CAP實(shí)驗(yàn)室認(rèn)可計(jì)劃-檢查流程總覽(中英文對(duì)照)課件

CollegeofAmericanPathologists

LaboratoryAccreditationProgram

OverviewInspectionProcessCollegeofAmericanPathologis美國(guó)病理學(xué)家學(xué)院實(shí)驗(yàn)室認(rèn)可計(jì)劃

檢查流程總覽美國(guó)病理學(xué)家學(xué)院實(shí)驗(yàn)室認(rèn)可計(jì)劃

CollegeofAmericanPathologists

(CAP)

OverviewoftheLaboratoryAccreditationProgram(LAP)TheInspectionProcessQuestions&Answers

CollegeofAmericanPathologi

美國(guó)病理學(xué)家學(xué)院

(CAP)

實(shí)驗(yàn)室認(rèn)可計(jì)劃(LAP)總覽檢查流程問題與回答

美國(guó)病理學(xué)家學(xué)院

(CAP)

實(shí)驗(yàn)室認(rèn)可計(jì)劃(LAP)LAPPhilosophyPromoteaCultureofQualityQualitycontrolPerformanceimprovementProficiencytestingRegulatoryroleAssesscompliancewithCAPrequirements,includingCLIA-88regulationsLAPPhilosophyPromoteaCultLAP哲學(xué)提升質(zhì)量文化質(zhì)量控制性能的提高能力驗(yàn)證法規(guī)的作用評(píng)價(jià)與CAP的要求,包括CLIA-88的規(guī)定的一致性LAP哲學(xué)提升質(zhì)量文化WhyAccreditation?ParticipationinaVoluntaryLaboratoryAccreditationProgramImprovestheQualityofServicesforPatients.

WhyAccreditation?Participatio為什么要認(rèn)可?參與一個(gè)自愿的實(shí)驗(yàn)室認(rèn)可計(jì)劃可

提高對(duì)病人服務(wù)的質(zhì)量.

為什么要認(rèn)可?參與一個(gè)自愿的實(shí)驗(yàn)室認(rèn)可計(jì)劃可LaboratoryAccreditationintheUS

StateLicensureMinimumrequirementssetbyaregulatorybody.Mayrequireaccreditationinaddition.CertificationAssurancethataqualitysystemisinplaceandisconsistentwithcertainstandards(e.g..ISO9000).AccreditationDemonstrationthatanorganizationhasmetstandardsofqualityasdefinedbytheprofession.

LaboratoryAccreditationinth美國(guó)的實(shí)驗(yàn)室認(rèn)可情況

國(guó)家給予許可法規(guī)設(shè)置機(jī)構(gòu)的最低要求可能需要另外的認(rèn)可證明確保所使用的質(zhì)量系統(tǒng)適合并和某些國(guó)際標(biāo)準(zhǔn)一致(e.g.ISO9000)認(rèn)可聲明某一機(jī)構(gòu)已經(jīng)達(dá)到了由專業(yè)機(jī)構(gòu)制定的質(zhì)量標(biāo)準(zhǔn)美國(guó)的實(shí)驗(yàn)室認(rèn)可情況

國(guó)家給予許可LaboratoryAccreditationintheUS

GovernmentRegulations(CLIA’88)CentersforMedicareandMedicaidServices(CMS)Ultimateregulatoryauthority,enforcestheClinicalLaboratoryImprovementAmendmentsof1988(CLIA-88)In1995,approvedCAPasanaccreditingorganizationunderCLIA–88In2001,extendedapprovalthrough9/07LaboratoryAccreditationinth美國(guó)的實(shí)驗(yàn)室認(rèn)可情況

政府法規(guī)(CLIA’88)醫(yī)療保險(xiǎn)和醫(yī)療救助服務(wù)中心(CMS)

最終法規(guī)權(quán)威機(jī)構(gòu),加強(qiáng)1998年（CLIA-88）的臨床實(shí)驗(yàn)室改進(jìn)修正法案的實(shí)施1995年,批準(zhǔn)CAP作為在CLIA–88下的認(rèn)可組織2001年,通過9/07延長(zhǎng)批準(zhǔn)美國(guó)的實(shí)驗(yàn)室認(rèn)可情況

