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1.
Dermot Hayes 《Accreditation and quality assurance》1996,1(1):18-23
The pertinent issues necessary for the establishment of quality assurance in the microbiology laboratory are discussed. Quality
assurance is a planned system of control measures that enables management to ensure that the analytical data produced in the
laboratory are valid. To introduce quality assurance, all activities in the laboratory that affect the production of analytical
data must be documented and controlled. These include sampling, method selection, laboratory environment, equipment, reagents
and media, staff, reference materials and internal and external quality control. Laboratory accrediation in accordance with
EN45001 and ISO Guide 25 enables laboratories demonstrate to an external agency their ability to perform analytical work and
produce valid analytical data. This gives creditability to the laboratory and allows management to have confidence in the
data produced.
Received: 6 June 1995 Accepted: 3 July 1995 相似文献
2.
Cintia Jimnez Rosa Ventura Xavier de la Torre Jordi Segura 《Analytica chimica acta》2002,460(2):166-307
Internal quality control (IQC) is one of the most important elements contributing to quality assurance in the laboratory. In this study, the strategy for the implementation of an IQC program to monitor performance of the analytical procedures used in an antidoping control laboratory is presented. Different IQC parameters have been defined according to the aim of the method (qualitative or quantitative, screening or confirmation). They are based on the analysis of control and calibration samples in each analytical batch and on the use of an internal standard in chromatographic methods. IQC parameters for chromatographic and immunological methods and the acceptance criteria used to check the quality control data obtained are described and discussed. These IQC procedures have been applied during routine antidoping analyses of more than 5000 samples per year in a laboratory accredited by the International Olympic Committee (IOC) and meeting the requirements of the quality standard ISO 17025. 相似文献
3.
Keith W. Davies 《Accreditation and quality assurance》1999,4(1-2):18-26
Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and
accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical
and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled
equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New
management techniques have been developed to control the quality and appropriateness of results. Developments in internal
quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of
assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer
pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities
and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient
testing outside the laboratory. This will provide new challenges to the quality of the service provided.
Received: 2 July 1998 · Accepted: 1 August 1998 相似文献
4.
G. Meinrath P. Volke C. Helling E. G. Dudel B. J. Merkel 《Fresenius' Journal of Analytical Chemistry》1999,364(3):191-202
Interpretation of environmental behavior of uranium is based on several steps of data analysis and statistical inference.
First step is sampling and analyzing of uranium in field samples by routine laboratory methods. Such methods have to fulfill
multiple requirements like robustness, efficiency, low detection limit and precision. A comparison of different approaches
in assigning uncertainty to experimentally obtained analytical data shows that classical error estimation is not significantly
inferior to more sophisticated modern techniques like inverse regression or orthogonal regression. A second step is the correlation
of analytical data with current state of insight into environmental behavior of uranium. Such a correlation furthers the choice
of adequate geochemical models and quality of geochemical data base for subsequent detailed analysis, e.g. by geochemical
modeling. An appraisal of the individual steps in this complex analysis is given on the basis of statistical procedures for
calibration and an EH-pH diagram of uranium for atmospheric conditions.
Received: 30 July 1998 / Revised: 18 November 1998 / Accepted: 26 November 1998 相似文献
5.
Besides their role as an external quality control tool, PT results or samples could be used as an alternative to fulfil some of the quality assurance requirements such as analytical precision, uncertainty assessment, and internal quality control. This additional use of proficiency testing could help laboratories to reduce the financial impact of their quality assurance process. The purpose of this paper is to highlight some practical uses of PT results or samples in the environmental analytical field, which have been implemented at ISSeP (Institut Scientifique de Service Public), either for method validation or for internal quality control.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia 相似文献
6.
The micro element content of food is an important quality index due to the action of these elements on human health. In this
article, we discuss how to ensure the reliability of analytical data on micro elements in order to truly represent the condition
of food. Sampling, treatment of the analytical sample, selection of the analytical method, standard solution, and certified
reference material, blank test, calibration of the instrument and equipment, application of the quality control chart, assessment
of the final analytical result, and quality assurance system are briefly described.
Received: 5 July 2001 Accepted: 19 November 2001 相似文献
7.
W. Jäger 《Accreditation and quality assurance》1997,2(4):199-202
The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment
of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The
requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must
in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative
authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended
to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical
quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories
to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses.
This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory
by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation,
can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must
be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must
be demanded of all laboratories.
Received: 4 October 1996 Accepted: 15 January 1997 相似文献
8.
