糾正和預(yù)防措施控制程序

文件編號(hào)DN文件編號(hào)DN：QP220版本號(hào)Version：1.1主管部門Resp.Dept.：質(zhì)量部Quality發(fā)放編號(hào)DistributionNo.質(zhì)量管理體系程序文件QUALITYSYSTEMPROCEDURE糾正和預(yù)防措施控制程序糾正和預(yù)防措施控制程序CorrectiveandPreventiveActionControlProcedure編制Initiatedby： 審核Reviewedby： 批準(zhǔn)Approvedby： 發(fā)放范圍(appliedfor)： 生效日期(EffectiveDate)：2020年05月10日DNQP220Version1Revision1PageDNQP220Version1Revision1PagePAGE8of14目 錄TableofContent序號(hào) 名稱 頁碼Item# Title Page目的(Purpose) 2范圍(Scopes) 23.定義(Definitions) 2職責(zé)(Responsibilities) 2工作流程(Workingprocedures) 3相關(guān)文件(RelevantDocuments) 8相關(guān)記錄(RelevantRecords) 8附件(Appendixes) 8DocumentHistorySummary 13目的(Purpose)Theprocedureclarifiestheprocesstoadoptcorrectiveandpreventiveactiontoeliminatetheexistingorpotentialnon-conformingandpreventsimilarnon-conforminginthefutureandpromotethesustainedimprovementofthequalitymanagementsystem.范圍(Scopes)本程序適用于本公司質(zhì)量管理體系范圍內(nèi)糾正措施和預(yù)防措施的制定、實(shí)施與有效性驗(yàn)證。Theprocedureisapplicabletotheestablishment,implementationandvalidationofcorrectiveandpreventiveactionwithinthequalitymanagementsystem.定義(Definitions)糾正Correction:Actiontoeliminateadetectednonconformity.糾正措施Correctiveaction:Actiontoeliminatethecause(s)ofadetectednonconformityorotherundesirablesituation.預(yù)防措施Preventiveaction:Actiontoeliminatethecauseofapotentialnonconformityorotherundesirablepotential職責(zé)(Responsibilities)質(zhì)量管理體系內(nèi)各部門負(fù)責(zé)將質(zhì)量管理體系持續(xù)改進(jìn)的機(jī)會(huì)，包括不合格情況、潛在不合格情況、改進(jìn)QA。ThedepartmentswithinqualitymanagementsystemareresponsibleforreportingtoQAoftheimprovementopportunitiesofqualitymanagementsystem,includingnon-conforming,potentialnon-conformingandsustainedimprovement.QA,評(píng)審改進(jìn)部門制定的糾正預(yù)防措施，跟蹤糾正預(yù)防措施的實(shí)施情況，驗(yàn)證糾正預(yù)防措施的有效性。并對(duì)所有糾正預(yù)防措施進(jìn)行歸檔整理。QAisthesupervisingdepartmentforcorrectiveandpreventiveactionsandisresponsibletoanalyzeandevaluatetheopportunitiesofimprovement,verifythenecessityofadoptingcorrectiveandpreventiveactionsandconfirmtheresponsibledepartmenttoinvestigate.QAisalsoresponsiblefortheimplementationandvalidationoftheeffectivenessofcorrectiveandpreventiveactions.QAshallfilethefinalrecordsofcorrectiveandpreventiveactions.改進(jìn)部門負(fù)責(zé)制訂和評(píng)審糾正預(yù)防措施，并確保糾正預(yù)防措施按要求有效的執(zhí)行。Theresponsibledepartmentsareresponsibleforestablishingandreviewingthecorrectiveandpreventiveactionsandensuringtheimplementation.工作流程(Workingprocedures)糾正預(yù)防措施來自于質(zhì)量管理體系范圍內(nèi)，引起產(chǎn)品不合格或潛在不合格或者其他質(zhì)量問題的各過程。