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DocumentsandRecords1DocumentsandRecords1LearningObjectives
Attheconclusionofthissession,youwillbeableto:explainthedifferencebetweendocumentsandrecords;describethehierarchyofdocumentsandtheroleofeachlevel;outlinethecontentsofaqualitymanual;outlinethecontentthatshouldbeincludedinastandardoperatingprocedure;explaintheimportantsteps,orelements,ofalaboratorydocumentmanagementsystem;describemethodsandtoolstoproperlystoredocumentsandrecords.2DocumentsandRecords-Module16LearningObjectives AttheconScenariotestingalgorithmsafetymanualclienttestresultsstandardoperationprocedures(SOPs)foranapprovedHIVrapidtestmanufacturertestkitinsertssummaryoffindingsfromon-siteevaluationvisitreportofcorrectiveactionstemperaturelog(blankform)qualitycontrolrecord(blankform)dailymaintenancelog(completed)stockcardsandstockbook(completed)EQAspecimentransferlog(completed)Youhavefoundallthesepaperslyingonadesk.Whichofthesearedocumentsandwhicharerecords?3DocumentsandRecords-Module16ScenariotestingalgorithmreporTheQualityManagementSystemOrganizationPersonnelEquipmentPurchasing
&
InventoryProcessControlInformationManagementDocuments
&
RecordsOccurrenceManagementAssessmentProcessImprovementCustomerServiceFacilities
&
Safety4DocumentsandRecords-Module16TheQualityManagementSystemOWhydolaboratoriesneedtomanagedocumentsandrecords? Tofindinformation
wheneveritisneeded!5DocumentsandRecords-Module16WhydolaboratoriesneedtomaDocumentsandRecords—Howdotheydiffer?Documentscommunicateinformationviapolicies,processes,andproceduresneedupdatingRecordscaptureinformationonworksheets,forms,labels,andchartspermanent,donotchangeRECORDS6DocumentsandRecords-Module16DocumentsandRecords—HowdotInformationisthe
majorproduct
ofthelaboratory7DocumentsandRecords-Module167DocumentsandRecords-ModulProceduresProcessesPoliciesLaboratoryDocuments8DocumentsandRecords-Module16ProceduresProcessesPoliciesLabPolicies-The“WHATTODO”“Awrittenstatementofoverallintentionsanddirectionsdefinedbythoseintheorganizationandendorsedbymanagement.”(CLSIHS1-A3)Policies:tell“whattodo”inabroadandgeneralwayincludetheorganizationalmission,goals,andpurposeserveastheframeworkforthequalitysystemshouldalwaysbespecifiedinthequalitymanual9DocumentsandRecords-Module16Policies-The“WHATTODO”Processes-The“HOWITHAPPENS” A“setofinterrelatedorinteractingactivitiesthattransforminputsintooutputs.”(ISO90004.3.1)Processes:describethestepsinvolvedtocarryoutqualitypolicieseasilyrepresentedinflowchartsinvolveaseriesofsteps,usuallyoccurringoveraperiodoftime10DocumentsandRecords-Module16Processes-The“HOWITHAPPENProcedures-The“HOWTODOIT”
Standardoperatingprocedures(SOP)step-by-stepinstructionsforperformingasingleactivityJobaidashortenedversionoftheSOPdoesnotreplacetheSOP11DocumentsandRecords-Module16Procedures-The“HOWTODOITHierarchyofDocuments“Howtodoit”“Howithappens”“Whattodo”12DocumentsandRecords-Module16HierarchyofDocuments“HowtoWhyaredocumentsimportant?essentialguidelinesforlaboratoryqualitymanualSOPsreferencematerialsrequiredbyformallaboratorystandards
13DocumentsandRecords-Module16Whyaredocumentsimportant?esDocumentsarethecommunicatorsofthequalitymanagementsystemVerbalinstructionsoftenare:notheardmisunderstood quicklyforgottendifficulttofollow14DocumentsandRecords-Module16DocumentsarethecommunicatorDocumentsareareflectionofthelaboratory’sorganizationanditsqualitymanagement.
