全面品质管制.ppt

全面品質管制第一页，共十七页。 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，交付可靠的訊息第二页，共十七页。 Quality Management第三页，共十七页。 QP : Quality Planning (Plan)Purpose :prevent problem by implementing proper processesQLP :Quality Laboratory practices (DO) Purpose :establish laboratory standard processesQC :Quality control (Check)purpose :detect problem ,contain the damageQA :Quality assurance (Check)Purpose :detect problem, plan improvements第四页，共十七页。 第五页，共十七页。 QI : Quality improvement (action)Purpose :prevent problem by correcting processes第六页，共十七页。 Step in the control processChoose what is to be controlled (quality characteristic)Choose a unit of measurement (method)Set a standard for the quality characteristicChoose a sensing device which can measure the quality characteristic in terms of the unit measurementMeasure the actual performanceInterpret the difference between the actual quality and the standardTake action (if any) on the difference第七页，共十七页。 Control MaterialCalibrator: To establish a standard curve 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: To investigate the standard curve 利用已知濃度範圍的試劑(control serum) ，測定其與反應試劑作用之能量變化；並對照該反應之standard curve ，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第八页，共十七页。 Comparison of quality control materialsCriteriaFrozenLyophilizedLow-temperature liquidCostLowHighHighClarityClearTurbidClearStability12 months18~24 months18~24 monthsLyophili-zation errorAbsent PresentAbsent第九页，共十七页。 Selection of control materialThe analysts concentration should be at medically significantThe material should be available in large quantitiesThe material matrix should be as much like the human sample as possibleConstituents should be stable for a long period of time第十页，共十七页。 Selection of control materialMaterial should have low vial-to-vial variabilityAfter the vial has been opened and the material prepared it should be stable during the period of useThe material should be rea