政府法規(guī)(CLIA’88)LaboratoryAccreditationOrganizationsintheUS

CollegeofAmericanPathologists(CAP)JointCommissiononAccreditationofHealthcareOrganizations(JCAHO)COLAAmericanAssociationofBloodBanks(AABB)AmericanOsteopathicAssociation(AOA)AmericanSocietyofHistocompatibilityandImmunogenetics(ASHI)LaboratoryAccreditationOrgan美國(guó)的實(shí)驗(yàn)室認(rèn)可機(jī)構(gòu)

美國(guó)病理學(xué)家學(xué)院(CAP)醫(yī)療衛(wèi)生機(jī)構(gòu)認(rèn)可聯(lián)合委員會(huì)(JCAHO)COLA美國(guó)血庫協(xié)會(huì)(AABB)美國(guó)整骨療法協(xié)會(huì)

(AOA)美國(guó)組織配型和免疫遺傳協(xié)會(huì)(ASHI)美國(guó)的實(shí)驗(yàn)室認(rèn)可機(jī)構(gòu)

CAPLaboratoryAccreditationProgram:HistoryInExistenceSince1961ProgressiveGrowthRelationshipswithotherOrganizationsCAPLaboratoryAccreditationPCAP實(shí)驗(yàn)室認(rèn)可計(jì)劃:歷史從1961年開始成長(zhǎng)過程和其他機(jī)構(gòu)的關(guān)系CAP實(shí)驗(yàn)室認(rèn)可計(jì)劃:歷史從1961年開始CAPLaboratoryAccreditationProgram:TodayOver6,600ParticipatingLaboratoriesTentoTwelveInspectionsperDayWorldwideRecognition>124CivilianInternationallabs>70USMilitaryLabsOverseas>38CountriesCAPLaboratoryAccreditationPCAP實(shí)驗(yàn)室認(rèn)可計(jì)劃:今天有超過6,600個(gè)參與的實(shí)驗(yàn)室每天有10到12個(gè)檢查國(guó)際公認(rèn)>124私人國(guó)際實(shí)驗(yàn)室>70美國(guó)海外軍用實(shí)驗(yàn)室>38國(guó)家CAP實(shí)驗(yàn)室認(rèn)可計(jì)劃:今天有超過6,600個(gè)參與的實(shí)

InternationalParticipationNorthAmerica: Canada,UnitedStates,GreenlandCentralAmerica&Caribbean:Bermuda,Cuba,MexicoSouthAmerica: Argentina,Brazil,Columbia,PeruEurope: Belgium,Cyprus,France, Germany,Iceland,IrishRepublic, Italy,Lithuania,Portugal, UnitedKingdom,Spain,Sweden, Switzerland,Turkey.

InternationalParticipationNo

國(guó)際參與北美: Canada,UnitedStates,Greenland中美和加勒比:

Bermuda,Cuba,Mexico南美: Argentina,Brazil,Columbia,Peru歐洲: Belgium,Cyprus,France, Germany,Iceland,IrishRepublic, Italy,Lithuania,Portugal, UnitedKingdom,Spain,Sweden, Switzerland,Turkey.

國(guó)際參與北美: Canada,UnitedState

InternationalParticipationMiddleEast: Bahrain,Egypt,Lebanon, SaudiArabia,UAEAsia: China,India,Japan,Philippines, Singapore,SouthKorea, Taiwan,ThailandAfrica: SouthAfrica,Uganda

InternationalParticipationMi

國(guó)際參與中東: Bahrain,Egypt,Lebanon, SaudiArabia,UAE亞洲: China,India,Japan,Philippines, Singapore,SouthKorea, Taiwan,Thailand非洲: SouthAfrica,Uganda

