Software assurance standard

NASA Technical Reports Server (NTRS)

1992-01-01

This standard specifies the software assurance program for the provider of software. It also delineates the assurance activities for the provider and the assurance data that are to be furnished by the provider to the acquirer. In any software development effort, the provider is the entity or individual that actually designs, develops, and implements the software product, while the acquirer is the entity or individual who specifies the requirements and accepts the resulting products. This standard specifies at a high level an overall software assurance program for software developed for and by NASA. Assurance includes the disciplines of quality assurance, quality engineering, verification and validation, nonconformance reporting and corrective action, safety assurance, and security assurance. The application of these disciplines during a software development life cycle is called software assurance. Subsequent lower-level standards will specify the specific processes within these disciplines.

A Strategy for Improved System Assurance

DTIC Science & Technology

2007-06-20

Quality (Measurements Life Cycle Safety, Security & Others) ISO /IEC 12207 * Software Life Cycle Processes ISO 9001 Quality Management System...14598 Software Product Evaluation Related ISO /IEC 90003 Guidelines for the Application of ISO 9001:2000 to Computer Software IEEE 12207 Industry...Implementation of International Standard ISO /IEC 12207 IEEE 1220 Standard for Application and Management of the System Engineering Process Use in

NASA's Approach to Software Assurance

NASA Technical Reports Server (NTRS)

Wetherholt, Martha

2015-01-01

NASA defines software assurance as: the planned and systematic set of activities that ensure conformance of software life cycle processes and products to requirements, standards, and procedures via quality, safety, reliability, and independent verification and validation. NASA's implementation of this approach to the quality, safety, reliability, security and verification and validation of software is brought together in one discipline, software assurance. Organizationally, NASA has software assurance at each NASA center, a Software Assurance Manager at NASA Headquarters, a Software Assurance Technical Fellow (currently the same person as the SA Manager), and an Independent Verification and Validation Organization with its own facility. An umbrella risk mitigation strategy for safety and mission success assurance of NASA's software, software assurance covers a wide area and is better structured to address the dynamic changes in how software is developed, used, and managed, as well as it's increasingly complex functionality. Being flexible, risk based, and prepared for challenges in software at NASA is essential, especially as much of our software is unique for each mission.

Survey of Software Assurance Techniques for Highly Reliable Systems

NASA Technical Reports Server (NTRS)

Nelson, Stacy

2004-01-01

This document provides a survey of software assurance techniques for highly reliable systems including a discussion of relevant safety standards for various industries in the United States and Europe, as well as examples of methods used during software development projects. It contains one section for each industry surveyed: Aerospace, Defense, Nuclear Power, Medical Devices and Transportation. Each section provides an overview of applicable standards and examples of a mission or software development project, software assurance techniques used and reliability achieved.

Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study.

PubMed

Blagec, Kathrin; Jungwirth, David; Haluza, Daniela; Samwald, Matthias

2018-01-01

Medical device regulations which aim to ensure safety standards do not only apply to hardware devices but also to standalone medical software, e.g. mobile apps. To explore the effects of these regulations on the development and distribution of medical standalone software. We invited a convenience sample of 130 domain experts to participate in an online survey about the impact of current regulations on the development and distribution of medical standalone software. 21 respondents completed the questionnaire. Participants reported slight positive effects on usability, reliability, and data security of their products, whereas the ability to modify already deployed software and customization by end users were negatively impacted. The additional time and costs needed to go through the regulatory process were perceived as the greatest obstacles in developing and distributing medical software. Further research is needed to compare positive effects on software quality with negative impacts on market access and innovation. Strategies for avoiding over-regulation while still ensuring safety standards need to be devised.

Model-based engineering for medical-device software.

PubMed

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

GPM Timeline Inhibits For IT Processing

NASA Technical Reports Server (NTRS)

Dion, Shirley K.

