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.

     

Regulatory and compliance activities to protect food-allergic consumers in Canada: research in support of standard setting and consumer protection

An overview is presented of the activities of Health Canada and the Canadian Food Inspection Agency (CFIA) in the area of food allergens. Since the 1990s, changes were made in the Food and Drug Regulations in order to better protect allergic consumers by imposing labeling requirements to clearly identify sources of priority food allergens in prepackaged foods. Policies of application as well as risk management strategies are discussed with some statistics on allergen-related food recalls in Canada for the years 1997--2001. Health Canada's allergen method development program is a pioneering research initiative that was developed in the early 1990s in support of the changing Canadian regulatory environment. The objectives and some of the accomplishments of this program are presented. The development of the Canadian Compendium of Allergen Methodologies under a Web-based application to compile data on evaluated allergen detection methods will provide further support to compliance activities nationally, as well as to the international analytical community in both government and the food industry. Some emerging techniques for the confirmation of results generated by enzyme-linked immunosorbent assays are also discussed.     

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.     

表面增强拉曼光谱技术在食品检测中的应用研究进展

食品污染是危害公众健康和安全的重要问题,探究灵敏、快速、简单的技术,以便在痕量水平上检测污染物,对保障食品质量安全和风险评价具有十分重要的意义.表面增强拉曼光谱(SERS)是利用光与金、银等纳米结构材料相互作用产生很强的表面等离子激元共振效应,可显著增强吸附在纳米结构表面上分子的拉曼信号,以超灵敏获取样品自身或拉曼探针...     

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     

Implementation of a quality management system in a public research centre

In recent decades, it has become increasingly important for public research centres to attract external clients, including government, private and public bodies and companies. They do this by demonstrating their research excellence. A research centre??s ability to provide professional research services can be assessed by competent technical bodies which verify that the research centre??s laboratories operate according to certain predetermined criteria or standards. Although there is no set of generally accepted standards, some regional accreditation bodies already offer accreditation assessment for the R&D laboratories which are in their territory. This article analyses the successful application of a quality management system in a public research centre employing 57 people including researchers, technicians and administrative staff. This system is based on the scheme of regional accreditation of industrial research laboratories which was inspired by ISO 9001:2008 and ISO 17025:2005 and set up by the regional authority. The overall aim of the management system is to monitor all of the industrial research and services which the centre offers to external users, such as government, private and public bodies and companies, and to guarantee that final products, usually technical reports and prototypes, respond to their needs. The accreditation applies to all of the activity of the research centre except for basic research. In this article, the critical factors influencing the success of the implementation of the management system are outlined together with benefits and opportunities. Weak points and problems are analysed, and the actions which were undertaken in order to prevent and manage problems are described.     

Nuclear methods for food analysis at the U. S. Food and Drug Administration

An overview of radioanalytical techniques used in support of research,monitoring programs, and field assignments directed by the U. S. Food andDrug Administration's Center for Food Safety and Applied Nutrition (CFSAN)is presented. The Winchester Engineering and Analytical Center annually determinesradionuclide concentrations in 260 Total Diet Study foods, approximately 80imported foods, and a selection of domestic foods collected near U. S. nuclearpower plants. Radioanalytical techniques used at CFSAN's neutron activationanalysis laboratory at the National Institute of Standards and Technologyare discussed along with applications for research, quality control, and specialprojects.     

Regulations relating to mycotoxins in food

Regulations relating to mycotoxins have been established in many countries to protect the consumer from the harmful effects of these compounds. Different factors play a role in the decision-making process of setting limits for mycotoxins. These include scientific factors, for example the availability of toxicological data and occurrence data, detailed knowledge about possibilities for sampling and analysis, and socio-economic issues. By the end of 2003, approximately 100 countries (covering approximately 85% of the world’s inhabitants) had specific regulations or detailed guidelines for mycotoxins in food. The regulations were related to aflatoxins (B₁, B₂, G₁ and G₂), aflatoxin M₁, trichothecenes (deoxynivalenol, diacetoxyscirpenol, T-2 toxin and HT-2 toxin), fumonisins (B₁, B₂, and B₃), agaric acid, ergot alkaloids, ochratoxin A, patulin, phomopsins, sterigmatocystin, and zearalenone. In Europe, and in particular in the EU, regulatory and scientific interest in mycotoxins has undergone a development in the last decade from autonomous national activity towards more EU-driven activity with a structural and network character. Harmonized EU limits now exist for 40 mycotoxin–food combinations. It is expected this number will grow in 2007 to approximately 50. The direct or indirect influence of European organizations and programs on the EU mycotoxin regulatory developments is significant. They include the European Food Safety Authority, the Scientific Cooperation on Questions relating to Food, the Rapid Alert System for Food and Feed, the creation of an EU Community Reference Laboratory for Mycotoxins and a mandate of the EC to the European Standardization Committee in methods for analysis for mycotoxins in food. Large pan-European research and networking projects as “BioCop” and “MoniQA” are also important.     

Electrochemical biosensors for food analysis

Abstract  

Food analysis has become a very important and interesting area of research because of the rapid expansion of food trade and highly increased mobility of today’s populations. Food quality control is essential both for consumer protection and also for the food industry. Application of the electrochemical biosensors in the field of food analysis is promising. This review covers the recent developments and issues in electrochemical biosensors for food analysis, such as ease of preparation, robustness, sensitivity, and realization of mass production of the detection strategies. This review also emphasizes the current development of electrochemical biosensors combined with nanotechnology.     

