文件与记录控制培训

1DocumentsandRecordsDocumentsandRecords-Module162LearningObjectivesAttheconclusionofthissession,youwillbeableto:explainthedifferencebetweendocumentsandrecords;describethehierarchyofdocumentsandtheroleofeachlevel;outlinethecontentsofaqualitymanual;outlinethecontentthatshouldbeincludedinastandardoperatingprocedure;explaintheimportantsteps,orelements,ofalaboratorydocumentmanagementsystem;describemethodsandtoolstoproperlystoredocumentsandrecords.DocumentsandRecords-Module163Scenariotestingalgorithmsafetymanualclienttestresultsstandardoperationprocedures(SOPs)foranapprovedHIVrapidtestmanufacturertestkitinsertssummaryoffindingsfromon-siteevaluationvisitreportofcorrectiveactionstemperaturelog(blankform)qualitycontrolrecord(blankform)dailymaintenancelog(completed)stockcardsandstockbook(completed)EQAspecimentransferlog(completed)Youhavefoundallthesepaperslyingonadesk.Whichofthesearedocumentsandwhicharerecords?DocumentsandRecords-Module164TheQualityManagementSystemOrganizationPersonnelEquipmentPurchasing&InventoryProcessControlInformationManagementDocuments&RecordsOccurrenceManagementAssessmentProcessImprovementCustomerServiceFacilities&SafetyDocumentsandRecords-Module165Whydolaboratoriesneedtomanagedocumentsandrecords?Tofindinformationwheneveritisneeded!DocumentsandRecords-Module166DocumentsandRecords—Howdotheydiffer?Documentscommunicateinformationviapolicies,processes,andproceduresneedupdatingRecordscaptureinformationonworksheets,forms,labels,andchartspermanent,donotchangeRECORDSDocumentsandRecords-Module167InformationisthemajorproductofthelaboratoryDocumentsandRecords-Module168ProceduresProcessesPoliciesLaboratoryDocumentsDocumentsandRecords-Module169Policies-The“WHATTODO”“Awrittenstatementofoverallintentionsanddirectionsdefinedbythoseintheorganizationandendorsedbymanagement.”(CLSIHS1-A3)Policies:tell“whattodo”inabroadandgeneralwayincludetheorganizationalmission,goals,andpurposeserveastheframeworkforthequalitysystemshouldalwaysbespecifiedinthequalitymanualDocumentsandRecords-Module1610Processes-The“HOWITHAPPENS”A“setofinterrelatedorinteractingactivitiesthattransforminputsintooutputs.”(ISO90004.3.1)Processes:describethestepsinvolvedtocarryoutqualitypolicieseasilyrepresentedinflowchartsinvolveaseriesofsteps,usuallyoccurringoveraperiodoftimeDocumentsandRecords-Module1611Procedures-The“HOWTODOIT”Standardoperatingprocedures(SOP)step-by-stepinstructionsforperformingasingleactivityJobaidashortenedversionoftheSOPdoesnotreplacetheSOPDocumentsandRecords-Module1612HierarchyofDocuments“Howtodoit”“Howithappens”“Whattodo”DocumentsandRecords-Module1613Whyaredocumentsimportant?essentialguidelinesforlaboratoryqualitymanualSOPsreferencematerialsrequiredbyformallaboratorystandardsDocumentsandRecords-Module1614DocumentsarethecommunicatorsofthequalitymanagementsystemVerbalinstructionsoftenare:notheardmisunderstoodquicklyforgottendifficulttofollowDocumentsandRecords-Module1615Documentsareareflectionofthelaboratory’sorganizationanditsqualitymanagement.Agoodruletofollowis:“Dowhatyouwroteandwritewhatyouaredoing.”DocumentsandRecords-Module1616GoodDocumentsare:clearconciseuser-friendlyexplicitaccurateup-to-dateDocumentsandRecords-Module1617Documentsforworkprocessesshouldbeaccessibletostaffattheworksite:instructionsonhandlingincomingsamplesSOPsforeachtestqualitycontrolchartsandtrouble-shootinginstructionssafetymanualsandprecautionsDocumentsandRecords-Module1618TheQualityManualisadocumentdescribingthequalitymanagementsystemofanorganization(ISO15189)DocumentsandRecords-Module1619QualityManualcommunicatesinformationservesasaframeworkorroadmapformeetingqualitymanagementsystemrequirementsdemonstratesmanagementcommitmenttoqualityDocumentsandRecords-Module1620WritingaQualityManualDocumentsandRecords-Module1621WritingaQualityManualFormaSteeringCommitteeDescribehowtherelatedqualityprocessesoccurReferenceproceduresDocumentsandRecords-Module1622KeyPoints:QualityManualonlyONEofficialversionnever“done”,alwaysbeingimprovedreadandacceptedbyeveryoneusethebest-adaptedlanguageVerybigjob,butveryusefulDocumentsandRecords-Module1623StandardOperatingProcedures(SOPs)aredocumentsthat:describehowtoperformatestusingstep-by-stepinstructionswrittenSOPshelpensure:consistencyaccuracyqualityDocumentsandRecords-Module1624AGoodSOPprovidesdetailed,clear,andconcisedirectionfortestingtechniquesiseasilyunderstoodbynewpersonnelisreviewedandapprovedbymanagementisupdatedonaregularbasisDocumentsandRecords-Module1625StandardizedSOPFormatComputerizedprocedureStandardization:HeaderVersion/chapter/referenceAuthor/reader/validatorRecipientsVersiondate/ApplicationdateTypicaloutlineUpdatingandstorageofdifferentversionsiseasyJJohnson,RBSmithDocumentsandRecords-Module1626CompleteStandardizedHeaderUseatthetopofthefirstpageonlyDocumentsandRecords-Module1627ReducedStandardizedHeaderotherpagesofeveryprocedureuseatthetopofallotherpagesDocumentsandRecords-Module1628WhenPreparingSOPsestablishmeansforupdatinggatheralldocu