10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

14 CFR 1214.608 - Safety requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Space Shuttle Flights § 1214.608 Safety requirements. The contents of OFK's and PPK's must meet the requirements set forth in NASA Handbook 1700.7, “Safety Policy and Requirements for Payloads Using the Space...

14 CFR 1214.608 - Safety requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Space Shuttle Flights § 1214.608 Safety requirements. The contents of OFK's and PPK's must meet the requirements set forth in NASA Handbook 1700.7, “Safety Policy and Requirements for Payloads Using the Space...

Development of requirements on safety cases of machine industry products for power engineering

NASA Astrophysics Data System (ADS)

Aronson, K. E.; Brezgin, V. I.; Brodov, Yu. M.; Gorodnova, N. V.; Kultyshev, A. Yu.; Tolmachev, V. V.; Shablova, E. G.

2016-12-01

This article considers security assurance for power engineering machinery in the design and production phases. The Federal Law "On Technical Regulation" and the Customs Union Technical Regulations "On Safety of Machinery and Equipment" are analyzed in the legal, technical, and economic aspect with regard to power engineering machine industry products. From the legal standpoint, it is noted that the practical enforcement of most norms of the Law "On Technical Regulation" makes it necessary to adopt subordinate statutory instruments currently unavailable; moreover, the current level of adoption of technical regulations leaves much to be desired. The intensive integration processes observed in the Eurasian Region in recent years have made it a more pressing task to harmonize the laws of the region's countries, including their technical regulation framework. The technical aspect of analyzing the technical regulation of the Customs Union has been appraised by the IDEF0 functional modeling method. The object of research is a steam turbine plant produced at the turbine works. When developing the described model, we considered the elaboration of safety case (SC) requirements from the standpoint of the chief designer of the turbine works as the person generally responsible for the elaboration of the SC document. The economic context relies on risk analysis and appraisal methods. In their respect, these are determined by the purposes and objectives of analysis, complexity of considered objects, availability of required data, and expertise of specialists hired to conduct the analysis. The article proposes the description of all sources of hazard and scenarios of their actualization in all production phases of machinery life cycle for safety assurance purposes. The detection of risks and hazards allows forming the list of unwanted events. It describes the sources of hazard, various risk factors, conditions for their rise and development, tentative risk appraisals, and

Range Flight Safety Requirements

NASA Technical Reports Server (NTRS)

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.

45 CFR 98.41 - Health and safety requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Health and safety requirements. 98.41 Section 98.41 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.41 Health...

45 CFR 98.41 - Health and safety requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Health and safety requirements. 98.41 Section 98.41 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.41 Health...

45 CFR 98.41 - Health and safety requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Health and safety requirements. 98.41 Section 98.41 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.41 Health...

45 CFR 98.41 - Health and safety requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Health and safety requirements. 98.41 Section 98.41 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.41 Health...

45 CFR 98.41 - Health and safety requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Health and safety requirements. 98.41 Section 98.41 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.41 Health...

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

The Development and Implementation of Ground Safety Requirements for Project Orion Abort Flight Testing - A Case Study

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul D.; Williams, Jeffrey G.; Condzella, Bill R.

2008-01-01

A rigorous set of detailed ground safety requirements is required to make sure that ground support equipment (GSE) and associated planned ground operations are conducted safely. Detailed ground safety requirements supplement the GSE requirements already called out in NASA-STD-5005. This paper will describe the initial genesis of these ground safety requirements, the establishment and approval process and finally the implementation process for Project Orion. The future of the requirements will also be described. Problems and issues encountered and overcame will be discussed.

14 CFR § 1214.608 - Safety requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Aboard Space Shuttle Flights § 1214.608 Safety requirements. The contents of OFK's and PPK's must meet the requirements set forth in NASA Handbook 1700.7, “Safety Policy and Requirements for Payloads Using...

Implementation Procedure for STS Payloads, System Safety Requirements

NASA Technical Reports Server (NTRS)

1979-01-01

Guidelines and instructions for the implementation of the SP&R system safety requirements applicable to STS payloads are provided. The initial contact meeting with the payload organization and the subsequent safety reviews necessary to comply with the system safety requirements of the SP&R document are described. Waiver instructions are included for the cases in which a safety requirement cannot be met.

Development of U.S. Government General Technical Requirements for UAS Flight Safety Systems Utilizing the Iridium Satellite Constellation

NASA Technical Reports Server (NTRS)

Murray, Jennifer; Birr, Richard

2010-01-01

This slide presentation reviews the development of technical requirements for Unmanned Aircraft Systems (UAS) utilization of the Iridium Satellite Constellation to provide flight safety. The Federal Aviation Authority (FAA) required an over-the-horizon communication standard to guarantee flight safety before permitting widespread UAS flights in the National Air Space (NAS). This is important to ensure reliable control of UASs during loss-link and over-the-horizon scenarios. The core requirement was to utilize a satellite system to send GPS tracking data and other telemetry from a flight vehicle down to the ground. Iridium was chosen as the system because it is one of the only true satellite systems that has world wide coverage, and the service has a highly reliable link margin. The Iridium system, the flight modems, and the test flight are described.

Industrial requirements in food safety.

PubMed

Vincent, P M

1990-01-01

The principles of establishing industrial requirements in food safety are described, taking risk potentials all along the food chain into their respective account. Regulations will, in the future, lead to increased autocontrol in production. The rapid changes in food technology require constant adaptation to new problems, to keep the global quality of food at a high level. Regulatory authorities will, in the new European market, concentrate on enforcement of 'essential requirements' while industrialists will follow good manufacturing practices. Open dialogue between the latter, the former and the scientific community is highly desirable since mutual knowledge of the problem will help maintain a high level of food safety, for the benefit of everybody.

Microgravity Experiments Safety and Integration Requirements Document Tree

NASA Technical Reports Server (NTRS)

Hogan, Jean M.

1995-01-01

This report is a document tree of the safety and integration documents required to develop a space experiment. Pertinent document information for each of the top level (tier one) safety and integration documents, and their applicable and reference (tier two) documents has been identified. This information includes: document title, revision level, configuration management, electronic availability, listed applicable and reference documents, source for obtaining the document, and document owner. One of the main conclusions of this report is that no single document tree exists for all safety and integration documents, regardless of the Shuttle carrier. This document also identifies the need for a single point of contact for customers wishing to access documents. The data in this report serves as a valuable information source for the NASA Lewis Research Center Project Documentation Center, as well as for all developers of space experiments.

Model-Driven Development of Safety Architectures

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2017-01-01

We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

Guiding principles of safety as a basis for developing a pharmaceutical safety culture.

PubMed

Edwards, Brian; Olsen, Axel K; Whalen, Matthew D; Gold, Marla J

2007-05-01

Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.

Hazard Analysis and Safety Requirements for Small Drone Operations: To What Extent Do Popular Drones Embed Safety?

PubMed

Plioutsias, Anastasios; Karanikas, Nektarios; Chatzimihailidou, Maria Mikela

2018-03-01

Currently, published risk analyses for drones refer mainly to commercial systems, use data from civil aviation, and are based on probabilistic approaches without suggesting an inclusive list of hazards and respective requirements. Within this context, this article presents: (1) a set of safety requirements generated from the application of the systems theoretic process analysis (STPA) technique on a generic small drone system; (2) a gap analysis between the set of safety requirements and the ones met by 19 popular drone models; (3) the extent of the differences between those models, their manufacturers, and the countries of origin; and (4) the association of drone prices with the extent they meet the requirements derived by STPA. The application of STPA resulted in 70 safety requirements distributed across the authority, manufacturer, end user, or drone automation levels. A gap analysis showed high dissimilarities regarding the extent to which the 19 drones meet the same safety requirements. Statistical results suggested a positive correlation between drone prices and the extent that the 19 drones studied herein met the safety requirements generated by STPA, and significant differences were identified among the manufacturers. This work complements the existing risk assessment frameworks for small drones, and contributes to the establishment of a commonly endorsed international risk analysis framework. Such a framework will support the development of a holistic and methodologically justified standardization scheme for small drone flights. © 2017 Society for Risk Analysis.

Generation III reactors safety requirements and the design solutions

NASA Astrophysics Data System (ADS)

Felten, P.

2009-03-01

Nuclear energy's public acceptance, and hence its development, depends on its safety. As a reactor designer, we will first briefly remind the basic safety principles of nuclear reactors' design. We will then show how the industry, and in particular Areva with its EPR, made design evolution in the wake of the Three Miles Island accident in 1979. In particular, for this new generation of reactors, severe accidents are taken into account beyond the standard design basis accidents. Today, Areva's EPR meets all so-called "generation III" safety requirements and was licensed by several nuclear safety authorities in the world. Many innovative solutions are integrated in the EPR, some of which will be introduced here.

Evolution of safety-critical requirements post-launch

NASA Technical Reports Server (NTRS)

Lutz, R. R.; Mikulski, I. C.

2001-01-01

This paper reports the results of a small study of requirements changes to the onboard software of three spacecraft subsequent to launch. Only those requirement changes that resulted from post-launch anoma-lies (i.e., during operations) were of interest here, since the goal was to better understand the relation-ship between critical anomalies during operations and how safety-critical requirements evolve. The results of the study were surprising in that anomaly-driven, post-launch requirements changes were rarely due to previous requirements having been incorrect. Instead, changes involved new requirements (1) for the software to handle rare events or (2) for the software to compensate for hardware failures or limitations. The prevalence of new requirements as a result of post-launch anomalies suggests a need for increased requirements-engineering support of maintenance activities in these systems. The results also confirm both the difficulty and the benefits of pursuing requirements completeness, especially in terms of fault tolerance, during development of critical systems.

15 CFR 970.521 - Safety at sea requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 15 Commerce and Foreign Trade 3 2012-01-01 2012-01-01 false Safety at sea requirements. 970.521..., Conditions and Restrictions Terms, Conditions, and Restrictions § 970.521 Safety at sea requirements. The... and property at sea. These requirements will be established with reference to subpart H of this part. ...

15 CFR 970.521 - Safety at sea requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 15 Commerce and Foreign Trade 3 2014-01-01 2014-01-01 false Safety at sea requirements. 970.521..., Conditions and Restrictions Terms, Conditions, and Restrictions § 970.521 Safety at sea requirements. The... and property at sea. These requirements will be established with reference to subpart H of this part. ...

15 CFR 970.521 - Safety at sea requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Safety at sea requirements. 970.521..., Conditions and Restrictions Terms, Conditions, and Restrictions § 970.521 Safety at sea requirements. The... and property at sea. These requirements will be established with reference to subpart H of this part. ...

15 CFR 970.521 - Safety at sea requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Safety at sea requirements. 970.521..., Conditions and Restrictions Terms, Conditions, and Restrictions § 970.521 Safety at sea requirements. The... and property at sea. These requirements will be established with reference to subpart H of this part. ...

15 CFR 970.521 - Safety at sea requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 15 Commerce and Foreign Trade 3 2013-01-01 2013-01-01 false Safety at sea requirements. 970.521..., Conditions and Restrictions Terms, Conditions, and Restrictions § 970.521 Safety at sea requirements. The... and property at sea. These requirements will be established with reference to subpart H of this part. ...

Analyzing Software Requirements Errors in Safety-Critical, Embedded Systems

NASA Technical Reports Server (NTRS)

Lutz, Robyn R.

1993-01-01

This paper analyzes the root causes of safety-related software errors in safety-critical, embedded systems. The results show that software errors identified as potentially hazardous to the system tend to be produced by different error mechanisms than non- safety-related software errors. Safety-related software errors are shown to arise most commonly from (1) discrepancies between the documented requirements specifications and the requirements needed for correct functioning of the system and (2) misunderstandings of the software's interface with the rest of the system. The paper uses these results to identify methods by which requirements errors can be prevented. The goal is to reduce safety-related software errors and to enhance the safety of complex, embedded systems.

78 FR 46560 - Pipeline Safety: Class Location Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... class location requirements for gas transmission pipelines. Section 5 of the Pipeline Safety, Regulatory... and, with respect to gas transmission pipeline facilities, whether applying IMP requirements to...

DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

DOE Office of Scientific and Technical Information (OSTI.GOV)

D. A. MC CLURE; C. A. NELSON; R. L. BOUDRIE

2001-04-01

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 Alamosmore » 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.« less

A Review of Safety and Design Requirements of the Artificial Pancreas.

PubMed

Blauw, Helga; Keith-Hynes, Patrick; Koops, Robin; DeVries, J Hans

2016-11-01

As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

OSHA safety requirements and the general duty clause.

PubMed

Mills, Anne C; Chillock, Cynthia A; Edelman, Harold; Mills, Shannon E

2005-03-01

Dental offices and clinics are subject to the same general safety requirements as other workplaces. Current guidelines, inspections, education, and training focus on infectious disease as the major workplace hazard for dental health care personnel (DHCP). However, the Occupational Safety and Health Administration has cited an increasing variety and number of general safety hazards during inspections of dental offices. A review of the general safety requirements for personal protective equipment and fire safety as they relate to DHCP follows. The authors discuss the responsibility of both employers and employees to perform workplace hazard evaluation and to implement education, engineering controls, and work practice controls to minimize their exposure to recognized and emerging workplace hazards.

Vitamin D Safety and Requirements

PubMed Central

de Paula, Francisco J.A.; Rosen, Clifford J.

2011-01-01

Vitamin D an ancient secosteroid is essential for mineral homeostasis, bone remodeling, immune modulation, and energy metabolism. Recently, debates have emerged about the daily vitamin D requirements for healthy and elderly adults, the safety and efficacy of long term supplementation and the role of vitamin D deficiency in several chronic disease states. Since this molecule acts as both a vitamin and a hormone, it should not be surprising that the effects of supplementation are multi-faceted and complex. Yet despite significant progress in the last decade, our understanding of vitamin D physiology and the clinical relevance of low circulating levels of this vitamin remains incomplete. The present review provides the reader with a comprehensive and up-to-date understanding of vitamin D requirements and safety. It also raises some provocative research questions. PMID:22179017

Vehicle-to-infrastructure (V2I) safety applications : performance requirements, vol. 1, introduction and common requirements.

DOT National Transportation Integrated Search

2015-08-01

This document is the first of a seven volume report that describes performance requirements for connected vehicle vehicle-to-infrastructure (V2I) Safety Applications developed for the U.S. Department of Transportation (U.S. DOT). The applications add...

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

PubMed

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

15 CFR 971.422 - Safety at sea requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 15 Commerce and Foreign Trade 3 2012-01-01 2012-01-01 false Safety at sea requirements. 971.422...: Terms, Conditions and Restrictions Terms, Conditions and Restrictions § 971.422 Safety at sea... and property at sea. These requirements will be established with reference to subpart G of this part. ...

15 CFR 971.422 - Safety at sea requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Safety at sea requirements. 971.422...: Terms, Conditions and Restrictions Terms, Conditions and Restrictions § 971.422 Safety at sea... and property at sea. These requirements will be established with reference to subpart G of this part. ...

15 CFR 971.422 - Safety at sea requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Safety at sea requirements. 971.422...: Terms, Conditions and Restrictions Terms, Conditions and Restrictions § 971.422 Safety at sea... and property at sea. These requirements will be established with reference to subpart G of this part. ...

15 CFR 971.422 - Safety at sea requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 15 Commerce and Foreign Trade 3 2014-01-01 2014-01-01 false Safety at sea requirements. 971.422...: Terms, Conditions and Restrictions Terms, Conditions and Restrictions § 971.422 Safety at sea... and property at sea. These requirements will be established with reference to subpart G of this part. ...

15 CFR 971.422 - Safety at sea requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 15 Commerce and Foreign Trade 3 2013-01-01 2013-01-01 false Safety at sea requirements. 971.422...: Terms, Conditions and Restrictions Terms, Conditions and Restrictions § 971.422 Safety at sea... and property at sea. These requirements will be established with reference to subpart G of this part. ...

49 CFR 451.21 - Safety approval plate required.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Safety approval plate required. 451.21 Section 451.21 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Safety Approval...

49 CFR 451.21 - Safety approval plate required.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 6 2011-10-01 2011-10-01 false Safety approval plate required. 451.21 Section 451.21 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Safety Approval...

49 CFR 451.21 - Safety approval plate required.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 6 2012-10-01 2012-10-01 false Safety approval plate required. 451.21 Section 451.21 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Safety Approval...

49 CFR 451.21 - Safety approval plate required.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 6 2014-10-01 2014-10-01 false Safety approval plate required. 451.21 Section 451.21 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Safety Approval...

49 CFR 451.21 - Safety approval plate required.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 6 2013-10-01 2013-10-01 false Safety approval plate required. 451.21 Section 451.21 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Safety Approval...

OSHA safety requirements for hazardous chemicals in the workplace.

PubMed

Dohms, J

1992-01-01

This article outlines the Occupational Safety and Health Administration (OSHA) requirements set forth by the Hazard Communication Standard, which has been in effect for the healthcare industry since 1987. Administrators who have not taken concrete steps to address employee health and safety issues relating to hazardous chemicals are encouraged to do so to avoid the potential of large fines for cited violations. While some states administer their own occupational safety and health programs, they must adopt standards and enforce requirements that are at least as effective as federal requirements.

TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alan Bond

2001-04-01

This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

Research requirements to improve safety of civil helicopters

NASA Technical Reports Server (NTRS)

Waters, K. T.

1977-01-01

Helicopter and fixed-wing accident data were reviewed and major accident causal factors were established. The impact of accidents on insurance rates was examined and the differences in fixed-wing and helicopter accident costs discussed. The state of the art in civil helicopter safety was compared to military helicopters. Goals were established based on incorporation of known technology and achievable improvements that require development, as well as administrative-type changes such as the impact of improved operational planning, training, and human factors effects. Specific R and D recommendations are provided with an estimation of the payoffs, timing, and development costs.

78 FR 59906 - Pipeline Safety: Class Location Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-30

... 192 [Docket No. PHMSA-2013-0161] Pipeline Safety: Class Location Requirements AGENCY: Pipeline and... Location Requirements,'' seeking comments on whether integrity management program (IMP) requirements, or... for class location requirements. PHMSA has received two requests to extend the comment period to allow...

75 FR 1276 - Requirements for Subsurface Safety Valve Equipment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

...-0066] RIN 1010-AD45 Requirements for Subsurface Safety Valve Equipment AGENCY: Minerals Management... Edition of the American Petroleum Institute's Specification for Subsurface Safety Valve Equipment (API... 14A, Specification for Subsurface Safety Valve Equipment, Eleventh Edition, October 2005, Effective...

Health, safety and environmental requirements for composite materials

NASA Technical Reports Server (NTRS)

Hazer, Kathleen A.

1994-01-01

The health, safety and environmental requirements for the production of composite materials are discussed. The areas covered include: (1) chemical identification for each chemical; (2) toxicology; (3) industrial hygiene; (4) fire and safety; (5) environmental aspects; and (6) medical concerns.

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

Responsibility for the Violation of Ecological Safety Requirements

NASA Astrophysics Data System (ADS)

Selivanovskaya, J. I.; Gilmutdinova, I.

2018-01-01

The article deals with the problems of responsibility for the violation of ecological safety requirements from the point of view of sustainable development of the state. Such types of responsibility as property, disciplinary, financial, administrative and criminal responsibility in the area are analysed. Suggestions on the improvement of legislation are put forward. Among other things it is suggested to introduce criminal sanctions against legal bodies (enterprises) for ecological crimes with punishments in the form of fines, suspension or discontinuation of activities.

System safety in Stirling engine development

NASA Technical Reports Server (NTRS)

Bankaitis, H.

1981-01-01

The DOE/NASA Stirling Engine Project Office has required that contractors make safety considerations an integral part of all phases of the Stirling engine development program. As an integral part of each engine design subtask, analyses are evolved to determine possible modes of failure. The accepted system safety analysis techniques (Fault Tree, FMEA, Hazards Analysis, etc.) are applied in various degrees of extent at the system, subsystem and component levels. The primary objectives are to identify critical failure areas, to enable removal of susceptibility to such failures or their effects from the system and to minimize risk.

Safety-related requirements for photovoltaic modules and arrays. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Levins, A.

1984-03-01

Underwriters Laboratories has conducted a study to identify and develop safety requirements for photovoltaic module and panel designs and configurations for residential, intermediate, and large scale applications. Concepts for safety systems, where each system is a collection of subsystems which together address the total anticipated hazard situation, are described. Descriptions of hardware, and system usefulness and viability are included. This discussion of safety systems recognizes that there is little history on which to base the expected safety related performance of a photovoltaic system. A comparison of these systems, as against the provisions of the 1984 National Electrical Code covering photovoltaicmore » systems is made. A discussion of the UL investigation of the photovoltaic module evaluated to the provisions of the Proposed UL Standard for Flat-Plate Photovoltaic Modules and Panels is included. Grounding systems, their basis and nature, and the advantages and disadvantages of each are described. The meaning of frame grounding, circuit grounding, and the type of circuit ground are covered. The development of the Standard for Flat-Plate Photovoltaic Modules and Panels has continued, and with both industry comment and a product submittal and listing, the Standard has been refined to a viable document allowing an objective safety review of photovoltaic modules and panels. How this document, and other UL documents would cover investigations of certain other photovoltaic system components is described.« less

Space power development impact on technology requirements

NASA Technical Reports Server (NTRS)

Cassidy, J. F.; Fitzgerald, T. J.; Gilje, R. I.; Gordon, J. D.

1986-01-01

The paper is concerned with the selection of a specific spacecraft power technology and the identification of technology development to meet system requirements. Requirements which influence the selection of a given technology include the power level required, whether the load is constant or transient in nature, and in the case of transient loads, the time required to recover the power, and overall system safety. Various power technologies, such as solar voltaic power, solar dynamic power, nuclear power systems, and electrochemical energy storage, are briefly described.

10 CFR 851.11 - Development and approval of worker safety and health program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Development and approval of worker safety and health program. 851.11 Section 851.11 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.11 Development and approval of worker safety and health program. (a) Preparation and...

76 FR 5494 - Pipeline Safety: Mechanical Fitting Failure Reporting Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Safety: Mechanical Fitting Failure Reporting Requirements AGENCY: Pipeline and Hazardous Materials Safety... tightening. A widely accepted industry guidance document, Gas Pipeline Technical Committee (GPTC) Guide, does...

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

NASA Astrophysics Data System (ADS)

Wessels, H.; Stephan, H. J.

1991-08-01

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

Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

NASA Technical Reports Server (NTRS)

1972-01-01

Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

System safety engineering in the development of advanced surface transportation vehicles

NASA Technical Reports Server (NTRS)

Arnzen, H. E.

1971-01-01

Applications of system safety engineering to the development of advanced surface transportation vehicles are described. As a pertinent example, the paper describes a safety engineering efforts tailored to the particular design and test requirements of the Tracked Air Cushion Research Vehicle (TACRV). The test results obtained from this unique research vehicle provide significant design data directly applicable to the development of future tracked air cushion vehicles that will carry passengers in comfort and safety at speeds up to 300 miles per hour.

Proposed system safety design and test requirements for the microlaser ordnance system

NASA Technical Reports Server (NTRS)

Stoltz, Barb A.; Waldo, Dale F.

1993-01-01

Safety for pyrotechnic ignition systems is becoming a major concern for the military. In the past twenty years, stray electromagnetic fields have steadily increased during peacetime training missions and have dramatically increased during battlefield missions. Almost all of the ordnance systems in use today depend on an electrical bridgewire for ignition. Unfortunately, the bridgewire is the cause of the majority of failure modes. The common failure modes include the following: broken bridgewires; transient RF power, which induces bridgewire heating; and cold temperatures, which contracts the explosive mix away from the bridgewire. Finding solutions for these failure modes is driving the costs of pyrotechnic systems up. For example, analyses are performed to verify that the system in the environment will not see more energy than 20 dB below the 'No-fire' level. Range surveys are performed to determine the operational, storage, and transportation RF environments. Cryogenic tests are performed to verify the bridgewire to mix interface. System requirements call for 'last minute installation,' 'continuity checks after installation,' and rotating safety devices to 'interrupt the explosive train.' As an alternative, MDESC has developed a new approach based upon our enabling laser diode technology. We believe that Microlaser initiated ordnance offers a unique solution to the bridgewire safety concerns. For this presentation, we will address, from a system safety viewpoint, the safety design and the test requirements for a Microlaser ordnance system. We will also review how this system could be compliant to MIL-STD-1576 and DOD-83578A and the additional necessary requirements.

