医疗产品历史纪录控制.doc

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1、NyproPlastics&MoldingRev.Date.TotalPages.Products(Suzhou)Co.,Ltd.版本日期总页码　C2007.02.077Title:ControlofDeviceHistoryrecordPreparedby/DateReviewedby/DateApprovedby/Date医疗产品历史纪录控制编制/日期审核/日期批准/日期DocNo:NSU-2402-QC-005FrankLiYookieWangYongCWCONTENTSPAGECONTENTS1AMENDM

2、ENTHISTORY21.0PURPOSE32.0SCOPE33.0DEFFNICATIONS&ABBREVIATION34.0RESPONSIBILITIESANDAUTHORITIES35.0PROCEDURE4-56.0QUALITYRECORD67.0QUALIFICATIONSANDTRAINING78.0ASSOCIATEDPROCEDURESANDREFFERENCES7NSU-2402-QC-005Rev:CPage7of7耐普罗塑胶模具(苏州)有限公司NyproPlastics&MoldingPr

3、oducts(Suzhou)Co.,Ltd.AmendmentHistoryAmendmentHistory修改历史记录ChangeDate变更日期Rev.No.版本编号DescriptionofChanges变更说明Preparedby:编写人Approvedby:批准人2006-2-14AInitialreleaseSissiLuke2006-5-09BAmendedpointno.6.3ZengDefangLuke2007-2-07CAmendedpointno.4.0,5.0,8.0FrankliYongN

4、SU-2402-QC-005Rev:CPage7of71.0PURPOSE目的ToestablishandmaintainprocedurestomeettherequirementsofCFR820.184,toensurethatDHR’sforeachbatch,lot,orunitaremaintainedtodemonstratethatthedeviceismanufacturedinaccordancewiththeDMRandtherequirementsoftherespectivepart.按照

5、CFR820.184的要求建立和维护程序，以确保与DMR和产品的要求一致的每批或者每单元的产品历史记录的维护。2.0SCOPE范围DHRwillbepreparedonlyformedicalproducts只适用于医疗产品。3.0DEFINITIONS&ABBREVIATIONS定义和缩写3.1DHRDeviceHistoryRecord,basedontherequirementsofDMR,basicallyalot-specificfileortheproductionlotrecord.Adocument

6、isneededtoestablishthecontentsoftheDHR.产品制造历史记录，基于DMR的需求，基本上是一个基于专用批或者生产批次的记录。需要一个文件来建立DHR的内容。3.2QDQualityDepartment质量保证3.3QMQualityManger质量经理3.4CQECustomerQualityEngineer客户质量工程师3.5BOMBillofMaterial原材料清单3.6DCCDocumentControlCentre文控中心3.7QCQualityCheck质量检验3.8MR

7、BMaterialReviewBoard物料评审委员会3.9PMCProductionMaterialControl生产物料控制4.0RESPONSIBILITIESANDAUTHORITIES职责和权限NSU-2402-QC-005Rev:CPage7of74.1QASection质量保证QAManagerBuildandmaintaintheDHR.QAManager建立和维护DHR。CQEDefineDHRrequirement.CQE定义DHR需求。CQETransfertheDHRrequirements

8、torelatingdepartment.CQE将DHR需求传递给相关部门。CQE/DCCDefinelotnoformat,structureanddocumentation.CQE/DCC定义批号格式、结构和文件化形式。QCPerformpre-shipmentaudit,verifyDHReveryshipment.QC执行出货的检查，每批出货检查DH