Sample records for safety approval process
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Safety review and approval process for the TFTR
International Nuclear Information System (INIS)
Levine, J.D.; Howe, H.J.; Howe, K.E.
1983-01-01
The design, construction, and operation of the Tokamak Fusion Test Reactor (TFTR) has undergone an extensive safety and enviromental analysis involving Princeton Plasma Physics Laboratory (PPPL), the U.S. Department of Energy (DOE), the Ebasco/Grumman Industrial Subcontractor Team, and other organizations. This analysis, which is continuing during the TFTR operational phase, has been facilitated by the preparation, review and approval of several documents, including an Environmental Statement (Draft and Final), a Preliminary Safety Analysis Report (PSAR), a Final Safety Analysis Report (FSAR), Operations Safety Requirements (OSRs) and Safety Requirements (SRs), and various Operating and Maintenance Manuals. Through TFTR Safety Group participation in formal system design evaluations, change control boards, and reviews of project procurement and installation documentation, the TFTR Management Configuration Control System assures that all aspects of the project, including proposed design, installation and operational changes, receive prompt and thorough safety analyses. These efforts will continue as the TFTR Program moves into the neutral beam and D-T operational phases. The safety review and approval experience that has been acquired on the TFTR Project should serve as a foundation for similar efforts on future fusion devices
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Nuclear safety review requirements for launch approval
International Nuclear Information System (INIS)
Sholtis, J.A. Jr.; Winchester, R.O.
1992-01-01
Use of nuclear power systems in space requires approval which is preceded by extensive safety analysis and review. This careful study allows an informed risk-benefit decision at the highest level of our government. This paper describes the process as it has historically been applied to U.S. isotopic power systems. The Ulysses mission, launched in October 1990, is used to illustrate the process. Expected variations to deal with reactor-power systems are explained
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The approval process for biosimilar erythropoiesis-stimulating agents.
Wish, Jay B
2014-09-05
A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright
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Alcohol addiction - the safety of available approved treatment options.
Antonelli, Mariangela; Ferrulli, Anna; Sestito, Luisa; Vassallo, Gabriele A; Tarli, Claudia; Mosoni, Carolina; Rando, Maria M; Mirijello, Antonio; Gasbarrini, Antonio; Addolorato, Giovanni
2018-02-01
Alcohol Use Disorders (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a 'temporary recommendation for use' in France. Areas covered: The safety of the above mentioned medications on liver, digestive system, kidney function, nervous system, pregnancy and lactation and their possible side effects are described and discussed. Expert opinion: Mechanism of action and metabolism of these drugs as well as patients' clinical characteristics can affect the safety of treatment. All approved medications are valid tools for the treatment of AUD in patients without advanced liver disease. For some drugs, attention should be paid to patients with renal failure and medications may be used with caution, adjusting the dosage according to kidney function. In patients with AUD and advanced liver disease, at present only baclofen has been formally tested in randomized controlled trials showing its safety in this population.
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14 CFR 414.35 - Public notification of the criteria by which a safety approval was issued.
2010-01-01
... issued. For each grant of a safety approval, the FAA will publish in the Federal Register a notice of the... which a safety approval was issued. 414.35 Section 414.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety...
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2012-10-04
... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...
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A Safety Management Model for FAR 141 Approved Flight Schools
Mendonca, Flavio A. C.; Carney, Thomas Q
2017-01-01
The Safety Management Annex (Annex 19), which became applicable in November 2013, consolidates safety management provisions previously contained in six other International Civil Aviation Organization (ICAO) Annexes, and will serve as a resource for overarching state safety management responsibilities. Through Annex 19, ICAO has required that its member states develop and implement safety management systems (SMS) to improve safety. This mandate includes an approved training organization that i...
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40 CFR 123.61 - Approval process.
2010-07-01
... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...
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International Nuclear Information System (INIS)
Halme, Ville-Juhani
2015-01-01
Posiva is preparing geological final disposal in the Finnish bedrock in Olkiluoto, Eurajoki. The final disposal facility includes encapsulation plant and underground repository. Most of the main civil structures are concrete structures. STUK is the supervising authority in civil structures. The National Building Code of Finland and STUK's Regulatory Guide on nuclear safety (YVL) are the most important instructions when constructing concrete structures into nuclear installation. Posiva has classified concrete structures in two classes according STUK's YVL-guidance: EYT (non-nuclear) and Safety Class 3 (SC 3, nuclear safety significance). When building SC 3 concrete structures, specific protocol must be followed. Protocol includes planned routines for design, construction, supervision, quality control (QC) and quality assurance (QA) activities. Documents relating concrete structures must be approved by Posiva and STUK before construction work. After structures have been designed and actual building is ongoing, there are two main steps. Before concreting, readiness inspection for concreting must be arranged. Readiness inspection will be arranged according to a specific plan and the date must be informed to STUK. After establishing readiness for concreting, casting work can begin. Once concrete structures are done, inspected and approved, final documentation according to a quality control plan will be reviewed by Posiva. After Posiva's approval, final documentation will be sent for STUK's approval. In the end STUK will give the permission for commissioning of the concrete structures after approved commissioning inspection. The document is made up of an abstract and a poster
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40 CFR 145.31 - Approval process.
2010-07-01
... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...
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2012-11-06
... Standard on Process Safety Management of Highly Hazardous Chemicals; Extension of the Office of Management...) approval of the information collection requirements specified in the Standard on Process Safety Management...: The Standard on Process Safety Management of Highly Hazardous Chemicals (29 CFR 1910.119). OMB Number...
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Safety regulation for the design approval of special form radioactive sources
International Nuclear Information System (INIS)
Cho, Woon-Kap
2009-01-01
Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a regulatory expert body, Korea Institute of Nuclear Safety (KINS) assesses various types of application documents, such as safety analysis report, quality assurance program, and other documents evidencing fulfillment of requirements for design approval of the special form radioactive sources, submitted by a legal person who intends to produce special form radioactive sources and then reports the assessment result to MEST. A design approval certificate is issued to the applicant by MEST on the basis of a technical evaluation report presented by KINS.
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International Nuclear Information System (INIS)
Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.
1995-01-01
International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)
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2013-01-07
...] Petition for Positive Train Control Safety Plan Approval and System Certification of the Electronic Train... the Federal Railroad Administration (FRA) for Positive Train Control (PTC) Safety Plan (PTCSP) approval and system certification of the Electronic Train Management System (ETMS) as required by 49 U.S.C...
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Analysis of the Education Program Approval Process: A Program Evaluation.
Fountaine, Charles A.; And Others
A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…
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Preparation, review, and approval of implementation plans for nuclear safety requirements
International Nuclear Information System (INIS)
1994-10-01
This standard describes an acceptable method to prepare, review, and approve implementation plans for DOE Nuclear Safety requirements. DOE requirements are identified in DOE Rules, Orders, Notices, Immediate Action Directives, and Manuals
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48 CFR 1819.7203 - Mentor approval process.
2010-10-01
... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Mentor approval process... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...
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U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...
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Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.
Mattingly, T Joseph; Simoni-Wastila, Linda
2017-10-01
Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly
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Transportation Safety Excellence in Operations Through Improved Transportation Safety Document
International Nuclear Information System (INIS)
Dr. Michael A. Lehto; MAL
2007-01-01
A recent accomplishment of the Idaho National Laboratory (INL) Materials and Fuels Complex (MFC) Nuclear Safety analysis group was to obtain DOE-ID approval for the inter-facility transfer of greater-than-Hazard-Category-3 quantity radioactive/fissionable waste in Department of Transportation (DOT) Type A drums at MFC. This accomplishment supported excellence in operations through safety analysis by better integrating nuclear safety requirements with waste requirements in the Transportation Safety Document (TSD); reducing container and transport costs; and making facility operations more efficient. The MFC TSD governs and controls the inter-facility transfer of greater-than-Hazard-Category-3 radioactive and/or fissionable materials in non-DOT approved containers. Previously, the TSD did not include the capability to transfer payloads of greater-than-Hazard-Category-3 radioactive and/or fissionable materials using DOT Type A drums. Previous practice was to package the waste materials to less-than-Hazard-Category-3 quantities when loading DOT Type A drums for transfer out of facilities to reduce facility waste accumulations. This practice allowed operations to proceed, but resulted in drums being loaded to less than the Waste Isolation Pilot Plant (WIPP) waste acceptance criteria (WAC) waste limits, which was not cost effective or operations friendly. An improved and revised safety analysis was used to gain DOE-ID approval for adding this container configuration to the MFC TSD safety basis. In the process of obtaining approval of the revised safety basis, safety analysis practices were used effectively to directly support excellence in operations. Several factors contributed to the success of MFC's effort to obtain approval for the use of DOT Type A drums, including two practices that could help in future safety basis changes at other facilities. (1) The process of incorporating the DOT Type A drums into the TSD at MFC helped to better integrate nuclear safety
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Energy Technology Data Exchange (ETDEWEB)
Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.
2007-05-15
The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)
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2010-07-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...
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2013-06-12
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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2011-06-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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2013-03-21
... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...
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2013-08-19
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...
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2010-06-24
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...
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Credit Risk Management - Loan Approval Process
Directory of Open Access Journals (Sweden)
Lulzim Rashiti
2016-03-01
Full Text Available The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper will also explain in detail procedures and responsibilities shared along the process of loan acceptance by a banker. To sum up, the overall process from application to loan approval or denial will be explained pointing out the implications that are faced along the way
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78 FR 28275 - Office of Commercial Space Transportation; Safety Approval Performance Criteria
2013-05-14
... provide as a service, scenario based physiology training, which includes hypobaric chamber training. BST may offer its scenario based physiology altitude training as a service to a prospective launch and...: Notification of criteria used to evaluate the Black Sky Training, Inc. (BST) safety approval application...
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Evolution of International Space Station Program Safety Review Processes and Tools
Ratterman, Christian D.; Green, Collin; Guibert, Matt R.; McCracken, Kristle I.; Sang, Anthony C.; Sharpe, Matthew D.; Tollinger, Irene V.
2013-01-01
The International Space Station Program at NASA is constantly seeking to improve the processes and systems that support safe space operations. To that end, the ISS Program decided to upgrade their Safety and Hazard data systems with 3 goals: make safety and hazard data more accessible; better support the interconnection of different types of safety data; and increase the efficiency (and compliance) of safety-related processes. These goals are accomplished by moving data into a web-based structured data system that includes strong process support and supports integration with other information systems. Along with the data systems, ISS is evolving its submission requirements and safety process requirements to support the improved model. In contrast to existing operations (where paper processes and electronic file repositories are used for safety data management) the web-based solution provides the program with dramatically faster access to records, the ability to search for and reference specific data within records, reduced workload for hazard updates and approval, and process support including digital signatures and controlled record workflow. In addition, integration with other key data systems provides assistance with assessments of flight readiness, more efficient review and approval of operational controls and better tracking of international safety certifications. This approach will also provide new opportunities to streamline the sharing of data with ISS international partners while maintaining compliance with applicable laws and respecting restrictions on proprietary data. One goal of this paper is to outline the approach taken by the ISS Progrm to determine requirements for the new system and to devise a practical and efficient implementation strategy. From conception through implementation, ISS and NASA partners utilized a user-centered software development approach focused on user research and iterative design methods. The user-centered approach used on
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International Nuclear Information System (INIS)
JONES GL
2008-01-01
The objective is to describe the process used by the Office of River Protection (ORP) for evaluating and implementing Contractor-initiated changes to the Waste Treatment and Immobilization Plant (WTP) Authorization Basis (AB). The WTP Project's history has provided a unique challenge for establishing and maintaining an ORP-approved AB during design and construction. Until operations begin, the project cannot implement the classic Unreviewed Safety Question (USQ) process to determine when ORP approval of Contractor-initiated changes is required. A 'quasiUSQ' process has been implemented that defines when AB changes could occur. The three types of AB changes are (1) Limited Scope Changes, (2) Authorization Basis Deviations, and (3) Authorization Basis Amendment Request (ABAR). DOE RL/REG 97-13, 'Office of River Protection Position on Contractor-Initiated Changes to the Authorization Basis', describes the process the WTP Contractor must follow to make changes to the AB, with and without ORP approval. The process uses a 'safety evaluation' process that is similar to the USQ process but at a more qualitative level. The maturation of the WTP Contractor's facility design and activities, and other changing conditions, resulted in a process that allows the Contractor to make changes to the AB without ORP approval; however, those changes that may significantly affect nuclear safety do require ORP approval. This process balances the WTP regulatory principle of efficiency with assurance that adequate safety will not be compromised. The process has reduced the number of ABARs requiring ORP approval and reduced the potential for delays in design and procurement activities
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Safety update on the use of recombinant activated factor VII in approved indications.
Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie
2015-06-01
This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis. Copyright © 2015 Elsevier Ltd. All rights reserved.
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77 FR 58607 - Office of Commercial Space Transportation Safety Approval Performance Criteria
2012-09-21
...: Notification of criteria used to evaluate the National Aerospace Training and Research (NASTAR) Center safety... approval for the ability of its Falcon 12/4 Altitude Chamber to replicate pressures experienced at altitude...). NASTAR's Falcon 12/4 Altitude Chamber is capable of replicating any pressure experienced at altitudes...
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A Document Imaging Technique for Implementing Electronic Loan Approval Process
Directory of Open Access Journals (Sweden)
J. Manikandan
2015-04-01
Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.
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Radiation Safety Professional Certification Process in a Multi-Disciplinary Association
International Nuclear Information System (INIS)
Wilson, G.; Jones, P.; Ilson, R.
2004-01-01
There is no one set of criteria that defines the radiation safety professional in Canada. The many varied positions, from university and medical to industry and mining, define different qualifications to manage radiation safety programs. The national regulatory body has to assess many different qualifications when determining if an individual is acceptable to be approved for the role of radiation safety officer under any given licence. Some professional organizations specify education requirements and work experience as a prerequisite to certification. The education component specifies a degree of some type but does not identify specific courses or competencies within that degree. This could result in individuals with varying levels of radiation safety experience and training. The Canadian Radiation Protection Association (CRPA), responding to a need identified by the membership of the association, has initiated a process where the varying levels of knowledge of radiation safety can be addressed for radiation safety professionals. By identifying a core level set of radiation safety competencies, the basic level of radiation safety officer for smaller organizations can be met. By adding specialty areas, education can be pursued to define the more complex needs of larger organizations. This competency based process meets the needs of licensees who do not require highly trained health physicists in order to meet the licensing requirements and at the same time provides a stepping stone for those who wish to pursue a more specialized health physics option. (Author) 8 refs
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42 CFR 410.142 - CMS process for approving national accreditation organizations.
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false CMS process for approving national accreditation... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving national accreditation organizations. (a) General rule. CMS may approve and recognize a nonprofit or not...
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44 CFR 78.9 - Planning grant approval process.
2010-10-01
..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...
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2012-07-19
... DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1952 [Docket ID. OSHA 2012-0029] RIN 1218-AC78 Hawaii State Plan for Occupational Safety and Health; Proposed Modification of 18(e) Plan Approval AGENCY: Occupational Safety and Health Administration (OSHA), Department of...
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14 CFR 21.305 - Approval of materials, parts, processes, and appliances.
2010-01-01
..., and appliances. 21.305 Section 21.305 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION..., Parts, Processes, and Appliances § 21.305 Approval of materials, parts, processes, and appliances. Whenever a material, part, process, or appliance is required to be approved under this chapter, it may be...
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2010-03-12
..., information about changes to the safety culture of the affected workplaces will be used as one of several data...: RITA-2008-0002] Notice of Request for Approval To Collect New Information: Collection of Safety Culture.... mail to Federal offices in Washington, DC, we recommend that persons consider an alternative method...
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25 CFR 1200.15 - What is the approval process for management plans?
2010-04-01
... 25 Indians 2 2010-04-01 2010-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...
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Zuñiga, Leyre; Calvo, Begoña
2010-04-01
For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.
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Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs
Directory of Open Access Journals (Sweden)
Uwe Rudolf Max Reuter
2018-04-01
Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.
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Directory of Open Access Journals (Sweden)
Raghavendra Charan P Makam
Full Text Available Direct oral anticoagulants (DOACs have emerged as promising alternatives to vitamin K antagonists (VKAs for patients with non-valvular atrial fibrillation (NVAF or venous thromboembolism (VTE. Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs.We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE.Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR 0.76, 95% Confidence Interval (CI (0.68-0.84], any stroke (0.80, 0.73-0.88, systemic embolism (0.56, 0.34-0.93, and total mortality (0.89, 0.84-0.95. Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB. Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03, recurrent DVT (0.83, 0.66-1.05, recurrent non-fatal PE (0.97, 0.75-1.25, and total mortality (0.94, 0.79-1.12. Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB.Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.
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DEFF Research Database (Denmark)
Regnier, Stephane A; Larsen, Michael; Bezlyak, Vladimir
2015-01-01
OBJECTIVE: To compare the efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion (BRVO). DESIGN: Randomised controlled trials (RCTs) evaluating the efficacy and safety of approved treatments for macular oedema secondary to BRVO were identified from...... an updated systematic review. SETTING: A Bayesian network meta-analysis of RCTs of treatments for macular oedema secondary to BRVO. INTERVENTIONS: Ranibizumab 0.5 mg pro re nata, aflibercept 2 mg monthly (2q4), dexamethasone 0.7 mg implant, laser photocoagulation, ranibizumab+laser, or sham intervention...... pressure (IOP)/ocular hypertension (OH). RESULTS: 8 RCTs were identified for inclusion with 1743 adult patients. The probability of being the most efficacious treatment at month 6 or 12 based on letters gained was 54% for ranibizumab monotherapy, 30% for aflibercept, 16% for ranibizumab plus laser...
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Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M.
2011-01-01
Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. Objective:
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International Nuclear Information System (INIS)
1983-04-01
The Safety Evaluation Report for the application filed by General Electric Company for the Final Design Approval for the General Electric Standard Safety Analysis Report (GESSAR II FSAR) has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report summarizes the results of the staff's safety review of the GESSAR II BWR/6 Nuclear Island Design. Subject to favorable resolution of items discussed in the Safety Evaluation Report, the staff concludes that the facilities referencing GESSAR II, subject to approval of the balance-of-plant design, can conform with the provisions of the Act and the regulations of the Nuclear Regulatory Commission
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International Nuclear Information System (INIS)
Petti, D.A.; Haire, J.C.
1993-12-01
The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project
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44 CFR 78.10 - Project grant approval process.
2010-10-01
..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...
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2010-08-12
...] Baseline Safety and Health Practices; Office of Management and Budget's (OMB) Approval of Information... health practices of private sector establishments in agriculture (with 10 or more workers) and non... monitor and more effectively implement practices to mitigate workplace hazards, thereby reducing the...
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USAR managing and updating process
International Nuclear Information System (INIS)
Prah, M.; Spiler, J.
1996-01-01
In this paper basis and background of the FSAR (Final Safety Analysis Report) document and its conversion process to the USAR (Updated Safety Analysis Report) document are described. In addition, there are internal and external reviews as approval process presented. The following is included in our new approach to manage USAR changes: initiating the USAR change, technical reviewing, preparing a safety evaluation, KSC (Krsko Safety Committee) and KOC (Krsko Operating Committee) review, ESD Director approval, and the Regulatory Body review or approval. The intensive technological modification activities started in the year 1992 when the NEK Engineering Services Division was established. These activities are one of the most important reason for a very intensive USAR items change. The other reason for its conversation to an electronic format is a possibility for easier and faster searching, updating and changing process and introducing a new systematic USAR managing approach as mentioned above. (author)
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K Basins Spent Nuclear Fuel (SNF) Project Safety Analysis Report for Packaging (SARP) approval plan
International Nuclear Information System (INIS)
1995-01-01
This document delineates the plan for preparation, review, and approval of the K Basins Spent Nuclear Fuel (SNF) Packaging Design Criteria (PDC) document and the on-site Safety Analysis Report for Packaging (SARP). The packaging addressed in these documents is used to transport SNF in a Multi- canister Overpack (MCO) configuration
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Sampers, I.; Toyofuku, H.; Luning, P.A.; Uyttendaele, M.; Jacxsens, L.
2012-01-01
This study aimed to gain an insight in the performance of Hazard Analysis and Critical Control Points (HACCP)-based food safety management systems (FSMS) implemented in Japanese milk processing plants. Since 1995, Japan has a comprehensive approval system for food manufacturing establishments by
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IAEA Issues Report on Mission to Review Japan's Nuclear Power Plant Safety Assessment Process
International Nuclear Information System (INIS)
2012-01-01
Full text: A team of international nuclear safety experts has delivered its report on a mission it conducted from 21-31 January 2012 to review Japan's process for assessing nuclear safety at the nation's nuclear power plants. International Atomic Energy Agency (IAEA) officials delivered the IAEA Mission Report to Japanese officials yesterday and made it publicly available today. Following the 11 March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station, Japan's Nuclear and Industrial Safety Agency (NISA) announced the development of a revised safety assessment process for the nation's nuclear power reactors. At the request of the Government of Japan, the IAEA organized a team of five IAEA and three international nuclear safety experts and visited Japan to review NISA's approach to the Comprehensive Assessments for the Safety of Existing Power Reactor Facilities and how NISA examines the results submitted by nuclear operators. A Preliminary Summary Report was issued on 31 January. 'The mission report provides additional information regarding the team's recommendations and overall finding that NISA's instructions to power plants and its review process for the Comprehensive Safety Assessments are generally consistent with IAEA Safety Standards', said team leader James Lyons, Director of the IAEA's Nuclear Installation Safety Division. National safety assessments and their peer review by the IAEA are a key component of the IAEA Action Plan on Nuclear Safety, which was approved by the Agency's Member States following last year's nuclear accident at Fukushima Daiichi Nuclear Power Station. The IAEA safety review mission held meetings in Tokyo with officials from NISA, the Japanese Nuclear Energy Safety Organization (JNES), and the Kansai Electric Power Company (KEPCO), and the team visited the Ohi Nuclear Power Station to see an example of how Japan's Comprehensive Safety Assessment is being implemented by nuclear operators. In its report delivered today
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Existing and future international standards for the safety of radioactive waste disposal
International Nuclear Information System (INIS)
Linsley, G.
1999-01-01
In this paper the essential features of the current international safety standards are summarised and the issues being raised for inclusion in future standards are discussed. The safety standards of the IAEA are used as the basis for the review and discussion. The IAEA has established a process for establishing international standards of safety for radioactive waste management through its Radioactive Waste Safety Standards (RADWASS) programme. The RADWASS documents are approved by a comprehensive process involving regulatory and other experts from all concerned IAEA Member States. A system of committees for approving the IAEAs safety standards has been established. For radioactive waste safety the committee for review and approval is the Waste Safety Standards Advisory Committee (WASSAC). In 1995 the IAEA published 'The Principles of Radioactive Waste Management' as the top level document in the RADWASS programme. The report sets out the basis principles which most experts believe are fundamental to the safe management of radioactive wastes
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International Nuclear Information System (INIS)
MORENO, M.R.
2004-01-01
DOE set clear expectations on a cost-effective approach for achieving compliance with the Nuclear Safety Management requirements (20 CFR 830, Nuclear Safety Rule), which ensured long-term benefit to Hanford, via issuance of a nuclear safety strategy in February 2003. To facilitate implementation of these expectations, tools were developed to streamline and standardize safety analysis and safety document development with the goal of a shorter and more predictable DOE approval cycle. A Hanford Safety Analysis and Risk Assessment Handbook (SARAH) was approved to standardize methodologies for development of safety analyses. A Microsoft Excel spreadsheet (RADIDOSE) was approved for the evaluation of radiological consequences for accident scenarios often postulated at Hanford. Standard safety management program chapters were approved for use as a means of compliance with the programmatic chapters of DOE-STD-3009, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports''. An in-process review was developed between DOE and the Contractor to facilitate DOE approval and provide early course correction. The new Documented Safety Analysis (DSA) developed to address the operations of four facilities within the Solid Waste Operations Complex (SWOC) necessitated development of an Implementation Validation Review (IVR) process. The IVR process encompasses the following objectives: safety basis controls and requirements are adequately incorporated into appropriate facility documents and work instructions, facility personnel are knowledgeable of controls and requirements, and the DSA/TSR controls have been implemented. Based on DOE direction and safety analysis tools, four waste management nuclear facilities were integrated into one safety basis document. With successful completion of implementation of this safety document, lessons-learned from the in-process review, safety analysis tools and IVR process were documented for future action
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Auditing the process of ethics approval for Master's degrees at a ...
African Journals Online (AJOL)
Objective. This study audited the process of ethics approval for Master's research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa. Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.
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HSE statement on the approval of dosimetry services
International Nuclear Information System (INIS)
1992-09-01
This statement is intended to assist dosimetry services who may wish to be approved by the U.K. Health and Safety Executive under Regulation 15 of the Ionising Radiations Regulations 1985. It also serves to inform approved dosimetry services of changes in the arrangements which HSE makes for approval and reassessment of dosimetry services. A general description of the administrative arrangements for making application is given and the subsequent processing of such applications by the HSE is outlined. Background notes on the requirements of the Regulations are given in Appendix I. The fees which are chargeable from 20/8/92 are given in Appendix II. (Author)
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Setting up a randomized clinical trial in the UK: approvals and process.
Greene, Louise Eleanor; Bearn, David R
2013-06-01
Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.
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Directory of Open Access Journals (Sweden)
Staletović Novica M.
2015-01-01
Full Text Available This paper presents a model of risk assessment in terms of safety and health at work in the process of geological work/ drilling. Optimization model estimates OH & S risk for work place qualified driller, is in line with the provisions of the Mining and Geological exploration, the Law on Safety and Health at Work, the application of the requirements of ISO 31000 and criteria Kinny methods. Model estimates OH & S risks is the basis for the development and implementation of the management system of protection of health and safety at work according to BS OHSAS 18001: 2008 model is applied, checked and verified the approved exploration areas during execution and supervision applied geological exploration (of metals on the territory of the Republic of Serbia.
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Radiation processing of food to ensure food safety and security
International Nuclear Information System (INIS)
Gautam, Satyendra
2016-01-01
Radiation processing of food utilizes the controlled application of energy from ionizing radiations such as γ-rays , electrons and X-rays on food. Gamma-rays and X-rays are short wavelength radiations of the electromagnetic spectrum. The approved sources of gamma radiation for food processing are radioisotopes (Cobalt-60 and Caesium-137), electron beam (up to 10 MeV) and X-rays (up to 5 MeV) wherein the latter two are generated by machines using electricity. γ-radiation can penetrate deep into the food materials causing the desired effects. Irradiation works by disrupting the biological processes that lead to decay. While interacting with water and other biomolecules that constitute the food and living organisms, radiation energy is absorbed by these molecules. The interactions of radiation and radiolytic products of water with DNA impair the reproduction of microorganism and insects, and thus help in achieving the desired objectives pertaining to food safety and security
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Process safety improvement-Quality and target zero
Energy Technology Data Exchange (ETDEWEB)
Van Scyoc, Karl [Det Norske Veritas (U.S.A.) Inc., DNV Energy Solutions, 16340 Park Ten Place, Suite 100, Houston, TX 77084 (United States)], E-mail: karl.van.scyoc@dnv.com
2008-11-15
Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The 'plan, do, check, act' improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.
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Process safety improvement-Quality and target zero
International Nuclear Information System (INIS)
Van Scyoc, Karl
2008-01-01
Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The 'plan, do, check, act' improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given
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Process safety improvement--quality and target zero.
Van Scyoc, Karl
2008-11-15
Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.
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Process hazards analysis (PrHA) program, bridging accident analyses and operational safety
International Nuclear Information System (INIS)
Richardson, J.A.; McKernan, S.A.; Vigil, M.J.
2003-01-01
Recently the Final Safety Analysis Report (FSAR) for the Plutonium Facility at Los Alamos National Laboratory, Technical Area 55 (TA-55) was revised and submitted to the US. Department of Energy (DOE). As a part of this effort, over seventy Process Hazards Analyses (PrHAs) were written and/or revised over the six years prior to the FSAR revision. TA-55 is a research, development, and production nuclear facility that primarily supports US. defense and space programs. Nuclear fuels and material research; material recovery, refining and analyses; and the casting, machining and fabrication of plutonium components are some of the activities conducted at TA-35. These operations involve a wide variety of industrial, chemical and nuclear hazards. Operational personnel along with safety analysts work as a team to prepare the PrHA. PrHAs describe the process; identi fy the hazards; and analyze hazards including determining hazard scenarios, their likelihood, and consequences. In addition, the interaction of the process to facility systems, structures and operational specific protective features are part of the PrHA. This information is rolled-up to determine bounding accidents and mitigating systems and structures. Further detailed accident analysis is performed for the bounding accidents and included in the FSAR. The FSAR is part of the Documented Safety Analysis (DSA) that defines the safety envelope for all facility operations in order to protect the worker, the public, and the environment. The DSA is in compliance with the US. Code of Federal Regulations, 10 CFR 830, Nuclear Safety Management and is approved by DOE. The DSA sets forth the bounding conditions necessary for the safe operation for the facility and is essentially a 'license to operate.' Safely of day-to-day operations is based on Hazard Control Plans (HCPs). Hazards are initially identified in the PrI-IA for the specific operation and act as input to the HCP. Specific protective features important to worker
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International Nuclear Information System (INIS)
Brisbin, S.A.
1996-01-01
This document delineates the plan for preparation, review, and approval of the Packaging Design Crieteria for the K Basin Sludge Transportation System and the Associated on-site Safety Analysis Report for Packaging. The transportation system addressed in the subject documents will be used to transport sludge from the K Basins using bulk packaging
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International Nuclear Information System (INIS)
Gordon, C.W.; Bartels, H.-W.; Honda, T.; Raeder, J.; Topilski, L.; Iseli, M.; Moshonas, K.; Taylor, N.; Gulden, W.; Kolbasov, B.; Inabe, T.; Tada, E.
2001-01-01
Safety has been an integral part of the design process for ITER since the Conceptual Design Activities of the project. The safety approach adopted in the ITER-FEAT design and the complementary assessments underway, to be documented in the Generic Site Safety Report (GSSR), are expected to help demonstrate the attractiveness of fusion and thereby set a good precedent for future fusion power reactors. The assessments address ITER's radiological hazards taking into account fusion's favourable safety characteristics. The expectation that ITER will need regulatory approval has influenced the entire safety design and assessment approach. This paper summarises the ITER-FEAT safety approach and assessments underway. (author)
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A drug's life: the pathway to drug approval.
Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A
2013-10-01
In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.
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Navigating the Process of Ethical Approval: A methodological note
Directory of Open Access Journals (Sweden)
Eileen Carey, RNID, BSc. (hons, MSc.
2010-12-01
Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.
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2013-09-05
...-01] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal... Commerce's approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal Identity... Information Processing Standards (FIPS). Homeland Security Presidential Directive (HSPD) 12, entitled ``Policy...
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Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement
Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline
2010-01-01
We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.
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40 CFR 68.65 - Process safety information.
2010-07-01
... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.65 Process safety... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Process safety information. 68.65... compilation of written process safety information before conducting any process hazard analysis required by...
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International Nuclear Information System (INIS)
Busche, D.M.
1995-09-01
During Fiscal Year 1992, the US Department of Energy, Richland Operations Office (RL) separately transmitted the following US Department of Energy (DOE) Orders to Westinghouse Hanford Company (WHC) for compliance: DOE 5480.21, ''Unreviewed Safety Questions,'' DOE 5480.22, ''Technical Safety Requirements,'' and DOE 5480.23, ''Nuclear Safety Analysis Reports.'' WHC has proceeded with its impact assessment and implementation process for the Orders. The Orders are closely-related and contain some requirements that are either identical, similar, or logically-related. Consequently, WHC has developed a strategy calling for an integrated implementation of the three Orders. The strategy is comprised of three primary objectives, namely: Obtain DOE approval of a single list of DOE-owned and WHC-managed Nuclear Facilities, Establish and/or upgrade the ''Safety Basis'' for each Nuclear Facility, and Establish a functional Unreviewed Safety Question (USQ) process to govern the management and preservation of the Safety Basis for each Nuclear Facility. WHC has developed policy-revision and facility-specific implementation plans to accomplish near-term tasks associated with the above strategic objectives. This plan, which as originally submitted in August 1993 and approved, provided an interpretation of the new DOE Nuclear Facility definition and an initial list of WHC-managed Nuclear Facilities. For each current existing Nuclear Facility, existing Safety Basis documents are identified and the plan/status is provided for the ISB. Plans for upgrading SARs and developing TSRs will be provided after issuance of the corresponding Rules
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Energy Technology Data Exchange (ETDEWEB)
Conover, David R.
2014-09-11
The purpose of this document is to identify laws, rules, model codes, codes, standards, regulations, specifications (CSR) related to safety that could apply to stationary energy storage systems (ESS) and experiences to date securing approval of ESS in relation to CSR. This information is intended to assist in securing approval of ESS under current CSR and to identification of new CRS or revisions to existing CRS and necessary supporting research and documentation that can foster the deployment of safe ESS.
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Supplement to safety analysis report. 306-W building operations safety requirement
International Nuclear Information System (INIS)
Richey, C.R.
1979-08-01
The operations safety requirements (OSRs) presented in this report define the conditions, safe boundaries, and management control needed for safely conducting operations with radioactive materials in the Pacific Northwest Laboratory (PNL) 306-W building. The safety requirements are organized in five sections. Safety limits are safety-related process variables that are observable and measurable. Limiting conditions cover: equipment and technical conditions and characteristics of the facility and operations necessary for continued safe operation. Surveillance requirements prescribe the requirements for checking systems and components that are essential to safety. Equipment design controls require that changes to process equipment and systems be independently checked and approved to assure that the changes will have no adverse effect on safety. Administrative controls describe and discuss the organization and administrative systems and procedures to be used for safe operation of the facility. Details of the implementation of the operations safety requirements are prescribed by internal PNL documents such as criticality safety specifications and radiation work procedures
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2012-03-06
...-02] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure... approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS... Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS). FIPS 180-4...
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IMPLEMENTING CHANGES TO AN APPROVED AND IN-USE DOCUMENTED SAFETY ANALYSIS
International Nuclear Information System (INIS)
KING JP
2008-01-01
The Plutonium Finishing Plant (PFP) has refined a process to ensure a comprehensive and complete DSA/TSR change implementation. Successful Nuclear Facility Safety Basis implementation is essential to avoid creating a Potential Inadequacy in Safety Analysis (PISA) situation, or implementing a facility into a non-compliance that can result in a TSR violation. Once past initial implementation, additional changes to Documented Safety Analysis (DSA) and Technical Safety Requirements (TSRs) are often needed due to needed requirement clarifications, operating experience indicating that Conditions/Required Actions/Surveillance Requirements could be improved, changes in facility conditions, or changes in facility mission etc. An effective change implementation process is essential to ensuring compliance with 10 CFR 830.202(a), 'The contractor responsible for a hazard category 1,2, or 3 DOE nuclear facility must establish and maintain the safety basis for the facility'
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2000-04-18
This document amends OSHA's regulations to reflect the Assistant Secretary's decision granting final approval to the Nevada State plan. As a result of this affirmative determination under section 18(e) of the Occupational Safety and Health Act of 1970, Federal OSHA's standards and enforcement authority no longer apply to occupational safety and health issues covered by the Nevada plan, and authority for Federal concurrent jurisdiction is relinquished. Federal enforcement jurisdiction is retained over any private sector maritime employment, private sector employers on Indian land, and any contractors or subcontractors on any Federal establishment where the land is exclusive Federal jurisdiction. Federal jurisdiction remains in effect with respect to Federal government employers and employees. Federal OSHA will also retain authority for coverage of the United States Postal Service (USPS), including USPS employees, contract employees, and contractor-operated facilities engaged in USPS mail operations.
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15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.
2010-01-01
... approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations... REGULATIONS OF THE FOREIGN-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.32 Procedure for review of request for approval of manufacturing or processing. (a) Request as part of application...
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Proposed Changes to EPA's Transuranic Waste Characterization Approval Process
International Nuclear Information System (INIS)
Joglekar, R.D.; Feltcorn, E.M.; Ortiz, A.M.
2003-01-01
This paper describes the changes to the waste characterization (WC) approval process proposed in August 2002 by the U.S. Environmental Protection Agency (EPA or the Agency or we). EPA regulates the disposal of transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) repository in Carlsbad, New Mexico. EPA regulations require that waste generator/storage sites seek EPA approval of WC processes used to characterize TRU waste destined for disposal at WIPP. The regulations also require that EPA verify, through site inspections, characterization of each waste stream or group of waste streams proposed for disposal at the WIPP. As part of verification, the Agency inspects equipment, procedures, and interviews personnel to determine if the processes used by a site can adequately characterize the waste in order to meet the waste acceptance criteria for WIPP. The paper discusses EPA's mandate, current regulations, inspection experience, and proposed changes. We expect that th e proposed changes will provide equivalent or improved oversight. Also, they would give EPA greater flexibility in scheduling and conducting inspections, and should clarify the regulatory process of inspections for both Department of Energy (DOE) and the public
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Safety guides development process in Spain
International Nuclear Information System (INIS)
Butragueno, J.L.; Perello, M.
1979-01-01
Safety guides have become a major factor in the licensing process of nuclear power plants and related nuclear facilities of the fuel cycle. As far as the experience corroborates better and better engineering methodologies and procedures, the results of these are settled down in form of standards, guides, and similar issues. This paper presents the actual Spanish experience in nuclear standards and safety guides development. The process to develop a standard or safety guide is shown. Up to date list of issued and on development nuclear safety guides is included and comments on the future role of nuclear standards in the licensing process are made. (author)
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Setting clear expectations for safety basis development
International Nuclear Information System (INIS)
MORENO, M.R.
