PCH质量社会责任环境健康与安全有害物质商业合作伙伴贸易安全验厂准备清单OK

PCH验厂准备清单,,,,,

QualitySystem品质体系,,,,,

CheckList审核项目,PCHRatingDefined评分标准定义,,准备事宜,责任部门,责任部门

"QualitySystemandCertifications

品质体系及认证","

Score1

•Doesnothaveanycertifiedqualitysystemanddoesnothavethebasicfundamentalqualityprocedureandsysteminplace.Noindicationorcommitmentoffutureimprovementtoobtaincertification.

没有任何认证的品质管理管理体系，没有最基本的品质系统，流程等，没有任何未来通过改善来获取认证的承诺或迹象。

Score2

•Doesnothavethecertifiedqualitysystembuthavebasicandfundamentalqualityprocedureinplace.WillingtoimproveimmediatelytomeetPCH'sminimumrequirementandhasplantoobtaincertification.

没有认证的品质管理体系但有最基本的品质管理流程，有意愿立即改善来达到PCH最低要求以及有获取体系认证的计划。

Score3

•ISO9000familycertifiedqualitysystem.However,Qualitytargetsarenotappropriateorclearlydefined.Systemwassetupforcertificateonly,lackofinternalauditandmanagementreview.Fromlastqualitysystemauditthepracticeisalreadydeviatefarfromthedocumentrequirement,majorbreakdownwasfoundforfundamentalpracticeandwillcausepotentialqualitycrisistoPCH

有ISO9000系列体系认证，然而，品质目标没有恰当及清晰的定义，系统只是为认证而建立，缺乏内审及管理评审，从上一次的体系审核结果来看，该审核对象运作已经明显偏离文件的定义，最基本的运作过程中发现有严重不符合项并会导致对PCH的潜在品质危机。

Score4

•ISO9000familycertifiedqualitysystem.Qualityobjectives/metricsareappropriatelyidentifiedanddefined.Practicewassticktooriginalqualitysystemalthoughminorissuecanbedetected

有ISO9000系列体系认证,品质目标有恰当的识别与定义，日常运作有符合品质体系要求尽管还能发现一些轻微不符合项。

•FactoryabletoabtaintheISO13485certifiedqualitysystemformedicaldeviceproduct.

工厂有能力或已经获得ISO13485医疗器械品质管理体系

Score5

•OtherthanISO9000familycertifiedqualitysystem,theyalsoobtaincertificationstootherstandardsorindustrialrequirement.

除ISO9000系列认证外，审核对象同时获得了其他认证。

•Anextensiveandeffectivesystemexisttolinkcustomersneedswithcontinuousimprovedmeasurement.

具备广泛及有效的系统并能够持续改善满足客户需求。

•Formedicaldeviceproduct,factoryalreadyFDAregistedandfollowCFRpart820QSRrequirement.

对医疗器械产品，工厂已经有FDA注册并按照CFRpart820QSR体系执行。",,ISO9001证书、ISO14001证书、ISO13485证书,体系部,

interestedpartiesrequirementandexpection（相关方的要求和期望）,"

Score1

•Thereisnotanyprocedureorcontrolplantodefinetheinterstiedpartiesinthiscompany

公司没有定义相关方这个定义。

Score2

•thereisproceduredefinedbutthereisnotanymanagementplantomeetinterestingparties'requirement.。

公司有相关方的定义，但是没有任何管理措施去满足相关方的要求

Score3

•Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirement

公司有相关方的定义，并且有相关的管理措施满足相关方的要求

Score4

•Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirementandexpection

公司有相关方的定义，并且有相关的管理措施满足相关方的要求和期望

Score5

•Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirementandexpection,rewiewinterestingparties'srequirementandexpectionperiodicallyandadjustitscontrolledplan

公司有相关方的定义，并且有相关的管理措施满足相关方的要求和期望。并且定期评估，调整管理措施

。",,质量手册、经营计划管理程序,总经办,

风险管理rikassessment,"

Score1

•Thereisnotanyprocedureorcontrolplantoforriskassessmentithiscompany

公司没有定义风险管理这个定义。

Score2

riskhavebeenidetified。butthereisnotanyconrtrolmanagementplanaddressedtotherisk.

公司有风险管理定义，但没有任何措施去控制风险

Score3

riskhavebeenidetified,thereisconrtrolmanagementplanaddressedtotherisk.