2014-01-01

The Safety Inhibit Timeline Tool was created as one approach to capturing and understanding inhibits and controls from IT through launch. Global Precipitation Measurement (GPM) Mission, which launched from Japan in March 2014, was a joint mission under a partnership between the National Aeronautics and Space Administration (NASA) and the Japan Aerospace Exploration Agency (JAXA). GPM was one of the first NASA Goddard in-house programs that extensively used software controls. Using this tool during the GPM buildup allowed a thorough review of inhibit and safety critical software design for hazardous subsystems such as the high gain antenna boom, solar array, and instrument deployments, transmitter turn-on, propulsion system release, and instrument radar turn-on. The GPM safety team developed a methodology to document software safety as part of the standard hazard report. As a result of this process, a new tool safety inhibit timeline was created for management of inhibits and their controls during spacecraft buildup and testing during IT at GSFC and at the launch range in Japan. The Safety Inhibit Timeline Tool was a pathfinder approach for reviewing software that controls the electrical inhibits. The Safety Inhibit Timeline Tool strengthens the Safety Analysts understanding of the removal of inhibits during the IT process with safety critical software. With this tool, the Safety Analyst can confirm proper safe configuration of a spacecraft during each IT test, track inhibit and software configuration changes, and assess software criticality. In addition to understanding inhibits and controls during IT, the tool allows the Safety Analyst to better communicate to engineers and management the changes in inhibit states with each phase of hardware and software testing and the impact of safety risks. Lessons learned from participating in the GPM campaign at NASA and JAXA will be discussed during this session.

Software Development Standard Processes (SDSP)

NASA Technical Reports Server (NTRS)

Lavin, Milton L.; Wang, James J.; Morillo, Ronald; Mayer, John T.; Jamshidian, Barzia; Shimizu, Kenneth J.; Wilkinson, Belinda M.; Hihn, Jairus M.; Borgen, Rosana B.; Meyer, Kenneth N.;

Requirements for a multifunctional code architecture

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

Tiihonen, O.; Juslin, K.

1997-07-01

The present paper studies a set of requirements for a multifunctional simulation software architecture in the light of experiences gained in developing and using the APROS simulation environment. The huge steps taken in the development of computer hardware and software during the last ten years are changing the status of the traditional nuclear safety analysis software. The affordable computing power on the safety analysts table by far exceeds the possibilities offered to him/her ten years ago. At the same time the features of everyday office software tend to set standards to the way the input data and calculational results aremore » managed.« less

Safety Characteristics in System Application of Software for Human Rated Exploration Missions for the 8th IAASS Conference

NASA Technical Reports Server (NTRS)

Mango, Edward J.

2016-01-01

NASA and its industry and international partners are embarking on a bold and inspiring development effort to design and build an exploration class space system. The space system is made up of the Orion system, the Space Launch System (SLS) and the Ground Systems Development and Operations (GSDO) system. All are highly coupled together and dependent on each other for the combined safety of the space system. A key area of system safety focus needs to be in the ground and flight application software system (GFAS). In the development, certification and operations of GFAS, there are a series of safety characteristics that define the approach to ensure mission success. This paper will explore and examine the safety characteristics of the GFAS development. The GFAS system integrates the flight software packages of the Orion and SLS with the ground systems and launch countdown sequencers through the 'agile' software development process. A unique approach is needed to develop the GFAS project capabilities within this agile process. NASA has defined the software development process through a set of standards. The standards were written during the infancy of the so-called industry 'agile development' movement and must be tailored to adapt to the highly integrated environment of human exploration systems. Safety of the space systems and the eventual crew on board is paramount during the preparation of the exploration flight systems. A series of software safety characteristics have been incorporated into the development and certification efforts to ensure readiness for use and compatibility with the space systems. Three underlining factors in the exploration architecture require the GFAS system to be unique in its approach to ensure safety for the space systems, both the flight as well as the ground systems. The first are the missions themselves, which are exploration in nature, and go far beyond the comfort of low Earth orbit operations. The second is the current exploration system will launch only one mission per year even less during its developmental phases. Finally, the third is the partnered approach through the use of many different prime contractors, including commercial and international partners, to design and build the exploration systems. These three factors make the challenges to meet the mission preparations and the safety expectations extremely difficult to implement. As NASA leads a team of partners in the exploration beyond earth's influence, it is a safety imperative that the application software used to test, checkout, prepare and launch the exploration systems put safety of the hardware and mission first. Software safety characteristics are built into the design and development process to enable the human rated systems to begin their missions safely and successfully. Exploration missions beyond Earth are inherently risky, however, with solid safety approaches in both hardware and software, the boldness of these missions can be realized for all on the home planet.