2003-01-01
DOE-RL has set clear expectations for a cost-effective approach for achieving compliance with the Nuclear Safety Management requirements (10 CFR 830, Nuclear Safety Rule) which will ensure long-term benefit to Hanford. To facilitate implementation of these expectations, tools were developed to streamline and standardize safety analysis and safety document development resulting in a shorter and more predictable DOE approval cycle. A Hanford Safety Analysis and Risk Assessment Handbook (SARAH) was issued to standardized methodologies for development of safety analyses. A Microsoft Excel spreadsheet (RADIDOSE) was issued for the evaluation of radiological consequences for accident scenarios often postulated for Hanford. A standard Site Documented Safety Analysis (DSA) detailing the safety management programs was issued for use as a means of compliance with a majority of 3009 Standard chapters. An in-process review was developed between DOE and the Contractor to facilitate DOE approval and provide early course correction. As a result of setting expectations and providing safety analysis tools, the four Hanford Site waste management nuclear facilities were able to integrate into one Master Waste Management Documented Safety Analysis (WM-DSA)
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Overview of the U. S. flight safety process for space nuclear power
International Nuclear Information System (INIS)
Bennett, G.L.
1981-01-01
The two current types of nuclear power sources used in U. S. spacecraft are described along with the flight safety philosophies governing their use. In the case of radioisotope thermoelectric generators, the design philosophy consists of containment, immobilization, and recovery of the nuclear materials. For reactors, the emphasis is on maintaining a subcritical configuration in all credible accident environments. To document the safety activities, a safety analysis report is prepared for each mission. These reports, which are based on the probabilistic risk assessment methodology pioneered by the space nuclear safety community, are subjected to an interagency safety review before a recommendation is made to approve the launch of a nuclear-powered spacecraft
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Seeking ethical approval for an international study in primary care patient safety
Dovey, S.; Hall, K.; Makeham, M.; Rosser, W.; Kuzel, A.; Weel, C. van; Esmail, A.; Phillips, R.
2011-01-01
Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a
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REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS
International Nuclear Information System (INIS)
Markman, D.W.
1999-01-01
Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control
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2013-07-19
...-01] Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard.... SUMMARY: This notice announces the Secretary of Commerce's approval of Federal Information Processing... changes are effective on July 19, 2013. FOR FURTHER INFORMATION CONTACT: Elaine Barker (301) 975-2911...
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International Nuclear Information System (INIS)
1983-12-01
This report presents the results of a survey and evaluation of existing federal, state and local regulatory considerations affecting siting approval of power plants in the United States. Those factors that may impede early site approval of nuclear power plants are identified, and findings related to the removal of these impediments and the general improvement of the approval process are presented. A brief evaluation of standardization of nuclear plant design is also presented
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44 CFR 78.6 - Flood Mitigation Plan approval process.
2010-10-01
... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...
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Chemical process safety at fuel cycle facilities
International Nuclear Information System (INIS)
Ayres, D.A.
1997-08-01
This NUREG provides broad guidance on chemical safety issues relevant to fuel cycle facilities. It describes an approach acceptable to the NRC staff, with examples that are not exhaustive, for addressing chemical process safety in the safe storage, handling, and processing of licensed nuclear material. It expounds to license holders and applicants a general philosophy of the role of chemical process safety with respect to NRC-licensed materials; sets forth the basic information needed to properly evaluate chemical process safety; and describes plausible methods of identifying and evaluating chemical hazards and assessing the adequacy of the chemical safety of the proposed equipment and facilities. Examples of equipment and methods commonly used to prevent and/or mitigate the consequences of chemical incidents are discussed in this document
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International Nuclear Information System (INIS)
1997-01-01
The document presents the status as of 17 March 1997 of signature, ratification, acceptance, approval or accession by Member States of the Convention on Nuclear Safety adopted on 17 June 1994 by the Diplomatic Conference convened by the IAEA at its Headquarters between 14-17 June 1994. The Convention entered into force on 24 October 1996. There are 65 signatories and 35 parties. Reservations/declarations deposited upon signature are also included
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18 CFR 1304.4 - Application review and approval process.
2010-04-01
... hearing is requested by the USACE pursuant to the TVA/Corps joint processing Memorandum of Understanding... the application as appropriate. (b) If a hearing is held for any of the reasons described in paragraph... contained in the hearing notice. (c) Hearings concerning approval of applications are conducted (in...
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International Nuclear Information System (INIS)
1997-02-01
DOE 5480.23, Nuclear Safety Analysis Reports, requires that the US Department of Energy conduct an independent, defensible, review in order to approve a Safety Analysis Report (SAR). That review and the SAR approval basis is documented in this formal Safety Evaluation Report (SER). This SER documents the DOE's review of the Waste Isolation Pilot Plant SAR and provides the Carlsbad Area Office Manager, the WIPP SAR approval authority, with the basis for approving the safety document. It concludes that the safety basis documented in the WIPP SAR is comprehensive, correct, and commensurate with hazards associated with planned waste disposal operations
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Implementing process safety management in gas processing operations
International Nuclear Information System (INIS)
Rodman, D.L.
1992-01-01
The Occupational Safety and Health Administration (OSHA) standard entitled Process Safety Management of Highly Hazardous Chemicals; Explosives and Blasting Agents was finalized February 24, 1992. The purpose of the standard is to prevent or minimize consequences of catastrophic releases of toxic, flammable, or explosive chemicals. OSHA believes that its rule will accomplish this goal by requiring a comprehensive management program that integrates technologies, procedures, and management practices. Gas Processors Association (GPA) member companies are significantly impacted by this major standard, the requirements of which are extensive and complex. The purpose of this paper is to review the requirements of the standard and to discuss the elements to consider in developing and implementing a viable long term Process Safety Management Program
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47 CFR 69.119 - Basic service element expedited approval process.
2010-10-01
... 47 Telecommunication 3 2010-10-01 2010-10-01 false Basic service element expedited approval process. 69.119 Section 69.119 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element...
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Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide
Energy Technology Data Exchange (ETDEWEB)
NONE
2012-07-15
This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.
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Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide
International Nuclear Information System (INIS)
2012-01-01
This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.
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... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...
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DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY
International Nuclear Information System (INIS)
MC CLURE, D. A.; NELSON, C. A.; BOUDRIE, R. L.
2001-01-01
This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamos National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety
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Safety analyses for reprocessing and waste processing
International Nuclear Information System (INIS)
1983-03-01
Presentation of an incident analysis of process steps of the RP, simplified considerations concerning safety, and safety analyses of the storage and solidification facilities of the RP. A release tree method is developed and tested. An incident analysis of process steps, the evaluation of the SRL-study and safety analyses of the storage and solidification facilities of the RP are performed in particular. (DG) [de
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U.S. Nuclear Regulatory Commission Safety Culture Oversight
International Nuclear Information System (INIS)
Sieracki, D. J.
2016-01-01
The NRC recognises that it is important for all organizations performing or overseeing regulated activities to establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. The NRC’s approach to safety culture is based on the premise that licencees bear the primary responsibility for safety. The NRC provides oversight of safety culture through expectations detailed in policy statements, safety culture assessor training for NRC inspectors, the oversight process, and the Allegations and Enforcement Programs. The NRC’s Safety Culture Policy Statement (SCPS) sets forth the Commission’s expectation that individuals and organizations establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. The SCPS is not a regulation. It applies to all licencees, certificate holders, permit holders, authorisation holders, holders of quality assurance program approvals, vendors and suppliers of safety-related components, and applicants for a licence, certificate, permit, authorisation, or quality assurance program approval, subject to NRC authority.
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Wing, Deborah A; Powers, Barbara; Hickok, Durlin
2010-04-01
The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.
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Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo, Richard A
2004-01-01
Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
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9 CFR 317.4 - Labeling approval.
2010-01-01
... undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and...
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Sikweyiya, Yandisa; Jewkes, Rachel
2011-10-01
Does research on gender-based violence (GBV) pose greater than minimal risk to researchers and participants? This question needs to be understood particularly in light of hesitancy by Institutional Review Boards to approve research on GBV. The safety and risks of doing GBV studies and the implications for the ethical review process have not been a focus of much research. This qualitative study collected data through in-depth interviews with 12 experienced GBV researchers from various countries and a desk review. This paper explores researchers' interpretation of and meanings of the safety recommendations as provided in the WHO guidelines and whether there is empirical evidence on the presence of risks and safety concerns unique to GBV research. Informants raised a number of safety concerns about GBV research, yet in the interviews there were very few examples of problems having occurred, possibly because of the precautions applied. This paper argues that the notion that GBV studies carry greater than minimal risk when ethics precautions are followed is based on speculation, not evidence. It highlights the need for empirical evidence to support assertions of risk in research.
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McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R
2014-10-01
Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.
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International Nuclear Information System (INIS)
Oh, B. J.; Ahn, H. Z.; Kim, S. W.; Yoo, S. O.; Kang, S. C.; Yang, S. H.; Han, S. J.; Kim, H. S.; Kim, H. J.
2002-01-01
In accordance with 2001 amendment of the Atomic Energy Act(AEA), KINS also amended its internal 'Regulation on Implementation of Entrusted AEA-related Work'. Up to now the nuclear safety-specialized institute has used its internally developed guidelines in the safety regulation. From now on, however, the institute will enhance the objectivity and transparency by having the instruments approved by the Ministry of Science ad Technology. In this paper, we introduced the major points and directions to be considered to the development of the safety regulatory guides on Inspection for the quality assurance of the nuclear reactor facilities and the use of radioisotopes, and review and inspection for dosimeter reading
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Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J
2017-08-01
We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.
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47 CFR 400.5 - Approval and award.
2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false Approval and award. 400.5 Section 400.5 Telecommunication NATIONAL TELECOMMUNICATIONS AND INFORMATION ADMINISTRATION, DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E-911 GRANT PROGRAM § 400.5 Approval...
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Report of the Design Approval and the Safety Issues of the Ion Accelerator for Manufacturing
Energy Technology Data Exchange (ETDEWEB)
Min, Yi Sub; Lee, Chan Young [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)
2013-05-15
The application of ion implantation technology has been extended to the field of semiconductor, as well as of metals, ceramics and polymers. A change in the characteristics of the surface that is required in industries is various. To manufacture these devices which are by requirements of industrial, anyone must be licensed by nuclear law; producing permit. And that device must be certified to safety through the design approval. For the first time in domestic, Korea Multipurpose Accelerator Complex (KOMAC) has finished the producing facility inspection as well as the producing permit in August 2012 that can produce four types of radiation generator(RG)
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Interface management: Effective communication to improve process safety
International Nuclear Information System (INIS)
Kelly, Brian; Berger, Scott
2006-01-01
Failure to successfully communicate maintenance activities, abnormal conditions, emergency response procedures, process hazards, and hundreds of other items of critical information can lead to disaster, regardless of the thoroughness of the process safety management system. Therefore, a well-functioning process safety program depends on maintaining successful communication interfaces between each involved employee or stakeholder and the many other employees or stakeholders that person must interact with. The authors discuss a process to identify the critical 'Interfaces' between the many participants in a process safety management system, and then to establish a protocol for each critical interface
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Safety assessment of genetically modified foods
Kleter, G.A.; Noordam, M.Y.
2016-01-01
The cultivation of genetically modified (GM) crops has steadily increased since their introduction to the market in the mid-1990s. Before these crops can be grown and sold they have to obtain regulatory approval in many countries, the process of which includes a pre-market safety assessment. The
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Safety monitoring in process and control
International Nuclear Information System (INIS)
Esparza, V. Jr.; Sebo, D.E.
1984-01-01
Safety Functions provide a method of ensuring the safe operation of any large-scale processing plant. Successful implementation of safety functions requires continuous monitoring of safety function values and trends. Because the volume of information handled by a plant operator occassionally can become overwhelming, attention may be diverted from the primary concern of maintaining plant safety. With this in mind EG and G, Idaho developed various methods and techniques for use in a computerized Safety Function Monitoring System and tested the application of these techniques using a simulated nuclear power plant, the Loss-of-Fluid Test Facility (LOFT) at the Idaho National Engineering Laboratory (INEL). This paper presents the methods used in the development of a Safety Function Monitoring System
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Safety assessment of the liquid-fed ceramic melter process
International Nuclear Information System (INIS)
Buelt, J.L.; Partain, W.L.
1980-08-01
As part of its development program for the solidification of high-level nuclear waste, Pacific Northwest Laboratory assessed the safety issues for a complete liquid-fed ceramic melter (LFCM) process. The LFCM process, an adaption of commercial glass-making technology, is being developed to convert high-level liquid waste from the nuclear fuel cycle into glass. This safety assessment uncovered no unresolved or significant safety problems with the LFCM process. Although in this assessment the LFCM process was not directly compared with other solidification processes, the safety hazards of the LFCM process are comparable to those of other processes. The high processing temperatures of the glass in the LFCM pose no additional significant safety concerns, and the dispersible inventory of dried waste (calcine) is small. This safety assessment was based on the nuclear power waste flowsheet, since power waste is more radioactive than defense waste at the time of solidification, and all accident conditions for the power waste would have greater radiological consequences than those for defense waste. An exhaustive list of possible off-standard conditions and equipment failures was compiled. These accidents were then classified according to severity of consequence and type of accident. Radionuclide releases to the stack were calculated for each group of accidents using conservative assumptions regarding the retention and decontamination features of the process and facility. Two recommendations that should be considered by process designers are given in the safety assessment
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Are classical process safety concepts relevant to nanotechnology applications?
International Nuclear Information System (INIS)
Amyotte, Paul R
2011-01-01
The answer to the question posed by the title of this paper is yes - with adaptation to the specific hazards and challenges found in the field of nanotechnology. The validity of this affirmative response is demonstrated by relating key process safety concepts to various aspects of the nanotechnology industry in which these concepts are either already practised or could be further applied. This is accomplished by drawing on the current author's experience in process safety practice and education as well as a review of the relevant literature on the safety of nanomaterials and their production. The process safety concepts selected for analysis include: (i) risk management, (ii) inherently safer design, (iii) human error and human factors, (iv) safety management systems, and (v) safety culture.
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Hauptmanns, Ulrich
2015-01-01
Accidents in technical installations are random events. Hence they cannot be totally avoided. Only the probability of their occurrence may be reduced and their consequences be mitigated. The book proceeds from hazards caused by materials and process conditions to indicating technical and organizational measures for achieving the objectives of reduction and mitigation. Qualitative methods for identifying weaknesses of design and increasing safety as well as models for assessing accident consequences are presented. The quantitative assessment of the effectiveness of safety measures is explained. The treatment of uncertainties plays a role there. They stem from the random character of the accident and from lacks of knowledge on some of the phenomena to be addressed. The reader is acquainted with the simulation of accidents, safety and risk analyses and learns how to judge the potential and limitations of mathematical modelling. Risk analysis is applied amongst others to “functional safety” and the determinat...
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Research ethics board approval for an international thromboprophylaxis trial.
Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah
2012-06-01
Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.
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Trial endpoints for drug approval in oncology: Chemoprevention.
Beitz, J
2001-04-01
As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.
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Food and Drug Administration Drug Approval Process: A History and Overview.
Williams, Christopher Ty
2016-03-01
In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.
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17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.
2010-04-01
... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...
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30 CFR 90.206 - Approved sampling devices; equivalent concentrations.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...
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International Nuclear Information System (INIS)
1971-01-01
This Order approves the General Regulations for Health and Safety at Work in Industrial Establishments. Section V which concerns ionizing radiations lays down that radiation protection measures currently in force must be observed in all premises where radioactive substances are stored, handled or used and where devices producing ionizing radiations are operated. (NEA) [fr
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Regulations for the safe transport of radioactive material, 2005 edition. Safety requirements
International Nuclear Information System (INIS)
2005-01-01
This publication includes amendments to the 1996 Edition (As Amended 2003) arising from the second cycle of the biennial review and revision process, as agreed by the Transport Safety Standards Committee (TRANSSC) at its ninth meeting in March 2004, as endorsed by the Commission on Safety Standards at its meeting in June 2004 and as approved by the IAEA Board of Governors in November 2004. Although this publication is identified as a new edition, there are no changes that affect the administrative and approval requirements in Section VIII. The fields covered are General Provisions (radiation protection; emergency response; quality assurance; compliance assurance; non-compliance; special arrangement and training); Activity Limits and Materials Restrictions, Requirement and Controls for Transport , Requirements for Radioactive Materials and for Packagings and Packages, Test Procedures, Approval and Administrative Requirements
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Safety Considerations in the Chemical Process Industries
Englund, Stanley M.
There is an increased emphasis on chemical process safety as a result of highly publicized accidents. Public awareness of these accidents has provided a driving force for industry to improve its safety record. There has been an increasing amount of government regulation.
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Behavior based safety process - a pragmatic approach
International Nuclear Information System (INIS)
Sharma, R.K.; Malaikar, N.L.; Belokar, S.G.; Arora, Yashpal
2009-01-01
Materials handling, processing and storage of hazardous chemicals has grown exponentially. The chemical industries has reacted to the situation by introducing numerous safety systems such as IS18001, 'HAZOP', safety audits, risk assessment, training etc, which has reduced hazards and improved safety performance, but has not totally eliminated exposure to the hazards. These safety systems aim to bring change in attitude of the persons which is difficult to change or control. However, behaviour of plant personnel can be controlled or improved upon, which should be our aim. (author)
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Recent advances in radiation processing of food
International Nuclear Information System (INIS)
Sharma, Arun
2013-01-01
Commercial application of radiation technology for food processing started in the nineties after it was approved by FAO/IAEA/WHO and Codex Alimentarius Commission in the eighties. Sanitary applications were initially explored commercially with microbial decontamination of spices and dry ingredients as the primary commodities to be processed on a large scale. Subsequently, with the emergence of E.coli O157:H7 as the potential food poisoning risk in ground beef, irradiation of meat was initiated in the late nineties in the USA. Since then irradiation, has become a very useful food safety tool and the technology has been approved for addressing food safety risks in moluscan shellfish and vegetables like lettuce, spinach, and more recently for raw uncooked meat by USFDA. Phytosanitary applications assumed importance after USFDA approved irradiation as a method of phytosanitary treatment and subsequent endorsement of the process by International Plant Protection Convention (IPPC) in 2003. These approvals were responsible for development of international trade in agricultural commodities. The first to demonstrate the feasibility of the process were India and Australia, the countries that exported mangoes to New Zealand and USA, respectively. As far as the source of radiation is concerned, the world is slowly moving towards deployment of machine sources, thereby reducing its dependence on radioisotopes for commercial irradiation. (author)
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Processes on Uncontrolled Aerodromes and Safety Indicators - Part II
Directory of Open Access Journals (Sweden)
Vladimír Plos
2014-01-01
Full Text Available This article follows on the Part I, where the basic processes on uncontrolled aerodromes were introduced. The uncontrolled aerodromes face with the growing traffic and from that result the higher workload on AFIS officer. This means a higher potential for dangerous situations.The article describes some models of sub-processes and creates several safety indicators related to the operation at uncontrolled aerodromes. Thanks to monitoring and evaluation of safety indicators can be adopted targeted safety measures and thus increase safety on small uncontrolled aerodromes.
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The Evolution of Process Safety: Current Status and Future Direction.
Mannan, M Sam; Reyes-Valdes, Olga; Jain, Prerna; Tamim, Nafiz; Ahammad, Monir
2016-06-07
The advent of the industrial revolution in the nineteenth century increased the volume and variety of manufactured goods and enriched the quality of life for society as a whole. However, industrialization was also accompanied by new manufacturing and complex processes that brought about the use of hazardous chemicals and difficult-to-control operating conditions. Moreover, human-process-equipment interaction plus on-the-job learning resulted in further undesirable outcomes and associated consequences. These problems gave rise to many catastrophic process safety incidents that resulted in thousands of fatalities and injuries, losses of property, and environmental damages. These events led eventually to the necessity for a gradual development of a new multidisciplinary field, referred to as process safety. From its inception in the early 1970s to the current state of the art, process safety has come to represent a wide array of issues, including safety culture, process safety management systems, process safety engineering, loss prevention, risk assessment, risk management, and inherently safer technology. Governments and academic/research organizations have kept pace with regulatory programs and research initiatives, respectively. Understanding how major incidents impact regulations and contribute to industrial and academic technology development provides a firm foundation to address new challenges, and to continue applying science and engineering to develop and implement programs to keep hazardous materials within containment. Here the most significant incidents in terms of their impact on regulations and the overall development of the field of process safety are described.
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The practice of safety culture construction in radiation processing enterprise
International Nuclear Information System (INIS)
Kong Xiangshan; Zhang Yue; Yang Bin; Xu Tao; Liu Wei; Hao Jiangang
2014-01-01
Security is an integral part of the process of business operations. The radiation processing enterprises due to their own particularity, more need to focus on the operation of the safety factors, the construction of corporate safety culture is of great significance in guiding carry out the work of the Radiation Protection. Radiation processing enterprises should proceed from their own characteristics, the common attitude of security systems and security construction, and constantly improved to ensure the personal safety of radiation workers in the area of safety performance. (authors)
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77 FR 11677 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations
2012-02-27
... for Medicare & Medicaid Services 42 CFR Part 431 Department of the Treasury 31 CFR Part 33 Department of Health and Human Services 45 CFR Part 155 Medicaid Program; Review and Approval Process for... Regulations#0;#0; [[Page 11678
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Interim process report for the safety assessment SR-Can
International Nuclear Information System (INIS)
Sellin, Patrick
2004-08-01
This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses
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Interim process report for the safety assessment SR-Can
Energy Technology Data Exchange (ETDEWEB)
Sellin, Patrick (ed.)
2004-08-01
This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses.
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Integrating system safety into the basic systems engineering process
Griswold, J. W.
1971-01-01
The basic elements of a systems engineering process are given along with a detailed description of what the safety system requires from the systems engineering process. Also discussed is the safety that the system provides to other subfunctions of systems engineering.
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Test process for the safety-critical embedded software
International Nuclear Information System (INIS)
Sung, Ahyoung; Choi, Byoungju; Lee, Jangsoo
2004-01-01
Digitalization of nuclear Instrumentation and Control (I and C) system requires high reliability of not only hardware but also software. Verification and Validation (V and V) process is recommended for software reliability. But a more quantitative method is necessary such as software testing. Most of software in the nuclear I and C system is safety-critical embedded software. Safety-critical embedded software is specified, verified and developed according to V and V process. Hence two types of software testing techniques are necessary for the developed code. First, code-based software testing is required to examine the developed code. Second, after code-based software testing, software testing affected by hardware is required to reveal the interaction fault that may cause unexpected results. We call the testing of hardware's influence on software, an interaction testing. In case of safety-critical embedded software, it is also important to consider the interaction between hardware and software. Even if no faults are detected when testing either hardware or software alone, combining these components may lead to unexpected results due to the interaction. In this paper, we propose a software test process that embraces test levels, test techniques, required test tasks and documents for safety-critical embedded software. We apply the proposed test process to safety-critical embedded software as a case study, and show the effectiveness of it. (author)
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Buffer and backfill process report for the safety assessment SR-Can
Energy Technology Data Exchange (ETDEWEB)
Sellin, Patrik (comp.)
2006-09-15
This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling.
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Buffer and backfill process report for the safety assessment SR-Can
International Nuclear Information System (INIS)
Sellin, Patrik
2006-09-01
This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling
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Observations and suggestions for improved transport/packaging approvals
International Nuclear Information System (INIS)
Vaughan, C.
2004-01-01
This paper has been developed from my personal experience as Manager, Facility Licensing with Global Nuclear Fuels in Wilmington, NC over the past four years. All of my examples involve the movement of Type A, fissile material, however, the observations and recommendations clearly have universal application to the movement of other nuclear materials. The observations are global in nature embracing the US, Canada, Japan, the European Union as well others. All of these countries openly report and ascribe to the fact that they have adopted the IAEA Regulations for the Safe Transport of Radioactive Material. The materials involved typically include UF 6 , UO 2 powder, BWR fuel assemblies and process intermediates. Many of the papers here discuss the technical details of testing and the interpretation of the test results associated with the approval of transport packages. The technical details of demonstrating safety are of course very important in the overall assurance of safety. My discussion involves, for the most part, Section VIII - Approval and Administrative Requirements of TS-R-1. I have focused on this area because significant non-productive time is spent on these administrative matters and to a degree this non-productive time spent potentially detracts from meeting the objective of safe transport of nuclear materials
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Safety research activities on radioactive waste management in JNES
International Nuclear Information System (INIS)
Otsuka, Ichiro; Aoki, Hiroomi; Suko, Takeshi; Onishi, Yuko; Masuda, Yusuke; Kato, Masami
2010-01-01
Research activities in safety regulation of radioactive waste management are presented. Major activities are as follows. As for the geological disposal, major research areas are, developing 'safety indicators' to judge the adequacy of site investigation results presented by an implementer (NUMO), compiling basic requirements of safety design and safety assessment needed to make a safety review of the license application and developing an independent safety assessment methodology. In proceeding research, JNES, Japan Atomic Energy Agency (JAEA) and the National Institute of Advanced Industrial Science and Technology (AIST) signed an agreement of cooperative study on geological disposal in 2007. One of the ongoing joint studies under this agreement has been aimed at investigating regional-scale hydrogeological modeling using JAEA's Horonobe Underground Research Center. In the intermediate depth disposal, JNES conducted example analysis of reference facility and submitted the result to Nuclear Safety Commission of Japan (NSC). JNES is also listing issues to be addressed in the safety review of the license application and tries to make criteria of the review. Furthermore, JNES is developing analysis tool to evaluate long term safety of the facility and conducting an experiment to investigate long term behavior of engineered barrier system. In the near surface disposal of waste package, it must be confirmed by a regulatory inspector whether each package meets safety requirements. JNES continuously updates the confirmation methodology depending on new processing technologies. The clearance system was established in 2005. Two stages of regulatory involvement were adapted, 1) approval for measurement and judgment methods developed by the nuclear operator and 2) confirmation of measurement and judgment results based on approved methods. JNES is developing verification methodology for each stage. As for decommissioning, based on the regulatory needs and a research program
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Advancing perinatal patient safety through application of safety science principles using health IT.
Webb, Jennifer; Sorensen, Asta; Sommerness, Samantha; Lasater, Beth; Mistry, Kamila; Kahwati, Leila
2017-12-19
The use of health information technology (IT) has been shown to promote patient safety in Labor and Delivery (L&D) units. The use of health IT to apply safety science principles (e.g., standardization) to L&D unit processes may further advance perinatal safety. Semi-structured interviews were conducted with L&D units participating in the Agency for Healthcare Research and Quality's (AHRQ's) Safety Program for Perinatal Care (SPPC) to assess units' experience with program implementation. Analysis of interview transcripts was used to characterize the process and experience of using health IT for applying safety science principles to L&D unit processes. Forty-six L&D units from 10 states completed participation in SPPC program implementation; thirty-two (70%) reported the use of health IT as an enabling strategy for their local implementation. Health IT was used to improve standardization of processes, use of independent checks, and to facilitate learning from defects. L&D units standardized care processes through use of electronic health record (EHR)-based order sets and use of smart pumps and other technology to improve medication safety. Units also standardized EHR documentation, particularly related to electronic fetal monitoring (EFM) and shoulder dystocia. Cognitive aids and tools were integrated into EHR and care workflows to create independent checks such as checklists, risk assessments, and communication handoff tools. Units also used data from EHRs to monitor processes of care to learn from defects. Units experienced several challenges incorporating health IT, including obtaining organization approval, working with their busy IT departments, and retrieving standardized data from health IT systems. Use of health IT played an integral part in the planning and implementation of SPPC for participating L&D units. Use of health IT is an encouraging approach for incorporating safety science principles into care to improve perinatal safety and should be incorporated
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Safety-related control air systems - approved 1977
International Nuclear Information System (INIS)
Anon.
1978-01-01
This standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements
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30 CFR 75.600-1 - Approved cables; flame resistance.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved cables; flame resistance. 75.600-1 Section 75.600-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... cables; flame resistance. Cables shall be accepted or approved by MSHA as flame resistant. [57 FR 61223...
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2010-03-29
... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1671] Approval for Processing Authority, Foreign-Trade Zone 196, ATC Logistics & Electronics (Personal Navigation Devices), Fort Worth... & Electronics, an operator of Foreign-Trade Zone 196, has requested processing authority within FTZ 196 in Fort...
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Process management - critical safety issues with focus on risk management
International Nuclear Information System (INIS)
Sanne, Johan M.
2005-12-01
Organizational changes focused on process orientation are taking place among Swedish nuclear power plants, aiming at improving the operation. The Swedish Nuclear Power Inspectorate has identified a need for increased knowledge within the area for its regulatory activities. In order to analyze what process orientation imply for nuclear power plant safety a number of questions must be asked: 1. How is safety in nuclear power production created currently? What significance does the functional organization play? 2. How can organizational forms be analysed? What consequences does quality management have for work and for the enterprise? 3. Why should nuclear power plants be process oriented? Who are the customers and what are their customer values? Which customers are expected to contribute from process orientation? 4. What can one learn from process orientation in other safety critical systems? What is the effect on those features that currently create safety? 5. Could customer values increase for one customer without decreasing for other customers? What is the relationship between economic and safety interests from an increased process orientation? The deregulation of the electricity market have caused an interest in increased economic efficiency, which is the motivation for the interest in process orientation. among other means. It is the nuclear power plants' owners and the distributors (often the same corporations) that have the strongest interest in process orientation. If the functional organization and associated practices are decomposed, the prerequisites of the risk management regime changes, perhaps deteriorating its functionality. When nuclear power operators consider the introduction of process orientation, the Nuclear Power Inspectorate should require that 1. The operators perform a risk analysis beforehand concerning the potential consequences that process orientation might convey: the analysis should contain a model specifying how safety is currently
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International Nuclear Information System (INIS)
Sepeda, Adrian L.
2006-01-01
Learning from the experiences of others has long been recognized as a valued and relatively painless process. In the world of process safety, this learning method is an essential tool since industry has neither the time and resources nor the willingness to experience an incident before taking corrective or preventative steps. This paper examines the need for and value of process safety incident databases that collect incidents of high learning value and structure them so that needed information can be easily and quickly extracted. It also explores how they might be used to prevent incidents by increasing awareness and by being a tool for conducting PHAs and incident investigations. The paper then discusses how the CCPS PSID meets those requirements, how PSID is structured and managed, and its attributes and features
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International Nuclear Information System (INIS)
2012-01-01
Full text: A team of international nuclear safety experts today completed a review of Japan's two-stage process for assessing nuclear safety at the nation's nuclear power plants. The team began its work on 23 January and delivered a Preliminary Summary Report to Japanese officials today and plans to finish the final report by the end of February. National safety assessments and their peer review by the IAEA are a key component of the IAEA's Action Plan on Nuclear Safety, which was approved by the Agency's 152 Member States following last year's nuclear accident at Fukushima Daiichi Nuclear Power Station. At the request of the Government of Japan, the International Atomic Energy Agency (IAEA) organized a 10-person team to review the Japanese Nuclear and Industrial Safety Agency's (NISA) approach to the Comprehensive Assessments for the Safety of Existing Power Reactor Facilities and how NISA examines the results submitted by nuclear operators. The IAEA safety review mission consisted of five IAEA and three international nuclear safety experts. To help its review, the team held meetings in Tokyo with officials from NISA, the Japanese Nuclear Energy Safety (JNES) Organization, and the Kansai Electric Power Company (KEPCO), and the team visited the Ohi Nuclear Power Station to see an example of how Japan's Comprehensive Safety Assessment is being implemented by nuclear operators. 'We concluded that NISA's instructions to power plants and its review process for the Comprehensive Safety Assessments are generally consistent with IAEA Safety Standards', said team leader James Lyons, director of the IAEA's Nuclear Installation Safety Division. In its Preliminary Summary Report delivered today, the team highlighted a number of good practices and identified some improvements that would enhance the overall effectiveness of the Comprehensive Safety Assessment process. Good practices identified by the mission team include: Based on NISA instructions and commitments of the
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The transport system approval concept
International Nuclear Information System (INIS)
Pettersson, B.G.
1991-01-01
The needs for, and merits of, a new concept for the safety assessment and approval of shipments of radioactive materials is introduced and discussed. The purpose of the new concept is to enable and encourage integration of analysis and review of transport safety with similar safety analysis and review of the handling operations involving the radioactive material at the despatching and receiving ends of a shipment. Safety contributing elements or functions of the means of transport (the Transport System) can thus readily be taken into account in the assessment. The objective is to avoid constraints -experienced or potential - introduced by the package functional provisions contained in the transport regulations, whilst maintaining safety during transport, as well as during facility handling operations, at least at the level at the level currently established. (author)
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30 CFR 90.204 - Approved sampling devices; maintenance and calibration.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...
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Directory of Open Access Journals (Sweden)
Str
2015-05-01
Full Text Available Vibeke Strand,1 Louis F McIntyre,2 William R Beach,3 Larry E Miller,4,5 Jon E Block5 1Stanford University School of Medicine, Palo Alto, CA, USA; 2New York University Medical Center, White Plains, NY, USA; 3Tuckahoe Orthopaedics, Richmond, VA, USA; 4Miller Scientific Consulting, Inc., Asheville, NC, USA; 5The Jon Block Group, San Francisco, CA, USA Background: Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA. The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. Methods: We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. Results: A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193 were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001. Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001. There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: –0.2 to 1.5% for serious adverse events, 0% (95% CI: –0.4 to 0.4% for treatment-related serious adverse
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Safety cases and siting processes
International Nuclear Information System (INIS)
Metlay, Daniel; Ewing, Rodney
2014-01-01
Central to any process for building a deep-mined geologic repository for high-activity radioactive waste is the development of a safety case. To date, such cases, in various forms have been elaborated for a variety of concepts for geologic disposal, including in salt, clay, argillite, crystalline rock (granite and gneiss) and volcanic tuff formations. In addition to the technical effort required to develop a safety case, increasingly nations have come to believe that it is also critical to obtain the consent of the region or community where the facility might be located. The purpose of this paper is to explore issues associated with just one aspect of consent-based siting: How can such a process be designed so that willingness to accept a site for a repository continues to be meaningful even as new technical knowledge and insights emerge during site characterisation? In short, what is the meaning of 'informed consent' in the context of repository development? (authors)
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78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products
2013-05-21
... Approval of Mining Products AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice. SUMMARY..., and approval of mining products; it allows MSHA to collect fees up to $2,499,000 for the testing, evaluation, and approval of certain mining equipment. MSHA is continuing to collect these fees for 2013 as...
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75 FR 56946 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations
2010-09-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 431 [CMS-2325-P] RIN 0938-AQ46 Medicaid Program; Review and Approval Process for Section 1115 Demonstrations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This...
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Investigating road safety management processes in Europe.
Jähi, H. Muhlrad, N. Buttler, I. Gitelman, V. Bax, C. Dupont, E. Giustiniani, G. Machata, K. Martensen, H. Papadimitriou, E. Persia, L. Talbot, R. Vallet, G. & Yannis, G.
2012-01-01
The work package 1 of the EC FP7 project DaCoTA investigates road safety management processes in Europe. It has drafted a model to investigate the state of the art of road safety policy-making and management at the national level and to define “good practice”. The DaCoTA “good practice”
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No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.
Kelly, Jeremiah J; David, Michael
2009-01-01
Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.
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A graded approach to safety documentation at processing facilities
International Nuclear Information System (INIS)
Cowen, M.L.
1992-01-01
Westinghouse Savannah River Company (WSRC) has over 40 major Safety Analysis Reports (SARs) in preparation for non-reactor facilities. These facilities include nuclear material production facilities, waste management facilities, support laboratories and environmental remediation facilities. The SARs for these various projects encompass hazard levels from High to Low, and mission times from startup, through operation, to shutdown. All of these efforts are competing for scarce resources, and therefore some mechanism is required for balancing the documentation requirements. Three of the key variables useful for the decision making process are Depth of Safety Analysis, Urgency of Safety Analysis, and Resource Availability. This report discusses safety documentation at processing facilities
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30 CFR 90.205 - Approved sampling devices; operation; air flowrate.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...
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Safety system upgrades to a research reactor: A regulatory perspective
International Nuclear Information System (INIS)
Lamarre, G.B.; Martin, W.G.
2003-01-01
The NRU (National Research Universal) reactor, located at the Chalk River Laboratories of Atomic Energy of Canada Limited (AECL), first achieved criticality November 3, 1957. AECL continues to operate NRU for research to support safety and reliability studies for CANDU reactors and as a major supplier of medical radioisotopes. Following a detailed systematic review and assessment of NRU's design and the condition of its primary systems, AECL formally notified the Canadian Nuclear Safety Commission's (CNSC) predecessor - the Atomic Energy Control Board - in 1992 of its intention to upgrade NRU's safety systems. AECL proposed seven major upgrades to provide improvements in shutdown capability, heat removal, confinement, and reactor monitoring, particularly during and after a seismic event. From a CNSC perspective, these upgrades were necessary to meet modern safety standards. From the start of the upgrades project, the CNSC provided regulatory oversight aimed at ensuring that AECL maintained a structured approach to the upgrades. The elements of the approach include, but are not limited to, the determination of project milestones and target dates; the formalization of the design process and project quality assurance requirements; the requirements for updated documentation, including safety reports, safety notes and commissioning reports; and the approval and authorization process. This paper details, from a regulatory perspective, the structured approach used in approving the design, construction, commissioning and subsequent operation of safety system upgrades for an existing and operating research reactor, including the many challenges faced when attempting to balance the requirements of the upgrades project with AECL's need to keep NRU operating to meet its important research and production objectives. (author)
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Number of patients studied prior to approval of new medicines
DEFF Research Database (Denmark)
Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M
2013-01-01
length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo). CONCLUSIONS: For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy....... Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later...
