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1.
In our article we explain the connections between the implementation of quality assurance (QA) in research and routine analytical laboratories. J. K. Taylor claims that QA in an analytical laboratory consists of two independent but closely related terms, quality control and quality assessment. If we construct the QA system according to his ideas, problems concerning quality can be solved with only one concept regardless of the type of analytical laboratory. Therefore there is no need to introduce new QA standards for research laboratories as suggested in some papers. In the routine laboratory quality control is more important, while in the research laboratory quality assessment is dominant.
相似文献2.
J. Wieling H. A. Bakkeren R. J. B. Peters W. J. C. G. van Gils E. W. B. de Leer S. A. Mulder P. A. van der Burg J. A. D. van Renesse van Duivenbode 《Fresenius' Journal of Analytical Chemistry》1994,348(11):703-711
In analytical research laboratories, the problem of quality assurance is more difficult to solve than in laboratories devoted exclusively to routine analysis: the former usually have to deal with a much greater variety of samples and may have to develop entirely new methods of analysis. For research laboratories we have developed several alternative methods of quality assurance. These methods can be used to distinguish between different analytical methods, between different types of equipment, between different levels of skill among laboratory technicians, or even between the performance of technicians of the same level of skill. 相似文献
3.
Anti-HIV quality assurance programs in Australia and the southeast Asian and Western Pacific regions
A. Gust Sandy Walker Roderick J. Chappel Elizabeth M. Dax 《Accreditation and quality assurance》2001,6(4-5):168-172
Anti-HIV testing is the most regulated area of laboratory medicine in Australia. These regulations have placed the National
Sero-logy Reference Laboratory, Australia (NRL) in a unique position to implement a comprehensive quality assurance (QA) program
for HIV testing. The elements of our QA program include pre-market evaluation of assays, external quality assessment schemes
(EQAS), quality control, specificity monitoring, consultations, and training workshops. The results of the NRL EQAS for Australian
laboratories were compared with those of a program developed by the NRL for reference laboratories in the Southeast Asian
and Western Pacific (SEAWP) regions. For laboratories authorized to use tests for HIV in Australia, participation in the entire
QA program is mandatory, whereas the SEAWP EQAS program is voluntary. While the overall percentage of discrepant results for
these programs are similar, the percentage of false negatives, variation in laboratory results, and choice of assay differ.
These differences have decreased with time with improvements in assays and laboratory testing practices. The educational component
of both EQAS, which comprises workshops, laboratory questionnaires, consultancies, and newsletters, has had a critical impact
on the testing practices of laboratories.
Received: 30 October 2000 Accepted: 9 December 2000 相似文献
4.
Derliane Oliveira Sook Fan Yap Siripan Wongwanich Baldip Khan Juan Cristina 《Accreditation and quality assurance》2010,15(2):89-97
Nucleic acid-based technologies have opened new perspectives in diagnosis, prognosis, and treatment in clinical medicine.
To maintain patient confidence in this rapidly expanding field and to provide the highest standard of analysis, strict laboratory
quality assurance procedures must be followed. While impressive break-through are taking place in this field, the need for
an appropriate and suitable quality assurance (QA) plan for nucleic acid-based diagnostic laboratories must be a top priority.
In this study, we developed a systematic QA plan for this kind of diagnostic laboratories that would enable us to assure the
highest quality standards of their services. We focus on those labs that would like to start introducing a quality system
for the first time and discuss the most appropriate ways to pave the way to implement a QA plan from the beginning. This QA
plan is suitable for any nucleic acid-based techniques laboratory regardless of the field or services provided. 相似文献
5.
If we agree that quality assurance (QA) in R&;D indeed provides added value, just how do we show the public that such a QA system is operating well? At the Belgian Nuclear Research Centre (SCKÖbullet CEN), where a QA system has been implemented by various laboratories in accordance with the EN 45001 standard within the general framework of ISO 9001 at the institutional level, several laboratories have already been accredited. At the request of one of our customers the Belgian Agency for Radioactive Waste Management (NIRAS/ONDRAF), we implemented a quality system for research projects related to the characterization, treatment and processing of radioactive wastes in view of disposal. We obtained accreditation for this research in 1999. In this paper, we discuss the implementation of our QS and important issues related to the overall management of the QA system, broken down into three parts: organizational, technical and project-specific quality elements such as the QA plan and internal communication. 相似文献
6.