A. Sahuquillo R. Compañó R. Rubio G. Rauret 《Accreditation and quality assurance》2004,9(4-5):259-265
Since the academic year 2001–2002, inter-laboratory trials for students of Analytical Chemistry in Spanish Universities have been organised by the Department of Analytical Chemistry at the University of Barcelona in collaboration with the Complutense University of Madrid, the University of Cordoba and the University of Huelva. The aim of these exercises is to train students in the use of tools for the assessment and improvement of quality in analytical laboratories.Representative samples of environmental and food analysis, agricultural soils and a type of beer were selected. The ethanol content of the beer and the pH, conductivity, and extractable phosphorus and potassium content in the soil were the chosen analytical parameters.Sample preparation, homogeneity and stability studies, as well as the statistical treatment of data from participants, were carried out by the laboratory Mat Control of the Department of Analytical Chemistry of the University of Barcelona.The paper presented heregives the results obtained after two years of experience.Presented at BERM-9—Ninth International Symposium on Biological and Environmental Reference Materials, June 15–19, 2003, Berlin, Germany. 相似文献
9.
The paper covers the main principles of setting up and the function of the Russian system of metrological assurance of analytical
measurements for the production of light alloys and superalloys.
Received: 20 October 1998 / Accepted: 9 November 1998 相似文献
10.
Maintaining the quality of testing in remote locations can be demanding of laboratory resources in terms of daily visits
to instruments and providing support outside of normal working hours. Recently technology and software solutions have appeared
to reduce this burden for laboratory scientists dramatically. The AVL Auto QC unit, in conjunction with OMNILink software,
allow laboratory staff to perform many quality control and maintenance procedures on instruments in wards and medical units
from a PC in the central laboratory. Assessment of this technology and software in the Special Baby Care Unit at Bradford
Royal Infirmary has demonstrated many benefits including reduction in ward visits, better support out of hours, regular quality
control checks, and improved analytical quality.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
11.
A harmonized European framework for method validation to support research on emerging pollutants 总被引:1,自引:0,他引:1
Any investigation of environmental processes related to chemical substances or their effects depends on reliable, comparable analytical data. This also holds true for the impact of climate change on occurrence, distribution and effects of emerging pollutants, with respect to which there is particular concern regarding the reliability of analytical data, due to lack of harmonization in method validation and requirements for quality assurance and quality control (QA/QC).We present a recent European approach to developing a harmonized framework for method validation, QA/QC and provision of environmental data on emerging pollutants. The validation approach has been tested and improved by three case studies. We outline the main concept of the validation approach as well as the results of the case studies. This European validation framework turned out to be a feasible tool to check the fitness for purpose of analytical methods and to improve the reliability of environmental analytical data, particularly for emerging pollutants. 相似文献
12.
Bernard King 《Accreditation and quality assurance》1999,4(8):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.
Received: 24 December 1998 · Accepted: 18 May 1999 相似文献
13.
A five-step model for a quality assurance system is developed for an internal quality control check. It includes the quality
control of the decomposition method and the detection method as steps belonging together. The Wickbold combustion technique
as decomposition method in combination with atomic absorption spectrometry was chosen. The vaporization of the elements mercury,
arsenic, lead, antimony and selenium is based on combustion in an oxyhydrogen flame. To check the efficiency of the analytical
system, the uncertainty of results was calculated on the basis of the "Guide to the Expression of Uncertainty in Measurement".
Received: 13 January 1997 · Accepted: 29 March 1997 相似文献
14.
On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement
Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement
(CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by
imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human
body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum
requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow
manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently
run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process.
Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional
organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint
Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has
still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
15.
This review focuses on a number of key procedural steps in the analysis of volatile organic compounds (VOCs) in estuarine waters. The most critical step, from an analytical point of view, is sample preparation. So far, only purge-and-trap and, to some extent, membrane inlet mass spectrometry have successfully been applied in estuarine monitoring of VOCs. The advantages and disadvantages of both techniques are discussed and novel developments are reviewed. Other key elements in VOC analysis and assessment include quality assurance (QA), quality control (QC) and statistical data analysis. This paper gives a brief overview of QA/QC measures of interest in the estuarine monitoring exercise, and provides guidelines for adequate statistical treatment of environmental data. Finally, field measurements of VOCs in estuarine waters are reviewed. Concentrations are reported, and distribution patterns, sources and time-trends are discussed. In addition to literature data, results of a 3-year monitoring survey (May 1998–November 2000) in the Scheldt estuary are presented. 相似文献
16.
Wolfgang Werner 《Fresenius' Journal of Analytical Chemistry》1992,342(10):783-786
Summary Systematic quality assurance, e.g. in accordance with the provisions of ISO 9000, requires not only the targeted use of quality as a management tool, but also a revised attitude to operational procedures. Although sophisticated checking of the final results of a procedure (e.g. results of analyses, sales products, reports) meets the legal requirements and often also the customers' requirements, this misses the chance of being able to influence the quality of a final result at the earliest possible stage. It is then only possible subsequently to take the uneconomic decision as to whether the result of the work is useable or must be discarded or the object reworked. Within quality assurance, all operations are to be considered as processes with the aim of arriving at a statistically controlled process. The advantages of statistical process control are explained by way of examples from analytical procedures and production. The status of internal audits is explained as it interrelates with process control. 相似文献
17.
