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Assurance
Kinds of Assurance Terms modified by Assurance Selected AbstractsALLEE EFFECT AND SELF-FERTILIZATION IN HERMAPHRODITES: REPRODUCTIVE ASSURANCE IN DEMOGRAPHICALLY STABLE POPULATIONSEVOLUTION, Issue 12 2004Pierre-Olivier Cheptou Abstract The fact that selfing increases seed set (reproductive assurance) has often been put forward as an important selective force for the evolution of selfing. However, the role of reproductive assurance in hermaphroditic populations is far from being clear because of a lack of theoretical work. Here, I propose a theoretical model that analyzes selffertilization in the presence of reproductive assurance. Because reproductive assurance directly influences the per capita growth rate, I developed an explicit demographic model for partial selfers in the presence of reproductive assurance, specifically when outcrossing is limited by the possibility of pollen transfer (Allee effect). Mating system parameters are derived as a function of the underlying demographical parameters. The functional link between population demography and mating system parameters (reproductive assurance, selfing rate) can be characterized. The demographic model permits the analysis of the evolution of self-fertilization in stable populations when reproductive assurance occurs. The model reveals some counterintuitive results such as the fact that increasing the fraction of selfed ovules can, in certain circumstances, increase the fraction of outcrossed ovules. Moreover, I demonstrate that reproductive assurance per se cannot account for the evolution of stable mixed selfing rates. Also, the model reveals that the extinction of outcrossing populations depends on small changes in population density (ecological perturbations), while the transition from outcrossing to selfing can, in certain cases, lead the population to extinction (evolutionary suicide). More generally, this paper highlights the fact that self-fertilization affects both the dynamics of individuals and the dynamics of selfing genes in hermaphroditic populations. [source] Assessing immunophenotyping performance: Proficiency-validation for adopting improved flow cytometry methodsCYTOMETRY, Issue 4 2007Lance E. Hultin Abstract Background: The continuous improvement and evolution of immune cell phenotyping requires periodic upgrading of laboratory methods and technology. Flow cytometry laboratories that are participating in research protocols sponsored by the NIAID are required to perform "switch" studies to validate performance before methods for T-cell subset analysis can be changed. Methods: Switch studies were conducted among the four flow cytometry laboratories of the Multicenter AIDS Cohort Study (MACS), comparing a 2-color, lyse-wash method and a newer, 3-color, lyse no-wash method. Two of the laboratories twice failed to satisfy the criteria for acceptable differences from the previous method. Rather than repeating more switch studies, these laboratories were allowed to adopt the 3-color, lyse no-wash method. To evaluate the impact of the switch to the new method at these two sites, their results with the new method were evaluated within the context of all laboratories participating in the NIH-NIAID-Division of AIDS Immunology Quality Assurance (IQA) proficiency-testing program. Results: Laboratory performance at these two sites substantially improved relative to the IQA standard test results. Variation across the four MACS sites and across replicate samples was also reduced. Conclusions: Although switch studies are the conventional method for assessing comparability of laboratory methods, two alternatives to the requirement of repeating failed switch studies should be considered: (1) test the new method and assess performance on the proficiency testing reference panel, and (2) prior to adoption of the new methods, use both the old and the new method on the reference panel samples and demonstrate that performance with the new method is better according to standard statistical procedures. These alternatives may help some laboratories' transition to a new and superior methodology more quickly than if they are required to attempt multiple, serial switch studies. © 2007 Clinical Cytometry Society [source] European guidelines for quality assurance in cervical cancer screening: recommendations for cytology laboratories,CYTOPATHOLOGY, Issue 2 2007H. G. Wiener The quality of a cervical cytology laboratory depends on adequate handling and staining of the samples, screening and interpretation of the slides and reporting of the results. These guidelines give an overview of procedures recommended in Europe to manage the balance between best patient care possible, laboratory quality assurance and cost effectiveness and will be published as a chapter 4 in the European Guidelines for Quality Assurance in Cervical Cancer Screening. The laboratory guidelines include protocols for personnel and organisation, material requirements, handling and analysing cervical samples, recording of results, quality management and communication. The section on quality management is comprehensive and includes protocols for all aspects of internal and external quality assurance. The guidelines are extensively referenced and as far as possible the recommendations are