| 供应商质量体系审核检查表checklist-supplieraudit |
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| 1、平面布置图和过程流程图/PlantLayoutandProcessFlowDiagram |
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| isthereadatedcopyofthecurrentfloorplanreadilyavailable? |
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| 平面布置图上是否有所有装配、生产和检测岗位、原材料、半成品、成品的区域划分? |
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| doesthefloorplanidentifythefollowing:allrequiredassembly,processandinspectionstations?locationsforallrawmaterial,workinprocess(WIP)andfinishedproduct? |
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| areprocessflowchartsdatedandcurrent? |
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| 操作要求/implementation/processquestions |
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| doestheactualmaterialandproductionflowfollowtheprocessflowchart? |
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| 2、设计和过程FMEA/designandprocessFMEA |
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| DFMEA(含有设计职责)/DFMEA(ifsupplierisdesignresponsible) |
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| DFMEA的零件编号、修订版本、原始日期和审定日期是否正确? |
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| doestheDFMEAhavethecorrectPart#,RevisionLevel,Orig.DateandRev.Date? |
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| DFMEA是否包括了顾客的所有性能要求、外观标准、特殊特性和安全要求? |
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| doestheDFMEAincludeallfunctionalspecifications,appearancespecifications,SCsandSafetyRequirementsasdefinedbycustomerdrawings? |
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| 是否对每个失效模式的RPN都进行了计算,并对RPN值高的采取了建议措施? |
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| arethereRPNcalculationsforeachfailuremodeandrecommendedactionsforhighRPNs? |
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| PFMEA是否按图纸的规定包括了所有顾客和内部要求的特殊特性和安全要求? |
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| doesthePFMEAincludeallcustomerandinteralScsandSafetyRequirementsasdefinedbycustomerdrawingsandinteralrequirements? |
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| 是否对每个失效模式的RPN都进行了计算,并对RPN值高的采取了建议措施? |
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| arethereRPNcalculationsforeachfailuremodeandrecommendedactionsforhighRPNs? |
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| DoesthePFMEAfollowtheprocessflow? |
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| 控制计划是否有正确的产品编号、修订号、原始日期和修订日期? |
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| DoestheControlPlanhavethecorrectPart#,RevisionLevel,Orig.DateandRev.Date? |
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| Doesthecontrolplanfollowtheprocessflowchart? |
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| 控制计划内是否包括了:进料检验、过程检验和控制、出厂检验以及返工/返修要求? |
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| DoestheControlPlanincludethefollowing:IncomingInspection,In-processInspection&Controls,Finalinspectionandrework/repairRequirements? |
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| 控制计划是否按顾客图纸的要求包括了所有顾客的特殊特性和产品安全要求? |
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| DoestheControlPlanincludeallthecustomerSCsandSafetyRequirementsasdefinedbycustomerdrawings? |
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| PFMEA中视别的潜在失效模式是否通过控制计划进行得到控制? |
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| Areappropriatepotentialfailuremodes,asidentifiedinthePFMEA,addressedthroughthecontrolplan? |
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| 控制计划中是否包括了检验和试验的要求?(包括数量、频次、以及规范要求) |
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| DoesControlPlanincludebothgageandtestrequirements? (includingquantity,frequency,andrequiredspecifications?) |
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| 所有控制计划中要求的控制(包括SPC)是否在生产过程中得到实施? |
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| Areallcontrols(includingSPC),identifiedontheControlPlan,beingusedintheproductionprocess? |
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| Areallcontrolsverifiedonaperiodicbasistoensuredesiredresults? |
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| 4、检验和试验/InspectionandTesting |
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| 接受准则不是零缺陷的计数数据,供方是否将接受准则形成文件并由顾客批准? |
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| forattributedatawithacceptancecriteriaotherthanzerodefects,doesthesupplierdocumentacceptancecriteriaandhavecustomerapproval? |