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes

29 CFR 500.131 - Exclusion from housing safety and health requirement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... OF LABOR REGULATIONS MIGRANT AND SEASONAL AGRICULTURAL WORKER PROTECTION Motor Vehicle Safety and Insurance for Transportation of Migrant and Seasonal Agricultural Workers, Housing Safety and Health for Migrant Workers Housing Safety and Health § 500.131 Exclusion from housing safety and health requirement...

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

ERIC Educational Resources Information Center

Renfrew, Malcolm M., Ed.; Palladino, George F.

1980-01-01

Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

Development of Large-Scale Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

Ruff, Gary A.; Urban, David; Fernandez-Pello, A. Carlos; T'ien, James S.; Torero, Jose L.; Legros, Guillaume; Eigenbrod, Christian; Smirnov, Nickolay; Fujita, Osamu; Cowlard, Adam J.;

Safety policy and requirements for payloads using the space transportation system

NASA Technical Reports Server (NTRS)

1989-01-01

The safety policy and requirements are established applicable to the Space Transportation System (STS) payloads and their ground support equipment (GSE). The requirements are intended to protect flight and ground personnel, the STS, other payloads, GSE, the general public, public-private property, and the environment from payload-related hazards. The technical and system safety requirements applicable to STS payloads (including payload-provided ground and flight supports systems) during ground and flight operations are contained.

Engineering Safety- and Security-Related Requirements for Software-Intensive Systems

DTIC Science & Technology

2010-04-27

Requirements Negative (shall not) Requirements Hardware Requirements equ remen s System / Documentation Requirements eve oper Requirements Operational ...Validation Actual / Proposed Defensibility C li Operational Vulnerability Analysis VulnerabilityVulnerability Safety Vulnerability performs System ...including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson

42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of patient...

Safety policy and requirements for payloads using the Space Transportation System (STS)

NASA Technical Reports Server (NTRS)

1982-01-01

The Space Transportation Operations (STO) safety policy is to minimize STO involvement in the payload and its GSE (ground support equipment) design process while maintaining the assurance of a safe operation. Requirements for assuring payload mission success are the responsibility of the payload organization and are beyond the scope of this document. The intent is to provide the overall safety policies and requirements while allowing for negotiation between the payload organization and the STO operator in the method of implementation of payload safety. This revision provides for a relaxation in the monitoring requirements for inhibits, allows the payload organization to pursue design options and reflects, additionally, some new requirements. As of the issue date of this NHB, payloads which have completed the formal safety assessment reviews of their preliminary design on the basis of the May 1979 issue will be reassessed for compliance with the above changes.

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

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 2 2011-07-01 2011-07-01 false Safety and pollution prevention equipment... pollution prevention equipment quality assurance requirements. (a) General requirements. (1) Except as provided in paragraph (b)(1) of this section, you may install only certified safety and pollution...

Modeling safety requirements of an FMS using Petri-nets

NASA Astrophysics Data System (ADS)

Hanna, Moheb M.; Buck, A. A.; Smith, R.

1993-08-01

This paper is concerned with the modelling of safety requirements using Petri nets as a tool to model and simulate a Flexible Manufacturing System (FMS). The FMS cell described comprises a pick and place robot, a multi-head drilling machine together with a vision system and illustrates how the hierarchical structure of Petri nets can be used to ensure that all fail- safe requirements are satisfied; block diagrams together with fully detailed example Petri nets are given. The work demonstrates the use of cell and robot control Petro nets together with robot subnets for the x, y and z axes and associated output nets; the control and output nets are linked together with a safety net. Individual machines are linked with the control and safety nets of an FMS at cell level. The paper also illustrates how a Petri net can act as a decision maker during image inspection and identifies the unsafe conditions that can arise within an FMS.

14 CFR 382.115 - What requirements apply to on-board safety briefings?

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false What requirements apply to on-board safety briefings? 382.115 Section 382.115 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF... TRAVEL Services on Aircraft § 382.115 What requirements apply to on-board safety briefings? As a carrier...

14 CFR 382.115 - What requirements apply to on-board safety briefings?

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false What requirements apply to on-board safety briefings? 382.115 Section 382.115 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF... TRAVEL Services on Aircraft § 382.115 What requirements apply to on-board safety briefings? As a carrier...

14 CFR 382.115 - What requirements apply to on-board safety briefings?

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false What requirements apply to on-board safety briefings? 382.115 Section 382.115 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF... TRAVEL Services on Aircraft § 382.115 What requirements apply to on-board safety briefings? As a carrier...

14 CFR 382.115 - What requirements apply to on-board safety briefings?

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false What requirements apply to on-board safety briefings? 382.115 Section 382.115 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF... TRAVEL Services on Aircraft § 382.115 What requirements apply to on-board safety briefings? As a carrier...

14 CFR 382.115 - What requirements apply to on-board safety briefings?

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false What requirements apply to on-board safety briefings? 382.115 Section 382.115 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF... TRAVEL Services on Aircraft § 382.115 What requirements apply to on-board safety briefings? As a carrier...

49 CFR 1106.3 - Actions for which Safety Integration Plan is required.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false Actions for which Safety Integration Plan is... TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.3 Actions for which Safety Integration Plan is required. A SIP...

Safe laser application requires more than laser safety

NASA Astrophysics Data System (ADS)

Frevel, A.; Steffensen, B.; Vassie, L.

1995-02-01

An overview is presented concerning aspects of laser safety in European industrial laser use. Surveys indicate that there is a large variation in the safety strategies amongst industrial laser users. Some key problem areas are highlighted. Emission of hazardous substances is a major problem for users of laser material processing systems where the majority of the particulate is of a sub-micrometre size, presenting a respiratory hazard. Studies show that in many cases emissions are not frequently monitored in factories and uncertainty exists over the hazards. Operators of laser machines do not receive adequate job training or safety training. The problem is compounded by a plethora of regulations and standards which are difficult to interpret and implement, and inspectors who are not conversant with the technology or the issues. A case is demonstrated for a more integrated approach to laser safety, taking into account the development of laser applications, organizational and personnel development, in addition to environmental and occupational health and safety aspects. It is necessary to achieve a harmonization between these elements in any organization involved in laser technology. This might be achieved through establishing technology transfer centres in laser technology.

Developing an educational safety program for pharmacy employees.

PubMed

Hayman, J N

1980-02-01

The need for developing educational safety programs for pharmacy employees is discussed. A three-part program is offered as a guide for structuring a departmental safety program. Part I deals with environmental hazards such as wet floors, poor lighting, and cluttered walk areas. Precautions that should be taken to avoid accidental exposure to patients with communicable diseases are also included. Hazards that may result from improper handling of materials or equipment are addressed in Part II. Included are precautions for handling chemicals, needles, ladders, and electrical equipment. Proper methods of lifting heavy objects are also discussed. Part III details plans to protect staff members in the event of a fire. Plans for reporting fires and evacuating the pharmacy and hospital are discussed. The outlined program requires self-study by staff members during initial employee orientation, followed by annual retraining. Employees are tested and graded on safety topics, and training records are filed for future reference. The program outlined is thought to offer a simple yet effective means of acquainting staff members with established institutional and departmental safety procedures.

29 CFR 500.130 - Application and scope of safety and health requirement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of the aforesaid capacities. (d) The Occupational Safety and Health Administration (OSHA) is the agency of the U.S. Department of Labor which administers the Occupational Safety and Health Act (29 U.S.C... 29 Labor 3 2010-07-01 2010-07-01 false Application and scope of safety and health requirement. 500...

30 CFR 250.459 - What are the safety requirements for drilling fluid-handling areas?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What are the safety requirements for drilling... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Drilling Fluid Requirements § 250.459 What are the safety requirements for...

77 FR 75439 - Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

... Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE...) and bioavailability (BA) and bioequivalence (BE) studies. DATES: Submit either electronic or written... Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE...

Vehicle-to-infrastructure (V2I) safety applications performance requirements, vol. 2, curve speed warning (CSW).

DOT National Transportation Integrated Search

2015-08-01

This document is the second of a seven volume report that describe the Performance Requirements for the connected vehicle vehicle-to-infrastructure (V2I) safety applications developed for the U.S. Department of Transportation (U.S. DOT). This volume ...

Interdependence of science requirements and safety limitations on the space station

NASA Technical Reports Server (NTRS)

Barber, Patrick G.

1990-01-01

One of the benefits of experimentation on the Space Station is the ability to carry out the experiment, to immediately analyze the results, to calculate improved experimental parameters, and to quickly repeat the experiment. In this improved mode of operation there are new safety considerations that must be addressed in the design stages of both the station and the experiments. Some of the chemical and procedural requirements are shared, and some of the earth-bound storage, dispensing, and disposal techniques that may assist in the development of analogous procedures for the Space Station are discussed.

Nuclear safety policy working group recommendations on nuclear propulsion safety for the space exploration initiative

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Lee, James H.; Mcculloch, William H.; Sawyer, J. Charles, Jr.; Bari, Robert A.; Cullingford, Hatice S.; Hardy, Alva C.; Niederauer, George F.; Remp, Kerry; Rice, John W.

1993-01-01

An interagency Nuclear Safety Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program. These recommendations, which are contained in this report, should facilitate the implementation of mission planning and conceptual design studies. The NSPWG has recommended a top-level policy to provide the guiding principles for the development and implementation of the SEI nuclear propulsion safety program. In addition, the NSPWG has reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. These recommendations should be useful for the development of the program's top-level requirements for safety functions (referred to as Safety Functional Requirements). The safety requirements and guidelines address the following topics: reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations.

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... programs and business practices that not only ensure good service but also enhance the safety, operational...) “Equivalent to the services sought by DOD” means service offered to qualify for DOD approval must be... § 861.4 DOD air transportation quality and safety requirements. (a) General. The DOD, as a customer of...

75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... with the new requirements in the final rule entitled ``Investigational New Drug Safety Reporting...] Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New... the agency considers your comment on this draft guidance before it begins work on the final version of...

Request for Naval Reactors Comment on Proposed Prometheus Space Flight Nuclear Reactor High Tier Reactor Safety Requirements and for Naval Reactors Approval to Transmit These Requirements to JPL

DOE Office of Scientific and Technical Information (OSTI.GOV)

D. Kokkinos

2005-04-28

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 philosophymore » 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.« less

Safety margins in the implementation of planetary quarantine requirements

NASA Technical Reports Server (NTRS)

Schalkowsky, S.; Jacoby, I.

1972-01-01

The formulation of planetary quarantine requirements, and their implementation as determined by a risk allocation model, is discussed. The model defines control safety margins with particular emphasis on utility in achieving the desired minimization of excessive margins, and their effect on implementation procedures.

42 CFR 9.10 - Occupational Health and Safety Program (OHSP) and biosafety requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Occupational Health and Safety Program (OHSP) and... SANCTUARY SYSTEM § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. (a) How are employee Occupational Health and Safety Program risks and concerns addressed? The sanctuary shall...

42 CFR 9.10 - Occupational Health and Safety Program (OHSP) and biosafety requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Occupational Health and Safety Program (OHSP) and... SANCTUARY SYSTEM § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. (a) How are employee Occupational Health and Safety Program risks and concerns addressed? The sanctuary shall...

42 CFR 9.10 - Occupational Health and Safety Program (OHSP) and biosafety requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Occupational Health and Safety Program (OHSP) and... SANCTUARY SYSTEM § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. (a) How are employee Occupational Health and Safety Program risks and concerns addressed? The sanctuary shall...

42 CFR 9.10 - Occupational Health and Safety Program (OHSP) and biosafety requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Occupational Health and Safety Program (OHSP) and... SANCTUARY SYSTEM § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. (a) How are employee Occupational Health and Safety Program risks and concerns addressed? The sanctuary shall...

42 CFR 9.10 - Occupational Health and Safety Program (OHSP) and biosafety requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Occupational Health and Safety Program (OHSP) and... SANCTUARY SYSTEM § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. (a) How are employee Occupational Health and Safety Program risks and concerns addressed? The sanctuary shall...

Qualification of Simulation Software for Safety Assessment of Sodium Cooled Fast Reactors. Requirements and Recommendations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brown, Nicholas R.; Pointer, William David; Sieger, Matt

2016-04-01

The goal of this review is to enable application of codes or software packages for safety assessment of advanced sodium-cooled fast reactor (SFR) designs. To address near-term programmatic needs, the authors have focused on two objectives. First, the authors have focused on identification of requirements for software QA that must be satisfied to enable the application of software to future safety analyses. Second, the authors have collected best practices applied by other code development teams to minimize cost and time of initial code qualification activities and to recommend a path to the stated goal.

Vehicle-to-infrastructure (V2I) safety applications performance requirements, vol. 3, red light violation warning (RLVW).

DOT National Transportation Integrated Search

2015-08-01

This document is the third of a seven volume report that describe the Performance Requirements for the connected vehicle vehicle-to-infrastructure (V2I) safety applications developed for the U.S. Department of Transportation (U.S. DOT). This volume d...

Vehicle-to-infrastructure (V2I) safety applications : performance requirements, vol. 7, stop sign gap assist (SSGA).

DOT National Transportation Integrated Search

2015-08-01

This document is the seventh of a seven volume report that describe the Performance Requirements for the connected vehicle vehicle-to-infrastructure (V2I) safety applications developed for the U.S. Department of Transportation (U.S. DOT). This volume...

30 CFR 250.459 - What are the safety requirements for drilling fluid-handling areas?

Code of Federal Regulations, 2012 CFR

2012-07-01

... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Drilling Fluid Requirements § 250.459 What are the safety... 30 Mineral Resources 2 2012-07-01 2012-07-01 false What are the safety requirements for drilling...

30 CFR 250.459 - What are the safety requirements for drilling fluid-handling areas?

Code of Federal Regulations, 2013 CFR

2013-07-01

... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Drilling Fluid Requirements § 250.459 What are the safety... 30 Mineral Resources 2 2013-07-01 2013-07-01 false What are the safety requirements for drilling...

30 CFR 250.459 - What are the safety requirements for drilling fluid-handling areas?

Code of Federal Regulations, 2014 CFR

2014-07-01

... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Drilling Fluid Requirements § 250.459 What are the safety... 30 Mineral Resources 2 2014-07-01 2014-07-01 false What are the safety requirements for drilling...

41 CFR 128-1.8006 - Seismic Safety Program requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... reviewer shall verify that the current level of seismic resistance of the existing building at least equals the seismic resistance level of the building before the addition. (c) The Department Seismic Safety... conduct the reviews required under this section, as appropriate. (a) New building projects. Construction...

Electronic availability of microgravity experiments safety and integration requirements documents

NASA Technical Reports Server (NTRS)

Hogan, Jean M.

1995-01-01

This follow-on to NASA Contractor Report 195447, Microgravity Experiments Safety and Integration Requirements Document Tree, provides the details for accessing the systems that contain the official, electronic versions of the documents initially researched in NASA Contractor Report 195447. The data in this report serves as a valuable information source for the NASA Lewis Research Center Project Documentation Center (PDC), as well as for all developers of space experiments. The PDC has acquired the hardware, software, ID's, and passwords necessary to access most of these systems and is now able to provide customers with current document information as well as immediate delivery of available documents in either electronic or hard copy format.

Development and Validation of Career Development Guidelines by Task/Activity Analysis of Occupational Safety and Health Professions: Industrial Hygiene and Safety Professional. Final Report. Technical Report XII.

ERIC Educational Resources Information Center

Vernon, Ralph J.; And Others

This report summarizes research findings which resulted in development of curricula for occupational safety and health professions based on task/activity analyses and related performance objectives. The first seven chapters focus on the seven objectives. Chapter 1, Literature Review and Selection of Employers, concerns tasks required for…

Assessment of the impact of dipped guideways on urban rail transit systems: Ventilation and safety requirements

NASA Technical Reports Server (NTRS)

1982-01-01

The ventilation and fire safety requirements for subway tunnels with dipped profiles between stations as compared to subway tunnels with level profiles were evaluated. This evaluation is based upon computer simulations of a train fire emergency condition. Each of the tunnel configurations evaluated was developed from characteristics that are representative of modern transit systems. The results of the study indicate that: (1) The level tunnel system required about 10% more station cooling than dipped tunnel systems in order to meet design requirements; and (2) The emergency ventilation requirements are greater with dipped tunnel systems than with level tunnel systems.

[The Scope, Quality and Safety Requirements of Drug Abuse Testing].

PubMed

Küme, Tuncay; Karakükcü, Çiğdem; Pınar, Aslı; Coşkunol, Hakan

2017-01-01

The aim of this review is to inform about the scopes and requirements of drug abuse testing. Drug abuse testing is one of the tools for determination of drug use. It must fulfill the quality and safety requirements in judgmental legal and administrative decisions. Drug abuse testing must fulfill some requirements like selection of the appropriate test matrix, appropriate screening test panel, sampling in detection window, patient consent, identification of the donor, appropriate collection site, sample collection with observation, identification and control of the sample, specimen custody chain in preanalytical phase; analysis in authorized laboratories, specimen validity tests, reliable testing METHODS, strict quality control, two-step analysis in analytical phase; storage of the split specimen, confirmation of the split specimen in the objection, result custody chain, appropriate cut-off concentration, the appropriate interpretation of the result in postanalytical phase. The workflow and analytical processes of drug abuse testing are explained in last regulation of the Department of Medical Laboratory Services, Ministry of Health in Turkey. The clinical physicians have to know and apply the quality and safety requirements in drug abuse testing according to last regulations in Turkey.

Current state of nuclear fuel cycles in nuclear engineering and trends in their development according to the environmental safety requirements

NASA Astrophysics Data System (ADS)

Vislov, I. S.; Pischulin, V. P.; Kladiev, S. N.; Slobodyan, S. M.

2016-08-01

The state and trends in the development of nuclear fuel cycles in nuclear engineering, taking into account the ecological aspects of using nuclear power plants, are considered. An analysis of advantages and disadvantages of nuclear engineering, compared with thermal engineering based on organic fuel types, was carried out. Spent nuclear fuel (SNF) reprocessing is an important task in the nuclear industry, since fuel unloaded from modern reactors of any type contains a large amount of radioactive elements that are harmful to the environment. On the other hand, the newly generated isotopes of uranium and plutonium should be reused to fabricate new nuclear fuel. The spent nuclear fuel also includes other types of fission products. Conditions for SNF handling are determined by ecological and economic factors. When choosing a certain handling method, one should assess these factors at all stages of its implementation. There are two main methods of SNF handling: open nuclear fuel cycle, with spent nuclear fuel assemblies (NFAs) that are held in storage facilities with their consequent disposal, and closed nuclear fuel cycle, with separation of uranium and plutonium, their purification from fission products, and use for producing new fuel batches. The development of effective closed fuel cycles using mixed uranium-plutonium fuel can provide a successful development of the nuclear industry only under the conditions of implementation of novel effective technological treatment processes that meet strict requirements of environmental safety and reliability of process equipment being applied. The diversity of technological processes is determined by different types of NFA devices and construction materials being used, as well as by the composition that depends on nuclear fuel components and operational conditions for assemblies in the nuclear power reactor. This work provides an overview of technological processes of SNF treatment and methods of handling of nuclear fuel

Safety-related requirements for photovoltaic modules and arrays

NASA Technical Reports Server (NTRS)

Levins, A.; Smoot, A.; Wagner, R.

1984-01-01

Safety requirements for photovoltaic module and panel designs and configurations for residential, intermediate, and large scale applications are investigated. Concepts for safety systems, where each system is a collection of subsystems which together address the total anticipated hazard situation, are described. Descriptions of hardware, and system usefulness and viability are included. A comparison of these systems, as against the provisions of the 1984 National Electrical Code covering photovoltaic systems is made. A discussion of the Underwriters Laboratory UL investigation of the photovoltaic module evaluated to the provisions of the proposed UL standard for plat plate photovoltaic modules and panels is included. Grounding systems, their basis and nature, and the advantages and disadvantages of each are described. The meaning of frame grounding, circuit groundings, and the type of circuit ground are covered.

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Crewed Space Vehicle Battery Safety Requirements Revision D

NASA Technical Reports Server (NTRS)

Russell, Samuel

2017-01-01

The Crewed Space Vehicle Battery Safety Requirements document has been prepared for use by designers of battery-powered vehicles, portable equipment, and experiments intended for crewed spaceflight. The purpose of the requirements document is to provide battery designers with information on design provisions to be incorporated in and around the battery and on the verification to be undertaken to demonstrate a safe battery is provided. The term "safe battery" means that the battery is safe for ground personnel and crew members to handle and use; safe to be used in the enclosed environment of a crewed space vehicle; and safe to be mounted or used in unpressurized spaces adjacent to habitable areas. Battery design review, approval, and certification is required before the batteries can be used for ground operations and be certified for flight.

30 CFR 285.800 - How must I conduct my activities to comply with safety and environmental requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... safety and environmental requirements? 285.800 Section 285.800 Mineral Resources MINERALS MANAGEMENT... OUTER CONTINENTAL SHELF Environmental and Safety Management, Inspections, and Facility Assessments for... safety and environmental requirements? (a) You must conduct all activities on your lease or grant under...

A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

The potential for further development of passive safety.

PubMed

Frampton, Richard; Lenard, James

2009-10-01

In Europe, emphasis is being transferred from injury prevention to accident prevention to reduce road casualties. This study attempted to identify the current potential for serious casualty reduction using passive safety by examining the crash performance of new cars with seriously injured occupants. The Co-operative Crash Injury Study conducts in-depth investigations of around 1200 vehicles per year from seven sample regions around England. Attention was focussed on passenger cars manufactured from 2004 to 2008 with at least one occupant injured to AIS level 3 or more. 28% of MAIS 3+ occupants were unbelted and 40% were belted but involved in crashes with limited potential for passive protection. A further 32% of occupants were belted and involved in crashes with potential for improved crashworthiness design. For these occupants, five major functional requirements were identified for crashworthiness improvement: a reduction of seatbelt loads on the chest and abdomen in frontal crashes, particularly for seniors; reduction in femur and tibia loads in frontal crashes; provision of head and chest protection in near-side crashes; and reduction of occupant lateral excursion in far-side impacts. Together these functions accounted for 70% of the identified requirements. Other smaller requirements were identified, each contributing up to 5% of total. Overall, the case supporting further developments in passive safety still appears significant.

The Potential for Further Development of Passive Safety

PubMed Central

Frampton, Richard; Lenard, James

2009-01-01

In Europe, emphasis is being transferred from injury prevention to accident prevention to reduce road casualties. This study attempted to identify the current potential for serious casualty reduction using passive safety by examining the crash performance of new cars with seriously injured occupants. The Co-operative Crash Injury Study conducts in-depth investigations of around 1200 vehicles per year from seven sample regions around England. Attention was focussed on passenger cars manufactured from 2004 to 2008 with at least one occupant injured to AIS level 3 or more. 28% of MAIS 3+ occupants were unbelted and 40% were belted but involved in crashes with limited potential for passive protection. A further 32% of occupants were belted and involved in crashes with potential for improved crashworthiness design. For these occupants, five major functional requirements were identified for crashworthiness improvement: a reduction of seatbelt loads on the chest and abdomen in frontal crashes, particularly for seniors; reduction in femur and tibia loads in frontal crashes; provision of head and chest protection in near-side crashes; and reduction of occupant lateral excursion in far-side impacts. Together these functions accounted for 70% of the identified requirements. Other smaller requirements were identified, each contributing up to 5% of total. Overall, the case supporting further developments in passive safety still appears significant. PMID:20184832

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

The development and psychometric evaluation of a safety climate measure for primary care.

