WorldWideScience

Sample records for assuring blood safety

  1. Reactor system safety assurance

    International Nuclear Information System (INIS)

    The philosophy of reactor safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operation, special systems should be provided for accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' Additionally, the safety of nuclear power plants relies on ''safety systems'' to assure acceptable response to design basis events. Operating experience has shown the need to study plant response to more frequent upset conditions and to account for the influence of operators and non-safety systems on overall performance. Defense in depth is being supplemented by risk and reliability assessment

  2. Does a liberal national transfusion law assure blood safety? A survey of blood bank directors' perspectives in Lebanon.

    Science.gov (United States)

    Haddad, Antoine; Bou Assi, Tarek; Ammar, Walid; Baz, Elizabeth

    2013-11-01

    In transfusion medicine today, 'zero risk' has become a universal objective. Thus, we investigated whether the level of blood safety as defined by Lebanese legislation is satisfactory. Our work covered the period from September 2008 to June 2012. First, we studied each chapter in law and regulations, and compared them with the latest French regulations. The standards of Good Manufacturing Practice, characteristics of blood products and their storage, and the overall organization and haemovigilance for recipients and donors are not defined. Our analysis revealed numerous problems in today's blood safety situation. There is, for example, no clear definition or identification of the different blood safety components. Then, we conducted a national survey of blood bank directors to assess their perception of blood safety in Lebanon. Our survey revealed a negative perception (52.4 per cent) of the current blood safety situation, with more than 90 per cent of respondents in favor of national regulatory improvements.

  3. GSFC Safety and Mission Assurance Organization

    Science.gov (United States)

    Kelly, Michael P.

    2010-01-01

    This viewgraph presentation reviews NASA Goddard Space Flight Center's approach to safety and mission assurance. The contents include: 1) NASA GSFC Background; 2) Safety and Mission Assurance Directorate; 3) The Role of SMA-D and the Technical Authority; 4) GSFC Mission assurance Requirements; 5) GSFC Systems Review Office (SRO); 6) GSFC Supply Chain Management Program; and 7) GSFC ISO9001/AS9100 Status Brief.

  4. Globalisation and blood safety.

    Science.gov (United States)

    Farrugia, Albert

    2009-05-01

    Globalisation may be viewed as the growing interdependence of countries worldwide through the increasing volume and variety of cross-border transactions in goods and services, and also through the more rapid and widespread diffusion of technology. Globalisation is not just an economic phenomenon, although it is frequently described as such, but includes commerce, disease and travel, and immigration, and as such it affects blood safety and supply in various ways. The relatively short travel times offered by modern aviation can result in the rapid spread of blood-borne pathogens before measures to counteract transmission can be put in place; this would have happened with SARS if the basic life cycle of the SARS virus included an asymptomatic viraemia. This risk can be amplified by ecological factors which effect the spread of these pathogens once they are transferred to a naïve ecosystem, as happened with West Nile Virus (WNV) in North America. The rationalization and contraction of the plasma products industry may be viewed as one aspect of globalisation imposed by the remorseless inevitability of the market; the effect of this development on the safety and supply of products has yet to be seen, but the oversight and assurance of a shrinking number of players will present particular challenges. Similarly, the monopolization of technology, through patent enforcement which puts access beyond the reach of developing countries, can have an effect on blood safety. The challenges presented to blood safety by globalisation are heightening the tensions between the traditional focus on the product safety - zero risk paradigm and the need to view the delivery of safe blood as an integrated process. As an illustration of this tension, donor deferral measures imposed by globalisation-induced risks such as vCJD and WNV have resulted in the loss of the safest and most committed portion of the blood donor population in many Western countries, leading to an increased risk to

  5. Globalisation and blood safety.

    Science.gov (United States)

    Farrugia, Albert

    2009-05-01

    Globalisation may be viewed as the growing interdependence of countries worldwide through the increasing volume and variety of cross-border transactions in goods and services, and also through the more rapid and widespread diffusion of technology. Globalisation is not just an economic phenomenon, although it is frequently described as such, but includes commerce, disease and travel, and immigration, and as such it affects blood safety and supply in various ways. The relatively short travel times offered by modern aviation can result in the rapid spread of blood-borne pathogens before measures to counteract transmission can be put in place; this would have happened with SARS if the basic life cycle of the SARS virus included an asymptomatic viraemia. This risk can be amplified by ecological factors which effect the spread of these pathogens once they are transferred to a naïve ecosystem, as happened with West Nile Virus (WNV) in North America. The rationalization and contraction of the plasma products industry may be viewed as one aspect of globalisation imposed by the remorseless inevitability of the market; the effect of this development on the safety and supply of products has yet to be seen, but the oversight and assurance of a shrinking number of players will present particular challenges. Similarly, the monopolization of technology, through patent enforcement which puts access beyond the reach of developing countries, can have an effect on blood safety. The challenges presented to blood safety by globalisation are heightening the tensions between the traditional focus on the product safety - zero risk paradigm and the need to view the delivery of safe blood as an integrated process. As an illustration of this tension, donor deferral measures imposed by globalisation-induced risks such as vCJD and WNV have resulted in the loss of the safest and most committed portion of the blood donor population in many Western countries, leading to an increased risk to

  6. Causal Models for Safety Assurance Technologies Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Fulfillment of NASA's System-Wide Safety and Assurance Technology (SSAT) project at NASA requires leveraging vast amounts of data into actionable knowledge. Models...

  7. Safety Assurance in NextGen

    Science.gov (United States)

    HarrisonFleming, Cody; Spencer, Melissa; Leveson, Nancy; Wilkinson, Chris

    2012-01-01

    The generation of minimum operational, safety, performance, and interoperability requirements is an important aspect of safely integrating new NextGen components into the Communication Navigation Surveillance and Air Traffic Management (CNS/ATM) system. These requirements are used as part of the implementation and approval processes. In addition, they provide guidance to determine the levels of design assurance and performance that are needed for each element of the new NextGen procedures, including aircraft, operator, and Air Navigation and Service Provider. Using the enhanced Airborne Traffic Situational Awareness for InTrail Procedure (ATSA-ITP) as an example, this report describes some limitations of the current process used for generating safety requirements and levels of required design assurance. An alternative process is described, as well as the argument for why the alternative can generate more comprehensive requirements and greater safety assurance than the current approach.

  8. Safety and Mission Assurance Knowledge Management Retention

    Science.gov (United States)

    Johnson, Teresa A.

    2006-01-01

    This viewgraph presentation reviews the issues surrounding the management of knowledge in regards to safety and mission assurance. The JSC workers who were hired in the 1960's are slated to retire in the next two to three years. The experiences and knowledge of these NASA workers must be identified, and disseminated. This paper reviews some of the strategies that the S&MA is developing to capture that valuable institutional knowledge.

  9. Quality assurance for software important to safety

    International Nuclear Information System (INIS)

    Software applications play an increasingly relevant role in nuclear power plant systems. This is particularly true of software important to safety used in both: calculations for the design, testing and analysis of nuclear reactor systems (design, engineering and analysis software); and monitoring, control and safety functions as an integral part of the reactor systems (monitoring, control and safety system software). Computer technology is advancing at a fast pace, offering new possibilities in nuclear reactor design, construction, commissioning, operation, maintenance and decommissioning. These advances also present new issues which must be considered both by the utility and by the regulatory organization. Refurbishment of ageing instrumentation and control systems in nuclear power plants and new safety related application areas have emerged, with direct (e.g. interfaces with safety systems) and indirect (e.g. operator intervention) implications for safety. Currently, there exist several international standards and guides on quality assurance for software important to safety. However, none of the existing documents provides comprehensive guidance to the developer, manager and regulator during all phases of the software life-cycle. The present publication was developed taking into account the large amount of available documentation, the rapid development of software systems and the need for updated guidance on how to do it. It provides information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety. Expected users are managers, performers and assessors from nuclear utilities, regulatory bodies, suppliers and technical support organizations involved with the development and use of software applied in nuclear power plants

  10. Nuclear power plant safety and reliability assurance

    International Nuclear Information System (INIS)

    The philosophy of nuclear power plant safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operations, special systems should be provided for response to accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' In recent years, with the accumulation of operating experience and the unexpected complexity of the present generation of light water reactors, the defense in depth philosophy has been supplemented by risk and reliability assessments. Reliability assurance programs based on these probabilistic engineering assessments provide a means of integrating design review, maintenance, testing, replacement of parts, failure reporting, and corrective action, so that the protection of the plant and the public can be systematically ensured

  11. A method of safety assurance for fusion experimental reactor

    International Nuclear Information System (INIS)

    The present report describes safety assurance method for fusion experimental reactor. The ALARA (As Low As Reasonably Achievable) principle for a normal condition and the defence in depth principle for states deviated from the normal condition can be used as basic principles of safety assurance of the reactor. The method includes safety design for systems, importance categorization method to impose suitable demands to their systems, safety evaluation method to validate the design and application of the method. It is considered that this method can be a strong candidate for safety assurance method. (author)

  12. Coalmine Safety Assurance Information System Based on GIS

    Institute of Scientific and Technical Information of China (English)

    LIU Qiao-xi; MAO Shan-jun; MA Ai-nai; MAO Yun-de; BAO Qing-guo

    2003-01-01

    The mine ventilation and safety is one of the most important factors to influence on the coal production.More attention has been paid to manage safety information in scientific, efficient, and real-time way. Therefore, it is important to develop a practical mine safety assurance information system (CSAIS). Based on analyzing the actual management mode for ventilation and safety on mine, the paper studies the structure and function of the mine safety assurance information system based on GIS in detail. Moreover, it also suggests some applications and solutions. By combining with the practical situation, the paper realizes the whole function of the present system.

  13. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test

    Science.gov (United States)

    2013-09-04

    ... Process'' on May 13, 2002 (67 FR 31978), which became effective January 1, 2003. Subpart D of 49 CFR part... determine if the carrier is exercising basic safety management controls. On December 16, 2008 (73 FR 76472... TRANSPORTATION Federal Motor Carrier Safety Administration New Entrant Safety Assurance Program Operational...

  14. Changing the Safety and Mission Assurance (S and MA) Paradigm

    Science.gov (United States)

    Malone, Roy W.; Safie, Fayssal M.

    2010-01-01

    This slide presentation reviews the change in the work and impact of the Safety and Mission Assurance directorate at Marshall Space Flight Center. It reviews the background and the reasons given for a strong Safety & Mission Assurance presence in all planning for space flight. This was pointed out by the Rogers Commission Report after the Space Challenger accident, by the Columbia Accident Investigation Board (CAIB) and by a 2006 NASA Exploration Safety Study (NESS) Team. The overall objective of the work in this area was to improve and maintain S&MA expertise and skills. Training for this work was improved and the S&MA organization was reorganized. This has resulted in a paradigm shift for NASA's safety efforts, which is described. The presentation then reviews the impact of the new S&MA work in the Ares I design and development.

  15. Safety Assurance Process for FRMS: eJcase Implementation

    NARCIS (Netherlands)

    Stewart, S.; Koornneef, F.; Akselsson, R.; Barton, P.

    2009-01-01

    Chapter 6: Safety Assurance Process for FRMS - eJcase Implementation The European Commission HILAS project (Human Integration into the Lifecycle of Aviation Systems - a project supported by the European Commission’s 6th Framework between 2005-2009) was focused on using human factors knowledge and m

  16. Viral metagenomics and blood safety.

    Science.gov (United States)

    Sauvage, V; Eloit, M

    2016-02-01

    The characterization of the human blood-associated viral community (also called blood virome) is essential for epidemiological surveillance and to anticipate new potential threats for blood transfusion safety. Currently, the risk of blood-borne agent transmission of well-known viruses (HBV, HCV, HIV and HTLV) can be considered as under control in high-resource countries. However, other viruses unknown or unsuspected may be transmitted to recipients by blood-derived products. This is particularly relevant considering that a significant proportion of transfused patients are immunocompromised and more frequently subjected to fatal outcomes. Several measures to prevent transfusion transmission of unknown viruses have been implemented including the exclusion of at-risk donors, leukocyte reduction of donor blood, and physicochemical treatment of the different blood components. However, up to now there is no universal method for pathogen inactivation, which would be applicable for all types of blood components and, equally effective for all viral families. In addition, among available inactivation procedures of viral genomes, some of them are recognized to be less effective on non-enveloped viruses, and inadequate to inactivate higher viral titers in plasma pools or derivatives. Given this, there is the need to implement new methodologies for the discovery of unknown viruses that may affect blood transfusion. Viral metagenomics combined with High Throughput Sequencing appears as a promising approach for the identification and global surveillance of new and/or unexpected viruses that could impair blood transfusion safety. PMID:26778104

  17. Safer electronic health records safety assurance factors for EHR resilience

    CERN Document Server

    Sittig, Dean F

    2015-01-01

    This important volume provide a one-stop resource on the SAFER Guides along with the guides themselves and information on their use, development, and evaluation. The Safety Assurance Factors for EHR Resilience (SAFER) guides, developed by the editors of this book, identify recommended practices to optimize the safety and safe use of electronic health records (EHRs). These guides are designed to help organizations self-assess the safety and effectiveness of their EHR implementations, identify specific areas of vulnerability, and change their cultures and practices to mitigate risks.This book pr

  18. Changing the S and MA [Safety and Mission Assurance] Paradigm

    Science.gov (United States)

    Malone, Roy W., Jr.

    2010-01-01

    Objectives: 1) Optimize S&MA organization to best facilitate Shuttle transition in 2010, successfully support Ares developmental responsibilities, and minimize the impacts of the gap between last Shuttle flight and start of Ares V Project. 2) Improve leveraging of critical skills and experience between Shuttle and Ares. 3) Split technical and supervisory functions to facilitate technical penetration. 4) Create Chief Safety and Mission Assurance Officer (CSO) stand-alone position for successfully implementation of S&MA Technical Authority. 5) Minimize disruption to customers. 6) Provide early involvement of S&MA leadership team and frequent/open communications with S&MA team members and steak-holders.

  19. Assuring fish safety and quality in international fish trade.

    Science.gov (United States)

    Ababouch, Lahsen

    2006-01-01

    International trade in fishery commodities reached US 58.2 billion dollars in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US 17.4 billion dollars in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building. PMID:17052733

  20. Assuring fish safety and quality in international fish trade

    International Nuclear Information System (INIS)

    International trade in fishery commodities reached US$ 58.2 billion in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US$ 17.4 billion in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building

  1. Assuring fish safety and quality in international fish trade

    Energy Technology Data Exchange (ETDEWEB)

    Ababouch, Lahsen [United Nations, Food and Agricultural Organization, Chief, Fish Utilization and Marketing Services, FAO Headquarters, F-607 Rome (Italy)]. E-mail lahsen.ababouch@fao.org

    2006-07-01

    International trade in fishery commodities reached US$ 58.2 billion in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US$ 17.4 billion in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building.

  2. Rigid performance requirements assure public safety by regulations

    Energy Technology Data Exchange (ETDEWEB)

    Nickell, R.E.; Glass, R.E.

    1987-07-01

    Title 10, Part 71 of the Code of Federal Regulations (10 CFR 71) provides a set of prescriptive performance test requirements for spent nuclear fuel and high-level waste transport packaging containment systems. The hypothetical accident conditions, which involve a sequence of impact, puncture, fire, and water immersion events, are referred to as rigid because of their extremely prescriptive nature. These hypothetical accident events have now been placed within the context of real transportation accidents, at least for conventional austenitic stainless steel/ lead gamma shielded cask designs. The assurance of public safety, including the issue of safety margin for very severe accident events is discussed in this paper for both conventional and innovative cask design concepts. A particular risk assessment approach that follows from work at the Lawrence Livermore National Laboratory is suggested.

  3. Rigid performance requirements assure public safety by regulations

    Energy Technology Data Exchange (ETDEWEB)

    Nickell, R.E.; Glass, R.E.

    1987-01-01

    Title 10, Part 71 of the Code of Federal Regulations (10 CFR 71) provides a set of prescriptive performance test requirements for spent nuclear fuel and high-level waste transport packaging containment systems. The hypothetical accident conditions, which involve a sequence of impact, puncture, fire, and water immersion events, are referred to as rigid because of their extremely prescriptive nature. These hypothetical accident events have now been placed within the context of real transportation accidents, at least for conventional austenitic stainless steel/lead gamma shielded cask designs. The assurance of public safety, including the issue of safety margin for very severe accident events, is discussed in this paper for both conventional and innovative cask design concepts. A particular risk assessment approach that follows from work at the Lawrence Livermore National Laboratory is suggested. 6 refs., 2 figs.

  4. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Safety Assurance Criteria and Processes C Appendix... Pt. 236, App. C Appendix C to Part 236—Safety Assurance Criteria and Processes (a) What is the purpose of this appendix? This appendix provides safety criteria and processes that the designer must...

  5. Assuring future competence in nuclear safety in Finland

    International Nuclear Information System (INIS)

    Full text: Background: Within last few years we have been faced the fact that ageing of experts in nuclear safety field cannot be ignored in Finland. A great number of all experts/specialists with special competence on nuclear safety studied in the early 70's and had their first permanent jobs in the 'golden era' of nuclear power. These experts are going to retire within next ten years. Therefore both the regulatory body and licensees in Finland have the situation where the age distribution of staff member has become distorted. Also the amount of students in universities which have nuclear technology as their major subject has diminished remarkably until the decision of the new nuclear power plant unit in Finland was made in May 2001. After that the amount of students has risen. Assuring competences within the regulatory body STUK adopted the systematic approach to training in early 90's, this method is widely presented in IAEA TECDOC 1254 (2001). However, the very low turnover of staff led to decrease of training needs and therefore also the systematic training efforts decreased. In 2001 a need to restart the systematic approach to assuring competences was identified. To improve competence management at the regulatory body a competence analysis was carried out and a human resource plan for nuclear safety area for the near future was made. Competence analysis is a method which is quite commonly used on public sector and governmental organisations in Finland. STUK studied carefully the models used in other public sector organisations and adjusted the method to its own purposes. The model used has four competence categories: substance related, management skills, common working skills and STUK related working skills. Substance related competences were defined and described at working unit level. Descriptions for the rest three categories were made at STUK level and those were common for all departments. Substance related competencies common to all working at the

  6. Cascade Distillation System Design for Safety and Mission Assurance

    Science.gov (United States)

    Sarguisingh, Miriam; Callahan, Michael R.; Okon, Shira

    2015-01-01

    Per the NASA Human Health, Life Support and Habitation System Technology Area 06 report "crewed missions venturing beyond Low-Earth Orbit (LEO) will require technologies with improved reliability, reduced mass, self-sufficiency, and minimal logistical needs as an emergency or quick-return option will not be feasible".1 To meet this need, the development team of the second generation Cascade Distillation System (CDS 2.0) chose a development approach that explicitly incorporate consideration of safety, mission assurance, and autonomy. The CDS 2.0 preliminary design focused on establishing a functional baseline that meets the CDS core capabilities and performance. The critical design phase is now focused on incorporating features through a deliberative process of establishing the systems failure modes and effects, identifying mitigation strategies, and evaluating the merit of the proposed actions through analysis and test. This paper details results of this effort on the CDS 2.0 design.

  7. SAFEGUARD: An Assured Safety Net Technology for UAS

    Science.gov (United States)

    Dill, Evan T.; Young, Steven D.; Hayhurst, Kelly J.

    2016-01-01

    As demands increase to use unmanned aircraft systems (UAS) for a broad spectrum of commercial applications, regulatory authorities are examining how to safely integrate them without loss of safety or major disruption to existing airspace operations. This work addresses the development of the Safeguard system as an assured safety net technology for UAS. The Safeguard system monitors and enforces conformance to a set of rules defined prior to flight (e.g., geospatial stay-out or stay-in regions, speed limits, altitude limits). Safeguard operates independently of the UAS autopilot and is strategically designed in a way that can be realized by a small set of verifiable functions to simplify compliance with regulatory standards for commercial aircraft. A framework is described that decouples the system from any other devices on the UAS as well as introduces complementary positioning source(s) for applications that require integrity and availability beyond what the Global Positioning System (GPS) can provide. Additionally, the high level logic embedded within the software is presented, as well as the steps being taken toward verification and validation (V&V) of proper functionality. Next, an initial prototype implementation of the described system is disclosed. Lastly, future work including development, testing, and system V&V is summarized.

  8. Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

    Science.gov (United States)

    Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona

    2010-01-01

    Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium). PMID:21113564

  9. Final Report of the NASA Office of Safety and Mission Assurance Agile Benchmarking Team

    Science.gov (United States)

    Wetherholt, Martha

    2016-01-01

    To ensure that the NASA Safety and Mission Assurance (SMA) community remains in a position to perform reliable Software Assurance (SA) on NASAs critical software (SW) systems with the software industry rapidly transitioning from waterfall to Agile processes, Terry Wilcutt, Chief, Safety and Mission Assurance, Office of Safety and Mission Assurance (OSMA) established the Agile Benchmarking Team (ABT). The Team's tasks were: 1. Research background literature on current Agile processes, 2. Perform benchmark activities with other organizations that are involved in software Agile processes to determine best practices, 3. Collect information on Agile-developed systems to enable improvements to the current NASA standards and processes to enhance their ability to perform reliable software assurance on NASA Agile-developed systems, 4. Suggest additional guidance and recommendations for updates to those standards and processes, as needed. The ABT's findings and recommendations for software management, engineering and software assurance are addressed herein.

  10. Quality Management, Quality Assurance and Quality Control in Blood Establishments

    OpenAIRE

    Bolbate, N

    2008-01-01

    Quality terms and the roots of the matter are analyzed according to European Committee’s recommendations. Essence of process and product quality control as well as essence of quality assurance is described. Quality system’s structure including quality control, quality assurance and management is justified in the article.

  11. Philosophy of safety assurance after the Fukushima Daiichi accident. From views of experts

    International Nuclear Information System (INIS)

    Knowledge incorporating meetings were held to exchange views of experts in order to learn respective safety concept and philosophy of safety assurance except nuclear area, how should be prepared for beyond expectation and what was needed to build social credibility, and how to upgrade safety measures of nuclear power station after the Fukushima Daiichi accident. Meeting had been held twice a year since FY2012 and two lecturers were invited at each meeting to give a lecture on the specified theme such as safety assurance in aviation area and chemical plants, and 'safety target of engineering system'. Common or different views on safety assurance between nuclear and other areas were identified, and risk concept and sincere attitude of explaining engineer were mentioned quite important for preparation for beyond expectation and building social credibility. (T. Tanaka)

  12. Blood safety in the world updated

    Institute of Scientific and Technical Information of China (English)

    Silvano Wandel

    2010-01-01

    @@ Blood safety is of paramount importance in any medical context, given that it represents one of the most impor-tant supportive procedures in medicine. Nearly all medical fields that lead with very critical patients will depend on blood products as part of supporting medical strategies (both clinical and surgical). Thus, it is im-portant that every country in the world relies on a well established national blood program.

  13. Software quality assurance for safety analysis and risk management at the Savannah River Site

    International Nuclear Information System (INIS)

    As part of its Reactor Operations Improvement Program at the Savannah River Site (SRS), Westinghouse Savannah River Company (WSRC), in cooperation with the Westinghouse Hanford Company, has developed and implemented quality assurance for safety-related software for technical programs essential to the safety and reliability of reactor operations. More specifically, the quality assurance process involved the development and implementation of quality standards and attendant procedures based on industry software quality standards. These procedures were then applied to computer codes in reactor safety and probabilistic risk assessment analyses. This paper provides a review of the major aspects of the WSRC safety-related software quality assurance. In particular, quality assurance procedures are described for the different life cycle phases of the software that include the Requirements, Software Design and Implementation, Testing and Installation, Operation and Maintenance, and Retirement Phases. For each phase, specific provisions are made to categorize the range of activities, the level of responsibilities, and the documentation needed to assure the control of the software. The software quality assurance procedures developed and implemented are evolutionary in nature, and thus, prone to further refinements. These procedures, nevertheless, represent an effective controlling tool for the development, production, and operation of safety-related software applicable to reactor safety and probabilistic risk assessment analyses

  14. Code on the safety of nuclear power plants: Quality assurance

    International Nuclear Information System (INIS)

    This revised Code provides the principles and objectives for the establishment and implementation of quality assurance programmes applied to both the overall and each of the constituent activities associated with a nuclear power plant project. The quality assurance principles enumerated in the present Code can be usefully applied to nuclear facilities other than nuclear power plants. The quality assurance programme encompasses: (1) the activities that are necessary to achieve the appropriate quality of the respective item or service; and (2) the activities that are necessary for verifying that the required quality is achieved and that objective evidence is produced to that effect. Quality assurance is an essential aspect of good management and the quality assurance programme is the main management tool for a disciplined approach to all activities affecting quality, including, where appropriate, verification that each task has been satisfactorily performed and that necessary corrective actions have been implemented. The principles and objectives provided by the Code are applicable by all those responsible for the nuclear power plant, by plant designers, suppliers, architect-engineers, plant constructors, plant operators and other organizations participating in activities affecting quality. The Code is a revision of the previous Code of Practice (1978) on the same subject of interest to regulatory bodies and experts in quality assurance for design, siting and operation of nuclear power plants. Contents: Definitions; 1. Introduction; 2. Quality assurance programmes; 3. Organization; 4. Document control; 5. Design control; 6. Procurement control; 7. Control of items; 8. Process control; 9. Inspection and test control; 10. Non-conformance control; 11. Corrective actions; 12, Records; 13. Audits

  15. Manual on quality assurance for computer software related to the safety of nuclear power plants

    International Nuclear Information System (INIS)

    The objective of the Manual is to provide guidance in the assurance of quality of specification, design, maintenance and use of computer software related to items and activities important to safety (hereinafter referred to as safety related) in nuclear power plants. This guidance is consistent with, and supplements, the requirements and recommendations of Quality Assurance for Safety in Nuclear Power Plants: A Code of Practice, 50-C-QA, and related Safety Guides on quality assurance for nuclear power plants. Annex A identifies the IAEA documents referenced in the Manual. The Manual is intended to be of use to all those who, in any way, are involved with software for safety related applications for nuclear power plants, including auditors who may be called upon to audit management systems and product software. Figs

  16. [Haemovigilance and blood safety in overseas military].

    Science.gov (United States)

    Sailliol, A; Plang, S; Martinaud, C; Pouget, T; Vedy, S; Clavier, B; Cellarier, V; Roche, C; Civadier, C; Ausset, S

    2014-11-01

    The French military blood institute (FMBI) is the only military blood supplier in France. FMBI operates independently and autonomously under the Ministry of Defense's supervision, and accordingly, to the French, European and NATO technical and safety guidelines. FMBI is in charge of the collection, preparation and distribution of blood products to supply transfusion support to armed forces, especially during overseas operations. In overseas military, a primary physician is responsible for haemovigilance in permanent relation with an expert in the FMBI to manage any adverse reaction. Additionally, traceability of delivered or collected blood products during overseas operation represents a priority, allowing an appropriate management of transfusion inquiries and assessment of practices aiming to improve and update procedures and training. Transfusion safety in overseas operation is based on regular and specific training of people concerned by blood supply chain in exceptional situation. PMID:25284434

  17. Call for NDT leadership role in assuring safety of nuclear power

    International Nuclear Information System (INIS)

    Nondestructive Testing and its potential role in assuring the safety of nuclear power were given emphasis at a conference on Nondestructive Testing in the Nuclear Industry sponsored by the American Society for Metals Dec. 1--3 in Denver, Colo. Excerpts from two major addresses challenging the NDT community to assume leadership in solving nuclear safety problems are presented

  18. Assuring consumer safety without animals: Applications for tissue engineering

    OpenAIRE

    Westmoreland, Carl; Holmes, Anthony M

    2009-01-01

    Humans are exposed to a variety of chemicals in their everyday lives through interactions with the environment and through the use of consumer products. It is a basic requirement that these products are tested to assure they are safe under normal and reasonably foreseeable conditions of use. Within the European Union, the majority of tests used for generating toxicological data rely on animals. However recent changes in legislation (e.g., 7th amendment of the Cosmetics Directive and REACH) ar...

  19. Quality assurance and human error effects on the structural safety

    International Nuclear Information System (INIS)

    Statistical surveys show that the frequency of failure of structures is much larger than that expected by the codes. Evidence exists that human errors (especially during the design process) is the main cause for the difference between the failure probability admitted by codes and the reality. In this paper, the attenuation of human error effects using tools of quality assurance is analyzed. In particular, the importance of the independent design review is highlighted, and different approaches are discussed. The experience from the Atucha II project, as well as the USA and German practice on independent design review, are summarized. (Author)

  20. Management of National Nuclear Power Programs for assured safety

    International Nuclear Information System (INIS)

    Topics discussed in this report include: nuclear utility organization; before the Florida Public Service Commission in re: St. Lucie Unit No. 2 cost recovery; nuclear reliability improvement and safety operations; nuclear utility management; training of nuclear facility personnel; US experience in key areas of nuclear safety; the US Nuclear Regulatory Commission - function and process; regulatory considerations of the risk of nuclear power plants; overview of the processes of reliability and risk management; management significance of risk analysis; international and domestic institutional issues for peaceful nuclear uses; the role of the Institute of Nuclear Power Operations (INPO); and nuclear safety activities of the International Atomic Energy Agency (IAEA)

  1. Management of National Nuclear Power Programs for assured safety

    Energy Technology Data Exchange (ETDEWEB)

    Connolly, T.J. (ed.)

    1985-01-01

    Topics discussed in this report include: nuclear utility organization; before the Florida Public Service Commission in re: St. Lucie Unit No. 2 cost recovery; nuclear reliability improvement and safety operations; nuclear utility management; training of nuclear facility personnel; US experience in key areas of nuclear safety; the US Nuclear Regulatory Commission - function and process; regulatory considerations of the risk of nuclear power plants; overview of the processes of reliability and risk management; management significance of risk analysis; international and domestic institutional issues for peaceful nuclear uses; the role of the Institute of Nuclear Power Operations (INPO); and nuclear safety activities of the International Atomic Energy Agency (IAEA).

  2. Unilever food safety assurance system for refined vegetable oils and fats

    Directory of Open Access Journals (Sweden)

    van Duijn Gerrit

    2010-03-01

    Full Text Available The Unilever Food Safety Assurance system for refined oils and fats is based on risk assessments for the presence of contaminants or pesticide residues in crude oils, and refining process studies to validate the removal of these components. Crude oil risk assessments were carried out by combining supply chain visits, and analyses of the contaminant and pesticide residue levels in a large number of crude oil samples. Contaminants like poly-aromatic hydrocarbons and hydrocarbons of mineral origin, and pesticide residues can largely be removed by refining. For many years, this Food Safety Assurance System has proven to be effective in controlling contaminant levels in refined vegetable oils and fats.

  3. Implementation of quality assurance program for operational safety of P2TBDU installation

    International Nuclear Information System (INIS)

    According to Decree of Head of BAPETEN No : 07/Ka-BAPETEN/V-99 which determines the duties to perform the quality assurance function for each nuclear installation, the Head of P2TBDU has decided to perform and maintain the quality assurance program controlling each activity which may influence the safety. The P2TBDU Quality Assurance Program has been arranged and put into force since 1993, however the implementation of the program has not been effective as expected. The change of organization structure shall cause the changes of organisation's function and main duty, therefore it requires that the change/revision be made to accommodate the new policy on the quality assurance program. The Quality Assurance Program revision 1 has been arranged and put into force since Nov. 19, 1999 which incorporated the change of the organizational structure. The effectiveness of implementation of the program shall extremely be determined y commitment of the P2TBDU management as well as awareness of each personal of the organization on the necessity of Quality Assurance Program for operational safety of the installation. (author)

  4. [Blood transfusion and supply chain management safety].

    Science.gov (United States)

    Quaranta, Jean-François; Caldani, Cyril; Cabaud, Jean-Jacques; Chavarin, Patricia; Rochette-Eribon, Sandrine

    2015-02-01

    The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments.

  5. [Blood transfusion and supply chain management safety].

    Science.gov (United States)

    Quaranta, Jean-François; Caldani, Cyril; Cabaud, Jean-Jacques; Chavarin, Patricia; Rochette-Eribon, Sandrine

    2015-02-01

    The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments. PMID:25578550

  6. Feminist Heuristics: Transforming the Foundation of Food Quality and Safety Assurance Systems

    Science.gov (United States)

    Kimura, Aya Hirata

    2012-01-01

    Food safety and quality assurance systems have emerged as a key mechanism of food governance in recent years and are also popular among alternative agrofood movements, such as the organic and fair trade movements. Rural sociologists have identified many problems with existing systems, including corporate cooptation, the marginalization of small…

  7. Technical Excellence and Communication: The Cornerstones for Successful Safety and Mission Assurance Programs

    Science.gov (United States)

    Malone, Roy W.; Livingston, John M.

    2010-01-01

    The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center (MSFC) Safety and Mission Assurance (S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

  8. Safety assurance of RBMK-type NPPs against explosion effects

    International Nuclear Information System (INIS)

    This presentation covers the following subjects: concept of the RBMK type NPPs safety under special impacts; analysis of potential sources of air impact wave for RBMK type category 1 buildings and structures, analysis of explosive danger sources located on the NPP site; analysis of explosive danger sources on ground transport main roads; outside the NPP site; from marine water area; analysis of loads acting on category 1 RBMK type NPP building constructions at spontaneous explosion. The loading level and design limits are compared. According to calculations the effect of air impact wave from existing potential sources of explosion can be dangerous for RBMK type NPP building and structures. Preliminary assessment had shown that strengthening the building supporting structures up to level required for safety is connected with a considerable work. An alternative is proposed, to develop complex administrative and technical measures for decreasing the air impact wave loads on the basis of marginal distance principle. The obtained experimental values would allow specification of design models of behaviour of RBMK type buildings and structures under spontaneous explosion effects

  9. Risk Classification and Risk-based Safety and Mission Assurance

    Science.gov (United States)

    Leitner, Jesse A.

    2014-01-01

    Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

  10. Modern Approaches to Safety Assurance of a New Generation of Sodium Fast Reactors

    International Nuclear Information System (INIS)

    In the stage of designing sodium cooled fast reactors (SFRs) of a new generation there is a task to improve their inherent safety up to the level higher than that of the previous SFR designs. Modern safety requirements to the SFR of the fourth generation are described. Through the example of the BN-1200 reactor, approaches to safety assurance are demonstrated using development of inherent safety properties up to a brand new level compared to that of the earlier commercial reactor designs (BN-600 and BN-800). Also, passive safety devices and systems applied in the BN-1200 design are described. The goal is to eliminate the necessity for evacuation of residents under conditions of any possible realistic accidents. The paper presents properties of inherent self-protection of the BN-1200 reactor and estimation of their effectiveness in terms of safety assurance. The basic design approaches concerning safety are considered, including additional measures as applied to the BN-1200 reactor. These include measures aimed at the elimination or minimization of sodium leaks; design approaches to the passive shutdown systems (PSS) using various operation principles, namely: hydraulically suspended absorber rods operating in case of coolant flow rate decrease (PSS-H) and absorber rods operating in the case of increase of the core outlet coolant temperature above a certain value (PSS-T); passive decay heat removal system; sodium plenum above the core; gastight compartment above the reactor; core catcher made of refractory metal; and reactor guard vessel. (author)

  11. Assuring future competence in nuclear safety in Finland

    International Nuclear Information System (INIS)

    To improve competence management at the regulatory body a competence analysis was carried out and a human resource plan for nuclear safety area for the near future was made. STUK studied carefully the models used in other public sector organisations and adjusted the method to its own purposes. The model used has four competence categories: substance related, management skills, common working skills and STUK related working skills. Substance related competences were defined and described at working unit level. Descriptions for the rest three categories were made at STUK level and those were common for all departments. Results of competence analysis are encouraging. Most competence areas are covered at proper level, some will need to be improved but none was totally missing. For the future challenges extra attention should be paid to knowledge management. Two separate plans were made on the basis of these results: plan for training regulatory personnel and HR-plan (at the first stage recruiting plan for next five years). It is STUK's experience that the competence analysis is worth the trouble. It gives the organisation and employees a common conception on its competences and on future needs. It also makes it easier to motivate all staff members to use their working hours on training and capability building. On the other hand it must be admitted that it takes resources and all employees have not been very anxious to do this. The results of competence analysis should lead to some improvement projects. The progress of improvement actions should be followed-up on regularly basis. It is important not to forget to communicate the results to employees

  12. The laboratory is a key partner in assuring patient safety.

    Science.gov (United States)

    Stankovic, Ana K

    2004-12-01

    Medical errors have a great impact on patient outcomes. They can cause serious injury to patients or even result in their deaths. However, morbidity and mortality can sometimes be prevented by the timely and effective action of health care workers. Several IOM Reports have focused on the problem of errors in the United States health care system and identified gaps that need to be addressed. As part of the overall health care system, clinical laboratories are vulnerable to medical errors. Because of significant efforts on the part of both the laboratories and the manufacturers of laboratory equipment and reagents, the errors in the analytic phase of the total testing process now represent the smallest portion of testing errors. Currently, laboratory testing errors occur most frequently in the preanalytic phase. The primary reason for the high prevalence of preanalytic errors is that, at the present time, it is difficult to monitor all preanalytic variables and to implement necessary improvement processes, particularly when some of the variables (like phlebotomy) are not under the control of the laboratory. Considerable efforts have been made by laboratory professionals and other stakeholders to decrease testing errors. Minimal quality requirements have been set through regulations for both laboratory testing and the manufacture of medical equipment and reagents. At the same time, nonregulatory approaches have greatly affected the quality of laboratory testing. These include laboratory standards, various quality improvement programs, voluntary reporting of adverse events, and, in the near future, the National Report on the Quality of Laboratory Services. The introduction of successful approaches from other industries, such as Six Sigma and Lean, also will help reduce the rate of laboratory errors. The clinical laboratory has done more than most other sectors of health care to decrease the occurrence of medical errors, making it a key partner inpatient safety. PMID

  13. Role of human factor in safety assurance in the nuclear industry

    International Nuclear Information System (INIS)

    The authors discuss the issues of human resource activities in the Rosatom Corporation that aim to achieve and maintain the required levels of safety culture and qualification of personnel involved in the operations of nuclear energy sites. These activities are supported by the appropriate resources, organisational management structure and quality control system, legislation, regulations and methodological support. It is emphasized that systematic and versatile HR-related activities in the nuclear industry represent one of the key areas of production operations that assure safety and reliability of nuclear sites at all stages of their life cycle. Especially important is the assurance of high professional level of nuclear regulators. They believe that it would appear sensible, in addition to the existing system of training, to engage the mechanisms of rotation of personnel from utility organisations to regulatory authorities

  14. Radiation safety and quality control assurance in X-ray diagnostics 1998

    International Nuclear Information System (INIS)

    The report is based on a seminar course of lectures 'Radiation safety and quality assurance in X-ray diagnostics 1998' organized by the Radiation and Nuclear Safety Authority (STUK) in Finland. The lectures included actual information on X-ray examinations: methods of quality assurance, methods of measuring and calculating patient doses, examination frequencies, patient doses, occupational doses, and radiation risks. Paediatric X-ray examinations and interventional procedures were the most specific topics. The new Council Directive 97/43/Euratom on medical exposure, and the European Guidelines on quality criteria for diagnostic radiographic images, were discussed in several lectures. Lectures on general radiation threats and preparedness, examples of radiation accidents, and emergency preparedness in hospitals were also included. (editor)

  15. Software quality assurance and software safety in the Biomed Control System

    International Nuclear Information System (INIS)

    The Biomed Control System is a hardware/software system used for the delivery, measurement and monitoring of heavy-ion beams in the patient treatment and biology experiment rooms in the Bevalac at the Lawrence Berkeley Laboratory (LBL). This paper describes some aspects of this system including historical background philosophy, configuration management, hardware features that facilitate software testing, software testing procedures, the release of new software quality assurance, safety and operator monitoring. 3 refs

  16. John F. Kennedy Space Center, Safety, Reliability, Maintainability and Quality Assurance, Survey and Audit Program

    Science.gov (United States)

    1994-01-01

    This document is the product of the KSC Survey and Audit Working Group composed of civil service and contractor Safety, Reliability, and Quality Assurance (SR&QA) personnel. The program described herein provides standardized terminology, uniformity of survey and audit operations, and emphasizes process assessments rather than a program based solely on compliance. The program establishes minimum training requirements, adopts an auditor certification methodology, and includes survey and audit metrics for the audited organizations as well as the auditing organization.

  17. Safety and Mission Assurance Knowledge Management Retention: Managing Knowledge for Successful Mission Operations

    Science.gov (United States)

    Johnson, Teresa A.

    2006-01-01

    Knowledge Management is a proactive pursuit for the future success of any large organization faced with the imminent possibility that their senior managers/engineers with gained experiences and lessons learned plan to retire in the near term. Safety and Mission Assurance (S&MA) is proactively pursuing unique mechanism to ensure knowledge learned is retained and lessons learned captured and documented. Knowledge Capture Event/Activities/Management helps to provide a gateway between future retirees and our next generation of managers/engineers. S&MA hosted two Knowledge Capture Events during 2005 featuring three of its retiring fellows (Axel Larsen, Dave Whittle and Gary Johnson). The first Knowledge Capture Event February 24, 2005 focused on two Safety and Mission Assurance Safety Panels (Space Shuttle System Safety Review Panel (SSRP); Payload Safety Review Panel (PSRP) and the latter event December 15, 2005 featured lessons learned during Apollo, Skylab, and Space Shuttle which could be applicable in the newly created Crew Exploration Vehicle (CEV)/Constellation development program. Gemini, Apollo, Skylab and the Space Shuttle promised and delivered exciting human advances in space and benefits of space in people s everyday lives on earth. Johnson Space Center's Safety & Mission Assurance team work over the last 20 years has been mostly focused on operations we are now beginning the Exploration development program. S&MA will promote an atmosphere of knowledge sharing in its formal and informal cultures and work processes, and reward the open dissemination and sharing of information; we are asking "Why embrace relearning the "lessons learned" in the past?" On the Exploration program the focus will be on Design, Development, Test, & Evaluation (DDT&E); therefore, it is critical to understand the lessons from these past programs during the DDT&E phase.

  18. Quality Assurance for the Safety and Security of Radioactive Sources in Pakistan

    International Nuclear Information System (INIS)

    The paper deals with the safety and security of radioactive sources that are used by different establishments of Pakistan Atomic Energy Commission (PAEC), with emphasis on the quality assurance to make their best use for the benefit of humans and to eliminate the risk of their malicious use to protect people and environment, as per IAEA recommendation. The outcome of this study identifies the strengths and good practices used in PAEC establishments for safety and security of radioactive sources. It also identifies the gaps that exist between present practices and in the codes and guidelines of the IAEA and the Pakistan Nuclear Regulatory Authority. (author)

  19. International small dam safety assurance policy benchmarks to avoid dam failure flood disasters in developing countries

    Science.gov (United States)

    Pisaniello, John D.; Dam, Tuyet Thi; Tingey-Holyoak, Joanne L.

    2015-12-01

    In developing countries small dam failure disasters are common yet research on their dam safety management is lacking. This paper reviews available small dam safety assurance policy benchmarks from international literature, synthesises them for applicability in developing countries, and provides example application through a case study of Vietnam. Generic models from 'minimum' to 'best' practice (Pisaniello, 1997) are synthesised with the World Bank's 'essential' and 'desirable' elements (Bradlow et al., 2002) leading to novel policy analysis and design criteria for developing countries. The case study involved 22 on-site dam surveys finding micro level physical and management inadequacies that indicates macro dam safety management policy performs far below the minimum benchmark in Vietnam. Moving assurance policy towards 'best practice' is necessary to improve the safety of Vietnam's considerable number of hazardous dams to acceptable community standards, but firstly achieving 'minimum practice' per the developed guidance is essential. The policy analysis/design process provides an exemplar for other developing countries to follow for avoiding dam failure flood disasters.

  20. Report on nuclear industry quality assurance procedures for safety analysis computer code development and use

    International Nuclear Information System (INIS)

    As a result of a request from Commissioner V. Gilinsky to investigate in detail the causes of an error discovered in a vendor Emergency Core Cooling System (ECCS) computer code in March, 1978, the staff undertook an extensive investigation of the vendor quality assurance practices applied to safety analysis computer code development and use. This investigation included inspections of code development and use practices of the four major Light Water Reactor Nuclear Steam Supply System vendors and a major reload fuel supplier. The conclusion reached by the staff as a result of the investigation is that vendor practices for code development and use are basically sound. A number of areas were identified, however, where improvements to existing vendor procedures should be made. In addition, the investigation also addressed the quality assurance (QA) review and inspection process for computer codes and identified areas for improvement

  1. Quality factors quantification/assurance for software related to safety in nuclear power plants

    International Nuclear Information System (INIS)

    Quality assurance plan is needed to guarantee the software quality. The use of such a plan involves activities that should take place all along the life cycle, and which can be evaluated using the so called quality factors. This is due to the fact that the quality itself cannot be measured, but some of its manifestations can be used for this purpose. In the present work, a methodology to quantify a set of quality factors is proposed, for software based systems to be used in safety related areas in nuclear power plants. (author)

  2. Which agents threaten blood safety in the future?

    Science.gov (United States)

    Kitchen, A D; Barbara, J A

    2000-12-01

    The safety of the blood supply is critical to many parts of modern medicine. In a time when prescriber's and the public's expectations are increasing, it is essential that transfusion services globally ensure the safety of the blood supply. There are, however, many threats to this safety, one being the appearance of new infectious agents. Such agents may be truly 'novel', or may be existing agents, known but not routinely screened for, posing a new or increased threat. However, before an agent is considered to be a true threat to blood safety it must be well characterized, and evidence must be presented that (i) transfusion transmission is a significant route of spread, and (ii) the agent causes significant clinical disease. If either of these criteria are not met, the question has to be asked as to whether the agent is truly a threat to blood safety.

  3. One complex tool and three simple approaches to the improvement of quality assurance and safety in external beam radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Salinas, F.; Sansogne, R.; Arbiser, S.; Suarez, V., E-mail: flavio.salinas@rtp.com.ar [Vidt Centro Medico (Argentina); Franco, M., E-mail: mauricio.franco@rtp.com.ar [Centro de Radioterapia San Juan (Argentina); Escobar, J., E-mail: jorge.escobar@iprc.com.ar [Instituto Privado de Radioterapia Cuyo, Buenos Aires (Argentina)

    2013-10-01

    Quality assurance and safety controls in radiation therapy delivery processes that involve the Physics Department of an institution are commonly time consuming tasks. Carrying out daily controls in very busy clinics without compromising patient schedule is challenging. This work describes the usage of Electronic Portal Imaging Devices in combination with some in-house software to simplify and systematize three different tasks of the Physics Department Quality Assurance Program, improving the easiness, reliability and velocity of daily tests. (author)

  4. The development and validation of dried blood spots for external quality assurance of syphilis serology

    Directory of Open Access Journals (Sweden)

    Smit Pieter W

    2013-02-01

    Full Text Available Abstract Background Syphilis causes up to 1,500,000 congenital syphilis cases annually. These could be prevented if all pregnant women were screened, and those with syphilis treated with a single dose of penicillin before 28 weeks gestation. In recent years, rapid point-of-care tests have allowed greater access to syphilis screening, especially in rural or remote areas, but the lack of quality assurance of rapid testing has been a concern. We determined the feasibility of using dried blood spots (DBS as specimens for quality assurance of syphilis serological assays. Methods We developed DBS extraction protocols for use with Treponema pallidum particle agglutination assay (TPPA, Treponema pallidum haemagglutination assay (TPHA and an enzyme immunoassay (EIA and compared the results with those using matching plasma samples from the same patient. Results Since DBS samples showed poor performance with TPHA and EIA (TPHA sensitivity was 50.5% (95% confidence interval: 39.9–61.2% and EIA specificity was 50.4% (95% CI: 43.7–57.1%, only the DBS TPPA was used in the final evaluation. DBS TPPA showed an sensitivity of 95.5% (95% CI: 91.3–98.0% and a specificity of 99.0% (95% CI: 98.1–99.5% compared to TPPA using plasma samples as a reference. Conclusion DBS samples can be recommended for use with TPPA, and may be of value for external quality assurance of point-of-care syphilis testing.