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| howdoesthesupplierassurethatincomingproducthasbeeninspectedorotherwiseverifiedtomeetrequirements,priortoreleaseforproduction? |
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| 没有验证而用于生产的的原材料是否被明确标识并作好记录? |
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| ispositiveidentificationprovidedandrecordedformaterialusedinproductionbutnotverified? |
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| 检验指导书中是否包括抽样计划、检验频次以及检测内容和规范要求(包括进料、过程、最终) |
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| doestheinspectioninstructionsincludesamlingquantity,frequency,inspectionitemsandrequiredspecifications(incoming\process\out-going). |
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| 来料接受计划必须包括以下一种或多种方法:1、进行统计数据接收与评价;2、进货检验和/或试验(根据性能的抽样);3、当有可接收质量性能的记录时,由第二方或第三方评审或审核。 |
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| theacceptanceplanmustincludeoneormoreofthefollowing:1、receiptandevaluationofstatisticaldata;2、receivinginspectionand/ortesting(samplingbasedonperformance);3、2ndor3rdpartyassessmentsorauditsofcoupledwithrecordsofacceptablequalityperformance;4、partevaluationbyaccreditedlaboratory. |
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| 在所有要求的检验和试验完成或必要的报告收到和验证前,不得将产品放行,除非有可靠追回程序时才可放行? |
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| doesthesupplierholdproductuntiltherequiredinspectionsandtestshavebeencompletedornecessaryreportshavebeenreceivedandverified,exceptforreleaseunderpositiverecall? |
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| 供方是否只在文件或控制计划中所有要求的各项活动已圆满完成后,产品才发出? |
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| doesthesupplierassurethatnoproductisdispatcheduntilallactivitiesspecifiedinthedocumentand/orcontrolplanhavebeensatisfactorilycompleted? |
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| 在控制计划和/或文件化程序中是否具体规定了标识(如:盖章、标签、贮存位置等)? |
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| istheidentificationspecifiedinthecontrolplanand/ordocumentedprocedures(e.g.stampmarks,tags,storagelocation.) |
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| 在生产过程中是否提供文件表明:只有通过了检验和/或试验的材料才能提供给顾客? |
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| arethereprovisionsintheprocessthatonlymaterialthathaspassedtheinspectionsand/ortestcanbeprovidedtothecustomer? |
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| 是否在整个生产过程中都保持了产品适当的检验和/或试验状态的标识? |
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| isinspectionand/orteststatussuitablyidentifiedthroughouttheproductionprocess? |
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| 是否按文件和/或控制计划的要求对产品进行检验/试验? |
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| isproductinspected/testedasrequiredbydocumentedproceduresand/orthecontrolplan? |
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| 最终检验和试验是否根据文件和/或控制计划的要求进行? |
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| isfinalinspectionandtestingconductedinaccordancewithdocumentedproceduresand/orthecontrolplan? |
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| istheproceduretore-qualifyallreworked/repairedmaterialbeingfollowed? |
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| 是否进行了作业准备验证,使用的是哪一种(末件比较/首件检查)? |
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| arejobsetupsverifiedwheneverasetupisperformed?Whichisused(Last-offpartcomparisonorfirstpartcheck)? |
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| doesthesuppliermaintainadequaterecordsofallinspectionsandtests? |
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| 检验和试验记录是否清楚的表明产品是否已通过了检验和/或试验? |
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| doinspectionandtestrecordsclearlyshowwhethertheproducthaspassedorfailedtheinspectionand/ortest? |
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| dotherecordsidentifytheinspectionauthorityresponsibleforthereleaseoftheproduct? |
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| 必须按要求的频次对所有产品进行全忙于检验和功能验证(按顾客的工程材料及性能标准),其结果必须可供顾客评审。 |
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| Alayoutinspectionandafunctionalverification(toapplicablecustomerengineeringmateralandperformancestandards)shallbeperformedforallproductsataestablishedfrequency,resultsshallbeavailableforcustomerreview. |
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| 5、产品规范与图纸/ProductSpecifications&Drawings |
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| Isthecurrentrevisionofthecustomerspecification(s)onhand? |
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| 产品规范是否正确地反映在供应商的图纸和相关文件上(如:控制计划、操作指导书、检验指导书)? |
