PCH供應(yīng)商質(zhì)量社會(huì)責(zé)任環(huán)境健康與安全有害物質(zhì)商業(yè)合作伙伴貿(mào)易安全Checklist清單+自評(píng)范本OK

"SupplierQualificationSurvey-SupplierQualitySystemAssessmentChecklist

供應(yīng)商資格調(diào)查-品質(zhì)體系",,,,,

,,,,,,

,,Itemswithredfontshouldbestrictlyreviewedformedicaldevicetypeofproduct（紅色字體部分為醫(yī)療器械產(chǎn)品相關(guān)條款需嚴(yán)格對(duì)照）,,,

QualitySystem品質(zhì)體系,,,,,

CheckList審核項(xiàng)目,PCHRatingDefined評(píng)分標(biāo)準(zhǔn)定義,,Auditfindingordiscrepancies審核發(fā)現(xiàn)或差異項(xiàng),Rating評(píng)分,Attachment附件

"QualitySystemandCertifications

品質(zhì)體系及認(rèn)證","

Score1

?Doesnothaveanycertifiedqualitysystemanddoesnothavethebasicfundamentalqualityprocedureandsysteminplace.Noindicationorcommitmentoffutureimprovementtoobtaincertification.

沒(méi)有任何認(rèn)證的品質(zhì)管理管理體系，沒(méi)有最基本的品質(zhì)系統(tǒng)，流程等，沒(méi)有任何未來(lái)通過(guò)改善來(lái)獲取認(rèn)證的承諾或跡象。

Score2

?Doesnothavethecertifiedqualitysystembuthavebasicandfundamentalqualityprocedureinplace.WillingtoimproveimmediatelytomeetPCH'sminimumrequirementandhasplantoobtaincertification.

沒(méi)有認(rèn)證的品質(zhì)管理體系但有最基本的品質(zhì)管理流程，有意愿立即改善來(lái)達(dá)到PCH最低要求以及有獲取體系認(rèn)證的計(jì)劃。

Score3

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

有ISO9000系列體系認(rèn)證，然而，品質(zhì)目標(biāo)沒(méi)有恰當(dāng)及清晰的定義，系統(tǒng)只是為認(rèn)證而建立，缺乏內(nèi)審及管理評(píng)審，從上一次的體系審核結(jié)果來(lái)看，該審核對(duì)象運(yùn)作已經(jīng)明顯偏離文件的定義，最基本的運(yùn)作過(guò)程中發(fā)現(xiàn)有嚴(yán)重不符合項(xiàng)并會(huì)導(dǎo)致對(duì)PCH的潛在品質(zhì)危機(jī)。

Score4

?ISO9000familycertifiedqualitysystem.Qualityobjectives/metricsareappropriatelyidentifiedanddefined.Practicewassticktooriginalqualitysystemalthoughminorissuecanbedetected

有ISO9000系列體系認(rèn)證,品質(zhì)目標(biāo)有恰當(dāng)?shù)淖R(shí)別與定義，日常運(yùn)作有符合品質(zhì)體系要求盡管還能發(fā)現(xiàn)一些輕微不符合項(xiàng)。

?FactoryabletoabtaintheISO13485certifiedqualitysystemformedicaldeviceproduct.

工廠有能力或已經(jīng)獲得ISO13485醫(yī)療器械品質(zhì)管理體系

Score5

?OtherthanISO9000familycertifiedqualitysystem,theyalsoobtaincertificationstootherstandardsorindustrialrequirement.

除ISO9000系列認(rèn)證外，審核對(duì)象同時(shí)獲得了其他認(rèn)證。

?Anextensiveandeffectivesystemexisttolinkcustomersneedswithcontinuousimprovedmeasurement.

具備廣泛及有效的系統(tǒng)并能夠持續(xù)改善滿足客戶需求。

?Formedicaldeviceproduct,factoryalreadyFDAregistedandfollowCFRpart820QSRrequirement.

對(duì)醫(yī)療器械產(chǎn)品，工廠已經(jīng)有FDA注冊(cè)并按照CFRpart820QSR體系執(zhí)行。",,,4,

interestedpartiesrequirementandexpection（相關(guān)方的要求和期望）,"

Score1

?Thereisnotanyprocedureorcontrolplantodefinetheinterstiedpartiesinthiscompany

公司沒(méi)有定義相關(guān)方這個(gè)定義。

Score2

?thereisproceduredefinedbutthereisnotanymanagementplantomeetinterestingparties'requirement.。

公司有相關(guān)方的定義，但是沒(méi)有任何管理措施去滿足相關(guān)方的要求

Score3

?Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirement

公司有相關(guān)方的定義，并且有相關(guān)的管理措施滿足相關(guān)方的要求

Score4

?Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirementandexpection

公司有相關(guān)方的定義，并且有相關(guān)的管理措施滿足相關(guān)方的要求和期望

Score5

?Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirementandexpection,rewiewinterestingparties'srequirementandexpectionperiodicallyandadjustitscontrolledplan

公司有相關(guān)方的定義，并且有相關(guān)的管理措施滿足相關(guān)方的要求和期望。并且定期評(píng)估，調(diào)整管理措施

。",,,4,

風(fēng)險(xiǎn)管理rikassessment,"

Score1

?Thereisnotanyprocedureorcontrolplantoforriskassessmentithiscompany

公司沒(méi)有定義風(fēng)險(xiǎn)管理這個(gè)定義。

Score2

riskhavebeenidetified。butthereisnotanyconrtrolmanagementplanaddressedtotherisk.

