Quality assurance in analytical laboratories engaged in research and development activities

 Research and development activities are carried out by various types of laboratories that are not the typical testing and calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance for non-routine analytical laboratories. Received: 11 July 2002 Accepted: 29 November 2002 Presented at Analytica Conference, 23–26 April 2002, Munich, Germany Correspondence to M. Valcárcel     

Proficiency testing schemes for polytechnic students: an educational project in The Netherlands

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).     

Ensuring the reliability of stable isotope ratio data—beyond the principle of identical treatment

The need for inter-laboratory comparability is crucial to facilitate the globalisation of scientific networks and the development of international databases to support scientific and criminal investigations. This article considers what lessons can be learned from a series of inter-laboratory comparison exercises organised by the Forensic Isotope Ratio Mass Spectrometry (FIRMS) network in terms of reference materials (RMs), the management of data quality, and technical limitations. The results showed that within-laboratory precision (repeatability) was generally good but between-laboratory accuracy (reproducibility) called for improvements. This review considers how stable isotope laboratories can establish a system of quality control (QC) and quality assurance (QA), emphasising issues of repeatability and reproducibility. For results to be comparable between laboratories, measurements must be traceable to the international δ-scales and, because isotope ratio measurements are reported relative to standards, a key aspect is the correct selection, calibration, and use of international and in-house RMs. The authors identify four principles which promote good laboratory practice. The principle of identical treatment by which samples and RMs are processed in an identical manner and which incorporates three further principles; the principle of identical correction (by which necessary corrections are identified and evenly applied), the principle of identical scaling (by which data are shifted and stretched to the international δ-scales), and the principle of error detection by which QC and QA results are monitored and acted upon. To achieve both good repeatability and good reproducibility it is essential to obtain RMs with internationally agreed δ-values. These RMs will act as the basis for QC and can be used to calibrate further in-house QC RMs tailored to the activities of specific laboratories. In-house QA standards must also be developed to ensure that QC-based calibrations and corrections lead to accurate results for samples. The δ-values assigned to RMs must be recorded and reported with all data. Reference materials must be used to determine what corrections are necessary for measured data. Each analytical sequence of samples must include both QC and QA materials which are subject to identical treatment during measurement and data processing. Results for these materials must be plotted, monitored, and acted upon. Periodically international RMs should be analysed as an in-house proficiency test to demonstrate results are accurate.     

The establishment of quality systems in veterinary diagnostic testing laboratories in developing countries: experiences with the FAO/IAEA External Quality Assurance Programme

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.     

New opportunities for the enhanced NAA services through the research reactor coalitions and networks

Although the number of research reactors (RRs) is steadily decreasing, more than half of the operational RRs are still heavily underutilized, and in most cases, underfunded. The decreasing and rather old fleet of RRs needs to ensure the provision of useful services to the community, in some cases with adequate revenue generation for reliable, safe and secure facility management and operations. Enhancement of low and medium power research reactor (RR) utilization is often pursued by increasing the neutron activation analysis (NAA) activities. In this paper we will present the strategy and concrete actions how NAA as one of the most popular RR applications can contribute to the above goals in particular through (a) RR coalitions and networks, (b) implementation of automation in different stages of NAA, (c) QA/QC, including skills improvement of involved personnel, (d) dedicated proficiency tests performed by a number of targeted analytical laboratories. We also show that despite the IAEA’s efforts, some of the NAA laboratories still perform badly in proficiency tests, do not have formal QA/QC procedures implemented, have not implemented automation to process large number of samples or lack of clear marketing strategies. Some concrete actions are proposed and outlined to address these issues in the near future.     

Are there two decks on the analytical chemistry boat?

 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.     

Quality assurance in the microbiology laboratory

 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     

Quality system implementation in a Brazilian university laboratory

The introduction of quality systems in laboratories at universities is a difficult task. Test services for external customers are provided to generate additional budget, and there may be a clear awareness about the need for systematic QA/QC actions. However, offering services is not of the highest priority within most university environments. The staff performance is commonly evaluated on basis of published papers and teaching activities, giving little or no weight for the test services. Therefore, implementation of a quality system is often pushed back to a lower priority leading to postponement. The efforts for creating a quality system in a laboratory from a Brazilian university are described in this paper, along with the results produced.     

