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Guidelines for establishing the suitability of
food microbiology methods

CCFRA Guideline No. 29
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Adopt standardised criteria for assessing the suitability of microbiological methods for food analysis, to ensure reliability of results, achieve or sustain laboratory accreditation, or support a due diligence defence.

All food microbiology laboratories should be able to demonstrate that the methods they use are suitable for the intended purpose and are being used correctly. This not only gives confidence in the results but also supports laboratory accreditation and strengthens due diligence cases. Whilst 'external' validations - perhaps carried out by a manufacturer or via an independent validation scheme - can demonstrate that a particular method works, it is unlikely to show how the method will perform in a specific laboratory with all relevant food, drinks and related materials.

This guide provides a systematic and practicable approach to support external validation data with evidence of suitability of a particular method in a specific laboratory for specified food materials. The guidelines give advice on how to carry out an in-house method assessment for laboratories wishing to:

  • Introduce a new method
  • Apply existing methods to new food and drink types
  • Make modifications to an existing method
  • Assess the continued suitability of a method

It does not cover inter-laboratory trials nor the validation of new non-standard methods, for which other guides exist.


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Intended audience

This guide is aimed at food and drink company microbiologists, technical managers and laboratory personnel involved in the microbiological analysis of food and drink.


Contents

Introduction

Scope

Planning an assessment

Purpose and scope of the suitability study

Establishment of criteria for method assessment

Review of previous validation data and published literature

Determination of experimental design

  • Familiarisation with method and GLP
  • Choice of samples and micro-organisms
  • Preparation of test micro-organisms
  • Preparation of spiked samples
  • External QA materials
  • Confirmation of positive and negative results
  • Number and matching of samples

Methods of data analysis

  • Enumeration methods
  • Detection methods

Worked examples

  • Paired enumeration
  • Unpaired enumeration
  • Paired detection
  • Unpaired detection

Appendices

  • Independent method validation schemes
  • Source of reference cultures
  • Production of aerobic spore crops
  • Production of anaerobic spore crops
  • External quality assessment schemes
  • Commercially available preparations of known numbers of micro-organisms




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