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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.2, #2)
Nutritional labeling legislation by W. J. de Koe (pp. 56-62).
With respect to nutrition labeling, many countries in the world rely on what the Codex Alimentarius Commission (the agency responsible for the implementation of the joint FAO/WHO foods standards programme) has accomplished over the past decades in this field. The Codex General Standard for the Labeling of Prepackaged Foods is one of the most significant standards developed by the Commission and forms the basis for many developments in general with respect to labeling in the world. In order to promote a consistent international approach also on nutrition labeling, the Codex adopted almost at the same time in 1985 guidelines on this subject, which were worked out by the committee involved in labeling. The driving force for nutrition labeling was actually the view both of consumers and producers that neither improved ingredient listing nor a declaration of e.g. macro-nutrients such as fat and protein could replace information on the actual nutrient content of a food. In response to consumers' interest in nutrition, producers provided information about the nutrients which they considered to be attractive to the consumer. Because producers provided a hotchpotch of nutrient information (including claims) on labels, the need for a systematic presentation of this information as "nutrition labeling" was triggered. Nutrition labeling can be defined as a description intended to inform the consumer of the nutritional properties of a food. The Codex guidelines require that the nutrient declaration should appear on the label whenever a nutrition claim is made for a food. In accordance with the Codex guidelines, nutrition labeling will enable consumers to follow the dietary guidelines within their country. In 1988, a joint FAO/WHO expert consultation on recommended allowances for food labeling purposes, hosted by the government of Finland, developed a set of nutrient reference values (NRVs) to serve as the reference standard for the Codex guidelines. Although the question whether nutrition labeling should be "voluntary" or "mandatory" has been under discussion for a long time, most countries of the world have opted so far for the voluntary system: the nutrient declaration should appear on the label whenever a nutrition claim is made and the labeling should follow the criteria as set out in the Codex guidelines or another set of rules such as those of the European Community Council Directive 90/496/EEC on nutrition labeling of foodstuffs. Actions of both Codex Committees (the one on food labeling and the one on nutrition and foods for special dietary uses) to come to agreement, especially on health claims, could not prevent the United States from going their own regulatory way by enacting in 1990 the Nutrition Labeling and Education Act (NLEA) and more recently the Dietary Supplement Health and Education Act (DSH&EA). Both acts actually impede international trade. Although both the voluntary and the mandatory systems have their own advantages and disadvantages, the overall international nutrition labeling approaches have many similarities. The benefits of the mandatory approach in the field of nutrition, consumer education and developments in related fields such as the analytical, must not be underestimated. By recently throwing out the health claims temporarily, the food labeling committee agreed at its last meeting to forward the draft guidelines for use of nutrition claims to the Codex Commission for adoption at step 8, with the understanding that the table of conditions would be considered by the coming session of the committee on nutrition and foods for special dietary uses. In Europe, where the subsidiarity principle seems to prevail, it is difficult to forecast whether a worldwide uniform system of nutrition labeling can be or will be developed after the Edinburgh (1991) decision by politicians not to embark on nutrition labeling in the Community.
Keywords: Key words Nutrition labeling; Codex Alimentarius; Nutrition Labeling and Education Act (NLEA); Dietary Supplement Health and Education Act (DSH&EA); Health Claims
Approach to Quality System in Research and Development by R. Mathur-De-Vré (pp. 63-68).
There is growing interest in developing a general strategy and quality standards for possible accreditation or certification of R&D laboratories. This article discusses the scope and limitations of Quality Systems in R&D activities. The extension of QA to R&D centres in general requires emphasis on project management and scientific competence in addition to quality management and technical competence.
Keywords: Key words Quality; QA; R&D; Research
A comprehensive approach to method validation based on object technology by M. H. Feinberg; Alice Gerbanowski; D. N. Rutledge (pp. 69-75).
Method validation procedure requires a strategy for collecting those validation data that are best adapted to the analytical technique used. A flexible and general approach based on Object Linking and Embedding technology is proposed. It allows a traceable validation strategy using modular objects which encapsulate documentation, analytical data and processing logic. The contents of these objects are accessible through a standard user interface. This paper demonstrates how this can reduce experiment time, simplify evaluation efforts, and increase the ease of use of validation figures of merit. An illustration using Microsoft Visual Basic for Applications is presented, and some specific aspects are described. It consists of the evaluation of a time domain NMR technique for determining the moisture content of foods involving a multivariate calibration step. This study also illustrates how guidelines such as Good Validation Practices could be defined to present all validation documents in a standardised manner.
Keywords: Key words Method validation; Computer techniques; Object linking and embedding technology; Spreadsheet
Implementation of ISO 9001 in a medical testing laboratory by L. Burnett; Colin Rochester; Mark Mackay; Anné Proos; Warwick Shaw; Gabe Hegedus (pp. 76-81).
The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales, Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services, it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper describes the Quality System that the Department developed and which has been successfully maintained and extended since original certification. Important features of the Quality System are:1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements.2. Use of national Quality Award criteria to identify key business processes.3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective action procedures.4. Implementation without external resources.Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process. However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible when this process is undertaken at the level of the entire organisation.
Keywords: Key words ISO 9000 Quality System; Clinical chemistry; Medical testing; Pathology; Health care
EURACHEM's role and position with respect to the accreditation of analytical laboratoriesEURACHEM 2000
by P. De Bieùre; R. Kaarls; B. King (pp. 89-91).