Certification of COTS Software in NASA Human Rated Flight Systems

NASA Technical Reports Server (NTRS)

Goforth, Andre

2012-01-01

Adoption of commercial off-the-shelf (COTS) products in safety critical systems has been seen as a promising acquisition strategy to improve mission affordability and, yet, has come with significant barriers and challenges. Attempts to integrate COTS software components into NASA human rated flight systems have been, for the most part, complicated by verification and validation (V&V) requirements necessary for flight certification per NASA s own standards. For software that is from COTS sources, and, in general from 3rd party sources, either commercial, government, modified or open source, the expectation is that it meets the same certification criteria as those used for in-house and that it does so as if it were built in-house. The latter is a critical and hidden issue. This paper examines the longstanding barriers and challenges in the use of 3rd party software in safety critical systems and cover recent efforts to use COTS software in NASA s Multi-Purpose Crew Vehicle (MPCV) project. It identifies some core artifacts that without them, the use of COTS and 3rd party software is, for all practical purposes, a nonstarter for affordable and timely insertion into flight critical systems. The paper covers the first use in a flight critical system by NASA of COTS software that has prior FAA certification heritage, which was shown to meet the RTCA-DO-178B standard, and how this certification may, in some cases, be leveraged to allow the use of analysis in lieu of testing. Finally, the paper proposes the establishment of an open source forum for development of safety critical 3rd party software.

The integration of the risk management process with the lifecycle of medical device software.

PubMed

Pecoraro, F; Luzi, D

2014-01-01

The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

Fault Injection Validation of a Safety-Critical TMR Sysem

NASA Astrophysics Data System (ADS)

Irrera, Ivano; Madeira, Henrique; Zentai, Andras; Hergovics, Beata

2016-08-01

Digital systems and their software are the core technology for controlling and monitoring industrial systems in practically all activity domains. Functional safety standards such as the European standard EN 50128 for railway applications define the procedures and technical requirements for the development of software for railway control and protection systems. The validation of such systems is a highly demanding task. In this paper we discuss the use of fault injection techniques, which have been used extensively in several domains, particularly in the space domain, to complement the traditional procedures to validate a SIL (Safety Integrity Level) 4 system for railway signalling, implementing a TMR (Triple Modular Redundancy) architecture. The fault injection tool is based on JTAG technology. The results of our injection campaign showed a high degree of tolerance to most of the injected faults, but several cases of unexpected behaviour have also been observed, helping understanding worst-case scenarios.

A study of software standards used in the avionics industry

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.

1994-01-01

Within the past decade, software has become an increasingly common element in computing systems. In particular, the role of software used in the aerospace industry, especially in life- or safety-critical applications, is rapidly expanding. This intensifies the need to use effective techniques for achieving and verifying the reliability of avionics software. Although certain software development processes and techniques are mandated by government regulating agencies, no one methodology has been shown to consistently produce reliable software. The knowledge base for designing reliable software simply has not reached the maturity of its hardware counterpart. In an effort to increase our understanding of software, the Langley Research Center conducted a series of experiments over 15 years with the goal of understanding why and how software fails. As part of this program, the effectiveness of current industry standards for the development of avionics is being investigated. This study involves the generation of a controlled environment to conduct scientific experiments on software processes.

Evaluation of features to support safety and quality in general practice clinical software

PubMed Central

2011-01-01

Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics) that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62%) were fully implemented, 9-13 (18-26%) partially implemented, and 9-20 (18-40%) not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

Identification of features of electronic prescribing systems to support quality and safety in primary care using a modified Delphi process.

