质量体系审核表+自评回复范本Quality System Audit Rev15-长城

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,1:QualitySystemRequirements,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remark

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,55,,Counts:,55,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

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,1.1,"Hasthesupplierdefinedanddocumenteditscorporatequalitypolicyandqualityobjectives？Achievequalityobjectives?

供应商是否有明确并文件化的公司质量方针和制定质量目标?质量目标是否达标？",,,,,,,,,,,,,,,Criticalitems关键项,5,"HH-QEM-01质量环境手册A>质量方针：

群策群力、品质至上；精益求精、客户满意。D>公司总目标

准时交货达成率、客户满意度、进料检验批合格率、客户投诉和重大SR事故,达成，见质量目标统计表",,,,,

,1.2,"Doesthesupplierconductmanagementreviewsofthesuitabilityandeffectivenessofthequalitymanagementsystematappropriateintervals?(i.e.doesthequalitysystemmeetcustomerrequirements?)Areimplementationofactionitemsfrommanagementreviewtracked?

对质量体系的符合性和有效性是否进行定期的管理评审（如品质体系是否满足客户要求？）管理评审的改善行动是否实施？",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-03管理评审管理程序,,,,,

,1.3,"Dotheinternalauditsverifycompliancewithplannedarrangements?Dothefollowupactivitiesincludeverificationoftheactionstakenandthereportingofverificationresults?

内部审核是否按计划实施？内审问题点是否有改善行动的确认，以及报告记录确认结果？",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-04内部审核管理程序,,,,,

,1.4,"Isthereasystemthatidentifiestrainingrequirementsforallpersonnelaffectingthequalityoftheproduct?Areaccuratetrainingrecordsmaintained?

对影响产品品质的人员是否有明确的培训体系？是否有准确的培训记录并保存？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-32人力资源管理程序-人力资源部,,,,,

,1.5,"Isthereaproductenvironmentmanagement(ROHS/REACH,HFetc.)controlfile?Proofofexecution?

是否有产品环境管理物质（ROHS/REACH/无卤等）控制文件？执行的证据？",,,,,,,,,,,,,,,Criticalitems关键项,5,QC080000-2017手册+程序文件,,,,,REACH/无卤适用于有要求的产品

,1.6,"DoessupplierhaveISO9001certification?WhetherthereistheimplementationofISO9001-2015version

供应商是否有ISO9001认可？是否有推行ISO9001-2015版",,,,,,,,,,,,,,,Thresholditems门槛项,5,有证书编号：16421Q30005R1M，有效期：2023/12/18,,,,,

,1.7,"Isthereamedicalproductriskidentificationandprogramdocumentation?Isthedocumentexecuted?

是否有医疗产品风险识别及程序文件？是否依文件执行？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-41产品风险管理程序,,,,,适用于医疗器械产品

,1.8,"DoessupplierhaveISO14001certification?Ifnot,doessupplierhaveaplan/roadmaptoachievethecertification?

供应商是否有ISO14001认可？是否有推行ISO14001-2015版，如没有，是否有认可计划？",,,,,,,,,,,,,,,Generalitems普通项,5,有证书编号：16421E30004R1M，有效期：2023/12/18,,,,,

,1.9,"Ifsuppliersareinthepollutingindustries,suchasplastics,PCB,packagingplants,electroplatingplants,wastedisposalreportsshouldbeprovidedtocheckwhetherenvironmentalpermitsarestillvalid？

供应商若属于污染行业，如塑料，PCB，包装厂，电镀厂，则要提供废水废弃处理报告，检查环保许可证是否还有效？",,,,,,,,,,,,,,,Generalitems普通项,5,废水废弃物有委托有资质的厂商合规处理，不属于污染行业，不需要取得环保许可证,,,,,

,1.10,"DoessupplierhaveISO13485certification?Ifnot,doessupplierhaveaplan/roadmaptoachievethecertification?

供应商是否有ISO13485认可？如没有，是否有认可计划？",,,,,,,,,,,,,,,Criticalitems关键项,5,有,,,,,适用于医疗关键部件供应商

,1.11,"DoessupplierhaveISO45001certification?Ifnot,doessupplierhaveaplan/roadmaptoachievethecertification?