國(guó)際參與中東: Bahrain,Egypt,LebanInspectionPhilosophyVoluntaryprogramLaboratoryImprovementPeerReviewEducationInspectionPhilosophyVoluntary檢查的哲學(xué)自愿的項(xiàng)目實(shí)驗(yàn)室改進(jìn)同行互審教育檢查的哲學(xué)自愿的項(xiàng)目VoluntaryProgramMeetsUSCLIA-88regulatoryrequirementsOftenmorestringentthanCLIA-88requirementsVoluntaryProgramMeetsUSCLIA自愿計(jì)劃符合美國(guó)CLIA-88法規(guī)要求常常比CLIA-88的要求更加嚴(yán)格自愿計(jì)劃符合美國(guó)CLIA-88法規(guī)要求LaboratoryImprovementInspectionispartofLab’sQILaboratoryImprovementInspecti實(shí)驗(yàn)室改進(jìn)檢查是實(shí)驗(yàn)室質(zhì)量改進(jìn)的一個(gè)部分實(shí)驗(yàn)室改進(jìn)檢查是實(shí)驗(yàn)室質(zhì)量改進(jìn)的一個(gè)部分PeerReviewWhatIsaPeer?Equalstanding(pathologist,technologist,etc.)LaboratoryprofessionalFirst-handknowledgeOffersconstructivefeedbackPeerReviewWhatIsaPeer?同行互審什么是同行?相等的身份(病理學(xué)家,技術(shù)專家等.)實(shí)驗(yàn)室專業(yè)人員直接的認(rèn)識(shí)提供建設(shè)性的反饋同行互審什么是同行?PeerReviewInspectorswithSpecialtyExpertiseScientificResourcesNewTechnologyOngoingMonitoringEducationand ImprovementPeerReviewInspectorswithSpe同行互審具備專業(yè)知識(shí)的檢查官科學(xué)資源新技術(shù)持續(xù)監(jiān)控教育和改進(jìn)同行互審具備專業(yè)知識(shí)的檢查官PeerReviewBenefitsofBeinganInspector:PromotesthelaboratoryprofessiontothepublicGainsinsightthroughinteractingwithpeerprofessionalsContinuingeducationPeerReviewBenefitsofBeinga同行互審成為一名檢查官的好處:推動(dòng)實(shí)驗(yàn)專業(yè)的公眾化通過和同行的互動(dòng)獲得洞察力繼續(xù)教育同行互審成為一名檢查官的好處:EducationOn-SiteInspectionsInterimSelf-InspectionsPTMonitoringTechnical/RegionalResourcesDocuments/ManualsSeminarsWebsiteScientificResourceCommitteesEducationOn-SiteInspectionsDo教育現(xiàn)場(chǎng)檢查中間的自查PT監(jiān)測(cè)技術(shù)/區(qū)域的資源文件/手冊(cè)研討會(huì)網(wǎng)頁科學(xué)資源委員會(huì)教育現(xiàn)場(chǎng)檢查文件/手冊(cè)CAPPatientSafetyGoalsImprove:PatientandsampleidentificationVerificationandcommunicationoflife-threateningorlife-alteringinformationIdentification,communication,andcorrectionoferrorsIntegrationandcoordinationofthelaboratory’spatientsafetyrolewithinoverallorganization.CAPPatientSafetyGoalsImprovCAP患者安全目標(biāo)改進(jìn):病人和樣本的唯一編碼對(duì)威脅和改變生命的信息的確認(rèn)和溝通錯(cuò)誤的識(shí)別，溝通和更正在整個(gè)機(jī)構(gòu)中，整合并協(xié)調(diào)實(shí)驗(yàn)室的患者安全任務(wù)CAP患者安全目標(biāo)改進(jìn):VolunteerInspectorInspectionscarriedoutbythousandsoftrained,knowledgeablevolunteerteamleadersandmembers.

VolunteerInspectorInspections志愿者檢查官檢查由上千的經(jīng)培訓(xùn)的,資深的志愿者組長(zhǎng)和組員完成.

