IMSP-05-纠正措施控制程序-CA-control-procedure-R02V00

Prepared:ApexHeVerified:DepartmentVerifiedDepartmentVerifiedQualityFacility&EHSApproved:Date:SandvikMiningandConstruction(China)Co.,Ltd.AssemblyCenter(Jiading)纠正措施控制程序CAControlProcedureIMSP-05IMSP-05_CORRECTIVEACTIONCONTROLPROCEDURE_R02V00SandvikMiningandConstructionACJiadingPrintedCopiesUncontrolledPage2of8ModificationRecordRev.&Mod.No.Issue.DateDescriptionPreparedVerifiedApprovedCommentR00V002013.6.8NewReleaseFrankZhuSeemainpageDanielJSun/R01V002014-4-28ModificationFrankZhuGordonGeGordonGe/R02V002016-4-22Completelyrewriteaccording2015QMSApexHeSeemainpageGordonGe/IMSP-05_CORRECTIVEACTIONCONTROLPROCEDURE_R02V00SandvikMiningandConstructionACJiadingPrintedCopiesUncontrolledPage3of81.Purpose目的Toidentifythedetectedorpotentialnonconformities,determinepropertycorrectiveandpreventiveactionstoeliminatetherootcauseofnonconformities,andtopreventtheiroccurrence.对已经发生或潜在的事故、事件、不符合进行识别、分析和改进，查明不合格或不符合的根本原因，采取适当的纠正及预防措施，防止类似事故、事件及不符合重复发生。2.Scope范围Besuitabletocorrectivethedetectedorpotentialnonconformitiesoccurredinintegratemanagementsystem.本程序适用于山特维克矿山工程机械（中国）有限公司嘉定装配中心矿山机械产品的整合管理体系中已发生或潜在的不符合的改进。3.Definition定义3.1Correction:actiontoeliminateadetectednonconformity;纠正：为消除已发现的不合格所采取的措施；3.2Correctiveaction:actiontoeliminatethecauseofanonconformity(3.4.3)andtopreventrecurrence；纠正措施：用来消除不合格的原因并防止再次发生的措施；3.3CA:Correctiveaction;纠正措施：缩写为CA；4.Responsibility职责4.1QualityDept.isresponsiblefortheestablishandtheupdateofthedocumentcontrolprocedure;质量部负责本程序的建立和更新；4.2EachdepartmentisresponsiblefortheexecuteofCAoftheirown.各部门负责各自部门纠正措施的执行；4.3QualityDept.andFacility&EHSDept.isresponsibleforthearchiveandmanagementofCAdocumentsandrecords.质量部和设备及环境健康安全部负责CA文件和记录的保存和管理；4.4Otherresponsiblepersonfordetailcansee”5.3”;过程中的确认、验证以及批准的责任人详见“5.3”IMSP-05_CORRECTIVEACTIONCONTROLPROCEDURE_R02V00SandvikMiningandConstructionACJiadingPrintedCopiesUncontrolledPage4of85.Procedure流程纠正措施控制程序质量部&EHS各部门识别已发生或潜在的不符合开据不符合项报告提交质量部或EHS判断不符合项类别产品不符合转入NCR流程根据要求提交NCR报告并归档客诉不符合项转入客户投诉流程根据要求提交8D报告并归档整合体系不符合项是否需要纠正预防措施原因分析Yes制定纠正预防措施跟踪验证是否满足关闭条件不符合项关闭YesNoEHS不符合转入危险源及事件处理流程提交危险源及事件报告并归档CAControlProcessQualityandEHSEachDepartmentIdentifyalreadyhappenedorpotentialNon-conformityIssueNCReportSubmittoQualityDepartmentorEHSJudgeNCcategoryProductNon-conformityenterintoNCRprocessCollect&recordallNCRProductNon-conformityfromcustomercomplaintenterintocustomerclaimprocessSubmit8DreportanddocumentitQMSNon-conformityNeedCAPAornot?RootcauseanalysisYesCreateCAPAVerificationMeetclosecondition?CloseNCReportYesNoEHSNon