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xxxxLTD.不合格品控制程序NONCONFORMINGPRODUCTCONTROLPROCEDURE文件编号:OP-QA-10DocumentNo.:OP-QA-10版本:01Version:01页次:1of9Page:1of9程序文件ControlProcedure制定单位PreparingDepartment:QADepartment生效日期EffectiveDate:08-Oct-2xxx制定Preparedbyxxx审核:Checkedby:批准:Approvedby:日期Date20xxx–09–27日期Date日期DateDistributionlist分发签收清单客服部CSDept日期Date开发部D&DDept日期Date物料部MaterialDept日期Date品质部QADept日期Date生产部Prod.Dept日期Date货仓部WH.Dept日期Date运作部OPDept.日期Date采购开发部SourcingDept日期Date工程部EngineeringDept日期Date人事&行政部HR&Admin.Dept日期Date未经授权不可拷贝!ItisnotallowedtomakeanycopywithoutauthorizationxxxxLTD.不合格品控制程序NONCONFORMINGPRODUCTCONTROLPROCEDURE文件编号:OP-QA-10DocumentNo.:OP-QA-10版本:01Version:01页次:2of9Page:2of91.RevisionHistory修改记录REVISION版本DESCRIPTIONOFCHANGE修订内容ORIGINATOR起草人RELEASEDATE发行日期01OriginalRelease新版发行xxx20xx-10-08xxxxLTD.不合格品控制程序NONCONFORMINGPRODUCTCONTROLPROCEDURE文件编号:OP-QA-10DocumentNo.:OP-QA-10版本:01Version:01页次:3of9Page:3of9P2.purpose目的为有效地杜绝不合格的物料、半成品及成品的误用、流出;并对其予以恰当处理.Toavoidnonconformingmaterials,semi-finishedproductsandfinishedproductsfrommisuseandOutflow,anddisposethemproperly.3.scope范围适用于不同阶段的产品及物料：如进料、制程、成品、库存及客户退货.Applicableformaterialandproductsindifferentlevel:Incoming,process,finishedgoods,stockandcustomerreturns.4.ReferenceDocument参考文件4.1《MRB运作程序》MRBoperationprocedure4.2《记录管理程序》Recordcontrolprocedure4.3《进料品质控制程序》Incomingqualitycontrolprocedure4.4《过程质量控制程序》Processqualitycontrolprocedure4.5《出货质量控制程序》Outgoingqualitycontrolprocedure4.6《纠正与预防措施管理程序》Correctiveandpreventiveactionmanagementprocedure4.7《产品标识及追溯性管理程序》Productidentificationandtraceabilitymanagementprocedure5.Definition定义5.1合格：满足要求.Conforming:Satisfytherequirement5.2不合格：未满足要求.Nonconforming:Disatisfytherewuirement.6.Responsibility职责6.1品质部：负责对不合格原料及成品的检验判定及标识。QADept.:Responsibleforinspection,judgmentandidentificationofnonconformingmaterialandproducts.6.2生产部：负责对在线不合格物料及产品的隔离。ProductionDept.:Responsibleforseparationofnonconformingmaterialorproductsinprocess.6.3货仓部：负责对不合格物料及成品的隔离WarehouseDept.:Responsibleforseparationofnonconformingmaterialsandfinishedproducts.7.Generalprocedure一般程序7.1总则General7.1.1本公司的不合格品的处理方式为：退货、暂允收货、返工、挑选使用、报废。Disposalwaysfornonconformingproductare:reject,useasis,rework,sortingandscrapped.7.1.2经检验判定、标识与隔离的不合格品，在未做适当处理决议前,任何人不得领用或使用。xxxxLTD.不合格品控制程序NONCONFORMINGPRODUCTCONTROLPROCEDURE文件编号:OP-QA-10DocumentNo.:OP-QA-10版本:01Version:01页次:4of9Page:4of9Nooneshouldusenonconformingmaterialorproductswhichwerejudged,identifiedandseparatedunlessthereisaproperdecision.7.1.3不合格品之判定，应参照对应的检验规范或确认样品。