evidence-based. [source] A national survey of the current state of screening services for diabetic retinopathy: ABCD,Diabetes UK survey of specialist diabetes services 2006DIABETIC MEDICINE, Issue 12 2009D. K. Nagi Abstract The main aims were to ascertain the progress made in the implementation of retinal screening services and to explore any barriers or difficulties faced by the programmes. The survey focused on all the essential elements for retinal screening, including assessment and treatment of screen-positive cases. Eighty-five per cent of screening programmes have a coordinated screening service and 73% of these felt that they have made significant progress. Eighty-five per cent of screening units use ,call and recall' for appointments and 73.5% of programmes follow the National Screening Committee (NSC) guidance. Although many units worked closely with ophthalmology, further assessment and management of screen-positive patients was a cause for concern. The fast-track referral system, to ensure timely and appropriate care, has been difficult to engineer by several programmes. This is demonstrated by 48% of programmes having waiting lists for patients identified as needing further assessment and treatment for retinopathy. Ophthalmology service for people with diabetic retinopathy was provided by a dedicated ophthalmologist in 89.4% of the programmes. Sixty-six per cent of the programmes reported inadequate resources to sustain a high-quality service, while 26% highlighted the lack of infrastructure and 49% lacked information technology (IT) support. In conclusion, progress has been made towards establishing a national screening programme for diabetic retinopathy by individual screening units, with a number of programmes providing a structured retinal screening service. However, programmes face difficulties with resource allocation and compliance with Quality Assurance (QA) standards, especially those which apply to ophthalmology and IT support. Screening programmes need to be resourced adequately to ensure comprehensive coverage and compliance with QA. [source] GMO Food Labelling in the EU: Tracing ,the Seeds of Dispute'EUROCHOICES, Issue 1 2003Maria L. Loureiro Summary GMO Food Labelling in the EU: Tracinq ,the Seeds of Dispute' Genetically modified (GM) food labelling has become a critical issue in the international trade arena. Policymakers and consumers in the European Union (EU) seem to agree on the need to control the use of biotechnology in the food industry. As a consequence, recently the EU Commission approved a measure that establishes strict rules on genetically modified organisms (GMOs), but which lifts the moratorium on GMO production and marketing. This new Directive deals with mandatory labelling of GM foods and their traceability along the food chain. In spite of the substantial effort made to reconcile the different opinions in the escalating debate about biotechnology, the new GMO regulation seems to be unsatisfactory for too many interest groups. A system of total traceability from ,farm to fork' and mandatory labelling for genetically modified products may be considered too complex and too expensive to implement, particularly by those countries or industries that have produced GMO foods for many years. Yet, giving European consumers the freedom to choose GMOs may be the only option that there is until Europeans restore their confidence in the food system and food regulators. A market or consumer-driven solution may eventually terminate the GMO dispute between the two transatlantic trading blocks. , Assurance , Revenud a ns , Agriculture Européenne ,étiquetage des aliments contenant des organismes génétiquement modifyés (OGM) est devenu une question cruciale sur la scène du commerce international. Tant les décideurs politiques que les citoyens de , Union européenne semblent s'accorder sur la nécessité de soumettre à contrôle , utilisation des biotechnologies dans , industrie alimentaire. En conséquence, la Commission européenne a récemment approuvé une mesure qui établit des règies strictes sur les OGM, mais qui lève le moratoire sur leur production et leur commercialisation. Cette nouvelle directive concerne ,étiquetage obligatoire des aliments contenant des OGM et la façon ? en assurer le suivi dans les filières alimentaires. Ce nouveau règlement OGM, en dépit des efforts réels effectués pour réconcilier les différents points de vue dans la montée du débat sur les biotechnologies, semble inconciliable avec trop de groupes ? intérêts pour être satisfaisant. Un système assurant une traçabilité totale, ,du champ à la fourchette' et un étiquetage obligatoire pour tout produit contenant des OGM, paraît bien trop complexe et coûteux à mettre en ,uvre, en particulier pour les pays ou les industries qui produisent des aliments génétiquement modifyés depuis des années. Et pourtant, il se pourrait bien que la seule façpn de restaurer la confiance perdue des Européens dans le système alimentaire et ses institutions soit justement de leur donner le droit de choisir. La fin de la querelle des OGM entre les blocs commerciaux des deux rives de , Atlantique peut venir de solutions apportées par le marché et issues des consommateurs. Einkommenversicherung in der Europäischen Landwirtschaft Die Kennzeichnung von genetisch veränderten Lebensmitteln ist zu einer der