Page 76 - 2013 ISPAM Mid-Year Mtg Book

Microbiology of food and animal feed – Method validation Verification– Part 4:
Protocol for the verification of reference and alternative methods implemented in a
single laboratory using validated or non-validated matrices
1 Scope
This document deals with verification of methods for the detection or enumeration of
microorganisms, with particular emphasis on the implementation of a method
(reference/alternative method) in the user laboratory and verification of a method
(reference/alternative method) using matrices not included in the original validation study.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
(EN) ISO/DIS 16140-1 Microbiology of food and animal feed - Method validation - Part 1:
Vocabulary
(EN) ISO/DIS 16140-2 Microbiology of food and animal feed - Method validation - Part 2:
Protocol for the validation of alternative (proprietary) methods against a reference method
ISO/TS 19036 Microbiology of food and animal feeding stuffs – Guidelines for the estimation
of measurement uncertainty for quantitative determinations.
ISO 5725-2 Accuracy (trueness and precision) of measurement method and results – Part 2:
Basic method for the determination of repeatability and reproducibility of a standard
measurement method.
ISO 7218 Microbiology of food and animal feeding stuffs – General requirements and
guidance for microbiological examinations.
3 Terms and definitions
See ISO/DIS 16140-1.
4 Principles
In the process of method validation two steps are recognized: primary validation and
secondary validation or verification.
The verification protocol can comprise two phases:
- Determination of the relevant performance characteristics of one relevant matrix
present in the scope of the primary validation. The result is used by the laboratory to
demonstrate that it can meet the specifications established in the primary validation.
- Determination of the relevant performance characteristics of other matrices within the
scope, but not covered in the primary validation. Matrices shall be relevant to the user
laboratory.
The specifications of a validated method are determined by the type of microbiological
method – qualitative or quantitative.