公司有風(fēng)險(xiǎn)管理定義，但沒(méi)有任何措施去控制風(fēng)險(xiǎn)

Score3

riskhavebeenidetified,thereisconrtrolmanagementplanaddressedtotherisk.

公司有風(fēng)險(xiǎn)管理的定義，并且有措施控制風(fēng)險(xiǎn)

Score4

riskhavebeenidetifiedtotally。hereisconrtrolmanagementplanaddressedtotherisk.defineditsKPIandtrackingitseffectiveness

公司有風(fēng)險(xiǎn)管理定義，識(shí)別很完整，并且有措施和KPI控制，及時(shí)確認(rèn)有效性

Score5riskhavebeenidetifiedtotally。hereisconrtrolmanagementplanaddressedtotherisk.defineditsKPIandtrackingitseffectiveness,rewiewitsassementperiodicallyandindicateinthemanagementreview

公司有風(fēng)險(xiǎn)管理的定義，風(fēng)險(xiǎn)識(shí)別的很完整，并且有措施和KPI控制，及時(shí)確認(rèn)有效性，定期評(píng)審，并體現(xiàn)在管審里面

。",,,4,

"CompanyKPImanagement

公司績(jī)效管理","

Score1

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

審核對(duì)象沒(méi)有設(shè)立績(jī)效包括客戶反饋，供應(yīng)商表現(xiàn)，制程品質(zhì)及其他運(yùn)作過(guò)程中的KPI,沒(méi)人清楚公司運(yùn)作表現(xiàn)，審核對(duì)象甚至不了解什么是KPI.

Score2

?Supplierhaspartialofqualitydatacollected,butlackofhighlevelsummarytobemanagedbyseniormanagementteam,seniormanagementhaslimitedunderstandhowthequalityperformanceofthecompany,duringaudit,managementrepresentativeisunabletounderstandthecurrentperformanceandseekhelpfromvariousteam.

審核對(duì)象有收集部分的品質(zhì)數(shù)據(jù)但管理團(tuán)隊(duì)缺乏系統(tǒng)化的匯總，管理團(tuán)隊(duì)對(duì)公司運(yùn)作表現(xiàn)了解有限+B10:C11，在審核過(guò)程中，管理者代表不清楚公司運(yùn)作狀況只能求助于其他團(tuán)隊(duì)。

Score3

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

公司層面的KPI有被定義并在跨部門間定義評(píng)審，大家清楚從品質(zhì)，交期，服務(wù)等層面公司績(jī)效表現(xiàn)。

Score4

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

對(duì)DPMU,LRR,OTD,周轉(zhuǎn)率等方面有程序定義來(lái)改善KPI,管理團(tuán)隊(duì)有對(duì)項(xiàng)目及對(duì)策進(jìn)行管理。

Score5.

?ThecompanyareuseBIC(bestinclass)programtomanagementcompanyKPIlikeutilizethesixsigmaapproach,leanprocess,etc.

公司有用BIC程序來(lái)管理公司KPI例如推行6Sigma,精益生產(chǎn)等。",,,3,

"ManagementReview

管理評(píng)審","

Score1

?Supplierdoesnotsetupaprogramfortimelymanagementreviewonthequalitysystemandperformance,systemisfardeviatefromdocumentation.

審核對(duì)象沒(méi)有程序定義需定期對(duì)品質(zhì)體系進(jìn)行管理評(píng)審，體系運(yùn)作嚴(yán)重偏離文件定義。

Score2

?Supplierhassetupyearlyqualitymanagementreviewbutfailedtoidentifygapstothequalitysystemrequirementandcontinueimprovementrequirement,reviewisonthesurfaceofprocessonly.

審核對(duì)象雖定義了管理評(píng)審但沒(méi)有有效的在持續(xù)改善及品質(zhì)體系要求偏差分析上做有效的識(shí)別，管理評(píng)審只是停留在表面。

Score3

?Supplierabletofoundsomegapsbaseonperformance,however,managementisfailedtosupportresourceandfinancetothecontinueimprovementactivities.

審核對(duì)象基于績(jī)效有識(shí)別出一些偏差，然而，公司沒(méi)有提供資源去持續(xù)改善。

Score4

?Supplierrunningmanagementreviewinefficientway,gapswasidentifiedandmanagementhasashorttermplanandlongtermplantofixmajorbreakdown.

審核對(duì)象管理評(píng)審有效的在進(jìn)行，有短期長(zhǎng)期計(jì)劃去解決識(shí)別出來(lái)的那些主要偏差。

Score5

?Managementreviewhasproactiveapproach,notonlysolvetheproblembutalsohasplantofixpotentialissueandmanypreventionactionsisfoundinthemanagementreview.

