标准化文件没有修改之前，质量问题应添加到JES背面。问题关闭的退出标准和时间要求要有明确定义纠正措施要横向展开到相似操作。 VerifythattheFastResponseprocessisusedforallsignificantqualityissues(customer/VisualInspectionstation/GP12).ConfirmthatthePlantManagementensurestheapplicabilityandthetimelycompletionoftheitemsbeingtracked.ConfirmthattheplantstafflevelpersonnelactivelyparticipateindailymeetingVerifythattherequireddocumentsarereviewedandupdated(e.g.FastResponsetrackingsheet,problemsolvingdocument,PFMEA,Processcontrolplan,standardizedwork,layeredaudits,lessonslearned,etc.)Confirmthatthereisreadacrossofcorrectiveactionstolikeoperations. 0 BIQS-9 TeamProblemSolvingProcessAwelldeveloped,standardizedproblemsolvingprocessexistsatalllevelsoftheorganization.Formalproblemsolvingactivitiesareinitiatedaccordingtoaspecifiedcriteria.Issuesareidentified,rootcausesanalyzedandrobustactionscompletedinatimelymanner.ProblemsolvingisdrivenattheTeamlevelandallTeamsareinvolved.Leadersareactivelyinvolvedcoachingandguidingtheprocess.1.有标准化的、完善的问题解决流程2.根据明确的标准启动正式的问题解决活动3.问题识别，根本原因和有效对策实施要及时4.推动问题解决的团队合作，各职能团队都加入到这个活动中。领导层也积极参与，以提供指导和帮助。 Toprovidecommonmethodsforsolvingproblemsthatareunderstoodandusedbyall.Astandardizedproblemsolvingprocessexists.Arangeofproblemsolvingactivitiesareconductedfordifferentproblemtypesandcomplexities,includingsingle(special)cause,common(repetitive)cause,aswellasmorecomplexmultiple-causeproblems.AsktotalkthroughsomeproblemswithTeamLeadersandSupervisors.Askhowmanyformalproblemsolvingactivitiestheteamhasworkedoninrecentmonths?Lookforallteamsshouldbeinvolvedinproblemsolvingactivities.Lookforastandardizedprocessthatincludes:issuedescriptionanddefinition,containment,probablecauseanalysis,rootcauseanalysis(5Whys),countermeasures,implementationplan,verification,approvaltoclose,andescalationorreadacrossifneeded.LookforLeadershipinvolvement(reviews,coaching,escalation,support,readacross,etc.) 0 BIQS-10 QualityFocusedChecksHighriskitemsfromCritical(Delta)operationshaveaQualityFocusedcheckperformedeachshift.HighriskqualityfocuseditemsfromcustomerfeedbackandproblemsolvingareincludedintheQualityFocusedaudit,orothersuitablechecklist,andcheckedeachshift.1.关键工艺的高风险项在每班都应进行质量关注检查。2.来自于客户反馈和问题解决的高风险项目应包含在质量关注检查中，或者其他合适的检查清单内，并且每班都进行检查。 LookforhighriskqualityfocuseditemsfromFastResponse,customerfeedbackandproblemsolvingtobeincludedinthequalityfocusedsectionofthelayeredaudit,orothersuitablechecklistandcheckedeachshift.LookforhighriskqualityfocuseditemsfromDeltaCoperationstobeincludedinthequalityfocusedsectionofthelayeredauditandcheckedeachshift. 0 StandardizedWork BIQS-11 StandardizedWorkAllworkisdocumentedusingastandardformatandmeetsallsafety,qualityandelementtimerequirements.1.所有作业（循环重复作业和非循环重复作业）都要有文件化的标准方式以满足安全，质量和作业时间的要求。 ToestablishaStandardtofacilitatetrainingandunderstandingofdocumentationacrosstheentireplant/organization.UsetheplantapproveddocumentstocaptureStandardizedWork.StandardizeWorkDocumentsshouldincludewhat,how&whyfortasksperformed.Checkifstandardizedworkisavailableattheworkstationsandfollowed. 0 ManagingChange BIQS-12 ProcessChangeControlPlantprocessesarevalidatedrelativetochangesinDesign,Man,Machine,Material,MethodandEnvironment.Theplantfollowsadocumentedchangecontrolprocessforcustomersandinternalchanges.ThePFMEAisupdatedtoreflectanychange,asrequired.与设计，人员，设备，物料，工艺和环境变化相关的过程得到充分验证。工厂遵循文件化的变化点控制流程，PFMEA根据需要结合变化点进行更新。 Confirmthatallplantchangesareprocessedthroughtheplantcrossfunctionalprocesschangeapprovalsystem.ConfirmifPTRisnecessary. 