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| Arespecificationsreflectedonsupplierdrawingsandrelevantdocumentscorrectly(eg:controlplan,inspectioninstruction,operationinstruction)? |
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| doesthesuppliermaintainarecordofthedateonwhicheachchangeisimplementedinproduction. |
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| howtocontroltheproductsbetweenthenew/oldspecifications. |
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| 操作要求/implementation/processquestions——无/none |
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| 6、过程监控与操作指导书/ProcessMonitoring&OperatorInstructions |
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| 每一个生产岗位是否有有效的工作空间和足够的照明,以达到有效的工作环境? |
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| doeseachworkstationprovideadequatelightingandsufficientspacetopromoteeffectiveworkingconditions? |
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| 是否有一个用以查证操作工已进行了可视样品、量具和操作指导书等的培训的系统? |
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| Isasysteminplacetoverifyoperatortrainingongages,visualaids,andoperatorinstructions? |
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| doestheorganizationprovideon-the-jobtrainingforpersonnelinanynewormodifiedjobaffectingproductquality.Arerecordsoftrainingmaintained? |
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| 操作指导书、结构图、检验指导书是否受控并且能追赶溯到生产零件的级别? |
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| OperatorInstructions,Set-upSheetsandInspectioninstructionsarecontrolledandtraceabletothelevelpartsbeingproduced |
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| OperatorandprocessmonitoringinstructionscomplywithQS4.9.1 |
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| arethestatisticaltechniquesusedintheprocesscontrolling(eg.Controlchart)? |
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| 所有超出控制和不良趋势是否都被备注和采取纠正措施? |
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| Aretrendsandoutofcontrolsituationsbeingnotedandcorrected? |
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| 是否按规定的方法确保所有现场的工程文件都为正确的修订版本(规范、PFMEA、控制计划、结构图、操作指导书、可视辅具)? |
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| Isthesystembeingfollowedtoensurethecorrectrevisionlevelisinplaceforallengineeringdocuments?(Specifications,PFMEA,ControlPlans,SetupSheets,OperatorInstructions,VisualAids) |
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| Haspilotbuilddatabeencollectedandstored? |
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| 是否有文件化程序规定对返工/返修的材料进行重新检查? |
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| Isthereaproceduretore-qualifyallreworked/repairedmaterial? |
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| 是否有一个书面的详细的批次管理系统存在,管理系统涉及原材料从进料到发运包括离线、返工/返修的操作。 |
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| Awrittendetailedlottracebilitysystemexiststhroughallstagesofmaterialflowfromincomingtoshipping,includingoff-lineandrework/repairoperations. |
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| 是否在生产、交付的所有阶段都有保持了产品的标识? |
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| aretheidentificationsmaintainedduringallstagesofproduction,delivery? |
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| 在每个工作岗位,操作工是否能很容易地得到可视辅具(包括合适的临界样品)和操作指导书,并按其进行操作? |
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| Arevisualaids(includingappropriateboundarysamples)andoperatorinstructionsreadilyaccessiblebytheoperatorsateachstationandbeingfollowed? |
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| 在生产线上是否都可得到好的样品/不良样品?它们是否都有状态标识? |
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| Areall"MasterGood/MasterBad"samplesavailableonline?Aretheysigned? |
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| Theinstructionsarelegibleandvisibletotheoperator. |
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| Arereworkandrepairproceduresinplaceandbeingfollowed? |
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| 在生产现场是否划分出合格品、不合格品、待检品的区域,并加以标识。 |
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| isthereanidentifiedareaforconforming\nonconforming\awaitinginspectingmaterial/product,segregatedfromthemanufacturingarea? |
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| isthereactiontopreventthesimilarproductsfrommixing. |
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| areinspectionpointlocationseffectiveinpreventingshipmentofnonconformingproducts? |
