不合格品控制程序

文件編號DN：QP200版本號Version：主管部門Resp.Dept.：質(zhì)量部發(fā)放編號DistributionNo.:XXXXXXX有限公司質(zhì)量管理體系程序文件QUALITYSYSTEMPROCEDURE不合格品控制程序不合格品控制程序NonconformityControlProcedure編制Initiatedby： 審核Reviewedby： 批準Approvedby： 發(fā)放范圍(appliedfor)：各部門Variousdepartments 生效日期(EffectiveDate)：2017年02月09日DNQP200Version1Revision1PageDNQP200Version1Revision1PagePAGE9of15目 錄序號 內(nèi)容 頁碼目的Purpose 2適用范圍Scope 2職責Responsibilities 2不合格原輔料的控制ControlofNonconformingRawMaterials 3不合格半成品、成品的控制ControlofNonconformingSemi-FinishedProductsandFinishedProducts66不合格品處理報告單的管理ManagementofNonconformingProductHandlingReport 107、相關文件RelevantDocuments 118、質(zhì)量記錄QualityRecords 12PurposeThisprocedurespecifiesrequirementsforeffectivelycontrollingnonconformingproductsofidentification,separation,reviewandhandlingtopreventtheunintendeduse.Italsoregulatesthatconsequencesresultingfromnonconformingactivitiesshallbeinvestigated,accuratelyevaluatedandcorrespondinglydisposed.適用范圍Scope本程序適用于從采購產(chǎn)品進廠到成品出廠的所有階段的不合格品的控制以及退回不合格品的處置。Thisprocedureisapplicabletocontrollingnonconformingproductsofallphasesfromtheproductspurchasedtothefactorytotheirdelivery,aswellashandlingofreturnednonconformingproducts.Responsibilities質(zhì)量部：QualityDepartment:對原輔料、半成品和成品檢驗項目的符合性進行評估，收集整理相關數(shù)據(jù)，描述不合格狀況并傳遞相關信息至各功能單位進行處理；對不合格品進行標識;Evaluatetheconformityofinspectionitemsforrawmaterial,ancillarymaterials,semi-finishedproductsandfinishedproducts,collectandsummarizerelevantdata,describenonconformingconditionsandpassrelevantinformationtoeachfunctionaldivisiontohandlethenonconformities,andidentifythenonconformingproducts.負責組織對不合格產(chǎn)生的原因進行調(diào)查，確定對不合格品的處理措施。Organizeinteresteddivisionstoinvestigatethecauseofthenonconformitiesanddeterminethehandlingmeasurestothenonconformingproducts.生產(chǎn)部:ManufacturingDepartment:負責對生產(chǎn)過程中發(fā)現(xiàn)的不合格品進行標識、隔離和報告；Identify,separateandreportthenonconformingproductsfoundduringthemanufacturingprocess.協(xié)助質(zhì)量部對不合格品進行原因調(diào)查、風險分析、并采取糾正/預防措施。Giveassistancetothequalitydepartmenttoinvestigatethecauseofthenonconformingproductsandtoanalyzerelatedrisks,andtakecorrespondingcorrectiveorpreventiveactions.生產(chǎn)技術部：ManufacturingTechniques:協(xié)助質(zhì)量部對不合格品進行原因調(diào)查、風險分析、并采取糾正/預防措施；Giveassistancetothequalitydepartmenttoinvestigatethecauseofthenonconformingproductsandtoanalyzerelatedrisks,andtakecorrespondingcorrectiveorpreventiveactions.對不合格品的處置、評審提供技術支持。Providetechnicalsupportstohandleandreviewthenonconformingproducts.采購部負責聯(lián)絡供應商，反饋不合格原輔料信息及協(xié)助不合格原輔料的處理；PurchasingDepartmentshalltakechargeofcontactingsuppliers,feedingbackinformationaboutnonconformitiesofrawmaterialsandancillarymaterials,andgiveassistancetohandlesuchnonconformities.倉庫負責對產(chǎn)品、原輔料在入庫、儲存、出庫等過程中發(fā)現(xiàn)的不合格品進行隔離和報告；Warehouseshalltakechargeofseparatingandreportingthenonconformingproductsfoundduringtheprocesseswhenproducts,rawmaterialsandancillarymaterialsarewarehoused,stored,delivered,etc.