Workshop on "Quality Management in Analytical Chemical Research and Development"

 Maintaining a high quality of research and development (R&D) is fundamental for the competitiveness of European industry. The development of new technologies and the improvement of existing technologies, products, production processes, measurement instrumentation and methods as well as basic research is essential. The objective of the workshop on "Quality Management in Analytical Chemical Research and Development" was to bring together experts from the academic world, industrial and institutional laboratories and also accreditation bodies to discuss the actual state of the art in the field of quality management in R&D, and to set up milestones for further activities. Furthermore, an important objective was to present the EURACHEM/CITAC Guide 2. The paper outlines the programme of the workshop and summarises the round-table discussions and expert recommendations. Most of the contributions to the round-table discussions will be published as full papers in a forthcoming issue of Accreditation and Quality Assurance. The workshop was organised by the Institut für Chemo- und Biosensorik (ICB), Münster, with the financial support of the SMT-Programme of the European Commission (Contract No.: SMT4-CT98-6534).     

Quality assurance of qualitative analysis in the framework of the European project ’MEQUALAN’

 The European Commission has supported the G6MA-CT-2000–01012 project on ”Metrology of Qualitative Chemical Analysis” (MEQUALAN), which was developed during 2000–2002. The final result is a document produced by a group of scientists with expertise in different areas of chemical analysis, metrology and quality assurance. One important part of this document deals, therefore, with aspects involved in analytical quality assurance of qualitative analysis. This article shows the main conclusions reported in the document referring to the implementation of quality principles in qualitative analysis: traceability, reliability (uncertainty), validation, and internal/external quality control for qualitative methods. Received: 15 October 2002 Accepted: 20 October 2002 This paper is a summary of the Quality Assurance section included in the final report of the MEQUALAN project. The authors of this paper correspond to the members of the MEQUALAN Consortium. One of them (K.H.) does not fully agree with some parts of the text. Correspondence to A. Ríos     

Implementation of ISO 9002 for research in occupational epidemiology

 The Department of Epidemiology, which forms part of the French National Institute for Research and Safety (INRS), is involved in research on occupational risks. It provides results of industry-based epidemiological studies focused on the relationship between occupational exposure and diseases of the respiratory system, central and peripheral nervous systems and cancer. This paper describes the Quality Assurance System developed by our department, which has been successfully maintained and extended since being granted ISO 9002 certification by the French Association for Quality Assurance. The quality system includes procedures specific to epidemiological study conduct and scientific peer reviews. It has been designed in order to meet the required ISO elements, including quality aims and policy, quality procedures for management of personnel, sub-contractors and facilities, nonconformities, corrective and preventive actions, archiving and traceability and planning of internal quality audits. Improvements in management, technical and service quality have resulted from this process. Although epidemiological studies differ markedly from industrial production for which the standards were originally drawn up, we have found that Quality Assurance is both applicable and useful in epidemiological research on occupational risks. Therefore, we conclude that a certified Quality Assurance Scheme including scientific peer reviews can be recommended to ensure reliable epidemiological results. Received: 22 July 1998 · Accepted: 5 October 1998     

Analytical Intercomparison Exercises and Harmonization within Environmental Laboratories from Developing Countries

Abstract

Since the early 60's, the IAEA implements a Quality Assurance (QA) programme for the Member States. As part of this programme, the IAEA organized more than 150 analytical intercomparison exercises and produced more than 70 Certified Reference Materials for a wide range of determinands, encompassing radionuclides, trace elements, petroleum hydrocarbons, pesticides and PCBs. From the IAEA — Marine Environment Laboratory in Monaco, analytical Quality Assurance services are provided for non-nuclear contaminants in marine materials.

Results of recently organized worldwide intercomparison exercises using the sample materials IAEA-142 (mussel tissue homogenate) and IAEA-140 (seaweed homogenate), show that some progress was achieved worldwide in the analyses of the more common environmental contaminants. However, results also show that difficulties in obtaining accurate data for trace elements and especially for organic contaminants are still widespread, particularly in developing countries. Therefore, the success of international cooperative programmes as well as of many regional environmental monitoring programmes, depends on improved quality and comparability of data which has to be achieved still through reinforced Quality Assurance programmes. To this aim, the IAEA/UNEP/IOC-UNESCO inter-agency programme on marine pollution promotes the adoption of Reference Methods for harmonization of techniques used in developing and developed countries, organizes frequent intercomparison exercises, and produces certified marine Reference Materials which are made available to laboratories worldwide.     

