CAPAProcedure糾正和預(yù)防措施程序1

第頁文件類型DocumentType品質(zhì)管理體系程序QMSPROCEDURE應(yīng)用范圍ApplicationScope通用GENERAL

修訂記錄REVISIONHISTORY版本Rev.修改內(nèi)容RevisedContents作者Author生效日期EFF.DateAInitialreleasingwithISO/TS16949requirementsXXXNov.07,2019BChangethetitlefrom“改正和預(yù)防行動(dòng)程序CorrectiveandPreventiveActionProcedure”to“糾正和預(yù)防措施程序ProcedureforCorrective&PreventiveAction”XXXJan.10th,2009CRevisedtheproceduretomeetISO13485regulations(China)&CFR21FDA21CFRQSR(QualitySystemRegulation)820(USA)requirementsXXX15-07-2019

文件審批APPROVAL本文件須經(jīng)相關(guān)部門工程師（或主管）簽批，請(qǐng)作者指定。ThisdocumentshallbereviewedbyISOCoordinatorand.Theauthorshalldetermine.編寫部門ORIGINATEDEPT.相關(guān)部門RELEVANTDEPT.部門名稱DEPT.TITLEQAManufacturingMachiningEngineeringPE工程師姓名NAMEOFENGINEER工程師簽署SIGNATURE經(jīng)理姓名NAMEOFMANAGER經(jīng)理簽署SIGNATURE管理者代表簽署SIGNATUREOFM.R.Ditto總經(jīng)理簽署SIGNATUREOFGM.拒簽理由Reasonofreject:

文件分發(fā)DISTRIBUTION部門DEPT.數(shù)量Q’TY部門DEPT.數(shù)量Q’TY部門DEPT.數(shù)量Q’TYEngineeringAssemblyOFFQA1PlatingSourcingHRStampingFinanceMaintenanceMolding目的Purpose本程序規(guī)范了為消除存在或潛在的不合格而采取糾正預(yù)防措施的流程，以確保類似不合格不再發(fā)生或潛在不合格的發(fā)生，促進(jìn)質(zhì)量管理體系的持續(xù)改進(jìn)。ThisproceduredefinetheprocessoftakingcorrectiveandorpreventiveactionstoEliminateexistingorpotentialnon-conformity,topreventsimilarnon-conformityfromReoccurringoroccurringofpotentialnon-conformity.PromotecontinuousImprovementofqualitysystems.2范圍Scope本程序適用于公司質(zhì)量管理體系范圍內(nèi)糾正和預(yù)防措施的制定、實(shí)施及驗(yàn)證。Thisprocedureisapplicabletotheformulation,implementationandverificationofCorrectiveactionandpreventiveactioninthecompanyqualitymanagementsystems3定義Definition3.1不合格：未滿足指定要求。“要求”是指明示的、通常隱含的或必須履行的需求或期望，如法規(guī)、行業(yè)標(biāo)準(zhǔn)要求，公司文件要求等Non-conformity:Non-fulfillmentofaspecifiedrequirement.“requirement”referstotheexplicit,usuallyimplicit,Ortheneedorexpectationisamusttofulfill.Suchasregulation,industryrequirement,companydocumentsetc.3.2關(guān)鍵不符合：違反法定工藝、超出內(nèi)控質(zhì)量標(biāo)準(zhǔn)或違反生產(chǎn)相關(guān)法規(guī)規(guī)定，將會(huì)造成產(chǎn)品整批報(bào)廢、產(chǎn)品召回、重大客戶投訴.不符合關(guān)系到安全、企業(yè)的品牌形象和產(chǎn)品的市場影響。Criticalnon-conformity:Violatelegalprocess,beyondstandardofinternalcontrolorviolationofrelatedregulationrequirement,whichwillcausescrapofthewholebatchproducts,recallofproduct,majorcustomercomplains,Thenon-conformityrelatedtosafety,brandimageofenterpriseandnegativemarketimpactofproduct.3.3糾正：存在不合格的處置包括修理，返工或調(diào)整。Correction:repair,rework,oradjustmentrelatestothedispositionofanexistingnonconformity.3.4糾正措施：消除已發(fā)生的不符合或者其他不期望的情況的原因的措施。Correctiveaction:theactiontakentoeliminatethecausesofanexistingnonconformity,defectorotherundesirablesituationinordertopreventrecurrence.3.5預(yù)防措施：消除潛在不符合或者其他不期望的情況的原因的措施。