Agoodruletofollowis:
“Dowhatyouwroteandwritewhatyouaredoing.”15DocumentsandRecords-Module1615DocumentsandRecords-ModuGoodDocumentsare:clearconciseuser-friendlyexplicitaccurateup-to-date
16DocumentsandRecords-Module16GoodDocumentsare:clear16DocuDocumentsforworkprocessesshouldbeaccessibletostaffattheworksite:instructionsonhandlingincomingsamplesSOPsforeachtestqualitycontrolcharts
andtrouble-shooting
instructionssafetymanuals
andprecautions17DocumentsandRecords-Module16DocumentsforworkprocessessTheQualityManualisadocumentdescribingthe
qualitymanagementsystem
ofanorganization
(ISO15189)18DocumentsandRecords-Module16TheQualityManual18Documents
QualityManualcommunicatesinformationservesasaframeworkorroadmapformeetingqualitymanagementsystemrequirementsdemonstratesmanagementcommitmenttoquality19DocumentsandRecords-Module16QualityManualcommunicatesinWritingaQualityManualStyleandstructureareflexible;maketobestmeettheneedsof20DocumentsandRecords-Module16WritingaQualityManualStyleWritingaQualityManualFormaSteeringCommitteeSetpolicyfor
12QS
essentialsDescribehowtherelatedqualityprocessesoccur
Referenceprocedures21DocumentsandRecords-Module16WritingaQualityManualFormaKeyPoints:QualityManualonlyONEofficialversionnever“done”,alwaysbeingimprovedreadandacceptedbyeveryoneusethebest-adaptedlanguage
Verybigjob,butveryuseful22DocumentsandRecords-Module16KeyPoints:QualityManualonlyStandardOperatingProcedures(SOPs)aredocumentsthat:describehowtoperformatestusingstep-by-stepinstructionswrittenSOPshelpensure:consistencyaccuracyquality23DocumentsandRecords-Module16StandardOperatingProceduresAGoodSOPprovidesdetailed,clear,andconcisedirectionfortestingtechniquesiseasilyunderstoodbynewpersonnelisreviewedandapprovedbymanagementisupdatedonaregularbasis24DocumentsandRecords-Module16AGoodSOPprovidesdetailed,cStandardizedSOPFormatComputerizedprocedureStandardization:HeaderVersion/chapter/referenceAuthor/reader/validatorRecipientsVersiondate/ApplicationdateTypicaloutlineUpdatingandstorageofdifferentversionsiseasyJJohnson,
RBSmith25DocumentsandRecords-Module16StandardizedSOPFormatJJohnsCompleteStandardizedHeaderUseatthetopofthefirstpageonly26DocumentsandRecords-Module16CompleteStandardizedHeader26ReducedStandardizedHeaderotherpagesofeveryprocedureuseatthetopofallotherpages27DocumentsandRecords-Module16ReducedStandardizedHeaderothWhenPreparingSOPsestablish
meansfor
updatinggatherall
documentsinclude
eachstepassess
scientific
validitydetermine
procedure
touse28DocumentsandRecords-Module16WhenPreparingSOPsestablishSuggestedOutlineforSOPsTitle:NameofTestPurpose:MedicaluseInstructions:PreexaminationExaminationPostexaminationReferencestoverifythemethodisestablishedAuthor’snameApprovalsignature(s)–initialanddate29DocumentsandRecords-Module16SuggestedOutlineforSOPsTitlAvoidDrowninginDetail…..BADEXAMPLE:“Thepurposeofthisprocedureistodocumenttheaforementionedactivities,herinafterreferredtoastheprescribedtasksintermsthatprecludetheirexecutioninaninconsistentmanner,wherinsuchinconsistencymaypotentiallyresultintheprescribedtasksdeliveringaresultthatisnotrepeatableorreproducible”…30DocumentsandRecords-Module16AvoidDrowninginDetail…..BADDonotrelysolelyonmanufacturerproductinserts
