PCH供應商質量社會責任環(huán)境健康與安全有害物質商業(yè)合作伙伴貿易安全Checklist清單+自評范本OK

"SupplierQualificationSurvey-SupplierQualitySystemAssessmentChecklist

供應商資格調查-品質體系",,,,,

,,,,,,

,,Itemswithredfontshouldbestrictlyreviewedformedicaldevicetypeofproduct（紅色字體部分為醫(yī)療器械產品相關條款需嚴格對照）,,,

QualitySystem品質體系,,,,,

CheckList審核項目,PCHRatingDefined評分標準定義,,Auditfindingordiscrepancies審核發(fā)現或差異項,Rating評分,Attachment附件

"QualitySystemandCertifications

品質體系及認證","

Score1

?Doesnothaveanycertifiedqualitysystemanddoesnothavethebasicfundamentalqualityprocedureandsysteminplace.Noindicationorcommitmentoffutureimprovementtoobtaincertification.

沒有任何認證的品質管理管理體系，沒有最基本的品質系統，流程等，沒有任何未來通過改善來獲取認證的承諾或跡象。

Score2

?Doesnothavethecertifiedqualitysystembuthavebasicandfundamentalqualityprocedureinplace.WillingtoimproveimmediatelytomeetPCH'sminimumrequirementandhasplantoobtaincertification.

沒有認證的品質管理體系但有最基本的品質管理流程，有意愿立即改善來達到PCH最低要求以及有獲取體系認證的計劃。

Score3

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

有ISO9000系列體系認證，然而，品質目標沒有恰當及清晰的定義，系統只是為認證而建立，缺乏內審及管理評審，從上一次的體系審核結果來看，該審核對象運作已經明顯偏離文件的定義，最基本的運作過程中發(fā)現有嚴重不符合項并會導致對PCH的潛在品質危機。

Score4

?ISO9000familycertifiedqualitysystem.Qualityobjectives/metricsareappropriatelyidentifiedanddefined.Practicewassticktooriginalqualitysystemalthoughminorissuecanbedetected

有ISO9000系列體系認證,品質目標有恰當的識別與定義，日常運作有符合品質體系要求盡管還能發(fā)現一些輕微不符合項。

?FactoryabletoabtaintheISO13485certifiedqualitysystemformedicaldeviceproduct.

工廠有能力或已經獲得ISO13485醫(yī)療器械品質管理體系

Score5

?OtherthanISO9000familycertifiedqualitysystem,theyalsoobtaincertificationstootherstandardsorindustrialrequirement.

除ISO9000系列認證外，審核對象同時獲得了其他認證。

?Anextensiveandeffectivesystemexisttolinkcustomersneedswithcontinuousimprovedmeasurement.

具備廣泛及有效的系統并能夠持續(xù)改善滿足客戶需求。

?Formedicaldeviceproduct,factoryalreadyFDAregistedandfollowCFRpart820QSRrequirement.

對醫(yī)療器械產品，工廠已經有FDA注冊并按照CFRpart820QSR體系執(zhí)行。",,,4,

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

Score1

?Thereisnotanyprocedureorcontrolplantodefinetheinterstiedpartiesinthiscompany

公司沒有定義相關方這個定義。

Score2

?thereisproceduredefinedbutthereisnotanymanagementplantomeetinterestingparties'requirement.。

公司有相關方的定義，但是沒有任何管理措施去滿足相關方的要求

Score3

?Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirement

公司有相關方的定義，并且有相關的管理措施滿足相關方的要求

Score4

?Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirementandexpection

公司有相關方的定義，并且有相關的管理措施滿足相關方的要求和期望

Score5

?Thereisprocduredefinedandthereismanagementplantomeetinterestingparties'requirementandexpection,rewiewinterestingparties'srequirementandexpectionperiodicallyandadjustitscontrolledplan

公司有相關方的定義，并且有相關的管理措施滿足相關方的要求和期望。并且定期評估，調整管理措施

。",,,4,

風險管理rikassessment,"

Score1

?Thereisnotanyprocedureorcontrolplantoforriskassessmentithiscompany

公司沒有定義風險管理這個定義。

Score2

riskhavebeenidetified。butthereisnotanyconrtrolmanagementplanaddressedtotherisk.