數(shù)據(jù)來源一般來自于日常管理以及定期的統(tǒng)計(jì)分析，可包括但不僅僅限于以下來源：ACAPAmayariseduetoaflawintheprocessthatmayhavecausedproductnon-conformance,potentialnon-conformanceand/orotherqualityproblemsinthescopeofthequalitysystem.TheDataisbasedondailymanagementandperiodicdataanalysis.Thisdataincludesbutisnotlimitedtothefollowing:產(chǎn)品的讓步接收和產(chǎn)品不合格的處理Concessionalacceptanceofproductsandthedispositionofnon-conforming；體系審核與評(píng)審（包括管理評(píng)審、內(nèi)部質(zhì)量體系審核、認(rèn)證公司或顧客委托進(jìn)行的第三方審核、顧客的第二方審核）Systemauditorreview(includingmanagementreview,internalaudit,authenticationcompanyorthethirdpartythecustomerconsigned,thesecondauditconductedbythecustomer)；EngineeringandEquipmentManagementProcess；VendorManagementProcess；Customercomplaintormarketingfeedback；Productwithdrawal；Productionabnormityanddeviation；Processtechnicalanalysisandimprovement；OtherprocessanalysisopportunitiesUnforeseenpotentialinputsthatmaywarrantevaluationandapproval。TheinitiationofcorrectiveandpreventiveactionsTheinitiationconditionofthecorrectiveandpreventiveactions1）CAPA；CAPAshouldbeinitiatedwhenanon-conformanceisgeneratedfromaninternalorexternal-audit.CAPA；CAPAshouldbeinitiatedaccordingtotherequestoftherelevantprocedureswhenthereisacustomercomplaint,productionabnormity,and/orNCMR.（潛在不合格QA2（潛在不合格）信息進(jìn)行分析，以評(píng)審采取糾正預(yù)防措施的必要性。風(fēng)險(xiǎn)評(píng)估需記錄在《糾正預(yù)防措施報(bào)告單》SectionA。Foranon-conformance(potentialnonconformity)generatedfromothersources,QAshouldcooperatewithrelevantdepartmenttodeterminethenecessityoftheinitiationofcorrectiveandpreventiveactionsaccordingtotheAppendix2“RiskAssessment”.TheriskassessmentresultshouldberecordedinthesectionAof“ReportofCorrectiveandPreventiveAction”.CAPASectionA:（潛在不合格的描述時(shí),應(yīng)針對(duì)不合格（潛在不合格）的事實(shí)進(jìn)行陳述;并明確不合格（潛在不合格）的來源；同時(shí)QA負(fù)責(zé)將其登記于糾正預(yù)防措施數(shù)據(jù)庫中，對(duì)產(chǎn)生的糾正預(yù)防措施的狀態(tài)進(jìn)行跟蹤匯總。TheinitiatingdepartmentshallfillinSectionA“ReportofCorrectiveandPreventiveAction”aboutthedescriptionofnon-conformingorpotentialnon-conforming;pointoutthesourceofthenon-conforming(potentialnon-conforming);andtheCAPAshouldberegisteredbyQAinthecorrectiveandpreventiveactionsdata-baseandfollowuponthem.CAPAQABC-××***××表示糾正預(yù)防措施發(fā)生年份，***表示各年度各類糾正預(yù)防措施的順序號(hào)。TheCAPAnumbershouldbeassignedbyQA.Thenumberingof“ReportofCorrectiveandPreventiveAction”isBC-××***.××indicatestheyearwhencorrectiveandpreventiveactionsoccur.***indicatesthesequentialnumbersoftheoccurredcorrectiveandpreventiveactionsineachyear.CAPACAPAQS包括：不合格（潛在不合格）來源及情況描述、提出人、日期、糾正/糾正（預(yù)防）措施的制訂、改進(jìn)部門、預(yù)計(jì)完成時(shí)間、糾正預(yù)防措施的實(shí)施和糾正預(yù)防措施有效性確認(rèn)。