bedeutendsten Streitfragen auf dem Gebiet des internationalen Handels geworden. Politische Entscheidungsträger und Verbraucher in der Europäischen Union scheinen dahingehend überein zu stimmen, dass der Einsatz von Biotechnologie in der Nahrungsmittel-industrie kontrolliert werden sollte. Als Reaktion darauf hat die EU-Kommission kürzlich einer Maßnahme zugestimmt, welche ein strenges Regelwerk für genetisch veränderte Organismen (GVO) festschreibt, mit der aber gleichzeitig das Moratorium für die Produktion und Vermarktung von GVO aufgehoben wird. Die neue Richtlinie beschäftigt sich mit der Pflichtkennzeichnung von genetisch veränderten Nahrungsmitteln und mit ihrer Rückverfolgbarkeit entlang der Nahrungsmittelkette. Trotz der erheblichen Anstrengungen, die verschiedenen Standpunkte in der eskalierenden Debatte um Biotechnologie zu berücksichtigen, scheint die neue GVO Richtlinie in den Augen (zu) vieler Interessengruppen unbefriedigend zu sein. Ein System der vollständigen Rückverfolgbarkeit vom Stall bis zum Teller und die Pflichtkennzeichnung von genetisch veränderten Nahrungsmitteln mag in der Umsetzung als zu komplex und zu teuer betrachtet werden, insbesondere von den Ländern oder Industriezweigen, welche seit vielen Jahren GVO-Nahrungsmittel hergestellt haben. Dennoch könnte der Ansatz, den europäischen Verbrauchern die freie Wahl für oder gegen GVO zu gewähren, der einzig gangbare Weg sein, bis die Europäer ihr Vertrauen in das Produktions- und Kontrollsystem für Nahrungsmittel zurückgewonnen haben. Eine markt- oder verbraucherorientierte Lösung könnte letztlich den Streit um GVO zwischen den beiden transatlantischen Handelsblöcken beenden. [source] Quality assurance and benchmarking: an approach for European dental schoolsEUROPEAN JOURNAL OF DENTAL EDUCATION, Issue 3 2007M. L. Jones Abstract:, This document was written by Task Force 3 of DentEd III, which is a European Union funded Thematic Network working under the auspices of the Association for Dental Education in Europe (ADEE). It provides a guide to assist in the harmonisation of Dental Education Quality Assurance (QA) systems across the European Higher Education Area (EHEA). There is reference to the work, thus far, of DentEd, DentEd Evolves, DentEd III and the ADEE as they strive to assist the convergence of standards in dental education; obviously QA and benchmarking has an important part to play in the European HE response to the Bologna Process. Definitions of Quality, Quality Assurance, Quality Management and Quality Improvement are given and put into the context of dental education. The possible process and framework for Quality Assurance are outlined and some basic guidelines/recommendations suggested. It is recognised that Quality Assurance in Dental Schools has to co-exist as part of established Quality Assurance systems within faculties and universities, and that Schools also may have to comply with existing local or national systems. Perhaps of greatest importance are the 14 ,requirements' for the Quality Assurance of Dental Education in Europe. These, together with the document and its appendices, were unanimously supported by the ADEE at its General Assembly in 2006. As there must be more than one road to achieve a convergence or harmonisation standard, a number of appendices are made available on the ADEE website. These provide a series of ,toolkits' from which schools can ,pick and choose' to assist them in developing QA systems appropriate to their own environment. Validated contributions and examples continue to be most welcome from all members of the European dental community for inclusion at this website. It is realised that not all schools will be able to achieve all of these requirements immediately, by definition, successful harmonisation is a process that will take time. At the end of the DentEd III project, ADEE will continue to support the progress of all schools in Europe towards these aims. [source] The Relationship between Health Plan Performance Measures and Physician Network Overlap: Implications for Measuring Plan QualityHEALTH SERVICES RESEARCH, Issue 4 2010Daniel D. Maeng Objective. To examine the extent to which health plan quality measures capture physician practice patterns rather than plan characteristics. Data Source. We gathered and merged secondary data from the following four sources: a private firm that collected information on individual physicians and their health plan affiliations, The National Committee for Quality Assurance, InterStudy, and the Dartmouth Atlas. Study Design. We constructed two measures of physician network overlap for all health plans in our sample and linked them to selected measures of plan performance. Two linear regression models were estimated to assess the relationship between the measures of physician network overlap and the plan performance measures. Principal Findings. The results indicate that in the presence of a higher degree of provider network overlap, plan performance measures tend to converge to a lower level of quality. Conclusions. Standard health plan performance measures reflect physician practice patterns rather than plans' effort to improve quality. This implies that more provider-oriented measurement, such as would be possible with accountable care organizations or medical homes, may facilitate patient decision