研發(fā)部負責對轉(zhuǎn)用于研究使用的不合格品進行控制，防止與正常品混用；R&Dshalltakechargeofcontrollingthenonconformingproductsforresearchusestopreventfrombeingmixedwithauthenticproducts.不合格原輔料的控制ControlofNonconformingRawMaterials原物料不合格的報告ReportofnonconformingrawmaterialsQC將檢驗結(jié)果記錄在相應原輔料來料檢驗報告單上，不合格QP200-RE-01QA進行處理。NonconformingrawmaterialsfoundintheincominginspectionshallberecordedintheIncomingInspectionReportbyQCoftheQualityDepartment.TheconforminginformationshallbesenttotheLogisticsmanagement.AndtheNonconformityHandlingReport(QP200-RE-01)shallbecompletedandsubmittedtoQAtohandlethenonconformingproducts.生產(chǎn)部在生產(chǎn)過程中發(fā)現(xiàn)的不合格原輔料，應作好隔離，當數(shù)量、比例或嚴重程度超出標準范圍時，按QR204《生產(chǎn)異常處理操作程序》執(zhí)行，同時盡量提供不合格樣品或圖片。NonconformingrawmaterialsfoundinthemanufacturingprocessshallbeseparatedbytheManufacturingDepartment.ConditionsshallbeconductedaccordingtotheManufacturingDeviationHandling&OperatingProcedure(QR123)whenquantity,proportionorseverityisoutoftheranges.Meanwhile,thenonconformingsamplesorphotosshallbeprovided.QC對不合格品做好標識；倉庫/生產(chǎn)對不合格品移入不合格區(qū)進行隔離。QCoftheQualityDepartmentshallidentifythenonconformingproducts,whileWarehouseorManufacturingDepartmentshallphysicallyseparatethenonconformingproductstotherejectedareas.原物料不合格的原因調(diào)查InvestigationofrawmaterialnonconformitiesQAQP200-RE-01《風險評估表》進行風險評估，若涉及功能性問題由生產(chǎn)技術調(diào)查并進行風險評估。QAoftheQualityDepartmentshallorganizeinteresteddivisionstoinvestigatethecauseofthenonconformityafterobtainingtheNonconformityHandlingReport(QP200-RE-01)andevaluaterelatedrisksaccordingtotheAppendix1RiskEvaluationForm.Ifanyperformanceissuesareconcerned,theManufacturingTechniquesshallinvestigatethenonconformityandperformtheriskevaluation.QP110-RE-04《供方質(zhì)量信息反饋單》()QP110-RE-04QP200-RE-01《不合格品處理報告單》中。Accordingtotheresultofriskevaluation,theQualityDepartmentshalldeterminewhetheraSupplier’sQualityInformationFeedback(QP110-RE-04)isrequiredtosendtothesupplieriftherawmaterialnonconformitiesresultfromsuppliers.(ASupplier’sQualityInformationFeedbackmustbeinitiatediftheresultofriskevaluationishigh.Foramediumorlowriskevaluationresult,whetheraSupplier’sQualityInformationFeedbackisnecessaryornotshallbedeterminedaccordingtothespecificconditionsofthenonconformity.)AndthecorrespondingnumberoftheSupplier’sQualityInformationFeedback(QP110-RE-04)shallberecordedintheNonconformityHandlingReport(QP200-RE-01).CAPA（風險評估結(jié)果CAPACAPCAPA單號記錄在相應的報告單中。CAPAQP220《糾正和預防措施控制程序》進行。Forrawmaterialnonconformitiesresultingfromourcompany,theQualityDepartmentshalldeterminewhetheraCAPAisnecessarytoinitiateornotaccordingtotheresultofriskevaluation(ACAPAmustbeinitiatediftheresultofriskevaluationishigh.Foralowormediumriskevaluationresult,whetheraCAPAisnecessarytoopenornotshallbedeterminedaccordingtothespecificconditionsofthenonconformity).AndthenumberoftheCAPAshallberecordedinthecorrespondingreport.TheoperationofCAPAshallrefertotheCorrectiveandPreventiveActionControlProcedure(QP220).原物料不合格的處置HandlingofrawmaterialnonconformitiesQP200-RE-01(QP200-RE-01).報廢：因本公司原因造成的不合格作報廢處理。Scrap:nonconformitiesresultingfromourcompanyshallbescrapped.