Insertsdonotprovidespecificinformationfortestsites,
suchas:materialsrequired,butnotinkitspecificsafetyrequirementsexternalqualitycontrolrequirements31DocumentsandRecords-Module16DonotrelysolelyonmanufactJobAidsshortenedversionofSOPshandwrittenorprintedvisiblelocationattestingsiteusefultooltoassurealltestingstepsarecorrectlyperformed32DocumentsandRecords-Module16JobAidsshortenedversionofSJobAids33DocumentsandRecords-Module16JobAids33DocumentsandRecordJobAids34DocumentsandRecords-Module16JobAids34DocumentsandRecordDocumentControlassuresthatthe
mostcurrent
versionisusedensuresavailability
whenneededorganizationaltool35DocumentsandRecords-Module16DocumentControlassuresthattDocumentControlElementssystemfororganizing,suchasnumberingorcodingsystemapproval,distribution,andrevisionprocessmasterlogthatdescribeswhichdocumentsareincirculationaccessibilityofdocumentsatthepointofusesystemforarchiving36DocumentsandRecords-Module16DocumentControlElementssysteequipment
service
manualsSOPstexts,
articles,
reference
booksControlled
documents
regulations
and
standards37DocumentsandRecords-Module16equipment
service
manualsSOPDocumentsofExternalOriginIncludeinthelaboratorydocumentcontrolsystem:instrumentservicemanualsindustryregulationsISOstandardsreferencesusedfordocumentation38DocumentsandRecords-Module16DocumentsofExternalOriginInNumberingSystemneeduniformnumberingsystemdonotchangeacurrentsystemthatworksonesystem:letterforthetypeofdocumentandthenanincrementednumber:B1,B2,B3forbooksandT1,T2forofficialtextsnumberallpagesofdocumentreferencebydocumentcode,pages,locationcode:Booknumber2,pages188-200,onbookshelf1:B2,188-200,BS139DocumentsandRecords-Module16NumberingSystemneeduniformnDocumentPreparationandControlProcessPreparationReviewIssue
DistributionRevisionApproval40DocumentsandRecords-Module16DocumentPreparationandContrImplementingDocumentControlcollectexistingdocumentsandrecordsreviewandupdatedetermineadditionalneedsdeveloporobtaindocuments,forms,worksheets,logbooks,reportsinvolvestakeholders41DocumentsandRecords-Module16ImplementingDocumentControlcCommonDocumentControlProblemsoutdateddocumentstoomanydocumentsaredistributedandthesystem
cannotbemaintainedlackofcontrolofdocuments
ofexternalandinternalorigin42DocumentsandRecords-Module16CommonDocumentControlProbleWhyarerecordsessential?Sample
tracking
throughout
processManagement
tool
IdentifyproblemsContinuous
monitoring
of
qualitysystem43DocumentsandRecords-Module16Whyarerecordsessential?SampPatienttestreportsEQA/PTrecordsQualitycontroldataMaintenancerecordsInstrumentprintouts
WorkbooksWorksheetsSamplelogbookorregisterLaboratoryRecords44DocumentsandRecords-Module16PatientEQA/QualityMaintenanCriticalcommunicationsCustomerfeedbackUsersurveysContinuousimprovementExternalauditsresultsInternalauditsresultsPersonnel
recordsMoreRecords45DocumentsandRecords-Module16CriticalCustomerUserContinuKeeptheThingsYouMight
