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首页 记录管理SOP

记录管理SOP.doc

记录管理SOP

poemcloud
2018-09-10 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《记录管理SOPdoc》,可适用于医药卫生领域

文件题目DocumentTitle记录管理SOPSOP–Recordmanagement文件编号DocumentCode文件版本号VersionCode()文件种类CategoryofDocument管理类Management发放部门DepartmentofIssueQA人员Person类别Category姓名职位NamePosition签名Signature日期Date编写人Compiledby审核人Checkby批准人Approvedby生效日期Validfrom文件分发部门:()Departmentofdocumentdistributed:序号SerialNo部门名称DepartmentName房间号RoomNo负责人Manager文件变更历史:Historyofdocumentchanging:版本号VersionCode变更日期ChangingDate变更内容摘要AbstractofChangingContents()建立文件Filefoundation目的Aim规范记录的管理程序。Tostandardizesthemanagementproceduresofrecords范围Scope本SOP适用于公司记录的发放、填写、审核、归档、保存、回收销毁等程序。ThisSOPisapplytothedistribution,filling,checking,filing,saving,recallinganddestroyingproceduresofrecordofcompany职责ResponsibilityQA部作为公司记录的主要管理部门负责本SOP的制定及更新。QAdepartmentisresponsibleforcreatingandupdatingthisSOPasthemainlymanagementdepartmentofcompany’srecord各操作部门负责在操作的同时及时、真实地填写原始记录并进行整理。Theoperatedepartmentsareresponsibleforfillingtheoriginalrecordstimelyandfactuallywhenoperating,andneateningoftherecords各部门负责归档保存本部门的管理记录。DepartmentsareresponsibleforfilingandsavingthemanagementrecordoftheirdepartmentsQA部负责保存与产品相关的记录包括批生产记录、批检验记录、产品放行记录、投诉和召回记录等。QAdepartmentisresponsibleforsavingtheproductrelatedrecord,includingthebatchproductionrecord,batchtestrecordandcomplainandrecallrecord内容Content发放Delivering批生产记录的发放DeliveringofBatchProductionRecord由使用部门的车间负责人或工艺员按生产指令在生产前到文件管理QA处领取由QA文件管理员利用该文件的原件在QA文件资料室进行复印在复印件的每一页下方用盖上蓝色流水号。流水号的编制方式如下:S年份后两位月份三位流水号如年月第一次使用的批生产记录应编号为:S第二次使用的记录编号为S以此类推。如遇到设备故障或停电等原因暂停生产的要及时收回未使用的记录并进行登记。QA在发放和收回记录时要及时登记《批生产记录发放、收回登记表》(附录)。Forthedeliveryofbatchproductionrecords,workshopheaderorprocesscontrollerofusingdepartmentreceivetherecordwithblueserialnumberonthebelowofeachpageaccordingtomanufactureorderbeforetheproductionTherecordiscopiedbydocumentmanagementQAwiththeoriginaldocumentindocumentroomofQAdepartmentTheformationofserialnumberislikebelow:“Sthebehindtwonumbersofyearthebehindtwonumbersofmonththreefollowingnumber”Forexample,thefirstusedbatchproductionrecordinJanshouldbenumberedasS,thesecondusedbatchproductionrecordinJanshouldbenumberedasS,andsoonIftheproductionwouldbestoppedbythereasonsofequipmentfaultorstoppingsource,theunusedrecordsshouldberecalledatonceandregisteredQAshouldregister“Recallanddeliveryregisteraccountofbatchproductionrecords”timelywhendeliveryandrecallrecords,seeannex批检验记录的发放DeliveringofBatchTestRecord对于批检验记录的发放由QC负责人指定专人按生产指令或请验单到文件管理QA处领取由文件管理QA利用该文件原件在文件管理室复印出来在记录的每一页下方用盖上流水号。流水号的编制方式如下:X年份后两位月份三位流水号。