PubMed

de Wet, C; Spence, W; Mash, R; Johnson, P; Bowie, P

2010-12-01

Building a safety culture is an important part of improving patient care. Measuring perceptions of safety climate among healthcare teams and organisations is a key element of this process. Existing measurement instruments are largely developed for secondary care settings in North America and many lack adequate psychometric testing. Our aim was to develop and test an instrument to measure perceptions of safety climate among primary care teams in National Health Service for Scotland. Questionnaire development was facilitated through a steering group, literature review, semistructured interviews with primary care team members, a modified Delphi and completion of a content validity index by experts. A cross-sectional postal survey utilising the questionnaire was undertaken in a random sample of west of Scotland general practices to facilitate psychometric evaluation. Statistical methods, including exploratory and confirmatory factor analysis, and Cronbach and Raykov reliability coefficients were conducted. Of the 667 primary care team members based in 49 general practices surveyed, 563 returned completed questionnaires (84.4%). Psychometric evaluation resulted in the development of a 30-item questionnaire with five safety climate factors: leadership, teamwork, communication, workload and safety systems. Retained items have strong factor loadings to only one factor. Reliability coefficients was satisfactory (α = 0.94 and ρ = 0.93). This study is the first stage in the development of an appropriately valid and reliable safety climate measure for primary care. Measuring safety climate perceptions has the potential to help primary care organisations and teams focus attention on safety-related issues and target improvement through educational interventions. Further research is required to explore acceptability and feasibility issues for primary care teams and the potential for organisational benchmarking.

Impact of biomarker development on drug safety assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Marrer, Estelle, E-mail: estelle.marrer@novartis.co; Dieterle, Frank

2010-03-01

Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative andmore » 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.« less

Nursing Information Systems Requirements: A Milestone for Patient Outcome and Patient Safety Improvement.

PubMed

Farzandipour, Mehrdad; Meidani, Zahra; Riazi, Hossein; Sadeqi Jabali, Monireh

2016-12-01

Considering the integral role of understanding users' requirements in information system success, this research aimed to determine functional requirements of nursing information systems through a national survey. Delphi technique method was applied to conduct this study through three phases: focus group method modified Delphi technique and classic Delphi technique. A cross-sectional study was conducted to evaluate the proposed requirements within 15 general hospitals in Iran. Forty-three of 76 approved requirements were clinical, and 33 were administrative ones. Nurses' mean agreements for clinical requirements were higher than those of administrative requirements; minimum and maximum means of clinical requirements were 3.3 and 3.88, respectively. Minimum and maximum means of administrative requirements were 3.1 and 3.47, respectively. Research findings indicated that those information system requirements that support nurses in doing tasks including direct care, medicine prescription, patient treatment management, and patient safety have been the target of special attention. As nurses' requirements deal directly with patient outcome and patient safety, nursing information systems requirements should not only address automation but also nurses' tasks and work processes based on work analysis.

78 FR 65427 - Pipeline Safety: Reminder of Requirements for Liquefied Petroleum Gas and Utility Liquefied...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2013-0097] Pipeline Safety: Reminder of Requirements for Liquefied Petroleum Gas and Utility Liquefied Petroleum Gas Pipeline Systems AGENCY: Pipeline and Hazardous Materials Safety Administration...

Development of Guidance for States Transitioning to New Safety Analysis Tools

ERIC Educational Resources Information Center

Alluri, Priyanka

2010-01-01

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act--A Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway…

76 FR 3646 - Safety Requirements and Manning Exemption Eligibility on Distant Water Tuna Fleet Vessels

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

...Pursuant to Section 904 of the 2010 Coast Guard Authorization Act, the Coast Guard announces the availability of a draft policy regarding distant water tuna fleet vessels manning exemption eligibility and safety requirements. We request your comments on the Safety Requirements and Manning Exemption Eligibility on Distant Water Tuna Fleet Vessels.

A Safety and Health Guide for Vocational Educators. Incorporating Requirements of the Occupational Safety and Health Act of 1970, Relevant Pennsylvania Requirements with Particular Emphasis for Those Concerned with Cooperative Education and Work Study Programs. Volume 15. Number 1.

ERIC Educational Resources Information Center

Wahl, Ray

Intended as a guide for vocational educators to incorporate the requirements of the Occupational Safety and Health Act (1970) and the requirements of various Pennsylvania safety and health regulations with their cooperative vocational programs, the first chapter of this document presents the legal implications of these safety and health…

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive

Capturing Safety Requirements to Enable Effective Task Allocation Between Humans and Automaton in Increasingly Autonomous Systems

NASA Technical Reports Server (NTRS)

Neogi, Natasha A.

2016-01-01

There is a current drive towards enabling the deployment of increasingly autonomous systems in the National Airspace System (NAS). However, shifting the traditional roles and responsibilities between humans and automation for safety critical tasks must be managed carefully, otherwise the current emergent safety properties of the NAS may be disrupted. In this paper, a verification activity to assess the emergent safety properties of a clearly defined, safety critical, operational scenario that possesses tasks that can be fluidly allocated between human and automated agents is conducted. Task allocation role sets were proposed for a human-automation team performing a contingency maneuver in a reduced crew context. A safety critical contingency procedure (engine out on takeoff) was modeled in the Soar cognitive architecture, then translated into the Hybrid Input Output formalism. Verification activities were then performed to determine whether or not the safety properties held over the increasingly autonomous system. The verification activities lead to the development of several key insights regarding the implicit assumptions on agent capability. It subsequently illustrated the usefulness of task annotations associated with specialized requirements (e.g., communication, timing etc.), and demonstrated the feasibility of this approach.

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

75 FR 74022 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD [Recommendation 2010-1] Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers AGENCY: Defense Nuclear Facilities Safety Board... Nuclear Facilities Safety Board has made a recommendation to the Secretary of Energy requesting an...

10 CFR 73.58 - Safety/security interface requirements for nuclear power reactors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety/security interface requirements for nuclear power reactors. 73.58 Section 73.58 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF... requirements for nuclear power reactors. (a) Each operating nuclear power reactor licensee with a license...

10 CFR 73.58 - Safety/security interface requirements for nuclear power reactors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Safety/security interface requirements for nuclear power reactors. 73.58 Section 73.58 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF... requirements for nuclear power reactors. (a) Each operating nuclear power reactor licensee with a license...

10 CFR 73.58 - Safety/security interface requirements for nuclear power reactors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Safety/security interface requirements for nuclear power reactors. 73.58 Section 73.58 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF... requirements for nuclear power reactors. (a) Each operating nuclear power reactor licensee with a license...

10 CFR 73.58 - Safety/security interface requirements for nuclear power reactors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Safety/security interface requirements for nuclear power reactors. 73.58 Section 73.58 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF... requirements for nuclear power reactors. (a) Each operating nuclear power reactor licensee with a license...

10 CFR 73.58 - Safety/security interface requirements for nuclear power reactors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Safety/security interface requirements for nuclear power reactors. 73.58 Section 73.58 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF... requirements for nuclear power reactors. (a) Each operating nuclear power reactor licensee with a license...

75 FR 69648 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-15

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD [Recommendation 2010-1] Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers AGENCY: Defense Nuclear Facilities Safety Board... Facilities Safety Board has made a recommendation to the Secretary of Energy requesting an amendment to the...

46 CFR 53.05-1 - Safety valve requirements for steam boilers (modifies HG-400 and HG-401).

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Safety valve requirements for steam boilers (modifies HG... requirements for steam boilers (modifies HG-400 and HG-401). (a) The pressure relief valve requirements and the safety valve requirements for steam boilers must be as indicated in HG-400 and HG-401 of section IV of...

32 CFR 643.22 - Policy-Public safety: Requirement for early identification of lands containing dangerous materials.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Policy-Public safety: Requirement for early identification of lands containing dangerous materials. 643.22 Section 643.22 National Defense Department of...—Public safety: Requirement for early identification of lands containing dangerous materials. (a) DA will...

32 CFR 643.22 - Policy-Public safety: Requirement for early identification of lands containing dangerous materials.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 4 2011-07-01 2011-07-01 false Policy-Public safety: Requirement for early identification of lands containing dangerous materials. 643.22 Section 643.22 National Defense Department of...—Public safety: Requirement for early identification of lands containing dangerous materials. (a) DA will...

The development of neural stimulators: a review of preclinical safety and efficacy studies.

PubMed

Shepherd, Robert K; Villalobos, Joel; Burns, Owen; Nayagam, David

2018-05-14

Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to

Collaborating with nurse leaders to develop patient safety practices.

PubMed

Kanerva, Anne; Kivinen, Tuula; Lammintakanen, Johanna

2017-07-03

Purpose The organisational level and leadership development are crucial elements in advancing patient safety, because patient safety weaknesses are often caused by system failures. However, little is known about how frontline leader and director teams can be supported to develop patient safety practices. The purpose of this study is to describe the patient safety development process carried out by nursing leaders and directors. The research questions were: how the chosen development areas progressed in six months' time and how nursing leaders view the participatory development process. Design/methodology/approach Participatory action research was used to engage frontline nursing leaders and directors into developing patient safety practices. Semi-structured group interviews ( N = 10) were used in data collection at the end of a six-month action cycle, and data were analysed using content analysis. Findings The participatory development process enhanced collaboration and gave leaders insights into patient safety as a part of the hospital system and their role in advancing it. The chosen development areas advanced to different extents, with the greatest improvements in those areas with simple guidelines to follow and in which the leaders were most participative. The features of high-reliability organisation were moderately identified in the nursing leaders' actions and views. For example, acting as a change agent to implement patient safety practices was challenging. Participatory methods can be used to support leaders into advancing patient safety. However, it is important that the participants are familiar with the method, and there are enough facilitators to steer development processes. Originality/value Research brings more knowledge of how leaders can increase their effectiveness in advancing patient safety and promoting high-reliability organisation features in the healthcare organisation.

76 FR 10524 - Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-25

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 571 and 585 [Docket No. NHTSA-2011-0004] RIN 2127-AK23 Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements; Incorporation by Reference Correction In rule document 2011-547...

Developing a Practical and Sustainable Faculty Development Program With a Focus on Teaching Quality Improvement and Patient Safety: An Alliance for Independent Academic Medical Centers National Initiative III Project.

PubMed

Rodrigue, Christopher; Seoane, Leonardo; Gala, Rajiv B; Piazza, Janice; Amedee, Ronald G

2012-01-01

Teaching the next generation of physicians requires more than traditional teaching models. The Accreditation Council for Graduate Medical Education's Next Accreditation System places considerable emphasis on developing a learning environment that fosters resident education in quality improvement and patient safety. The goal of this project was to develop a comprehensive and sustainable faculty development program with a focus on teaching quality improvement and patient safety. A multidisciplinary team representing all stakeholders in graduate medical education developed a validated survey to assess faculty and house officer baseline perceptions of their experience with faculty development opportunities, quality improvement tools and training, and resident participation in quality improvement and patient safety programs at our institution. We then developed a curriculum to address these 3 areas. Our pilot survey revealed a need for a comprehensive program to teach faculty and residents the art of teaching. Two other areas of need are (1) regular resident participation in quality improvement and patient safety efforts and (2) effective tools for developing skills and habits to analyze practices using quality improvement methods. Resident and faculty pairs in 17 Ochsner training programs developed and began quality improvement projects while completing the first learning module. Resident and faculty teams also have been working on the patient safety modules and incorporating aspects of patient safety into their individual work environments. Our team's goal is to develop a sustainable and manageable faculty development program that includes modules addressing quality improvement and patient safety in accordance with Accreditation Council for Graduate Medical Education accreditation requirements.

Safe use of vaccines and vaccine compliance with food safety requirements.

PubMed

Grein, K; Papadopoulos, O; Tollis, M

2007-08-01

Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

30 CFR 250.405 - What are the safety requirements for diesel engines used on a drilling rig?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What are the safety requirements for diesel... Gas Drilling Operations General Requirements § 250.405 What are the safety requirements for diesel engines used on a drilling rig? You must equip each diesel engine with an air take device to shut down the...

Information requirements of the National Aeronautics and Space Administration's safety, environmental health, and occupational medicine programs

NASA Technical Reports Server (NTRS)

Whyte, A. A.

1978-01-01

A survey of the internal and external reporting and recordkeeping procedures of these programs was conducted and the major problems associated with them are outlined. The impact of probable future requirements on existing information systems is evaluated. This report also presents the benefits of combining the safety and health information systems into one computerized system and recommendations for the development and scope of that system.

33 CFR 149.696 - What are the requirements for a helicopter landing deck safety net?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false What are the requirements for a helicopter landing deck safety net? 149.696 Section 149.696 Navigation and Navigable Waters COAST GUARD... helicopter landing deck safety net? A helicopter landing deck safety net must comply with 46 CFR 108.235...

33 CFR 149.696 - What are the requirements for a helicopter landing deck safety net?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false What are the requirements for a helicopter landing deck safety net? 149.696 Section 149.696 Navigation and Navigable Waters COAST GUARD... helicopter landing deck safety net? A helicopter landing deck safety net must comply with 46 CFR 108.235...

33 CFR 149.696 - What are the requirements for a helicopter landing deck safety net?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false What are the requirements for a helicopter landing deck safety net? 149.696 Section 149.696 Navigation and Navigable Waters COAST GUARD... helicopter landing deck safety net? A helicopter landing deck safety net must comply with 46 CFR 108.235...

33 CFR 149.696 - What are the requirements for a helicopter landing deck safety net?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false What are the requirements for a helicopter landing deck safety net? 149.696 Section 149.696 Navigation and Navigable Waters COAST GUARD... helicopter landing deck safety net? A helicopter landing deck safety net must comply with 46 CFR 108.235...

33 CFR 149.696 - What are the requirements for a helicopter landing deck safety net?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false What are the requirements for a helicopter landing deck safety net? 149.696 Section 149.696 Navigation and Navigable Waters COAST GUARD... helicopter landing deck safety net? A helicopter landing deck safety net must comply with 46 CFR 108.235...

Infrastructural requirements for local implementation of safety policies: the discordance between top-down and bottom-up systems of action.

PubMed

Timpka, Toomas; Nordqvist, Cecilia; Lindqvist, Kent

2009-03-09

Safety promotion is planned and practised not only by public health organizations, but also by other welfare state agencies, private companies and non-governmental organizations. The term 'infrastructure' originally denoted the underlying resources needed for warfare, e.g. roads, industries, and an industrial workforce. Today, 'infrastructure' refers to the physical elements, organizations and people needed to run projects in different societal arenas. The aim of this study was to examine associations between infrastructure and local implementation of safety policies in injury prevention and safety promotion programs. Qualitative data on municipalities in Sweden designated as Safe Communities were collected from focus group interviews with municipal politicians and administrators, as well as from policy documents, and materials published on the Internet. Actor network theory was used to identify weaknesses in the present infrastructure and determine strategies that can be used to resolve these. The weakness identification analysis revealed that the factual infrastructure available for effectuating national strategies varied between safety areas and approaches, basically reflecting differences between bureaucratic and network-based organizational models. At the local level, a contradiction between safety promotion and the existence of quasi-markets for local public service providers was found to predispose for a poor local infrastructure diminishing the interest in integrated inter-agency activities. The weakness resolution analysis showed that development of an adequate infrastructure for safety promotion would require adjustment of the legal framework regulating injury data exchange, and would also require rational financial models for multi-party investments in local infrastructures. We found that the "silo" structure of government organization and assignment of resources was a barrier to collaborative action for safety at a community level. It may therefore be

78 FR 42889 - Pipeline Safety: Reminder of Requirements for Utility LP-Gas and LPG Pipeline Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 192 [Docket No. PHMSA-2013-0097] Pipeline Safety: Reminder of Requirements for Utility LP-Gas and LPG Pipeline Systems AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION...

33 CFR 150.601 - What are the safety and health requirements for the workplace on a deepwater port?

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements for the workplace on a deepwater port? 150.601 Section 150.601 Navigation and Navigable Waters... Workplace Safety and Health Safety and Health (general) § 150.601 What are the safety and health requirements for the workplace on a deepwater port? (a) Each operator of a deepwater port must ensure that the...

Manned space flight nuclear system safety. Volume 5: Nuclear System safety guidelines. Part 1: Space base nuclear safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space base nuclear system safety are presented. Guidelines and requirements are presented for the space base subsystems, nuclear hardware (reactor, isotope sources, dynamic generator equipment), experiments, interfacing vehicles, ground support systems, range safety and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

Software Dependability and Safety Evaluations ESA's Initiative

NASA Astrophysics Data System (ADS)

Hernek, M.

ESA has allocated funds for an initiative to evaluate Dependability and Safety methods of Software. The objectives of this initiative are; · More extensive validation of Safety and Dependability techniques for Software · Provide valuable results to improve the quality of the Software thus promoting the application of Dependability and Safety methods and techniques. ESA space systems are being developed according to defined PA requirement specifications. These requirements may be implemented through various design concepts, e.g. redundancy, diversity etc. varying from project to project. Analysis methods (FMECA. FTA, HA, etc) are frequently used during requirements analysis and design activities to assure the correct implementation of system PA requirements. The criticality level of failures, functions and systems is determined and by doing that the critical sub-systems are identified, on which dependability and safety techniques are to be applied during development. Proper performance of the software development requires the development of a technical specification for the products at the beginning of the life cycle. Such technical specification comprises both functional and non-functional requirements. These non-functional requirements address characteristics of the product such as quality, dependability, safety and maintainability. Software in space systems is more and more used in critical functions. Also the trend towards more frequent use of COTS and reusable components pose new difficulties in terms of assuring reliable and safe systems. Because of this, its dependability and safety must be carefully analysed. ESA identified and documented techniques, methods and procedures to ensure that software dependability and safety requirements are specified and taken into account during the design and development of a software system and to verify/validate that the implemented software systems comply with these requirements [R1].

Assessment of documentation requirements under DOE 5481. 1, Safety Analysis and Review System (SARS)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Browne, E.T.

1981-03-01

This report assesses the requirements of DOE Order 5481.1, Safety Analysis and Review System for DOE Operations (SARS) in regard to maintaining SARS documentation. Under SARS, all pertinent details of the entire safety analysis and review process for each DOE operation are to be traceable from the initial identification of a hazard. This report is intended to provide assistance in identifying the points in the SARS cycle at which documentation is required, what type of documentation is most appropriate, and where it ultimately should be maintained.

Space station pressurized laboratory safety guidelines

NASA Technical Reports Server (NTRS)

Mcgonigal, Les

1990-01-01

Before technical safety guidelines and requirements are established, a common understanding of their origin and importance must be shared between Space Station Program Management, the User Community, and the Safety organizations involved. Safety guidelines and requirements are driven by the nature of the experiments, and the degree of crew interaction. Hazard identification; development of technical safety requirements; operating procedures and constraints; provision of training and education; conduct of reviews and evaluations; and emergency preplanning are briefly discussed.

Vehicle-to-infrastructure (V2I) safety applications performance requirements, vol. 6, spot weather information warning – diversion (SWIW-D).

DOT National Transportation Integrated Search

2015-08-01

This document is the sixth of a seven volume report that describe the Performance Requirements for the connected vehicle vehicle-to-infrastructure (V2I) safety applications developed for the U.S. Department of Transportation (U.S. DOT). This volume d...

78 FR 67326 - Safety and Environmental Management System Requirements for Vessels on the U.S. Outer Continental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... 1625-AC05 Safety and Environmental Management System Requirements for Vessels on the U.S. Outer... ``Safety and Environmental Management System Requirements for Vessels on the U.S. Outer Continental Shelf... of industry to ensure stakeholders have adequate time to submit complete responses. DATES: Comments...

Advanced silver zinc battery development for the SRB and ET range safety subsystems

NASA Technical Reports Server (NTRS)

Adamedes, Zoe

1994-01-01

This document presents in viewgraph format the design and development of silver zinc (AgZn) batteries for the solid rocket booster (SRB) and external tank (ET) range safety subsystems. Various engineering techniques, including composite separator systems, new electrode processing techniques, and new restraint techniques, were used to meet difficult requirements.

Early Engagement of Safety and Mission Assurance Expertise Using Systems Engineering Tools: A Risk-Based Approach to Early Identification of Safety and Assurance Requirements

NASA Technical Reports Server (NTRS)

Darpel, Scott; Beckman, Sean

2016-01-01

Decades of systems engineering practice have demonstrated that the earlier the identification of requirements occurs, the lower the chance that costly redesigns will needed later in the project life cycle. A better understanding of all requirements can also improve the likelihood of a design's success. Significant effort has been put into developing tools and practices that facilitate requirements determination, including those that are part of the model-based systems engineering (MBSE) paradigm. These efforts have yielded improvements in requirements definition, but have thus far focused on a design's performance needs. The identification of safety & mission assurance (S&MA) related requirements, in comparison, can occur after preliminary designs are already established, yielding forced redesigns. Engaging S&MA expertise at an earlier stage, facilitated by the use of MBSE tools, and focused on actual project risk, can yield the same type of design life cycle improvements that have been realized in technical and performance requirements.

24 CFR 3280.208 - Smoke alarm requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. (a) Labeling. Each smoke alarm required under paragraph (b) of this section must conform with the...

24 CFR 3280.208 - Smoke alarm requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. (a) Labeling. Each smoke alarm required under paragraph (b) of this section must conform with the...

24 CFR 3280.208 - Smoke alarm requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. (a) Labeling. Each smoke alarm required under paragraph (b) of this section must conform with the...

33 CFR 164.72 - Navigational-safety equipment, charts or maps, and publications required on towing vessels.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Navigational-safety equipment, charts or maps, and publications required on towing vessels. 164.72 Section 164.72 Navigation and... NAVIGATION SAFETY REGULATIONS § 164.72 Navigational-safety equipment, charts or maps, and publications...

49 CFR 176.704 - Requirements relating to transport indices and criticality safety indices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 2 2011-10-01 2011-10-01 false Requirements relating to transport indices and... Requirements relating to transport indices and criticality safety indices. (a) The sum of the transport indices..., transport and unloading are to be supervised by persons qualified in the transport of radioactive material...

49 CFR 176.704 - Requirements relating to transport indices and criticality safety indices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Requirements relating to transport indices and... Requirements relating to transport indices and criticality safety indices. (a) The sum of the transport indices..., transport and unloading are to be supervised by persons qualified in the transport of radioactive material...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

Analysis of safety reports involving area navigation and required navigation performance procedures.

DOT National Transportation Integrated Search

2010-11-03

In order to achieve potential operational and safety benefits enabled by Area Navigation (RNAV) and Required Navigation Performance (RNP) procedures it is important to monitor emerging issues in their initial implementation. Reports from the Aviation...

Is Model-Based Development a Favorable Approach for Complex and Safety-Critical Computer Systems on Commercial Aircraft?

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

A system is safety-critical if its failure can endanger human life or cause significant damage to property or the environment. State-of-the-art computer systems on commercial aircraft are highly complex, software-intensive, functionally integrated, and network-centric systems of systems. Ensuring that such systems are safe and comply with existing safety regulations is costly and time-consuming as the level of rigor in the development process, especially the validation and verification activities, is determined by considerations of system complexity and safety criticality. A significant degree of care and deep insight into the operational principles of these systems is required to ensure adequate coverage of all design implications relevant to system safety. Model-based development methodologies, methods, tools, and techniques facilitate collaboration and enable the use of common design artifacts among groups dealing with different aspects of the development of a system. This paper examines the application of model-based development to complex and safety-critical aircraft computer systems. Benefits and detriments are identified and an overall assessment of the approach is given.

Annotated Bibliography of Rail Transit Safety, 1975-1980, with Emphasis on Safety Research and Development.

DOT National Transportation Integrated Search

1981-09-01

The bibliography provides a comprehensive review of published literature concerning rail transit safety and includes 186 annotated entries. The report covers domestic and foreign material on rail transit safety and related safety research and develop...