Forget!dispositionofrejectedsamplesreferralofsamplestoanotherlaboratoryrecordsofadverseoccurrencesorproblemsinventoryandstoragerecordsequipmentpurchasedata,preventivemaintenance,andtroubleshooting46DocumentsandRecords-Module16KeeptheThingsYouMight
ForTestReportContentsISO15189testidentificationlaboratoryidentificationpatientuniqueidentificationandlocationnameandaddressofrequestordateandtimeofcollectiontimeofreceiptinlabdateandtimeofreleaseofreportprimarysampletyperesults(SIunits)biologicalreferenceintervalsinterpretivecommentspersonauthorizingrelease,withsignaturewhenpossiblenoteifreportingacorrectedresult47DocumentsandRecords-Module16TestReportContentsISO15189PaperSystemsPermanence
bindbooksnumberpagesusepermanentinkcontrolstorageAccessibilityusesystemthatwillalloweaseofaccessSecurity
maintainconfidentialitykeepsafefromenvironmentalhazardsTraceabilityallowfortrackingofaspecimenthroughoutallprocesses48DocumentsandRecords-Module16PaperSystemsPermanenceSecuri49DocumentsandRecords-Module1649DocumentsandRecords-ModuElectronicSystemspermanencecomputersystemmaintenance,backupssecurityaccessconfidentialitytraceability50DocumentsandRecords-Module16ElectronicSystemspermanence50Testing
process
reviewTime
between
assessments
-auditsResearch
purposesNational
legislation
and
regulationFactors
affecting
retention
times51DocumentsandRecords-Module16Testing
process
reviewTime
SummaryDocuments:includewrittenpolicies,processes,andproceduresneedtobeupdatedandmaintainedRecords:includeinformationcapturedinprocessesarepermanent,donotrequireupdatingAgooddocumentcontrolprogram:mostcurrentversionusedavailabilityandeaseofaccess52DocumentsandRecords-Module16SummaryDocuments:52DocumentsaKeyMessagesInformationisourproduct.Documentsareessentialforassuringaccuracyandconsistencyinthelaboratory.
53DocumentsandRecords-Module16KeyMessagesInformationisourScenariotestingalgorithmsafetymanualclienttestresultsstandardoperationprocedures(SOPs)foranapprovedHIVrapidtestmanufacturertestkitinsertssummaryoffindingsfromon-siteevaluationvisitreportofcorrectiveactionstemperaturelog(blankform)qualitycontrolrecord(blankform)dailymaintenancelog(completed)stockcardsandstockbook(completed)EQAsampletransferlog(completed)Youhavefoundallthesepaperslyingonadesk.Whichofthesearedocumentsandwhicharerecords?54DocumentsandRecords-Module16ScenariotestingalgorithmreporScenariotestingalgorithmsafetymanualclienttestresultsstandardoperationprocedures(SOPs)foranapprovedHIVrapidtest
manufacturertestkitinsertssummaryoffindingsfromon-siteevaluationvisitreportofcorrectiveactionstemperaturelog(blankform)qualitycontrolrecord(blankform)dailymaintenancelog(completed)stockcardsandstockbook(completed)EQAsampletransferlog(completed)Youhavefoundallthesepaperslyingonadesk.Whichofthesearedocumentsandwhicharerecords?55DocumentsandRecords-Module16ScenariotestingalgorithmreporQuestions?
Comments?OrganizationPersonnelEquipmentPurchasing
&
InventoryProcessControlInformationManagementDocuments
&
RecordsOccurrenceManagementAssessmentProcessImprovementCustomerServiceFacilities
&
Safety56DocumentsandRecords-Module16Questions?