PubMed

Sweidan, Michelle; Williamson, Margaret; Reeve, James F; Harvey, Ken; O'Neill, Jennifer A; Schattner, Peter; Snowdon, Teri

2010-04-15

Electronic prescribing is increasingly being used in primary care and in hospitals. Studies on the effects of e-prescribing systems have found evidence for both benefit and harm. The aim of this study was to identify features of e-prescribing software systems that support patient safety and quality of care and that are useful to the clinician and the patient, with a focus on improving the quality use of medicines. Software features were identified by a literature review, key informants and an expert group. A modified Delphi process was used with a 12-member multidisciplinary expert group to reach consensus on the expected impact of the features in four domains: patient safety, quality of care, usefulness to the clinician and usefulness to the patient. The setting was electronic prescribing in general practice in Australia. A list of 114 software features was developed. Most of the features relate to the recording and use of patient data, the medication selection process, prescribing decision support, monitoring drug therapy and clinical reports. The expert group rated 78 of the features (68%) as likely to have a high positive impact in at least one domain, 36 features (32%) as medium impact, and none as low or negative impact. Twenty seven features were rated as high positive impact across 3 or 4 domains including patient safety and quality of care. Ten features were considered "aspirational" because of a lack of agreed standards and/or suitable knowledge bases. This study defines features of e-prescribing software systems that are expected to support safety and quality, especially in relation to prescribing and use of medicines in general practice. The features could be used to develop software standards, and could be adapted if necessary for use in other settings and countries.

Identification of features of electronic prescribing systems to support quality and safety in primary care using a modified Delphi process

PubMed Central

2010-01-01

Background Electronic prescribing is increasingly being used in primary care and in hospitals. Studies on the effects of e-prescribing systems have found evidence for both benefit and harm. The aim of this study was to identify features of e-prescribing software systems that support patient safety and quality of care and that are useful to the clinician and the patient, with a focus on improving the quality use of medicines. Methods Software features were identified by a literature review, key informants and an expert group. A modified Delphi process was used with a 12-member multidisciplinary expert group to reach consensus on the expected impact of the features in four domains: patient safety, quality of care, usefulness to the clinician and usefulness to the patient. The setting was electronic prescribing in general practice in Australia. Results A list of 114 software features was developed. Most of the features relate to the recording and use of patient data, the medication selection process, prescribing decision support, monitoring drug therapy and clinical reports. The expert group rated 78 of the features (68%) as likely to have a high positive impact in at least one domain, 36 features (32%) as medium impact, and none as low or negative impact. Twenty seven features were rated as high positive impact across 3 or 4 domains including patient safety and quality of care. Ten features were considered "aspirational" because of a lack of agreed standards and/or suitable knowledge bases. Conclusions This study defines features of e-prescribing software systems that are expected to support safety and quality, especially in relation to prescribing and use of medicines in general practice. The features could be used to develop software standards, and could be adapted if necessary for use in other settings and countries. PMID:20398294

Long range targeting for space based rendezvous

NASA Technical Reports Server (NTRS)

Everett, Louis J.; Redfield, R. C.

1995-01-01

The work performed under this grant supported the Dexterous Flight Experiment one STS-62 The project required developing hardware and software for automating a TRAC sensor on orbit. The hardware developed by for the flight has been documented through standard NASA channels since it has to pass safety, environmental, and other issues. The software has not been documented previously, therefore, this report provides a software manual for the TRAC code developed for the grant.

Non-standard analysis and embedded software

NASA Technical Reports Server (NTRS)

Platek, Richard

1995-01-01

One model for computing in the future is ubiquitous, embedded computational devices analogous to embedded electrical motors. Many of these computers will control physical objects and processes. Such hidden computerized environments introduce new safety and correctness concerns whose treatment go beyond present Formal Methods. In particular, one has to begin to speak about Real Space software in analogy with Real Time software. By this we mean, computerized systems which have to meet requirements expressed in the real geometry of space. How to translate such requirements into ordinary software specifications and how to carry out proofs is a major challenge. In this talk we propose a research program based on the use of no-standard analysis. Much detail remains to be carried out. The purpose of the talk is to inform the Formal Methods community that Non-Standard Analysis provides a possible avenue to attack which we believe will be fruitful.

