CAPA Procedure 纠正和预防措施程序

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1、文件制（修）订申请单DOCUMENTINITIATED/CHANGEDREQUEST(DICR)文件编号DocNo.D0B0046版本RevisionC页码PageNO.Page1of12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/TS16949

2、requirementsXXXNov.07,2006BChangethetitlefrom“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

3、)820(USA)requirementsXXX15-07-2014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SI

4、GNATURE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所有没有红色“文件受控章”的打印文件仅供参考，

5、并且不作更新。Alltheprinteddocumentswithoutreddocumentcontrolstampsarejustforreferenceonly,andwon’tbeupdated.FormNo.:Q1D0001B文件制（修）订申请单DOCUMENTINITIATED/CHANGEDREQUEST(DICR)文件编号DocNo.D0B0046版本RevisionC页码PageNO.Page1of12所有没有红色“文件受控章”的打印文件仅供参考，并且不作更新。Alltheprinted

6、documentswithoutreddocumentcontrolstampsarejustforreferenceonly,andwon’tbeupdated.FormNo.:Q1D0001B纠正和预防措施程序CAPAProcedure文件编号DocNo.D0B0046版本RevisionC页码PageNO.Page12of121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。Thisprocedu

7、redefinetheprocessoftakingcorrectiveandorpreventiveactionstoEliminateexistingorpotentialnon-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

8、纠正和预防措施的制定、实施与验证。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