  5. Probability of loss of assured safety in temperature dependent systems with multiple weak and strong links.

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Jay Dean (ProStat, Mesa, AZ); Oberkampf, William Louis; Helton, Jon Craig (Arizona State University, Tempe, AZ)

    2004-12-01

    Relationships to determine the probability that a weak link (WL)/strong link (SL) safety system will fail to function as intended in a fire environment are investigated. In the systems under study, failure of the WL system before failure of the SL system is intended to render the overall system inoperational and thus prevent the possible occurrence of accidents with potentially serious consequences. Formal developments of the probability that the WL system fails to deactivate the overall system before failure of the SL system (i.e., the probability of loss of assured safety, PLOAS) are presented for several WWSL configurations: (i) one WL, one SL, (ii) multiple WLs, multiple SLs with failure of any SL before any WL constituting failure of the safety system, (iii) multiple WLs, multiple SLs with failure of all SLs before any WL constituting failure of the safety system, and (iv) multiple WLs, multiple SLs and multiple sublinks in each SL with failure of any sublink constituting failure of the associated SL and failure of all SLs before failure of any WL constituting failure of the safety system. The indicated probabilities derive from time-dependent temperatures in the WL/SL system and variability (i.e., aleatory uncertainty) in the temperatures at which the individual components of this system fail and are formally defined as multidimensional integrals. Numerical procedures based on quadrature (i.e., trapezoidal rule, Simpson's rule) and also on Monte Carlo techniques (i.e., simple random sampling, importance sampling) are described and illustrated for the evaluation of these integrals. Example uncertainty and sensitivity analyses for PLOAS involving the representation of uncertainty (i.e., epistemic uncertainty) with probability theory and also with evidence theory are presented.

  6. ASVCP guidelines: quality assurance for portable blood glucose meter (glucometer) use in veterinary medicine.

    Science.gov (United States)

    Gerber, Karen L; Freeman, Kathleen P

    2016-03-01

    Portable blood glucose meters (PBGM, glucometers) are a convenient, cost effective, and quick means to assess patient blood glucose concentration. The number of commercially available PBGM is constantly increasing, making it challenging to determine whether certain glucometers may have benefits over others for veterinary testing. The challenge in selection of an appropriate glucometer from a quality perspective is compounded by the variety of analytic methods used to quantify glucose concentrations and disparate statistical analysis in many published studies. These guidelines were developed as part of the ASVCP QALS committee response to establish recommendations to improve the quality of testing using point-of-care testing (POCT) handheld and benchtop devices in veterinary medicine. They are intended for clinical pathologists and laboratory professionals to provide them with background knowledge and specific recommendations for quality assurance (QA) and quality control (QC), and to serve as a resource to assist the provision of advice to veterinarians and technicians to improve the quality of results obtained when using PBGM. These guidelines are not intended to be all-inclusive; rather they provide a minimum standard for management of PBGM in the veterinary setting.

  7. Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India

    Directory of Open Access Journals (Sweden)

    Sonawane A

    2010-01-01

    Full Text Available We conducted a radiological safety and quality assurance (QA audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp, linearity of tube current (mA station and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM (Model RAD/FLU-9001, dose Test-O-Meter (ToM (Model 6001, ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%, lack of congruence of radiation and optical field (23%, nonlinearity of mA station (16% and timer (9%, improper collimator/diaphragm (19.6%, faulty adjustor knob for alignment of field size (4%, nonavailability of warning light (red light at the entrance of the X-ray room (29%, and use of mobile protective barriers without lead glass viewing window (14%. The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body.

  8. Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India

    International Nuclear Information System (INIS)

    We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body. (author)

  9. Safety and Mission Assurance for In-House Design Lessons Learned from Ares I Upper Stage

    Science.gov (United States)

    Anderson, Joel M.

    2011-01-01

    This viewgraph presentation identifies lessons learned in the course of the Ares I Upper Stage design and in-house development effort. The contents include: 1) Constellation Organization; 2) Upper Stage Organization; 3) Presentation Structure; 4) Lesson-Importance of Systems Engineering/Integration; 5) Lesson-Importance of Early S&MA Involvement; 6) Lesson-Importance of Appropriate Staffing Levels; 7) Lesson-Importance S&MA Team Deployment; 8) Lesson-Understanding of S&MA In-Line Engineering versus Assurance; 9) Lesson-Importance of Close Coordination between Supportability and Reliability/Maintainability; 10) Lesson-Importance of Engineering Data Systems; 11) Lesson-Importance of Early Development of Supporting Databases; 12) Lesson-Importance of Coordination with Safety Assessment/Review Panels; 13) Lesson-Implementation of Software Reliability; 14) Lesson-Implementation of S&MA Technical Authority/Chief S&MA Officer; 15) Lesson-Importance of S&MA Evaluation of Project Risks; 16) Lesson-Implementation of Critical Items List and Government Mandatory Inspections; 17) Lesson-Implementation of Critical Items List Mandatory Inspections; 18) Lesson-Implementation of Test Article Safety Analysis; and 19) Lesson-Importance of Procurement Quality.

  10. Pacific Northwest Laboratory annual report for 1988 to the Assistant Secretary for Environment, Safety, and Health: Part 5, Environment, safety, health, and quality assurance

    International Nuclear Information System (INIS)

    This document summarizes the research programs now underway at Battelle's Pacific Northwest Laboratory in the areas of environmental safety, health, and quality assurance. Topics include internal irradiation, emergency plans, dose equivalents, risk assessment, dose equivalents, surveys, neutron dosimetry, and radiation accidents

  11. Pacific Northwest Laboratory annual report for 1988 to the Assistant Secretary for Environment, Safety, and Health: Part 5, Environment, safety, health, and quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Faust, L.G.; Pennell, W.T.; Selby, J.M.

    1989-02-01

    This document summarizes the research programs now underway at Battelle's Pacific Northwest Laboratory in the areas of environmental safety, health, and quality assurance. Topics include internal irradiation, emergency plans, dose equivalents, risk assessment, dose equivalents, surveys, neutron dosimetry, and radiation accidents. (TEM)

  12. The Role of R and D Technical Support for the Assessment, Assurance and Improvement of Nuclear Installation Safety

    International Nuclear Information System (INIS)

    In the introduction of this paper some specific safety aspects of CANDU Cernavoda NPP are considered, emphasizing the importance and the contents of the technical support, including R and D components, for the assessment, assurance and the continued improvement of the nuclear installations safety on a medium and long term basis, with references to the Convention on nuclear safety. It focuses on techniques of nuclear safety assessment, as an essentially step for periodic verification of nuclear safety and the identification of the measures for assurance and improvements of nuclear safety. Considered as an important component of the technical support, the R and D activity in INR Pitesti devoted to the Cernavoda NPP nuclear safety has as main objectives the maintenance and development of the methods and evaluation tools used for the prediction of the plant behavior during accident conditions as well as maintenance and development of the experimental data for different plant components. In this respect the main activities carried out at INR Pitesti in the frame of the nuclear safety and reactor physics R and D program are presented. It is emphasized the importance of maintaining and developing a national competence in the field in order to provide a technical support on a medium and long term basis for a safe operation of the nuclear power plant as well as for a further consolidation of a positive perception of the public for nuclear power

  13. Cavern disposal concepts for HLW/SF: assuring operational practicality and safety with maximum programme flexibility

    International Nuclear Information System (INIS)

    Most conventional engineered barrier system (EBS) designs for HLW/SF repositories are based on concepts developed in the 1970s and 1980s that assured feasibility with high margins of safety, in order to convince national decision makers to proceed with geological disposal despite technological uncertainties. In the interval since the advent of such 'feasibility designs', significant progress has been made in reducing technological uncertainties, which has lead to a growing awareness of other, equally important uncertainties in operational implementation and challenges regarding social acceptance in many new, emerging national repository programs. As indicated by the NUMO repository concept catalogue study (NUMO, 2004), there are advantages in reassessing how previous designs can be modified and optimised in the light of improved system understanding, allowing a robust EBS to be flexibly implemented to meet nation-specific and site-specific conditions. Full-scale emplacement demonstrations, particularly those carried out underground, have highlighted many of the practical issues to be addressed; e.g., handling of compacted bentonite in humid conditions, use of concrete for support infrastructure, remote handling of heavy radioactive packages in confined conditions, quality inspection, monitoring / ease of retrieval of emplaced packages and institutional control. The CAvern REtrievable (CARE) concept reduces or avoids such issues by emplacement of HLW or SF within multi-purpose transportation / storage / disposal casks in large ventilated caverns at a depth of several hundred metres. The facility allows the caverns to serve as inspectable stores for an extended period of time (up to a few hundred years) until a decision is made to close them. At this point the caverns are backfilled and sealed as a final repository, effectively with the same safety case components as conventional 'feasibility designs'. In terms of operational practicality an d safety, the CARE

  14. Assuring safety without animal testing: the case for the human testis in vitro.

    Science.gov (United States)

    Chapin, Robert E; Boekelheide, Kim; Cortvrindt, Rita; van Duursen, Majorie B M; Gant, Tim; Jegou, Bernard; Marczylo, Emma; van Pelt, Ans M M; Post, Janine N; Roelofs, Maarke J E; Schlatt, Stefan; Teerds, Katja J; Toppari, Jorma; Piersma, Aldert H

    2013-08-01

    From 15 to 17 June 2011, a dedicated workshop was held on the subject of in vitro models for mammalian spermatogenesis and their applications in toxicological hazard and risk assessment. The workshop was sponsored by the Dutch ASAT initiative (Assuring Safety without Animal Testing), which aims at promoting innovative approaches toward toxicological hazard and risk assessment on the basis of human and in vitro data, and replacement of animal studies. Participants addressed the state of the art regarding human and animal evidence for compound mediated testicular toxicity, reviewed existing alternative assay models, and brainstormed about future approaches, specifically considering tissue engineering. The workshop recognized the specific complexity of testicular function exemplified by dedicated cell types with distinct functionalities, as well as different cell compartments in terms of microenvironment and extracellular matrix components. This complexity hampers quick results in the realm of alternative models. Nevertheless, progress has been achieved in recent years, and innovative approaches in tissue engineering may open new avenues for mimicking testicular function in vitro. Although feasible, significant investment is deemed essential to be able to bring new ideas into practice in the laboratory. For the advancement of in vitro testicular toxicity testing, one of the most sensitive end points in regulatory reproductive toxicity testing, such an investment is highly desirable. PMID:23612449

  15. Probability of loss of assured safety in systems with multiple time-dependent failure modes.

    Energy Technology Data Exchange (ETDEWEB)

    Helton, Jon Craig; Pilch, Martin.; Sallaberry, Cedric Jean-Marie.

    2012-09-01

    Weak link (WL)/strong link (SL) systems are important parts of the overall operational design of high-consequence systems. In such designs, the SL system is very robust and is intended to permit operation of the entire system under, and only under, intended conditions. In contrast, the WL system is intended to fail in a predictable and irreversible manner under accident conditions and render the entire system inoperable before an accidental operation of the SL system. The likelihood that the WL system will fail to deactivate the entire system before the SL system fails (i.e., degrades into a configuration that could allow an accidental operation of the entire system) is referred to as probability of loss of assured safety (PLOAS). Representations for PLOAS for situations in which both link physical properties and link failure properties are time-dependent are derived and numerically evaluated for a variety of WL/SL configurations, including PLOAS defined by (i) failure of all SLs before failure of any WL, (ii) failure of any SL before failure of any WL, (iii) failure of all SLs before failure of all WLs, and (iv) failure of any SL before failure of all WLs. The effects of aleatory uncertainty and epistemic uncertainty in the definition and numerical evaluation of PLOAS are considered.

  16. Argonne National Laboratory Internal Appraisal Program environment, safety, health/quality assurance oversight

    Energy Technology Data Exchange (ETDEWEB)

    Winner, G.L.; Siegfried, Y.S.; Forst, S.P.; Meshenberg, M.J.

    1995-06-01

    Argonne National Laboratory`s Internal Appraisal Program has developed a quality assurance team member training program. This program has been developed to provide training to non-quality assurance professionals. Upon successful completion of this training and approval of the Internal Appraisal Program Manager, these personnel are considered qualified to assist in the conduct of quality assurance assessments. The training program has been incorporated into a self-paced, computerized, training session.

  17. Blood safety in the United States: Current status and challenges

    Institute of Scientific and Technical Information of China (English)

    R. Y. Dodd

    2010-01-01

    @@ Introduction Since the emergence of AIDS/HIV in the 1980s,blood safety has been considered to be a priority in the Unit-ed States (US). Not only is a great deal of attention paid to the major transfusion transmissible infections,but there is also concern about emerging infections.Although blood is collected by a range of independent organizations in the US, it is highly regulated by the US Food and Drug Administration and most blood collec-tion agencies are also subject to voluntary accreditation through professional organizations such as AABB.

  18. IMEKO TC1-TC7 Symposium in London: The assurance as a result of blood chemical analysis by ISO-GUM and QE

    Science.gov (United States)

    Iwaki, Y.

    2010-07-01

    Degree (EFD) which thought the number of samples is important. Free degree is based on maximum likelihood method of an improved information criterion (AIC) for a Quality Control (QC). The assurance performance of ISO-GUM is come out by set up of the confidence interval [3] and is decided. The result of research of "Decided level/Minimum Detectable Concentration (DL/MDC)" was able to profit by the operation. QE has developed for the QC of industry. However, these have been processed by regression analysis by making frequency probability of a statistic value into normalized distribution. The occurrence probability of the statistics value of a fault element which is accompanied element by a natural phenomenon becomes an abnormal distribution in many cases. The abnormal distribution needs to obtain an assurance value by other method than statistical work of type B in ISO-GUM. It is tried fusion the improvement of worker by QE became important for reservation of the reliability of measurement accuracy and safety. This research was to make the result of Blood Chemical Analysis (BCA) in the field of clinical test.

  19. Radiation safety and quality control assurance in X-ray diagnostics 1998; Saeteilyturvallisuus ja laadunvarmistus roentgendiagnostiikassa 1998

    Energy Technology Data Exchange (ETDEWEB)

    Servomaa, A. [ed.

    1998-03-01

    The report is based on a seminar course of lectures `Radiation safety and quality assurance in X-ray diagnostics 1998` organized by the Radiation and Nuclear Safety Authority (STUK) in Finland. The lectures included actual information on X-ray examinations: methods of quality assurance, methods of measuring and calculating patient doses, examination frequencies, patient doses, occupational doses, and radiation risks. Paediatric X-ray examinations and interventional procedures were the most specific topics. The new Council Directive 97/43/Euratom on medical exposure, and the European Guidelines on quality criteria for diagnostic radiographic images, were discussed in several lectures. Lectures on general radiation threats and preparedness, examples of radiation accidents, and emergency preparedness in hospitals were also included. (editor)

  20. Decree of the Czechoslovak Atomic Energy Commission No. 436/1990 on quality assurance of selected facilities with respect to nuclear safety of nuclear facilities

    International Nuclear Information System (INIS)

    The Decree specifies basic quality assurance requirements applicable to machines, their parts and materials, civil engineering structures, means for automated control of technological processes including hardware and software, and electricity supply systems related to nuclear safety of nuclear facilities, and stipulates binding procedures for the implementation of technical and organizational provisions associated with the quality of selected equipment to ensure nuclear safety of nuclear facilities. Safety classes are defined for selected equipment. Requirements laid on safety assurance documentation are specified, and requirements placed on safety assurance programmes, their preparation, finalization and approval are defined. Quality assurance requirements are also specified with respect to the designing, manufacture, construction, operation, repair, modification and decommissioning of nuclear facilities. The Decree entered into force on 1 December 1990. (J.B.)

  1. Application of quality assurance human factors and reliability principles to the prevention of major environment, safety, and health incidents

    Energy Technology Data Exchange (ETDEWEB)

    Trauth, C.A. Jr.; Ellingson, A.C.; Farr, D.E.; Jercinovic, L.M.

    1978-12-01

    The study described in this report is part of a program to investigate how proven principles and techniques from the disciplines of quality assurance, reliability, and human factors might be used, or modified, to support environment, health, and safety programs. This report describes a study undertaken to determine whether there appears to be genuine, potential benefit from the use or modification of such principles or techniques in accident prevention. Results are based on a hindsight analysis of major accidents which have occurred.

  2. Assuring nuclear safety education into the 21st century in Sweden

    International Nuclear Information System (INIS)

    Full text: In many countries in the Western world there has been a concern for the future competence in nuclear safety in particular and nuclear technology in general. There have been many reasons for this concern, i.e. nuclear power has been debated in many countries, declining research in nuclear safety - and technology area, retiring professors are not replaced and in the case of Sweden the parliament has decided to phase out nuclear power (which resulted in that Barsebaeck 1 reactor was shut down in 1999). Since the beginning of the 1990's the Swedish Centre for Nuclear Technology (SKC) was established and financed by SKI, ABB-Atom (later Westinghouse) and the Swedish utilities. The purpose was to support PhD students with full PhD grants in topics related to nuclear technology. The budget was in the year 2001 about 10 MSEK/year. In Sweden the Government's appropriations directive to SKI for 2001 (and the following years) states that 'SKI shall take action to ensure that the competence required for the safety and non-proliferation work is maintained and developed within SKI as well as at the licensees and elsewhere in the country'. From an educational point of view the year 2001 was a crucial year since undergraduate and postgraduate education at universities and institutes of technology wound up in the risk zone when several professors in nuclear subjects retired. In this situation the Royal Institute of Technology (KTH) announced that financial support was needed in order to fill some of these positions. This applied to the professorships in Nuclear Chemistry and Reactor Technology at KTH. KTH also needed support for the professorship in Reactor Physics. Chalmers University in Technology (Chalmers), on the other hand, had decided to appoint a replacement for the professorship in Nuclear Chemistry. This situation was resolved for the professorship in Nuclear Chemistry at KTH as the Swedish Nuclear Fuel and Waste Management Company decided to support this

  3. Automated nucleic acid amplification testing in blood banks: An additional layer of blood safety

    Directory of Open Access Journals (Sweden)

    Pragati Chigurupati

    2015-01-01

    Full Text Available Context: A total of 30 million blood components are transfused each year in India. Blood safety thus becomes a top priority, especially with a population of around 1.23 billion and a high prevalence rate of human immunodeficiency virus (HIV, hepatitis B virus (HBV and hepatitis C virus (HCV in general population. Nucleic acid amplification testing (NAT in blood donor screening has been implemented in many developed countries to reduce the risk of transfusion-transmitted viral infections (TTIs. NAT takes care of the dynamics of window period of viruses and offers the safest blood pack for donation. Aims: The aim of this study is to show the value of NAT in blood screening. Settings and Design: Dhanavantari Blood Bank, Rajahmundry, Andhra Pradesh, India. Subjects and Methods: Over a period of 1 year from January 2012 to December 2012, a total number of 15,000 blood donor samples were subjected to tests for HIV, HBV, and HCV by enzyme-linked immunosorbent assay (ELISA method and 8000 ELISA nonreactive samples were subjected for NAT using multiplex polymerase chain reaction technology. Results: Of the 15,000 donors tested, 525 were seroreactive. In 8000 ELISA negative blood samples subjected to NAT, 4 donor samples were reactive for HBV. The NAT yield was 1 in 2000. Conclusions: NAT could detect HIV, HBV, and HCV cases in blood donor samples those were undetected by serological tests. NAT could interdict 2500 infectious donations among our approximate 5 million annual blood donations.

  4. Netcentric Information Orchestration: Assuring Information and System Quality in Public Safety Networks

    NARCIS (Netherlands)

    Bharosa, N.

    2011-01-01

    During daily operations, relief agencies such as police, fire brigade and medical services manage information in accordance with their respective processes and organization structure. When disaster strikes, the ad-hoc combinations of such hierarchy based information systems fail to assure high infor

  5. Review: The procurement, storage and quality assurance of frozen blood and tissue biospecimens

    Directory of Open Access Journals (Sweden)

    Manoj S. Charde

    2014-05-01

    Full Text Available The preserved frozen biospecimens are ideal for evaluating the genome, transcriptome, and proteome. Here we present a current overview of experimental data regarding procurement, storage, and quality assurance that can informthe handling of frozen biospecimens. Degradation of frozen biospecimens can be affected by collecting methodology, premortem agonal changes and warm ischemic time during surgery.  Tissue storage at− 80 °C can preserve DNA and protein but RNA show degradation at 5 years, therefore storage at − 150 °C provides significant advantages.  Histologic quality assurance of tissue biospecimens is typically performed at the time of surgery but should also be conducted on the aliquot to be distributed because of tissue heterogeneity.Additional qualityassurance testing should be dictated by the anticipated downstream applications.

  6. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Science.gov (United States)

    2010-07-01

    ... includes the following: (i) Surface safety valves (SSV) and actuators; (ii) Underwater safety valves (USV..., remanufacturing, or hot work such as welding, you must replace it with certified SPPE. (c) Recognizing...

  7. Pathogen Inactivation Technologies: The Advent of Pathogen-Reduced Blood Components to Reduce Blood Safety Risk.

    Science.gov (United States)

    Devine, Dana V; Schubert, Peter

    2016-06-01

    Pathogen inactivation technologies represent a shift in blood safety from a reactive approach to a proactive protective strategy. Commercially available technologies demonstrate effective killing of most viruses, bacteria, and parasites and are capable of inactivating passenger leukocytes in blood products. The use of pathogen inactivation causes a decrease in the parameters of products that can be readily measured in laboratory assays but that do not seem to cause any alteration in hemostatic effect of plasma or platelet transfusions. Effort needs to be made to further develop these technologies so that the negative quality impact is ameliorated without reducing the pathogen inactivation effectiveness. PMID:27112999

  8. Surgical innovation-enhanced quality and the processes that assure patient/provider safety: A surgical conundrum.

    Science.gov (United States)

    Bruny, Jennifer; Ziegler, Moritz

    2015-12-01

    Innovation is a crucial part of surgical history that has led to enhancements in the quality of surgical care. This comprises both changes which are incremental and those which are frankly disruptive in nature. There are situations where innovation is absolutely required in order to achieve quality improvement or process improvement. Alternatively, there are innovations that do not necessarily arise from some need, but simply are a new idea that might be better. All change must assure a significant commitment to patient safety and beneficence. Innovation would ideally enhance patient care quality and disease outcomes, as well stimulate and facilitate further innovation. The tensions between innovative advancement and patient safety, risk and reward, and demonstrated effectiveness versus speculative added value have created a contemporary "surgical conundrum" that must be resolved by a delicate balance assuring optimal patient/provider outcomes. This article will explore this delicate balance and the rules that govern it. Recommendations are made to facilitate surgical innovation through clinical research. In addition, we propose options that investigators and institutions may use to address competing priorities.

  9. Radiation safety and quality assurance in diagnostic x-ray imaging 1999

    International Nuclear Information System (INIS)

    In the European Union, the Directive 97/43/Euratom concerning the medical use of radiation brings many new tasks to radiation users. Quality assurance, patient dose measurement, staff training and clinical audit are among the most essential of these tasks. The Finnish radiation legislation has been modified to comply with the Directive. Much work is still required for practical implementation of these rules. This report deals with applications of the medical radiation Directive. Most applications are still at the planning stage, and clear guidance is lacking. However, the users have to know in time about these plans and future duties concerning them. Experience on quality assurance and clinical audit in hospitals are especially valuable in providing practical information on benefits and problems of these practices. Other radiation related topics, such as radiation risks, radioactivity in foods, and use of radiation in other European countries, are also included in the report. (orig.)

  10. Systematic assessment of core assurance activities in a company specific food safety management system

    NARCIS (Netherlands)

    Luning, P.A.; Marcelis, W.J.; Rovira, J.; Spiegel, van der M.; Uyttendaele, M.; Jacxsens, L.

    2009-01-01

    The dynamic environment wherein agri-food companies operate and the high requirements on food safety force companies to critically judge and improve their food safety management system (FSMS) and its performance. The objective of this study was to develop a diagnostic instrument enabling a systemati

  11. Probability evaluation in problems of structural safety and quality assurance through oriented simulation

    International Nuclear Information System (INIS)

    The procedure described in this work may be considered to improve the Harbitz method by a limitation of the directions corresponding to the sampling points. By the introduction of polar coordinates n-dimensional system, these directions may be limited to those contained in an hypercone, whose axis contains the design point. Some problems with strongly convex failure domain presented in some structural systems (Igusa and Der Kiureghian, 1988; Nadim, 1990) and also in the acceptance probability of analysis and rejection of quality assurance methods may be efficiently treated. (Author)

  12. Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol

    OpenAIRE

    Singh, Hardeep; Ash, Joan S.; Sittig, Dean F.

    2013-01-01

    Background Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to...

  13. Establishment and implementation of common product assurance and safety requirements for the contractors of the Columbus programme

    Science.gov (United States)

    Wessels, H.; Stephan, H. J.

    1991-08-01

    When establishing the Columbus Product Assurance (PA)/safety requirements, the international environment of the Space Station Freedom program has to be taken into account. Considerations given to multiple ways of requirement definition and stages within the European Space Agency (ESA) Procedures, Specifications, and Standards (PSS-01) series of documents and the NASA Space Station requirements are discussed. A series of adaptations introduced by way of tailoring the basic ESA and NASA requirement sets to the Columbus program's needs are described. For the implementation of these tailored requirements, a scheme is developed, which recognizes the PA/safety approach within the European industries by way of various company handbooks and manuals. The changes introduced in the PSS-01 series and the applicable NASA Space Station requirements in recent years, has coincided with the establishment of Columbus PA/safety requirements. To achieve the necessary level of cooperation between ESA and the Columbus industries, a PA Working Group (PAWG) is established. The PAWG supervises the establishement of the Common PA/Safety Plan and the Standards to be used. Due to the high number of European industries participating in the Columbus program, a positive influence on the evolution of the industrial approaches in PA/safety can be expected. Cooperation in the PAWG has brought issues to light which are related to the ESA PSS-01 series and its requirements. Due to the rapid changes of recent years, basic company documentation has not followed the development, specifically as various recent ESA projects use different project specifc issues of the evolving PSS-01 documents.

  14. Safety assurance of cosmetics in Japan: current situation and future prospects.

    Science.gov (United States)

    Inomata, Shinji

    2014-01-01

    The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue. PMID:24389794

  15. Safety assurance of cosmetics in Japan: current situation and future prospects.

    Science.gov (United States)

    Inomata, Shinji

    2014-01-01

    The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue.

  16. Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: A systematic review with regional discussion

    Directory of Open Access Journals (Sweden)

    Asa'ah Nkohkwo

    2016-02-01

    Full Text Available Background: Despite vast improvements in transfusion services in sub-Saharan Africa over the last decade, there remain serious concerns on the safety and adequacy of the blood supply across the region.Objective: This review paper ascertains the role of pathogen reduction technology (PRT in improving blood safety and supply adequacy in the region.Method: The state of blood safety in sub-Saharan Africa was reviewed. Meetings, seminars and correspondence were undertaken with key clinicians, scientists and professional bodies in the region, including the World Health Organization’s Regional Office for Africa, to examine the suitability of PRT for improving the safety of whole blood transfusion, a prevalent transfusion format in the region.Results: Existing literature suggests that combining PRT with current blood safety measures (such as serology would improve the safety and adequacy of the blood supply for transfusions in sub-Saharan Africa. This was echoed by the findings of the stakeholder meetings.Conclusion: Following a detailed appraisal of two leading PRT systems, the Mirasol® PRT System and the Cerus S-303 System, we suggest that companies conduct comprehensive toxicological evaluation of the agents used for PRT and publish this in the scientific literature. We also recommend that the safety and efficacy of these technologies should be established in a randomised clinical trial conducted in sub-Saharan Africa.

  17. Quick assessment tool for assurance of structural safety in the building process

    NARCIS (Netherlands)

    Terwel, K.C.; Jansen, S.J.T.

    2014-01-01

    From forensic investigation it is known that many structural failures can be attributed to human errors and organizational factors. To provide project leaders with information on the current state of factors in the building process influencing structural safety, we developed a quick assessment tool.

  18. Processing and storage of blood components: strategies to improve patient safety

    Directory of Open Access Journals (Sweden)

    Pietersz RNI

    2015-08-01

    Full Text Available Ruby NI Pietersz, Pieter F van der Meer Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, the Netherlands Abstract: This review focuses on safety improvements of blood processing of various blood components and their respective storage. A solid quality system to ensure safe and effective blood components that are traceable from a donor to the patient is the foundation of a safe blood supply. To stimulate and guide this process, National Health Authorities should develop guidelines for blood transfusion, including establishment of a quality system. Blood component therapy enabled treatment of patients with blood constituents that were missing, only thus preventing reactions to unnecessarily transfused elements. Leukoreduction prevents many adverse reactions and also improves the quality of the blood components during storage. The safety of red cells and platelets is improved by replacement of plasma with preservative solutions, which results in the reduction of isoantibodies and plasma proteins. Automation of blood collection, separation of whole blood into components, and consecutive processing steps, such as preparation of platelet concentrate from multiple donations, improves the consistent composition of blood components. Physicians can better prescribe the number of transfusions and therewith reduce donor exposure and/or the risk of pathogen transmission. Pathogen reduction in cellular blood components is the latest development in improving the safety of blood transfusions for patients. Keywords: blood components, red cell concentrates, platelet concentrates, plasma, transfusion, safety 

  19. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    Science.gov (United States)

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. PMID:19025323

  20. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    Science.gov (United States)

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study.

  1. FOOD QUALITY AND SAFETY ASSURANCE IN TERMS OF LOSS AND WASTE LIMITATION

    Directory of Open Access Journals (Sweden)

    Maria Śmiechowska

    2016-06-01

    Full Text Available One of the greatest challenges of 21st century is satisfying the food needs of the fast growing population of the world. Food must fulfill quality and safety standards.  The access to safe and appropriate food is not the same everywhere.  Food excess and, in consequence, food waste is present in many regions of the world. This study is meant to explain the causes of food waste on the basis of the author’s own research and study results of other scientists. The lack of authenticity and falsification belong to the new factors endangering food safety and food waste related thereto. This analysis proves that the authenticity of food improves its safety through the implementation of quality management systems, the appropriate system of food labelling and food identification by means of applicable law regulations, supervision and control systems. Main aim of this study is to address why, even though there are so many quality standards and systems, a significant problem with food loss and waste constantly occurs. Waste-causing factors have been determined on the example of bread and the handling of unconsumed bread has been attempted in this study. Waste limiting actions are necessary as food production is significantly overburdening the natural environment and generating increasing amount of waste, hazardous to the clean air. 

  2. Assuring nuclear safety competence into the 21. century a swedish perspective

    International Nuclear Information System (INIS)

    Many initiatives have been taken and are being considered to maintain and develop competence in the nuclear field in Sweden. The number of qualified nuclear engineering staff at the plants and at the regulatory bodies appears to be rather small for all important tasks to be carried out. Nevertheless, the current programmes indicate that one can look at future recruitment and competence with some confidence-in spite of the age profile of qualified staff with many approaching retirement. The Swedish Nuclear Power Inspectorate, (SKI), the academic community, and the Industry are conducting several research projects that support the optimistic view expressed above. Examples include: Safety research at SKI and universities: Since many years, SKI is sponsoring research in safety analysis within the framework of its Research Programme. In this programme the regulator supports two professors, one in Nuclear Power Safety at KTH and the other in the Interaction of Man, Technology and Organisation at the University of Stockholm. Swedish Centre of Nuclear Technology: A main activity of the Centre is to support PhD candidates (with scientific advice and economy) in topics related to nuclear technology. The Industry also makes great efforts to support recruitment by various initiatives: Design reconstitution projects: Each one of the older operating plants was subject to a design review that engaged a large number of young staff at the utilities and the vendors. 'Young Generation': It constitutes a communication network among young engineers at European nuclear plants, regulators, and other organisations. (authors)

  3. Revitalizing quality assurance

    International Nuclear Information System (INIS)

    The image of someone inspecting or auditing often comes to mind when people hear the term quality assurance. Although partially correct, this image is not the complete picture. The person doing the inspecting or auditing is probably part of a traditional quality assurance organization, but that organization is only one aspect of a properly conceived and effectively implemented quality assurance system whose goal is improved facility safety and reliability. This paper introduces the underlying philosophies and basic concepts of the International Atomic Energy Agency's new quality assurance initiative that began in 1991 as part of a broad Agency-wide program to enhance nuclear safety. The first product of that initiative was publication in 1996 of a new Quality Assurance Code 50-C/SG-Q and fourteen related Safety Guides. This new suite of documents provide the technical and philosophical foundation upon which Member States can base their quality assurance programs. (author)

  4. Targeting of blood safety measures to affected areas with ongoing local transmission of malaria.

    Science.gov (United States)

    Domanović, D; Kitchen, A; Politis, C; Panagiotopoulos, T; Bluemel, J; Van Bortel, W; Overbosch, D; Lieshout-Krikke, R; Fabra, C; Facco, G; Zeller, H

    2016-06-01

    An outbreak of locally acquired Plasmodium vivax malaria in Greece started in 2009 and peaked in 2011. Targeting of blood safety measures to affected areas with ongoing transmission of malaria raised questions of how to define spatial boundaries of such an area and when to trigger any specific blood safety measures, including whether and which blood donation screening strategy to apply. To provide scientific advice the European Centre for Disease Prevention and Control (ECDC) organised expert meetings in 2013. The outcomes of these consultations are expert opinions covering spatial targeting of blood safety measures to affected areas with ongoing local transmission of malaria and blood donation screening strategy for evidence of malaria infection in these areas. Opinions could help EU national blood safety authorities in developing a preventive strategy during malaria outbreaks. PMID:27238883

  5. Engineering support services for the DOE/GRI coal gasification research program. Safety assurance study of high-Btu coal-gasification pilot plants and process development units

    Energy Technology Data Exchange (ETDEWEB)

    Bostwick, L.E.; Chen, R.G.; Coyle, D.A.; Ethridge, T.R.; Hubbard, D.A.; Scales, D.; Senules, E.A.; Shah, K.V.; Singer, D.L.; Smith, M.R.

    1981-04-01

    The purpose of this study was to identify risks and provide suggestions to improve and assure the safety of the high BTU coal gasification units (pilot plants and process development units) currently in the joint US Department of Energy and The Gas Research Institute (DOE/GRI) program. This was accomplished by performing a systematic detailed investigation of the gasifiers for each of the processes to identify operating conditions or equipment deficiences that could lead to potential hazards. This report documents the potential hazards identified to date. It is expected that the study will contribute to the improved safety aspect of larger scale production units by providing descriptions of the lessons learned. This safety assurance study involved a detailed systematic investigation of the gasifier area and related equipment of six different gasification units: Bell Aerosopace, BI-GAS, Exxon, Hygas, Rockwell and Westinghouse.

  6. Optical biosensors for food quality and safety assurance-a review.

    Science.gov (United States)

    Narsaiah, K; Jha, Shyam Narayan; Bhardwaj, Rishi; Sharma, Rajiv; Kumar, Ramesh

    2012-08-01

    Food quality and safety is a scientific discipline describing handling, preparation and storage of food in ways that prevent food borne illness. Food serves as a growth medium for microorganisms that can be pathogenic or cause food spoilage. Therefore, it is imperative to have stringent laws and standards for the preparation, packaging and transportation of food. The conventional methods for detection of food contamination based on culturing, colony counting, chromatography and immunoassay are tedious and time consuming while biosensors have overcome some of these disadvantages. There is growing interest in biosensors due to high specificity, convenience and quick response. Optical biosensors show greater potential for the detection of pathogens, pesticide and drug residues, hygiene monitoring, heavy metals and other toxic substances in the food to check whether it is safe for consumption or not. This review focuses on optical biosensors, the recent developments in the associated instrumentation with emphasis on fiber optic and surface plasmon resonance (SPR) based biosensors for detecting a range of analytes in food samples, the major advantages and challenges associated with optical biosensors. It also briefly covers the different methods employed for the immobilization of bio-molecules used in developing biosensors. PMID:23904648

  7. Medicinal plants in the treatment of women's disorders: Analytical strategies to assure quality, safety and efficacy.

    Science.gov (United States)

    Masullo, Milena; Montoro, Paola; Mari, Angela; Pizza, Cosimo; Piacente, Sonia

    2015-09-10

    During last decades an increasing number of herbal products specifically targeting women's disorders has appeared in the worldwide marketplace. This growth highlights the need for a critical evaluation of quality, safety and efficacy of these products. Analytical techniques applied to the quality control of the main medicinal plants used for women health (relief of menopause and menstrual related symptoms) have been reviewed. Thanks to the innovation in analytical technology, identification and detection of secondary metabolites dramatically improved. In particular, hyphenated techniques have proved to be the most suitable for the rapid identification of compounds in plant matrix. Moreover, taking into account that differences in sample quality are not only found in the main compounds or in the chemical markers but also in the low-concentration compounds, fingerprint analysis might be a simple way for identification and quality control of herbal products containing a large number of low amounts of unknown compounds. Furthermore in several papers the informations obtained from the analysis of a plant have been processed by statistical elaborations. Medicinal plants here discussed are classified on the basis of the chemical markers used for their quality control. PMID:25863356

  8. Optical biosensors for food quality and safety assurance-a review.

    Science.gov (United States)

    Narsaiah, K; Jha, Shyam Narayan; Bhardwaj, Rishi; Sharma, Rajiv; Kumar, Ramesh

    2012-08-01

    Food quality and safety is a scientific discipline describing handling, preparation and storage of food in ways that prevent food borne illness. Food serves as a growth medium for microorganisms that can be pathogenic or cause food spoilage. Therefore, it is imperative to have stringent laws and standards for the preparation, packaging and transportation of food. The conventional methods for detection of food contamination based on culturing, colony counting, chromatography and immunoassay are tedious and time consuming while biosensors have overcome some of these disadvantages. There is growing interest in biosensors due to high specificity, convenience and quick response. Optical biosensors show greater potential for the detection of pathogens, pesticide and drug residues, hygiene monitoring, heavy metals and other toxic substances in the food to check whether it is safe for consumption or not. This review focuses on optical biosensors, the recent developments in the associated instrumentation with emphasis on fiber optic and surface plasmon resonance (SPR) based biosensors for detecting a range of analytes in food samples, the major advantages and challenges associated with optical biosensors. It also briefly covers the different methods employed for the immobilization of bio-molecules used in developing biosensors.

  9. Use of decision criteria based on expected values to support decision-making in a production assurance and safety setting

    International Nuclear Information System (INIS)

    We consider decision problems related to production assurance and safety. The issue is to what extent we should use decision criteria based on expected values, such as the expected net present value (E[NPV]) and the expected cost per expected number of saved lives (ICAF), to guide the decision. Such criteria are recognised as practical tools for supporting decision-making under uncertainty, but is uncertainty adequately taken into account by these criteria? Based on the prevailing practice and the existing literature, we conclude that there is a need for a clarification of the rationale of these criteria. Adjustments of the standard approaches have been suggested to reflect risks and uncertainties, but can cautionary and precautionary concerns be replaced by formulae and mechanical procedures? These issues are discussed in the present paper, particularly addressing the company level. We argue that the search for such formulae and procedures should be replaced by a more balanced perspective acknowledging that there will always be a need for management review and judgment beyond the realm of the analyses. Most of the suggested adjustments of the E[NPV] and ICAF approaches should be avoided. They add more confusion than value.

  10. Blood donor selection and deferral pattern as an important tool for blood safety in a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Manisha Shrivastava

    2016-01-01

    Full Text Available Context: Blood donor selection criteria based on science and regulatory rules influence donor as well recipient safety and demographics. Aim: To evaluate and analyze the blood donor deferral pattern and its causes among blood donors in a tertiary care hospital blood bank and to review its influence on blood safety. Settings and Design: Hospital based blood bank, retrospective analysis. Subjects and Methods: The data available as donor deferral record over a period of 13 years from 2001 to 2013 was analyzed. Results: The blood donor deferral rate was 11.5%, the deferral rate in various categories was 4.8%, 4.7%, 1.6%, and 0.3% in Category 1, Category 2, Category 3, and Category 4, respectively. The majority of deferrals were temporary deferrals (62.8% of young donors. The maximum number of donors deferred (28.2% due to a history of jaundice (permanent followed by 19.4% due to low hemoglobin (temporary. History of malaria, intake of medicines, infections, underweight, last blood donation within 3 months (temporary deferral, and history of heart and lung diseases, diabetes, and with suspicious identity (permanent deferral were other major causes identified. Conclusion: The pattern of donor deferral identified is an important tool for blood safety and also provides key areas to focus on a region or policy formulation nationally for donor selection as well ensure donor safety. The value of determining donor deferral pattern by the categories described is in calling back donors deferred due to temporary reasons and can help retain pool of motivated blood donors.

  11. Applications of radiation processing in combination with conventional treatments to assure food safety: New development

    Energy Technology Data Exchange (ETDEWEB)

    Lacroix, M. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada)], E-mail: monique.lacroix@iaf.inrs.ca; Turgis, M. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada); Borsa, J. [MDS Nordion, 447 March Road, Kanata, Ontario, K2K 2P7 (Canada); Millette, M.; Salmieri, S.; Caillet, S. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada); Han, J. [Sungkyunkwan University, Department of Food Science and Biotechnology, Suwon 440-746 (Korea, Republic of)

    2009-11-15

    Spice extracts under the form of essential oils (Eos) were tested for their efficiency to increase the relative bacterial radiosensitivity (RBR) of Listeria monocytogenes, Escherichia coli and Salmonellatyphi in culture media under different atmospheric conditions. The selected Eos were tested for their ability to reduce the dose necessary to eliminate E. coli and S.typhi in medium fat ground beef (23% fat) and Listeria in ready-to-eat carrots when packed under air or under atmosphere rich in oxygen (MAP). Results have demonstrated that depending of the compound added and the combined treatment used, the RBR increased from 2 to 4 times. In order to evaluate the industrial feasibility, EOs were added in ground beef at a concentration which does not affect the taste and treated at a dose of 1.5 kGy. The content of total mesophilic aerobic, E. coli, Salmonella, total coliform, lactic acid bacteria, and Pseudomonas was determined during 28 days. The results showed that the combined treatment (radiation and EOs) can eliminate Salmonella and E. coli when done under air. When done under MAP, Pseudomonas could be eliminated and a shelf life of more than 28 days was observed. An active edible coating containing EOs was also developed and sprayed on ready-to-eat carrots before radiation treatment and Listeria was evaluated. A complete inhibition of Listeria was obtained at a dose of 0.5 kGy when applied under MAP. Our results have shown that the combination of an edible coating, MAP, and radiation can be used to maintain the safety of meat and vegetables.

  12. Applications of radiation processing in combination with conventional treatments to assure food safety: New development

    International Nuclear Information System (INIS)

    Spice extracts under the form of essential oils (Eos) were tested for their efficiency to increase the relative bacterial radiosensitivity (RBR) of Listeria monocytogenes, Escherichia coli and Salmonellatyphi in culture media under different atmospheric conditions. The selected Eos were tested for their ability to reduce the dose necessary to eliminate E. coli and S.typhi in medium fat ground beef (23% fat) and Listeria in ready-to-eat carrots when packed under air or under atmosphere rich in oxygen (MAP). Results have demonstrated that depending of the compound added and the combined treatment used, the RBR increased from 2 to 4 times. In order to evaluate the industrial feasibility, EOs were added in ground beef at a concentration which does not affect the taste and treated at a dose of 1.5 kGy. The content of total mesophilic aerobic, E. coli, Salmonella, total coliform, lactic acid bacteria, and Pseudomonas was determined during 28 days. The results showed that the combined treatment (radiation and EOs) can eliminate Salmonella and E. coli when done under air. When done under MAP, Pseudomonas could be eliminated and a shelf life of more than 28 days was observed. An active edible coating containing EOs was also developed and sprayed on ready-to-eat carrots before radiation treatment and Listeria was evaluated. A complete inhibition of Listeria was obtained at a dose of 0.5 kGy when applied under MAP. Our results have shown that the combination of an edible coating, MAP, and radiation can be used to maintain the safety of meat and vegetables.

  13. Applications of radiation processing in combination with conventional treatments to assure food safety: New development

    Science.gov (United States)

    Lacroix, M.; Turgis, M.; Borsa, J.; Millette, M.; Salmieri, S.; Caillet, S.; Han, J.

    2009-11-01

    Spice extracts under the form of essential oils (Eos) were tested for their efficiency to increase the relative bacterial radiosensitivity (RBR) of Listeria monocytogenes, Escherichia coli and Salmonellatyphi in culture media under different atmospheric conditions. The selected Eos were tested for their ability to reduce the dose necessary to eliminate E. coli and S.typhi in medium fat ground beef (23% fat) and Listeria in ready-to-eat carrots when packed under air or under atmosphere rich in oxygen (MAP). Results have demonstrated that depending of the compound added and the combined treatment used, the RBR increased from 2 to 4 times. In order to evaluate the industrial feasibility, EOs were added in ground beef at a concentration which does not affect the taste and treated at a dose of 1.5 kGy. The content of total mesophilic aerobic, E. coli, Salmonella, total coliform, lactic acid bacteria, and Pseudomonas was determined during 28 days. The results showed that the combined treatment (radiation and EOs) can eliminate Salmonella and E. coli when done under air. When done under MAP, Pseudomonas could be eliminated and a shelf life of more than 28 days was observed. An active edible coating containing EOs was also developed and sprayed on ready-to-eat carrots before radiation treatment and Listeria was evaluated. A complete inhibition of Listeria was obtained at a dose of 0.5 kGy when applied under MAP. Our results have shown that the combination of an edible coating, MAP, and radiation can be used to maintain the safety of meat and vegetables.

  14. Improving health profile of blood donors as a consequence of transfusion safety efforts

    DEFF Research Database (Denmark)

    Edgren, Gustaf; Tran, Trung Nam; Hjalgrim, Henrik;

    2007-01-01

    BACKGROUND: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted in impro......BACKGROUND: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted...

  15. Investments in blood safety improve the availability of blood to underserved areas in a sub-saharan african country

    NARCIS (Netherlands)

    Pitman, J.P.; Wilkinson, R.L.; Basavaraju, S.V.; Von Finckenstein, B.G.; Sibinga, C.T.H.; Marfin, A.; Postma, M.J.; Mataranyika, M.N.; Tobias, J.L.