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Licensing process for safety-critical software-based systems
Energy Technology Data Exchange (ETDEWEB)
Haapanen, P. [VTT Automation, Espoo (Finland); Korhonen, J. [VTT Electronics, Espoo (Finland); Pulkkinen, U. [VTT Automation, Espoo (Finland)
2000-12-01
System vendors nowadays propose software-based technology even for the most critical safety functions in nuclear power plants. Due to the nature of software faults and the way they cause system failures new methods are needed for the safety and reliability evaluation of these systems. In the research project 'Programmable automation systems in nuclear power plants (OHA)', financed together by the Radiation and Nuclear Safety Authority (STUK), the Ministry of Trade and Industry (KTM) and the Technical Research Centre of Finland (VTT), various safety assessment methods and tools for software based systems are developed and evaluated. As a part of the OHA-work a reference model for the licensing process for software-based safety automation systems is defined. The licensing process is defined as the set of interrelated activities whose purpose is to produce and assess evidence concerning the safety and reliability of the system/application to be licensed and to make the decision about the granting the construction and operation permissions based on this evidence. The parties of the licensing process are the authority, the licensee (the utility company), system vendors and their subcontractors and possible external independent assessors. The responsibility about the production of the evidence in first place lies at the licensee who in most cases rests heavily on the vendor expertise. The evaluation and gauging of the evidence is carried out by the authority (possibly using external experts), who also can acquire additional evidence by using their own (independent) methods and tools. Central issue in the licensing process is to combine the quality evidence about the system development process with the information acquired through tests, analyses and operational experience. The purpose of the licensing process described in this report is to act as a reference model both for the authority and the licensee when planning the licensing of individual applications
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Licensing process for safety-critical software-based systems
International Nuclear Information System (INIS)
Haapanen, P.; Korhonen, J.; Pulkkinen, U.
2000-12-01
System vendors nowadays propose software-based technology even for the most critical safety functions in nuclear power plants. Due to the nature of software faults and the way they cause system failures new methods are needed for the safety and reliability evaluation of these systems. In the research project 'Programmable automation systems in nuclear power plants (OHA)', financed together by the Radiation and Nuclear Safety Authority (STUK), the Ministry of Trade and Industry (KTM) and the Technical Research Centre of Finland (VTT), various safety assessment methods and tools for software based systems are developed and evaluated. As a part of the OHA-work a reference model for the licensing process for software-based safety automation systems is defined. The licensing process is defined as the set of interrelated activities whose purpose is to produce and assess evidence concerning the safety and reliability of the system/application to be licensed and to make the decision about the granting the construction and operation permissions based on this evidence. The parties of the licensing process are the authority, the licensee (the utility company), system vendors and their subcontractors and possible external independent assessors. The responsibility about the production of the evidence in first place lies at the licensee who in most cases rests heavily on the vendor expertise. The evaluation and gauging of the evidence is carried out by the authority (possibly using external experts), who also can acquire additional evidence by using their own (independent) methods and tools. Central issue in the licensing process is to combine the quality evidence about the system development process with the information acquired through tests, analyses and operational experience. The purpose of the licensing process described in this report is to act as a reference model both for the authority and the licensee when planning the licensing of individual applications. Many of the
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Safety assessment as basis for the decision making process
International Nuclear Information System (INIS)
Ilie, P.; Didita, L.; Danchiv, A.
2005-01-01
This paper deals with the safety assessment for a new near surface repository, particularly for the early stage of repository development using ISAM (Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities) safety assessment methodology. In this stage of the repository life cycle the main purpose of the safety assessment is to demonstrate that the plant is capable to be constructed and operated safely. The paper is based on development of the ASAM (Application of the Safety Assessment Methodologies for Near-Surface Disposal Facilities) Decision Support Subgroup of the Common Aspects Working Group. The implications of decision making for the application of the ISAM methodology on post-closure safety assessment are analysed. Some important elements of the decision-making process with impact on key components of the ISAM process are described. Following the development of Decision Support Subgroup of the ASAM Common Aspects Working Group the proposed change of ISAM methodology is analysed. This approach puts all activities in a decision context where the first iteration of the safety assessment is based on the existing state of knowledge and the initial engineering design. Confidence in the process is accomplished through the direct inclusion of all decision makers and stakeholders in the formulation of decisions, the definition of the state of knowledge, and decision making activities. The decision process is developed in context of undertaking assessments with little site-specific information, this situation is specifically for new planned repository. Limited site-specific information can result in a high degree of uncertainty, therefore it is important first of all to identify the sources of uncertainty arising from the limited nature of the site-specific information and then to apply appropriate approaches to manage the uncertainties and to determine whether the uncertainties are important to the overall safety of the disposal facility
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Safety applications of computer based systems for the process industry
International Nuclear Information System (INIS)
Bologna, Sandro; Picciolo, Giovanni; Taylor, Robert
1997-11-01
Computer based systems, generally referred to as Programmable Electronic Systems (PESs) are being increasingly used in the process industry, also to perform safety functions. The process industry as they intend in this document includes, but is not limited to, chemicals, oil and gas production, oil refining and power generation. Starting in the early 1970's the wide application possibilities and the related development problems of such systems were recognized. Since then, many guidelines and standards have been developed to direct and regulate the application of computers to perform safety functions (EWICS-TC7, IEC, ISA). Lessons learnt in the last twenty years can be summarised as follows: safety is a cultural issue; safety is a management issue; safety is an engineering issue. In particular, safety systems can only be properly addressed in the overall system context. No single method can be considered sufficient to achieve the safety features required in many safety applications. Good safety engineering approach has to address not only hardware and software problems in isolation but also their interfaces and man-machine interface problems. Finally, the economic and industrial aspects of the safety applications and development of PESs in process plants are evidenced throughout all the Report. Scope of the Report is to contribute to the development of an adequate awareness of these problems and to illustrate technical solutions applied or being developed
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Kimemia, David; van Niekerk, Ashley; Govender, Rajen; Seedat, Mohamed
2018-06-01
This study is a follow-on to an intervention project that implemented South African Bureau of Standards approved kerosene stoves and safety education in 150 households of a Johannesburg informal settlement. An investigation conducted 12 months later established that 43 stoves had operational defects, yet 23 households continued using the faulty appliances. This study focuses on (1) the psychological and behavioural factors associated with continued use of faulty stoves by the 23 households, and (2), the specific technical failures of these stoves. The study involved one-on-one recall interviews with the households using defective stoves (N=21) and laboratory-based stove tests for seven of the affected appliances. The results indicate that the stoves had defects in critical safety features such as flame control and the self-extinguishing mechanism. Four stove malfunctions of minor burn affect were reported in the study. Continued use of the damaged stoves was significantly associated with the time from receipt of the stove to detection of first failure: stoves that failed later on were more significantly likely to remain in use as compared to those that failed sooner. The findings point to the need for strengthening enforcement of appliance standards, public education on kerosene stove use, and structural change for the energy-poor. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.
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75 FR 49536 - Petitions for Modification of Existing Mandatory Safety Standards
2010-08-13
... wells utilizing the following terms and conditions: 1. District Manager Approval; (a) a safety barrier.... After District Manager approval, the mine operator will then mine within the safety barrier of the well... DEPARTMENT OF LABOR Mine Safety and Health Administration Petitions for Modification of Existing...
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ENHANCING FOOD SAFETY AND STABILITY THROUGH IRRADIATION: A REVIEW
Directory of Open Access Journals (Sweden)
Manzoor Ahmad Shah
2014-04-01
Full Text Available Food irradiation is one of the non thermal food processing methods. It is the process of exposing food materials to the controlled amounts of ionizing radiations such as gamma rays, X-rays and accelerated electrons, to improve microbiological safety and stability. Irradiation disrupts the biological processes that lead to decay of food quality. It is an effective tool to reduce food-borne pathogens, spoilage microorganisms and parasites; to extend shelf-life and for insect disinfection. The safety and consumption of irradiated foods have been extensively studied at national levels and in international cooperations and have concluded that foods irradiated under appropriate technologies are both safe and nutritionally adequate. Specific applications of food irradiation have been approved by national legislations of more than 55 countries worldwide. This review aims to discuss the applications of irradiation in food processing with the emphasis on food safety and stability.
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Safety assessment of research reactors and preparation of the safety analysis report
International Nuclear Information System (INIS)
1994-01-01
This Safety Guide presents guidelines, approved by international consensus, for the preparation, review and assessment of safety documentation for research reactors such as the Safety Analysis Report. While the Guide is most applicable to research reactors in the design and construction stage, it is also recommended for use during relicensing or reassessment of existing reactors
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2010-07-01
... 40 Protection of Environment 16 2010-07-01 2010-07-01 false What is the process for approval of a... voluntary consensus-based standards bodies. For such a method to be approved, the following information must... approved: Any test method approved by a voluntary consensus-based standards body, such as the American...
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Electronic Approval of Invoices (AEF)
2004-01-01
With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...
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Geosphere process report for the safety assessment SR-Site
International Nuclear Information System (INIS)
Skagius, Kristina
2010-11-01
This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/
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Geosphere process report for the safety assessment SR-Site
Energy Technology Data Exchange (ETDEWEB)
Skagius, Kristina (ed.) (Kemakta Konsult AB, Stockholm (Sweden))
2010-11-15
This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/
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PNRA Process for Utilizing Experience Feedback for Enhancing Nuclear Safety
International Nuclear Information System (INIS)
Shah, Z.H.
2016-01-01
One of the elements essential for any organization to become a learning organization is to learn from its own and others experience. The importance of utilizing experience feedback for enhancing operational safety is highlighted in nuclear industry again and again and this has resulted in establishment of several national and international forums. In addition, IAEA action plan on nuclear safety issued after Fukushima accident further highlighted the importance of experience sharing among nuclear community to enhance global nuclear safety regime. PNRA utilizes operating experience feedback gathered through different sources in order to improve its regulatory processes. During the review of licensing submissions, special emphasis is given to utilize the lessons learnt from experience feedback relating to nuclear industry within and outside the country. This emphasis has gradually resulted in various safety improvements in the facilities and processes. Accordingly, PNRA has developed a systematic process of evaluation of international operating experience feedback with the aim to create safety conscious approach. This process includes collecting information from different international forums such as IAEA, regulatory bodies of other countries and useful feedback of past accidents followed by its screening, evaluation and suggesting recommendations both for PNRA and its licensees. As a result of this process, several improvements concerning regulatory inspection plans of PNRA as well as in regulatory decision making and operational practices of licensees have been highlighted. This paper will present PNRA approach for utilizing experience feedback in its regulatory processes for enhancing / improving nuclear safety. (author)
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EFFICIENT QUANTITATIVE RISK ASSESSMENT OF JUMP PROCESSES: IMPLICATIONS FOR FOOD SAFETY
Nganje, William E.
1999-01-01
This paper develops a dynamic framework for efficient quantitative risk assessment from the simplest general risk, combining three parameters (contamination, exposure, and dose response) in a Kataoka safety-first model and a Poisson probability representing the uncertainty effect or jump processes associated with food safety. Analysis indicates that incorporating jump processes in food safety risk assessment provides more efficient cost/risk tradeoffs. Nevertheless, increased margin of safety...
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IRT‑Sofia, HEU to LEU conversion: regulatory approval tasks solution overview
International Nuclear Information System (INIS)
Mitev, Mladen; Belousov, Sergey; Dimitrov, Dobromir
2014-01-01
The HEU to LEU conversion of the IRT–Sofia research reactor of the Institute for Nuclear Research and Nuclear Energy of the Bulgarian Academy of Sciences was jointly studied with the Argonne National Laboratory as a part of the RERTR Programme. The main purpose of the collaboration consisted in accomplishment of safety analyses and preparation of documents used for regulatory approval tasks solution. The main steps and results which are fundamental for the preparation of IRT–Sofia Safety Analyses Report including Operating Limits and Conditions are presented in this paper. The documents prepared by INRNE in accordance with the European nuclear safety requirements and IAEA recommendations were submitted for approval to the Bulgarian Nuclear Regulatory Agency at the end of 2010. Key words: research reactor, safety analyses report, Nuclear Regulatory Agency
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Hellemans, Marc
2009-01-01
The Safety Valve Handbook is a professional reference for design, process, instrumentation, plant and maintenance engineers who work with fluid flow and transportation systems in the process industries, which covers the chemical, oil and gas, water, paper and pulp, food and bio products and energy sectors. It meets the need of engineers who have responsibilities for specifying, installing, inspecting or maintaining safety valves and flow control systems. It will also be an important reference for process safety and loss prevention engineers, environmental engineers, and plant and process designers who need to understand the operation of safety valves in a wider equipment or plant design context. . No other publication is dedicated to safety valves or to the extensive codes and standards that govern their installation and use. A single source means users save time in searching for specific information about safety valves. . The Safety Valve Handbook contains all of the vital technical and standards informat...
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Reflections on the Ethics-Approval Process
Murray, Lee; Pushor, Debbie; Renihan, Pat
2012-01-01
It is sometimes a difficult journey receiving ethics approval for research involving vulnerable populations, research involving our own children, or innovative research methodologies such as autoethnography. This autoethnographical account is a story about one student who wanted to write a PhD dissertation in a very different way and also the…
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Risk and Work Configuration Management as a Function of Integrated Safety Management
International Nuclear Information System (INIS)
Lana Buehrer; Michele Kelly; Fran Lemieux; Fred Williams
2007-01-01
National Security Technologies, LLC (NSTec), has established a work management program and corresponding electronic Facilities and Operations Management Information System (e-FOM) to implement Integrated Safety Management (ISM). The management of work scopes, the identification of hazards, and the establishment of implementing controls are reviewed and approved through electronic signatures. Through the execution of the program and the implementation of the electronic system, NSTec staff work within controls and utilize feedback and improvement process. The Integrated Work Control Manual further implements the five functions of ISM at the Activity level. By adding the Risk and Work Configuration Management program, NSTec establishes risk acceptance (business and physical) for liabilities within the performance direction and work management processes. Requirements, roles, and responsibilities are specifically identified in the program while e-FOM provides the interface and establishes the flowdown from the Safety Chain to work and facilities management processes to company work-related directives, and finally to Subject Matter Expert concurrence. The Program establishes, within the defined management structure, management levels for risk identification, risk mitigation (controls), and risk acceptance (business and physical) within the Safety Chain of Responsibility. The Program also implements Integrated Safeguards and Security Management within the NSTec Safety Chain of Responsibility. Once all information has been entered into e-FOM, approved, and captured as data, the information becomes searchable and sortable by hazard, location, organization, mitigating controls, etc
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Regulatory considerations for computational requirements for nuclear criticality safety
International Nuclear Information System (INIS)
Bidinger, G.H.
1995-01-01
As part of its safety mission, the U.S. Nuclear Regulatory Commission (NRC) approves the use of computational methods as part of the demonstration of nuclear criticality safety. While each NRC office has different criteria for accepting computational methods for nuclear criticality safety results, the Office of Nuclear Materials Safety and Safeguards (NMSS) approves the use of specific computational methods and methodologies for nuclear criticality safety analyses by specific companies (licensees or consultants). By contrast, the Office of Nuclear Reactor Regulation approves codes for general use. Historically, computational methods progressed from empirical methods to one-dimensional diffusion and discrete ordinates transport calculations and then to three-dimensional Monte Carlo transport calculations. With the advent of faster computational ability, three-dimensional diffusion and discrete ordinates transport calculations are gaining favor. With the proper user controls, NMSS has accepted any and all of these methods for demonstrations of nuclear criticality safety
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Dosimetry and process control for radiation processing
International Nuclear Information System (INIS)
Mod Ali, N.
2002-01-01
Complete text of publication follows. Accurate radiation dosimetry can provide quality assurance in radiation processing. Considerable relevant experiences in dosimetry by the SSDL-MINT has necessitate the development of methods making measurement at gamma plant traceable to the national standard. It involves the establishment of proper calibration procedure and selection of appropriate transfer system/technique to assure adequate traceability to a primary radiation standard. The effort forms the basis for irradiation process control, the legal approval of the process by the public health authorities (medical product sterilization and food preservation) and the safety and acceptance of the product
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What is the Process Approvals for Survey Research in the Department of Defense (DoD)
2017-04-26
persons as individuals / representatives of agencies that elicit attitudes, opinions, behavior , and related demographic, social, and economic data to...processes are reported to be confusing. The survey approval process between services is inconsistent and time consuming . Barriers, real or perceived...The working group formed as part of the Behavioral Health Research Interest Group
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A 'Toolbox' Equivalent Process for Safety Analysis Software
International Nuclear Information System (INIS)
O'Kula, K.R.; Eng, Tony
2004-01-01
Defense Nuclear Facilities Safety Board (DNFSB) Recommendation 2002-1 (Quality Assurance for Safety-Related Software) identified a number of quality assurance issues on the use of software in Department of Energy (DOE) facilities for analyzing hazards, and designing and operating controls that prevent or mitigate potential accidents. The development and maintenance of a collection, or 'toolbox', of multiple-site use, standard solution, Software Quality Assurance (SQA)-compliant safety software is one of the major improvements identified in the associated DOE Implementation Plan (IP). The DOE safety analysis toolbox will contain a set of appropriately quality-assured, configuration-controlled, safety analysis codes, recognized for DOE-broad, safety basis applications. Currently, six widely applied safety analysis computer codes have been designated for toolbox consideration. While the toolbox concept considerably reduces SQA burdens among DOE users of these codes, many users of unique, single-purpose, or single-site software may still have sufficient technical justification to continue use of their computer code of choice, but are thwarted by the multiple-site condition on toolbox candidate software. The process discussed here provides a roadmap for an equivalency argument, i.e., establishing satisfactory SQA credentials for single-site software that can be deemed ''toolbox-equivalent''. The process is based on the model established to meet IP Commitment 4.2.1.2: Establish SQA criteria for the safety analysis ''toolbox'' codes. Implementing criteria that establish the set of prescriptive SQA requirements are based on implementation plan/procedures from the Savannah River Site, also incorporating aspects of those from the Waste Isolation Pilot Plant (SNL component) and the Yucca Mountain Project. The major requirements are met with evidence of a software quality assurance plan, software requirements and design documentation, user's instructions, test report, a
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Plutonium Finishing Plant safety evaluation report
International Nuclear Information System (INIS)
1995-01-01
The Plutonium Finishing Plant (PFP) previously known as the Plutonium Process and Storage Facility, or Z-Plant, was built and put into operation in 1949. Since 1949 PFP has been used for various processing missions, including plutonium purification, oxide production, metal production, parts fabrication, plutonium recovery, and the recovery of americium (Am-241). The PFP has also been used for receipt and large scale storage of plutonium scrap and product materials. The PFP Final Safety Analysis Report (FSAR) was prepared by WHC to document the hazards associated with the facility, present safety analyses of potential accident scenarios, and demonstrate the adequacy of safety class structures, systems, and components (SSCs) and operational safety requirements (OSRs) necessary to eliminate, control, or mitigate the identified hazards. Documented in this Safety Evaluation Report (SER) is DOE's independent review and evaluation of the PFP FSAR and the basis for approval of the PFP FSAR. The evaluation is presented in a format that parallels the format of the PFP FSAR. As an aid to the reactor, a list of acronyms has been included at the beginning of this report. The DOE review concluded that the risks associated with conducting plutonium handling, processing, and storage operations within PFP facilities, as described in the PFP FSAR, are acceptable, since the accident safety analyses associated with these activities meet the WHC risk acceptance guidelines and DOE safety goals in SEN-35-91
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A software engineering process for safety-critical software application
International Nuclear Information System (INIS)
Kang, Byung Heon; Kim, Hang Bae; Chang, Hoon Seon; Jeon, Jong Sun
1995-01-01
Application of computer software to safety-critical systems in on the increase. To be successful, the software must be designed and constructed to meet the functional and performance requirements of the system. For safety reason, the software must be demonstrated not only to meet these requirements, but also to operate safely as a component within the system. For longer-term cost consideration, the software must be designed and structured to ease future maintenance and modifications. This paper presents a software engineering process for the production of safety-critical software for a nuclear power plant. The presentation is expository in nature of a viable high quality safety-critical software development. It is based on the ideas of a rational design process and on the experience of the adaptation of such process in the production of the safety-critical software for the shutdown system number two of Wolsung 2, 3 and 4 nuclear power generation plants. This process is significantly different from a conventional process in terms of rigorous software development phases and software design techniques, The process covers documentation, design, verification and testing using mathematically precise notations and highly reviewable tabular format to specify software requirements and software requirements and software requirements and code against software design using static analysis. The software engineering process described in this paper applies the principle of information-hiding decomposition in software design using a modular design technique so that when a change is required or an error is detected, the affected scope can be readily and confidently located. it also facilitates a sense of high degree of confidence in the 'correctness' of the software production, and provides a relatively simple and straightforward code implementation effort. 1 figs., 10 refs. (Author)
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Radiation processing of minimally processed fruits and vegetables to ensure microbiological safety
International Nuclear Information System (INIS)
Bandekar, J.R.; Saroj, S.D.; Shashidhar, R.; Dhokane, V.S.; Hajare, S.N.; Nagar, V.; Sharma, A.
2009-01-01
Minimally processed fruits and vegetables are in demand as they offer ready rich source of nutrients and convenience to consumers. However, these products are often unsafe due to contamination with harmful pathogens. Therefore, a study was carried out to analyze microbiological quality of minimally processed fruits, vegetables and sprouts and to optimize radiation dose necessary to ensure safety of these commodities. Microbiological quality of these products was found to be poor. Decimal reduction dose (D 10 ) for Salmonella Typhimurium and Listeria monocytogenes in these minimally processed foods (MPF) were in the range of 164 to 588 Gy. Radiation processing with 2 kGy dose of gamma radiation resulted in 5 log reduction of S. Typhimurium and 4 log reduction of L. monocytogenes. The treatment did not significantly affect nutritional, organoleptic and textural properties. These results suggest that radiation processing can ensure safety of these products. (author)
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Chemical process safety management within the Department of Energy
International Nuclear Information System (INIS)
Piatt, J.A.
1995-07-01
Although the Department of Energy (DOE) is not well known for its chemical processing activities, the DOE does have a variety of chemical processes covered under OSHA's Rule for Process Safety Management of Highly Hazardous Chemicals (the PSM Standard). DOE, like industry, is obligated to comply with the PSM Standard. The shift in the mission of DOE away from defense programs toward environmental restoration and waste management has affected these newly forming process safety management programs within DOE. This paper describes the progress made in implementing effective process safety management programs required by the PSM Standard and discusses some of the trends that have supported efforts to reduce chemical process risks within the DOE. In June of 1994, a survey of chemicals exceeding OSHA PSM or EPA Risk Management Program threshold quantities (TQs) at DOE sites found that there were 22 processes that utilized toxic or reactive chemicals over TQs; there were 13 processes involving flammable gases and liquids over TQs; and explosives manufacturing occurred at 4 sites. Examination of the survey results showed that 12 of the 22 processes involving toxic chemicals involved the use of chlorine for water treatment systems. The processes involving flammable gases and liquids were located at the Strategic Petroleum Reserve and Naval petroleum Reserve sites
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The Agency's Safety Standards and Measures
International Nuclear Information System (INIS)
1976-04-01
The Agency's Health and Safety Measures were first, approved by the Board of Governors on 31 March 1960 in implementation of Articles III.A.6 and XII of the Statute of the Agency. On the basis of the experience gained from applying those measures to projects carried out by Members under agreements concluded with the Agency, the Agency's Health and Safety Measures were revised in 1975 and approved by the Board of Governors on 25 February 1976. The Agency's Safety Standards and Measures as revised are reproduced in this document for the information of all Members
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Review of experiments for research reactors - approved 1974
International Nuclear Information System (INIS)
Anon.
1977-01-01
This standard establishes guidelines for the review and approval of experiments performed at research reactor facilities. This standard identifies the major areas that shall be reviewed for each experiment to ensure that it (a) falls within the limits delineated in the technical specifications, (b) does not present an unreviewed safety question as defined in 10 CFR Section 50.59 π2-, (c) does not constitute a threat to the health and safety of any individual or group of individuals, and (d) does not constitute a hazard to the reactor facility or other equipment. In addition, this standard recommends a system for classifying experiments to establish levels of review and approval commensurate with the level of risk inherent in the experiment
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Streamlining the Capstone Process: A Time-Saving Approval System for Graduate Theses/Projects
Grooms, James; Kline, Douglas; Cummings, Jeffrey
2016-01-01
Capstones have become an integral part of many information systems programs, both at the undergraduate and graduate level. One of the challenges can be tracking the process from the start of the capstone to completion. This paper describes the analysis, design and implementation of a web application for the approval workflow of a master's program…
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2011-10-01
they must be ISO / IEC 17025 compliant. A list of laboratories accredited to also certify terminal apparatus is available on the Industry Canada...accredited by Standards Council of Canada or Certified to ISO / IEC 17025 . The emphasis in the approval process is on the independence of testing or the...of Canada. Industry Canada takes a similar approach depending on ISO / IEC 17025 certified labs for most testing. In summary, technical/testing
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Safety analysis of tritium processing system based on PHA
International Nuclear Information System (INIS)
Fu Wanfa; Luo Deli; Tang Tao
2012-01-01
Safety analysis on primary confinement of tritium processing system for TBM was carried out with Preliminary Hazard Analysis. Firstly, the basic PHA process was given. Then the function and safe measures with multiple confinements about tritium system were described and analyzed briefly, dividing the two kinds of boundaries of tritium transferring through, that are multiple confinement systems division and fluid loops division. Analysis on tritium releasing is the key of PHA. Besides, PHA table about tritium releasing was put forward, the causes and harmful results being analyzed, and the safety measures were put forward also. On the basis of PHA, several kinds of typical accidents were supposed to be further analyzed. And 8 factors influencing the tritium safety were analyzed, laying the foundation of evaluating quantitatively the safety grade of various nuclear facilities. (authors)
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Miracle drug: Brazil approves never-tested cancer medicine.
Kuchenbecker, Ricardo S; Mota, Daniel M
2017-07-01
Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.
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30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.
2010-07-01
... District Manager and posting. 71.301 Section 71.301 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... plan; approval by District Manager and posting. (a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager...
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The Implementation and Maintenance of a Behavioral Safety Process in a Petroleum Refinery
Myers, Wanda V.; McSween, Terry E.; Medina, Rixio E.; Rost, Kristen; Alvero, Alicia M.
2010-01-01
A values-centered and team-based behavioral safety process was implemented in a petroleum oil refinery. Employee teams defined the refinery's safety values and related practices, which were used to guide the process design and implementation. The process included (a) a safety assessment; (b) the clarification of safety-related values and related…
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Status of the safety certification process of the TRANSRAPID system
Energy Technology Data Exchange (ETDEWEB)
Blomerius, J [TUEV Rheinland, Koeln (Germany). Inst. fuer Software, Elektronik, Bahntechnik
1996-12-31
Since 20 years TUeV Rheinland is involved in safety certification of maglev technology of the TRANSRAPID type. The process applied is called PASC (Programm Accompanying Safety Certification). The paper reports on safety assessment of relevant subsystems and components (TR07, OCS, guideway components) as well as safety certification in the final program. (HW)
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A History of the Sonocare CST-100: The First FDA-approved HIFU Device
Muratore, Robert
2006-05-01
The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.
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Aviation Safety Reporting System: Process and Procedures
Connell, Linda J.
1997-01-01
The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.
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International Nuclear Information System (INIS)
1982-01-01
A report to the Prime Minister by the Nuclear Safety Commission was presented concerning the safety in the installation alteration of the fuel reprocessing facilities, as PNC had requested its approval to the Prime Minister. The safety was confirmed. The items of examination on the safety made by the committee on Examination of Nuclear Fuel Safety of NSC were the aseismic design of liquid waste storage, uranium denitration facility, intermediate gate and radioactive solid waste storage; the criticality safety design of the denitration facility; the radiation shielding design of the liquid waste storage, denitration facility and solid waste storage; the function of radioactive material containment of the liquid waste storage and denitration facility; the radiation control in the liquid waste storage, denitration facility and solid waste storage; the waste management in the liquid waste storage and denitration facility; fire and explosion prevention in the liquid waste storage; exposure dose from the liquid waste storage and denitration facility. (Mori, K.)
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Microbial and preservative safety of fresh and processed fruit salads ...
African Journals Online (AJOL)
The producers and traders of fresh fruit and the processers should implement quality management practices and safety standards in farming, fresh fruit, processing and storage. This is to ensure safety, enhance consumption of fruits and fruit products for health of consumers and eliminate wastage. Key words: Fresh fruit, ...
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Probabilistic Safety Assessment of Waste from PyroGreen Processes
International Nuclear Information System (INIS)
Ju, Hee Jae; Ham, In hye; Hwang, Il Soon
2016-01-01
The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.
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Probabilistic Safety Assessment of Waste from PyroGreen Processes
Energy Technology Data Exchange (ETDEWEB)
Ju, Hee Jae; Ham, In hye; Hwang, Il Soon [Seoul National University, Seoul (Korea, Republic of)
2016-05-15
The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.
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Marketing Approval of Ethical Kampo Medicines.
Hakamatsuka, Takashi
2017-01-01
Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.
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14 CFR 415.117 - Ground safety.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Ground safety. 415.117 Section 415.117... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety review...
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14 CFR 415.115 - Flight safety.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety. 415.115 Section 415.115... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's...
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Increased Efficiencies in the INEEL SAR/TSR/USQ Process
International Nuclear Information System (INIS)
Cole, N.E.
2002-01-01
The Idaho National Engineering and Environmental Laboratory (INEEL) has implemented a number of efficiencies to reduce the time and cost of preparing safety basis documents. The INEEL is continuing to look at other aspects of the safety basis process to identify other efficiencies that can be implemented and remain in compliance with Title 10 Code of Federal Regulations (CFR) Part 830. A six-sigma approach is used to identify areas to improve efficiencies and develop the action plan for implementation of the new process, as applicable. Three improvement processes have been implemented: The first was the development of standardized Documented Safety Analysis (DSA) and technical safety requirement (TSR) documents that all nuclear facilities use, by adding facility-specific details. The second is a material procurement process, which is based on safety systems specified in the individual safety basis documents. The third is a restructuring of the entire safety basis preparation and approval process. Significant savings in time to prepare safety basis document, cost of materials, and total cost of the documents are currently being realized
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International Nuclear Information System (INIS)
Barrett, J.A.; Gill, J.R.; Gray, R.C.; Turton, D.; Young, T.O.
1989-01-01
The legal background to dosimetry for workers is described with a structured approach to ensuring that this dosimetry meets certain minimum standards in Great Britain. Some of the advantages and disadvantages of obtaining uniformity whilst maintaining flexibility are summarised. The approval process described places emphasis on the quality assurance controls to be put into practice by dosimetry services. (author)
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Periodic safety review of the HTR-10 safety analysis
International Nuclear Information System (INIS)
Chen Fubing; Zheng Yanhua; Shi Lei; Li Fu
2015-01-01
Designed by the Institute of Nuclear and New Energy Technology (INET) of Tsinghua University, the 10 MW High Temperature Gas-cooled Reactor-Test Module (HTR-10) is the first modular High Temperature Gas-cooled Reactor (HTGR) in China. According to the nuclear safety regulations of China, the periodic safety review (PSR) of the HTR-10 was initiated by INET after approved by the National Nuclear Safety Administration (NNSA) of China. Safety analysis of the HTR-10 is one of the key safety factors of the PSR. In this paper, the main contents in the review of safety analysis are summarized; meanwhile, the internal evaluation on the review results is presented by INET. (authors)
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2012-09-27
... account for any future changes to the emission model, projection model and other input data. \\2\\ A safety... changes in the emissions model and vehicle miles traveled (VMT) projection model. EPA is approving this... Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal...
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Aspects of safety assessments for package with additional equipment components
International Nuclear Information System (INIS)
Reiche, I.; Boerst, F.M.; Krietsch, T.
2004-01-01
Many paragraphs in TS-R-1 contain the terms ''package'' or ''packaging''. These terms are defined in TS-R-1 paras 230 and 231 and explained in TS-G-1.1 paras 230.1 - 230.6. The importance of a consistent understanding of these definitions has been shown by recent discussions during the assessment of applications for package design approval. There was disagreement, if equipment components attached to the container body during transport, e.g. a transport frame, should be considered part of the package and taken into account in the safety assessment for the package. Discussions were also caused by the way inner design components are treated in the safety assessment of the package. This paper summarises the regulatory requirements to such additional equipment components and presents the way of their inclusion into the package design approval process in Germany
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Operation safety at Ignalina NPP
International Nuclear Information System (INIS)
Zheltobriukh, G.
1999-01-01
An improvement of operational safety at Ignalina NPP covers: improvement of management structure and safety culture; symptom-based emergency operating procedures; staff training and full scope simulator; program of components ageing; metal inspection; improvement of fire safety. The first plan of Ignalina NPP Safety culture development for 1997 purposed to the SAR recommendation implementation was prepared and approved by the General Director
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75 FR 57019 - Pesticide Product Registrations; Conditional Approval
2010-09-17
..., the Agency was able to make basic health and safety determinations which show that use of flutriafol... unreasonable adverse effects to man and the environment. III. Conditional Approval Form EPA issued a notice...
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Pharmacovigilance of biologicals : dynamics in post-approval safety learning
Vermeer, N.S.
2015-01-01
Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict
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Rouvroye, J.L.; Nieuwenhuizen, J.K.; Brombacher, A.C.; Stavrianidis, P.; Spiker, R.Th.E.; Pyatt, D.W.
1995-01-01
At this moment there is no standardised method for the assessment for safety in the process industry. Many companies and institutes use qualitative techniques for safety analysis while other companies and institutes use quantitative techniques. The authors of this paper will compare different
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Price, performance, and the FDA approval process: the example of home HIV testing.
Paltiel, A David; Pollack, Harold A
2010-01-01
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.
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49 CFR 1106.4 - The Safety Integration Plan process.
2010-10-01
... 49 Transportation 8 2010-10-01 2010-10-01 false The Safety Integration Plan process. 1106.4 Section 1106.4 Transportation Other Regulations Relating to Transportation (Continued) SURFACE... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS...
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Krsko periodic safety review project prioritization process
International Nuclear Information System (INIS)
Basic, I.; Vrbanic, I.; Spiler, J.; Lambright, J.
2004-01-01
Definition of a Krsko Periodic Safety Review (PSR) project is a comprehensive safety review of a plant after last ten years of operation. The objective is a verification by means of a comprehensive review using current methods that Krsko NPP remains safety when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. This objective encompasses the three main criteria or goals: confirmation that the plant is as safe as originally intended, determination if there are any structures, systems or components that could limit the life of the plant in the foreseeable future, and comparison the plant against modern safety standards and to identify where improvements would be beneficial at justifiable cost. Krsko PSR project is structured in the three phases: Phase 1: Preparation of Detailed 10-years PSR Program, Phase 2: Performing of 10-years PSR Program and preparing of associated documents (2001-2003), and Phase 3: Implementation of the prioritized compensatory measures and modifications (development of associated EEAR, DMP, etc.) after agreement with the SNSA on the design, procedures and time-scales (2004-2008). This paper presents the NEK PSR results of work performed under Phase 2 focused on the ranking of safety issues and prioritization of corrective measures needed for establishing an efficient action plan. Safety issues were identified in Phase 2 during the following review processes: Periodic Safety Review (PSR) task; Krsko NPP Regulatory Compliance Program (RCP) review; Westinghouse Owner Group (WOG) catalog items screening/review; SNSA recommendations (including IAEA RAMP mission suggestions/recommendations).(author)
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Safety philosophy and licensing practice in different member states of IAEA: Canada
International Nuclear Information System (INIS)
Boyd, F.C.
1981-01-01
The lecture will provide an outline of the Canadian nuclear organization and basic characteristics of the CANDU reactor as a background for a brief description of the nuclear power plant licensing process and the safety philosophy followed. The regulatory agency (Atomic Energy Control Board) follows a three step licensing procedure, Site Acceptance, Construction Approval, Operating Licence. Defense in depth is followed as a general safety concept, but is applied in a special way. Completely separate and independant safety systems are required and basic criteria established through reference dose limits for any assumed failure (or initiating event) in any process (operating) system and for any such failure combined with complete failure at any safety system. The application of the Canadian approach in other countries will be mentioned. (orig./RW)
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Developing international safety standards for the geological disposal of radioactive waste
International Nuclear Information System (INIS)
Metcalf, P.
2001-01-01
In the context of the International Atomic Energy Agency's (IAEA) programme to create a corpus of internationally accepted Radioactive Waste Safety Standards (RADWASS), focus is currently being placed on establishing standards for the 'geological disposal of radioactive waste'. This is a challenging task and to help the standards development process there is a need to stimulate discussion of some of the associated scientific and technical issues. A number of position papers developed in recent years by a subgroup of the Waste Safety Standards Committee (WASSC), the subgroup on Principles and Criteria for Radioactive Waste Disposal, address many of the relevant issues. These include a common safety based framework for radioactive waste disposal, appropriate time frames for safety assessment, different possible indicators of long-term safety, the safety implications of reversibility and retrievability, the assessment of possible human intrusion into the repository, the role and limitations of institutional control, establishing reference critical groups and biospheres for long-term assessment, and what is meant by 'compliance' with the standards. These papers will be discussed at a Specialists Meeting to be held at the IAEA in June 2001 as a means of establishing the extent to which they enjoy the general support of experts. In order to broaden that consensus, the conclusions reached at the Specialists Meeting on the issues listed above will be presented and discussed with participants at a number of international meetings. Later this year, a draft safety standard on the geological disposal of radioactive waste which takes account of the consensus positions reached through the various consultations will be submitted for the consideration of Waste Safety Standards Committee (WASSC), the officially approved body within the IAEA for the review and approval of waste safety standards. The Committee is made up of government appointed radioactive waste regulators
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Study on 'Safety qualification of process computers used in safety systems of nuclear power plants'
International Nuclear Information System (INIS)
Bertsche, K.; Hoermann, E.