Preventiveaction:actiontakentoeliminatethecauseofapotentialnonconformity,defect,orotherundesirablesituationinordertopreventoccurrence.一個(gè)不符合或者潛在不符合可能有多個(gè)原因。Therecanbemorethanonecausefornon-conformityorapotentialnon-conformity.糾正和糾正措施是有區(qū)別的，糾正是針對(duì)不符合的，而糾正措施是針對(duì)不符合的原因的。Correctionandcorrectiveactionsaredifferent.Correctionisagainstnon-conformitywhereascorrectiveactionisagainstthecauseofnonconformity.糾正措施用于防止不符合再發(fā)生，而預(yù)防措施用于防止不符合發(fā)生。Correctiveactionistakentopreventrecurrenceofnonconformitywhereaspreventiveactionistakentopreventoccurrenceofnon-conformity.3.6趨勢分析-一種數(shù)據(jù)分析，是指通過對(duì)CAPA的輸入以及輸入之間交叉關(guān)系分析，根據(jù)趨勢分析潛在質(zhì)量問題.Trendanalysis–Onetypeofdataanalysis,throughcrossrelationshipanalysisBetweenCAPAinputs,IdentifythepotentialqualityissuesbasedonThetrendanalysis.3.7風(fēng)險(xiǎn)控制–在特定的水平內(nèi),經(jīng)過討論采取保護(hù)措施以降低或控制對(duì)人、財(cái)產(chǎn)或環(huán)境的風(fēng)險(xiǎn)的過程。Riskcontrol-Inthespecificlevel,perdiscussiontheprocesstakenprotectiveactionsToreduceorcontrolriskonhuman,propertyorenvironment3.8糾正預(yù)防措施負(fù)責(zé)人：負(fù)責(zé)協(xié)調(diào)某一特定糾正預(yù)防措施報(bào)告的決定和實(shí)施的個(gè)人。CAPAResponsibility:thepersonwhoisresponsibleforcoordinationofthespecificCAPAreportdecisionandimplementation4.職責(zé)和權(quán)限RESPONSIBILITYANDAUTHORITY4.1問題產(chǎn)生的主管部門負(fù)責(zé)主導(dǎo)對(duì)不合格執(zhí)行分析、制定、執(zhí)行相應(yīng)的糾正措施，對(duì)潛在不合格負(fù)責(zé)實(shí)施預(yù)防措施。ThedepartmentinwhichIssuesarisingfromisresponsibleforleadingofanalyzing,FormulatingandimplementingcorrespondingcorrectiveactionsfortheexistingNonconformities,andtakepreventiveactionsforthepotentialnonconformities.4.2質(zhì)量管理部門全面負(fù)責(zé)糾正措施及預(yù)防措施的運(yùn)行：QAisresponsibleforthecentralizedmanagementof《CAPAreport》品質(zhì)文員負(fù)責(zé)《糾正措施及預(yù)防措施報(bào)告》編號(hào),歸檔管理QAclerkisresponsibleforthecoding,registrationandarchivemanagement.QA工程師確定不符合是否需要有CAPA流程，糾正及預(yù)防措施計(jì)劃的審批及定期的統(tǒng)計(jì)分析,跟蹤糾正預(yù)防措施的實(shí)施過程并驗(yàn)證其有效性。QAengineerisresponsibleforthedeterminationifCAPAisneeded,periodicalStatisticalanalysis,followuptheimplementationofcorrective&preventiveactionsandVerifytheeffectiveness品質(zhì)經(jīng)理負(fù)責(zé)所有CAPA糾正預(yù)防措施計(jì)劃及CAPA關(guān)閉的審核。Qualitymanagerisresponsibleforreviewofallcorrective&preventiveplanandClosureofCAPA.4.4公司總經(jīng)理負(fù)責(zé)CAPA糾正預(yù)防措施計(jì)劃及CAPA關(guān)閉的的最終審批。Siteleaderisresponsibleforthefinalapprovalofallcorrective&preventiveplanandClosureofCAPA4.5公司管理層負(fù)責(zé)對(duì)糾正預(yù)防措施進(jìn)行年度評(píng)審CompanymanagementteamisresponsiblefortheannualreviewofcorrectiveActionsandpreventiveactions.工作流程WORKINGFLOWCHART5.程序Procedure5.1糾正預(yù)防措施輸入:Inputofcorrective&preventiveactions5.1.1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。