告單QP200-RE-02依據(jù)附表由質(zhì)量部決定是否可以讓步接收，若質(zhì)量部無法形成最終結(jié)論的，由總經(jīng)理決定，并將最終處理為讓步放QP200-RE-02（物料需求部門為視物料不合格情況確定）Concession:duetospecialconditions,forrawmaterialsnotaffectingtheproductfunctionandperformanceandconformingtolawsandregulations,thematerial-demandeddepartmentcanapplyforaconcessionwithacompletedConcessionApplicationForm(QP200-RE-02)fromthedaywhentheIncomingInspectionReportisissuedtothenextworkday(excludingholidays).Also,basedontherequirementoftheQualityDepartment,interesteddivisionsshallbeorganizedtoreviewtheapplicationandperformtherelevantriskevaluation(accordingtotheAppendix1RiskEvaluationForm).Finally,theQualityDepartmentshalldeterminewhethertheconcessionisacceptedornot.IftheQualityDepartmentcan’tgiveafinalconclusionoftheconcession,thegeneralmanagershalldeterminewhethertheconcessionisacceptedornot。Iftheconcessionisaccepted,thenumberoftheConcessionApplicationForm(QP200-RE-02)shallberecordedinthecorrespondingNonconformityHandlingForm.(Thematerial-demandeddepartmentshallbeconfirmedaccordingtothenonconformitiesofthematerials.)其它：如上述處理方式均不適用，應將處理方式描述清楚。例如啟動產(chǎn)品更改、人員培訓以及文件修訂QR086QP090《更改控制程序》執(zhí)行；人員培訓根據(jù)QR031QP000《文件控制程序》執(zhí)行。Others:ifabovehandlingmethodsareallnotapplicable,thehandlingmethodsshallbeclearlydescribed.Forexample,starttheproductchange,traininganddocumentrevisionetc.Abouttheproductchange,shallbeconductedaccordingtotheChangeControlProcedure(QP090)andChangeAssessmentProcedure（QR086）.Forthetraining,shallbeconductedaccordingtotheTrainingManagementProcedure(QR031).Forthedocumentrevision,shallbeconductedaccordingtotheDocumentControlProcedure(QP000).原物料不合格處理實施ImplementationofhandlingrawmaterialnonconformitiesQP200-RE-01《不合格品處理報告單》分發(fā)到相關部門。TheQualityDepartmentshalldistributethehandledNonconformityHandlingReport(QP200-RE-01)tointeresteddepartments.QP110-RE-04《供方質(zhì)量信息反饋單》發(fā)給采購，由采購發(fā)給供應商，采購將供應商回復的結(jié)果反饋給質(zhì)量部，具體按照QP110《采購控制程序》執(zhí)行。Fornonconformitiesrequiredtofeedbacktothesupplierinthemanneroftheinformationfeedback,theSupplier’sQualityInformationFeedback(QP110-RE-04)shallbesenttothePurchasingDepartment.ThenthePurchasingDepartmentshallsendthefeedbacktothesupplier.Also,thePurchasingDepartmentshallfeedbackthesupplier’sreplytotheQualityDepartment,whichshallbeconductedaccordingtothePurchasingControlProcedure(QP110).原物料不合格結(jié)果驗證Verificationoftheresultofrawmaterialnonconformities《不合格品處CAPAQP220-RE-01《糾正預防QP110-RE-04《供方質(zhì)量信息反饋單》上進行。TheQualityDepartmentshalltakechargeoftracingtheimplementationofthenonconformityhandlingandrecordtheresultandrelevantrecordnumberintheNonconformityHandlingReport(QP200-RE-01).Also,theQualityshallinitiateCAPAsandthesupplier’squalityinformationfeedbacksandcompletethesubsequentmeasuresandeffectivenessconfirmationinReportofCorrectiveandPreventiveAction(QP220-RE-01)andQualityFeedbacktoSupplierNo.