公司有風險管理定義，但沒有任何措施去控制風險

Score3

riskhavebeenidetified,thereisconrtrolmanagementplanaddressedtotherisk.

公司有風險管理的定義，并且有措施控制風險

Score4

riskhavebeenidetifiedtotally。hereisconrtrolmanagementplanaddressedtotherisk.defineditsKPIandtrackingitseffectiveness

公司有風險管理定義，識別很完整，并且有措施和KPI控制，及時確認有效性

Score5riskhavebeenidetifiedtotally。hereisconrtrolmanagementplanaddressedtotherisk.defineditsKPIandtrackingitseffectiveness,rewiewitsassementperiodicallyandindicateinthemanagementreview

公司有風險管理的定義，風險識別的很完整，并且有措施和KPI控制，及時確認有效性，定期評審，并體現在管審里面

。",,,4,

"CompanyKPImanagement

公司績效管理","

Score1

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

審核對象沒有設立績效包括客戶反饋，供應商表現，制程品質及其他運作過程中的KPI,沒人清楚公司運作表現，審核對象甚至不了解什么是KPI.

Score2

?Supplierhaspartialofqualitydatacollected,butlackofhighlevelsummarytobemanagedbyseniormanagementteam,seniormanagementhaslimitedunderstandhowthequalityperformanceofthecompany,duringaudit,managementrepresentativeisunabletounderstandthecurrentperformanceandseekhelpfromvariousteam.

審核對象有收集部分的品質數據但管理團隊缺乏系統化的匯總，管理團隊對公司運作表現了解有限+B10:C11，在審核過程中，管理者代表不清楚公司運作狀況只能求助于其他團隊。

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審，大家清楚從品質，交期，服務等層面公司績效表現。

Score4

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

對DPMU,LRR,OTD,周轉率等方面有程序定義來改善KPI,管理團隊有對項目及對策進行管理。

Score5.

?ThecompanyareuseBIC(bestinclass)programtomanagementcompanyKPIlikeutilizethesixsigmaapproach,leanprocess,etc.

公司有用BIC程序來管理公司KPI例如推行6Sigma,精益生產等。",,,3,

"ManagementReview

管理評審","

Score1

?Supplierdoesnotsetupaprogramfortimelymanagementreviewonthequalitysystemandperformance,systemisfardeviatefromdocumentation.

審核對象沒有程序定義需定期對品質體系進行管理評審，體系運作嚴重偏離文件定義。

Score2

?Supplierhassetupyearlyqualitymanagementreviewbutfailedtoidentifygapstothequalitysystemrequirementandcontinueimprovementrequirement,reviewisonthesurfaceofprocessonly.

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

Score3

?Supplierabletofoundsomegapsbaseonperformance,however,managementisfailedtosupportresourceandfinancetothecontinueimprovementactivities.

審核對象基于績效有識別出一些偏差，然而，公司沒有提供資源去持續(xù)改善。

Score4

?Supplierrunningmanagementreviewinefficientway,gapswasidentifiedandmanagementhasashorttermplanandlongtermplantofixmajorbreakdown.

審核對象管理評審有效的在進行，有短期長期計劃去解決識別出來的那些主要偏差。

Score5

?Managementreviewhasproactiveapproach,notonlysolvetheproblembutalsohasplantofixpotentialissueandmanypreventionactionsisfoundinthemanagementreview.

有積極主動的做管理評審，表現在不僅僅是為解決發(fā)現的問題，同時也做了大量對潛在問題的解決及采取了大量的預防措施。

?Qualitypolicy/objectivesreviewedincludedintomanagementreview,managementrepresentativepersonbepointed.

管理評審中有涵蓋品質政策，目標，有指定管理者代表。",,,4,

"AuditManagement

審核管理","

Score1

?Noevidenceshowssupplierhasainternalassessmentprogramexist.