志愿者檢查官檢查由上千的經(jīng)培訓(xùn)的,資深的志愿者組長(zhǎng)和組員完FocusonConsistencyConsistentinspectionprocessthrough:InspectorTrainingTeamleader/memberselectionChecklistinspectiontoolFocusonConsistencyConsistent關(guān)注一致性一致的檢查過程通過:檢查官培訓(xùn)團(tuán)隊(duì)組長(zhǎng)/組員的選擇檢查條款為檢查工具關(guān)注一致性一致的檢查過程通過:InspectorTraining-EarnCME/CENationwideliveseminars(8hours)TeamLeaderWorkshops(2hours)AudioconferencesOn-lineeducation ()VirtuallibrarycontainspreviouslybroadcastaudioconferencesNEWeLearningTeamLeaderInspectorSelf-studyavailableJune1,2006NEWeLearningTeamMemberInspectorSelf-studyavailableJuly1,2006InspectorTraining-EarnCME/檢查官培訓(xùn)

-獲得CME/CE國(guó)內(nèi)的現(xiàn)場(chǎng)研討會(huì)(8小時(shí))團(tuán)隊(duì)組長(zhǎng)工作會(huì)(2小時(shí))可視會(huì)議在線教育 ()虛擬圖書館，包含先前可視會(huì)議廣播自2006年6月1日起可獲得“新的電子學(xué)習(xí)團(tuán)隊(duì)組長(zhǎng)檢查官自學(xué)課程”自2006年7月1日起可獲得“新的電子學(xué)習(xí)團(tuán)隊(duì)組員檢查官自學(xué)課程”檢查官培訓(xùn)

-獲得CME/CE國(guó)內(nèi)的現(xiàn)場(chǎng)研討會(huì)(8InspectionTeamInspectorsshouldbepeersoflabstaffManyinternationalinspectorsaffiliatedwithCAP-LAPInspectorsneedspecificexpertisefor:FlowCytometryCytogeneticsMolecularPathologyHistocompatibilityInspectionTeamInspectorssho檢查組檢查官應(yīng)該為實(shí)驗(yàn)室員工的同行

許多國(guó)際的檢查官隸屬于CAP-LAP檢查官需有特定的專業(yè)知識(shí)，包括:流式細(xì)胞學(xué)細(xì)胞遺傳學(xué)分子病理學(xué)組織配型學(xué)檢查組檢查官應(yīng)該為實(shí)驗(yàn)室員工的同行StandardsandChecklistsPurposes:StandardsarethebroadprinciplesthelaboratorymustmeetinordertoachieveaccreditationChecklistsprovidedetailedrequirementsthatinspectorsusetodeterminewhetherlaboratoriesmeettheStandardsStandardsandChecklistsPurpos標(biāo)準(zhǔn)和檢查條款目的:標(biāo)準(zhǔn)是指實(shí)驗(yàn)室需滿足的含蓋面廣的原則，目的是通過認(rèn)可。檢查條款提供具體要求，檢查員用它來看實(shí)驗(yàn)室是否滿足了標(biāo)準(zhǔn)標(biāo)準(zhǔn)和檢查條款目的:TheStandardsfor

LaboratoryAccreditationStandardI DirectorStandardII PhysicalFacilities& SafetyStandardIII QualityControland PerformanceImprovementStandardIV InspectionRequirementsTheStandardsfor

