Looking for guidance

Abstract

How to design, perform and evaluate measurements and their quality assurance for obtaining reliable results which are fit for purpose? This question comes up much more frequently than years ago. Indeed, economic, regulatory and societal decision making is requesting much more measurement results and expects the availability of such data in an increasing range of application sectors, from nanoto biotechnology or from personalized medicine to food authentication. In addition, globalization processes are relying on a geographically much broader, often worldwide, comparability and (metrologically speaking) equivalence of measurement results. Therefore, it is not surprising that the number of requests for guidance on good, i.e., problem adequate, measurement practices is increasing as well. I am receiving frequently such requests from around the world. At a first glance, this may sound surprising in the ‘internet age.’ However, various surveys and discussions at meetings reveal that people are looking for different kinds of guidance in dependence on their application needs, education background, knowledge level, professional environment, etc. A guidance document is certainly not available for each specific purpose. On the other hand, an appropriate paper may get lost in the flood of existing information. A considerable part of my communication is devoted to facilitate the identification and distribution of relevant guidance. The selection criteria include the aspect on who has written and reviewed the released document. Obviously, ‘authoritative advice’ undergoes a renaissance in the time of internet databases and search engines. Standardization organizations have released a wealth of documentary standards addressing also many measurement methods and corresponding quality assurance tools and measures. However, such standards are often written in a more generalized manner for covering various peculiarities of individual measurement procedures. Therefore, their application requires further interpretation and specification by the analytical laboratories. Over the years, a cascade of additional guidance documents has evolved to assist in the common understanding and implementation of standardized measurement methods and related activities, such as estimation of measurement uncertainty and laboratory internal quality control. There are guides from officially mandated bodies such as ISO which have actually undergone the same consensus-building steps like their international standards. On a less formal level, various sectorial organizations, such as AOAC International for food analysis or the Clinical Laboratory Standards Institute (CLSI) for clinical analysis, have developed guidance documents describing specific measurement procedures, preparation and use of certain types of reference materials, tailored data evaluations, etc. In addition to laboratory internal documentation, which is nowadays usually a main component of quality management systems, laboratory staff often appreciates external explanatory documents for performing selected steps of an analytical process under specific conditions. Here, the availability of documents in the appropriate language—in the sense of both the regionally spoken language and the technical language of the respective application area or scientific sub-discipline—is of utmost importance. On the other hand, there is still a tendency to ‘reinvent the wheel’ regarding ideas and best practice as well as terms and definitions, arguing that new approaches would H. Emons (&) Geel, Belgium e-mail: JRC-IRMM-ACQUAL@ec.europa.eu