    2014-01-01

    Background: Since 2004, several African countries, including Namibia, have received assistance from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Aims: Gains have been documented in the safety and number of collected units in these countries, but the distribution of blood has not bee

  16. Safety and radiation risks in the labelling of blood cells

    International Nuclear Information System (INIS)

    Risk in the management of radioactive material and biological exposition to infectious agents. Protocols and normative to observe GOOD RADIOPHARMACY Practices. Main infectious agents that may be transmitted during preparation of a blood cell radiopharmaceutical. Problems of contamination

  17. Introduction to Iranian Blood Transfusion Organization and Blood Safety in Iran

    Directory of Open Access Journals (Sweden)

    H Abolghasemi

    2009-03-01

    Full Text Available "nCurrently, in Iran blood transfusion is an integral part of the national health system and blood donation is voluntary and non­remu­nerated and blood and its components may not be a source of profit. In 1974 and following establishment of Iranian Blood Transfusion Organization (IBTO all blood transfusion activities from donor recruitment to production of blood com­po­nents and delivery of blood and blood products were centralized. The activities of IBTO are followed the laws and regu­la­tions of Ministry of Health and criteria of Iran National Regulatory Authority. In order to meet the country's demand in 2007 IBTO collected about 1.7 millions units of blood from the population of 70 millions. In 1979 coincided with the Is­lamic revolution the number of  blood units collected throughout the country were 124,000 units or 3.4 unit per 1000 popu­la­tion whereas after about 30 years this increased to about 25 unit per 1000 population. With improving the pool of vol­un­tary donors, IBTO has been successful in excluding "family replacement" donation since 2007 and reached to 100% volun­tary and nonremunerated blood donation. Currently more than 92% of blood donors in Iran are male and contribution of fe­male in blood donation is less than 8%. Although all donated blood in Iran screened for HBsAg since 1974, screening of blood units for HIV and HCV started since 1989 and 1996, respectively. The frequency of HBV infection in blood do­nors showed a significant decline from 1.79% in 1998 to 0.4% in 2007. The overall frequency of HCV and HIV infection are 0.13% and 0.004% respectively.

  18. Blood safety measures and the role of central blood institute in Japan

    Institute of Scientific and Technical Information of China (English)

    Kenji Tadokoro

    2010-01-01

    @@ 1 Japanese Blood Programme Japanese Red Cross Blood Service is the sole conductor of blood service in Japan. It collects 5.3 million volun-tary non-remunerated donations from 127 million popu-lations and distributes 18 million units ( one unit = 200 ml,2 million Liter) blood matching the medical needs.A part of plasma is supplied to the JRCBS fractionation center and other 3 commercial manufacturers for pro-duction of plasma derivatives.

  19. [Quality and quality assurance, a European problem].

    Science.gov (United States)

    Schmitt, H

    1994-01-01

    The problem of quality and quality assurance for the free exchange of blood and blood products in Europe is discussed. The background of all discussion of quality is the categorical theory of Aristoteles. The philosophical basis is described. The fundamental law of the daily work of a blood center has to be a philosophy of quality which depends on the sociodemographic situation in the region. This basic varies from country to country in Europe. The importance of the supranational bodies in Europe is mentioned. The weightness of the Code of Ethics is discussed. Virus safety, purity and validity of blood and blood products are described as parameters of the quality aspects. Finally it is confirmed that a well running blood program is a multicategorical problem.

  20. Quality assurance for safety in nuclear power plants and other nuclear installations. Code and safety guides Q1-Q14. A publication within the NUSS programme

    International Nuclear Information System (INIS)

    The code provides the basic requirements for establishing and implementing quality assurance programmes for the stages of siting, design, construction, commissioning, operation and decommissioning of nuclear power plants. These basic requirements apply to all individuals and organizations, including designers, suppliers, constructors, manufacturers and operators. The basic quality assurance requirements presented in this Code also apply, with appropriate modifications, to nuclear installations other than nuclear power plants

  1. Towards improvement in quality assurance

    International Nuclear Information System (INIS)

    This first document in the series of the International Nuclear Safety Advisory Group (INSAG) Technical Notes is a general guideline for the establishment of effective quality assurance procedures at nuclear facilities. It sets out primary requirements such as quality objectives, methods for measuring the effectiveness of the quality assurance programme, priority of activities in relation to importance of safety of items, motivation of personnel

  2. 基于供应链视域的我国食品安全保障模式研究%Research on Food Safety Assurance Mode from the Perspective of Food Supply Chains

    Institute of Scientific and Technical Information of China (English)

    代文彬; 慕静; 马永军

    2014-01-01

    针对目前供应链食品安全保障模式研究不足的问题,本文以案例研究为基本研究方法,选取中粮集团、双汇集团和寿光蔬菜为案例研究对象,探索供应链食品安全保障先进模式。研究认为供应链食品安全保障模式是食品安全战略规划、食品安全内控环境、食品安全信息科技、食品安全风险防控等方面耦合作用的一种运行状态;通过对供应链食品安全保障模式的具体内容进行阐释,期望为食品供应链核心企业加强食品安全保障提供理论参考。%Due to research on food safety assurance mode of food supply chains is insufficient at present , the paper, a-dopts case study as its basic research method , and selects COFCO , Shineway Group and Shouguang Vegetables as study objects to explore advanced food safety assurance mode of food supply chains. The findings reveal that food safety assur-ance mode of food supply chains is the result of coupling effect of food safety strategy and planning , food safety internal control environment , food safety information and technology , food safety risk prevention and control .Clarifying food safe-ty assurance mode of supply chains in details helps to offer theoretical references for core enterprises in food supply chains to strengthen food safety assurance .

  3. Expensive blood safety initiatives may offer less benefit than we think

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Hjalgrim, Henrik; Edgren, Gustaf;

    2010-01-01

    Various blood safety initiatives have ensured a historically low risk of infection transmission through blood transfusion. Although further prevention of infection transmission is possible through, for example, nucleic acid testing and future introduction of pathogen inactivation, such initiatives...... are very costly in relation to the benefit they offer. Although estimation of the cost-effectiveness requires detailed information about the survival of transfusion recipients, previous cost-effectiveness analyses have relied on incorrect survival assumptions....

  4. Review of the Constellation Level II Safety, Reliability, and Quality Assurance (SR&QA) Requirements Documents during Participation in the Constellation Level II SR&QA Forum

    Science.gov (United States)

    Cameron, Kenneth D.; Gentz, Steven J.; Beil, Robert J.; Minute, Stephen A.; Currie, Nancy J.; Scott, Steven S.; Thomas, Walter B., III; Smiles, Michael D.; Schafer, Charles F.; Null, Cynthia H.; Bay, P. Michael

    2009-01-01

    At the request of the Exploration Systems Mission Directorate (ESMD) and the Constellation Program (CxP) Safety, Reliability; and Quality Assurance (SR&QA) Requirements Director, the NASA Engineering and Safety Center (NESC) participated in the Cx SR&QA Requirements forum. The Requirements Forum was held June 24-26; 2008, at GRC's Plum Brook Facility. The forums purpose was to gather all stakeholders into a focused meeting to help complete the process of refining the CxP to refine its Level II SR&QA requirements or defining project-specific requirements tailoring. Element prime contractors had raised specific questions about the wording and intent of many requirements in areas they felt were driving costs without adding commensurate value. NESC was asked to provide an independent and thorough review of requirements that contractors believed were driving Program costs, by active participation in the forum. This document contains information from the forum.

  5. Healthcare Software Assurance

    OpenAIRE

    Cooper, Jason G.; Pauley, Keith A.

    2006-01-01

    Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Dru...

  6. Dengue viremia in blood donors in Northern India: Challenges of emerging dengue outbreaks to blood transfusion safety

    Directory of Open Access Journals (Sweden)

    Sadhana Mangwana

    2015-01-01

    Full Text Available Backdround: Emerging infectious diseases pose threats to the general human population; including recipients of blood transfusions. Dengue is spreading rapidly to new areas and with increasing frequency of major outbreaks. Screening blood for dengue antigens in dengue-endemic countries would be costly and should, therefore, be recommended only after careful assessment of risk for infection and cost. Aim: A prospective study was conducted to establish the magnitude of the threat that dengue poses to blood safety where it is sporadic with seasonal variations, to quantify risk and to assess that whether screening is feasible and cost-effective. Materials and Methods: Nonstructural protein 1 (NS1 antigen test was done on 1709 donations during dengue outbreak in the months August to November 2013 as an additional test using Bio-Rad Platelia Dengue NS1AG test kit which is one step sandwich format microplate enzyme immunoassay using murine monoclonal antibodies for capture and revelation. Chi-square test was used to find statistical significance. Results and Conclusions: Majority cases were whole blood, replacement, male donors with 76.10% donors in <35 years age group. About 17.85% were single donor platelet donations. NS1 antigen in all donors was negative. In the past, dengue affected mainly children who do not donate blood. With the changing trend, mean age of infection increased affecting the population that does donate blood, further reducing blood donation pool. Further studies need to be done in different geographic regions of the country during dengue transmission season to establish maximum incidence of viremic donations, rates of transfusion transmission and clinical consequences in recipients. If risk is found to be substantial, decision will be taken by the policymakers at what threshold screening should be instituted to ensure safe blood transfusion.

  7. Radiation safety and quality assurance in diagnostic x-ray imaging 1999; Saeteilyturvallisuus ja laadunvarmistus roentgendiagnostiikassa 1999

    Energy Technology Data Exchange (ETDEWEB)

    Servonmaa, A. [ed.

    1999-04-01

    In the European Union, the Directive 97/43/Euratom concerning the medical use of radiation brings many new tasks to radiation users. Quality assurance, patient dose measurement, staff training and clinical audit are among the most essential of these tasks. The Finnish radiation legislation has been modified to comply with the Directive. Much work is still required for practical implementation of these rules. This report deals with applications of the medical radiation Directive. Most applications are still at the planning stage, and clear guidance is lacking. However, the users have to know in time about these plans and future duties concerning them. Experience on quality assurance and clinical audit in hospitals are especially valuable in providing practical information on benefits and problems of these practices. Other radiation related topics, such as radiation risks, radioactivity in foods, and use of radiation in other European countries, are also included in the report. (orig.)

  8. Separation Assurance and Collision Avoidance

    Science.gov (United States)

    Lauderdale, Todd

    2010-01-01

    Objective SACA-1: Determine the level of safety provided by tactical separation assurance safety monitoring systems for UAS missions. a) Rationale: Continuous mission-risk monitoring can provide equivalent levels of safety for UAS operations possibly reducing the burden on other safety systems. b) Approach: Utilize and adapt algorithms and approaches developed for the NextGen Airspace Systems Program for UAS applications.

  9. Leucoreduction of blood components: an effective way to increase blood safety?

    Science.gov (United States)

    Bianchi, Maria; Vaglio, Stefania; Pupella, Simonetta; Marano, Giuseppe; Facco, Giuseppina; Liumbruno, Giancarlo M; Grazzini, Giuliano

    2016-05-01

    Over the past 30 years, it has been demonstrated that removal of white blood cells from blood components is effective in preventing some adverse reactions such as febrile non-haemolytic transfusion reactions, immunisation against human leucocyte antigens and human platelet antigens, and transmission of cytomegalovirus. In this review we discuss indications for leucoreduction and classify them into three categories: evidence-based indications for which the clinical efficacy is proven, indications based on the analysis of observational clinical studies with very consistent results and indications for which the clinical efficacy is partial or unproven. PMID:26710353

  10. Blood donation in China: sustaining efforts and challenges in achieving safety and availability.

    Science.gov (United States)

    Yin, Yong-Hua; Li, Chang-Qing; Liu, Zhong

    2015-10-01

    China has entered a new phase in blood safety and availability through persistent efforts in the past decades. Based on national data from 2008 to 2012, we present a comprehensive review on the blood services ranging from policy and organization, supply, donors, screening and processing, and clinical use to government response in contemporary China. Current evidence suggests that the Chinese blood industries, after continual efforts in reforms on the legal framework and national management system, have been in a relatively steady but bottleneck stage. Although the blood industries have had an impressive track record on management and resolving problems, such as low availability, limited donors, deficient laboratory tests, shortage of blood products, and unnecessary clinical usage of blood still exist nationwide. While medical technology and services have seen a rapid increase in progress in recent years, they have not coordinated with the development of the national health care system. This article presents an analysis with detailed data, rich contents, and recent response from the Chinese government, allowing readers to appreciate how China, a country with more than 19.13% of the world's population, has long endeavored to improve safety and availability of blood. Meantime, the article sincerely welcomes the guidance on policymaking and technical assistance from the international community. Data in this article do not include those of Hong Kong, Macao, or Taiwan.

  11. Practical experience with quality assurance and quality control of instrumentation and control systems - the safety assessors view

    International Nuclear Information System (INIS)

    The paper shows up the inital situation (approx. 1974) concerning QA and QC of I and C-Systems of the Austrian Nuclear Power PLant at Zwentendorf. The main problems were the diversity of manufacturers, QA-levels, parameters. Good communication between all involved parts (vendor, utility, safety assessors) turned out to be one of the most important prerequisites for the safety review work. Then it is exposed how the safety review work was done and some highlights are mentioned. (auth.)

  12. Health economics of blood transfusion safety - focus on sub-Saharan Africa

    NARCIS (Netherlands)

    van Hulst, Marinus; Sibinga, Cees Th. Smit; Postma, Maarten J.

    2010-01-01

    Background and objectives. Health economics provides a standardised methodology for valid comparisons of interventions in different fields of health care. This review discusses the health economic evaluations of strategies to enhance blood product safety in sub-Saharan Africa Methods. We reviewed he

  13. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-12-08

    ... HUMAN SERVICES Nominations to the Advisory Committee on Blood Safety and Availability AGENCY: Office of... Committee for up to four-year terms. DATES: All nominations must be received no later than 4 p.m. EDT on... nominate themselves for consideration of appointment to the Committee. All nominations must include...

  14. Post-thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes.

    Science.gov (United States)

    Morgenstern, Daniel A; Ahsan, Gulrukh; Brocklesby, Margaret; Ings, Stuart; Balsa, Carmen; Veys, Paul; Brock, Penelope; Anderson, John; Amrolia, Persis; Goulden, Nicholas; Cale, Catherine M; Watts, Michael J

    2016-09-01

    Standard quality assurance (QA) of cryopreserved peripheral blood stem cells (PBSC) uses post-thaw viable CD34(+) cell counts. In 2013, concerns arose at Great Ormond Street Hospital (GOSH) about 8 patients with delayed engraftment following myeloablative chemotherapy with cryopreserved cell rescue, despite adequate post-thaw viable cell counts in all cases. Root cause analysis was undertaken; investigations suggested the freeze process itself was a contributing factor to suboptimal engraftment. Experiments were undertaken in which a single PBSC product was divided into three and cryopreserved in parallel using a control-rate freezer (CRF) or passive freezing method (-80°C freezer) at GOSH, or the same passive freezing at another laboratory. Viable CD34(+) counts were equivalent and adequate in each. Granulocyte-monocyte colony-forming unit assays demonstrated colonies from the products cryopreserved using passive freezing (both laboratories), but no colonies from products cryopreserved using the CRF. The CRF was shown to be operating within manufacturer's specifications with freeze-profile within acceptable limits. This experience has important implications for quality assurance for all transplant programmes, particularly those using cryopreserved products. The failure of post-thaw viable CD34(+) counts, the most widely used routine QA test available, to ensure PBSC function is of great concern and should prompt reassessment of protocols and QA procedures. PMID:27291859

  15. An Application Example Analysis of Quality Assurance Program for STELLA(Sodium Integral Effect Test Loop for Safety Simulation and Assessment) Project

    International Nuclear Information System (INIS)

    KAERI has been conducting various basic R and D activities in the field of nuclear technology. In addition, KAERI is now participating in the Generation IV International Forum (GIF), preparing for the development of key technologies for Generation IV nuclear energy system, including Sodium cooled Fast Reactor (SFR) development. All of the key technologies for SFR development need an appropriate level of QA activities to achieve the GIF safety and performance objectives. Therefore, QA activities have been conducted as an essential part of the national SFR project. As a result, QAM (Quality Assurance Manual) and QAP (Quality Assurance Procedures) have been developed for the SFR project, which are based on ASME NQA-1, KEPIC QAP and the GIF Quality Management System Guidelines. In this work, the introduction background and application examples of the QA program for the STELLA project were investigated. Application of the QA for the STELLA project has great significance because the QA has been mainly applied for the nuclear power plant area in operation, which helps ensure the reliability of the test data and completeness of the research performance. Nevertheless, developing more appropriate QA procedures remains a major task because some parts of them are not applicable to the Na-experiment

  16. Guidance for the design and management of a maintenance plan to assure safety and improve the predictability of a DOE nuclear irradiation facility. Final report

    International Nuclear Information System (INIS)

    A program is recommended for planning the maintenance of DOE nuclear facilities that will help safety and enhance availability throughout a facility's life cycle. While investigating the requirements for maintenance activities, a major difference was identified between the strategy suitable for a conventional power reactor and one for a research reactor facility: the latter should provide a high degree of predicted availability (referred to hereafter as ''predictability'') to its users, whereas the former should maximize total energy production. These differing operating goals necessitate different maintenance strategies. A strategy for scheduling research reactor facility operation and shutdown for maintenance must balance safety, reliability,and predicted availability. The approach developed here is based on three major elements: (1) a probabilistic risk analysis of the balance between assured reliability and predictability (presented in Appendix C), (2) an assessment of the safety and operational impact of maintenance activities applied to various components of the facility, and (3) a data base of historical and operational information on the performance and requirements for maintenance of various components. These factors are integrated into a set of guidelines for designing a new highly maintainable facility, for preparing flexible schedules for improved maintenance of existing facilities, and for anticipating the maintenance required to extend the life of an aging facility. Although tailored to research reactor facilities, the methodology has broader applicability and may therefore be used to improved the maintenance of power reactors, particularly in anticipation of peak load demands

  17. Quality-Assurance Program Plan

    International Nuclear Information System (INIS)

    This Quality Assurance Program Plan (QAPP) is provided to describe the Quality Assurance Program which is applied to the waste management activities conducted by AESD-Nevada Operations at the E-MAD Facility located in Area 25 of the Nevada Test Site. The AESD-Nevada Operations QAPP provides the necessary systematic and administrative controls to assure activities that affect quality, safety, reliability, and maintainability during design, procurement, fabrication, inspection, shipments, tests, and storage are conducted in accordance with established requirements

  18. WHO informal consultation on the application of molecular methods to assure the quality, safety and efficacy of vaccines, Geneva, Switzerland, 7-8 April 2005.

    Science.gov (United States)

    Shin, Jinho; Wood, David; Robertson, James; Minor, Philip; Peden, Keith

    2007-03-01

    In April 2005, the World Health Organization convened an informal consultation on molecular methods to assure the quality, safety and efficacy of vaccines. The consultation was attended by experts from national regulatory authorities, vaccine industry and academia. Crosscutting issues on the application of molecular methods for a number of vaccines that are currently in use or under development were presented, and specific methods for further collaborative studies were discussed and identified. The main points of recommendation from meeting participants were fourfold: (i) that molecular methods should be encouraged; (ii) that collaborative studies are needed for many methods/applications; (iii) that basic science should be promoted; and (iv) that investment for training, equipment and facilities should be encouraged.

  19. Summary report of the Department of Energy, Division of Operational and Environmental Safety: Quality Assurance Programs 9 through 12

    International Nuclear Information System (INIS)

    Analaytical Laboratories which provide environmental monitoring data for assessment of radioactive contamination, under the Department of Energy (DOE) Contract, were requested to participate in a Quality Assurance Program. The Environmental Measurement Laboratory (EML) was asked to prepare intercomparison samples for radionuclide analysis of soil, water, air filters, tissue ash and vegetation ash for distribution to the Analytical Laboratories. Samples were collected in the environment of DOE facilities, since only water and air samples could be conveniently spiked. A set of 6 to 8 samples is distributed quarterly to 34 laboratories. EML performed multiple analyses on the samples, however, the results are considered intercomparisons, not standards. The program is summarized, and data for Quality Assessment Programs (QAP) 9 through 12 are evaluated

  20. Does a perception of increased blood safety mean increased blood transfusion? An assessment of the risk compensation theory in Canada

    Directory of Open Access Journals (Sweden)

    Wilson Kumanan

    2004-06-01

    Full Text Available Abstract Background The risk compensation theory is a widely used concept in transport economics to analyze driver risk behaviour. This article explores the feasibility of applying the theory in blood transfusion to raise important questions regarding the increased blood safety measures and their possible effects on blood usage (e.g., the appropriateness in transfusion. Further, it presents the findings of a pilot survey of physicians in Canada. Discussion While studies have attempted to define transfusion appropriateness, this article argues that if the risk compensation theory holds true for transfusion practice, physicians may actually be transfusing more. This may increase the possibility of contracting other unknown risks, such as the variant Creutzfeldt-Jakob Disease (vCJD, as well as increasing the risk of non-infectious transfusion risks, such as transfusion reactions. Summary A much larger study involving psychosocial assessment of physician decision making process to fully assess physician behaviour within the context of risk compensation theory and transfusion practice in Canada is needed to further explore this area.

  1. Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

    Science.gov (United States)

    Manshanden, Johan S.J.; Gielen, Chantal L.I.; de Borgie, Corianne A.J.M.; Klautz, Robert J.M.; de Mol, Bas A.J.M.; Koolbergen, David R.

    2015-01-01

    Background Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial. PMID:26501121

  2. Essence of demands of standard ISO 22000:2005 in aspect of assurances of milk health safety Istota wymagań standardu ISO 22000:2005 w aspekcie zapewnienia bezpieczeństwa zdrowotnego mleka

    Directory of Open Access Journals (Sweden)

    Justyna Górna

    2008-09-01

    Full Text Available The article presents the essence of demands of ISO 22000 as a standard which allows of control milk health safety in a more effective way. The implementation of system HACCP in the dairy companies undoubtedly make for more safety health products, however microbiological research of pasterized milk shows that it is scarce. The elementary advantage for organization which comes from food quality management system meeting demands included in standard ISO 22000 is undoubtedly assurance of legal demands concerning production of food safety and more effective control of risk of food safety. The dairy companies should aspire for implementation of more rigorous standard ISO 22000:2005.

  3. Mission Assurance and Flight Safety of Manned Space Flight: Implications for Future Exploration of the Moon and Mars

    Science.gov (United States)

    Kezirian, M. T.

    2007-01-01

    As NASA implements the nation's Vision for Space Exploration to return to the moon and travel to Mars, new considerations will be be given to the processes governing design and operations of manned spaceflight. New objectives bring new technical challenges; Safety will drive many of these decisions.

  4. Guidance Note on Health Care Worker Safety from HIV and Other Blood Borne Infections

    OpenAIRE

    Gold, Julian; Tomkins, Maggy; Melling, Phillip; Bates, Nicholas

    2004-01-01

    The safety of heath care workers (HCWs) who take care of people with HIV/AIDS and other infectious diseases is of paramount importance. Occupational transmission of blood borne infections is not regarded as a common problem in developed country settings, but this is not the case in resource poor countries where the incidence and impact of such exposures is under-reported and is now becomin...

  5. Physical aspects of quality assurance in nuclear medicine and radiotherapy, regulatory approach of the National Nuclear Safety Center

    International Nuclear Information System (INIS)

    The physical aspects of the quality guarantee in Nuclear Medicine and Radiotherapy its are of cardinal importance to guarantee the quality of the diagnoses and treatments that are carried out to the patients in this type of services. The OIEA, the OMS and other scientific and professional organizations have contributed significantly to the elaboration of recommendations, Protocols, etc. applicable in the quality control programs and safety of the Nuclear Medicine and Radiotherapy departments. In spite of the great effort developed in this sense the Installation of the programs of quality control and safety of the Nuclear Medicine and Radiotherapy departments can fail if the same ones are not based in three decisive elements that are: the existence of national regulations, the existence of the infrastructure required for it and the existence of enough qualified personnel to develop this programs. The present work shows the regulatory focus that on this topic, it has followed the National Center of Nuclear Safety of Cuba (CNSN). The same left of strengthen all the existent Synergies in the different organizations of the country and it went in two fundamental directions: installation of the regulatory requirements that govern this activity and the Authorization of a Cuban Entity, specialized in carrying out audits to the quality control and safety programs of the Nuclear Medicine and Radiotherapy departments. After 4 work years in this direction, the results confirm the validity of the experience developed by the CNSN, at the moment all the services of Nuclear Medicine and Radiotherapy of Cuba possess quality control and safety programs, these programs are annually Auditing by an Authorized entity by the CNSN and the Inspectors of the Regulatory Authority, control, during the inspections, the one execution of the established requirements in the national regulations. The work developed so far can serve, modestly, of reference to others countries of Latin America that

  6. [Blood Safety in the XXI century. Transfusion transmitted infectious diseases. International and Mexican view].

    Science.gov (United States)

    Rojo Medina, Julieta

    2014-01-01

    Currently worldwide, the transfusion of blood components cannot be done without residual risks, as compared to those countries with a high human development index, mostly in Europe, that have blood donation systems based on 100% repeat volunteer donors and use molecular biology techniques in screening for infectious diseases. In Latin America and the Caribbean countries, prevention of transfusion-transmissible diseases requires special and different strategies due to several factors: the high prevalence of replacement donors, their specific geographical location, climate, genetic, and sociocultural status of the population make them vulnerable to endemic diseases such as dengue, malaria, and Chagas disease. Thus it is necessary to create local approaches to increase blood safety and achieve the goals set by the Pan American Health Organization.

  7. Pacific Northwest Laboratory annual report for 1987 to the Assistant Secretary for Environment, Safety, and Health: Part 5: Environment, safety, health, and quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Faust, L.G.; Steelman, B.L.; Selby, J.M.

    1988-02-01

    Part 5 of the 1987 Annual Report to the US Department of Energy's Assistant Secretary for Environment, Safety, and Health presents Pacific Northwest Laboratory's progress on work performed for the Office of Nuclear Safety, the Office of Environmental Guidance and Compliance, the Office of Environmental Audit, and the Office of National Environmental Policy Act Project Assistance. For each project, as identified by the Field Work Proposal, articles describe progress made during fiscal year 1987. Authors of these articles represent a broad spectrum of capabilities derived from five of the seven technical centers of the Laboratory, reflecting the interdisciplinary nature of the work.

  8. Pacific Northwest Laboratory annual report for 1987 to the Assistant Secretary for Environment, Safety, and Health: Part 5: Environment, safety, health, and quality assurance

    International Nuclear Information System (INIS)

    Part 5 of the 1987 Annual Report to the US Department of Energy's Assistant Secretary for Environment, Safety, and Health presents Pacific Northwest Laboratory's progress on work performed for the Office of Nuclear Safety, the Office of Environmental Guidance and Compliance, the Office of Environmental Audit, and the Office of National Environmental Policy Act Project Assistance. For each project, as identified by the Field Work Proposal, articles describe progress made during fiscal year 1987. Authors of these articles represent a broad spectrum of capabilities derived from five of the seven technical centers of the Laboratory, reflecting the interdisciplinary nature of the work

  9. Experiment Safety Assurance Package for Mixed Oxide Fuel Irradiation in an Average Power Position (I-24) in the Advanced Test Reactor

    Energy Technology Data Exchange (ETDEWEB)

    J. M . Ryskamp; R. C. Howard; R. C. Pedersen; S. T. Khericha

    1998-10-01

    The Fissile Material Disposition Program Light Water Reactor Mixed Oxide Fuel Irradiation Test Project Plan details a series of test irradiations designed to investigate the use of weapons-grade plutonium in MOX fuel for light water reactors (LWR) (Cowell 1996a, Cowell 1997a, Thoms 1997a). Commercial MOX fuel has been successfully used in overseas reactors for many years; however, weapons-derived test fuel contains small amounts of gallium (about 2 parts per million). A concern exists that the gallium may migrate out of the fuel and into the clad, inducing embrittlement. For preliminary out-of-pile experiments, Wilson (1997) states that intermetallic compound formation is the principal interaction mechanism between zircaloy cladding and gallium. This interaction is very limited by the low mass of gallium, so problems are not expected with the zircaloy cladding, but an in-pile experiment is needed to confirm the out-of-pile experiments. Ryskamp (1998) provides an overview of this experiment and its documentation. The purpose of this Experiment Safety Assurance Package (ESAP) is to demonstrate the safe irradiation and handling of the mixed uranium and plutonium oxide (MOX) Fuel Average Power Test (APT) experiment as required by Advanced Test Reactor (ATR) Technical Safety Requirement (TSR) 3.9.1 (LMITCO 1998). This ESAP addresses the specific operation of the MOX Fuel APT experiment with respect to the operating envelope for irradiation established by the Upgraded Final Safety Analysis Report (UFSAR) Lockheed Martin Idaho Technologies Company (LMITCO 1997a). Experiment handling activities are discussed herein.

  10. 10 CFR 76.93 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each...

  11. Contribution of the Retrovirus Epidemiology Donor Study (REDS to research on blood transfusion safety in Brazil

    Directory of Open Access Journals (Sweden)

    Paula Loureiro

    2014-04-01

    Full Text Available The Retrovirus Epidemiology Donor Study (REDS program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018.

  12. Nova laser assurance-management system

    International Nuclear Information System (INIS)

    In a well managed project, Quality Assurance is an integral part of the management activities performed on a daily basis. Management assures successful performance within budget and on schedule by using all the good business, scientific, engineering, quality assurance, and safety practices available. Quality assurance and safety practices employed on Nova are put in perspective by integrating them into the overall function of good project management. The Nova assurance management system was developed using the quality assurance (QA) approach first implemented at LLNL in early 1978. The LLNL QA program is described as an introduction to the Nova assurance management system. The Nova system is described pictorially through the Nova configuration, subsystems and major components, interjecting the QA techniques which are being pragmatically used to assure the successful completion of the project

  13. The margin of safety in the use of a straight path centrifugal blood pump.

    Science.gov (United States)

    Kijima, T; Nojiri, C; Oshiyama, H; Horiuchi, K; Nogawa, A; Hamasaki, H; Ogihara, M; Katsuda, H S; Amano, N; Fukasawa, H

    1994-09-01

    A new centrifugal blood pump with a rotor that arranges 6 straight paths radially was developed for open heart surgery and temporary circulatory support. We describe comparative studies of the margin of safety in the practical use of the new pump. This pump was evaluated for temperature increase, cavitation, and pressure sensitivity. Two commercially available centrifugal pumps, the Biomedicus cone type and the Sarns 3M impeller type, were used as control pumps. The temperature increase in the new pump was four times slower than in the impeller pump when the outlet and the inlet of the pump was clamped. No sign of cavitation was observed when 0.1 ml air was introduced to the pump inlet under a negative pressure of 200 mm Hg in fresh bovine blood. As for pressure sensitivity of centrifugal pumps in practical applications, circuit resistance was a more essential factor than flow-pressure curves of the pump.

  14. Safety of predeposit autologous blood donation in the third trimester of pregnancy.

    Science.gov (United States)

    Lindenbaum, C R; Schwartz, I R; Chhibber, G; Teplick, F B; Cohen, A W

    1990-05-01

    The option of predeposit autologous blood donation (PABD) before elective surgery has been gaining popularity as a means of eliminating the transmission of the acquired immune deficiency syndrome and hepatitis. It also prevents potential antigen sensitization and transfusion reactions. The use of PABD in pregnant women has been described, but its safety for both mother and fetus, especially in the first and third trimester, has not been established. After studying 16 third-trimester pregnant women with antenatal surveillance techniques and continuous fetal monitoring, we concluded that PABD is a safe procedure for both mother and fetus. PMID:2352248

  15. Flow assurance

    Energy Technology Data Exchange (ETDEWEB)

    Mullins, O.C.; Dong, C. [Schlumberger-Doll Research Center, Cambridge, MA (United States); Elshahawi, H. [Shell Exploration and Production Company, The Hague (Netherlands)

    2008-07-01

    This study emphasized the need for considering flow assurance for producing oil and gas, particularly in high cost areas such as deepwater. Phase behaviour studies, sticking propensities, and interfacial interactions have been investigated in many laboratory studies using asphaltenes, wax, hydrates, organic and inorganic scale, and even diamondoids. However, the spatial variation of reservoir fluids has received little attention, despite the fact that it is one of the most important factors affecting flow assurance. This issue was difficult to address in a systematic way in the past because of cost constraints. Today, reservoir fluid variation and flow assurance can be considered at the outset of a project given the technological advances in downhole fluid analysis. This study described the origins of reservoir fluid compositional variations and the controversies surrounding them. It also described the indispensable chemical analytical technology. The impact of these reservoir fluid compositional variations on flow assurance considerations was also discussed. A methodology that accounts for these variations at the outset in flow assurance evaluation was also presented.

  16. Financial assurances

    International Nuclear Information System (INIS)

    US Ecology is a full service waste management company. The company operates two of the nation's three existing low-level radioactive waste (LLRW) disposal facilities and has prepared and submitted license applications for two new LLRW disposal facilities in California and Nebraska. The issue of financial assurances is an important aspect of site development and operation. Proper financial assurances help to insure that uninterrupted operation, closure and monitoring of a facility will be maintained throughout the project's life. Unfortunately, this aspect of licensing is not like others where you can gauge acceptance by examining approved computer codes, site performance standards or applying specific technical formulas. There is not a standard financial assurance plan. Each site should develop its requirements based upon the conditions of the site, type of design, existing state or federal controls, and realistic assessments of future financial needs. Financial assurances at U.S. Ecology's existing sites in Richland, Washington, and Beatty, Nevada, have been in place for several years and are accomplished in a variety of ways by the use of corporate guarantees, corporate capital funds, third party liability insurance, and post closure/long-term care funds. In addressing financial assurances, one can divide the issue into three areas: Site development/operations, third party damages, and long-term care/cleanup

  17. Acute effects of electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate in the cat: an evaluation of safety.

    OpenAIRE

    Eyre, J A; Flecknell, P. A.; Kenyon, B R; Koh, T H; Miller, S.

    1990-01-01

    The influence of repeated high intensity electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate has been investigated in the cat, to evaluate the safety of the method. The observations have been made in preparations under propofol anaesthesia before, during and after periods of anoxia. Electromagnetic stimulation of the brain evoked activity in descending motor pathways and was recorded by activity in the median nerve and by muscle tw...

  18. Introduction to quality assurance

    International Nuclear Information System (INIS)

    Safety requirements set forth in the regulatory requirement, codes, standards as well as other requirements for various aspects of nuclear power plant design and operation are strictly implemented through QA activities. The overall QA aim is to assure that the plant is soundly and correctly designed and that it is built, tested and operated in accordance with stringent quality standards and conservative engineering practices. In this way a high degree of freedom from faults and errors can be achieved. (orig.)

  19. Managing blood pressure control in Asian patients: safety and efficacy of losartan.

    Science.gov (United States)

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

    Hypertension is common in Asian populations and is a major cause of cardiovascular diseases. The prevalence of hypertension is increasing in many Asian countries. The overall prevalence of hypertension in India and the People's Republic of China has been estimated to be 20.6% in men and 22.6% in women. However, the rates of detection, treatment, and control of hypertension remain low in Asia. This reflects a low level of literacy and education, as well as a low level of access to medical care. To overcome these obstacles, strategies targeted at education, promotion, and optimization of medical care, are crucial to achieve target blood pressure control. Angiotensin receptor blockers are one of the first-line treatments for essential hypertension because they confer better cardiovascular outcomes. Losartan has been widely evaluated for the management of hypertension. Although some studies suggested that the blood pressure-lowering effect of losartan is perhaps lower than for other angiotensin receptor blockers, losartan has been demonstrated to be beneficial in terms of renal protection in patients with diabetes, heart failure resulting from either systolic or diastolic dysfunction, and diuretic-induced hyperuricemia. However, most of these data were obtained from Caucasian populations. The efficacy and safety of losartan in Asian populations may be different because of genetic and ethnic variations. Therefore, the efficacy and safety of losartan in Asian patients with hypertension warrant further study.

  20. Safety of human blood products: inactivation of retroviruses by heat treatment at 60 degrees C.

    Science.gov (United States)

    Hilfenhaus, J; Mauler, R; Friis, R; Bauer, H

    1985-04-01

    Acquired immune deficiency syndrome (AIDS) can be transferred to patients by blood transfusions or human blood preparations, such as cryoprecipitates or factor VIII concentrates. Retroviruses have been discussed as infectious AIDS agents and more recently human T-lymphotropic retroviruses designated as HTLV type III and LAV (lymphadenopathy-associated virus) have been isolated from AIDS patients. Whether heat treatment at 60 degrees C (pasteurization) of liquid human plasma protein preparations inactivates retroviruses was therefore investigated. Pasteurization had already been included in the routine manufacturing process of human plasma protein preparations in order to guarantee safety with regard to hepatitis B. Since high titer preparations of human retroviruses were not available, heat inactivation was studied using Rous sarcoma virus added to the various plasma protein preparations tested. This retrovirus which was obtained in preparations of 6.0 log10 FFU/ml was shown to be at least as heat stable as two mammalian retroviruses studied, i.e., feline and simian sarcoma virus. In all of eight different plasma protein preparations tested, Rous sarcoma virus was completely inactivated after a heat treatment lasting no longer than 4 hr. It is thus concluded that pasteurization of liquid plasma protein preparations at 60 degrees C over a period of 10 hr must confer safety to these products with respect to AIDS, provided that the AIDS agents are retroviruses of comparable heat stability as Rous sarcoma virus and the mammalian retroviruses tested.

  1. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    The IAEA directed extensive efforts during the years 1991 to 1995 to the integral revision of all NUSS quality assurance publications, which were approved and issued as Safety Series No.50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations (1996). When these quality assurance publications were developed, their prime focus was on requirements against which work performed by the licensees could be measured and assessed by the regulatory bodies. In this way, they only helped to facilitate the functions of regulators. No requirements or recommendations were provided on how the regulators should ensure the effective implementation of their own activities. The present publication is a first attempt to collect, integrate and offer available experience to directly support performance of regulatory activities. It presents a comprehensive compilation on the application of quality assurance principles and methods by regulatory bodies to their activities. The aim is consistent good performance of regulatory activities through a systematic approach

  2. Quality assurance records system

    International Nuclear Information System (INIS)

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the IAEA Code of Practice on Quality Assurance for Safety in Nuclear Power Plants (IAEA Safety Series No.50-C-QA), which requires that for each nuclear power plant a system for the generation, identification, collection, indexing, filing, storing, maintenance and disposition of quality assurance records shall be established and executed in accordance with written procedures and instructions. The purpose of this Safety Guide is to provide assistance in the establishment and operation of such a system. An orderly established and maintained records system is considered to be part of the means of providing a basis for an appropriate level of confidence that the activities which affect the quality of a nuclear power plant have been performed in accordance with the specific requirements and that the required quality has been achieved and is maintained

  3. Quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Gillespie, B.M.; Gleckler, B.P.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the quality assurance and quality control practices of Hanford Site environmental monitoring and surveillance programs. Samples are analyzed according to documented standard analytical procedures. This section discusses specific measures taken to ensure quality in project management, sample collection, and analytical results.

  4. Quality assurance in radiotherapy

    International Nuclear Information System (INIS)

    Good radiotherapy results and safety of treatment require the radiation to be optimally applied to a specified target area and the correct dose. According to international recommendations, the average uncertainty in therapeutic dose should not exceed 5%. The need for high precision in therapeutic dose requires quality assurance covering the entire radiotherapy process. Besides the physical and technical characteristics of the therapy equipment, quality assurance must include all radiotherapy equipment and procedures that are significant for the correct magnitude and precision of application of the therapeutic dose. The duties and responsibilities pertaining to various stages of treatment must also be precisely defined. These requirements may be best implemented through a quality system. The general requirements for supervision and quality assurance of medical radiation apparatus are prescribed in section 40 of the Radiation Act (592/1991, amendment 1142/1998) and in sections 18 and 32 of the Decree of the Ministry of Social Affairs and Health on the medical use of radiation (423/2000). Guide ST 2.2 imposes requirements on structural radiation shielding of radiotherapy equipment and the premises in which it is used, and on warning and safety arrangements. Guide ST 1.1 sets out the general safety principles for radiation practices and regulatory control procedure for the use of radiation. Guide ST 1.6 provides general requirements for operational measures in the use of radiation. This Guide sets out the duties of responsible parties (the party running a radiation practice) in respect of arranging and maintaining radiotherapy quality assurance. The principles set out in this Guide and Guide ST 6.3 may be applied to radionuclide therapy

  5. Malaria and blood transfusion: major issues of blood safety in malaria-endemic countries and strategies for mitigating the risk of Plasmodium parasites.

    Science.gov (United States)

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal

    2016-01-01

    Malaria inflicts humankind over centuries, and it remains as a major threat to both clinical medicine and public health worldwide. Though hemotherapy is a life-sustaining modality, it continues to be a possible source of disease transmission. Hence, hemovigilance is a matter of grave concern in the malaria-prone third-world countries. In order to pursue an effective research on hemovigilance, a comprehensive search has been conducted by using the premier academic-scientific databases, WHO documents, and English-language search engines. One hundred two appropriate articles were chosen for data extraction, with a particular reference to emerging pathogens transmitted through blood transfusion, specifically malaria. Blood donation screening is done through microscopic examination and immunological assays to improve the safety of blood products by detection major blood-borne pathogens, viz., HIV, HBV, HCV, syphilis, and malarial parasites. Transfusion therapy significantly dwindles the preventable morbidity and mortality attributed to various illnesses and diseases, particularly AIDS, tuberculosis, and malaria. Examination of thick and thin blood smears are performed to detect positivity and to identify the Plasmodium species, respectively. However, all of these existing diagnostic tools have their own limitations in terms of sensitivity, specificity, cost-effectiveness, and lack of resources and skilled personnel. Globally, despite the mandate need of screening blood and its components according to the blood-establishment protocols, it is seldom practiced in the low-income/poverty-stricken settings. In addition, each and every single phase of transfusion chain carries sizable inherent risks from donors to recipients. Interestingly, opportunities also lie ahead to enhance the safety of blood-supply chain and patients. It can be achieved through sustainable blood-management strategies like (1) appropriate usage of precise diagnostic tools/techniques, (2) promoting

  6. Malaria and blood transfusion: major issues of blood safety in malaria-endemic countries and strategies for mitigating the risk of Plasmodium parasites.

    Science.gov (United States)

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal

    2016-01-01

    Malaria inflicts humankind over centuries, and it remains as a major threat to both clinical medicine and public health worldwide. Though hemotherapy is a life-sustaining modality, it continues to be a possible source of disease transmission. Hence, hemovigilance is a matter of grave concern in the malaria-prone third-world countries. In order to pursue an effective research on hemovigilance, a comprehensive search has been conducted by using the premier academic-scientific databases, WHO documents, and English-language search engines. One hundred two appropriate articles were chosen for data extraction, with a particular reference to emerging pathogens transmitted through blood transfusion, specifically malaria. Blood donation screening is done through microscopic examination and immunological assays to improve the safety of blood products by detection major blood-borne pathogens, viz., HIV, HBV, HCV, syphilis, and malarial parasites. Transfusion therapy significantly dwindles the preventable morbidity and mortality attributed to various illnesses and diseases, particularly AIDS, tuberculosis, and malaria. Examination of thick and thin blood smears are performed to detect positivity and to identify the Plasmodium species, respectively. However, all of these existing diagnostic tools have their own limitations in terms of sensitivity, specificity, cost-effectiveness, and lack of resources and skilled personnel. Globally, despite the mandate need of screening blood and its components according to the blood-establishment protocols, it is seldom practiced in the low-income/poverty-stricken settings. In addition, each and every single phase of transfusion chain carries sizable inherent risks from donors to recipients. Interestingly, opportunities also lie ahead to enhance the safety of blood-supply chain and patients. It can be achieved through sustainable blood-management strategies like (1) appropriate usage of precise diagnostic tools/techniques, (2) promoting

  7. Current Probiotics—Safety Assured?

    OpenAIRE

    Salminen, Seppo; Wright, Atte von

    2011-01-01

    Traditionally probiotics are defined as viable microorganisms (bacteria or yeasts) that have a beneficial effect on the health of the host. Probiotics are used in fermented dairy products, but also in other foods, clinical foods and pharmaceutical preparations and they are also increasingly used as added functional ingredients in non-fermented foods. The selection of new probiotic organisms targets on new strains and even genera that are more beneficial or specific. When totally novel microbe...

  8. Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.

    Directory of Open Access Journals (Sweden)

    Rolf Burghaus

    Full Text Available Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist, enoxaparin (an indirect thrombin/Factor Xa inhibitor and dabigatran (a direct thrombin inhibitor. A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration-effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies.

  9. Establishment of a rationalized safety assurance logic aiming at FBRs with enhanced social acceptance (1). Interim report of CEA/JNC collaboration NWP-5(a) from 1999 to 2001: common view and JNC's contribution

    International Nuclear Information System (INIS)

    This is an interim report describing the progress and the results of the collaborative research works between JNC and CEA on the safety logic in future fast reactors under the title of 'Establishment of a Rationalized Safety Assurance Logic Aiming at FBRs with Enhanced Social Acceptance' from 1999 to 2001. This contains JNC's contribution and common view of both partners. (1) Safety goals are proposed from JNC and CEA. Significant coherency is found such as to keep defense-in depth concept, mitigation measures against core melt are taken into account for containment design, evacuation free' concept is pursued, quantitative safety target is also considered as well as deterministic approach, and improvement of social acceptance is considered from the development stage of the fuel cycle including nuclear power plants. (2) Safety characteristics of each candidate coolant were compared and discussed. Gas-cooled fast reactor is a common interest area. Discussions are focused on: safety design requirements, safety evaluation events list, transient behavior analysis, core catcher designs, and so on. (3) JNC's results include criticality map for predicting CDA behavior and consequences, and CDA analysis results of lead-cooled and gas-cooled fast reactors with SIMMER-III. The collaboration on the action NWP-5a is recognized as being of great importance for the orientation of the innovative design studies. (author)

  10. Quality assurance during site construction

    International Nuclear Information System (INIS)

    During the time of planing and construction of a nuclear power plant, the following proceeding is approved: - the deliverer of a nuclear power plant provides the reports fixing the quality assurance program, it means that he is responsible to write the safety analysis report, the specifications for the erection of the components, the working manuals and specifications for testing (eg nondestr. testing) - the manufacturing of components or systems will be controlled by an own independent quality assurance group, provided that this group was checked by the quality assurance group of the applicant - the TUeV with its independent assessors will fix the requirements relating to quality assurance in its assessment. On this basis the examination of the applicants specifications, working manuals, testing specifications will be done. The efficiency of quality assurance at the manufacturer and at the applicant will be checked by the TUeV specialists by considering specifications of modifications, repairs or tolerances. A mean point of the quality assurance in Germany is the dynamic adjustment, of an action on the latest state of engineering or science. If there exists a change of rules or guidelines, the quality assurance requirements have to be fit on this state in so far as it is feasible from the technical point of view. (orig./RW)

  11. Quality assurance in the ambulatory care setting.

    Science.gov (United States)

    Tyler, R D

    1989-01-01

    One of the most utilitarian developments in the field of quality assurance in health care has been the introduction of industrial concepts of quality management. These concepts, coupled with buyer demand for accountability, are bringing new perspectives to health care quality assurance. These perspectives provide a new view of quality assurance as a major responsibility and strategic opportunity for management; a competitive and marketable commodity; and a method of improving safety, effectiveness, and satisfaction with medical care.