Establishment of a quality system for nuclear analytical laboratories

Comprehensive Quality Control (QC) and Quality Assurance (QA) Program is stated on the quality policy, organization, methods and records for nuclear analytical laboratories which are necessary for improvement of productivity, to upgrade the performance, credibility and reputation. The proper and complete identification of quality elements for management and technical requirements are being written in Quality Manual as well as analytical and organizational procedures and working instructions according to ISO 17025 standard. Technical ability of gamma, X-ray and a/b laboratories in the Center has been checked by participation in proficiency test, critical technical variables, and quality results. Performance of quality system has been controlled by external audit inspection, progress reports and service to clients. The present study is a framework of the model project of IAEA, coded RER/2/004, which has resulted self-sustainable accreditation from the national body, TURKAK. This revised version was published online in August 2006 with corrections to the Cover Date.     

A quality systems approach for identifying and controlling sources of error with point of care testing devices

Historically, due to the size and nature of the instrumentation, highly skilled laboratory professionals performed clinical testing in centralized laboratories. Today’s clinicians demand realtime test data at the point of care. This has led to a new generation of compact, portable instruments permitting ”laboratory” testing to be performed at or near the patient’s bedside by nonlaboratory workers who are unfamiliar with testing practices. Poorly controlled testing processes leading to poor quality test results are an insidious problem facing point of care testing today. Manufacturers are addressing this issue through instrument design. Providers of clinical test results, regardless of location, working with manufacturers and regulators must create and manage complete test systems that eliminate or minimize sources of error. The National Committee for Clinical Laboratory Standards (NCCLS) in its EP18 guideline, ”Quality management for unit-use testing,” has developed a quality management system approach specifically for test devices used for point of care testing (POCT). Simply stated, EP18 utilizes a ”sources of error” matrix to identify and address potential errors that can impact the test result. The key is the quality systems approach where all stakeholders – professionals, manufacturers and regulators – collaboratively seek ways to manage errors and ensure quality. We illustrate the use of one quality systems approach, EP18, as a means to advance the quality of test results at point of care. Received: 26 June, 2002 Accepted: 17 July 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Abbreviations NCCLS National Committee for Clinical Laboratory Standards (formerly) · POCT point of care testing · QC quality control · HACCP hazard analysis critical control points · CLIA clinical laboratory improvement amendments (of 1988) Correspondence to S. S. Ehrmeyer     

A harmonized European framework for method validation to support research on emerging pollutants

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.     

Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon

Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.     

Approach to Quality System in Research and Development

 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. Received: 11 September 1996 Accepted: 13 November 1996     

How valid are our QA assumptions: an examination of underpinning Axioms

 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     

Quality assurance systems in research and routine analytical laboratories

 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.

     

Unification of the quality assurance systems of public health laboratories conformed to ISO 17025, ISO 15189, and ISO 9000: a major organizational change

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.     

Quality assurance systems in research and routine analytical laboratories

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.     

Investigation of air pollution in Chile using biomonitors

A project has been undertaken to carry out a long term study on atmospheric air pollution in Chile using biomonitors. Samples of different species of lichens were collected in clean areas (native forest), analyzed and transplanted to the Santiago Metropolitan Area. In addition, samples of Tillandsia recurvata were collected in the Metropolitan Area for comparison purposes. The preparation of the samples was done under controlled, cryogenic conditions and analyzed by neutron activation analysis and solid sampling atomic absorption spectrometry. As part of the routine QA/QC procedures, the analytical laboratories, have participated in intercomparison runs organized by the IAEA for the determination of trace and minor elements in two lichens samples. The present paper describes the activities carried out within the framework of this project. This revised version was published online in July 2006 with corrections to the Cover Date.     

The U.S. Department of Energy (DOE) Sampling and Analytical Chemistry Guide: Doe Methods for Evaluating Environmental and Waste Management Samples

Abstract

DOE Methods for Evaluating Environmental and Waste Management Samples (DOE Methods) is a guidance/methods document to support sampling and analysis activities at DOE sites. DOE Methods is intended to supplement existing guidance documents (e.g., EPA's Test Methods for Evaluating Solid Waste, SW-846), which generally apply to low-level or nonradioactive samples. DOE Methods targets the complexities of DOE radioactive mixed waste and environmental samples. The document contains quality assurance (QA), quality control (QC), safety, sampling, organic analysis, inorganic analysis, and radioanalytical guidance as well as sampling and analytical methods. An addendum is distributed every six months (April and October) with updated guidance and additional methods.

DOE Methods provides a vehicle for technology transfer within the environmental restoration (ER) and waste management (WM) (collectively known as EM) community. As DOE Methods evolves, its usefulness and applicability are anticipated to grow to meet the demands of the DOE/EM mission. At the present time, DOE Methods contains methods and guidance information supplied by DOE sites. Because the EM activities in DOE are not unique to the United States, the international environmental community could benefit from the information gathered for the DOE program. This information could provide additional resources for their EM activities.