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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.5, #1)
The scope and limitations of a QA system in research by R. Mathur-De Vré (pp. 3-10).
The article analyses the scope and limitations of quality systems for research centres in the light of the problems involved, foreseen advantages, and growing need created in the context of the globalisation phenomenon. Some propositions are put forward concerning the development of possible quality assurance strategies for research activities.
Keywords: Key words Quality system; Research; Research and development; Quality assurance
Sense and nonsense of quality assurance in an R&D environment by P. Vermaercke (pp. 11-15).
Quality has always been one of the key issues in laboratories in general and formal quality assurance (QA) in testing laboratories has gained popularity over the last decade. However, the implementation QA in research and development (R&D) laboratories is still the domain of a few pioneers. We can even ask whether a QA system in research makes sense at all and if such a system really provides any added value? Difficulties with respect to the implementation of such a system are mainly associated with the nature of the research process itself. However, it is obvious that QA offers clear advantages in R&D, if some critical success factors have been taken into account. An important issue is the selection of a good QA standard for R&D. This is certainly not an easy task, since there are no specific standards. Fortunately, some useful international guides have been published recently.
Keywords: Key words Quality assurance; Research and development environment; Total quality management; Good laboratory practice
Quality management in analytical R&D in the pharmaceutical industry: Building quality from GLP by F. Geijo (pp. 16-20).
The pharmaceutical industry is one of the most regulated activity sectors. The regulation includes specific quality systems such as good laboratory practice (GLP), good clinical practice (GCP) and good manufacture practice (GMP). The principles of GLP mainly cover the formal quality aspects of a procedure and do not evaluate the technical aspects in depth. On the other hand, EN 45001 accreditation covers technical performance and is not suitable for pharmaceutical research and development (R&D) as it is almost impossible to comply with the requirements of the European standard in the pharmaceutical environment. The challenge to the pharmaceutical industry is, therefore, to develop quality systems, compatible with GLP principles, that not only cover formal quality items but also ensure good scientific and technical performance. An implementation process focused on real quality improvement is the best way to achieve this objective, culminating in formal recognition of the quality system by third-party assessment.In the case of analytical R&D, the EURACHEM/CITAC Guide CG2 is a very good tool that can help in the definition, analysis and selection of the non GLP quality elements that will be useful.
Keywords: Key words Quality management; Good laboratory practice; EN 45001; Analytical research and development; Pharmaceutical research and development
Implementing quality assurance in an R&D environment at the Belgian Nuclear Research Centre – SCK·CEN by P. Vermaercke; F. Verrezen; S. Boden (pp. 21-27).
If we agree that quality assurance (QA) in R&D indeed provides added value, just how do we show the public that such a QA system is operating well? At the Belgian Nuclear Research Centre (SCKÖbullet CEN), where a QA system has been implemented by various laboratories in accordance with the EN 45001 standard within the general framework of ISO 9001 at the institutional level, several laboratories have already been accredited. At the request of one of our customers the Belgian Agency for Radioactive Waste Management (NIRAS/ONDRAF), we implemented a quality system for research projects related to the characterization, treatment and processing of radioactive wastes in view of disposal. We obtained accreditation for this research in 1999. In this paper, we discuss the implementation of our QS and important issues related to the overall management of the QA system, broken down into three parts: organizational, technical and project-specific quality elements such as the QA plan and internal communication.
A specific standard for quality in fundamental research by J. -C. Petit; A. Muret (pp. 28-34).
The specific standard described here constitutes the heart of the quality system set up by the Commissariat à l'Energie Atomique – French Atomic Energy Commission – for its main "Fundamental Research" entity, the Directorate for the Sciences of Matter. It is a coherent standard (set of shared rules and provisions laid out in a clear fashion) designed, in the first instance, to provide those taking part in research, including the hierarchy, with the means to satisfy their requirements in the field of quality. And, secondly, to create the conditions for recognition of this action by third parties, which all research entities must nowadays convince of their trustworthiness (supervisory ministries, research partners, industrial companies, etc.). This standard places particular emphasis on the preponderant roles of initiative and freedom in fundamental research, which are a prerequisite for creativity, innovation and, last but not least, the motivation of personnel.
Keywords: Key words Fundamental research; Specific standard; Quality
Are there two decks on the analytical chemistry boat? by Z. Plzák (pp. 35-36).
This paper examines some problems of implementation of quality assurance (QA) principles in chemical measurement in the university academic environment. Being developed and introduced in practice by industrial and independent commercial laboratories, the 'quality lifestyle' has been largely ignored by the academic analytical community. The academic community is now faced with the fact that teaching, education and training of analytical QA and analytical quality management are no longer a matter of choice.
Keywords: Key words Quality assurance; Quality management; Accreditation; Human aspects; University laboratory