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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.4, #8)
How valid are our QA assumptions: an examination of underpinning Axioms by Bernard King (pp. 326-335).
There is no universally accepted approach to analytical quality assurance (QA) and different laboratories place emphasis on widely different aspects. The difficulties in agreeing what constitutes best practice originate, in part, from a lack of clarity concerning the underpinning principles or axioms. This paper aims to set out some of the axioms which underpin current thinking and to discuss their validity and interplay, in order to provide a more rational, or at least transparent basis, for the evaluation of different strategies. The selection of issues and the discussion are necessarily subjective and based on the authors experience. It is concluded that current practice is generally soundly based but there is a need for a better understanding of the efficacy and cost-benefit of the various QA techniques available. Scepticism concerning the value of systems and documentation is not well founded, provided they are not taken to excess. There are, however, issues concerning the military-based command-and-control style and the engineering origins of ISO 9000 and ISO Guide 25 requirements which make them not entirely suitable for a modern analytical laboratory. There are also dangers that the command-and-control style could discourage measurement scientists from thinking for themselves or lull them into a false sense of security.
Keywords: Key words Analytical quality; Cost-benefit; Quality improvement; Accreditation
Quality issues in proficiency testing by Ian Robert Juniper (pp. 336-341).
Proficiency testing is a means of assessing the ability of laboratories to competently perform specific tests and/or measurements. It supplements a laboratory's own internal quality control procedure by providing an additional external audit of their testing capability and provides laboratories with a sound basis for continuous improvement. It is also a means towards achieving comparability of measurement between laboratories. Participation is one of the few ways in which a laboratory can compare its performance with that of other laboratories. Good performance in proficiency testing schemes provides independent evidence and hence reassurance to the laboratory and its clients that its procedures, test methods and other laboratory operations are under control. For test results to have any credibility, they must be traceable to a standard of measurement, preferably in terms of SI units, and must be accompanied by a statement of uncertainty. Analytical chemists are coming to realise that this is just as true in their field as it is for physical measurements, and applies equally to proficiency testing results and laboratory test reports. Recent approaches toward ensuring the quality and comparability of proficiency testing schemes and the means of evaluating proficiency test results are described. These have led to the drafting of guidelines and subsequently to the development of international requirements for the competence of scheme providers.
Keywords: Key words Proficiency testing; Quality; Competence; Second-party approval; Approved provider
Do we need to accredit proficiency testing schemes? by N. P. Boley (pp. 347-349).
Proficiency testing (PT) is being increasingly used as an important quality assurance tool for laboratories. The subject of quality of the providers of PT schemes has been discussed increasingly in recent years. Some countries have implemented systems for the accreditation of PT schemes. This paper looks at the background to the accreditation of PT schemes, the likely mechanisms which could be employed for accreditation, and some of the practical aspects.
Keywords: Key words Proficiency testing; Accreditation; Quality assurance; International recognition
Metrology in laboratory medicine – A necessity by R. Dybkaer; Ulf Örnemark; Adam Uldall; Wolfgang Richter (pp. 349-351).
In a recent Letter to the Editor, Dr. B. Neidhart questioned the need to make clinical chemical measurement results traceable to international standards and to incorporate the principles of analytical quality assurance into clinical chemistry. An analysis of the arguments presented shows that modern laboratory medicine has to deliver accurate results, which are comparable over space and time, in order to improve the accuracy of diagnostic tools and minimize cost. The means to achieve accuracy and comparability are metrological traceability and quality assurance as supported by many national and international initiatives.
Keywords: Key words Accuracy; Analytical quality assurance; Clinical chemistry; Metrology; Laboratory medicine; Traceability
Method validation of modern analytical techniques by D. B. Hibbert (pp. 352-356).
Validation of analytical methods of well-characterised systems, such as are found in the pharmaceutical industry, is based on a series of experimental procedures to establish: selectivity, sensitivity, repeatability, reproducibility, linearity of calibration, detection limit and limit of determination, and robustness. It is argued that these headings become more difficult to apply as the complexity of the analysis increases. Analysis of environmental samples is given as an example. Modern methods of analysis that use arrays of sensors challenge validation. The output may be a classification rather than a concentration of analyte, it may have been established by imprecise methods such as the responses of human taste panels, and the state space of possible responses is too large to cover in any experimental-design procedure. Moreover the process of data analysis may be done by non-linear methods such as neural networks. Validation of systems that rely on computer software is well established. The combination of software validation with validation of the analytical responses of the hardware is the challenge for the analytical chemist. As with validation of automated equipment such as programmable logic controllers in the synthesis of pharmaceuticals, method developers may need to concentrate on the process of validation, as well as the minutiae of what is done.
Keywords: Key words Method validation; Sensors; Electronic nose
The establishment of an Australian National Analytical Reference Laboratory (NARL) by B. King (pp. 357-360).