QualitydepartmentshallkeeprecordsontheAccessoftheCAPAControl.ThedatabaseislocatedintheQSfolder,including:sourceanddescriptionoftheissue,initiator,date,proposedCorrection/Corrective(Preventive)Actions,improvementdepartment,duedate,CAPAimplementationandVerificationoftheCAPAEffectiveness.TheinvestigationQA，QA根據(jù)不合格（潛在不合格）描述指定調(diào)查部門（或調(diào)查人）對(duì)不合格情況進(jìn)行調(diào)查分析，確定產(chǎn)生不合格（潛在不合格）發(fā)生的原因。Theinitiatingdepartmentshallsubmit“ReportofCorrectiveandPreventiveAction”toQA.QAshalldesignateinvestigationdepartmentsorinvestigatortocarryouttheinvestigationonthenon-conformingaccordingtothedescriptionofnon-conformingorpotentialnon-conformingtoclarifythereasonsfornon-conformingorpotentialnon-conforming.調(diào)查部門（或調(diào)查人）5個(gè)工作日內(nèi)得出調(diào)查結(jié)果（對(duì)技術(shù)性問題的調(diào)查時(shí)間要求在10天之內(nèi)完成）,并將調(diào)查分析填寫在SectionB上。調(diào)查分析應(yīng)包括所有發(fā)生背景，發(fā)生的原因，改進(jìn)部門（一項(xiàng)不合格可能包括幾個(gè)責(zé)任部門。Investigationdepartmentorinvestigatorshallcarryoutinvestigationintimeandresultsshallbereachedinnomorethanfiveworkdays.（technicalproblemshouldbeInvestigatedwithin10days）,TheanalysisofinvestigationshallbefilledinSectionB.Investigationanalysisshallincludethebackground,causes,andresponsibledepartments(asinglenon-conformingispossiblyaffectseveralresponsibledepartments).糾正/Theestablishmentofcorrection/correctiveandpreventiveactionQAQA對(duì)原因分析和調(diào)查結(jié)果有異議，應(yīng)協(xié)同調(diào)查部門（人）進(jìn)行再調(diào)查。QAshallconfirmtheinvestigationdescribedbyinvestigatoranddistributethe‘ReportofCorrectiveandPreventiveAction’totheresponsibledepartments.IfQAdisagreewiththecausation,QAshouldcooperatewithinvestigationdepartments(personnel)toinvestigateitagain.根據(jù)原因的調(diào)查分析，改進(jìn)部門需要進(jìn)行糾正、制定糾正(預(yù)防)SectionC中。Basedontheinvestigation,theresponsibledepartmentsshouldmakethecorrectionandthecorrectiveactions(preventiveactions)plan;andrecordtheminthesectionC.當(dāng)某一不合格項(xiàng)的改進(jìn)需幾個(gè)部門共同進(jìn)行時(shí)，QA需將《糾正預(yù)防措施單》交于相關(guān)部門分別制定糾正預(yù)防措施。IfnotonedepartmentisresponsibleforoneCAPA.QAshouldcopythe‘ReportofCorrectiveandPreventiveAction’anddistributetorelateddepartmentstoseparatelyestablishcorrectiveandpreventiveactions.改進(jìn)部門應(yīng)針對(duì)調(diào)查分析結(jié)果制定糾正預(yù)防措施，改進(jìn)部門可從人、機(jī)、料、法、環(huán)、測(cè)等影響產(chǎn)品質(zhì)量的角度制定糾正和預(yù)防措施，糾正預(yù)防措施的制定應(yīng)關(guān)注其可執(zhí)行性和執(zhí)行效果。Thecorrectiveandpreventiveactionsshallbecreatedbasedonthequalityinfluencefactorssuchaspersonnel,equipment,material,methodandenvironment.Theestablishmentofactionsshouldtakeattentionofthefeasibilityandimplementation.SectionC中寫明理由,QA根據(jù)情況決定是否采取糾正預(yù)防措施。若不需則在此欄中注明“不需制定”。