Comments?Organizat演講完畢，謝謝觀看！演講完畢，謝謝觀看！DocumentsandRecords58DocumentsandRecords1LearningObjectives
Attheconclusionofthissession,youwillbeableto:explainthedifferencebetweendocumentsandrecords;describethehierarchyofdocumentsandtheroleofeachlevel;outlinethecontentsofaqualitymanual;outlinethecontentthatshouldbeincludedinastandardoperatingprocedure;explaintheimportantsteps,orelements,ofalaboratorydocumentmanagementsystem;describemethodsandtoolstoproperlystoredocumentsandrecords.59DocumentsandRecords-Module16LearningObjectives AttheconScenariotestingalgorithmsafetymanualclienttestresultsstandardoperationprocedures(SOPs)foranapprovedHIVrapidtestmanufacturertestkitinsertssummaryoffindingsfromon-siteevaluationvisitreportofcorrectiveactionstemperaturelog(blankform)qualitycontrolrecord(blankform)dailymaintenancelog(completed)stockcardsandstockbook(completed)EQAspecimentransferlog(completed)Youhavefoundallthesepaperslyingonadesk.Whichofthesearedocumentsandwhicharerecords?60DocumentsandRecords-Module16ScenariotestingalgorithmreporTheQualityManagementSystemOrganizationPersonnelEquipmentPurchasing
&
InventoryProcessControlInformationManagementDocuments
&
RecordsOccurrenceManagementAssessmentProcessImprovementCustomerServiceFacilities
&
Safety61DocumentsandRecords-Module16TheQualityManagementSystemOWhydolaboratoriesneedtomanagedocumentsandrecords? Tofindinformation
wheneveritisneeded!62DocumentsandRecords-Module16WhydolaboratoriesneedtomaDocumentsandRecords—Howdotheydiffer?Documentscommunicateinformationviapolicies,processes,andproceduresneedupdatingRecordscaptureinformationonworksheets,forms,labels,andchartspermanent,donotchangeRECORDS63DocumentsandRecords-Module16DocumentsandRecords—HowdotInformationisthe
majorproduct
ofthelaboratory64DocumentsandRecords-Module167DocumentsandRecords-ModulProceduresProcessesPoliciesLaboratoryDocuments65DocumentsandRecords-Module16ProceduresProcessesPoliciesLabPolicies-The“WHATTODO”“Awrittenstatementofoverallintentionsanddirectionsdefinedbythoseintheorganizationandendorsedbymanagement.”(CLSIHS1-A3)Policies:tell“whattodo”inabroadandgeneralwayincludetheorganizationalmission,goals,andpurposeserveastheframeworkforthequalitysystemshouldalwaysbespecifiedinthequalitymanual66DocumentsandRecords-Module16Policies-The“WHATTODO”Processes-The“HOWITHAPPENS” A“setofinterrelatedorinteractingactivitiesthattransforminputsintooutputs.”(ISO90004.3.1)Processes:describethestepsinvolvedtocarryoutqualitypolicieseasilyrepresentedinflowchartsinvolveaseriesofsteps,usuallyoccurringoveraperiodoftime67DocumentsandRecords-Module16Processes-The“HOWITHAPPENProcedures-The“HOWTODOIT”
Standardoperatingprocedures(SOP)step-by-stepinstructionsforperformingasingleactivityJobaidashortenedversionoftheSOPdoesnotreplacetheSOP68DocumentsandRecords-Module16Procedures-The“HOWTODOITHierarchyofDocuments“Howtodoit”“Howithappens”“Whattodo”69DocumentsandRecords-Module16HierarchyofDocuments“HowtoWhyaredocumentsimportant?essentialguidelinesforlaboratoryqualitymanualSOPsreferencematerialsrequiredbyformallaboratorystandards
70DocumentsandRecords-Module16Whyaredocumentsimportant?esDocumentsarethecommunicatorsofthequalitymanagementsystemVerbalinstructionsoftenare:notheardmisunderstood quicklyforgottendifficulttofollow71DocumentsandRecords-Module16DocumentsarethecommunicatorDocumentsareareflectionofthelaboratory’sorganizationanditsqualitymanagement.