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.     

Correction to: Combined uncertainty factor for sampling and analysis

Accreditation and Quality Assurance - In the penultimate paragraph of the original publication, a confidence interval of 93 mg/kg to 971 mg/kg was reported. These values should be...     

The quality approach and fundamental research: Working towards a constructive alliance (Part II)

 An appropriate Quality approach in fundamental research should have its roots in the very principles of the "scientific method". Quality and fundamental research could thus reconcile at the condition, on the one hand, that Quality practioners understand and take into account the reality of the "science in action" and, on the other hand, that scientists improve their awareness of the new deal which is being made between science, technology and society as well as of the actual issues of Quality. A modern Quality approach, well adapted to this specific activity, should help both scientists, decision-makers and the public face the issues concerning the role of science in society in the future. In this context, I specify a number of practical proposals concerning, in particular, the adaptation of the requirements of the quality approach to the type of research, the distinction between the three major steps of a research programme (i.e. quality of the objective, the process and the results) and the encouragement of experience feedback. Received: 8 March 1998 / Accepted: 8 December 1998     

Metrology for chemical engineers

 The first full-semester course on Quality Assurance in Chemical Measurement was held at the Technical University of Denmark from September to December 1999. The course required sufficient knowledge of basic statistics to understand and apply the methods recommended in ISO 5725–1/6 Accuracy of Measurement Methods and Results. The main purpose of the course was, however, to familiarize PhD students with the BIPM philosophy, using the International Organization for Standardization (ISO) Guide to Expression of Uncertainty in Measurement, which was accepted by IUPAC and other international scientific organizations in 1993. Chemists are notoriously reluctant to accept the BIPM philosophy, but the appearance of a new Draft Guide Quantifying Uncertainty in Analytical Measurement at the EURACHEM Workshop in Helsinki in June 1999 stimulated us to make an attempt to overcome such chemical prejudice. After thorough reading of the examples presented in the Draft Guide, each of the participating students had to prepare an uncertainty budget for their own particular project and present it to the other participants for discussion. Eventually the students learned how to verify their uncertainty budgets by means of experimental results; this invariably entailed a re-evaluation of the uncertainty components in the original budget. The revised budget was again verified, and this iteration was continued until the budget correctly predicted the uncertainty of individual results covering the whole range of applicability of the analytical method. The paper presents the detailed structure of this first course, as well as improvements in the next course scheduled for the year 2000.     

Development of primary standard gas mixtures containing 10 µmol/mol oxygen in nitrogen with verification by a two-oven GC-TCD system for effective separation of oxygen from argon in presence of plenty of nitrogen

Accreditation and Quality Assurance - Primary standard gas mixtures (PSMs) containing 10 µmol/mol oxygen in nitrogen were prepared in aluminum alloy cylinders from pure nitrogen and...     

The Hitchhiker's guide to quality assurance

A report is given on a 2-day symposium “The Hitchhikers Guide to Quality Assurance” held in Brisbane Australia, in 2005. More than 100 representatives of field laboratories attended this educational exercise organised by the Royal Australian Chemical Institute.     

FDA Quality assurance for radioactivity in foods and radiopharmaceuticals

Summary The Food and Drug Administration (FDA) has regulatory responsibility for radionuclides in foods and radiopharmaceuticals and must maintain an ongoing Quality Assurance Program. These Quality Control Programs involve the U.S. Environmental Protection Agency (EPA) [1, 2] and the National Institute of Standards and Technology (NIST) [3], who supply the necessary reference materials and standards to ensure that the measurements are accurate and reproduceable. Data from EPA (1987 to 1991) and from a NIST Blind Source study (1985 to 1991) show the results are accurate with an average variation from NIST values of 1.8% [4–10]. The use of standard materials with the same matrices as the samples being analyzed provides credibility to the measurements.     

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     

Effect of irradiation for sterilization on beverage reference materials for the analysis of food additives

Accreditation and Quality Assurance - Reference materials for proficiency testing (PT) were prepared for 6 years. The target analytes were food additives, sorbic acid, benzoic acid, and...     

The experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission

The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation.     

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).     