公司有风险管理的定义，并且有措施控制风险

Score4

riskhavebeenidetifiedtotally。hereisconrtrolmanagementplanaddressedtotherisk.defineditsKPIandtrackingitseffectiveness

公司有风险管理定义，识别很完整，并且有措施和KPI控制，及时确认有效性

Score5riskhavebeenidetifiedtotally。hereisconrtrolmanagementplanaddressedtotherisk.defineditsKPIandtrackingitseffectiveness,rewiewitsassementperiodicallyandindicateinthemanagementreview

公司有风险管理的定义，风险识别的很完整，并且有措施和KPI控制，及时确认有效性，定期评审，并体现在管审里面

。",,PCB手册、风险清单及控制措施、KPI,总经办,

"CompanyKPImanagement

公司绩效管理","

Score1

•SupplierdoesnotsetupacompanylevelKPIperformancerequirement(includemonitoringcustomerfeedback,supplierperformance,processqualityperformance,andotheroperationKPI),nooneisclearunderstandhowtheperformanceofcompanyis.duringaudit,supplierhardlyunderstandwhatisKPImeans

审核对象没有设立绩效包括客户反馈，供应商表现，制程品质及其他运作过程中的KPI,没人清楚公司运作表现，审核对象甚至不了解什么是KPI.

Score2

•Supplierhaspartialofqualitydatacollected,butlackofhighlevelsummarytobemanagedbyseniormanagementteam,seniormanagementhaslimitedunderstandhowthequalityperformanceofthecompany,duringaudit,managementrepresentativeisunabletounderstandthecurrentperformanceandseekhelpfromvariousteam.

审核对象有收集部分的品质数据但管理团队缺乏系统化的汇总，管理团队对公司运作表现了解有限+B10:C11，在审核过程中，管理者代表不清楚公司运作状况只能求助于其他团队。

Score3

•CompanylevelofKPIisdefinedandmanagementandcrossfunctionalteamisreviewedtimely,teamunderstandtheperformanceofthecompanyfromdifferentview(quality,delivery,services),basicresponsetotheKPIchangeisinitialized

公司层面的KPI有被定义并在跨部门间定义评审，大家清楚从品质，交期，服务等层面公司绩效表现。

Score4

•ThereisaprogramtoimprovetheKPI(DPMU,LRR,OTD,turnoveretc),actionsandprojectismanagedandreviewedbymanagementteam

对DPMU,LRR,OTD,周转率等方面有程序定义来改善KPI,管理团队有对项目及对策进行管理。

Score5.

•ThecompanyareuseBIC(bestinclass)programtomanagementcompanyKPIlikeutilizethesixsigmaapproach,leanprocess,etc.

公司有用BIC程序来管理公司KPI例如推行6Sigma,精益生产等。",,绩效的监视和测量管理程序、KPI,总经办,

"ManagementReview

管理评审","

Score1

•Supplierdoesnotsetupaprogramfortimelymanagementreviewonthequalitysystemandperformance,systemisfardeviatefromdocumentation.

审核对象没有程序定义需定期对品质体系进行管理评审，体系运作严重偏离文件定义。

Score2

•Supplierhassetupyearlyqualitymanagementreviewbutfailedtoidentifygapstothequalitysystemrequirementandcontinueimprovementrequirement,reviewisonthesurfaceofprocessonly.

审核对象虽定义了管理评审但没有有效的在持续改善及品质体系要求偏差分析上做有效的识别，管理评审只是停留在表面。

Score3

•Supplierabletofoundsomegapsbaseonperformance,however,managementisfailedtosupportresourceandfinancetothecontinueimprovementactivities.

审核对象基于绩效有识别出一些偏差，然而，公司没有提供资源去持续改善。

Score4

•Supplierrunningmanagementreviewinefficientway,gapswasidentifiedandmanagementhasashorttermplanandlongtermplantofixmajorbreakdown.

审核对象管理评审有效的在进行，有短期长期计划去解决识别出来的那些主要偏差。

Score5

•Managementreviewhasproactiveapproach,notonlysolvetheproblembutalsohasplantofixpotentialissueandmanypreventionactionsisfoundinthemanagementreview.