其輸入有以下幾個(gè)方面：ThesourcesofCAPAarefromeachprocessthatCausednon-conformityorpotentialnon-ConformityInthequalitymanagementsystemincludes:5.1.1.1和原材料,半產(chǎn)品,成品有關(guān)的接收活動(dòng),Theinspectionactivitiesrelatedtorawmaterials,inprocessproductsandfinishedgoods,5.1.1.2客戶投訴,產(chǎn)品退回等問題Customercomplaints,productsreturnetc.issues5.1.1.3質(zhì)量審核Qualityaudit5.1.1.4管理評(píng)審Managementreview5.1.1.5安全問題Safetyissues5.1.1.6其他必要的分析數(shù)據(jù)Otheranalysisdataasnecessary5.2分析糾正預(yù)防措施輸入AnalyzeCAPAsourceofdata5.2.1質(zhì)量工程師根據(jù)分析糾正預(yù)防措施的輸入,如果是關(guān)鍵的質(zhì)量問題,則需馬上啟動(dòng)糾正預(yù)防措施,如果是非關(guān)鍵問題,則應(yīng)對(duì)該問題進(jìn)行分析之后確定是否啟動(dòng)糾正預(yù)防措施。QualityengineerrefertotheattachmentItoanalyzetheinputofCAPA.Forthekeynon-Conformities,CAPAshallbelaunchedimmediately,fornon-keynon-formalities,needConductanalysisontheissues,thendetermineifCAPAisneededtolaunch.5.2.2所有的審核發(fā)現(xiàn)的不合格,客戶投訴，F(xiàn)QC退貨以及管理評(píng)審將馬上啟動(dòng)糾正預(yù)防措施。Forallnon-conformitiesraisedduringaudit,customercomplaints,FQCrejectionsandnon-Conformitiesfrommanagementreview,CAPAshallbelaunchedimmediately5.2.3必要時(shí),運(yùn)用適當(dāng)?shù)慕y(tǒng)計(jì)方法識(shí)別重復(fù)發(fā)生的質(zhì)量問題。AppropriatestatisticalmethodologyshallbeemployedwherenecessarytodetectrecurringQualityproblems統(tǒng)計(jì)方法包括Statisticalmethodologyincludes:柏拉圖Paretocharts運(yùn)行圖Runcharts控制圖Controlcharts平均值和標(biāo)準(zhǔn)偏差Meanandstandarddeviation比較t檢驗(yàn)Ttestsforcomparisons實(shí)驗(yàn)設(shè)計(jì)Experimentaldesign(DOE)圖形方法（魚刺圖，直方圖，散布圖，電子表格等）Graphicalmethods(fishbonediagrams,histograms,scatterplots,spreadsheets,etc.)5.3糾正預(yù)防措施的啟動(dòng)LaunchofCAPA5.3.1經(jīng)過對(duì)糾正預(yù)防措施輸入分析并確認(rèn)必要性后,質(zhì)量工程師將填寫《糾正預(yù)防措施報(bào)告》，完成以下部分：Qualityengineershallfillin<CAPAreport>peranalysisonCAPAinput巨andconfirmtheNecessity,theinputincludes:5.3.1.1指定一個(gè)糾正預(yù)防措施控制號(hào)。編號(hào)規(guī)則為：糾正預(yù)防措施/年/號(hào)碼順序。例：CAPA14001(CAPA=糾正預(yù)防措施,14=2019,001=這一年的第一份報(bào)告)。Specifyonecode#ofCAPA,codingruleas:CAPA/Year/thesequenceofcode#.Forexample:CAPA14001(CAPA=Correctiveactions&Preventiveactions,14=2019,001=thefirstreportoftheyear.5.3.1.2填寫“提出人”和提出日期。Fillin“sponsor”andsponsordate5.3.1.3對(duì)糾正預(yù)防措施問題進(jìn)行描述。盡可能詳細(xì)地參考相關(guān)程序，規(guī)定和客戶要求等。附上所有有幫助的其他信息資料。Describetheissueinasmuchdetailaspossiblereferencetorelevantprocedures,Specificationandcustomerrequirements,attachothersupportingdata.5.3.2質(zhì)量工程師對(duì)糾正預(yù)防措施報(bào)告進(jìn)行復(fù)制存放于糾正預(yù)防措施文檔中以做跟蹤之用。并將糾正預(yù)防措施報(bào)告原件，發(fā)給糾正預(yù)防措施負(fù)責(zé)人。QualityengineercopyCAPAreportandstoreinthefolder<CAPAfile>forfollowupandSendtheoriginalCAPAreporttotheresponsibleperson.5.3.3同時(shí)質(zhì)量工程師應(yīng)在糾正預(yù)防措施跟蹤記錄表中記錄報(bào)告編號(hào)、發(fā)出人、發(fā)出時(shí)間、質(zhì)量問題類型及問題的描述以便于跟蹤。