Development and Pilot Testing of a Food Safety Curriculum for Managers and Staff of Residential Childcare Institutions (RCCIs)

ERIC Educational Resources Information Center

Pivarnik, Lori F.; Patnoad, Martha S.; Nyachuba, David; McLandsborough, Lynne; Couto, Stephen; Hagan, Elsina E.; Breau, Marti

2013-01-01

Food safety training materials, targeted for residential childcare institution (RCCI) staff of facilities of 20 residents or less, were developed, piloted, and evaluated. The goal was to assist in the implementation of a Hazard Analysis Critical Control Points (HACCP)-based food safety plan as required by Food and Nutrition Service/United States…

CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kessler, S

2009-04-21

With the implementation of DOE Order 420.1B, Facility Safety, and DOE-STD-3007-2007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities', a new requirement was imposed that all criticality safety controls be evaluated for inclusion in the facility Documented Safety Analysis (DSA) and that the evaluation process be documented in the site Criticality Safety Program Description Document (CSPDD). At the Hanford site in Washington State the CSPDD, HNF-31695, 'General Description of the FH Criticality Safety Program', requires each facility develop a linking document called a Criticality Control Review (CCR) to document performance of these evaluations. Chapter 5,more » Appendix 5B of HNF-7098, Criticality Safety Program, provided an example of a format for a CCR that could be used in lieu of each facility developing its own CCR. Since the Plutonium Finishing Plant (PFP) is presently undergoing Deactivation and Decommissioning (D&D), new procedures are being developed for cleanout of equipment and systems that have not been operated in years. Existing Criticality Safety Evaluations (CSE) are revised, or new ones written, to develop the controls required to support D&D activities. Other Hanford facilities, including PFP, had difficulty using the basic CCR out of HNF-7098 when first implemented. Interpretation of the new guidelines indicated that many of the controls needed to be elevated to TSR level controls. Criterion 2 of the standard, requiring that the consequence of a criticality be examined for establishing the classification of a control, was not addressed. Upon in-depth review by PFP Criticality Safety staff, it was not clear that the programmatic interpretation of criterion 8C could be applied at PFP. Therefore, the PFP Criticality Safety staff decided to write their own CCR. The PFP CCR provides additional guidance for the evaluation team to use by clarifying the evaluation criteria in DOE-STD-3007

Electrical safety of conducted electrical weapons relative to requirements of relevant electrical standards.

PubMed

Panescu, Dorin; Nerheim, Max; Kroll, Mark

2013-01-01

TASER(®) conducted electrical weapons (CEW) deliver electrical pulses that can inhibit a person's neuromuscular control or temporarily incapacitate. TASER X26, X26P, and X2 are among CEW models most frequently deployed by law enforcement agencies. The X2 CEW uses two cartridge bays while the X26 and X26P CEWs have only one. The TASER X26P CEW electronic output circuit design is equivalent to that of any one of the two TASER X2 outputs. The goal of this paper was to analyze the nominal electrical outputs of TASER X26, X26P, and X2 CEWs in reference to provisions of several international standards that specify safety requirements for electrical medical devices and electrical fences. Although these standards do not specifically mention CEWs, they are the closest electrical safety standards and hence give very relevant guidance. The outputs of two TASER X26 and two TASER X2 CEWs were measured and confirmed against manufacturer and other published specifications. The TASER X26, X26P, and X2 CEWs electrical output parameters were reviewed against relevant safety requirements of UL 69, IEC 60335-2-76 Ed 2.1, IEC 60479-1, IEC 60479-2, AS/NZS 60479.1, AS/NZS 60479.2 and IEC 60601-1. Prior reports on similar topics were reviewed as well. Our measurements and analyses confirmed that the nominal electrical outputs of TASER X26, X26P and X2 CEWs lie within safety bounds specified by relevant requirements of the above standards.

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

Nuclear safety

NASA Technical Reports Server (NTRS)

Buden, D.

1991-01-01

Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

Vehicle-to-infrastructure (V2I) safety applications performance requirements, vol. 5, spot weather information warning – reduced speed (SWIW-RS).

DOT National Transportation Integrated Search

2015-08-01

This document is the fifth of a seven volume report that describe the Performance Requirements for the connected vehicle vehicle-to-infrastructure (V2I) safety applications developed for the U.S. Department of Transportation (U.S. DOT). This volume d...

Vehicle-to-infrastructure (V2I) safety applications performance requirements, vol. 4, reduced speed zone warning with lane closure (RSZW/LC).

DOT National Transportation Integrated Search

2015-08-01

This document is the fourth of a seven volume report that describe the Performance Requirements for the connected vehicle vehicle-to-infrastructure (V2I) safety applications developed for the U.S. Department of Transportation (U.S. DOT). This volume ...

Analysis of Operational Hazards and Safety Requirements for Traffic Aware Strategic Aircrew Requests (TASAR)

NASA Technical Reports Server (NTRS)

Koczo, Stefan, Jr.

2013-01-01

Safety analyses of the Traffic Aware Strategic Aircrew Requests (TASAR) Electronic Flight Bag (EFB) application are provided to establish its Failure Effects Classification which affects certification and operational approval requirements. TASAR was developed by NASA Langley Research Center to offer flight path improvement opportunities to the pilot during flight for operational benefits (e.g., reduced fuel, flight time). TASAR, using own-ship and network-enabled information concerning the flight and its environment, including weather and Air Traffic Control (ATC) system constraints, provides recommended improvements to the flight trajectory that the pilot can choose to request via Change Requests to ATC for revised clearance. This study reviews the Change Request process of requesting updates to the current clearance, examines the intended function of TASAR, and utilizes two safety assessment methods to establish the Failure Effects Classification of TASAR. Considerable attention has been given in this report to the identification of operational hazards potentially associated with TASAR.

Development of a Comprehensive Database System for Safety Analyst

PubMed Central

Paz, Alexander; Veeramisti, Naveen; Khanal, Indira; Baker, Justin

2015-01-01

This study addressed barriers associated with the use of Safety Analyst, a state-of-the-art tool that has been developed to assist during the entire Traffic Safety Management process but that is not widely used due to a number of challenges as described in this paper. As part of this study, a comprehensive database system and tools to provide data to multiple traffic safety applications, with a focus on Safety Analyst, were developed. A number of data management tools were developed to extract, collect, transform, integrate, and load the data. The system includes consistency-checking capabilities to ensure the adequate insertion and update of data into the database. This system focused on data from roadways, ramps, intersections, and traffic characteristics for Safety Analyst. To test the proposed system and tools, data from Clark County, which is the largest county in Nevada and includes the cities of Las Vegas, Henderson, Boulder City, and North Las Vegas, was used. The database and Safety Analyst together help identify the sites with the potential for safety improvements. Specifically, this study examined the results from two case studies. The first case study, which identified sites having a potential for safety improvements with respect to fatal and all injury crashes, included all roadway elements and used default and calibrated Safety Performance Functions (SPFs). The second case study identified sites having a potential for safety improvements with respect to fatal and all injury crashes, specifically regarding intersections; it used default and calibrated SPFs as well. Conclusions were developed for the calibration of safety performance functions and the classification of site subtypes. Guidelines were provided about the selection of a particular network screening type or performance measure for network screening. PMID:26167531

Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

NASA Technical Reports Server (NTRS)

1972-01-01

A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

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.

NASA Software Safety Standard

NASA Technical Reports Server (NTRS)

Rosenberg, Linda

1997-01-01

If software is a critical element in a safety critical system, it is imperative to implement a systematic approach to software safety as an integral part of the overall system safety programs. The NASA-STD-8719.13A, "NASA Software Safety Standard", describes the activities necessary to ensure that safety is designed into software that is acquired or developed by NASA, and that safety is maintained throughout the software life cycle. A PDF version, is available on the WWW from Lewis. A Guidebook that will assist in the implementation of the requirements in the Safety Standard is under development at the Lewis Research Center (LeRC). After completion, it will also be available on the WWW from Lewis.

78 FR 40443 - Submission for OMB Review; Comment Request-Recordkeeping Requirements Under the Safety Standard...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-05

... Request--Recordkeeping Requirements Under the Safety Standard for Infant Walkers AGENCY: Consumer Product... for infant walkers, 16 CFR part 1216. No comments were received in response to that notice. Therefore... has been incorporated by reference in the safety standard for infant walkers, 16 CFR part 1216...

46 CFR 53.05-1 - Safety valve requirements for steam boilers (modifies HG-400 and HG-401).

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Safety valve requirements for steam boilers (modifies HG-400 and HG-401). 53.05-1 Section 53.05-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Pressure Relieving Devices (Article 4) § 53.05-1 Safety valve requirements for steam boilers (modifies HG...

46 CFR 53.05-1 - Safety valve requirements for steam boilers (modifies HG-400 and HG-401).

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Safety valve requirements for steam boilers (modifies HG-400 and HG-401). 53.05-1 Section 53.05-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Pressure Relieving Devices (Article 4) § 53.05-1 Safety valve requirements for steam boilers (modifies HG...

46 CFR 53.05-1 - Safety valve requirements for steam boilers (modifies HG-400 and HG-401).

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Safety valve requirements for steam boilers (modifies HG-400 and HG-401). 53.05-1 Section 53.05-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Pressure Relieving Devices (Article 4) § 53.05-1 Safety valve requirements for steam boilers (modifies HG...

46 CFR 53.05-1 - Safety valve requirements for steam boilers (modifies HG-400 and HG-401).

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Safety valve requirements for steam boilers (modifies HG-400 and HG-401). 53.05-1 Section 53.05-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING HEATING BOILERS Pressure Relieving Devices (Article 4) § 53.05-1 Safety valve requirements for steam boilers (modifies HG...

30 CFR 250.405 - What are the safety requirements for diesel engines used on a drilling rig?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What are the safety requirements for diesel... are the safety requirements for diesel engines used on a drilling rig? You must equip each diesel engine with an air take device to shut down the diesel engine in the event of a runaway. (a) For a diesel...

Initial development of a practical safety audit tool to assess fleet safety management practices.

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Global road safety online course development.

DOT National Transportation Integrated Search

2017-06-01

The Global Road Safety Online Curriculum Development project involved the adaptation of in-person classroom materials and development of new materials to be used in an online setting. A short-course format was selected to pilot the course, and four t...

The First Development of Human Factors Engineering Requirements for Application to Ground Task Design for a NASA Flight Program

NASA Technical Reports Server (NTRS)

Dischinger, H. Charles, Jr.; Stambolian, Damon B.; Miller, Darcy H.

2008-01-01

The National Aeronautics and Space Administration has long applied standards-derived human engineering requirements to the development of hardware and software for use by astronauts while in flight. The most important source of these requirements has been NASA-STD-3000. While there have been several ground systems human engineering requirements documents, none has been applicable to the flight system as handled at NASA's launch facility at Kennedy Space Center. At the time of the development of previous human launch systems, there were other considerations that were deemed more important than developing worksites for ground crews; e.g., hardware development schedule and vehicle performance. However, experience with these systems has shown that failure to design for ground tasks has resulted in launch schedule delays, ground operations that are more costly than they might be, and threats to flight safety. As the Agency begins the development of new systems to return humans to the moon, the new Constellation Program is addressing this issue with a new set of human engineering requirements. Among these requirements is a subset that will apply to the design of the flight components and that is intended to assure ground crew success in vehicle assembly and maintenance tasks. These requirements address worksite design for usability and for ground crew safety.

24 CFR 3280.208 - Smoke alarm requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Smoke alarm requirements. 3280.208... URBAN DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.208 Smoke alarm requirements. Link to an amendment published at 78 FR 73982, Dec. 9, 2013. (a) Labeling. Each smoke alarm...

NASA Safety Manual. Volume 3: System Safety

NASA Technical Reports Server (NTRS)

1970-01-01

This Volume 3 of the NASA Safety Manual sets forth the basic elements and techniques for managing a system safety program and the technical methods recommended for use in developing a risk evaluation program that is oriented to the identification of hazards in aerospace hardware systems and the development of residual risk management information for the program manager that is based on the hazards identified. The methods and techniques described in this volume are in consonance with the requirements set forth in NHB 1700.1 (VI), Chapter 3. This volume and future volumes of the NASA Safety Manual shall not be rewritten, reprinted, or reproduced in any manner. Installation implementing procedures, if necessary, shall be inserted as page supplements in accordance with the provisions of Appendix A. No portion of this volume or future volumes of the NASA Safety Manual shall be invoked in contracts.

Overview of Energy Systems' safety analysis report programs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

30 CFR 250.459 - What are the safety requirements for drilling fluid-handling areas?

Code of Federal Regulations, 2011 CFR

2011-07-01

..., REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Drilling Fluid Requirements § 250.459 What are... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What are the safety requirements for drilling...

Federal motor carrier safety administration safety 2010 strategy and performance planning : project description

DOT National Transportation Integrated Search

2000-12-01

The Motor Carrier Safety Improvement Act (MCSIA) of 1999, Pub. L. 106-159, created the Federal Motor Carrier Safety Administration (FMCSA) in January 2000. Section 104 of the Act requires the Secretary to develop a long-term strategy for improving co...

78 FR 47015 - Software Requirement Specifications for Digital Computer Software Used in Safety Systems of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Requirement Specifications for Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission... issuing a revised regulatory guide (RG), revision 1 of RG 1.172, ``Software Requirement Specifications for...

Improved processes for meeting the data requirements for implementing the Highway Safety Manual (HSM) and Safety Analyst in Florida : [summary].

DOT National Transportation Integrated Search

2014-03-01

Similar to an ill patient, road safety issues can : also be diagnosed, if the right tools are available. : Statistics on roadway incidents can locate areas : that have a high rate of incidents and require : a solution, such as better signage, lightin...

Software safety

NASA Technical Reports Server (NTRS)

Leveson, Nancy

1987-01-01

Software safety and its relationship to other qualities are discussed. It is shown that standard reliability and fault tolerance techniques will not solve the safety problem for the present. A new attitude requires: looking at what you do NOT want software to do along with what you want it to do; and assuming things will go wrong. New procedures and changes to entire software development process are necessary: special software safety analysis techniques are needed; and design techniques, especially eliminating complexity, can be very helpful.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

[Storage of plant protection products in farms: minimum safety requirements].

PubMed

Dutto, Moreno; Alfonzo, Santo; Rubbiani, Maristella

2012-01-01

Failure to comply with requirements for proper storage and use of pesticides in farms can be extremely hazardous and the risk of accidents involving farm workers, other persons and even animals is high. There are still wide differences in the interpretation of the concept of "securing or making safe", by workers in this sector. One of the critical points detected, particularly in the fruit sector, is the establishment of an adequate storage site for plant protection products. The definition of "safe storage of pesticides" is still unclear despite the recent enactment of Legislative Decree 81/2008 regulating health and work safety in Italy. In addition, there are no national guidelines setting clear minimum criteria for storage of plant protection products in farms. The authors, on the basis of their professional experience and through analysis of recent legislation, establish certain minimum safety standards for storage of pesticides in farms.

Development of a master file of essential highway safety planning and evaluation data.

DOT National Transportation Integrated Search

1978-01-01

The National Highway Traffic Safety Administration requires each state to file an Annual Highway Safety Work Program as a prerequisite for obtaining federal section 402 safety monies. However, the work program serves as more than a mechanism for obta...

Development of decision support tools to assess pedestrian and bicycle safety : development of safety performance functions : final report.

DOT National Transportation Integrated Search

2016-11-15

While a number of studies have developed Safety Performance Functions (SPFs) for : motorized traffic, there has been a very limited focus on developing SPFs for non-motorized : traffic. Lack of exposure measures for pedestrians and bicyclists has bee...

Safety in numbers: the development of Leapfrog's composite patient safety score for U.S. hospitals.

PubMed

Austin, J Matthew; D'Andrea, Guy; Birkmeyer, John D; Leape, Lucian L; Milstein, Arnold; Pronovost, Peter J; Romano, Patrick S; Singer, Sara J; Vogus, Timothy J; Wachter, Robert M

2014-03-01

To develop a composite patient safety score that provides patients, health-care providers, and health-care purchasers with a standardized method to evaluate patient safety in general acute care hospitals in the United States. The Leapfrog Group sought guidance from a panel of national patient safety experts to develop the composite score. Candidate patient safety performance measures for inclusion in the score were identified from publicly reported national sources. Hospital performance on each measure was converted into a "z-score" and then aggregated using measure-specific weights. A reference mean score was set at 3, with scores interpreted in terms of standard deviations above or below the mean, with above reflecting better than average performance. Twenty-six measures were included in the score. The mean composite score for 2652 general acute care hospitals in the United States was 2.97 (range by hospital, 0.46-3.94). Safety scores were slightly lower for hospitals that were publicly owned, rural in location, or had a larger percentage of patients with Medicaid as their primary insurance. The Leapfrog patient safety composite provides a standardized method to evaluate patient safety in general acute care hospitals in the United States. While constrained by available data and publicly reported scores on patient safety measures, the composite score reflects the best available evidence regarding a hospital's efforts and outcomes in patient safety. Additional analyses are needed, but the score did not seem to have a strong bias against hospitals with specific characteristics. The composite score will continue to be refined over time as measures of patient safety evolve.

47 CFR 5.311 - Additional requirements related to safety of the public.

Code of Federal Regulations, 2014 CFR

2014-10-01

... safety of the public. In addition to the notification requirements of § 5.309, for experiments that may... bands and geographic area as the planned experiment and, as appropriate, their end users; (b) Rapid identification, and elimination, of any harm the experiment may cause; and (c) Identifying an alternate means for...

47 CFR 5.311 - Additional requirements related to safety of the public.

Code of Federal Regulations, 2013 CFR

2013-10-01

... safety of the public. In addition to the notification requirements of § 5.309, for experiments that may... bands and geographic area as the planned experiment and, as appropriate, their end users; (b) Rapid identification, and elimination, of any harm the experiment may cause; and (c) Identifying an alternate means for...

Health and safety in clinical laboratories in developing countries: safety considerations.

PubMed

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

Developing an industry-oriented safety curriculum using the Delphi technique.

PubMed

Chen, Der-Fa; Wu, Tsung-Chih; Chen, Chi-Hsiang; Chang, Shu-Hsuan; Yao, Kai-Chao; Liao, Chin-Wen

2016-09-01

In this study, we examined the development of industry-oriented safety degree curricula at a college level. Based on a review of literature on the practices and study of the development of safety curricula, we classified occupational safety and health curricula into the following three domains: safety engineering, health engineering, and safety and health management. We invited 44 safety professionals to complete a four-round survey that was designed using a modified Delphi technique. We used Chi-square statistics to test the panel experts' consensus on the significance of the items in the three domains and employed descriptive statistics to rank the participants' rating of each item. The results showed that the top three items for each of the three domains were Risk Assessment, Dangerous Machinery and Equipment, and Fire and Explosion Prevention for safety engineering; Ergonomics, Industrial Toxicology, and Health Risk Assessment for health engineering; and Industrial Safety and Health Regulations, Accident Investigation and Analysis, and Emergency Response for safety and health management. Only graduates from safety programmes who possess practical industry-oriented abilities can satisfy industry demands and provide value to the existence of college safety programmes.

Curriculum Development and Implementation of a National Interprofessional Fellowship in Patient Safety.

PubMed

Watts, Bradley V; Williams, Linda; Mills, Peter D; Paull, Douglas E; Cully, Jeffrey A; Gilman, Stuart C; Hemphill, Robin R

2018-06-15

Developing a workforce skilled in improving the safety of medical care has often been cited as an important means to achieve safer care. Although some educational programs geared toward patient safety have been developed, few advanced training programs have been described in the literature. We describe the development of a patient safety fellowship program. We describe the development and curriculum of an Interprofessional Fellowship in Patient Safety. The 1-year in residence fellowship focuses on domains such as leadership, spreading innovations, medical improvement, patient safety culture, reliability science, and understanding errors. Specific training in patient safety is available and has been delivered to 48 fellows from a wide range of backgrounds. Fellows have accomplished much in terms of improvement projects, educational innovations, and publications. After completing the fellowship program, fellows are obtaining positions within health-care quality and safety and are likely to make long-term contributions. We offer a curriculum and fellowship design for the topic of patient safety. Available evidence suggests that the fellowship results in the development of patient safety professionals.

An interagency space nuclear propulsion safety policy for SEI - Issues and discussion

NASA Technical Reports Server (NTRS)

Marshall, A. C.; Sawyer, J. C., Jr.

1991-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of Safety Functional Requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top level safety requirements and guidelines to address these issues. Safety topics include reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations. In this paper the emphasis is placed on the safety policy and the issues and considerations that are addressed by the NSPWG recommendations.

DOE explosives safety manual

NASA Astrophysics Data System (ADS)

1990-05-01

The Department of Energy (DOE) policy requires that all activities be conducted in a manner that protects the safety of the public and provides a safe and healthful workplace for employees. DOE has also prescribed that all personnel be protected in any explosives operation undertaken. The level of safety provided shall be at least equivalent to that of the best industrial practice. The risk of death or serious injury shall be limited to the lowest practicable minimum. DOE and contractors shall continually review their explosives operations with the aim of achieving further refinements and improvements in safety practices and protective features. This manual describes the Department's explosive safety requirements applicable to operations involving the development, testing, handling, and processing of explosives or assemblies containing explosives. It is intended to reflect the state-of-the-art in explosives safety. In addition, it is essential that applicable criteria and requirements for implementing this policy be readily available and known to those responsible for conducting DOE programs. This document shall be periodically reviewed and updated to establish new requirements as appropriate. Users are requested to submit suggestions for improving the DOE Explosives Safety Manual through their appropriate Operations Office to the Office of Quality Programs.

Evolution of area access safety training required for gaining access to Space Shuttle launch and landing facilities

NASA Technical Reports Server (NTRS)

Willams, M. C.

1985-01-01

Assuring personnel and equipment are fully protected during the Space Shuttle launch and landing operations has been a primary concern of NASA and its associated contractors since the inception of the program. A key factor in support of this policy has been the area access safety training requirements for badging of employees assigned to work on Space Shuttle Launch and Facilities. This requirement was targeted for possible cost savings and the transition of physical on-site walkdowns to the use of television tapes has realized program cost savings while continuing to fully satisfy the area access safety training requirements.

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

Transportation safety data and analysis : Volume 2, Calibration of the highway safety manual and development of new safety performance functions.

DOT National Transportation Integrated Search

2011-03-01

This report documents the calibration of the Highway Safety Manual (HSM) safety performance function (SPF) : for rural two-lane two-way roadway segments in Utah and the development of new models using negative : binomial and hierarchical Bayesian mod...

Explore The NASA Safety Center

NASA Image and Video Library

2015-07-01

The NASA Safety Center (NSC) reports to NASA’s Office of Safety and Mission Assurance and supports the Safety and Mission Assurance (SMA) requirements of NASA’s portfolio of programs and projects. The NSC focuses on development of the personnel, processes and tools needed for the safe and successful achievement of NASA’s strategic goals.

49 CFR 214.507 - Required safety equipment for new on-track roadway maintenance machines.

Code of Federal Regulations, 2010 CFR

2010-10-01

... windshield wipers are incompatible with the windshield material; (5) A machine braking system capable of... Roadway Maintenance Machines and Hi-Rail Vehicles § 214.507 Required safety equipment for new on-track...

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

Evaluation of Testing Methods to Develop Test Requirements for a Workstation Table Safety Standard

DOT National Transportation Integrated Search

2010-10-12

Investigations of passenger train accidents have revealed serious safety hazards associated with the thin, rigid tops of workstation tables, which are common fixtures aboard rail cars. Thoracic and abdominal injuries caused by occupant impact with wo...

Development of a safety management protocol.

DOT National Transportation Integrated Search

2008-09-01

The UC Berkeley Traffic Safety Center (TSC) has produced this report under a contract from the California Department of Transportation : (Caltrans). The aim is to address workplace injuries and accidents among Caltrans employees and develop recommend...

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

Microbiological food safety: a dilemma of developing societies.

PubMed

Akhtar, Saeed; Sarker, Mahfuzur R; Hossain, Ashfaque

2014-11-01

Current food safety issues are deleteriously reshaping the life style of the population in the developing world. Socioeconomic status of the population in poorer economies is one of the major determinants to delineate the availability of safe food to the vulnerable population. Assessment of the prevalence of foodborne illness in developing world is the most neglected area to control disease. Botulism, Shigellosis, Campylobacteriosis, Escherichia coli infection, Staphylococcus aureus infection, Salmonellosis, Listeriosis and Cholerae are extensively prevalent and pose a major threat to human health in underdeveloped communities. The existing food safety status of many African, South Asian, Central, and South American developing countries is distressing therefore; it seems much timely to highlight the areas for the improvement to ensure the supply of safe food to the population in these regions. Extensive literature search at PubMed, Science Direct and Medline was carried out during the current year to catch on relevant data from 1976 to date, using selective terms like food safety, South East Asia, Africa, Central and South America, and foodborne illness etc. Efforts were made to restrict the search to low income countries of these regions with reference to specific foodborne pathogens. This report briefly discusses the present food safety situation in these developing countries and associated consequences as prime issues, suggesting foodborne illness to be the most distressing threat for human health and economic growth.

