11. Mistakes to avoid
11.1 Never try to validate a method under development
It is essential to remember that validation should always take place after the method has been developed and its operating procedure written. Attempting to carry out validation tests with a method that is still poorly understood could lead to serious disappointment, and the conclusion that it is not valid.
Some results can be surprising or disappointing. In such cases, an explanation must be found. We may suspect the materials used, their state of preservation or a matrix effect. You need to think carefully about the choice of materials, and how they are prepared and preserved. In short, don't underestimate the practical and logistical aspects.
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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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