Axel Colling Martyn Jeggo Helder Louvandini Mamadou Lelenta Mark Robinson 《Accreditation and quality assurance》2008,13(1):33-45
Quality systems, established to internationally accepted standards, are one mechanism that can assist in evaluations of the
sustainability of technology transfer, the proficiency of the user, and the reliability and comparability of data generated,
resulting in potential enhancement of laboratory credibility. The means of interpreting existing standards and implementing
quality systems in developing country veterinary diagnostic laboratories has become a significant adjunct to the technology
transfer element within the Food and Agriculture/ International Atomic Energy Agency, FAO/IAEA programme. The FAO/IAEA External
Quality Assurance Programme (EQAP) is given as an example for an initial step towards enhancing the “quality” culture in developing
country veterinary laboratories. In 1995 the EQAP began as an effort to assure that test results emanating from laboratories
using FAO/IAEA ELISA kits for animal disease diagnosis are valid. For this purpose 15 international external quality-assurance
rounds have been performed to date for a variety of animal diseases e.g. Rinderpest, brucellosis, trypanosomosis, and foot-and-mouth
disease (FMD). Results indicate that the EQAP is a valuable tool in the assessment of both the results provided by, and use
of the ELISA kits provided through, the joint FAO/IAEA programme. Furthermore EQAP can assist laboratory diagnosticians to
enhance quality control/quality assurance (QC/QA) procedures for conducting FAO/IAEA ELISAs and to advise on the implementation
of similar QC/QA procedures in other laboratory activities. Based on the experiences made during the implementation of the
EQAP a proposal for establishing a quality system standard was ratified through the World Organization for Animal Health (OIE)
general conference in May 2000. The OIE Standard On Management And Technical Requirements For Laboratories Conducting Tests
For Infectious Animal Diseases is based on ISO 17025 and provides a clear formula for establishing quality systems in veterinary
diagnostic laboratories world-wide. 相似文献
7.
B. Palenzuela L. Manganiello R. Bauza A. Ríos M. Valcárcel 《Accreditation and quality assurance》2005,10(5):219-228
Systematic performance testing activities for supercritical fluid extractors consistent with the implementation of quality systems in analytical laboratories are proposed. In this context, supercritical fluid extraction (SFE) is used for the automatic processing of complex samples. Ensuring reproducible operation of SFE equipment is crucial with a view to obtaining traceable results. To this end, an assessment protocol including recommended preventive and corrective actions, and complementary internal quality control activities, was developed with a view to facilitating the use of SFE equipment by routine analytical laboratories. 相似文献
8.
H.A. van''t Klooster H.A. Deckers C.J. Baijense I.J.B. Meuwsen M.L. Salm 《Trends in analytical chemistry : TRAC》1994,13(10):419-425
This article presents the results of a comparative study of the main quality assurance (QA) and good laboratory practice (GLP) regulation systems and standards for analytical chemical laboratories currently being applied in Europe. A growing number of laboratories are being confronted with the need to cope with two or more of these systems, which involves separate audits and inspections for certification and accreditation. As these regulatory systems have essentially the same aims, there is an increasing interest in harmonization of QA and GLP guidelines. As a first step in exploring the possibilities of harmonization, similarities and differences of the current systems, compiled in the form of cross reference tables, have been analyzed (from a laboratory practice point of view) by a study group of EURACHEM, The Netherlands. The conclusions of this study have recently been endorsed by the Committee of EURACHEM Europe. 相似文献
9.
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
10.
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
11.
Z. Plzák 《Accreditation and quality assurance》2000,5(1):35-36
This paper examines some problems of implementation of quality assurance (QA) principles in chemical measurement in the university
academic environment. Being developed and introduced in practice by industrial and independent commercial laboratories, the
'quality lifestyle' has been largely ignored by the academic analytical community. The academic community is now faced with
the fact that teaching, education and training of analytical QA and analytical quality management are no longer a matter of
choice. 相似文献
12.