Improving data quality in food composition databanks: a EuroFIR contribution

Food composition databanks (FCDBs) should provide nutrient composition data comparable over time at national and international levels. However, the linkage between national database compilers and permanent structures to support the upgrading and monitoring of nutrient values in foods are far from satisfactory. This paper focuses on European efforts to improve the quality of nutrient values entered into FCDBs, emphasizing initiatives under the EU Network of Excellence: European Food Information Resource (EuroFIR – NoE). The general concept of quality assurance is described and results obtained in the project’s first year are presented. A survey among EuroFIR partners aimed at evaluating the current situation in comparability of nutrient values suggests that an integrated approach has two requirements: the implementation of a quality management system (QMS) and a harmonized data-quality assessment system (DQAS) to select values from different sources. The use of reference materials (RMs) is a key criterion in deciding on comparability and reliability of candidate nutrient values. Consequently, results of a survey on food matrix reference materials are presented. These suggest that developments in RMs for nutrient analysis in foods have a great impact on the quality of data to be included in FCDBs.     

Regulatory aspects of food irradiation in the Asia–Pacific region

The latest information on the countries in the Asia/Pacific region with approvals for food to be irradiated is provided. Differences in the type of regulations used are contrasted. However, progress has been made towards greater uniformity in regulations based around the Codex General Standard for Irradiated Food.

Australia and New Zealand instituted, respectively, a moratorium and a ban on food irradiation in 1988. Australia has proposed a new draft Standard for food irradiation and this is the subject of public discussion under the Australia New Zealand Food Authority. The draft Standard is a prohibition with the possibility of exemptions being given on a case-by-case basis. Some details of the draft Standard are provided.     

Implementing quality assurance in an R&D environment at the Belgian Nuclear Research Centre – SCK·CEN

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.     

Quality assurance in the elemental analysis of foods by inductively coupled plasma spectroscopy

The U.S. Food and Drug Administration, Department of Agriculture, and Environmental Protection Agency are conducting a joint study of elemental background levels in raw agricultural crops. More than three thousand samples have been analysed for 12 elements by inductively coupled plasma-optical emission spectroscopy (ICP). A quality assurance program has been designed to assure the accuracy and reliability of these analyses. The development and rationale for this program are described and illustrated by analytical results.     

Trends in trace element determinations in environmental and food matrices: Conclusions of the workshop

The improvement and development of analytical techniques for the determination of trace elements in environmental and food matrices are one of the main challenges of analytical chemists nowadays. The need for a good quality control of these determinations has led the Measurements and Testing Programme (BCR) to organize series of intercomparisons and to produce certified reference materials (CRM's) for improving the quality of environmental and food matrices. At this stage, it was deemed necessary to discuss the research which should be undertaken to further improve the state of the art of trace element determinations and to develop new methodologies. A workshop on Trends in Trace Element Determinations in Environmental and Food Matrices has therefore been held in Thessaloniki in October 1994 which allowed to identify the research needs and make some recommendations based on round-table discussions. This paper gives a summary of the conclusions of the discussions. An outline of the programme along with the panel of experts participating in this workshop is given in the appendix.     

科研实验室管理体系实施项目化管理的探索——以中国科学院南京土壤研究所所级公共技术服务中心为例

针对科研实验室管理面临的效率偏低的现状和问题,以中国科学院南京土壤研究所公共技术服务中心为主体,在现有的认可准则管理框架下,探讨了项目管理的方法在科研实验室管理中的应用. 通过项目化分解管理体系任务而提高管理效率,从而为高效开展科研实验室管理提供了新思路.     

Electrochemical biosensors for food analysis

Abstract  Food analysis has become a very important and interesting area of research because of the rapid expansion of food trade and highly increased mobility of today’s populations. Food quality control is essential both for consumer protection and also for the food industry. Application of the electrochemical biosensors in the field of food analysis is promising. This review covers the recent developments and issues in electrochemical biosensors for food analysis, such as ease of preparation, robustness, sensitivity, and realization of mass production of the detection strategies. This review also emphasizes the current development of electrochemical biosensors combined with nanotechnology. Graphical abstract        

Computational chemistry in pharmaceutical research: at the crossroads

Computational approaches are an integral part of pharmaceutical research. However, there are many of unsolved key questions that limit the scientific progress in the still evolving computational field and its impact on drug discovery. Importantly, a number of these questions are not new but date back many years. Hence, it might be difficult to conclusively answer them in the foreseeable future. Moreover, the computational field as a whole is characterized by a high degree of heterogeneity and so is, unfortunately, the quality of its scientific output. In light of this situation, it is proposed that changes in scientific standards and culture should be seriously considered now in order to lay a foundation for future progress in computational research.     

Need for quality management in research and development

 There is growing interest in setting up a general concept for quality management and quality control in research and development, which in this case means, for example, research in the fields of medicine and social sciences. This article is a strong plea for a quality management system in all fields of research and development and will probably initiate broad discussion on this delicate topic. Received: 28 June 1998 · Accepted: 13 July 1998     

Quality assurance in research laboratories

During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories.     

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