making and provide further incentives to improve performance. [source] EQAS for peripheral blood morphology in Spain: a 6-year experienceINTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY, Issue 6 2008G. GUTIÉRREZ Summary The Spanish haematology external quality assessment scheme (EQAS), established in 1984, is run by the Spanish Haematology and Haemotherapy Association (AEHH) [Quality Assurance in Health Care 3 (1991) 75] and functions to evaluate the quality and reproducibility of the assessment of diagnostic samples by clinical laboratories. The Hospital Clinic of the University of Barcelona (HCB) serves as the EQAS Coordination Centre and follows the guidelines established by the International Committee for Standardization in Haematology [Annali dell'Istituto superiore di Sanità 31 (1995) 95; International Journal of Hematology 68 (1998) 45]. During the period 2001,2006, replicates of 25 different blood films were sent to 604 EQAS participants for cell morphology evaluation. Some patient details corresponding to the samples were disclosed, such us age, sex, haemoglobin value and white blood cell count. The participants were asked to select up to four significant morphology features using a coding list, provided by the Coordination Centre, which included significant morphological alterations that appear in haematopoietic cells. For each survey, individual results were assessed against the morphological reference results (MRR) established by the Cytology Group of the AEHH (,true' answers). This paper describes the organization of the 6-year-long study and the evaluation of laboratory performance for blood smear interpretation by the Spanish haematology EQAS. Different performance levels were detected relative to the laboratory category. Laboratories providing services to hospitalized patients showed higher performances compared with laboratories providing services to nonhospitalized patients. Pathological lymphoid cells were the most difficult to identify by the participants. To improve the results in EQAS peripheral blood morphology, the development of specific cytology educational trainings is discussed. [source] Peer observation of teaching in the online environment: an action research approachJOURNAL OF COMPUTER ASSISTED LEARNING, Issue 5 2008D. Swinglehurst Abstract This paper describes a collaborative action research approach used to explore peer observation of teaching (POT) within the online environment. Although POT has become familiar in face-to-face teaching contexts, little is understood of its potential role in online settings. We conducted ,virtual' focus groups to explore the experience and views of 28 teachers and subjected our data to a thematic analysis. This informed the implementation of an innovative programme of POT, ,Peer-to-peer Reflection on Pedagogical Practice' (PROPP) among tutors of a Web-based MSc in International Primary Health Care at University College London. Modeled on an action learning set, the programme encourages collaborative reflection on teaching practices, based on participants' specific examples of online teaching. The PROPP model is consistent with Quality Enhancement, which we distinguish from Quality Assurance. Here, we describe the implementation of the PROPP programme within an action research framework and identify the factors that we consider critical to the success of peer observation within online courses. We highlight examples of aspects of teaching that have been discussed within the PROPP programme and offer suggestions of the kinds of evidence that could be incorporated into a portfolio to demonstrate the effectiveness of such an initiative. [source] CLOTHING MOVEMENT , VISUAL SENSORY EVALUATION AND ITS CORRELATION TO FABRIC PROPERTIESJOURNAL OF SENSORY STUDIES, Issue 3 2002PAULA GRIFFITHS ABSTRACT Clothing movement was evaluated on a video screen by a descriptive analysis sensory technique and correlated to tactile attributes and fabric mechanical properties. Six fabrics were tailored into identical wide-leg trousers and dresses, animated by a professional model, filmed and edited for sensory evaluation. Tactile attributes were assessed sensorially and fabric mechanical properties were characterized by F.A.S.T. (Fabric Assurance by Simple Testing) and drape measurements. The following bipolar attribute pairs dominate movement language and perception: flowing to stiff and heavyweight to lightweight. Perceptual space of clothing movement is essentially two dimensional and high correlation coefficients between visual and tactile attributes were found. The fabric drape coefficient correlates highly with visual and tactile attributes and is a simple screening method for clothing movement prediction. [source] INVITED REVIEW: Key issues in European food science research: a review of the European Food Science Day 2009QUALITY ASSURANCE & SAFETY OF CROPS & FOOD, Issue 3 2010Daniel Spichtinger Abstract This paper is a report on the European Food Science Day (Brussels, 18 November 2009, organized by the CommNet network of food science communicators) and its outcomes. The article presents FP 7 as a key funding mechanism in European food and nutrition research and it puts research in this sector in a socio-economic context. The article then reviews the specific activities of several EU-funded projects in the field