General Paper

Accreditation and Quality Assurance

, Volume 6, Issue 6, pp 257-263

First online:

Uncertainty calculations in the certification of reference materials

3. Stability study
  • Adriaan M. H. van der VeenAffiliated withNederlands Meetinstituut, Schoemakerstraat 97, 2600 AR Delft, The Netherlands e-mail: avdveen@nmi.nl Tel.: +31–15–2691 733 Fax: +31–15–261 29 71
  • , Thomas P. J. LinsingerAffiliated withEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Retieseweg, 2440 Geel, Belgium
  • , Andree LambertyAffiliated withEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Retieseweg, 2440 Geel, Belgium
  • , Jean PauwelsAffiliated withEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Retieseweg, 2440 Geel, Belgium

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Abstract 

To serve as a measurement standard, a (certified) reference material must be stable. For this purpose, the material should undergo stability testing after it has been prepared. This paper looks at the statistical aspects of stability testing. Essentially, these studies can be described with analysis of variance statistics, including variant regression analysis. The latter is used in practice for both trend analysis and for the development of expressions for extrapolations. Extrapolation of stability data is briefly touched upon, as far as the combined standard uncertainty of the reference material is concerned. There are different options to validate the extrapolations made from initial stability studies, and some of them might influence the uncertainty of the reference material and/or the shelf-life. The latter is the more commonly observed consequence of what is called ’stability monitoring’.

Keywords Uncertainty Reference materials Stability testing Analysis of variance Regression analysis