1991-01-01
The study aims at developing safety standards for hardware and software of computer systems which are increasingly used also for important safety systems in nuclear power plants. The survey of the present state-of-the-art of safety requirements and specifications for safety-relevant systems and, additionally, for process computer systems has been compiled from national and foreign rules. In the Federal Republic of Germany the KTA safety guides and the BMI/BMU safety criteria have to be observed. For the design of future computer-aided systems in nuclear power plants it will be necessary to apply the guidelines in [DIN-880] and [DKE-714] together with [DIN-192]. With the aid of a risk graph the various functions of a system, or of a subsystem, can be evaluated with regard to their significance for safety engineering. (orig./HP) [de
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An approved personal dosimetry service based on an electronic dosimeter
International Nuclear Information System (INIS)
Marshall, T.O.; Bartlett, D.T.; Burgess, P.H.; Campbell, J.I.; Hill, C.E.; Pook, E.A.; Sandford, D.J.
1991-01-01
At the Second Conference on Radiation Protection and Dosimetry a paper was presented which, in part, announced the development of an electronic dosimeter to be undertaken in the UK by the National Radiological Protection Board (NRPB) and Siemens Plessey Controls Ltd. This dosimeter was to be of a standard suitable for use as the basis of an approved personal dosimetry service for photon and beta radiations. The project has progressed extremely well and dosimeters and readers are about to become commercially available. The system and the specification of the dosimeter are presented. The NRPB is in the process of applying for approval by the Health and Safety Executive (HSE) to operate as personal monitoring service based on this dosimeter. As part of the approval procedure the dosimeter is being type tested and is also undergoing an HSE performance test and wearer trials. The tests and the wearer trials are described and a summary of the results to date presented. The way in which the service will be organized and operated is described and a comparison is made between the running of the service and others based on passive dosimeters at NRPB
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International Nuclear Information System (INIS)
1995-02-01
All facilities at which radioactive wastes are processed, stored and disposed of have the potential for causing hazards to humans and to the environment. Precautions must be taken in the siting, design and operation of the facilities to ensure that an adequate level of safety is achieved. The processes by which this is evaluated is called safety assessment. An important part of safety assessment is the documentation of the process. A well prepared safety analysis report (SAR) is essential if approval of the facility is to be obtained from the regulatory authorities. This TECDOC describes the format and content of a safety analysis report for a near surface radioactive waste disposal facility and will serve essentially as a checklist in this respect
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Hawaii State Plan for Occupational Safety and Health. Final rule.
2012-09-21
This document announces the Occupational Safety and Health Administration's (OSHA) decision to modify the Hawaii State Plan's ``final approval'' determination under Section 18(e) of the Occupational Safety and Health Act (the Act) and to transition to ``initial approval'' status. OSHA is reinstating concurrent federal enforcement authority over occupational safety and health issues in the private sector, which have been solely covered by the Hawaii State Plan since 1984.
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International Nuclear Information System (INIS)
D. Kokkinos
2005-01-01
The purpose of this letter is to request Naval Reactors comments on the nuclear reactor high tier requirements for the PROMETHEUS space flight reactor design, pre-launch operations, launch, ascent, operation, and disposal, and to request Naval Reactors approval to transmit these requirements to Jet Propulsion Laboratory to ensure consistency between the reactor safety requirements and the spacecraft safety requirements. The proposed PROMETHEUS nuclear reactor high tier safety requirements are consistent with the long standing safety culture of the Naval Reactors Program and its commitment to protecting the health and safety of the public and the environment. In addition, the philosophy on which these requirements are based is consistent with the Nuclear Safety Policy Working Group recommendations on space nuclear propulsion safety (Reference 1), DOE Nuclear Safety Criteria and Specifications for Space Nuclear Reactors (Reference 2), the Nuclear Space Power Safety and Facility Guidelines Study of the Applied Physics Laboratory
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Environment, safety and health progress assessment manual
International Nuclear Information System (INIS)
1992-12-01
On June 27, 1989, the Secretary of Energy announced a 1O-Point Initiative to strengthen environment,safety, and health (ES ampersand H) programs, and waste management activities at involved conducting DOE production, research, and testing facilities. One of the points independent Tiger Team Assessments of DOE operating facilities. The Office of Special Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This volume contains appendices to the Environment, Safety and Health Progress Assessment Manual
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Keys to effective third-party process safety audits
International Nuclear Information System (INIS)
Birkmire, John C.; Lay, James R.; McMahon, Mona C.
2007-01-01
The Occupational Safety and Health Administration's (OSHA's) Process Safety Management (PSM) regulation was promulgated in 1992. The U.S. Environmental Protection Agency's (EPA's) corresponding Risk Management Program (RMP) rule followed in 1996. Both programs include requirements for triennial compliance audits. Effective compliance audits are critical in identifying program weaknesses and ensuring the safety of facility personnel and the surrounding public. Large companies with corporate and facility health, safety, and environmental groups typically have the resources and experience to conduct audits internally, either through a corporate audit team or the sharing of personnel between multiple facilities. Small to medium sized businesses frequently do not have the expertise or the resources to perform compliance audits, and rely on third-party consultants to provide these services. This paper will discuss the observations of the authors in performing audits and working with PSM/RMP programs across a number of market sectors (e.g. chemical, petrochemical, pharmaceutical, food and beverage, water treatment), including effective practices, hurdles to successful implementation and execution of programs, and typical program shortcomings. The paper will also discuss steps to improve the audit process and increase effectiveness whether performed by a third party or internally
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A holistic approach to control process safety risks: Possible ways forward
International Nuclear Information System (INIS)
Pasman, H.J.; Knegtering, B.; Rogers, W.J.
2013-01-01
Pursuing process safety in a world of continuously increasing requirements is not a simple matter. Keeping balance between producing quality and volume under budget constraints while maintaining an adequate safety level proves time and time again a difficult task given that evidently major accidents cannot be avoided. Lack of resilience from an organizational point of view to absorb unwanted and unforeseen disturbances has in recent years been put forward as a major cause, while organizational erosive drift is shown to be responsible for complacency and degradation of safety attitude. A systems approach to safety provides a new paradigm with the promise of new comprehensive tools. At the same time, one realizes that risk assessment will fall short of identifying and quantifying all possible scenarios. First, human error is in most assessments not included. It is even argued that determining human failure probability by decomposing it to basic elements of error is not possible. Second, the crux of the systemic approach is that safety is an emergent property, which means the same holds for the technological aspect: risk is not fully predictable from failure of components. By surveying and applying recent literature, besides analysing, this paper proposes a way forward by considering resilience of a socio-technical system both from an organizational and a technical side. The latter will for a large part be determined by the plant design. Sufficient redundancy and reserve shall be kept to preserve sufficient resilience, but the question that rises is how. Available methods are risk assessment and process simulation. It is helpful that the relation between risk and resilience analysis has been recently defined. Also, in a preliminary study the elements of resilience of a process have become listed. In the latter, receiving and interpreting weak signals to boost situational awareness plays an important role. To maintain alertness on the functioning of a safety management
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How important is vehicle safety in the new vehicle purchase process?
Koppel, Sjaanie; Charlton, Judith; Fildes, Brian; Fitzharris, Michael
2008-05-01
Whilst there has been a significant increase in the amount of consumer interest in the safety performance of privately owned vehicles, the role that it plays in consumers' purchase decisions is poorly understood. The aims of the current study were to determine: how important vehicle safety is in the new vehicle purchase process; what importance consumers place on safety options/features relative to other convenience and comfort features, and how consumers conceptualise vehicle safety. In addition, the study aimed to investigate the key parameters associated with ranking 'vehicle safety' as the most important consideration in the new vehicle purchase. Participants recruited in Sweden and Spain completed a questionnaire about their new vehicle purchase. The findings from the questionnaire indicated that participants ranked safety-related factors (e.g., EuroNCAP (or other) safety ratings) as more important in the new vehicle purchase process than other vehicle factors (e.g., price, reliability etc.). Similarly, participants ranked safety-related features (e.g., advanced braking systems, front passenger airbags etc.) as more important than non-safety-related features (e.g., route navigation systems, air-conditioning etc.). Consistent with previous research, most participants equated vehicle safety with the presence of specific vehicle safety features or technologies rather than vehicle crash safety/test results or crashworthiness. The key parameters associated with ranking 'vehicle safety' as the most important consideration in the new vehicle purchase were: use of EuroNCAP, gender and education level, age, drivers' concern about crash involvement, first vehicle purchase, annual driving distance, person for whom the vehicle was purchased, and traffic infringement history. The findings from this study are important for policy makers, manufacturers and other stakeholders to assist in setting priorities with regard to the promotion and publicity of vehicle safety features
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Management by process based systems and safety focus
International Nuclear Information System (INIS)
Rydnert, Bo; Groenlund, Bjoern
2005-12-01
An initiative from The Swedish Nuclear Power Inspectorate led to this study carried out in the late autumn of 2005. The objective was to understand in more detail how an increasing use of process management affects organisations, on the one hand regarding risks and security, on the other hand regarding management by objectives and other management and operative effects. The main method was interviewing representatives of companies and independent experts. More than 20 interviews were carried out. In addition a literature study was made. All participating companies are using Management Systems based on processes. However, the methods chosen, and the results achieved, vary extensively. Thus, there are surprisingly few examples of complete and effective management by processes. Yet there is no doubt that management by processes is effective and efficient. Overall goals are reached, business results are achieved in more reliable ways and customers are more satisfied. The weaknesses found can be translated into a few comprehensive recommendations. A clear, structured and acknowledged model should be used and the processes should be described unambiguously. The changed management roles should be described and obeyed extremely legibly. New types of process objectives need to be formulated. In addition one fact needs to be observed and effectively fended off. Changes are often met by mental opposition on management level, as well as among co-workers. This fact needs attention and leadership. Safety development is closely related to the design and operation of a business management system and its continual improvement. A deep understanding of what constitutes an efficient and effective management system affects the understanding of safety. safety culture and abilities to achieve safety goals. Concerning risk, the opinions were unambiguous. Management by processes as such does not result in any further risks. On the contrary. Processes give a clear view of production and
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The safety culture change process performed in Polish research reactor MARIA
International Nuclear Information System (INIS)
Golab, Andrzej
2002-01-01
The Safety Culture Change Process Performed in research reactor MARIA is described in this paper. The essential issues fulfilled in realization of the Safety Culture Enhancement Programme are related to the attitude and behaviour of top management, co-operating groups, operational personnel, relations between the operating organization and the supervising and advising organizations. Realization of this programme is based on changing the employees understanding of safety, changing their attitudes and behaviours by means of adequate training, requalification process and performing the broad self-assessment programme. Also a high level Quality Assurance Programme helps in development of the Safety Culture. (author)
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Health and safety regulation of uranium mining and milling
International Nuclear Information System (INIS)
Dory, A.B.
1980-07-01
The Canadian Atomic Energy Control Board licenses all nuclear facilities in Canada, including uranium mines and mills. The protection of health, safety and the environment is one of the requirements of each licence. A limit of 4 Working Level Months exposure to radon and radon daughters annually has been set, and guidelines for weekly or more frequent workplace monitoring have been established. Personal monitoring devices are being tested, and thermoluminescent dosimeters are to be introduced. The Board reviews its licensees' ventilation plans continuously. The staged licensing process involves the granting of the following documents: 1) ore removal; 2) underground exploration permit; 3) site and construction approval; 4) mining facility operating licence; 5) shut-down approval. Compliance with regulations and licence conditions is monitored mainly by inspectors appointed by provincial agencies, with Board staff exercising auditing fuctions. The Board involves the workers directly with their own health and safety by sending their unions copies of all relevant documents and inviting comments
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2010-10-01
... TRANSPORTATION HAZARDOUS MATERIALS AND OIL TRANSPORTATION HAZARDOUS MATERIALS PROGRAM PROCEDURES Approvals... before the disposition of an application. (b) At any time during the processing of an application, the...
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Digital Signal Processing for In-Vehicle Systems and Safety
Boyraz, Pinar; Takeda, Kazuya; Abut, Hüseyin
2012-01-01
Compiled from papers of the 4th Biennial Workshop on DSP (Digital Signal Processing) for In-Vehicle Systems and Safety this edited collection features world-class experts from diverse fields focusing on integrating smart in-vehicle systems with human factors to enhance safety in automobiles. Digital Signal Processing for In-Vehicle Systems and Safety presents new approaches on how to reduce driver inattention and prevent road accidents. The material addresses DSP technologies in adaptive automobiles, in-vehicle dialogue systems, human machine interfaces, video and audio processing, and in-vehicle speech systems. The volume also features: Recent advances in Smart-Car technology – vehicles that take into account and conform to the driver Driver-vehicle interfaces that take into account the driving task and cognitive load of the driver Best practices for In-Vehicle Corpus Development and distribution Information on multi-sensor analysis and fusion techniques for robust driver monitoring and driver recognition ...
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Radiation requirements for uranium project approvals
International Nuclear Information System (INIS)
Hondros, J.
2014-01-01
Uranium mining projects in Australia must receive approval under both state and national laws based on a wide ranging impact assessment of the project. The process may take a number of years and involves multiple levels and parts of government and public consultation and scrutiny. The impact assessment is broad and usually covers; environmental, social, health, public safety and economic aspects. Information provided in the approvals documentation needs to be presented in a credible and understandable manner for all audiences. This means making complex information simpler, while making sure that it maintains its technical integrity. Poorly communicated information, which is overly complex, overly simplified or incomplete, can result in significant delays to the project approval which can potentially impact on project timelines. For uranium projects, along with other projects involving radioactive materials, such as minerals sands and rare earths, radiation and its impacts usually draw a disproportionate amount of both government and public scrutiny compared to other potential impacts and risks. It is therefore of key importance that radiation assessments are properly performed and results clearly presented and communicated with sufficient detail for stakeholders to make informed decisions. It is also important to ensure that the radiation risk is presented in perspective with other risks of the project. This presentation outlines a structure for a radiation impact assessment based on experience from a number of projects in Australia. The structure aims to be clear and simple and ensure the right balance between scientific fact, digestible information and demonstrable competence. (author)
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International Nuclear Information System (INIS)
1985-01-01
Supplement 3 to the Safety Evaluation Report (SER) for the application filed by General Electric Company for the final design approval for the GE BWR/6 nuclear island design has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report supplements the GESSAR II SER (NUREG-0979), issued in April 1983, summarizing the results of the staff's safety review of the GESSAR II BWR/6 nuclear island design. Subject to favorable resolution of the items discussed in this supplement, the staff concludes that the GESSAR II design satisfactorily addresses the severe-accident concerns described in draft NUREG-1070
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Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan
2013-01-01
This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843
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14 CFR 431.33 - Safety organization.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 431.33 Section 431.33... Launch and Reentry of a Reusable Launch Vehicle § 431.33 Safety organization. (a) An applicant shall maintain a safety organization and document it by identifying lines of communication and approval authority...
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Microbial safety of minimally processed foods
National Research Council Canada - National Science Library
Novak, John S; Sapers, Gerald M; Juneja, Vijay K
2003-01-01
...-course meals. All are expected to be portioned and minimally processed to balance the naturalness of unaltered foods with a concern for safety. Yet the responsibility for proper food preparation and handling remains with the naïve modern consumer, who may be less adept in food preparations than his or her less sophisticated ancestors. As a result,...
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Directory of Open Access Journals (Sweden)
Yaoshan Xu
Full Text Available This study explores the precursors of employees' safety behaviors based on a dual-process model, which suggests that human behaviors are determined by both controlled and automatic cognitive processes. Employees' responses to a self-reported survey on safety attitudes capture their controlled cognitive process, while the automatic association concerning safety measured by an Implicit Association Test (IAT reflects employees' automatic cognitive processes about safety. In addition, this study investigates the moderating effects of inhibition on the relationship between self-reported safety attitude and safety behavior, and that between automatic associations towards safety and safety behavior. The results suggest significant main effects of self-reported safety attitude and automatic association on safety behaviors. Further, the interaction between self-reported safety attitude and inhibition and that between automatic association and inhibition each predict unique variances in safety behavior. Specifically, the safety behaviors of employees with lower level of inhibitory control are influenced more by automatic association, whereas those of employees with higher level of inhibitory control are guided more by self-reported safety attitudes. These results suggest that safety behavior is the joint outcome of both controlled and automatic cognitive processes, and the relative importance of these cognitive processes depends on employees' individual differences in inhibitory control. The implications of these findings for theoretical and practical issues are discussed at the end.
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Keys to effective third-party process safety audits
Energy Technology Data Exchange (ETDEWEB)
Birkmire, John C. [Tourgee and Associates Inc., 11459 Cronhill Drive, Suite A, Owings Mills, MD 21117 (United States)]. E-mail: jbirkmire@taiengineering.com; Lay, James R. [5644 High Tor Hill, Columbia, MD 21045 (United States)]. E-mail: jim.lay21045@gmail.com; McMahon, Mona C. [General Physics Corporation, 6095 Marshalee Drive, Suite 300, Elkridge, MD 21075 (United States)]. E-mail: mmcmahon@gpworldwide.com
2007-04-11
The Occupational Safety and Health Administration's (OSHA's) Process Safety Management (PSM) regulation was promulgated in 1992. The U.S. Environmental Protection Agency's (EPA's) corresponding Risk Management Program (RMP) rule followed in 1996. Both programs include requirements for triennial compliance audits. Effective compliance audits are critical in identifying program weaknesses and ensuring the safety of facility personnel and the surrounding public. Large companies with corporate and facility health, safety, and environmental groups typically have the resources and experience to conduct audits internally, either through a corporate audit team or the sharing of personnel between multiple facilities. Small to medium sized businesses frequently do not have the expertise or the resources to perform compliance audits, and rely on third-party consultants to provide these services. This paper will discuss the observations of the authors in performing audits and working with PSM/RMP programs across a number of market sectors (e.g. chemical, petrochemical, pharmaceutical, food and beverage, water treatment), including effective practices, hurdles to successful implementation and execution of programs, and typical program shortcomings. The paper will also discuss steps to improve the audit process and increase effectiveness whether performed by a third party or internally.
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Geosphere process report for the safety assessment SR-Can
International Nuclear Information System (INIS)
Skagius, Kristina
2006-09-01
This report documents geosphere processes identified as relevant to the long-term safety of a KBS- repository, and forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The following excerpts describe the methodology, and clarify the role of this process report in the assessment. The repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock and the biosphere in the proximity of the repository, will evolve over time. Future states of the system will depend on the initial state of the system, a number of radiation related, thermal, hydraulic, mechanical, chemical and biological processes acting within the repository system over time, and external influences acting on the system. A methodology in ten steps has been developed for SR-Can described below. Identification of factors to consider (FEP processing): This step consists of identifying all the factors that need to be included in the analysis. Experience from earlier safety assessments and KBS-specific and international databases of relevant features, events and processes influencing long-term safety are utilised. Based on the results of the FEP processing, an SR-Can FEP catalogue, containing FEPs to be handled in SR-Can, has been established. The initial state of the system is described based on the design specifications of the KBS repository, a descriptive model of the repository site and a site-specific layout of the repository. The initial state of the fuel and the engineered components is that immediately after deposition, as described in the SR-Can Initial state report. The initial state of the geosphere and the biosphere is that of the natural system prior to excavation, as described in the site descriptive models. The repository layouts adapted to the sites are provided in underground
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Geosphere process report for the safety assessment SR-Can
Energy Technology Data Exchange (ETDEWEB)
Skagius, Kristina [Kemakta Konsult AB, Stockholm (SE)] (ed.)
2006-09-15
This report documents geosphere processes identified as relevant to the long-term safety of a KBS- repository, and forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The following excerpts describe the methodology, and clarify the role of this process report in the assessment. The repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock and the biosphere in the proximity of the repository, will evolve over time. Future states of the system will depend on the initial state of the system, a number of radiation related, thermal, hydraulic, mechanical, chemical and biological processes acting within the repository system over time, and external influences acting on the system. A methodology in ten steps has been developed for SR-Can described below. Identification of factors to consider (FEP processing): This step consists of identifying all the factors that need to be included in the analysis. Experience from earlier safety assessments and KBS-specific and international databases of relevant features, events and processes influencing long-term safety are utilised. Based on the results of the FEP processing, an SR-Can FEP catalogue, containing FEPs to be handled in SR-Can, has been established. The initial state of the system is described based on the design specifications of the KBS repository, a descriptive model of the repository site and a site-specific layout of the repository. The initial state of the fuel and the engineered components is that immediately after deposition, as described in the SR-Can Initial state report. The initial state of the geosphere and the biosphere is that of the natural system prior to excavation, as described in the site descriptive models. The repository layouts adapted to the sites are provided in underground
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Rotary mode core sampling approved checklist: 241-TX-113
International Nuclear Information System (INIS)
Fowler, K.D.
1998-01-01
The safety assessment for rotary mode core sampling was developed using certain bounding assumptions, however, those assumptions were not verified for each of the existing or potential flammable gas tanks. Therefore, a Flammable Gas/Rotary Mode Core Sampling Approved Checklist has been completed for tank 241-TX-113 prior to sampling operations. This transmittal documents the dispositions of the checklist items from the safety assessment
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Rotary mode core sampling approved checklist: 241-TX-116
International Nuclear Information System (INIS)
FOWLER, K.D.
1999-01-01
The safety assessment for rotary mode core sampling was developed using certain bounding assumptions, however, those assumptions were not verified for each of the existing or potential flammable gas tanks. Therefore, a Flammable Gas/Rotary Mode Core Sampling Approved Checklist has been completed for tank 241-TX-116 prior to sampling operations. This transmittal documents the dispositions of the checklist items from the safety assessment
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Radiation protection and safety of radiation sources international basic safety standards
International Atomic Energy Agency. Vienna
2014-01-01
The Board of Governors of the IAEA first approved Basic Safety Standards in June 1962; they were published by the IAEA as IAEA Safety Series No. 9. A revised edition was issued in 1967. A third revision was published by the IAEA as the 1982 Edition of IAEA Safety Series No. 9 ; this edition was jointly sponsored by the IAEA, ILO, OECD/NEA and the WHO. The next edition was International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, published by the IAEA as IAEA Safety Series No. 115 in February 1996, and jointly sponsored by the FAO, IAEA, ILO, OECD/NEA, PAHO and the WHO.
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The Conceptual Framework for Ensuring Economic Safety of Corporate Integration Processes
Directory of Open Access Journals (Sweden)
Gutsaliuk Oleksii M.
2016-08-01
Full Text Available The objective growth of the number of displays and influence of negative factors of threats from the environment actualizes the issue of ensuring economic safety of national economic entities. The article notes that simultaneously with counteracting threats enterprises are working for development, one form of which is the establishment of corporate structures and implementation of integration processes. It is proposed to ensure achieving the desired level of the corporate structure economic safety through optimizing the correlation of resources and competencies, skills and technologies for their use within the integrated logistics value chain. In this case it is the implementation of the integration process that serves as an instrument for achieving this optimal correlation, and the level of economic safety is considered as one of the optimization criteria. The system of authors’ hypotheses is taken as the basis for ensuring economic safety of the corporate integration process. Each of the hypotheses corresponds to a set of conceptual principles aimed at practical implementation of the proposed approaches. Within these conceptual principles the relationship between incentives and benefits of integration and the basis for ensuring their safety is presented, the differences between safety of functioning and safety of development are studied, the use of the methodology of logistics to harmonize the interests of participants of the corporate structure is justified, the relevance of applying the resource approach to manage the integration and development safety is proved. The graphical representation of causal relationships between the proposed conceptual principles allowed formalizing the subject area of studying corporate integration safety
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75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products
2010-12-29
..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...
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Implementation of safety goals in NRC's regulatory process
International Nuclear Information System (INIS)
Murley, T.E.
1985-01-01
In May 1983 the Nuclear Regulatory Commission issued a policy statement on Safety Goals For Nuclear Power Plant Operation. The Commission at the same time judged that a two-year evaluation period was necessary to judge the effectiveness of the goals and design objectives, and directed the staff to develop information and understanding as to how to further define and use the design objectives and the cost-benefit guidelines. In carrying out the Commission's mandate, the staff framed three major questions to be addressed during the safety goal evaluation period. These three questions are: 1) to what extent is it practical to use safety goals in the regulatory process. 2) Should the quantitative design objectives be modified or supplemented. If so, how. 3) How should the safety goals be implemented at the end of the evaluation period. The staff's conclusions are discussed
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Practicing chemical process safety: a look at the layers of protection
International Nuclear Information System (INIS)
Sanders, Roy E.
2004-01-01
This presentation will review a few public perceptions of safety in chemical plants and refineries, and will compare these plant workplace risks to some of the more traditional occupations. The central theme of this paper is to provide a 'within-the-fence' view of many of the process safety practices that world class plants perform to pro-actively protect people, property, profits as well as the environment. It behooves each chemical plant and refinery to have their story on an image-rich presentation to stress stewardship and process safety. Such a program can assure the company's employees and help convince the community that many layers of safety protection within our plants are effective, and protect all from harm
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Electronic Approval of Invoices (AEF)
2003-01-01
With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95
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Regulatory review of NPP Krsko Periodic Safety Review
International Nuclear Information System (INIS)
Lovincic, D.; Muehleisen, A.; Persic, A.
2004-01-01
At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)
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Safety Assurance Process for FRMS : EJcase Implementation
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
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Incorporation of Safety into Design Process : A Systems Engineering Perspective
Rajabalinejad, M.
2018-01-01
This paper suggests integrating the best safety practices with the design process. This integration enriches the exploration experience for designers and adds extra values and competitor advantages for customers. The paper introduces the safety cube for combining common blocks for design, hazard
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Fuel and canister process report for the safety assessment SR-Site
International Nuclear Information System (INIS)
Werme, Lars; Lilja, Christina
2010-12-01
This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/
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Fuel and canister process report for the safety assessment SR-Site
Energy Technology Data Exchange (ETDEWEB)
Werme, Lars; Lilja, Christina (eds.)
2010-12-15
This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/
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Application for approval to construct the Waste Receiving And Processing facility
International Nuclear Information System (INIS)
1993-02-01
The following Application For Approval Of Construction is being submitted by the US Department of Energy, Richland Field Office pursuant to 40 CFR 61.07, ''Application for Approval of Construction or Modification,'' for the Waste Receiving and Processing (WRAP) Module 1 facility (also referred to as WRAP 1). The WRAP 1 facility will be a new source of radioactive emissions to the atmosphere. The WRAP 1 facility will be housed in the new 2336-W Building, which will be located in the 200 West Area south of 23rd Street and west of Dayton Avenue. The 200 West Area is located within the boundary of the Hanford Site. The mission of the WRAP 1 facility is to examine, assay, characterize, treat, and repackage solid radioactive and mixed waste to enable permanent disposal of the waste in accordance with all applicable regulations. The solid wastes to be handled in the WRAP 1 facility include low-level waste (LLW), Transuranic (TRU) waste, TRU mixed waste, and low-level mixed waste (LLMW). The WRAP 1 facility will only accept contact handled (CH) waste containers. CH waste is a waste category whose external surface dose rate does not exceed 200 mrem/h. These containers have a surface dose rate of less than 200 mrem/h
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Cultural safety as an ethic of care: a praxiological process.
McEldowney, Rose; Connor, Margaret J
2011-10-01
New writings broadening the construct of cultural safety, a construct initiated in Aotearoa New Zealand, are beginning to appear in the literature. Therefore, it is considered timely to integrate these writings and advance the construct into a new theoretical model. The new model reconfigures the constructs of cultural safety and cultural competence as an ethic of care informed by a postmodern perspective. Central to the new model are three interwoven, co-occurring components: an ethic of care, which unfolds within a praxiological process shaped by the context. Context is expanded through identifying the three concepts of relationality, generic competence, and collectivity, which are integral to each client-nurse encounter. The competence associated with cultural safety as an ethic of care is always in the process of development. Clients and nurses engage in a dialogue to establish the level of cultural safety achieved at given points in a care trajectory.
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Quantitative safety goals for the regulatory process
International Nuclear Information System (INIS)
Joksimovic, V.; O'Donnell, L.F.
1981-01-01
The paper offers a brief summary of the current regulatory background in the USA, emphasizing nuclear, related to the establishment of quantitative safety goals as a way to respond to the key issue of 'how safe is safe enough'. General Atomic has taken a leading role in advocating the use of probabilistic risk assessment techniques in the regulatory process. This has led to understanding of the importance of quantitative safety goals. The approach developed by GA is discussed in the paper. It is centred around definition of quantitative safety regions. The regions were termed: design basis, safety margin or design capability and safety research. The design basis region is bounded by the frequency of 10 -4 /reactor-year and consequences of no identifiable public injury. 10 -4 /reactor-year is associated with the total projected lifetime of a commercial US nuclear power programme. Events which have a 50% chance of happening are included in the design basis region. In the safety margin region, which extends below the design basis region, protection is provided against some events whose probability of not happening during the expected course of the US nuclear power programme is within the range of 50 to 90%. Setting the lower mean frequency to this region of 10 -5 /reactor-year is equivalent to offering 90% assurance that an accident of given severity will not happen. Rare events with a mean frequency below 10 -5 can be predicted to occur. However, accidents predicted to have a probability of less than 10 -6 are 99% certain not to happen at all, and are thus not anticipated to affect public health and safety. The area between 10 -5 and 10 -6 defines the frequency portion of the safety research region. Safety goals associated with individual risk to a maximum-exposed member of public, general societal risk and property risk are proposed in the paper
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DEFF Research Database (Denmark)
Debois, Søren; Hildebrandt, Thomas; Slaats, Tijs
2015-01-01
and verification of flexible, run-time adaptable process-aware information systems, moved into practice via the Dynamic Condition Response (DCR) Graphs notation co-developed with our industrial partner. Our key contributions are: (1) A formal theory of dynamic sub-process instantiation for declarative, event......We study modularity, run-time adaptation and refinement under safety and liveness constraints in event-based process models with dynamic sub-process instantiation. The study is part of a larger programme to provide semantically well-founded technologies for modelling, implementation......-based processes under safety and liveness constraints, given as the DCR* process language, equipped with a compositional operational semantics and conservatively extending the DCR Graphs notation; (2) an expressiveness analysis revealing that the DCR* process language is Turing-complete, while the fragment cor...
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A new approach to preparing safety cases for existing nuclear plant (COSR)
International Nuclear Information System (INIS)
Rice, S.A.; Buchan, A.B.
2000-01-01
BNFL is committed to achieving world class safety performance, through a process of continuously reviewing and improving its safety practices. In the mid 1990s, as part of this process, the company began to develop a new type of safety case, for existing non-reactor nuclear plants, called the continued operation safety report (COSR). Following a significant amount of development work from experts within BNFL and important contributions from its regulators, the first approved COSR was recently completed and submitted to the Nuclear Installations Inspectorate. The COSR aims to provide a visibly integrated safety and engineering case for the adequacy of continued operation of a nuclear facility. It achieves this by identifying the main plant structures, systems and components that have a safety function and provides the appropriate supporting engineering substantiation. The COSR aims to explore plant safety and identify worthwhile improvements. The document also aims to be reader-friendly by focusing on the main safety issues. It is therefore a slim safety summary which provides operators, safety specialists and regulators with an overview and introduction into the broader, more detailed safety case. This paper provides an overview of the COSR and its production process, describing the safety case improvements that have been made by comparing it to its predecessor, the fully developed safety case. The paper also illustrates the benefits of the COSR by providing current examples of its application on existing BNFL plant. Finally, the paper describes ongoing development work aimed at further improving the COSR and its production process. (author)
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Lessons Learned from a Five-year Evaluation of the Belgian Safety Culture Oversight Process
International Nuclear Information System (INIS)
Bernard, B.
2016-01-01
The Belgian Regulatory Body has implemented a Safety Culture oversight process since 2010. In a nutshell, this process is based on field observations provided by inspectors or safety analysts during any contact with a licencee (inspections, meetings, phone calls, etc). These observations are recorded within an observation (excel) sheet—aiming at describing factual and contextual issues — and are linked to IAEA Safety Culture attributes. It should be stressed that the purpose of the process is not to give a comprehensive view of a licencee safety culture but to address findings that require attention or action on the part of a licencee. In other words, gathering safety culture observations aims at identifying cultural, organizational or behavioural issues in order to feed a regulatory response to potential problems. Safety Culture Observations (SCO) are then fully integrated in routine inspection activities and must be seen as an input of the overall oversight process. As a result, the assessment of the SCO is inserted within the yearly safety evaluation report performed by Bel V and transmitted to the licencee. However, observing safety culture is not a natural approach for engineers. Guidance, training and coaching must be provided in order to open up safety dimensions to be captured. In other words, a SCO process requires a continuous support in order to promote a holistic and systemic view of safety.
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Safety implications of computerized process control in nuclear power plants
International Nuclear Information System (INIS)
1991-02-01
Modern nuclear power plants are making increasing use of computerized process control because of the number of potential benefits that accrue. This practice not only applies to new plants but also to those in operation. Here, the replacement of both conventional process control systems and outdated computerized systems is seen to be of benefit. Whilst this contribution is obviously of great importance to the viability of nuclear electricity generation, it must be recognized that there are major safety concerns in taking this route. However, there is the potential for enhancing the safety of nuclear power plants if the full power of microcomputers and the associated electronics is applied correctly through well designed, engineered, installed and maintained systems. It is essential that areas where safety can be improved be identified and that the pitfalls are clearly marked so that they can be avoided. The deliberations of this Technical Committee Meeting are a step on the road to this goal of improved safety through computerized process control. This report also contains the papers presented at the technical committee meeting by participants. A separate abstract was prepared for each of these 15 presentations. Refs, figs and tabs
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Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B
2016-12-12
The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.
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Robotic and nuclear safety for an automated/teleoperated glove box system
International Nuclear Information System (INIS)
Domning, E.E.; McMahon, T.T.; Sievers, R.H.
1991-09-01
Lawrence Livermore National Laboratory (LLNL) is developing a fully automated system to handle the processing of special nuclear materials (SNM). This work is performed in response to the new goals at the Department of Energy (DOE) for hazardous waste minimization and radiation dose reduction. This fully automated system, called the automated test bed (ATB), consists of an IBM gantry robot and automated processing equipment sealed within a glove box. While the ATB is a cold system, we are designing it as a prototype of the future hot system. We recognized that identification and application of safety requirements early in the design phase will lead to timely installation and approval of the hot system. This paper identifies these safety issues as well as the general safety requirements necessary for the safe operation of the ATB. 4 refs., 2 figs
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Moloughney, Brent W; Bursey, Gayle E; Neumann, Jana; Leeming, Daniel H; Gutmann, Christine E; Sivanand, Bhavna; Mowat, David L
2014-09-12
This project involved development of a Health Background Study (HBS) Framework to support consideration of health impacts within municipalities' approval process for land use development. Peel Public Health and Toronto Public Health led the project with the participation of planners, urban designers, engineers, public health staff and development industry representatives. Historical growth in the Region of Peel and suburban Toronto has resulted in extensive low-density development, creating car-dependent communities with disconnected streets and segregated land uses. The inclusion of an HBS in developers' applications to municipalities is one approach by which health-related expectations for the built environment can be established within the approval process. Development of the HBS Framework used the six core elements of the built environment with the strongest evidence for impact on health and was informed by analysis of the provincial and local policy contexts, practices of other municipalities and stakeholder interviews. The Framework's contents were refined according to feedback from multidisciplinary stakeholder workshops. The HBS Framework identifies minimum standards for built environment core elements that developers need to address in their applications. The Framework was created to be simple and instructive with applicability to a range of development locations and scales, and to various stages of the development approval process. Peel Public Health is leading several initiatives to support the use of the HBS as a part of the development application process. The HBS Framework is a tool that public health and planning can use to support the consideration of health impacts within municipalities' land use development processes.
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Energy Technology Data Exchange (ETDEWEB)
Bennion, N; Driewer, J; Denniston, K; Zhen, W; Enke, C [University of Nebraska Medical Center, Omaha, NE (United States); Jacobs, K; Poole, M; McMahon, R; Wilson, K; Yager, A [Nebraska Medicine, Omaha, NE (United States)
2015-06-15
Purpose: Successful radiation therapy requires multi-step processes susceptible to unnecessary delays that can negatively impact clinic workflow, patient satisfaction, and safety. This project applied process improvement tools to assess workflow bottlenecks and identify solutions to barriers for effective implementation. Methods: We utilized the DMAIC (define, measure, analyze, improve, control) methodology, limiting our scope to the treatment planning process. From May through December of 2014, times and dates of each step from simulation to treatment were recorded for 507 cases. A value-stream map created from this dataset directed our selection of outcome measures (Y metrics). Critical goals (X metrics) that would accomplish the Y metrics were identified. Barriers to actions were binned into control-impact matrices, in order to stratify them into four groups: in/out of control and high/low impact. Solutions to each barrier were then categorized into benefit-effort matries to identify those of high benefit and low effort. Results: For 507 cases, the mean time from simulation to treatment was 235 total hours. The mean process and wait time were 60 and 132 hours, respectively. The Y metric was to increase the ratio of all non-emergent plans completed the business day prior to treatment from 47% to 75%. Project X metrics included increasing the number of IMRT QAs completed at least 24 hours prior to treatment from 19% to 80% and the number of non-IMRT plans approved at least 24 hours prior to treatment from 33% to 80%. Intervals from simulation to target contour and from initial plan completion to plan approval were identified as periods that could benefit from intervention. Barriers to actions were binned into control-impact matrices and solutions by benefit-effort matrices. Conclusion: The DMAIC method can be successfully applied in radiation therapy clinics to identify inefficiencies and prioritize solutions for the highest impact.
