Total error and uncertainty: Friends or foes?

被引:27
作者
Rozet, E. [1 ]
Marini, R. D. [1 ]
Ziemons, E. [1 ]
Dewe, W. [2 ]
Rudaz, S. [3 ]
Boulanger, B. [4 ]
Hubert, Ph. [1 ]
机构
[1] Univ Liege, Analyt Chem Lab, Dept Pharm, CHU, B-4000 Liege, Belgium
[2] GlaxoSmithKline Biol, B-1330 Rixensart, Belgium
[3] Univ Geneva, Lab Pharmaceut Analyt Chem, Sch Pharm, CH-1211 Geneva 4, Switzerland
[4] Arlenda SA, Liege, Belgium
关键词
ISO; 15189; 17025; Measurement uncertainty; Quality assurance; Quality of results; Random error; Systematic error; Total error; Uncertainty; Validation; QUANTITATIVE ANALYTICAL PROCEDURES; SFSTP PROPOSAL; METHOD VALIDATION; QUALITY; BIAS; STRATEGIES; HARMONIZATION; TRACEABILITY; PERFORMANCE; GUIDELINES;
D O I
10.1016/j.trac.2010.12.009
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Guidelines ISO 17025 and ISO 15189 aim to improve the quality-assurance scheme of laboratories. Reliable analytical results are of central importance due to the critical decisions that are taken with them. ISO 17025 and ISO 15189 therefore require that analytical methods be validated and that laboratories can routinely provide the measurement uncertainty of the results of measurements. To evaluate the fitness of purpose of analytical methods, total error is increasingly applied to assess the reliability of results generated by analytical methods. However, the ISO requirement to estimate measurement uncertainty seems opposed to the concept of total error, leading to delays in laboratories implementing ISO 17025 and ISO 15189 and confusion for the analysts. This article therefore aims to clarify the divergences between total error and measurement uncertainty, but also to discuss their main similarities and emphasize their implementation. (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码:797 / 806
页数:10
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