有積極主動(dòng)的做管理評(píng)審，表現(xiàn)在不僅僅是為解決發(fā)現(xiàn)的問(wèn)題，同時(shí)也做了大量對(duì)潛在問(wèn)題的解決及采取了大量的預(yù)防措施。

?Qualitypolicy/objectivesreviewedincludedintomanagementreview,managementrepresentativepersonbepointed.

管理評(píng)審中有涵蓋品質(zhì)政策，目標(biāo)，有指定管理者代表。",,,4,

"AuditManagement

審核管理","

Score1

?Noevidenceshowssupplierhasainternalassessmentprogramexist.

供應(yīng)商沒(méi)有內(nèi)部審核程序

Score2

?Primaryinternalauditsarescheduledrandomly,andsomeauditfindingsareobserved,butmanyfindingsarenotdocumentedincloseloopactions,someauditorshasnotrainingrecordandcertificatewasnotfound

有隨機(jī)的初步的內(nèi)審計(jì)劃，內(nèi)審中有一些發(fā)現(xiàn)但是很多的發(fā)現(xiàn)沒(méi)有有效的改善對(duì)策，一些內(nèi)審員沒(méi)有經(jīng)過(guò)培訓(xùn)也沒(méi)有資格證書。

Score3

?Amasterschedulewassetuptocoverallareaofbusiness,allauditorsarefullytrainedandequipwiththeskillofaudit,allactionsareclosedwithpropercloseloopactions

有定義較完善的審核計(jì)劃涵蓋各各個(gè)部門，所有審核員都有經(jīng)過(guò)培訓(xùn)并證明有足夠的審核能力，所有改善對(duì)策有持續(xù)的追蹤直至結(jié)案。

Score4.

?Managementarereviewtheinternalauditfromtimetotime,auditfindingswereusedastoolstoimproveoverallbusiness,suppliernotonlyfixtheproblemsonthepointfortheproblemarefinding,butdrillwidetoothersimilararea

管理者有不定期的評(píng)審內(nèi)審結(jié)果，內(nèi)審結(jié)果作為一個(gè)工具用于持續(xù)改進(jìn)公司業(yè)績(jī)，公司不僅能對(duì)審核發(fā)現(xiàn)去針對(duì)性改善而且還能做到對(duì)類似區(qū)域改善舉一反三。

Score5

?Companyarefullyutilizedtheauditasatooltodrivingcompanyimprovementstrategically,auditfindingsareusingforcompanystrategicsystemimprovementactions.

公司能策略性的并完整的將內(nèi)審作為推動(dòng)公司績(jī)效改善的工具，內(nèi)審結(jié)果用來(lái)推動(dòng)公司策略系統(tǒng)改善。",,,4,

"Trainings

培訓(xùn)","

Score1

?Notrainingplanexistandlackofinternaltrainingandexternaltrainingwithinlastyear

在上一個(gè)年度中，沒(méi)有培訓(xùn)計(jì)劃并缺乏內(nèi)外部培訓(xùn)

Score2

?Occasionaltrainingswerehappened,butcompanyfailedtomanagementitasacompanylevelplan.Engineer/operatorhasavoiceoflackoftraining.Trainingbudgetplanalwaysreject

偶爾有培訓(xùn)，但是沒(méi)有在公司管理層面上做計(jì)劃，員工有提出缺乏培訓(xùn)，培訓(xùn)預(yù)算計(jì)劃經(jīng)常被否決。

Score3

?Acompletecompanytrainingplanisexistandwithcompanybudgetsupport,atleast70%trainingswerehostedbaseontrainingplan.

?Trainingrecordwasmaintainedforallleveloftraining

有公司層面的完整培訓(xùn)計(jì)劃并有預(yù)算支持，至少70%以上的培訓(xùn)計(jì)劃有沒(méi)執(zhí)行，培訓(xùn)記錄有被完整的保留。

Score4

?Suppliertrainingplanincludeonjobtraining,newhiretraining,SOPtraining,problemsolvingtraining,aswellasnecessarytrainingforeachfunction,forexample

培訓(xùn)計(jì)劃包括職位培訓(xùn)，入職培訓(xùn)，SOP培訓(xùn),問(wèn)題解決培訓(xùn)以及與部門相關(guān)的有必要的培訓(xùn)，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.

對(duì)醫(yī)療器械產(chǎn)品，應(yīng)對(duì)從業(yè)人員進(jìn)行特殊流程及行業(yè)標(biāo)準(zhǔn)，醫(yī)療器械品質(zhì)管理體系，法規(guī)等培訓(xùn)

?Trainingeffectivenessisreviewed,assessedforeachindividualcourse

培訓(xùn)效果有評(píng)審，并對(duì)每門課程都有單獨(dú)的評(píng)估。

Score5

?Supplierhasbestinclasstrainingprogram(foxexampleemployeeeducationassistantprogram,longtermcontractwithqualifiedexternalsourcetoprovidetrainingtoemployeetimely)

供應(yīng)商有完善的培訓(xùn)流程，例如員工輔助學(xué)歷教育，有與外部有資質(zhì)的培訓(xùn)機(jī)構(gòu)簽訂合同并定期的對(duì)員工進(jìn)行培訓(xùn)。",,,4,

"IncomingInspection

來(lái)料檢查","

Score1

?NodedicateIQCareasetupinsupplierfacilities沒(méi)有固定的來(lái)料檢查區(qū)域

?NoproperIQCdocument,operatorscheckbaseoncommonsenseandexperiencesonly沒(méi)有適當(dāng)?shù)腎QC文件，員工基于自己經(jīng)驗(yàn)及常識(shí)進(jìn)行來(lái)料檢驗(yàn)

?Nosufficienttoolsforoperatorconducttraininglikemeasurementinstrument(caliper,projector)沒(méi)有充足的工具用來(lái)培訓(xùn)員工例如卡尺投影儀等

?Nosampleplanwassetuptoeachcommodity沒(méi)有對(duì)產(chǎn)品檢驗(yàn)指定抽樣計(jì)劃

Score2

?ThereisIQCareaexistbutwasnotmanagementinaeffectivemanner,thereismixing/damageconcernwasfoundinthearea有IQC區(qū)域但沒(méi)有有效的管理，發(fā)現(xiàn)存在混料或者產(chǎn)品損傷的風(fēng)險(xiǎn)

?IQCdocumentisdrafted,butisnotsufficienttocovercriticaltofunctionrequirementandoperatorisnotfullyuseit有IQC文件但不足以涵蓋關(guān)鍵IQC功能而且員工沒(méi)有完全使用

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

一些設(shè)備有在IQC但基于抽樣計(jì)劃，這些設(shè)備產(chǎn)能可能存在瓶頸。

?Sampleplanexistformostofcomponent,butdefinethesamplingplanisdecidedbyengineer'ssensenotthroughaassessmenttoolslikeFMEA對(duì)多數(shù)產(chǎn)品有制定相應(yīng)的抽樣計(jì)劃，但抽樣計(jì)劃來(lái)自于工程師的意識(shí)，經(jīng)驗(yàn)而不是來(lái)自于一些評(píng)估的工具例如FMEA.

Score3

?WellmanagedIQCarea,5S,identification&labeling,visualmanagementisclearandthereislowriskofmixing,wrong,damageandescapinginspection區(qū)域有較好的管理包括5s,標(biāo)識(shí)，混料，損傷產(chǎn)品，漏檢等風(fēng)險(xiǎn)較低。

?IQCareaiscontrolledwithmoistureandtemperaturebaseonthepartspecification,lightingissufficient基于產(chǎn)品規(guī)格IQC區(qū)域有管控溫濕度，照度足夠

?IQCequipmentissufficienttotestallrequiredfunctionandwithsufficientcapacity有足夠的應(yīng)對(duì)產(chǎn)品功能檢驗(yàn)的設(shè)備并且產(chǎn)能足夠

?Samplingbaseoncustomerrequirement/historyperformance,aIQCreportwasrunningtomonitoringthesupplierincomingperformance,properactionwasagainstsupplierbaseonthedata(RTV,sorting,onsitechecking)抽樣計(jì)劃基于客戶要求或歷史表現(xiàn)，有IQC報(bào)告用來(lái)監(jiān)控供應(yīng)商來(lái)料表現(xiàn)，基于RTV,sorting等數(shù)據(jù)有對(duì)相應(yīng)的供應(yīng)商采取適當(dāng)?shù)膶?duì)策。

?IQCinspectionstandardcoversallpointsneedbecheck,whichoftenuseasatoolsforoperatortoassesstheincomingstatusandgivearightdecision檢驗(yàn)計(jì)劃涵蓋了所有的關(guān)注點(diǎn)，檢驗(yàn)員能用其為評(píng)估來(lái)料狀況并作出正確決定的工具。

?Formedicaldevice,ifnecessary,specialcontrollikesterilizationisinplaceaswellforincomingarea醫(yī)療器械，適當(dāng)時(shí)，IQC區(qū)域應(yīng)采用特殊管控，例如滅菌。

Score4

?IQCareausingcomputingsystemtoautomaticmanagethestatusofinspection,locationandstatus,firstinfirstoutprogramwasdesigntoIQCaswell有用到信息化系統(tǒng)來(lái)自動(dòng)管理檢驗(yàn)狀態(tài)，區(qū)域等，有FIFO

?IQCareawasequippedwithallnecessaryinstructionandaids,manyequipmentarehighendequipment,precisionandmaintanceisinverygoodcondition(CMM,VMMfordimension,LCRforeletronicsparts,toolmarkermicroscopeetc)有完善的檢具及設(shè)備并且保養(yǎng)得當(dāng)例如CMM,VMM,色差儀等

?IQChassetupgoldensampleandlimitedsample,thosesamplesarekeptingoodcondition,arefreshprogramismaintainingonthesamplestatus有建立標(biāo)準(zhǔn)及限度樣品庫(kù)并妥善維護(hù)，有對(duì)應(yīng)的維護(hù)及更新程序