Giuliana Blasi Annalisa Petruzzelli Donatella Ottaviani Stefano Fisichella Enrico Di Raimo Andrea Valiani Marinella Capuccella Stefania Scuota M. Naceur Haouet 《Accreditation and quality assurance》2013,18(2):143-148
The validation of food microbiology methods and assessment of measurement uncertainty are required for laboratories operating EN ISO/IEC 17025 accreditation systems. This paper aims to describes the statistical approach adopted by a multi-site laboratory to satisfy these requirements and to routinely check the performance of the methods. A validation protocol was performed, reflecting a great variability of experimental conditions, represented by the period of time during which determinations were made, the different laboratories concerned, the large number of technicians involved, the differences in the level of contamination of the matrix analyzed and the operating conditions (equipment, reagents, culture media, environmental conditions, etc.). Despite the very high variability of the experimental conditions, the values of repeatability and reproducibility obtained for the methods were lower than those stated in the respective regulations. In addition, the top-down approach adopted in this study is to be considered effective overtime and allows to randomize all variable factors, including the effects of sensitivity and specificity, in order to simulate the conditions of real reproducibility. A specific Excel spreadsheet was also developed for the routine expression of analytical results. This spreadsheet represents a very useful tool for operators to calculate and routinely check the results, as well as to assess the uncertainty of measurement. This particular quality assessment system is enabling the multi-site laboratory to implement the accuracy, reliability and comparability of the analytical results and to ensure the analytical control of data output. 相似文献
13.
Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise. 相似文献
14.
The complexity of different quality standards can, in principle, be covered by different approaches and strategies. In-depth
process mapping of quality control (QC) work streams was used by the analytical laboratories of Lonza AG to show up the principle
differences in being compliant to different quality systems. The results identified two main drivers for all necessary actions:
process-related activities and infrastructure-related activities. In addition, a clear indication of the economic impact of
these driving forces was gained, which led the laboratories to decide on a process-oriented approach. This approach has the
advantage of being able to reflect the different demands of different quality assurance (QA) regulations within the same QC
organizational structure. Following the process helps avoid unnecessary efforts in analytical work and represents a very economical
approach, at the same time, providing high flexibility to react to different QA or customer demands.
Received: 5 July 2002 Accepted: 12 November 2002
Acknowledgements The process-oriented approach resulted from many, very challenging discussions for which I would like to thank the staff
of my organization (Analytics & QC), especially, the QA staff and the LIMS team.
Presented at Analytica Conference, 23–26 April 2002, Munich, Germany
Correspondence to B. Ciommer 相似文献
15.
《Trends in analytical chemistry : TRAC》1999,18(9-10):644-649
Quality in the analytical laboratory is essential nowadays, must prove to meet the needs of customers, attract their confidence (and that of others who make use of the results), and represent value for money. There are innumerable areas where the results of chemical analysis are important (e.g., in the determination of the quality of manufactured products, in support of health and safety, in establishing environmental legislation, and in forensic science). However, although the concept of quality control and quality assurance is well understood by modern laboratories (whether commercial or with national responsibilities) –which are often accredited in various analytical sectors – there is an enormous gap in the transfer of knowledge to smaller laboratories. Training actions are therefore urgently needed, especially for analysts working in routine laboratories. This article describes two initiatives carried out under the umbrella of the EC Standards, Measurements and Testing Programme. 相似文献
16.
P. Vermaercke 《Accreditation and quality assurance》2000,5(1):11-15
Quality has always been one of the key issues in laboratories in general and formal quality assurance (QA) in testing laboratories has gained popularity over the last decade. However, the implementation QA in research and development (R&;D) laboratories is still the domain of a few pioneers. We can even ask whether a QA system in research makes sense at all and if such a system really provides any added value? Difficulties with respect to the implementation of such a system are mainly associated with the nature of the research process itself. However, it is obvious that QA offers clear advantages in R&;D, if some critical success factors have been taken into account. An important issue is the selection of a good QA standard for R&;D. This is certainly not an easy task, since there are no specific standards. Fortunately, some useful international guides have been published recently. 相似文献
17.
E. C. Nielsen 《Journal of Radioanalytical and Nuclear Chemistry》2008,276(2):347-351
During the early and intermediate phases of a nuclear or radiological incident, the Federal Radiological Monitoring and Assessment
Center (FRMAC) collects environmental samples that are analyzed by organizations with radioanalytical capability. Resources
dedicated to quality assurance (QA) activities must be sufficient to assure that appropriate radioanalytical measurement quality
objectives (MQOs) and assessment data quality objectives (DQOs) are met. As the emergency stabilizes, QA activities will evolve
commensurate with the need to reach appropriate DQOs. The MQOs represent a compromise between precise analytical determinations
and the timeliness necessary for emergency response activities. Minimum detectable concentration (MDC), lower limit of detection,
and critical level tests can all serve as measurements reflecting the MQOs. The relationship among protective action guides
(PAGs), derived response levels (DRLs), and laboratory detection limits is described. The rationale used to determine the
appropriate laboratory detection limit is described. 相似文献
18.