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The US Food and Drug Administration's tentative approval process and the global fight against HIV.
Chahal, Harinder Singh; Murray, Jeffrey S; Shimer, Martin; Capella, Peter; Presto, Ryan; Valdez, Mary Lou; Lurie, Peter G
2017-12-01
In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. In this paper, we describe the
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CESAR cost-efficient methods and processes for safety-relevant embedded systems
Wahl, Thomas
2013-01-01
The book summarizes the findings and contributions of the European ARTEMIS project, CESAR, for improving and enabling interoperability of methods, tools, and processes to meet the demands in embedded systems development across four domains - avionics, automotive, automation, and rail. The contributions give insight to an improved engineering and safety process life-cycle for the development of safety critical systems. They present new concept of engineering tools integration platform to improve the development of safety critical embedded systems and illustrate capacity of this framework for end-user instantiation to specific domain needs and processes. They also advance state-of-the-art in component-based development as well as component and system validation and verification, with tool support. And finally they describe industry relevant evaluated processes and methods especially designed for the embedded systems sector as well as easy adoptable common interoperability principles for software tool integratio...
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International Nuclear Information System (INIS)
2016-01-01
After having recalled the regulatory context and sanctions susceptible to be applied, the first volume presents the accreditation process for a package model: file content, tests programme, safety file, certification studies, documents to be produced, accreditation prorogation request, accreditation extension or package model modifications, instruction delays. Some peculiar cases are described. Models of accreditation certificate are provided, and obligations concerning packaging design, fabrication, use and maintenance are briefly discussed. The second volume is a European technical guide which is intended to assist in the preparation of the Package Design Safety Report (PDSR) to demonstrate compliance of a package design for the transport of radioactive material with the regulatory requirements. It covers package designs requiring competent authority approval, and also covers package designs not requiring competent authority approval. In its first two chapters, this document provides a generic structure and contents of a PDSR which applies to all package types. The contents are described in a comprehensive way to cover all important aspects. Some of these aspects may not be applicable to specific package type and details can be found in the annexes which provide further guidance for the scope of the contents of a PDSR, specifically for each package type. The third volume presents recommendations made by the ASN for all stakeholders to guarantee the compliance to regulation of package models which are 'not submitted to competent authority approval'. After an indication and a comment of the regulatory context, it presents requirements to be applied for the design of those package models, and then describes and comments the structure and content of a safety file for such package models (generalities, authorised contents, packaging description, safety demonstration, receipt, use and maintenance instruction, management system). The last part presents the
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National nuclear safety report 1998. Convention on nuclear safety
International Nuclear Information System (INIS)
1998-01-01
The Argentine Republic subscribed the Convention on Nuclear Safety, approved by a Diplomatic Conference in Vienna, Austria, in June 17th, 1994. According to the provisions in Section 5th of the Convention, each Contracting Party shall submit for its examination a National Nuclear Safety Report about the measures adopted to comply with the corresponding obligations. This Report describes the actions that the Argentine Republic is carrying on since the beginning of its nuclear activities, showing that it complies with the obligations derived from the Convention, in accordance with the provisions of its Article 4. The analysis of the compliance with such obligations is based on the legislation in force, the applicable regulatory standards and procedures, the issued licenses, and other regulatory decisions. The corresponding information is described in the analysis of each of the Convention Articles constituting this Report. The present National Report has been performed in order to comply with Article 5 of the Convention on Nuclear Safety, and has been prepared as much as possible following the Guidelines Regarding National Reports under the Convention on Nuclear Safety, approved in the Preparatory Meeting of the Contracting Parties, held in Vienna in April 1997. This means that the Report has been ordered according to the Articles of the Convention on Nuclear Safety and the contents indicated in the guidelines. The information contained in the articles, which are part of the Report shows the compliance of the Argentine Republic, as a contracting party of such Convention, with the obligations assumed
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Processes on Uncontrolled Aerodromes and Safety Indicators - Part I
Directory of Open Access Journals (Sweden)
Vladimír Plos
2013-09-01
Full Text Available This article describes the processes that take place at the beginning of each duty of dispatcher at uncontrolled aerodromes.Thanks to modeling and analysis of these processes, there is a possible to find critical ones and implement precise targeted safety measures.
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Spent nuclear fuel project cold vacuum drying facility safety equipment list
International Nuclear Information System (INIS)
IRWIN, J.J.
1999-01-01
This document provides the safety equipment list (SEL) for the Cold Vacuum Drying Facility (CVDF). The SEL was prepared in accordance with the procedure for safety structures, systems, and components (SSCs) in HNF-PRO-516, ''Safety Structures, Systems, and Components,'' Revision 0 and HNF-PRO-097, Engineering Design and Evaluation, Revision 0. The SEL was developed in conjunction with HNF-SO-SNF-SAR-O02, Safety Analysis Report for the Cold Vacuum Drying Facility, Phase 2, Supporting Installation of Processing Systems (Garvin 1998). The SEL identifies the SSCs and their safety functions, the design basis accidents for which they are required to perform, the design criteria, codes and standards, and quality assurance requirements that are required for establishing the safety design basis of the SSCs. This SEL has been developed for the CVDF Phase 2 Safety Analysis Report (SAR) and shall be updated, expanded, and revised in accordance with future phases of the CVDF SAR until the CVDF final SAR is approved
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Auditing the process of ethics approval for Master’s degrees at a South African university
Directory of Open Access Journals (Sweden)
Damian Clarke
2014-04-01
Full Text Available Introduction. This study audited the process of ethics approval for Master’s research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa.Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master’s proposal for the year 2010 was reviewed. Results. A total of 53 proposals for Master’s degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32 for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC to respond to each of the 53 proposals. Twenty-three studies (43.4% received provisional approval on the first response, 2 proposals (3.8% were rejected, and 28 proposals (52.8% were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.
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2012-03-22
... Monitoring System and the Food Safety Mobile Questionnaire) AGENCY: Food Safety and Inspection Service, USDA... Safety Mobile questionnaire. The approval for this information collection is due to expire. FSIS is... post their personal contact information--mailing address, email address, and telephone number-- on the...
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10 CFR 712.36 - Medical assessment process.
2010-01-01
... and psychological evaluation. HRP medical assessments and psychological evaluations may not be... psychological assessment (test) approved by the Director, Office of Health and Safety or his or her designee and... psychological assessment (test) approved by the Director, Office of Health and Safety or his or her designee. (4...
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Verification and validation process for the safety software in KNICS
International Nuclear Information System (INIS)
Kwon, Kee-Choon; Lee, Jang-Soo; Kim, Jang-Yeol
2004-01-01
This paper describes the Verification and Validation (V and V ) process for safety software of Programmable Logic Controller (PLC), Digital Reactor Protection System (DRPS), and Engineered Safety Feature-Component Control System (ESF-CCS) that are being developed in Korea Nuclear Instrumentation and Control System (KNICS) projects. Specifically, it presents DRPS V and V experience according to the software development life cycle. The main activities of DRPS V and V process are preparation of software planning documentation, verification of Software Requirement Specification (SRS), Software Design Specification (SDS) and codes, and testing of the integrated software and the integrated system. In addition, they include software safety analysis and software configuration management. SRS V and V of DRPS are technical evaluation, licensing suitability evaluation, inspection and traceability analysis, formal verification, preparing integrated system test plan, software safety analysis, and software configuration management. Also, SDS V and V of RPS are technical evaluation, licensing suitability evaluation, inspection and traceability analysis, formal verification, preparing integrated software test plan, software safety analysis, and software configuration management. The code V and V of DRPS are traceability analysis, source code inspection, test case and test procedure generation, software safety analysis, and software configuration management. Testing is the major V and V activity of software integration and system integration phase. Software safety analysis at SRS phase uses Hazard Operability (HAZOP) method, at SDS phase it uses HAZOP and Fault Tree Analysis (FTA), and at implementation phase it uses FTA. Finally, software configuration management is performed using Nu-SCM (Nuclear Software Configuration Management) tool developed by KNICS project. Through these activities, we believe we can achieve the functionality, performance, reliability and safety that are V
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2011-06-06
...) Program--Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties AGENCY... approve revisions to the Pennsylvania State Implementation Plan (SIP). The revision consists of a change... prior SIP-approved I/M program to change the duration of the timing of quality assurance audits...
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2012-08-06
... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety Commission. ACTION... information collection requirements for manufacturers and importers of children's articles known as baby...
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Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark
2017-06-01
An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post
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Safety certification of airborne software: An empirical study
International Nuclear Information System (INIS)
Dodd, Ian; Habli, Ibrahim
2012-01-01
Many safety-critical aircraft functions are software-enabled. Airborne software must be audited and approved by the aerospace certification authorities prior to deployment. The auditing process is time-consuming, and its outcome is unpredictable, due to the criticality and complex nature of airborne software. To ensure that the engineering of airborne software is systematically regulated and is auditable, certification authorities mandate compliance with safety standards that detail industrial best practice. This paper reviews existing practices in software safety certification. It also explores how software safety audits are performed in the civil aerospace domain. The paper then proposes a statistical method for supporting software safety audits by collecting and analysing data about the software throughout its lifecycle. This method is then empirically evaluated through an industrial case study based on data collected from 9 aerospace projects covering 58 software releases. The results of this case study show that our proposed method can help the certification authorities and the software and safety engineers to gain confidence in the certification readiness of airborne software and predict the likely outcome of the audits. The results also highlight some confidentiality issues concerning the management and retention of sensitive data generated from safety-critical projects.
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Rising calls for food safety. Radiation technology becomes a timely answer
International Nuclear Information System (INIS)
Loaharanu, Paisan
2001-01-01
Food safety has become an issue of high priority to many governments. Well publicized cases have shown that an outbreak of a major foodborne disease can have health, political, and economic consequences. Coupled with the increasing interest and publicity by the media, public awareness and concerns about food safety have reached a new height. Issues related to mad cow disease, and genetically modified food have attracted further attention and concern. Awareness of risks involving microbiological contamination of food has increased significantly in the past decade. There have been several major foodborne disease outbreaks caused by various pathogenic bacteria and parasites and widespread coverage by the media. The outbreaks have focused closer attention on food processing technologies to ensure the safety and quality of food. This article reports on developments for the application of irradiation technology for food processing, which has been approved for use in more than 40 countries
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Use of safety analysis results to support process operation
International Nuclear Information System (INIS)
Karvonen, I.; Heino, P.
1990-01-01
Safety and risk analysis carried out during the design phase of a process plant produces useful knowledge about the behavior and the disturbances of the system. This knowledge, however, often remains to the designer though it would be of benefit to the operators and supervisors of the process plant, too. In Technical Research Centre of Finland a project has been started to plan and construct a prototype of an information system to make use of the analysis knowledge during the operation phase. The project belongs to a Nordic KRM project (Knowledge Based Risk Management System). The information system is planned to base on safety and risk analysis carried out during the design phase and completed with operational experience. The safety analysis includes knowledge about potential disturbances, their causes and consequences in the form of Hazard and Operability Study, faut trees and/or event trees. During the operation disturbances can however, occur, which are not included in the safety analysis, or the causes or consequences of which have been incompletely identified. Thus the information system must also have an interface for the documentation of the operational knowledge missing from the analysis results. The main tasks off the system when supporting the management of a disturbance are to identify it (or the most important of the coexistent ones) from the stored knowledge and to present it in a proper form (for example as a deviation graph). The information system may also be used to transfer knowledge from one shift to another and to train process personnel
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Guidance for package approvals in the United Kingdom
International Nuclear Information System (INIS)
Morgan-Warren, E.J.
2004-01-01
Approval is required under the transport regulations for a wide range of package designs and operations, and applications for competent authority approval and validation are received from many sources, both in the UK and overseas. To assist package designers and applicants for approval, and to promote consistency in applications and their assessment, the UK Department for Transport issues guidance on the interpretation of the transport regulations and the requirements of an application for approval and its supporting safety case. The general guidance document, known as the Guide to an Application for UK Competent Authority Approval of Radioactive Material in Transport, has been issued for many years and updated to encompass the provisions of each successive edition of the IAEA transport regulations. The guide has been referred to in a number of international fora, including PATRAM, and was cited as a 'good practice' in the report of the IAEA TRANSAS appraisal of the UK in 2002. Specialist guides include the Guide to the Suitability of Elastomeric Seal Materials, which is the subject of a separate paper in this conference, and the Guide to the Approval of Freight Containers as Types IP-2 and IP-3 Packages. This paper discusses the guidance material and summarises the administrative and technical information required in support of applications for approval of package designs, special form and low-dispersible radioactive materials, shipments, special arrangements, modifications and validations. (author)
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78 FR 32010 - Pipeline Safety: Public Workshop on Integrity Verification Process
2013-05-28
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Hazardous Materials Safety Administration, DOT. ACTION: Notice of public meeting. SUMMARY: This notice is announcing a public workshop to be held on the concept of ``Integrity Verification Process.'' The Integrity...
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Consumer approval of irradiated meat still tentative
International Nuclear Information System (INIS)
Hollingsworth, P.
1998-01-01
Although the FDA has approved irradiation of red meat, consumers may not be so accepting of the use of this technology. Irradiation is a process used to improve food safety in food products susceptible to disease-causing microorganisms. The red meat ruling was widely praised by federal officials and food industry leaders, but consumers seem less sure. Indeed, on the night of the red meat announcement last December, CBS Evening News reported that over 70 percent of U.S. consumers would not knowingly eat irradiated food. There is hope, however, as a study by the Center for Consumer Research at the University of California, Davis, revealed that consumer interest in buying irradiated food can be substantially improved by providing consumers with information, thereby enabling them to see the benefits and to overcome the myths of irradiation
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The micro-processor controlled process radiation monitoring system for reactor safety systems
International Nuclear Information System (INIS)
Mizuno, K.; Noguchi, A.; Kumagami, S.; Gotoh, Y.; Kumahara, T.; Arita, S.
1986-01-01
Digital computers are soon expected to be applied to various real-time safety and safety-related systems in nuclear power plants. Hitachi is now engaged in the development of a micro-processor controlled process radiation monitoring system, which operates on digital processing methods employed with a log ratemeter. A newly defined methodology of design and test procedures is being applied as a means of software program verification for these safety systems. Recently implemented micro-processor technology will help to achieve an advanced man-machine interface and highly reliable performance. (author)
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Environment, safety and health progress assessment manual
International Nuclear Information System (INIS)
1992-12-01
On June 27, 1989, the Secretary of Energy announced a 10-Point Initiative to strengthen environment, safety, and health (ES ampersand H) programs, and waste management activities at DOE production, research, and testing facilities. One of the points involved conducting dent Tiger Team Assessments of DOE operating facilities. The Office of Special independent Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This manual documents the processes to be used to perform the ES ampersand H Progress Assessments. It was developed based upon the lessons learned from Tiger Team Assessments, the two pilot Progress Assessments, and Progress Assessments that have been completed. The manual will be updated periodically to reflect lessons learned or changes in policy
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International Nuclear Information System (INIS)
Biscan, Romeo; Fifnja, Igor
2014-01-01
Nuklearna Elektrarna Krsko (NEK) has undertaken Nuclear Safety Upgrade Projects as a safety improvement driven by the lessons learned from the Fukushima-Daiichi Accident. Among other projects, new modification 1008-VA-L Passive Containment Filtered Vent (PCFV) System has been installed which acts as the last barrier minimizing the release of radioactive material into the environment in case of failure of all safety systems, and to insure containment integrity during beyond design basis accidents (BDBA). In addition, modification 1002-GH-L Severe Accident Hydrogen Control System (PAR) has been implemented to prevent and mitigate the consequences of explosive gas generation (hydrogen and carbon monoxide) in case of reactor core melting. To ensure containment integrity for all design basis accidents (DBA) and BDBA conditions, NEK has eliminated existing safety-related electrical recombiners, replaced them with two safety-related passive autocatalytic recombiners (PARs) and added 20 new PARs designed for the BDBA conditions. Krsko NPP Quality Assurance Plan has been applied to Nuclear Safety Upgrade Projects (PCFV System and PAR System) through the following activities: · Internal audit of modification process was performed. · Supplier audits were performed to evaluate QA program efficiency of the main design organization and engineering organizations. · Evaluation and approval of Suppliers were performed. · QA engineer was involved in the review and approval of 1008-VA-L and 1002-GH-L modification documentation (Conceptual Design Package, Design Modification Package, Installation Package, Field Design Change Request, Problem/Deficiency Report, and Final Documentation Package). · Purchasing documentation for modifications 1008-VA-L and 1002-GH-L (technical specifications, purchase orders) has been verified and approved by QA. · QA and QC engineers were involved in oversight of production and testing of the new 1008-VA-L and 1002-GH-L plant components.
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2012-09-11
... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0038] Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety... collection requirements for manufacturers and importers of children's articles known as baby-bouncers and...
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International Nuclear Information System (INIS)
1992-12-01
This report is to provide a comprehensive description of the implementation and verification status of Three Mile Island (TMI) Action Plan requirements, safety issues designated as Unresolved Safety Issues (USIs), Generic Safety Issues(GSIs), and other Multiplant Actions (MPAs) that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional purpose of this NUREG report is to serve as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees
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29 CFR 1956.24 - Procedures for withdrawal of approval.
2010-07-01
... 29 Labor 9 2010-07-01 2010-07-01 false Procedures for withdrawal of approval. 1956.24 Section 1956.24 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... do so, at least developmentally), no industrial or occupational issues may be considered a separable...
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9 CFR 355.34 - Labels, approval of, by Administrator.
2010-01-01
... INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF...
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Process value of care safety: women's willingness to pay for perinatal services.
Anezaki, Hisataka; Hashimoto, Hideki
2017-08-01
To evaluate the process value of care safety from the patient's view in perinatal services. Cross-sectional survey. Fifty two sites of mandated public neonatal health checkup in 6 urban cities in West Japan. Mothers who attended neonatal health checkups for their babies in 2011 (n = 1316, response rate = 27.4%). Willingness to pay (WTP) for physician-attended care compared with midwife care as the process-related value of care safety. WTP was estimated using conjoint analysis based on the participants' choice over possible alternatives that were randomly assigned from among eight scenarios considering attributes such as professional attendance, amenities, painless delivery, caesarean section rate, travel time and price. The WTP for physician-attended care over midwife care was estimated 1283 USD. Women who had experienced complications in prior deliveries had a 1.5 times larger WTP. We empirically evaluated the process value for safety practice in perinatal care that was larger than a previously reported accounting-based value. Our results indicate that measurement of process value from the patient's view is informative for the evaluation of safety care, and that it is sensitive to individual risk perception for the care process. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.
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Excipients and their role in approved injectable products: current usage and future directions.
Nema, Sandeep; Brendel, Ronald J
2011-01-01
This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications. Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving
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2013-04-12
... Control Number: 2120-XXXX. Title: Safety Awareness, Feedback, and Evaluation (SAFE) Program. Form Numbers: No FAA forms are associated with this collection. Type of Review: Clearance of a new information... Activities: Requests for Comments; Clearance of New Approval of Information Collection: Safety Awareness...
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77 FR 22384 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche
2012-04-13
... vehicle with the driver. The key contains a radio signal transponder which signals the control unit to... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety...
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Energy Technology Data Exchange (ETDEWEB)
Rydnert, Bo; Groenlund, Bjoern [SIS Forum AB, Stockholm (Sweden)
2005-12-15
An initiative from The Swedish Nuclear Power Inspectorate led to this study carried out in the late autumn of 2005. The objective was to understand in more detail how an increasing use of process management affects organisations, on the one hand regarding risks and security, on the other hand regarding management by objectives and other management and operative effects. The main method was interviewing representatives of companies and independent experts. More than 20 interviews were carried out. In addition a literature study was made. All participating companies are using Management Systems based on processes. However, the methods chosen, and the results achieved, vary extensively. Thus, there are surprisingly few examples of complete and effective management by processes. Yet there is no doubt that management by processes is effective and efficient. Overall goals are reached, business results are achieved in more reliable ways and customers are more satisfied. The weaknesses found can be translated into a few comprehensive recommendations. A clear, structured and acknowledged model should be used and the processes should be described unambiguously. The changed management roles should be described and obeyed extremely legibly. New types of process objectives need to be formulated. In addition one fact needs to be observed and effectively fended off. Changes are often met by mental opposition on management level, as well as among co-workers. This fact needs attention and leadership. Safety development is closely related to the design and operation of a business management system and its continual improvement. A deep understanding of what constitutes an efficient and effective management system affects the understanding of safety. safety culture and abilities to achieve safety goals. Concerning risk, the opinions were unambiguous. Management by processes as such does not result in any further risks. On the contrary. Processes give a clear view of production and
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This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable
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This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel
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This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel
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This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f
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78 FR 2315 - Projects Approved for Consumptive Uses of Water
2013-01-10
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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78 FR 15402 - Projects Approved for Consumptive Uses of Water
2013-03-11
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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78 FR 11947 - Projects Approved for Consumptive Uses of Water
2013-02-20
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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78 FR 17281 - Projects Approved for Consumptive Uses of Water
2013-03-20
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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77 FR 16317 - Projects Approved for Consumptive Uses of Water
2012-03-20
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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77 FR 21143 - Projects Approved for Consumptive Uses of Water
2012-04-09
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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77 FR 34455 - Projects Approved for Consumptive Uses of Water
2012-06-11
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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77 FR 55891 - Projects Approved for Consumptive Uses of Water
2012-09-11
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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77 FR 55892 - Projects Approved for Consumptive Uses of Water
2012-09-11
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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77 FR 59239 - Projects Approved for Consumptive Uses of Water
2012-09-26
... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...
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Preparation of Phased and Merged Safety Analysis Reports for New DOE Nuclear Facilities
International Nuclear Information System (INIS)
BISHOP, G.E.
2000-01-01
The Spent Nuclear Fuels Project (SNFP) is charged with moving to storage 2,100 metric tons of spent nuclear fuel elements left over from plutonium production at DOE'S Hanford site in Washington state. Two new facilities, the Cold Vacuum Drying Facility (CVDF) and the Canister Storage Building (CSB) are in final construction. In order to meet aggressive schedule commitments, the SNFP chose to prepare the safety analysis reports (SAR's) in phases that covered only specific portions of each facility's design as it was built. Each SAR also merged the preliminary and final safety analysis reports into a single SAR, thereby covering all aspects of design, construction, and operation for that portion (phase) of the facility. A policy of ''NRC equivalency'' was also implemented in parallel with this effort, with the goal of achieving a rigor of safety analysis equivalent to that of NRC-licensed fuel processing facilities. DOE Order 5480.23. ''Nuclear Safety Analysis Reports'' allows preparation of both a phased and a merged SAR to accelerate construction schedules. However, project managers must be aware that such acceleration is not guaranteed. Managers considering this approach for their project should be cognizant of numerous obstacles that will be encountered. Merging and phasing SAR's will create new, unique, and unanticipated difficulties which may actually slow construction unless expeditiously and correctly managed. Pitfalls to be avoided and good practices to be implemented in preparing phased and merged SAR's are presented. The value of applying NRC requirements to the DOE safety analysis process is also discussed. As of December, 1999, the SNFP has completed and approved a SAR for the CVDF. Approval of the SAR for the CSB is pending
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Applying for ethical approval for research: the main issues.
Gelling, Leslie
2016-01-13
The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.
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Leonard, Elizabeth Weeks
2009-01-01
On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
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Perspective on safety case to support a possible site recommendation decision
International Nuclear Information System (INIS)
Gil, A.V.; Gamble, R.P.
2002-01-01
The mission of the US Department of Energy (DOE) is to provide the basis for a national decision regarding the development of a geological repository for spent nuclear fuel and high-level radioactive waste at the Yucca Mountain site in Nevada. There are a number of steps in the decision process defined by US law that must be completed prior to development of a repository at this site. The DOE's focus is currently on the first two steps in this process: characterization of the site to support a determination by the DOE on whether the site is suitable for a geologic repository and a decision by the Secretary of Energy (the Secretary) on whether to recommend to the President that the site be approved for a repository. To enhance the confidence of multiple audiences in the basis for these actions, and to provide a basis for subsequent action by the President and the US Congress, information supporting the decision process must include the elements of a safety case consistent with the statutory and regulatory framework for these decisions. The idea of a safety case is to broaden the basis for confidence by decision-makers and the public in conclusions about safety. A safety case should cite multiple lines of evidence, or reasoning, beyond the results of a safety assessment to support the demonstration of safety, which includes compliance with applicable safety criteria. The multiple lines of evidence should show the basis for confidence in safety. To be most effective, such evidence requires information not directly used in the safety assessment. (author)
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14 CFR 125.211 - Seat and safety belts.
2010-01-01
... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Seat and safety belts. 125.211 Section 125... Requirements § 125.211 Seat and safety belts. (a) No person may operate an airplane unless there are available... the airplane who is at least 2 years old; and (2) An approved safety belt for separate use by each...
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A guide for approval of x-ray fluorescence analysis devices
International Nuclear Information System (INIS)
1990-01-01
This guide has been written to assist manufacturers, distributors and users of x-ray fluorescence analysis devices in the preparation of a submission to the Atomic Energy Control Board (AECB) in support of a request for approval of an x-ray fluorescence analysis device. Prior to the issuance of a Radioisotope licence authorizing the use or possession of an x-ray fluorescence analysis device in Canada, the design and construction of the device must be approved by the AECB. The AECB assessment is limited to the radiation safety aspects of use and packaging for transportation
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Use of nanotechnology in food processing, packaging and safety ...
African Journals Online (AJOL)
Use of nanotechnology in food processing, packaging and safety – review. ... application of nanotechnology in food packaging and food contact materials, ... developing active antimicrobial and antifungal surfaces, and sensing as well as ...
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Safety reviews of next-generation light-water reactors
International Nuclear Information System (INIS)
Kudrick, J.A.; Wilson, J.N.
1997-01-01
The Nuclear Regulatory Commission (NRC) is reviewing three applications for design certification under its new licensing process. The U.S. Advanced Boiling Water Reactor (ABWR) and System 80+ designs have received final design approvals. The AP600 design review is continuing. The goals of design certification are to achieve early resolution of safety issues and to provide a more stable and predictable licensing process. NRC also reviewed the Utility Requirements Document (URD) of the Electric Power Research Institute (EPRI) and determined that its guidance does not conflict with NRC requirements. This review led to the identification and resolution of many generic safety issues. The NRC determined that next-generation reactor designs should achieve a higher level of safety for selected technical and severe accident issues. Accordingly, NRC developed new review standards for these designs based on (1) operating experience, including the accident at Three Mile Island, Unit 2; (2) the results of probabilistic risk assessments of current and next-generation reactor designs; (3) early efforts on severe accident rulemaking; and (4) research conducted to address previously identified generic safety issues. The additional standards were used during the individual design reviews and the resolutions are documented in the design certification rules. 12 refs
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A proposed acceptance process for commercial off-the-shelf (COTS) software in reactor applications
International Nuclear Information System (INIS)
Preckshot, G.G.; Scott, J.A.
1996-03-01
This paper proposes a process for acceptance of commercial off-the-shelf (COTS) software products for use in reactor systems important to safety. An initial set of four criteria establishes COTS software product identification and its safety category. Based on safety category, three sets of additional criteria, graded in rigor, are applied to approve/disapprove the product. These criteria fall roughly into three areas: product assurance, verification of safety function and safety impact, and examination of usage experience of the COTS product in circumstances similar to the proposed application. A report addressing the testing of existing software is included as an appendix
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Image processing for safety assessment in civil engineering.
Ferrer, Belen; Pomares, Juan C; Irles, Ramon; Espinosa, Julian; Mas, David
2013-06-20
Behavior analysis of construction safety systems is of fundamental importance to avoid accidental injuries. Traditionally, measurements of dynamic actions in civil engineering have been done through accelerometers, but high-speed cameras and image processing techniques can play an important role in this area. Here, we propose using morphological image filtering and Hough transform on high-speed video sequence as tools for dynamic measurements on that field. The presented method is applied to obtain the trajectory and acceleration of a cylindrical ballast falling from a building and trapped by a thread net. Results show that safety recommendations given in construction codes can be potentially dangerous for workers.
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This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)
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Premarket safety and efficacy studies for ADHD medications in children.
Directory of Open Access Journals (Sweden)
Florence T Bourgeois
Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.
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International Nuclear Information System (INIS)
1991-08-01
The format of this report is a result of recommendations made by the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM) at its 6th meeting in November 1987. The database was at that time maintained on the main frame and it was felt that adapting it for use on a personal computer would allow more flexibility in data processing and reporting. This document supersedes TECDOC-552 ''Directory of National Competent Authorities' Approval Certificates for Package Design and Shipment of Radioactive Material 1990 Edition''. Since publication of TECDOC-552, some modifications affecting the structure of the database and reporting formats were undertaken. These are fully described in ''Working Material: The PACKTRAM Database National Competent Authority Package Approval Certificates, User Guide Rev. 1'', which was released in early 1991. The present report is contained in five tables. In each of these, information is presented in alphabetical order based on the certificate number. This is composed of the issuing Member State's VRI code, followed by a slash, then a three- or four-digit number, another slash and finally a code identifying the type of package involved. ''-85'' is appended to those certificates that were approved on the basis of the 1985 Edition of Safety Series No. 6. Tables 1 to 4 present administrative data including issue and expire, dates, package identification, package serial numbers, modes for which the package/shipment is approved and the edition of Safety Series No. 6 on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table. 5
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Radiation Safety (Qualifications) Regulations 1980
International Nuclear Information System (INIS)
1980-01-01
These Regulations, promulgated pursuant to the provisions of the Radiation Safety Act, 1975-1979, require persons engaged in activities involving radiation to pass a radiation safety examination or to possess an approved qualification in radiation. The National Health and Medical Research Council is authorised to exempt persons from compliance with these requirements or, conversely, to impose such requirements on persons other than those designated. (NEA) [fr
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Valdez, Michelle M; Liwanag, Maureen; Mount, Charles; Rodriguez, Rechell; Avalos-Reyes, Elisea; Smith, Andrew; Collette, David; Starsiak, Michael; Green, Richard
2018-03-14
Inefficiencies in the command approval process for publications and/or presentations negatively impact DoD Graduate Medical Education (GME) residency programs' ability to meet ACGME scholarly activity requirements. A preliminary review of the authored works approval process at Naval Medical Center San Diego (NMCSD) disclosed significant inefficiency, variation in process, and a low level of customer satisfaction. In order to facilitate and encourage scholarly activity at NMCSD, and meet ACGME requirements, the Executive Steering Council (ESC) chartered an interprofessional team to lead a Lean Six Sigma (LSS) Rapid Improvement Event (RIE) project. Two major outcome metrics were identified: (1) the number of authored works submissions containing all required signatures and (2) customer satisfaction with the authored works process. Primary metric baseline data were gathered utilizing a Clinical Investigations database tracking publications and presentations. Secondary metric baseline data were collected via a customer satisfaction survey to GME faculty and residents. The project team analyzed pre-survey data and utilized LSS tools and methodology including a "gemba" (environment) walk, cause and effect diagram, critical to quality tree, voice of the customer, "muda" (waste) chart, and a pre- and post-event value stream map. The team selected an electronic submission system as the intervention most likely to positively impact the RIE project outcome measures. The number of authored works compliant with all required signatures improved from 52% to 100%. Customer satisfaction rated as "completely or mostly satisfied" improved from 24% to 97%. For both outcomes, signature compliance and customer satisfaction, statistical significance was achieved with a p methodology and tools to improve signature compliance and increase customer satisfaction with the authored works approval process, leading to 100% signature compliance, a comprehensive longitudinal repository of all
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Development of safety analysis and constraint detection techniques for process interaction errors
Energy Technology Data Exchange (ETDEWEB)
Fan, Chin-Feng, E-mail: csfanc@saturn.yzu.edu.tw [Computer Science and Engineering Dept., Yuan-Ze University, Taiwan (China); Tsai, Shang-Lin; Tseng, Wan-Hui [Computer Science and Engineering Dept., Yuan-Ze University, Taiwan (China)
2011-02-15
Among the new failure modes introduced by computer into safety systems, the process interaction error is the most unpredictable and complicated failure mode, which may cause disastrous consequences. This paper presents safety analysis and constraint detection techniques for process interaction errors among hardware, software, and human processes. Among interaction errors, the most dreadful ones are those that involve run-time misinterpretation from a logic process. We call them the 'semantic interaction errors'. Such abnormal interaction is not adequately emphasized in current research. In our static analysis, we provide a fault tree template focusing on semantic interaction errors by checking conflicting pre-conditions and post-conditions among interacting processes. Thus, far-fetched, but highly risky, interaction scenarios involve interpretation errors can be identified. For run-time monitoring, a range of constraint types is proposed for checking abnormal signs at run time. We extend current constraints to a broader relational level and a global level, considering process/device dependencies and physical conservation rules in order to detect process interaction errors. The proposed techniques can reduce abnormal interactions; they can also be used to assist in safety-case construction.
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Development of safety analysis and constraint detection techniques for process interaction errors
International Nuclear Information System (INIS)
Fan, Chin-Feng; Tsai, Shang-Lin; Tseng, Wan-Hui
2011-01-01
Among the new failure modes introduced by computer into safety systems, the process interaction error is the most unpredictable and complicated failure mode, which may cause disastrous consequences. This paper presents safety analysis and constraint detection techniques for process interaction errors among hardware, software, and human processes. Among interaction errors, the most dreadful ones are those that involve run-time misinterpretation from a logic process. We call them the 'semantic interaction errors'. Such abnormal interaction is not adequately emphasized in current research. In our static analysis, we provide a fault tree template focusing on semantic interaction errors by checking conflicting pre-conditions and post-conditions among interacting processes. Thus, far-fetched, but highly risky, interaction scenarios involve interpretation errors can be identified. For run-time monitoring, a range of constraint types is proposed for checking abnormal signs at run time. We extend current constraints to a broader relational level and a global level, considering process/device dependencies and physical conservation rules in order to detect process interaction errors. The proposed techniques can reduce abnormal interactions; they can also be used to assist in safety-case construction.
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Criticality safety for deactivation of the Rover dry headend process
International Nuclear Information System (INIS)
Henrikson, D.J.
1995-01-01
The Rover dry headend process combusted Rover graphite fuels in preparation for dissolution and solvent extraction for the recovery of 235 U. At the end of the Rover processing campaign, significant quantities of 235 U were left in the dry system. The Rover Dry Headend Process Deactivation Project goal is to remove the remaining uranium bearing material (UBM) from the dry system and then decontaminate the cells. Criticality safety issues associated with the Rover Deactivation Project have been influenced by project design refinement and schedule acceleration initiatives. The uranium ash composition used for calculations must envelope a wide range of material compositions, and yet result in cost effective final packaging and storage. Innovative thinking must be used to provide a timely safety authorization basis while the project design continues to be refined
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International Nuclear Information System (INIS)
Buck, J.W.; Anderson, C.M.; Pulsipher, B.A.; Toth, J.J.; Turner, P.J.; Cash, R.J.; Dukelow, G.T.; Meacham, J.E.
1993-12-01
This document records the data quality objectives (DQO) process applied to the Ferrocyanide Waste Tank Safety Issue at the Hanford Site by the Pacific Northwest Laboratory and Westinghouse Hanford Company. Specifically, the major recommendations and findings from this Ferrocyanide DQO process are presented so that decision makers can determine the type, quantity, and quality of data required for addressing tank safety issues. The decision logic diagrams and error tolerance equations also are provided. Finally, the document includes the DQO sample-size formulas for determining specific tank sampling requirements
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This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs
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Shimazawa, Rumiko; Ikeda, Masayuki
2016-03-01
Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.
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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
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Safety assessment for the IS process in a hydrogen production facility
International Nuclear Information System (INIS)
Cho, Nam Chul
2005-08-01
A substitute energy development have been required due to the dry up of the fossil fuel and an environmental problem. Consequently, among substitute energy to be discussed, producing hydrogen from water which does not release carbon is a very promising technology. Also, Iodine-Sulfur(IS) thermochemical water decomposition is one of the promising process which is used to produce hydrogen efficiently using the high temperature gas-cooled reactor(HTGR) as an energy source that is possible to supply heat over 1000 .deg. C. In this study, to make a safety assessment of the hydrogen production using the IS process, an initiating events analysis and an accident scenario modeling considering the relief system were carried out. A method for initiating event identification used the Master Logic Diagram(MLD) that is logical and deductive. As a result, 9 initiating events that cause a leakage of the chemical material were identified. 6 accident scenario based on the initiating event are identified and quantified to the event trees. The frequency of the chemical material leakage produced by IS process is estimated relatively high to the value of 1.22x10 -4 /y. Therefore, it requires more effort on safety of the hydrogen production which can be considered as a part of the nuclear system and safety management research to increase social acceptability. Moreover, these methods will be helpful to the safety assessment of the hydrogen production system of the IS process in general
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Relationship of safety culture and process safety
International Nuclear Information System (INIS)
Olive, Claire; O'Connor, T. Michael; Mannan, M. Sam
2006-01-01
Throughout history, humans have gathered in groups for social, religious, and industrial purposes. As the conglomeration of people interact, a set of underlying values, beliefs, and principles begins to develop that serve to guide behavior within the group. These 'guidelines' are commonly referred to as the group culture. Modern-day organizations, including corporations, have developed their own unique cultures derived from the diversity of the organizational interests and the background of the employees. Safety culture, a sub-set of organizational culture, has been a major focus in recent years. This is especially true in the chemical industry due to the series of preventable, safety-related disasters that occurred in the late seventies and eighties. Some of the most notable disasters, during this time period, occurred at Bhopal, Flixborough, and Seveso. However, current events, like the September 11th terrorist attacks and the disintegration of the Columbia shuttle, have caused an assessment of safety culture in a variety of other organizations
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How important is vehicle safety for older consumers in the vehicle purchase process?