有积极主动的做管理评审，表现在不仅仅是为解决发现的问题，同时也做了大量对潜在问题的解决及采取了大量的预防措施。

•Qualitypolicy/objectivesreviewedincludedintomanagementreview,managementrepresentativepersonbepointed.

管理评审中有涵盖品质政策，目标，有指定管理者代表。",,管理评审管理程序、管理评审记录,总经办,

"AuditManagement

审核管理","

Score1

•Noevidenceshowssupplierhasainternalassessmentprogramexist.

供应商没有内部审核程序

Score2

•Primaryinternalauditsarescheduledrandomly,andsomeauditfindingsareobserved,butmanyfindingsarenotdocumentedincloseloopactions,someauditorshasnotrainingrecordandcertificatewasnotfound

有随机的初步的内审计划，内审中有一些发现但是很多的发现没有有效的改善对策，一些内审员没有经过培训也没有资格证书。

Score3

•Amasterschedulewassetuptocoverallareaofbusiness,allauditorsarefullytrainedandequipwiththeskillofaudit,allactionsareclosedwithpropercloseloopactions

有定义较完善的审核计划涵盖各各个部门，所有审核员都有经过培训并证明有足够的审核能力，所有改善对策有持续的追踪直至结案。

Score4.

•Managementarereviewtheinternalauditfromtimetotime,auditfindingswereusedastoolstoimproveoverallbusiness,suppliernotonlyfixtheproblemsonthepointfortheproblemarefinding,butdrillwidetoothersimilararea

管理者有不定期的评审内审结果，内审结果作为一个工具用于持续改进公司业绩，公司不仅能对审核发现去针对性改善而且还能做到对类似区域改善举一反三。

Score5

•Companyarefullyutilizedtheauditasatooltodrivingcompanyimprovementstrategically,auditfindingsareusingforcompanystrategicsystemimprovementactions.

公司能策略性的并完整的将内审作为推动公司绩效改善的工具，内审结果用来推动公司策略系统改善。",,内部审核管理程序、内部审核记录,体系部,

"Trainings

培训","

Score1

•Notrainingplanexistandlackofinternaltrainingandexternaltrainingwithinlastyear

在上一个年度中，没有培训计划并缺乏内外部培训

Score2

•Occasionaltrainingswerehappened,butcompanyfailedtomanagementitasacompanylevelplan.Engineer/operatorhasavoiceoflackoftraining.Trainingbudgetplanalwaysreject

偶尔有培训，但是没有在公司管理层面上做计划，员工有提出缺乏培训，培训预算计划经常被否决。

Score3

•Acompletecompanytrainingplanisexistandwithcompanybudgetsupport,atleast70%trainingswerehostedbaseontrainingplan.

•Trainingrecordwasmaintainedforallleveloftraining

有公司层面的完整培训计划并有预算支持，至少70%以上的培训计划有没执行，培训记录有被完整的保留。

Score4

•Suppliertrainingplanincludeonjobtraining,newhiretraining,SOPtraining,problemsolvingtraining,aswellasnecessarytrainingforeachfunction,forexample

培训计划包括职位培训，入职培训，SOP培训,问题解决培训以及与部门相关的有必要的培训，例如：

•IE/ME(Layout,linebalance,fixturedesign,mistakeproof,MSA,),ProductandQA(SPC,FMEA,basic7qualitytools,)etc.

•Trainingswerecoverallfunctionaloforganizationfromalldepartmentandalllevel,managementtooperator,productiontoQA,alllevelandallteamsreceivesufficienttrainingbaseonbusinessneeds

•Computersystemismanagesthestatusofemployee'straining

•Certificationprocessusedforkeyareatocontrolthequalificationstatusoftheemployee

•Formedicaldeviceproduct,specialprocess/industrialstandard/medicaldevicequalitymanagementsystemrequirementsaretrainedforallkeyperson.

