Guides

Guides

Current Eurachem Guides

Validation of Measurement Procedures that Include Sampling (1st Ed)

A supplement to:
“The Fitness for Purpose of Analytical Methods”
“Measurement Uncertainty arising from Sampling”

Vampis converge txt outGuidance is given on how to validate a measuring procedure that includes the primary sampling (VaMPIS). It is a supplement to existing Eurachem guidance on “The Fitness for Purpose of Analytical Methods” and “Measurement Uncertainty arising from Sampling”. The overall aim is to extend the concept of ‘validation of a measurement procedure’ beyond the validation of the analytical method (or procedure) alone, in order to include the primary sampling (and physical sample preparation) within the validation process.

Ideally, VaMPIS can be applied to validate the whole measurement procedure simultaneously. Alternatively, VaMPIS can be applied sequentially by using an analytical procedure that has already been validated for this purpose in isolation, but then extending it to include the sampling step.

The key characteristic that enables validation of both the sampling and the analytical procedures is the measurement uncertainty, when supported by the performance characteristics that apply to the analytical procedure, which are already described in the Fitness for Purpose guide.

Two worked examples are provided to demonstrate how VaMPIS can be applied to both ex situ analysis in a laboratory of an extracted sample, and also to in situ analysis made ‘in the field’, without extracting a physical sample. Guidance is also given on the management and QC issues that are needed in order to integrate the sampling and the analytical steps, which have previously usually not had a unified and coordinated approach to data quality.

Availability

This supplementary guidance is available in the following languages:

Citation

This publication should be cited* as:
M. H. Ramsey, P. D. Rostron, F. C. Raposo (eds.) Eurachem/EUROLAB/CITAC/Nordtest/AMC Guide: "Validation of Measurement Procedures that Include Sampling", Eurachem (2024).  Available from http://www.eurachem.org"

*Subject to journal requirements

Translations

Translation into other languages is permitted 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 Fitness for Intended Use of Analytical Equipment and Systems (1st Ed)

The Fitness for Intended Use of Analytical Equipment and Systems - A Laboratory Guide to the Life Cycle of Analytical Equipment and Systems, their Qualification and Related Topics

Vampis converge txt outA wide variety of analytical equipment is used in analytical laboratories, ranging from simple apparatus to complex computer-based systems, to collect data that helps to obtain a reportable result. Many of these pieces of equipment combine a measurement function with software control. There are many ways to demonstrate that an equipment is qualified and under control, including qualification, calibration, validation and maintenance. To ensure ‘fitness for purpose’, an integrated approach based on risk assessment is recommended.

For the purposes of this guide, the term ‘equipment’ includes all apparatus, devices, instruments or instrument systems used in chemical, physical or biological analyses. The instruments form the basis for analytical work, from the development of the method to its validation and routine use. Without this stable foundation, the reliability of the entire process is questionable.

This document is a laboratory guide to the life cycle of analytical equipment and systems and their qualification for laboratories working to various standards and regulations. It is designed to help the laboratory management and staff and other users of analytical equipment to find a common nomenclature to meet the requirements efficiently, to do their work efficiently and to better understand the characteristics and limitations of the equipment.

The guide covers the entire lifespan of the equipment. It begins with the design, development and production of new equipment by the manufacturer. At the user's end, it covers all processes from the considerations involved in purchasing new equipment to commissioning, operation, maintenance, requalification and decommissioning. The main focus of attention is on the fitness for the intended use of the analytical equipment.

Availability

This guidance is available in the following languages:

Citation

This publication should be cited* as:
Ernst P. Halder (ed.) Eurachem Guide: The Fitness for Intended Use of Analytical Equipment and Systems – A Laboratory Guide to the Life Cycle of Analytical Equipment and Systems, their Qualification and Related Topics (1st ed. 2025). ISBN 978-0-948926-41-9. Available from http://www.eurachem.org

*Subject to journal requirements

Translations

Translation into other languages is permitted 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.

Feedback

The working group is very interested in feedback from readers, particularly from those who are directly involved in using equipment. Comments can be provided via the AE&SQ Contact Form on this website.

 

Accreditation for Microbiological Laboratories (2023)

Microbiology plate. Original image from CDC via unsplash.com

Contents

This Eurachem Guide has been produced by an ad hoc Eurachem Working Group. This third edition of Accreditation for Microbiological Laboratories is a revision of the second edition published in 2013. The first edition from 2002 was produced by a joint EA/Eurachem Working Group.