供应商是否有ISO45001认可？如没有，是否有认可计划？",,,,,,,,,,,,,,,Generalitems普通项,5,有,,,,,

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,2:DesignControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,20,,Counts:,20,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

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,2.1,"是否已建立以下文件？例如，设计文件、技术标准和图纸

Istherehavethefollowingdocuments?

suchas,Designdocumentsandtechnicalspec./drawings?",,,,,,,,,,,,,,,Criticalitems关键项,5,是，见图纸,,,,,

,2.2,"Istherearequirementtoverifytheproductmeetsdesignspecificationspriortomassproduction?Istherehaveassessmentreportorcertificationrecords?

在批量生产之前，是否有核实产品符合设计标准的要求（规定）？是否有评估报告或验证记录？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-11新产品开发管理程序-工程部/ENG-WI-0070产前会议管理办法,,,,,

,2.3,"IstherehaveDesignFailureModeandEffectsAnalysisfordesignproducts？

自己设计的产品是否DFMEA文件（潜在失效模式分析）",,,,,,,,,,,,,,,Thresholditems门槛项,X,无设计，依客户图纸制造,,,,,供应商自行设计的医疗器械关键部件必须满足

,2.4,"WhethercancooperatewithcustomerstoprovideFAEsamplesandFAEdocuments？

是否可以配合客户提供FAE样品及完整的FAE资料",,,,,,,,,,,,,,,Criticalitems关键项,5,依客户要求执行,,,,,

,2.5,"DoessupplierestablishQMSdocumentorrequirementtoensureitsprovidedmaterialmeetscustomerspecificationordrawingrequirements?e.g.plasticpartmaterialcomposition,dimensionrequirementetc.

供应商是否建立质量体系文件或要求保证其提供的物料符合客户规格或图纸要求？例如：塑胶物料的物料成分、尺寸要求等",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-11新产品开发管理程序及客户要求提供物料成分、尺寸等等,,,,,

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,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

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,3:DocumentandRecordControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,40,,Counts:,40,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

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,3.1,"Doesthesupplierhaveestablishedanddocumentedproceduresfordocument？Thefollowingfileshasbeenestablished?b)Processcontroldocuments?(c)Workinstructions?

供应商是否建立并文件控制程序？是否已建立以下文件？工艺控制文件？工作指引？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-35文件、资料和记录管理程序,,,,,

,3.2,"Doestheprocedureensurethatallobsoletedocumentsarepromptlyremovedfromallpointsofissueoruse?haveusetheoldversionfile?

程序是否确保及时地从所有发放和使用地收回废止的文件？现场是否有使用旧版文件？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-35文件、资料和记录管理程序,,,,,

,3.3,"Arequalitydocumentsreviewedandapprovedforadequacybyauthorizedpersonnelpriortoissue?

质量文件在发行前是否经有权限的人员审核和批准？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-35文件、资料和记录管理程序,,,,,

,3.4,"Isthereaproceduretogovernengineeringchanges？Isthereasystemtoconfirmtherelateddepartmentreceivetheengineeringchangenotice?Engineeringchangeexecutionrecords?

是否有工程变更管理程序？是否有系统来确认相关部门收到工程变更通知？工程变更执行的记录？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-29工程变更管理程序-工程部,,,,,

,3.5,"Doesnoitifycustomerifanychangedefined？Suchas：a)Changeofrawmaterialsorsuppliers

b)Changeofproductstandardanddesign(includingchangeoftheinspection,packingandotherstandardsrelevanttoProduct)

c)ChangeofProductManagementPlan(PMP)

d)Changeofmainproductionequipmentorkeyindirectmaterials

e)Changeofsiteofmanufacturing

f)Changeofversionsofprocedureandsoftware;

g)AnyotherrelevantchangesthatmayaffectthequalityofProduct

是否有定义工程变更需通知客户？如以下情况

a.原材料或原材料供应商的变更

b.产品的设计和标准变更(包括检验、包装标准及其它与产品有关的标准的更改);

c.生产或工艺流程（PMP）的更改;

d.主要生产设备或关键辅助材料的变更;

e.生产场所变更；

f.程序软件版本的变更；

g.其它会影响产品质量的相关变更.",,,,,,,,,,,,,,,Thresholditems门槛项,5,HH-QEP-29工程变更管理程序-工程部,,,,,

,3.6,"Areallqualityrecordsidentified,indexed,filed,collected,stored,maintained,anddisposedafterstatedperiod?