of risk, safety, and health, discussing key issues and research questions in these fields. Spichtinger D., Pongratz I., Jönsson J., Braun S., Colmer C., Poms R., Smith R., Ashwell M., Demeneix B., Skerfving S., van der Poel W.H.M., van der Laag P., Kück M., Warkup C. (2010). Key issues in European food science research: a review of the European Food Science Day 2009. Quality Assurance and Safety of Crops & Foods, 2 114,119. [source] Quality Assurance and Safety of Crops & Foods: MoniQAQUALITY ASSURANCE & SAFETY OF CROPS & FOOD, Issue 1 2009Roland E. Poms Co-editor in Chief No abstract is available for this article. [source] Quality assurance program for spent radioactive sealed sources in EgyptQUALITY ASSURANCE JOURNAL, Issue 2 2009Yasser T. Mohamed Abstract Effective implementation of the Hot Laboratories Center Quality Assurance Program (QAP) is dependent on the efforts at all levels of all participants. Management is responsible for defining quality, developing appropriate plans to attain quality, and supporting the workers in the pursuit of quality. QA organizations of the program participants are responsible for verifying the achievement of quality in the implementation of the Hot Laboratories Center QA program. A written QAP shall be developed, implemented, and maintained. The QAP describes the organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work. The QAP shall describe the management processes, including planning, scheduling, and resource considerations. The organization, responsibilities/authorities of all participants, internal and external interfaces, and lines of communication should be established during the conceptual phase. Quality Assurance (QA) as an essential management tool is being strongly applied in the area of predisposal of Spent Radioactive Sealed Sources (SRSS). Quality Control is now considered as part of the planning and systematic actions of QA. To ensure compliance with the requirements, and to assure the envisaged behavior of the SRSS package and disposal system, a QAP for all stages of SRSS management, including SRSS conditioning, transportation, storage, and disposal are required. Copyright © 2009 John Wiley & Sons, Ltd. [source] Test substance characterization for the EPA: what you've always wanted to know but were afraid to ask,QUALITY ASSURANCE JOURNAL, Issue 3-4 2007William Barta Abstract The Society of Quality Assurance (SQA) GLP Specialty Section, a member of the SQA Regulatory Forum, is a group of participants from the regulated community which provides insight and guidance to our membership and the regulated community. The Specialty Section has encountered several participants who want to know what types of information and data are needed during an inspection by the US EPA's Office of Enforcement and Compliance Assurance (OECA). The OECA is responsible for monitoring studies submitted to the Office of Pesticide Programs in support of pesticide registrations as defined under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). All submitted studies are to be conducted according to the FIFRA US Good Laboratory Practice Standards (GLPS). The GLPS contain specific language concerning the characterization of test, control and reference substances used in these studies. This article clarifies those requirements and provides perspective on the EPA expectations on meeting those requirements. The topics of discussion include: regulatory requirements responsibilities of the testing facility management, study director, Quality Assurance Unit and the sponsor preparing for an inspection overview of data to be made available at the time of inspection composition of a Certificate of Analysis. Copyright © 2008 John Wiley & Sons, Ltd. [source] Integrating maintenance activities and Quality Assurance in a research and development (R&D) systemQUALITY ASSURANCE JOURNAL, Issue 4 2006Debasish Basak Abstract A well-balanced maintenance program furnishes information and instructions to personnel involved in maintaining existing equipment, provides current information on the availability and location of maintenance materials, improves utilization of labor forces and increases equipment reliability. Planned and preventive maintenance procedures where components are serviced and changed when they approach the end of their useful lives can be augmented by suitable means, which continuously check vital machine functions. Quality Assurance can be seen as a management system that brings maintenance activities undertaken by all parties under control with the aim of preventing things from going wrong and costing time, effort and money to put them right. An attempt has been made to highlight the integration of maintenance activities with Quality Assurance as a whole in a research and development (R&D) system. Copyright © 2006 John Wiley & Sons, Ltd. [source] The regulatory and business roles of a Study DirectorQUALITY ASSURANCE JOURNAL, Issue 4 2005Celeste A. Rose Abstract The role of Study Director can be a challenging one with technical, administrative, and compliance responsibilities. The Study Director often does not have direct responsibility for personnel and other resources required for his/her studies. In this article, we have attempted to identify traits and mechanisms to help the Study Director do his/her job in a professional and compliant