Koppel, Sjaan; Clark, Belinda; Hoareau, Effie; Charlton, Judith L; Newstead, Stuart V
2013-01-01
This study aimed to investigate the importance of vehicle safety to older consumers in the vehicle purchase process. Older (n = 102), middle-aged (n = 791), and younger (n = 109) participants throughout the eastern Australian states of Victoria, New South Wales, and Queensland who had recently purchased a new or used vehicle completed an online questionnaire about their vehicle purchase process. When asked to list the 3 most important considerations in the vehicle purchase process (in an open-ended format), older consumers were mostly likely to list price as their most important consideration (43%). Similarly, when presented with a list of vehicle factors (such as price, design, Australasian New Car Assessment Program [ANCAP] rating), older consumers were most likely to identify price as the most important vehicle factor (36%). When presented with a list of vehicle features (such as automatic transmission, braking, air bags), older consumers in the current study were most likely to identify an antilock braking system (41%) as the most important vehicle feature, and 50 percent of older consumers identified a safety-related vehicle feature as the highest priority vehicle feature (50%). When asked to list up to 3 factors that make a vehicle safe, older consumers in the current study were most likely to list braking systems (35%), air bags (22%), and the driver's behavior or skill (11%). When asked about the influence of safety in the new vehicle purchase process, one third of older consumers reported that all new vehicles are safe (33%) and almost half of the older consumers rated their vehicle as safer than average (49%). A logistic regression model was developed to predict the profile of older consumers more likely to assign a higher priority to safety features in the vehicle purchasing process. The model predicted that the importance of safety-related features was influenced by several variables, including older consumers' beliefs that they could protect themselves
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International Nuclear Information System (INIS)
Chou, I.-Hsin
2011-01-01
Highlights: → The proposed method emphasizes platform-independent security processes. → A hybrid process based on the nuclear SCM and security regulations is proposed. → Detailed descriptions and Process Flow Diagram are useful for software developers. - Abstract: The main difference between nuclear and generic software is that the risk factor is infinitely greater in nuclear software - if there is a malfunction in the safety system, it can result in significant economic loss, physical damage or threat to human life. However, secure software development environment have often been ignored in the nuclear industry. In response to the terrorist attacks on September 11, 2001, the US Nuclear Regulatory Commission (USNRC) revised the Regulatory Guide (RG 1.152-2006) 'Criteria for use of computers in safety systems of nuclear power plants' to provide specific security guidance throughout the software development life cycle. Software Configuration Management (SCM) is an essential discipline in the software development environment. SCM involves identifying configuration items, controlling changes to those items, and maintaining integrity and traceability of them. For securing the nuclear safety software, this paper proposes a Secure SCM Processes (S 2 CMP) which infuses regulatory security requirements into proposed SCM processes. Furthermore, a Process Flow Diagram (PFD) is adopted to describe S 2 CMP, which is intended to enhance the communication between regulators and developers.
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Process safety management for highly hazardous chemicals
Energy Technology Data Exchange (ETDEWEB)
NONE
1996-02-01
Purpose of this document is to assist US DOE contractors who work with threshold quantities of highly hazardous chemicals (HHCs), flammable liquids or gases, or explosives in successfully implementing the requirements of OSHA Rule for Process Safety Management of Highly Hazardous Chemicals (29 CFR 1910.119). Purpose of this rule is to prevent releases of HHCs that have the potential to cause catastrophic fires, explosions, or toxic exposures.
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Industrial high pressure applications. Processes, equipment and safety
Energy Technology Data Exchange (ETDEWEB)
Eggers, Rudolf (ed.) [Technische Univ. Hamburg-Harburg, Hamburg (Germany). Inst. fuer Thermische Verfahrenstechnik
2012-07-01
Industrial high pressure processes open the door to many reactions that are not possible under 'normal' conditions. These are to be found in such different areas as polymerization, catalytic reactions, separations, oil and gas recovery, food processing, biocatalysis and more. The most famous high pressure process is the so-called Haber-Bosch process used for fertilizers and which was awarded a Nobel prize. Following an introduction on historical development, the current state, and future trends, this timely and comprehensive publication goes on to describe different industrial processes, including methanol and other catalytic syntheses, polymerization and renewable energy processes, before covering safety and equipment issues. With its excellent choice of industrial contributions, this handbook offers high quality information not found elsewhere, making it invaluable reading for a broad and interdisciplinary audience.
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IRSN global process for leading a comprehensive fire safety analysis for nuclear installations
International Nuclear Information System (INIS)
Ormieres, Yannick; Lacoue, Jocelyne
2013-01-01
A fire safety analysis (FSA) is requested to justify the adequacy of fire protection measures set by the operator. A recent document written by IRSN outlines a global process for such a comprehensive fire safety analysis. Thanks to the French nuclear fire safety regulation evolutions, from prescriptive requirements to objective requirements, the proposed fire safety justification process focuses on compliance with performance criteria for fire protection measures. These performance criteria are related to the vulnerability of targets to effects of fire, and not only based upon radiological consequences out side the installation caused by a fire. In his FSA, the operator has to define the safety functions that should continue to ensure its mission even in the case of fire in order to be in compliance with nuclear safety objectives. Then, in order to maintain these safety functions, the operator has to justify the adequacy of fire protection measures, defined according to defence in depth principles. To reach the objective, the analysis process is based on the identification of targets to be protected in order to maintain safety functions, taken into account facility characteristics. These targets include structures, systems, components and personal important to safety. Facility characteristics include, for all operating conditions, potential ignition sources and fire protections systems. One of the key points of the fire analysis is the assessment of possible fire scenarios in the facility. Given the large number of possible fire scenarios, it is then necessary to evaluate 'reference fires' which are the worst case scenarios of all possible fire scenarios and which are used by the operator for the design of fire protection measures. (authors)
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Technical safety appraisal of the Idaho Chemical Processing Plant
International Nuclear Information System (INIS)
1992-05-01
On June 27, 1989, Secretary of Energy, Admiral James D. Watkins, US Navy (Retired), announced a 10-point initiative to strengthen environment, safety, and health (ES ampersand H) programs and waste management operations in the Department of Energy (DOE). One of the initiatives involved conducting independent Tiger Team Assessments (TTA) at DOE operating facilities. A TTA of the Idaho National Engineering Laboratory (INEL) was performed during June and July 1991. Technical Safety Appraisals (TSA) were conducted in conjunction with the TTA as its Safety and Health portion. However, because of operational constraints the the Idaho Chemical Processing Plant (ICPP), operated for the DOE by Westinghouse Idaho Nuclear Company, Inc. (WINCO), was not included in the Safety and Health Subteam assessment at that time. This TSA, conducted April 12 - May 8, 1992, was performed by the DOE Office of Performance Assessment to complete the normal scope of the Safety and Health portion of the Tiger Team Assessment of the Idaho National Engineering Laboratory. The purpose of TSAs is to evaluate and strengthen DOE operations by verifying contractor compliance with DOE Orders, to assure that lessons learned from commercial operations are incorporated into facility operations, and to stimulate and encourage pursuit of excellence; thus, the appraisal addresses more issues than would be addressed in a strictly compliance-oriented appraisal. A total of 139 Performance Objectives have been addressed by this appraisal in 19 subject areas. These 19 areas are: organization and administration, quality verification, operations, maintenance, training and certification, auxiliary systems, emergency preparedness, technical support, packaging and transportation, nuclear criticality safety, safety/security interface, experimental activities, site/facility safety review, radiological protection, worker safety and health compliance, personnel protection, fire protection, medical services and natural
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Food safety issues of high pressure processed fruit/vegetable juices
Czech Academy of Sciences Publication Activity Database
Houška, M.; Strohalm, J.; Totušek, J.; Tříska, Jan; Vrchotová, Naděžda; Gabrovská, D.; Otová, B.; Gresová, P.
2007-01-01
Roč. 27, č. 1 (2007), s. 157-162 ISSN 0895-7959 R&D Projects: GA MZe QF3287 Institutional research plan: CEZ:AV0Z60870520 Keywords : Vegetable juices * High pressure processing * Food safety * Anti-mutagenic activity Subject RIV: GM - Food Processing Impact factor: 0.840, year: 2007
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Quantification of microbial quality and safety in minimally processed foods
Zwietering, M.H.
2002-01-01
To find a good equilibrium between quality and margin of safety of minimally processed foods, often various hurdles are used. Quantification of the kinetics should be used to approach an optimum processing and to select the main aspects. Due to many factors of which the exact quantitative effect is
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International Nuclear Information System (INIS)
Weber, J.P.; Reichenbach, D.; Tscherkashow, J.M.
1995-01-01
On the basis of information and documents from the RBMK operation countries, the Western consortium mainly examined the two most modern plants, Ignalin-2 and Smolensk-3. The identification of numerous shortcomings, some of which had already been recongized by the participating Eastern organizations, resulted in some 300 specific recommendations to reactor designers, operators and licensing authorities. These recommendations are to be acted upon at once; only a small number did not meet with the approval of the Eastern partners. The safety review provided the Western consotrium with a profound insight into the design and safety of third-generation RBMK reactors; the Eastern partners were able to accumulate experience in working with Western safety philosophy. (orig.) [de
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23 CFR 420.209 - What are the conditions for approval?
2010-04-01
... Management § 420.209 What are the conditions for approval? (a) As a condition for approval of FHWA planning... management process that identifies and results in implementation of RD&T activities expected to address high priority transportation issues. The management process must include: (1) An interactive process for...
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Adoption of digital safety protection system in Japan
International Nuclear Information System (INIS)
Ogiso, Z.
1998-01-01
The application of micro-processor-based digital controllers has been widely propagated among various industries in recent years. While in the nuclear power plant industry, the application of them has also been expanding gradually starting from non-safety related systems, taking advantage of their reliability and maintainability over the conventional analog devices. Based on the careful study of the feasibility of digital controllers to the safety protection system, the Tokyo Electric Power Company proposed on May 1989 the adoption of digital controllers to the safety protection system in the Application for Permission of Establishment of Kashiwazaki-Kariwa units 6 and 7 (ABWR-1350Mwe each). MITI, Ministry of International Trade and Industry, the Japanese regulatory body for electric power generating facilities, had approved this application after careful review. This paper describes a series of supporting activities leading to the MITI's approval of the digital safety protection system and the MITI's licensing activities. (author)
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International Nuclear Information System (INIS)
Mengolini, A.; Debarberis, L.
2008-01-01
Safety performance indicators are widely collected and used in hazardous installations. The IAEA, OECD and other international organisations have developed approaches that strongly promote deployment of safety performance indicators. These indicators focus mainly on operational performance, but some of them also address organisational and safety culture aspects. However, operators of hazardous installations, in particular those with limited resources and time constraints, often find it difficult to collect the large number of different safety performance indicators. Moreover, they also have difficulties with giving a meaning to the numbers and trends recorded, especially to those that should reflect a positive safety culture. In this light, the aim of this article is to address the need to monitor and assess progress on implementation of a programme to enhance safety and organisational culture. It proposes a specific process-view approach to effectiveness evaluation of organisational and safety culture indicators by means of a multi-level system in which safety processes and staff involvement in defining improvement activities are central. In this way safety becomes fully embedded in staff activities. Key members of personnel become directly involved in identifying and supplying leading indicators relating to their own daily activity and become responsible and accountable for keeping the measurement system alive. Besides use of lagging indicators, particular emphasis is placed on the importance of identifying and selecting leading indicators which can be used to drive safety performance for organisational and safety culture aspects as well
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Mengolini, A; Debarberis, L
2008-06-30
Safety performance indicators are widely collected and used in hazardous installations. The IAEA, OECD and other international organisations have developed approaches that strongly promote deployment of safety performance indicators. These indicators focus mainly on operational performance, but some of them also address organisational and safety culture aspects. However, operators of hazardous installations, in particular those with limited resources and time constraints, often find it difficult to collect the large number of different safety performance indicators. Moreover, they also have difficulties with giving a meaning to the numbers and trends recorded, especially to those that should reflect a positive safety culture. In this light, the aim of this article is to address the need to monitor and assess progress on implementation of a programme to enhance safety and organisational culture. It proposes a specific process-view approach to effectiveness evaluation of organisational and safety culture indicators by means of a multi-level system in which safety processes and staff involvement in defining improvement activities are central. In this way safety becomes fully embedded in staff activities. Key members of personnel become directly involved in identifying and supplying leading indicators relating to their own daily activity and become responsible and accountable for keeping the measurement system alive. Besides use of lagging indicators, particular emphasis is placed on the importance of identifying and selecting leading indicators which can be used to drive safety performance for organisational and safety culture aspects as well.
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Safety analysis of IFR fuel processing in the Argonne National Laboratory Fuel Cycle Facility
International Nuclear Information System (INIS)
Charak, I; Pedersen, D.R.; Forrester, R.J.; Phipps, R.D.
1993-01-01
The Integral Fast Reactor (IFR) concept developed by Argonne National Laboratory (ANL) includes on-site processing and recycling of discharged core and blanket fuel materials. The process is being demonstrated in the Fuel Cycle Facility (FCF) at ANL's Idaho site. This paper describes the safety analyses that were performed in support of the FCF program; the resulting safety analysis report was the vehicle used to secure authorization to operate the facility and carry out the program, which is now under way. This work also provided some insights into safety-related issues of a commercial IFR fuel processing facility. These are also discussed
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Expert evaluation in NPP safety important systems licensing process
International Nuclear Information System (INIS)
Mikhail, A Yastrebenetsky; Vasilchenko, V.N.
2001-01-01
Expert evaluation of nuclear power plant safety important systems modernization is an integral part of these systems licensing process. The paper contains some aspects of this evaluation which are based on Ukrainian experience of VVER-1000 and VVER-440 modernization. (authors)
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Expert evaluation in NPP safety important systems licensing process
Energy Technology Data Exchange (ETDEWEB)
Mikhail, A Yastrebenetsky; Vasilchenko, V.N. [Ukrainian State Scientific Technical Center of Nuclear and Radiation Safety (Ukraine)
2001-07-01
Expert evaluation of nuclear power plant safety important systems modernization is an integral part of these systems licensing process. The paper contains some aspects of this evaluation which are based on Ukrainian experience of VVER-1000 and VVER-440 modernization. (authors)
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Fissile materials principles of criticality safety in handling and processing
International Nuclear Information System (INIS)
1976-01-01
This Swedish Standard consists of the English version of the International Standard ISO 1709-1975-Nuclear energy. Fissile materials. Principles of criticality safety in handling and processing. (author)
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30 CFR 90.301 - Respirable dust control plan; approval by District Manager; copy to part 90 miner.
2010-07-01
... District Manager; copy to part 90 miner. 90.301 Section 90.301 Mineral Resources MINE SAFETY AND HEALTH... control plan; approval by District Manager; copy to part 90 miner. (a) The District Manager will approve... District Manager shall consider whether: (1) The respirable dust control measures would be likely to...
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International Nuclear Information System (INIS)
1991-01-01
Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval in relation to external radiations (including accidents). (author)
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Validation of calculational methods for nuclear criticality safety - approved 1975
International Nuclear Information System (INIS)
Anon.
1977-01-01
The American National Standard for Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors, N16.1-1975, states in 4.2.5: In the absence of directly applicable experimental measurements, the limits may be derived from calculations made by a method shown to be valid by comparison with experimental data, provided sufficient allowances are made for uncertainties in the data and in the calculations. There are many methods of calculation which vary widely in basis and form. Each has its place in the broad spectrum of problems encountered in the nuclear criticality safety field; however, the general procedure to be followed in establishing validity is common to all. The standard states the requirements for establishing the validity and area(s) of applicability of any calculational method used in assessing nuclear criticality safety
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Enhancing Safety of Artificially Ventilated Patients Using Ambient Process Analysis.
Lins, Christian; Gerka, Alexander; Lüpkes, Christian; Röhrig, Rainer; Hein, Andreas
2018-01-01
In this paper, we present an approach for enhancing the safety of artificially ventilated patients using ambient process analysis. We propose to use an analysis system consisting of low-cost ambient sensors such as power sensor, RGB-D sensor, passage detector, and matrix infrared temperature sensor to reduce risks for artificially ventilated patients in both home and clinical environments. We describe the system concept and our implementation and show how the system can contribute to patient safety.
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High level radioactive waste siting processes: critical lessons from Canadian siting successes
International Nuclear Information System (INIS)
Hardy, D.R.
1996-01-01
While not without controversy, Canada's Crown Corporations, municipalities, agencies and private companies have had success in siting and achieving approval for operating: toxic and hazardous waste facilities; dry radioactive materials storage facilities; the Federal low-level radioactive waste disposal facility; and, several large and small domestic landfills. The cumulative experience gained from these siting and approval processes provides valuable advice in support of the siting and approval of high-level radioactive disposal facilities. Among the critical elements for the success of these siting efforts are: 1) the tinting, scope and character of the siting process reflects the cultural and social values of affected people; 2) the siting and approval processes has integrity -- characterized as rational processes in pursuit of the public interest; 3) sufficient time and resources are dedicated to listening carefully and examining issues seen to be important by the public; 4) all information is shared -- even if the information is potentially detrimental to the approval of the facility; 5) proponent has a prioritized multiple focus on 'health, safety and environment issues', on 'insuring that the environmental assessment process is socially acceptable' as well as on the 'approval considerations'; 6) the implementing agency seeks cooperation and win-win solutions with the local community; 7) the community has the option of opting-out of the process and the do-nothing and/or the not here option continues to be considered by the proponent; 8) local emergency response people are well-trained and accepting of the facility; 9) the community has a strong role in determining the terms, conditions and compensation related to the future facility. (author)
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49 CFR 575.301 - Vehicle Labeling of Safety Rating Information.
2010-10-01
... providing them with safety rating information developed by NHTSA in its New Car Assessment Program (NCAP..., as specified at 15 U.S.C. 1231-1233. (2) Safety rating label means the label with NCAP safety rating... has approved an optional NCAP test that will cover that category, the manufacturer may depict vehicles...
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Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi
2018-03-01
Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.
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International Nuclear Information System (INIS)
1991-01-01
Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval in relation to internal radiations (including radon decay products). (author)
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Drug safety: withdrawn medications are only part of the picture.
Rawson, Nigel S B
2016-02-13
In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2.
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International Nuclear Information System (INIS)
Hill, R.L.
2000-01-01
This paper summarizes the development and implementation of Integrated Safety Management (ISM) at an Order Compliance Site (Savannah River Site) and a Necessary and Sufficient Site (Nevada Test Site). A discussion of each core safety function of ISM is followed by an example from an Order Compliance Site and a Necessary and Sufficient Site. The Savannah River Site was the first DOE site to have a DOE Headquarters-validated and approved ISM System. The NTS is beginning the process of verification and validation. This paper defines successful strategies for integrating Environment, Safety, and Health management into work under various scenarios
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Consideration of social scientific issues in a safety case. Final report
International Nuclear Information System (INIS)
Sailer, Michael; Kallenbach-Herbert, Beate; Brohmann, Bettina; Spieth-Achtnich, Angelika
2010-01-01
The research outcome presented here - a model for identifying and describing safety-relevant social scientific issues - provides a scientific basis for addressing these issues in a safety case. In order for them to be implemented in a repository process, it would be necessary to elaborate in greater detail the initial conceptual foundations that have been laid in this research project in line with the project's terms of reference. The requisite elaboration relates to binding rules for designing the repository process, particularly with regard to the stages in which the safety case is to be developed during planning, approval, construction and operation through to repository closure. Such detailed elaboration also needs to involve specifying the extent to which each social scientific issue and sub-issue is to be addressed in the different stages. Consideration would need to be given not only to the relevance of the issue for a given stage but also to the various options and methods for providing proof of safety. It would be possible to draw on experiences with handling safety management in nuclear power plants - a sphere in which over the last ten years efforts have been ongoing to develop methods for presentation by the operator and review by the authorities. Furthermore, it is likely that the social scientific issues relevant to a safety case cannot be defined once and for all in a single process, but that the need for continual revision and adaptation will arise due to both the increasing knowledge acquired during the course of the repository process and the experiences and expectations of stakeholders (similarly to experiences in the sphere of scientific-technological requirements). Appropriate conditions need to be defined for such a process. This process could be supported by implementing the option mentioned above whereby a regulatory definition of safety management for geological disposal is formulated which encompasses all safety-relevant social scientific
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[Process management in the hospital pharmacy for the improvement of the patient safety].
Govindarajan, R; Perelló-Juncá, A; Parès-Marimòn, R M; Serrais-Benavente, J; Ferrandez-Martí, D; Sala-Robinat, R; Camacho-Calvente, A; Campabanal-Prats, C; Solà-Anderiu, I; Sanchez-Caparrós, S; Gonzalez-Estrada, J; Martinez-Olalla, P; Colomer-Palomo, J; Perez-Mañosas, R; Rodríguez-Gallego, D
2013-01-01
To define a process management model for a hospital pharmacy in order to measure, analyse and make continuous improvements in patient safety and healthcare quality. In order to implement process management, Igualada Hospital was divided into different processes, one of which was the Hospital Pharmacy. A multidisciplinary management team was given responsibility for each process. For each sub-process one person was identified to be responsible, and a working group was formed under his/her leadership. With the help of each working group, a risk analysis using failure modes and effects analysis (FMEA) was performed, and the corresponding improvement actions were implemented. Sub-process indicators were also identified, and different process management mechanisms were introduced. The first risk analysis with FMEA produced more than thirty preventive actions to improve patient safety. Later, the weekly analysis of errors, as well as the monthly analysis of key process indicators, permitted us to monitor process results and, as each sub-process manager participated in these meetings, also to assume accountability and responsibility, thus consolidating the culture of excellence. The introduction of different process management mechanisms, with the participation of people responsible for each sub-process, introduces a participative management tool for the continuous improvement of patient safety and healthcare quality. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.
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Poet North Manchester Approval
This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable
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Reactor Safety Commission Code of Practice for Pressurized Water Reactors
International Nuclear Information System (INIS)
1990-01-01
The Reactor Safety Commission of the Federal German Republic has summarized in the form of Official Guidelines the safety requirements which, in the Commission's view, have to be met in the design, construction and operation of a nuclear power station equipped with a pressurized water reactor. The Third Edition of the RSK Guidelines for pressurized water reactors dated 14.10.81. is a revised and expanded version of the Second Edition dated 24.1.79. The Reactor Safety Commission will with effect from October 1981 use these Guidelines in consultations on the siting of and safety concept for the installation approval of future pressurized water reactors and will assess these nuclear power stations during their erection in the light of these Guidelines. They have not however been immediately conceived for the adaptation of existing nuclear power stations, whether under construction or in operation. The scope of application of these Guidelines to such nuclear power stations will have to be examined for each individual case. The main aim of the Guidelines is to simplify the consultation process within the reactor Safety Commission and to provide early advice on the safety requirements considered necessary by the Commission. (author)
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Integrated program of using of Probabilistic Safety Analysis in Spain
International Nuclear Information System (INIS)
1998-01-01
Since 25 June 1986, when the CSN (Nuclear Safety Conseil) approve the Integrated Program of Probabilistic Safety Analysis, this program has articulated the main activities of CSN. This document summarize the activities developed during these years and reviews the Integrated programme
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MedWatch, the FDA Safety Information and Adverse Event Reporting Program
... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...
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System Safety Program Plan for Project W-314, tank farm restoration and safe operations
International Nuclear Information System (INIS)
Boos, K.A.
1996-01-01
This System Safety Program Plan (SSPP) outlines the safety analysis strategy for project W-314, ''Tank Farm Restoration and Safe Operations.'' Project W-314 will provide capital improvements to Hanford's existing Tank Farm facilities, with particular emphasis on infrastructure systems supporting safe operation of the double-shell activities related to the project's conceptual Design Phase, but is planned to be updated and maintained as a ''living document'' throughout the life of the project to reflect the current safety analysis planning for the Tank Farm Restoration and Safe Operations upgrades. This approved W-314 SSPP provides the basis for preparation/approval of all safety analysis documentation needed to support the project
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International Nuclear Information System (INIS)
Herborn, D.I.
1993-11-01
Westinghouse Hanford Company (WHC) is the Integrating Contractor for the Hanford Waste Vitrification Plant (HWVP) Project, and as such is responsible for preparation of the HWVP Preliminary Safety Analysis Report (PSAR). The HWVP PSAR was prepared pursuant to the requirements for safety analyses contained in US Department of Energy (DOE) Orders 4700.1, Project Management System (DOE 1987); 5480.5, Safety of Nuclear Facilities (DOE 1986a); 5481.lB, Safety Analysis and Review System (DOE 1986b) which was superseded by DOE order 5480-23, Nuclear Safety Analysis Reports, for nuclear facilities effective April 30, 1992 (DOE 1992); and 6430.lA, General Design Criteria (DOE 1989). The WHC procedures that, in large part, implement these DOE requirements are contained in WHC-CM-4-46, Nonreactor Facility Safety Analysis Manual. This manual describes the overall WHC safety analysis process in terms of requirements for safety analyses, responsibilities of the various contributing organizations, and required reviews and approvals
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The main chemical safety problems in main process of nuclear fuel reprocessing plant
International Nuclear Information System (INIS)
Song Fengli; Zhao Shangui; Liu Xinhua; Zhang Chunlong; Lu Dan; Liu Yuntao; Yang Xiaowei; Wang Shijun
2014-01-01
There are many chemical reactions in the aqueous process of nuclear fuel reprocessing. The reaction conditions and the products are different so that the chemical safety problems are different. In the paper the chemical reactions in the aqueous process of nuclear fuel reprocessing are described and the main chemical safety problems are analyzed. The reference is offered to the design and accident analysis of the nuclear fuel reprocessing plant. (authors)
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Criteria Document for B-plant's Surveillance and Maintenance Phase Safety Basis Document
International Nuclear Information System (INIS)
SCHWEHR, B.A.
1999-01-01
This document is required by the Project Hanford Managing Contractor (PHMC) procedure, HNF-PRO-705, Safety Basis Planning, Documentation, Review, and Approval. This document specifies the criteria that shall be in the B Plant surveillance and maintenance phase safety basis in order to obtain approval of the DOE-RL. This CD describes the criteria to be addressed in the S and M Phase safety basis for the deactivated Waste Fractionization Facility (B Plant) on the Hanford Site in Washington state. This criteria document describes: the document type and format that will be used for the S and M Phase safety basis, the requirements documents that will be invoked for the document development, the deactivated condition of the B Plant facility, and the scope of issues to be addressed in the S and M Phase safety basis document
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Halbesleben, Jonathon R B; Savage, Grant T; Wakefield, Douglas S; Wakefield, Bonnie J
2010-01-01
Health care organizations have redesigned existing and implemented new work processes intended to improve patient safety. As a consequence of these process changes, there are now intentionally designed "blocks" or barriers that limit how specific work actions, such as ordering and administering medication, are to be carried out. Health care professionals encountering these designed barriers can choose to either follow the new process, engage in workarounds to get past the block, or potentially repeat work (rework). Unfortunately, these workarounds and rework may lead to other safety concerns. The aim of this study was to examine rework and workarounds in hospital medication administration processes. Observations and semistructured interviews were conducted with 58 nurses from four hospital intensive care units focusing on the medication administration process. Using the constant comparative method, we analyzed the observation and interview data to develop themes regarding rework and workarounds. From this analysis, we developed an integrated process map of the medication administration process depicting blocks. A total of 12 blocks were reported by the participants. Based on the analysis, we categorized them as related to information exchange, information entry, and internal supply chain issues. Whereas information exchange and entry blocks tended to lead to rework, internal supply chain issues were more likely to lead to workarounds. A decentralized pharmacist on the unit may reduce work flow blocks (and, thus, workarounds and rework). Work process redesign may further address the problems of workarounds and rework.
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Range Flight Safety Requirements
Loftin, Charles E.; Hudson, Sandra M.
2018-01-01
The purpose of this NASA Technical Standard is to provide the technical requirements for the NPR 8715.5, Range Flight Safety Program, in regards to protection of the public, the NASA workforce, and property as it pertains to risk analysis, Flight Safety Systems (FSS), and range flight operations. This standard is approved for use by NASA Headquarters and NASA Centers, including Component Facilities and Technical and Service Support Centers, and may be cited in contract, program, and other Agency documents as a technical requirement. This standard may also apply to the Jet Propulsion Laboratory or to other contractors, grant recipients, or parties to agreements to the extent specified or referenced in their contracts, grants, or agreements, when these organizations conduct or participate in missions that involve range flight operations as defined by NPR 8715.5.1.2.2 In this standard, all mandatory actions (i.e., requirements) are denoted by statements containing the term “shall.”1.3 TailoringTailoring of this standard for application to a specific program or project shall be formally documented as part of program or project requirements and approved by the responsible Technical Authority in accordance with NPR 8715.3, NASA General Safety Program Requirements.
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Development methodology for the software life cycle process of the safety software
Energy Technology Data Exchange (ETDEWEB)
Kim, D. H.; Lee, S. S. [BNF Technology, Taejon (Korea, Republic of); Cha, K. H.; Lee, C. S.; Kwon, K. C.; Han, H. B. [KAERI, Taejon (Korea, Republic of)
2002-05-01
A methodology for developing software life cycle processes (SLCP) is proposed to develop the digital safety-critical Engineered Safety Features - Component Control System (ESF-CCS) successfully. A software life cycle model is selected as the hybrid model mixed with waterfall, prototyping, and spiral models and is composed of two stages , development stages of prototype of ESF-CCS and ESF-CCS. To produce the software life cycle (SLC) for the Development of the Digital Reactor Safety System, the Activities referenced in IEEE Std. 1074-1997 are mapped onto the hybrid model. The SLCP is established after the available OPAs (Organizational Process Asset) are applied to the SLC Activities, and the known constraints are reconciled. The established SLCP describes well the software life cycle activities with which the Regulatory Authority provides.
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Development methodology for the software life cycle process of the safety software
International Nuclear Information System (INIS)
Kim, D. H.; Lee, S. S.; Cha, K. H.; Lee, C. S.; Kwon, K. C.; Han, H. B.
2002-01-01
A methodology for developing software life cycle processes (SLCP) is proposed to develop the digital safety-critical Engineered Safety Features - Component Control System (ESF-CCS) successfully. A software life cycle model is selected as the hybrid model mixed with waterfall, prototyping, and spiral models and is composed of two stages , development stages of prototype of ESF-CCS and ESF-CCS. To produce the software life cycle (SLC) for the Development of the Digital Reactor Safety System, the Activities referenced in IEEE Std. 1074-1997 are mapped onto the hybrid model. The SLCP is established after the available OPAs (Organizational Process Asset) are applied to the SLC Activities, and the known constraints are reconciled. The established SLCP describes well the software life cycle activities with which the Regulatory Authority provides
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International Nuclear Information System (INIS)
Girard, J-.P; Taylor, N.; Garin, P.; Uzan-Elbez, J.; GULDEN, W.; Rodriguez-Rodrigo, L.
2006-01-01
The site for the construction of ITER has been chosen in June 2005. The facility will be implemented in Europe, south of France close to Marseille. The generic safety scheme is now under revision to adapt the design to the host country regulation. Even though ITER will be an international organization, it will have to comply with the French requirements in the fields of public and occupational health and safety, nuclear safety, radiation protection, licensing, nuclear substances and environmental protection. The organization of the central team together with its partners organized in domestic agencies for the in-kind procurement of components is a key issue for the success of the experimentation. ITER is the first facility that will achieve sustained nuclear fusion. It is both important for the experimental one-of-a-kind device, ITER itself, and for the future of fusion power plants to well understand the key safety issues of this potential new source of energy production. The main safety concern is confinement of the tritium, activated dust in the vacuum vessel and activated corrosion products in the coolant of the plasma-facing components. This is achieved in the design through multiple confinement barriers to implement the defence in depth approach. It will be demonstrated in documents submitted to the French regulator that these barriers maintain their function in all postulated incident and accident conditions. The licensing process started by examination of the safety options. This step has been performed by Europe during the candidature phase in 2002. In parallel to the final design, and taking into account the local regulations, the Preliminary Safety Report (RPrS) will be drafted with support of the European partner and others in the framework of ITER Task Agreements. Together with the license application, the RPrS will be forwarded to the regulatory bodies, which will launch public hearings and a safety review. Both processes must succeed in order to
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Regulatory practices of radiation safety of SNF transportation in Russia
International Nuclear Information System (INIS)
Kuryndina, Lidia; Kuryndin, Anton; Stroganov, Anatoly
2008-01-01
This paper overviews current regulatory practices for the assurance of nuclear and radiation safety during railway transportation of SNF on the territory of Russian Federation from NPPs to longterm-storage of reprocessing sites. The legal and regulatory requirements (mostly compliant with IAEA ST-1), licensing procedure for NM transportation are discussed. The current procedure does not require a regulatory approval for each particular shipment if the SNF fully comply with the Rosatom's branch standard and is transported in approved casks. It has been demonstrated that SNF packages compliant with the branch standard, which is knowingly provide sufficient safety margin, will conform to the federal level regulations. The regulatory approval is required if a particular shipment does not comply with the branch standard. In this case, the shipment can be approved only after regulatory review of Applicant's documents to demonstrate that the shipment still conformant to the higher level (federal) regulations. The regulatory review frequently needs a full calculation test of the radiation safety assurance. This test can take a lot of time. That's why the special calculation tools were created in SEC NRS. These tools aimed for precision calculation of the radiation safety parameters by SNF transportation use preliminary calculated Green's functions. Such approach allows quickly simulate any source distribution and optimize spent fuel assemblies placement in cask due to the transport equation property of linearity relatively the source. The short description of calculation tools are presented. Also, the paper discusses foreseen implications related to transportation of mixed-oxide SNF. (author)
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Zohydro approval by food and drug administration: controversial or frightening?
Manchikanti, Laxmaiah; Atluri, Sairam; Candido, Kenneth D; Boswell, Mark V; Simopoulos, Thomas T; Grider, Jay S; Falco, Frank J E; Hirsch, Joshua A
2014-01-01
The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health
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The NASA Commercial Crew Program (CCP) Mission Assurance Process
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.
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Energy Technology Data Exchange (ETDEWEB)
Gupta, Mukesh [URS Professional Solutions LLC, Aiken, SC (United States); Niemi, Belinda [Washington River Protection Solutions, LLC, Richland, WA (United States); Paik, Ingle [Washington River Protection Solutions, LLC, Richland, WA (United States)
2015-09-02
In 2012, One System Nuclear Safety performed a comparison of the safety bases for the Tank Farms Operations Contractor (TOC) and Hanford Tank Waste Treatment and Immobilization Plant (WTP) (RPP-RPT-53222 / 24590-WTP-RPT-MGT-12-018, “One System Report of Comparative Evaluation of Safety Bases for Hanford Waste Treatment and Immobilization Plant Project and Tank Operations Contract”), and identified 25 recommendations that required further evaluation for consensus disposition. This report documents ten NSSC approved consistent methodologies and guides and the results of the additional evaluation process using a new set of evaluation criteria developed for the evaluation of the new methodologies.
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This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS
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Guidelines for approved medical officers on health surveillance of radiation workers
International Nuclear Information System (INIS)
O'Donovan, N.; Hone, C.
1988-11-01
As a result of the adoption of the Council of the European Communities Directive No. 80/836 Euratom which lays down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, there is a need for nominating Approved Medical Officers whose functions in respect of hospital workers are outlined in the Department of Health Circular, Oct. 1983 (Appendix 1), and which are considered applicable to all other workers. This document outlines the role of the Approved Medical Officer and proides information to aid him/her in this work (author)
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Digital mammography. Why hasn't it been approved for U.S. hospitals?
2000-01-01
Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.
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77 FR 62433 - Hazard Communication Standard; Approval of Information Collection Requirements
2012-10-15
... safety data sheets (SDSs). The final standard harmonizes the U.S. system with international norms and as.... ACTION: Final rule; notice of the Office of Management and Budget's (OMB) approval of information... FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, U.S...
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International Nuclear Information System (INIS)
1991-01-01
Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval for coordination and record keeping. (author)
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An analysis of legal warnings after drug approval in Thailand.
Sriphiromya, Pakawadee; Theeraroungchaisri, Anuchai
2015-02-01
Drug risk management has many tools for minimizing risk and black-boxed warnings (BBWs) are one of those tools. Some serious adverse drug reactions (ADRs) emerge only after a drug is marketed and used in a larger population. In Thailand, additional legal warnings after drug approval, in the form of black-boxed warnings, may be applied. Review of their characteristics can assist in the development of effective risk mitigation. This study was a cross sectional review of all legal warnings imposed in Thailand after drug approval (2003-2012). Any boxed warnings for biological products and revised warnings which were not related to safety were excluded. Nine legal warnings were evaluated. Seven related to drugs classes and two to individual drugs. The warnings involved four main types of predictable ADRs: drug-disease interactions, side effects, overdose and drug-drug interactions. The average time from first ADRs reported to legal warnings implementation was 12 years. The triggers were from both safety signals in Thailand and regulatory measures in other countries outside Thailand. Copyright © 2014 Elsevier Inc. All rights reserved.
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Competent authority approval of package designs in the United Kingdom
International Nuclear Information System (INIS)
Morgan-Warren, E.J.
