4. Organize the validation and calibration experimental plans
4.1 The validation experience plan
In order to best reflect routine sample processing, measurements must be made in such a way as to take account of the various sources of uncertainty, i.e., according to the vocabulary of ISO 5725, under conditions of intermediate precision. In this example, the simplest solution was to repeat the measurements over several days, as this would allow us to take into account changes in the samples, the diversity of operators, calibration variability, ageing of reagents, changes in instrument settings, etc.
By definition, repetitions on the same day form a series. This raises three questions.
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Organize the validation and calibration experimental plans
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Bibliography
Collège Français de Métrologie: Application of the new VIM3 calibration concept (Reissued 2014)
Commission Decision of August 12, 2002 implementing Council Directive 96/23/EC as regards the performance of analytical methods and the interpretation of results (2002/657/EC)
Feinberg (M.), Labo-Stat: Guide de validation des méthodes d'analyse...
Normative references
ISO 16140: 2003 Microbiology of food: validation protocol for alternative methods (2003) ISO, Geneva
NF EN ISO/CEI 17025 : 2005 General requirements for the competence of testing and calibration laboratories (2005) ISO, Geneva
NF V03-110 (May 2010) Analysis of agricultural and food products – Characterization protocol for the validation of a quantitative analysis method...
Websites
Arlenda is a bio-statistics consultancy that has developed software for validating analytical methods.
This site offers commercial software for validating analytical methods.
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