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ID:51312024
大小:3.92 MB
页数:56页
时间:2020-03-21
《文件与记录控制培训.ppt》由会员上传分享,免费在线阅读,更多相关内容在应用文档-天天文库。
1、DocumentsandRecords1LearningObjectivesAttheconclusionofthissession,youwillbeableto:explainthedifferencebetweendocumentsandrecords;describethehierarchyofdocumentsandtheroleofeachlevel;outlinethecontentsofaqualitymanual;outlinethecontentthatshouldbeincludedinastandardoperatingproced
2、ure;explaintheimportantsteps,orelements,ofalaboratorydocumentmanagementsystem;describemethodsandtoolstoproperlystoredocumentsandrecords.2DocumentsandRecords-Module16Scenariotestingalgorithmsafetymanualclienttestresultsstandardoperationprocedures(SOPs)foranapprovedHIVrapidtestmanuf
3、acturertestkitinsertssummaryoffindingsfromon-siteevaluationvisitreportofcorrectiveactionstemperaturelog(blankform)qualitycontrolrecord(blankform)dailymaintenancelog(completed)stockcardsandstockbook(completed)EQAspecimentransferlog(completed)Youhavefoundallthesepaperslyingonadesk.W
4、hichofthesearedocumentsandwhicharerecords?3DocumentsandRecords-Module16TheQualityManagementSystemOrganizationPersonnelEquipmentPurchasing&InventoryProcessControlInformationManagementDocuments&RecordsOccurrenceManagementAssessmentProcessImprovementCustomerServiceFacilities&Sa
5、fety4DocumentsandRecords-Module16Whydolaboratoriesneedtomanagedocumentsandrecords?Tofindinformationwheneveritisneeded!5DocumentsandRecords-Module16DocumentsandRecords—Howdotheydiffer?Documentscommunicateinformationviapolicies,processes,andproceduresneedupdatingRecordscaptureinfor
6、mationonworksheets,forms,labels,andchartspermanent,donotchangeRECORDS6DocumentsandRecords-Module16Informationisthemajorproductofthelaboratory7DocumentsandRecords-Module16LaboratoryDocuments8DocumentsandRecords-Module16Policies-The“WHATTODO”“Awrittenstatementofoverallintentionsan
7、ddirectionsdefinedbythoseintheorganizationandendorsedbymanagement.”(CLSIHS1-A3)Policies:tell“whattodo”inabroadandgeneralwayincludetheorganizationalmission,goals,andpurposeserveastheframeworkforthequalitysystemshouldalwaysbespecifiedinthequalitymanual9DocumentsandRecords-Module16Pr
8、ocesses-The“HOWITHAPPENS”A“setofi
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