对医疗器械产品，应对从业人员进行特殊流程及行业标准，医疗器械品质管理体系，法规等培训

•Trainingeffectivenessisreviewed,assessedforeachindividualcourse

培训效果有评审，并对每门课程都有单独的评估。

Score5

•Supplierhasbestinclasstrainingprogram(foxexampleemployeeeducationassistantprogram,longtermcontractwithqualifiedexternalsourcetoprovidetrainingtoemployeetimely)

供应商有完善的培训流程，例如员工辅助学历教育，有与外部有资质的培训机构签订合同并定期的对员工进行培训。",,人力资源管理程序、培训计划和记录,人力资源部,

"IncomingInspection

来料检查","

Score1

•NodedicateIQCareasetupinsupplierfacilities没有固定的来料检查区域

•NoproperIQCdocument,operatorscheckbaseoncommonsenseandexperiencesonly没有适当的IQC文件，员工基于自己经验及常识进行来料检验

•Nosufficienttoolsforoperatorconducttraininglikemeasurementinstrument(caliper,projector)没有充足的工具用来培训员工例如卡尺投影仪等

•Nosampleplanwassetuptoeachcommodity没有对产品检验指定抽样计划

Score2

•ThereisIQCareaexistbutwasnotmanagementinaeffectivemanner,thereismixing/damageconcernwasfoundinthearea有IQC区域但没有有效的管理，发现存在混料或者产品损伤的风险

•IQCdocumentisdrafted,butisnotsufficienttocovercriticaltofunctionrequirementandoperatorisnotfullyuseit有IQC文件但不足以涵盖关键IQC功能而且员工没有完全使用

•Someequipment(includetestingdimension,function,reliability)areinstalledintheIQCareaorachievebyIQCdepartment,Thereisaconcernonthecapacityoftheequipmentbaseonthesamplingplan

一些设备有在IQC但基于抽样计划，这些设备产能可能存在瓶颈。

•Sampleplanexistformostofcomponent,butdefinethesamplingplanisdecidedbyengineer'ssensenotthroughaassessmenttoolslikeFMEA对多数产品有制定相应的抽样计划，但抽样计划来自于工程师的意识，经验而不是来自于一些评估的工具例如FMEA.

Score3

•WellmanagedIQCarea,5S,identification&labeling,visualmanagementisclearandthereislowriskofmixing,wrong,damageandescapinginspection区域有较好的管理包括5s,标识，混料，损伤产品，漏检等风险较低。

•IQCareaiscontrolledwithmoistureandtemperaturebaseonthepartspecification,lightingissufficient基于产品规格IQC区域有管控温湿度，照度足够

•IQCequipmentissufficienttotestallrequiredfunctionandwithsufficientcapacity有足够的应对产品功能检验的设备并且产能足够

•Samplingbaseoncustomerrequirement/historyperformance,aIQCreportwasrunningtomonitoringthesupplierincomingperformance,properactionwasagainstsupplierbaseonthedata(RTV,sorting,onsitechecking)抽样计划基于客户要求或历史表现，有IQC报告用来监控供应商来料表现，基于RTV,sorting等数据有对相应的供应商采取适当的对策。

•IQCinspectionstandardcoversallpointsneedbecheck,whichoftenuseasatoolsforoperatortoassesstheincomingstatusandgivearightdecision检验计划涵盖了所有的关注点，检验员能用其为评估来料状况并作出正确决定的工具。

•Formedicaldevice,ifnecessary,specialcontrollikesterilizationisinplaceaswellforincomingarea医疗器械，适当时，IQC区域应采用特殊管控，例如灭菌。

Score4

•IQCareausingcomputingsystemtoautomaticmanagethestatusofinspection,locationandstatus,firstinfirstoutprogramwasdesigntoIQCaswell有用到信息化系统来自动管理检验状态，区域等，有FIFO

•IQCareawasequippedwithallnecessaryinstructionandaids,manyequipmentarehighendequipment,precisionandmaintanceisinverygoodcondition(CMM,VMMfordimension,LCRforeletronicsparts,toolmarkermicroscopeetc)有完善的检具及设备并且保养得当例如CMM,VMM,色差仪等

•IQChassetupgoldensampleandlimitedsample,thosesamplesarekeptingoodcondition,arefreshprogramismaintainingonthesamplestatus有建立标准及限度样品库并妥善维护，有对应的维护及更新程序

•IQCinspectionstandardisverydetails,coverssamplingplan,equipment,process,protectiononthepart(ESD,moisture,damageetc)anddispositionplan,operatorisfullytrainedwithinspectionstandardwithrecord检验标准非常详细，涵盖了抽样计划，设备，流程，工艺，保护（ESD,湿度等）处理计划，检验员有经过完整的培训并有记录

Score5

•IQCwaslayoutwithleanconcept(materialflow,informationflow,processflow),cyclytimeisstudiedandspacingandmaterialroutingiswelldesignedtoreducetheoverloadoftemporarystorageplaceinIQC

