【正文】 performance against laboratory scope rather than PT program criteria 在一定范圍內(nèi)評審實驗室的表現(xiàn)，而不是 PT方案準則 ? Consider “fit for purpose” 考慮適宜性 60 Excellence on a Global Scale Third Party Assessment 第三方評審 Regulators政府管理部門 ? May be involved in development of PT programs 可能參與 PT方案的開發(fā) ? May require assistance from program coordinator to assess results 可能需要方案協(xié)調(diào)人來幫助評審結(jié)果 61 Excellence on a Global Scale Third Party Assessment 第三方評審 Customers客戶 ? When using PT results as a performance standard ensure target is realistic 當使用 PT結(jié)果作為能力標準時，確保目標是現(xiàn)實的 ? Must investigate program。 not just results 必須調(diào)查方案，而不僅是結(jié)果 62 Excellence on a Global Scale Reference Materials 參考物質(zhì) 5 types（ 5種類型） ? Pure substance（ 純物質(zhì)） ? Standard solutions and gas mixtures（ 標準溶液和氣體混合物） ? Matrix RM’s（ 基體參考物質(zhì)） ? Physical properties（ 物理特性） ? Reference objects (artifacts)（ 參考目標）（參考品） 63 Excellence on a Global Scale Reference Materials 參考物質(zhì) May be used for 可用于 ? Internal QC內(nèi)部質(zhì)量控制 ? Method validation方法確認 ? Calibration校準 ? Estimating uncertainty評估不確定度 ? Training培訓 64 Excellence on a Global Scale Classification分類 Certified Reference Materials有證參考物質(zhì) ? Directly traceable直接溯源 ? Each property has an uncertainty associated with it每一特性有相應不確定度 Reference material參考物質(zhì) ? Properties are homogenous and thoroughly characterized to be used for calibration or method assessment ? 特性是均勻的，并完整定值，以用于校準或方法評價 65 Excellence on a Global Scale Availability可獲得性 Generally poor therefore expensive(不容易獲得 ,費用高 ) ? Government agencies政府機構(gòu) NIST, NRC, EUBCR ? Trade associations貿(mào)易協(xié)會 AOAC, AOCA (Oil Chemists)石油化學 ? Commercial suppliers商業(yè)供貨商 66 Excellence on a Global Scale RM in Validation 方法確認中參考物質(zhì)的使用 Estimation of bias between method and true value評估方法和真值間的偏差 Estimation of bias between two methods評估方法間的偏差 ? Requires less rigorously certified RM ? 要求的有證標準物質(zhì)相對不是太嚴格 Limited by uncertainty of certified values ? 受參考值不確定度的限制 67 Excellence on a Global Scale RM in Validation 參考物質(zhì)在方法確認中的應用 Matrix RM must be within scope of the method參考物質(zhì)的基體必須適用于該方法 Multiple RM’s may be required to cover range of method含多種成分的參考物質(zhì)應適用于該方法 68 Excellence on a Global Scale RM in Calibration 參考物質(zhì)在方法校正中的應用 Usually use pure substance常用純物質(zhì) Uncertainty associated with purity will contribute to uncertainty of the method與純度相關(guān)的不確定度是方法不確定度的分量 Some methodology requires RM for calibration of entire process (XRF)有些方法學需要用參考物質(zhì)對整個過程校準 (XRF) 69 Excellence on a Global Scale RM in Training 參考物質(zhì)在方法培訓中的應用 Qualifying new analysts培養(yǎng)合格的新分析人員 Checking methods used infrequently檢查不常用的分析方法 Troubleshooting methods解決分析方法中的疑難問題 70 Excellence on a Global Scale RM as QC 參考物質(zhì)用于質(zhì)量控制 Must be characterized with respect to stability and homogeneity必須穩(wěn)定、均勻 ,認定特征值 71 Excellence on a Global Scale Suitability適用性 Matrix match (interferences)基體匹配程度 (干擾 ) Concentration range濃度范圍 Uncertainty of certified values參考值的不確定度 Source (conformance with standards)來源 (與標準的符合性 ) Ongoing availability目前是否可得到 But – How to assess但是 – 如何進行評估呢 ? 72 Excellence on a Global Scale Inhouse production 內(nèi)部研究 What would the requirements be需要具備哪些必要條件 ? 73 Excellence on a Global Scale 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH