醫(yī)療產(chǎn)品歷史紀(jì)錄控制

1、NyproPlastics&MoldingRev.Date.TotalPages.Products(Suzhou)Co.,Ltd.版本日期總貞碼C2007.02.077Title:ControlofDeviceHistoryrecordPreparedby/DateReviewedby/DateApprovedby/Date醫(yī)療產(chǎn)品歷史紀(jì)錄控制編制/日期審核/日期批準(zhǔn)/日期DocNo:NSU-2402-QC-005FrankLiYookieWangYongCWCONTENTSPAGECONTENTS1AMENDMENTHISTORY21.0PURPOSE32.0SCOPE33.0DEF

2、FNICATIONS&ABBREVIATION34.0RESPONSIBILITIESANDAUTHORITIES35.0PROCEDURE4-56.0QUALITYRECORD67.0QUALIFICATIONSANDTRAINING78.0ASSOCIATEDPROCEDURESANDREFFERENCESLtd.耐普羅塑膠模具(蘇州)有限公司NyproPlastics&MoldingProducts(Suzhou)Co.,AmendmentHistoryAmendmentHistory修改歷史記錄ChangeDate變更日期Rev.No.版本編號(hào)Descriptionof

3、Changes變更說(shuō)明Preparedby:編寫(xiě)人Approvedby:打匕準(zhǔn)人2006-2-14AInitialreleaseSissiLuke2006-5-09BAmendedpointno.6.3ZengDefangLuke2007-2-07CAmendedpointno.4.0,5.0,8.0FrankliYong1.0PURPOSE目的ToestablishandmaintainprocedurestomeettherequirementsofCFR820.184,toensurethatDHR'sforeachbatch,lot,orunitaremaintainedtod

4、emonstratethatthedeviceismanufacturedinaccordancewiththeDMRandtherequirementsoftherespectivepart.按照CFR820.184的要求建立和維護(hù)程序，以確保與DMR和產(chǎn)品的要求一致的每批或者每單元的產(chǎn)品歷史記錄的維護(hù)。2.0SCOPE范圍DHRwillbepreparedonlyformedicalproducts只適用于醫(yī)療產(chǎn)品。3.0DEFINITIONS&ABBREVIATIONS定義和縮寫(xiě)3.1DHRDeviceHistoryRecord,basedontherequirementsofD

5、MR,basicallyalot-specificfileortheproductionlotrecord.AdocumentisneededtoestablishthecontentsoftheDHR.產(chǎn)品制造歷史記錄，基于DMR勺需求，基本上是一個(gè)基于專用批或者生產(chǎn)批次的記錄。需要一個(gè)文件來(lái)建立DHR勺內(nèi)容。3.2 QDQualityDepartment質(zhì)量保證3.3 QMQualityManger質(zhì)量經(jīng)理3.4 CQECustomerQualityEngineer客戶質(zhì)量工程師3.5 BOMBillofMaterial原材料清單3.6 DCCDocumentControlCentre文控

6、中心3.7 QCQualityCheck質(zhì)量檢驗(yàn)3.8 MRBMaterialReviewBoard物料評(píng)審委員會(huì)3.9 PMCProductionMaterialControl生產(chǎn)物料控制4.0RESPONSIBILITIESANDAUTHORITIES職責(zé)和權(quán)限4.1 QASection質(zhì)量保證QAManagerBuildandmaintaintheDHR.QAManager建立和維護(hù)DHR。CQEDefineDHRrequirement.CQE定義DHF需求。CQETransfertheDHRrequirementstorelatingdepartment.CQE將DHF需求傳遞給相關(guān)部

7、門(mén)。CQE/DCCDefinelotnoformat,structureanddocumentation.CQE/DCC定義批號(hào)格式、結(jié)構(gòu)和文件化形式。QCPerformpre-shipmentaudit,verifyDHFeveryshipment.QC執(zhí)行出貨的檢查、每批出貨檢查DHF。QCFeleaseproductsafterthereviewofDHFrecords.QC依據(jù)DHR己錄結(jié)果發(fā)放產(chǎn)品。QCCollectandtransferrecordstoDCCQC每天收集并移交記錄給DCC。4.2 DCC文控中心Keeprecordsbyabovelotnoformat.依據(jù)以上格

8、式保管相關(guān)記錄。4.3 Productiondepartment生產(chǎn)夸6門(mén)Fecords.記錄。CollectrecordsandtransferittoQC.每班收集記錄并交給QC.5.1 PFOCEDUFE程序5.1 Developtemplateaccordingtoproductstructure;依據(jù)產(chǎn)品結(jié)構(gòu)建立模板；5.2 Defineinformationneeded.InformationneededinDHR:明確需要的信息。在DHF需要的信息如下：5.3 Materialsinformation原材料信息5.4 Productiontraceabilitydatainfor

9、mation產(chǎn)品生產(chǎn)追溯數(shù)據(jù)信息5.5 Thelabelorlabelingrecordsusedforeachproductionunit每個(gè)生產(chǎn)單元的標(biāo)簽或鑒別方法5.6 Thedatesandthequantitiesofmanufacture制造日期/制造數(shù)量5.7 Keyproductionrunsheets各種關(guān)鍵生產(chǎn)運(yùn)行表格5.8 Qualityassurancetestreports質(zhì)量保證測(cè)試報(bào)告5.9 Deviationnoticesordiscrepancystatementsduringthemanufactureoflot每個(gè)D(J造批次的偏差說(shuō)明5.10 Resul

10、tsoftestfailureinvestigations不合格產(chǎn)品的調(diào)查結(jié)果5.11 Definetherecordsaccordingtherequirementsabove;根據(jù)以上需求定義需要的記錄；5.12 Implementtherecordscollection,check,productreleaseandstorage.執(zhí)行記錄收集、檢查、產(chǎn)品放行、記錄歸檔保存工作。5.13 Generalstepsandrolesassignment正常步驟與職責(zé)分工流程如下：Thenormalprocessasbelow正常流程如下ProcessRoles:QMCQECQEProduct

11、ion/QCProduction/QCQCQCQCDCCTimeBeforeproductionBeforeproductionBeforeproductionAfterDHREachshiftinproductionEachshiftinproductionEachshiftinproductiocEachday5.2 RECORDS言己6.1 Foreachdeviceorproject,needtodefinetherequiredDHRrecordsduetoproductstructure.對(duì)于每個(gè)具體的產(chǎn)品或項(xiàng)目，需要根據(jù)產(chǎn)品的特性定義DHR具體需要的記錄。6.2 Recordsk

12、eeper:DCC記錄保管者：文控中心6.3 Recordsstorerequirement記錄保管要求Nolessthan7years,accordingtoGMPrequirementoraspertheCustomer'srequirement;whicheverisgreater,依據(jù)GMP標(biāo)準(zhǔn)不少于7年?；蛘甙凑湛蛻舻囊蟆?.0QUALIFICATIONSANDTRAINING培笥”要求TherecordcollectingpeopleneedadditionaltrainingforDHRrequirements.記錄收集人員需要專門(mén)的DHR要求培m|。8.0ASSOCIATEDPROCEDURESANDREFERENCES相關(guān)程序和參考文件Documentcontrolprocedure(NSU-2402-QC-001)文件控制程序(NSU-2402-QC-001)ControlofQualityrecordsprocedure(NSU2402-QC-002)記錄控制程序(N