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.     

Risk-based thinking for chemical testing

Accreditation and Quality Assurance - As a result of the changes to the ISO 9001 in 2015, integration of risk-based thinking into the quality management system is going to be a new requirement in...     

Taking laboratory uncertainties into account in the Hampel estimator

Accreditation and Quality Assurance - According to ISO/IEC 17025:2017, testing and calibration laboratories should apply procedures for estimating measurement uncertainty. It would thus make sense...     

Quality-based model for Life Sciences research guidelines

Nowadays, the requirement to define adequate standards and to identify and validate general guidelines for scientific activity is becoming increasingly apparent also in non-regulated scientific research. Guidelines are fundamental tools to provide valid indications for proper conduct in a research laboratory, the correct use of equipment and procedures, as well as for aligning and standardizing the procedures used in different scientific contexts. The identification, dissemination and application of common guidelines can improve significantly the reproducibility of the scientific results and the exchange of materials and data in the context of scientific consortia, comprising also industrial partners and meta-analysis projects. A Quality and Project Management OpenLab research network was formed in 2012 to develop and apply Total Quality Management models to Life Sciences research laboratories. One of the main tasks of the network has been the definition of a model for the drafting of guidelines, firmly based on quality principles and documentation management. The outcome is an operational flow describing all the phases of the process, which has been validated by four different drafting groups through the production of 13 guidelines ranging from research activity to equipment and facility management. Different institutes of the National Research Council are currently following these guidelines; some of them have also been used to define the procedures included in a certified Quality Management System for a research laboratory. Our experience shows that the model for guidelines we have developed makes drafting guidelines easier and more immediate, and significantly, it is applicable to different scientific contexts and disciplines, including both non-regulated research and technology transfer-oriented research, and also the Quality Management System of a scientific laboratory.     

GIQAR position paper on pathology peer review

The pathology peer review (PR) is an important part of the assessment process of key toxicological results and increases confidence in the quality of histopathology study data. On the other hand, in the last few years, on the basis of findings recorded in the Food and Drug Administration warning letters, a large debate on PR took place and several position papers were issued by either scientific association of pathologists and Quality Assurance (QA) associations. The Guidance on the GLP requirements for Peer Review of Histopathology was issued in May 2010 by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). This document gave an opportunity to the Italian Group of Quality Assurance in Research (the Italian acronym for which is GIQAR) to discuss more in depth this matter in an ad hoc Round Table. The decision to comment the above MHRA document in order to issue a GIQAR position paper was based on the lack of guidance regarding pathology PR and on the need for a thorough exchange of views among all involved parties as well as to provide recommendations to QA professionals on this specific issue.     

Quality management in research: management process of the laboratories of Moroccan faculties of sciences and techniques

Accreditation and Quality Assurance - The implementation of a quality management system including management tools in the industrial sector has several advantages. In this perspective, can we use...     

Quality assurance in clinical chemistry laboratories in the UK

 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     

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...     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.

     

“双碳”背景下能源关键元素暴露的神经效应研究进展

为了实现“双碳”目标,能源关键元素(Energy-critical elements, ECEs)在全球范围内的应用将显著增加,增加了人群暴露风险,但是其健康效应尚未明确。ECEs主要为金属元素,如锂、钴及稀土元素。为了解金属ECEs的潜在健康效应,重点关注其神经危害或风险,为其在可持续发展过程中可能产生的健康问题提出干预策略。回顾了与金属ECEs相关的毒理学、职业安全和健康问题以及流行病学调查的文献报道,主要在分子和细胞水平、实验动物和人群流行病学研究等方面对上述金属ECEs神经效应的综述。目前,金属ECEs健康效应的研究面临一些挑战：现有的人群研究数量有限,亟需更多的研究为建立有关健康、环境影响和安全的监测系统提供科学依据,为绿色能源行业建立一个可持续、安全和健康的职业环境,助力实现“双碳”目标。     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.     

Revision of ISO 19229 to support the certification of calibration gases for purity

Accreditation and Quality Assurance - The second edition of ISO 19229 expands the guidance in its predecessor in two ways. Firstly, it provides more support and examples describing possible...     

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

 The quality approach is being progressively used in scientific research and is likely to become a key point in the future. This article critically examines the applicability of the quality approach to fundamental research. A critical survey of the basic concepts of the quality approach is proposed (conformity to a reference, satisfaction of requirements and/or adaptation to use, planning and formalization). The need for quality in fundamental research is then discussed through a review of the scientific, economic and financial, human, social and environmental issues that research will face in the future. An attempt is made to demonstrate that the quality approach incorporates concerns and current practices of the scientific community which are not normally identified and labelled as pertaining to the field of Quality. Received: 8 March 1998 / Accepted: 8 December 1998     

Quality assurance in daily practice

 A report based on the workshop on "Quality Assurance in Daily Practice", organised by the study group "Quality Assurance and Accreditation" from the Division of Analytical Chemistry of the Federation of European Chemical Societies (SGQAA/DAC/FECS) held at the EUROANALYSIS-10 conference in Basle, 6–11 September 1998.     

The process of management review

Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000 standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness, and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources, etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are taken that improve the effectiveness of the quality-management system. As output from the management review process, there should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements; corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the processes involved and using the process approach in the management review ensures the continual improvement of the quality system. Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

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.     

The integration of quality management systems in testing laboratories: a practitioner’s report

Accreditation and Quality Assurance - When routine laboratories merge or are taken over by larger entities, their quality management systems usually need to be integrated. In many laboratories,...     

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     

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

The production of pharmaceuticals is one of the most highly regulated fields in terms of quality. The body of good manufacturing practice (GMP) represents the standard required by law; GMP embraces the guidelines that regulate all activities related to the production and quality control of medicinal products for human and veterinary use. This paper deals with the implementation of a quality management system (QMS) in compliance with GMP and ISO 9001 standards for the production and distribution of radiopharmaceuticals in a public research institute. The production of 2-[18F]fluoro-2-deoxy-d-glucose has been implemented according to GMP standards and has been licensed by the national Authority in 2007. In 2010, a project to orient the system??s GMP compliance to ISO 9001 standards has been approved. A QMS conforming to ISO 9001:2008 should be considered an important additional step in terms of quality, because ISO 9001 also takes into account economic and financial aspects, design and development aspects and introduces management review for measurement and analysis of the process with the aim of improving performances. The harmonization between GMP and ISO has been defined following the Pharmaceutical Quality System Q10 guideline developed by International Conference on Harmonization.     

Relevant elements of laboratory competence

 The staff of a laboratory, and its pre-conditions in terms of management principles and work procedures, constitute the basis for customer satisfaction including the quality of the results. It is argued here that there is a rather limited core of principles and procedures, the relevant elements of which are essential for "laboratory competence". These elements are treated as part of the requirements in international quality standards, in particular the draft revision of the ISO/IEC-Guide 25. It is suggested that it should be possible to structure them in a more flexible way and to integrate the elements into the ordinary management system of a laboratory.