Haim Hacham Nurit Tetro Salit Kochavi-Azolai Nava Stern Dana Mizrahi Anna Lisenker Emanuel Gazit 《Accreditation and quality assurance》2007,12(8):409-413
The Department of Public Health Laboratories consists of five major laboratories located across the country of Israel: four
environmental laboratories performing microbiological and chemical testing of food and water products [accredited according
to International Organization for Standardization (ISO) 17025 since 1999) and a fifth laboratory that is dedicated to virology
testing (certified according to ISO 9000 since 2003). Historically, each laboratory operated independently and developed its
own quality assurance (QA). On November 2004, an important strategic decision was made: to unify all five laboratories’ QA
systems conformed to ISO 17025, ISO 15189, and ISO 9000—a transition from five laboratories operating independently in the
field of QA toward establishing a multisite laboratory. This process was considered and visualized as a major organizational
change and therefore raised some resistance among both QA managers and the professional laboratories’ management. Thus, it
was necessary to overcome the resistance and at the same time induce thoughts of ways of reshaping and formatting the new
and uniform quality manual and uniform standard operating procedures (SOPs). In September 2005, the first phase of the process
was completed, and all four environmental public health laboratories successfully passed a reaccreditation audit using a uniform
QA manual guide and partially uniform SOPs. We shall share our experience and discuss the major contributions of this process
to overall laboratory management.
Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel. 相似文献
18.
Bauke te Nijenhuis Karin Heutinck Ben van Schijndel 《Analytical and bioanalytical chemistry》2001,369(7-8):741-743
Participation in proficiency testing schemes (PT-schemes) is an important way to prove and to improve the skills of analytical chemical students. It gives valuable information on the professional capabilities of the students and is thus an important step in the training of laboratory engineers and technicians. In the programme described three types of samples are offered to the students: chemical, environmental and clinical samples. A guiding protocol presents instructions to the participating student groups. Standard operating procedures are available, but the students are also free to select their own method. The results are methodologically and statistically judged by professional PT-organisers and are presented in the customary way: the dataset, the mean (consensus) value of all participants and the Z-scores. The final presentation of the results takes place in an annual symposium where awards are presented to the best performing student groups, and a lecture programme is presented with subjects in the area of quality assurance and quality control. A selection of results from the KILO/PT/1998–1999 and the KILO/PT/1999–2000 programme is presented. 相似文献
19.
In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA) (). The CLIA link test quality and adherence to a body of testing regulations intended to ensure accurate, reliable, and timely patient test results. The goal of the CLIA legislation was to ensure a minimum, fundamental level of quality. In the context of “NEXUS,” quality must “go beyond getting the ‘right’ answer on the ‘right’ patient that can be interpreted against ‘right’ reference values. CLIA regulations with specific minimum, performance requirements, or safeguards, are designed to prevent testing errors. The US Institute of Medicine found that testing processes fail as a result of human error, lack of documentation, and lack of test management. In the latest (2004) interpretations of CLIA regulations, the minimum quality control requirement continues to be analyzing at least two external, liquid quality control materials per test per day. In 1995, we proposed that the responsibility for achieving quality test results shifts from the sole purview of the laboratory director to an “alliance” of laboratory professionals, manufacturers, and regulators. The EQC (equivalent quality control) concept as proposed is a positive step in achieving this alliance. With the obvious lack of scientific and statistical robustness, EQC falls far short of ensuring quality. Achieving the “NEXUS Vision” for quality laboratory testing will not come solely from laboratory professionals. The NEXUS is about how to ensure the full-quality assessment of the testing process – pre-analytical, analytical, and post-analytical.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium. 相似文献
20.
V. I. Dvorkin 《Journal of Analytical Chemistry》2001,56(7):613-625
In this problem-oriented article, regarding the author's experience, a review of the methods of intralaboratory quality control based on systematic analysis of reference samples (control materials) is given. The requirements imposed on reference samples are briefly considered. The principles of selection of an inspection plan and the requirements on the evaluation period of statistical characteristics are formulated. The techniques for graphically representing the results of intralaboratory control and the algorithms for detecting out-of-control analytical processes are considered. Control charts for average values and ranges or charts for cumulative sums and geometric (exponentially weighted) moving averages are recommended as the main or auxiliary graphical representation, respectively. Westgard rules and the simplest rules for ranges are recommended as the main algorithms for revealing out-of-control analytical processes. Multivariate statistical process control methods, which are recommended for use in the cases of a great number of simultaneously determined factors, are briefly discussed. 相似文献