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Accreditation and Quality Assurance: Journal for Quality, Comparability
and Reliability in Chemical
Measurement (v.7, #2)
Internal audits in private medical laboratory practice – a Finnish experience in 1996–2000
by Solveig Linko (pp. 55-59).
Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally, audits performed at the workbench were not considered as the best possible for fruitful discussions.
Keywords: Keywords Quality systems; Accreditation criteria; Laboratory assessment; ISO/IEC 17025
Implementation of a ”data filter” for the UK National Marine Monitoring Programme
by M. Gardner; Judith Dobson; Brian Miller; Colin Allchin; David McMullan; Trevor Oliver; David Wells; R. Hudson; Richard Toft; Mike Jessep (pp. 60-65).
The implementation of a strategy for the assessment of the validity of environmental monitoring data – a ”data filter”– is described. The approach was developed through the UK National Marine AQC Scheme for application to data collected during the UK National Marine Monitoring Programme. Data reported for the year 1999, by nine laboratories, for 74 determinand-matrix combinations were assessed on the basis of the completeness of their supporting quality assurance and quality control information. The approach to the establishment of criteria of acceptability for quality information is described.
Keywords: Keywords Quality control; Data quality; Quality assurance; Proficiency tests; Fitness for purpose
Analysis of nonconforming work as a tool for status analysis and continuous improvement
by D. Glavič-Cindro; Matjaž Korun; Matic Korun (pp. 66-72).
The methodology for statistical processing of reports on nonconforming work and unexpected situations which occur in the laboratory of Gamma-Ray Spectrometry Group at the Jožef Stefan Institute is presented. The results of statistical analyses are discussed. Pareto analysis has shown that the majority of cases of nonconforming work originates in errors made by personnel. The sociological and psychological aspects of strategies aimed at preventing careless work are discussed. It is proposed that motivation should be used as a tool against habits that lessen awareness during routine operations. Specific recommendations regarding communication with personnel are given.
Keywords: Keywords Quality assurance; Nonconforming work; Descriptive statistic; Pareto analysis; Management of human resources
A dedicated External Quality Assessment system for immunoassays of reproductive hormones
by S. Z. Cekan (pp. 73-76).
A dedicated External Quality Assessment (EQA) system for immunoassays of reproductive hormones (LH, FSH, prolactin, hCG, progesterone, estradiol, testosterone) and cortisol was developed. This catered for the needs of a group of laboratories conducting collaborative research with the WHO in the field of human reproduction. This system was designed to provide the maximum information on assay quality with the final aim of achieving and maintaining the highest possible comparability in monitored multi-center clinical studies. The EQA was based on the assays of 32 control samples per year in 4 quarterly assay runs and the evaluation of the following parameters: bias, between-run imprecision within a laboratory, number of outliers, frequency of returned assays of control samples, and between-laboratory imprecision. The data obtained were combined in a performance index for each laboratory, EQA run, and analyte. This index was then subjected to ranking. It may be assumed that the EQA system contributed to improvements of analytical work and/or the maintenance of a high assay quality in participating laboratories.
Keywords: Keywords External Quality Assessment; Peptide hormones; Steroid hormones
An arrogance of technicians
by Gary Price (pp. 77-78).
A recent article in this journal, reflecting a commonly held view, has sought to denigrate the contribution that might be made by legal metrology to public confidence in chemical measurements. This article disputes those contentions.
Keywords: Keywords Weights and measures; Chemical measurement; Legal metrology
Introducing the concept of uncertainty of measurement in testing in association with the application of the standard ISO/IEC 17025
by N. Mueller (pp. 79-80).
ISO/IEC 17025 requests laboratories to estimate the overall uncertainty associated with a test result. In many cases this means a new requirement to laboratories. It is essential to understand the importance of the knowledge of the uncertainty of measurements as well as the principle that not always the smallest possible uncertainty is needed, but fitness for purpose has to be achieved. The paper suggests a policy on the implementation of the concept of uncertainty and guidance on how to proceed, taking into account the present state of the art of understanding the problem.
Keywords: Keywords Accreditation; Testing; Uncertainty of measurement
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