全面品质管制(ppt 16)

来自中国最大的资料库下载何謂品質ISO定義:一個產品或一項服務的整體特色和性質，此特色和性質讓使用者覺得滿意的程度。臨床檢驗服務定義:在約定的費用與時間內，以及約定的條件下和事後必須的處置，交付可靠的訊息来自(Plan)Purpose:preventproblembyimplementingproperprocessesQLP:QualityLaboratorypractices(DO)Purpose:establishlaboratorystandardprocessesQC:Qualitycontrol(Check)purpose:detectproblem,containthedamageQA:Qualityassurance(Check)Purpose:detectproblem,planimprovements来自(action)Purpose:preventproblembycorrectingprocesses来自Choosewhatistobecontrolled(qualitycharacteristic)Chooseaunitofmeasurement(method)SetastandardforthequalitycharacteristicChooseasensingdevicewhichcanmeasurethequalitycharacteristicintermsoftheunitmeasurementMeasuretheactualperformanceInterpretthedifferencebetweentheactualqualityandthestandardTakeaction(ifany)onthedifference来自Calibrator:Toestablishastandardcurve利用已知濃度的試劑(standard/calibrator)，測定其與反應試劑作用之能量變化；並將此能量變化值與該已知濃度值，做成函數關係圖。Control:Toinvestigatethestandardcurve利用已知濃度範圍的試劑(controlserum)，測定其與反應試劑作用之能量變化；並對照該反應之standardcurve，將能量變化值換算成濃度值後，比較是否在原已知範圍濃度內来自~24months18~24monthsLyophili-zationerrorAbsentPresentAbsent来自TheanalystsconcentrationshouldbeatmedicallysignificantThematerialshouldbeavailableinlargequantitiesThematerialmatrixshouldbeasmuchlikethehumansampleaspossibleConstituentsshouldbestableforalongperiodoftime来自Materialshouldhavelowvial-to-vialvariabilityAfterthevialhasbeenopenedandthematerialprepareditshouldbestableduringtheperiodofuseThematerialshouldbeready-to-useorrequireminimumpreparationControlshouldbeimmediatelyavailableinemergencysituationsThecontrolmaterialshouldbereasonablypriced来自為Youdon於1967年提出的品管圖，以正常(低值)及異常(高值)兩種品管同時測定，製成雙值管理圖(TwinPlotsMethod)低值畫在水平軸，高值畫在垂直軸，形成正方形圖，正方形的中心點，即為兩個平均值的交叉點来自Externalqualitycontrol1946withBelkandSunderman1947CollegeofAmericanPathologists(CAP)Performancelimitsandgradinga:1966~1969—within+2Sasacceptable，exceeding+2Sasnotacceptableb:1970—within+1Sasgood，within+2Sasacceptable，beyond+2Sasnotacceptable来自(SDI)SDI=(laboratoryvalue-groupmean)/groupSValuesoutsidethegroupmeans+2SDIlimitsarenotacceptable来自臨床檢驗品質管理理論與實務林明泉榮昇圖書事業股份有限公司TaiwansymposiumonQualitycontrolJamesO.Westgard臨床品質管制學(中山講義)江惠玲