供應商沒有內部審核程序

Score2

?Primaryinternalauditsarescheduledrandomly,andsomeauditfindingsareobserved,butmanyfindingsarenotdocumentedincloseloopactions,someauditorshasnotrainingrecordandcertificatewasnotfound

有隨機的初步的內審計劃，內審中有一些發(fā)現但是很多的發(fā)現沒有有效的改善對策，一些內審員沒有經過培訓也沒有資格證書。

Score3

?Amasterschedulewassetuptocoverallareaofbusiness,allauditorsarefullytrainedandequipwiththeskillofaudit,allactionsareclosedwithpropercloseloopactions

有定義較完善的審核計劃涵蓋各各個部門，所有審核員都有經過培訓并證明有足夠的審核能力，所有改善對策有持續(xù)的追蹤直至結案。

Score4.

?Managementarereviewtheinternalauditfromtimetotime,auditfindingswereusedastoolstoimproveoverallbusiness,suppliernotonlyfixtheproblemsonthepointfortheproblemarefinding,butdrillwidetoothersimilararea

管理者有不定期的評審內審結果，內審結果作為一個工具用于持續(xù)改進公司業(yè)績，公司不僅能對審核發(fā)現去針對性改善而且還能做到對類似區(qū)域改善舉一反三。

Score5

?Companyarefullyutilizedtheauditasatooltodrivingcompanyimprovementstrategically,auditfindingsareusingforcompanystrategicsystemimprovementactions.

公司能策略性的并完整的將內審作為推動公司績效改善的工具，內審結果用來推動公司策略系統改善。",,,4,

"Trainings

培訓","

Score1

?Notrainingplanexistandlackofinternaltrainingandexternaltrainingwithinlastyear

在上一個年度中，沒有培訓計劃并缺乏內外部培訓

Score2

?Occasionaltrainingswerehappened,butcompanyfailedtomanagementitasacompanylevelplan.Engineer/operatorhasavoiceoflackoftraining.Trainingbudgetplanalwaysreject

偶爾有培訓，但是沒有在公司管理層面上做計劃，員工有提出缺乏培訓，培訓預算計劃經常被否決。

Score3

?Acompletecompanytrainingplanisexistandwithcompanybudgetsupport,atleast70%trainingswerehostedbaseontrainingplan.

?Trainingrecordwasmaintainedforallleveloftraining

有公司層面的完整培訓計劃并有預算支持，至少70%以上的培訓計劃有沒執(zhí)行，培訓記錄有被完整的保留。

Score4

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

培訓計劃包括職位培訓，入職培訓，SOP培訓,問題解決培訓以及與部門相關的有必要的培訓，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.

對醫(yī)療器械產品，應對從業(yè)人員進行特殊流程及行業(yè)標準，醫(yī)療器械品質管理體系，法規(guī)等培訓

?Trainingeffectivenessisreviewed,assessedforeachindividualcourse

培訓效果有評審，并對每門課程都有單獨的評估。

Score5

?Supplierhasbestinclasstrainingprogram(foxexampleemployeeeducationassistantprogram,longtermcontractwithqualifiedexternalsourcetoprovidetrainingtoemployeetimely)

供應商有完善的培訓流程，例如員工輔助學歷教育，有與外部有資質的培訓機構簽訂合同并定期的對員工進行培訓。",,,4,

"IncomingInspection

來料檢查","

Score1

?NodedicateIQCareasetupinsupplierfacilities沒有固定的來料檢查區(qū)域

?NoproperIQCdocument,operatorscheckbaseoncommonsenseandexperiencesonly沒有適當的IQC文件，員工基于自己經驗及常識進行來料檢驗

?Nosufficienttoolsforoperatorconducttraininglikemeasurementinstrument(caliper,projector)沒有充足的工具用來培訓員工例如卡尺投影儀等

?Nosampleplanwassetuptoeachcommodity沒有對產品檢驗指定抽樣計劃

Score2

?ThereisIQCareaexistbutwasnotmanagementinaeffectivemanner,thereismixing/damageconcernwasfoundinthearea有IQC區(qū)域但沒有有效的管理，發(fā)現存在混料或者產品損傷的風險

?IQCdocumentisdrafted,butisnotsufficienttocovercriticaltofunctionrequirementandoperatorisnotfullyuseit有IQC文件但不足以涵蓋關鍵IQC功能而且員工沒有完全使用

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

一些設備有在IQC但基于抽樣計劃，這些設備產能可能存在瓶頸。

?Sampleplanexistformostofcomponent,butdefinethesamplingplanisdecidedbyengineer'ssensenotthroughaassessmenttoolslikeFMEA對多數產品有制定相應的抽樣計劃，但抽樣計劃來自于工程師的意識，經驗而不是來自于一些評估的工具例如FMEA.