  12. Quality assurance program

    International Nuclear Information System (INIS)

    This topical report describes the Gibbs and Hill Quality Assurance Program and sets forth the methods to be followed in controlling quality-related activities performed by Gibbs and Hill and its contractors. The program is based on company experience in nuclear power and related work, and defines a system found effective in providing independent control of quality-related functions and documentation. The scope of the report covers activities involving nuclear safety-related structures, systems, and components covered by Gibbs and Hill' contractual obligation to the Utility Owner for each project

  13. Grading of quality assurance requirements

    International Nuclear Information System (INIS)

    The present Manual provides guidance and illustrative examples for applying a method by which graded quality assurance requirements may be determined and adapted to the items and services of a nuclear power plant in conformance with the requirements of the IAEA Nuclear Safety Standards (NUSS) Code and Safety Guides on quality assurance. The Manual replaces the previous publication IAEA-TECDOC-303 on the same subject. Various methods of grading quality assurance are available in a number of Member States. During the development of the present Manual it was not considered practical to attempt to resolve the differences between those methods and it was preferred to identify and benefit from the good practices available in all the methods. The method presented in this Manual deals with the aspects of management, documentation, control, verification and administration which affect quality. 1 fig., 4 tabs

  14. Dengue viremia in blood donors in Northern India: Challenges of emerging dengue outbreaks to blood transfusion safety

    OpenAIRE

    Sadhana Mangwana

    2015-01-01

    Backdround: Emerging infectious diseases pose threats to the general human population; including recipients of blood transfusions. Dengue is spreading rapidly to new areas and with increasing frequency of major outbreaks. Screening blood for dengue antigens in dengue-endemic countries would be costly and should, therefore, be recommended only after careful assessment of risk for infection and cost. Aim: A prospective study was conducted to establish the magnitude of the threat that dengue pos...

  15. 30 CFR 7.7 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants...

  16. 30 CFR 15.8 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under...

  17. 30 CFR 14.8 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a)...

  18. Safety and Feasibility of Achieving Lower Systolic Blood Pressure Goals in Persons With Type 2 Diabetes: The SANDS Trial

    Science.gov (United States)

    Weir, Matthew R.; Yeh, Fawn; Silverman, Angela; Devereux, Richard B.; Galloway, James M.; Henderson, Jeffrey A.; Howard, William J.; Russell, Marie; Wilson, Charlton; Ratner, Robert; Sorkin, John; Umans, Jason; Fleg, Jerome L.; Stylianou, Mario; Lee, Elisa; Howard, Barbara V.

    2009-01-01

    The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (≤115 / 75 mm Hg vs ≤130 / 80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/ dL, aggressive systolic blood pressure–lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus. PMID:19817934

  19. The variant Creutzfeldt-Jakob Disease: Risk, uncertainty or safety in the use of blood and blood derivatives?

    Science.gov (United States)

    Liras, Antonio

    2008-01-01

    It has been long since French physician Jean-Baptiste Denys carried out the first successful blood transfusion to a human being. Using bird feathers as canules, sheep blood was transfused to a young man. The patient died soon after Denys' treatment and Denys was accused of murder. In the XXI century, known as the biotechnology century, we face new challenges in Medicine. New emerging and reemerging diseases, such as Creutzfeldt-Jakob disease (CJD) or "mad cow disease" and its human variant (vCJD), challenge the biosafety aspects of a widely extended and extremely useful technique, that is, the perfusion of blood, of its derived components and of other pharmacological products obtained from plasma. To face these new challenges we need innovative prevention strategies. PMID:18573217

  20. The variant Creutzfeldt-Jakob Disease: Risk, uncertainty or safety in the use of blood and blood derivatives?

    OpenAIRE

    Liras, Antonio

    2008-01-01

    It has been long since French physician Jean-Baptiste Denys carried out the first successful blood transfusion to a human being. Using bird feathers as canules, sheep blood was transfused to a young man. The patient died soon after Denys' treatment and Denys was accused of murder. In the XXI century, known as the biotechnology century, we face new challenges in Medicine. New emerging and reemerging diseases, such as Creutzfeldt-Jakob disease (CJD) or "mad cow disease" and its human variant (v...

  1. Concepts of nuclear quality assurance

    International Nuclear Information System (INIS)

    While the safety record of the nuclear industry continues to be excellent, the forced outage rates for recent years continue to be 15% or more. Quality assurance, therefore, needs to be applied not only to nuclear safety matters, but to the goals of increased productivity and reduced construction and operating costs. Broadening the application of the general concept of quality assurance in this way leads to the introduction of reliability technology. The total activity might better be called reliability assurance. That effective quality assurance systems do pay off is described by examples from the utility industry, from a manufacturer of instruments and systems and from the experience of Westinghouse Electric Company's manufacturing divisions. The special situation of applying quality assurance to nuclear fuel is discussed. Problems include the lack of a fully developed regulatory policy in this area, incomplete understanding of the mechanism for pellet-clad interaction failures, incomplete access to manufacturers design and process information, inability to make desirable changes on a timely basis and inadequate feedback of irradiation experience. (author)

  2. Graded quality assurance in procurement

    International Nuclear Information System (INIS)

    The Code of Federal Regulations, Part 50, Appendix B, requires every applicant for an operating license to include in its final safety analysis report information pertaining to the managerial and administrative controls to be used to ensure safe operation. This appendix establishes quality assurance requirements for the design, construction, and operation of those structures, systems, and components (SSC) that perform safety-related functions. The activities affecting safety-related SSC functions include designing, purchasing, fabricating, and so forth, Title 10 CFR 50.65 established requirements to ensure that the maintenance activities conducted by licensees are effective. This is also known as the maintenance rule

  3. Safety and feasibility of countering neurological impairment by intravenous administration of autologous cord blood in cerebral palsy

    OpenAIRE

    Lee Young-Ho; Choi Kyung; Moon Jin; Jun Hyun-Joo; Kang Hye-Ryeong; Oh Se-In; Kim Hyung; Um Jang; Kim Mi; Choi Yun; Lee Young-Jun; Kim Hee-Jin; Lee Jong-Hwa; Son Su; Choi Soo-Jin

    2012-01-01

    Abstract Backgrounds We conducted a pilot study of the infusion of intravenous autologous cord blood (CB) in children with cerebral palsy (CP) to assess the safety and feasibility of the procedure as well as its potential efficacy in countering neurological impairment. Methods Patients diagnosed with CP were enrolled in this study if their parents had elected to bank their CB at birth. Cryopreserved CB units were thawed and infused intravenously over 10~20 minutes. We assessed potential effic...

  4. Screening for transfusion transmissible infections using rapid diagnostic tests in Africa: a potential hazard to blood safety?

    Science.gov (United States)

    Prugger, C; Laperche, S; Murphy, E L; Bloch, E M; Kaidarova, Z; Tafflet, M; Lefrère, J-J; Jouven, X

    2016-02-01

    Rapid diagnostic tests (RDTs) are routinely used in African blood centres. We analysed data from two cross-sectional studies representing 95 blood centres in 29 African countries. Standardized panels of sera containing varying concentrations of anti-human immunodeficiency virus (HIV) antibodies (Ab), hepatitis B virus antigen (HBsAg) and antihepatitis C virus (HCV) Ab were screened using routine operational testing procedures at the centres. Sensitivity of detection using RDTs was high for HIV Ab-positive samples, but low for intermediately HBsAg (51·5%) and HCV Ab (40·6%)-positive samples. These findings suggest that current RDT use in Africa could pose a hazard to blood safety. PMID:26646317

  5. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  6. Quality Assurance - Construction

    DEFF Research Database (Denmark)

    Gaarslev, Axel

    1996-01-01

    Gives contains three main chapters:1. Quality Assurance initiated by external demands2. Quality Assurance initiated by internal company goals3. Innovation strategies......Gives contains three main chapters:1. Quality Assurance initiated by external demands2. Quality Assurance initiated by internal company goals3. Innovation strategies...

  7. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  8. Introduction to quality assurance

    International Nuclear Information System (INIS)

    In today's interpretation 'quality assurance' means 'good management'. Quality assurance has to cover all phases of a work, but all quality assurance measures must be adapted to the relevance and complexity of the actual task. Examples are given for the preparation of quality classes, the organization of quality assurance during design and manufacturing and for auditing. Finally, efficiency and limits of quality assurance systems are described. (orig.)

  9. The effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension

    Institute of Scientific and Technical Information of China (English)

    贾坦

    2013-01-01

    Objective To evaluate the effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension.Methods A total of 1051 mild to moderate essential

  10. Redefining and expanding quality assurance.

    Science.gov (United States)

    Robins, J L

    1992-12-01

    To meet the current standards of excellence necessary for blood establishments, we have learned from industry that a movement toward organization-wide quality assurance/total quality management must be made. Everyone in the organization must accept responsibility for participating in providing the highest quality products and services. Quality must be built into processes and design systems to support these quality processes. Quality assurance has been redefined to include a quality planning function described as the most effective way of designing quality into processes. A formalized quality planning process must be part of quality assurance. Continuous quality improvement has been identified as the strategy every blood establishment must support while striving for error-free processing as the long-term objective. The auditing process has been realigned to support and facilitate this same objective. Implementing organization-wide quality assurance/total quality management is one proven plan for guaranteeing the quality of the 20 million products that are transfused into 4 million patients each year and for moving toward the new order. PMID:1286566

  11. Software Assurance Using Structured Assurance Case Models

    OpenAIRE

    Rhodes, Thomas; Boland, Frederick; Fong, Elizabeth; Kass, Michael

    2010-01-01

    Software assurance is an important part of the software development process to reduce risks and ensure that the software is dependable and trustworthy. Software defects and weaknesses can often lead to software errors and failures and to exploitation by malicious users. Testing, certification and accreditation have been traditionally used in the software assurance process to attempt to improve software trustworthiness. In this paper, we examine a methodology known as a structured assurance mo...

  12. Blood gas and patient safety: considerations based on experience developed in accordance with the Risk Management perspective.

    Science.gov (United States)

    Rambaldi, Marco; Baranzoni, Mariateresa; Coppolecchia, Pasquale; Moschello, Jennifer N; Novaco, Francesca

    2007-01-01

    It is the responsibility of health organizations to guarantee a high level of healthcare by using adequate methodologies and instruments, creating secure conditions for treatment, and preventing adverse events due to human or system errors. It is necessary to introduce Risk Management programs, and in particular to promote Clinical Risk Management, one of the constituent elements of Clinical Governance, to assure the delivery of high-quality performance and services. In the point-of-care testing (POCT) context, using an analysis of our experiences, we discuss the entire analytical process, including acquisition and usage, while focusing on blood gas analyzers. Our experience confirms that within a Clinical Governance framework, it is necessary to apply, even when choosing instruments, a systematic vision that is not limited to analytical validation, but also includes an in-depth analysis of the impact in a specific context. Assessment of the correlated risks, independent of the analytical methodology used, is indispensable in a clinical environment to identify the most suitable approach for such risks. A study of the latent factors can be proactively performed to identify (and stimulate) what the pre-organizational environment (producer companies) can offer in terms of product orientation to effectively reduce correlated risk during use. Among the different options for possible treatment of risk, one involves the transfer of the assumption of risk to third parties (e.g., maintenance and quality controls). Transferring the responsibility for control operations to the operator of the instrument, which follows the quality controls with total autonomy, is equivalent to transferring the correlated risk for the clinician (in the POCT case) to the producer, who becomes the guarantor. In practice this is equivalent to a specific assurance stipulation with zero cost. PMID:17579531

  13. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  14. Determination of safety margins for whole blood concentrations of alcohol and nineteen drugs in driving under the influence cases.

    Science.gov (United States)

    Kristoffersen, Lena; Strand, Dag Helge; Liane, Veronica Horpestad; Vindenes, Vigdis; Tvete, Ingunn Fride; Aldrin, Magne

    2016-02-01

    Legislative limits for driving under the influence of 20 non-alcohol drugs were introduced in Norway in February 2012. Per se limits corresponding to blood alcohol concentrations (BAC) of 0.2g/kg were established for 20 psychoactive drugs, and limits for graded sanctions corresponding to BACs of 0.5 and 1.2g/kg were determined for 13 of these drugs. This new legislation made it possible for the courts to make sentences based on the analytical results, similar to the situation for alcohol. To ensure that the reported concentration is as least as high as the true concentration, with a 99% safety level, safety margins had to be calculated for each of the substances. Diazepam, tetrahydrocannabinol (THC) and alcohol were used as model substances to establish a new model for estimating the safety margins. The model was compared with a previous used model established several years ago, by a similar yet much simpler model, and they were found to be in agreement. The measurement uncertainties depend on the standard batch used, the work list and the measurements' replicate. A Bayesian modelling approach was used to determine the parameters in the model, using a dataset of 4700 diazepam positive specimens and 5400 THC positive specimens. Different safety margins were considered for low and high concentration levels of diazepam (≤2μM (0.6mg/L) and >2μM) and THC (≤0.01μM (0.003mg/L) and >0.01μM). The safety margins were for diazepam 19.5% (≤2μM) and 34% (>2μM), for THC 19.5% (≤0.01μM) and 24.9% (>0.01μM). Concentration dependent safety margins for BAC were based on a dataset of 29500 alcohol positive specimens, and were in the range 10.4% (0.1g/kg) to 4.0% (4.0g/kg) at a 99% safety level. A simplified approach was used to establish safety margins for the compounds amphetamine, MDMA, methamphetamine, alprazolam, phenazepam, flunitrazepam, clonazepam, nitrazepam, oxazepam, buprenorphine, GHB, methadone, ketamine, cocaine, morphine, zolpidem and zopiclone. The

  15. Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

    Directory of Open Access Journals (Sweden)

    Johan S.J. Manshanden

    2015-09-01

    Conclusions: CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial.

  16. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety

    OpenAIRE

    Rajesh Kumar; Sonia Gupta; Amarjit Kaur; Manvi Gupta

    2015-01-01

    Background: Transfusion-transmitted infections (TTIs) are one of the biggest threats to blood transfusion safety. Nucleic acid testing (NAT) in blood donor screening has been implemented in many countries to reduce the risk of TTIs. NAT shortens this window period, thereby offering blood centers a much higher sensitivity for detecting viral infections. Aims: The objective was to assess the role of individual donor-NAT (ID-NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis C virus (HCV...

  17. A research agenda for information quality assurance in public safety networks: information orchestration as the middle ground between hierarchical and netcentric approaches

    NARCIS (Netherlands)

    Bharosa, N.; Janssen, M.; Tan, Y.-H.

    2011-01-01

    One of the key challenges in public safety networks is to ensure a high level of information quality (IQ) during disaster response. Since many evaluation reports on disaster response efforts have revealed instances of poor IQ, both academics and practitioners are in search of information architectur

  18. A systematic assessment of quality assurance-based food safety management system of Chinese edible oil manufacturer in view of context characteristics

    NARCIS (Netherlands)

    Ren, Yingxue; He, Zhen; Luning, Pieternel A.

    2016-01-01

    This study uses a framework of a food safety management system-diagnostic instrument (FSMS-DI), for the assessment of the context of a Chinese edible oil manufacture through the view of a case study, and an evaluation of the performance of the FSMS of a Chinese edible oil company. The study inclu

  19. Half a decade of mini-pool nucleic acid testing: Cost-effective way for improving blood safety in India

    Directory of Open Access Journals (Sweden)

    Shivaram Chandrashekar

    2014-01-01

    Full Text Available Background and Objectives: It is well established that Nucleic acid testing (NAT reduces window phase of transfusion transmissible infections (TTI and helps improve blood safety. NAT testing can be done individually or in pools. The objectives of this study were to determine the utility, feasibility and cost effectiveness of an in-house minipool-NAT(MP-NAT. Materials and Methods: Blood donors were screened by history, tested by ELISA and sero-negative samples were subjected to an in-house NAT by using reverse transcriptase-polymerase chain reaction (RT-PCR. Testing was done in mini-pools of size eight (8. Positive pools were repeated with individual samples. Results: During the study period of Oct 2005-Sept 2010 (5 years all blood donors (n=53729 were screened by ELISA. Of which 469 (0.87% were positive for HIV-1, HBV or HCV. Sero-negative samples (n=53260 were screened by in-house MP-NAT. HIV-NAT yield was 1/53260 (n=1 and HBV NAT yield (n=2 was 1/26630. Conclusion: NAT yield was lower than other India studies possibly due to the lower sero-reactivity amongst our donors. Nevertheless it intercepted 9 lives including the components prepared. The in-house assay met our objective of improving blood safety at nominal cost and showed that it is feasible to set up small molecular biology units in medium-large sized blood banks and deliver blood within 24-48 hours. The utility of NAT (NAT yield will vary based on the donor population, the type of serological test used, the nature of kit employed and the sensitivity of NAT test used. The limitations of our in-house MP-NAT consisted of stringent sample preparation requirements, with labor and time involved. The benefits of our MP-NAT were that it acted as a second level of check for ELISA tests, was relatively inexpensive compared to ID-NAT and did not need sophisticated equipment.

  20. Efficacy and safety of plant stanols and sterols in the control of blood cholesterol levels

    NARCIS (Netherlands)

    Katan, M.B.; Grundy, S.M.; Jones, P.J.H.; Law, M.R.; Miettinen, T.; Paoletti, R.

    2003-01-01

    Foods with plant stanol or sterol esters lower serum cholesterol levels. We summarize the deliberations of 32 experts on the efficacy and safety of sterols and stanols. A meta-analysis of 41 trials showed that intake of 2 g/d of stanols or sterols reduced low-density lipoprotein (LDL) by 10%; higher

  1. Multinational Quality Assurance

    Science.gov (United States)

    Kinser, Kevin

    2011-01-01

    Multinational colleges and universities pose numerous challenges to the traditional models of quality assurance that are designed to validate domestic higher education. When institutions cross international borders, at least two quality assurance protocols are involved. To guard against fraud and abuse, quality assurance in the host country is…

  2. Computer software quality assurance

    International Nuclear Information System (INIS)

    The author defines some criteria for the evaluation of software quality assurance elements for applicability to the regulation of the nuclear industry. The author then analyses a number of software quality assurance (SQA) standards. The major extracted SQA elements are then discussed, and finally specific software quality assurance recommendations are made for the nuclear industry

  3. Individualized conditioning regimes in cord blood transplantation : Towards improved and predictable safety and efficacy

    NARCIS (Netherlands)

    Admiraal, R; Boelens, J J

    2016-01-01

    INTRODUCTION: The conditioning regimen used in cord blood transplantation (CBT) may significantly impact the outcomes. Variable pharmacokinetics (PK) of drugs used may further influence outcome. Individualized dosing takes inter-patient differences in PK into account, tailoring drug dose for each in

  4. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2010-05-21

    .... This and other related FDA policies are designed to address the major sources of known risk to the... would likely be reduced if computerized inventory controls were in place in all blood facilities. At the... monitoring tools or surveillance activities would need to be in place before implementing a policy...

  5. General safety aspects

    International Nuclear Information System (INIS)

    In this part next aspects are described: (1) Priority to safety; (2) Financial and human resources;; (3) Human factor; (4) Operator's quality assurance system; (5) Safety assessment and Verification; (6) Radiation protection and (7) Emergency preparedness

  6. Xenotropic Murine Leukemia Virus-Related Virus (XMRV) and the Safety of the Blood Supply.

    Science.gov (United States)

    Johnson, Andrew D; Cohn, Claudia S

    2016-10-01

    In 2006, a new virus, xenotropic murine leukemia virus-related virus (XMRV), was discovered in a cohort of U.S. men with prostate cancer. Soon after this initial finding, XMRV was also detected in samples from patients with chronic fatigue syndrome (CFS). The blood community, which is highly sensitive to the threat of emerging infectious diseases since the HIV/AIDS crisis, recommended indefinite deferral of all blood donors with a history of CFS. As XMRV research progressed, conflicting results emerged regarding the importance of this virus in the pathophysiology of prostate cancer and/or CFS. Molecular biologists traced the development of XMRV to a recombination event in a laboratory mouse that likely occurred circa 1993. The virus was propagated via cell lines derived from a tumor present in this mouse and spread through contamination of laboratory samples. Well-controlled experiments showed that detection of XMRV was due to contaminated samples and was not a marker of or a causal factor in prostate cancer or CFS. This paper traces the development of XMRV in the prostate and CFS scientific communities and explores the effect it had on the blood community. PMID:27358491

  7. Work plan, health and safety plan, and quality assurance project plan for hazardous waste removal at the CTF K-1654B underground collection tank

    Energy Technology Data Exchange (ETDEWEB)

    Panter, M.S.; Burman, S.N.; Landguth, D.C.; Uziel, M.S.

    1991-10-01

    The Central Training Facility (CTF), located on Bear Creek Road approximately two miles south of the K-25 Site, is utilized for training security personnel at Martin Marietta Energy Systems, Inc., Oak Ridge, Tennessee. At the request of the CTF staff, this plan has been developed for the removal of the waste contents in the facility's 500-gal septic tank and associated distribution box. The septic tank and distribution box were historically located beneath the K-1654B trailer and adjacent to the K-1654A Indoor Firing Range. Recently, however, the K-1654B trailer was removed to accommodate the objectives of this work plan as well as future construction activities planned at CTF. The purpose of this plan is to develop and assign responsibilities, establish personnel protection requirements and mandatory safety procedures, and provide for contingencies that may arise while operations are being conducted by ORNL/MAD at the CTF K-1654B underground collection tank site. This document addresses requirements of 29 CFR 1910.120, Final Rule, with respect to aspects of health and safety applicable to an underground collection tank waste removal.

  8. The National Heart, Lung, and Blood Institute retrovirus epidemiology donor studies (Retrovirus Epidemiology Donor Study and Retrovirus Epidemiology Donor Study-II): twenty years of research to advance blood product safety and availability.

    Science.gov (United States)

    Kleinman, Steven; King, Melissa R; Busch, Michael P; Murphy, Edward L; Glynn, Simone A

    2012-10-01

    The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989 to 2001, and the REDS-II, conducted from 2004 to 2012, were National Heart, Lung, and Blood Institute-funded, multicenter programs focused on improving blood safety and availability in the United States. The REDS-II also included international study sites in Brazil and China. The 3 major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as xenotropic murine leukemia virus-related virus. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of human immunodeficiency virus, human T-lymphotropic virus 1/2, hepatitis C virus, hepatitis B virus, West Nile virus, cytomegalovirus, human herpesvirus 8, parvovirus B19, malaria, Creutzfeldt-Jakob disease, influenza, and Trypanosoma cruzi infections. Other analyses have characterized blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors' perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, 2 large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these 2 REDS programs. In 2011, a new 7-year program, the Recipient Epidemiology and Donor Evaluation Study-III, was launched. The Recipient Epidemiology and Donor Evaluation Study-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting and adds a third country, South Africa

  9. [Jean-Jacques Lefrère: A miscarried ambition for blood safety in francophone Africa].

    Science.gov (United States)

    Tayou Tagny, C; Laperche, S; Murphy, E

    2016-02-01

    The announcement of the death of Professor Jean-Jacques Lefrère caused considerable emotion and surprise within the francophone Africa blood transfusion research network. The group was created in 2007 in Paris. Each member that works within this group wanted to pay their last respects through dedicated publication for a brilliant researcher and writer. The tribute describes the creation of the group, its goals, its operations, its achievements and the prospects of its activities while emphasizing the essential role that Professor Lefrère played within the group. PMID:26762688

  10. The Blood Quality Monitoring Network System's Role in the Safety of Blood Transfusion%血液质量监测网络体系在输血安全中的作用

    Institute of Scientific and Technical Information of China (English)

    胡秀兰; 田志彬; 李忠杰; 玄红霞; 陈书芳

    2013-01-01

    目的探寻建立血站血液质量监测网络体系,确保血液质量与安全。方法对献血者献血前的血液标本进行初筛,对采血场所、关键原辅材料、关键设备进行质量控制,同时加强采后血液的质量监测以及各供血库的监测。结果比较质量监测网络体系建立前后血液质量情况,发现血液质量监测网络体系建立后血液质量有明显提高。结论建立完整有效、安全的血液质量监测网络体系,对血液的采集、检验、保存、运送和使用等多个环节进行血液质量监测,监控血液"从血管到血管"的全过程,确保献血者、用血者身体健康和生命安全。%Objective To explore the establishment of a blood bank blood quality monitoring network system to ensure the quality and safety of blood. Methods for screening blood donors before blood samples, blood col ection establishments, the key raw materials, key equipment for quality control quality, while strengthening the postharvest quality monitoring of blood as wel as monitoring for blood banks. Results the comparative quality monitoring network system to establish the quality of blood before and after situation, significantly improved blood quality monitoring network system to establish the quality of blood. Conclusions to establish a complete and ef ective, safe blood quality monitoring network system for blood col ection, testing, preservation, transportation and use of other aspects of the blood quality monitoring, monitoring of blood"from the blood vessels to the blood vessels,"the whole process to ensure donors with blood by the health and safety of life.

  11. Quality Control of the Key Link of Safety Management of Blood%血液安全管理关键环节质量控制

    Institute of Scientific and Technical Information of China (English)

    贺许华

    2013-01-01

    输血是临床抢救和治疗病人不可缺少的重要手段,同时输血安全也日益受到重视,已成为一个重要的公共安全问题。加强血液安全管理,保证输血安全关键环节包括:科学判断献血者资格,严格血液采集;加强实验室管理,构建血液检测安全屏障;建立疫情报告制度,屏蔽不合格献血者;严格成分血液制备,确保贮存运输条件;科学评估输血指征,合理有效输血;做好输血前检查,保证输血安全有效;核对输血相关信息,填写输血记录。影响输血安全的因素很多,关键因素是“人”,只有牢固树立血液质量理念,建立输血质量管理体系,人人牢记质量,个个关注质量,不断完善血液从采集到输注(即血管到血管)整个流程的质量管理,血站和临床紧密结合,环环相扣,树立输血存在风险意识,科学合理用血,提高输血技术水平,才能保障临床用血安全有效。%Blood transfusion is an important means for clinical treatment and patients indispensable, and blood transfusion safety has received increasing attention, has become an important issue of public safety. strengthen the blood safety management, ensure the safety of blood transfusion: including key scientific judgment donors qualification, strict blood collection; strengthen the management of the laboratory, construction of blood safety barrier; establish the epidemic reporting system, shielding the unqualified blood donors; strict blood component preparation, ensure storage and transportation conditions;scientific evaluation of the indications for transfusion, reasonable and effective blood transfusion; do the examination before the blood transfusion, ensure blood transfusion is safe and effective; check the transfusion related information, fill in the record of the transfusion. Many factors influence the safety of blood transfusion, the key factor is "people", only to

  12. The Safety of Autologous Peripheral Blood Stem Cell Transplantation by Intracoronory Infusion in Patients with Acute Myocardial Infarction

    Institute of Scientific and Technical Information of China (English)

    Zhang Ming; Li Zhanquan; Cui Lijie; Jin Yuanzhe; Yuan Long; Zhang Weiwei; Zhao Hongyuan

    2005-01-01

    Objectives Bone-marrow stem-cell transplantation has been shown to improve cardiac function in patients with acute myocardial infarction (AMI), but the safety of intracoronory infusion of autologous peripheral blood stem-cell (PBSCs) in patients with AMI is unknown. For this reason, we observe the feasibility and safety of PBSCs transplantation by intracoronory infusion in such patients. Methods 41 patients with AMI were allocated to receive granulocyte colony-stimulating factor (GCSF: Filgrastim, 300μg) with the dose of 300μg~600μg/day to mobilize the stem cell, and the duration of applying G-CSF was 5 days. On the sixth day, PBSCs were separated by Baxter CS 3000 blood cel 1 separator into suspend liquid 57 ml. Then the suspend liquid was infused into the infarct related artery (IRA)by occluding the over the wire balloon and infusing artery through balloon center lumen. In the process of the intracoronary infusion of PBSCs, the complications should be observed, which were arrhythmias including of bradycardia, sinus arrest or atrial ventricular block,premature ve. ntricular beats , ven~icular tachycardia,ventricular fibrillation; and hypotention, etc. Results There were total 10 cases with complications during the intracoronary infusion of PBSCs. The incidence of complications was 24.4% ( 10/41 ), including bradycardia was 2.4 % (1/41), sinus arrest or atrial ventricular block was 4.0% (2/41), ventricular fibrillation was 2.4 %(1/41), hypotentionwas 14.6 % (6/41).Conclusions In patients with AMI, intracoronary infusion of PBSCs is feasible and safe.

  13. Assurance of quality in the diagnostic X-ray department

    International Nuclear Information System (INIS)

    A handbook has been prepared on the 'Assurance of Quality in the Diagnostic X-ray Department'. Part 1 discusses applied techniques which covers organization and methods, reject analysis, radiation protection, status tests, tolerance limits, practical tests for X-ray equipment and electrical and mechanical safety. Part 2 discusses the systematic approach to quality assurance. Part 3 discusses quality assurance for computed tomography, magnetic resource imaging systems and digital subtraction angiography. (U.K.)

  14. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  15. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  16. Quality assurance in fabrication of boilers and pressure vessels

    International Nuclear Information System (INIS)

    Quality assurance for safety and reliability of boilers and pressure vessels is a systematic approach involving various stages right from material identification to final stages of testing, transportation and storage before commissioning. This paper brings out various quality . Assurance aspects to be implemented by manufacturers of boilers and pressure vessels. 1 fig

  17. Safety Validation of Repeated Blood-Brain Barrier Disruption Using Focused Ultrasound.

    Science.gov (United States)

    Kobus, Thiele; Vykhodtseva, Natalia; Pilatou, Magdalini; Zhang, Yongzhi; McDannold, Nathan

    2016-02-01

    The purpose of this study was to investigate the effects on the brain of multiple sessions of blood-brain barrier (BBB) disruption using focused ultrasound (FUS) in combination with micro-bubbles over a range of acoustic exposure levels. Six weekly sessions of FUS, using acoustical pressures between 0.66 and 0.80 MPa, were performed under magnetic resonance guidance. The success and degree of BBB disruption was estimated by signal enhancement of post-contrast T1-weighted imaging of the treated area. Histopathological analysis was performed after the last treatment. The consequences of repeated BBB disruption varied from no indications of vascular damage to signs of micro-hemorrhages, macrophage infiltration, micro-scar formations and cystic cavities. The signal enhancement on the contrast-enhanced T1-weighted imaging had limited value for predicting small-vessel damage. T2-weighted imaging corresponded well with the effects on histopathology and could be used to study treatment effects over time. This study demonstrates that repeated BBB disruption by FUS can be performed with no or limited damage to the brain tissue.

  18. High assurance services computing

    CERN Document Server

    2009-01-01

    Covers service-oriented technologies in different domains including high assurance systemsAssists software engineers from industry and government laboratories who develop mission-critical software, and simultaneously provides academia with a practitioner's outlook on the problems of high-assurance software development

  19. Authentication Assurance Levels

    International Nuclear Information System (INIS)

    This Common Criteria approach has been applied to create a definition of Authentication Assurance Levels that can quantify the level of assurance reached for a system subject to a set of authentication procedures. The arms-control authentication application of the Common Criteria expands on more typical information security evaluations in that it must contend with information barriers and preclude sophisticated intentional subversion attempts.

  20. Quality assurance program

    International Nuclear Information System (INIS)

    The concept of levels of quality assurance as applied to CANDU-type nuclear power plant components, i.e. maintaining an appropriate cost/benefit ratio, is introduced. The design process itself has quality assurance features by virtue of multi-level review. (E.C.B.)

  1. Where to Donate Blood

    Science.gov (United States)

    ... zip code using the Blood Bank Locator below: Blood Bank Locator City: State/Province: ZIP Code: Country: Show ... safety and care. The Association sets standards for blood banks and transfusion services, and accredits member blood banks ...

  2. Quality assurance plan, Westinghouse Nuclear Energy Systems Divisions

    International Nuclear Information System (INIS)

    The Quality Assurance Plan used by Westinghouse Nuclear Energy Systems Water Reactor Divisions is described. The purpose of the program is to assure that the design, materials, and workmanship on Nuclear Steam Supply System (NSSS) equipment meet applicable safety requirements, fulfill the requirements of the contracts with the applicants, and satisfy the applicable codes, standards, and regulatory requirements. This document replaces the contents of Chapter 17 Safety Analysis Reports, except for any special or unique requirements. (auth)

  3. Quality assurance for gamma knives

    Energy Technology Data Exchange (ETDEWEB)

    Jones, E.D.; Banks, W.W.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)

    1995-09-01

    This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys, interlock systems, exposure monitoring, good medical physics practices, etc.) and to be compliant with NRC teletherapy regulations. There are, however, current practices for the Gamma Knife not covered by existing, formalized regulations, standards, or guidelines. These practices have been adopted by Gamma Knife users and continue to be developed with further experience. Some of these have appeared in publications or presentations and are slowly finding their way into recommendations of professional organizations.

  4. Quality assurance for gamma knives

    International Nuclear Information System (INIS)

    This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys, interlock systems, exposure monitoring, good medical physics practices, etc.) and to be compliant with NRC teletherapy regulations. There are, however, current practices for the Gamma Knife not covered by existing, formalized regulations, standards, or guidelines. These practices have been adopted by Gamma Knife users and continue to be developed with further experience. Some of these have appeared in publications or presentations and are slowly finding their way into recommendations of professional organizations

  5. Towards Run-time Assurance of Advanced Propulsion Algorithms

    Science.gov (United States)

    Wong, Edmond; Schierman, John D.; Schlapkohl, Thomas; Chicatelli, Amy

    2014-01-01

    This paper covers the motivation and rationale for investigating the application of run-time assurance methods as a potential means of providing safety assurance for advanced propulsion control systems. Certification is becoming increasingly infeasible for such systems using current verification practices. Run-time assurance systems hold the promise of certifying these advanced systems by continuously monitoring the state of the feedback system during operation and reverting to a simpler, certified system if anomalous behavior is detected. The discussion will also cover initial efforts underway to apply a run-time assurance framework to NASA's model-based engine control approach. Preliminary experimental results are presented and discussed.

  6. Software quality assurance handbook

    Energy Technology Data Exchange (ETDEWEB)

    1990-09-01

    There are two important reasons for Software Quality Assurance (SQA) at Allied-Signal Inc., Kansas City Division (KCD): First, the benefits from SQA make good business sense. Second, the Department of Energy has requested SQA. This handbook is one of the first steps in a plant-wide implementation of Software Quality Assurance at KCD. The handbook has two main purposes. The first is to provide information that you will need to perform software quality assurance activities. The second is to provide a common thread to unify the approach to SQA at KCD. 2 figs.

  7. Safety and feasibility of countering neurological impairment by intravenous administration of autologous cord blood in cerebral palsy

    Directory of Open Access Journals (Sweden)

    Lee Young-Ho

    2012-03-01

    Full Text Available Abstract Backgrounds We conducted a pilot study of the infusion of intravenous autologous cord blood (CB in children with cerebral palsy (CP to assess the safety and feasibility of the procedure as well as its potential efficacy in countering neurological impairment. Methods Patients diagnosed with CP were enrolled in this study if their parents had elected to bank their CB at birth. Cryopreserved CB units were thawed and infused intravenously over 10~20 minutes. We assessed potential efficacy over 6 months by brain magnetic resonance imaging (MRI-diffusion tensor imaging (DTI, brain perfusion single-photon emission computed tomography (SPECT, and various evaluation tools for motor and cognitive functions. Results Twenty patients received autologous CB infusion and were evaluated. The types of CP were as follows: 11 quadriplegics, 6 hemiplegics, and 3 diplegics. Infusion was generally well-tolerated, although 5 patients experienced temporary nausea, hemoglobinuria, or urticaria during intravenous infusion. Diverse neurological domains improved in 5 patients (25% as assessed with developmental evaluation tools as well as by fractional anisotropy values in brain MRI-DTI. The neurologic improvement occurred significantly in patients with diplegia or hemiplegia rather than quadriplegia. Conclusions Autologous CB infusion is safe and feasible, and has yielded potential benefits in children with CP.

  8. Peripheral blood stem cells transplantation in patients with heart failure after myocardial infarction: their efficiency and safety

    Institute of Scientific and Technical Information of China (English)

    Xiang Gu; Houtian Xu; Minghui Li

    2007-01-01

    Objective To compare the efficiency and safety of intracoronary transplantation of peripheral blood stem cells (PBSC) between elderly and younger patients with heart failure after myocardial infarction (MI). Methods Twenty-five patients with heart failure after MI were divided into aged group(≥60 years,n=13) and non-aged group (<60years,n=12) to receive intracoronary PBSC transplantation (PBSCT) following bone marrow cells mobilized by granulocyte colony-stimulating factor (G-CSF). Clinical data including coronary lesion characteristic, left ventricular shape, infarct region area and cardiac function, as well as adverse side effects between the two groups were compared. Left ventricular function was evaluated before and 6 months after the treatment by single photon emission computed tomography (SPECT). Results At 6 months, the left ventricular ejection fraction (LVEF) and 6 minute walk test (6MWT)distance increased, while the left ventricular diastolic diameter (LVDd) decreased significantly in both groups. There were no significant difference between the two groups in absolute change in the cardiac function parameters. Conclusions The present study demonstrated that autologous intracoronary PBSCT might be safe and feasible for both old and younger patients with heart failure after MI and left ventricular function is significantly improved.

  9. Phase 2 sampling and analysis plan, Quality Assurance Project Plan, and environmental health and safety plan for the Clinch River Remedial Investigation: An addendum to the Clinch River RCRA Facility Investigation plan

    International Nuclear Information System (INIS)

    This document contains a three-part addendum to the Clinch River Resource Conservation and Recovery Act (RCRA) Facility Investigation Plan. The Clinch River RCRA Facility Investigation began in 1989, as part of the comprehensive remediation of facilities on the US Department of Energy Oak Ridge Reservation (ORR). The ORR was added to the National Priorities List in December 1989. The regulatory agencies have encouraged the adoption of Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) terminology; therefore, the Clinch River activity is now referred to as the Clinch River Remedial Investigation (CRRI), not the Clinch River RCRA Facility Investigation. Part 1 of this document is the plan for sampling and analysis (S ampersand A) during Phase 2 of the CRRI. Part 2 is a revision of the Quality Assurance Project Plan for the CRRI, and Part 3 is a revision of the Environmental Health and Safety Plan for the CRRI. The Clinch River RI (CRRI) is designed to address the transport, fate, and distribution of waterborne contaminants (radionuclides, metals, and organic compounds) released from the DOE Oak Ridge Reservation (ORR) and to assess potential risks to human health and the environment associated with these contaminants. Primary areas of investigation are Melton Hill Reservoir, the Clinch River from Melton Hill Dam to its confluence with the Tennessee River, Poplar Creek, and Watts Bar Reservoir. The contaminants identified in the Clinch River/Watts Bar Reservoir (CR/WBR) downstream of the ORR are those associated with the water, suspended particles, deposited sediments, aquatic organisms, and wildlife feeding on aquatic organisms. The purpose of the Phase 2 S ampersand A Plan is to describe the proposed tasks and subtasks developed to meet the primary objectives of the CRRI

  10. Model Based Mission Assurance: Emerging Opportunities for Robotic Systems

    Science.gov (United States)

    Evans, John W.; DiVenti, Tony

    2016-01-01

    The emergence of Model Based Systems Engineering (MBSE) in a Model Based Engineering framework has created new opportunities to improve effectiveness and efficiencies across the assurance functions. The MBSE environment supports not only system architecture development, but provides for support of Systems Safety, Reliability and Risk Analysis concurrently in the same framework. Linking to detailed design will further improve assurance capabilities to support failures avoidance and mitigation in flight systems. This also is leading new assurance functions including model assurance and management of uncertainty in the modeling environment. Further, the assurance cases, a structured hierarchal argument or model, are emerging as a basis for supporting a comprehensive viewpoint in which to support Model Based Mission Assurance (MBMA).

  11. Transfusion safety in francophone African countries: An analysis of strategies for the medical selection of blood donors

    OpenAIRE

    Tagny, CT; Kouao, MD; Touré, H.; Gargouri, J; Fazul, AS

    2011-01-01

    BACKGROUND: The goal of selecting a healthy blood donor is to safeguard donors and reduce the risks of infections and immunologic complications for recipients. STUDY DESIGN AND METHODS: To evaluate the blood donor selection process, a survey was conducted in 28 blood transfusion centers located in 15 francophone African countries. Data collected included availability of blood products, risk factors for infection identified among blood donor candidates, the processing of the information collec...

  12. RAVEN Quality Assurance Activities

    Energy Technology Data Exchange (ETDEWEB)

    Cogliati, Joshua Joseph [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-09-01

    This report discusses the quality assurance activities needed to raise the Quality Level of Risk Analysis in a Virtual Environment (RAVEN) from Quality Level 3 to Quality Level 2. This report also describes the general RAVEN quality assurance activities. For improving the quality, reviews of code changes have been instituted, more parts of testing have been automated, and improved packaging has been created. For upgrading the quality level, requirements have been created and the workflow has been improved.

  13. RAVEN Quality Assurance Activities

    International Nuclear Information System (INIS)

    This report discusses the quality assurance activities needed to raise the Quality Level of Risk Analysis in a Virtual Environment (RAVEN) from Quality Level 3 to Quality Level 2. This report also describes the general RAVEN quality assurance activities. For improving the quality, reviews of code changes have been instituted, more parts of testing have been automated, and improved packaging has been created. For upgrading the quality level, requirements have been created and the workflow has been improved.

  14. The NASA Commercial Crew Program (CCP) Mission Assurance Process

    Science.gov (United States)

    Canfield, Amy

    2016-01-01

    In 2010, NASA established the Commercial Crew Program in order to provide human access to the International Space Station and low earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine the commercial providers transportation system complies with Programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted Hazard Reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100 percent of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (SMA) model does not support the nature of the Commercial Crew Program. To that end, NASA SMA is implementing a Risk Based Assurance (RBA) process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications. This paper will describe the evolution of the CCP Mission Assurance process from the beginning of the Program to its current incarnation. Topics to be covered include a short history of the CCP; the development of the Programmatic mission assurance requirements; the current safety review process; a description of the RBA process and its products and ending with a description of the Shared Assurance Model.

  15. Animal Drug Safety FAQs

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  16. [The francophone Africa blood transfusion research network: a five-year report].

    Science.gov (United States)

    Tagny, Claude Tayou; Murphy, Edward L; Lefrère, Jean-Jacques

    2014-03-01

    There has been little blood safety research in sub-Saharan Africa, often consisting of local efforts whose findings had limited impact The "Francophone Africa Transfusion Research Network" was created in May 2007 with the objective of developing common evidence-based blood safety policies that may be adapted to each country's situation. The Group's activities to date have focused mainly on obtaining epidemiological and laboratory data on blood transfusion and on suggesting blood safety strategies, particularly in the field of TTIs. To carry out such research activities, the group works closely with the National Blood Transfusion Services (NBTS), the Regional Blood Transfusion Services (RBTS), the hospital blood banks (HBB) and collection stations. For the first 5years, four research priorities were identified: (i) descriptive studies of the characteristics of francophone African blood donors and blood centers; (ii) estimation of the residual risk of transfusion-transmitted major viral infections; (iii) an analysis of blood donor deferral strategies; and (iv) a description of TTI screening strategies and an external quality assurance system (EQAS) project. During this period, seven projects have been implemented at the national level and published and five multicenter studies were conducted and published. The present review reports the main observations and recommendations from those studies that could improve blood safety statute in Africa.

  17. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-09-01

    This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness.

  18. General safety considerations

    International Nuclear Information System (INIS)

    This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness

  19. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety

    Directory of Open Access Journals (Sweden)

    Rajesh Kumar

    2015-01-01

    Full Text Available Background: Transfusion-transmitted infections (TTIs are one of the biggest threats to blood transfusion safety. Nucleic acid testing (NAT in blood donor screening has been implemented in many countries to reduce the risk of TTIs. NAT shortens this window period, thereby offering blood centers a much higher sensitivity for detecting viral infections. Aims: The objective was to assess the role of individual donor-NAT (ID-NAT for human immunodeficiency virus-1 (HIV-1, hepatitis C virus (HCV and hepatitis B virus (HBV and its role in blood safety. Materials and Methods: A total of 32978 donations were tested for all three viruses using enzyme-linked immuno-sorbent assay (Vironostika ® HIV Ag-Ab, Hepanostika ® HCV ultra and hepatitis B surface antigen ultra by Biomerieux and ID-NAT using Procleix Ultrio plus ® Assay (Novartis Diagnostic, USA. All initial NAT reactive samples and serology nonreactive were retested in triplicate and NAT discriminatory assay for HIV-1, HCV and HBV were performed. Results: Of the 32978 samples, 43 (0.13% were found to be ID-NAT reactive but seronegative. Out of 43, one for HIV-1, 13 for HCV and 27 for HBV were reactive by discriminatory assays. There were two samples that were reactive for both HCV-HBV and counted as HCV-HBV co-infection NAT yield. The prevalence of these viruses in our sample, tested by ID-NAT is 0.06%, 0.71%, and 0.63% for HIV-1, HCV and HBV respectively. The combined NAT yield among blood donors was 1 in 753. Conclusion: ID-NAT testing for HIV-1, HCV and HBV can tremendously improve the efficacy of screening for protecting blood recipient from TTIs. It enables detection of these viruses that were undetected by serological test and thus helped in providing safe blood to the patients.

  20. Safety strategy

    International Nuclear Information System (INIS)

    The basis for safety strategy in nuclear industry and especially nuclear power plants is the prevention of radioactivity release inside or outside of the technical installation. Therefore either technical or administrative measures are combined to a general strategy concept. This introduction will explain in more detail the following topics: - basic principles of safety - lines of assurance (LOA) - defense in depth - deterministic and probabilistic methods. This presentation is seen as an introduction to the more detailed discussion following in this course, nevertheless some selected examples will be used to illustrate the aspects of safety strategy development although they might be repeated later on. (orig.)

  1. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis

    OpenAIRE

    WANG, Meng; Zheng, Xin-Feng; Jiang, Lei-Sheng

    2015-01-01

    Background Routine use of antifibrinolytic agents in spine surgery is still an issue of debate. Objective To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery. Methods We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrosp...