Achieving compatibility of State and Federal safety requirements

DOT National Transportation Integrated Search

1990-08-01

The Commercial Motor Vehicle Safety Regulatory Review Panel (Safety Panel) has prepared this report in response to Sections 207, 208, and 209 of the Motor Carrier Safety Act of 1984 (Public Law 98-554). This report provides the Secretary of Transport...

76 FR 31351 - Safety Requirements and Manning Exemption Eligibility on Distant Water Tuna Fleet Vessels

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

...The Coast Guard announces the availability of Office of Vessel Activities Policy Letter 11-05 regarding Distant Water Tuna Fleet vessels manning exemption eligibility and safety requirements. This final policy clarifies the requirements to allow a distant water tuna fleet vessel to engage foreign citizens under a temporary manning exemption.

Safety assessment for EPS electron-proton spectrometer

NASA Technical Reports Server (NTRS)

Gleeson, P.

1971-01-01

A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

HSE's safety assessment principles for criticality safety.

PubMed

Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

2008-06-01

The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf).

Progress on the development of a master file of highway safety planning and evaluation data.

DOT National Transportation Integrated Search

1981-01-01

The National Highway Traffic Safety Administration requires each state to submit an annual Highway Safety Plan as a prerequisite for obtaining federal section 402 safety monies. The Highway Safety Plan serves as more than a mechanism for obtaining fu...

Developing Probabilistic Safety Performance Margins for Unknown and Underappreciated Risks

NASA Technical Reports Server (NTRS)

Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris

2015-01-01

Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.

30 CFR 250.405 - What are the safety requirements for diesel engines used on a drilling rig?

Code of Federal Regulations, 2012 CFR

2012-07-01

... engines used on a drilling rig? 250.405 Section 250.405 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.405 What are the safety...

30 CFR 250.405 - What are the safety requirements for diesel engines used on a drilling rig?

Code of Federal Regulations, 2014 CFR

2014-07-01

... engines used on a drilling rig? 250.405 Section 250.405 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.405 What are the safety...

30 CFR 250.405 - What are the safety requirements for diesel engines used on a drilling rig?

Code of Federal Regulations, 2013 CFR

2013-07-01

... engines used on a drilling rig? 250.405 Section 250.405 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.405 What are the safety...

Models Extracted from Text for System-Software Safety Analyses

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2010-01-01

This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

requirements. This allows the projects leeway to meet these requirements in many forms that best suit a particular project's needs and safety risk. In other words, it tells the project what to do, not how to do it. This update also incorporated advances in the state of the practice of software safety from academia and private industry. It addresses some of the more common issues now facing software developers in the NASA environment such as the use of Commercial-Off-the-Shelf Software (COTS), Modified OTS (MOTS), Government OTS (GOTS), and reused software. A team from across NASA developed the update and it has had both NASA-wide internal reviews by software engineering, quality, safety, and project management. It has also had expert external review. This presentation and paper will discuss the new NASA Software Safety Standard, its organization, and key features. It will start with a brief discussion of some NASA mission failures and incidents that had software as one of their root causes. It will then give a brief overview of the NASA Software Safety Process. This will include an overview of the key personnel responsibilities and functions that must be performed for safety-critical software.

Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

PubMed

Groves, Patricia S; Bunch, Jacinda L

2018-05-18

The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

Ares I-X Range Safety Analyses Overview

NASA Technical Reports Server (NTRS)

Starr, Brett R.; Gowan, John W., Jr.; Thompson, Brian G.; Tarpley, Ashley W.

2011-01-01

Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies.

PubMed

Kanesa-thasan, Niranjan; Shaw, Alan; Stoddard, Jeffrey J; Vernon, Thomas M

2011-05-01

Vaccine safety is increasingly a focus for the general public, health care providers, and vaccine manufacturers, because the efficacy of licensed vaccines is accepted as a given. Commitment to ensuring safety of all vaccines, including childhood vaccines, is addressed by the federal government, academia, and industry. Safety activities conducted by the vaccine research, development, and manufacturing companies occur at all stages of product development, from selection and formulation of candidate vaccines through postlicensure studies and surveillance of adverse-event reports. The contributions of multiple interacting functional groups are required to execute these tasks through the life cycle of a product. We describe here the safeguards used by vaccine manufacturers, including specific examples drawn from recent experience, and highlight some of the current challenges. Vaccine-risk communication becomes a critical area for partnership of vaccine companies with government, professional associations, and nonprofit advocacy groups to provide information on both benefits and risks of vaccines. The crucial role of the vaccine companies in ensuring the optimal vaccine-safety profile, often overlooked, will continue to grow with this dynamic arena.

Formal Foundations for Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2015-01-01

Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

49 CFR 236.1015 - PTC Safety Plan content requirements and PTC System Certification.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Administrator finds that the PTCSP and supporting documentation support a finding that the system complies with... additional requirements apply to: (1) Non-vital overlay. A PTC system proposed as an overlay on the existing... greater than the level of safety for the previous PTC systems. (2) Vital overlay. A PTC system proposed on...

49 CFR 236.1015 - PTC Safety Plan content requirements and PTC System Certification.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Administrator finds that the PTCSP and supporting documentation support a finding that the system complies with... additional requirements apply to: (1) Non-vital overlay. A PTC system proposed as an overlay on the existing... greater than the level of safety for the previous PTC systems. (2) Vital overlay. A PTC system proposed on...

49 CFR 236.1015 - PTC Safety Plan content requirements and PTC System Certification.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Administrator finds that the PTCSP and supporting documentation support a finding that the system complies with... additional requirements apply to: (1) Non-vital overlay. A PTC system proposed as an overlay on the existing... greater than the level of safety for the previous PTC systems. (2) Vital overlay. A PTC system proposed on...

Developing a Comprehensive Animal Care Occupational Health and Safety Program at a Land-Grant Institution.

PubMed

Goodly, Lyndon J; Jarrell, Vickie L; Miller, Monica A; Banks, Maureen C; Anderson, Thomas J; Branson, Katherine A; Woodward, Robert T; Peper, Randall L; Myers, Sara J

2016-01-01

The Public Health Service Policy on the Humane Care and Use of Laboratory Animals and sound ethical practices require institutions to provide safe working environments for personnel working with animals; this mandate is achieved in part by establishing an effective animal care Occupational Health and Safety Program (OHSP). Land-grant institutions often face unique organizational challenges in fulfilling this requirement. For example, responsibilities for providing health and safety programs often have historically been dispersed among many different divisions scattered around the campus. Here we describe how our institutional management personnel overcame organizational structure and cultural obstacles during the formation of a comprehensive campus-wide animal care OHSP. Steps toward establishing the animal care OHSP included assigning overall responsibility, identifying all stakeholders, creating a leadership group, and hiring a fulltime Animal Care OHSP Specialist. A web-based portal was developed, implemented, and refined over the past 7 y and reflected the unique organizational structures of the university and the needs of our research community. Through this web-based portal, hazards are identified, risks are assessed, and training is provided. The animal care OHSP now provides easy mandatory enrollment, supports timely feedback regarding hazards, and affords enrollees the opportunity to participate in voluntary medical surveillance. The future direction and development of the animal care OHSP will be based on the research trends of campus, identification of emerging health and safety hazards, and ongoing evaluation and refinement of the program.

Developing a Comprehensive Animal Care Occupational Health and Safety Program at a Land-Grant Institution

PubMed Central

Goodly, Lyndon J; Jarrell, Vickie L; Miller, Monica A; Banks, Maureen C; Anderson, Thomas J; Branson, Katherine A; Woodward, Robert T; Peper, Randall L; Myers, Sara J

2016-01-01

The Public Health Service Policy on the Humane Care and Use of Laboratory Animals and sound ethical practices require institutions to provide safe working environments for personnel working with animals; this mandate is achieved in part by establishing an effective animal care Occupational Health and Safety Program (OHSP). Land-grant institutions often face unique organizational challenges in fulfilling this requirement. For example, responsibilities for providing health and safety programs often have historically been dispersed among many different divisions scattered around the campus. Here we describe how our institutional management personnel overcame organizational structure and cultural obstacles during the formation of a comprehensive campus-wide animal care OHSP. Steps toward establishing the animal care OHSP included assigning overall responsibility, identifying all stakeholders, creating a leadership group, and hiring a fulltime Animal Care OHSP Specialist. A web-based portal was developed, implemented, and refined over the past 7 y and reflected the unique organizational structures of the university and the needs of our research community. Through this web-based portal, hazards are identified, risks are assessed, and training is provided. The animal care OHSP now provides easy mandatory enrollment, supports timely feedback regarding hazards, and affords enrollees the opportunity to participate in voluntary medical surveillance. The future direction and development of the animal care OHSP will be based on the research trends of campus, identification of emerging health and safety hazards, and ongoing evaluation and refinement of the program. PMID:26817980

Safety of High Speed Magnetic Levitation Transportation Systems - Comparison of U.S. and Foreign Safety Requirements for Application to U.S. Maglev Systems

DOT National Transportation Integrated Search

1993-09-01

This report presents the results of a systematic review of the safety requirements selected for the German Transrapid : electromagnetic (EMS) type maglev system to determine their applicability and completeness with respect to the : construction and ...

A comprehensive study on regulatory requirements for development and filing of generic drugs globally

PubMed Central

Handoo, Shweta; Arora, Vandana; Khera, Deepak; Nandi, Prafulla Kumar; Sahu, Susanta Kumar

2012-01-01

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. PMID:23373001

33 CFR 96.320 - What is involved to complete a safety management audit and when is it required to be completed?

Code of Federal Regulations, 2011 CFR

2011-07-01

... certificate or a Safety Management Certificate; (3) Periodic audits including— (i) An annual verification... safety management audit and when is it required to be completed? 96.320 Section 96.320 Navigation and... SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems Be...

46 CFR 109.103 - Requirements of the International Convention for Safety of Life at Sea, 1974.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Requirements of the International Convention for Safety of Life at Sea, 1974. 109.103 Section 109.103 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS General § 109.103 Requirements of the International...

46 CFR 109.103 - Requirements of the International Convention for Safety of Life at Sea, 1974.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Requirements of the International Convention for Safety of Life at Sea, 1974. 109.103 Section 109.103 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS General § 109.103 Requirements of the International...

46 CFR 109.103 - Requirements of the International Convention for Safety of Life at Sea, 1974.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 4 2013-10-01 2013-10-01 false Requirements of the International Convention for Safety of Life at Sea, 1974. 109.103 Section 109.103 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS General § 109.103 Requirements of the International...

46 CFR 109.103 - Requirements of the International Convention for Safety of Life at Sea, 1974.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Requirements of the International Convention for Safety of Life at Sea, 1974. 109.103 Section 109.103 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS General § 109.103 Requirements of the International...

46 CFR 109.103 - Requirements of the International Convention for Safety of Life at Sea, 1974.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 4 2011-10-01 2011-10-01 false Requirements of the International Convention for Safety of Life at Sea, 1974. 109.103 Section 109.103 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS General § 109.103 Requirements of the International...

The Development of Laboratory Safety Questionnaire for Middle School Science Teachers

ERIC Educational Resources Information Center

Akpullukcu, Simge; Cavas, Bulent

2017-01-01

The purpose of this paper is to develop a "valid and reliable laboratory safety questionnaire" which could be used to identify science teachers' understanding about laboratory safety issues during their science laboratory activities. The questionnaire was developed from a literature review and prior instruments developed on laboratory…

A conceptual framework to development of construction safety culture in Indonesia

NASA Astrophysics Data System (ADS)

Armyn Machfudiyanto, Rossy; Latief, Yusuf

2017-12-01

Working accidents in the construction industry are among the highest in the world, affecting the three levels of both macro (National) mezzo (Enterprise) and micro (Projects) that need to be integrated in building a safety culture. The purpose of this research is to develop a conceptual framework in improving safety culture in the construction industry in Indonesia. The methodology was developed using literature study and deductive analysis which then performed expert validation to ensure the concept developed. The result of this research is that policy and institution as input to build safety culture which need to be followed up with increasing of company maturity which have implication to safety performance and construction project performance.

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2014 CFR

2014-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2013 CFR

2013-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

Developing and Testing the Health Care Safety Hotline

PubMed Central

Schneider, Eric C.; Ridgely, M. Susan; Quigley, Denise D.; Hunter, Lauren E.; Leuschner, Kristin J.; Weingart, Saul N.; Weissman, Joel S.; Zimmer, Karen P.; Giannini, Robert C.

2017-01-01

Abstract This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers. PMID:28845353

12 CFR Appendix A to Part 1720 - Policy Guidance; Minimum Safety and Soundness Requirements

Code of Federal Regulations, 2010 CFR

2010-01-01

..., DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS SAFETY AND SOUNDNESS Pt. 1720, App. A... effectively and to model the effect of differing interest rate scenarios on the Enterprise's financial... are implemented effectively, and that the Enterprise's organization structure and assignment of...

Development of a Culturally Informed Child Safety Curriculum for American Indian Families.

PubMed

Berns, Ryan M; Tomayko, Emily J; Cronin, Kate A; Prince, Ronald J; Parker, Tassy; Adams, Alexandra K

2017-04-01

American Indian (AI) children are disproportionately affected by unintentional injuries, with injury mortality rates approximately 2.3 times higher than the combined rates for all children in the United States. Although multiple risk factors are known to contribute to these increased rates, a comprehensive, culturally informed curriculum that emphasizes child safety is lacking for this population. In response to this need, academic and tribal researchers, tribal community members, tribal wellness staff, and national child safety experts collaborated to develop a novel child safety curriculum. This paper describes its development and community delivery. We developed the safety curriculum as part of a larger randomized controlled trial known as Healthy Children, Strong Families 2 (HCSF2), a family-based intervention targeting obesity prevention in early childhood (2-5 years). During the development of the HCSF2 intervention, participating tribal communities expressed concern about randomizing enrolled families to a control group who would not receive an intervention. To address this concern and the significant disparities in injuries and unintentional death rates among AI children, we added an active control group (Safety Journey) that would utilize our safety curriculum. Satisfaction surveys administered at the 12-month time point of the intervention indicate 94% of participants (N = 196) were either satisfied or very satisfied with the child safety curriculum. The majority of participants (69%) reported spending more than 15 min with the curriculum materials each month, and 83% thought the child safety newsletters were either helpful or very helpful in making changes to improve their family's safety. These findings indicate these child safety materials have been well received by HCSF2 participants. The use of community-engaged approaches to develop this curriculum represents a model that could be adapted for other at-risk populations and serves as an initial

Scale development of safety management system evaluation for the airline industry.

PubMed

Chen, Ching-Fu; Chen, Shu-Chuan

2012-07-01

The airline industry relies on the implementation of Safety Management System (SMS) to integrate safety policies and augment safety performance at both organizational and individual levels. Although there are various degrees of SMS implementation in practice, a comprehensive scale measuring the essential dimensions of SMS is still lacking. This paper thus aims to develop an SMS measurement scale from the perspective of aviation experts and airline managers to evaluate the performance of company's safety management system, by adopting Schwab's (1980) three-stage scale development procedure. The results reveal a five-factor structure consisting of 23 items. The five factors include documentation and commands, safety promotion and training, executive management commitment, emergency preparedness and response plan and safety management policy. The implications of this SMS evaluation scale for practitioners and future research are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

Preliminary Assessment of Operational Hazards and Safety Requirements for Airborne Trajectory Management (ABTM) Roadmap Applications

NASA Technical Reports Server (NTRS)

Cotton, William B.; Hilb, Robert; Koczo, Stefan, Jr.; Wing, David J.

2016-01-01

A set of five developmental steps building from the NASA TASAR (Traffic Aware Strategic Aircrew Requests) concept are described, each providing incrementally more efficiency and capacity benefits to airspace system users and service providers, culminating in a Full Airborne Trajectory Management capability. For each of these steps, the incremental Operational Hazards and Safety Requirements are identified for later use in future formal safety assessments intended to lead to certification and operational approval of the equipment and the associated procedures. Two established safety assessment methodologies that are compliant with the FAA's Safety Management System were used leading to Failure Effects Classifications (FEC) for each of the steps. The most likely FEC for the first three steps, Basic TASAR, Digital TASAR, and 4D TASAR, is "No effect". For step four, Strategic Airborne Trajectory Management, the likely FEC is "Minor". For Full Airborne Trajectory Management (Step 5), the most likely FEC is "Major".

Study on development and application of platform with students' safety based on SOA

NASA Astrophysics Data System (ADS)

Jiang, Derong

2011-10-01

Students' safety management is a very important work, which is responsible for the entire school student security problems, student safety primarily prevent, only advance predict various of the imminent problems, to better protect their safety. The system mainly used on the development request the student safety management, safety evaluation, safety education, and etc, which are for daily management work completed for students in the security digital management. Development of the system can reduce the safety management for department working pressure, meanwhile, can reduce the labor force to use, accelerate query speed, strengthens the management, as well as the national various departments about the information step, making each management standardized. Therefore, developing a set of suitability and the populace, compatibly good system is very necessary.

An aspect-oriented approach for designing safety-critical systems

NASA Astrophysics Data System (ADS)

Petrov, Z.; Zaykov, P. G.; Cardoso, J. P.; Coutinho, J. G. F.; Diniz, P. C.; Luk, W.

The development of avionics systems is typically a tedious and cumbersome process. In addition to the required functions, developers must consider various and often conflicting non-functional requirements such as safety, performance, and energy efficiency. Certainly, an integrated approach with a seamless design flow that is capable of requirements modelling and supporting refinement down to an actual implementation in a traceable way, may lead to a significant acceleration of development cycles. This paper presents an aspect-oriented approach supported by a tool chain that deals with functional and non-functional requirements in an integrated manner. It also discusses how the approach can be applied to development of safety-critical systems and provides experimental results.

Mathematical modelling of active safety system functions as tools for development of driverless vehicles

NASA Astrophysics Data System (ADS)

Ryazantsev, V.; Mezentsev, N.; Zakharov, A.

2018-02-01

This paper is dedicated to a solution of the issue of synthesis of the vehicle longitudinal dynamics control functions (acceleration and deceleration control) based on the element base of the vehicle active safety system (ESP) - driverless vehicle development tool. This strategy helps to reduce time and complexity of integration of autonomous motion control systems (AMCS) into the vehicle architecture and allows direct control of actuators ensuring the longitudinal dynamics control, as well as reduction of time for calibration works. The “vehicle+wheel+road” longitudinal dynamics control is complicated due to the absence of the required prior information about the control object. Therefore, the control loop becomes an adaptive system, i.e. a self-adjusting monitoring system. Another difficulty is the driver’s perception of the longitudinal dynamics control process in terms of comfort. Traditionally, one doesn’t pay a lot of attention to this issue within active safety systems, and retention of vehicle steerability, controllability and stability in emergency situations are considered to be the quality criteria. This is mainly connected to its operational limits, since it is activated only in critical situations. However, implementation of the longitudinal dynamics control in the AMCS poses another challenge for the developers - providing the driver with comfortable vehicle movement during acceleration and deceleration - while the possible highest safety level in terms of the road grip is provided by the active safety system (ESP). The results of this research are: universal active safety system - AMCS interaction interface; block diagram for the vehicle longitudinal acceleration and deceleration control as one of the active safety system’s integrated functions; ideology of adaptive longitudinal dynamics control, which enables to realize the deceleration and acceleration requested by the AMCS; algorithms synthesised; analytical experiments proving the

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

PubMed

Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

2017-12-01

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Development and Implementation of a Food Safety Knowledge Instrument

ERIC Educational Resources Information Center

Byrd-Bredbenner, Carol; Wheatley, Virginia; Schaffner, Donald; Bruhn, Christine; Blalock, Lydia; Maurer, Jaclyn

2007-01-01

Little is known about the food safety knowledge of young adults. In addition, few knowledge questionnaires and no comprehensive, criterion-referenced measure that assesses the full range of food safety knowledge could be identified. Without appropriate, valid, and reliable measures and baseline data, it is difficult to develop and implement…

Understanding adolescent development: implications for driving safety.

PubMed

Keating, Daniel P

2007-01-01

The implementation of Graduated Driver Licensing (GDL) programs has significantly improved the crash and fatality rates of novice teen drivers, but these rates remain unacceptably high. A review of adolescent development research was undertaken to identify potential areas of improvement. Research support for GDL was found to be strong, particularly regarding early acquisition of expertise in driving safety (beyond driving skill), and to limitations that reduce opportunities for distraction. GDL regimes are highly variable, and no US jurisdictions have implemented optimal regimes. Expanding and improving GDL to enhance acquisition of expertise and self-regulation are indicated for implementation and for applied research. Driver training that effectively incorporates safety goals along with driving skill is another target. The insurance industry will benefit from further GDL enhancements. Benefits may accrue to improved driver training, improved simulation devices during training, and automated safety feedback instrumentation.

46 CFR 12.623 - Requirements to qualify for an STCW endorsement as Global Maritime Distress and Safety System...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 1 2014-10-01 2014-10-01 false Requirements to qualify for an STCW endorsement as Global Maritime Distress and Safety System (GMDSS) at-sea maintainer. 12.623 Section 12.623 Shipping... as Global Maritime Distress and Safety System (GMDSS) at-sea maintainer. To qualify for an STCW...

Research and development of a safety standard for workstation tables in the United States

DOT National Transportation Integrated Search

2013-02-21

The US safety standard for workstation tables is presented to an international audience, : such that rail operators and equipment manufacturers may better understand the research : behind the requirements, the process through which the safety standar...

Ares I-X Range Safety Flight Envelope Analysis

NASA Technical Reports Server (NTRS)

Starr, Brett R.; Olds, Aaron D.; Craig, Anthony S.

2011-01-01

Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

Development of a multilevel health and safety climate survey tool within a mining setting.

PubMed

Parker, Anthony W; Tones, Megan J; Ritchie, Gabrielle E

2017-09-01

This study aimed to design, implement and evaluate the reliability and validity of a multifactorial and multilevel health and safety climate survey (HSCS) tool with utility in the Australian mining setting. An 84-item questionnaire was developed and pilot tested on a sample of 302 Australian miners across two open cut sites. A 67-item, 10 factor solution was obtained via exploratory factor analysis (EFA) representing prioritization and attitudes to health and safety across multiple domains and organizational levels. Each factor demonstrated a high level of internal reliability, and a series of ANOVAs determined a high level of consistency in responses across the workforce, and generally irrespective of age, experience or job category. Participants tended to hold favorable views of occupational health and safety (OH&S) climate at the management, supervisor, workgroup and individual level. The survey tool demonstrated reliability and validity for use within an open cut Australian mining setting and supports a multilevel, industry specific approach to OH&S climate. Findings suggested a need for mining companies to maintain high OH&S standards to minimize risks to employee health and safety. Future research is required to determine the ability of this measure to predict OH&S outcomes and its utility within other mine settings. As this tool integrates health and safety, it may have benefits for assessment, monitoring and evaluation in the industry, and improving the understanding of how health and safety climate interact at multiple levels to influence OH&S outcomes. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

RDS - A systematic approach towards system thermal hydraulics input code development for a comprehensive deterministic safety analysis

NASA Astrophysics Data System (ADS)

Salim, Mohd Faiz; Roslan, Ridha; Ibrahim, Mohd Rizal Mamat @

2014-02-01

Deterministic Safety Analysis (DSA) is one of the mandatory requirements conducted for Nuclear Power Plant licensing process, with the aim of ensuring safety compliance with relevant regulatory acceptance criteria. DSA is a technique whereby a set of conservative deterministic rules and requirements are applied for the design and operation of facilities or activities. Computer codes are normally used to assist in performing all required analysis under DSA. To ensure a comprehensive analysis, the conduct of DSA should follow a systematic approach. One of the methodologies proposed is the Standardized and Consolidated Reference Experimental (and Calculated) Database (SCRED) developed by University of Pisa. Based on this methodology, the use of Reference Data Set (RDS) as a pre-requisite reference document for developing input nodalization was proposed. This paper shall describe the application of RDS with the purpose of assessing its effectiveness. Two RDS documents were developed for an Integral Test Facility of LOBI-MOD2 and associated Test A1-83. Data and information from various reports and drawings were referred in preparing the RDS. The results showed that by developing RDS, it has made possible to consolidate all relevant information in one single document. This is beneficial as it enables preservation of information, promotes quality assurance, allows traceability, facilitates continuous improvement, promotes solving of contradictions and finally assisting in developing thermal hydraulic input regardless of whichever code selected. However, some disadvantages were also recognized such as the need for experience in making engineering judgments, language barrier in accessing foreign information and limitation of resources. Some possible improvements are suggested to overcome these challenges.