成品批检验记录X应为“C”中间产品批检验记录X应为“Z”原料批检验记录X应为“Y”辅料批检验记录X应为“F”包材批检验记录X应为“B”介质的批检验记录X应为“J”。如年月第一次使用的成品批检验记录应编号为:C第二次使用的记录编号为C以此类推。如遇到设备故障或停电等原因暂停生产的要及时收回未使用的记录并进行登记。QA在发放和收回记录时要及时登记《批检验记录发放、收回登记表》(附录)。Forthedeliveryofbatchinspectionrecords,someonespecifiedbyQCheaderreceivetherecordwithblueserialnumberonthebelowofeachpageaccordingtomanufactureorderorApplicationlistTherecordiscopiedbydocumentmanagementQAwiththeoriginaldocumentindocumentroomofQAdepartmentTheformationofserialnumberislikebelow:“Xthebehindtwonumbersofyearthebehindtwonumbersofmonththreefollowingnumber”Forfinishproductbatchinspectionrecord,“X”shouldbe“C”Forintermediateproductbatchinspectionrecord,“X”shouldbe“Z”ForAPIbatchinspectionrecord,“X”shouldbe“Y”Forexcipientbatchinspectionrecord,“X”shouldbe“F”Forpackagematerialbatchinspectionrecord,“X”shouldbe“B”Formediabatchinspectionrecord,“X”shouldbe“J”Forexample,thefirstusedfinishproductbatchinspectionrecordinJanshouldbenumberedasC,thesecondusedfinishproductbatchinspectionrecordinJanshouldbenumberedasC,andsoonIftheproductionwouldbestoppedbythereasonsofequipmentfaultorstoppingsource,theunusedrecordsshouldberecalledatonceandregisteredQAshouldregister“Recallanddeliveryregisteraccountofbatchinspectionrecords”timelywhendeliveryandrecallrecords,seeannex确认验证记录的发放DeliveringofQualificationValidationRecord由确认验证负责人到文件管理QA处领取QA文件管理员利用该文件的原件在文件资料室复印出来在记录的每一页下方用盖上流水号。流水号的编制方式如下:Q年份后两位月份三位流水号。如遇到设备故障或停电等原因暂停验证的要及时收回未使用的记录并进行登记。QA在发放和收回记录时要及时登记《确认验证记录发放、收回登记表》。Forthedeliveryofqualificationvalidationrecords,theresponsiblepersonofqualificationvalidationreceivetherecordwithblueserialnumberonthebelowofeachpageTherecordiscopiedbydocumentmanagementQAwiththeoriginaldocumentindocumentroomofQAdepartmentTheformationofserialnumberislikebelow:“Qthebehindtwonumbersofyearthebehindtwonumbersofmonththreefollowingnumber”Ifthequalificationvalidationwouldbestoppedbythereasonsofequipmentfaultorstoppingsource,theunusedrecordsshouldberecalledatonceandregisteredQAshouldregister“Recallanddeliveryregisteraccountofqualificationvalidationrecords”timelywhendeliveryandrecallrecords,seeannex各部门管理记录的发放DeliveringofManagementRecordofDepartments由各部门文件负责人员到文件管理QA处领取文件管理QA根据文件的原件进行复印在每一页盖上流水号计数发放。流水号的编制方式如下:年份后两位月份三位流水号。由于管理记录的使用量大使用频繁故一次发放一个月使用量以上登记《部门管理记录发放记录》并由每个月初由现场QA核实上个月部门管理记录的剩余情况再由部门文件负责人员进行补领。《部门管理记录发放记录》应由各部门自行保管领用时凭该表及QA确认情况进行补领。