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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.3, #5)
The determination of the uncertainty of reference materials certified by laboratory intercomparison by Jean Pauwels; Andrée Lamberty; Heinz Schimmel (pp. 180-184).
A pragmatic method is proposed for the implementation of the Guide to the expression of uncertainty in measurement in the certification of reference materials by laboratory intercomparison. It is based on the establishment of a full uncertainty budget for each laboratory result and the estimation of the impact of various laboratory standard uncertainties and of between-units variability on the certified reference material (CRM) uncertainty.
Keywords: Key words Reference material; Laboratory intercomparison; Certified value; Uncertainty
The optimal amount of isotopic spike solution for ultratrace analysis by isotope dilution mass spectrometry by R. Hoelzl; Christian Hoelzl; Ludwig Kotz; Lazlo Fabry (pp. 185-188).
Inductively coupled plasma mass spectrometry (ICP-MS) and high resolution inductively coupled plasma mass spectrometry (HR-ICP-MS) are powerful methods of determining metallic impurities in the low- and sub-ppt level in process media such as ultra-pure water used in semiconductor and wafer manufacturing. By using mass spectrometers for analysis, an isotope dilution analysis (IDMS) is possible. The reproducibility of an IDMS is unmatched. For concentration levels near the instrument detection limit a novel method is reported to find the optimal amount of isotopic spike solution. This optimal value can be derived by the law of propagation of uncertainty combined with the Poisson statistics of the measured number of counts. Generally, an excess of isotopic spike solution should be used to provide results of lowest possible uncertainty. The results are presented in a diagram for easy practical use.
Keywords: Key words Isotope dilution; Mass spectrometry; Ultratrace analysis; Calibration; Ultra-pure water
Validation requirements for chemical methods in quantitative analysis – horses for courses? by R. J. Wells (pp. 189-193).
Although the validation process necessary to ensure that an analytical method is fit for purpose is universal, the emphasis placed on different aspects of that process will vary according to the end use for which the analytical procedure is designed. It therefore becomes difficult to produce a standard method validation protocol which will be totally applicable to all analytical methods. It is probable that far more than 30% of the methods in routine laboratory use have not been validated to an appropriate level to suit the problem at hand. This situation needs to change and a practical assessment of the degree to which a method requires to be validated is the first step to a reliable and cost effective analytical industry.
Keywords: Key words Validation; Verification; Veterinary drugs; Anabolic steroids
Validation criteria for developing ion-selective membrane electrodes for analysis of pharmaceuticals by Raluca-Ioana Stefan; H. Y. Aboul-Enein (pp. 194-196).
The problem of validation criteria for developing ion-selective membrane electrodes for the analysis of pharmaceuticals arises from the connection between the reliability of ion-selective membrane electrodes construction and the reliability of the analytical information. Liquid membrane selective electrodes are more suitable for validation than the solid variety. The influence of the stability of ion pair complexes from the membrane on various parameters (e.g. response, limit of detection, and selectivity) is discussed. Validation criteria are proposed.
Keywords: Key words Ion-selective membrane electrodes; Reliability of construction; Reliability of analytical information; Validation criteria; Analysis of pharmaceuticals
Basic steps towards a self-sustainable quality system and laboratory accreditation by P. Bode; K. Heydorn; R. W. Innes; R. Wood; R. Zeisler (pp. 197-202).
Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories.
Keywords: Key words Pathway; Quality system; Implementation; Self-sustainable; accreditation
The Swiss External Quality Assessment Scheme in Bacteriology and Mycology 1992–1996 by H. H. Siegrist; V. Pünter-Streit; A. von Graevenitz (pp. 203-207).
The Swiss External Quality Assessment Scheme in Bacteriology and Mycology was created in 1980 and has been organised since 1983 by the Department of Medical Microbiology in Zurich. The number of Swiss participants has steadily risen from 66 in 1989 to 92 in 1996. Twelve bacterial and fungal strains are sent to the participants in four despatches, each containing three specimens, per year. Scores are allocated per specimen and range between 0 and 1. Participants with mean scores of ≤0.75 are considered poor performers. The mean scores increased from 0.85 in 1992 to 0.91 in 1996. This improvement can be attributed to the educational effect of the external quality control scheme, since all participants receive a detailed discussion for each specimen together with their individual results. On average, both large University and Cantonal (state) laboratories as well as private laboratories show satisfactory performance. In particular, laboratories officially recognised by the Swiss Federal Office of Public Health (SFOPH) rate better than non-recognised participants. Many small regional hospital laboratories, most of them not SFOPH-recognised, are often among the poor performers. They are often managed by technical staff and lack a trained microbiologist. The recently introduced legislation in Switzerland renders participation in external quality assessment schemes compulsory, and all clinical microbiology laboratories are required to employ qualified microbiologists. This will certainly help to improve the quality standards of all laboratories performing microbiological tests.
Keywords: Key words Bacteriology; Mycology; External quality assessment; Quality control
European Quality Promotion Policy for improving the competitiveness of european industry by A. Julin (pp. 208-210).
The Community legislative policy for the free movement of industrial goods has evolved from an approach based purely on legislation and public intervention towards a more voluntary approach based on a homogeneous system combining regulatory and voluntary assessment of conformity with standards and/or customer specifications. This has led to an increased participation of the economic operators in the legislative process and a better reallocation of responsibilities between the public and private sectors. The European Union has now to go beyond legislation, standardisation and certification, in order to contribute further to increasing the competitiveness of European industry. At present, Community activities concentrate on reinforcing the Single Market and the necessary quality infrastructures, and in the proper implementation of existing legislation, in particular the application and interpretation of the CE marking requirements. These measures, however, do not solve all the problems relating either to conformity with regulatory requirements or to enhancing competitiveness. The European Quality Promotion Policy has the ambition of constituting above all an awareness policy to give political visibility and support to a European-wide range of quality instruments and actions. Simultaneously, it should be seen as a logical step on the road from conformity with safety regulations (in particular CE marking directives) to competitiveness and business excellence through quality management strategies.
Keywords: Key words Quality; Competitiveness; Regulations; Standards; Conformity assessment
Different approaches to legal requirements on validation of test methods for official control of foodstuffs and of veterinary drug residues and element contaminants in the EC by H. Hey (pp. 211-214).
In order to ensure food consumer protection as well as to avoid barriers to trade and unnecessary duplications of laboratory tests and to gain mutual recognition of results of analyses, the quality of laboratories and test results has to be guaranteed. For this purpose, the EC Council and the Commission have introducedprovisions– on measures for quality assurance for official laboratories concerning the analyses of foodstuffs on the one hand and animals and fresh meat on the other,– on the validation of test methods to obtain results of sufficient accuracy.This article deals with legal requirements in the European Union on basic principles of laboratory quality assurance for official notification to the EC Commission and on method validation concerning official laboratories. Widespread discussions and activities on measurement uncertainty are in progress, and the European validation standards for official purposes may serve as a basis for world-wide efforts on quality harmonization of analytical results. Although much time has already been spent, definitions and requirements have to be revised and further additions have to be made.
Keywords: Key words Laboratories for offical control of foodstuffs; veterinary drug residues and element contaminants; Validation of test methods; Legal requirements