The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

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

Hughes, P. J.; Westwood, R.N; Mark, R. T.

2006-07-01

The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety casesmore » for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)« less

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines.

PubMed

Zhou, Lu-Jie; Cao, Qing-Gui; Yu, Kai; Wang, Lin-Lin; Wang, Hai-Bin

2018-04-26

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines

PubMed Central

Zhou, Lu-jie; Cao, Qing-gui; Yu, Kai; Wang, Lin-lin; Wang, Hai-bin

2018-01-01

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines. PMID:29701715

Revealing the ISO/IEC 9126-1 Clique Tree for COTS Software Evaluation

NASA Technical Reports Server (NTRS)

Morris, A. Terry

2007-01-01

Previous research has shown that acyclic dependency models, if they exist, can be extracted from software quality standards and that these models can be used to assess software safety and product quality. In the case of commercial off-the-shelf (COTS) software, the extracted dependency model can be used in a probabilistic Bayesian network context for COTS software evaluation. Furthermore, while experts typically employ Bayesian networks to encode domain knowledge, secondary structures (clique trees) from Bayesian network graphs can be used to determine the probabilistic distribution of any software variable (attribute) using any clique that contains that variable. Secondary structures, therefore, provide insight into the fundamental nature of graphical networks. This paper will apply secondary structure calculations to reveal the clique tree of the acyclic dependency model extracted from the ISO/IEC 9126-1 software quality standard. Suggestions will be provided to describe how the clique tree may be exploited to aid efficient transformation of an evaluation model.

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

Code of Federal Regulations, 2010 CFR

2010-10-01

..., national, or international standards. (f) The reviewer shall analyze all Fault Tree Analyses (FTA), Failure... cited by the reviewer; (4) Identification of any documentation or information sought by the reviewer...) Identification of the hardware and software verification and validation procedures for the PTC system's safety...

RICIS Symposium 1992: Mission and Safety Critical Systems Research and Applications

NASA Technical Reports Server (NTRS)

1992-01-01

This conference deals with computer systems which control systems whose failure to operate correctly could produce the loss of life and or property, mission and safety critical systems. Topics covered are: the work of standards groups, computer systems design and architecture, software reliability, process control systems, knowledge based expert systems, and computer and telecommunication protocols.

NASA's Core Trajectory Sub-System Project: Using JBoss Enterprise Middleware for Building Software Systems Used to Support Spacecraft Trajectory Operations

NASA Technical Reports Server (NTRS)

Stensrud, Kjell C.; Hamm, Dustin

2007-01-01

NASA's Johnson Space Center (JSC) / Flight Design and Dynamics Division (DM) has prototyped the use of Open Source middleware technology for building its next generation spacecraft mission support system. This is part of a larger initiative to use open standards and open source software as building blocks for future mission and safety critical systems. JSC is hoping to leverage standardized enterprise architectures, such as Java EE, so that its internal software development efforts can be focused on the core aspects of their problem domain. This presentation will outline the design and implementation of the Trajectory system and the lessons learned during the exercise.

Raven-II: an open platform for surgical robotics research.

PubMed

Hannaford, Blake; Rosen, Jacob; Friedman, Diana W; King, Hawkeye; Roan, Phillip; Cheng, Lei; Glozman, Daniel; Ma, Ji; Kosari, Sina Nia; White, Lee

2013-04-01

The Raven-II is a platform for collaborative research on advances in surgical robotics. Seven universities have begun research using this platform. The Raven-II system has two 3-DOF spherical positioning mechanisms capable of attaching interchangeable four DOF instruments. The Raven-II software is based on open standards such as Linux and ROS to maximally facilitate software development. The mechanism is robust enough for repeated experiments and animal surgery experiments, but is not engineered to sufficient safety standards for human use. Mechanisms in place for interaction among the user community and dissemination of results include an electronic forum, an online software SVN repository, and meetings and workshops at major robotics conferences.

