CAPAProcedure纠正和预防措施程序1

第页文件类型DocumentType品质管理体系程序QMSPROCEDURE应用范围ApplicationScope通用GENERAL

修订记录REVISIONHISTORY版本Rev.修改内容RevisedContents作者Author生效日期EFF.DateAInitialreleasingwithISO/TS16949requirementsXXXNov.07,2019BChangethetitlefrom“改正和预防行动程序CorrectiveandPreventiveActionProcedure”to“纠正和预防措施程序ProcedureforCorrective&PreventiveAction”XXXJan.10th,2009CRevisedtheproceduretomeetISO13485regulations(China)&CFR21FDA21CFRQSR(QualitySystemRegulation)820(USA)requirementsXXX15-07-2019

文件审批APPROVAL本文件须经相关部门工程师（或主管）签批，请作者指定。ThisdocumentshallbereviewedbyISOCoordinatorand.Theauthorshalldetermine.编写部门ORIGINATEDEPT.相关部门RELEVANTDEPT.部门名称DEPT.TITLEQAManufacturingMachiningEngineeringPE工程师姓名NAMEOFENGINEER工程师签署SIGNATURE经理姓名NAMEOFMANAGER经理签署SIGNATURE管理者代表签署SIGNATUREOFM.R.Ditto总经理签署SIGNATUREOFGM.拒签理由Reasonofreject:

文件分发DISTRIBUTION部门DEPT.数量Q’TY部门DEPT.数量Q’TY部门DEPT.数量Q’TYEngineeringAssemblyOFFQA1PlatingSourcingHRStampingFinanceMaintenanceMolding目的Purpose本程序规范了为消除存在或潜在的不合格而采取纠正预防措施的流程，以确保类似不合格不再发生或潜在不合格的发生，促进质量管理体系的持续改进。ThisproceduredefinetheprocessoftakingcorrectiveandorpreventiveactionstoEliminateexistingorpotentialnon-conformity,topreventsimilarnon-conformityfromReoccurringoroccurringofpotentialnon-conformity.PromotecontinuousImprovementofqualitysystems.2范围Scope本程序适用于公司质量管理体系范围内纠正和预防措施的制定、实施及验证。Thisprocedureisapplicabletotheformulation,implementationandverificationofCorrectiveactionandpreventiveactioninthecompanyqualitymanagementsystems3定义Definition3.1不合格：未满足指定要求。“要求”是指明示的、通常隐含的或必须履行的需求或期望，如法规、行业标准要求，公司文件要求等Non-conformity:Non-fulfillmentofaspecifiedrequirement.“requirement”referstotheexplicit,usuallyimplicit,Ortheneedorexpectationisamusttofulfill.Suchasregulation,industryrequirement,companydocumentsetc.3.2关键不符合：违反法定工艺、超出内控质量标准或违反生产相关法规规定，将会造成产品整批报废、产品召回、重大客户投诉.不符合关系到安全、企业的品牌形象和产品的市场影响。Criticalnon-conformity:Violatelegalprocess,beyondstandardofinternalcontrolorviolationofrelatedregulationrequirement,whichwillcausescrapofthewholebatchproducts,recallofproduct,majorcustomercomplains,Thenon-conformityrelatedtosafety,brandimageofenterpriseandnegativemarketimpactofproduct.3.3纠正：存在不合格的处置包括修理，返工或调整。Correction:repair,rework,oradjustmentrelatestothedispositionofanexistingnonconformity.3.4纠正措施：消除已发生的不符合或者其他不期望的情况的原因的措施。Correctiveaction:theactiontakentoeliminatethecausesofanexistingnonconformity,defectorotherundesirablesituationinordertopreventrecurrence.3.5预防措施：消除潜在不符合或者其他不期望的情况的原因的措施。Preventiveaction:actiontakentoeliminatethecauseofapotentialnonconformity,defect,orotherundesirablesituationinordertopreventoccurrence.一个不符合或者潜在不符合可能有多个原因。Therecanbemorethanonecausefornon-conformityorapotentialnon-conformity.纠正和纠正措施是有区别的，纠正是针对不符合的，而纠正措施是针对不符合的原因的。Correctionandcorrectiveactionsaredifferent.Correctionisagainstnon-conformitywhereascorrectiveactionisagainstthecauseofnonconformity.纠正措施用于防止不符合再发生，而预防措施用于防止不符合发生。