所有品质记录是否按规定的时间段标识，索引，整理，储存，保护以及处理",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-35文件、资料和记录管理程序,,,,,

,3.7,"Haveretentiontimesofqualityrecordsbeenestablishedandrecorded?

有规定品质记录的保存时间和相关记录？",,,,,,,,,,,,,,,Generalitems普通项,5,记录清单,,,,,

,3.8,"Whethertodoqualityrecordkeepingtimeisgreaterthanorequaltotheproductlifecycle,productlifecycleislessthantwoyears,savefortwoyears？

是否做到品质记录的保存时间大于等于产品寿命周期，产品寿命周期少于两年的，保存两年。",,,,,,,,,,,,,,,Thresholditems门槛项,5,记录清单,,,,,针对医疗器械供应商要求必须做到

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,4:SupplierQualityControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,25,,Counts:,25,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,4.1,"Aresubcontractorsselectedonthebasisoftheirabilitytomeetsubcontractrequirements,includingcost,quality,technologyrequirements?Areup-to-daterecordskeptofacceptable/approvedsubcontractors?

是否有次级供应商选择评估的要求，包括成本、品质、技术评估来选择次级供应商？是否有最新的可接受、受批准供应商记录？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-13供应商管理程序-采购部,,,,,

,4.2,"Isthesubcontractorappraisedperiodicallybythecriteriaofcost,quality,technologyandservice?

是否有对次级供应商根据成本、品质、技术和服务的标准进行定期考核？",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-13供应商管理程序-采购部,,,,,

,4.3,"Doesthepartapprovalincludeverificationof:IsthereaProcesscontrolparameters/documents(GR&R,PFMEA,processmanagementplan,productionflowchart,drawings,etc.)?IsthereaCriticalparameters/dimensionscontrol?(includingcapabilityindexCpk)

部件批准是否包括以下方面的确认？流程控制参数、文件（重复性,过程失效模式分析,制程管理计划PMP,生产流程图,图纸等)?关键参数和尺寸控制？（包括能力指数CPK）",,,,,,,,,,,,,,,Criticalitems关键项,X,HH-QEP-13供应商管理程序-采购部,,,,,

,4.4,"DoesthesupplierhaveeffectiveRMAcontrolwithsubcontractors?（RMA=ReturnMaterialAuthorization)

供应商是否有对次承包商的有效RMA控制？(RMA=客户退货）",,,,,,,,,,,,,,,Criticalitems关键项,5,QCD-WI-0089进料检验指导书,,,,,

,4.5,"DoesthesupplierhaveHazardoussubstances(ROHS,REACH,halogenfree,etc.)controlwithsubcontractors?Requiredtoprovideenvironmentalrequirementstatement,testreport？

供应商是否有对次承包商物料进行有害物质（ROHS,REACH，无卤等）控制，是否要求提供环保声明，第三方测试报告？",,,,,,,,,,,,,,,Thresholditems门槛项,5,HH-QEP-13供应商管理程序-采购部,,,,,

,4.6,"Doesthesupplierhaveinvestigateitsupstreamresources,andprovidetherelevantinvestigationrecordswhencustomeraudit,ifthecustomerhavethesurveyrequirementsforconflictminerals(canprovidecustomersdemandsurveyform,orneedrelateddeclarationdocuments)？

客户有矿产冲突调查需求的，供应商是否对其上游资源进行调查，并在审核时提供相关调查记录（可提供客户需求的调查表格，或者需要相关声明资料）",,,,,,,,,,,,,,,Criticalitems关键项,5,有调查,,,,,适用于客户有矿产冲突调查需求的供应商

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,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,5:IQCControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,30,,Counts:,30,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,5.1,"IsthetargetofincomingqualitysuchasLARDPPMdefinedindocument?Anycorrectiveactiontakenfortheseun-achievedtarget?