?IQCinspectionstandardisverydetails,coverssamplingplan,equipment,process,protectiononthepart(ESD,moisture,damageetc)anddispositionplan,operatorisfullytrainedwithinspectionstandardwithrecord檢驗(yàn)標(biāo)準(zhǔn)非常詳細(xì)，涵蓋了抽樣計(jì)劃，設(shè)備，流程，工藝，保護(hù)（ESD,濕度等）處理計(jì)劃，檢驗(yàn)員有經(jīng)過(guò)完整的培訓(xùn)并有記錄

Score5

?IQCwaslayoutwithleanconcept(materialflow,informationflow,processflow),cyclytimeisstudiedandspacingandmaterialroutingiswelldesignedtoreducetheoverloadoftemporarystorageplaceinIQC

?Samplingplanwasselectbaseonthesystemway(FMEAfactorondetection/serverity/Occuracyetc,samplingsizepoweranalysisetc)

區(qū)域基于精益生產(chǎn)理念來(lái)規(guī)劃（物料流動(dòng)，信息流程，過(guò)程）有研究設(shè)計(jì)檢驗(yàn)時(shí)間，空間，物料流動(dòng)路線用來(lái)減少臨時(shí)存放區(qū)域過(guò)載的情況

基于系統(tǒng)思維來(lái)制定抽樣計(jì)劃例如基于FMEA中嚴(yán)重度，可偵測(cè)度，發(fā)生頻率等因素

",,,4,

"SupplierManagement

供應(yīng)商管理","

Score1

?Supplierdoesnothaveasuppliermanagementsystem,purchasingisbaseonquotationonly,noqualityratingofthesystembeforereleasePO沒(méi)有供應(yīng)商管理系統(tǒng)，采購(gòu)只是基于報(bào)價(jià)，下單前沒(méi)有對(duì)供方品質(zhì)體系評(píng)估

Score2

?Supplierhasbasicsupplierratingsystem,buttheratingsystemisverybasicandcouldnotcovertherequirmentthanISO9000有基本的供方評(píng)估系統(tǒng)但非常初級(jí)不能完整涵蓋ISO9000的要求

?Examplesfoundmajorsupplierhavenoevidencetogothroughthequalityassessmentbaseonsupplier'sratingsystembelowusethem發(fā)現(xiàn)有主要的供應(yīng)商沒(méi)有經(jīng)過(guò)評(píng)估過(guò)程

Score3

?Acomprehensiveaudittoolsfromorganizationcouldscientificallyratingthesupplier,supplierisselectstratelyandwithlongtermrelationship有綜合的審核工具用來(lái)系統(tǒng)化的評(píng)估供應(yīng)商，有策略性的選擇供應(yīng)商并保持長(zhǎng)期穩(wěn)定的關(guān)系

?SupplierhassetupmonthlyscoreCAPAdorequavelanttomonitoringthesub-tier'sperformanceandkeepactionplanbaseonsupplierchange有對(duì)供方采用類似月度評(píng)分的工具來(lái)監(jiān)督供應(yīng)商表現(xiàn)并采取相應(yīng)的對(duì)策

?SupplierCAPAisoftenusedtomanagesupplier,theleadtimeandnumberismonitoredascriticalinputfortheperformanceofsub-tier經(jīng)常用CAPA來(lái)管理供應(yīng)商，CAPA時(shí)效性作為一個(gè)關(guān)鍵指標(biāo)來(lái)評(píng)估供應(yīng)商表現(xiàn)

Score4

?SupplierhasNPIearlyinvolveplanwithstrategicsub-tiersupplier,qualitypreventionplanisjointdevelopedbetweensub-tier有策略性的在開發(fā)階段invlove供應(yīng)商并有品質(zhì)預(yù)防計(jì)劃

?Supplierhasasuppliercertificateprogram,goodperformancesupplierswereacknowledgedandrewarded有供應(yīng)商認(rèn)證流程，好的供應(yīng)商有得到認(rèn)可與獎(jiǎng)勵(lì)

?Supplierhasshiptodeckprogram,supplierismanagementbytheperformanceofincomingmaterial

Score5

?Supplierisdriveinglongtermimprovementwithsub-tierwithqualityimprovementtoollike6-sigmaandleanmanufacturing有用品質(zhì)改善工具用來(lái)長(zhǎng)期性的推動(dòng)供應(yīng)商改善

?Supplierhasinvolvethesub-tieraspartofproductqualityplan,criticalparameteriswellmanagemedallthetime有將供應(yīng)商納入產(chǎn)品品質(zhì)計(jì)劃的一部分，關(guān)鍵特性總是有很好的被管理

",,,3,

"WarehouseManagement

倉(cāng)庫(kù)管理","

Score1

?Nodedicatewarehousefromsupplier,materialisstockinanywherewithdisorder/mess.Operatorishardlytofoundamaterial沒(méi)有固定的倉(cāng)庫(kù)區(qū)域，材料堆積混亂，員工很難招到材料

Score2

?Dedicatewarehouseareaexist,separatetorawmaterialwarehouse,finishgoodwarehouse,WIPwarehouseatleast,materialstoredindedicatearea有固定的倉(cāng)庫(kù)分開存儲(chǔ)原料，成品，在制品等