Correctiveactionistakentopreventrecurrenceofnonconformitywhereaspreventiveactionistakentopreventoccurrenceofnon-conformity.3.6趋势分析-一种数据分析，是指通过对CAPA的输入以及输入之间交叉关系分析，根据趋势分析潜在质量问题.Trendanalysis–Onetypeofdataanalysis,throughcrossrelationshipanalysisBetweenCAPAinputs,IdentifythepotentialqualityissuesbasedonThetrendanalysis.3.7风险控制–在特定的水平内,经过讨论采取保护措施以降低或控制对人、财产或环境的风险的过程。Riskcontrol-Inthespecificlevel,perdiscussiontheprocesstakenprotectiveactionsToreduceorcontrolriskonhuman,propertyorenvironment3.8纠正预防措施负责人：负责协调某一特定纠正预防措施报告的决定和实施的个人。CAPAResponsibility:thepersonwhoisresponsibleforcoordinationofthespecificCAPAreportdecisionandimplementation4.职责和权限RESPONSIBILITYANDAUTHORITY4.1问题产生的主管部门负责主导对不合格执行分析、制定、执行相应的纠正措施，对潜在不合格负责实施预防措施。ThedepartmentinwhichIssuesarisingfromisresponsibleforleadingofanalyzing,FormulatingandimplementingcorrespondingcorrectiveactionsfortheexistingNonconformities,andtakepreventiveactionsforthepotentialnonconformities.4.2质量管理部门全面负责纠正措施及预防措施的运行：QAisresponsibleforthecentralizedmanagementof《CAPAreport》品质文员负责《纠正措施及预防措施报告》编号,归档管理QAclerkisresponsibleforthecoding,registrationandarchivemanagement.QA工程师确定不符合是否需要有CAPA流程，纠正及预防措施计划的审批及定期的统计分析,跟踪纠正预防措施的实施过程并验证其有效性。QAengineerisresponsibleforthedeterminationifCAPAisneeded,periodicalStatisticalanalysis,followuptheimplementationofcorrective&preventiveactionsandVerifytheeffectiveness品质经理负责所有CAPA纠正预防措施计划及CAPA关闭的审核。Qualitymanagerisresponsibleforreviewofallcorrective&preventiveplanandClosureofCAPA.4.4公司总经理负责CAPA纠正预防措施计划及CAPA关闭的的最终审批。Siteleaderisresponsibleforthefinalapprovalofallcorrective&preventiveplanandClosureofCAPA4.5公司管理层负责对纠正预防措施进行年度评审CompanymanagementteamisresponsiblefortheannualreviewofcorrectiveActionsandpreventiveactions.工作流程WORKINGFLOWCHART5.程序Procedure5.1纠正预防措施输入:Inputofcorrective&preventiveactions5.1.1纠正预防措施来自于质量管理体系范围内，引起产品不合格或潜在不合格或者其他质量问题的各过程。其输入有以下几个方面：ThesourcesofCAPAarefromeachprocessthatCausednon-conformityorpotentialnon-ConformityInthequalitymanagementsystemincludes:5.1.1.1和原材料,半产品,成品有关的接收活动,Theinspectionactivitiesrelatedtorawmaterials,inprocessproductsandfinishedgoods,5.1.1.2客户投诉,产品退回等问题Customercomplaints,productsreturnetc.issues5.1.1.3质量审核Qualityaudit5.1.1.4管理评审Managementreview5.1.1.5安全问题Safetyissues5.1.1.6其他必要的分析数据Otheranalysisdataasnecessary5.2分析纠正预防措施输入AnalyzeCAPAsourceofdata5.2.1质量工程师根据分析纠正预防措施的输入,如果是关键的质量问题,则需马上启动纠正预防措施,如果是非关键问题,则应对该问题进行分析之后确定是否启动纠正预防措施。QualityengineerrefertotheattachmentItoanalyzetheinputofCAPA.Forthekeynon-Conformities,CAPAshallbelaunchedimmediately,fornon-keynon-formalities,needConductanalysisontheissues,thendetermineifCAPAisneededtolaunch.5.2.2所有的审核发现的不合格,客户投诉，FQC退货以及管理评审将马上启动纠正预防措施。Forallnon-conformitiesraisedduringaudit,customercomplaints,FQCrejectionsandnon-Conformitiesfrommanagementreview,CAPAshallbelaunchedimmediately5.2.3必要时,运用适当的统计方法识别重复发生的质量问题。