LaboratoryA實(shí)驗(yàn)室認(rèn)可的標(biāo)準(zhǔn)標(biāo)準(zhǔn)I 主任標(biāo)準(zhǔn)II 物理設(shè)施和安全標(biāo)準(zhǔn)III 質(zhì)控和性能提高標(biāo)準(zhǔn)IV 檢查要求實(shí)驗(yàn)室認(rèn)可的標(biāo)準(zhǔn)標(biāo)準(zhǔn)I 主任LAPChecklistsTeamLeaderChecklistLaboratoryGeneralHematology&Coag.Chemistry&ToxicologyUrinalysisMicrobiologyTransfusionMedicineDiagnosticImmunologyAnatomicPathologyCytopathologyCytogeneticsHistocompatibilityFlowCytometryMolecularPathologyLimitedServicePointofCareLAPChecklistsAnatomicPatholoLAP檢查條款團(tuán)隊(duì)組長(zhǎng)檢查條款通用實(shí)驗(yàn)室條款血液和凝血生化和毒理學(xué)尿液分析微生物學(xué)輸血醫(yī)學(xué)診斷免疫學(xué)解剖病理學(xué)細(xì)胞病理學(xué)細(xì)胞遺傳學(xué)組織配型流式細(xì)胞學(xué)分子病理學(xué)限制服務(wù)床旁診斷LAP檢查條款解剖病理學(xué)ChecklistsChecklistsguidetheinspectionbyassistingwiththeinterpretationofLAPStandards.ChecklistsChecklistsguidethe檢查條款檢查條款通過幫助對(duì)LAP標(biāo)準(zhǔn)的解釋來指導(dǎo)檢查.檢查條款檢查條款通過幫助對(duì)LAPChecklistsHelppaintacompletepictureDetailBroadvantagepointProvideguidelinesfordevelopmentofpolicies,proceduresandprocessesHelpensureaccurate,reliabletestresultsChecklistsHelppaintacomplet檢查條款幫助描繪一張完整的宏圖具體內(nèi)容含蓋全面的點(diǎn)提供對(duì)政策，程序和流程發(fā)展的指導(dǎo)有助于確保得到準(zhǔn)確、可靠的測(cè)試結(jié)果檢查條款幫助描繪一張完整的宏圖ChecklistQuestionsPhaseIDonotseriouslyaffectpatientcareandsafety/welfareoflabworkersPhaseIIMayhaveaseriousaffectonpatientcareormayseriouslyaffectsafety/welfareoflabworkersChecklistQuestionsPhaseI檢查條款的問題階段I不會(huì)嚴(yán)重影響患者醫(yī)療和實(shí)驗(yàn)室工作人員的安全/福利階段II可能會(huì)嚴(yán)重影響患者醫(yī)療和實(shí)驗(yàn)室工作人員的安全/福利檢查條款的問題階段IAnsweringChecklistQuestionsPossibleresponses:Yes,No,orNotApplicable(N/A)PartialcomplianceLikelytoaffectpatientcareorworkersafety?Ifyes,citeaDeficiencyInspectorexpectedtousejudgmentMinornoncompliancedoesnotchangePhaseIItoPhaseIAnsweringChecklistQuestionsP回答檢查條款的問題可能的回答:是,否,或不適用(N/A)部分的符合會(huì)影響患者醫(yī)療或員工安全嗎?如果是,記錄為一個(gè)缺陷檢查者須做出判斷較小的不符合不會(huì)改變階段II到階段I回答檢查條款的問題可能的回答:是,否,或不適用(N/ChecklistRevisionsOver3,200ChecklistQuestionsChecklistsarerevisedto:IncorporatenewtechnologyEliminateoutdatedtechnologyAllowformoreappropriatetechnologyNowCustomizedtoLaboratory’sspecificactivitymenuChecklistRevisionsOver3,200檢查條款的修訂超過3,200個(gè)檢查條款問題檢查條款會(huì)被修訂用來:整合新技術(shù)去除過時(shí)的技術(shù)允許更多適合的技術(shù)目前根據(jù)實(shí)驗(yàn)室的特殊活動(dòng)菜單用戶化檢查條款的修訂超過3,200個(gè)檢查條款問題ChecklistDevelopmentChecklistModifications

Participants

Commissioners

ResourceCommittees

TechnicalStaff

ChecklistDevelopmentChecklist檢查條款的發(fā)展檢查條款的修改參與者

委員

資源委員會(huì)