TheresponsibledepartmentshallgiveexplanationinsectionCwhenheregardsitisunnecessaryorimpossibletoestablishcorrectiveandpreventiveactionsaccordingtonon-conformingcircumstanceandactuallyissues.QAshalldecidewhethertoestablishcorrectiveandpreventiveactionsornotandgiveclearindicationof“unnecessary”.（QR091-RE-01）進(jìn)行評(píng)估。IfthecorrectiveandpreventiveactionisrelatedtoaChange,the“ChangeAssessmentForm”（QR091-RE-01）shouldbecompletedfirst.Therequirementsonthetimelineofcorrectiveandpreventiveactions對(duì)于非技術(shù)性的糾正預(yù)防措施，責(zé)任部門應(yīng)在七個(gè)工作日內(nèi)制訂，同時(shí)確定預(yù)計(jì)完成期限，一般要求在Non-technicalcorrectiveandpreventiveactionsaregenerallyrequiredtobeestablishedwithin7workdaysbyimprovementdepartments.Theduedateshouldbeissuedbyimprovementdepartmentsandisgenerallyrequiredwithinonemonth.Thetechnicalcorrectiveandpreventiveactionsshouldbeestablishedwithonemonthandshouldgivedeadlineforimplementation.Theimproveddepartmentsmayincludetheschedulebasedonthecomplexityregardingtechnicalcorrectiveandpreventiveactionsifnecessary.以確保糾正預(yù)防措施能使質(zhì)量風(fēng)險(xiǎn)與成本得到平衡。Theestablishmentofcorrectiveactionsshalltakefullconsiderationoftheexistingproblems’effectonproductquality,productioncost,performance,andcustomersatisfactiontomakesurethatthecorrectiveactionsbalancethequalityrisksandcosts.TheapprovalofcorrectiveandpreventiveactionQA，QA對(duì)該糾正預(yù)防措施的充分性及適宜性再次進(jìn)行審批。Thedepartmentsupervisorshallexamineandapprovethecorrectiveandpreventiveactionstoverifythesufficiencyandappropriateness.Theprojectsupervisorshallexamineandapprovethetechnicalcorrectiveandpreventiveactionsrelatingtoparticularproductstoverifytherationality.Theresponsibledepartmentsshallsubmittheapproved‘ReportofCorrectiveandPreventiveAction’toQA.QAshallexaminethesufficiencyandappropriatenessforasecondtime.糾正預(yù)防措施的實(shí)施與有效性驗(yàn)證Theimplementationandeffectivenessverificationofcorrectiveandpreventiveaction責(zé)任部門按要求實(shí)施糾正預(yù)防措施，并保留相關(guān)的原始記錄。糾正預(yù)防措施完成后，責(zé)任部門應(yīng)將完成QA；Theresponsibledepartmentsshallimplementcorrectiveandpreventiveactionsuponrequirementsandkeeptherelatedoriginalrecords.TheresponsibledepartmentsshallsendtheinformationtoQAuponthecompletionoftheactions.責(zé)任部門若未能按預(yù)計(jì)完成期限完成糾正預(yù)防措施,QA說明原因，并再次確定完成期限；TheresponsibledepartmentsshallcompleteaCAPAStatusReportwithanexplanationtoQAandprovideanewcompletiondateifcorrectiveandpreventiveactionsarenotfulfilledontheanticipateddate.QAQA指定人員對(duì)糾正預(yù)防措施的實(shí)施進(jìn)行跟蹤,（以獲得足夠多的數(shù)據(jù)對(duì)措施的有效性進(jìn)行驗(yàn)證，同時(shí)確認(rèn)糾正預(yù)防措施是否對(duì)產(chǎn)品產(chǎn)生不利影響。