Agoodruletofollowis:
“Dowhatyouwroteandwritewhatyouaredoing.”72DocumentsandRecords-Module1615DocumentsandRecords-ModuGoodDocumentsare:clearconciseuser-friendlyexplicitaccurateup-to-date
73DocumentsandRecords-Module16GoodDocumentsare:clear16DocuDocumentsforworkprocessesshouldbeaccessibletostaffattheworksite:instructionsonhandlingincomingsamplesSOPsforeachtestqualitycontrolcharts
andtrouble-shooting
instructionssafetymanuals
andprecautions74DocumentsandRecords-Module16DocumentsforworkprocessessTheQualityManualisadocumentdescribingthe
qualitymanagementsystem
ofanorganization
(ISO15189)75DocumentsandRecords-Module16TheQualityManual18Documents
QualityManualcommunicatesinformationservesasaframeworkorroadmapformeetingqualitymanagementsystemrequirementsdemonstratesmanagementcommitmenttoquality76DocumentsandRecords-Module16QualityManualcommunicatesinWritingaQualityManualStyleandstructureareflexible;maketobestmeettheneedsof77DocumentsandRecords-Module16WritingaQualityManualStyleWritingaQualityManualFormaSteeringCommitteeSetpolicyfor
12QS
essentialsDescribehowtherelatedqualityprocessesoccur
Referenceprocedures78DocumentsandRecords-Module16WritingaQualityManualFormaKeyPoints:QualityManualonlyONEofficialversionnever“done”,alwaysbeingimprovedreadandacceptedbyeveryoneusethebest-adaptedlanguage
Verybigjob,butveryuseful79DocumentsandRecords-Module16KeyPoints:QualityManualonlyStandardOperatingProcedures(SOPs)aredocumentsthat:describehowtoperformatestusingstep-by-stepinstructionswrittenSOPshelpensure:consistencyaccuracyquality80DocumentsandRecords-Module16StandardOperatingProceduresAGoodSOPprovidesdetailed,clear,andconcisedirectionfortestingtechniquesiseasilyunderstoodbynewpersonnelisreviewedandapprovedbymanagementisupdatedonaregularbasis81DocumentsandRecords-Module16AGoodSOPprovidesdetailed,cStandardizedSOPFormatComputerizedprocedureStandardization:HeaderVersion/chapter/referenceAuthor/reader/validatorRecipientsVersiondate/ApplicationdateTypicaloutlineUpdatingandstorageofdifferentversionsiseasyJJohnson,
RBSmith82DocumentsandRecords-Module16StandardizedSOPFormatJJohnsCompleteStandardizedHeaderUseatthetopofthefirstpageonly83DocumentsandRecords-Module16CompleteStandardizedHeader26ReducedStandardizedHeaderotherpagesofeveryprocedureuseatthetopofallotherpages84DocumentsandRecords-Module16ReducedStandardizedHeaderothWhenPreparingSOPsestablish
meansfor
updatinggatherall
documentsinclude
eachstepassess
scientific
validitydetermine
procedure
touse85DocumentsandRecords-Module16WhenPreparingSOPsestablishSuggestedOutlineforSOPsTitle:NameofTestPurpose:MedicaluseInstructions:PreexaminationExaminationPostexaminationReferencestoverifythemethodisestablishedAuthor’snameApprovalsignature(s)–initialanddate86DocumentsandRecords-Module16SuggestedOutlineforSOPsTitlAvoidDrowninginDetail…..BADEXAMPLE:“Thepurposeofthisprocedureistodocumenttheaforementionedactivities,herinafterreferredtoastheprescribedtasksintermsthatprecludetheirexecutioninaninconsistentmanner,wherinsuchinconsistencymaypotentiallyresultintheprescribedtasksdeliveringaresultthatisnotrepeatableorreproducible”…87DocumentsandRecords-Module16AvoidDrowninginDetail…..BADDonotrelysolelyonmanufacturerproductinserts
Insertsdonotprovidespecificinformationfortestsites,