manner. In addition to regulatory and scientific expertise, Study Director quality attributes include possession of appropriate soft skills and character traits and are key to the success of a study. Study Directors must have an aptitude for effective communication, relationship building, training, mentoring, and delegation. While these soft skills/desirable traits often require additional effort on the part of the Study Director, they have a large impact on the rate of success, efficiency, and compliance of the study overall. The workshop presented by the authors took a 'hands-on' approach building on the creativity, and experience of Study Directors, supervisors, managers, and Quality Assurance (QA) personnel who participated. The participants deliberated problem scenarios from a Study Director's perspective. The tables and discussion in this article summarize compliant solutions, which arose from the resourcefulness that comes from experience of the participants. Copyright © 2005 John Wiley & Sons, Ltd. [source] GIQAR position paper on ,Archiving and Good Laboratory Practice',QUALITY ASSURANCE JOURNAL, Issue 4 2005M. M. Brunetti Abstract Archiving of documents and specimens generated during a non-clinical laboratory study is a basic Good Laboratory Practice (GLP) requirement. The records and materials that should be archived as well as the characteristics and the organisation of archive facilities are addressed in the OECD Series on Principles of Good Laboratory Practice No. 1 (OECD Principles of Good Laboratory Practice (as revised in 1997) [1]. However, in recent years, questions concerning archiving have been raised and the need for a more detailed guidance on this matter has become evident The aim of the Society for Applied Pharmacological Sciences/Italian Group of Quality Assurance in Research (SSFA/GIQAR) working group on ,Archiving according to GLP' was to issue a position paper, present it for discussion in an ad hoc round table with representatives of the Italian GLP monitoring authority to promote common standards and to provide additional recommendations on storage and retention of records. Copyright © 2005 John Wiley & Sons, Ltd. [source] Behavioral phenomena in quality assurance auditingQUALITY ASSURANCE JOURNAL, Issue 4 2003Terry Winchell Abstract There are some unique considerations involved with the management and direction of a Quality Assurance (QA) auditing operation in both government and industry. An adequate understanding of not only the technical but also the unique behavioral dimensions of this profession are essential to effective operation and management. Copyright © 2003 John Wiley & Sons, Ltd. [source] Principles in quality assurance.QUALITY ASSURANCE JOURNAL, Issue 1 2003Part 2. Abstract In order to achieve and sustain effective compliance with the quality regulations, an understanding of the rationale for compliance must be developed throughout an organization. Developing such an organizational understanding is difficult to attain through training based solely on the text of the regulations or the company's Standard Operating Procedures (SOPs). These do have their place, but there is too much information, and the effects of training dissipate rapidly because personnel cannot effectively retain detailed information. In our organization, we undertook a process of simplification of the regulations, in an attempt to define the smallest number of basic quality principles that are embodied in Good Laboratory Practice (GLP) and associated regulations. The systematic application of these quality principles is a mechanism by which Quality Assurance (QA) can be clear and consistent in its monitoring and training activities. This process empowers all personnel to make correct compliance decisions without having to consult the detail of the regulations at every turn. The establishment and application of this concept at a bioanalytical contract research laboratory is described in this article. Copyright © 2003 John Wiley & Sons, Ltd. [source] Principles in quality assurance.QUALITY ASSURANCE JOURNAL, Issue 4 2002Part 1. Abstract The regulated pharmaceutical industry is an ocean of complexity and detail through which Quality Assurance (QA) professionals must steer the best course, playing a crucial role in the profitability of the industry and the well-being of patients. How best to keep the 'good ship' QA stable and effective while being battered by the numerous changing priorities, last-minute demands, or unforeseen events, is a challenge to us all, and the subject of this paper. The ideas presented here are simple, perhaps simplistic, and stem from the idea that, in order to be effective in this complex environment, we have to find some fundamental unifying concepts that can be applied consistently to our work. Semantics aside, we will consider these unifying concepts to be 'principles' and this paper will describe their definition and application within a bioanalytical Contract Research Organization (CRO). Copyright © 2002 John Wiley & Sons, Ltd. [source] Meeting the challenges of implementing good laboratory practices compliance in a university settingQUALITY ASSURANCE JOURNAL, Issue 1 2002Sandra Hancock Abstract The number of university laboratories participating in good laboratory practices (GLP) studies is on the rise, as evidenced by