1999-01-01
Type B packages and all packages containing fissile material, as well as special form radioactive materials, special arrangements and certain shipments, are required to be approved by the competent authority. In the United Kingdom competent authority approval is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division (RMTD) of the Department of the Environment, Transport and the Regions (DETR). Competent authority approval of a package design is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The engineering assessor ensures that the designer has demonstrated the integrity of the containment and shielding systems under the regulatory conditions. The criticality assessor examines criticality safety and radiation protection measures, and together with the engineering assessor, decides whether this is maintained under regulatory conditions. The quality assurance assessor verifies that the applicant has established the necessary controls to ensure that the design requirements are met. The applicant is responsible for making the case for approval, but the assessment is facilitated if the competent authority is involved with the designer at an early stage in development and during the construction of any test prototype. When a regulatory test programme is required, it is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test programme, the applicant submits a formal application, supported by a design safety report (DSR). The DSR provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package
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Dozza, Marco; González, Nieves Pañeda
2013-11-01
New trends in research on traffic accidents include Naturalistic Driving Studies (NDS). NDS are based on large scale data collection of driver, vehicle, and environment information in real world. NDS data sets have proven to be extremely valuable for the analysis of safety critical events such as crashes and near crashes. However, finding safety critical events in NDS data is often difficult and time consuming. Safety critical events are currently identified using kinematic triggers, for instance searching for deceleration below a certain threshold signifying harsh braking. Due to the low sensitivity and specificity of this filtering procedure, manual review of video data is currently necessary to decide whether the events identified by the triggers are actually safety critical. Such reviewing procedure is based on subjective decisions, is expensive and time consuming, and often tedious for the analysts. Furthermore, since NDS data is exponentially growing over time, this reviewing procedure may not be viable anymore in the very near future. This study tested the hypothesis that automatic processing of driver video information could increase the correct classification of safety critical events from kinematic triggers in naturalistic driving data. Review of about 400 video sequences recorded from the events, collected by 100 Volvo cars in the euroFOT project, suggested that drivers' individual reaction may be the key to recognize safety critical events. In fact, whether an event is safety critical or not often depends on the individual driver. A few algorithms, able to automatically classify driver reaction from video data, have been compared. The results presented in this paper show that the state of the art subjective review procedures to identify safety critical events from NDS can benefit from automated objective video processing. In addition, this paper discusses the major challenges in making such video analysis viable for future NDS and new potential
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Radio-Frequency Applications for Food Processing and Safety.
Jiao, Yang; Tang, Juming; Wang, Yifen; Koral, Tony L
2018-03-25
Radio-frequency (RF) heating, as a thermal-processing technology, has been extending its applications in the food industry. Although RF has shown some unique advantages over conventional methods in industrial drying and frozen food thawing, more research is needed to make it applicable for food safety applications because of its complex heating mechanism. This review provides comprehensive information regarding RF-heating history, mechanism, fundamentals, and applications that have already been fully developed or are still under research. The application of mathematical modeling as a useful tool in RF food processing is also reviewed in detail. At the end of the review, we summarize the active research groups in the RF food thermal-processing field, and address the current problems that still need to be overcome.
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Safety concerns and suggested design approaches to the HTGR Reformer process concept
Energy Technology Data Exchange (ETDEWEB)
Green, R.C.
1981-09-01
This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept.
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Safety concerns and suggested design approaches to the HTGR Reformer process concept
International Nuclear Information System (INIS)
Green, R.C.
1981-09-01
This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept
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Directory of Open Access Journals (Sweden)
Lin-Chau Chang
Full Text Available Standardised MedDRA Queries (SMQs have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA and Biologics License Application (BLA submissions to the United States Food and Drug Administration (USFDA.We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed.A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59% of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18% of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated. Most searches (75% of 227 searches with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process.SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.
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Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D
2017-01-01
Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.
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This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro
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The National School Safety Framework: A framework for preventing ...
African Journals Online (AJOL)
The National School Safety Framework (NSSF) – approved by the Minister of Education in April 2015 - is located within a range of international and national laws and policies that recognise the safety of learners and educators as a prerequisite for quality learning and teaching at school. The framework affirms the ...
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Process Control Systems in the Chemical Industry: Safety vs. Security
Energy Technology Data Exchange (ETDEWEB)
Jeffrey Hahn; Thomas Anderson
2005-04-01
Traditionally, the primary focus of the chemical industry has been safety and productivity. However, recent threats to our nation’s critical infrastructure have prompted a tightening of security measures across many different industry sectors. Reducing vulnerabilities of control systems against physical and cyber attack is necessary to ensure the safety, security and effective functioning of these systems. The U.S. Department of Homeland Security has developed a strategy to secure these vulnerabilities. Crucial to this strategy is the Control Systems Security and Test Center (CSSTC) established to test and analyze control systems equipment. In addition, the CSSTC promotes a proactive, collaborative approach to increase industry's awareness of standards, products and processes that can enhance the security of control systems. This paper outlines measures that can be taken to enhance the cybersecurity of process control systems in the chemical sector.
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Safety Evaluation for Hull Waste Treatment Process in JNC
International Nuclear Information System (INIS)
Kojima, H.; Kurakata, K.
2002-01-01
Hull wastes and some scrapped equipment are typical radioactive wastes generated from reprocessing process in Tokai Reprocessing Plant (TRP). Because hulls are the wastes remained in the fuel shearing and dissolution, they contain high radioactivity. Japan Nuclear Cycle Development Institute (JNC) has started the project of Hull Waste Treatment Facility (HWTF) to treat these solid wastes using compaction and incineration methods since 1993. It is said that Zircaloy fines generated from compaction process might burn and explode intensely. Therefore explosive conditions of the fines generated in compaction process were measured. As these results, it was concluded that the fines generated from the compaction process were not hazardous material. This paper describes the outline of the treatment process of hulls and results of safety evaluation
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Incorporating Human Factors into design change processes - a regulator's perspective
International Nuclear Information System (INIS)
Staples, L.; McRobbie, H.
2003-01-01
Nuclear power plants in Canada must receive written approval from the Canadian Nuclear Safety Commission (CNSC) when making certain changes that are defined in their licenses. The CNSC expects the design change process to include a method for ensuring that the human-machine interface and workplace design support the safe and reliable performance of required tasks. When reviewing design changes for approval, the CNSC looks for evidence of analysis work, use of appropriate human factors design guide-lines, and verification and validation testing of the design. In addition to reviewing significant design changes, evaluations are conducted to ensure design change processes adequately address human performance. Findings from reviews and evaluations highlight the need to integrate human factors into the design change process, provide human factors training and support to engineering staff, establish processes to ensure coordination between the various groups with a vested interest in human factors, and develop more rigorous methods to validate changes to maintenance, field operations and testing interfaces. (author)
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Directory of Open Access Journals (Sweden)
Frédéric Bernier
2017-06-01
Full Text Available The mission of nuclear safety authorities in national radioactive waste disposal programmes is to ensure that people and the environment are protected against the hazards of ionising radiations emitted by the waste. It implies the establishment of safety requirements and the oversight of the activities of the waste management organisation in charge of implementing the programme. In Belgium, the safety requirements for geological disposal rest on the following principles: defence-in-depth, demonstrability and the radiation protection principles elaborated by the International Commission on Radiological Protection (ICRP. Applying these principles requires notably an appropriate identification and characterisation of the processes upon which the safety functions fulfilled by the disposal system rely and of the processes that may affect the system performance. Therefore, research and development (R&D on safety-relevant thermo-hydro-mechanical-chemical (THMC issues is important to build confidence in the safety assessment. This paper points out the key THMC processes that might influence radionuclide transport in a disposal system and its surrounding environment, considering the dynamic nature of these processes. Their nature and significance are expected to change according to prevailing internal and external conditions, which evolve from the repository construction phase to the whole heating–cooling cycle of decaying waste after closure. As these processes have a potential impact on safety, it is essential to identify and to understand them properly when developing a disposal concept to ensure compliance with relevant safety requirements. In particular, the investigation of THMC processes is needed to manage uncertainties. This includes the identification and characterisation of uncertainties as well as for the understanding of their safety-relevance. R&D may also be necessary to reduce uncertainties of which the magnitude does not allow
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10 CFR 70.62 - Safety program and integrated safety analysis.
2010-01-01
...; (iv) Potential accident sequences caused by process deviations or other events internal to the... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process... this safety program; namely, process safety information, integrated safety analysis, and management...
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Quality and Safety Assurance of Iron Casts and Manufacturing Processes
Kukla S.
2016-01-01
The scope of this work focuses on the aspects of quality and safety assurance of the iron cast manufacturing processes. Special attention was given to the processes of quality control and after-machining of iron casts manufactured on automatic foundry lines. Due to low level of automation and huge work intensity at this stage of the process, a model area was established which underwent reorganization in accordance with the assumptions of the World Class Manufacturing (WCM). An analysis of wor...
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Electronic Voucher Approval - Financial Management
US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...
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Preliminary report of radiological safety to hydrology 1993 campaign
International Nuclear Information System (INIS)
Badano, A.; Suarez Antola, R.; Dellepere, A.; Barreiro, M.
1993-01-01
This report has been prepared based on the interaction between project managers and division radiological Protection and Nuclear Safety. In seeking to establish a basis for approval from the point of view of radiation safety practices . The idea for the audit has been provided at all times because the interest was the exchange of ideas and the use of common sense to improve the safety of radioactive substances, security of operators and public safety and environment.The above shows that in the planned radiation safety condition described in this report,the practice can be carried out according to the criteria of safety accepted .
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International Nuclear Information System (INIS)
Motta, E.S.; Sousa, A.L.B. de; Paiva, R.L.C. de; Mezrahi, A.
2013-01-01
The main objective of the Nuclear Fuel Cycle Facilities licensing processes is to ensure the safety of these installations in their entire life cycle (in the installation site selection, designing, construction, pre-operational tests, operational and decommissioning phases). The Brazilian licensing process requires from the operator, among others, before the operating license: (I) a Site Report and a Final Safety Analysis Report, ensuring that all safety related issues are adequately analyzed and understood; (II) a formal structured Management System focused on the installation safety; and (III) dissemination of safety related information to all involved operator employees and subcontractors. Therefore, these requirements reflect in an adequate operator actions and practices, ensuring a working environment with a high level of safety culture. (author)
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Energy Technology Data Exchange (ETDEWEB)
Motta, E.S.; Sousa, A.L.B. de; Paiva, R.L.C. de; Mezrahi, A., E-mail: emotta@cnen.gov.br [Comissao Nacional de Energia Nuclear (CNEN-RJ), Rio de Janeiro, RJ (Brazil)
2013-07-01
The main objective of the Nuclear Fuel Cycle Facilities licensing processes is to ensure the safety of these installations in their entire life cycle (in the installation site selection, designing, construction, pre-operational tests, operational and decommissioning phases). The Brazilian licensing process requires from the operator, among others, before the operating license: (I) a Site Report and a Final Safety Analysis Report, ensuring that all safety related issues are adequately analyzed and understood; (II) a formal structured Management System focused on the installation safety; and (III) dissemination of safety related information to all involved operator employees and subcontractors. Therefore, these requirements reflect in an adequate operator actions and practices, ensuring a working environment with a high level of safety culture. (author)
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Radiation processing in the United States
International Nuclear Information System (INIS)
Brynjolfsson, A.
1986-01-01
In animal feeding studies, including the huge animal feeding studies on radiation sterilized poultry products irradiated with sterilizing dose of 58 kGy revealed no harmful effects. This finding is corroborated by the very extensive analysis of the radiolytic products, which indicated that the radiolytic products could not in the quantity found in the food be expected to produce any toxic effect. It thus appears to be proven with reasonable certainty that no harm will result from the proposed use of the process. Accordingly, FDA is moving forward with approvals while allowing the required time for hearings and objection. On July 5, 1983 FDA permitted gamma irradiation for control of microbial contamination in dried spices and dehydrated vegetable seasoning at doses up to 10 kGy; on June 19, 1984 the approval was expanded to cover insect infection; and additional seasonings and irradiation of dry or dehydrated enzyme preparations were approved on February 12 and June 4, respectively, 1985. In addition, in July 1985, FDA cleared irradiation of pork products with doses of 0.3 to 1 kGy for eliminating trichinosis. Approvals of other agencies, including Food and Drug Administration, Department of Agriculture, the Nuclear Regulatory Commission, Occupational Safety and Health Administration, Department of Transportation, Environmental Protection Agency, and States and local communities, are usually of a technological nature and can then be obtained if the process is technologically feasible. (Namekawa, K.)
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International Nuclear Information System (INIS)
Thomas, Jay E.; Bickley, Donald W.; Conatser, E. Ray
2000-01-01
In the first four years of the Foreign Research Reactor (FRR) Spent Nuclear Fuel (SNF) Return Program following resumption of the SNF return program with the DOE-EIS ROD in May 1996, 13 shipments involving 77 casks with over 2,600 assemblies have been safely received and stored at the Savannah River Site (SRS). Each fuel type has gone through a rigorous pre-shipment preparation process that includes fuel characterization, criticality safety reviews, and operational reviews, culminating in the Department of Energy's (DOE's) authorization to ship. Ideally, the authorization to ship process should begin two years in advance of the fuel receipt with an agreement between the Department of Energy - Head Quarters (DOE-HQ) and the research reactor government on the conditions and protocol for the spent nuclear fuel return, with a target of DOE shipment authorization at least two months before facility loading. A visit by representatives from the Department of Energy - Savannah River (DOE-SR) and Westinghouse Savannah River Company (WSRC), DOE's Management and Operations (M and O) Contractor for the SRS, to the research reactor facility is then scheduled for the purpose of finalizing contractual arrangements (DOE-SR), facility assessments, and initial fuel inspections. An extensive effort is initiated at this time to characterize the fuel in a standard format as identified in the Appendix A attachment to the contract. The Appendix A must be finalized in an accurate and timely manner because it serves as the base reference document for WSRC and other involved stakeholders such as the cask owners and the competent authorities throughout the approval process. With the approval of the Appendix A, criticality safety reviews are initiated to evaluate the unloading and storage configurations. Operational reviews are conducted to allow for necessary adaptation of fuel handling facilities, procedures, and training. WSRC has proceduralized this process, 'Certification to Receive and
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2012-05-07
... Listed and Approved for Use in the Production of Meat and Poultry Products AGENCY: Food Safety and... the regulations prohibit for use in meat or poultry products. Under this proposal, new uses of these substances in meat or poultry products would continue to be approved by the Food and Drug Administration (FDA...
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International Nuclear Information System (INIS)
TOFFER, H.
2006-01-01
Since the end of the cold war, the need for operating weapons production facilities has faded. Criticality Safety Limits and controls supporting production modes in these facilities became outdated and furthermore lacked the procedure based rigor dictated by present day requirements. In the past, in many instances, the formalism of present day criticality safety evaluations was not applied. Some of the safety evaluations amounted to a paragraph in a notebook with no safety basis and questionable arguments with respect to double contingency criteria. When material stabilization, clean out, and deactivation activities commenced, large numbers of these older criticality safety evaluations were uncovered with limits and controls backed up by tenuous arguments. A dilemma developed: on the one hand, cleanup activities were placed on very aggressive schedules; on the other hand, a highly structured approach to limits development was required and applied to the cleanup operations. Some creative approaches were needed to cope with the limits development process
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The Evolution of the NASA Commercial Crew Program Mission Assurance Process
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.
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Tank waste remediation system nuclear criticality safety inspection and assessment plan
International Nuclear Information System (INIS)
VAIL, T.S.
1999-01-01
This plan provides a management approved procedure for inspections and assessments of sufficient depth to validate that the Tank Waste Remediation System (TWRS) facility complies with the requirements of the Project Hanford criticality safety program, NHF-PRO-334, ''Criticality Safety General, Requirements''
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Energy Technology Data Exchange (ETDEWEB)
Sanne, Johan M. [Linkoeping Univ. (Sweden). The Tema Inst. - Technology and Social Change
2005-12-15
Organizational changes focused on process orientation are taking place among Swedish nuclear power plants, aiming at improving the operation. The Swedish Nuclear Power Inspectorate has identified a need for increased knowledge within the area for its regulatory activities. In order to analyze what process orientation imply for nuclear power plant safety a number of questions must be asked: 1. How is safety in nuclear power production created currently? What significance does the functional organization play? 2. How can organizational forms be analysed? What consequences does quality management have for work and for the enterprise? 3. Why should nuclear power plants be process oriented? Who are the customers and what are their customer values? Which customers are expected to contribute from process orientation? 4. What can one learn from process orientation in other safety critical systems? What is the effect on those features that currently create safety? 5. Could customer values increase for one customer without decreasing for other customers? What is the relationship between economic and safety interests from an increased process orientation? The deregulation of the electricity market have caused an interest in increased economic efficiency, which is the motivation for the interest in process orientation. among other means. It is the nuclear power plants' owners and the distributors (often the same corporations) that have the strongest interest in process orientation. If the functional organization and associated practices are decomposed, the prerequisites of the risk management regime changes, perhaps deteriorating its functionality. When nuclear power operators consider the introduction of process orientation, the Nuclear Power Inspectorate should require that 1. The operators perform a risk analysis beforehand concerning the potential consequences that process orientation might convey: the analysis should contain a model specifying how safety is currently
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Presentation on development of safety assessment reports in Romania
International Nuclear Information System (INIS)
Goicea, L.
2002-01-01
This presentation shows whole steps of Cernavoda 2 NPP licensing and accident management relevant changes considered. There are description of CANDU Safety principles and design criteria, as well as FSAR structured according to NRC Regulatory Guide 1.70, format of presentation of accident analyses, applicable acceptant criteria to analyses and Design Codes, Safety standards and Safety Guides used. The main features of CANDU reactors are presented, including of base design characteristics and describing of structures of CANDU reactors. During the licensing Cernavoda 2 are passed through Site approval, Construction permits of NPP system (1980-1993), Final construction license (1993) and Commissioning license (1995). In the May 1998 the First operating license is issued, based on FSAR Phase 1, Full power probationary report and carried out the requirements related to revising the FSAR and initiating of the Modernization program. To achieve the defense in depth concept are used and implemented the norms and quality standards during all plant stages, as well as selecting the high quality materials. During all plant stages is keeps strictly accomplishment of the quality requirements, and ensures a high level of reliability by using of operating principle and fabrication. In NPP operation is established using of the approved operating concept permitting only the safe condition for reactor operation. In the process of Cernavoda NPP licensing and operating the CSA and CGSB Canadian Standards, ASME and ANSI American Standards, Romanian Norms are implemented. Another useful Codes and Standards are implemented too, as ACI, ASTM, ANSI, AWS and others. In accident analysis for Safety Analysis Report for Cernavoda Unit 1 are involved 37 computer codes, in such areas as Reactor physics, Thermal-hydraulics, Fuel behavior, Fuel channel, Containment, and Fission product release and dose calculation
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Guidelines regarding the Review Process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2011-01-01
These guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views [fr
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Guidelines regarding the review process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2002-01-01
These guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views
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Guidelines regarding the review process under the convention on nuclear safety
International Nuclear Information System (INIS)
1998-01-01
These guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing national reports submitted in accordance with Article 5 and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of national reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views
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Guidelines regarding the Review Process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2011-01-01
These guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views
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Guidelines regarding the review process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
1999-01-01
These guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing national reports submitted in accordance with Article 5 and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of national reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views
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Guidelines regarding the Review Process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2011-01-01
These guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views [es
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TU-AB-204-01: Device Approval Process
International Nuclear Information System (INIS)
Delfino, J.
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-01: Device Approval Process
Energy Technology Data Exchange (ETDEWEB)
Delfino, J. [Food & Drug Administration (United States)
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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The Agency's Health and Safety Measures
Energy Technology Data Exchange (ETDEWEB)
NONE
1960-05-31
The Agency's health and safety measures as approved by the Board of Governors on 31 March 1960 in implementation of Articles III. A. 6 and XII of the Statute of the Agency are reproduced in this document for the information of all Members.
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Fuel and canister process report for the safety assessment SR-Can
International Nuclear Information System (INIS)
Werme, Lars
2006-10-01
This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The report is written by, and for, experts in the relevant scientific fields. It should though be possible for a generalist in the area of long-term safety assessments of geologic nuclear waste repositories to comprehend the contents of the report. The report is an important part of the documentation of the SR-Can project and an essential reference within the project, providing a scientifically motivated plan for the handling of geosphere processes. It is, furthermore, foreseen that the report will be essential for reviewers scrutinising the handling of geosphere issues in the SR-Can assessment. Several types of fuel will be emplaced in the repository. For the reference case with 40 years of reactor operation, the fuel quantity from boiling water reactors, BWR fuel, is estimated at 7,000 tonnes, while the quantity from pressurized water reactors, PWR fuel, is estimated at about 2,300 tonnes. In addition, 23 tonnes of mixed-oxide fuel (MOX) fuel of German origin from BWR and PWR reactors and 20 tonnes of fuel from the decommissioned heavy water reactor in Aagesta will be disposed of. To allow for future changes in the Swedish nuclear programme, the safety assessment assumes a total of 6,000 canister corresponding to 12,000 tonnes of fuel
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Fuel and canister process report for the safety assessment SR-Can
Energy Technology Data Exchange (ETDEWEB)
Werme, Lars (ed.)
2006-10-15
This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The report is written by, and for, experts in the relevant scientific fields. It should though be possible for a generalist in the area of long-term safety assessments of geologic nuclear waste repositories to comprehend the contents of the report. The report is an important part of the documentation of the SR-Can project and an essential reference within the project, providing a scientifically motivated plan for the handling of geosphere processes. It is, furthermore, foreseen that the report will be essential for reviewers scrutinising the handling of geosphere issues in the SR-Can assessment. Several types of fuel will be emplaced in the repository. For the reference case with 40 years of reactor operation, the fuel quantity from boiling water reactors, BWR fuel, is estimated at 7,000 tonnes, while the quantity from pressurized water reactors, PWR fuel, is estimated at about 2,300 tonnes. In addition, 23 tonnes of mixed-oxide fuel (MOX) fuel of German origin from BWR and PWR reactors and 20 tonnes of fuel from the decommissioned heavy water reactor in Aagesta will be disposed of. To allow for future changes in the Swedish nuclear programme, the safety assessment assumes a total of 6,000 canister corresponding to 12,000 tonnes of fuel.
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International Nuclear Information System (INIS)
You, Gil Sung; Choung, W. M.; Ku, J. H.; Cho, I. J.; Kook, D. H.; Park, S. W.; Bek, S. Y.; Lee, E. P.
2004-10-01
The advanced spent fuel conditioning process(ACP) proposed to reduce the overall volume of the PWR spent fuel and improve safety and economy of the long-term storage of spent fuel. In the next phase(2004∼2006), the hot test will be carried out for verification of the ACP in a laboratory scale. For the hot test, the hot cell facilities of α- type and auxiliary facilities are required essentially for safe handling of high radioactive materials. As the hot cell facilities for demonstration of the ACP, a existing hot cell of β- type will be refurbished to minimize construction expenditures of hot cell facility. Up to now, the detail design of hot cell facilities and process were completed, and the safety analysis was performed to substantiate secure of conservative safety. The design data were submitted for licensing which was necessary for construction and operation of hot cell facilities. The safety investigation of KINS on hot cell facilities was completed, and the license for construction and operation of hot cell facilities was acquired already from MOST. In this report, the safety analysis report submitted to KINS was summarized. And also, the questionnaires issued from KINS and answers of KAERI in process of safety investigation were described in detail
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Incorporation of human factors into design change processes - a regulator's perspective
International Nuclear Information System (INIS)
Staples, L.; McRobbie, H.
2003-01-01
Nuclear power plants in Canada must receive written approval from the Canadian Nuclear Safety Commission (CNSC) when making certain changes that are defined in their licenses. The CNSC expects the design change process to include a method for ensuring that the human-machine interface and workplace design support the safe and reliable performance of required tasks. When reviewing design changes for approval, the CNSC looks for evidence of analysis work, use of appropriate human factors design guidelines, and verification and validation testing of the design. In addition to reviewing significant design changes, evaluations are conducted to ensure design change processes adequately address human performance. Findings from reviews and evaluations highlight the need to integrate human factors into the design change process, provide human factors training and support to engineering staff, establish processes to ensure coordination between the various groups with a vested interest in human factors, and develop more rigorous methods to validate changes to maintenance, field operations and testing interfaces. (author)
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International Nuclear Information System (INIS)
Bratzel, D.R.
1997-01-01
Following a 1990 investigation into flammable gas generation, retention, and release mechanisms within the Hanford Site high-level waste tanks, personnel concluded that the existing Authorization Basis documentation did not adequately evaluate flammable gas hazards. This declaration was based primarily on the fact that personnel did not adequately consider hydrogen and nitrous oxide evolution within the material in certain waste tanks and subsequent hypothetical ignition in the development of safety documentation for the waste tanks. The US Department of Energy-Headquarters subsequently declared an Unreviewed Safety Question (USQ). Although work scope has been focused on closure of the USQ since 1990, the DOE has yet to close the USQ because of considerable uncertainty regarding essential technical parameters and associated risk. The DOE recently approved a Basis for Interim Operation to revise the Authorization Basis for managing the tank farms, however, the USQ remains open. The two fundamental requirements for closure of the flammable gas USQ are as follows: development of a defensible technical basis for existing controls; development of a process to assess the adequacy of controls as the waste tank mission progresses
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Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S
2017-02-08
To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. A cohort study. New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval-of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons-including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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Post Fukushima safety enhancements in Indian PHWRS
International Nuclear Information System (INIS)
Ramasomayajulu, M.; Khot, Pankaj; Chauhan, Ashok
2016-01-01
Fukushima event was reviewed in Nuclear Power Corporation of India (NPCIL) and based on these reviews, safety enhancements were identified for Indian PHWRs. Safety enhancements such as additional emergency power sources, enhanced onsite water inventories, external water injection arrangements (Hook up points), measures related to hydrogen management, containment venting provision, seismic trip, mobile pumps, onsite emergency support Centre. These safety enhancements were reviewed by the regulatory body (Atomic Energy Regulatory Board, AERB) and were approved for implementation. Most of these are either implemented or in the advance stage of implementation. The paper elaborates above safety enhancements implemented post Fukushima accident; and preparedness to use these provisions. (author)
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2011 Annual Criticality Safety Program Performance Summary
Energy Technology Data Exchange (ETDEWEB)
Andrea Hoffman
2011-12-01
TSR limits fuel plate bundles to 1085 grams U-235, which is the maximum loading of an ATR fuel element. The overloaded fuel plate bundle contained 1097 grams U-235 and was assembled under an 1100 gram U-235 limit in 1982. In 2003, the limit was reduced to 1085 grams citing a new criticality safety evaluation for ATR fuel elements. The fuel plate bundle inventories were not checked for compliance prior to implementing the reduced limit. A subsequent review of the NMIS inventory did not identify further violations. Requirements Management - The INL Criticality Safety program is organized and well documented. The source requirements for the INL Criticality Safety Program are from 10 CFR 830.204, DOE Order 420.1B, Chapter III, 'Nuclear Criticality Safety,' ANSI/ANS 8-series Industry Standards, and DOE Standards. These source requirements are documented in LRD-18001, 'INL Criticality Safety Program Requirements Manual.' The majority of the criticality safety source requirements are contained in DOE Order 420.1B because it invokes all of the ANSI/ANS 8-Series Standards. DOE Order 420.1B also invokes several DOE Standards, including DOE-STD-3007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities.' DOE Order 420.1B contains requirements for DOE 'Heads of Field Elements' to approve the criticality safety program and specific elements of the program, namely, the qualification of criticality staff and the method for preparing criticality safety evaluations. This was accomplished by the approval of SAR-400, 'INL Standardized Nuclear Safety Basis Manual,' Chapter 6, 'Prevention of Inadvertent Criticality.' Chapter 6 of SAR-400 contains sufficient detail and/or reference to the specific DOE and contractor documents that adequately describe the INL Criticality Safety Program per the elements specified in DOE Order 420.1B. The Safety Evaluation Report for SAR-400
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International Nuclear Information System (INIS)
1992-08-01
Being in a unique position to facilitate information exchange, the Secretariat of the International Atomic Energy Agency was requested by its Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM) to collate package approval data and publish periodical reports thereon. A database was implemented on the mainframe computer in the mid-1980s but this was soon adapted for use on a personal computer. A fully menu-driven system programme was designed that allows both contributing Member States and the Secretariat more flexibility in data processing and reporting. Complete documentation is available in the form of a user guide. The cut-off date used for this report is 31 August 1992. This report supersedes IAEA-TECDOC-617 ''Directory of National Competent Authorities' Approval Certificates for Package Design, Special Form Material and Shipment of Radioactive Material, 1991 Edition''. The information contained in this report is given in six tables. In each of these, information is presented in alphabetical order based on the certificate number. The certificate number is identical with the competent authority identification mark. It is composed of the issuing Member State's international vehicle registration identification (VRI) code, followed by a slash, then a unique number specific to a particular design or shipment that is assigned by the competent authority, another slash and finally a code identifying the type of package involved. ''-85'' is appended to those certificates that were approved on the basis of the 1985 Edition of Safety Series No. 6. Tables 1 to 4 present administrative data including issue and expiry dates, package identification, package serial numbers, modes for which the package/shipment is approved and the edition of Safety Series No. 6 on which the approval has been based. The technical information on package mass, authorized contents, and detailed and general description of the package are contained in Table 5. Table 6
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Safety is paramount; Sicherheit ist das oberste Gebot
Energy Technology Data Exchange (ETDEWEB)
NONE
2013-11-15
Since 20 years nuclear power plants provider a contribution to the power supply in Germany. In this long period the safety concept has been approved and was completed ever more. Aim of the safety concept is the operational personnel and the population from ionizing (radioactive) radiation, which arises in the nuclear fission itself or is emitted by the radionuclides produced in the nuclear fission. Base of the safety concept is the concerted action of facility safety, safety management, qualification of co-workers, and living safety culture. German nuclear power plants belong concidedly to the worldwide safest. They were and are currently fitted to the progressing status of technology and offer the guarantee that they also during the remaining operational time are operated on the highest safety level.
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Guidelines regarding the Review Process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2013-01-01
These Guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 of the Convention and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views. [fr
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Guidelines regarding the Review Process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2013-01-01
These Guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 of the Convention and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views.
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Guidelines regarding the Review Process under the Convention on Nuclear Safety
International Nuclear Information System (INIS)
2013-01-01
These Guidelines, established by the Contracting Parties pursuant to Article 22 of the Convention, are intended to be read in conjunction with the text of the Convention. Their purpose is to provide guidance to the Contracting Parties on the process for reviewing National Reports submitted in accordance with Article 5 of the Convention and thereby to facilitate the efficient review of implementation by the Contracting Parties of their obligations under the Convention. The aim of the review process should be to achieve a thorough examination of National Reports submitted in accordance with Article 5 of the Convention, so that Contracting Parties can learn from each other's solutions to common and individual nuclear safety problems and, above all, contribute to improving nuclear safety worldwide through a constructive exchange of views. [es
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Energy Technology Data Exchange (ETDEWEB)
1994-06-20
This document was prepared to take the place of a Safety Evaluation Report since the Baseline Safety Analysis File (BSAF)and associated Baseline Technical Safety Requirements (TSR) File do not meet the requirements of a complete safety analysis documentation. Its purpose is to present in summary form the background of how the BSAF and Baseline TSR originated and a description of the process by which it was produced and approved for use in the Environmental Restoration Program.The BSAF is a facility safety reference document for INEL environmental restoration activities including environmental remediation of inactive waste sites and decontamination and decommissioning (D&D) of surplus facilities. The BSAF contains safety bases common to environmental restoration activities and guidelines for performing and documenting safety analysis. The common safety bases can be incorporated by reference into the safety analysis documentation prepared for individual environmental restoration activities with justification and any necessary revisions. The safety analysis guidelines in BSAF provide an accepted method for hazard analysis; analysis of normal, abnormal, and accident conditions; human factors analysis; and derivation of TSRS. The BSAF safety bases and guidelines are graded for environmental restoration activities.
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International Nuclear Information System (INIS)
1994-01-01
This document was prepared to take the place of a Safety Evaluation Report since the Baseline Safety Analysis File (BSAF)and associated Baseline Technical Safety Requirements (TSR) File do not meet the requirements of a complete safety analysis documentation. Its purpose is to present in summary form the background of how the BSAF and Baseline TSR originated and a description of the process by which it was produced and approved for use in the Environmental Restoration Program.The BSAF is a facility safety reference document for INEL environmental restoration activities including environmental remediation of inactive waste sites and decontamination and decommissioning (D ampersand D) of surplus facilities. The BSAF contains safety bases common to environmental restoration activities and guidelines for performing and documenting safety analysis. The common safety bases can be incorporated by reference into the safety analysis documentation prepared for individual environmental restoration activities with justification and any necessary revisions. The safety analysis guidelines in BSAF provide an accepted method for hazard analysis; analysis of normal, abnormal, and accident conditions; human factors analysis; and derivation of TSRS. The BSAF safety bases and guidelines are graded for environmental restoration activities
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Nab-paclitaxel for the treatment of breast cancer: efficacy, safety, and approval
Directory of Open Access Journals (Sweden)
Iwase H
2011-07-01
Full Text Available Yutaka Yamamoto1, Ichiro Kawano2, Hirotaka Iwase11Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; 2Department of Surgery, Asahino General Hospital, Kumamoto, JapanAbstract: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel is a novel formulation of paclitaxel that does not require solvents such as polyoxyethylated castor oil and ethanol. Use of these solvents has been associated with toxic response, including hypersensitivity reactions and prolonged sensory neuropathy, as well as a negative impact in relation to the therapeutic index of paclitaxel. nab-paclitaxel displays greater antitumor activity and less toxicity than solvent-base paclitaxel. In a phase I trial of single nab-paclitaxel, the maximum tolerated dose was 300 mg/m2 with the dose limiting toxicities being sensory neuropathy, stomatitis, and superficial keratopathy. In the metastatic setting, a pivotal comparative randomized phase III study demonstrated that nab-paclitaxel (at 260 mg/m2 over 30 minutes infusion without premedication every 3 weeks mediated a superior objective response rate and prolonged time to progression compared with solvent-based paclitaxel (at 175 mg/m2 over a 3-hour injection with standard premedication. The nab-paclitaxel-treated group showed a higher incidence of sensory neuropathy than the solvent-based paclitaxel group. However, these adverse side effects rapidly resolved after interruption of treatment and dose reduction. Weekly administration of nab-paclitaxel was also more active and displayed less toxicity compared with 100 mg/m2 docetaxel given triweekly. Nab-paclitaxel has already been approved in 42 countries for the treatment of metastatic breast cancer previously treated with anthracycline, based on confirmation of the efficacy and manageable toxicity in the metastatic setting. This review summarizes the most relevant knowledge on nab-paclitaxel for treating breast cancer
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International Nuclear Information System (INIS)
2008-03-01
The current issue presents information about the following activities: 1) International Conference on Illicit Nuclear Trafficking which took place in November 2007 in Edinburgh. The principal aim of the conference was to examine the threat and context of illicit nuclear trafficking of radioactive material, specifically, what is being done to combat such trafficking and where more needs to be done. The conference was also to consider how the obligations and commitments of the legally binding and non-binding international instruments could be and are being implemented by various States. 2) INSAG Message on Nuclear Safety Infrastructure in which the INSAG Chairman Richard Meserve addressed nuclear safety in the current context and various issues that warrant special attention. 3) approved for publication the Safety Requirements publication on Safety of Nuclear Fuel Cycle Facilities. 4) The Asian Nuclear Safety Network (ANSN)
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DOE-RL Integrated Safety Management System Description
International Nuclear Information System (INIS)
SHOOP, D.S.
2000-01-01
The purpose of this Integrated Safety Management System Description (ISMSD) is to describe the U.S. Department of Energy (DOE), Richland Operations Office (RL) ISMS as implemented through the RL Integrated Management System (RIMS). This ISMSD does not impose additional requirements but rather provides an overview describing how various parts of the ISMS fit together. Specific requirements for each of the core functions and guiding principles are established in other implementing processes, procedures, and program descriptions that comprise RIMS. RL is organized to conduct work through operating contracts; therefore, it is extremely difficult to provide an adequate ISMS description that only addresses RL functions. Of necessity, this ISMSD contains some information on contractor processes and procedures which then require RL approval or oversight. This ISMSD does not purport to contain a full description of the contractors' ISM System Descriptions
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DOE-RL Integrated Safety Management System Description
Shoop, D S
2000-01-01
The purpose of this Integrated Safety Management System Description (ISMSD) is to describe the U.S. Department of Energy (DOE), Richland Operations Office (RL) ISMS as implemented through the RL Integrated Management System (RIMS). This ISMSD does not impose additional requirements but rather provides an overview describing how various parts of the ISMS fit together. Specific requirements for each of the core functions and guiding principles are established in other implementing processes, procedures, and program descriptions that comprise RIMS. RL is organized to conduct work through operating contracts; therefore, it is extremely difficult to provide an adequate ISMS description that only addresses RL functions. Of necessity, this ISMSD contains some information on contractor processes and procedures which then require RL approval or oversight. This ISMSD does not purport to contain a full description of the contractors' ISM System Descriptions.
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2013-10-02
... 173 [Docket No. PHMSA-2013-0205; Notice No. 13-14] Clarification on Fireworks Policy Regarding Approvals or Certifications for Firework Series AGENCY: Pipeline and Hazardous Materials Safety... applications for firework device series. PHMSA has required separate applications for each individual firework...
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2013-10-02
... 173 [Docket No. PHMSA-2013-0206; Notice No. 13-15] Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks Devices AGENCY: Pipeline and Hazardous Materials Safety... applications for specialty fireworks devices. Specialty fireworks devices are fireworks devices in various...