Development and validation of a remote home safety protocol.

PubMed

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

Development and Validation of a Safety Climate Scale for Manufacturing Industry

PubMed Central

Ghahramani, Abolfazl; Khalkhali, Hamid R.

2015-01-01

Background This paper describes the development of a scale for measuring safety climate. Methods This study was conducted in six manufacturing companies in Iran. The scale developed through conducting a literature review about the safety climate and constructing a question pool. The number of items was reduced to 71 after performing a screening process. Results The result of content validity analysis showed that 59 items had excellent item content validity index (≥ 0.78) and content validity ratio (> 0.38). The exploratory factor analysis resulted in eight safety climate dimensions. The reliability value for the final 45-item scale was 0.96. The result of confirmatory factor analysis showed that the safety climate model is satisfactory. Conclusion This study produced a valid and reliable scale for measuring safety climate in manufacturing companies. PMID:26106508

2005 Donor Eligibility Requirements: Unintended Consequences for Stem Cell Development.

PubMed

Couture, Larry A; Carpenter, Melissa K

2015-10-01

Several human embryonic stem cell (hESC)-derived cell therapeutics have entered clinical testing and more are in various stages of preclinical development. The U.S. Food and Drug Administration (FDA) regulates these products under existing regulations and has stated that these products do not constitute a new class of biologic. However, as human tissue, hESCs are subject to regulations that were developed before hESCs were first described. The regulations have not been revised since 2005, well before the first hESC-derived product entered clinical studies. The current regulations require donors of hESCs to be tested in the same manner as donors of tissues intended for transplantation. However, because hESC-derived cell products are more than minimally manipulated, they are also subject to the same end-of-production release testing as most other biologic agents. In effect, this makes hESC products subject to redundant testing. No other biologic is subject to a similar testing requirement. Furthermore, the regulations that require donor testing are specifically applicable to hESC cells harvested from donors after a date in 2005. It is unclear which regulations cover hESCs harvested before 2005. Ambiguity in the guidelines and redundant testing requirements have unintentionally created a burdensome regulatory paradigm for these products and reluctance on the part of developers to invest in these promising therapeutics. We propose a simple solution that would address FDA safety concerns, eliminate regulatory uncertainty and risk, and provide flexibility for the FDA in the regulation of hESC-derived cell therapies. Regulatory ambiguity concerning donor eligibility screening and testing requirements for human embryonic stem cell lines, in particular those lines created before 2005, are causing significant concern for drug developers. Technically, most of these lines fail to meet eligibility under U.S. Food and Drug Administration (FDA) rules for product licensure, and

Person-centered endoscopy safety checklist: Development, implementation, and evaluation

PubMed Central

Dubois, Hanna; Schmidt, Peter T; Creutzfeldt, Johan; Bergenmar, Mia

2017-01-01

AIM To describe the development and implementation of a person-centered endoscopy safety checklist and to evaluate the effects of a “checklist intervention”. METHODS The checklist, based on previously published safety checklists, was developed and locally adapted, taking patient safety aspects into consideration and using a person-centered approach. This novel checklist was introduced to the staff of an endoscopy unit at a Stockholm University Hospital during half-day seminars and team training sessions. Structured observations of the endoscopy team’s performance were conducted before and after the introduction of the checklist. In addition, questionnaires focusing on patient participation, collaboration climate, and patient safety issues were collected from patients and staff. RESULTS A person-centered safety checklist was developed and introduced by a multi-professional group in the endoscopy unit. A statistically significant increase in accurate patient identity verification by the physicians was noted (from 0% at baseline to 87% after 10 mo, P < 0.001), and remained high among nurses (93% at baseline vs 96% after 10 mo, P = nonsignificant). Observations indicated that the professional staff made frequent attempts to use the checklist, but compliance was suboptimal: All items in the observed nurse-led “summaries” were included in 56% of these interactions, and physicians participated by directly facing the patient in 50% of the interactions. On the questionnaires administered to the staff, items regarding collaboration and the importance of patient participation were rated more highly after the introduction of the checklist, but this did not result in statistical significance (P = 0.07/P = 0.08). The patients rated almost all items as very high both before and after the introduction of the checklist; hence, no statistical difference was noted. CONCLUSION The intervention led to increased patient identity verification by physicians - a patient safety

Development of an evaluation framework for African-European hospital patient safety partnerships.

PubMed

Rutter, Paul; Syed, Shamsuzzoha B; Storr, Julie; Hightower, Joyce D; Bagheri-Nejad, Sepideh; Kelley, Edward; Pittet, Didier

2014-04-01

Patient safety is recognised as a significant healthcare problem worldwide, and healthcare-associated infections are an important aspect. African Partnerships for Patient Safety is a WHO programme that pairs hospitals in Africa with hospitals in Europe with the objective to work together to improve patient safety. To describe the development of an evaluation framework for hospital-to-hospital partnerships participating in the programme. The framework was structured around the programme's three core objectives: facilitate strong interhospital partnerships, improve in-hospital patient safety and spread best practices nationally. Africa-based clinicians, their European partners and experts in patient safety were closely involved in developing the evaluation framework in an iterative process. The process defined six domains of partnership strength, each with measurable subdomains. We developed a questionnaire to measure these subdomains. Participants selected six indicators of hospital patient safety improvement from a short-list of 22 based on their relevance, sensitivity to intervention and measurement feasibility. Participants proposed 20 measures of spread, which were refined into a two-part conceptual framework, and a data capture tool created. Taking a highly participatory approach that closely involved its end users, we developed an evaluation framework and tools to measure partnership strength, patient safety improvements and the spread of best practice.

[Patient safety in education and training of healthcare professionals in Germany].

PubMed

Hoffmann, Barbara; Siebert, H; Euteneier, A

2015-01-01

In order to improve patient safety, healthcare professionals who care for patients directly or indirectly are required to possess specific knowledge and skills. Patient safety education is not or only poorly represented in education and examination regulations of healthcare professionals in Germany; therefore, it is only practiced rarely and on a voluntary basis. Meanwhile, several training curricula and concepts have been developed in the past 10 years internationally and recently in Germany, too. Based on these concepts the German Coalition for Patient Safety developed a catalogue of core competencies required for safety in patient care. This catalogue will serve as an important orientation when patient safety is to be implemented as a subject of professional education in Germany in the future. Moreover, teaching staff has to be trained and educational and training activities have to be evaluated. Patient safety education and training for (undergraduate) healthcare professional will require capital investment.

Advancing a sociotechnical systems approach to workplace safety--developing the conceptual framework.

PubMed

Carayon, Pascale; Hancock, Peter; Leveson, Nancy; Noy, Ian; Sznelwar, Laerte; van Hootegem, Geert

2015-01-01

Traditional efforts to deal with the enormous problem of workplace safety have proved insufficient, as they have tended to neglect the broader sociotechnical environment that surrounds workers. Here, we advocate a sociotechnical systems approach that describes the complex multi-level system factors that contribute to workplace safety. From the literature on sociotechnical systems, complex systems and safety, we develop a sociotechnical model of workplace safety with concentric layers of the work system, socio-organisational context and the external environment. The future challenges that are identified through the model are highlighted. Understanding the environmental, organisational and work system factors that contribute to workplace safety will help to develop more effective and integrated solutions to deal with persistent workplace safety problems. Solutions to improve workplace safety need to recognise the broad sociotechnical system and the respective interactions between the system elements and levels.

Transit safety retrofit package development : final report.

DOT National Transportation Integrated Search

2014-07-01

This report provides a summary of the Transit Safety Retrofit Package (TRP) Development project and its results. The report documents results of each project phase, and provides recommended next steps as well as a vision for a next generation TRP. Th...

Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

PubMed

Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

2018-01-01

Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

The impact of nursing leadership on patient safety in a developing country.

PubMed

Stewart, Lee; Usher, Kim

2010-11-01

This article is a report of a study to identify the ways nursing leaders and managers in a developing country have an impact on patient safety. The attempt to address the problem of patient safety in health care is a global issue. Literature addressing the significant impact that nursing leadership has on patient safety is extensive and focuses almost exclusively on the developed world. A critical ethnography was conducted with senior registered nursing leaders and managers throughout the Fiji Islands, specifically those in the Head Office of the Fiji Ministry of Health and the most senior nurse in a hospital or community health service. Semi-structured interviews were conducted with senior nursing leaders and managers in Fiji. Thematic analysis of the interviews was undertaken from a critical theory perspective, with reference to the macro socio-political system of the Fiji Ministry of Health. Four interrelated issues regarding the nursing leaders and managers' impact on patient safety emerged from the study. Empowerment of nursing leaders and managers, an increased focus on the patient, the necessity to explore conditions for front-line nurses and the direct relationship between improved nursing conditions and increased patient safety mirrored literature from developed countries. The findings have significant implications for developing countries and it is crucial that support for patient safety in developing countries become a focus for the international nursing community. Nursing leaders and managers' increased focus on their own place in the hierarchy of the health care system and on nursing conditions as these affect patient safety could decrease adverse patient outcomes. The findings could assist the global nursing community to better support developing countries in pursuing a patient safety agenda. © 2010 Blackwell Publishing Ltd.

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Developing patient safety in dentistry.

PubMed

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

Latest developments in cryogenic safety

NASA Astrophysics Data System (ADS)

Webster, T.

1982-05-01

The Cryogenic Safety Manual, published under the auspices of the British Cryogenics Council, is summarized. Since an awareness of the physical properties of the cryogenic fluids being dealt with is considered important in directing attention to hazardous situations which may arise, the manual lists the more important properties, such as molecular weight, boiling point, and freezing point. Since hydrogen and helium are very light, the possibility arises of explosive mixtures being formed at high points in buildings. Since argon is unexpectedly heavy, its removal requires suction rather than blowing. It is also pointed out that the use of inert liquid nitrogen can lead to the creation of a noninert atmosphere which supports combustion because it contains oxygen. Attention is also given to the danger of asphyxiation posed by the growing use of inert gases.

Technology Development for Fire Safety in Exploration Spacecraft and Habitats

NASA Technical Reports Server (NTRS)

Ruff, Gary A.; Urban, David L.

2007-01-01

Fire during an exploration mission far from Earth is a particularly critical risk for exploration vehicles and habitats. The Fire Prevention, Detection, and Suppression (FPDS) project is part of the Exploration Technology Development Program (ETDP) and has the goal to enhance crew health and safety on exploration missions by reducing the likelihood of a fire, or, if one does occur, minimizing the risk to the mission, crew, or system. Within the past year, the FPDS project has been formalized within the ETDP structure and has seen significant progress on its tasks in fire prevention, detection, and suppression. As requirements for Constellation vehicles and, specifically, the CEV have developed, the need for the FPDS technologies has become more apparent and we continue to make strides to infuse them into the Constellation architecture. This paper describes the current structure of the project within the ETDP and summarizes the significant programmatic activities. Major technical accomplishments are identified as are activities planned for FY07.

Technology Development for Fire Safety in Exploration Spacecraft and Habitats

NASA Technical Reports Server (NTRS)

Ruff, Gary A.; Urban, David L.

2006-01-01

Fire during an exploration mission far from Earth is a particularly critical risk for exploration vehicles and habitats. The Fire Prevention, Detection, and Suppression (FPDS) project is part of the Exploration Technology Development Program (ETDP) and has the goal to enhance crew health and safety on exploration missions by reducing the likelihood of a fire, or, if one does occur, minimizing the risk to the mission, crew, or system. Within the past year, the FPDS project has been formalized within the ETDP structure and has seen significant progress on its tasks in fire prevention, detection, and suppression. As requirements for Constellation vehicles and, specifically, the CEV have developed, the need for the FPDS technologies has become more apparent and we continue to make strides to infuse them into the Constellation architecture. This paper describes the current structure of the project within the ETDP and summarizes the significant programmatic activities. Major technical accomplishments are identified as are activities planned for FY07.

78 FR 54727 - Reports, Forms, and Record Keeping Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

... age school children in developing age appropriate traffic safety knowledge and practical pedestrian... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [U.S. DOT Docket No. NHTSA-2013-0087] Reports, Forms, and Record Keeping Requirements AGENCY: National Highway Traffic Safety...

Design of a Conceptual Bumper Energy Absorber Coupling Pedestrian Safety and Low-Speed Impact Requirements

PubMed Central

Mo, Fuhao; Zhao, Siqi; Yu, Chuanhui; Duan, Shuyong

2018-01-01

The car front bumper system needs to meet the requirements of both pedestrian safety and low-speed impact which are somewhat contradicting. This study aims to design a new kind of modular self-adaptive energy absorber of the front bumper system which can balance the two performances. The X-shaped energy-absorbing structure was proposed which can enhance the energy absorption capacity during impact by changing its deformation mode based on the amount of external collision energy. Then, finite element simulations with a realistic vehicle bumper system are performed to demonstrate its crashworthiness in comparison with the traditional foam energy absorber, which presents a significant improvement of the two performances. Furthermore, the structural parameters of the X-shaped energy-absorbing structure including thickness (t u), side arc radius (R), and clamping boost beam thickness (t b) are analyzed using a full factorial method, and a multiobjective optimization is implemented regarding evaluation indexes of both pedestrian safety and low-speed impact. The optimal parameters are then verified, and the feasibility of the optimal results is confirmed. In conclusion, the new X-shaped energy absorber can meet both pedestrian safety and low-speed impact requirements well by altering the main deformation modes according to different impact energy levels. PMID:29581728

Design of a Conceptual Bumper Energy Absorber Coupling Pedestrian Safety and Low-Speed Impact Requirements.

PubMed

Mo, Fuhao; Zhao, Siqi; Yu, Chuanhui; Xiao, Zhi; Duan, Shuyong

2018-01-01

The car front bumper system needs to meet the requirements of both pedestrian safety and low-speed impact which are somewhat contradicting. This study aims to design a new kind of modular self-adaptive energy absorber of the front bumper system which can balance the two performances. The X-shaped energy-absorbing structure was proposed which can enhance the energy absorption capacity during impact by changing its deformation mode based on the amount of external collision energy. Then, finite element simulations with a realistic vehicle bumper system are performed to demonstrate its crashworthiness in comparison with the traditional foam energy absorber, which presents a significant improvement of the two performances. Furthermore, the structural parameters of the X-shaped energy-absorbing structure including thickness ( t u ), side arc radius ( R ), and clamping boost beam thickness ( t b ) are analyzed using a full factorial method, and a multiobjective optimization is implemented regarding evaluation indexes of both pedestrian safety and low-speed impact. The optimal parameters are then verified, and the feasibility of the optimal results is confirmed. In conclusion, the new X-shaped energy absorber can meet both pedestrian safety and low-speed impact requirements well by altering the main deformation modes according to different impact energy levels.

Protect Their Eyes: An Eye Safety Guide for the Classroom.

ERIC Educational Resources Information Center

Ohio Society to Prevent Blindness, Columbus.

This guide provides information on eye safety and aids educators, administrators, and supervisors in the development and implementation of eye safety programs. The American National Standards Institute (AMSI) requirements for both street and safety glasses; essential eyewear for safety in hazardous areas; the National Society to Prevent…

Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

DOT National Transportation Integrated Search

1995-01-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

Regulatory and Safety Requirements for Food Cultures

PubMed Central

Laulund, Svend; Wind, Anette; Derkx, Patrick M. F.; Zuliani, Véronique

2017-01-01

The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product. PMID:28545249

Workforce perceptions of hospital safety culture: development and validation of the patient safety climate in healthcare organizations survey.

PubMed

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-10-01

To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's alpha coefficients ranged from 0.50 to 0.89. It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes.

2011 Annual Criticality Safety Program Performance Summary

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andrea Hoffman

Criticality Safety Program. No new source requirements were released in 2011. A revision to LRD-18001 is planned for 2012 to clarify design requirements for criticality alarms. Training - Criticality Safety Engineering has developed training and provides training for many employee positions, including fissionable material handlers, facility managers, criticality safety officers, firefighters, and criticality safety engineers. Criticality safety training at the INL is a program strength. A revision to the training module developed in 2010 to supplement MFC certified fissionable material handlers (operators) training was prepared and presented in August of 2011. This training, 'Applied Science of Criticality Safety,' builds upon existing training and gives operators a better understanding of how their criticality controls are derived. Improvements to 00INL189, 'INL Criticality Safety Principles' are planned for 2012 to strengthen fissionable material handler training.« less

Development and initial validation of an Aviation Safety Climate Scale.

PubMed

Evans, Bronwyn; Glendon, A Ian; Creed, Peter A

2007-01-01

A need was identified for a consistent set of safety climate factors to provide a basis for aviation industry benchmarking. Six broad safety climate themes were identified from the literature and consultations with industry safety experts. Items representing each of the themes were prepared and administered to 940 Australian commercial pilots. Data from half of the sample (N=468) were used in an exploratory factor analysis that produced a 3-factor model of Management commitment and communication, Safety training and equipment, and Maintenance. A confirmatory factor analysis on the remaining half of the sample showed the 3-factor model to be an adequate fit to the data. The results of this study have produced a scale of safety climate for aviation that is both reliable and valid. This study developed a tool to assess the level of perceived safety climate, specifically of pilots, but may also, with minor modifications, be used to assess other groups' perceptions of safety climate.

Challenges in Developing Competency-based Training Curriculum for Food Safety Regulators in India.

PubMed

Thippaiah, Anitha; Allagh, Komal Preet; Murthy, G V

2014-07-01

The Food Safety and Standards Act have redefined the roles and responsibilities of food regulatory workforce and calls for highly skilled human resources as it involves complex management procedures. 1) Identify the competencies needed among the food regulatory workforce in India. 2) Develop a competency-based training curriculum for food safety regulators in the country. 3) Develop training materials for use to train the food regulatory workforce. The Indian Institute of Public Health, Hyderabad, led the development of training curriculum on food safety with technical assistance from the Royal Society for Public Health, UK and the National Institute of Nutrition, India. The exercise was to facilitate the implementation of new Act by undertaking capacity building through a comprehensive training program. A competency-based training needs assessment was conducted before undertaking the development of the training materials. THE TRAINING PROGRAM FOR FOOD SAFETY OFFICERS WAS DESIGNED TO COMPRISE OF FIVE MODULES TO INCLUDE: Food science and technology, Food safety management systems, Food safety legislation, Enforcement of food safety regulations, and Administrative functions. Each module has a facilitator guide for the tutor and a handbook for the participant. Essentials of Food Hygiene-I (Basic level), II and III (Retail/ Catering/ Manufacturing) were primarily designed for training of food handlers and are part of essential reading for food safety regulators. The Food Safety and Standards Act calls for highly skilled human resources as it involves complex management procedures. Despite having developed a comprehensive competency-based training curriculum by joint efforts by the local, national, and international agencies, implementation remains a challenge in resource-limited setting.

33 CFR 96.320 - What is involved to complete a safety management audit and when is it required to be completed?

Code of Federal Regulations, 2010 CFR

2010-07-01

... up the safety management system. (c) Actions required during safety management audits for a company... management system, as defined in subpart B of this part. (2) Make sure the audit complies with this subpart... safety management system is found during an audit, it must be reported in writing by the auditor: (1) For...

Spacecraft fire-safety experiments for space station: Technology development mission

NASA Technical Reports Server (NTRS)

Youngblood, Wallace W.

1988-01-01

Three concept designs for low-gravity, fire-safety related experiments are presented, as selected for the purpose of addressing key issues of enhancing safety and yet encouraging access to long-duration, manned spacecraft such as the NASA space station. The selected low-gravity experiments are the following: (1) an investigation of the flame-spread rate and combustion-product evolution of the burning of typical thicknesses of spacecraft materials in very low-speed flows; (2) an evaluation of the interaction of fires and candidate extinguishers in various fire scenarios; and (3) an investigation of the persistence and propagation of smoldering and deep-seated combustion. Each experiment is expected to provide fundamental combustion-science data, as well as the fire-safety applications, and each requires the unique long-duration, low-gravity environment of the space station. Two generic test facilities, i.e., the Combustion Tunnel Facility and the Combustion Facility, are proposed for space station accommodation to support the selected experiments. In addition, three near-term, fire-safety related experiments are described along with other related precursor activities.

Development of a nursing handoff tool: a web-based application to enhance patient safety.

PubMed

Goldsmith, Denise; Boomhower, Marc; Lancaster, Diane R; Antonelli, Mary; Kenyon, Mary Anne Murphy; Benoit, Angela; Chang, Frank; Dykes, Patricia C

2010-11-13

Dynamic and complex clinical environments present many challenges for effective communication among health care providers. The omission of accurate, timely, easily accessible vital information by health care providers significantly increases risk of patient harm and can have devastating consequences for patient care. An effective nursing handoff supports the standardized transfer of accurate, timely, critical patient information, as well as continuity of care and treatment, resulting in enhanced patient safety. The Brigham and Women's/Faulkner Hospital Healthcare Information Technology Innovation Program (HIP) is supporting the development of a web based nursing handoff tool (NHT). The goal of this project is to develop a "proof of concept" handoff application to be evaluated by nurses on the inpatient intermediate care units. The handoff tool would enable nurses to use existing knowledge of evidence-based handoff methodology in their everyday practice to improve patient care and safety. In this paper, we discuss the results of nursing focus groups designed to identify the current state of handoff practice as well as the functional and data element requirements of a web based Nursing Handoff Tool (NHT).

Fire safety

Treesearch

Robert H. White; Mark A. Dietenberger

1999-01-01

Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Since basic data on fire behavior of wood products...

The method to divide a sentence of requirement into individual requirements and the development of requirement specification editor which can describe individual requirements.

PubMed

Sato, Kuniya; Ooba, Masahiro; Takagi, Tomohiko; Furukawa, Zengo; Komiya, Seiichi; Yaegashi, Rihito

2013-12-01

Agile software development gains requirements from the direct discussion with customers and the development staff each time, and the customers evaluate the appropriateness of the requirement. If the customers divide the complicated requirement into individual requirements, the engineer who is in charge of software development can understand it easily. This is called division of requirement. However, the customers do not understand how much and how to divide the requirements. This paper proposes the method to divide a complicated requirement into individual requirements. Also, it shows the development of requirement specification editor which can describe individual requirements. The engineer who is in charge of software development can understand requirements easily.

Development of instruction in hospital electrical safety for medical education.

PubMed

Yoo, J H; Broderick, W A

1978-01-01

Although hospital electrical safety is receiving increased attention in the literature of engineers, it is not, at present, reflected in the curricula of medical schools. A possible reason for this omission is that biomedical and/or clinical engineers knowledgeable in electrical safety are not usually trained to teach. One remedy for this problem is to combine the knowledge of engineers with that of instructional developers to design a systematic curriculum for a course in hospital electrical safety. This paper describes such an effort at the University of Texas Health Science Center at San Antonio (UTHSCSA). A biomedical engineer and an instructional developer designed an instructional module in hospital electrical safety; the engineer taught the module, and both evaluated the results. The process and outcome of their collaboration are described. This model was effectively applied in the classroom as a four-hour segment in hospital electrical safety for first-year medical students at UTHSCSA. It is hoped that an additional benefit of this system will be that it offers an opportunity for continuing improvement in this kind of instruction at other medical schools and hospitals.