The National Analytical Reference Laboratory (NARL) was established by the Commonwealth Government within the Australian Government Analytical Laboratories (AGAL) Public Interest Programme in 1997, to help provide Australian scientists with the chemical standards they need to make reliable measurements. Reliable chemical measurements are vital to many aspects of our social and economic life including public health, environmental control, industrial productivity, trade innovation and government regulation. Mutual recognition of measurement results and the avoidance of costly disputes require the development of a structured and common system of measurement. Working-level measurements should be directly linked to national standards, which are themselves interlinked through international comparisons. Although metrology in chemistry is still in its infancy, increasing numbers of countries are establishing facilities to serve both national needs and to contribute to the international measurement system. The aim at NARL is to lead the development of an Australian chemical measurement system, which is harmonized with similar systems in other countries. This paper was presented at the Co-operation on Traceability in Analytical Chemistry (CITAC) symposium on Analytical Quality Assurance for the Twenty-first Century, held in Sydney on 15–16 October 1998. It describes the rationale for establishing NARL, the process of getting it started, the positioning, aims and strategy of NARL, the development of its work programme and plans for both national and international collaboration. If you would like more information or would like to contribute to the work of NARL please contact us at the above address.
Keywords: Key words Metrology in chemistry; Reference materials; Primary methods; Traceability; Analytical quality
Accreditation of reference material producers by R. F. Walker (pp. 360-365).
The use of reference materials is the most pragmatic means by which the analyst can achieve comparability of data. Reference material producers therefore need to have adequate quality systems in place for ensuring the reliability of their materials. In order to provide guidance to both producers and assessors, ISO Guide 34 has recently been produced detailing the quality system requirements for the production of reference materials. CITAC, REMCO and ILAC are now collaborating in the revision of this guide to produce a free-standing document detailing the general requirements for the competence of reference material producers. This paper discusses some of the more important issues described in these documents. The possible formation of an international register containing details of a reference material producer's quality system status is also discussed.
Keywords: Key words Reference materials; Accreditation; Quality systems
Revision of ISO guide 25 by Maire Caitriona Walsh (pp. 365-368).
ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval" in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper will discuss the implications of the technical requirements of the current document for analytical chemistry with particular emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998.
Keywords: Key words Accreditation; ISO/IEC DIS 17025; Quality systems; Analytical chemistry; Method validation
Quality assurance in daily practice by Alenka Gogala; Bauke te Nijenhuis (pp. 368-370).
A report based on the workshop on "Quality Assurance in Daily Practice", organised by the study group "Quality Assurance and Accreditation" from the Division of Analytical Chemistry of the Federation of European Chemical Societies (SGQAA/DAC/FECS) held at the EUROANALYSIS-10 conference in Basle, 6–11 September 1998.
Keywords: Key words Quality assurance; Quality; Daily practice; Education
Report on the IUPAC, ISO-REMCO, BAM, EUROLAB-D Workshop on "Proper Use of Environmental Matrix Reference Materials"
by A. Fajgelj (pp. 370-371).
Matrix reference materials – provision in Australia by Roderick Geoffrey Millar (pp. 371-374).
Until quite recently, Australia has not been much involved in the preparation and certification of matrix reference materials for chemical testing. Even today, the vast bulk of chemical reference materials used in Australia are imported from other world producers. Increased international focus on the accuracy, traceability and comparability of chemical measurements has led to the establishment of the National Analytical Reference Laboratory (NARL) within the Australian Government Analytical Laboratories. Part of the work of NARL will be to supply matrix reference materials, not available from existing sources, to meet specific Australian requirements. This need has been addressed in the past by a combination of industry and government initiatives. Examples include a series of certified matrix reference materials for chemical testing of iron ore, coal and mineral sands produced by Standards Australia and a series of three animal fat matrix reference materials certified for a range of pesticide residues produced by the Australian Chemical Standards Laboratory (now part of NARL). To make effective use of limited resources, it will be important for NARL to focus on identified priorities and to maximise the use of available Australian resources and expertise through technical collaboration for reference material production. An important part of this process should be input on needs and priorities from reference material "users" such as government legislators, regulatory authorities, standards setting bodies, industry and the analytical community. The aim will be to produce matrix certified reference materials that are traceable to SI or other international standards at a stated level of measurement uncertainty.
Keywords: Key words Reference materials; Matrix; Chemical analysis; Trace level
The synthesis and characterization of pure substance reference materials for forensic, agricultural and drugs-in-sport analysis by Bruce Noble (pp. 374-377).
The paper reports work on the synthesis, purification and certification of pure substance (organic) reference materials as conducted within the National Analytical Reference Laboratory (NARL). Areas of interest include illicit drugs, agricultural and veterinary chemicals, and steroids and steroid metabolites and their deuterates. The discussion covers the prioritization of work requirements, procedures for synthesis and production, quality assurance, characterization, homogeneity, storage and stability testing, and certification of materials. Future plans for establishing traceability are also discussed.
Keywords: Key words Pure substance reference materials; Characterization; Certification; Quality assurance and control; Purification