CAP 改整报告模办.doc

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1、CorrectiveActionPlan(CAP)CAP-001Re0v:0CAPInformationAuditRelatedProductRelatedOtherSpecify:CAPNo:DateInitiated:(2016/05/11)ReferencesT---02-ULCAPAuthor:________________TMSCreataULIntertekOtherSpecify:1.DescriptionofNon-compliance(s)1.1.2Noprocedureandeviden

2、ceofrelevantrecordstorevealedthatfactoryhadcheckedtheQMLforincomingABSandPPresinmaterials2.RootCauseAnalysis由于公司这两种原材料在国外采购，来货时是没有追踪资料的。本厂在产品开发阶段做SDW资料时已经由香港QA进行核对QML,OK后才将SDW上传给TMSQA，同时知会本厂工程部制定FeasBOM和内部BOM文件。所以在来货时本厂IQC也就没有再核查QML#，只是按BOM核对物料供应商名称、型号和外观检查

3、。AstheABSandPPresinareorderedfromoverseas,thereisnotracebilityrecordprovidedbytheresinsupplier.Incurrentpractice,ourHKQAwillprovideandcheckthevalidQML#duringSDWpreparationandsubmittoTMSQAforapproval,atthesametime,ourEngteamwillpreparetheFEASBOMandinternalBO

4、Mdocuments.Therefore,factoryIQCteamwillreferencetotheBOMtocheckthesuppliername,modelnumberandvisualinspection,infact,noQML#willbechecked.Preparedby:Date:3.CorrectiveAndPreventativeActions(CAPA’s)1．立即更新QA-016”化学品控制管理程序“，详细描述来货时QML检查核对方法.2．从现在起，IQC检验报告增加注明QML

5、核查结果。1.UpdatetoQA-16ChemicalcontrolprocedureinordertoidentifytheQMLcheckingprocesswhenthematerialdelivered.2.Withimmediateeffect,IQCinspectorwilllistdowntheQML#checkingrecordintheIQCinspectionreport.Preparedby:_Date:Reviewedby:FilledbylabDate:4.Verification

6、Reviewedby:Date:ReviewStatusSatisfactoryUnsatisfactory5.ClosureReviewReviewedby:Date:ReviewStatusSatisfactoryUnsatisfactory