  2. Vega flow assurance system

    Energy Technology Data Exchange (ETDEWEB)

    Larsen, Marit; Munaweera, Sampath

    2010-07-01

    Vega is a gas condensate field located at the west coast of Norway and developed as a tie-in to the Gjoea platform. Operator is Statoil, production startup is estimated to the end of 2010. Flow assurance challenges are high reservoir pressure and temperature, hydrate and wax control, liquid accumulation and monitoring the well/template production rates. The Vega Flow Assurance System (FAS) is a software that supports monitoring and operation of the field. The FAS is based FlowManagerTM designed for real time systems. This is a flexible tool with its own steady state multiphase- and flow assurance models. Due to the long flowlines lines and the dynamic behavior, the multiphase flow simulator OLGA is also integrated in the system. Vega FAS will be used as: - An online monitoring tool - An offline what-if simulation and validation tool - An advisory control system for well production allocation. (Author)

  3. Tainted blood

    DEFF Research Database (Denmark)

    Deleuran, Ida; Sheikh, Zainab Afshan; Hoeyer, Klaus

    2015-01-01

    study of the historical rise and current workings of safety practices in the Danish blood system. Here, we identify a strong focus on contamination in order to avoid 'tainted blood', at the expense of working with risks that could be avoided through enhanced blood monitoring practices. Of further...... significance to this focus are the social dynamics found at the heart of safety practices aimed at avoiding contamination. We argue that such dynamics need more attention, in order to achieve good health outcomes in transfusion medicine. Thus, we conclude that, to ensure continuously safe blood systems, we...... need to move beyond the bifurcation of the social and medical aspects of blood supply as two separate issues and approach social dynamics as key medical safety questions....

  4. Quality assurance considerations for nuclear power system selection

    International Nuclear Information System (INIS)

    Factors that influence the selection of a nuclear power system, from considerations of quality assurance are discussed. These are categorised as reliability, public safety, technological resources, economics, industrial security, and regulatory framework. The key quality assurance principle to be applied is to establish that the technological basis is understood and used properly. Knowledgeable and capable personnel with experience in the application are needed, and they must have access to appropriate engineering, laboratory and manufacturing facilities. A suitable balance must be maintained between the responsibilities of the seller-supplier and the purchaser-owner to assure an even-handed treatment of the implementation programme. Safety and reliability must be inherent to the regulatory framework. There must be flexibility in the purchaser-owner resources to overcome unanticipated adversity. Given these quality assurance elements, the nuclear system selection process should result in a high probability that the performance objectives will be satisfied. (U.K.)

  5. Quality Assurance for All

    Science.gov (United States)

    Cheung, Peter P. T.; Tsui, Cecilia B. S.

    2010-01-01

    For higher education reform, most decision-makers aspire to achieving a higher participation rate and a respectable degree of excellence with diversity at the same time. But very few know exactly how. External quality assurance is a fair basis for differentiation but there can be doubt and resistance in some quarters. Stakeholder interests differ…

  6. Mission Operations Assurance

    Science.gov (United States)

    Faris, Grant

    2012-01-01

    Integrate the mission operations assurance function into the flight team providing: (1) value added support in identifying, mitigating, and communicating the project's risks and, (2) being an essential member of the team during the test activities, training exercises and critical flight operations.

  7. 医院输血科生物安全管理现状及对策%Current management of biological safety in hospital blood transfusion and countermeasures

    Institute of Scientific and Technical Information of China (English)

    吴争胜; 蒋璐茜; 陈秉宇

    2011-01-01

    目的 根据浙江省输血科(血库)生物安全建设的现状,探讨进行规范化管理的方法. 方法 随机调查浙江省30所医院输血科(血库)存在的生物安全隐患,探讨制定切实可行的管理措施. 结果 综合性医院输血科生物安全管理方面存在诸多隐患,其中管理制度、操作规程等完善的合格率仅60.0%,66.7%输血科工作区布局不够合理、工作人员感染防范意识较差、医疗废弃物处理不规范等,个人防护的基本配置>90.0%,但实际使用率欠佳. 结论 必须严格执行生物安全的法律法规,制定和健全规章制度,才能确保输血科生物安全,有效预防与控制医院感染.%OBJECTIVE To approach standardized management of biological safety in blood transfusion based upon the present situation in this field in Zhejiang.METHODS A randomized survey of hidden hazardous factors threatening biological safety was conducted among the departments of blood transfusion in 30 hospitals and the data were statistically analyzed.RESULTS Several risky issues were found in the management of blood transfusion and biological safety.The qualified rate of supervising system and operating rules was only 60.0 %, unreasonable layout of workspace, poor awareness of prevention of infection, inadequate disposition of medical wastes accounted for 66.7%, staff's body sheltering was equipped over 90.0%, but the actual using rate was unexpectedly low.CONCLUSION In order to ensure the biological safety in blood transfusion and effective prevention and control of hospital infection, the relevant laws and regulations concerning biological safety should be established and strictly carried out.

  8. Quality assurance program preparation - review of requirements and plant systems - selection of program levels

    International Nuclear Information System (INIS)

    The establishment and implementation for a practicable quality assurance program for a nuclear power plant demands a detailed background in the field of engineering, manufacturing, organization and quality assurance. It will be demonstrated with examples to define and control the achievement of quality related activities during the phases of design, procurement, manufactoring, commissioning and operation. In general the quality assurance program applies to all items, processes and services important to safety of nuclear power plant. The classification for safety related and non-safety related items and services demonstrate the levels of quality assurance requirements. The lecture gives an introduction of QA Program preparation under the following topics: -Basic criteria and international requirements - Interaction of QA activities - Modular and product oriented QA programs - Structuring of organization for the QA program - Identification of the main quality assurance functions and required actions - Quality Assurance Program documentation - Documentation of planning of activities - Control of program documents - Definitions. (orig./RW)

  9. A basic study on molecular hydrogen (H2 inhalation in acute cerebral ischemia patients for safety check with physiological parameters and measurement of blood H2 level

    Directory of Open Access Journals (Sweden)

    Ono Hirohisa

    2012-08-01

    Full Text Available Abstract Background In animal experiments, use of molecular hydrogen ( H2 has been regarded as quite safe and effective, showing benefits in multiple pathological conditions such as ischemia-reperfusion injury of the brain, heart, kidney and transplanted tissues, traumatic and surgical injury of the brain and spinal cord, inflammation of intestine and lung , degenerative striatonigral tissue and also in many other situations. However, since cerebral ischemia patients are in old age group, the safety information needs to be confirmed. For the feasibility of H2 treatment in these patients, delivery of H2 by inhalation method needs to be checked for consistency. Methods Hydrogen concentration (HC in the arterial and venous blood was measured by gas chromatography on 3 patients, before, during and after 4% (case 1 and 3% (case2,3 H2 gas inhalation with simultaneous monitoring of physiological parameters. For a consistency study, HC in the venous blood of 10 patients were obtained on multiple occasions at the end of 30-min H2 inhalation treatment. Results The HC gradually reached a plateau level in 20 min after H2 inhalation in the blood, which was equivalent to the level reported by animal experiments. The HC rapidly decreased to 10% of the plateau level in about 6 min and 18 min in arterial and venous blood, respectively after H2 inhalation was discontinued. Physiological parameters on these 3 patients were essentially unchanged by use of hydrogen. The consistency study of 10 patients showed the HC at the end of 30-min inhalation treatment was quite variable but the inconsistency improved with more attention and encouragement. Conclusion H2 inhalation of at least 3% concentration for 30 min delivered enough HC, equivalent to the animal experiment levels, in the blood without compromising the safety. However, the consistency of H2 delivery by inhalation needs to be improved.

  10. Era of blood component therapy: time for mandatory pre-donation platelet count for maximizing donor safety and optimizing quality of platelets.

    Science.gov (United States)

    Das, Sudipta Sekhar; Zaman, R U; Biswas, Dipak

    2013-12-01

    Blood bank regulatory agencies including the Drug and Cosmetics Act (DCA) of India do not mandate a predonation platelet count in whole blood donation. Mandating such practice will definitely optimize the quality of random donor platelets (RDP) in terms of platelet yield and patient therapeutic benefit. We observed poor platelet yield in RDP concentrates prepared at our center with a significant number not meeting the DCA guideline of ≥ 4.5 × 10(10) per bag processed from 450 ml of whole blood. Therefore we planned this study to evaluate the pre-donation hematological values in our blood donor population and effect of these values on the quality of platelet concentrates. The prospective study included 221 blood donors eligible for donating 450 ml of whole blood (WB). Following the departmental standard operating procedure (SOP) RDPs were prepared using the 'Top & Bottom' quadruple bag system and automated component extractor. Quality of RDP was assessed as per departmental protocol. All results were recorded and subsequently transcribed to SPSS working sheet. A significant (pplatelets reduced by 0.72 g/dl and 22.1 × 10(6)/ml respectively. Quality of RDPs in terms of platelet yield was significantly better (pplatelet count was >200 × 10(6)/ml. Although platelet yield significantly correlated with the donor platelet count however quality of RDPs in terms of red cell contamination showed no correlation with the donor hematocrit. Platelet yield in random donor platelets is a concern in Eastern India. A platelet yield of 4.5 × 10(10) per bag as mandated by the DCA of India was only achieved when the donor platelet count was >200 × 10(6)/ml. Posttransfusion platelet recovery (PPR) was unsatisfactory in the transfused patient. Introduction of pre-donation platelet count in whole blood donation will maximize donor safety and optimize patient platelet transfusion management.

  11. Quality assurance in clinical trials.

    NARCIS (Netherlands)

    Ottevanger, P.B.; Therasse, P.; Veld, C.J.H. van de; Bernier, J.; Krieken, J.H.J.M. van; Grol, R.P.T.M.; Mulder, P.H.M. de

    2003-01-01

    From the literature that was initially searched by electronic databases using the keywords quality, quality control and quality assurance in combination with clinical trials, surgery, pathology, radiotherapy, chemotherapy and data management, a comprehensive review is given on what quality assurance

  12. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a...

  13. Creating Quality Assurance and International Transparency for Quality Assurance Agencies

    DEFF Research Database (Denmark)

    Kristoffersen, Dorte; Lindeberg, Tobias

    2004-01-01

    , on the one hand, to advance internationalisation of quality assurance of higher education, and on the other hand, allow for the differences in the national approaches to quality assurance. The paper will focus on two issues: first, the strength and weaknesses of the method employed and of the use of the ENQA......The paper presents the experiences gained in the pilot project on mutual recognition conducted by the quality assurance agencies in the Nordic countries and the future perspective for international quality assurance of national quality assurance agencies. The background of the project was the need...

  14. Creating quality assurance and international transparency for quality assurance agencies

    DEFF Research Database (Denmark)

    Lindeberg, Tobias Høygaard; Kristoffersen, Dorte

    2004-01-01

    , on the one hand, to advance internationalisation of quality assurance of higher education, and on the other hand, allow for the differences in the national approaches to quality assurance. The paper will focus on two issues: first, the strength and weaknesses of the method employed and of the use of the ENQA......The paper presents the experiences gained in the pilot project on mutual recognition conducted by the quality assurance agencies in the Nordic countries and the future perspective for international quality assurance of national quality assurance agencies. The background of the project was the need...

  15. Irregular antibodies screening before blood transfusion and safety in blood transfusion%输血前不规则抗体筛查与输血安全

    Institute of Scientific and Technical Information of China (English)

    苗伶俐

    2015-01-01

    Objective:To explore the importance of irregular antibodies screening before blood transfusion. Methods:From March 2009 to March 2012,3 215 cases of patients with blood transfusion were selected as treatment group,and irregular antibody was detected before blood transfusion by polybrene method and microcolumn gel test. From January 2009 to February 2009,3 113 cases of patients with blood transfusion were selected as control group,and the incidence of adverse transfusion reaction was counted. Results:The positive rate of treatment group was 0. 40%,and the positive rate of female(0. 60%,10/1 500) was 3. 5 times of male(0. 17%, 3/1 715). Of the entire female positive,maternal positive rate was 1. 14%,8/701,4. 5 times of non-maternal(0. 25%,2/799). Depart-ment of hepatobiliary surgery,general surgery and nephrology have 10 cases of positive(76. 92%,10/13),while other departments have 3 only(23. 08%,3/13). The difference was statistically significant(P<0. 05). There were 29 cases of adverse transfusion reaction in control group(0. 93%),while 3 cases in treatment group(0. 093%). The difference has statistical significance(χ2 =9. 239,P <0. 05). Conclusion:Patients with pregnant history and department of hepatobiliary surgery,general surgery and nephrology are high-risk groups in blood transfusion. With the strict implementation of irregular antibodies screening process,the occurrence rates of blood trans-fusion adverse reactions reduced apparently in clinical blood transfusion.%目的::探讨输血前不规则抗体筛查在输血安全中的重要性。方法:选取我院2009年3月至2012年3月共3215例输血患者为试验组,采用聚凝胺法、微柱凝胶法行输血前不规则抗体筛查。以2006年1月至2009年2月期间我院3113例输血患者为对照组,统计输血反应不良发生率。结果:试验组阳性率0.40%,女性阳性率(0.60%,10/1500)为男性(0.17%,3/1715)的3.5倍;女性阳性患者中,孕产妇阳性率(1.14%,8/701)是非

  16. Operational safety

    International Nuclear Information System (INIS)

    The PNL Safety, Standards and Compliance Program contributed to the development and issuance of safety policies, standards, and criteria; for projects in the nuclear and nonnuclear areas. During 1976 the major emphasis was on developing criteria, instruments and methods to assure that radiation exposure to occupational personnel and to people in the environs of nuclear-related facilities is maintained at the lowest level technically and economically practicable. Progress in 1976 is reported on the preparation of guidelines for radiation exposure; Pu dosimetry studies; the preparation of an environmental monitoring handbook; and emergency instrumentation preparedness

  17. Revenue assurance in utilities

    OpenAIRE

    Rihar, Miha

    2010-01-01

    In recent times utility companies have to orient to effective business due to hard market conditions. Thus, companies want to diminish business expenses and increase the revenues. Effective revenue capture is, after all, the aim of revenue assurance. Actually the revenue capture is usually not perfect and without losses. A part of revenues are always lost on the way from a service to payment, which is called revenue leakage and causes a financial loss. The revenue leakage is above all the ...

  18. Power transformers quality assurance

    CERN Document Server

    Dasgupta, Indrajit

    2009-01-01

    About the Book: With the view to attain higher reliability in power system operation, the quality assurance in the field of distribution and power transformers has claimed growing attention. Besides new developments in the material technology and manufacturing processes of transformers, regular diagnostic testing and maintenance of any engineering product may be ascertained by ensuring: right selection of materials and components and their quality checks. application of correct manufacturing processes any systems engineering. the user`s awareness towards preventive maintenance. The

  19. Natriuretic Peptides as Cardiovascular Safety Biomarkers in Rats: Comparison With Blood Pressure, Heart Rate, and Heart Weight.

    Science.gov (United States)

    Engle, Steven K; Watson, David E

    2016-02-01

    Cardiovascular (CV) toxicity is an important cause of failure during drug development. Blood-based biomarkers can be used to detect CV toxicity during preclinical development and prioritize compounds at lower risk of causing such toxicities. Evidence of myocardial degeneration can be detected by measuring concentrations of biomarkers such as cardiac troponin I and creatine kinase in blood; however, detection of functional changes in the CV system, such as blood pressure, generally requires studies in animals with surgically implanted pressure transducers. This is a significant limitation because sustained changes in blood pressure are often accompanied by changes in heart rate and together can lead to cardiac hypertrophy and myocardial degeneration in animals, and major adverse cardiovascular events (MACE) in humans. Increased concentrations of NPs in blood correlate with higher risk of cardiac mortality, all-cause mortality, and MACE in humans. Their utility as biomarkers of CV function and toxicity in rodents was investigated by exploring the relationships between plasma concentrations of NTproANP and NTproBNP, blood pressure, heart rate, and heart weight in Sprague Dawley rats administered compounds that caused hypotension or hypertension, including nifedipine, fluprostenol, minoxidil, L-NAME, L-thyroxine, or sunitinib for 1-2 weeks. Changes in NTproANP and/or NTproBNP concentrations were inversely correlated with changes in blood pressure. NTproANP and NTproBNP concentrations were inconsistently correlated with relative heart weights. In addition, increased heart rate was associated with increased heart weights. These studies support the use of natriuretic peptides and heart rate to detect changes in blood pressure and cardiac hypertrophy in short-duration rat studies. PMID:26609138

  20. Revenue assurance methodology

    OpenAIRE

    Filipová, Michaela

    2006-01-01

    Práce se zabývá návrhem uceleného teoreticko-metodologického rámce nové podnikové funkce revenue assurance pro telekomunikační společnosti, které usilují o systematický a koncepční přístup k zajištění a maximalizaci příjmů. Popsány jsou role revenue assurance funkce v podniku, cíle, vývojová stádia. Dále jsou popsány hrozby a konkrétní podoby úniků a nadhodnocení příjmů. Podrobně je rozebrána metodika pro plnění úkolů revenue assurance a techniky pro eliminaci úniků a nadhodnocení příjmů. Prá...

  1. Measurement quality assurance

    International Nuclear Information System (INIS)

    The quality of a radiation protection program can be no better than the quality of the measurements made to support it. In many cases, that quality is unknown and is merely implied on the basis of a calibration of a measuring instrument. If that calibration is inappropriate or is performed improperly, the measurement result will be inaccurate and misleading. Assurance of measurement quality can be achieved if appropriate procedures are followed, including periodic quality control actions that demonstrate adequate performance. Several national measurement quality assurance (MQA) programs are operational or under development in specific areas. They employ secondary standards laboratories that provide a high-quality link between the National Bureau of Standards and measurements made at the field use level. The procedures followed by these secondary laboratories to achieve MQA will be described, as well as plans for similar future programs. A growing general national interest in quality assurance, combined with strong specific motivations for MQA in the area of ionizing radiation, will provide continued demand for appropriate national programs. Such programs must, however, employ procedures that are cost effective and must be developed with participation by all affected parties

  2. The quality assurance liaison: Combined technical and quality assurance support

    International Nuclear Information System (INIS)

    This paper describes the role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years. The role of the quality assurance liaison has had a very positive impact on the Los Alamos Yucca Mountain Site Characterization (YW) quality assurance program. Having both technical and quality assurance expertise, the quality assurance liaisons are able to facilitate communications with scientists on quality assurance issues and requirements, thereby generating greater productivity in scientific investigations. The quality assurance liaisons help ensure that the scientific community knows and implements existing requirements, is aware of new or changing regulations, and is able to conduct scientific work within Project requirements. The influence of the role of the quality assurance liaison can be measured by an overall improvement in attitude of the staff regarding quality assurance requirements and improved job performance, as well as a decrease in deficiencies identified during both internal and external audits and surveillances. This has resulted in a more effective implementation of quality assurance requirements

  3. The quality assurance liaison: Combined technical and quality assurance support

    Science.gov (United States)

    Bolivar, S. L.; Day, J. L.

    1993-03-01

    The role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years are described. The role of the quality assurance liaison has had a very positive impact on the Los Alamos Yucca Mountain Site Characterization (YW) quality assurance program. Having both technical and quality assurance expertise, the quality assurance liaisons are able to facilitate communications with scientists on quality assurance issues and requirements, thereby generating greater productivity in scientific investigations. The quality assurance liaisons help ensure that the scientific community knows and implements existing requirements, is aware of new or changing regulations, and is able to conduct scientific work within Project requirements. The influence of the role of the quality assurance liaison can be measured by an overall improvement in attitude of the staff regarding quality assurance requirements and improved job performance, as well as a decrease in deficiencies identified during both internal and external audits and surveillances. This has resulted in a more effective implementation of quality assurance requirements.

  4. Medical radio-physics. Quality assurance. Transparency

    International Nuclear Information System (INIS)

    This short presentation, given by the national safety authority (ASN) at the meeting of July 1, 2009 of the high committee for the nuclear safety transparency and information (HCTISN), recalls, first, the missions of the ASN in the medical domain (radiation protection, control and inspections). Then it presents the reactions of the ASN in response to the increase of the number of radiological accidents since 2005: regulation reminder, circular letters, guidebooks, communication to the public and to the mass media. Finally, it defines the main priorities of the ASN with respect to radiotherapy: increase of human resources (radio-physicists shortage), declaration of incidents/accidents, quality assurance for the control of radiation doses delivered to patients, inspection of radiotherapy centres, expertise of new devices, improvement of softwares safety and ergonomics. (J.S.)

  5. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Meng Wang

    Full Text Available Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA and epsilon aminocaproic acid (EACA, traditionally known as Amicar in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs, retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data. Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57-621.94 ml, 250.30 ml postoperatively (95% CI, 35.31-465.30, and 601.40 ml overall (95% CI, 306.64-896.16 ml. The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30-754.67 ml. The transfusion rate was 44.6% (108/242 in the patients with antifibrinolytic agents and 68.3% (142/208 in the patients with placebo. (OR 0.38; 95% CI; 0.25-0.58; P<0.00001, I2 = 9%. All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group.The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements

  6. Quality assurance services

    International Nuclear Information System (INIS)

    For over 20 years the quality assurance services at the Springfields Laboratories have been concerned with manufacturing both simple and complex engineering products to the highest standard. The scientists working there have considerable expertise in the practical application of quality control and the development and design of inspection and non-destructive testing equipment. The folder contains six sheets or leaflets illustrating the work and equipment. The subjects are the mechanical standards laboratory, non-destructive testing, the digitising table, the peripheral camera, automated measurement, data handling and presentation, and the computer controlled three axis co-ordinate measuring machine. (U.K.)

  7. West Valley Reprocessing Plant. Safety analysis report, supplement 21

    International Nuclear Information System (INIS)

    Supplement No. 21 contains responses to USNRC questions on quality assurance contained in USNRC letter to NFS dated January 22, 1976, revised pages for the safety analysis report, and Appendix IX ''Quality Assurance Manual--West Valley Construction Projects.''

  8. Development of quality assurance procedures for production of sealed radiation source

    CERN Document Server

    Nam, J H; Cho, W K; Han, H S; Hong, S B; Kim, K H; Kim, S D; Lee, Y G; Lim, N J

    2001-01-01

    The quality assurance procedures for sealed radiation sources production using HANARO and RIPF have been developed. The detailed quality assurance procedures are essential to manage the whole work process effectively and ensure the quality of the produced sealed sources. Through applying this quality assurance procedures to the entire production works of the sealed radiation sources, it is expected that the quality of the products, the safety of the works and the satisfaction of the customers will be increased.

  9. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    This manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

  10. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    This Manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The Manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this Manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this Manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

  11. Safety and tolerability of fixed antihypertensive combinations in blood pressure control: focus on olmesartan medoxomil and amlodipine combination

    OpenAIRE

    Ijlal Uddin; Shakil Aslam

    2010-01-01

    Ijlal Uddin, Shakil AslamDivision of Nephrology and Hypertension, Georgetown University Hospital, Washington, District of Columbia, USAAbstract: Hypertension is a major health problem worldwide and remains underdiagnosed and undertreated. Although public awareness and control of hypertension have improved over the last decade, only one-third of hypertensive patients achieve the rather conservative blood pressure (BP) goal of <140/90 mmHg. Most hypertensive patients require more than on...

  12. The Use of Back-up Units to Enhance the Safety of Unrelated Donor Cord Blood Transplantation

    OpenAIRE

    Ponce, Doris M.; Lubin, Marissa; Gonzales, Anne Marie; Byam, Courtney; Wells, Deborah; Ferrante, Rosanna; Heller, Glenn; Giralt, Sergio; Papadopoulos, Esperanza B.; Kernan, Nancy A.; Scaradavou, Andromachi; Barker, Juliet N.

    2012-01-01

    The inability to obtain additional stem cells is a disadvantage of unrelated donor cord blood (CB) transplantation (CBT). Moreover, in the event of problems with unit shipment, compromised unit quality, thaw mishaps, or graft failure, the time to secure a back-up graft could be unacceptable. Emergent shipment of 1-2 back-up units that have been previously typed and reserved could overcome this limitation. However, the advantages of this approach are not established. Therefore, we present our ...

  13. THE PROBLEMS OF PROVIDING INFECTIOUS DISEASE SAFETY FOR ORGAN AND TISSUE DONATION BY SCREENING BLOOD-BORNE VIRAL INFECTIONS

    OpenAIRE

    M. Sh. Khubutiya; S. A. Solonin; M. A. Godkov

    2016-01-01

    It provided data on the prevalence, clinical signifi cance and methods of laboratory diagnostics for occult forms of blood-borne viral infections (BBVIs). It considered causes of such forms of infection and their signifi cance for clinical transplantation. We analyzed the existing algorithm of laboratory screening of a potential organ donor for BBVIs in Russia. It is shown that the current screening algorithm doesn’t allow detecting hidden forms of BBVIs.

  14. The case of sustainability assurance: constructing a new assurance service

    NARCIS (Netherlands)

    B. O'Dwyer

    2011-01-01

    This paper presents an in-depth longitudinal case study examining the processes through which practitioners in two Big 4 professional services firms have attempted to construct sustainability assurance (independent assurance on sustainability reports). Power’s (1996, 1997, 1999, 2003) theorization o

  15. Operating and Assurance Program Plan. Revision 4

    Energy Technology Data Exchange (ETDEWEB)

    1994-07-01

    The LBL Operating and Assurance Program (OAP) is a management system and a set of requirements designed to maintain the level of performance necessary to achieve LBL`s programmatic and administrative objectives effectively and safely through the application of quality assurance and related conduct of operations and maintenance management principles. Implement an LBL management philosophy that supports and encourages continual improvement in performance and quality at the Laboratory. Provide an integrated approach to compliance with applicable regulatory requirements and DOE orders. The OAP is intended to meet the requirements of DOE Order 5700.6C, Quality Assurance. The Program also contains management system elements of DOE Orders 5480.19, Conduct of Operations Requirements for DOE Facilities; 5480.25, Safety of Accelerator Facilities; and 4330.4A, Maintenance Management Program, and is meant to integrate these elements into the overall LBL approach to Laboratory management. The requirements of this program apply to LBL employees and organizations, and to contractors and facility users as managed by their LBL sponsors. They are also applicable to external vendors and suppliers as specified in procurement documents and contracts.

  16. Quality assurance during site construction of nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations related to the establishment and implementation of a quality assurance programme for the site construction activities at nuclear power plants. These include activities such as fabricating, erecting, installing, handling, storing, cleaning, flushing, inspecting, testing, modifying, repairing, and maintaining

  17. Efficacy and safety of Chinese herbal medicine for chronic prostatitis associated with damp-heat and blood-stasis syndromes: a meta-analysis and literature review

    Science.gov (United States)

    Wang, Zhiqiang; Yuan, Lei; Wang, Yongchuan; Yang, Baizhi; Dong, Xiaohong; Gao, Zhaowang

    2016-01-01

    Objective The aim of this meta-analysis and systematic review is to evaluate the safety and efficacy of Chinese herbal medicine (CHM) for chronic prostatitis (CP) associated with damp-heat and blood-stasis syndromes. Methods An electronic search of 13 databases up to May 2016 was screened to identify randomized controlled trials comparing the safety and efficacy of CHM for the treatment of CP associated with damp-heat and blood-stasis syndromes. Studies reporting on effective rates, adverse events, National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) scores, and symptom index of Chinese medicine for chronic prostatitis (SI-CM) scores as outcomes were included in the analysis. Data were analyzed by fixed- or random-effect models using the Review Manager software. Results Thirteen articles with the modified Jadad score ≥4 were identified. It was found that CHM was superior to placebo in increasing the efficacy (odds ratio: 6.72, 95% confidence interval [CI]: 2.78–9.48, P<0.00001) and reducing the SI-CM scores (standardized mean difference: −1.08, 95% CI: −1.35 to −0.81, P<0.00001). Oral CHMs were significantly more effective than placebo at reducing NIH-CPSI scores, with a mean difference of −1.39 (95% CI: −1.87 to −0.92, P<0.00001). Nevertheless, no significant differences were found between Prostant and placebo (standardized mean difference: −0.23, 95% CI: −0.46 to 0.01, P=0.06). The frequency of adverse events associated with oral CHM was similar to that associated with placebo (risk ratio: 1.36, 95% CI: 0.72–2.55, P=0.34) and less than that associated with Prostant (risk ratio: 1.63, 95% CI: 1.14–2.34, P=0.008). Conclusion Our novel analysis demonstrates that CHM ranks highest in terms of improvement of CP associated with damp-heat and blood-stasis syndromes. While Prostant showed some efficacy in this disorder, it was associated with a smaller reduction in NIH-CPSI scores. In conclusion, CHM monotherapy is safe and

  18. Subsurface quality assurance practices

    International Nuclear Information System (INIS)

    This report addresses only the concept of applying Nuclear Quality Assurance (NQA) practices to repository shaft and subsurface design and construction; how NQA will be applied; and the level of detail required in the documentation for construction of a shaft and subsurface repository in contrast to the level of detail required in the documentation for construction of a traditional mine. This study determined that NQA practices are viable, attainable, as well as required. The study identified the appropriate NQA criteria and the repository's major structures, systems, items, and activities to which the criteria are applicable. A QA plan, for design and construction, and a list of documentation, for construction, are presented. 7 refs., 1 fig., 18 tabs

  19. Construction quality assurance report

    Energy Technology Data Exchange (ETDEWEB)

    Roscha, V.

    1994-09-08

    This report provides a summary of the construction quality assurance (CQA) observation and test results, including: The results of the geosynthetic and soil materials conformance testing. The observation and testing results associates with the installation of the soil liners. The observation and testing results associated with the installation of the HDPE geomembrane liner systems. The observation and testing results associated with the installation of the leachate collection and removal systems. The observation and testing results associated with the installation of the working surfaces. The observation and testing results associated with in-plant manufacturing process. Summary of submittal reviews by Golder Construction Services, Inc. The submittal and certification of the piping material specifications. The observation and verification associated of the Acceptance Test Procedure results of the operational equipment functions. Summary of the ECNs which are incorporated into the project.

  20. FESA Quality Assurance

    CERN Document Server

    CERN. Geneva

    2015-01-01

    FESA is a framework used by 100+ developers at CERN to design and implement the real-time software used to control the accelerators. Each new version must be tested and qualified to ensure that no backward compatibility issues have been introduced and that there is no major bug which might prevent accelerator operations. Our quality assurance approach is based on code review and a two-level testing process. The first level is made of unit-test (Python unittest & Google tests for C++). The second level consists of integration tests running on an isolated test environment. We also use a continuous integration service (Bamboo) to ensure the tests are executed periodically and the bugs caught early. In the presentation, we will explain the reasons why we took this approach, the results and some thoughts on the pros and cons.

  1. Concrete quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Holz, N. [Harza Engineering Company, Chicago, IL (United States)

    2000-08-01

    This short article reports on progress at the world's largest civil construction project, namely China's Three Gorges hydro project. Work goes on around the clock to put in place nearly 28 M m{sup 3} of concrete. At every stage of the work there is strong emphasis on quality assurance (QA) and concrete is no exception. The US company Harza Engineering has been providing QA since the mid-1980s and concrete QA has been based on international standards. Harza personnel work in the field with supervisors developing educational tools for supervising concrete construction and quality, as well as providing training courses in concrete technology. Some details on flood control, capacity, water quality and environmental aspects are given..

  2. Construction quality assurance report

    International Nuclear Information System (INIS)

    This report provides a summary of the construction quality assurance (CQA) observation and test results, including: The results of the geosynthetic and soil materials conformance testing. The observation and testing results associates with the installation of the soil liners. The observation and testing results associated with the installation of the HDPE geomembrane liner systems. The observation and testing results associated with the installation of the leachate collection and removal systems. The observation and testing results associated with the installation of the working surfaces. The observation and testing results associated with in-plant manufacturing process. Summary of submittal reviews by Golder Construction Services, Inc. The submittal and certification of the piping material specifications. The observation and verification associated of the Acceptance Test Procedure results of the operational equipment functions. Summary of the ECNs which are incorporated into the project

  3. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan.

    Directory of Open Access Journals (Sweden)

    Shin-Yu Lin

    Full Text Available BACKGROUND: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women. METHODS: This prospective trial (NCT01514708 enrolled 46 pregnant women who received a single intramuscular dose of trivalent flu vaccine (AdimFlu-S® containing 15 mcg of hemagglutinin for each strain/0.5 mL from influenza A (H1N1, influenza A (H3N2, and influenza B after the first trimester. Blood samples were collected at day 0 and 28 after vaccination, and at delivery. Cord blood was also collected. Hemagglutination inhibition (HAI assays were performed to determine seroprotection and seroconversion rates and fold increase in the HAI geometric mean titer (GMT. RESULTS: Twenty-eight days after vaccination the seroprotection rate against H1N1, H3N2, and influenza B was 91.3%, 84.8% and 56.5%, respectively. The GMT fold increase was 12.8, 8.4, and 4.6 for H1N1, H3N2, and influenza B, respectively. At delivery, both the seroprotection rate (86.4%, 68.2%, and 47.7% and GMT fold increase (9.4, 5.7 and 3.8 were slightly lower than day 28. The seroprotection rate and GMT fold increase in maternal and cord blood samples were comparable. No significant adverse effects were detected. CONCLUSIONS: Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects. TRIAL REGISTRATION: Clinical Trials. gov NCT01514708.

  4. Quality assurance of qualitative analysis

    DEFF Research Database (Denmark)

    Ríos, Ángel; Barceló, Damiá; Buydens, Lutgarde;

    2003-01-01

    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...

  5. Recent Trends in Quality Assurance

    Science.gov (United States)

    Amaral, Alberto; Rosa, Maria Joao

    2010-01-01

    In this paper we present a brief description of the evolution of quality assurance in Europe, paying particular attention to its relationship to the rising loss of trust in higher education institutions. We finalise by analysing the role of the European Commission in the setting up of new quality assurance mechanisms that tend to promote…

  6. Evaluation Research and Quality Assurance.

    Science.gov (United States)

    Pesta, George; Respress, Trinetia; Major, Aline K.; Arazan, Christine; Coxe, Terry

    2002-01-01

    Describes the Juvenile Justice Educational Enhancement Program's implementation of an evaluation research-driven quality assurance process for Florida's juvenile justice educational programs. Reviews the literature on juvenile justice educational practices and describes the educational quality assurance standards and annual modifications that draw…

  7. Quality assurance auditing for nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations for establishing and implementing a system of internal and external audits during the design, manufacture, construction, commissioning and operation of nuclear power plants. It provides for the planning, performance, reporting and follow-up of the quality assurance audit activity. It defines in general terms the responsibilities of the auditing and audited organizations. The Guide also covers auditing in the context of supplier evaluation; it does not include inspection for the sole purpose of process control or product acceptance. Like the Code, the present Guide was prepared as part of the IAEA's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to land-based stationary thermal neutron power plants

  8. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    International Nuclear Information System (INIS)

    S.M. Stoller Corporation is the contractor for the Technical Assistance Contract (TAC) for the U.S. Department of Energy (DOE) Office of Legacy Management (LM) operations. Stoller employs a management system that applies to all programs, projects, and business management systems funded through DOE-LM task orders. The management system incorporates the philosophy, policies, and requirements of health and safety, environmental compliance, and quality assurance (QA) in all aspects of project planning and implementation. Health and safety requirements are documented in the Health and Safety Manual (STO 2), the Radiological Control Manual (STO 3), the Integrated Safety Management System Description (STO 10), and the Drilling Health and Safety Requirements (STO 14). Environmental compliance policy and requirements are documented in the Environmental Management Program Implementation Manual (STO 11). The QA Program is documented in the Quality Assurance Manual (STO 1). The QA Manual (STO 1) implements the specific requirements and philosophy of DOE Order 414.1C, Quality Assurance. This manual also includes the requirements of other standards that are regularly imposed by customers, regulators, or other DOE orders. Title 10 Code of Federal Regulations Part 830, 'Quality Assurance Requirements', ANSI/ASQC E4-2004, 'Quality Systems for Environmental Data and Technology Programs - Requirements with Guidance for Use', and ISO 14001-2004, 'Environmental Management Systems', have been included. These standards are similar in content. The intent of the QA Manual (STO 1) is to provide a QA management system that incorporates the requirements and philosophy of DOE and other customers within the QA Manual. Criterion 1, 'Quality Assurance Program', identifies the fundamental requirements for establishing and implementing the QA management system; QA Instruction (QAI) 1.1, 'QA Program Implementation', identifies the TAC organizations that have responsibility for implementing the QA

  9. Operational and environmental safety

    International Nuclear Information System (INIS)

    The responsibility of the DOE Office of Operational and Environmental Safety is to assure that DOE-controlled activities are conducted in a manner that will minimize risks to the public and employees and will provide protection for property and the environment. The program supports the various energy technologies by identifying and resolving safety problems; developing and issuing safety policies, standards, and criteria; assuring compliance with DOE, Federal, and state safety regulations; and establishing procedures for reporting and investigating accidents in DOE operations. Guidelines for the radiation protection of personnel; radiation monitoring at nuclear facilities; an assessment of criticality accidents by fault tree analysis; and the preparation of environmental, safety, and health standards applicable to geothermal energy development are discussed

  10. Quality assurance in the procurement, design and manufacture of nuclear fuel assemblies

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations for quality assurance programmes that are relevant for the unique features of the procurement, design, manufacture, inspection, testing, packaging, shipping, storage, and receiving inspection of fuel assemblies for nuclear power plants. The generic quality assurance requirements of the Code and related Safety Guides are referred to where applicable, and are duplicated in this document where increased emphasis is desirable

  11. Infection with human T-lymphotropic virus types-1 and -2 (HTLV-1 and -2): Implications for blood transfusion safety.

    Science.gov (United States)

    Murphy, E L

    2016-02-01

    Many countries currently perform antibody screening for HTLV-1 infection in blood donors, and this intervention is likely cost-effective in preventing HTLV-1 related diseases in high prevalence countries. However, a number of high-income countries with low prevalence of HTLV-1 infection also perform universal HTLV-1 screening and debate has arisen regarding the cost-effectiveness of these strategies. Filter-based leukoreduction is likely to substantially reduce HTLV-1 transmission by removing infected lymphocytes, but actual laboratory data on its efficacy is currently lacking. Similarly, cost-effectiveness research on HTLV-1 prevention strategies is limited by poor data on prevalence, transmission efficacy and the cost of treating HTLV1 diseases. PMID:26778839

  12. An integrative pharmacological approach to radio telemetry and blood sampling in pharmaceutical drug discovery and safety assessment

    Directory of Open Access Journals (Sweden)

    Kamendi Harriet W

    2011-01-01

    Full Text Available Abstract Background A successful integration of the automated blood sampling (ABS and telemetry (ABST system is described. The new ABST system facilitates concomitant collection of physiological variables with blood and urine samples for determination of drug concentrations and other biochemical measures in the same rat without handling artifact. Method Integration was achieved by designing a 13 inch circular receiving antenna that operates as a plug-in replacement for the existing pair of DSI's orthogonal antennas which is compatible with the rotating cage and open floor design of the BASi Culex® ABS system. The circular receiving antenna's electrical configuration consists of a pair of electrically orthogonal half-toroids that reinforce reception of a dipole transmitter operating within the coil's interior while reducing both external noise pickup and interference from other adjacent dipole transmitters. Results For validation, measured baclofen concentration (ABST vs. satellite (μM: 69.6 ± 23.8 vs. 76.6 ± 19.5, p = NS and mean arterial pressure (ABST vs. traditional DSI telemetry (mm Hg: 150 ± 5 vs.147 ± 4, p = NS variables were quantitatively and qualitatively similar between rats housed in the ABST system and traditional home cage approaches. Conclusion The ABST system offers unique advantages over traditional between-group study paradigms that include improved data quality and significantly reduced animal use. The superior within-group model facilitates assessment of multiple physiological and biochemical responses to test compounds in the same animal. The ABST also provides opportunities to evaluate temporal relations between parameters and to investigate anomalous outlier events because drug concentrations, physiological and biochemical measures for each animal are available for comparisons.

  13. Development of quality assurance program for production of sealed radiation source

    CERN Document Server

    Nam, J H; Cho, W K; Han, H S; Hong, S B; Kim, K H; Kim, S D; Lee, Y G; Lim, N J

    2001-01-01

    The quality assurance program for production of sealed radiation sources has been developed to increase the efficiency and safety of production work and to meet the demand of the customers. The quality assurance program are applied to the entire work scope of the production of sealed radiation sources. Every workers related to the production of sealed radiation sources will be required to follow this quality assurance program. It is expected that the sealed radiation source products produced according to this quality assurance program can meet the regulatory requirements, customer's demand and have good competitiveness in the domestic and world markets.

  14. Operating the plant, quality assurance, and the job of the operating staff, Volume Twelve

    International Nuclear Information System (INIS)

    Subject matter includes operating the plant (the role of the operator, the control room, plant technical specifications, plant operating procedures, initial startup program, BWR/PWR plant startup, BWR/PWR steady state power operation, BWR/PWR transient operation, emergency operation), quality assurance (what is quality, what is quality control, quality assurance includes quality control, government regulation and quality assurance, administrative controls for nuclear power plants, the necessity of reviews and audits, practical quality assurance), and the job of the operating staff (the plant operating staff, plant safety, first aid and resuscitation, general plant hazards, personnel protective equipment, handling chemicals, handling compressed gas, equipment repair and maintenance, communicating with others

  15. Weaving an Assurance Case from Design: A Model-Based Approach

    OpenAIRE

    Kelly, Tim; Hawkins, Richard David; Habli, Ibrahim; Kolovos, Dimitris; Paige, Richard Freeman

    2015-01-01

    Assurance cases are used to demonstrate confidence in properties of interest for a system, e.g. For safety or security. A model-based assurance case seeks to bring the benefits of model-driven engineering, such as automation, transformation and validation, to what is currently a lengthy and informal process. In this paper we develop a model-based assurance approach, based on a weaving model, which allows integration between assurance case, design and process models and meta-models. In our app...

  16. Unresolved clinical aspects and safety hazards of blood derived- EV/MV in stored blood components: From personal memory lanes to newer perspectives on the roles of EV/MV in various biological phenomena.

    Science.gov (United States)

    Seghatchian, Jerard; Amiral, Jean

    2016-08-01

    Blood cells generate heterogeneous populations of vesicles that are delivered, as small-specialized packages of highly active cell fragments in blood circulation, having almost similar functional activities, as the mother cells. These so called extracellular vesicles are the essential part of an energy-dependent natural apoptotic process; hence their beneficial and harmful biological functions cannot be ignored. Evidence is accumulating, that cellular derived vesicles, originate from all viable cells including: megakaryocytes, platelets, red blood cells, white blood cells and endothelial cells, the highest in proportions from platelets. Shedding can also be triggered by pathological activation of inflammatory processes and activation of coagulation or complement pathways, or even by shear stress in the circulation. Structurally, so called MV/EV appear to be, sometimes inside-out and sometimes outside-in cell fragments having a bilayered phospholipid structure exposing coagulant-active phosphatidylserine, expressing various membrane receptors, and they serve as cell-to-cell shuttles for bioactive molecules such as lipids, growth factors, microRNAs, and mitochondria. Ex vivo processing of blood into its components, embodying centrifugation, processing by various apheresis procedures, leukoreduction, pathogen reduction, and finally storage in different media and different types of blood bags, also have major impacts on the generation and retention of MV content. These artificially generated small, but highly liable packages, together with the original pool of MVs collected from the donor, do exhibit differing biological activities, and are not inert elements and should be considered as a parameter of blood safety in haemovigilance programmes. Harmonization and consensus in sampling protocols, sample handling, processing, and assessment methods, in particular converting to full automation, are needed to achieve consensual interpretations. This review focuses on some of

  17. Patient safety: Safety culture and patient safety ethics

    DEFF Research Database (Denmark)

    Madsen, Marlene Dyrløv

    2006-01-01

    challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... the problems, and suggest possible solutions for improving patient safety through the promotion of safety culture and ethics. I seek to illuminate theissues of patient safety from several perspectives; the organizational healthcare system, in particular the healthcare workers perspectives and experiences...

  18. Determinants for conducting food safety culture research

    NARCIS (Netherlands)

    Nyarugwe, Shingai P.; Linnemann, Anita; Hofstede, Gert Jan; Fogliano, Vincenzo; Luning, Pieternel A.