The aim of this guide is to provide microbiological laboratories with guidance on how to fulfil the requirements of ISO/IEC 17025. The content, however, should also be of use to organisations seeking accreditation or certification against the requirements of standards such as ISO 15189, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), and GCP (Good Clinical Practice)). Specific national regulations may override the guidance given in this document. The Guide will also provide useful information for laboratories that wish to establish a quality management system but are not seeking formal recognition.

The principal changes in the third edition are:

  • update on recent trends in microbiology, e.g. PCR (polymerase chain reaction) techniques for the detection of microorganisms;
  • addition of a list of abbreviations and symbols;
  • addition of a section on risk-based thinking;
  • updated sections on method verification and validation to reflect current ISO standards;
  • references to the use of a decision rule;
  • updated Annex A on terminology relevant to microbiology;
  • new Annex C on reporting confidence intervals;
  • new Annex D on estimation of uncertainty from sampling;
  • the order of sections in adherence with ISO/IEC 17025:2017.

 

Availability

This third edition is currently available in English and can be downloaded at no cost from the link below:

Download the guide in English [pdf, 272 kB] (2023-05-23)+

+ Date of publication on this site

Translations

Translation into other languages is permitted 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.

Citation

This guidance should be cited* as:

“B Magnusson and K C Tsimillis (eds.) Accreditation for Microbiological Laboratories (3rd ed. 2023). ISBN 978-91-519-6581-9. Available from www.eurachem.org.”

*Subject to journal requirements

Previous versions

The second edition of this Guide can be found in the publication archive on this website.

 

 

 

 

Assessment of performance and uncertainty in qualitative chemical analysis

Introduction

Mass spectrometric identification of pesticide in lettuceMany decisions with socio-economic or individual impact depend on qualitative analysis, including decisions related to food safety, clinical diagnosis, and forensic evidence, are based primarily on qualitative, rather than quantitative, chemical analysis. Qualitative analysis is analysis that returns a classification rather than a numerical value, such as the identity of a chemical substance, the type of plastic of a microparticle, the potential source of an oil spill, the presence of a banned sports doping substance, or the presence of accelerant in fire debris. Sometimes, such classifications rely solely on qualitative tests; others may use measurement results (such as line frequencies in a spectrum) to reach a conclusion.

Qualitative analysis, like quantitative analysis, needs to be demonstrably reliable. Part of the purpose of the guide is accordingly to show how the performance of a qualitative analysis procedure can be quantified to ensure its fitness for purpose. Practical difficulties and limitations in reliable quantification of low false result rates are discussed, and recommendations are made for checking the validity of these analyses. Brief recommendations are also made for ensuring that any measurements undertaken in the course of a qualitative analysis are reliable.

Although laboratories accredited following the ISO/IEC 17025 standard are not currently required to express qualitative analysis results with uncertainty, the guide provides some metrics that can be used to convey the level of confidence in conclusions from qualitative analysis. In addition, the guide provides suggestions for reporting results with an indication of confidence if desired. 

This guide does not make recommendations on whether or not laboratories should routinely report information on the confidence, or uncertainty, associated with qualitative analysis results. Nevertheless, an understanding of performance, or of the uncertainty associated with a qualitative analysis result, can help laboratories to better advise customers; it can also help to identify quality improvements or determine (for example) whether additional confirmatory tests might be needed.

This Eurachem/CITAC guide accordingly aims to provide some tools to help improve the quality of qualitative analysis and of their interpretation, to make sure that interests dependent on these analyses are well protected.

Content of the guide

This guide includes information on 

  • The nature and relevance of qualitative analysis.
  • Different types of qualitative analysis - for example, those that depend on qualitative tests alone, and others that use quantitative information to come to a conclusion.
  • Experimental and other strategies for estimating false response rates, which are fundamental to establishing reliability.
  • Expressions of confidence in qualitative analysis.
  • Reporting qualitative analysis results.
  • Examples showing how false response rates and other metrics can be determined.
  • The statistical basis for some important measures of confidence in a qualitative result.

 

Availability

The guide may be downloaded from this website at no cost.

* First published 2021-11-11. Publication dates above are dates of file publication on this website.

Translation

Translation into other languages is permitted 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.

Citation

This guidance should be cited* as
"R Bettencourt da Silva and S L R Ellison (eds.) Eurachem/CITAC Guide: Assessment of performance and uncertainty in qualitative chemical analysis. First Edition, Eurachem (2021). ISBN 978-0-948926-39-6.
Available from www.eurachem.org."

*Subject to journal requirements.

Previous editions

There are no earlier editions of this Guide.