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International Nuclear Information System (INIS)
Lokner, V.; Levanat, I.; Subasic, D.
2000-01-01
An iterative process of safety assessment, presently focusing on the site-specific evaluation of the post-closure phase for the prospective LILW repository on Trgovska gora in Croatia, has recently been initiated. The primary aim of the first assessment iterations is to provide the experts involved, the regulators and the general public with a reasonable assurance that the applicable long term performance and safety objectives can be met. Another goal is to develop a sufficient understanding of the system behavior to support decisions about the site investigation, the facility design, the waste acceptance criteria and the closure conditions. In this initial phase, the safety assessment is structured in a manner following closely methodology of the ISAM. The International Programme for Improving Long Term Safety Assessment Methodologies for Near Surface Radioactive Waste Disposal Facilities the IAEA coordinated research program started in 1997. Results of the safety assessment first iteration will be organized and presented in the form of a preliminary safety analysis report (PSAR), expected to be completed in the second part of the year 2000. As the first report on the initiated safety assessment activities, the PSAR will describe the concept and aims of the assessment process. Particular emphasis will be placed on description of the key elements of a safety assessment approach by: a) defining the assessment context; b) providing description of the disposal system; c) developing and justifying assessment scenarios; d) formulating and implementing models; and e) interpreting the scoping calculations. (author)
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Advanced nuclear reactor safety issues and research needs
International Nuclear Information System (INIS)
2002-01-01
On 18-20 February 2002, the OECD Nuclear Energy Agency (NEA) organised, with the co-sponsorship of the International Atomic Energy Agency (IAEA) and in collaboration with the European Commission (EC), a Workshop on Advanced Nuclear Reactor Safety Issues and Research Needs. Currently, advanced nuclear reactor projects range from the development of evolutionary and advanced light water reactor (LWR) designs to initial work to develop even further advanced designs which go beyond LWR technology (e.g. high-temperature gas-cooled reactors and liquid metal-cooled reactors). These advanced designs include a greater use of advanced technology and safety features than those employed in currently operating plants or approved designs. The objectives of the workshop were to: - facilitate early identification and resolution of safety issues by developing a consensus among participating countries on the identification of safety issues, the scope of research needed to address these issues and a potential approach to their resolution; - promote the preservation of knowledge and expertise on advanced reactor technology; - provide input to the Generation IV International Forum Technology Road-map. In addition, the workshop tried to link advancement of knowledge and understanding of advanced designs to the regulatory process, with emphasis on building public confidence. It also helped to document current views on advanced reactor safety and technology, thereby contributing to preserving knowledge and expertise before it is lost. (author)
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Configuration and Data Management Process and the System Safety Professional
Shivers, Charles Herbert; Parker, Nelson C. (Technical Monitor)
2001-01-01
This article presents a discussion of the configuration management (CM) and the Data Management (DM) functions and provides a perspective of the importance of configuration and data management processes to the success of system safety activities. The article addresses the basic requirements of configuration and data management generally based on NASA configuration and data management policies and practices, although the concepts are likely to represent processes of any public or private organization's well-designed configuration and data management program.
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Effect of generic issues program on improving safety
International Nuclear Information System (INIS)
Fard, M. R.; Kauffman, J. V.
2010-01-01
The U.S. Nuclear Regulatory Commission (NRC) identifies (by its assessment of plant operation) certain issues involving public health and safety, the common defense and security, or the environment that could affect multiple entities under NRC jurisdiction. The Generic Issues Program (GIP) addresses the resolution of these Generic Issues (GIs). The resolution of these issues may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect nuclear power plant licensees, nuclear material certificate holders, or holders of other regulatory approvals. U.S. NRC provides information related to the past and ongoing GIP activities to the general public by the use of three main resources, namely NUREG-0933, 'Resolution of Generic Safety Issues, ' Generic Issues Management Control System (GIMCS), and GIP public web page. GIP information resources provide information such as historical information on resolved GIs, current status of the open GIs, policy documents, program procedures, GIP annual and quarterly reports and the process to contact GIP and propose a GI This paper provides an overview of the GIP and several examples of safety improvements resulting from the resolution of GIs. In addition, the paper provides a brief discussion of a few recent GIs to illustrate how the program functions to improve safety. (authors)
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Auditing the process of ethics approval for Master's degrees at a ...
African Journals Online (AJOL)
2014-05-01
May 1, 2014 ... of ethics approval for Master's level research at the Nelson R Mandela ... The following information was retrieved: ... Any system designed to improve this situation must ensure that high standards of vigilance are maintained, ...
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ITER final design report, cost review and safety analysis (FDR) and relevant documents
International Nuclear Information System (INIS)
1999-01-01
This volume contains the fourth major milestone report and documents associated with its acceptance, review and approval. This ITER Final Design Report, Cost Review and Safety Analysis was presented to the ITER Council at its 13th meeting in February 1998 and was approved at its extraordinary meeting on 25 June 1998. The contents include an outline of the ITER objectives, the ITER parameters and design overview as well as operating scenarios and plasma performance. Furthermore, design features, safety and environmental characteristics and schedule and cost estimates are given
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75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water
2010-11-22
... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18...
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Irradiation emerges as processing alternative
International Nuclear Information System (INIS)
Hatfield, D.
1985-01-01
Anticipating that food irradiation may soon become an important addition to the many food processing techniques currently available, this article discusses many aspects of this process. Primarily, the benefits of irradiation for all foods include insect and bacterial control, increasing the potential to reduce incidences of food-borne illnesses, in addition to delaying the deterioration of fruits and vegetables. Currently approved uses of food irradiation in the U.S. and other countries, a summary of the proposed rule for wider application, and the labeling issue encompassed in the proposal are addressed. Additionally, the areas of great consumer concern--safety and public health implications, are talked about with the conclusion that food irradiation has been declared safe
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Safety measures for integrity test apparatus for IS process. Sulfuric acid decomposition section
International Nuclear Information System (INIS)
Noguchi, Hiroki; Kubo, Shinji; Iwatsuki, Jin; Onuki, Kaoru
2013-07-01
Hazardous substances such as sulfuric acid, sulfur dioxide and hydrogen iodide acid are employed in thermochemical Iodine-Sulfur (IS) process. It is necessary to take safety measure against workers and external environments to study experimentally on IS process. Presently we have been conducting to verify the soundness of main components made of engineering material in actual corrosive condition. An integrity test apparatus for the components of sulfuric acid decomposition was set up. We will use the hazardous substances such as sulfuric acid and sulfur dioxide and perform the experiment in pressurized condition in this integrity test. Safety measures for the test apparatus, operation and abnormal situation were considered prior to starting the test. This report summarized the consideration results for the safety measures on the integrity test apparatus for the components of sulfuric acid decomposition. (author)
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International Nuclear Information System (INIS)
2009-01-01
This guide presents the recommendations made by the ASN to applicants in order to facilitate approval requests and shipping approvals related to the transportation of radioactive products. After a recall of the legal context, these recommendations address the documents to be provided in support of an approval request or of a shipping approval, the content of the safety file, the instruction delay, the approval certificate, and changes brought to the parcel model. Appendices contain issues raised by expertise based on experiences, the European PDSR (Package Design Safety Report), and a model for the elaboration of a certificate project
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International Nuclear Information System (INIS)
Ellingson, D.R.
1993-06-01
The review guide is based on the shared experiences, approaches, and philosophies of the Environmental Restoration/Decontamination and Decommissioning (ER/D ampersand D) subgroup members. It is presented in the form of a review guide to maximize the benefit to both the safety analyses practitioner and reviewer. The guide focuses on those challenges that tend to be unique to ER/D ampersand D cleanup activities. Some of these experiences, approaches, and philosophies may find application or be beneficial to a broader spectrum of activities such as terminal cleanout or even new operations. Challenges unique to ER/D ampersand D activities include (1) consent agreements requiring activity startup on designated dates; (2) the increased uncertainty of specific hazards; and (3) the highly variable activities covered under the broad category of ER/D ampersand D. These unique challenges are in addition to the challenges encountered in all activities; e.g., new and changing requirements and multiple interpretations. The experiences in approaches, methods, and solutions to the challenges are documented from the practitioner and reviewer's perspective, thereby providing the viewpoints on why a direction was taken and the concerns expressed. Site cleanup consent agreements with predetermined dates for restoration activity startup add the dimension of imposed punitive actions for failure to meet the date. Approval of the safety analysis is a prerequisite to startup. Actions that increase expediency are (1) assuring activity safety; (2) documenting that assurance; and (3) acquiring the necessary approvals. These actions increase the timeliness of startup and decrease the potential for punitive action. Improvement in expediency has been achieved by using safety analysis techniques to provide input to the line management decision process rather than as a review of line management decisions. Expediency is also improved by sharing the safety input and resultant decisions with
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Directory of Open Access Journals (Sweden)
Ai Lin Evelyn Teo
2016-12-01
Full Text Available Despite the safety improvement drive that has been implemented in the construction industry in Singapore for many years, the industry continues to report the highest number of workplace fatalities, compared to other industries. The purpose of this paper is to discuss the theoretical framework of the safety aspect of a proposed BIM System to determine a Safety Index. An online questionnaire survey was conducted to ascertain the current workplace safety and health situation in the construction industry and explore how BIM can be used to improve safety performance in the industry. A safety hazard library was developed based on the main contributors to fatal accidents in the construction industry, determined from the formal records and existing literature, and a series of discussions with representatives from the Workplace Safety and Health Institute (WSH Institute in Singapore. The results from the survey suggested that the majority of the firms have implemented the necessary policies, programmes and procedures on Workplace Safety and Health (WSH practices. However, BIM is still not widely applied or explored beyond the mandatory requirement that building plans should be submitted to the authorities for approval in BIM format. This paper presents a discussion of the safety aspect of the Intelligent Productivity and Safety System (IPASS developed in the study. IPASS is an intelligent system incorporating the buildable design concept, theory on the detection, prevention and control of hazards, and the Construction Safety Audit Scoring System (ConSASS. The system is based on the premise that safety should be considered at the design stage, and BIM can be an effective tool to facilitate the efforts to enhance safety performance. IPASS allows users to analyse and monitor key aspects of the safety performance of the project before the project starts and as the project progresses.
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2010-08-31
.... PHMSA-2010-0226] Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas... safety standards for siting liquefied natural gas (LNG) facilities. Those standards require that an..., and Handling of Liquefied Natural Gas. That consensus [[Page 53372
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75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water
2010-05-04
... SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice of approved projects. SUMMARY: This notice... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e...
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Criticality safety analysis of the NPP Krsko storage racks
International Nuclear Information System (INIS)
Kromar, M.; Kurincic, B.
2002-01-01
NPP Krsko is going to increase the capacity of the spent fuel storage pool by replacement of the existing racks with high-density racks. This will be the second reracking campaign since 1983 when storage was increased from 180 to 828 storage locations. The pool capacity will increase from 828 to 1694 with partial reracking by the spring 2003. The installed capacity will be sufficient for the current design plant lifetime. Complete reracking of the spent fuel pool will additionally increase capacity to 2321 storage locations. The design, rack manufacturing and installation has been awarded to the Framatome ANP GmbH. Burnup credit methodology, which was approved by the Slovenian Nuclear Safety Administration in previous licensing of existing racks, will be again implemented in the licensing process with the recent methodology improvements. Specific steps of the criticality safety analysis and representative results are presented in the paper.(author)
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ESTIMATION OF PROCESSES REALIZATION RISK AS A MANNER OF SAFETY MANAGEMENT IN THE INTEGRATED SYSTEMS
Directory of Open Access Journals (Sweden)
Tatiana Karkoszka
2011-12-01
Full Text Available Realization of quality, environmental and occupational health and safety policy using the proposed model of processes' integrated risk estimation leads to the improvement of the analyzed productive processes by the preventive and corrective actions, and in consequence - to their optimization from the point of view of products' quality and in the aspect of quality of environmental influence and occupational health and safety.
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ESTIMATION OF PROCESSES REALIZATION RISK AS A MANNER OF SAFETY MANAGEMENT IN THE INTEGRATED SYSTEMS
Directory of Open Access Journals (Sweden)
Tatiana Karkoszka
2011-06-01
Full Text Available Realization of quality, environmental and occupational health and safety policy using the proposed model of processes' integrated risk estimation leads to the improvement of the analyzed productive processes by the preventive and corrective actions, and in consequence - to their optimization from the point of view of products' quality and in the aspect of quality of environmental influence and occupational health and safety.
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5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.
2010-01-01
... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment under...
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Safety classification of items in Tianwan Nuclear Power Plant
International Nuclear Information System (INIS)
Sun Yongbin
2005-01-01
The principle of integrality, moderation and equilibrium should be considered in the safety classification of items in nuclear power plant. The basic ways for safety classification of items is to classify the safety function based on the effect of the outside enclosure damage of the items (parts) on the safety. Tianwan Nuclear Power Plant adopts Russian VVER-1000/428 type reactor, it safety classification mainly refers to Russian Guidelines and standards. The safety classification of the electric equipment refers to IEEE-308(80) standard, including 1E and Non 1E classification. The safety classification of the instrumentation and control equipment refers to GB/T 15474-1995 standard, including safety 1E, safety-related SR and NC non-safety classification. The safety classification of Tianwan Nuclear Power Plant has to be approved by NNSA and satisfy Chinese Nuclear Safety Guidelines. (authors)
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International Nuclear Information System (INIS)
Asakura, Toshihide; Sato, Makoto; Matsumura, Masakazu; Morita, Yasuji
2005-01-01
This paper reviews the succeeding development and utilization of Extraction System Simulation Code for Advanced Reprocessing (ESSCAR). From the viewpoint of development, more tests with spent fuel and calculations should be performed with better understanding of the physico-chemical phenomena in a separation process. From the viewpoint of process safety research on fuel cycle facilities, it is important to know the process behavior of a key substance; being highly reactive but existing only trace amount. (author)
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Krsko NPP Periodic Safety Review program
International Nuclear Information System (INIS)
Basic, I.; Spiler, J.; Novsak, M.
2001-01-01
The need for conducting a Periodic Safety Review for the Krsko NPP has been clearly recognized both by the NEK and the regulator (SNSA). The PSR would be highly desirable both in the light of current trends in safety oversight practices and because of many benefits it is capable to provide. On January 11, 2001 the SNSA issued a decision requesting the Krsko NPP to prepare a program and determine a schedule for the implementation of the program for 'Periodic Safety Review of NPP Krsko'. The program, which is required to be in accordance with the IAEA safety philosophy and with the EU practice, was submitted for the approval to the SNSA by the end of March 2001. The paper summarizes Krsko NPP Periodic Safety Review Program [1] including implemented SNSA and IAEA Expert Mission comments.(author)
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Game prototype for understanding safety issues of life boat launching process.
Jiang, Min; Chang, Jian; Dodwell, M.; Jekins, J.; Yang, H.J.; Zhang, Jian J.
2016-01-01
Novel advanced game techniques provide us with new possibilities to mimic a complicated training process, with the benefit of safety enhancement. In this paper, we design and implement a 3D game which imitates the lifeboat launching process. Lifeboat launching is such a complex but vital process which can on one side saving people's life on sea and on the other side associating many potential hazards. It involves both the tractor manoeuvres and boat operations. The primary objective of the ga...
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Software Safety Risk in Legacy Safety-Critical Computer Systems
Hill, Janice L.; Baggs, Rhoda
2007-01-01
Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.
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Safety assessment in development and operation of modular continuous-flow processes
Kockmann, N.; Thenée, P.; Fleischer-Trebes, C.; Laudadio, G.; Noël, T.
2017-01-01
Improved safety is one of the main drivers for microreactor application in chemical process development and small-scale production. Typical examples of hazardous chemistry are presented indicating potential risks also in miniaturized equipment. Energy balance and kinetic parameters describe the heat
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Directory of Open Access Journals (Sweden)
Moedjiono Moedjiono
2016-11-01
Full Text Available In the field of services, customer satisfaction is a very important factor and determine the success of an enterprise. In the field of outsourcing, customer satisfaction indicator is the labor required delivery in a timely manner and has a level of quality in accordance with the terms proposed by the customer. To provide the best talent to customers, team recruitment and selection must perform a series of tests with a variety of methods to match the criteria of office given by the user with the criteria owned candidates and in order to support growth in graduation rates force a partner at the stage of user approval. For this purpose, the authors conducted a study with the method of observation, interviews, document reviews the candidate recruitment process, so as to provide recommendations for candidates with the highest quality delivery to the user at the stage of approval. The author put forward a model of decision support that is supported by the method of profile matching and Analytical Hierarchy Process (AHP in problem solving. The final results of this study can be used to support a decision in order to improve the effectiveness of the delivery of quality candidates, increase customer satisfaction, lower costs and improve gross operational margin of the company.
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MANAGEMENT PROCESS OF HEALTH AND SAFETY RISK IN THE NIGERIA CONSTRUCTION INDUSTRY
Akwu, Ifeoma Claris
2017-01-01
The study examined the state of health and safety risk management practices in the building sector of the construction industry with the objective to examine the health and safety risk management processes adopted by the construction industry in Nigeria; the study adopted the survey and case study research design. It employed the use of Delphi’s technique in the distribution of questionnaire and made use of chi-square analytical technique for the analysis of gathered data. The findings reveal...
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Necessary and Sufficient Standards Closure Process pilot: F- and H-Area groundwater remediation
International Nuclear Information System (INIS)
Bullington, M.
1995-01-01
The DOE Standards Committee's Necessary and Sufficient (N and S) Standards Closure Process was piloted at SRS on the F- and H- Area Seepage Basins Groundwater Remediation Project. For this existing Environmental Restoration project, the set of N and S standards for design and safety documentation were identified, independently confirmed and approved. Implementation of these standards on the project can lead to a $2.8 Million cost savings on the design, construction/installation, and safety documentation scope of $18 Million. These savings were primarily from site design of power distribution and piping for the water treatment units. Also contributing to the savings were a more appropriate level of safety documentation and the alternate ''commercial'' bids made by vendors in response to a request for proposals for water treatment units. The use of the N and S Process on an ER activity, details on the cost savings, lessons learned and recommendations for broader implementation of the N and S Process are described herein
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Directory of Open Access Journals (Sweden)
Dajana Gašo-Sokač
2010-01-01
Full Text Available Human food is a very complex biological mixture and food processing and safety are very important and essential disciplines. Proteomics technology using different high-performance separation techniques such as two-dimensional gel electrophoresis, one-dimensional and multidimensional chromatography, combined with high-resolution mass spectrometry has the power to monitor the protein composition of foods and their changes during the production process. The use of proteomics in food technology is presented, especially for characterization and standardization of raw materials, process development, detection of batch-to-batch variations and quality control of the final product. Further attention is paid to the aspects of food safety, especially regarding biological and microbial safety and the use of genetically modified foods.
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International Nuclear Information System (INIS)
Kinney, Michael D.; Barrick, William D.
2008-01-01
This session will examine a method developed by Federal and Contractor personnel at the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) to examine long-term maintenance of DOE Integrated Safety Management System (ISMS) criteria, including safety culture attributes, as well as identification of process improvement opportunities. This process was initially developed in the summer of 2000 and has since been expanded to recognize the importance of safety culture attributes, and associated safety culture elements, as defined in DOE M 450.4-1, 'Integrated Safety Management System Manual'. This process has proven to significantly enhance collective awareness of the importance of long-term ISMS implementation as well as support commitments by NNSA/NSO personnel to examine the continued effectiveness of ISMS processes
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2011-11-25
Under the authority granted to the National Coordinator for Health Information Technology by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this final rule establishes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also addresses the status of ONC-Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA.
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Recommended safety guides for industrial laboratories and shops
Allison, W. W.
1971-01-01
Booklet provides references to 29 publications providing information on hazard control and approved safety practices. Areas include pressurized gas and vacuum systems. Guidelines are presented for safeguarding facilities where machinery, equipment, electrical devices, or hazardous chemicals are used.
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International Nuclear Information System (INIS)
Baltes, B.
1994-01-01
There is a generally accepted system of framework safety conditions governing the construction, operation, and post-operational monitoring of radwaste repositories. Although the development of these framework conditions may vary from country to country, the resulting criteria are based on the commonly accepted system of priciples and purposes established for ultimate radioactive waste disposal. The experience accumulated by GRS in the course of the plan approval procedure for the Konrad mine site and the safety-relevant studies performed for the planned Morsleben repository clearly show demand for further development of the safety criteria. In Germany, it is especially the safety criteria and detailed requirements filling the framework safety conditions that need revision and in-depth definition, as well as comparison and harmonisation with internationally applied criteria. These activities will particularly consider the international convention on radioactive waste management currently in preparation under the auspieces of the IAEA. (orig.) [de
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RADWASS update. Radioactive Waste Safety Standards Programme
International Nuclear Information System (INIS)
Delattre, D.
2000-01-01
By the late 1980s, the issue of radioactive wastes and their management was becoming increasingly politically important. The IAEA responded by establishing a high profile family of safety standards, the Radioactive Waste Safety Standards (RADWASS). By this means, the IAEA intended to draw attention to the fact that well-established procedures for the safe management of radioactive wastes already were in place. The programme was intended to establish an ordered structure for safety documents on waste management and to ensure comprehensive coverage of all relevant subject areas. RADWASS documents are categorized under four subject areas - discharges, predisposal, disposal, and environmental restoration. The programme is overseen through a formalized review and approval mechanism that was established in 1996 for all safety standards activities. The Waste Safety Standards Committee (WASSC) is a standing body of senior regulatory officials with technical expertise in radioactive waste safety. To date, three Safety Requirements and seven Safety Guides have been issued
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International Nuclear Information System (INIS)
Vnukov, V.S.; Rjazanov, B.G.; Sviridov, V.I.; Frolov, V.V.; Zubkov, Y.N.
1991-01-01
The paper describes the general principles of nuclear criticality safety for handling, processing, transportation and fissile materials storing. Measures to limit the consequences of critical accidents are discussed for the fuel processing plants and fissile materials storage. The system of scientific and technical measures on nuclear criticality safety as well as the system of control and state supervision based on the rules, limits and requirements are described. The criticality safety aspects for various stages of handling nuclear materials are considered. The paper gives descriptions of the methods and approaches for critical risk assessments for the processing facilities, plants and storages. (Author)
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Safety research needs for Russian-designed reactors / report by an OECD Support Group
International Nuclear Information System (INIS)
1996-01-01
Seven Task Teams were formed within the OECD Support Group, addressing the following topics: Thermal-Hydraulics/Plant Transients for VVERs, Integrity of Equipment and Structures for VVERs, Severe Accidents for VVERs, Operational Safety Issues, Thermal-Hydraulics/Plant Transients for RBMKs, Integrity of Equipment and Structures for RBMKs, Severe Accidents for RBMKs. Each Task Team prepared and presented its report to the Support Group as a whole for review and approval. Consequently, the report represents a consensus of the Support Group that outlines the arguments for the safely research needs with the focus on the main technical issues that justify the need and urgency. The written text addresses three basic questions: What is the safety concern? What are the open issues? What are the safety research needs? The safety research needs as identified by the seven Task Teams, and approved by the Support Group, are reflected in the structure of the report. The chapter on the Uses of Safety Research provides examples on how Western research has been applied to improve the safety of nuclear power plants. In addition, the chapter emphasises the need for a national safety research policy
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International Nuclear Information System (INIS)
Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R.
2011-01-01
Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)
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Energy Technology Data Exchange (ETDEWEB)
Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R., E-mail: grecco@ien.gov.b, E-mail: luquetti@ien.gov.b, E-mail: paulov@ien.gov.b [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil). Div. de Instrumentacao e Confiabilidade Humana; Vidal, Mario C.R., E-mail: mvidal@ergonomia.ufrj.b [Coordenacao dos Programas de Pos-Graduacao de Engenharia (PEP/COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia de Producao. Grupo de Ergonomia e Novas Tecnologias (GENTE)
2011-07-01
Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)
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Safety aspect of digital reactor protection system in Japan
International Nuclear Information System (INIS)
Ogiso, Zen-Ichi
1998-01-01
It was early in 1980's that the digital controllers were first applied to nuclear power plant in japan. After that, their application area had been expanding gradually, reaching to the overall integrated digital system including the safety system in Kashiwazaki-Kariwa units 6 and 7. The software for computer-based systems has been produced using the graphical language ''POL'' in Japanese nuclear power plants. It is the fundamental principle that the reliability of the software should be assured through the properly managed quality assurance. The POL-based system is fitted to this principle. In applying POL-based systems to safety system, the MITI, Ministry of International Trade and Industry, identified the licensing issues as the regulatory body, while the utilities had developed the digital technology feasible to the safety application. Through the activities, a specific industrial design guide for the software important to safety was established and the adequacy of the technology was certified through the demonstration tests of the integrated system. In the safety examination of the digital reactor protection system of K-6/7, the application of POL were approved. The POL-based systems in nuclear power plants were successful design and production process of the POL-based systems. This paper describes the activities in licensing and maintaining the computer-based systems by the utilities and manufacturers as well as the MITI. (author)
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Directory of Open Access Journals (Sweden)
Robert P. Martin
2012-01-01
Full Text Available A general evaluation methodology development and application process (EMDAP paradigm is described for the resolution of severe accident safety issues. For the broader objective of complete and comprehensive design validation, severe accident safety issues are resolved by demonstrating comprehensive severe-accident-related engineering through applicable testing programs, process studies demonstrating certain deterministic elements, probabilistic risk assessment, and severe accident management guidelines. The basic framework described in this paper extends the top-down, bottom-up strategy described in the U.S Nuclear Regulatory Commission Regulatory Guide 1.203 to severe accident evaluations addressing U.S. NRC expectation for plant design certification applications.
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Contribution of computerization to alarm processing: A French safety view
Energy Technology Data Exchange (ETDEWEB)
Cette, W [CEA Centre d` Etudes de Fontenay-aux-Roses, 92 (France). Inst. de Protection et de Surete Nucleaire
1997-09-01
Following the TMI accident and according to the requirement of the French safety authority, very important studies were performed by the French utility, Electricite de France (EDF), and assessed by the Institute for Nuclear Safety and Protection (IPSN) on reactor operation in conventional control rooms, particularly on alarm processing. These studies dealt with the man-machine interface, as well as design and exploitation requirements, presentation and management of alarm signals, and associated operating documents. The conclusions of these studies have led to improvements in French conventional control rooms. The current state of these control rooms and links between alarm sets and operating documents will be shortly presented in the first part of the paper. More recently, the computerized means implemented in the PWR 1400 MWe control rooms (N4) profoundly modified reactor operation. In particular, major advances concern alarm processing in comparison with conventional control rooms. The N4 plants provide a more rigorous approach in processing and presentation of alarms than in the past. Indeed, EDF wanted to have less alarms switched on during plant upsets and to make them more characteristic of a specific situation of the process. For example, computerization makes it easier to validate or inhibit alarms according to the situation, to allow the operator to manage alarm presentation and to propose on-line alarm sheets to the operator etc. This approach in comparison with conventional control rooms, and the IPSN assessment will be presented in the second part of this paper. (author).
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Contribution of computerization to alarm processing: A French safety view
International Nuclear Information System (INIS)
Cette, W.
1997-01-01
Following the TMI accident and according to the requirement of the French safety authority, very important studies were performed by the French utility, Electricite de France (EDF), and assessed by the Institute for Nuclear Safety and Protection (IPSN) on reactor operation in conventional control rooms, particularly on alarm processing. These studies dealt with the man-machine interface, as well as design and exploitation requirements, presentation and management of alarm signals, and associated operating documents. The conclusions of these studies have led to improvements in French conventional control rooms. The current state of these control rooms and links between alarm sets and operating documents will be shortly presented in the first part of the paper. More recently, the computerized means implemented in the PWR 1400 MWe control rooms (N4) profoundly modified reactor operation. In particular, major advances concern alarm processing in comparison with conventional control rooms. The N4 plants provide a more rigorous approach in processing and presentation of alarms than in the past. Indeed, EDF wanted to have less alarms switched on during plant upsets and to make them more characteristic of a specific situation of the process. For example, computerization makes it easier to validate or inhibit alarms according to the situation, to allow the operator to manage alarm presentation and to propose on-line alarm sheets to the operator etc. This approach in comparison with conventional control rooms, and the IPSN assessment will be presented in the second part of this paper. (author)
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Supplements and other changes to an approved application. Final rule.
2004-04-08
The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.
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Requirements on the provisional safety analyses and technical comparison of safety measures
International Nuclear Information System (INIS)
2010-04-01
The concept of a Geological Underground Repository (SGT) was adopted by the Swiss Federal Council on April 2 nd , 2008. It fixes the goals and the safety technical criteria as well as the procedures for the choice of the site for an underground repository. Those responsible for waste management evaluate possible site regions according to the present status of geological knowledge and based on the safety criteria defined in SGT as well as on technical feasibility. In a first step, they propose geological repository sites for high level (HAA) and for low and intermediate level (SMA) radioactive wastes and justify their choice in a report delivered to the Swiss Federal Office of Energy. The Swiss Federal Council reviews the choices presented and, in the case of positive evaluation, approves them and considers them as an initial orientation. In a second step, based on the possible sites according to step 1, the waste management institution responsible has to reduce the repositories chosen for HAA and SMA by taking into account safety aspects, technical feasibility as well as space planning and socio-economical aspects. In making this choice, safety aspects have the highest priority. The criteria used for the evaluation in the first step have to be defined using provisional quantitative safety analyses. On the basis of the whole appraisal, including space planning and socio-economical aspects, those responsible for waste management propose at least two repository sites for HAA- and SMA-waste. Their selection is then reviewed by the authorities and, in the case of a positive assesment, the selection is taken as an intermediate result. The remaining sites are further studied to examine site choice and the delivery of a request for a design license. If necessary, the requested geological knowledge has to be confirmed by new investigations. Based on the results of the choosing process and a positive evaluation by the safety authorities, the Swiss Federal Council has to
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Evaluation of the food safety risk associated with de-boning of Danish sows
DEFF Research Database (Denmark)
Pedersen, Tanja Østergaard; Bækbo, Anne Kristine; Petersen, Jesper Valentin
2017-01-01
-boning (approved/rejected), and additional information from abattoir employees were obtained and analysed. Abscesses and muscle samples from 105 sows sent for de-boning and 60 muscle samples from fully approved sows were collected at the abattoir. The isolated bacteria were identified using MALDITOF. Results from...... reason for condemnation after de-boning. Staphylococcus aureus was assessed to be the only potential food safety hazard. There was no association between presence of bacteria in muscle samples and abscesses from the same animals, neither for bacteria in general (P= 1) nor for Staphylococcus aureus......, specifically (P= 1). Furthermore, no association regarding presence of bacteria was found in the meat from de-boned sows and fully approved sows (P= 0.67). It was concluded that the de-boning procedure is not contributing to food safety. The authors suggest replacing de-boning with a more thorough inspection...
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2011-10-26
... others for safety assessment, planning, forecasting, cost/benefit analysis, and to target areas for... assessment, planning, forecasting, cost/benefit analysis, and to target areas for research. Respondents... invites public comments about our intention to request the Office of Management and Budget (OMB) approval...
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2013-12-12
... others for safety assessment, planning, forecasting, cost/benefit analysis, and to target areas for... assessment, planning, forecasting, cost/benefit analysis, and to target areas for research. Respondents... invites public comments about our intention to request the Office of Management and Budget (OMB) approval...
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2009-09-01
Changing At-Risk Behavior (CAB) is a safety process that is being conducted at Union Pacifics San Antonio Service Unit (SASU) with the aim of improving road and yard safety. CAB is an example of a proactive safety risk-reduction method called Clea...
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MO-AB-201-00: Radiation Safety Officer Update
Energy Technology Data Exchange (ETDEWEB)
NONE
2015-06-15
The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35
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MO-AB-201-00: Radiation Safety Officer Update
International Nuclear Information System (INIS)
2015-01-01
The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35
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10CFR50.59 safety evaluation training and expert system development
International Nuclear Information System (INIS)
Kline, S.W.; Dickinson, D.B.
1988-01-01
10CFR50.59 permits utilities to make changes to and conduct tests or experiments on operating nuclear power plants without prior US Nuclear Regulatory Commission (NCR) approval unless the proposed change, test, or experiment (i.e, the proposed activity) involves a change to the plant technical specifications or an unreviewed safety question (USQ). To provide guidance to their engineers for making the determination of whether a proposed activity involves a USQ. Bechtel has developed a safety evaluation training program. This training program incorporates the guidance in and NRC comments to the November 1987 draft Nuclear Management and Resources Council safety evaluation guidance document, NRC statements contained in inspection reports and other documents, and the experience of senior Bechtel engineers. To further develop the question and concerns that need to be addressed in a safety evaluation in a systematic manner, Bechtel is incorporating the training program guidance and other information into an IBM PC-AT-based working model of an expert system using the NEXPERT expert system development tool. The development and use of this expert system working model are being undertaken to provide consistency and completeness to the thought process used and the output provided by Bechtel engineers when performing a safety evaluation
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The European Medicines Agency's approval of new medicines for type 2 diabetes.
Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A
2018-05-08
Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.
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Electronics and data processing for safety
International Nuclear Information System (INIS)
1995-01-01
Industrial installations, and in particular installations involving risk, are more and more monitored and controlled by computerized systems. The use of such systems raises questions about their contribution to the installation safety and about the qualities required in these systems to avoid additional risk. The February 1995 Electronics Days were organized by the CEA-LETI Department of Electronics and Nuclear Instrumentation to try to answer these questions. Four sessions were organized on the following topics: computerized systems and functioning safety, components and architectures, softwares and norms, and tools and methods. Only the communications dealing with the safety of computerized systems and components involved in nuclear applications have been retained (17 over 36). (J.S.)
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14 CFR 1274.936 - Breach of safety or security.
2010-01-01
... property equal to or greater than $1 million; or in any “willful” or “repeat” violation cited by the Occupational Safety and Health Administration (OSHA) or by a state agency operating under an OSHA approved plan...
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International Nuclear Information System (INIS)
Kadadunna, K.P.I.K.; Mod Ali, Noriah
2008-01-01
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
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Criticality safety of solvent extraction process
International Nuclear Information System (INIS)
Tachimori, Shoichi; Miyoshi, Yoshinori
1987-01-01
The article presents some comments on criticality safety of solvent extraction processes. When used as an extracting medium, tributyl phosphate extracts nitric acid and water, in addition to nitrates of U and Pu, into the organic phase. The amount of these chemical species extracted into the organic phase is dependent on and restricted by the concentrations of tributyl phosphate and other components. For criticality control, measures are taken to decrease the concentration of tributyl phosphate in the organic phase, in addition to control of the U and Pu concentrations in the feed water phase. It should be remembered that complexes of tributyl phosphate with nitrates of such metals as Pu(IV), Pu(VI), U(IV) and Th(IV) do not dissolve uniformly in the organic phase. In criticality calculation for solution-handling systems, U and Pu are generally assumed to have a valence of 6 and 4, respectively. In the reprocessing extraction process, however, U and Pu can have a valence of 4, and 3 and 6, respectively. The organic phase and aqueous phase contact in a counter-current flow. U and Pu will be accumulated if they are not brought out of the extraction system by this flow. (Nogami, K.)
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Implementation of the new regulation on radiological safety in Peru
International Nuclear Information System (INIS)
Medina Gironzini, E.
1997-01-01
Since its creation in 1975, the Peruvian Institute of Nuclear Energy (IPEN) has enacted three regulations of national importance on the norms of protection against ionizing radiation. The first regulation, which is called regulation of radiological protection (1980) approved by a resolution of IPEN, is the result of the work of a committee constituted by IPEN and the Ministry of Health. Its implementation caused some problems as result of which, in 1989, a new regulation on radiological protection was enacted through a supreme decree. Taking into account the new recommendation of the International Commission on Radiological Protection and the International Basic Safety Standard for Protection against Ionizing Radiation and for the Safety of Radiation Sources, approved in May 1997, the regulation of radiological safety also considers evolving aspects in the Project ARCAL XVII/IAEA. This regulation includes various topics such as exclusions, requirements of protection (medical exposure, occupational exposure, public exposure, chronic exposure), requirements of source safety, interventions and emergencies, control of sources and practices (exemptions, authorizations, inspections) etc. The implementation of this regulation at the national level falls to IPEN, the unique authority commissioned to control nuclear installations, radioactivity and x ray facilities in medicine, industry and research
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2013-10-24
... Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS[supreg] Cask System AGENCY: Nuclear...] Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No... Safety Analysis Report for the Standardized NUHOMS[supreg] Horizontal Modular Storage System for...
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Karanikas, Nektarios
2016-01-01
This paper presents an alternative way to use records from safety investigations as a means to support the evaluation of safety management (SM) aspects. Datasets from safety investigation reports and progress records of an aviation organization were analyzed with the scope of assessing safety
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Montana Advanced Biofuels Great Falls Approval
This November 20, 2015 letter from EPA approves the petition from Montana Advanced Biofuels, LLC, Great Falls facility, regarding ethanol produced through a dry mill process, qualifying under the Clean Air Act for advanced biofuel (D-code 5) and renewable
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Linaclotide: first global approval.
McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate
2012-11-12
Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.
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French regulatory approach to establishing the safety case for ageing NPP's
International Nuclear Information System (INIS)
Delage, M.
1994-06-01
The French regulatory procedures make provision for three main stages in the safety assessment of nuclear power plants. The first stage ends up with the construction licence and focuses on the assessment of the preliminary safety report. The second stage makes it possible to issue the fuel loading approval following evaluation of the provisional safety report. The third stage permits to declare the start of normal operation of the installation. The procedure, the tests and the assessment forming the overall strategy for safety regulations are described in detail. (R.P.)