Score3

?WellmanagedIQCarea,5S,identification&labeling,visualmanagementisclearandthereislowriskofmixing,wrong,damageandescapinginspection區(qū)域有較好的管理包括5s,標識，混料，損傷產品，漏檢等風險較低。

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

?IQCequipmentissufficienttotestallrequiredfunctionandwithsufficientcapacity有足夠的應對產品功能檢驗的設備并且產能足夠

?Samplingbaseoncustomerrequirement/historyperformance,aIQCreportwasrunningtomonitoringthesupplierincomingperformance,properactionwasagainstsupplierbaseonthedata(RTV,sorting,onsitechecking)抽樣計劃基于客戶要求或歷史表現，有IQC報告用來監(jiān)控供應商來料表現，基于RTV,sorting等數據有對相應的供應商采取適當的對策。

?IQCinspectionstandardcoversallpointsneedbecheck,whichoftenuseasatoolsforoperatortoassesstheincomingstatusandgivearightdecision檢驗計劃涵蓋了所有的關注點，檢驗員能用其為評估來料狀況并作出正確決定的工具。

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

Score4

?IQCareausingcomputingsystemtoautomaticmanagethestatusofinspection,locationandstatus,firstinfirstoutprogramwasdesigntoIQCaswell有用到信息化系統來自動管理檢驗狀態(tài)，區(qū)域等，有FIFO

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

?IQChassetupgoldensampleandlimitedsample,thosesamplesarekeptingoodcondition,arefreshprogramismaintainingonthesamplestatus有建立標準及限度樣品庫并妥善維護，有對應的維護及更新程序

?IQCinspectionstandardisverydetails,coverssamplingplan,equipment,process,protectiononthepart(ESD,moisture,damageetc)anddispositionplan,operatorisfullytrainedwithinspectionstandardwithrecord檢驗標準非常詳細，涵蓋了抽樣計劃，設備，流程，工藝，保護（ESD,濕度等）處理計劃，檢驗員有經過完整的培訓并有記錄

Score5

?IQCwaslayoutwithleanconcept(materialflow,informationflow,processflow),cyclytimeisstudiedandspacingandmaterialroutingiswelldesignedtoreducetheoverloadoftemporarystorageplaceinIQC

?Samplingplanwasselectbaseonthesystemway(FMEAfactorondetection/serverity/Occuracyetc,samplingsizepoweranalysisetc)

區(qū)域基于精益生產理念來規(guī)劃（物料流動，信息流程，過程）有研究設計檢驗時間，空間，物料流動路線用來減少臨時存放區(qū)域過載的情況

基于系統思維來制定抽樣計劃例如基于FMEA中嚴重度，可偵測度，發(fā)生頻率等因素

",,,4,

"SupplierManagement

供應商管理","

Score1

?Supplierdoesnothaveasuppliermanagementsystem,purchasingisbaseonquotationonly,noqualityratingofthesystembeforereleasePO沒有供應商管理系統，采購只是基于報價，下單前沒有對供方品質體系評估

Score2

?Supplierhasbasicsupplierratingsystem,buttheratingsystemisverybasicandcouldnotcovertherequirmentthanISO9000有基本的供方評估系統但非常初級不能完整涵蓋ISO9000的要求

?Examplesfoundmajorsupplierhavenoevidencetogothroughthequalityassessmentbaseonsupplier'sratingsystembelowusethem發(fā)現有主要的供應商沒有經過評估過程