?Apaperstoragematerialstoragelistisexistforassitoperatortoidentifythelocationofrawmaterial,riskofmix/missing/damageexist有紙檔記錄材料清單用來(lái)識(shí)別原料區(qū)域但存在混料，丟失，損壞等風(fēng)險(xiǎn)。

Score3

?Warehousehasdefinedclearidentificationprogram,materialistagedandmarkedclearly有清晰的標(biāo)識(shí)流程，材料有清晰的被標(biāo)識(shí)

?DedicatedRMAwarehouseissetupandpreventitmixwithgoodmaterial有固定的RMA倉(cāng)用來(lái)避免混入良品中

?Warehouseenvironmentiswellmanagedbaseonthematerialrequirement,environmentwasmonitoredandincaseofoutofcontrol,aimmediateactionistriggered基于材料特性要求有很好的管控倉(cāng)庫(kù)環(huán)境，一旦超出管控，相應(yīng)對(duì)策能馬上實(shí)施。

Score4

?ComputersystemusetomanagethewarehouseusingMRPsystemlikeoracle,SAPetc,materialstatusisclearandtransparentthroughoutthewholefactory有采用MRP,SAP等IT系統(tǒng)來(lái)管理倉(cāng)庫(kù)，物料狀態(tài)流向清晰。

?Firstinfirstoutiswellmanaged.NomajorFIFOrisk有FIFO管理且沒(méi)有發(fā)現(xiàn)主要FIFO風(fēng)險(xiǎn)

?Allmaterialclosetoshelllifehaswarningsignaltomaterialplanningteam,aftertheshelflifeexpired,properactionismanagedbythefactory(scrap,rework,returnetc)有管理材料壽命，一旦接近保存壽命，有相應(yīng)的處置動(dòng)作例如報(bào)廢，退貨，返工等。

?Materialiswellkeptedbaseonmaterialspecification(ESDsensitive,Rohs,moisutresensitive,dustetc).noviolationisfoundwhichcausetherisktodegradingthequalityofthestoragedmaterial基于材料規(guī)格來(lái)保管物料，沒(méi)有發(fā)現(xiàn)違規(guī)而導(dǎo)致影響材料品質(zhì)的案例。

?Warehousespaceissufficientandwithnotoverloaded,10%bufferissetup倉(cāng)庫(kù)區(qū)域足夠，沒(méi)有爆倉(cāng)，有至少10%的緩沖空間

?Insectcontrolprocessavailable,fumigationschedulearestrictlyfollowed有防蟲計(jì)劃，嚴(yán)格執(zhí)行了煙熏除蟲計(jì)劃

Score5

?Warehouselayoutisclassifiedbaseontheleanstudy,whichreducetheinventorylevelandreducetheunecessarymovement倉(cāng)庫(kù)規(guī)劃基于精益生產(chǎn)思維，減少了庫(kù)存量及不必要的搬動(dòng)

?Automaticwarehousesystemisapplied,inoutismanagedbyautomaticequipment有自動(dòng)倉(cāng)庫(kù)存儲(chǔ)系統(tǒng)且進(jìn)出實(shí)現(xiàn)了自動(dòng)化

",,,4,

"MaterialTraceability/Processtraceablity

可追溯性","

Score1

?Notraceabilityprogramtomanagementtheincomingmaterial/tooling/operator/processchange沒(méi)有追溯程序來(lái)管理來(lái)料，模具，制程變更等。

Score2

?Manualtraceabilityprogramisexist,lotnumber/datecodeisrecordinanyreleaseofmaterial,whichcouldlinktoamanufacturingdateorworkorder有手工追溯系統(tǒng)，批次號(hào)，日期號(hào)等信息能鏈接到生產(chǎn)日期，工單。

Score3

?Acomputeraidsystemlikeshopfloorsystemisavailabletorecordthematerialusagehistoryandprocesshistory,traceabilityprogramcantrackbackonmanufacturingdateorworkorderlevel有shopfloor等信息系統(tǒng)用來(lái)記錄材料及制程歷史，能用其追溯回生產(chǎn)日期或工單等信息。

Score4

?Serialnumberisappliedtoallshipoutproduct,eachserialnumberisdirectlylinkwithmateriallothistoryinadigitalsystem,thecomputersystemiseasytosearchingarecordinaquickmanner每個(gè)出貨產(chǎn)品都有序列號(hào)，通過(guò)信息化系統(tǒng)每個(gè)序列號(hào)都能直接帶出材料批次信息，電腦信息化系統(tǒng)能輕易的查詢類似信息。

Score5

?Supplierisproactivelydrivetraceabilityimprovementinsub-tier.有主動(dòng)的推動(dòng)下階供應(yīng)商改善可追溯性

?Customer/supplierisabletochecktraceabilityhistorydirectlyonlinetoviewthestatus客戶或者供應(yīng)商能通過(guò)網(wǎng)絡(luò)直接查詢追溯

系統(tǒng)",,,3,

"Non-Conformingmaterialmanagement

不合格品管控","