•Samplingplanwasselectbaseonthesystemway(FMEAfactorondetection/serverity/Occuracyetc,samplingsizepoweranalysisetc)

区域基于精益生产理念来规划（物料流动，信息流程，过程）有研究设计检验时间，空间，物料流动路线用来减少临时存放区域过载的情况

基于系统思维来制定抽样计划例如基于FMEA中严重度，可侦测度，发生频率等因素

",,检验和试验管理程序、进料检验指导书、原材料进行检验标准和检验记录,品管部,

"SupplierManagement

供应商管理","

Score1

•Supplierdoesnothaveasuppliermanagementsystem,purchasingisbaseonquotationonly,noqualityratingofthesystembeforereleasePO没有供应商管理系统，采购只是基于报价，下单前没有对供方品质体系评估

Score2

•Supplierhasbasicsupplierratingsystem,buttheratingsystemisverybasicandcouldnotcovertherequirmentthanISO9000有基本的供方评估系统但非常初级不能完整涵盖ISO9000的要求

•Examplesfoundmajorsupplierhavenoevidencetogothroughthequalityassessmentbaseonsupplier'sratingsystembelowusethem发现有主要的供应商没有经过评估过程

Score3

•Acomprehensiveaudittoolsfromorganizationcouldscientificallyratingthesupplier,supplierisselectstratelyandwithlongtermrelationship有综合的审核工具用来系统化的评估供应商，有策略性的选择供应商并保持长期稳定的关系

•SupplierhassetupmonthlyscoreCAPAdorequavelanttomonitoringthesub-tier'sperformanceandkeepactionplanbaseonsupplierchange有对供方采用类似月度评分的工具来监督供应商表现并采取相应的对策

•SupplierCAPAisoftenusedtomanagesupplier,theleadtimeandnumberismonitoredascriticalinputfortheperformanceofsub-tier经常用CAPA来管理供应商，CAPA时效性作为一个关键指标来评估供应商表现

Score4

•SupplierhasNPIearlyinvolveplanwithstrategicsub-tiersupplier,qualitypreventionplanisjointdevelopedbetweensub-tier有策略性的在开发阶段invlove供应商并有品质预防计划

•Supplierhasasuppliercertificateprogram,goodperformancesupplierswereacknowledgedandrewarded有供应商认证流程，好的供应商有得到认可与奖励

•Supplierhasshiptodeckprogram,supplierismanagementbytheperformanceofincomingmaterial

Score5

•Supplierisdriveinglongtermimprovementwithsub-tierwithqualityimprovementtoollike6-sigmaandleanmanufacturing有用品质改善工具用来长期性的推动供应商改善

•Supplierhasinvolvethesub-tieraspartofproductqualityplan,criticalparameteriswellmanagemedallthetime有将供应商纳入产品品质计划的一部分，关键特性总是有很好的被管理

",,采购控制管理程序、供应商管理程序和采购订单、供应商审核计划、协议、供应商评价,采购部,

"WarehouseManagement

仓库管理","

Score1

•Nodedicatewarehousefromsupplier,materialisstockinanywherewithdisorder/mess.Operatorishardlytofoundamaterial没有固定的仓库区域，材料堆积混乱，员工很难招到材料

Score2

•Dedicatewarehouseareaexist,separatetorawmaterialwarehouse,finishgoodwarehouse,WIPwarehouseatleast,materialstoredindedicatearea有固定的仓库分开存储原料，成品，在制品等

•Apaperstoragematerialstoragelistisexistforassitoperatortoidentifythelocationofrawmaterial,riskofmix/missing/damageexist有纸档记录材料清单用来识别原料区域但存在混料，丢失，损坏等风险。

Score3

•Warehousehasdefinedclearidentificationprogram,materialistagedandmarkedclearly有清晰的标识流程，材料有清晰的被标识

•DedicatedRMAwarehouseissetupandpreventitmixwithgoodmaterial有固定的RMA仓用来避免混入良品中

•Warehouseenvironmentiswellmanagedbaseonthematerialrequirement,environmentwasmonitoredandincaseofoutofcontrol,aimmediateactionistriggered基于材料特性要求有很好的管控仓库环境，一旦超出管控，相应对策能马上实施。

