TheQualityManagement質量管理體系組人設流程管采購與TheQualityManagement質量管理體系組人設流程管采購與庫存信息管理EventMgnt件的管理評文檔記設施和安全持續(xù)改聚焦于客戶2WhatisanWhatisan評審是什么？SomeoneisWhatisbeing做了HowdoesthiscomplywithwrittenpoliciesandComparisonofactualresultsto實際結果與預期的對Whyassess?Whymeasure?為什么要評審為什么要Whyassess?Whymeasure?為什么要評審為什么要測量Howdoyouknowifyouaremeetingyour如何知道你是否達到了目標？HowdoyouknowifyouareyourcustomerneedsandHowdoyoucomparewith如何與其它實驗室進行比較？Howdoyouknowifachangeisan如何知道你是否進步了？外部評審groupor外部評審groupor外部團體或機構評審內部評Quality優(yōu)質實驗室TypesofAssessments評審TypesofAssessments評審的Internal內部評審Qualityindicators質量指標（及測量值BloodutilizationExternal外部評審Accreditationorlicensureassessment,mandatoryandtestingwhenPTisnot內部評外部內部評外部評審Assessing/Auditing/Assessing/Auditing/評審/審核/監(jiān)GatherComparefindingswithdocumentedqualitymanagementIdentifygapsinsystemordeparturefromproceduresReportUseaudit8assignsfortheassessment指派評assignsfortheassessment指派評審項目的職責評審結果–Quality質量管理者 corrective 實驗室主任開發(fā)計劃表select&train開發(fā)計劃表select&train選擇&培訓內部評審員管理糾正coordinatetheauditprocesses協(xié)調審核流程評審結果向員工reportto向管理部門報告QualityManagerResponsibility質量管理establishandmaintainanqualityassessment建立和維護質量評審系統(tǒng)Preparationü組üGatherandrecords收集信息和Preparationü組üGatherandrecords收集信息和記錄üSchedulewithstaff與員工制時間ü計AuditsShouldLeadtoAuditsShouldLeadto審核后應該予以行動Audit-審核-監(jiān)行識別改進的機會QSEASSESSMENTS質QSEASSESSMENTS質量系統(tǒng)要素：評內部評審InternalAuditsand內部審InternalAuditsand內部審核和監(jiān)測靈LookatyourownprocessesCostsless減小成§requiredbyISOstandardISO標準中的要求§conductedonaregularbasisANDwhenproblemsidentifiedInternalISOInternalISO內部審核：ISO標準要求§musthaveanaudit§mustdocument§auditorsindependentofactivitywhenpossible§resultsdocumentedreportedtomanagementfor§promptfollow-up§必須具有審核項§必須記錄審核程§評審員盡可能獨立于實驗§記錄結果并向管理層報告§促使后續(xù)行AssesstheentireQMSandpathof評審完整的質量管理體系及AssesstheentireQMSandpathof評審完整的質量管理體系及其工作流學實驗室工作流程檢驗????????檢驗檢驗????標本檢??樣發(fā)管評 質量體系要 持續(xù)改文檔&記 信息管 不符合事管人 采購&庫 設 流程管組 聚焦于客 設施和安AssessAssesstheentireQMSandpathof評審整個工作流的質量管理體系以及路徑評審類系統(tǒng)評審類系統(tǒng)評流程評審產(chǎn)品/服務評評審方法回評審方法回前定義:系統(tǒng)評審Determineswhetherthemultipleprocessesinasystemmeet確定系統(tǒng)的多個流程是否符合要 Looksatprocess,products,servicesandsupporting Objectiveevidencedemonstratingthatelementsofthesystemare:客觀證據(jù)顯示系統(tǒng)的要素是 Developed,documented,and建立、存檔和實施 Incompliancewith符合要求 適合的 有效的?定義：流程評審Determineswhethertheinputs,actions,andoutputsofasingleprocessoccurasProcessauditscantraceaselectedprocessforwardorbackwardDefinitions:Focused定義：重點評審?ExaminationofaproductorDefinitions:Focused定義：重點評審?Examinationofaproductorservicetoevaluatewhetheritconformstorequirements檢查“產(chǎn)品”以評估它是否符合要?續(xù)任一情Reviewof回PTrecordsforQCexceptions室cttio前Patient病人調樣本標優(yōu)秀實驗室Quality微生物實驗室Internal內部審核Donotauditown優(yōu)秀實驗室Quality微生物實驗室Internal內部審核Donotauditown尿檢實驗室內另一間實驗室的顧問病毒學實驗室Int.todetail注意細todetail注意細有效經(jīng)過培for評審員的重要技技術/質量管善于溝QualityQuality質量指標質量指標是一個度量標準(measuredprocess（測量了流程信息DeterminequalityofHighlightpotentialqualityIdentifyareasthatneedfurtherstudyandTrackchangesoverMetricsQuality質量指Quality質量控–––?MetricsQuality質量指Quality質量控–––????ProcessInstrument––––––Operator?ReactiontimeFluorescenceColonyCountUsingtheUsingtheRight使用正確的度量標準Brown,MarkGraham–KeepingScoreDONotWasteTimeDONotWasteTimeand不要浪費時間和精力Establishingindicatorsthatyou……定期測解釋改MeasureOutofyourToomany不能控制變量太多Whatto計劃：去測量什么？以病人為Whatto計劃：去測量什么？以病人為中心的CustomerPathof管理質量體系ASSESSMENTS評ASSESSMENTS評EXTERNAL外部評審ExternalAuditors外部ExternalAuditors外部認可機構實驗室資助項Preparingforanexternal外部評審Preparingforanexternal外部評審的準TobeüSchedulewith要想成功：ü計劃ü組üGatherinformation,documents,ü收集必要的息、文檔錄and“Auditsare“AuditsarefactfindingnotfaultExternalExternal外部評審：室間質評ExternalQualityAssessmentExternalQualityAssessmentAsystemforobjectivelycheckingthelaboratory’sperformanceusinganexternalagencyorfacility一個用外部機構或者設施去客觀檢查實驗室性能的系統(tǒng)P室間質評組織/提供分寄送檢驗室間質評能力報告P室間質評組織/提供分寄送檢驗室間質評能力報告PTsamples定期發(fā)送室間質評樣本評PTISO樣樣LaboratoryAnalyzesameISO樣樣LaboratoryAnalyzesamemannerwithsamepersonnel由同一位員工以同的操作分FinalPT間質改betweenlabsLaboratory 評 評TAKING采取行FindingsandPlanof發(fā)現(xiàn)和行動FindingsandPlanof發(fā)現(xiàn)和行動計劃實驗室理解報告中的建總結報RecordresultsandWriteIdentify識別差Developtimeline制定時間線；指派責Plancorrective計劃糾正措即時的和糾正的措施TheseactionsarethestepstakentoimproveaprocessortocorrectaWhoisQuality由誰質量管理者Documents文?InternalauditDocuments文?Internalaudit內部審核項selecting,establishingandmonitoringQIhostingexternalassessmentsEQA室間質評項???monitoringmonitoringisthekeyelementtosuccessintheQualitySystemquality監(jiān)控&評quality監(jiān)控&評估客質量控質量提高計劃持續(xù)的質量提升Action糾正行為計劃 “Itisn’t“Itisn’twhatyoufind…it’swhatyoudoaboutwhatyouPhilip?Assessmentisimportant?Assessmentisimportantinmoni