Score1

?Supplierdoesnothaveasystemtomanagethenon-conformingmaterial,highriskofnon-conformingmaterialwillmixwithgoodunits沒(méi)有系統(tǒng)管理不合格品，混料可能性極高

Score2

?Abaiscsystemisexisttomanagethenon-conformingmaterial,violationisfoundnon-conformingarefoundcloseandwithinconformingmaterials有基本的不合格品管控，有發(fā)現(xiàn)不合格品混入或者接近良品

?SupplierRMAreviewisnotsufficient,storageofRMApartismorethanexpectedcycletime.RMAareaisoverloadedRMA沒(méi)有足夠評(píng)審處理，超出周轉(zhuǎn)時(shí)間，RMA倉(cāng)爆倉(cāng)。

Score3

?Non-conformingdispositionsysteminplaceandcycletimeissufficientandwellmanaged,andthosematerialispurgedontime不合格品處理系統(tǒng)有實(shí)施并很好的管控周轉(zhuǎn)時(shí)間，不合格品有被及時(shí)處理

?RMAareaiswelldesigned,noriskofmixing/missingduringmaterialmovementandhandlingRMA區(qū)域有很好的設(shè)計(jì)，沒(méi)有在搬運(yùn)過(guò)程中混料，丟失的風(fēng)險(xiǎn)

?Non-conformingfunctionisdesigntheallrequiredarea(IQC,production,warehouse)supportwithcleartagandidentification.Supportbinsaresufficient,nomistakeusefoundinthewholefacility所有相關(guān)區(qū)域從IQC,產(chǎn)線到倉(cāng)庫(kù)，都有導(dǎo)入不合格品控制，有清晰的標(biāo)識(shí)，存儲(chǔ)盒數(shù)量足夠，整個(gè)工廠沒(méi)有發(fā)現(xiàn)違規(guī)案例。

?Abasicvisualmanagementisutilizedinthearea,likecolor/routingarrow/heightlimitationlabel有基本的目視管理系統(tǒng)，例如顏色管理，物流方向指示，高度限制標(biāo)簽等

Score4

?Non-conformingismanagedbyMRPsystem,systemisveryeasytolocatedthenon-conformingmaterialMRP系統(tǒng)來(lái)管理不合格品，用該系統(tǒng)非常容易能定位到不合格品。

?Verygoodfactoryvisualmanagementsystemisapplied,RMAisclearlyisolated非常好的目視管理系統(tǒng)，RMA被清楚的隔離

Score5

?Supplierisusenon-conformingrealtimedatathroughSPCmethology,dataareusingtodrivesupplieractions通過(guò)SPC方法來(lái)報(bào)告實(shí)時(shí)不合格品數(shù)據(jù)，并將數(shù)據(jù)用來(lái)推動(dòng)供應(yīng)商改善

?RMAreduceprogramrunningthroughcontinueimprovementprogramhasachievesignificantresultwithinlastyear在上一個(gè)年度中，作為持續(xù)改善項(xiàng)目之一，減少RMA目標(biāo)有明顯的達(dá)成。

",,,3,

"QualityPlan

品質(zhì)計(jì)劃","

Score1

?NoqualityplanduringNPIandnoqualityplanrevisedinmassproductionduringprocesssetup新產(chǎn)品開發(fā)過(guò)程中沒(méi)有品質(zhì)計(jì)劃，在量測(cè)制程建立過(guò)程中沒(méi)有修正品質(zhì)計(jì)劃

Score2

?SupplierhassetupqualitycheckpointanddocumentthemajorpointinSOPbutnotinasystemway有在SOP中定義關(guān)鍵性的品質(zhì)管控點(diǎn)但不系統(tǒng)

?ThereisviolationinsystemarenotfollowthoseSOP有發(fā)現(xiàn)違反SOP的案例

Score3

?Supplierhassetupproductmanagementplanformajorproduct,andSOPvsPMPissychronizeallthetime,majorqualityissuewillupdatethecontrolpointandsamplingplanbaseonexperiences.有對(duì)主要產(chǎn)品建立管控計(jì)劃，SOPPMP有同步，基于經(jīng)驗(yàn)在異常發(fā)生后有相應(yīng)的修改管控計(jì)劃及抽樣計(jì)劃

?Controlplanwasdevelopedwithcrossfunctionalteam,anduseitinrealproductionandasabasicdocumenttocommunicatetheprocessimprovementduringallCIPprocess跨部門合作開發(fā)控制計(jì)劃并用其在生產(chǎn)過(guò)程中及作為持續(xù)改善項(xiàng)目中一個(gè)基本文件。

Score4

?PMPorcontrolplanisreviseallthetimethroughapredictionanalysislikeFMEA/FMCA/PHAetc,highriskfailuremode(RPN>80etc)isunderspecialcontrol通過(guò)FMEA等預(yù)防性的工具，PMP或者控制計(jì)劃有實(shí)時(shí)更新，高風(fēng)險(xiǎn)項(xiàng)目有列入特別管控

?Suppliernotonlycontroltheprocessoutput,andalsocriticaltofunctioninputparameterinthePMP不僅有管控制程輸出，PMP中還管控了關(guān)鍵功能輸入?yún)?shù)