Score3

?Acomprehensiveaudittoolsfromorganizationcouldscientificallyratingthesupplier,supplierisselectstratelyandwithlongtermrelationship有綜合的審核工具用來系統化的評估供應商，有策略性的選擇供應商并保持長期穩(wěn)定的關系

?SupplierhassetupmonthlyscoreCAPAdorequavelanttomonitoringthesub-tier'sperformanceandkeepactionplanbaseonsupplierchange有對供方采用類似月度評分的工具來監(jiān)督供應商表現并采取相應的對策

?SupplierCAPAisoftenusedtomanagesupplier,theleadtimeandnumberismonitoredascriticalinputfortheperformanceofsub-tier經常用CAPA來管理供應商，CAPA時效性作為一個關鍵指標來評估供應商表現

Score4

?SupplierhasNPIearlyinvolveplanwithstrategicsub-tiersupplier,qualitypreventionplanisjointdevelopedbetweensub-tier有策略性的在開發(fā)階段invlove供應商并有品質預防計劃

?Supplierhasasuppliercertificateprogram,goodperformancesupplierswereacknowledgedandrewarded有供應商認證流程，好的供應商有得到認可與獎勵

?Supplierhasshiptodeckprogram,supplierismanagementbytheperformanceofincomingmaterial

Score5

?Supplierisdriveinglongtermimprovementwithsub-tierwithqualityimprovementtoollike6-sigmaandleanmanufacturing有用品質改善工具用來長期性的推動供應商改善

?Supplierhasinvolvethesub-tieraspartofproductqualityplan,criticalparameteriswellmanagemedallthetime有將供應商納入產品品質計劃的一部分，關鍵特性總是有很好的被管理

",,,3,

"WarehouseManagement

倉庫管理","

Score1

?Nodedicatewarehousefromsupplier,materialisstockinanywherewithdisorder/mess.Operatorishardlytofoundamaterial沒有固定的倉庫區(qū)域，材料堆積混亂，員工很難招到材料

Score2

?Dedicatewarehouseareaexist,separatetorawmaterialwarehouse,finishgoodwarehouse,WIPwarehouseatleast,materialstoredindedicatearea有固定的倉庫分開存儲原料，成品，在制品等

?Apaperstoragematerialstoragelistisexistforassitoperatortoidentifythelocationofrawmaterial,riskofmix/missing/damageexist有紙檔記錄材料清單用來識別原料區(qū)域但存在混料，丟失，損壞等風險。

Score3

?Warehousehasdefinedclearidentificationprogram,materialistagedandmarkedclearly有清晰的標識流程，材料有清晰的被標識

?DedicatedRMAwarehouseissetupandpreventitmixwithgoodmaterial有固定的RMA倉用來避免混入良品中

?Warehouseenvironmentiswellmanagedbaseonthematerialrequirement,environmentwasmonitoredandincaseofoutofcontrol,aimmediateactionistriggered基于材料特性要求有很好的管控倉庫環(huán)境，一旦超出管控，相應對策能馬上實施。

Score4

?ComputersystemusetomanagethewarehouseusingMRPsystemlikeoracle,SAPetc,materialstatusisclearandtransparentthroughoutthewholefactory有采用MRP,SAP等IT系統來管理倉庫，物料狀態(tài)流向清晰。

?Firstinfirstoutiswellmanaged.NomajorFIFOrisk有FIFO管理且沒有發(fā)現主要FIFO風險

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

?Materialiswellkeptedbaseonmaterialspecification(ESDsensitive,Rohs,moisutresensitive,dustetc).noviolationisfoundwhichcausetherisktodegradingthequalityofthestoragedmaterial基于材料規(guī)格來保管物料，沒有發(fā)現違規(guī)而導致影響材料品質的案例。

?Warehousespaceissufficientandwithnotoverloaded,10%bufferissetup倉庫區(qū)域足夠，沒有爆倉，有至少10%的緩沖空間

?Insectcontrolprocessavailable,fumigationschedulearestrictlyfollowed有防蟲計劃，嚴格執(zhí)行了煙熏除蟲計劃

Score5

?Warehouselayoutisclassifiedbaseontheleanstudy,whichreducetheinventorylevelandreducetheunecessarymovement倉庫規(guī)劃基于精益生產思維，減少了庫存量及不必要的搬動