Structural Design Requirements and Factors of Safety for Spaceflight Hardware: For Human Spaceflight. Revision A

NASA Technical Reports Server (NTRS)

Bernstein, Karen S.; Kujala, Rod; Fogt, Vince; Romine, Paul

2011-01-01

This document establishes the structural requirements for human-rated spaceflight hardware including launch vehicles, spacecraft and payloads. These requirements are applicable to Government Furnished Equipment activities as well as all related contractor, subcontractor and commercial efforts. These requirements are not imposed on systems other than human-rated spacecraft, such as ground test articles, but may be tailored for use in specific cases where it is prudent to do so such as for personnel safety or when assets are at risk. The requirements in this document are focused on design rather than verification. Implementation of the requirements is expected to be described in a Structural Verification Plan (SVP), which should describe the verification of each structural item for the applicable requirements. The SVP may also document unique verifications that meet or exceed these requirements with NASA Technical Authority approval.

NASA safety program activities in support of the Space Exploration Initiatives Nuclear Propulsion program

NASA Technical Reports Server (NTRS)

Sawyer, J. C., Jr.

1993-01-01

The activities of the joint NASA/DOE/DOD Nuclear Propulsion Program Technical Panels have been used as the basis for the current development of safety policies and requirements for the Space Exploration Initiatives (SEI) Nuclear Propulsion Technology development program. The Safety Division of the NASA Office of Safety and Mission Quality has initiated efforts to develop policies for the safe use of nuclear propulsion in space through involvement in the joint agency Nuclear Safety Policy Working Group (NSPWG), encouraged expansion of the initial policy development into proposed programmatic requirements, and suggested further expansion into the overall risk assessment and risk management process for the NASA Exploration Program. Similar efforts are underway within the Department of Energy to ensure the safe development and testing of nuclear propulsion systems on Earth. This paper describes the NASA safety policy related to requirements for the design of systems that may operate where Earth re-entry is a possibility. The expected plan of action is to support and oversee activities related to the technology development of nuclear propulsion in space, and support the overall safety and risk management program being developed for the NASA Exploration Program.

Automating the Generation of Heterogeneous Aviation Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

2012-01-01

A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

Health, Safety, and Environment Division

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wade, C

1992-01-01

The primary responsibility of the Health, Safety, and Environmental (HSE) Division at the Los Alamos National Laboratory is to provide comprehensive occupational health and safety programs, waste processing, and environmental protection. These activities are designed to protect the worker, the public, and the environment. Meeting these responsibilities requires expertise in many disciplines, including radiation protection, industrial hygiene, safety, occupational medicine, environmental science and engineering, analytical chemistry, epidemiology, and waste management. New and challenging health, safety, and environmental problems occasionally arise from the diverse research and development work of the Laboratory, and research programs in HSE Division often stem from thesemore » applied needs. These programs continue but are also extended, as needed, to study specific problems for the Department of Energy. The results of these programs help develop better practices in occupational health and safety, radiation protection, and environmental science.« less

Implementing Software Safety in the NASA Environment

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Radley, Charles F.

1994-01-01

Until recently, NASA did not consider allowing computers total control of flight systems. Human operators, via hardware, have constituted the ultimate safety control. In an attempt to reduce costs, NASA has come to rely more and more heavily on computers and software to control space missions. (For example. software is now planned to control most of the operational functions of the International Space Station.) Thus the need for systematic software safety programs has become crucial for mission success. Concurrent engineering principles dictate that safety should be designed into software up front, not tested into the software after the fact. 'Cost of Quality' studies have statistics and metrics to prove the value of building quality and safety into the development cycle. Unfortunately, most software engineers are not familiar with designing for safety, and most safety engineers are not software experts. Software written to specifications which have not been safety analyzed is a major source of computer related accidents. Safer software is achieved step by step throughout the system and software life cycle. It is a process that includes requirements definition, hazard analyses, formal software inspections, safety analyses, testing, and maintenance. The greatest emphasis is placed on clearly and completely defining system and software requirements, including safety and reliability requirements. Unfortunately, development and review of requirements are the weakest link in the process. While some of the more academic methods, e.g. mathematical models, may help bring about safer software, this paper proposes the use of currently approved software methodologies, and sound software and assurance practices to show how, to a large degree, safety can be designed into software from the start. NASA's approach today is to first conduct a preliminary system hazard analysis (PHA) during the concept and planning phase of a project. This determines the overall hazard potential of

Intranet-based safety documentation in management of major hazards and occupational health and safety.

PubMed

Leino, Antti

2002-01-01

In the European Union, Council Directive 96/82/EC requires operators producing, using, or handling significant amounts of dangerous substances to improve their safety management systems in order to better manage the major accident potentials deriving from human error. A new safety management system for the Viikinmäki wastewater treatment plant in Helsinki, Finland, was implemented in this study. The system was designed to comply with both the new safety liabilities and the requirements of OHSAS 18001 (British Standards Institute, 1999). During the implementation phase experiences were gathered from the development processes in this small organisation. The complete documentation was placed in the intranet of the plant. Hyperlinks between documents were created to ensure convenience of use. Documentation was made accessible for all workers from every workstation.

Development of a British Road Safety Education Support Materials Curriculum.

ERIC Educational Resources Information Center

Bouck, Linda H.

Road safety education needs to be a vital component in the school curriculum. This paper describes a planned road safety education support materials curriculum developed to aid educators in the Wiltshire County (England) primary schools. Teaching strategies include topic webs, lecture, class discussion, group activities, and investigative learning…

The Development and Deployment of a Maintenance Operations Safety Survey.

PubMed

Langer, Marie; Braithwaite, Graham R

2016-11-01

Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. © 2016, Human Factors and Ergonomics Society.

The Development and Deployment of a Maintenance Operations Safety Survey

PubMed Central

Langer, Marie; Braithwaite, Graham R.

2016-01-01

Objective: Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Background: Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. Method: In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. Results: In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. Conclusion: This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. Application: MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. PMID:27411354

Towards a Competency-based Vision for Construction Safety Education

NASA Astrophysics Data System (ADS)

Pedro, Akeem; Hai Chien, Pham; Park, Chan Sik

2018-04-01

Accidents still prevail in the construction industry, resulting in injuries and fatalities all over the world. Educational programs in construction should deliver safety knowledge and skills to students who will become responsible for ensuring safe construction work environments in the future. However, there is a gap between the competencies current pedagogical approaches target, and those required for safety in practice. This study contributes to addressing this issue in three steps. Firstly, a vision for competency-based construction safety education is conceived. Building upon this, a research scheme to achieve the vision is developed, and the first step of the scheme is initiated in this study. The critical competencies required for safety education are investigated through analyses of literature, and confirmed through surveys with construction and safety management professionals. Results from the study would be useful in establishing and orienting education programs towards current industry safety needs and requirements

Environmental safety & health requirements for a federal facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

Campbell, G.; Wong, J.

1995-09-01

I would like to take this opportunity to discuss the challenges that face an environmental, safety, and health (ES&H) manager at a federal facility situated in California. The challenges are, in many aspects, similar to those facing ES&H professionals all over this country: dwindling resources and increasing regulatory demands. The Laboratory (LLNL) is under closer scrutiny than other R&D facilities located in California because some of its research activities involve nuclear weapon design. Today I would like to talk about two actions we, the ES&H management at LLNL, have taken to decrease the impact of dwindling resources and increasing regulatorymore » demands: (1) Institution of a performance-based contract, which the University of California negotiated with the Department of Energy (DOE) to reduce the impact of special mandates required of federal facilities. Under this contract, ES&H performance is measured by results rather than by process; (2) Redesign of the LLNL Hazards Control Department to a flat organization that incorporates employee empowerment and Self-Managed Work Teams (SMWTs).« less

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study

PubMed Central

Zahoor, Hafiz; Chan, Albert P. C.; Utama, Wahyudi P.; Gao, Ran; Zafar, Irfan

2017-01-01

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation, and negative impact on number of self-reported accidents/injuries. However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation, safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries. PMID:28350366

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

PubMed

Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

2017-03-28

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation , and negative impact on number of self-reported accidents/injuries . However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation , safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

Extending Safety Culture Development through Communication - 12366

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sneve, M.K.; Kiselev, M.; Shandala, N.K.

2012-07-01

The Norwegian Radiation Protection Authority has been implementing a regulatory support program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective is the enhancement of safety culture. The project outputs have included appropriate regulatory threat assessments, to determine the hazardous activities which are most in need of enhanced regulatory supervision; and development of the norms, standards and regulatory procedures, necessary to address the often abnormal conditions at nuclear legacy sites. Project outputs have been prepared and subsequently confirmed asmore » official regulatory documents of the Russian Federation. The continuing program of work focuses on practical application of the enhanced regulatory framework as applied to legacy sites, including safe management of radioactive wastes arising in the process of site remediation. One of the lessons learnt from this practical application is the importance of effective communication at all levels: - between managers and shop workers; - between different operators - e.g. waste producers and waste disposal organisations; - between operators and regulators; - between nuclear safety regulators, radiation protection regulators and other pollution and safety regulators; - between scientists, policy makers and wider stakeholders; and - between all of those mentioned above. A key message from this work is that it is not just an issue of risk communication; rather all aspects of communication can contribute to safety culture enhancement to support effective and efficient risk management, including the role of regulatory supervision. (authors)« less

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

Challenges in Developing Competency-based Training Curriculum for Food Safety Regulators in India

PubMed Central

Thippaiah, Anitha; Allagh, Komal Preet; Murthy, G. V.

2014-01-01

Context: The Food Safety and Standards Act have redefined the roles and responsibilities of food regulatory workforce and calls for highly skilled human resources as it involves complex management procedures. Aims: 1) Identify the competencies needed among the food regulatory workforce in India. 2) Develop a competency-based training curriculum for food safety regulators in the country. 3) Develop training materials for use to train the food regulatory workforce. Settings and Design: The Indian Institute of Public Health, Hyderabad, led the development of training curriculum on food safety with technical assistance from the Royal Society for Public Health, UK and the National Institute of Nutrition, India. The exercise was to facilitate the implementation of new Act by undertaking capacity building through a comprehensive training program. Materials and Methods: A competency-based training needs assessment was conducted before undertaking the development of the training materials. Results: The training program for Food Safety Officers was designed to comprise of five modules to include: Food science and technology, Food safety management systems, Food safety legislation, Enforcement of food safety regulations, and Administrative functions. Each module has a facilitator guide for the tutor and a handbook for the participant. Essentials of Food Hygiene-I (Basic level), II and III (Retail/ Catering/ Manufacturing) were primarily designed for training of food handlers and are part of essential reading for food safety regulators. Conclusion: The Food Safety and Standards Act calls for highly skilled human resources as it involves complex management procedures. Despite having developed a comprehensive competency-based training curriculum by joint efforts by the local, national, and international agencies, implementation remains a challenge in resource-limited setting. PMID:25136155

Workforce Perceptions of Hospital Safety Culture: Development and Validation of the Patient Safety Climate in Healthcare Organizations Survey

PubMed Central

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-01-01

Objective To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Data Sources/Study Setting Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Study Design Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. Data Collection We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). Principal Findings We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's α coefficients ranged from 0.50 to 0.89. Conclusions It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes. PMID:17850530

Development of a Medication Safety and Quality Survey for Small Rural Hospitals.

PubMed

Winterstein, Almut G; Johns, Thomas E; Campbell, Kyle N; Libby, Joel; Pannell, Bob

2017-12-01

We summarize the development and initial implementation of a survey tool to assess medication safety in small rural hospitals. As part of an ongoing rural hospital medication safety improvement program, we developed a survey tool in all 13 critical access hospitals (CAHs) in Florida. The survey was compiled from existing medication safety assessments and standards, clinical practice guidelines, and published literature. Survey items were selected based on considerations regarding practicality and relevance to the CAH setting.The final survey instrument included 134 items representing 17 medication safety domains. Overall hospital scores ranged from 41% to 95%, with a median of 59%. Most hospitals showed large variation in scores across domains, with 5 hospitals having at least 1 domain with scores less than 10%. Highest scores across all facilities were seen for safety procedures concerning high-alert or look-alike medications and the assembly of emergency carts. The lowest median scores included availability and consistent use of standardized order sets and the effective implementation of medication safety committees. Most hospitals used the survey results to identify and prioritize quality improvement activities. The survey can be used to conduct a short medication safety assessment specific to a limited number of areas and services in CAHs. It showed good ability to discriminate medication safety levels across participating sites and highlighted opportunities for improvement. It may need modification if case mix or services differ in other states or if the status quo of medication safety in CAHs or related standards advance. The described process of survey development might be helpful to support such modifications.

Development of E-Learning Materials for Machining Safety Education

NASA Astrophysics Data System (ADS)

Nakazawa, Tsuyoshi; Mita, Sumiyoshi; Matsubara, Masaaki; Takashima, Takeo; Tanaka, Koichi; Izawa, Satoru; Kawamura, Takashi

We developed two e-learning materials for Manufacturing Practice safety education: movie learning materials and hazard-detection learning materials. Using these video and sound media, students can learn how to operate machines safely with movie learning materials, which raise the effectiveness of preparation and review for manufacturing practice. Using these materials, students can realize safety operation well. Students can apply knowledge learned in lectures to the detection of hazards and use study methods for hazard detection during machine operation using the hazard-detection learning materials. Particularly, the hazard-detection learning materials raise students‧ safety consciousness and increase students‧ comprehension of knowledge from lectures and comprehension of operations during Manufacturing Practice.

Lunar mission safety and rescue: Hazards analysis and safety requirements

NASA Technical Reports Server (NTRS)

1971-01-01

The results are presented of the hazards analysis which was concerned only with hazards to personnel and not with loss of equipment or property. Hazards characterization includes the definition of a hazard, the hazard levels, and the hazard groups. The analysis methodology is described in detail. The methodology was used to prepare the top level functional flow diagrams, to perform the first level hazards assessment, and to develop a list of conditions and situations requiring individual hazard studies. The 39 individual hazard study results are presented in total.

Measuring cross-cultural patient safety: identifying barriers and developing performance indicators.

PubMed

Walker, Roger; St Pierre-Hansen, Natalie; Cromarty, Helen; Kelly, Len; Minty, Bryanne

2010-01-01

Medical errors and cultural errors threaten patient safety. We know that access to care, quality of care and clinical safety are all impacted by cultural issues. Numerous approaches to describing cultural barriers to patient safety have been developed, but these taxonomies do not provide a useful set of tools for defining the nature of the problem and consequently do not establish a sound base for problem solving. The Sioux Lookout Meno Ya Win Health Centre has implemented a cross-cultural patient safety (CCPS) model (Walker 2009). We developed an analytical CCPS framework within the organization, and in this article, we detail the validation process for our framework by way of a literature review and surveys of local and international healthcare professionals. We reinforce the position that while cultural competency may be defined by the service provider, cultural safety is defined by the client. In addition, we document the difficulties surrounding the measurement of cultural competence in terms of patient outcomes, which is an underdeveloped dimension of the field of patient safety. We continue to explore the correlation between organizational performance and measurable patient outcomes.

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

PubMed

Ward, Jane K; McEachan, Rosemary R C; Lawton, Rebecca; Armitage, Gerry; Watt, Ian; Wright, John

2011-05-27

Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient

Supervisor Health and Safety Support: Scale Development and Validation

PubMed Central

Butts, Marcus M.; Hurst, Carrie S.; Eby, Lillian T.

2013-01-01

Executive Summary Two studies were conducted to develop a psychometrically sound measure of supervisor health and safety support (SHSS). We identified three dimensions of supervisor support (physical health, psychological health, safety) and used Study 1 to develop items and establish content validity. Study 2 was used to establish the dimensionality of the new measure and provide criterion-related and discriminant validity evidence of the measure using supervisor and subordinate data. The measure had incremental validity in predicting employee performance and psychological strain outcomes above and beyond general work support variables. Implications of these findings and for workplace support theory and practice are discussed. PMID:24771991

[Improvement of sanitary and epidemiological safety of rail transport--a requirement of the new legislation of the Russian Federation].

PubMed

2012-01-01

Brief analysis of the legal framework in recent years, both in the sphere of technical regulation, and in the field of sanitary and epidemiological welfare of the population is presented in this article. The necessity of inclusion in the technical regulations for the safety of railway rolling stock and elements of railway infrastructure the requirements for sanitary-epidemiological safety and hygiene regulations has been proved. Fragments of technical regulations for railway equipment and infrastructure elements, including the basic requirements for the sanitary-epidemiological security are presented. The position of authors in the processing of the regulatory framework in the field of sanitary-epidemiological welfare of population in standardization documents in accordance with the requirements of federal law "On technical regulation" has been reflected.

The patient safety climate in healthcare organizations (PSCHO) survey: Short-form development.

PubMed

Benzer, Justin K; Meterko, Mark; Singer, Sara J

2017-08-01

Measures of safety climate are increasingly used to guide safety improvement initiatives. However, cost and respondent burden may limit the use of safety climate surveys. The purpose of this study was to develop a 15- to 20-item safety climate survey based on the Patient Safety Climate in Healthcare Organizations survey, a well-validated 38-item measure of safety climate. The Patient Safety Climate in Healthcare Organizations was administered to all senior managers, all physicians, and a 10% random sample of all other hospital personnel in 69 private sector hospitals and 30 Veterans Health Administration hospitals. Both samples were randomly divided into a derivation sample to identify a short-form subset and a confirmation sample to assess the psychometric properties of the proposed short form. The short form consists of 15 items represented 3 overarching domains in the long-form scale-organization, work unit, and interpersonal. The proposed short form efficiently captures 3 important sources of variance in safety climate: organizational, work-unit, and interpersonal. The short-form development process was a practical method that can be applied to other safety climate surveys. This safety climate short form may increase response rates in studies that involve busy clinicians or repeated measures. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Technology and Tool Development to Support Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2017-01-01

The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

46 CFR 11.604 - Requirements for an STCW endorsement for Global Maritime Distress and Safety System (GMDSS) radio...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 1 2014-10-01 2014-10-01 false Requirements for an STCW endorsement for Global Maritime Distress and Safety System (GMDSS) radio operators. 11.604 Section 11.604 Shipping COAST GUARD, DEPARTMENT... Credentialing of Radio Officers § 11.604 Requirements for an STCW endorsement for Global Maritime Distress and...

Private-public sector co-operation to improve pesticide safety standards in developing countries.

PubMed

Ellis, W W

1998-01-01

This paper draws on the author's experiences of the pilot phase of the Safe Use Project (SUP) in Thailand; this project is a part of a major GIFAP initiative carried out in some developing countries. The SUP's objectives were; i) to raise awareness and compliance in the safe handling and storage of pesticides within the industry, the medical profession and the end-users; ii) to reduce the incidence of pesticide poisoning; iii) to protect the environment; iiii) to help relevant government agencies with resources, expertise and training. To achieve those objectives, the SUP used local-language training resources, provided basic training, lobbied for changes in governmental policies and regulations, and acted as a focal point for pesticide safety-related information. The SUP targeted the whole distribution chain, from importer/formulator, through to the endusers. Also medical profession, teachers and school students were targeted. On the base of independent audit and surveys, a general improvement in awareness has been shown within targeted groups; a longer time frame is required to detect meaningful changes in farmer practice. The SUP key programmes have been: I) training of trainers, retailers and farmers; II) schools programme; III) medical training; IV) protective clothing; V) industry standards; VI) model farm. The main conclusions of the pilot phase were: i) pesticide safety needs to be addressed by all concerned agencies in a joint effort; ii) a rural development perspective must be adopted in improving pesticide safety; iii) integrated pest management training programmes must include precautionary advice for proper handling, use and disposal of pesticides, wherever these are necessary.

Advancing a sociotechnical systems approach to workplace safety – developing the conceptual framework

PubMed Central

Carayon, Pascale; Hancock, Peter; Leveson, Nancy; Noy, Ian; Sznelwar, Laerte; van Hootegem, Geert

2015-01-01

Traditional efforts to deal with the enormous problem of workplace safety have proved insufficient, as they have tended to neglect the broader sociotechnical environment that surrounds workers. Here, we advocate a sociotechnical systems approach that describes the complex multi-level system factors that contribute to workplace safety. From the literature on sociotechnical systems, complex systems and safety, we develop a sociotechnical model of workplace safety with concentric layers of the work system, socio-organisational context and the external environment. The future challenges that are identified through the model are highlighted. Practitioner Summary: Understanding the environmental, organisational and work system factors that contribute to workplace safety will help to develop more effective and integrated solutions to deal with persistent workplace safety problems. Solutions to improve workplace safety need to recognise the broad sociotechnical system and the respective interactions between the system elements and levels. PMID:25831959

Deep Borehole Disposal Safety Analysis.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

Child Development Associate. Safety for Young Children.

ERIC Educational Resources Information Center

Oscar Rose Junior Coll., Midwest City, OK.

This Child Development Associate (CDA) training module, one of a series of 18, provides a guide to establishing a safe and healthy preschool environment and promoting health and safety practices among preschool children. Upon completion of the module, CDA trainees are expected to be able to create a safe learning environment for children,…

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS

EPA Science Inventory

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS
Pastoor, Timothy1, Barton, Hugh2
1 Syngenta Crop Protection, Greensboro, NC, USA.
2 EPA, Office of Research and Development-NHEERL, RTP, NC, USA.

A multi-stakeholder series of discussions d...

Complying with the Occupational Safety and Health Administration's Bloodborne Pathogens Standard: implementing needleless systems and intravenous safety devices.

PubMed

Marini, Michelle A; Giangregorio, Maeve; Kraskinski, Joanna C

2004-03-01

Preventing the transmission of bloodborne pathogens to healthcare workers has been a mission and a challenge of the healthcare industry for over 20 years. The development of the Occupational Safety and Health Administration Bloodborne Pathogens Standard in 1991 and the passing of the Needlestick Safety Act in 2000 mandated hospitals to develop an Exposure Control Plan to protect workers from these pathogens. Children's Hospital Boston began implementation of a needleless system in 1993. Employees readily accepted these systems into practice, because they were convenient and easy to use. A marked decrease in exposures to bloodborne pathogens naturally followed, which is consistent with the national data. The transition to intravenous (i.v.) safety devices at Children's Hospital began in 2000 and proved to be more of a challenge. First, the clinicians must choose a safety product, which requires developing and implementing a trial plan with potential catheters. This selection process is especially difficult in pediatrics where successful placement of the smallest-gauge catheter, no. 24, is imperative. After choosing an i.v. safety product, successful transition is dependent upon the thoroughness of i.v. safety device training and a commitment by the clinicians to the use of these products. Although the number of needlestick injuries and subsequent transmission of bloodborne pathogens have been further reduced with the use of i.v. safety devices, needlestick injuries still occur. This results from a lack of familiarity with the engineering of the device and therefore poor technique or a failure to activate the safety mechanism. Staff resistance due to loss of expertise with the new device and patient care concerns are additional barriers to the use of these new products. Addressing these obstacles and providing adequate training for all clinicians were required for successful implementation of these i.v. safety devices.

32 CFR 643.22 - Policy-Public safety: Requirement for early identification of lands containing dangerous materials.

Code of Federal Regulations, 2013 CFR

2013-07-01

... identification of lands containing dangerous materials. 643.22 Section 643.22 National Defense Department of...—Public safety: Requirement for early identification of lands containing dangerous materials. (a) DA will... lands by explosives, military chemical or other dangerous materials. (c) Procedures with respect to...

32 CFR 643.22 - Policy-Public safety: Requirement for early identification of lands containing dangerous materials.

Code of Federal Regulations, 2014 CFR

2014-07-01

... identification of lands containing dangerous materials. 643.22 Section 643.22 National Defense Department of...—Public safety: Requirement for early identification of lands containing dangerous materials. (a) DA will... lands by explosives, military chemical or other dangerous materials. (c) Procedures with respect to...

32 CFR 643.22 - Policy-Public safety: Requirement for early identification of lands containing dangerous materials.

Code of Federal Regulations, 2012 CFR

2012-07-01

... identification of lands containing dangerous materials. 643.22 Section 643.22 National Defense Department of...—Public safety: Requirement for early identification of lands containing dangerous materials. (a) DA will... lands by explosives, military chemical or other dangerous materials. (c) Procedures with respect to...

User-Centered Collaborative Design and Development of an Inpatient Safety Dashboard.