技術(shù)人員

檢查條款的發(fā)展檢查條款參與者委員ChecklistDevelopmentModificationsChecklistCommissionerCAPResourceCommitteesCommissiononLaboratoryAccreditationCMSLabsPrintingChecklistDevelopmentModificat檢查條款的發(fā)展修改檢查條款委員CAP資源委員會(huì)實(shí)驗(yàn)室認(rèn)可的委員會(huì)CMS實(shí)驗(yàn)室打印檢查條款的發(fā)展修改檢查條款委員CAP資源委員會(huì)實(shí)驗(yàn)室認(rèn)可的TeamLeaderChecklistReleasedOctober2005AssessesLaboratoryDirector’squalificationsandeffectivenessMostquestionsnotnewbutmovedfromLabGeneralChecklistAdditionaloverarchingquestionsaboutqualitymanagement,patientsafetyanddirectorauthorityTeamLeaderChecklistReleased檢查組組長(zhǎng)的檢查條款2005年10月發(fā)布評(píng)估實(shí)驗(yàn)室主任的資質(zhì)和有效性大多數(shù)問題不是新的，是從實(shí)驗(yàn)室通用檢查條款中搬過來的另外的關(guān)于質(zhì)量控制,患者安全和主任權(quán)限等方面的問題檢查組組長(zhǎng)的檢查條款2005年10月發(fā)布TeamLeaderChecklistDetailedinstructionsonhowto:ConductinspectionandinterviewsAssessDirector’sinvolvementandcommitmenttoqualityChecklistmustbecompletedbyTeamLeaderTeamLeaderChecklistDetailed檢查組組長(zhǎng)的檢查條款對(duì)以下的詳細(xì)的說明:完成檢查和審核評(píng)估主任的業(yè)績(jī)和對(duì)質(zhì)量的承諾檢查條款必須由團(tuán)隊(duì)組長(zhǎng)完成檢查組組長(zhǎng)的檢查條款對(duì)以下的詳細(xì)的說明:InspectionProcessAssignmentandPreparationConductingtheinspectionDocumentinginspectionfindingsReportingfindingstothelabPost-InspectionInspectionProcessAssignmenta檢查過程分配任務(wù)和準(zhǔn)備現(xiàn)場(chǎng)檢查記錄檢查中的發(fā)現(xiàn)告之實(shí)驗(yàn)室檢查結(jié)果檢查后檢查過程分配任務(wù)和準(zhǔn)備Teamleadernotifiedupto12monthspriortoanniversarydateLabisnotifiedofteamleaderandteammembersTeamLeadercontactslabtoarrangeinspectiondateInspectionmayinvolve severallaboratoriesFollow-uplettertolabDirectorInspectorAssignmentTeamleadernotifiedupto12團(tuán)隊(duì)組長(zhǎng)在檢查年到期的12個(gè)月前通報(bào)實(shí)驗(yàn)室會(huì)接到團(tuán)隊(duì)組長(zhǎng)和組員通知團(tuán)隊(duì)組長(zhǎng)和實(shí)驗(yàn)室聯(lián)系以確定檢查日期檢查可能包括幾個(gè)實(shí)驗(yàn)室給主任的確認(rèn)函檢查官的委派團(tuán)隊(duì)組長(zhǎng)在檢查年到期的12個(gè)月前通報(bào)檢查官的委派InspectionPacketLaboratorydemographicsDirectorandSupervisor(s)NumberoftestsyearlyNumberofpersonnelActivityMenuTestsandmethodsineachsectionProficiencytestingrequirementsInstrumentationChecklistsusedineachsectionInspectionPacketLaboratoryde檢查資料實(shí)驗(yàn)室信息主任和主管每年測(cè)試數(shù)員工數(shù)量活動(dòng)菜單每個(gè)部分測(cè)試和檢測(cè)方法能力驗(yàn)證的要求使用儀器每個(gè)部分適用的檢查條款檢查資料實(shí)驗(yàn)室信息InspectionPacketStandardsforLaboratoryAccreditationLaboratoryAccreditationManualPreviouson-siteinspectionreportLaboratoryorganization&floorplanCurriculumvitaeofLabDirectorVariantProficiencyTestingReportInspectionPacketStandardsfor檢查資料實(shí)驗(yàn)室認(rèn)可標(biāo)準(zhǔn)實(shí)驗(yàn)室認(rèn)可手冊(cè)先前現(xiàn)場(chǎng)檢查報