是否有文件定义IQC的来料品质目标,如LAR,DPPM?未达标的情况有无改善措施?",,,,,,,,,,,,,,,Criticalitems关键项,5,DCC-WI-005质量目标管理办法,,,,,

,5.2,"Aretheincominginspectionpersonneltrainedandcertifiedfortheoperations?Dotherecordsevidencethis?

是否来料检验人员受过培训,并发上岗资格证?是否有记录为证?",,,,,,,,,,,,,,,Generalitems,5,有培训发上岗证,,,,,

,5.3,"IsthereWIforincominginspectionincludinginspectioncriteria,productsampleplan?

是否有来料的检验指引,并包括了检验标准和抽样计划?",,,,,,,,,,,,,,,Criticalitems关键项,5,QCD-WI-0089进料检验指导书,,,,,

,5.4,"IsthereWItodefineprocedureofincominginspection,passed/failedmaterialdispostion,materialstorage?Arethesematerialplacedonspecifiedareaseparately?IsthereanyevidencetoindicatethatIQCfollowstheprocedurecorrectly?

是否有来指引定义来料检验的流程,合格/不合格来料的处置,物料的存放?并分别放置于指定区域？是否有证据显示IQC正确按指引操作?",,,,,,,,,,,,,,,Criticalitems关键项,5,QCD-WI-0089进料检验指导书/HH-QEP-39不合格品管理程序-品管部,,,,,

,5.5,"DothefailedinspectionresultstriggerCorrectiveActionsbacktothesupplierandrequestCAreport?

对不合格物料是否要求供应商的改善行动并要求提供报告?",,,,,,,,,,,,,,,Generalitems普通项,5,QCD-WI-0089进料检验指导书/8D报告,,,,,

,5.6,"IsthereaROHSmeasuringequipment?IsthereIQCtodoROHScontroltheincomingmaterial?

是否有ROHS测量设备?IQC是否对来料进行ROHS控制？",,,,,,,,,,,,,,,Criticalitems关键项,5,QCD-WI-0120原物料进料检验指导书，有ROHS1.0/2.0设备,,,,,

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,6:ProcessControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,40,,Counts:,40,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,6.1,"Isthereaprocedureordocumenttospecifyallcriticalparametersandproductcharacteristicswhichneedmonitoringorcontrol?PMPfilesorqualitycontrolplan？

是否有流程和文件指定了所有需要监控和控制的关键参数和产品特性?（PMP文件或质量控制计划）",,,,,,,,,,,,,,,Thresholditems门槛项,5,,,,,,

,6.2,"Arethereworkinstructionsdefiningthemannerofproduction,installationsforeachprocess/station?(WI=WorkInstruction)Dotheworkinstructionsclearlyspecifythemachines,fixtures,tools,gaugesandprogramtobeused?Doindicateassemblyspecificationsandmachinesetting?(e.g.,temp,pressure,torquedriversetting,andadjustment/testspecifications)

是否有工作指引定义了生产,装配中每个岗位的操作?是否工作指引清楚的指定了要使用的机器,工装,工具,量具和程序?规定关键参数设置范围(如温度,压力,扭力批的设置,调节/测试规格)？",,,,,,,,,,,,,,,Generalitems普通项,5,,,,,,

,6.3,"Arethereproceduresandpracticesinplacetoassureproducttraceabilitythroughallstagesofproduction?Areassembliesproperlymarkedandtrackedthroughtheassemblyprocesstoensurenostepsintheprocessflowaremissed

是否有流程和方法确保产品在整个生产流程各个环节的可追溯性?是否被装配的部件在装配流程中被正确打标记和追溯,确保生产流程中没有步骤被遗漏?",,,,,,,,,,,,,,,Criticalitems关键项,5,,,,,,

,6.4,"IsthereacomprehensivePreventiveMaintenancePlanandrecordformachines,equipment?Accordingtotheplan?

是否有针对机器,设备,的全面预防性维护计划，是否有保养维护记录?是否依计划实施？",,,,,,,,,,,,,,,Criticalitems关键项,5,,,,,,

,6.5,"AreallESDsystemsareproperlyinstalledandmaintained?e.g.groundingmainsystem,instrument,fixture…etc.

