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Procedure (not method…) validation!

According to VIM3 [1], a method is:

a “generic description of a logical organization of operations used in a measurement” (Entry 2.5) (e.g. standard addition method or gas-chromatography)

…therefore, methods cannot be validated because are too general.

The detailed description of the analytical methodology, subject to validation, is a procedure: Measurement procedure (Entry 2.6): “detailed description of a measurement according to one or more measurement principles and to a given measurement method, based on a measurement model and including any calculation to obtain a measurement result”.

Changing “method validation” to “procedure validation” is not easy for most analysts, but we should be prepared to update commonly used terms with the internationally agreed new ones.

1. International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM 3rd edition), JCGM 200:2012 (JCGM 200:2008 with minor corrections) (https://www.bipm.org/en/publications/guides/vim.html)