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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.8, #2)
Too small uncertainties: the fear of looking ”bad” versus the desire to look ”good”
by Paul De Bièvre (pp. 45-45).
Metrological traceability in laboratory medicine by R. Dybkaer (pp. 46-52).
The establishment of a reference examination system necessary for metrological traceability of the many types of sophisticated examination result in laboratory medicine is a daunting task, which has been made mandatory by the EU Directive on in vitro diagnostic medical devices and the requirements for accreditation. Following a definition of examinand and allowed examination uncertainty, a dedicated calibration hierarchy is established from stated reference through alternating reference examination procedures and calibrators providing a traceability chain from examination result to the reference, often a definition of a measurement unit. The various types of possible calibration hierarchy are outlined in EN ISO Standards. Recent efforts by national and international stakeholders to establish a global reference examination system have led to the creation of a Joint Committee on Traceability in Laboratory Medicine with the International Committee for Weights and Measures, International Bureau of Weights and Measures, International Federation of Clinical Chemistry and Laboratory Medicine, International Laboratory Accreditation Cooperation, and World Health Organization as the principal promoters. This structure will identify reference procedures, reference materials, and reference laboratories, and seek support for further prioritised and coordinated development of the system.
Keywords: Keywords Calibration hierarchy ; Comparability of results ; Joint Committee on Traceability in Laboratory Medicine ; Metrological traceability ; Reference examination system
Experience gained from the application of GLP principles to multi-site studies in plant protection by P. Capon (pp. 53-60).
The multi-site study (MSS) concept is not new and was already being used by the Swiss plant protection and pharmaceutical industries, across all areas of expertise, 11 years before the publication of the Organisation for Economic Co-operation and Development (OECD) Consensus Document No. 13. The need for this type of study set-up was and remains unavoidable, not only because of the way in which field studies for the determination of product residues in food are conducted in the plant protection industry, but also because of the fractionation of other study types ( e.g. toxicology studies) and the related subcontracting to contract labs as a consequence of insufficient capacity and/or lack of expertise as well as for cost reduction reasons. This paper deals with the historical background of the introduction of the MSS concept, its development, known facts, reasons for its extension to other areas, frequent difficulties in its daily implementation, regulatory and monitoring weaknesses, as well as, consequences and measures. Statements are corroborated by practical examples. Experience shows that there are weaknesses ( differences) among the various national Compliance Monitoring Authorities in charge of inspecting MMSs and there are still substantial differences from country to country regarding the interpretation and enforcement of GLP principles. Doubts are arising about the sense of OECD Mutual Joint Visits, and the mutual acceptance of data appears to be at jeopardy. A lot of time and patience is still needed to improve harmonisation at the international level so that GLP principles are followed uniformly across companies and countries. There is also the need for increased involvement of quality assurance units and Compliance Monitoring Authorities.
Keywords: Keywords Good laboratory practice; Multi-site studies; CRO; Quality assurance; Compliance monitoring
Strategies for multi-site GLP studies by Joris Van Loco; Maureen Moerenhout; Hedwig Beernaert (pp. 61-67).
A GLP study can be performed at more than one site. This is called a multi-site study. Although, the study is performed at different sites, it is still one study and must completely comply with the GLP principles. The fact that different activities are conducted at different sites implies that the planning, the organization and the communication are crucial for the success of the study. This means that all the staff involved should know their responsibilities and should have the knowledge and skills to realize all the phases of the study according to the GLP principles. To achieve a well managed multi-site study, several strategies for setting up such a study can be followed. This paper focuses on the responsibilities, communication, and collaboration of the personnel, which are involved in a multi-site study. Several case studies are highlighted, and we concluded that the basic communication triangle in a single-site GLP study between test facility management, study director, and the quality assurance unit should be extended to the communication among test facility and test site management, study director, principle investigator(s), and the quality assurance units at the test sites.Introduction
Keywords: Keywords Good laboratory practice ; Multi-site study ; Responsibilities ; Communication
Quality assurance of qualitative analysis in the framework of the European project ’MEQUALAN’ by A. Ríos; D. Barceló; L. Buydens; S. Cárdenas; K. Heydorn; B. Karlberg; K. Klemm; B. Lendl; B. Milman; B. Neidhart; R. W. Stephany; A. Townshend; A. Zschunke; M. Valcárcel (pp. 68-77).
The European Commission has supported the G6MA-CT-2000–01012 project on ”Metrology of Qualitative Chemical Analysis” (MEQUALAN), which was developed during 2000–2002. The final result is a document produced by a group of scientists with expertise in different areas of chemical analysis, metrology and quality assurance. One important part of this document deals, therefore, with aspects involved in analytical quality assurance of qualitative analysis. This article shows the main conclusions reported in the document referring to the implementation of quality principles in qualitative analysis: traceability, reliability (uncertainty), validation, and internal/external quality control for qualitative methods.
Keywords: Keywords Qualitative analysis ; Quality assurance ; Metrology ; MEQUALAN Project
Quality assurance in analytical laboratories engaged in research and development activities by M. Valcárcel; Angel Ríos (pp. 78-81).
Research and development activities are carried out by various types of laboratories that are not the typical testing and calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance for non-routine analytical laboratories.
Keywords: Keywords Quality assurance ; R&D laboratories
Using a process-centered approach to minimize the effort of compliance by B. Ciommer (pp. 82-85).
The complexity of different quality standards can, in principle, be covered by different approaches and strategies. In-depth process mapping of quality control (QC) work streams was used by the analytical laboratories of Lonza AG to show up the principle differences in being compliant to different quality systems. The results identified two main drivers for all necessary actions: process-related activities and infrastructure-related activities. In addition, a clear indication of the economic impact of these driving forces was gained, which led the laboratories to decide on a process-oriented approach. This approach has the advantage of being able to reflect the different demands of different quality assurance (QA) regulations within the same QC organizational structure. Following the process helps avoid unnecessary efforts in analytical work and represents a very economical approach, at the same time, providing high flexibility to react to different QA or customer demands.
Keywords: Keywords Process-oriented approach ; Compliance to different quality systems ; Process mapping ; QC infrastructure in a GMP environment ; Certification according ISO 9001:2000
Estimation of uncertainties for the application of electrochemical sensors in clinical analysis by R. I. Stefan; Jacobus Frederick van Staden; Hassan Y. Aboul-Enein (pp. 86-89).
The influence of the selection of type of electrochemical sensor, its design and calibration, data processing and sample history on the uncertainty of measurements in clinical analysis is discussed. Special requirements for in vivo analysis that may minimize the value of uncertainty of measurements are given.
Keywords: Keywords Electrochemical sensors ; Uncertainty ; Clinical analysis