?SPCiswidelyusedinthecontrolplantodefinesomeinput/outputparameterunderstandstatisticcontrol,reactionplanisdektostoplineprocessandescalationprocessSPC被廣泛的用在管控計(jì)劃中，措施計(jì)劃鏈接到停線，向上報(bào)告流程中

Score5

?SomecontrolplanwasdevelopedthroughDOEapproach,asurfaceresponsestudy,factordesign,Taguchistudyisfoundthemostimportantcontrolparameterandwhatisbestprocesswindow一些管控計(jì)劃是基于DOE方法，因子設(shè)計(jì)，田口方法被用于最重要的參數(shù)管控

?Controlplanwasnotonlymanagethequalityrequirementbutalsocontroltheleadtimeandinventoryleveltoreducewaste管控計(jì)劃不僅用于品質(zhì)管控而且被用在效率提升，庫(kù)存周轉(zhuǎn)減少浪費(fèi)上。

?APQPprocessisusedtodefinetheprocessdesignandprocessmanagement制程設(shè)計(jì)及管理有采用APQP流程

",,,4,

"ProcessCapability&StatisticControl

統(tǒng)計(jì)過(guò)程控制","

Score1

?Supplierhasnoideatheprocesscapability,theyarenotunderstandthequalitysigmaleveloftheirproductandprocess對(duì)過(guò)程能力沒(méi)有概念，不知道他們產(chǎn)品或制程的6sigma水平

Score2

?SupplierRandomlychecktheprocesscapability,severalcriticalinputandoutputparameterwasverifythecpk,distributionoccasionalpercustomerrequireandqualityissueraisedduringNPIandwhenissuehappened

有隨機(jī)的檢查制程能力，在客戶要求或者項(xiàng)目開發(fā)時(shí)出過(guò)品質(zhì)異常時(shí)曾經(jīng)對(duì)一些許關(guān)鍵輸入輸出做過(guò)CPK,分布圖分析

Score3

?SupplierhasincludethecriticalparameterintotheirSPCplan,x-Rbarchart,controllimtedchart,I-MRchartetcisusedtomonitoringthosekeyparameters.CPKlevelanddistributionisverifiedfromtimetotimeforthosekeyparameter.有將關(guān)鍵參數(shù)納入SPC計(jì)劃,X-R圖，控制圖,I-MR圖等，有不時(shí)的確認(rèn)CPK等級(jí)

?Supplieruseattributecontrolcharttomanagetheattributedata(p-chart,U-chart,C-chartetc)有用到p-chart,U-chart,C-chart等記數(shù)型管控圖

Score4

?SupplierhassomeCIPprogramtoimprovetheprocesscapability,significantsavingandimprovewasseeinlastyear;sactivities過(guò)去一年中有在持續(xù)改善項(xiàng)目總有明顯的提升制程能力

Score5

?Supplierisfullyutilizethesix-sigmatoresolvethemajorcapabilitylowperformancearea,3ormore6-sigmaprojectwascompleteforimprovetheoverallsituation有完全用6-sigma方法解決主要低制程能力區(qū)域，3個(gè)sigma以上項(xiàng)目改善經(jīng)驗(yàn)。

",,,3,

"NPI

新產(chǎn)品開發(fā)","

Score1

?Noprocedureexistsfornewproduct/technology/servicelaunches.沒(méi)有程序定義新產(chǎn)品/技術(shù)/服務(wù)開發(fā)管理

Score2

?Newproductlaunchproceduresexist,butdocumentationisincompleteandcomplianceisinconsistent.有新產(chǎn)品開發(fā)流程但文件記錄及符合性不一致

?Newproductlaunchproceduresarebeingfollowedbysomemajorareasofthebusiness.However,someofthesepolicieslacktherequirementsforappropriateapprovalsanddefiningqualityobjectives.在一些主要功能區(qū)域符合新產(chǎn)品開發(fā)流程但缺乏適當(dāng)?shù)钠焚|(zhì)目標(biāo)與審批。

Score3

?Newproductlaunchflowchartandprocedureiswelldocumentedandthepoliciesrequireclearandcompleteprojectplansdocumentedwithappropriatequalityobjectivesandresponsibilitiesforimplementation.新產(chǎn)品開發(fā)流程有很好的被記錄，有完整的品質(zhì)目標(biāo)及職責(zé)定義在完整的項(xiàng)目計(jì)劃中

?Thereareafewexamplesofwellplannedandsuccessfulnewproduct/technology/servicedevelopmentprojects.Qualityobjectivesandresponsibilityforimplementationaredefined.有幾個(gè)很好的案例

?ThequalificationdatapercustomerspecificationandFirstArticleinspectiondataarecollectedandAppropriatemanagementapprovalsarebuiltintotheprocess(includecustomerapproval,ifrequired).審批過(guò)程中有體現(xiàn)很好的基于客戶規(guī)格的qualification的數(shù)據(jù)及首件記錄。

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,assembly,repair,environment,safetyetc)fortheirowndesigneditemorequivalentforallnewproduc