PubMed

Mlaver, Eli; Schnipper, Jeffrey L; Boxer, Robert B; Breuer, Dominic J; Gershanik, Esteban F; Dykes, Patricia C; Massaro, Anthony F; Benneyan, James; Bates, David W; Lehmann, Lisa S

2017-12-01

Patient safety remains a key concern in hospital care. This article summarizes the iterative participatory development, features, functions, and preliminary evaluation of a patient safety dashboard for interdisciplinary rounding teams on inpatient medical services. This electronic health record (EHR)-embedded dashboard collects real-time data covering 13 safety domains through web services and applies logic to generate stratified alerts with an interactive check-box function. The technological infrastructure is adaptable to other EHR environments. Surveyed users perceived the tool as highly usable and useful. Integration of the dashboard into clinical care is intended to promote communication about patient safety and facilitate identification and management of safety concerns. Copyright © 2017 The Joint Commission. All rights reserved.

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

PubMed

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Developing and Testing the Health Care Safety Hotline: A Prototype Consumer Reporting System for Patient Safety Events.

PubMed

Schneider, Eric C; Ridgely, M Susan; Quigley, Denise D; Hunter, Lauren E; Leuschner, Kristin J; Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C

2017-06-01

This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism

PubMed Central

Gao, Ran; Chan, Albert P.C.; Utama, Wahyudi P.; Zahoor, Hafiz

2016-01-01

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors’ expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers’ caring and communication (CCC) and coworkers’ role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry. PMID:27834823

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism.

PubMed

Gao, Ran; Chan, Albert P C; Utama, Wahyudi P; Zahoor, Hafiz

2016-11-08

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors' expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers' caring and communication (CCC) and coworkers' role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry.

Achieving the Proper Balance between Crew & Public Safety

NASA Astrophysics Data System (ADS)

Wilde, P.; Gowan, J.; Silvestri, R.; Stahl, B.; Rosati, P.

2012-01-01

A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Crewed vehicle perspectives from the Federal Aviation Administration and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

Boundary conditions for developing a safety concept for an exothermal reaction.

PubMed

Hauptmanns, Ulrich

2007-09-05

Kinetic calculations for an example exothermal chemical process, the production of TCB, are carried out. They address both parameter uncertainties and random failures of the cooling system. In this way, they enable one to establish comprehensive boundary conditions for a safety system in terms of unavailability, the quantities of the undesired by-product (TCDD) produced and the times available before a required intervention, if a pre-determined quantity of TCDD is tolerated. It is shown that accounting for stochastic effects and uncertainties derived from insufficient knowledge provides a broader and more realistic knowledge base for devising a viable safety concept.

78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...

Development of safety performance monitoring procedures.

DOT National Transportation Integrated Search

2010-02-01

Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

75 FR 57081 - Revised Draft Safety Culture Policy Statement: Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

... on Safety Culture at the Health Physics Society Annual Meeting, and presentations on the development... holders \\2\\ establish and maintain a positive safety culture that protects public health and safety and... public health and safety, the Commission has required the regulated entity involved to determine the...

Manned space flight nuclear system safety. Voluem 5: Nuclear system safety guidelines. Part 2: Space shuttle/nuclear payloads safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space shuttle nuclear system transportation are presented. Guidelines and requirements are presented for the shuttle, nuclear payloads (reactor, isotope-Brayton and small isotope sources), ground support systems and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

Development of safety performance functions for North Carolina.

DOT National Transportation Integrated Search

2011-12-06

"The objective of this effort is to develop safety performance functions (SPFs) for different types of facilities in North Carolina : and illustrate how they can be used to improve the decision making process. The prediction models in Part C of the H...

48 CFR 323.7002 - Actions required.

Code of Federal Regulations, 2014 CFR

2014-10-01

... requirements: (1) Services or products. (2) Research, development, or test projects. (3) Transportation of... contract; (2) Evaluating a prospective contractor's safety and health programs; and (3) Conducting post...

48 CFR 323.7002 - Actions required.

Code of Federal Regulations, 2012 CFR

2012-10-01

... requirements: (1) Services or products. (2) Research, development, or test projects. (3) Transportation of... contract; (2) Evaluating a prospective contractor's safety and health programs; and (3) Conducting post...

48 CFR 323.7002 - Actions required.

Code of Federal Regulations, 2013 CFR

2013-10-01

... requirements: (1) Services or products. (2) Research, development, or test projects. (3) Transportation of... contract; (2) Evaluating a prospective contractor's safety and health programs; and (3) Conducting post...

48 CFR 323.7002 - Actions required.

Code of Federal Regulations, 2011 CFR

2011-10-01

... requirements: (1) Services or products. (2) Research, development, or test projects. (3) Transportation of... contract; (2) Evaluating a prospective contractor's safety and health programs; and (3) Conducting post...

Safety Climate Among Nontraditional Workers in Construction: Arguing for a Focus on Construed External Safety Image.

PubMed

Stiehl, Emily; Forst, Linda

2018-05-01

Safety climate, employees' perceptions of work-related safety, 1 has been promoted as a leading indicator of workplace safety in construction. 2 , 3 While research has primarily examined internal organizational sources (e.g., manager attitudes, formal organizational policies) on these perceptions, external sources of information might be more relevant to construction workers in nontraditional jobs who work for a limited time and/or have limited interaction with other employees. This paper argues for the future development of a construed external safety image scale to measure employees' perceptions about how external groups view their organization's safety. 4 The construed external safety image would capture the external sources that nontraditional workers use to assess safety climate and will allow public health researchers to identify and change dangerous workplaces while more effectively communicating information about safe workplaces to workers. The public health relevance of safety climate and construed external safety image for monitoring and communicating safety to nontraditional workers require examination.

78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...

Nuclear-safety institution in France: emergence and development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vallet, B.M.

1986-01-01

This research work examines the social construction of the nuclear-safety institution in France, and the concurrent increased focus on the nuclear-risk issue. Emphasis on risk and safety, as primarily technical issues, can partly be seen as a strategy. Employed by power elites in the nuclear technostructure, this diverts emphasis away from controversial and normative questions regarding the political and social consequences of technology to questions of technology that appear to be absolute to the technology itself. Nuclear safety, which started from a preoccupation with risk related to the nuclear energy research and development process, is examined using the analytic conceptmore » of field. As a social arena patterned to achieve specific tasks, this field is dominated by a body of state engineers recognized to have high-level scientific and administrative competences. It is structured by procedures and administrative hierarchies as well as by technical rules, norms, and standards. These are formalized and rationalized through technical, economic, political, and social needs; over time; they consolidate the field into an institution. The study documents the nuclear-safety institution as an integral part of the nuclear technostructure, which has historically used the specificity of its expertise as a buffer against outside interference.« less

Exenatide Once-Weekly Clinical Development: Safety and Efficacy Across a Range of Background Therapies

PubMed Central

Stonehouse, Anthony; Walsh, Brandon

2011-01-01

Abstract In patients with type 2 diabetes mellitus (T2DM), the physiologic glucagon-like peptide-1 (GLP-1) response, which is involved in glucose regulation through several mechanisms, is dysfunctional. GLP-1 receptor agonists can fill an unmet therapeutic need in the treatment of T2DM: improving glycemic control without increasing the risk of hypoglycemia (except with concomitant sulfonylureas) and reducing weight in a substantial proportion of patients. GLP-1 receptor agonists have impacted established disease treatment algorithms for T2DM. For example, in 2009 the American Diabetes Association and European Association for the Study of Diabetes revised their consensus treatment algorithm to incorporate GLP-1 receptor agonists. GLP-1 receptor agonists were originally represented by exenatide BID (ExBID), a short-acting agent requiring twice-daily injections at mealtime. The longer-acting agent liraglutide, requiring once-daily injections, recently received regulatory approval. Several other long-acting agents are in clinical development, one of which is the once-weekly formulation of exenatide (exenatide once weekly [ExQW]). This article reviews the clinical development of ExQW in the DURATION program. Patients in theses clinical trials were receiving various background treatments, ranging from lifestyle therapy to combination oral therapy, although the majority (68%) received metformin monotherapy. Specifically, safety, glycemic control, and weight were compared in patients treated with ExQW versus ExBID, sitagliptin, pioglitazone, or insulin glargine. Moreover, measures of β-cell function, cardiovascular risk, inflammation, and hepatic health were investigated. During ExQW clinical development, consistent clinical efficacy (glycosylated hemoglobin, −1.5% to −1.9%; weight, −2 kg to −4 kg) and safety data were observed in patients with T2DM treated with ExQW. PMID:21732798

33 CFR 164.72 - Navigational-safety equipment, charts or maps, and publications required on towing vessels.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., either a LORAN-C receiver or a satellite navigational system such as the Global Positioning System (GPS... the following navigational-safety equipment: (1) Marine radar. By August 2, 1997, a marine radar that meets the following applicable requirements: (i) For a vessel of less than 300 tons gross tonnage that...

Using Contemporary Leadership Skills in Medication Safety Programs.

PubMed

Hertig, John B; Hultgren, Kyle E; Weber, Robert J

2016-04-01

The discipline of studying medication errors and implementing medication safety programs in hospitals dates to the 1970s. These initial programs to prevent errors focused only on pharmacy operation changes - and not the broad medication use system. In the late 1990s, research showed that faulty systems, and not faulty people, are responsible for errors and require a multidisciplinary approach. The 2013 ASHP Statement on the Role of the Medication Safety Leader recommended that medication safety leaders be integrated team members rather than a single point of contact. Successful medication safety programs must employ a new approach - one that embraces the skills of all health care team members and positions many leaders to improve safety. This approach requires a new set of leadership skills based on contemporary management principles, including followership, team-building, tracking and assessing progress, storytelling and communication, and cultivating innovation, all of which promote transformational change. The application of these skills in developing or changing a medication safety program is reviewed in this article.

The development and efficacy of safety training for commercial fishermen.

PubMed

Dzugan, Jerry

2010-10-01

Commercial fishing is still the most dangerous occupation in the United States. Efforts to have more stringent safety regulations in this industry beginning in the 1960s, culminated in the Commercial Fishing Vessel Safety Act of 1988. The purpose of this paper is to provide a short history of the development of safety training in the United States and the current training infrastructure. This paper will also review studies available regarding the effectiveness of safety training in reducing fatalities among fishermen. The lack of familiarity and practice with marine survival equipment such as life rafts, immersion suits, and emergency-locating beacons has been noted in National Transportation Safety Board and US Coast Guard casualty reports as a contributing factor in fatalities. These reports have demonstrated the importance of not just having survival equipment onboard, but training in how to use it effectively in an emergency. There is evidence that safety training has made a measurable impact in surviving an emergency at sea and that recent training (within 5 years) is most effective in saving lives. More recently, studies have been completed to understand how skills may diminish over time since initial training.

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.; Moses, Kelly

2004-01-01

This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

Quo Vadis Payload Safety?

NASA Technical Reports Server (NTRS)

Fodroci, Michael P.; Schwartz, MaryBeth

2008-01-01

As we complete the preparations for the fourth Hubble Space Telescope (HST) servicing mission, we note an anniversary approaching: it was 30 years ago in July that the first HST payload safety review panel meeting was held. This, in turn, was just over a year after the very first payload safety review, a Phase 0 review for the Tracking and Data Relay Satellite and its Inertial Upper Stage, held in June of 1977. In adapting a process that had been used in the review and certification of earlier Skylab payloads, National Aeronautics and Space Administration (NASA) engineers sought to preserve the lessons learned in the development of technical payload safety requirements, while creating a new process that would serve the very different needs of the new space shuttle program. Their success in this undertaking is substantiated by the fact that this process and these requirements have proven to be remarkably robust, flexible, and adaptable. Furthermore, the payload safety process has, to date, served us well in the critical mission of safeguarding our astronauts, cosmonauts, and spaceflight participants. Both the technical requirements and their interpretation, as well as the associated process requirements have grown, evolved, been streamlined, and have been adapted to fit multiple programs, including the International Space Station (ISS) program, the Shuttle/Mir program, and most recently the United States Constellation program. From its earliest days, it was anticipated that the payload safety process would be international in scope, and so it has been. European Space Agency (ESA), Japan Aerospace Exploration Agency (JAXA), German Space Agency (DLR), Canadian Space Agency (CSA), Russian Space Agency (RSA), and many additional countries have flown payloads on both the space shuttle and on the ISS. Our close cooperation and long-term working relationships have culminated in the franchising of the payload safety review process itself to our partners in ESA, which in

Principles of Safety Pharmacology

PubMed Central

Pugsley, M K; Authier, S; Curtis, M J

2008-01-01

Safety Pharmacology is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events. This gives Safety Pharmacology its unique character. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. This article sets out to explain the drivers for Safety Pharmacology so that the wider pharmacology community is better placed to understand the discipline. It concludes with a summary of principles that may help inform future resolution of unmet needs (especially establishing model validation for accurate risk assessment). Subsequent articles in this issue of the journal address specific aspects of Safety Pharmacology to explore the issues of model choice, the burden of proof and to highlight areas of intensive activity (such as testing for drug-induced rare event liability, and the challenge of testing the safety of so-called biologics (antibodies, gene therapy and so on.). PMID:18604233

Consideration of future safety consequences: a new predictor of employee safety.

PubMed

Probst, Tahira M; Graso, Maja; Estrada, Armando X; Greer, Sarah

2013-06-01

Compliance with safety behaviors is often associated with longer term benefits, but may require some short-term sacrifices. This study examines the extent to which consideration of future safety consequences (CFSC) predicts employee safety outcomes. Two field studies were conducted to evaluate the reliability and validity of the newly developed Consideration of Future Safety Consequences (CFSC) scale. Surveys containing the CFSC scale and other measures of safety attitudes, behaviors, and outcomes were administered during working hours to a sample of 128 pulp and paper mill employees; after revising the CFSC scale based on these initial results, follow-up survey data were collected in a second sample of 212 copper miners. In Study I, CFSC was predictive of employee safety knowledge and motivation, compliance, safety citizenship behaviors, accident reporting attitudes and behaviors, and workplace injuries - even after accounting for conscientiousness and demographic variables. Moreover, the effects of CFSC on the variables generally appear to be direct, as opposed to mediated by safety knowledge or motivation. These findings were largely replicated in Study II. CFSC appears to be an important personality construct that may predict those individuals who are more likely to comply with safety rules and have more positive safety outcomes. Future research should examine the longitudinal stability of CFSC to determine the extent to which this construct is a stable trait, rather than a safety attitude amenable to change over time or following an intervention. Copyright © 2013 Elsevier Ltd. All rights reserved.

Improved processes for meeting the data requirements for implementing the Highway Safety Manual (HSM) and Safety Analyst in Florida.

DOT National Transportation Integrated Search

2014-03-01

Recent research in highway safety has focused on the more advanced and statistically proven techniques of highway : safety analysis. This project focuses on the two most recent safety analysis tools, the Highway Safety Manual (HSM) : and SafetyAnalys...

10 CFR 850 Implementation of Requirements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, S

2012-01-05

10 CFR 850 defines a contractor as any entity, including affiliated entities, such as a parent corporation, under contract with DOE, including a subcontractor at any tier, with responsibility for performing work at a DOE site in furtherance of a DOE mission. The Chronic Beryllium Disease Prevention Program (CBDPP) applies to beryllium-related activities that are performed at the Lawrence Livermore National Laboratory (LLNL). The CBDPP or Beryllium Safety Program is integrated into the LLNL Worker Safety and Health Program and, thus, implementation documents and responsibilities are integrated in various documents and organizational structures. Program development and management of the CBDPPmore » is delegated to the Environment, Safety and Health (ES&H) Directorate, Worker Safety and Health Functional Area. As per 10 CFR 850, Lawrence Livermore National Security, LLC (LLNS) periodically submits a CBDPP to the National Nuclear Security Administration/Livermore Site Office (NNSA/LSO). The requirements of this plan are communicated to LLNS workers through ES&H Manual Document 14.4, 'Working Safely with Beryllium.' 10 CFR 850 is implemented by the LLNL CBDPP, which integrates the safety and health standards required by the regulation, components of the LLNL Integrated Safety Management System (ISMS), and incorporates other components of the LLNL ES&H Program. As described in the regulation, and to fully comply with the regulation, specific portions of existing programs and additional requirements are identified in the CBDPP. The CBDPP is implemented by documents that interface with the workers, principally through ES&H Manual Document 14.4. This document contains information on how the management practices prescribed by the LLNL ISMS are implemented, how beryllium hazards that are associated with LLNL work activities are controlled, and who is responsible for implementing the controls. Adherence to the requirements and processes described in the ES&H Manual ensures

A strategic framework for the development and enhancement of safety culture in the artificial tanning sector in Greece.

PubMed

Petri, Aspasia; Karabetsos, Efthymios

2018-06-08

Herein, the strategic framework for the development and enhancement of safety culture in the artificial tanning sector in Greece is presented. This framework has been designed and promoted by the competent national regulatory authority, which is the Greek Atomic Energy Commission (EEAE). The aim is to ensure a common understanding regarding ultraviolet radiation (UVR) and artificial tanning among the artificial tanning professionals, the stakeholders and the general public. The strategic framework is founded on the international organizations' recommendations, the EU requirements and the relevant technical standards. It is comprised of three autonomous but interconnected components: A) A sunbed operators' e-training course and certification process, B) A code of practice addressed individually to the business owners, the sunbeds operators and the sunbeds users, C) Communication strategies aiming to raise awareness regarding UVR and artificial tanning to all the interested parties. The artificial tanning safety culture framework presented here is the policy option that EEAE undertook and it is embedded in the upcoming legislation and regulations for the provision of artificial tanning services in Greece. EEAE considers that the structure of the artificial tanning safety culture strategic framework will serve as the guide for the development and promotion of relevant safety culture strategic frameworks for the provision of aesthetic/wellness services that utilize other non-ionizing radiation sources, which currently don't exist. © 2018 IOP Publishing Ltd.

Achieving the Proper Balance Between Crew and Public Safety

NASA Technical Reports Server (NTRS)

Gowan, John; Silvestri, Ray; Stahl, Ben; Rosati, Paul; Wilde, Paul

2011-01-01

A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the Federal Aviation Administration (FAA) and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

10 CFR 851.11 - Development and approval of worker safety and health program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... workers at multi-contractor workplaces. (3) The worker safety and health program must describe how the... may be performed at a covered workplace unless an approved worker safety and health program is in... 10 Energy 4 2010-01-01 2010-01-01 false Development and approval of worker safety and health...

Design and development of food safety knowledge and attitude scales for consumer food safety education.

PubMed

Medeiros, Lydia C; Hillers, Virginia N; Chen, Gang; Bergmann, Verna; Kendall, Patricia; Schroeder, Mary

2004-11-01

The objective of this study was to design and develop food safety knowledge and attitude scales based on food-handling guidelines developed by a national panel of food safety experts. Knowledge (n=43) and attitude (n=49) questions were developed and pilot-tested with a variety of consumer groups. Final questions were selected based on item analysis and on validity and reliability statistical tests. Knowledge questions were tested in Washington State with participants in low-income nutrition education programs (pretest/posttest n=58, test/retest n=19) and college students (pretest/posttest n=34). Attitude questions were tested in Ohio with nutrition education program participants (n=30) and college students (non-nutrition majors n=138, nutrition majors n=57). Item analysis, paired sample t tests, Pearson's correlation coefficients, and Cronbach's alpha were used. Reliability and validity tests of individual items and the question sets were used to reduce the scales to 18 knowledge questions and 10 attitude questions. The knowledge and attitude scales covered topics ranked as important by a national panel of experts and met most validity and reliability standards. The 18-item knowledge questionnaire had instructional sensitivity (mean score increase of more than three points after instruction), internal reliability (Cronbach's alpha >.75), and produced similar results in test-retest without intervention (coefficient of stability=.81). Knowledge of correct procedures for hand washing and avoiding cross-contamination was widespread before instruction. Knowledge was limited regarding avoiding food preparation while ill, cooking hamburgers, high-risk foods, and whether cooked rice and potatoes could be stored at room temperature. The 10-item attitude scale had an appropriate range of responses (item difficulty) and produced similar results in test-retest ( P safety is

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

PubMed

Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

2011-04-01

Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

NASA ELV Payload Safety Program Information Exchange

NASA Technical Reports Server (NTRS)

Staubus, Cal; Palo, Tom; Dook, Mike; Donovan, Shawn

2007-01-01

This presentation details the Expendable Launch Vehicle (ELV) Payload Safety Program in its development and plan for implementation. It is an overview of the program's policies, process and requirements.

The Exposure Index: Developing firefighter safety performance measures

Treesearch

Dave Calkin; John Phipps; Tom Holmes; Jon Rieck; Matt Thompson

2011-01-01

A cornerstone of effective institutional learning and accountability is the development, tracking, and analysis of informative performance measures. In a previous issue of Fire Management Today ("A New Look at Risk Management," Winter 2011), a series of articles highlighted the importance of organizational safety and risk management and the challenges of...

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Development of a medical information system that minimizes staff workload and secures system safety at a small medical institution

NASA Astrophysics Data System (ADS)

Haneda, Kiyofumi; Koyama, Tadashi

2005-04-01

We developed a secure system that minimizes staff workload and secures safety of a medical information system. In this study, we assess the legal security requirements and risks occurring from the use of digitized data. We then analyze the security measures for ways of reducing these risks. In the analysis, not only safety, but also costs of security measures and ease of operability are taken into consideration. Finally, we assess the effectiveness of security measures by employing our system in small-sized medical institution. As a result of the current study, we developed and implemented several security measures, such as authentications, cryptography, data back-up, and secure sockets layer protocol (SSL) in our system. In conclusion, the cost for the introduction and maintenance of a system is one of the primary difficulties with its employment by a small-sized institution. However, with recent reductions in the price of computers, and certain advantages of small-sized medical institutions, the development of an efficient system configuration has become possible.

Framework Development Supporting the Safety Portal

DOE Office of Scientific and Technical Information (OSTI.GOV)

Prescott, Steven Ralph; Kvarfordt, Kellie Jean; Vang, Leng

2015-07-01

In a collaborating scientific research arena it is important to have an environment where analysts have access to a shared repository of information, documents, and software tools, and be able to accurately maintain and track historical changes in models. The new Safety Portal cloud-based environment will be accessible remotely from anywhere regardless of computing platforms given that the platform has available Internet access and proper browser capabilities. Information stored at this environment would be restricted based on user assigned credentials. This report discusses current development of a cloud-based web portal for PRA tools.

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?

PubMed Central

Laverty, HG; Benson, C; Cartwright, EJ; Cross, MJ; Garland, C; Hammond, T; Holloway, C; McMahon, N; Milligan, J; Park, BK; Pirmohamed, M; Pollard, C; Radford, J; Roome, N; Sager, P; Singh, S; Suter, T; Suter, W; Trafford, A; Volders, PGA; Wallis, R; Weaver, R; York, M; Valentin, JP

2011-01-01

Given that cardiovascular safety liabilities remain a major cause of drug attrition during preclinical and clinical development, adverse drug reactions, and post-approval withdrawal of medicines, the Medical Research Council Centre for Drug Safety Science hosted a workshop to discuss current challenges in determining, understanding and addressing ‘Cardiovascular Toxicity of Medicines’. This article summarizes the key discussions from the workshop that aimed to address three major questions: (i) what are the key cardiovascular safety liabilities in drug discovery, drug development and clinical practice? (ii) how good are preclinical and clinical strategies for detecting cardiovascular liabilities? and (iii) do we have a mechanistic understanding of these liabilities? It was concluded that in order to understand, address and ultimately reduce cardiovascular safety liabilities of new therapeutic agents there is an urgent need to: Fully characterize the incidence, prevalence and impact of drug-induced cardiovascular issues at all stages of the drug development process. Ascertain the predictive value of existing non-clinical models and assays towards the clinical outcome. Understand the mechanistic basis of cardiovascular liabilities; by addressing areas where it is currently not possible to predict clinical outcome based on preclinical safety data. Provide scientists in all disciplines with additional skills to enable them to better integrate preclinical and clinical data and to better understand the biological and clinical significance of observed changes. Develop more appropriate, highly relevant and predictive tools and assays to identify and wherever feasible to eliminate cardiovascular safety liabilities from molecules and wherever appropriate to develop clinically relevant and reliable safety biomarkers. PMID:21306581

Development of the Oregon traffic safety data archive : phases 1 and 2.

DOT National Transportation Integrated Search