Score4

•ComputersystemusetomanagethewarehouseusingMRPsystemlikeoracle,SAPetc,materialstatusisclearandtransparentthroughoutthewholefactory有采用MRP,SAP等IT系统来管理仓库，物料状态流向清晰。

•Firstinfirstoutiswellmanaged.NomajorFIFOrisk有FIFO管理且没有发现主要FIFO风险

•Allmaterialclosetoshelllifehaswarningsignaltomaterialplanningteam,aftertheshelflifeexpired,properactionismanagedbythefactory(scrap,rework,returnetc)有管理材料寿命，一旦接近保存寿命，有相应的处置动作例如报废，退货，返工等。

•Materialiswellkeptedbaseonmaterialspecification(ESDsensitive,Rohs,moisutresensitive,dustetc).noviolationisfoundwhichcausetherisktodegradingthequalityofthestoragedmaterial基于材料规格来保管物料，没有发现违规而导致影响材料品质的案例。

•Warehousespaceissufficientandwithnotoverloaded,10%bufferissetup仓库区域足够，没有爆仓，有至少10%的缓冲空间

•Insectcontrolprocessavailable,fumigationschedulearestrictlyfollowed有防虫计划，严格执行了烟熏除虫计划

Score5

•Warehouselayoutisclassifiedbaseontheleanstudy,whichreducetheinventorylevelandreducetheunecessarymovement仓库规划基于精益生产思维，减少了库存量及不必要的搬动

•Automaticwarehousesystemisapplied,inoutismanagedbyautomaticequipment有自动仓库存储系统且进出实现了自动化

",,"产品搬运，储存，包装与防护管理程序、产品标识和可追溯性管理程序

先进先出管理制度和物料台帐、物料标识卡",物管部,

"MaterialTraceability/Processtraceablity

可追溯性","

Score1

•Notraceabilityprogramtomanagementtheincomingmaterial/tooling/operator/processchange没有追溯程序来管理来料，模具，制程变更等。

Score2

•Manualtraceabilityprogramisexist,lotnumber/datecodeisrecordinanyreleaseofmaterial,whichcouldlinktoamanufacturingdateorworkorder有手工追溯系统，批次号，日期号等信息能链接到生产日期，工单。

Score3

•Acomputeraidsystemlikeshopfloorsystemisavailabletorecordthematerialusagehistoryandprocesshistory,traceabilityprogramcantrackbackonmanufacturingdateorworkorderlevel有shopfloor等信息系统用来记录材料及制程历史，能用其追溯回生产日期或工单等信息。

Score4

•Serialnumberisappliedtoallshipoutproduct,eachserialnumberisdirectlylinkwithmateriallothistoryinadigitalsystem,thecomputersystemiseasytosearchingarecordinaquickmanner每个出货产品都有序列号，通过信息化系统每个序列号都能直接带出材料批次信息，电脑信息化系统能轻易的查询类似信息。

Score5

•Supplierisproactivelydrivetraceabilityimprovementinsub-tier.有主动的推动下阶供应商改善可追溯性

•Customer/supplierisabletochecktraceabilityhistorydirectlyonlinetoviewthestatus客户或者供应商能通过网络直接查询追溯

系统",,产品标识和可追溯性管理程序,各部门,

"Non-Conformingmaterialmanagement

不合格品管控","

Score1

•Supplierdoesnothaveasystemtomanagethenon-conformingmaterial,highriskofnon-conformingmaterialwillmixwithgoodunits没有系统管理不合格品，混料可能性极高

Score2

•Abaiscsystemisexisttomanagethenon-conformingmaterial,violationisfoundnon-conformingarefoundcloseandwithinconformingmaterials有基本的不合格品管控，有发现不合格品混入或者接近良品

•SupplierRMAreviewisnotsufficient,storageofRMApartismorethanexpectedcycletime.RMAareaisoverloadedRMA没有足够评审处理，超出周转时间，RMA仓爆仓。

Score3

•Non-conformingdispositionsysteminplaceandcycletimeissufficientandwellmanaged,andthosematerialispurgedontime不合格品处理系统有实施并很好的管控周转时间，不合格品有被及时处理

•RMAareaiswelldesigned,noriskofmixing/missingduringmaterialmovementandhandlingRMA区域有很好的设计，没有在搬运过程中混料，丢失的风险