QualityengineershallrecordCAPAcode,sponsor,time,qualityissuetypesandissue5.3.4問題產(chǎn)生的主管部門負(fù)責(zé)主導(dǎo)糾正預(yù)防措施的調(diào)查及措施制定直到完成。除非得到質(zhì)量管理部負(fù)責(zé)人的確認(rèn),糾正預(yù)防措施調(diào)查分析/制定措施必須在7個(gè)工作日內(nèi)完成。DepartmentfunctionalleaderisresponsiblefortheinvestigationandactionsoftheCAPAuntilthecompletion.CAPArootcauseinvestigationandactionsshallbeCompletedwithin7workdaysunlessitisconfirmedbyqualitymanager.5.4不合格根源調(diào)查以確定根本原因Rootcauseanalysisofnon-conformitiestoidentifytherootcause5.4.1調(diào)查有關(guān)產(chǎn)品，過程,品質(zhì)系統(tǒng)不合格的原因Investigatethecauseofnonconformitiesrelatingtoproduct,process,andthequalitySystem.5.4.2確定問題和特性Identifyproblemandcharacterize,5.4.3確定范圍和影響Determinescopeandimpact5.4.4調(diào)查要根據(jù)人、機(jī)、料、法、環(huán)可能的影響因素Investigaterefertoman,machine,material,method,environmentetc.factors.5.4.5問題根源分析工具Rootcauseanalysistools-魚刺圖Fishbonediagrams-5個(gè)為什么5”whys”-故障樹分析Fault-treeanalysis-其它Amongothers5.4.6確定問題根源Determinerootcause指定一個(gè)根本原因以用于趨向分析。Specifyrootcauseforthetrendanalysis.5.5確定糾正預(yù)防措施Identifycorrectiveandpreventiveactions5.5.1問題根源產(chǎn)生的主管部門針對(duì)根本原因制定全面的、適當(dāng)?shù)募m正和預(yù)防性措施,采取糾正和預(yù)防性措施消除或減少存在的或潛在的不合格程度應(yīng)及不合格的影響以及風(fēng)險(xiǎn)等級(jí)一致。Thedepartmentresponsibleforthenon-conformitiesshalldefinecomprehensive,Appropriatecorrectiveandpreventiveactionsbasedontherootcause.ThedegreeofcorrectiveandpreventiveactionstakentoeliminateorminimizeactualorPotentialnonconformitiesmustbeappropriatetothemagnitudeoftheproblemandCommensuratewiththerisksencountered.5.5.2在《糾正預(yù)防措施報(bào)告》中記錄將要采取的措施，指定責(zé)任人，并對(duì)每個(gè)措施計(jì)劃指定完成日期，并要求責(zé)任人簽字確認(rèn)。Recordtheactionsinthe《CAPAreport>,definetheresponsiblepersonandcompletionDateforeachaction,requestresponsiblepersontosignforconfirmation.5.5.3在完成上述步驟后，糾正預(yù)防措施負(fù)責(zé)人會(huì)在報(bào)告的“CAPA負(fù)責(zé)人”處簽署姓名和日期，并提交給部門經(jīng)理審核及簽名。然后糾正預(yù)防措施負(fù)責(zé)人把此份CAPA報(bào)告提交質(zhì)量工程師以供其審核。Aftertheabovestepsarecompleted,CAPAresponsiblepersonshallsignhis(her)nameAnddateandsubmitthereporttodepartmentfunctionalleaderforreviewandsignature.5.5.4質(zhì)量工程師將在糾正預(yù)防措施追蹤表上記錄“措施計(jì)劃接收日期”。QualityengineershallrecordthereceiptdateofCAPAinCAPAtrackinglogsheet.ThenCAPAresponsiblepersonsubmittheCAPAreporttoqualityengineerforreview.5.6執(zhí)行糾正預(yù)防措施Implementationcorrectiveandpreventiveactions5.6.1責(zé)任部門負(fù)責(zé)人負(fù)責(zé)糾正預(yù)防措施的實(shí)施。TheresponsibledepartmentmanagerisresponsiblefortheimplementationofCAPAandRecordchanges.5.6.2如果糾正措施沒有在計(jì)劃的日期內(nèi)實(shí)施，質(zhì)量工程師應(yīng)將該情況報(bào)告給質(zhì)量經(jīng)理。