?Automaticwarehousesystemisapplied,inoutismanagedbyautomaticequipment有自動倉庫存儲系統且進出實現了自動化

",,,4,

"MaterialTraceability/Processtraceablity

可追溯性","

Score1

?Notraceabilityprogramtomanagementtheincomingmaterial/tooling/operator/processchange沒有追溯程序來管理來料，模具，制程變更等。

Score2

?Manualtraceabilityprogramisexist,lotnumber/datecodeisrecordinanyreleaseofmaterial,whichcouldlinktoamanufacturingdateorworkorder有手工追溯系統，批次號，日期號等信息能鏈接到生產日期，工單。

Score3

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

Score4

?Serialnumberisappliedtoallshipoutproduct,eachserialnumberisdirectlylinkwithmateriallothistoryinadigitalsystem,thecomputersystemiseasytosearchingarecordinaquickmanner每個出貨產品都有序列號，通過信息化系統每個序列號都能直接帶出材料批次信息，電腦信息化系統能輕易的查詢類似信息。

Score5

?Supplierisproactivelydrivetraceabilityimprovementinsub-tier.有主動的推動下階供應商改善可追溯性

?Customer/supplierisabletochecktraceabilityhistorydirectlyonlinetoviewthestatus客戶或者供應商能通過網絡直接查詢追溯

系統",,,3,

"Non-Conformingmaterialmanagement

不合格品管控","

Score1

?Supplierdoesnothaveasystemtomanagethenon-conformingmaterial,highriskofnon-conformingmaterialwillmixwithgoodunits沒有系統管理不合格品，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)現不合格品混入或者接近良品

?SupplierRMAreviewisnotsufficient,storageofRMApartismorethanexpectedcycletime.RMAareaisoverloadedRMA沒有足夠評審處理，超出周轉時間，RMA倉爆倉。

Score3

?Non-conformingdispositionsysteminplaceandcycletimeissufficientandwellmanaged,andthosematerialispurgedontime不合格品處理系統有實施并很好的管控周轉時間，不合格品有被及時處理

?RMAareaiswelldesigned,noriskofmixing/missingduringmaterialmovementandhandlingRMA區(qū)域有很好的設計，沒有在搬運過程中混料，丟失的風險

?Non-conformingfunctionisdesigntheallrequiredarea(IQC,production,warehouse)supportwithcleartagandidentification.Supportbinsaresufficient,nomistakeusefoundinthewholefacility所有相關區(qū)域從IQC,產線到倉庫，都有導入不合格品控制，有清晰的標識，存儲盒數量足夠，整個工廠沒有發(fā)現違規(guī)案例。

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

Score4

?Non-conformingismanagedbyMRPsystem,systemisveryeasytolocatedthenon-conformingmaterialMRP系統來管理不合格品，用該系統非常容易能定位到不合格品。

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

Score5

?Supplierisusenon-conformingrealtimedatathroughSPCmethology,dataareusingtodrivesupplieractions通過SPC方法來報告實時不合格品數據，并將數據用來推動供應商改善

?RMAreduceprogramrunningthroughcontinueimprovementprogramhasachievesignificantresultwithinlastyear在上一個年度中，作為持續(xù)改善項目之一，減少RMA目標有明顯的達成。

",,,3,

"QualityPlan

品質計劃","

Score1

?NoqualityplanduringNPIandnoqualityplanrevisedinmassproductionduringprocesssetup新產品開發(fā)過程中沒有品質計劃，在量測制程建立過程中沒有修正品質計劃

Score2

?SupplierhassetupqualitycheckpointanddocumentthemajorpointinSOPbutnotinasystemway有在SOP中定義關鍵性的品質管控點但不系統

?ThereisviolationinsystemarenotfollowthoseSOP有發(fā)現違反SOP的案例

Score3

?Supplierhassetupproductmanagementplanformajorproduct,andSOPvsPMPissychronizeallthetime,majorqualityissuewillupdatethecontrolpointandsamplingplanbaseonexperiences.有對主要產品建立管控計劃，SOPPMP有同步，基于經驗在異常發(fā)生后有相應的修改管控計劃及抽樣計劃

