Quality Management - How reliable are your results: Advancing Laboratory Quality culture by Proficiency Testing and Data Analysis

eFOODLab_International_03_2014

Advancing Laboratory Quality Culture through Effective Proficiency Testing and Data Analysis Our authors: PD Dr. habil. Steffen Uhlig, QuoData GmbH, Munich/Freising (GER) and Ravinder Reddy PhD, US FDA - Institute for Food Safety and Health (Chicago) 3/14 eFOOD-Lab international 9 How reliable are your results? At the IAFP 2014, the US-FDA (Ravinder Reddy) and QuoData (Steffen Uhlig) conducted a symposium called „Advancing Worldwide Laboratory Quality Culture and Food Safety through Effective Proficiency Testing and Data Analysis“. The symposium had several objectives. First, it was intended to demonstrate that the US Food Safety & Modernization Act (FSMA) contains several directives which are perfectly consistent with the use of analytical quality assurance tools such as proficiency testing (PT). The second objective was to present a survey of perspectives on international PT by bringing together speakers from the USA, the EU, South America and China able to address relevant issues of international PT and to present instructive case studies. The third aim of the symposium was to demonstrate the need for effective proficiency testing and data analysis in order to fulfill the requirements of FSMA, especially with respect to the FSMA’s following overarching objectives (1) supporting laboratory accreditation, (2) building domestic Figure 1: Individual test results of PT Manganese in green cabbage (BVL) Upper chart: Individual test results (duplicate determination) by participant Lower chart: Kernel density estimation of the data and international laboratory capacity, (3) surveillance, (4) training, and (5) development of laboratory standards. During the different presentations, it became apparent that, when it comes to the implementation and performance of PT, the challenges vary greatly from country to country. For example, in South America availability of PT schemes is very limited, as described in the talk held by Maria Teresa Destro (Biomerieux São Paulo). In many cases, this lack of available PT schemes translates to a major hurdle for laboratories seeking to obtain or maintain accreditation. At the opposite end of the spectrum, the US-FDA can look back on more than 60 years’ experience in the performance of PTs for the monitoring of milk and dairy products. As emphasized in the presentation given by Ravinder Reddy (US-FDA), the focus of the US-FDA is now the implementation of the FSMA directives. This new focus implies a considerable change in the way the tools of analytical quality assurance are applied. The aim of PT schemes is no longer seen to be merely to identify dysfunctions and insufficient competence. Rather, PT schemes are now also seen as tools for learning about and improving processes and analytical methods. Qualit y Management


eFOODLab_International_03_2014
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