TheadministratorofeachdepartmentreceivetherecordsatdocumentmanageQATherecordiscopiedbydocumentmanagementQAwiththeoriginaldocumentindocumentroomofQAdepartmentEachpageofthecopymustbestampedaserialnumberlikebelow:“thebehindtwonumbersofyearthebehindtwonumbersofmonththreefollowingnumber”TherecordsshouldbereleasedmorethanamonthusageamountbecausetheyarefrequentlyusedFillthe“DeliveringRecordofDepartmentmanagementRecord”Atthebeginningofeachmonth,siteQAinspectorshouldcheckthesurplusrecordlastmonth,andthedepartmentdocumentadministerreceivethenewrecordagainThe“DeliveringRecordofDepartmentmanagementRecord”shouldbesavedbydepartmentsthemself,receivenewrecordwiththissheetandQA’sconfirmation状态标识、标签等由于其印制量大故应对其印制量及发放加以控制实行部门负责人、管理人员、操作工分级控制由使用部门根据批指令分次分批发放。原件应全部留存使用过程中出现的废件要妥善管理保存不得随意丢弃最后交由现场QA进行销毁。现场QA要认真检查督促。TheprintingquantitymustberecordedanddeliveryofstatesignsandlabelsbecausethelargenumberofprintingItisnecessarytoimplementsteppingcontrolbytheheadofrelated–department,managerialstaffandoperatorsAlloriginaldocumentsmustbesavedWehavetomanageandsavethedefectivedocumentswhicharegeneratingwhenusingproperlyandcannotrejectoptionallyThenhandthesedefectivedocumentstoQAinsitetodestroyQAinsiteshouldinspectandsuperviseseriously填写Fillingout本公司的原始记录(包括文件的签名)统一使用蓝色不褪色的碳素中性笔填写。Consistentlyusebluecarbongelpenwhichwillnotfadetofilloutoriginalrecords(includingthesignatureofdocument)oftheCompany记录应由操作人在操作的第一时间真实、及时地填写不得事后补填。填写记录应字迹清晰、易辨别不得容易混淆。填写记录应完整不得有“见…”、“同上”之类的填写方式。Recordshallbethefirstoperatorintheoperationtimeistrue,completeandtimelymanner,nolaterfillingcomplementCompleterecordsshallbelegibleandeasytoidentify,notconfusingCompleterecordsshouldbecompleteandno"see","ditto"fillinlikemanner品名等应写全名并按标准名填写不可写简名。ProductNameshouldbefullwrittenaccordingtostandardizedname,nottowritesimplename签名要签写全名不得简写不得盖印代替。Signthefullname,notshortname,notinsteadbystamping数据的修约应采用舍进机会相同的修约原则即“”舍“”入“”留双。Therevisionofthedatashouldadopttheprinciple“Banker'sRounding”按表格内容填写齐全、数据完整除备注外不得留有空格如无内容可填写可对角划斜线表示。Completetheformfilledbythecontent,dataintegrity,inadditiontoNotes,shallnotleaveaspace,suchasnocontentcanbefilled,candrawadiagonalslashsaid记录填写错误时填写人不得用涂改液涂改或用笔涂黑后涂改。应用笔在原数据或文字上轻划一条横线然后在旁边写上正确的数据或文字。并在修正处签上姓名和日期。原数据或文字应仍清晰可辨认。数据需更改时应整体划线不能只更改局部。如“:”须改为“:”时应为“::”而不能为“:”。FillintheerrorlogwhencompletedshallnotbealteredwithcorrectionfluidorapentoblackenafterthealterationsUseapentodrawahorizontallineontheoriginaldataortextlight,andthenwritethecorrectdataortextbyitssideAndsigninnameanddateatamendmentOriginaldataortextshouldremainclearlyidentifiableTheoverallneedtochangethedatashouldbecrossed,notjustchangethepartSuchas":"tobechangedto":",theshouldbe"::",butnotforthe":"记录填写完成后应及时汇总交给部门负责人。Afterthecompletedrecordshallbepromptlycollecttothedepartmenthead审核Checking各部门管理人员负责对本部门的管理记录进行审核。Administrativestaffofeachdepartmentisresponsibleforcheckingofthemanagementrecord确认验证部门负责对本部门的确认验证记录进行审核。