?Controlplanwasdevelopedwithcrossfunctionalteam,anduseitinrealproductionandasabasicdocumenttocommunicatetheprocessimprovementduringallCIPprocess跨部門合作開發(fā)控制計劃并用其在生產過程中及作為持續(xù)改善項目中一個基本文件。

Score4

?PMPorcontrolplanisreviseallthetimethroughapredictionanalysislikeFMEA/FMCA/PHAetc,highriskfailuremode(RPN>80etc)isunderspecialcontrol通過FMEA等預防性的工具，PMP或者控制計劃有實時更新，高風險項目有列入特別管控

?Suppliernotonlycontroltheprocessoutput,andalsocriticaltofunctioninputparameterinthePMP不僅有管控制程輸出，PMP中還管控了關鍵功能輸入參數

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

Score5

?SomecontrolplanwasdevelopedthroughDOEapproach,asurfaceresponsestudy,factordesign,Taguchistudyisfoundthemostimportantcontrolparameterandwhatisbestprocesswindow一些管控計劃是基于DOE方法，因子設計，田口方法被用于最重要的參數管控

?Controlplanwasnotonlymanagethequalityrequirementbutalsocontroltheleadtimeandinventoryleveltoreducewaste管控計劃不僅用于品質管控而且被用在效率提升，庫存周轉減少浪費上。

?APQPprocessisusedtodefinetheprocessdesignandprocessmanagement制程設計及管理有采用APQP流程

",,,4,

"ProcessCapability&StatisticControl

統計過程控制","

Score1

?Supplierhasnoideatheprocesscapability,theyarenotunderstandthequalitysigmaleveloftheirproductandprocess對過程能力沒有概念，不知道他們產品或制程的6sigma水平

Score2

?SupplierRandomlychecktheprocesscapability,severalcriticalinputandoutputparameterwasverifythecpk,distributionoccasionalpercustomerrequireandqualityissueraisedduringNPIandwhenissuehappened

有隨機的檢查制程能力，在客戶要求或者項目開發(fā)時出過品質異常時曾經對一些許關鍵輸入輸出做過CPK,分布圖分析

Score3

?SupplierhasincludethecriticalparameterintotheirSPCplan,x-Rbarchart,controllimtedchart,I-MRchartetcisusedtomonitoringthosekeyparameters.CPKlevelanddistributionisverifiedfromtimetotimeforthosekeyparameter.有將關鍵參數納入SPC計劃,X-R圖，控制圖,I-MR圖等，有不時的確認CPK等級

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

Score4

?SupplierhassomeCIPprogramtoimprovetheprocesscapability,significantsavingandimprovewasseeinlastyear;sactivities過去一年中有在持續(xù)改善項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sigma以上項目改善經驗。

",,,3,

"NPI

新產品開發(fā)","

Score1

?Noprocedureexistsfornewproduct/technology/servicelaunches.沒有程序定義新產品/技術/服務開發(fā)管理

Score2

?Newproductlaunchproceduresexist,butdocumentationisincompleteandcomplianceisinconsistent.有新產品開發(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)域符合新產品開發(fā)流程但缺乏適當的品質目標與審批。

Score3

?Newproductlaunchflowchartandprocedureiswelldocumentedandthepoliciesrequireclearandcompleteprojectplansdocumentedwithappropriatequalityobjectivesandresponsibilitiesforimplementation.新產品開發(fā)流程有很好的被記錄，有完整的品質目標及職責定義在完整的項目計劃中

?Thereareafewexamplesofwellplannedandsuccessfulnewproduct/technology/servicedevelopmentprojects.Qualityobjectivesandresponsibilityforimplementationaredefined.有幾個很好的案例

?ThequalificationdatapercustomerspecificationandFirstArticleinspectiondataarecollectedandAppropriatemanagementapprovalsarebuiltintotheprocess(includecustomerapproval,ifrequired).審批過程中有體現很好的基于客戶規(guī)格的qualification的數據及首件記錄。

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