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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.2, #6)


Protocols for traceability in chemical analysis by P. De Bièvre; Robert Kaarls; H. Steffen Peiser; S. D. Rasberry; William P. Reed (pp. 270-274).
 In continuing their attempt to bring general issues concerned with trustworthy chemical measurements to review and international discussion, the authors propose basic aims and requirements for protocols of chemical-measurement procedures with traceability to the SI or, where this is not possible, to units of internationally recognized measurement scales. Documents describing such protocols could be useful in science, technology, law, or trade. Concepts and definitions for protocols have been introduced in Part I of this contribution. Part II here deals with the development and application of protocols for intended in-laboratory, commercial, national, or international recognition. Protocols deal with measurement methods, instrumentation, and the estimation of uncertainties from all possible sources of measurement errors. Uncertainties define the quality of all links in a traceability chain starting from the value of a measurand in a sample, often through a certified value in a reference material, either to the SI, or – if this is not possible – to a value on a suitable, internationally agreed measurement scale. A protocol may concern itself with the complex interplay between uncertainties, tolerances, and any limit values introduced by the set aims of specific measurements.

Keywords: Key words Traceability; Protocol analysis; Reference Material; Uncertainty


Instrumental validation in capillary electrophoresis and checkpoints for method validation by G. A. Ross (pp. 275-284).
 Capillary electrophoresis (CE) is increasingly being used in regulated and testing environments which demand validation. The design, development and production of CE instrumentation should be governed by qualifications which ensure the quality of the finished product. The vendor should therefore provide guidelines and procedures which assist the user in ensuring the adequate operation of the instrumentation and especially in designing installation qualification (IQ) and operational qualification/performance verification (OQ/PV) procedures. OQ/PV should test those functions of an instrument which directly affect the CE analysis, i.e. voltage, temperature, injection precision and detector function. In validation of CE methods care should be taken that those aspects which directly affect the precision of peak parameters are appreciated. The relationship between CE instrumentation, chemistry and validation parameters is discussed and guidelines are presented for definition of a CE method for submission to regulatory authorities.

Keywords: Key words Instrument; Method; Validation; Capillary; Electrophoresis


Integration of parallel-operating quality systems by Christian Bonk-Kassner; J. Ehmann; Gudrun Gallhoff; David S. Moore; Barbara Moos; Bernd Siegemund (pp. 285-293).
 Since the 1980s, quality systems have become an essential element in successful companies and institutions. Today those systems are indispensable to fulfill the needs of the customers and last but not least the requirements of the society. Depending on the company's activities and fields of services, it is necessary to establish various quality systems. The Institut Fresenius (IF) Group runs a number of analytical laboratories and sampling groups. The whole group was accredited according to DIN EN 45001 in 1994. Good Laboratory Practice (GLP) was introduced in 1992 and was certified by the national authority. For certain customers, IF Group is also obliged to work according DIN EN ISO 9001 or GMP. A comparison of these systems with respect to their different priorities shows the possibility of integrating their rules into one comprehensive quality system. The IF Group has therefore installed a quality system operating in parallel. Multilocation accreditations and/or certifications are taking these efforts into account. The benefits are: high transparency of the system for the customers, auditors and personnel, a reduction of maintenance costs, and great flexibility to react to new standards. Could these activities lead to a new Integrated Management System?

Keywords: Key words Quality Management; Accreditation; Certification; Good Laboratory Practice; Good Manufacturing Practice


The UK National Marine Analytical Quality Control Scheme by J. E. Dobson; M. J. Gardner; A. H. Griffiths; M. A. Jessep; J. E. Ravenscroft (pp. 294-300).
 The approach to analytical quality control adopted for the UK National Marine Analytical Quality Control Scheme is described. The Scheme began in 1991 and is in its fifth year of operation. The aim of the programme of work is to ensure adequate control over the accuracy of analysis, such that the aims of the UK National Marine Monitoring Plan are satisfied. The results of interlaboratory tests for the determination of nutrients in water samples and metals, organic compounds in waters, sediments and biological samples are summarised.

Keywords: Key words Analytical quality control; Marine monitoring; Accuracy


Validation of an analytical method to determine trace metal impurities in fluoride compounds by flame atomic absorption spectroscopy by M. P. Carril; M. Soledad Corbillón; J. Manuel Madariaga (pp. 301-308).
 The development of an analytical method for the determination of some heavy metals (Fe, Cu, Co, Zn and Ni) in fluoride compounds [Cu(BF4)2, Sn(BF4)2, Pb(BF4)2 and HBF4] by flame atomic absorption spectroscopy is described. This method is to be used as a routine analytical method in an industrial quality control laboratory. To this end the "performance characteristics" of an instrumental analytical method such as matrix effects, sensitivity, linearity, detection and quantitation limits, precision and accuracy were evaluated for every system under study. The results of these investigations showed that non-spectral interferences (due to the presence of large concentrations of major metals such as Cu, Sn and Pb) were observed. Nevertheless it was possible to define a matrix concentration interval where matrix effects were not statistically significant, and therefore a direct calibration approach could be used as the calibration tool whenever the major metal concentration was not higher than 40×10–3 kg l–1. A guide to the developement of an analytical method for trace metal determination is provided. General tools for quality control have been used in order to show how an analytical method can be tested daily and evaluated in a convenient manner.

Keywords: Key words Analytical method validation; Flame atomic absorption spectroscopy; Matrix effects examination; Trace metals determination


The development of a National Accreditation System in South and Southern Africa by M. A. Peet; S. P. MacCurtain (pp. 309-311).
 In South African industry there is a strong appreciation of Quality Assurance. More than 1400 companies have been certified as complying with ISO 9000, and this, of course, has resulted in a strong demand for accredited calibration and test facilities. Work on the development of a national calibration service started in 1976, and the South African National Calibration Service (SANCS) was inaugurated in 1980 with 13 calibration laboratories. The early maturity of the SANCS can be judged by the fact that by 1984 it had the technical capability to establish a mutual recognition agreement with a European country. It now has a total of some 191 accredited laboratories, 139 calibration laboratories and 52 testing laboratories. In 1993, the SANCS signed mutual recognition agreements with the CNLA (Taiwan) and the European Co-operation for the Accreditation of Laboratories (EAL). In 1994 it entered the field of testing laboratory accreditation and is already experiencing a strong influence therefrom, and in 1997 it changed its name to National Laboratory Accreditation Service (NLA). In May 1995, the NLA was appointed by the Department of Trade and Industry to establish a South African National Accreditation System (SANAS). Progress with this work up to the present time has been substantial.

Keywords: Key words Accreditation; SANAS; Competence; Recognition; NLA
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