(QP110-RE-04)..ControlofNonconformingSemi-FinishedProductsandFinishedProducts半成品、成品不合格的報告Reportofsemi-finishedproductandfinishedproductnonconformitiesQR204-RE-01QA：Semi-finishedproductsfoundinthemanufacturingprocessshallbeidentifiedandseparatedbytheManufacturingDepartment.AManufacturingDeviationForm(QR204-RE-01)shallbecompletedandthenonconformitiesshallbegivennoticetoQAoftheQualityDepartmentwhenthefollowingconditionsoccur.a、當數(shù)量、比例或嚴重程度超出標準范圍時Quantity,proportionorseverityisoutofthereferenceranges;b、不合格類型以往從未出現(xiàn)過的Thetypesofnonconformitieshaveneveroccurredbefore.除上述情況的其他情形，不合格品由生產(chǎn)部統(tǒng)一收集后向質(zhì)量部QA申請不合格證，由質(zhì)量部QA授權生產(chǎn)部貼上不合格證后退回倉庫。Forothersapartfromthementionedconditions,nonconformingproductsshallbeharmoniouslycollectedbytheManufacturingDepartment.A“DisqualificationCertificate”shallbeappliedtoQAoftheQualityDepartmentandQAshallempowertheManufacturingDepartmenttopastethe“DisqualificationCertification”onthenonconformingproducts.Finally,thenonconformingproductswith“DisqualificationCertificate”shallbereturnedtothewarehouse.QCQP200-RE-01《不合格品處理報告單》中的SectionA；并通知生產(chǎn)部/倉庫對不合格品進行隔離。NonconformingproductsfoundintheQCinspectionprocessoftheQualityDepartmentshallbeidentifiedatfirst.AndconcernedinformationshallbecompletedintheSectionAoftheNonconformityHandlingReport(QP200-RE-01).Also,theManufacturingDepartmentorWarehouseshallbeinformedtophysicallyseparatethenonconformingproducts.對于從顧客處退回的產(chǎn)品，質(zhì)量部QC在檢驗過程中發(fā)現(xiàn)不合格，應首先對不合格品進行標識，并填寫QP200-RE-01《不合格品處理報告單》中的SectionA，通知倉庫對不合格品進行隔離。Fortheproductsreturnedfromthecustomers,nonconformingproductsfoundintheQCinspectionprocessoftheQualityDepartmentshallbeidentifiedatfirst.AndinvolvedinformationshallbecompletedintheSectionAoftheNonconformityHandlingReport(QP200-RE-01).Also,theWarehouseshallbeinformedtophysicallyseparatethenonconformingproducts.半成品、成品不合格的原因調(diào)查Causeinvestigationofsemi-finishedproductandfinishedproductnonconformitiesQA接到相關的不合格報告后，組織對不合格原因進行調(diào)查分析，其它相關部門應協(xié)助質(zhì)量部進CAPACAPACAPA單號記錄在相應的報告單中，以便于跟蹤。CAPAQP220《糾正和預防措施控制程序》進行。Withtheassistanceofotherinteresteddivisions,QAoftheQualityDepartmentshallorganizetoinvestigateandanalyzethecausesofnonconformitiesaftergettingtherelevantnonconformingreports.Meanwhile,theriskevaluationshallbeperformedaccordingtoAppendix1RiskEvaluationForm.ACAPAshallbeinitiatedtoimprovethenonconformityiftheresultoftheriskevaluationishigh.However,whetheraCAPAisnecessarytoopenornotshallbedeterminedaccordingtothespecificconditionsofthenonconformitieswhentheresultoftheriskevaluationislowormedium.TheopenedCAPAnumbershallberecordedinthecorrespondingreportforthetraceability.TheoperationofCAPAshallbeconductedaccordingtotheCorrectiveandPreventiveActionControlProcedure(QP220).成品性能不合格調(diào)查過程中，應確認使用在此批成品中的半成品是否用到了其他的成品批號中，若有，需確認該批半成品的功能性狀況；Duringtheinvestigationprocessofafinishedproduct’sperformancenonconformity,whetherthesemi-finishedproductscomposingthislotoffinishedproductshavebeenusedinotherfinishedproductlotsshallbeconfirmed.Ifhave,thefunctionalconditionsofthislotofsemi-finishedproductsshallbeconfirmed.