Decisiononnonconformingproductsshallrefertotherelevantinspectionstandardorapprovedsample.7.1.4不合格品应该进行标识与隔离。Nonconformingproductsmustbeidentifiedandseparated.7.1.5经过返工/修理后的产品必须再次接受检验,并保留检验记录.Reworkedandrepairedproductsmustbere-inspectedandkeepaninspectionrecord.7.2进料不合格品IncomingNonconformingMaterials7.2.1拒收不合格品需贴红色“IQC不合格标签”,并放置在不合格品区域;Rejectedmaterialsshallbestuckwithared“IQCrejectionlabel”andplacedinnonconformingmaterialarea.7.2.2检验员将不合格现象及判定结果记录于《来料检查报告》中，交品管部主管及经理审核;NonconformingphenomenaandjudgmentsarerecordedinIncomingInspectionReportbyinspectorandsendtosupervisorandmanagerforapproval.7.2.3当不合格物料生产急需时，可通过MRB会议对物料进行评审,其结果记录在《MRB报告》中，具体参见《MRB运作程序》。Incasethenonconformingmaterialisurgentlyused,aMRBmeetingisheldtoreviewit.ResultwillrecordinMRBReport,thedetailsreferstoMRBOperationProcedure7.2.4品质部分发《来料检查报告》,通知物控部,品质部同时将纠正及预防措施报告分发给供应商，要求供应商回复改善对策。IncomingInspectionReportisdistributedbyQADepttoinformMCDeptandmeanwhileissueCorrectiveandPreventiveActionRequesttosupplierforimprovementcountermeasure.7.2.5若物料退货，则MC根据IQC检验报告结果知会货仓退货，货仓开出《退货单》,在供应商运回货物时，将该单要求供应商签名。IncasematerialisjudgedasRTV,MCinformwarehousetoreturnaccordingtotheresultof“IQCinspectionreport”.WarehouseissueaMaterialReturnSlipandaskforasignaturefromsupplierwhenreturntosupplier.7.3制程不合格品NonconformingProductsInProcess7.3.1制程中发现不合格品时，发现者需报告给生产主管,不合格品应用红色箱子进行隔离;Whennonconformingproductsfoundinprocess,thefindershallreporttotheproductionsupervisorandtheseproductsshallbeseparatedwithredbox.7.3.2PQC发现不合格品时，需将结果记录在《巡拉报告表》中，不合格品由生产车间负责改善.PQCshallrecordtheresultinLineMonitoringReportWhenfindingnonconformingxxxxLTD.不合格品控制程序NONCONFORMINGPRODUCTCONTROLPROCEDURE文件编号:OP-QA-10DocumentNo.:OP-QA-10版本:01Version:01页次:5of9Page:5of9productswhichshallbeimprovedbyproductionfloor.7.3.3生产中发现不合格品是因为原材料的原因而导致的，由生产单位填写《原物料异常报告表》经品质部QA核实，交IQC/MC/采购部共同处理.AnAbnormalMaterialsReportshallbeissuedbyproductionandcheckedbyQAWhenfoundnonconformingproductscausedbyrawmaterials,andIQC/MC/Purchasingwillhandleittogether.7.4成品不合格品FinishedNonconformingProducts7.4.1QA人员将不合格品记录在检查报告中并要求生产车间返工，返工后交QA重验，直至合格为止。QAinspectorwillrecordnonconformingproductsinQAOutgoingInspectionReportandrequestproductiontoreworkthem.Thereworkedproductswillberecheckeduntiltheyareallconforming.7.5库存不合格品NonconformingProductsInStock7.5.1库存原物料/半成品及成品若经重检不合格将按7.2/7.3/7.4处理。Incasethere-inspectionoftherawmaterial,semi-finishedproductsandfinishedproductsinstockfailed.Nonconformingmaterialorproductswillbedisposedaccordingto7.2/7.3/7.4.7.6顾客退货不合格品NonconformingProductsReturnedbyCustomer7.6.1客服部在收到顾客退货或投诉时，应立即交品质部;CSDept