QAorassignedspecificallypersonshouldtracktheimplementationofthecorrectiveandpreventiveactionsandrecordtheresultsintheCAPAEffectivenessReport.Atleastthreemonthslaterafteralltheactionshavebeencompleted;QAandCAPAownershouldverifytheeffectivenessoftheactionsandensurethatsuchactiondoesnotadverselyaffectthefinisheddevice;Theconclusionofwhethertheactioniseffectiveornotcouldbereliedonstatisticswiththefollowingqualitydata,i.e.;suchas,customercomplaintdata,auditinformation,manufacturingoperation,technicalprocessinformation,non-conformingmaterialstatus,calibrationandmaintenanceofapparatusesandequipment,newproductsresearchand/orresearchanddevelopmentinformation,etc.ThenverifyingmethodsandresultsshouldberecordedintheCAPAEffectivenessReport.QA應(yīng)持續(xù)關(guān)注各糾正預(yù)防措施項(xiàng)的實(shí)施情況，必要時(shí)（如糾正預(yù)防措施實(shí)施效果不佳）重新制定糾正預(yù)防措施。EveryimprovementdepartmentsandQAshouldtakecontinuanceattentiontoeachaction.Ifnecessary(theeffectofimplementationisnotgood),thecorrectiveandpreventiveactionwillbeworking-outagain.StatusReportofCorrectiveandPreventiveAction5.8.1若相關(guān)部門不能按上面規(guī)定的工作時(shí)間按時(shí)完成原因調(diào)查分析、糾正預(yù)防措施的制定、實(shí)施的工作，必須根據(jù)要求填寫《糾正預(yù)防措施狀態(tài)報(bào)告》向QA說明原因。TheresponsibledepartmentsshallfillinStatusReportofCorrectiveandPreventiveActionandprovideanexplanationtoQAiftheinvestigationastowhytheestablishmentandimplementationofcorrectiveandpreventiveactionwerenotfulfilledontheanticipateddate.ThestatisticalanalysisreportoncorrectiveandpreventiveactionQA12個(gè)月啟動(dòng)的糾正預(yù)防措施進(jìn)行分類匯總統(tǒng)計(jì)分析，內(nèi)容包括：糾正預(yù)防措施的狀態(tài)統(tǒng)計(jì)無效糾正預(yù)防措施的統(tǒng)計(jì)糾正預(yù)防措施的來源分布（人（機(jī)（料（法、環(huán)境改進(jìn)（環(huán)）等進(jìn)行的分類分析和統(tǒng)計(jì)。統(tǒng)計(jì)分析的結(jié)果如有趨勢(shì)性，需根據(jù)附件2《風(fēng)險(xiǎn)評(píng)估表》評(píng)估是否需啟動(dòng)CAPA。QAshallsortandanalyzethecorrectiveandpreventiveactionsinitiatedwithinthelast12monthsonamonthlybasis.Thefollowingitemsshallbeanalyzed:ThestatisticsofstatusforcorrectiveandpreventiveactionsThestatisticsofnon-effectivecorrectiveandpreventiveactionsThesourcesofcorrectiveandpreventiveactionsTocarryoutanalysisandstatisticsonimprovementofpersonneltraining(man),equipment(machine),rawandadjuvantmaterial(material),workmanshipandproductperformance,operationprocedures(method),andenvironment.Iftheanalysisresultsshowthereisanybadtrend,QAshouldevaluateifit’snecessarytoinitiateaCAPAaccordingtotheAppendix2<<riskassessment>>.糾正預(yù)防措施分析報(bào)告應(yīng)提交管理評(píng)審。Theanalysisreportoneffectivenessofcorrectiveandpreventiveactionsshallbesubmittedformanagementreview.