    2016-01-01

    Background Foodborne outbreaks continue to occur regardless of existing food safety measures indicating the shortcomings of these measures to assure food safety. This has led to the recognition of food safety culture as a key contributory factor to the food safety performance of food establishmen

  19. Ballistic quality assurance

    International Nuclear Information System (INIS)

    This review describes the ballistic quality assurance for stereotactic intracranial irradiation treatments delivered with Gamma KnifeR either dedicated or adapted medical linear accelerators. Specific and periodic controls should be performed in order to check the mechanical stability for both irradiation and collimation systems. If this step remains under the responsibility of the medical physicist, it should be done in agreement with the manufacturer's technical support. At this time, there are no recent published guidelines. With technological developments, both frequency and accuracy should be assessed in each institution according to the treatment mode: single versus hypo-fractionated dose, circular collimator versus micro-multi-leaf collimators. In addition, 'end-to-end' techniques are mandatory to find the origin of potential discrepancies and to estimate the global ballistic accuracy of the delivered treatment. Indeed, they include frames, non-invasive immobilization devices, localizers, multimodal imaging for delineation and in-room positioning imaging systems. The final precision that could be reasonably achieved is more or less 1 mm. (authors)

  20. Analytical strategies for the early quality and safety assurance in the global feed chain. Approaches for nitrogen adulterants in soybean meal and mineral and transformer oils in vegetable oils

    NARCIS (Netherlands)

    Jong, de Jacob; Lopez Sanchez, Patricia; Mol, Hans

    2016-01-01

    In the past decade, several major food safety crises originated from problems with feed. Consequently, there is an urgent need for early detection of fraudulent adulteration and contamination in the feed chain. Strategies are presented for two specific cases, viz. adulterations of (i) soybean mea

  1. Efficacy and safety of Chinese herbal medicine for chronic prostatitis associated with damp-heat and blood-stasis syndromes: a meta-analysis and literature review

    Directory of Open Access Journals (Sweden)

    Wang Z

    2016-09-01

    Full Text Available Zhiqiang Wang,1 Lei Yuan,1 Yongchuan Wang,2 Baizhi Yang,1 Xiaohong Dong,1 Zhaowang Gao3 1Department of Urology, Shouguang Hospital of Traditional Chinese Medicine, Shouguang, 2Department of Urology, Weifang Traditional Chinese Hospital, Weifang, 3Department of Urology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Shandong, People’s Republic of China Objective: The aim of this meta-analysis and systematic review is to evaluate the safety and efficacy of Chinese herbal medicine (CHM for chronic prostatitis (CP associated with damp-heat and blood-stasis syndromes.Methods: An electronic search of 13 databases up to May 2016 was screened to identify randomized controlled trials comparing the safety and efficacy of CHM for the treatment of CP associated with damp-heat and blood-stasis syndromes. Studies reporting on effective rates, adverse events, National Institutes of Health chronic prostatitis symptom index (NIH-CPSI scores, and symptom index of Chinese medicine for chronic prostatitis (SI-CM scores as outcomes were included in the analysis. Data were analyzed by fixed- or random-effect models using the Review Manager software.Results: Thirteen articles with the modified Jadad score ≥4 were identified. It was found that CHM was superior to placebo in increasing the efficacy (odds ratio: 6.72, 95% confidence interval [CI]: 2.78–9.48, P<0.00001 and reducing the SI-CM scores (standardized mean difference: -1.08, 95% CI: -1.35 to -0.81, P<0.00001. Oral CHMs were significantly more effective than placebo at reducing NIH-CPSI scores, with a mean difference of -1.39 (95% CI: -1.87 to -0.92, P<0.00001. Nevertheless, no significant differences were found between Prostant and placebo (standardized mean difference: -0.23, 95% CI: -0.46 to 0.01, P=0.06. The frequency of adverse events associated with oral CHM was similar to that associated with placebo (risk ratio: 1.36, 95% CI: 0.72–2.55, P=0.34 and less than that

  2. Quality assurance during operation of nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations for the establishment and implementation of quality assurance for activities important to safety during commissioning, operation and decommissioning of a nuclear power plant, hereinafter referred to in this Guide as the operation phase or operation. It applies to activities such as: operating, inspecting, testing, commissioning, refuelling, maintaining, repairing, modifying and eventual shut-down and decommissioning of nuclear power plants. It applies also to associated activities related to safety, such as environmental monitoring and responses to emergencies

  3. Physical aspects of quality assurance in nuclear medicine and radiotherapy, regulatory approach of the National Nuclear Safety Center; Aspectos fisicos de garantia de calidad en medicina nuclear y radioterapia. Enfoque regulatorio del centro Nacional de Seguridad Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez C, D.; Fuente P, A. de la; Quevedo G, J.R.; Lopez F, Y. [CNSN, Calle 28 No. 504 e/5 y 7, Ave. Miramar, La Habana (Cuba); Varela C, C. [CCEEM, Calle 4 No. 455 e/19 y 21, Ave. Vedado, La Habana (Cuba)]. e-mail: cruz@orasen.co.cu

    2006-07-01

    The physical aspects of the quality guarantee in Nuclear Medicine and Radiotherapy its are of cardinal importance to guarantee the quality of the diagnoses and treatments that are carried out to the patients in this type of services. The OIEA, the OMS and other scientific and professional organizations have contributed significantly to the elaboration of recommendations, Protocols, etc. applicable in the quality control programs and safety of the Nuclear Medicine and Radiotherapy departments. In spite of the great effort developed in this sense the Installation of the programs of quality control and safety of the Nuclear Medicine and Radiotherapy departments can fail if the same ones are not based in three decisive elements that are: the existence of national regulations, the existence of the infrastructure required for it and the existence of enough qualified personnel to develop this programs. The present work shows the regulatory focus that on this topic, it has followed the National Center of Nuclear Safety of Cuba (CNSN). The same left of strengthen all the existent Synergies in the different organizations of the country and it went in two fundamental directions: installation of the regulatory requirements that govern this activity and the Authorization of a Cuban Entity, specialized in carrying out audits to the quality control and safety programs of the Nuclear Medicine and Radiotherapy departments. After 4 work years in this direction, the results confirm the validity of the experience developed by the CNSN, at the moment all the services of Nuclear Medicine and Radiotherapy of Cuba possess quality control and safety programs, these programs are annually Auditing by an Authorized entity by the CNSN and the Inspectors of the Regulatory Authority, control, during the inspections, the one execution of the established requirements in the national regulations. The work developed so far can serve, modestly, of reference to others countries of Latin America that

  4. Efficacy and safety of integrative medical program based on blood cooling and detoxification recipe in treating patients with hepatitis B virus related acute-on-chronic liver failure:a randomized controlled clinical study

    Institute of Scientific and Technical Information of China (English)

    刘慧敏

    2014-01-01

    Objective To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe(BCDR)in treating patients with hepatitis B virus related acute-on-chronic liver failure(HBV-ACLF)of heat-toxicity accumulation syndrome(HTAS).Methods Adopting randomized controlled

  5. Quality Assurance: A Balancing Act

    OpenAIRE

    Žváčková Jitka

    2015-01-01

    Language Centre Quality Assurance can be used for a wide range of purposes, from audits of services and procedures to reflection on best practices and improvements of language education. Quality Assurance systems across Europe differ considerably. The Czech Republic, unlike the UK or Spain, applies no unified national standards, therefore, the Masaryk University Language Centre (CJV MU), in compliance with the Masaryk University strategic plan, is obliged to set its own standards and procedur...

  6. FOOD SAFETY: WHAT IS ECONOMISTS' VALUE ADDED?

    OpenAIRE

    Julie A Caswell

    2003-01-01

    Economists are contributing to the food safety arena by analyzing demand for food safety, the consumer level benefits of improved food safety, the costs and benefits to companies from quality assurance for food safety, and the benefits and costs of government regulations aimed at improving food safety. In the food safety area, too much attention has been paid to risk assessment and not enough to risk management. Economists have a very important role to play in improving private and public ris...

  7. Manual on quality assurance for the survey, evaluation and confirmation of nuclear power plant sites

    International Nuclear Information System (INIS)

    The present Manual on Quality Assurance for the Survey, Evaluation and Confirmation of Nuclear Power Plant Sites contains supporting material and illustrates examples for implementing the requirements contained in the Code of Practice on Quality Assurance for Safety in Nuclear Power Plants to the activities of survey, evaluation and confirmation of nuclear power plant sites. At the same time the Code of Practice for Safety in Nuclear Power Plant Siting, and Safety Guides in the siting series contain requirements and recommendations to implement a quality assurance programme in selected activities of the siting process. This manual is intended to provide guidance and illustrate examples on this implementation. During preparation and reviews of this Manual it was found out that the methodology of implementation of the quality assurance programme in siting activities is still under development. For these reasons it was considered appropriate to publish this Manual as a temporary publication for trial use

  8. Long-Term Safety of Repeated Blood-Brain Barrier Opening via Focused Ultrasound with Microbubbles in Non-Human Primates Performing a Cognitive Task.

    Directory of Open Access Journals (Sweden)

    Matthew E Downs

    Full Text Available Focused Ultrasound (FUS coupled with intravenous administration of microbubbles (MB is a non-invasive technique that has been shown to reliably open (increase the permeability of the blood-brain barrier (BBB in multiple in vivo models including non-human primates (NHP. This procedure has shown promise for clinical and basic science applications, yet the safety and potential neurological effects of long term application in NHP requires further investigation under parameters shown to be efficacious in that species (500 kHz, 200-400 kPa, 4-5 μm MB, 2 minute sonication. In this study, we repeatedly opened the BBB in the caudate and putamen regions of the basal ganglia of 4 NHP using FUS with systemically-administered MB over 4-20 months. We assessed the safety of the FUS with MB procedure using MRI to detect edema or hemorrhaging in the brain. Contrast enhanced T1-weighted MRI sequences showed a 98% success rate for openings in the targeted regions. T2-weighted and SWI sequences indicated a lack edema in the majority of the cases. We investigated potential neurological effects of the FUS with MB procedure through quantitative cognitive testing of' visual, cognitive, motivational, and motor function using a random dot motion task with reward magnitude bias presented on a touchpanel display. Reaction times during the task significantly increased on the day of the FUS with MB procedure. This increase returned to baseline within 4-5 days after the procedure. Visual motion discrimination thresholds were unaffected. Our results indicate FUS with MB can be a safe method for repeated opening of the BBB at the basal ganglia in NHP for up to 20 months without any long-term negative physiological or neurological effects with the parameters used.

  9. Risk-based requirements management framework with applications to assurance cases

    Science.gov (United States)

    Feng, D.; Eyster, C.

    The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

  10. 2007 special equipment safety

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ The General Administration of Quality Supervision, Inspection and Quarantine of P.R.China (AQSIQ) issued a notice on May 28, 2007,requiring various locations to rectify their procedures for checking special equipment and hoisting machines for hidden problems. To further clarify and implement responsibility in the safety management of special equipment in enterprises, inspection responsibilities and test organizations related to technical assurance are to be established. Further, quality inspection departments will be supervised by law in order to improve special equipment safety.

  11. Safety of nuclear installations

    International Nuclear Information System (INIS)

    The safety philosophy of a PWR type reactor distinguishing three levels of safety, is presented. At the first level, the concept of reactivity defining coefficients which measure the reactivity variation is introduced. At the second level, the reactor protection system establishing the design criteria to assure the high reliability, is defined. At the third level, the protection barriers to contain the consequences of accident evolution, are defined. (M.C.K.)

  12. Thoughts on Internal and External Quality Assurance

    Science.gov (United States)

    Zhang, Jianxin

    2012-01-01

    Quality assurance of higher education is made up of two parts: internal quality assurance (IQA) and external quality assurance (EQA). Both belong to a union of the coexistence and balance of yin and yang. But in reality there exists a paradox of "confusion of quality assurance (QA) subject consciousness, singularity of social QA and lack of QA…

  13. 10 CFR 71.37 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under...

  14. Quality Assurance Review of SKB's Copper Corrosion Experiments

    International Nuclear Information System (INIS)

    SKB is preparing a license application for the construction of a final repository for spent nuclear fuel in Sweden. This application will be supported by the safety assessment SR-Site for the post-closure phase. The assessment of long-term safety is based on a broad range of experimental results from laboratory scale, intermediate scale and up to full scale experiments. It is essential that there is a satisfactory level of assurance that experiments have been carried out with sufficient quality, so that results can be considered to be reliable within the context of their use in safety assessment. The former named authority, SKI, has initiated a series of reviews of SKB's methods of quality assurance and their implementation. This quality assurance review is focused on the work of copper corrosion being conducted in at SKB's Hard Rock Laboratory (HRL) in Aespoe, LOT and Miniature canister (Minican) experiments. In order for the reviewers to get a broad understanding of the issue of copper corrosion both SKB reports as well as the viewpoint of MKG was collected prior to commencement of the actual review task. The purpose of this project is to assess SKB's quality assurance with the view of providing input for the preparation of the SR-Site safety assessment. This has been achieved by examination of the corrosion part of the LOT and Minican experiments using a check list, visits to the relevant facilities, and meetings with contractors and a few members of the SKB staff. The same approach for quality assurance reviews has been used earlier in similar review tasks. During the quality review of the selected projects, several QA- related issues of different degree of severity was noted by the reviewers. The most significant finding was that SKB has chosen to present only selected real-time corrosion monitoring data in TR-09-20. This was surprising and SSM expect that SKB will analyse the reason for this thoroughly. The reviewers also made other observations which can be

  15. Enhancing Transfusion Safety: Nurse’s Role

    Directory of Open Access Journals (Sweden)

    Kyriazi Vasiliki

    2011-01-01

    Full Text Available Background: Despite strict clinical measures, there are distinct steps in transfusion process which require acute attention.The nurse is responsible for insuring that the right unit is administered to the right patient. Knowledge of risks is essential toadminister and monitor transfusions safely.Aim: This study summarizes the available data concerning transfusion adverse events and provides theoretical and technicalaspects for improving transfusion practice.Methodology: A systematic review in PubMed, MedLine and MDConsult database was conducted. The research limitsincluded English texts, referring to transfusion risks and technological means aiming at transfusion safety.Results: Blood transfusion is a medical intervention that saves lives and improves the quality of life. The regulations forensuring the availability and assuring the quality of the blood component cannot avoid transfusion errors, placing patients atrisk. Most frequent errors are attributed to practitioners involved in the clinical transfusion process. Based on reports toSerious Hazards of Transfusion (SHOT the risk of transfusion error is estimated at 1:16,500. Over the last years severalcommittees have recommended guidance for enhancing the safety of blood ordering and administration. Moreover, newtechnology like barcode on patient wristband manages to improve the performance in each step.Conclusion: Safe transfusion process depends on a series of linked processes and nurses should take specific measuresreferring to pre- and post-transfusion stage. Technological innovations could help patients in need of transfusion therapy.

  16. [The external quality assessment schemes for lead in blood organized by the French national agency for medicine and health product safety: a synthesis of 15 years of activity].

    Science.gov (United States)

    Pineau, Alain; Otz, Jocelyne; Guillard, Olivier; Fauconneau, Bernard; Dumont, Gilles; François-Burg, Elisabeth

    2014-01-01

    In 1992, at the request of the French labor ministry following questions on the ability of medical biology laboratories to satisfactorily measure blood lead level (PbB), a national PbB quality control came into being. Only in 1996 did this external quality control include a number of laboratories sufficient to allow for a significant retrospective evaluation. After fifteen years (1996-2011), The French National Agency for Medicines and Health Products Safety wished to exploit the database collected. The number of participating laboratories went down from 73 to 41. On the other hand, the key finding pertained to the highly improved performance of the laboratories, which was associated with a spread decrease of the results over the entire range of tested PbBs (9 to 700 μg/L). Since 2006, we have observed increasing use of the inductively coupled plasma with mass spectrometry and decreasing use of electrothermal atomic absorption spectrometry. Provided that they rely on identical metrology expertise, the two analytical techniques lead to results on all the tested concentrations that are not statistically different.

  17. Assurance in Agent-Based Systems

    International Nuclear Information System (INIS)

    Our vision of the future of information systems is one that includes engineered collectives of software agents which are situated in an environment over years and which increasingly improve the performance of the overall system of which they are a part. At a minimum, the movement of agent and multi-agent technology into National Security applications, including their use in information assurance, is apparent today. The use of deliberative, autonomous agents in high-consequence/high-security applications will require a commensurate level of protection and confidence in the predictability of system-level behavior. At Sandia National Laboratories, we have defined and are addressing a research agenda that integrates the surety (safety, security, and reliability) into agent-based systems at a deep level. Surety is addressed at multiple levels: The integrity of individual agents must be protected by addressing potential failure modes and vulnerabilities to malevolent threats. Providing for the surety of the collective requires attention to communications surety issues and mechanisms for identifying and working with trusted collaborators. At the highest level, using agent-based collectives within a large-scale distributed system requires the development of principled design methods to deliver the desired emergent performance or surety characteristics. This position paper will outline the research directions underway at Sandia, will discuss relevant work being performed elsewhere, and will report progress to date toward assurance in agent-based systems

  18. NIF Projects Controls and Information Systems Software Quality Assurance Plan

    International Nuclear Information System (INIS)

    Quality achievement for the National Ignition Facility (NIF) and the National Ignition Campaign (NIC) is the responsibility of the NIF Projects line organization as described in the NIF and Photon Science Directorate Quality Assurance Plan (NIF QA Plan). This Software Quality Assurance Plan (SQAP) is subordinate to the NIF QA Plan and establishes quality assurance (QA) activities for the software subsystems within Controls and Information Systems (CIS). This SQAP implements an activity level software quality assurance plan for NIF Projects as required by the LLNL Institutional Software Quality Assurance Program (ISQAP). Planned QA activities help achieve, assess, and maintain appropriate quality of software developed and/or acquired for control systems, shot data systems, laser performance modeling systems, business applications, industrial control and safety systems, and information technology systems. The objective of this SQAP is to ensure that appropriate controls are developed and implemented for management planning, work execution, and quality assessment of the CIS organization's software activities. The CIS line organization places special QA emphasis on rigorous configuration control, change management, testing, and issue tracking to help achieve its quality goals.

  19. Mixed Waste Integrated Program Quality Assurance requirements plan

    International Nuclear Information System (INIS)

    Mixed Waste Integrated Program (MWIP) is sponsored by the US Department of Energy (DOE), Office of Technology Development, Waste Management Division. The strategic objectives of MWIP are defined in the Mixed Waste Integrated Program Strategic Plan, and expanded upon in the MWIP Program Management Plan. This MWIP Quality Assurance Requirement Plan (QARP) applies to mixed waste treatment technologies involving both hazardous and radioactive constituents. As a DOE organization, MWIP is required to develop, implement, and maintain a written Quality Assurance Program in accordance with DOE Order 4700.1 Project Management System, DOE Order 5700.6C, Quality Assurance, DOE Order 5820.2A Radioactive Waste Management, ASME NQA-1 Quality Assurance Program Requirements for Nuclear Facilities and ANSI/ASQC E4-19xx Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. The purpose of the MWIP QA program is to establish controls which address the requirements in 5700.6C, with the intent to minimize risks and potential environmental impacts; and to maximize environmental protection, health, safety, reliability, and performance in all program activities. QA program controls are established to assure that each participating organization conducts its activities in a manner consistent with risks posed by those activities

  20. NIF Projects Controls and Information Systems Software Quality Assurance Plan

    Energy Technology Data Exchange (ETDEWEB)

    Fishler, B

    2011-03-18

    Quality achievement for the National Ignition Facility (NIF) and the National Ignition Campaign (NIC) is the responsibility of the NIF Projects line organization as described in the NIF and Photon Science Directorate Quality Assurance Plan (NIF QA Plan). This Software Quality Assurance Plan (SQAP) is subordinate to the NIF QA Plan and establishes quality assurance (QA) activities for the software subsystems within Controls and Information Systems (CIS). This SQAP implements an activity level software quality assurance plan for NIF Projects as required by the LLNL Institutional Software Quality Assurance Program (ISQAP). Planned QA activities help achieve, assess, and maintain appropriate quality of software developed and/or acquired for control systems, shot data systems, laser performance modeling systems, business applications, industrial control and safety systems, and information technology systems. The objective of this SQAP is to ensure that appropriate controls are developed and implemented for management planning, work execution, and quality assessment of the CIS organization's software activities. The CIS line organization places special QA emphasis on rigorous configuration control, change management, testing, and issue tracking to help achieve its quality goals.

  1. Quality assurance in the procurement of items and services for nuclear power plants

    International Nuclear Information System (INIS)

    Since the inception of nuclear power development in the country, maintaining high safety standards has been a matter of prime importance. Atomic Energy Regulatory Board (AERB) has been entrusted with the responsibility of laying down safety standards and framing rules and regulations in respect of regulatory and safety functions envisaged under the Atomic Energy Act of 1962. This safety guide provides guidance for assuring quality in the procurement of items and services important to nuclear power plant safety. While elaborating the requirements stated in the code of practice on quality assurance (QA) for safety in nuclear power plants, this guide provides necessary information to assist managers in the establishment of the QA programme, for procurement of items and services important to nuclear power plant safety

  2. Review of SKB's Quality Assurance Programme

    Energy Technology Data Exchange (ETDEWEB)

    Baldwin, Tamara D.; Hicks, Timothy W. (Galson Sciences LTD, Oakham, Rutland (United Kingdom))

    2009-06-15

    SKB is preparing a license application for the construction of a final repository for spent nuclear fuel in Sweden. This application will be supported by the safety assessment SR-Site for the post-closure phase. The assessment of long-term safety is based on a broad range of experimental results from laboratory scale, intermediate scale and up to full scale experiments. It is essential that there is a satisfactory level of assurance that experiments have been carried of with sufficient quality, so that results can be considered to be reliable within the context of their use in safety assessment. SSM has initiated a series of reviews of SKB's methods of quality assurance and their implementation. This project includes reviews of the quality assurance (QA) procedures and instructions that have been prepared for the SR-Site assessment as well as reviews of QA implementation at the canister and buffer/backfill laboratories in Oskarshamn, Sweden. The purpose of this project is to assess SKB's quality assurance with the view of providing a good basis for subsequent quality reviews in the context of future licensing. This has been achieved by examination of a number of SKB experiments using a check list, visits to the relevant facilities, and meetings with contractors and a few members of the SKB staff. Overall, the reviewed set of QA documents and instructions do provide reasonably comprehensive coverage of quality-affecting issues relating to the SR-Site safety assessment and, if implemented correctly, will generate confidence in the reliability of the safety assessment results. The results show that the efforts involving quality assurance are increasing within the SKB programme and in general appear to be satisfactory for ongoing experiments and measurements. However, progress in development of the QA documents and instructions has been relatively recent and it may be difficult for these to be fully implemented in the short period remaining before the planned

  3. Quality assurance in individual monitoring

    International Nuclear Information System (INIS)

    Measurement and assessment of radiation dose to the individual radiation worker, called 'Individual monitoring', is one of the most important aspects of radiation protection. International Commission on Radiation Protection (ICRP-75) has outlined three main objectives of personal monitoring viz assessment of the effectively equivalent dose to demonstrate compliance with managerial and regulatory requirements; to contribute to control of operation and design of facilities and in case of accidental overexposure, to provide valuable information for the initiation and support of any health surveillance and treatment. To meet these objectives, it is essential that the measurements are reliable and accurate as defined by National and International Standards. This requires setting up of well defined internal as well as external quality assurance protocol in the individual monitoring program. External quality assurance program is meant to provide a reliable and qualitative as well as quantitative assessment of the service provided by the service provider. In India, individual monitoring is based on CaSO4:Dy based TLD badge and the task of conducting external quality assurance (QA) is being performed by RP and AD, Bhabha Atomic Research Centre. The paper presents the methodology of Quality assurance, Performance evaluation standards and criteria. It discusses the results and important observations of last few QA cycles conducted for all the TLD Labs. The quality assurance check has indicated that the performance of all the Labs is satisfactory in accordance with ANSI as well as Trumpet curve methodology. It provided feedback on further improvements in the quality

  4. U.S. Coast Guard, Office of Boating Safety

    Science.gov (United States)

    ... Report Recalls Product Assurance Branch Boating Safety Circulars Beacon Alerts Marine Safety Alerts Multimedia PSA's Image Library ... Grants Nonprofit Organization Grants Grant Archives Grant Links Beacon Alerts FY17 National Nonprofit Organization Funding Opportunity Application ...

  5. Traceability and Assurance Protocols in the Global Food System

    OpenAIRE

    Jones, Eluned; Poghosyan, Arsen; Gonzalez-Diaz, Francisco; Bolotova, Yuliya

    2004-01-01

    In the 21st century, the food supply chain has become a complex, interconnected system with strategies that are aimed at creating improved products to satisfy consumers' demand for safer foods. To stay competitive and ensure consumer confidence, agribusiness firms develop and implement strategies that take into account not only traditional economic factors driving the food demand, but also issues such as food safety and quality. Traceability and assurance protocols help agribusiness companies...

  6. Participation in Quality Assurance Programs in the Apple Industry

    OpenAIRE

    Bewsell, Denise; Kaine, Geoff

    2006-01-01

    There are several quality assurance (QA) programs operating in Australia for horticulturalists. The documentation of orchard activities and decision making are key features of any QA system. Activities of interest are management of pest and diseases, irrigation, fertiliser management, and fruit production and packing. This documentation provides a means of tracing product flow and is evidence that growers are acting in an environmentally responsible manner to help achieve food safety. QA syst...

  7. Waste Management Quality Assurance Plan

    Energy Technology Data Exchange (ETDEWEB)

    Waste Management Group

    2006-08-14

    The WMG QAP is an integral part of a management system designed to ensure that WMG activities are planned, performed, documented, and verified in a manner that assures a quality product. A quality product is one that meets all waste acceptance criteria, conforms to all permit and regulatory requirements, and is accepted at the offsite treatment, storage, and disposal facility. In addition to internal processes, this QA Plan identifies WMG processes providing oversight and assurance to line management that waste is managed according to all federal, state, and local requirements for waste generator areas. A variety of quality assurance activities are integral to managing waste. These QA functions have been identified in the relevant procedures and in subsequent sections of this plan. The WMG QAP defines the requirements of the WMG quality assurance program. These requirements are derived from Department of Energy (DOE) Order 414.1C, Quality Assurance, Contractor Requirements Document, the LBNL Operating and Assurance Program Plan (OAP), and other applicable environmental compliance documents. The QAP and all associated WMG policies and procedures are periodically reviewed and revised, as necessary, to implement corrective actions, and to reflect changes that have occurred in regulations, requirements, or practices as a result of feedback on work performed or lessons learned from other organizations. The provisions of this QAP and its implementing documents apply to quality-affecting activities performed by the WMG; WMG personnel, contractors, and vendors; and personnel from other associated LBNL organizations, except where such contractors, vendors, or organizations are governed by their own WMG-approved QA programs.

  8. Waste Management Quality Assurance Plan

    International Nuclear Information System (INIS)

    The WMG QAP is an integral part of a management system designed to ensure that WMG activities are planned, performed, documented, and verified in a manner that assures a quality product. A quality product is one that meets all waste acceptance criteria, conforms to all permit and regulatory requirements, and is accepted at the offsite treatment, storage, and disposal facility. In addition to internal processes, this QA Plan identifies WMG processes providing oversight and assurance to line management that waste is managed according to all federal, state, and local requirements for waste generator areas. A variety of quality assurance activities are integral to managing waste. These QA functions have been identified in the relevant procedures and in subsequent sections of this plan. The WMG QAP defines the requirements of the WMG quality assurance program. These requirements are derived from Department of Energy (DOE) Order 414.1C, Quality Assurance, Contractor Requirements Document, the LBNL Operating and Assurance Program Plan (OAP), and other applicable environmental compliance documents. The QAP and all associated WMG policies and procedures are periodically reviewed and revised, as necessary, to implement corrective actions, and to reflect changes that have occurred in regulations, requirements, or practices as a result of feedback on work performed or lessons learned from other organizations. The provisions of this QAP and its implementing documents apply to quality-affecting activities performed by the WMG; WMG personnel, contractors, and vendors; and personnel from other associated LBNL organizations, except where such contractors, vendors, or organizations are governed by their own WMG-approved QA programs

  9. The Science of Mission Assurance

    Directory of Open Access Journals (Sweden)

    Kamal Jabbour

    2011-01-01

    Full Text Available The intent of this article is to describe—and prescribe—a scientific framework for assuring mission essential functions in a contested cyber environment. Such a framework has profound national security implications as the American military increasingly depends on cyberspace to execute critical mission sets. In setting forth this prescribed course of action, the article will first decompose information systems into atomic processes that manipulate information at all six phases of the information lifecycle, then systematically define the mathematical rules that govern mission assurance.

  10. Quality assurance of endoscopy units.

    Science.gov (United States)

    Stebbing, John F

    2011-06-01

    This chapter reflects on how England has led the world in service development and quality assurance of endoscopy. It draws out themes of leadership, strategic vision and organisational culture. It emphasises the pivotal importance of focussing service improvement on enhancing the quality of a patient's experience of endoscopy. It describes the processes used here for quality assurance of endoscopy units and how these have dovetailed with other strands of work in transforming the English endoscopy service. The chapter presents discussion of the responses to accreditation processes and how the design of the JAG Accreditation process maximises its effectiveness. PMID:21764004

  11. Fuel Receiving and Storage Station. Nuclear Regulatory Commission's safety evaluation report

    International Nuclear Information System (INIS)

    The safety evaluation report covers design of structures, components, equipment, and systems; nuclear criticality safety; radiological safety; accident analysis; conduct of operations; quality assurance; common defense and security; financial qualifications; financial protection and indemnity requirements; and technical specifications

  12. Querying Safety Cases

    Science.gov (United States)

    Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

    2014-01-01

    Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

  13. Case study India responds to international food safety requirements

    OpenAIRE

    Sareen, Shashi

    2003-01-01

    "As awareness grows about food safety issues, the need for countries to provide greater assurance about the safety and quality of food also grows....This brief reviews (1) how India utilizes the international framework for food safety standards set forth by the Codex Alimentarius Commission (hereafter referred to as Codex), and (2) how India provides safety assurances for exports and promotes access to international markets for exporters." from Text

  14. Standard guide for establishing a quality assurance program for uranium conversion facilities

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

    1.1 This guide provides guidance and recommended practices for establishing a comprehensive quality assurance program for uranium conversion facilities. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to use. 1.3 The basic elements of a quality assurance program appear in the following order: FUNCTION SECTION Organization 5 Quality Assurance Program 6 Design Control 7 Instructions, Procedures & Drawings 8 Document Control 9 Procurement 10 Identification and Traceability 11 Processes 12 Inspection 13 Control of Measuring and Test Equipment 14 Handling, Storage and Shipping 15 Inspection, Test and Operating Status 16 Control of Nonconforming Items 17 Corrective Actions 18 Quality Assurance Records 19 Audits 20 TABLE 1 NQA-1 Basic Requirements Relat...

  15. Quality Assurance 1992-2012

    Science.gov (United States)

    Brown, Roger

    2012-01-01

    As the author's contribution to a series marking the Golden Jubilee of the Association of University Administrators, he reflects on changes in quality assurance over the past twenty years and speculates on what the future may hold for quality as the association moves into a new and very different competitive regime. He begins by discussing the…

  16. Quality assurance during site construction

    International Nuclear Information System (INIS)

    Quality Assurance for Nuclear Power Plants under consideration of pipe assembling. Flow of Quality Requirements during: - Desing - Construction - Procurement - Prefabrication - Site. Organizational Requirements and Measurements during Erection: - Incoming Control - Material Storage - Surveillance of Tools - Weld Surveillance - Nondestructive Testing - Cleaning - Final Documentation. Qualification and Training of QA Personnel. (orig.)

  17. Japan Co-op's Assurance Policy on Food Safety and Its Implications%日本神户生协的食品安全保障策略及启示

    Institute of Scientific and Technical Information of China (English)

    王海航; 缪里英

    2012-01-01

    Japan Retail Co-operatives(Co-op for short) are cooperative associations to make purchase of daily commodi- ties for their members, also capital contributors, with the aim of improving their members' life in economy and culture. With the development of consumer cooperative movement, Co-op has distinguished itself as distribution business group while keep- ing the characteristics of consumers movement group. A relevant survey conducted by Institute of Co-op Integrated Research shows that good quality, safety of the products and the important position of food in Co-op are what its members trust and expect most. Through a case study of Japan Co-op Kobe, the largest cooperative in Japan and in the world, this article makes an attempt to find out the reason why Co-op enjoys trust and popularity and how it makes its food safe.%生协综合研究所的相关调查显示,生协会员对生协最为信任也最为期待的是产品的质量和安全。通过分析神户生协在食品安全质量方面所采取的严格自主检查制度、上门咨询订货送货制度、直营工厂和物流系统管理、导入生态理念的产直机制等特色食品经营管理策略.得出生协会员的广泛参与是神户生协实现食品“稳定、安全、放心”的关键所在,也是神户生协扎根阪神地区深得消费者信赖和支持的关键所在的结论。

  18. 首次交会对接任务发射场加注安全保障改进%Improvement of safety assurance conditions during spacecraft propellant injection procedure for China's first rendezvous and docking mission

    Institute of Scientific and Technical Information of China (English)

    罗克; 冯雷

    2011-01-01

    载人航天器加注是航天器研制过程中安全风险最高、危险作业工序最多的环节,必须采取严密的安全防护措施,确保万无一失.通过实践探索积累经验,全面周密的设计论证,对原有加注硬件条件进行改造,工作流程进行优化,从而大幅提高本质安全度,并在首次交会对接任务中加以应用和验证,取得了良好的效果,圆满完成了“天宫一号”、“神舟八号”发射任务的加注工作.%The propellant injection for spacecraft at the launch site is the most dangerous procedure in the whole R&D process, which involves many dangerous operations. Strict protective measures must be taken to avoid any mistakes. Based on the experience of previous practices, and by adequate design and discussion aimed at improving the current hardware conditions, the operation procedures for propellant injection of spacecrafts are optimized with a great enhancement of the intrinsic safety. These approaches have been applied in China's first rendezvous and docking mission, which brings about successful accomplishment of the propellant injection of the Tiangong-Ⅰ and Shenzhou-Ⅷ spacecraft.

  19. Policy-Based Security for Wireless Components in High Assurance Computer Systems

    OpenAIRE

    L. A. Wahsheh; J. Alves-Foss

    2007-01-01

    To enable the growth of wireless networks in high assurance computer systems, it is essential to establish a security engineering methodology that provides system security managers with a procedural engineering process to develop computer security policies. Our research demonstrates how wireless communication technology is deployed using the Multiple Independent Levels of Security (MILS) architecture for high assurance computer system design of security and safety-critical multi-enclave syste...

  20. Mechanism of Occult Hepatitis B Virus Infection and Its Effect on Blood Safety%隐匿性乙型肝炎病毒感染的机制及其对血液安全的影响

    Institute of Scientific and Technical Information of China (English)

    张蕾琳; 张轩

    2014-01-01

    血清匀月泽A早阴性者肝组织或血清中仍可检出匀月灾阅晕A,此现象称为隐匿性匀月灾感染(occult hepatitis B virus in-fection,韵月陨)。韵月陨对保障输血安全、临床诊断和匀月灾流行病学监控带来很大困难,进一步阐明其机制有利于韵月陨的预防和治疗。本文综述了近年来对韵月陨发生机制的研究进展、韵月陨对血液安全的影响以及核酸检测工作对血液安全的促进作用。%HBV DNA can be detected in one's serum or liver who is HBsAg negative in serum, and this phenomenon is called occult hepatitis B virus infection (OBI). OBI makes it particularly difficult to ensure blood transfusion safety, make clinical diagnosis and imple-ment epidemiological monitoring of HBV. Further study for the mechanism is beneficial for its prevention and treatment. This paper re-viewed the research progress of the mechanism of OBI in recent years, the impact on blood safety, and the promoting effect on blood safety of nucleic acid test.

  1. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    Energy Technology Data Exchange (ETDEWEB)

    Riddle, Donna L.

    2007-05-03

    S.M. Stoller Corporation is the contractor for the Technical Assistance Contract (TAC) for the U.S. Department of Energy (DOE) Office of Legacy Management (LM) operations. Stoller employs a management system that applies to all programs, projects, and business management systems funded through DOE-LM task orders. The management system incorporates the philosophy, policies, and requirements of health and safety, environmental compliance, and quality assurance (QA) in all aspects of project planning and implementation. Health and safety requirements are documented in the Health and Safety Manual (STO 2), the Radiological Control Manual (STO 3), the Integrated Safety Management System Description (STO 10), and the Drilling Health and Safety Requirements (STO 14). Environmental compliance policy and requirements are documented in the Environmental Management Program Implementation Manual (STO 11). The QA Program is documented in the Quality Assurance Manual (STO 1). The QA Manual (STO 1) implements the specific requirements and philosophy of DOE Order 414.1C, Quality Assurance. This manual also includes the requirements of other standards that are regularly imposed by customers, regulators, or other DOE orders. Title 10 Code of Federal Regulations Part 830, “Quality Assurance Requirements,” ANSI/ASQC E4-2004, “Quality Systems for Environmental Data and Technology Programs – Requirements with Guidance for Use,” and ISO 14001-2004, “Environmental Management Systems,” have been included. These standards are similar in content. The intent of the QA Manual (STO 1) is to provide a QA management system that incorporates the requirements and philosophy of DOE and other customers within the QA Manual. Criterion 1, “Quality Assurance Program,” identifies the fundamental requirements for establishing and implementing the QA management system; QA Instruction (QAI) 1.1, “QA Program Implementation,” identifies the TAC organizations that have responsibility for

  2. Quality assurance for environmental analytical chemistry: 1980

    Energy Technology Data Exchange (ETDEWEB)

    Gladney, E.S.; Goode, W.E.; Perrin, D.R.; Burns, C.E.

    1981-09-01

    The continuing quality assurance effort by the Environmental Surveillance Group is presented. Included are all standard materials now in use, their consensus or certified concentrations, quality control charts, and all quality assurance measurements made by H-8 during 1980.

  3. Chemical identification and its quality assurance

    CERN Document Server

    Milman, Boris L

    2013-01-01

    Chemical Identification and its Quality Assurance shows how to apply the principles of quality assurance for qualitative chemical analysis. The principles of identification and metrological basics are presented, in addition to the reliability and errors involved with chemical identification.

  4. Quality assurance - how to involve the employees

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard

    1996-01-01

    An overview of strategies for involvement of employees in quality assurance developement and implementation.......An overview of strategies for involvement of employees in quality assurance developement and implementation....

  5. Quality assurance manual: Volume 2, Appendices

    International Nuclear Information System (INIS)

    This paper contains quality assurance information on departments of the Stanford Linear Accelerator Center. Particular quality assurance policies and standards discussed are on: Mechanical Systems; Klystron and Microwave Department; Electronics Department; Plant Engineering; Accelerator Department; Purchasing; and Experimental Facilities Department

  6. Dukovany nuclear power plant safety

    International Nuclear Information System (INIS)

    Presentation covers recommended safety issues for the Dukovany NPP which have been solved with satisfactory conclusions. Safety issues concerned include: radiation safety; nuclear safety; security; emergency preparedness; health protection at work; fire protection; environmental protection; chemical safety; technical safety. Quality assurance programs at all stages on NPP life time is described. Report includes description of NPP staff training provision, training simulator, emergency operating procedures, emergency preparedness, Year 2000 problem, inspections and life time management. Description of Dukovany Plant Safety Analysis Projects including integrity of the equipment, modernisation, equipment innovation and safety upgrading program show that this approach corresponds to the actual practice applied in EU countries, and fulfilment of current IAEA requirements for safety enhancement of the WWER 440/213 units in the course of MORAWA Equipment Upgrading program

  7. Blood Clots

    Science.gov (United States)

    ... Index A-Z Blood Clots Blood clots are semi-solid masses of blood that can be stationary (thrombosis) ... treated? What are blood clots? Blood clots are semi-solid masses of blood. Normally, blood flows freely through ...

  8. Solar consumer assurance network briefing book

    Energy Technology Data Exchange (ETDEWEB)

    Connor, Lynda

    1980-06-01

    Background information is provided on the rationale and purpose of the Solar Consumer Assurance Network (SOLCAN) program. Mechanisms being instituted by states to meet solar consumer assurance needs are identified. Mechanisms being developed with Federal government support to encourage solar consumer assurance activities are described. The operation of the FY 80 SOLCAN effort is described. (MHR)

  9. 40 CFR 31.45 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 31.45 Section 31.45... Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's project... quality assurance practices consisting of policies, procedures, specifications, standards,...

  10. Quality assurance: a burden or an essential tool for management?

    International Nuclear Information System (INIS)

    The role of Quality Assurance in nuclear power plant management is discussed. Customer's satisfaction has always been considered by the supplier as a key factor to achieve his company's prosperity, provided that this satisfaction can be obtained in proper economical conditions. According to ISO standards, to satisfy the customer's need is in fact the definition of quality. Some twenty years ago nuclear safety introduced an additional notion: an evidence of satisfaction of customer's needs shall be provided - this is the Quality Assurance. Many companies on which this requirement was imposed experienced it and, in some cases continue to experience it, as an additional burden, due to the customer's lack of confidence. However, Code 50.C.QA clearly states in its introduction that Quality Assurance is an essential aspect of good management. It is very difficult to segregate the Quality Assurance Programme implementation efficiency from the company management efficiency. The arguments contained in the paper result in the following possible answer to the question in the title: a burden and an essential tool for management. (Z.S.)

  11. A Safety Argument Strategy for PCA Closed-Loop Systems: A Preliminary Proposal

    OpenAIRE

    Feng, Lu; King, Andrew L.; Chen, Sanjian; Ayoub, Anaheed; Park, Junkil; Bezzo, Nicola; Sokolsky, Oleg; Lee, Insup

    2014-01-01

    The emerging network-enabled medical devices impose new challenges for the safety assurance of medical cyber-physical systems (MCPS). In this paper, we present a case study of building a high-level safety argument for a patient-controlled analgesia (PCA) closed-loop system, with the purpose of exploring potential methodologies for assuring the safety of MCPS.

  12. Quality and safety in radiotherapy

    CERN Document Server

    Pawlicki, Todd

    2010-01-01

    The first text to focus solely on quality and safety in radiotherapy, this work encompasses not only traditional, more technically oriented, quality assurance activities, but also general approaches of quality and safety. It includes contributions from experts both inside and outside the field to present a global view. The task of assuring quality is no longer viewed solely as a technical, equipment-dependent endeavor. Instead, it is now recognized as depending on both the processes and the people delivering the service. Divided into seven broad categories, the text covers: Quality Management

  13. Quality assurance in the design

    International Nuclear Information System (INIS)

    System- and product-related quality assurance measures are completing one another. Certainly it is possible to detect a lot of defects in the single technical document by well controlled product related quality inspections and to avoid the consequences of these defects; but also a not unimportant part of defects and deviations has its origin in system linked deficiencies. The latter can be detected more easily and more securely by means of system related reviews (System audit, Product audit). But also the sole implementation of system related quality assurance measures keeps the danger to get stuck only in formality and to loose all references to the specific characteristics of the product. (orig./RW)

  14. Requirement Assurance: A Verification Process

    Science.gov (United States)

    Alexander, Michael G.

    2011-01-01

    Requirement Assurance is an act of requirement verification which assures the stakeholder or customer that a product requirement has produced its "as realized product" and has been verified with conclusive evidence. Product requirement verification answers the question, "did the product meet the stated specification, performance, or design documentation?". In order to ensure the system was built correctly, the practicing system engineer must verify each product requirement using verification methods of inspection, analysis, demonstration, or test. The products of these methods are the "verification artifacts" or "closure artifacts" which are the objective evidence needed to prove the product requirements meet the verification success criteria. Institutional direction is given to the System Engineer in NPR 7123.1A NASA Systems Engineering Processes and Requirements with regards to the requirement verification process. In response, the verification methodology offered in this report meets both the institutional process and requirement verification best practices.

  15. What dentition assures oral function?

    DEFF Research Database (Denmark)

    Gotfredsen, Klaus; Walls, Angus W G

    2007-01-01

    OBJECTIVE: To evaluate the relationship between dentition and oral function. MATERIAL AND METHODS: A search of the English literature was undertaken using PubMed and appropriate keywords. Citations were identified and hand sorted to confirm their validity against our inclusion criteria. Four spec...... for the year 2000, namely to maintain a natural dentition of not less than 20 teeth throughout life, is substantiated by the current literature review as this proposed dentition will assure an acceptable level of oral function....

  16. The efficacy and safety of a proprietary onion-pumpkin extract (OPtain120) on blood pressure: an open-label study

    OpenAIRE

    Orie Yoshinari; Jay Udani; Hiroyoshi Moriyama; Yoshiaki Shiojima; Xiaoming Chien

    2015-01-01

    Background: Nutraceuticals and functional foods are increasingly being used to help manage hypertension. Treatment with either pumpkin or onion can significantly lower systolic and diastolic blood pressure in animal studies. Traditionally, pumpkin has been used to support healthy blood pressure, glucose tolerance and lipid levels. Onion contains high levels of flavonoids, including quercetin, which decreases blood pressure and promotes restoration of healthy endothelial function. However, hum...

  17. Large hadron collider (LHC) project quality assurance plan

    Energy Technology Data Exchange (ETDEWEB)

    Gullo, Lisa; Karpenko, Victor; Robinson, Kem; Turner, William; Wong, Otis

    2002-09-30

    The LHC Quality Assurance Plan is a set of operating principles, requirements, and practices used to support Berkeley Lab's participation in the Large Hadron Collider Project. The LHC/QAP is intended to achieve reliable, safe, and quality performance in the LHC project activities. The LHC/QAP is also designed to fulfill the following objectives: (1) The LHC/QAP is Berkeley Lab's QA program document that describes the elements necessary to integrate quality assurance, safety management, and conduct of operations into the Berkeley Lab's portion of the LHC operations. (2) The LHC/QAP provides the framework for Berkeley Lab LHC Project administrators, managers, supervisors, and staff to plan, manage, perform, and assess their Laboratory work. (3) The LHC/QAP is the compliance document that conforms to the requirements of the Laboratory's Work Smart Standards for quality assurance (DOE O 414.1, 10 CFR 830.120), facility operations (DOE O 5480.19), and safety management (DOE P 450.4).

  18. Large hadron collider (LHC) project quality assurance plan

    International Nuclear Information System (INIS)

    The LHC Quality Assurance Plan is a set of operating principles, requirements, and practices used to support Berkeley Lab's participation in the Large Hadron Collider Project. The LHC/QAP is intended to achieve reliable, safe, and quality performance in the LHC project activities. The LHC/QAP is also designed to fulfill the following objectives: (1) The LHC/QAP is Berkeley Lab's QA program document that describes the elements necessary to integrate quality assurance, safety management, and conduct of operations into the Berkeley Lab's portion of the LHC operations. (2) The LHC/QAP provides the framework for Berkeley Lab LHC Project administrators, managers, supervisors, and staff to plan, manage, perform, and assess their Laboratory work. (3) The LHC/QAP is the compliance document that conforms to the requirements of the Laboratory's Work Smart Standards for quality assurance (DOE O 414.1, 10 CFR 830.120), facility operations (DOE O 5480.19), and safety management (DOE P 450.4)

  19. Quality assurance of custom software solutions

    OpenAIRE

    Herblan, Miha

    2014-01-01

    In thesis we look at problem of software quality assurance, especially when it comes to custom solutions projects. First we look at what quality assurance is, how do we mesure it and specialty why we do it. Afterwards we go through main principles, that apply when dealing with quality assurance in general. Since quality assurance is extensive topic, we take more detailed look on one part of quality assurance that is mostly used, that is testing of software. Because we are talking about softwa...

  20. Trends in Area of Safety Communications within Industrial Networks

    OpenAIRE

    Maria Franekova; Ales Janota; Karol Rastocny

    2005-01-01

    The paper deals with the problems of safety communication in industrial networks for purpose of assurance of functional safety. It is intents on analysis of treats on industry networks and there is described recommended safety protections and their location into layer communication protocol applicable in fieldbus network, which they are used within safety critical processes control.

  1. Safety analysis procedures for PHWR

    Energy Technology Data Exchange (ETDEWEB)

    Min, Byung Joo; Kim, Hyoung Tae; Yoo, Kun Joong

    2004-03-01

    The methodology of safety analyses for CANDU reactors in Canada, a vendor country, uses a combination of best-estimate physical models and conservative input parameters so as to minimize the uncertainty of the plant behavior predictions. As using the conservative input parameters, the results of the safety analyses are assured the regulatory requirements such as the public dose, the integrity of fuel and fuel channel, the integrity of containment and reactor structures, etc. However, there is not the comprehensive and systematic procedures for safety analyses for CANDU reactors in Korea. In this regard, the development of the safety analyses procedures for CANDU reactors is being conducted not only to establish the safety analyses system, but also to enhance the quality assurance of the safety assessment. In the first phase of this study, the general procedures of the deterministic safety analyses are developed. The general safety procedures are covered the specification of the initial event, selection of the methodology and accident sequences, computer codes, safety analysis procedures, verification of errors and uncertainties, etc. Finally, These general procedures of the safety analyses are applied to the Large Break Loss Of Coolant Accident (LBLOCA) in Final Safety Analysis Report (FSAR) for Wolsong units 2, 3, 4.

  2. Blood transfusion exposure in Denmark and Sweden

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Edgren, Gustaf; Rostgaard, Klaus;

    2009-01-01

    Although essential for the evaluation of blood transfusion safety, the prevalence of blood transfusion in the general population is not presently known. This study estimated the exposure to blood transfusion in the general Scandinavian population.......Although essential for the evaluation of blood transfusion safety, the prevalence of blood transfusion in the general population is not presently known. This study estimated the exposure to blood transfusion in the general Scandinavian population....