(bào)告實(shí)驗(yàn)室組織和平面圖實(shí)驗(yàn)室主任簡(jiǎn)歷不同的PT報(bào)告檢查資料實(shí)驗(yàn)室認(rèn)可標(biāo)準(zhǔn)InspectorPreparationReviewinspectionmaterialsMeetingwithteamleaderInspectortrainingMandatoryforteamleadersSoonmandatoryforteammembersOtherCAPresourcesInspectorquestions-accred@CAPwebsite-InspectorPreparationReviewin檢查官的準(zhǔn)備回顧檢查材料與團(tuán)隊(duì)組長(zhǎng)會(huì)面檢查官培訓(xùn)組長(zhǎng)的責(zé)任組員的責(zé)任其他CAP資源檢查官問題-accred@CAP網(wǎng)頁-檢查官的準(zhǔn)備回顧檢查材料InspectorConductFair,objective,open-mindedDoesthelabmeettheintentofthechecklistquestions?CompliancewithCAPStandardsNeedtociteappropriatedeficienciesSuperficialinspectionunfairtolabDirectorneedstoknowofproblemsInspectorConductFair,objec檢查官的行為公平,公正,思維開闊的實(shí)驗(yàn)室是否符合檢查條款問題的意圖?服從CAP標(biāo)準(zhǔn)需要恰當(dāng)?shù)刂赋鋈毕菽w淺的檢查對(duì)實(shí)驗(yàn)室來說是不公的主任需要知道存在的問題檢查官的行為公平,公正,思維開闊的InspectionSchedule0800-0830 Introductions,tour0830-1200 Inspectlargersection1200-1300 Workinglunch;review withteamleader1300-1500 Inspectsmallersection1500-1600 Presummationconf.1600-1700 SummationconferenceInspectionSchedule0800-0830檢查時(shí)間表0800-0830 介紹,巡回檢查0830-1200 檢查大的部分1200-1300 工作午餐;和團(tuán)隊(duì)組長(zhǎng)回顧1300-1500 檢查小的部分1500-1600 前總結(jié)會(huì)議1600-1700 總結(jié)會(huì)議檢查時(shí)間表0800-0830 介紹,巡回檢查ConductingtheInspectionReadObserveAskConductingtheInspectionReadO檢查閱讀觀察提問檢查閱讀觀察提問ConductingtheInspectionForeach3hoursinasection:1hourreading2hoursobservingandaskingInspectionapproachesFollowtheSpecimenDrillDown(in-depthanalysisofselectanalytes)TeachMe(PretendIamanewtrainee!)Useopen-endedquestionsConductingtheInspectionFore檢查在一個(gè)部分中的每3小時(shí):1個(gè)小時(shí)閱讀2個(gè)小時(shí)觀察和提問檢查方法跟隨樣本深入研究(對(duì)選定樣本深度分析)教我(假如我是一名新的工作人員!)使用開放式問題檢查在一個(gè)部分中的每3小時(shí):Documentationvs.PracticeForchecklistrequirements:Doesthelabdoit?Isitdocumented?

Allproceduresmustbedocumented;e.g.CHM.11000PhaseII“Isacompleteproceduremanualavailable…”)Doespracticematchdocumentation?“…actualpractice[must]match…thecontentsoftheproceduremanuals.”Documentationvs.PracticeFor文件vs.操作檢查條款的要求:實(shí)驗(yàn)室按文件操作了嗎？有文件嗎?

所以程序必須文件化;例如：CHM.11000PhaseII“是一種完全的可獲得的操作手冊(cè)…”)操作和文件吻合嗎?“…實(shí)際操作[必須]與…操作程序手冊(cè)吻合.”文件vs.操作檢查條款的要求:InspectorSummationReportPartAGeneralobservationsandconclusionsVerificationofDirector’squalificationsPartBDeficienciesRecommendationsCopyleftwithlaboratoryInspectorSummationReportPart檢查官匯總報(bào)告A部分總的觀察和結(jié)論主任資質(zhì)的確認(rèn)B部分缺陷建議副本留給實(shí)驗(yàn)室檢查官匯總報(bào)告A部分Pre-SummationConferenceTeammeetingatconclusionofinspectionSetsthetoneforthesummationconferenceReviewalldeficienciesAnswerteammembers’q