Method Validation and Quality Management in the Flexible Scope of Accreditation: An Example of Laboratories Testing for Genetically Modified Organisms

Abstract

Quality assurance is a prerequisite for accurate and reliable results in food and feed testing, ISO/IEC 17025 being recognized worldwide as the base standard. A flexible scope of accreditation enables testing laboratories to react quickly to customer demand and to cope with the large number of new methods, which have to be introduced in the laboratory. Precisely defined procedures for the validation of methods, together with performance and acceptance criteria, are the key points for flexible scope of accreditation. Testing for genetically modified organisms (GMO) is a challenging exercise, especially with more GMOs entering the world market. We describe here the organization and performance of validating quantitative detection methods for GMO testing in the context of the European Union legislation. Operational procedures for method validation organized by the Community Reference Laboratory for Genetically Modified Food and Feed, assisted by the European Network of GMO Laboratories, are described. A protocol for validating methods within an individual laboratory is proposed and discussed in terms of the requirements of flexible scope of accreditation. The system setup can be an example for other similar fields of analytical work.

Effect of Thermal Treatment on the Amplification and Quantification of Transgenic and Non-transgenic Soybean and Maize DNA

“…The responsibility of the Community Reference Laboratory for Genetically Modified Food and Feed (CRL-GMFF) to test and validate the provided methods was established. In order to cope with the increasing number of applications for authorisation, several new approaches to detect and quantify genetically modified organism (GMOs) were recently adopted by CRL-GMFF and also by members of the European Network of GMO Laboratories (Aguilera et al 2008(Aguilera et al , 2009Bellocchi et al 2008;Roth et al 2008;Žel et al 2008). The current status and future developments in analytical methodology, description of up-to-date instrumentation employed and standardization of methods used for GMOs monitoring were reviewed (Hernández et al 2005;Rodrígues-Lazáro et al 2007).…”

Assessment of Genetically Modified Organisms (GMO) in Meat Products by PCR

“…A common set of criteria for performance of GMO detection methods should be evaluated (Bertheau et al 2002 ;Bellocchi et al 2008 ;Ž el et al 2008 ). Recommendations for the validation of quantitative PCR methods are presented by H ü bner and coworkers (2001) , and currently there is an international standard that defi nes the PCR performance parameters for GMO analysis (ISO 2006 ).…”

The flexible scope of accreditation in GMO testing and its applicability to plant pathogen diagnostics1

“…During transition from a fixed to partially flexible scope of accreditation, the main efforts were put into establishment of a detailed plan of method introduction, validations, setting of acceptance criteria for validation parameters and authorization of personnel for key tasks in the process of method validation (Žel et al ., 2008). Furthermore, the laboratory had to establish a list of accredited methods which need to be updated regularly with newly introduced or modified methods.…”

“…With the transition to a flexible scope, the existing process became more structured, detailed and documented (Fig. 1; Žel et al ., 2008) and is now being applied to plant pathogen diagnostics. As with other approaches to accreditation it aims to guarantee quality, fulfil the requirements of customers and, at the same time, optimize implementation and validation of methods, keeping the strain on personnel and resources to a minimum.…”

“…A new document (Žel et al ., 2008) was designed to follow up the process, from the need for a new method to evaluation of its suitability for the purpose (schematic representation in Fig. 1).…”