•Non-conformingfunctionisdesigntheallrequiredarea(IQC,production,warehouse)supportwithcleartagandidentification.Supportbinsaresufficient,nomistakeusefoundinthewholefacility所有相关区域从IQC,产线到仓库，都有导入不合格品控制，有清晰的标识，存储盒数量足够，整个工厂没有发现违规案例。

•Abasicvisualmanagementisutilizedinthearea,likecolor/routingarrow/heightlimitationlabel有基本的目视管理系统，例如颜色管理，物流方向指示，高度限制标签等

Score4

•Non-conformingismanagedbyMRPsystem,systemisveryeasytolocatedthenon-conformingmaterialMRP系统来管理不合格品，用该系统非常容易能定位到不合格品。

•Verygoodfactoryvisualmanagementsystemisapplied,RMAisclearlyisolated非常好的目视管理系统，RMA被清楚的隔离

Score5

•Supplierisusenon-conformingrealtimedatathroughSPCmethology,dataareusingtodrivesupplieractions通过SPC方法来报告实时不合格品数据，并将数据用来推动供应商改善

•RMAreduceprogramrunningthroughcontinueimprovementprogramhasachievesignificantresultwithinlastyear在上一个年度中，作为持续改善项目之一，减少RMA目标有明显的达成。

",,不合格品管理程序,品管部、生产部和相关各部门,

"QualityPlan

品质计划","

Score1

•NoqualityplanduringNPIandnoqualityplanrevisedinmassproductionduringprocesssetup新产品开发过程中没有品质计划，在量测制程建立过程中没有修正品质计划

Score2

•SupplierhassetupqualitycheckpointanddocumentthemajorpointinSOPbutnotinasystemway有在SOP中定义关键性的品质管控点但不系统

•ThereisviolationinsystemarenotfollowthoseSOP有发现违反SOP的案例

Score3

•Supplierhassetupproductmanagementplanformajorproduct,andSOPvsPMPissychronizeallthetime,majorqualityissuewillupdatethecontrolpointandsamplingplanbaseonexperiences.有对主要产品建立管控计划，SOPPMP有同步，基于经验在异常发生后有相应的修改管控计划及抽样计划

•Controlplanwasdevelopedwithcrossfunctionalteam,anduseitinrealproductionandasabasicdocumenttocommunicatetheprocessimprovementduringallCIPprocess跨部门合作开发控制计划并用其在生产过程中及作为持续改善项目中一个基本文件。

Score4

•PMPorcontrolplanisreviseallthetimethroughapredictionanalysislikeFMEA/FMCA/PHAetc,highriskfailuremode(RPN>80etc)isunderspecialcontrol通过FMEA等预防性的工具，PMP或者控制计划有实时更新，高风险项目有列入特别管控

•Suppliernotonlycontroltheprocessoutput,andalsocriticaltofunctioninputparameterinthePMP不仅有管控制程输出，PMP中还管控了关键功能输入参数

•SPCiswidelyusedinthecontrolplantodefinesomeinput/outputparameterunderstandstatisticcontrol,reactionplanisdektostoplineprocessandescalationprocessSPC被广泛的用在管控计划中，措施计划链接到停线，向上报告流程中

Score5

•SomecontrolplanwasdevelopedthroughDOEapproach,asurfaceresponsestudy,factordesign,Taguchistudyisfoundthemostimportantcontrolparameterandwhatisbestprocesswindow一些管控计划是基于DOE方法，因子设计，田口方法被用于最重要的参数管控

•Controlplanwasnotonlymanagethequalityrequirementbutalsocontroltheleadtimeandinventoryleveltoreducewaste管控计划不仅用于品质管控而且被用在效率提升，库存周转减少浪费上。

•APQPprocessisusedtodefinetheprocessdesignandprocessmanagement制程设计及管理有采用APQP流程

",,产品品质控制计划MCP,品管部,

"ProcessCapability&StatisticControl

统计过程控制","

Score1

•Supplierhasnoideatheprocesscapability,theyarenotunderstandthequalitysigmaleveloftheirproductandprocess对过程能力没有概念，不知道他们产品或制程的6sigma水平

Score2

•SupplierRandomlychecktheprocesscapability,severalcriticalinputandoutputparameterwasverifythecpk,distributionoccasionalpercustomerrequireandqualityissueraisedduringNPIandwhenissuehappened