如果在跟蹤后3個(gè)工作日之后沒有進(jìn)展，質(zhì)量經(jīng)理應(yīng)將該情況報(bào)告給總經(jīng)理并開出一份新的CAPA報(bào)告IfCAPAsarenotimplementedwithinthedefinedschedule,qualityengineershallreportTheSituationtoqualitymanager,ifnoanyprogressesof3workdaysafterfollowup,QualityManagershallreportthesituationtositeleaderandissueanewCAPAreport.5.7核實(shí)及確認(rèn)糾正預(yù)防措施有效性Verifyorvalidatetheeffectivenessofcorrectiveandpreventiveactions5.7.1質(zhì)量工程師核實(shí)及確認(rèn)糾正預(yù)防措施是否有效，對(duì)產(chǎn)品沒有負(fù)面影響，確認(rèn)包括：糾正預(yù)防措施是否有效？是否可能產(chǎn)生別的潛在不良？評(píng)審數(shù)據(jù)是否關(guān)聯(lián)到核實(shí)及確認(rèn)活動(dòng)？措施實(shí)施后類似的問題是否存在？在《糾正預(yù)防措施報(bào)告》中記錄驗(yàn)證方法和計(jì)劃驗(yàn)證日期。QualityengineerverifyorvalidatethecorrectiveandpreventiveactionstoensurethatsuchActionsareeffectiveanddonotadverselyaffecttheproducts，TheverificationorvalidationActivityincludes:Effectiveness:Didtheactionswork?Diditcreateotherpotentialnonconformance?Reviewdataassociatedwithverificationorvalidationactivities,IfsimilarqualityproblemsExistafterimplementation.RecordtheverificationmethodanddateinTheCAPAreport.5.7.2如果質(zhì)量工程師驗(yàn)證糾正預(yù)防措施是有效的，不需要修改，質(zhì)量工程師會(huì)在《糾正預(yù)防措施報(bào)告》處簽署姓名和日期,,并提交CAPA報(bào)告給品質(zhì)經(jīng)理審批。IfQualityengineerverifiedorvalidatedthecorrectiveandpreventiveactionstobeEffective,TheCAPAReportsarenotneededtorevise,andthenqualityengineershallsignHisorhernameanddateintheCAPAreport,andsubmittheCAPAreportforQAmanagerApproval5.7.3質(zhì)量經(jīng)理提交其批準(zhǔn)的CAPA報(bào)告給公司總經(jīng)理作最終評(píng)審及簽名。QualitymanagersubmittheCAPAreporttositeleaderforfinalreviewandsignature.5.7.4對(duì)關(guān)鍵不符合CAPA糾正預(yù)防措施，需要上升到ITTICS運(yùn)作總監(jiān)審批Forcriticalnon-conformities,CAPAshallbeescalatetoITTICSoperationdirectorforApproval.5.7.5如果質(zhì)量工程師驗(yàn)證糾正預(yù)防措施是無效的，此《糾正預(yù)防措施報(bào)告》需上升到公司總經(jīng)理采取進(jìn)一步行動(dòng)計(jì)劃。IfQualityengineerverifiedorvalidatedthecorrectiveandpreventiveactionstobenotEffective,ThenCAPAreportshallbeescalatedtositeleaderforfurtheractionplans.注意:對(duì)措施計(jì)劃的修改可根據(jù)實(shí)際情況在糾正預(yù)防措施開啟的任何時(shí)間內(nèi)進(jìn)行。Note:ThemodificationofactionsplancanbedoneatanytimeoflaunchingofCAPAbasedonTheactualsituation.5.8文件化糾正預(yù)防措施及變更Documentthecorrectiveandpreventiveactionsandchange5.8.1糾正預(yù)防措施經(jīng)證實(shí)有效后，行動(dòng)責(zé)任人需文件化糾正預(yù)防措施及變更及知會(huì)，培訓(xùn)相關(guān)人員。ActionownersshalldocumenttheactionsandchangesafterthecorrectiveandpreventiveActionsareverifiedeffectiveanddisseminateortrainrelatedemployees.5.9糾正預(yù)防措施報(bào)告的關(guān)閉CAPAReportclosure5.9.1確認(rèn)批準(zhǔn)的糾正預(yù)防措施已經(jīng)全部完成，糾正預(yù)防措施的合理性、有效性和充分性證實(shí)后，CAPA報(bào)告應(yīng)予以關(guān)閉。品質(zhì)工程師并在CAPA驗(yàn)證人簽署姓名和日期。然后提交給品質(zhì)經(jīng)理，公司總經(jīng)理評(píng)審簽名。ConfirmtheapprovedcorrectiveandpreventiveactionstobecompletedandactionsareVerifiedasrationale,effectiveness,sufficiency,theCAPAreportcanbeclosed.QualityEngineershallsignhis/hernameanddateinthereport.Thensubmit