AppropriatestatisticalmethodologyshallbeemployedwherenecessarytodetectrecurringQualityproblems统计方法包括Statisticalmethodologyincludes:柏拉图Paretocharts运行图Runcharts控制图Controlcharts平均值和标准偏差Meanandstandarddeviation比较t检验Ttestsforcomparisons实验设计Experimentaldesign(DOE)图形方法（鱼刺图，直方图，散布图，电子表格等）Graphicalmethods(fishbonediagrams,histograms,scatterplots,spreadsheets,etc.)5.3纠正预防措施的启动LaunchofCAPA5.3.1经过对纠正预防措施输入分析并确认必要性后,质量工程师将填写《纠正预防措施报告》，完成以下部分：Qualityengineershallfillin<CAPAreport>peranalysisonCAPAinput巨andconfirmtheNecessity,theinputincludes:5.3.1.1指定一个纠正预防措施控制号。编号规则为：纠正预防措施/年/号码顺序。例：CAPA14001(CAPA=纠正预防措施,14=2019,001=这一年的第一份报告)。Specifyonecode#ofCAPA,codingruleas:CAPA/Year/thesequenceofcode#.Forexample:CAPA14001(CAPA=Correctiveactions&Preventiveactions,14=2019,001=thefirstreportoftheyear.5.3.1.2填写“提出人”和提出日期。Fillin“sponsor”andsponsordate5.3.1.3对纠正预防措施问题进行描述。尽可能详细地参考相关程序，规定和客户要求等。附上所有有帮助的其他信息资料。Describetheissueinasmuchdetailaspossiblereferencetorelevantprocedures,Specificationandcustomerrequirements,attachothersupportingdata.5.3.2质量工程师对纠正预防措施报告进行复制存放于纠正预防措施文档中以做跟踪之用。并将纠正预防措施报告原件，发给纠正预防措施负责人。QualityengineercopyCAPAreportandstoreinthefolder<CAPAfile>forfollowupandSendtheoriginalCAPAreporttotheresponsibleperson.5.3.3同时质量工程师应在纠正预防措施跟踪记录表中记录报告编号、发出人、发出时间、质量问题类型及问题的描述以便于跟踪。QualityengineershallrecordCAPAcode,sponsor,time,qualityissuetypesandissue5.3.4问题产生的主管部门负责主导纠正预防措施的调查及措施制定直到完成。除非得到质量管理部负责人的确认,纠正预防措施调查分析/制定措施必须在7个工作日内完成。DepartmentfunctionalleaderisresponsiblefortheinvestigationandactionsoftheCAPAuntilthecompletion.CAPArootcauseinvestigationandactionsshallbeCompletedwithin7workdaysunlessitisconfirmedbyqualitymanager.5.4不合格根源调查以确定根本原因Rootcauseanalysisofnon-conformitiestoidentifytherootcause5.4.1调查有关产品，过程,品质系统不合格的原因Investigatethecauseofnonconformitiesrelatingtoproduct,process,andthequalitySystem.5.4.2确定问题和特性Identifyproblemandcharacterize,5.4.3确定范围和影响Determinescopeandimpact5.4.4调查要根据人、机、料、法、环可能的影响因素Investigaterefertoman,machine,material,method,environmentetc.factors.5.4.5问题根源分析工具Rootcauseanalysistools-鱼刺图Fishbonediagrams-5个为什么5”whys”-故障树分析Fault-treeanalysis-其它Amongothers5.4.6确定问题根源Determinerootcause指定一个根本原因以用于趋向分析。Specifyrootcauseforthetrendanalysis.5.5确定纠正预防措施Identifycorrectiveandpreventiveactions5.5.1问题根源产生的主管部门针对根本原因制定全面的、适当的纠正和预防性措施,采取纠正和预防性措施消除或减少存在的或潜在的不合格程度应及不合格的影响以及风险等级一致。Thedepartmentresponsibleforthenon-conformitiesshalldefinecomprehensive,Appropriatecorrectiveandpreventiveactionsbasedontherootcause.ThedegreeofcorrectiveandpreventiveactionstakentoeliminateorminimizeactualorPotentialnonconformitiesmustbeappropriatetothemagnitudeoftheproblemandCommensuratewiththerisksencountered.5.5.2在《纠正预防措施报告》中记录将要采取的措施，指定责任人，并对每个措施计划指定完成日期，并要求责任人签字确认。Recordtheactionsinthe《CAPAreport>,definetheresponsiblepersonandcompletionDateforeachaction,requestresponsiblepersontosignforconfirmation.5.5.3在完成上述步骤后，纠正预防措施负责人会在报告的“CAPA负责人”处签署姓名和日期，并提交给部门经理审核及签名。然后纠正预防措施负责人把此份CAPA报告提交质量工程师以供其审核。