In the August 1999 issue of Accreditation and Quality Assurance reference was made to proficiency testing schemes organised for students at polytechnics in The Netherlands. The present paper describes in more detail this educational project which aims at increasing students' awareness of quality assurance and quality control (QA/QC) at polytechnics. The project has to be seen in relation to other regular activities to educate and train students and to prepare them for working in an analytical laboratory. This combined effort should result in well-educated and well-trained students with the right attitude to analytical work and to QA/QC. The project was organised under the auspices of the Working Group "Quality Assurance in Laboratory Education" (KILO). 相似文献
19.
A. Menditto S. Palleschi A. Minoprio B. Rossi A. Calibotti F. Chiodo M. Patriarca 《Microchemical Journal》2000,67(1-3)
The presence of chemicals in the environment is a matter of concern in that it poses potential health risks. At present, exposure to toxic chemicals and their biological and biochemical effects can be better estimated by biological monitoring, through the systematic collection of specimens from potentially exposed humans. Biological monitoring of human exposure to environmental pollutants is hampered by the difficulty to assess data reliability. As a consequence, the validity of biological monitoring should depend on the strict implementation of a quality assurance (QA) program, which includes a series of procedures aiming to ensure that laboratory results meet defined standards of quality and are reliable. For the validation and monitoring of methods’ performance, to ensure the trueness of measurements and to warrant the traceability to international standards, reference materials (RMs) and certified reference materials should be used. Internal quality control and external quality assessment (EQA) are part of overall QA and are carried out to verify that analytical errors are compatible with the specific requirements or needs of the user. In particular EQA schemes (EQAS) allow to test independently the analytical performance of participating laboratories. In the last decades, increasing concern has been raised by urban air pollution; lead and benzene, two gasoline components released by motor vehicle exhausts, are known to be toxic to humans. For biological monitoring of lead exposure of the general population, screening campaigns, utilizing lead in blood as a biomarker, have been carried out since the 1970s. Strict strategies were adopted to ensure data comparability, including the preparation of RMs, the organization of EQAS and the cross-exchange and analysis of blood samples between laboratories. Biological monitoring of benzene exposure could be carried out by means of various biomarkers such as benzene in blood and benzene, trans,trans-muconic acid (t,t-MA) and S-phenylmercapturic acid (S-PMA) in urine. At present, few RMs and EQAS are available for these biomarkers. A pilot EQAS for t,t-MA in urine, adopted to assess the reliability of data regarding benzene exposure, has been organized and carried out between 1996 and 1997 in Italy. From the accrued experience, it clearly emerges the importance of strategies designed to guarantee the quality of biological monitoring data. The use of RMs and the participation in EQAS are highly recommended in order to improve the global performance of methods and laboratories involved in biological monitoring. 相似文献
20.
A. Uldall 《Accreditation and quality assurance》1996,1(5):218-222
The clinical routine laboratory generally utilizes cheap, easy and rapid measurement procedures ("methods") in order to meet
the requirement for the production of many analytical results (500–3000 per day) of hundreds of different types. The measurement
procedures are optimized for the analysis of native patients' samples, but are frequently sensitive to deviation of the composition
of the matrix from that in normal fresh samples. The inherent lack of stability of patient samples means that control samples
need to be stabilized. The method of stabilization is critical. Furthermore, the method of "spiking" samples with pathological
material is a matter of concern. Generally, minimally processed patients' samples should be used in external quality assessment
(EQA) schemes. Consensus values are currently the most popular for use as a guide to the best results from participating laboratories
in EQA schemes; these often work fairly well. However, the uncertainty and traceability of this type of value is unknown,
and in some cases may even be misleading, tending to preserve bad routine methods when these are dominant in the participating
laboratories. Reference measurement procedure (RMP) values are recommended to provide scientifically based information, to
facilitate the proper choice of methods in the routine laboratories, and to validate the suitability of control materials
in EQA schemes. The present paper provides selected examples from a study comparing consensus values with RMP values on lyophilized
sera, and also presents results on a fresh frozen thawed serum for the study of commutability.
Received: 8 November 1995 Accepted: 8 May 1996 相似文献