Is it safe to have a laboratory test?

A recent US Institute of Medicine report indicated that up to 98,000 deaths and more than 1 million injuries occur each year in the United States due to medical errors. These include diagnostic errors, such as an error or delay in diagnosis, failure to employ indicated tests and the use of outmoded tests. Laboratory tests provide up to 80% of the information used by physicians to make important medical decisions, therefore it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. A review of the literature and a US Quality Institute Conference in 2003 indicates that errors in laboratory medicine occur most often in the pre-analytical and post-analytical steps in the testing process, but most of the quality improvement efforts focus on improving the analytical process. Measures must be developed and employed to reduce the potential for mistakes in laboratory medicine, including better indicators for the quality of laboratory service. Users of laboratory services must be linked with the laboratorys information system to assist them with decisions about test ordering, patient preparation, and test interpretation. Quality assessment efforts need to be expanded beyond external quality assessment programs to encompass the detection of non-analytical mistakes and improving communication between the users of and providers of laboratory services. The actual number of mistakes in laboratory testing is not fully recognized, because no widespread process is in place to either determine how often mistakes occur or to systematically eliminate sources of error. We also tend to focus on mistakes that result in adverse events, not the near misses that cause no observable harm. The users of laboratory services must become aware of where testing mistakes can occur and actively participate in designing processes to prevent mistakes. Most importantly, healthcare institutions need to adopt a culture of safety, which is implemented at all levels of the organization. This includes establishing closer links between providers of laboratory services and others in the healthcare delivery system. This was the theme of a 2003 Quality Institute Conference aimed at making the laboratory a key partner in patient safety. Plans to create a permanent public–private partnership, called the Institute for Quality in Laboratory Medicine, whose mission is to promote improvements in the use of laboratory tests and laboratory services are underway.Presented at the 9th Conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium.     

Identifying the critical cut-points of a quality control process for serological assays: results from parametric and semiparametric regression models

Accreditation and Quality Assurance - Quality control programs rely on continuous monitoring which may generate large volume of complex data. Assessing the precision of a biological assay using...     

A journey through quality control

The Euroanalysis VII conference in Vienna included a two-day session: Quality Assurance in Analytical Chemistry. The contributions comprised 15 lectures devoted to: intra-laboratory quality measures, inter-laboratory control, formal aspects and accreditation and implementation. The paper presents an overview of the main items developed by the contributors.A survey on the session on Quality Assurance in Analytical Chemistry of Euroanalysis VIIThe authors thank the organizers of EUROANALYSIS VII and in particular Dr. B. Griepink and Dr. E. Maier of the Community Bureau of Reference (BCR) of the CEC for their support and considerable contributions.     

Quality improvement in wellness reports in patients with Crohn’s disease

Quality-of-life tests are used because they provide information about symptoms, potential complications, and response to treatment with patients as active participants. We took Crohn’s disease (CD) during diet supplement with omega 3 or 6 fatty acids (ω-3FA vs. ω-6FA) Impact^® as an example and assessed three quality-of-life tests: The inflammatory bowel disease questionnaire (IBDQ), the Beck depression inventory (BDI), and the visual analogue scale (VAS). These tests have been found inconvenient, not informative in daily clinical use, and inhomogeneous in international studies.We used the body mass index (BMI) (kg/m²) as a clinical quantitative effect parameter and the patient self-rated quality of life as qualitative variables during recovery. All ratings were converted into numeric standardized percent point before isolation of optimized ratings.BMI increased on average 2 BMI units in both diet groups. The classical wellness tests or their traditional sub-scores identified improved outcome during recovery, primarily in the ω-3FA group. Separate items on bowel function, wellness, and asthenia possessed the best item responsiveness – (30–35 percent point). A new selective scale with the six most responsive items is proposed as a specific optimized questionnaire.Based on CD as an example, we described a method to isolate responsive items from quality-of-life tests and described a method to optimize their sensitivity. We propose for validation a new optimized disease – specific VAS scale for rating of wellness during treatment in inflammatory bowel disease, in which ω-3FA seemed superior in improving outcome.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium.     

Data integrity: requirements set in the accreditation standards

Accreditation and Quality Assurance - The requirements for the competence of laboratories are described in two standards, namely ISO/IEC 17025 and ISO 15189. The former applies to all laboratories...