-conformityenterintoHazardsandincidentsprocessSubmithazardsandincidentsreportanddocumentitIMSP-05_CORRECTIVEACTIONCONTROLPROCEDURE_R02V00SandvikMiningandConstructionACJiadingPrintedCopiesUncontrolledPage5of85.1Theresourceofdetectedofpotentialnonconformitycouldbe:已发生或潜在不符合的来源主要有以下几方面：5.1.1Auditfinding:thenonconformityidentifiedduringaudit;审核发现：审核中的发现的不符合项；5.1.2Non-auditfinding,includingcustomerfeedbackandinternalimprovement,suchas:非审核发现，包括客户反馈和内部改进，具体有：1）Interestedpartiescomplainandfeedback;相关方的抱怨及反馈意见；2）Resultofmanagementreview;管理评审的结果；3）Monitoringandmeasurementofin-process;产品实现过程的监视和测量结果；4）Checkresultofrelatedinstitute;有关部门的检查结果；5）Nonconformitycausedbythechangeoflaws,regulationsandstandards;法律、法规、标准变更引起的不符合；6）Nonconformityfoundduringthesurveyofsomeaccident;事故、事件调查时发现的不符合；7）Self-assessmentofIMSandproductionquality;8）管理体系以及产品质量自我评价的结果；Changesininternalandexternalissues.内外部因素的变化。5.2Nonconformitygradejudgment:不符合项严重程度的判定：Nonconformitycanbedividedinto3grades—observation,minorandmajor:不符合项可分为观察项、轻微以及严重三个等级：5.2.1Observation:nonconformityreportandcorrectiveactionisnotrequired,onlyoralorwrittenattentionisenough.Butshouldpayattentiontoit’strend;观察项：可不开列不合格报告，不要求采取纠正措施，只做口头或书面的提示，但应注意其发展趋势；5.2.2Minor:happenedaccidently,theresultisnotsoseriousandeasytobecorrective;轻微：指偶发、孤立，后果不严重，易于纠正的不符合项；5.2.3Major:loseeffectivenessinsomearea,andtheresultisserious;IMSP-05_CORRECTIVEACTIONCONTROLPROCEDURE_R02V00SandvikMiningandConstructionACJiadingPrintedCopiesUncontrolledPage6of8严重：指系统性以及区域性失效，造成的后果严重；5.3Thetypeofroot-cause/CAPAanalysisandrelatedresponsibleperson各类不符合原因分析形式及相关责任人：不符合的影响程度原因分析及纠正措施制定的形式原因分析及纠正措施的确认人跟踪验证批准关闭非审核过程中发现或潜在的轻微不符合由各部门管理人员在其职权范围内，召集有关人员，分析不合格或不符合原因，制定CA相关主管或部门经理质量部或设备及环境健康安全部，相关主管或部门经理部门经理非审核过程中发现的或潜在的严重不符合由质量部或设备及环境健康安全部经理、相关负责人以及问题发生部门经理共同分析原因并制定CA质量部或设备及环境健康安全部经理及问题发生部门经理质量部或设备及环境健康安全部管理者代表审核过程中发现的不符合项由质量部和设备及环境健康安全部、审核小组成员（内审时）以及被审核部门经理或指定人员共同分析原因并制定CA部门经理质量部和设备及环境健康安全部或审核小组成员（内审时）管理者代表Thetypeofroot-causeanalysisandrelatedresponsiblepersonEffectdegreeofnonconformityThetypeofroot-cause/CAanalysisRoot-cause/CAconfirmFollowandresultconfirmApprovedtobeclosedbyDetectedorpotentialminorNCwhichisnotfoundinnon-auditDept.leaderandrelatedpersontoanalyzerootcausetogetheranddetermineCAPARelatedsupervisorordept.managerQualityDept.orFacility&EHSDept.,relatedsupervisorordept.managerDept.managerDetectedorpotentialmajorNCwhichisnotfoundinnon-auditQualityorFacility&EHSDept.Manageranddetecteddept.leadertoanalyzerootcausetogetheranddetermineCAPAQualityorFacility&EHSDept.manageranddetecteddept.ma