若半成品合格，則使用了同一半成品的其他批號的成品無須確認，只需對此不合格批成品進行調(diào)查分析，調(diào)查出的原因如涉及到其他批號的產(chǎn)品時，應一并處理；Ifthesemi-finishedproductsarequalified,it’srequiredtoinvestigateandanalyzethislotofnonconformingfinishedproductsinsteadofconfirmingotherlotsoffinishedproductsusingthesamelotofsemi-finishedproducts.Otherlotsofproductsshallbehandledtogetheriftheinvestigatedcausesshowanyinvolvementsofthem.若半成品不合格，則需對使用了同一半成品的所有其他批號的成品的留樣進行確認，留樣合格的，則無須對其進行追溯，留樣不合格的，則需對所有不合格的成品批號進行處理。Ifthesemi-finishedproductsaredisqualified,thereservedsamplesofallfinishedproductlotsusingthesamelotofsemi-finishedproductsshallbeconfirmed.Traceabilityisnotrequiredifthereservedsamplesarequalified.Whileallnonconformingfinishedproductlotsarerequiredtohandleifthereservedsamplesaredisqualified.半成品、成品不合格的處置Handlingofsemi-finishedproductandfinishedproductnonconformities質(zhì)量部通過對不合格原因的調(diào)查、評估及風險分析的結(jié)果，作出最終處理結(jié)論，涉及成品不合格時，可組織相關部門進行評審。Basedontheinvestigationandevaluationofthenonconformingcausesaswellastheresultoftheriskanalysis,theQualityDepartmentshallgiveafinalhandlingconclusionandorganizeinteresteddivisionstoreviewwheninvolvingfinishedproductnonconformities.（包括返工QR202-RE-02QA簽QR202《物料處理程序》作報廢處理：Rejectedlabelsandpouchesgeneratedduringthemanufacturingprocess(includingrework)shallbescrappedbytheManufacturingDepartmentwithWarehousing/ScrapRecord(QR202-RE-02)underthesupervisionofQAwiththeconfirmationofasignature.ThefollowingconditionsshallbescrappedaftertheapprovaloftheprincipaloftheQualityDepartmentaccordingtotheMaterialHandlingProcedure(QR202).a、半成品、成品超過有效期的Semi-finishedproductsandfinishedproductsoutofdate;b、不合格半成品試劑條Nonconformingsemi-finishedreagentstrips;c、客戶退回的不合格產(chǎn)品（包括召回的產(chǎn)品）Nonconformingproductsreturnedfromthecustomers(includingrecalledproducts).不合格半成品、成品處置方式Handlingmethodsofnonconformingsemi-finishedproductsandfinishedproductsa、成品、半成品禁止讓步接收；Concessionforfinishedproductsandsemi-finishedproductsisprohibited.bQR200《返工程序》執(zhí)行，并QP200-RE-01《不合格品處理報告單》上；ReworkshallbeconductedaccordingtotheReworkProcedure(QR200)andthereworkformnumbershallberecordedintheNonconformityHandlingReport(QP200-RE-01).c、研發(fā)使用：當不合格品不能用于生產(chǎn)時，如經(jīng)過評審認為有研究試驗價值，不合格品可由研發(fā)領出使用，但保留原不合格證，防止混入正常產(chǎn)品；R&Duse:nonconformingproductswhichcan’tbeusedformanufacturingcanbetakenbyR&DforusageafterbeingreviewedvaluabletoR&Dtests,butthe“disqualificationcertificate”shallbekepttopreventmixingwithauthenticproducts;d、組件拆分后分別以原批號退回半成品倉庫；Separatedcomponentsshallberespectivelyreturnedtothesemi-finishedstorageinthenameoftheinitiallots;e、報廢：依照QR202《物料處理程序》執(zhí)行，并將報廢單號記錄在QP200-RE-01《不合格品處理報告單》；ScrapshallbeconductedaccordingtotheMaterialHandlingProcedure(QR202)andthescrapformnumbershallberecordedintheNonconformityProductHandlingReport(QP200-RE-01).f、其它：按4.3.4項執(zhí)行。Others:accordingtothe4.3.4execution.不合格半成品、成品處理的實施Implementationofnonconformingsemi-finishedproductandfinishedproducthandling質(zhì)量部負責將處理措施填寫完SectionA~C的QP200-RE-01《不合格品處理報告單》抄送至相關部門，由DNQP200Version1Revision1PageDNQP200Version1Revision1PagePAGE13of15各部門按處理意見實施對不合格品的處置。