ESD防护系统是否被安装和维护?如主接地系统,仪器,工装等.",,,,,,,,,,,,,,,Criticalitems关键项,5,,,,,,

,6.6,"Aretheremonitoringsystemsforenvironmentcondition,suchastemperature,humidity,particlecount…etc.?

是否有对环境条件如温度,湿度,空气微粒数的监控系统?",,,,,,,,,,,,,,,Generalitems普通项,5,,,,,,

,6.7,"Areallcriticalprocessesandparametersunderstatisticalcontrol?(e.g.,controlchart,Cp/Cpkstudy)，Areout-of-controlconditionsnotedoncontrolcharts,withcausesinvestigated,andactionsprovided?

是否所有的关键工序和参数都在使用统计方法控制(如控制图,Cp/Cpk研究)，对超出控制线的情况是否在控制图中有标注,并提供原因调查和改善行动?",,,,,,,,,,,,,,,Generalitems普通项,5,,,,,,

,6.8,"IfsuppliershaveproductionnonROHScompliantproduct,sononROHScompliantproductanditsproductionequipmentisclearlylabeledwithROHSproductsandproductionequipmentorisolate?

如果供应商有生产不符合ROHS的产品，那么不符合ROHS的产品及其生产设备是否与ROHS产品及其生产设备做明确标示或隔离？",,,,,,,,,,,,,,,Criticalitems关键项,5,,,,,,

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,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,7:InspectionandTesting/Status,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,30,,Counts:,30,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,7.1,"Doesthesupplierinspect,testandidentifyproductasrequiredbythequalityplanorPMPdocumentedprocedures?

供应商是否按要求的品质计划或PMP文件定义的流程检验,测量和识别产品?",,,,,,,,,,,,,,,Criticalitems关键项,5,QCP,,,,,

,7.2,"DoesthesupplierutilizeoutgoingproductinspectionandtestingsuchasOutofBoxAudits?Aretherecompleteshipmentreports?

供应商是否有出货检验和测试,如开箱检验?是否有完整的出货报告？",,,,,,,,,,,,,,,Thresholditems门槛项,5,QCD-WI-S1064OQC检验指导书,,,,,

,7.3,"Doesthesupplierutilizeextendedreliability/regulatorytestsonregularbasis?(e.g.Drop/vibration,EMI,reliability,safety,….)

供应商是否有常规的延伸的可靠性测试(如跌落,震动,EMI,可靠性,安全性)?",,,,,,,,,,,,,,,Generalitems普通项,5,QCD-WI-0119可信赖性测试计划说明,,,,,

,7.4,"Aretheredocumentedproceduresforcontrolofinspection,measuring,testequipment，Andequipmentmasterlist(referandfillappendix-2)?

是否有检验，测量及测试设备的的控制程序文件和受控仪器清单(参考并填写附表-2）？",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-18监视和测量装置控制程序-品管部,,,,,

,7.5,"EquipmentCalibrationscheduleandcalibrationrecord/report

测量设备校准计划和校准报告/记录",,,,,,,,,,,,,,,Criticalitems关键项,5,检测仪器校准清单,,,,,

,7.6,"Hasthepersonnelinchargeofcalibrationbeentrainedandformallycertified?

校准人员有无经过培训或资格认证？",,,,,,,,,,,,,,,Generalitems普通项,5,有内校资质,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,8:ProductIdentificationandLotTraceability,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,15,,Counts:,15,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,Remarks

,,,,,,,,,,,,,,,,,,,,,,,,,

,8.1,"Arein-stockandin-processmaterialsproperlyidentifiedandcontrolled?

是否在仓库和生产中的物料能被正确识别和控制?",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-17产品标识和可追溯性管理程序,,,,,

,8.2,"Canallmaterialsin-processandinwarehousebetraceable(includingFIFOmaterials)?（FIFO=FirstInFirstOut)

是否所有在在生产过程中和在仓库的物料都能被追溯，仓库物料是否遵循先进先出的原则？",,,,,,,,,,,,,,,Generalitems普通项,5,WH-WI-0003先进先出管理制度,,,,,

,8.3,"Isthereanevidencethatkeycomponentsfromsubcontractorcanbetraceable(datecode,lotnumber,...etc.)?