相關(guān)文件(RelevantDocuments)《不合格品控制程序》Non-ConformingControlProcedure（QP200）6.2《內(nèi)部質(zhì)量審核程序》InternalAuditProcedure（QP180）《更改控制程序》ChangeControlProcedure（QP090）《數(shù)據(jù)分析、應(yīng)用程序》DataAnalysisandApplicationProcedure（QP210）6.5《生產(chǎn)過程控制程序》ManufacturingProcessControlProcedure（QP120）6.6《顧客溝通程序》CustomerCommunicationProcedure（QP170）6.7《投訴處理流程》CustomerComplaintProcedure（QR311）6.8《更改評(píng)估程序》ChangeAssessmentProcedure(QR086)相關(guān)記錄(RelevantRecords)糾正預(yù)防措施報(bào)告單ReportofCorrectiveandPreventiveAction QP220-RE-01CAPAStatusReportQP220-RE-02CAPAEffectivenessReportQP220-RE-03附件(Appendixes)CAPACAPAworkingflowRiskAssessmentDNQP220Version1Revision1Page9of14DNQP220Version1Revision1Page9of14附件1CAPA工作流程不合格（潛在不合格

（CAPA的需要評(píng)估批準(zhǔn)的潛在輸入）回復(fù)提出部門 QA協(xié)同相關(guān)部門評(píng)審 QANO 是否有必要啟動(dòng)YES指定部門（人）調(diào)查根本原因 QANO QA對(duì)分析的原因及調(diào)查情況進(jìn)行確認(rèn) QAYES

改進(jìn)部門NO 預(yù)防措施

改進(jìn)部門主管QA經(jīng)理YES改進(jìn)部門實(shí)施糾正預(yù)防措施QA對(duì)CAPA進(jìn)行統(tǒng)計(jì)分析

改進(jìn)部門QAQANon-conforming(potentialnon-conforming)OtherSources(potentialinputsthatmayimpactCAPA’sand/orwarrantevaluationandreview)Appendix1 CAPAworkingflowNon-conforming(potentialnon-conforming)OtherSources(potentialinputsthatmayimpactCAPA’sand/orwarrantevaluationandreview)DNQP220Version1Revision1PageDNQP220Version1Revision1PagePAGE13of14相關(guān)部QAcooperatewithrelevantdepartmenttoQAcooperatewithrelevantdepartmenttoYESNO QADesignatedDept.(Personal)investigates rootcause QANOConfirm the investigate QAreasonsYESFollowuponcorrectiveandpreventiveactionbytheImprovementdept.

ImprovementDept.NO ImprovementDep.EvaluateandestablishcorrectiveandpreventiveactionbyrelatedpersonYES

QAmanagerApplicationofcorrectiveandpreventiveactionbytheImprovementdept.FollowupandconfirmationoftheactionbyQAStatisticalanalysisofCAPA

ImprovementDept.QAQA附件2《風(fēng)險(xiǎn)評(píng)估表》使用下列三個(gè)表格來判定風(fēng)險(xiǎn)的等級(jí)：A評(píng)估嚴(yán)重程度B評(píng)估概率程度CCAPA；如評(píng)判結(jié)果沒CCAPA。A嚴(yán)重程度說明嚴(yán)重的產(chǎn)品性能受到影響，且：直接導(dǎo)致使用者/病人死亡或健康嚴(yán)重?fù)p害，或會(huì)產(chǎn)生不正確的信息（比如出錯(cuò)的或損壞的數(shù)據(jù)，從而造成使用者/病人死亡或健康嚴(yán)重?fù)p害。中度的產(chǎn)品性能受到影響，且：直接對(duì)使用者/病人造成可逆的和/或暫時(shí)的傷害，或（逆的和/或暫時(shí)的傷害。微小的只是產(chǎn)品性能受到影響，不會(huì)對(duì)使用者/病人造成任何傷害。B發(fā)生概率說明很可能的在產(chǎn)品壽命期內(nèi)，在特定的操作下發(fā)生過，而且（或者）規(guī)律發(fā)生，或多次發(fā)生；偶爾的（或者罕見的在產(chǎn)品壽命期內(nèi)，在特定的操作下發(fā)生過一次，而且（或者）極少會(huì)發(fā)生，或未必發(fā)生；不可能的在產(chǎn)品壽命期內(nèi)，在特定的操作下預(yù)期中不會(huì)發(fā)生；C發(fā)生概率嚴(yán)重程度嚴(yán)重的中度的微小的很可能的高高中偶爾的高中低罕見的中低低不可能的低低低Appendix2 <<RiskAssessment>>TodeterminetheRiskAssessmentLevel:UseTableAtoassesstheseveritylevel.UseTableBtoassesstheprobabilitylevel.ThenusetheseverityandprobabilitylevelstojudgetheRiskLevel.Iftheresultisinthegrayarea,CAPAshouldbeimitated;iftheresultisnotinthegrayarea,CAPAneednotbeimitated.TableASev