TheQualityDepartmentshallcompletetheSectionA,BandCoftheNonconformityHandlingReport(QP200-RE-01)andsendittotheinteresteddepartments.Whileeachinvolveddepartmentshallimplementthehandlingtothenonconformingproductsaccordingtothesuggestions.結(jié)果驗證Resultverification《不合格品處CAPAQP220《糾正和預防措施控制程序》進行。TheQualityDepartmentshalltakechargeoftracingtheimplementationofthenonconformingproducthandlingandrecordtheresultandrelevantrecordnumberintheNonconformityHandlingReport(QP200-RE-01).IfaCAPAisinitiated,thesubsequentactionsandeffectivenessshallbeaccordingtoCorrectiveandPreventiveActionControlProcedure(QP220).不合格品處理報告單的管理ManagementofNonconformingProductHandlingReport質(zhì)量部對各不合格品處理報告單進行統(tǒng)一編號，以便于對不合格的統(tǒng)計分析。TheQualityDepartmentshallharmoniouslynumbereachnonconformingproducthandlingreportsoastostatisticallyanalyzethemconveniently.編號由兩位大寫英文字母和七位數(shù)字組成，七位數(shù)字前四位表示年份（2位、月份（2，最后三位表示順序號。兩位大寫英文字母如下：ThenumbersshallbemadeoftwodigitsofcapitalizedEnglishlettersandsevendigitsofArabicnumeralswhosefrontfourdigitsstandfortheyear(2digits)andthemonth(2digits)andthelastthreedigitsstandfortheserialnumber.ThetwocapitalizedEnglishlettersareasfollows:YB表示原輔料的不合格YBstandsforrawmaterialnonconformities;CB表示半成品/成品的不合格CBstandsforsemi-finishedproductorfinishedproductnonconformities.不合格品統(tǒng)計和趨勢分析Statisticsandtrendanalysisofnonconformingproducts（QP210）AccordingtotheDataAnalysisandApplicationProcedure(QP210),theQualityDepartmentshallrespectivelysummarizethenonconformingproductsandnonconformingratesofthepast12monthseachmonthandanalyzetheirtrendsaswell.PlansshallbeestablishedandrelevantimprovementsandCAPAsshallbetakenwhentheanalysisresultsshowadversetrends.33起以上。Non-performancenonconformitiesoffinishedproductsresultingfromthesamedepartmentaremorethan3(3included)withinamonth.33起以上。Thesameperformancenonconformitiesofthesamefinishedproductsaremorethan3(3included)withinamonth.55起以上。Incomingnonconformitiesresultingfromthesamedepartmentaremorethan5(5included)withinamonth.55起以上。Thesamematerialnonconformitiesofthesamesupplieraremorethan5(5included)withinamonth.5個月出現(xiàn)合格率下降。Thequalifiedratescontinuouslydropin5months.2個季度出現(xiàn)成品不合格率超標。Defectratesarecontinuouslyoutoftherangesin2quarters.不合格清單Nonconformitylist。質(zhì)量部負責建立和定期更新不合格清單。Thenonconformitylistshallincludethedatewhenthenonconformityoccurs,theformnumberofthenonconformity,batchcode,productname,quantity,project,nonconformitydescription,causes,nonconformityhandling,handlingdate,nonconformitytraceabilityandCAPA(ifhave).TheQualityDepartmentisresponsibleforestablishingandregularlyupdatingthenonconforminglist.、相關文件RelevantDocuments《監(jiān)視和測量裝置控制程序》QP160MonitoringandMeasuringApparatusControlProcedure《數(shù)據(jù)分析、應用程序》QP210DataAnalysisandApplicationProcedure《糾正和預防措施控制程序》QP220CorrectiveandPreventiveActionControlProcedure《生產(chǎn)異常處理操作程序》QR204ManufacturingDeviationHandlingandOperationProcedure《返工程序》QR200ReworkProcedure《采購控制程序》QP110PurchasingControlProcedure《物料處理程序》QR202MaterialHandlingProcedure7.8《更改評估程