  3. UMTRA Project Office quality assurance program plan. Revision 6

    International Nuclear Information System (INIS)

    The Uranium Mill Tailings Remedial Action (UMTRA) Project was established to accomplish remedial actions at inactive uranium mill tailings sites. The UMTRA Project's mission is to stabilize and control the residual radioactive materials at designated sites in a safe and environmentally sound manner so as to minimize or eliminate radiation health hazards to the public. Because these efforts may involve possible risks to public health and safety, a quality assurance (QA) program that conforms to the applicable criteria has been established to control the quality of the work. This document, the Quality Assurance Program Plan (QAPP), brings into one document the essential criteria to be applied on a selective basis, depending upon the nature of the activity being conducted, and describes how those criteria shall be applied to the UMTRA Project. QA requirements contained in this QAPP shall apply to all personnel, processes, and activities, including planning, scheduling, and cost control, performed by the UMTRA Project Office and its contractors

  4. Quality assurance methodology and applications to abdominal imaging PQI.

    Science.gov (United States)

    Paushter, David M; Thomas, Stephen

    2016-03-01

    Quality assurance has increasingly become an integral part of medicine, with tandem goals of increasing patient safety and procedural quality, improving efficiency, lowering cost, and ultimately improving patient outcomes. This article reviews quality assurance methodology, ranging from the PDSA cycle to the application of lean techniques, aimed at operational efficiency, to continually evaluate and revise the health care environment. Alignment of goals for practices, hospitals, and healthcare organizations is critical, requiring clear objectives, adequate resources, and transparent reporting. In addition, there is a significant role played by regulatory bodies and oversight organizations in determining external benchmarks of quality, practice, and individual certification and reimbursement. Finally, practical application of quality principles to practice improvement projects in abdominal imaging will be presented.

  5. Reliability assurance programme guidebook for advanced light water reactors

    International Nuclear Information System (INIS)

    To facilitate the implementation of reliability assurance programmes (RAP) within future advanced reactor programmes and to ensure that the next generation of commercial nuclear reactors achieves the very high levels of safety, reliability and economy which are expected of them, in 1996, the International Atomic Energy Agency (IAEA) established a task to develop a guidebook for reliability assurance programmes. The draft RAP guidebook was prepared by an expert consultant and was reviewed/modified at an Advisory Group meeting (7-10 April 1997) and at a consults meeting (7-10 October 1997). The programme for the RAP guidebook was reported to and guided by the Technical Working Group on Advanced Technologies for Light Water Reactors (TWG-LWR). This guidebook will demonstrate how the designers and operators of future commercial nuclear plants can exploit the risk, reliability and availability engineering methods and techniques developed over the past two decades to augment existing design and operational nuclear plant decision-making capabilities. This guidebook is intended to provide the necessary understanding, insights and examples of RAP management systems and processes from which a future user can derive his own plant specific reliability assurance programmes. The RAP guidebook is intended to augment, not replace, specific reliability assurance requirements defined by the utility requirements documents and by individual nuclear steam supply system (NSSS) designers. This guidebook draws from utility experience gained during implementation of reliability and availability improvement and risk based management programmes to provide both written and diagrammatic 'how to' guidance which can be followed to assure conformance with the specific requirements outlined by utility requirements documents and in the development of a practical and effective plant specific RAP in any IAEA Member State

  6. National Patient Safety Foundation

    Science.gov (United States)

    ... Professional Learning Series Webcasts CPPS Review Course E-Learning Patient Safety Curriculum CPPS Review Course Patient Blood Management Reducing Diagnostic Error Health Info Technology Publications Ask Me 3 For ...

  7. Food Safety for Seniors

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Foodborne Illness & Contaminants People at Risk of Foodborne Illness To Your Health! Food Safety for Seniors Share Tweet Linkedin Pin it ...

  8. Assuring Competency in Nuclear Power Plants: Regulatory Policy and Practice

    International Nuclear Information System (INIS)

    approaches to assuring competency, these include: Implementing new programs; Requiring a systematic approach to training (SAT); Responding to audit findings using the IAEA guidelines on training programs; Anticipating and addressing potential problems; Assuring licensee remains an intelligent customer; Assuring competence after organizational changes; Building a new facility: 'pre-regulation' concerns. Outcomes of proactive inspections: Checking on a new regulation; Checking contractor qualifications before an outage; Checking qualifications of managers: two examples; Checking training after a modification; Checking training as part of a quality system review; Outcomes of reactive inspections: In depth evaluation of incident leads to increased attention to competence; Deteriorating performance traced to poor training program; Licensee needs training in root cause analysis; Two licensees lose function that tracks training in safety related positions; The authors noted the following as concluding remarks: Regulators seem to be moving towards more process based regulations and/or process based inspection methods for the oversight of competency. There is increasing attention to training and qualifications of personnel outside of operations, particularly those in maintenance positions. Competency specialists are concerned about the effects of two trends that seem to be increasing - downsizing, and the increased use of contractors. While there is an increased emphasis on human factors areas in nuclear power regulation, there is still an emphasis on technical systems and hardware by regulators and utilities. There is also concern about inadequate availability of expertise in the area of human factors in nuclear power regulators and industry

  9. Quality assurance in the manufacture of items for nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations related to the establishment and implementation of a quality assurance programme for those organizations involved in the manufacture of items affecting the safety of nuclear power plants. The quality-assurance-related functions of a manufacturer may include activities such as designing, purchasing, fabricating, handling, shipping, storing, cleaning, inspecting, testing, modifying, repairing and maintaining. It is not the aim of the present Guide, which supplements the above-mentioned Code of Practice, to provide rules related to the quality assurance programme for the design of items. Manufacturers that generate designs shall follow the requirements and recommendations contained in the Safety Guide on Quality Assurance in the Design of Nuclear Power Plants (IAEA Safety Series No. 50-SG-QA6). All these publications form part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to land-based stationary thermal neutron power plants. A Provisional List of NUSS Programme Titles will be found at the end of this publication

  10. Information security assurance lifecycle research

    Institute of Scientific and Technical Information of China (English)

    XIE Cheng-shan; XUJIA Gu-yue; WANG Li

    2007-01-01

    This article proposes that problems of information security are mainly caused by the ineffective integration of people, operation, and technology, and not merely by the poor use of technology. Based on the information lifecycle, a model of the information security assurance lifecycle is presented. The crucial parts of the model are further discussed, with the information risk value and protect level, and the solution in each step of the lifecycle is presented with an ensured information risk level, in term of the integration of people, operation, and technology.

  11. Quality assurance in digital radiography

    International Nuclear Information System (INIS)

    At present, there is no standard way of evaluating performance characteristics of digital radiography systems. Continuous measurements of performance parameters are necessary in order to obtain images of high quality. Parameters of quality assurance in digital radiography, which can be evaluated with simple, quick methods, are spatial resolution, low-contrast detectability, dynamic range and exposure dose. Spatial resolution was determined by a lead bar pattern, whereas the other parameters were measured by commercially available phantoms. Performance measurements of 10 digital subtraction angiography (DSA) units and one digital radiography system for unsubtracted digital radiography were assessed. From these results, recommendations for performance parameter levels will be discussed. (author)

  12. Quality assurance and statistical control

    DEFF Research Database (Denmark)

    Heydorn, K.

    1991-01-01

    In scientific research laboratories it is rarely possible to use quality assurance schemes, developed for large-scale analysis. Instead methods have been developed to control the quality of modest numbers of analytical results by relying on statistical control: Analysis of precision serves...... through the origo. Calibration control is an essential link in the traceability of results. Only one or two samples of pure solid or aqueous standards with accurately known content need to be analyzed. Verification is carried out by analyzing certified reference materials from BCR, NIST, or others...

  13. Performance assurance for IT systems

    CERN Document Server

    King, Brian

    2004-01-01

    INDIVIDUAL AREAS OF INTERESTPreparing for the ChallengeAbstractIntroductionIn the BeginningThe Need to Address New ApplicationsDefinition of PerformanceThe Required SkillsPerformance Assurance Within a Project LifecycleSummaryCaveat Emptor (Let the Buyer Beware)AbstractSoftware Product LifecycleHardware Product LifecycleMarketingTechnical Reviews of ProductsLies, Damned Lies and BenchmarksAbstractIntroductionIndustry BenchmarksVendor BenchmarksIndependent BenchmarkingIn-House Benchmarking""Tricks of the Trade""Using Benchmarks Non-Functional Requirements and SolutionsAbstractIntroductionThe Pr

  14. Radiation Hardness Assurance (RHA) Guideline

    Science.gov (United States)

    Campola, Michael J.

    2016-01-01

    Radiation Hardness Assurance (RHA) consists of all activities undertaken to ensure that the electronics and materials of a space system perform to their design specifications after exposure to the mission space environment. The subset of interests for NEPP and the REAG, are EEE parts. It is important to register that all of these undertakings are in a feedback loop and require constant iteration and updating throughout the mission life. More detail can be found in the reference materials on applicable test data for usage on parts.

  15. JSC Safety and Mission Assurance Data Analysis Overview

    Science.gov (United States)

    Roelant, Henk

    2010-01-01

    These slides describe the data analysis methods that are used to determine inputs for probabilistic risk models supporting the Space Shuttle Program. Other applications can follow a similar path probably using different data sources. Statistical approaches are different and not addressed here. Topics included here: 1) Prior Distribution; 2) Likelihood Data; 3) Bayesian Updating; and 4) Uncertainty and Error. Note: This is a high-level discussion and is not intended to be a tutorial.

  16. Manual on quality assurance programme auditing

    International Nuclear Information System (INIS)

    The objective of this Manual is to provide guidance and illustrative examples of the methodology and techniques of internal and external audits that are consistent with the requirements and recommendations of the Code and the Safety Guide. The methodology and techniques are based on the practices of Member States having considerable experience in auditing QA programmes. This Manual is directed primarily towards QA programme auditors and managers and presents methods and techniques considered appropriate for the preparation and performance of audits and the evaluation of results. Its scope includes the techniques and methods used to carry out QA programme audits variously described as 'System', 'Product' and 'Process' audits. The techniques and methods described here may be used as one approach to the evaluation of suppliers' QA capabilities as defined in 50-SG-QA10. Although the Manual is primarily directed towards purchasers and suppliers, it is also relevant to regulatory organizations, such as government offices responsible for quality assurance, which carry out external audits independent of purchasers and suppliers. In such cases similar methods, procedures and techniques may be used

  17. Vaccine Safety

    Science.gov (United States)

    ... the safety of Tdap, Meningococcal, and HPV vaccines Human Papillomavirus (HPV) Vaccine is Very Safe Read about the safety of ... Hepatitis A Vaccine Safety Hepatitis B Vaccine Safety Human Papillomavirus (HPV) Vaccine Safety FAQs about HPV Safety Influenza (Flu) Vaccine ...

  18. Quality assurance in diagnostic ultrasound

    Energy Technology Data Exchange (ETDEWEB)

    Sipilae, Outi, E-mail: outi.sipila@hus.fi [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 340, 00029 HUS (Finland); Mannila, Vilma, E-mail: vilma.mannila@hus.fi [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 340, 00029 HUS (Finland); Department of Physics, University of Helsinki, P.O. Box 64, 00014 Helsinki University (Finland); Vartiainen, Eija, E-mail: eija.vartiainen@hus.fi [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 750, 00029 HUS (Finland)

    2011-11-15

    Objective: To setup a practical ultrasound quality assurance protocol in a large radiological center, results from transducer tests, phantom measurements and visual checks for physical faults were compared. Materials and methods: Altogether 151 transducers from 54 ultrasound scanners, from seven different manufacturers, were tested with a Sonora FirstCall aPerio{sup TM} system (Sonora Medical Systems, Inc., Longmont, CO, USA) to detect non-functional elements. Phantom measurements using a CIRS General Purpose Phantom Model 040 (CIRS Tissue Simulation and Phantom Technology, VA, USA) were available for 135 transducers. The transducers and scanners were also checked visually for physical faults. The percentages of defective findings in these tests were computed. Results: Defective results in the FirstCall tests were found in 17% of the 151 transducers, and in 16% of the 135 transducers. Defective image quality resulted with 15% of the transducers, and 25% of the transducers had a physical flaw. In 16% of the scanners, a physical fault elsewhere than in the transducer was found. Seven percent of the transducers had a concurrent defective result both in the FirstCall test and in the phantom measurements, 8% in the FirstCall test and in the visual check, 4% in the phantom measurements and in the visual check, and 2% in all three tests. Conclusion: The tested methods produced partly complementary results and seemed all to be necessary. Thus a quality assurance protocol is forced to be rather labored, and therefore the benefits and costs must be closely followed.

  19. Reactor safety systems

    International Nuclear Information System (INIS)

    The spectrum of possible accidents may become characterized by the 'maximum credible accident', which will/will not happen. Similary, the performance of safety systems in a multitude of situations is sometimes simplified to 'the emergency system will/will not work' or even 'reactors are/ are not safe'. In assessing safety, one must avoid this fallacy of reducing a complicated situation to the simple black-and-white picture of yes/no. Similarly, there is a natural tendency continually to improve the safety of a system to assure that it is 'safe enough'. Any system can be made safer and there is usually some additional cost. It is important to balance the increased safety against the increased costs. (orig.)

  20. Organizational Culture and Safety

    Science.gov (United States)

    Adams, Catherine A.

    2003-01-01

    '..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

  1. The efficacy and safety of a proprietary onion-pumpkin extract (OPtain120 on blood pressure: an open-label study

    Directory of Open Access Journals (Sweden)

    Orie Yoshinari

    2015-06-01

    Full Text Available Background: Nutraceuticals and functional foods are increasingly being used to help manage hypertension. Treatment with either pumpkin or onion can significantly lower systolic and diastolic blood pressure in animal studies. Traditionally, pumpkin has been used to support healthy blood pressure, glucose tolerance and lipid levels. Onion contains high levels of flavonoids, including quercetin, which decreases blood pressure and promotes restoration of healthy endothelial function. However, human trials on these food sources are limited, and the combined effects of pumpkin and onion have not been examined yet. Objective: We performed an open-label clinical study to evaluate the effects of a proprietary onion-pumpkin extract (OPtain120 on systolic and diastolic blood pressure. Methods: Healthy adults with systolic blood pressure (SBP and diastolic blood pressure (DBP in the elevated range of 140-159 and 80-90 mmHg, respectively, were enrolled in this study. Subjects consumed one capsule of onion-pumpkin extract twice daily for 12 weeks. Daily Home Blood Pressure Measurement (HBPM was taken upon waking and before bed. Office Blood Pressure Measurement (OBPM was taken in-clinic at Week 0, 6, and 12. Results: 52 subjects were screened and 12 were enrolled in the study, with a total of 10 subjects completing the study. Systolic HBPM taken before bed demonstrated a statistically significant reduction from baseline (147.23 mmHg to Week 12 (138.14 mmHg, representing a reduction of 9.09 mmHg (6.17%, p=0.021. Diastolic HBPM taken before bed demonstrated a decrease of 4.06 mmHg (4.46%, p=0.085, a significant reduction from baseline (91.07 mmHg at Week 12 (87.02 mmHg. Non-statistically significant reductions were seen in the early morning Systolic (3.14% and Diastolic (2.57% HBPM and in the Systolic (1.36% OBPM. Conclusion: OPtain120 was safely consumed over a 12-week period. OPtain120 appears to be effective in lowering Systolic Blood Pressure at bedtime in

  2. UMTRA technical assistance contractor quality assurance program plan

    International Nuclear Information System (INIS)

    This Quality Assurance Program Plan (QAPP) provides the primary requirements for the integration of quality functions into all Technical Assistance Contractor (TAC) Project organization activities. The QAPP is the written directive authorized by the TAc Program Manager to accomplish this task and to implement procedures that provide the controls and sound management practices needed to ensure TAC contractual obligations are met. The QA program is designed to use monitoring, audit, and surveillance functions as management tools to ensure that all Project organization functions are executed in a manner that will protect public health and safety, promote the success of the Project, and meet or exceed contract requirements

  3. Assessment of safety culture at INPP

    International Nuclear Information System (INIS)

    Safety Culture covers all main directions of plant activities and the plant departments involved through integration into the INPP Quality Assurance System. Safety Culture is represented by three components. The first is the clear INPP Safety and Quality Assurance Policy. Based on the Policy INPP is safely operated and managers' actions firstly aim at safety assurance. The second component is based on personal responsibility for safety and attitude of each employee of the plant. The third component is based on commitment to safety and competence of managers and employees of the plant. This component links the first two to ensure efficient management of safety at the plant. The above mentioned components including the elements which may significantly affect Safety Culture are also presented in the attachment. The concept of such model implies understanding of effect of different factors on the level of Safety Culture in the organization. In order to continuously correct safety problems, self-assessment of the Safety Culture level is performed at regular intervals. (author)

  4. Life Assurance Strategy for CANDU NPP

    International Nuclear Information System (INIS)

    Nuclear Plants have a nominal 'design life' that forms the basis of equipment specification, economic evaluations and licensing for some jurisdictions. Some component in the plant may require replacement, refurbishing and or rehabilitation during the plant 'design life'. Components which are extremely difficult or economically impossible to replace will place a limit on plant life. Rehabilitation programs completed to date on older CANDU plants to improve reliability of plant components, coupled with R and D programs, experimental data and advanced analytical methods form the basis for CANDU plant component life assurance. Life assurance is verified during plant operation by comprehensive in-service inspection programs and laboratory examinations. The paper provides an overview of the experiences to date on Refurbishment and Rehabilitation programs and some Canadian approaches on the main activities involved in scoping and managing nuclear plant life assurance. A number of proactive programs are underway to anticipate, detect and mitigate potential aging degradation at an early stage to ensure plant safety and reliability. Some of these programs include; systematic plant condition assessment, refurbishment and upgrading programs, environmental qualification programs and a program of examination of components from decommissioned reactors. These programs are part of an overall nuclear power plant maintenance strategy. Beyond life assurance, a longer term approach would be geared towards life extension as a viable option for the future. Recent CANDU designs have benefited from the early CANDU experience and are expected to require less rehabilitation. Examples of changes in CANDU 6 include fuel channel design and adopting a closed component cooling water system. New designs are based on 'design life' longer than that used for economic evaluations. The approach is to design for easy replace ability for components that can be economically replaced. Specific examples

  5. The safety of nuclear power plants

    International Nuclear Information System (INIS)

    A general presentation is given of reactor safety philosophy and risk analysis. The Rasmussen report (WASH-1400) is discussed and also the Lewis Commission's evaluation of that report. The future developments in reactor safety technology are outlined with emphasis on quality assurance. (JIW)

  6. The Assurance of CHRIST to His followers

    OpenAIRE

    Asumadu-Sarkodie, Samuel

    2012-01-01

    The Assurance of CHRIST to His followers. Assurance: grk. Hupostasis meaning: full and sustained confidence and trust; unwavering conviction. There is a favourite Ghanaian proverb which says "if a naked man says he will clothe you, listen to him quietly". Before someone could assure you of something, he must be self-reliant or independent. Christ Jesus has assured His followers because He is capable, has done it before, continues to do it and will do it. Isaiah 50:4-9a; talks about the qualif...

  7. Standards interoperability application of contemporary software assurance standards to the evolution of legacy software

    OpenAIRE

    Meacham, Desmond J.

    2006-01-01

    This thesis addresses software evolution from the perspective of standards interoperability. We address the issue of how to apply contemporary software safety assurance standards to legacy safety-critical systems, with the aim of recertifying the legacy systems to the contemporary standards. The application of RTCA DO-178B Software Considerations in Airborne Systems and Equipment Certification to modified legacy software is the primary focus of this thesis. We present a model to capture the r...

  8. Blood transfusions

    Science.gov (United States)

    ... called homologous blood donation. Many communities have a blood bank at which any healthy person can donate blood. ... need to arrange with your hospital or local blood bank before your surgery to have directed donor blood. ...

  9. Professionalism, Profession and Quality Assurance Practitioners in External Quality Assurance Agencies in Higher Education

    Science.gov (United States)

    Cheung, Jordan C. M.

    2015-01-01

    This article seeks to spark a dialectic discussion on the establishment of a set of professional competencies for quality assurance practitioners who serve in external quality assurance agencies in higher education. Such a need is identified due to the shortage of relevant and sufficient coverage in the quality assurance literature. To…

  10. Quality assurance and radiofrequency heating

    International Nuclear Information System (INIS)

    One pf the potential problems and limitations of scanning at high field strength is the deposition or radiofrequency (RF) power into the body. This paper proposes an inexpensive means of assessing radiofrequency power deposition in a magnet. This is particularly important at 3T where sequences approach Food and Drug Administration approved RF limits. It will also be of interest to operators at 1.5 T as part of their ongoing quality assurance programs. At 3T, we found that the RF power deposited in the magnet was less than that read by the MR power monitor. All measurements were performed with a 2.51 perspex spherical phantom. Copyright (2002) Blackwell Science Pty Ltd

  11. Islay development flow assurance challenges

    Energy Technology Data Exchange (ETDEWEB)

    Helingoe, Mark; Greder, Hugues

    2010-07-01

    The Islay field is located in the Northern North Sea UK sector in the vicinity of the Alwyn Platforms. This gas condensate Brent structure is planned to be developed subsea with first gas in 2011. The main development challenge for this HPHT field comes from the early expected formation water production which is the source of major hydrate related flow assurance issues. As continuous inhibition is not feasible, Total has progressed a development scenario based on seabed conditioning prior to pipe laying so that water can be collected and temporarily inhibited at specific low points after a shut-down. It is also intended to heat trace the pipeline as a back-up solution to avoid hydrate formation. Heat tracing has so far never been implemented in Subsea developments. The Islay pilot could open the path to a new hydrate management philosophy for future developments. (Author)

  12. Radiation safety audit

    International Nuclear Information System (INIS)

    Audit has been seen as one of the effective methods to ensure harmonization in radiation protection. A radiation safety audit is a formal safety performance examination of existing or future work activities by an independent team. Regular audit will assist the management in its mission to maintain the facilities environment that is inherently safe for its employees. The audits review the adequacy of facilities for the type of use, training, and competency of workers, supervision by authorized users, availability of survey instruments, security of radioactive materials, minimization of personnel exposure to radiation, safety equipment, and the required record keeping. All approved areas of use are included in these periodic audits. Any deficiency found in the audit shall be corrected as soon as possible after they are reported. Radiation safety audit is a proactive approach to improve radiation safety practices and identify and prevent any potential radiation accident. It is an excellent tool to identify potential problem to radiation users and to assure that safety measures to eliminate or reduce the problems are fully considered. Radiation safety audit will help to develop safety culture of the facility. It is intended to be the cornerstone of a safety program designed to aid the facility, staff and management in maintaining a safe environment in which activities are carried out. The initiative of this work is to evaluate the need of having a proper audit as one of the mechanism to manage the safety using ionizing radiation. This study is focused on the need of having a proper radiation safety audit to identify deviations and deficiencies of radiation protection programmes. It will be based on studies conducted on several institutes/radiation facilities in Malaysia in 2006. Steps will then be formulated towards strengthening radiation safety through proper audit. This will result in a better working situation and confidence in the radiation protection community

  13. Prostaglandin E2 Enhances Human Cord Blood Stem Cell Xenotransplants and Shows Long-Term Safety in Preclinical Nonhuman Primate Transplant Models

    NARCIS (Netherlands)

    Goessling, Wolfram; Allen, Robyn S.; Guan, Xiao; Jin, Ping; Uchida, Naoya; Dovey, Michael; Harris, James M.; Metzger, Mark E.; Bonifacino, Aylin C.; Stroncek, David; Stegner, Joseph; Armant, Myriam; Schlaeger, Thorsten; Tisdale, John F.; Zon, Leonard I.; Donahue, Robert E.; North, Trista E.

    2011-01-01

    Hematopoietic stem cells (HSCs) are used in transplantation therapy to reconstitute the hematopoietic system. Human cord blood (hCB) transplantation has emerged as an attractive alternative treatment option when traditional HSC sources are unavailable; however, the absolute number of hCB HSCE.; tran

  14. Teacher Reaction to ICP Quality Assurance Procedures.

    Science.gov (United States)

    Leonard, Ann

    An integral part of the Quality Assurance Manual developed by Southwest Regional Laboratory (SWRL) to accompany the Kindergarten Program is the end-of-program assessment of the Instructional Concepts Program (ICP). Following completion of ICP Quality Assurance assessment, four teachers were interviewed in order to gather information pertinent to…

  15. Tool Use Within NASA Software Quality Assurance

    Science.gov (United States)

    Shigeta, Denise; Port, Dan; Nikora, Allen P.; Wilf, Joel

    2013-01-01

    As space mission software systems become larger and more complex, it is increasingly important for the software assurance effort to have the ability to effectively assess both the artifacts produced during software system development and the development process itself. Conceptually, assurance is a straightforward idea - it is the result of activities carried out by an organization independent of the software developers to better inform project management of potential technical and programmatic risks, and thus increase management's confidence in the decisions they ultimately make. In practice, effective assurance for large, complex systems often entails assessing large, complex software artifacts (e.g., requirements specifications, architectural descriptions) as well as substantial amounts of unstructured information (e.g., anomaly reports resulting from testing activities during development). In such an environment, assurance engineers can benefit greatly from appropriate tool support. In order to do so, an assurance organization will need accurate and timely information on the tool support available for various types of assurance activities. In this paper, we investigate the current use of tool support for assurance organizations within NASA, and describe on-going work at JPL for providing assurance organizations with the information about tools they need to use them effectively.

  16. 40 CFR 30.54 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Post-Award Requirements Reports and Records § 30.54 Quality assurance. If the... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 30.54 Section...

  17. Quality Assurance in Chinese Higher Education

    Science.gov (United States)

    Li, Yuan

    2010-01-01

    Quality assurance has been integrated into the fabric of higher education in China, with the issue of quality in higher education--how to evaluate it and how to enhance it--now taking centre stage in Chinese higher education. In the past decade, the development of quality assurance in Chinese higher education has covered a broad spectrum of…

  18. Quality assurance manual: Volume 2, Appendices

    Energy Technology Data Exchange (ETDEWEB)

    Oijala, J.E.

    1988-06-01

    This paper contains quality assurance information on departments of the Stanford Linear Accelerator Center. Particular quality assurance policies and standards discussed are on: Mechanical Systems; Klystron and Microwave Department; Electronics Department; Plant Engineering; Accelerator Department; Purchasing; and Experimental Facilities Department. (LSP)

  19. 40 CFR 194.22 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Compliance Certification and Re-certification General Requirements § 194.22 Quality assurance. (a)(1) As soon as practicable after April 9, 1996, the... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Quality assurance. 194.22 Section...

  20. 48 CFR 2453.246 - Quality Assurance.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Quality Assurance. 2453.246 Section 2453.246 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT CLAUSES AND FORMS FORMS Prescription of Forms 2453.246 Quality Assurance....

  1. 30 CFR 74.9 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... CFR part 51. Persons may obtain a copy from the International Organization for Standardization at the... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 74.9 Section 74.9 Mineral... DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.9 Quality assurance....

  2. Quality Assurance in Sub-Saharan Africa

    Science.gov (United States)

    Materu, Peter; Righetti, Petra

    2010-01-01

    This article assesses the status and practice of higher education quality assurance in sub-Saharan Africa, focusing on degree-granting tertiary institutions. A main finding is that structured national-level quality assurance processes in African higher education are a very recent phenomenon and that most countries face major capacity constraints.…

  3. 78 FR 5813 - 2013 Assuring Radiation Protection

    Science.gov (United States)

    2013-01-28

    ... HUMAN SERVICES Food and Drug Administration 2013 Assuring Radiation Protection AGENCY: Food and Drug... protection program. The goal of the 2013 Assuring Radiation Protection will be to coordinate Federal, State... radiation protection. The recipient will establish committees, in accordance with Federal statutes...

  4. Hungary Higher Education Quality Assurance System

    Directory of Open Access Journals (Sweden)

    Che Ru-shan

    2013-07-01

    Full Text Available Higher education quality assurance system has drawn much attention since 1980s. Most countries are committed to build the higher education quality assurance system to meet international standards. Under such an international trend, Hungary also actively promotes higher education reform, and established Hungarian Accreditation Committee and in order to ensure the quality of higher education.

  5. Quality Assurance Program and Brain Drain

    Science.gov (United States)

    Lien, Donald

    2008-01-01

    The number of colleges and universities in most developing countries has increased drastically over the past decades. The quality variation of these institutions is an alarming concern. Quality assurance programs are proposed and implemented. This paper evaluates the effects of quality assurance on the demand for college education, study abroad,…

  6. Fault Management Architectures and the Challenges of Providing Software Assurance

    Science.gov (United States)

    Savarino, Shirley; Fitz, Rhonda; Fesq, Lorraine; Whitman, Gerek

    2015-01-01

    The satellite systems Fault Management (FM) is focused on safety, the preservation of assets, and maintaining the desired functionality of the system. How FM is implemented varies among missions. Common to most is system complexity due to a need to establish a multi-dimensional structure across hardware, software and operations. This structure is necessary to identify and respond to system faults, mitigate technical risks and ensure operational continuity. These architecture, implementation and software assurance efforts increase with mission complexity. Because FM is a systems engineering discipline with a distributed implementation, providing efficient and effective verification and validation (VV) is challenging. A breakout session at the 2012 NASA Independent Verification Validation (IVV) Annual Workshop titled VV of Fault Management: Challenges and Successes exposed these issues in terms of VV for a representative set of architectures. NASA's IVV is funded by NASA's Software Assurance Research Program (SARP) in partnership with NASA's Jet Propulsion Laboratory (JPL) to extend the work performed at the Workshop session. NASA IVV will extract FM architectures across the IVV portfolio and evaluate the data set for robustness, assess visibility for validation and test, and define software assurance methods that could be applied to the various architectures and designs. This work focuses efforts on FM architectures from critical and complex projects within NASA. The identification of particular FM architectures, visibility, and associated VVIVV techniques provides a data set that can enable higher assurance that a satellite system will adequately detect and respond to adverse conditions. Ultimately, results from this activity will be incorporated into the NASA Fault Management Handbook providing dissemination across NASA, other agencies and the satellite community. This paper discusses the approach taken to perform the evaluations and preliminary findings from the

  7. Functional safety of health information technology.

    LENUS (Irish Health Repository)

    Chadwick, Liam

    2012-03-01

    In an effort to improve patient safety and reduce adverse events, there has been a rapid growth in the utilisation of health information technology (HIT). However, little work has examined the safety of the HIT systems themselves, the methods used in their development or the potential errors they may introduce into existing systems. This article introduces the conventional safety-related systems development standard IEC 61508 to the medical domain. It is proposed that the techniques used in conventional safety-related systems development should be utilised by regulation bodies, healthcare organisations and HIT developers to provide an assurance of safety for HIT systems. In adopting the IEC 61508 methodology for HIT development and integration, inherent problems in the new systems can be identified and corrected during their development. Also, IEC 61508 should be used to develop a healthcare-specific standard to allow stakeholders to provide an assurance of a system\\'s safety.

  8. Reinforcing Quality Assurance in Romanian Higher Education

    Directory of Open Access Journals (Sweden)

    Ana-Maria Dima

    2010-07-01

    Full Text Available Since 1993, the quality assurance system in Romania has gained considerable experience. This experience was recently recognized in 2008 by the ENQA: European Association for Quality Assurance in Higher Education through the admission of ARACIS as a full member of EQAR: the European Quality Assurance Register. The Board of ENQA agreed to grant ARACIS’s full membership of ENQA for five years from 2 June 2009. This article explores the benefits of membership for the Romanian Agency for Quality Assurance in Higher Education – ARACIS, comparing to other regional and global quality assurance agencies networks. The common features and differences between ARACIS and other European agencies are questioned through the frameworks of ENQA and INQAAHE as a case study.

  9. Training, Quality Assurance Factors, and Tools Investigation: a Work Report and Suggestions on Software Quality Assurance

    Science.gov (United States)

    Lee, Pen-Nan

    1991-01-01

    Previously, several research tasks have been conducted, some observations were obtained, and several possible suggestions have been contemplated involving software quality assurance engineering at NASA Johnson. These research tasks are briefly described. Also, a brief discussion is given on the role of software quality assurance in software engineering along with some observations and suggestions. A brief discussion on a training program for software quality assurance engineers is provided. A list of assurance factors as well as quality factors are also included. Finally, a process model which can be used for searching and collecting software quality assurance tools is presented.

  10. Improvement of safety by analysis of costs and benefits of the system

    OpenAIRE

    Karkoszka, T.; M. Andraczke

    2011-01-01

    Purpose: of the paper has been the assessment of the dependence between improvement of the implemented occupational health and safety management system and both minimization of costs connected with occupational health and safety assurance and optimization of real work conditions.Design/methodology/approach: used for the analysis has included definition of the occupational health and safety system with regard to the rules and tool allowing for occupational safety assurance in the organisationa...

  11. Safe Management of Research Reactor MARIA with Special Emphasis on Safety Culture Enhancement Process

    International Nuclear Information System (INIS)

    This paper is focused on the presentation what is the role of the State, Regulatory Body and Operating Organization in the assurance of research reactor MARIA safety. Also the significance of high level of safety culture for safety assurance and the process of its improvement has been highlighted. The process of development and improvement of safety culture contains the issues described in this paper, which we're considerated as the most important and our efforts are focused on their achievement. (author)

  12. THE RISE OF PRIVATE FOOD QUALITY AND SAFETY STANDARDS: ILLUSTRATIONS FROM BRAZIL

    OpenAIRE

    Reardon, Thomas; Farina, Elizabeth Maria Mercier Querido

    2001-01-01

    Over the past decade, the private sector has rapidly built up an array of private food standards to assure quality and safety in a fiercely competitive market. These private standards have sometimes been to fill in for missing public standards, especially for safety, and to differentiate products and build reputation, for both quality and safety. Moreover, private standards are increasingly related to meta-management systems assuring both quality and safety at all levels of a chain, enforcing...

  13. LMFBR safety and sodium boiling

    Energy Technology Data Exchange (ETDEWEB)

    Hinkle, W.D.; Tschamper, P.M.; Fontana, M.H.; Henry, R.E.; Padilla, A. Jr.

    1978-01-01

    Within the U.S. Fast Breeder Reactor Safety R and D Work Breakdown Structure for Line of Assurance 2, Limit Core Damage, the influence of sodium boiling upon the progression and termination of accidents is being studied in loss of flow, transient overpower, loss of piping integrity, loss of shutdown heat removal system and local fault situations. The pertinent analytical and experimental results of this research to date are surveyed and compared with the requirements for demonstrating the effectiveness of this line of assurance. A discussion of specific technical issues concerned with sodium boiling and the need for future development work is also presented.

  14. They're Here! How to Prepare Your Blood Bank for Inspection.

    Science.gov (United States)

    Byrne, Karen M; Frank, Ernest G; Gedman, Lauren A; Ivey, Julie R

    2015-01-01

    The importance of an inspection ready blood bank cannot be overemphasized. Various agencies perform inspections to ensure that facilities are compliant with federal and state regulations, as well as with standards defined by professional organizations. Inspections may strike fear into the staff members of the organizations being inspected. When a laboratory is in a state of constant readiness, such anxiety is likely to be lessened. Facilities may differ in structure and size and yet be held to the same standards. This article discusses the who, when, and why of laboratory safety inspections. We share helpful information gathered from various resources, including interviews with a quality assurance specialist, a blood bank manager, and an assessor, to help facilities work towards an inspection ready state.

  15. Factors in enhancing blood safety by nucleic acid technology testing for human immunodeficiency virus, hepatitis C virus and hepatitis B virus

    Directory of Open Access Journals (Sweden)

    Venkatakrishna Shyamala

    2014-01-01

    Full Text Available In the last few decades through an awareness of transfusion transmitted infections (TTI, a majority of countries have mandated serology based blood screening assays for Human immunodeficiency virus (HIV, Hepatitis C virus (HCV, and Hepatitis B virus (HBV. However, despite improved serology assays, the transfusion transmission of HIV, HCV, and HBV continues, primarily due to release of serology negative units that are infectious because of the window period (WP and occult HBV infections (OBI. Effective mode of nucleic acid technology (NAT testing of the viruses can be used to minimize the risk of TTIs. This review compiles the examples of NAT testing failures for all three viruses; analyzes the causes for failure, and the suggestions from retrospective studies to minimize such failures. The results suggest the safest path to be individual donation testing (ID format for highest sensitivity, and detection of multiple regions for rapidly mutating and recombining viruses. The role of blood screening in the context of the donation and transfusion practices in India, the donor population, and the epidemiology is also discussed. World wide, as the public awareness of TTIs increases, as the recipient rights for safe blood are legally upheld, as the possibility to manage diseases such as hepatitis through expensive and prolonged treatment becomes accessible, and the societal responsibility to shoulder the health costs as in the case for HIV becomes routine, there is much to gain by preventing infections than treating diseases.

  16. National Program of Quality Assurance in Radiotherapy in Cuba

    International Nuclear Information System (INIS)

    It tries on the establishment of a Quality Assurance Nacional System, a Quality Assurance Committee implemented in Cuba, and a Quality Auditory National Program implemented in Cuba to control and assure radiotherapy quality

  17. Blood culture

    Science.gov (United States)

    Culture - blood ... A blood sample is needed . The site where blood will be drawn is first cleaned with an antiseptic such ... organism from the skin getting into (contaminating) the blood sample and causing a false-positive result (see ...

  18. Blood Thinners

    Science.gov (United States)

    If you have some kinds of heart or blood vessel disease, or if you have poor blood flow to your brain, your doctor may recommend that you take a blood thinner. Blood thinners reduce the risk of heart ...

  19. Blood Basics

    Science.gov (United States)

    ... Patient Group Links Advocacy Toolkit Home For Patients Blood Basics Blood is a specialized body fluid. It ... about 9 pints. Jump To: The Components of Blood and Their Importance Many people have undergone blood ...

  20. Blood pressure

    Science.gov (United States)

    ... the walls of the arteries is called blood pressure. Blood pressure is measured both as the heart contracts, which ... as it relaxes, which is called diastole. Normal blood pressure is considered to be a systolic blood pressure ...

  1. 受血者不规则抗体筛查与临床输血安全的研究%Study on the Safety of Irregular Antibody Screening and Blood Transfusion in Patients

    Institute of Scientific and Technical Information of China (English)

    王波; 凌励

    2015-01-01

    目的:研究受血者不规则抗体的阳性率以及不规则抗体的分布,为提高输血安全性提供有效依据。方法对2013年6月~2015年6月在我院拟输血或者手术备血的5000例患者进行不规则抗体筛选,对抗体的特异性进行分析。结果5000例患者中,一共检出20例为抗体阳性,阳性率为0.4%。不规则阳性患者筛查中非特异性抗体1例,占5%,特异性抗体19例,占95%。特异性分布情况:抗-M最高,其次为抗-D、抗-E、抗-C等。结论筛查不规则抗体能够为临床输血的研究提供事实依据,能够提高临床输血的安全性。%Objective To study the positive rate of irregular antibodies and the distribution of irregular antibodies in the blood,so as to provide an effective basis for improving the safety of blood transfusion.Methods 5 000 cases of patients with blood transfusion or surgery in our hospital from June 2013 to June 2015 were screened by irregular antibodies,and the specificity of the antibody was analyzed.Results In 5 000 patients,the positive was 20 cases,and the positive rate was 0.4%. Irregular positive patients in the screening of non-specific antibodies was 1 cases,accounting for 5%,specific antibodies was 19 cases,accounting for 95%. Specific distribution: Anti–m,the highest,followed by anti-D,anti-E,anti-C,etc.Conclusion Screening irregular antibodies can provide a large amount of evidence for clinical research, which can greatly improve the safety of blood transfusion.

  2. SWiFT Software Quality Assurance Plan.

    Energy Technology Data Exchange (ETDEWEB)

    Berg, Jonathan Charles [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2016-01-01

    This document describes the software development practice areas and processes which contribute to the ability of SWiFT software developers to provide quality software. These processes are designed to satisfy the requirements set forth by the Sandia Software Quality Assurance Program (SSQAP). APPROVALS SWiFT Software Quality Assurance Plan (SAND2016-0765) approved by: Department Manager SWiFT Site Lead Dave Minster (6121) Date Jonathan White (6121) Date SWiFT Controls Engineer Jonathan Berg (6121) Date CHANGE HISTORY Issue Date Originator(s) Description A 2016/01/27 Jon Berg (06121) Initial release of the SWiFT Software Quality Assurance Plan

  3. Establishing the quality assurance programme for a nuclear power plant project

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements, recommendations and illustrative examples for establishing the overall quality assurance programme, and its constituent programmes, for a nuclear power plant project. It also provides guidance on the planning and documenting of programme plans and actions that are intended to ensure the achievement of the appropriate quality throughout the design, procurement, manufacture, construction, commissioning, operation and decommissioning of the nuclear power plant. The provisions of this Safety Guide are applicable to all organizations performing activities affecting the quality of items important to safety, such as designing, purchasing, fabricating, manufacturing, handling, shipping, storing, cleaning, erecting, installing, testing, commissioning, operating, inspecting, maintaining, repairing, refuelling, modifying and decommissioning

  4. Advances in safety related maintenance

    International Nuclear Information System (INIS)

    The maintenance of systems, structures and components in nuclear power plants (NPPs) plays an important role in assuring their safe and reliable operation. Worldwide, NPP maintenance managers are seeking to reduce overall maintenance costs while maintaining or improving the levels of safety and reliability. Thus, the issue of NPP maintenance is one of the most challenging aspects of nuclear power generation. There is a direct relation between safety and maintenance. While maintenance alone (apart from modifications) will not make a plant safer than its original design, deficient maintenance may result in either an increased number of transients and challenges to safety systems or reduced reliability and availability of safety systems. The confidence that NPP structures, systems and components will function as designed is ultimately based on programmes which monitor both their reliability and availability to perform their intended safety function. Because of this, approaches to monitor the effectiveness of maintenance are also necessary. An effective maintenance programme ensures that there is a balance between the improvement in component reliability to be achieved and the loss of component function due to maintenance downtime. This implies that the safety level of an NPP should not be adversely affected by maintenance performed during operation. The nuclear industry widely acknowledges the importance of maintenance in NPP safety and operation and therefore devotes great efforts to develop techniques, methods and tools to aid in maintenance planning, follow-up and optimization, and in assuring the effectiveness of maintenance

  5. A philosophy for space nuclear systems safety

    International Nuclear Information System (INIS)

    The unique requirements and contraints of space nuclear systems require careful consideration in the development of a safety policy. The Nuclear Safety Policy Working Group (NSPWG) for the Space Exploration Initiative has proposed a hierarchical approach with safety policy at the top of the hierarchy. This policy allows safety requirements to be tailored to specific applications while still providing reassurance to regulators and the general public that the necessary measures have been taken to assure safe application of space nuclear systems. The safety policy used by the NSPWG is recommended for all space nuclear programs and missions

  6. Blood Screening for Influenza

    OpenAIRE

    Hourfar, Michael Kai; Themann, Anna; Eickmann, Markus; Puthavathana, Pilaipan; Laue, Thomas; Seifried, Erhard; Schmidt, Michael

    2007-01-01

    Influenza viruses, including highly pathogenic avian influenza virus (H5N1), could threaten blood safety. We analyzed 10,272 blood donor samples with a minipool nucleic acid amplication technique. Analytical sensitivity of the method was 804 geq/mL and 444 geq/mL for generic influenza primers and influenza (H5N1) subtype–specific primers. This study demonstrates that such screening for influenza viruses is feasible.

  7. Assuring the competence of nuclear power plant contractor personnel

    International Nuclear Information System (INIS)

    This report was prepared in response to a recommendation by the IAEA International Working Group on Training and Qualification of NPP Personnel (JWG-T and Q) and supported by a number of IAEA meetings on NPP personnel training. IAEA publications on NPP training are the only international documents available to all Member States with nuclear programmes. This report complements the following IAEA publications on NPP personnel training: Technical Reports Series No. 380, Nuclear Power Plant Personnel Training and its Evaluation, A Guidebook; IAEA-TECDOC-1057, Experience in the Use of Systematic Approach to Training (SAT) for Nuclear Power Plant Personnel and IAEA-TECDOC-1063, IAEA World Survey on Nuclear Power Plant Personnel Training. This TECDOC also supplements the IAEA Safety Guide 50-SG-O1 (Rev. 1), Staffing of Nuclear Power Plants and the Recruitment Training and Authorization of Operating Personnel and Safety Standards Series No. NS-R-2, Safety of Nuclear Power Plants. Operation. Within the context of this report NPP contractors are defined as any personnel working for a nuclear power plant who are not directly employed by the nuclear power plant. Competence is the ability to perform to identified standards; it comprises skills, knowledge and attitudes and may be developed through education, experience and training. Qualification is a formal statement of achievement, resulting from an auditable assessment; if competence is assessed, the qualification becomes a formal statement of competence and may be shown on a certificate, diploma, etc. It is recognized that personnel are used to perform tasks that are of a specialised or temporary nature where it is not feasible to hire or maintain a full-time NPP employee. Accordingly, contractors may be used in a variety of situations to support NPPs. Typical situations include: supplies and services being delivered by the contractors that are subject to different quality standards based on a graded approach to assuring

  8. 40 CFR 191.14 - Assurance requirements.

    Science.gov (United States)

    2010-07-01

    ..., HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES Environmental Standards for Disposal § 191.14 Assurance... Commission (see 10 CFR Part 60 for comparable provisions applicable to facilities regulated by the...

  9. Evaluation of financial assurance alternatives of licensees

    International Nuclear Information System (INIS)

    The Uranium and Thorium Mining Regulations of the Atomic Energy Control Act require that applicants/licensees indicate to the AECB what financial assurance plans they have made to fund the decommissioning plan they propose to put in place. We have determined through our own business knowledge from other projects, as well as information provided by contacts in the banking, accounting, legal, investment and insurance communities, what financial assurance plans might be available. We have tabulated these alternatives, included explanations of how each might be implemented, and recorded advantages and disadvantages of each alternative to both the AECB and the applicant/licensee. In addition we have ranked the alternatives in order of most suitable to least suitable, from the AECB's perspective. Although these financial assurance mechanisms have been tabulated with a view to decommissioning of a uranium mine, they could be used in other licence or business arrangements that require financial assurance. (author). 3 tabs., 1 fig

  10. Development of Quality Assurance System and Element for Digital I and C

    International Nuclear Information System (INIS)

    The Quality Assurance system should play an importance role in order to create safety operation. And management of KNICS R and D should have strong leadership to build he safety mind and quality mind. Quality assurance system can help to develop safety management system and to create a positive safety culture in operating organization of nuclear development. The establishment and implementation of QA system is prerequisite for achieving goals of the worker's health, quality, environment and public acceptance in operation of nuclear facilities whether they are regulated by the governmental requirements or not. The focus of nuclear QA system is brought on establishment of an appropriate system and assurance of implementation of the system by continuous improvement of quality problems. As for QA activities related to nuclear R and D, we set up QA systems and supported implementation of the system. We conducted periodic audit of KNICS projects related to safety system development and took corrective actions according to the result. Radiation exposure riskiness of the KAERI's nuclear facilities is lower than that of nuclear power plant and they are more safe. But their safety have being supervised by regulatory body in compliance with laws and technical requirements of nuclear power plant. The present QA system should be changed to an integrated safety management system where elements of environment management, safety management and quality management are complimentarily interacting, and thus meet legal requirements. It is necessary to compare subsystems with KNICS QA and management system requirements to improve the effectiveness of existing implementing procedures in other KNICS projects.

  11. Dose Assurance in Radiation Processing Plants

    DEFF Research Database (Denmark)

    Miller, Arne; Chadwick, K.H.; Nam, J.W.

    1983-01-01

    Radiation processing relies to a large extent on dosimetry as control of proper operation. This applies in particular to radiation sterilization of medical products and food treatment, but also during development of any other process. The assurance that proper dosimetry is performed at the...... radiation processing plant can be obtained through the mediation of an international organization, and the IAEA is now implementing a dose assurance service for industrial radiation processing....