the increase in university personnel that have joined the Society of Quality Assurance (SQA) during the past decade. However, the road to GLP compliance in the university setting has significant challenges. To evaluate how universities have implemented and managed GLP studies, a survey was conducted of SQA members with a university address. The results are described in this article. At Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM), we have been participating in GLP studies since 1989. Studies are conducted by research or clinical faculty members, with quality assurance (QA) provided by the College Quality Assurance Unit. Since the inception of our GLP Program, VMRCVM has made significant progress toward meeting the challenges of regulatory compliance. Copyright © 2002 John Wiley & Sons, Ltd. [source] Tips for surviving the GMC Quality Assurance of Basic Medical Education ProceduresTHE CLINICAL TEACHER, Issue 4 2006Anita Berlin First page of article [source] Assurance of Sustainability Reports: Impact on Report Users' Confidence and Perceptions of Information CredibilityAUSTRALIAN ACCOUNTING REVIEW, Issue 3 2009Kristy Hodge This study examines whether (1) assurance, (2) the level of assurance (reasonable vs limited) and (3) the type of assurance practitioner (accountant vs specialist consultant) affect users' perceptions of reliability of sustainability reports. Based on an experimental questionnaire, we find that the provision of assurance improves perceived reliability of the environmental and social information. There are no significant main effects for both the level of assurance and type of assurance practitioner. However, a significant interaction is found between these two experimental factors and report users' perceptions of reliability of such reports. More specifically, report users place more confidence in sustainability reports when the level of assurance provided is reasonable (that is, high but not absolute), and when such assurance is provided by a top tier accountancy firm, compared to when the assurance is provided by a specialist consultant. No such difference is found when the level of assurance provided is limited for either type of assurance practitioner group. The results of this study thus highlight the relevance of assurance for sustainability reporting. [source] Qualitätssicherung bei der Verwendung von hochfestem BetonBETON- UND STAHLBETONBAU, Issue 2 2005Frank Dehn Dr.-Ing. Die Verwendung von hochfestem Beton hat in den letzten Jahren stetig zugenommen. Dies belegen mehrere nationale und internationale Bauvorhaben [1], [2], [3]. Als Hauptargumente für die Verwendung dieser Betone werden vielfach die verbesserten Dauerhaftigkeitseigenschaften und die statisch-konstruktiven Aspekte, wie z. B. die Reduzierung von Überbaudicken, genannt. Aus Sicht der Betontechnologie sollen in den nachfolgenden Abschnitten einige Aspekte der Qualitätssicherung für hochfesten Beton beschrieben werden. Hinsichtlich der praktischen Erfahrungen mit hochfestem Beton im Brückenbau wird auf den folgenden Beitrag "Brücken aus hochfestem Beton , Praxiserfahrungen mit Pilotprojekten in Sachsen und Thüringen" auf Seite 106 bis 115 in diesem Heft verwiesen. Quality Assurance for the use of ready-mixed High Strength Concrete (HSC). The application of high strength concretes has been increased continuously in the recent years. This is shown by several national and international construction projects [1], [2], [3]. As main criterions for the use of these concretes improved durability properties but also static-constructive aspects are mentioned, e.g. the reduction of superstructure thicknesses. In the following chapters from a concrete technological point of view some aspects for a quality assurance of high strength concrete are described. Some practical experiences with high-strength concrete for bridges constructions are described in paper "Brücken aus hochfestem Beton , Praxiserfahrungen mit Pilotprojekten in Sachsen und Thüringen" on p. 106 to 115 in this magazine. [source] Re-Engineering the Immigration System: A Case for Data Mining and Information Assurance to Enhance Homeland Security: Part I: Identifying the Current ProblemsBULLETIN OF THE AMERICAN SOCIETY FOR INFORMATION SCIENCE & TECHNOLOGY (ELECTRONIC), Issue 1 2002Lee S. Strickland Visiting Professor First page of article [source] Re-Engineering the Immigration System: A Case for Data Mining and Information Assurance to Enhance Homeland Security: Part II: Where Do We Go from Here?BULLETIN OF THE AMERICAN SOCIETY FOR INFORMATION SCIENCE & TECHNOLOGY (ELECTRONIC), Issue 1 2002Lee S. Strickland Visiting Professor First page of article [source] Board Characteristics and Audit Fees,CONTEMPORARY ACCOUNTING RESEARCH, Issue 3 2002Joseph V. Carcello Abstract This paper examines the relations between three board characteristics (independence, diligence, and expertise) and Big 6 audit fees for Fortune 1000 companies. To protect its reputation capital, avoid legal liability, and promote shareholder interests, a more independent, diligent, and expert board may demand differentially higher audit quality (greater assurance, which requires more audit work) than the Big 6 audit firms normally provide. The audit fee increases as the auditor's additional costs are passed on to the client, such that we expect positive