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| Thelottraceabilityisdemonstratedtobeinplaceandeffective. |
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| 零件标识是否存在,并至少包括供应商编号,产品编号和生产日期。 |
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| PartidentificationisbasedonPS-4480with,ataminumum,includesSupplierCode,p/nandrundate. |
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| 批次数量大小不超过8小时或一天的生产产量中的较小者 |
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| Lotsizeisdesignatedasnottoexceed8hoursor1day'sproduction,whicheverissmaller. |
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| aretheidentificationoftraceabilitymaitainedandrecordedonthesite? |
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| Havethehandlingandstoragerequirementsofmaterial,includingdelicatecomponents,beenreviewed? |
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| 当零件或材料有特殊的搬运要求时,程序或作业指导书中是否清楚地说明了搬运的方法? |
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| Whenspecialhandlingofpartsormaterialisrequired,theproceduresorworkinstructionsclearlyindicatethehandlingmethod. |
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| arestorageareasappropriateforpreventingdamageordeteriorationoftheproduct? |
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| 供方是否以适宜的时间间隔检查库存品状况,以便及时发现变质情况? |
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| istheconditionofproductinstockassessedatappropriateintervalstodetectdeterioration? |
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| 操作要求/implementation/processquestions |
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| Isthestorageofmaterialadequatetoprotectitfromenvironmentalfactors? |
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| Isthestoragelocationforcomponentsorganized&monitored? |
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| 是否建立了一些控制方法以消除产品被污染或相似的产品被混合? |
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| Havecontrolsbeenestablishedtoeliminatethepotentialforanoperationtocontaminateormixsimilarproducts? |
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| 8、包装与发运规范/PartsPackaging/ShippingSpecifications |
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| Thefollowingdocumentationexistsandisincludedintheplan: |
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| Packagingrequirements/instructions/包装指导书 |
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| Labelingrequirements/instructions/标签指导书 |
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| Shippingrequirements/instructions/发运指导书 |
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| 包装是否按顾客要求已进行了测试,包括按实际或模拟路线和条件发运后的包装进行测试? |
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| Evidenceexiststhatthepackaginghasbeentested(asrequiredbytheusingplant)includingtestpacksshippedoveractualorsimulatedshippingrouteandconditions |
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| 在最终检验和试验后,供方是否采取保护产品质量的措施,合同要求时,这种保护应延续到交付的目的地? |
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| doesthesupplierarrangefortheprotectionofthequalityofproductafterfinalinspectionandtest,andwhencontractuallyspecifieddoesitextendtoincludedeliverytodestination? |
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| 供方是否建立支持百分之百按期装运的系统以满足顾客生产的要求? |
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| hasthesupplierestablishedasystemtosupport100%on-timeshipmentstomeetcustomerproductionrequirements? |
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| 如果未能保持百分之百按期装运,供方是否实施纠正措施以改进交付能力并与顾客就交付问题进行信息沟通? |
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| ifthesupplier’sdeliveryperformqnceisnot100%toschedule,isthereevidenceofimplementedcorrectiveactions,andofcommunicatinregardingdeliveryprobleminformationtothecustomer? |
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| Acontingencyplanexistswhichincludessecondaryroutesandcarriers,aswellas,logisticsforexpitedshipments |
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| 操作要求/implementation/processquestions |
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| Packagingandlabelingconformstothelatestcustomerstandard |
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| Inspectionplanwhichidentifiesdamagedorcontaminatedcontainersforremovalfromservice |
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| 所有运输容器、方法和标准包装已经过顾客材料部门主管的批准。 |
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| Allshippingcontainers,methodsandstandardpackshavebeenapprovedbytheusingplant'sMaterialsMgr. |
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