suchas:materialsrequired,butnotinkitspecificsafetyrequirementsexternalqualitycontrolrequirements88DocumentsandRecords-Module16DonotrelysolelyonmanufactJobAidsshortenedversionofSOPshandwrittenorprintedvisiblelocationattestingsiteusefultooltoassurealltestingstepsarecorrectlyperformed89DocumentsandRecords-Module16JobAidsshortenedversionofSJobAids90DocumentsandRecords-Module16JobAids33DocumentsandRecordJobAids91DocumentsandRecords-Module16JobAids34DocumentsandRecordDocumentControlassuresthatthe
mostcurrent
versionisusedensuresavailability
whenneededorganizationaltool92DocumentsandRecords-Module16DocumentControlassuresthattDocumentControlElementssystemfororganizing,suchasnumberingorcodingsystemapproval,distribution,andrevisionprocessmasterlogthatdescribeswhichdocumentsareincirculationaccessibilityofdocumentsatthepointofusesystemforarchiving93DocumentsandRecords-Module16DocumentControlElementssysteequipment
service
manualsSOPstexts,
articles,
reference
booksControlled
documents
regulations
and
standards94DocumentsandRecords-Module16equipment
service
manualsSOPDocumentsofExternalOriginIncludeinthelaboratorydocumentcontrolsystem:instrumentservicemanualsindustryregulationsISOstandardsreferencesusedfordocumentation95DocumentsandRecords-Module16DocumentsofExternalOriginInNumberingSystemneeduniformnumberingsystemdonotchangeacurrentsystemthatworksonesystem:letterforthetypeofdocumentandthenanincrementednumber:B1,B2,B3forbooksandT1,T2forofficialtextsnumberallpagesofdocumentreferencebydocumentcode,pages,locationcode:Booknumber2,pages188-200,onbookshelf1:B2,188-200,BS196DocumentsandRecords-Module16NumberingSystemneeduniformnDocumentPreparationandControlProcessPreparationReviewIssue
DistributionRevisionApproval97DocumentsandRecords-Module16DocumentPreparationandContrImplementingDocumentControlcollectexistingdocumentsandrecordsreviewandupdatedetermineadditionalneedsdeveloporobtaindocuments,forms,worksheets,logbooks,reportsinvolvestakeholders98DocumentsandRecords-Module16ImplementingDocumentControlcCommonDocumentControlProblemsoutdateddocumentstoomanydocumentsaredistributedandthesystem
cannotbemaintainedlackofcontrolofdocuments
ofexternalandinternalorigin99DocumentsandRecords-Module16CommonDocumentControlProbleWhyarerecordsessential?Sample
tracking
throughout
processManagement
tool
IdentifyproblemsContinuous
monitoring
of
qualitysystem100DocumentsandRecords-Module16Whyarerecordsessential?SampPatienttestreportsEQA/PTrecordsQualitycontroldataMaintenancerecordsInstrumentprintouts
WorkbooksWorksheetsSamplelogbookorregisterLaboratoryRecords101DocumentsandRecords-Module16PatientEQA/QualityMaintenanCriticalcommunicationsCustomerfeedbackUsersurveysContinuousimprovementExternalauditsresultsInternalauditsresultsPersonnel
recordsMoreRecords102DocumentsandRecords-Module16CriticalCustomerUserContinuKeeptheThingsYouMight
Forget!dispositionofrejectedsamplesreferralofsamplestoanotherlaboratoryrecordsofadverseoccurrencesorproblemsinventoryandstoragerecordsequipmentpurchasedata,preventivemaintenance,andtroubleshooting103DocumentsandRecords-Module16KeeptheThingsYouMight
ForTestReportContentsISO15189testidentificationlaboratoryidentificationpatientuniqueidentificationandlocationnameandaddressofrequestordateandtimeofcollectiontimeofreceiptinlabdateandtimeofreleaseofreportprimarysampletyperesults(SIunits)biologicalreferenceintervalsinterpretivecommentspersonauthorizingrelease,withsignaturewhenpossiblenoteifreportingacorrecte
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