relations between audit fees and the board characteristics examined. We find significant positive relations between audit fees and board independence, diligence, and expertise. The results persist when similar measures of audit committee "quality" are included in the model. The results add to the growing body of literature documenting relations between corporate governance mechanisms and various facets of the financial reporting and audit processes, as well as to our understanding of the determinants of audit fees. [source] Auditor Quality and the Accuracy of Management Earnings Forecasts,CONTEMPORARY ACCOUNTING RESEARCH, Issue 4 2000PETER M. CLARKSON Abstract In this study, we appeal to insights and results from Davidson and Neu 1993 and McConomy 1998 to motivate empirical analyses designed to gain a better understanding of the relationship between auditor quality and forecast accuracy. We extend and refine Davidson and Neu's analysis of this relationship by introducing additional controls for business risk and by considering data from two distinct time periods: one in which the audit firm's responsibility respecting the earnings forecast was to provide review-level assurance, and one in which its responsibility was to provide audit-level assurance. Our sample data consist of Toronto Stock Exchange (TSE) initial public offerings (IPOs). The earnings forecast we consider is the one-year-ahead management earnings forecast included in the IPO offering prospectus. The results suggest that after the additional controls for business risk are introduced, the relationship between forecast accuracy and auditor quality for the review-level assurance period is no longer significant. The results also indicate that the shift in regimes alters the fundamental nature of the relationship. Using data from the audit-level assurance regime, we find a negative and significant relationship between forecast accuracy and auditor quality (i.e., we find Big 6 auditors to be associated with smaller absolute forecast errors than non-Big 6 auditors), and further, that the difference in the relationship between the two regimes is statistically significant. [source] Twenty years of external quality assurance in clinical cell analysis , A tribute to Jean-Luc D'HautcourtCYTOMETRY, Issue 1 2007Bruno Brando Abstract External quality assurance (EQA) programs in clinical cell analysis are now a consolidated item of laboratory practice. All the flow cytometric testings with an impact on clinical decision making have been submitted to regular EQA programs during the last 20 years, and this has produced internationally homogeneous guidelines, with a remarkable improvement in result reproducibility. Jean-Luc D'Hautcourt was a pioneer in this field, and his valuable contributions to flow cytometric method standardization and to the dissemination of the educational aspects of EQA programs are recognized. The different methodological approaches undertaken in the United States and Europe are discussed. The educational role of SIHON in the Benelux Countries and of UKNEQAS for Leucocyte Immunophenotyping worldwide is emphasized. Accredited and accreditating EQA programs require an impressive degree of organization and technical knowledge, so that only major international providers can afford such a task nowadays. However, small local studies still provide the necessary stimulus to the continuous improvement of the scientifical aspects of EQA schemes. © 2006 Clinical Cytometry Society [source] Quality control of CD4+ T-lymphocyte enumeration: Results from the last 9 years of the United Kingdom national external quality assessment scheme for immune monitoring (1993,2001)CYTOMETRY, Issue 2 2002Liam Whitby Abstract The human immunodeficiency virus (HIV) global epidemic has necessitated the routine enumeration of T-lymphocyte subsets, which has created a need for external quality assurance (EQA). The United Kingdom National External Quality Assessment Scheme (UK NEQAS) for Immune Monitoring provides EQA for 296 laboratories in 40 countries. In 1993, UK NEQAS developed and incorporated into its program stabilized whole blood that enables the accurate monitoring of laboratory performance. Overall, the mean interlaboratory coefficient of variation (CV) for percentage CD4+ T-lymphocyte subset enumeration has fallen from 15% to less than 5%, as a direct result of the increased use of CD45/ side scatter (SSC) gating. Laboratories using alternative gating strategies (i.e., CD45/CD14 or forward scatter [FSC]/SSC) were about 7.4 times more likely to fail an EQA exercise. Furthermore, the adoption of single-platform technology resulted in a reduction of the overall mean interlaboratory CV for absolute CD4+ T lymphocytes from 56% (prior to the widespread use of single-platform technology) to 9.7%. Individual laboratory deficiencies were also identified using a performance monitoring system and, through re-education by collaboration with the coordinating center, satisfactorily resolved. In conclusion, during the last 9 years, the UK NEQAS for Immune Monitoring program has highlighted the significant technological advances made by laboratories worldwide that undertake lymphocyte subset enumeration. Cytometry (Clin. Cytometry) 50:102,110, 2002. © 2002 Wiley-Liss, Inc. [source] | ||||||||||||||||||||||||||||||||||||||||||||||||||||