0 BIQS-13 VerificationStation(FinalInspection/CARE/GP12)FinalInspection/GP12mustbeconductedonallfinishedproductpriortoshipping.Canbe100%inspectionorauditbasedonrisk.AllitemscheckedintheVerificationStation(FinalInspection/CARE/GP12)mustbeincludedinacheckatanupstreamstation.Qualitychecksareincludedinstandardizedwork.Point,touch,listenandcountinspectionmethodsareincorporated.SuccessiveProduction/Qualitychecksareincreasedincaseofhighriskssuchasmodellaunch,passthroughcomponentsandcharacteristicspassthrough,majorchanges,shutdownorcustomerfeedback.1.要有专门的验证工位（比如工段检查工位/终检工位/CARE/GP12）。2.根据风险可以是100%检查，也可以是抽检。CARE/GP12检查的项目不能是首次检查项目。检查过程要有标准化作业，可以结合用手指点、触摸、听、数数等方法。在风险较高时可能要增加检验项目或频次，比如项目开发阶段、Passthrough的零件、重要变更、停线或者有客户投诉。 ConfirmthatVerificationStation(FinalInspection/CARE/GP12)isimplementedperthelocalrequirement.Lookforpoint,touch,listenandcountinspectionmethodsincorporatedintoqualitychecks.Lookforincreasedqualitychecksforlaunch,shutdownorbasedoncustomerfeedback(eg.FastResponse). 0 BIQS-14 ChangeControl-ProductionTrialRun(PTR)Theplanthasregularmeetings,includingalldepartments,todiscussupcomingchanges(productengineeringchanges,plantprocesschanges,supplierprocesschanges)andcoordinatePTR's.AreasonablesamplesizeisusedforProductionTrialRun,basedonrisk.Changesareclearlycommunicatedandunderstoodatalllevels(e.g.teamlevel).Partsarecontained,storedandclearlyidentifiedpriortoandafterthePTRbuildandPPAPapproval.1.工厂有例会讨论近期的重要变更（设计变更，工艺变更，供应商工艺变更等），协调变更零件的生产试装。根据风险不同，确定试装零件的数量。变更内容要通知到生产相关的各个层级（比如班组），并得到充分理解。2.在PTR前后及PPAP批准前，变更零件要隔离存放并有明确标识。 Confirmthattheplanthasregularmeetings,includingalldepartments,todiscussupcomingchangesandcoordinatePTR'sforcustomersorinternalchanges.LookforareasonablesamplesizetobeusedforProductionTrialRun,basedonrisk.Ensurechangesareclearlycommunicated.Verifythatpartsarecontained,storedandclearlyidentifiedpriortoandafterthePTRbuild.ConfirmthatforchangesthatrequireacustomerPTR,allcustomerlocationsarenotified.Looktoseethatproductionbreakpointsarerecorded. 0 CallforHelp BIQS-15 AndonSystemImplementationAwellfunctioningAndonsystemisimplementedinallproductionareastosupporttheTeamMemberwhenabnormalconditionsoccurandcommunicaterelevantinformation.AlloperationalareasoftheorganizationareusingtheAndonprocessasintendedandthisshowstangibleresultsontheshopfloor.按灯系统在各个生产区域正常运转，目的是在出现异常时给员工提供帮助并沟通异常信息。所有区域的人员在使用按灯流程并在现场达到实际效果。 TheAndonsystemenablestheTeamMembertocallforhelpandsupportstheconceptof"DoNotAccept,BuildorShipaDefect".Andoncallscanberadio,pager,stacklights,andonboards,etc.CheckthattherequirementsofaneffectiveAndonsystemarepresentinallproductionareas.Takeafewoperatorstationsindifferentareasasanexample.AskTeamMembersandTeamLeadershowtheAndonisworkingandvalidatetheeffectiveness. 0 BIQS-16 AlarmandEscalationNonconformingproducthassufficientalarmslimitswithescalation.Alarmsarerespondedtoaccordingtothealarmandescalationprocess(reactionplan).对产品缺陷要有合理的报警界限，达到界限时要进行问题升级。根据报警升级流程，对发生的报警要有响应（反应计划）。 Verifythatnonconformingmaterialhassufficientalarmlimitswithescalation.Confirmthatalarmsarerespondedtoandtheresponseisdocumented. 0 VisualManagement BIQS-17 Visual/tactile/audibleControlsVisualStandardsarecommonwithinthefacility(e.g.multiplelines)aswellasbetweenfacilitiesbuildingthesameplatform/productlineglobally.1.如果有多条生产线生产同样的产品甚至在全球有不同工厂做同样产品时，产品质量标准应该相同。2.产品质量标准应该清晰的说明产品的状态、尺寸或数值要求，以满足客户、设计和法规要求。3.产品质量标准的变更（包括标准本身和实施过程）要有正式的变更流程，以确保各相关部门使用同样的标准。 