是否有证据显示来自次承包商的部件能被追溯(如日期代码,批次号等)?",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-17产品标识和可追溯性管理程序,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,9:ControlofNonconformingProduct,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,35,,Counts:,35,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,9.1,"IsthereaMRB（MaterialReviewBoard)proceduretoreviewthedispositionofnonconformingmaterial?(e.g.""useasis"",RTV,scrap,rework)

是否有关于不合格物料处理审核的MRB(不良物料处理）程序？（让步接受，退货，报废，返修等）",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-39不合格品管理程序-品管部,,,,,

,9.2,"Arerepairedproductsre-inspectedortestedaccordingtodocumentedprocedure?

是否有返工、返检或重新测试的程序文件？",,,,,,,,,,,,,,,Generalitems普通项,5,QCD-WI-S1055产品返工管理规范,,,,,

,9.3,"DoesthesupplierperformContinuousImprovementProcessfornonconformity?(Dataanalysis,FA,C/Aforworsttopsandtracking)improvementevidence？

对不合格（品）是否有要求供应商的持续改善的程序及改善证据？（对主要不合格项的数据分析，失效分析，纠正行动及跟踪）",,,,,,,,,,,,,,,Generalitems普通项,5,8D报告,,,,,

,9.4,"ForRMAreturnsorcustomerrejects,aretheappropriatecorrectiveorpreventiveactionsdevelopedtoeliminatethecauseofactualorpotentialnonconformance?

对RMA物料或客户拒收产品，是否有适当的纠正或预防行动去消除产生不合格的现有或潜在的因素？",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-39不合格品管理程序-品管部/HH-QEP-06纠正及持续改进管理程序-品管部,,,,,

,9.5,"whethertoadopttheappropriateisolationmeasuresforforthematerialsnotconformtotheenvironmental(ROHSetc.)requirements?Andputdistinctlabel？

不符合环保要求（ROHS等)的物料,是否采取恰当的隔离措施？并有明显标识,",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-39不合格品管理程序-品管部,,,,,

,9.6,"IsfailureanalysisperformedandissueaClosedLoopCorrectiveAction(CLCA)forin-processnonconformity?

制程中不合格品是否进行了失效分析，发出纠正行动要求？是否有改善报告？",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-39不合格品管理程序-品管部/HH-QEP-06纠正及持续改进管理程序-品管部,,,,,

,9.7,"Isacorrectiveactionrequestissuedintheeventaunitfailsreliabilitytest?Doesthecorrectiveactionrequestincludelongterm/preventiveaction?

是否对不良项含（可靠性测试失效）有纠正行动的要求，且改善行动要求是否含有长期措施和预防行动要求？",,,,,,,,,,,,,,,Generalitems普通项,5,HH-QEP-39不合格品管理程序-品管部/HH-QEP-06纠正及持续改进管理程序-品管部,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,"10:Handling,Packaging,Storage&Delivery",,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,25,,Counts:,25,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,10.1,"Arethereproceduresforhandling,storing,packaginganddeliveryofproductandmaterialsandcontrolrecords?

是否有产品和物料取放,存储,包装,周转的文件和记录?",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-15产品搬运，储存，包装与防护管理程序部,,,,,

,10.2,"AreallESD-sensitivematerialsstoredinanti-staticcontainers?

是否所有ESD敏感物料都被存放于防静电容器中?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,

,10.3,"Aredefectiveproduct/materialssegregatedtopreventmixing?

不良品（有缺陷的产品/物料）是否被隔离以防混淆?",,,,,,,,,,,,,,,Criticalitems关键项,5,HH-QEP-39不合格品管理程序-品管部,,,,,

,10.4,"Areappropriateenvironmentcontrol(temperatureandhumidity…),andshelflifedefinedandmonitoredinthesestorageareasonaregularbasis?

在这些存储区域,恰当的环境控制(温度和湿度等)和保存期限，是否被定义和定期监控?",,,,,,,,,,,,,,,Generalitems普通项,5,ENG-WI-0059物料储存检验周期控制指引,,,,,

,10.5,"Aremethodsforverificationanddispositionofmaterialsdefinedwhendeteriorationoroutofshelflifefound?