  12. Dose assurance in radiation processing plants

    International Nuclear Information System (INIS)

    Radiation processing relies to a large extent on dosimetry as control of proper operation. This applies in particular to radiation sterilization of medical products and food treatment, but also during development of any other process. The assurance that proper dosimetry is performed at the radiation processing plant can be obtained through the mediation of an international organization, and the IAEA is now implementing a dose assurance service for industrial radiation processing. (author)

  13. Dose assurance in radiation processing plants

    Science.gov (United States)

    Miller, A.; Chadwick, K. H.; Nam, J. W.

    Radiation processing relies to a large extent on dosimetry as control of proper operation. This applies in particular to radiation sterilization of medical products and food treatment, but also during development of any other process. The assurance that proper dosimetry is performed at the radiation processing plant can be obtained through the mediation of an international organization, and the IAEA is now implementing a dose assurance service for industrial radiation processing.

  14. Good manufacturing practice - quality assurance programs

    International Nuclear Information System (INIS)

    The concept of good manufacturing practice (GMP) in the medical device industry requires the use of controlled methods and equipment in performing each step in the device manufacturing process. Quality assurance programs are used to maintain compliance with GMP requirements by prescribing the operating and control procedures to be used. The specific elements of a quality assurance program for the radiation sterilization of medical devices are described. (author)

  15. Flow assurance studies for CO2 transport

    OpenAIRE

    Veltin, J.; Belfroid, S.P.C.

    2013-01-01

    In order to compensate for the relative lack of experience of the CCTS community, Flow Assurance studies of new CO2 pipelines and networks are a very important step toward reliable operation. This report details a typical approach for Flow Assurance study of CO2 transport pipeline. Considerations to take during the design of a pipeline are highlighted, with an emphasis on operability of the system. The steady state aspects of a pipeline operation are first addressed, putting some highlight in...

  16. Not Convinced: Lecturers' Conceptions of Quality Assurance

    OpenAIRE

    Sullivan, Hugh

    2012-01-01

    This dissertation is an investigation into how lecturers' conceptions of quality differ from the way quality is constructed by the quality assurance systems and procedures responsible for it. Lecturers opinions about these systems are also explored. Primary research was conducted in a research intensive Irish University with a view to uncovering lecturers' views about quality assurance. This was done through semistructured interviews which were then thematically analysed and compared with...

  17. Auto Safety

    Science.gov (United States)

    ... 5 Things to Know About Zika & Pregnancy Auto Safety KidsHealth > For Parents > Auto Safety Print A A ... by teaching some basic rules. Importance of Child Safety Seats Using a child safety seat (car seat) ...

  18. 'Sterility Testing of Blood Components and Advanced Therapy Medicinal Products' (Munich, April 29, 2010) Organized by the DGTI Section 'Safety in Hemotherapy' - Meeting Report.

    Science.gov (United States)

    Wagner, Beate; Grabein, Beatrice

    2011-10-01

    Neither screening method completely detects all clinically relevant bacterial contaminations. The effect of sampling time and volume as well as standardization of the assay applied has also to be taken into account. Therefore, minimizing the risk of contamination during manufacture by measures such as donor selection, skin disinfection, division, and processing within closed systems remains crucial. In this context new concepts in sterility testing, especially with instable advanced therapy medicinal products (ATMPs), are needed as well as reassessment of pathogen inactivation techniques. At present hemovigilance data indicate that shortening the shelf life of platelet concentrates as introduced in Germany 2008 reduced the risk of transfusion-transmitted bacterial infections to the same extent as bacterial screening as done in Canada or the Netherlands. The evolving methodological progress, e.g. by standardizing culture methods or enhancing detection systems, requires careful follow-up in parallel to hemovigilance data in order to ensure optimal bacterial safety in hemotherapy.

  19. 氨甲环酸对单侧全膝关节置换失血量的影响及安全性评价%Efficacy and safety of tranexamic acid on blood loss after unilateral total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    闵鹏; 彭银虓; 胡江海; 顾祖超

    2015-01-01

    背景:全膝关节置换围手术期出血较多,而输血不仅额外增加费用,延长康复时间,也存在免疫反应和传染疾病的风险.因此,减少全膝关节置换失血量显得十分重要.目的:评估氨甲环酸在全膝关节置换中止血的有效性和安全性.方法:将 64 例因骨关节病拟行单侧全膝关节置换的患者随机分为两组,每组 32 例.氨甲环酸组于置换前 15 min将氨甲环酸按10 mg/kg稀释于250 mL等渗盐水中静脉滴注;对照组同时间点给予等量生理盐水.对比术中失血量、置换后可见失血量、置换后血红蛋白减少量、输血量、输血人数和置换后纤维蛋白原、凝血酶原时间等凝血评价指标.观察置换后下肢深静脉栓塞的症状,并在置换后30 d行下肢血管多普勒检查.结果与结论:两组术中出血量差异无显著性意义(P>0.05),氨甲环酸组置换后可见失血量低于对照组(P<0.001),氨甲环酸组的输血量和输血人数同样低于对照组(P<0.001);置换后血红蛋白值氨甲环酸组明显高于对照组(P<0.001).置换后3 h两组的凝血指标差异无显著性意义;但两组D-二聚体均明显高于置换前,氨甲环酸组低于对照组,差异有显著性意义(P<0.001).两组患者置换后均未发现下肢深静脉血栓形成.提示氨甲环酸能够有效减少全膝关节置换后的失血量、降低输血率和输血量,且不增加置换后深静脉血栓形成的风险.%BACKGROUND:Total knee arthroplasty is always associated with peripheral blood loss.Blood transfusion not only involves additional cost and prolongs rehabilitation time,but also carries substantial risk of immunologic reaction and disease transmission.Therefore it is very important to reduce blood loss of total knee arthroplasty.OBJECTIVE:To investigate the efficacy and safety of tranexamic acid on reducing blood loss after total knee arthroplasty.METHODS:We enroled 64 patients with primary osteoarthritis

  20. Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU

    DEFF Research Database (Denmark)

    Holst, Lars B; Haase, Nicolai; Wetterslev, Jørn;

    2013-01-01

    BACKGROUND: Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients. METHODS: The Transfusion...... Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin...... and transfusion-related circulatory overload, and acute lung injury) and mortality at 28 days, 6 months and 1 year.The sample size will enable us to detect a 9% absolute difference in 90-day mortality assuming a 45% event rate with a type 1 error rate of 5% and power of 80%. An interim analysis will be performed...

  1. US Army blood program: 2025 and beyond.

    Science.gov (United States)

    Gonzales, Richard; Taylor, Audra L; Atkinson, Andrew J; Malloy, Wilbur W; Macdonald, Victor W; Cap, Andrew P

    2016-03-01

    In preparing to support the Army in 2025 and beyond, the Army Blood Program remains actively engaged with the research and advanced development of blood products and medical technology to improve blood safety and efficacy in conjunction with the US Army Medical Research and Materiel Command. National and International Blood Bank authorities have noted that the US Army research and development efforts in providing new blood products and improving blood safety operate on the cutting edge of technology and are transformational for the global blood industry. Over the past 14 years, the Army has transformed how blood support is provided and improved the survival rate of casualties. Almost every product or process developed by or for the military has found an application in treating civilian patients. Conflicts have many unwanted consequences; however, in times of conflict, one positive aspect is the identification of novel solutions to improve the safety and efficacy of the blood supply.

  2. Quality assurance in performance assessments

    Energy Technology Data Exchange (ETDEWEB)

    Maul, P.R.; Watkins, B.M.; Salter, P.; Mcleod, R [QuantiSci Ltd, Henley-on-Thames (United Kingdom)

    1999-01-01

    Following publication of the Site-94 report, SKI wishes to review how Quality Assurance (QA) issues could be treated in future work both in undertaking their own Performance Assessment (PA) calculations and in scrutinising documents supplied by SKB (on planning a repository for spent fuels in Sweden). The aim of this report is to identify the key QA issues and to outline the nature and content of a QA plan which would be suitable for SKI, bearing in mind the requirements and recommendations of relevant standards. Emphasis is on issues which are specific to Performance Assessments for deep repositories for radioactive wastes, but consideration is also given to issues which need to be addressed in all large projects. Given the long time over which the performance of a deep repository system must be evaluated, the demonstration that a repository is likely to perform satisfactorily relies on the use of computer-generated model predictions of system performance. This raises particular QA issues which are generally not encountered in other technical areas (for instance, power station operations). The traceability of the arguments used is a key QA issue, as are conceptual model uncertainty, and code verification and validation; these were all included in the consideration of overall uncertainties in the Site-94 project. Additionally, issues which are particularly relevant to SKI include: How QA in a PA fits in with the general QA procedures of the organisation undertaking the work. The relationship between QA as applied by the regulator and the implementor of a repository development programme. Section 2 introduces the discussion of these issues by reviewing the standards and guidance which are available from national and international organisations. This is followed in Section 3 by a review of specific issues which arise from the Site-94 exercise. An outline procedure for managing QA issues in SKI is put forward as a basis for discussion in Section 4. It is hoped that

  3. The Evolution of the NASA Commercial Crew Program Mission Assurance Process

    Science.gov (United States)

    Canfield, Amy C.

    2016-01-01

    In 2010, the National Aeronautics and Space Administration (NASA) established the Commercial Crew Program (CCP) in order to provide human access to the International Space Station and low Earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine that the Commercial Provider's transportation system complies with programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted hazard reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100% of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (S&MA) model does not support the nature of the CCP. To that end, NASA S&MA is implementing a Risk Based Assurance process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications.

  4. International Thermonuclear Experimental Reactor U.S. Home Team Quality Assurance Plan

    Energy Technology Data Exchange (ETDEWEB)

    Sowder, W. K.

    1998-10-01

    The International Thermonuclear Experimental Reactor (ITER) project is unique in that the work is divided among an international Joint Central Team and four Home Teams, with the overall responsibility for the quality of activities performed during the project residing with the ITER Director. The ultimate responsibility for the adequacy of work performed on tasks assigned to the U.S. Home Team resides with the U.S. Home Team Leader and the U.S. Department of Energy Office of Fusion Energy (DOE-OFE). This document constitutes the quality assurance plan for the ITER U.S. Home Team. This plan describes the controls exercised by U.S. Home Team management and the Performing Institutions to ensure the quality of tasks performed and the data developed for the Engineering Design Activities assigned to the U.S. Home Team and, in particular, the Research and Development Large Projects (7). This plan addresses the DOE quality assurance requirements of 10 CFR 830.120, "Quality Assurance." The plan also describes U.S. Home Team quality commitments to the ITER Quality Assurance Program. The ITER Quality Assurance Program is based on the principles described in the International Atomic Energy Agency Standard No. 50-C-QA, "Quality Assurance for Safety in Nuclear Power Plants and Other Nuclear Facilities." Each commitment is supported with preferred implementation methodology that will be used in evaluating the task quality plans to be submitted by the Performing Institutions. The implementing provisions of the program are based on guidance provided in American National Standards Institute/American Society of Mechanical Engineers NQA-1 1994, "Quality Assurance." The individual Performing Institutions will implement the appropriate quality program provisions through their own established quality plans that have been reviewed and found to comply with U.S. Home Team quality assurance plan commitments to the ITER Quality Assurance Program. The extent of quality program provisions

  5. Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design

    Science.gov (United States)

    Fitz, Rhonda; Whitman, Gerek

    2016-01-01

    Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IV&V) Program, with Software Assurance Research Program support, extracted FM architectures across the IV&V portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IV&V projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management. The identification of particular FM architectures, visibility, and associated IV&V techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. Additionally, the role FM has with regard to strengthened security requirements, with potential to advance overall asset protection of flight software systems, is being addressed with the development of an adverse conditions database encompassing flight software vulnerabilities. Capitalizing on the established framework, this TR suite provides assurance capability for a variety of FM architectures and varied development approaches. Research results are being disseminated across NASA, other agencies, and the

  6. Effect of consuming a purple-fleshed sweet potato beverage on health-related biomarkers and safety parameters in Caucasian subjects with elevated levels of blood pressure and liver function biomarkers: a 4-week, open-label, non-comparative trial.

    Science.gov (United States)

    Oki, Tomoyuki; Kano, Mitsuyoshi; Watanabe, Osamu; Goto, Kazuhisa; Boelsma, Esther; Ishikawa, Fumiyasu; Suda, Ikuo

    2016-01-01

    An open-label study with one treatment arm was conducted to investigate changes in health-related biomarkers (blood pressure and liver enzyme activity) and the safety of 4 weeks of consuming a purple-fleshed sweet potato beverage in Caucasian subjects. Twenty healthy adults, 18-70 years of age, with a body mass index >25 kg/m(2), elevated blood pressure and elevated levels of liver function biomarkers consumed two cartons of purple-fleshed sweet potato beverage (125 ml, including 117 mg anthocyanin per carton) daily for 4 weeks. Hematology, serum clinical profile, dipstick urinalysis and blood pressure were determined before consumption, at 2 and 4 weeks of consumption and after a 2-week washout period. A trend was found toward lowering systolic blood pressure during the treatment period (p=0.0590). No significant changes were found in diastolic blood pressure throughout the study period. Systolic blood pressure was significantly lower after 4 weeks of consumption compared with before consumption (p=0.0125) and was significantly higher after the 2-week washout period compared with after consumption (p=0.0496). The serum alanine aminotransferase level significantly increased over time, but aspartate aminotransferase and γ-glutamyltransferase levels stayed within the normal range of reference values. Safety parameters of the blood and urine showed no clinically relevant changes. The consumption of a purple-fleshed sweet potato beverage for 4 weeks resulted in no clinically relevant changes in safety parameters of the blood and urine and showed a trend toward lowering systolic blood pressure. PMID:27508114

  7. 10 CFR 26.137 - Quality assurance and quality control.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Quality assurance and quality control. 26.137 Section 26....137 Quality assurance and quality control. (a) Quality assurance program. Each licensee testing facility shall have a quality assurance program that encompasses all aspects of the testing...

  8. Quality assurance in non-interventional studies.

    Science.gov (United States)

    Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

    2009-01-01

    Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres - in between 2% and 5% of the centres depending on the number of participating centres. Before start of

  9. Quality assurance in non-interventional studies

    Directory of Open Access Journals (Sweden)

    Capan, Müge

    2009-11-01

    Full Text Available Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP were published by the U.S. Food and Drug Administration (FDA and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM together with the Paul Ehrlich Institute (PEI and the German Association of Research-Based Pharmaceutical Companies (VFA have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres

  10. Review of quality assurance criteria for nuclear power plants in Japan

    International Nuclear Information System (INIS)

    The present quality assurance guide of Japan Electric Association, JEAG-4101, was prepared in 1972 for the purpose of establishing the safety functions, insuring the public and employees' health, improving operational reliability and maintaining power supply. This guide reflects the state of nuclear power generation of those days. It stands on the point of recognition that quality assurance is controlled by the builders of plants. However, its contents are very simple, and do not mention the concrete means and methods of the items to be conducted, though the items are clear. Since then, international cooperation has progressed in nuclear power industries, and it may be natural that quality assurance criteria are eagerly required to be internationally adaptable. Thus it was decided to do the work for revising JEAG-4101 considering the matching with the Cord of Practice of IAEA. The scope is the quality assurance activity in design, manufacture, installation and trial operation, while operation practice is omitted because it is covered by the present ''security regulations''. The contents of the revised draft include the general description, quality assurance program, organization, document control, design control, procurement control, material and equipment control, manufacture and installation control, inspection and testing control, disqualification control and audit. (Wakatsuki, Y.)

  11. The implementation of quality assurance programs: basic aspect in nuclear plants management

    International Nuclear Information System (INIS)

    Experience in implementing and developing the Quality Assurance programme for the Almaraz nuclear power plant is briefly described. Almaraz was the first Spanish nuclear plant that had to apply specific Quality Assurance standards to its project and construction. The complexity of the project which was developed using standards in a continuous state of evolution, the large number of participating organizations and the numerous interrelationships between them, made the working methods required by the Quality Assurance standards a fundamental tool for establishing order within the framework of the projects, an essential requirement to achieve the objectives regarding costs, schedules and quality. The experience has shown that implementation of Quality Assurance programmes must be accomplished from the highest levels of management and must be thought of as being an essential management tool for achievement of the objectives established, and subjected to periodic revisions in order to check their effectiveness. This logically means that the scope of Quality Assurance must be extended to cover not only those aspects relating to safety but also all activities directly or indirectly affecting adequate operation of the plant, grading the requirements depending on several factors as impact on plant availability, costs of items, complexity of activities, etc. (author)

  12. Quality assurance/quality control, reliability and availability of nuclear power plants

    International Nuclear Information System (INIS)

    In a first part this lectures will present a survey on nuclear power production and plant performance in the Western World and discuss key parameters such as load factors and non-availability. Some main reasons for reliable performance of nuclear power plants are given. The second part of this lecture deals with the question how quality assurance and quality control measures do directly influence plant reliability, availability and, thus, economy. Derived from worldwide experience gained from operating nuclear power plants, it may be concluded that the implementation of an overall quality assurance programme does not only satisfy safety requirements set forth by the nuclear regulatory bodies, but has also a considerable impact on plant reliability and availability. A positive effect on these figures will be achieved if the established quality assurance programme provides for a coordinated approach to all activities affecting quality. It is discussed how the quality of a product should be controlled and what kind of quality assurance measures by performed examples are given to demonstrate that the expenditure for maintenance work on components will decrease if planned and systematic quality assurance actions have been implemented during all procurement stages. (orig./RW)

  13. Guidance for preparation of safety analysis reports

    International Nuclear Information System (INIS)

    Department of Energy (DOE) Order 5480.5, ''Safety of Nuclear Facilities,'' requires the preparation of appropriate safety analyses for each DOE operation and subsequent significant modifications including decommissioning, and independent review of each safety analysis. The purpose of this guide is to assist in the preparation and review of safety documentation for Oak Ridge Operations (ORO) nonreactor facilities and operations. This guide provides a narrative outline of the minimum information needed to prepare safety documentation for ORO moderate or high hazard facilities. Safety documentation is required for new, existing, and modified facilities. The basic purpose of the safety documentation process is to provide assurance that there is no significant increase in risk, as defined in DOE safety policy statements, to people or the environment from operation of ORO facilities

  14. Automating linear accelerator quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Eckhause, Tobias; Thorwarth, Ryan; Moran, Jean M., E-mail: jmmoran@med.umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan 48109-5010 (United States); Al-Hallaq, Hania; Farrey, Karl [Department of Radiation Oncology and Cellular Oncology, The University of Chicago, Chicago, Illinois 60637 (United States); Ritter, Timothy [Ann Arbor VA Medical Center, Ann Arbor, Michigan 48109 (United States); DeMarco, John [Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California, 90048 (United States); Pawlicki, Todd; Kim, Gwe-Ya [UCSD Medical Center, La Jolla, California 92093 (United States); Popple, Richard [Department of Radiation Oncology, University of Alabama Birmingham, Birmingham, Alabama 35249 (United States); Sharma, Vijeshwar; Park, SungYong [Karmanos Cancer Institute, McLaren-Flint, Flint, Michigan 48532 (United States); Perez, Mario; Booth, Jeremy T. [Royal North Shore Hospital, Sydney, NSW 2065 (Australia)

    2015-10-15

    Purpose: The purpose of this study was 2-fold. One purpose was to develop an automated, streamlined quality assurance (QA) program for use by multiple centers. The second purpose was to evaluate machine performance over time for multiple centers using linear accelerator (Linac) log files and electronic portal images. The authors sought to evaluate variations in Linac performance to establish as a reference for other centers. Methods: The authors developed analytical software tools for a QA program using both log files and electronic portal imaging device (EPID) measurements. The first tool is a general analysis tool which can read and visually represent data in the log file. This tool, which can be used to automatically analyze patient treatment or QA log files, examines the files for Linac deviations which exceed thresholds. The second set of tools consists of a test suite of QA fields, a standard phantom, and software to collect information from the log files on deviations from the expected values. The test suite was designed to focus on the mechanical tests of the Linac to include jaw, MLC, and collimator positions during static, IMRT, and volumetric modulated arc therapy delivery. A consortium of eight institutions delivered the test suite at monthly or weekly intervals on each Linac using a standard phantom. The behavior of various components was analyzed for eight TrueBeam Linacs. Results: For the EPID and trajectory log file analysis, all observed deviations which exceeded established thresholds for Linac behavior resulted in a beam hold off. In the absence of an interlock-triggering event, the maximum observed log file deviations between the expected and actual component positions (such as MLC leaves) varied from less than 1% to 26% of published tolerance thresholds. The maximum and standard deviations of the variations due to gantry sag, collimator angle, jaw position, and MLC positions are presented. Gantry sag among Linacs was 0.336 ± 0.072 mm. The

  15. Automating linear accelerator quality assurance

    International Nuclear Information System (INIS)

    Purpose: The purpose of this study was 2-fold. One purpose was to develop an automated, streamlined quality assurance (QA) program for use by multiple centers. The second purpose was to evaluate machine performance over time for multiple centers using linear accelerator (Linac) log files and electronic portal images. The authors sought to evaluate variations in Linac performance to establish as a reference for other centers. Methods: The authors developed analytical software tools for a QA program using both log files and electronic portal imaging device (EPID) measurements. The first tool is a general analysis tool which can read and visually represent data in the log file. This tool, which can be used to automatically analyze patient treatment or QA log files, examines the files for Linac deviations which exceed thresholds. The second set of tools consists of a test suite of QA fields, a standard phantom, and software to collect information from the log files on deviations from the expected values. The test suite was designed to focus on the mechanical tests of the Linac to include jaw, MLC, and collimator positions during static, IMRT, and volumetric modulated arc therapy delivery. A consortium of eight institutions delivered the test suite at monthly or weekly intervals on each Linac using a standard phantom. The behavior of various components was analyzed for eight TrueBeam Linacs. Results: For the EPID and trajectory log file analysis, all observed deviations which exceeded established thresholds for Linac behavior resulted in a beam hold off. In the absence of an interlock-triggering event, the maximum observed log file deviations between the expected and actual component positions (such as MLC leaves) varied from less than 1% to 26% of published tolerance thresholds. The maximum and standard deviations of the variations due to gantry sag, collimator angle, jaw position, and MLC positions are presented. Gantry sag among Linacs was 0.336 ± 0.072 mm. The

  16. Manual on quality assurance for installation and commissioning of instrumentation, control and electrical equipment in nuclear power plants

    International Nuclear Information System (INIS)

    The present Manual on Quality Assurance (QA) for Installation and Commissioning of Instrumentation, Control and Electrical (ICE) Equipment of Nuclear Power Plants contains supporting material and illustrative examples for implementing basic requirements of the quality assurance programme in procurement, receiving, installation and commissioning of this equipment. The Manual on Quality Assurance for Installation and Commissioning of ICE Equipment is designed to supplement and be consistent with the Guidebook as well as with the IAEA Code and Safety Guides on Quality Assurance. It is intended for the use of managerial staff and QA personnel of nuclear power plant owners or the organizations respectively responsible for the legal, technical, administrative and financial aspects of a nuclear power plant. The information provided in the Manual will also be useful to the inspection staff of the regulatory organization in the planning and performance of regulatory inspections at nuclear power plants

  17. Blood Types

    Science.gov (United States)

    ... How Can I Help a Friend Who Cuts? Blood Types KidsHealth > For Teens > Blood Types Print A A ... or straight hair instead of curly. ...Make Eight Blood Types The different markers that can be found in ...

  18. Quality assurance strategies in hospitals: Development, implementation and impact of quality assurance methods in Iranian hospitals

    NARCIS (Netherlands)

    A. Aghaei Hashjin

    2015-01-01

    This thesis concentrates on the subject of quality assurance strategies in hospitals; exploring the development, implementation and impact of quality assurance (QA) methods in Iranian hospitals. A series of descriptive and analytical studies using qualitative and quantitative data were performed. Th

  19. Seeking legitimacy for new assurance forms: The case of assurance on sustainability reporting

    NARCIS (Netherlands)

    B. O'Dwyer; D. Owen; J. Unerman

    2011-01-01

    Based on the development of a more refined conception of legitimacy than has been used in prior audit/assurance and sustainability accounting research, this paper analyses how the legitimation processes adopted by sustainability assurance practitioners in a large professional services firm have co-e

  20. Safety assessment and verification for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

  1. Quality Assurance Plan for the AL3 Test Procedure

    CERN Document Server

    Béjar-Alonso, Isabel

    1999-01-01

    This paper describes the new quality assurance plan for the Alarms-of-Level-3 (AL3) test. The aim of the plan is to introduce engineering techniques and to standardise and simplify the procedures for carrying out tests following Safety Instruction 37 (IS37). The procedures are to co-ordinate all the services involved (fire brigade, maintenance and computer support) and to create a consistent documentation. When the procedures are implemented, it will be possible to determine with confidence how field actions are carried out and to measure actual performance. The focus will be on personnel training and documentation. It is important however to keep documentation and procedures to a reasonable level that can be maintained at appropriate intervals. The plan is the result of an internal requirement from ST/MC and a formal request from Installations Nucléaires de Base (INB).

  2. Quality assurance aspects of the environmental code NECTAR

    International Nuclear Information System (INIS)

    This report describes the quality assurance (QA) procedures which have been adopted in respect of the Environment code NECTAR (Nuclear Environmental Consequences, Transport of Activity and Risks). These procedures involve the verification, validation and evaluation of the individual NECTAR modules, namely RICE, SIRKIT, ATMOS, POPDOS and FOODWEB. The verification and validation of each module are considered in turn, while the final part of the report provides an overall evaluation of the code. The QA procedures are designed to provide reassurance that the NECTAR code is free from systematic errors and will perform calculations within the range of uncertainty and limitations claimed in its documentation. Following consideration of a draft version of this report by the Off-site Dose Methodology Working Group, the ATMOS, POPDOS and FOODWEB modules of NECTAR have been endorsed for use by the Board in reactor design and safety studies. (author)

  3. Quality assurance in the design of nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides the requirements and recommendations related to the establishment and implementation of quality assurance for design of items for a nuclear power plant. The requirements of this Guide shall be applied to the extent necessary during all constituent activities of the nuclear power plant project, such as design, manufacture, construction, commissioning and operations. Its requirements and recommendations shall be implemented, as appropriate, by the responsible organization or by its designated representatives: by plant designers, architect-engineers or manufacturers, when involved in performing design activities related to items to be manufactured; by site constructors, when involved in field engineering activities; by plant operators and other organizations, when involved in design activities related to plant modifications or to selection of spare or replacement parts; and by design consultants and other technical organizations, when performing any engineering activity that affects the work of other design organizations during various stages of nuclear power plant projects

  4. The successful Chief Executive Officer understands quality assurance

    International Nuclear Information System (INIS)

    The successful Chief Executive Officer (CEO) will have recognized the benefits of, and have implemented, a total quality assurance program. The quality assurance program will be adequately defined in policies and procedures such that managers and supervisors of each organizational element understand their primary and supporting roles in carrying out an effective quality assurance program. The traditional practice of having all quality assurance activities reside in a quality assurance organization will have been cast aside. Instead, the quality assurance activities necessary to achieve and assure the quality of the desired end product will have been defined and assigned to responsible organization elements. The quality assurance organization's primary role will be to define the total quality assurance program, insure that the achieving and assuring functions are assigned in policies and procedures, conduct training necessary to have management and supervisors understand the total quality assurance program, measure the effectiveness of the program and feedback measurement data for improvements in the program. The successful CEO will have implemented a quality assurance program that provides for a graded approach for application of the program based upon the importance of the intended use of the product or service. The successful CEO will rely heavily on the scheduled progress reports and assessments to measure the pulse of his organization's successes and improvement needs. This paper will describe suggested approaches for the Quality Assurance Manager to implement a quality assurance program which results in his corporation's CEO being a supporter of and a driving force in the implementation of the quality assurance program

  5. Immunoelectrophoresis - blood

    Science.gov (United States)

    IEP - serum; Immunoglobulin electrophoresis - blood; Gamma globulin electrophoresis; Serum immunoglobulin electrophoresis ... A blood sample is needed. For information on how this is done, see: Venipuncture

  6. An Investigation of Proposed Techniques for Quantifying Confidence in Assurance Arguments

    Science.gov (United States)

    Graydon, Patrick J.; Holloway, C. Michael

    2016-01-01

    The use of safety cases in certification raises the question of assurance argument sufficiency and the issue of confidence (or uncertainty) in the argument's claims. Some researchers propose to model confidence quantitatively and to calculate confidence in argument conclusions. We know of little evidence to suggest that any proposed technique would deliver trustworthy results when implemented by system safety practitioners. Proponents do not usually assess the efficacy of their techniques through controlled experiment or historical study. Instead, they present an illustrative example where the calculation delivers a plausible result. In this paper, we review current proposals, claims made about them, and evidence advanced in favor of them. We then show that proposed techniques can deliver implausible results in some cases. We conclude that quantitative confidence techniques require further validation before they should be recommended as part of the basis for deciding whether an assurance argument justifies fielding a critical system.

  7. Physics and quality assurance of low dose rate brachytherapy

    International Nuclear Information System (INIS)

    Purpose: The purpose of this course is to review the physical principles underlying design, clinical application and execution of interstitial and intracavitary implants in the classical low dose-rate (LDR) range. This year, the course will focus on quality assurance of sources, applicators and treatment planning software. In addition, development of procedures and QA checks designed optimize treatment delivery accuracy and patient safety during each individual procedure will be reviewed. The level of presentation will be designed to accommodate both physicists and physicians. Implementation of recently published AAPM Task Group reports (no. 40, 'Comprehensive Quality Assurance' and No. 43, 'Dosimetry of Interstitial Brachytherapy Sources') will be reviewed. Outline: (A) General Principles (1) QA endpoints: temporal accuracy, positional accuracy, dose delivery accuracy, and safety of the patient, personnel, and the institution (2) QA procedure development: forms, checklists, test development and design of treatment delivery procedures (B) QA of treatment delivery devices (1) Source acceptance testing and QA a) calibration and source strength specification standards b) leakage tests and source geometry verification (2) Applicator acceptance testing and QA (3) Remote afterloading devices (4) Treatment planning systems a) graphic input/output devices, implant geometry reconstruction, and graphical display b) dose calculation accuracy i) review of brachytherapy dose calculation algorithms ii) dosimetric benchmarks available: Task Group 43 report (C) Procedure-specific QA 1) Organization of treatment delivery team 2) Preplanning and preparation 3) Applicator insertion 4) Radiographic examination of the implant, prescription, and treatment calculation 5) Source insertion 6) Treatment planning and physicist review of treatment plans 7) QA during patient treatment and removal of sources and applicators

  8. Producing health, producing safety. Developing a collective safety culture in radiotherapy

    International Nuclear Information System (INIS)

    This research thesis aims at a better understanding of safety management in radiotherapy and at proposing improvements for patient safety through the development of a collective safety culture. A first part presents the current context in France and abroad, addresses the transposition of other safety methods to the medical domain, and discusses the peculiarities of radiotherapy in terms of risks and the existing quality-assurance approaches. The second part presents the theoretical framework by commenting the intellectual evolution with respect to system safety and the emergence of the concept of safety culture, and by presenting the labour collective aspects and their relationship with system safety. The author then comments the variety of safety cultures among the different professions present in radiotherapy, highlights the importance of the collective dimension in correcting discrepancies at the end of the treatment process, and highlights how physicians take their colleagues work into account. Recommendations are made to improve patient safety in radiotherapy

  9. Quality assurance and organizational effectiveness in hospitals.

    Science.gov (United States)

    Hetherington, R W

    1982-01-01

    The purpose of this paper is to explore some aspects of a general theoretical model within which research on the organizational impacts of quality assurance programs in hospitals may be examined. Quality assurance is conceptualized as an organizational control mechanism, operating primarily through increased formalization of structures and specification of procedures. Organizational effectiveness is discussed from the perspective of the problem-solving theory of organizations, wherein effective organizations are those which maintain at least average performance in all four system problem areas simultaneously (goal-attainment, integration, adaptation and pattern-maintenance). It is proposed that through the realization of mutual benefits for both professionals and the bureaucracy, quality assurance programs can maximize such effective performance in hospitals.

  10. Assuring quality in high-consequence engineering

    Energy Technology Data Exchange (ETDEWEB)

    Hoover, Marcey L.; Kolb, Rachel R.

    2014-03-01

    In high-consequence engineering organizations, such as Sandia, quality assurance may be heavily dependent on staff competency. Competency-dependent quality assurance models are at risk when the environment changes, as it has with increasing attrition rates, budget and schedule cuts, and competing program priorities. Risks in Sandia's competency-dependent culture can be mitigated through changes to hiring, training, and customer engagement approaches to manage people, partners, and products. Sandia's technical quality engineering organization has been able to mitigate corporate-level risks by driving changes that benefit all departments, and in doing so has assured Sandia's commitment to excellence in high-consequence engineering and national service.

  11. Quality assurance and economic aspects to be considered in the construction of nuclear power plants

    International Nuclear Information System (INIS)

    Pipework design and installation is the example chosen to explain how safety, requirements and economic constraints can be reconciled to achieve quality assurance that is justifiable in both terms. The cost and time saving methods discussed include automatic welding techniques, inductive bending methods, and cold bending methods for small dimensions. The cost of testing and examination work on site can be reduced by personal-related examinations and the use of detector pigs. (orig./HP)

  12. Quality assurance for external personnel monitoring in nuclear industrial facilities, CNNC

    International Nuclear Information System (INIS)

    More than 6000 personnel are currently being monitored for occupational exposure in CNNC, China. Personnel monitoring is one of the important items of radiation protection. The data of individual dose are not only indispensable for radiation safety assessment but also the basis for radiation protection measures to be taken. Possibly, it could provide basic information for epidemiological studies, optimization procedure of radiation protection (risk/benefit analyses) and medical or legal purposes. Obviously, personnel monitoring and its quality assurance are very significant

  13. Building a global information assurance program

    CERN Document Server

    Curts, Raymond J

    2002-01-01

    INTRODUCTION TO INFORMATION ASSURANCE (IA)AuthenticationConfidentialityNon-repudiationBASIC CONCEPTSAttributesInformation AttributesPure Information AttributesAttributes Influenced by the SystemSystem AttributesSecurity AttributesInformation System Support Planning PrinciplesThe Bottom Line, RevisitedInformation Assurance (IA)Commercial CapabilitiesSecurityNetwork ViewsRisk ManagementCognitive HierarchyTypes of LogicSummaryRISK, THREAT AND VULNERABILITYOVERVIEW OF SYSTEMS ENGINEERINGA Systems Engineering Case StudyCase Study BackgroundThe MissionThe GoalAn Approach Toward A SolutionCase Tools:

  14. Quality Assurance for Operation of Nuclear Facilities

    International Nuclear Information System (INIS)

    This report describes QA activities performed within 'Quality Assurance for Nuclear facility project' and results thereof. Efforts were made to maintain and improve quality system of nuclear facilities. Varification activities whether quality system was implemented in compliance with requirements. QA department assisted KOLAS accredited testing and calibration laboratories, ISO 9001 quality system, establishment of QA programs for R and D, and carried out reviews and surveys for development of quality assurance technologies. Major items of this report are as follows : - Development and Improvement of QA Programs - QA Activities - Assessment of Effectiveness and Adequacy for QA Programs

  15. Quality Assurance Source Requirements Traceability Database

    Energy Technology Data Exchange (ETDEWEB)

    MURTHY, R., NAYDENOVA, A., DEKLEVER, R., BOONE, A.

    2006-01-30

    At the Yucca Mountain Project the Project Requirements Processing System assists in the management of relationships between regulatory and national/industry standards source criteria, and Quality Assurance Requirements and Description document (DOE/R W-0333P) requirements to create compliance matrices representing respective relationships. The matrices are submitted to the U.S. Nuclear Regulatory Commission to assist in the commission's review, interpretation, and concurrence with the Yucca Mountain Project QA program document. The tool is highly customized to meet the needs of the Office of Civilian Radioactive Waste Management Office of Quality Assurance.

  16. Nuclear safety

    International Nuclear Information System (INIS)

    The author proposes an overview of methods and concepts used in the nuclear industry, at the design level as well as at the exploitation level, to ensure an acceptable safety level, notably in the case of nuclear reactors. He first addresses the general objectives of nuclear safety and the notion of acceptable risk: definition and organisation of nuclear safety (relationships between safety authorities and operators), notion of acceptable risk, deterministic safety approach and main safety principles (safety functions and confinement barriers, concept of defence in depth). Then, the author addresses the safety approach at the design level: studies of operational situations, studies of internal and external aggressions, safety report, design principles for important-for-safety systems (failure criterion, redundancy, failure prevention, safety classification). The next part addresses safety during exploitation and general exploitation rules: definition of the operation domain and of its limits, periodic controls and tests, management in case of incidents, accidents or aggressions

  17. Study Abroad Programs: Making Safety a Priority

    Science.gov (United States)

    Buddan, Michael Craig; Budden, Connie B.; Juban, Rusty; Baraya, Aristides

    2014-01-01

    Increasingly, students are participating in study abroad programs. Such programs provide participants a variety of learning experiences. Developing cross-cultural appreciation, communication skills, maturity and a less ethno-centric mindset are among the impacts study abroad programs offer. However, care must be taken to assure student safety and…

  18. Safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Keen, L.J. [Canadian Nuclear Safety Commission, Ottawa, Ontario (Canada)

    2003-07-01

    Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

  19. Safety evaluation report. Fast Flux Test Facility. Project No. 448

    Energy Technology Data Exchange (ETDEWEB)

    1978-08-01

    Information on the safety of the FFTF Reactor is presented under the following chapter headings: site characteristics; design of structures, components, equipment, and systems; reactor; reactor coolant system and connected systems; engineered safety features; electric power; auxiliary systems; radioactive waste management systems; radiation protection; conduct of operations; initial test programs; accident analysis; and quality assurance.

  20. Elements of a nuclear criticality safety program

    International Nuclear Information System (INIS)

    Nuclear criticality safety programs throughout the United States are quite successful, as compared with other safety disciplines, at protecting life and property, especially when regarded as a developing safety function with no historical perspective for the cause and effect of process nuclear criticality accidents before 1943. The programs evolved through self-imposed and regulatory-imposed incentives. They are the products of conscientious individuals, supportive corporations, obliged regulators, and intervenors (political, public, and private). The maturing of nuclear criticality safety programs throughout the United States has been spasmodic, with stability provided by the volunteer standards efforts within the American Nuclear Society. This presentation provides the status, relative to current needs, for nuclear criticality safety program elements that address organization of and assignments for nuclear criticality safety program responsibilities; personnel qualifications; and analytical capabilities for the technical definition of critical, subcritical, safety and operating limits, and program quality assurance

  1. Quality assurance in the procurement of items and services for nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Agency's Code of Practice on Quality Assurance for Safety in Nuclear Power Plants (Safety Series No.50-C-QA), which states requirements for the control of procurement of items and services which are important to the safety of nuclear power plants, for the purpose of achieving quality. The establishment and implementation of controls over the procurement process provide a basis for establishing an appropriate level of confidence that the activities undertaken during procurement of items and services have been performed in accordance with the principles of quality assurance expressed in the Code, and that the required quality of items and services has been achieved. The purchaser, in establishing control over procurement, shall ensure that the quality criteria, quality level, and other quality requirements specified for the particular item or service are taken into account

  2. GLYCOHEMOGLOBIN - COMPARISON OF 12 ANALYTICAL METHODS, APPLIED TO LYOPHILIZED HEMOLYSATES BY 101 LABORATORIES IN AN EXTERNAL QUALITY ASSURANCE PROGRAM

    NARCIS (Netherlands)

    WEYKAMP, CW; PENDERS, TJ; MUSKIET, FAJ; VANDERSLIK, W

    1993-01-01

    Stable lyophilized ethylenediaminetetra-acetic acid (EDTA)-blood haemolysates were applied in an external quality assurance programme (SKZL, The Netherlands) for glycohaemoglobin assays in 101 laboratories using 12 methods. The mean intralaboratory day-to-day coefficient of variation (CV), calculate

  3. Assurance on sustainability reporting: An auditor's view

    NARCIS (Netherlands)

    Philip Wallage

    2000-01-01

    This article discusses initial experiences with a new assurance service: the verification of sustainability reports providing assertions regarding financial, environmental, and social issues. For illustration purposes, references to the verification ofThe Shell Report 2000 are made. Because of the n

  4. Dose Assurance in Radiation Processing Plants

    DEFF Research Database (Denmark)

    Miller, Arne; Chadwick, K.H.; Nam, J.W.

    1983-01-01

    Radiation processing relies to a large extent on dosimetry as control of proper operation. This applies in particular to radiation sterilization of medical products and food treatment, but also during development of any other process. The assurance that proper dosimetry is performed at the radiat...

  5. Quality Assurance in University Guidance Services

    Science.gov (United States)

    Simon, Alexandra

    2014-01-01

    In Europe there is no common quality assurance framework for the delivery of guidance in higher education. Using a case study approach in four university career guidance services in England, France and Spain, this article aims to study how quality is implemented in university career guidance services in terms of strategy, standards and models,…

  6. Sustainability performance and assurance: Influence on reputation

    OpenAIRE

    Alon, Anna; Vidovic, M.

    2015-01-01

    The positive impact of sustainability on reputation has been assumed but not sufficiently examined. This study probes the veracity of these claims by applying legitimacy and signaling perspectives to examine whether sustainability performance and assurance contribute to corporate reputation. We find superior sustainability performance has a positive association with sustainability reputation. Companies with better performance are also more likely to obtain external ...

  7. Modifiers for quality assurance in group facilitation

    NARCIS (Netherlands)

    Kolfschoten, G.L.; Grünbacher, P.; Briggs, R.O.

    2011-01-01

    A key task of a professional facilitator is to assure the quality of the knowledge products created through collaborative effort. To manage the quality of the knowledge a group generates, facilitators attend to, judge, and question the quality of the contributions a group makes, the decisions it mak

  8. On the development of quality assurance

    DEFF Research Database (Denmark)

    Andersen, Jens

    2014-01-01

    Contemporary research in quality assurance indicates that large uncertainties observed in interlaboratory comparisons to a large extent originate from a lack of competence of laboratory staff. This explanation is challenged by the present article for which six technologies and multiple series...

  9. 43 CFR 17.4 - Assurances required.

    Science.gov (United States)

    2010-10-01

    ... financial assistance to an institution of higher education (including assistance for construction, for... treatment of students. (2) The assurance required with respect to an institution of higher education, or any... encumber the real property as security for financing construction of new, or improvement of...

  10. 45 CFR 1110.4 - Assurances required.

    Science.gov (United States)

    2010-10-01

    ... case of any application for Federal financial assistance to an institution of higher education... of higher education or any other institution, insofar as the assurance relates to the institution's... mortgage or otherwise encumber the real property as security for financing construction of new,...

  11. 45 CFR 80.4 - Assurances required.

    Science.gov (United States)

    2010-10-01

    ... institution of higher education (including assistance for construction, for research, for special training... assurance required with respect to an institution of higher education, hospital, or any other institution... security for financing construction of new, or improvement of existing, facilities on such property for...

  12. Quality Assurance in Higher Education in Zimbabwe

    Science.gov (United States)

    Garwe, Evelyn Chiyevo

    2014-01-01

    The purpose of this paper is to furnish local and global stakeholders with detailed information regarding the development and current status of quality assurance in the Zimbabwean higher education sector. The study used document analysis, observation and interviews with key informants as sources of data. This paper addresses the dearth of…

  13. APPROACH TO QUALITY ASSURANCE IN HIGHER EDUCATION

    Directory of Open Access Journals (Sweden)

    Zora Arsovski

    2007-03-01

    Full Text Available Quality assurance in higher education is streamed in two interconnected concepts: (1 quality management according to ISO 9000 and (2 Bologna process. In this paper both concepts are presented, with point on internal state and term plan activities for quality improvement in higher education in Serbia.

  14. MCNP{trademark} Software Quality Assurance plan

    Energy Technology Data Exchange (ETDEWEB)

    Abhold, H.M.; Hendricks, J.S.

    1996-04-01

    MCNP is a computer code that models the interaction of radiation with matter. MCNP is developed and maintained by the Transport Methods Group (XTM) of the Los Alamos National Laboratory (LANL). This plan describes the Software Quality Assurance (SQA) program applied to the code. The SQA program is consistent with the requirements of IEEE-730.1 and the guiding principles of ISO 900.

  15. From quality assurance to total quality management

    OpenAIRE

    Andreea Ionică

    2003-01-01

    Quality assurance is broadly the prevention of quality problems through planned and systematic activities. These will include the establishment of a good quality management system and the assessment of its adequacy, the audit of the operation of the system, and the review of the system itself

  16. Ensuring Quality Assurance in Vocational Education

    Science.gov (United States)

    Idialu, Ethel E.

    2013-01-01

    Vocational education emphasises skill acquisition. Quality assurance in vocational education is a concept that is concerned with high performance involving activities with vocational education such as teaching, learning, infrastructures, students' behaviour and the entire academic process. Quality vocational education refers to input and output of…

  17. Quality Assurance of Ultrasonic Diagnosis in Breast

    International Nuclear Information System (INIS)

    Sonography is a subjective diagnostic method which is highly dependent on the experience of the operator and the equipment quality which requires real-time adjustments. Breast screening examination currently consists of clinical examination and mammography. Breast sonography, either supplementary to mammography or independently, is indicated for the dense breast, especially in younger women. Breast sonography is especially applicable for Korean women because of the denser breast parenchyma and the approximately 10-year younger incidence rate of breast cancer of Korean women compared to western women. To avoid unnecessary breast biopsy because of the high rate of false positive lesions in breast parenchyma, which is different from other body organs such as the liver or the kidney, a quality assurance program for breast sonography is essential. The quality assurance of breast ultrasound involves quality assurance of the equipment, imaging display and acquisition of clinical images, personnel qualifications and other aspects such as unification of lexicon, guideline of diagnostic examination and reporting system; US BI-RAD reporting system, assessment items and organization, education program, medical audit, certification issues, and medicolegal issues. A breast sonographic quality assurance system should be established before a scheme to initiate governmental medical insurance for breast sonography

  18. 36 CFR 6.10 - Financial assurance.

    Science.gov (United States)

    2010-07-01

    ... has established a bond under 40 CFR 258.74(b). (b) The Regional Director will not require a bond or... the estimated cost to accomplish all closure and post-closure care requirements as described in 40 CFR... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Financial assurance....

  19. Quality Assurance in Distance Learning Libraries

    Science.gov (United States)

    Tripathi, Manorama; Jeevan, V. K. J.

    2009-01-01

    Purpose: The paper aims to study how the present distance learning libraries can improve upon their existing services and introduce new ones to enhance quality of services to distance learners. Design/methodology/approach: The paper includes a review of literature on quality assurance in open and distance education in general and student support…

  20. Transuranic Waste Characterization Quality Assurance Program Plan

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-04-30

    This quality assurance plan identifies the data necessary, and techniques designed to attain the required quality, to meet the specific data quality objectives associated with the DOE Waste Isolation Pilot Plant (WIPP). This report specifies sampling, waste testing, and analytical methods for transuranic wastes.