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Information leaflets

Treatment of an observed bias

Content

bias img 240x194Bias is routinely determined during the validation of analytical methods. Usually, the observed bias is not exactly zero. It is then important to decide whether the observed bias can reasonably be treated as unimportant, or whether some further action needs to be taken. This can be particularly difficult to decide when applying the principles of the 'Guide to the Expression of Uncertainty in measurement', which assumes that a correction has been applied for any important bias. 

This information leaflet has been prepared by the Eurachem Measurement Uncertainty and Tracability Working Group (see here for details). The leaflet discusses whether or not an observed significant bias should be corrected and the impact this may have on the measurement uncertainty (MU). The leaflet does not describe how to apply a correction or how to increase the uncertainty to take account of an uncorrected bias, though it does provide relevant literature sources.

 

Availability

 * 2nd printing; editorial amendment only

Translation

Translation into other languages is encouraged for members of Eurachem. Other offers of translation should be directed to the Eurachem Secretariat for permission. The Eurachem policy on maintenance and development of Eurachem guidance, available on the Policies page, gives further information on translation.

Publication date

This leaflet was first published in English on 2017-05-27.

* The English copy on this page is a minor (editorial) amendment, published 2022-10-21; the recommendations are unchanged.

Setting Target Measurement Uncertainty

Contents

orange tree trn 180Measurement results are only fit for purpose if the reported uncertainty is correct and has a magnitude small enough for the intended use. The target measurement uncertainty (target MU) is the maximum admissible uncertainty defined for a specific measurement goal. This information leaflet provides a short and accessible introduction to the idea of target measurement uncertainty.

For detailed information on setting a target measurement uncertainty, see the Eurachem/CITAC guide "Setting and Using Target Uncertainty in Chemical Measurement"

Availability

Translations

Translation into other languages is encouraged for members of Eurachem. Other offers of translation should be directed to the Eurachem Secretariat for permission. The Eurachem policy on maintenance and development of Eurachem guidance, available on the Policies page, gives further information on translation.

The importance of method validation

Content

Factors affecting PT strategy

Method validation is an important requirement in the practice of analytical science. ISO/IEC 17025, OECD guidelines on Good Manufacturing Practice and many similar codes of practice require some level of validation, whether by verification of the laboratory's implementation of published standard methods, or by comprehensive validation studies of new, in-house, procedures. Most analytical chemists are aware of its importance, but why it should be done, when, and exactly what needs to be done, is not always clear.

This leaflet, prepared by the Eurachem Method Validation working group, gives a brief introduction to the overall process of validation and the key performance characteristics to be studied, and provides pointers to more detailed guidance.

Availability

Translation

Please consult the Method Validation Working Group if you would like to prepare a translation in your own language.

 

*Publication dates are dates of website publication. English version first published on this site on 2021-02-25.

What is the uncertainty factor?

Content

Distribution of GMO results showing approximately lognormal distribution

Appropriate expression of the measurement uncertainty (MU) is crucial, and there are situations when the traditional, symmetric, expanded uncertainty interval is not sufficient. This leaflet aims to explain the concept of the uncertainty factor and how it can be used to provide a convenient and realistic uncertainty interval in particular circumstances..

This leaflet was produced by the Eurachem Sampling Uncertainty Working Group and the Royal Society of Chemistry Analytical Methods Committee (AMC) Sampling Uncertainty Working Groups.

Availability

Translation

Please consult the Eurachem Sampling Uncertainty Working Group Chair, directly or by using the UfSWG contact form, if you would like to prepare a translation in your own language.

 

*Publication dates are dates of website publication. English version first published on this site on 2020-07-29.

VaMPIS - Validation of Measurement Procedures that Include Sampling

Word cloud - statistical terms

Content

WordCloudRect90rValidation of analytical methods (i.e. procedures) usually excludes the primary sampling, but this is now widely recognised as the first step in the measurement procedure. Validation of the whole measurement procedure therefore requires consideration of a performance characteristic that reflects the quality of all of the steps (including sampling and physical sample preparation). The uncertainty of the final measurement value is that key characteristic that unifies this whole measurement procedure and enables its validation, particularly when supported by performance characteristics that have an established role in the validation of an analytical procedure as a standalone activity.

This leaflet summarises the new Eurachem/CITAC guidance on the Validation of Measurement Procedures that Include Sampling (VaMPIS). It can be applied to the whole measurement process either simultaneously, where the sampling and analytical procedures are validated as a unified measurement procedure, or sequentially when the analytical procedure has previously been validated in isolation. .

Availability

The leaflet is currently available in English.

 

Translation

Please consult the Sampling Uncertainty Working Group Chair if you would like to prepare a translation in your own language.

 

Notes

1. Dates show date of publication of the linked file on this website.

2. First English edition (V1) published 2025-05-19. The present file version (V1a) includes a minor editorial correction to the publication date.