对损坏或超出保存期限的情况,是否定义验证和处理该物料的方法?",,,,,,,,,,,,,,,Generalitems普通项,5,ENG-WI-0059物料储存检验周期控制指引,,,,,

,10.6,"Arethematerialwithenvironmentalrequirement,flammable,corrosive,andtoxicmaterialsproperlystoredandsegregated?Andputdistinctlabel,storageconditionmeetsperifiedrequirement?Arenecessaryprotectionmeansinplaceforflammable,corrosiveandtoxicmaterials?

有环保要求的物料,易燃,有腐蚀性,有毒的物料是否恰当的存储和隔离,有明显标识,存放条件是否满足规定要求?是否有所需的针对易燃,有腐蚀性,有毒的物料的防护措施?",,,,,,,,,,,,,,,Generalitems普通项,5,存放化学品仓,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,11:CorrectiveAction&PreventionAction,,,,,,,,Self-rating,Avgscore:,,#DIV/0!,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,,,Self-rating,Subtotal:,,0,,Counts:,0,,,"0,1,2,3,4,5",参考文件名称&编号,"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依据,N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,11.1,"是否明确定义改善和预防措施流程，并建立相应的系统快速识别和改善不利于品质的根本因素？

Isthereaprocedurethatdescribesprocessfortakingcorrectiveandpreventiveaction?Isthereasystemofrootcauseimprovementactionsthatcanquicklyidentifyandimprovefactorsthatarenotconducivetoquality?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,11.2,"如何确保将品质异常问题或不合格品的有关信息传递到对保证产品品质或预防出现品质问题负有直接责任的人员？

Isitensuredthatinformationaboutqualityabnormalityornonconformingproductsistransmittedtothosewhoaredirectlyresponsibleforensuringproductqualityorpreventingtheoccurrenceofqualityproblems?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,11.3,"对于不良品退货或者客户拒收是否进行失效分析？是否采取适当的纠正和预防措施消除当前的和潜在的不良因素？是否执行闭环改善行动？

Istherefailureorrootcauseanalysisconductedfordefectivegoodsreturnedorrejectedbycustomers?Areappropriatecorrectiveandpreventivemeasurestakentoeliminatecurrentandpotentialnegativefactors?Areclosed-loopimprovementactionsimplemented?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,11.4,"改善行动是否包括识别根本原因、围堵措施、临时&长期的预防措施？纠正措施是否能够防止不良和类似问题的再次发生？

Docorrectiveactionsincludetheidentificationofrootcauses,containmentactions,temporary&long-termpreventivemeasures?Doesthecorrectiveactionspreventtherecurrenceofbadandsimilarproblems?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,11.5,"如果不良缺陷涉及到次级供应商，是否有定义反馈给IQC采取相应行动的制度？

Ifdefectsinvolvesub-suppliers,isthereadefinedprocessforfeedbacktoIQCforaction?",,,,,,,,,,,,,,,Generalitems普通项,X,,,,,,适用于医疗器械供应商

,11.6,"是否采用适当的统计技术以发现重复出现的质量问题？

Areappropriatestatisticaltechniquesusedtodetectrecurringqualityproblems?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,11.7,"是否有流程定义如何跟踪纠正措施和预防措施的执行状况？以确保改善行动的有效性，且不会对最终产品产生不利影响；

Isthereaprocesstodefinehowtotrackthestatusofcorrectiveandpreventiveactions?Toensurethatimprovedactioniseffectiveanddoesnotadverselyaffectthefinalproduct;",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,11.8,"纠正和预防的全部措施及结果是否予以记录并予以管理审核？是否有将失效分析和改善行动反馈给相关部门的制度？

Areallcorrectiveandpreventiveactionsandoutcomesdocumentedandmanagementreviewed?Isthereaprocedureforfeedbackoffailureanalysisandimprovementactionstorelevantdepartments?",,,,,,,,,,,,,,,Criticalitems关键项,X,,,,,,适用于医疗器械供应商

,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,12:TradeSecuritySurvey,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供应商自评,供应商备注,KF评分,,,,

,,,,,,,