Qualificationvalidationdepartmentsareresponsibleforcheckingofthequalificationvalidationrecordsoftheirdepartments生产技术部负责对批生产记录进行审核QC部负责对批检验记录进行审核。PandDdepartmentisresponsibleforcheckingbatchproductionrecordsQCdepartmentisresponsibleforcheckingbatchinspectionrecordsQA负责对批记录(包括批生产记录、批检验记录)、确认和验证记录及各部门的关键管理记录进行审核。其中批记录的审核程序参考《批记录管理SOP》(编码:)。QAisresponsibleforcheckingofbatchrecords(includingbatchproductionrecordandbatchinspectionrecord),qualificationvalidationrecordandthecriticalmanagementrecordofdepartmentsThecheckingprocedureofbatchrecordsee“SOPManagementofbatchrecords”(Code:)归档、销毁Filinganddestroying设备工程部负责保存与设备相关的记录。和设备相关的记录可作为设备档案的一部分。使用部门按年将每台设备的使用、内部校正记录、确认记录等汇总后交给设备工程部作为该设备的档案存档保存。设备记录保存至该设备报废。当设备报废时该设备相关的设备记录应由设备工程部填写《记录销毁申请单》向QA部提出申请经QA负责人及主管领导批准后销毁同时应完成《记录销毁登记表》。EquipmentdepartmentisresponsibleforsavingtheequipmentrelatedrecordsEquipmentrelatedrecordscanbeusedaspartofequipmentfilesTheusingdepartmentscollecttheuseandinternalcalibrationrecords,qualificationrecordsofeveryequipment,delivertoEquipmentdepartmentandsaveasthisequipment’sfileTheequipmentfilemustbesavedtilltheequipmentisscrappedWhentheequipmentisscrapped,Equipmentdepartmentshouldfill“ApplicationforDestructingRecord”,deliverittoQAdepartmentAfterapprovedbyHeadofQAandvicemanager,theequipmentrelatedrecordsmustbedestroyedand“DestructionRegisterofRecord”mustbefinishedatthesametime和产品相关的记录包括批生产记录、批检验记录、批放行记录、产品投诉处理记录、不良反应记录、确认验证记录等由QA负责归档保存。其中批记录的归档保存参考《批记录管理SOP》(编码:)。上述记录保存至该批产品有效期后一年。如果该产品有效期加一年仍不足五年记录应保存至少五年。超过保存期后由文件管理QA填写《记录销毁申请单》向QA部提出申请经QA负责人及主管领导批准后销毁同时应完成《记录销毁登记表》。QAisresponsibleforfilingandsavingtheproductrelatedrecords,includingbatchproductionrecords,batchinspectionrecords,batchreleaserecords,productcomplaintrecords,adversereactionrecords,qualificationvalidationrecordsThefilingandsavingofbatchrecordsee“SOPManagementofbatchrecords”(Code:)TheserecordsmustbesavedtilloneyearaftertheproductionexpirydateIftheproductionexpirydateislessthanyears,therecordsmustbesavedforatleastyearsWhenexceedthesavingperiod,thedocumentmanagementQAfill“ApplicationforDestructingRecord”,deliverittoQAdepartmentAfterapprovedbyHeadofQAandvicemanager,theequipmentrelatedrecordsmustbedestroyedand“DestructionRegisterofRecord”mustbefinishedatthesametime部门管理记录由各部门按年度负责归档保存保存时间一般为三年。超过保存期后由本部门填写《记录销毁申请单》向QA部提出申请经QA负责人及主管领导批准后销毁同时应完成《记录销毁登记表》。Themanagementrecordsofdepartmentsshouldbefiledandsavedbyrelateddepartmentbyyear,andthesavingtimeisordinaryyearsWhendocumentexceedthesavingperiod,thedepartmentshouldfill“ApplicationforDestructingRecord”,deliverittoQAdepartmentAfterapprovedbyHeadofQAandvicemanager,theequipmentrelatedrecordsmustbedestroyedand“DestructionRegisterofRecord”mustbefinishedatthesametime失效记录Invalidrecords在文件生效时发放到各部门前应收回失效版本的文件。