Lookforadocumentedprocesswhichiscommonandvalidfortheplant.DocumentmustbecontrolledbytheQualityManagementSystem.Alocalproceduresdescribestheprocess.Lookforengineeringchanges(ProductEngineering)andiftheyarereflectedintheVisualStandards.ConfirmVisualStandardsareupdatedasaresultfortheFastResponseprocesswhererequired. 0 BIQS-18 Visual/tactile/audibleStandards-CommunicatedandUnderstoodVisualStandardsareclearlycommunicatedtotheteammemberattheworkstationandincorporatedorreferencedinstandardizedwork.TeammembersareknowledgeableoftheVisualStandards.VisualStandardstohelpdifferentiate"GoodfromBad"mustsatisfycustomerrequirements.1.产品质量标准要清晰的传递给员工，并写入到或引用到作业指导书中。员工理解掌握产品质量标准。2.产品质量标准要满足客户要求，能够帮助区分良品和不良品。 TeammembersshallknowthecontentofVisualstandards.Interviewaminimum3operators.Allshallfulfilltherequirements.VisualStandards(checkingplans)shallbereferencedinstandardizedworkdocumentation.ConfirmthatVisualStandardsareclearlydifferentiategoodfrombad,areclearlyidentifiedasaProductQualityStandarddocumentandareclearlyreferencedinthestandardizedwork. 0 ProcessControl BIQS-19 ProcessControlPFMEAs,ProcessControlPlans,andstandardizedworkdocumentationarecomprehensive,sufficient,andflowonefromtheother..CriticaloperationsareidentifiedwithaDeltaattheoperationandinthestandardizedwork.1.PFMEA,控制计划及标准化作业文件要包含所有工序，内容要完整。几个文件之间一层一层传递，内容关联。2.关键工艺要在工位和作业指导书中用符号标识出来，比如倒三角符号。 SamplePFMEA,ProcessControlPlanandstandardizedworkdocumentstoensureprocesscontrolsflowonefromtheother.Reviewcriticaloperationstoensuretheyareidentifiedwithadeltaattheoperationandinthestandardizedwork. 0 BIQS-20 ProcessControlPlanImplementedProcessControlPlanchecksareperformedatthecorrectfrequencyandsamplesize.Checksaredocumentedusingthepropercontrolmethod(i.e.controlcharts,checksheets).Reactionplan(s)fromtheProcessControlPlanarepresent,followedandeffective.按照控制计划要求（检查项目，频次，样本数）进行检查。检查结果要用规定的方法进行记录（比如控制图、检查单等）。对检查出来的不符合项，响应计划要依据控制计划并有效实施。 Sampleprocesscontrolplansandensurechecksareperformedatthecorrectfrequencyandsamplesize.Confirmthatchecksaredocumentedusingthepropercontrolmethod(i.e.controlcharts,checksheets).Checkthatreactionplansfromtheprocesscontrolplanarepresent,followedandeffective. 0 BIQS-21 ProcessCapabilityReviewCapabilityreviewsofprocessequipmentwithhighrisk/impact(e.g.minimumKeyCharacteristicDesignationSystem)areheldtoidentifyprocesscapabilityandrequiredcorrectiveactions.Areactionplanfornoncapableprocessispresent.Correctiveactionisdocumented.对高风险/有重大影响的设备/过程进行过程能力分析，对能力达不到的过程要有对策及文件化的纠正措施。 LookforcapabilitystudiesonKPC'sandPQC'sandconfirmthatactionplansaredocumentedtoaddresscharacteristicswithlowcapability.Annualcapabilitystudiesarerequiredonallcriticalequipmentataminimum,verifythisistakingplace 0 Rework/RepairControl BIQS-22 Rework/RepairConfirmation/TearDownRepairs(bothonandoffline)arecompliantwithapprovedstandardizedwork.Repaired,reworkedorreprocessedmaterialisprocessedataminimumthroughanindependentrepairconfirmation(2ndpersonormachinepriortorepair).Reintroductionofreworkedpartincludesalldownstreamchecksinordertoensurethatallcontrolplaninspections&teststobeperformed.1.无论在线还是离线的返工都需要有标准化作业指导.2.返工返修或是返工材料需要有第2个人或机器确认.3.返工零件需要包含所有后续工位的检查来确保控制计划中的检查和试验项目都能实施. Confirmthatrepaired,reworkedorreprocessedmaterialisprocessedataminimumthroughanindependentrepairconfirmation(2ndpersonormachine).IstherepairprocessPPAPapprovedbythecustomer.Fortheteardownprocess,astandardizedworkmustbedevelopedtoguarantee,thatthecomponentsstillwithgoodqualityanddefinedeachonecanbereusedormustbescraped.Failuremodesofreworkar