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.