Aftertheabovestepsarecompleted,CAPAresponsiblepersonshallsignhis(her)nameAnddateandsubmitthereporttodepartmentfunctionalleaderforreviewandsignature.5.5.4质量工程师将在纠正预防措施追踪表上记录“措施计划接收日期”。QualityengineershallrecordthereceiptdateofCAPAinCAPAtrackinglogsheet.ThenCAPAresponsiblepersonsubmittheCAPAreporttoqualityengineerforreview.5.6执行纠正预防措施Implementationcorrectiveandpreventiveactions5.6.1责任部门负责人负责纠正预防措施的实施。TheresponsibledepartmentmanagerisresponsiblefortheimplementationofCAPAandRecordchanges.5.6.2如果纠正措施没有在计划的日期内实施，质量工程师应将该情况报告给质量经理。如果在跟踪后3个工作日之后没有进展，质量经理应将该情况报告给总经理并开出一份新的CAPA报告IfCAPAsarenotimplementedwithinthedefinedschedule,qualityengineershallreportTheSituationtoqualitymanager,ifnoanyprogressesof3workdaysafterfollowup,QualityManagershallreportthesituationtositeleaderandissueanewCAPAreport.5.7核实及确认纠正预防措施有效性Verifyorvalidatetheeffectivenessofcorrectiveandpreventiveactions5.7.1质量工程师核实及确认纠正预防措施是否有效，对产品没有负面影响，确认包括：纠正预防措施是否有效？是否可能产生别的潜在不良？评审数据是否关联到核实及确认活动？措施实施后类似的问题是否存在？在《纠正预防措施报告》中记录验证方法和计划验证日期。QualityengineerverifyorvalidatethecorrectiveandpreventiveactionstoensurethatsuchActionsareeffectiveanddonotadverselyaffecttheproducts，TheverificationorvalidationActivityincludes:Effectiveness:Didtheactionswork?Diditcreateotherpotentialnonconformance?Reviewdataassociatedwithverificationorvalidationactivities,IfsimilarqualityproblemsExistafterimplementation.RecordtheverificationmethodanddateinTheCAPAreport.5.7.2如果质量工程师验证纠正预防措施是有效的，不需要修改，质量工程师会在《纠正预防措施报告》处签署姓名和日期,,并提交CAPA报告给品质经理审批。IfQualityengineerverifiedorvalidatedthecorrectiveandpreventiveactionstobeEffective,TheCAPAReportsarenotneededtorevise,andthenqualityengineershallsignHisorhernameanddateintheCAPAreport,andsubmittheCAPAreportforQAmanagerApproval5.7.3质量经理提交其批准的CAPA报告给公司总经理作最终评审及签名。QualitymanagersubmittheCAPAreporttositeleaderforfinalreviewandsignature.5.7.4对关键不符合CAPA纠正预防措施，需要上升到ITTICS运作总监审批Forcriticalnon-conformities,CAPAshallbeescalatetoITTICSoperationdirectorforApproval.5.7.5如果质量工程师验证纠正预防措施是无效的，此《纠正预防措施报告》需上升到公司总经理采取进一步行动计划。IfQualityengineerverifiedorvalidatedthecorrectiveandpreventiveactionstobenotEffective,ThenCAPAreportshallbeescalatedtositeleaderforfurtheractionplans.注意:对措施计划的修改可根据实际情况在纠正预防措施开启的任何时间内进行。Note:ThemodificationofactionsplancanbedoneatanytimeoflaunchingofCAPAbasedonTheactualsituation.5.8文件化纠正预防措施及变更Documentthecorrectiveandpreventiveactionsandchange5.8.1纠正预防措施经证实有效后，行动责任人需文件化纠正预防措施及变更及知会，培训相关人员。ActionownersshalldocumenttheactionsandchangesafterthecorrectiveandpreventiveActionsareverifiedeffectiveanddisseminateortrainrelatedemployees.5.9纠正预防措施报告的关闭CAPAReportclosure5.9.1确认批准的纠正预防措施已经全部完成，纠正预防措施的合理性、有效性和充分性证实后，CAPA报告应予以关闭。品质工程师并在CAPA验证人签署姓名和日期。然后提交给品质经理，公司总经理评审签名。ConfirmtheapprovedcorrectiveandpreventiveactionstobecompletedandactionsareVerifiedasrationale,effectiveness,sufficiency,theCAPAreportcanbeclosed.QualityEngineershallsignhis/hernameanddateinthereport.Thensubmit