有随机的检查制程能力，在客户要求或者项目开发时出过品质异常时曾经对一些许关键输入输出做过CPK,分布图分析

Score3

•SupplierhasincludethecriticalparameterintotheirSPCplan,x-Rbarchart,controllimtedchart,I-MRchartetcisusedtomonitoringthosekeyparameters.CPKlevelanddistributionisverifiedfromtimetotimeforthosekeyparameter.有将关键参数纳入SPC计划,X-R图，控制图,I-MR图等，有不时的确认CPK等级

•Supplieruseattributecontrolcharttomanagetheattributedata(p-chart,U-chart,C-chartetc)有用到p-chart,U-chart,C-chart等记数型管控图

Score4

•SupplierhassomeCIPprogramtoimprovetheprocesscapability,significantsavingandimprovewasseeinlastyear;sactivities过去一年中有在持续改善项目总有明显的提升制程能力

Score5

•Supplierisfullyutilizethesix-sigmatoresolvethemajorcapabilitylowperformancearea,3ormore6-sigmaprojectwascompleteforimprovetheoverallsituation有完全用6-sigma方法解决主要低制程能力区域，3个sigma以上项目改善经验。

",,数据收集与统计管理程序和SPC计划，CPK等级、SPC统计表、品质周报,品管部,

"NPI

新产品开发","

Score1

•Noprocedureexistsfornewproduct/technology/servicelaunches.没有程序定义新产品/技术/服务开发管理

Score2

•Newproductlaunchproceduresexist,butdocumentationisincompleteandcomplianceisinconsistent.有新产品开发流程但文件记录及符合性不一致

•Newproductlaunchproceduresarebeingfollowedbysomemajorareasofthebusiness.However,someofthesepolicieslacktherequirementsforappropriateapprovalsanddefiningqualityobjectives.在一些主要功能区域符合新产品开发流程但缺乏适当的品质目标与审批。

Score3

•Newproductlaunchflowchartandprocedureiswelldocumentedandthepoliciesrequireclearandcompleteprojectplansdocumentedwithappropriatequalityobjectivesandresponsibilitiesforimplementation.新产品开发流程有很好的被记录，有完整的品质目标及职责定义在完整的项目计划中

•Thereareafewexamplesofwellplannedandsuccessfulnewproduct/technology/servicedevelopmentprojects.Qualityobjectivesandresponsibilityforimplementationaredefined.有几个很好的案例

•ThequalificationdatapercustomerspecificationandFirstArticleinspectiondataarecollectedandAppropriatemanagementapprovalsarebuiltintotheprocess(includecustomerapproval,ifrequired).审批过程中有体现很好的基于客户规格的qualification的数据及首件记录。

Score4

•Well-designednewproduct/technology/servicepoliciesandproceduresexistforallappropriateareasofthebusinessandthereisevidencethatallnewproduct/technology/serviceprojectsarecomplianttothepoliciesandprocedure.

•Managementassignsadedicatedprojectmanagertonewproduct/technology/servicelaunchesandotherappropriateresourcestoassurefullcompliancetosupplierreadinessactivitiesandthelaunchprocess.

•AQualificationdatacollectionsystemiscentralizedandusedthroughoutthemanufacturingareaandhastraceabilitycapabilitiesforproduct,manufacturedate,shift,lineetc.

•PPAP,FAI,Yielddata,reliabilitytest,ALTtest,visualInspectionandtestdataareappropriatelydocumentedandmaintained

•Organizationhascapabilityofperformingenvironmentaltesting,reliabilitytesting,safetytestingandFailureAnalysiscapabilityinhouse.

•processvalidationsysteminplace(IQ,OQ,PQ),Validationmasterplanavailable

Score5

•Newproduct/technology/servicepoliciesandproceduresarewellmaintainedandreviewedperiodically.Theyincorporatespecificcustomerrequirementsaswellaslessonslearnedfrompastlaunches.

•Thesuccessrateandcustomersatisfactionlevelofnewproducts/technologies/servicesclearlyprovidestheorganizationacompetitiveedge.Trendchartormetricforperformanceofdeliveryandqualityofnewproductlaunchismaintained.

•Proceduresexistwhichprovideforanescalationprocesstodelayaproductnotdeemedreadyforrelease.

•ManagementrequiresthedevelopmentofDFMEA/DFX(X=manufacturing,testing,