详见《文件的印制、发放、保管、收回及销毁SOP》(编码:)。当文件中包含记录文件管理QA应将已发放到现场的失效的空白记录收回核对记录编号、发放数量等在其它QA的监督下进行销毁同时应完成《记录销毁登记表》。Whennewversiondocumentcomeintoforce,theinvalidversiondocumentmustberecalledbeforedeliveringthenewversionSee“SOPPrinting,delivering,keeping,recallinganddestructionofdocuments”(code)Iftherearerecordsincludedinthedocument,documentmanageQAmustrecalltheinvalidblankrecordswhicharealreadydeliveredtosite,checktherecordnumberandamountandetcDestroytherecordsunderthesupervisingofanotherQA,andfillthe“DestructionRegisterofRecord”atthesametime附录Annex附录:《批生产记录发放、收回记录》编码:Annex:DeliveringandRecallingRecordofBatchProductionRecord附录:《批检验记录发放、收回记录》编码:Annex:DeliveringandRecallingRecordofBatchInspectionRecord附录:《确认、验证记录发放、收回记录》编码:Annex:DeliveringandRecallingRecordofQualificationValidationRecord附录:《部门管理记录发放记录》编码:Annex:DeliveringRecordofDepartmentmanagementRecord附录:《记录销毁申请表》编码:Annex:ApplicationforDestructingRecord附录:《记录销毁登记表》编码:Annex:DestructionRegisterofRecord批生产记录发放、收回记录DeliveringandRecallingRecordofBatchProductionRecord部门名称Dept:年year:月month:发放Delivering收回Recalling发放日期Date记录名称RecordName记录编号RecordCode份数Copy发放人Deliveredby接收人Receivedby收回日期Date份数Copy收回人Recalledby记录审查Recordinspection□合格Release□不合格Reject批检验记录发放、收回记录DeliveringandRecallingRecordofBatchInspectionRecord部门名称Dept:年year:月month:发放Delivering收回Recalling发放日期Date记录名称RecordName记录编号RecordCode份数Copy发放人Deliveredby接收人Receivedby收回日期Date份数Copy收回人Recalledby记录审查Recordinspection□合格Release□不合格Reject确认、验证记录发放、收回记录DeliveringandRecallingRecordofQualificationValidationRecord部门名称Dept:年year:月month:发放Delivering收回Recalling发放日期Date记录名称RecordName记录编号RecordCode份数Copy发放人Deliveredby接收人Receivedby收回日期Date份数Copy收回人Recalledby记录审查Recordinspection□合格Release□不合格Reject部门管理记录发放、收回记录DeliveringRecordofDepartmentmanagementRecord部门名称Dept:年year:月month:发放日期Date记录名称RecordName记录编号RecordCode份数Copy发放人Deliveredby接收人Receivedby记录审查Recordinspection□合格Release□不合格Reject记录销毁申请表ApplicationforDestructingDocument记录基本信息Basicinformationofrecord销毁原因Reasonsfordestruction销毁方法Destructionmethod销毁的最后期限Deadlineofdestruction提出销毁人RequestedAppliedby日期DateQA负责人意见StatementofQAmanager签名日期SIGdate分管领导意见Statementofrelatedmanager签名日期SIGdate销毁人Destructor监督人Supervisor记录销毁登记表Destructionregisterofrecord记录名称Title记录编号Codeofrecord所属部门Department销毁日期Destructiondate销毁方式Destructionmethod销毁地点Destructionplace销毁人Destructor监督人Supervisor备注Remark记录审查Recordinspection□合格Release□不合格Reject生效日期:Validfrom:版本号:Versioncode:页码:PageNo:

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