Rodent Bone Marrow Micronucleus Assay. Test Substance: Solvent Yellow 33 2-(2-Quinolyl)-1,3-indandione

DTIC Science & Technology

2011-01-18

Observations, and Micronucleus Scoring Data Table 10: Summary of Micronucleus Assay Results Appendix I: Software Systems Attachment A: Material Safety ...compliance with U.S. Food and Drug Administration regulations set forth in 21 CFR, Part 58, and with the Organization for Economic Co-Operation and...Solubility: Insoluble in water pH: 7 Storage Conditions: Room Temperature Safety Precautions: Standard Toxikon Laboratory Safety Precautions, Bovine

Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

NASA Technical Reports Server (NTRS)

Guarro, Sergio B.

2010-01-01

This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

Global Precipitation Measurement (GPM) Safety Inhibit Timeline Tool

NASA Technical Reports Server (NTRS)

Dion, Shirley

2012-01-01

The Global Precipitation Measurement (GPM) Observatory is a joint mission under the partnership by National Aeronautics and Space Administration (NASA) and the Japan Aerospace Exploration Agency (JAXA), Japan. The NASA Goddard Space Flight Center (GSFC) has the lead management responsibility for NASA on GPM. The GPM program will measure precipitation on a global basis with sufficient quality, Earth coverage, and sampling to improve prediction of the Earth's climate, weather, and specific components of the global water cycle. As part of the development process, NASA built the spacecraft (built in-house at GSFC) and provided one instrument (GPM Microwave Imager (GMI) developed by Ball Aerospace) JAXA provided the launch vehicle (H2-A by MHI) and provided one instrument (Dual-Frequency Precipitation Radar (DPR) developed by NTSpace). Each instrument developer provided a safety assessment which was incorporated into the NASA GPM Safety Hazard Assessment. Inhibit design was reviewed for hazardous subsystems which included the High Gain Antenna System (HGAS) deployment, solar array deployment, transmitter turn on, propulsion system release, GMI deployment, and DPR radar turn on. The safety inhibits for these listed hazards are controlled by software. GPM developed a "pathfinder" approach for reviewing software that controls the electrical inhibits. This is one of the first GSFC in-house programs that extensively used software controls. The GPM safety team developed a methodology to document software safety as part of the standard hazard report. As part of this process a new tool "safety inhibit time line" was created for management of inhibits and their controls during spacecraft buildup and testing during 1& Tat GSFC and at the Range in Japan. In addition to understanding inhibits and controls during 1& T the tool allows the safety analyst to better communicate with others the changes in inhibit states with each phase of hardware and software testing. The tool was very useful for communicating compliance with safety requirements especially when working with a foreign partner.

Healthcare software assurance.

PubMed

Cooper, Jason G; Pauley, Keith A

2006-01-01

Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA's software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted.

Healthcare Software Assurance

PubMed Central

Cooper, Jason G.; Pauley, Keith A.

2006-01-01

Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA’s software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. PMID:17238324

Development and Evaluation of a Computer-Based Program for Assessing Quality of Family Medicine Teams Based on Accreditation Standards

PubMed Central

Valjevac, Salih; Ridjanovic, Zoran; Masic, Izet

2009-01-01

CONFLICT OF INTEREST: NONE DECLARED SUMMARY Introduction Agency for healthcare quality and accreditation in Federation of Bosnia and Herzegovina (AKAZ) is authorized body in the field of healthcare quality and safety improvement and accreditation of healthcare institutions. Beside accreditation standards for hospitals and primary health care centers, AKAZ has also developed accreditation standards for family medicine teams. Methods Software development was primarily based on Accreditation Standards for Family Medicine Teams. Seven chapters / topics: (1. Physical factors; 2. Equipment; 3. Organization and Management; 4. Health promotion and illness prevention; 5. Clinical services; 6. Patient survey; and 7. Patient’s rights and obligations) contain 35 standards describing expected level of family medicine team’s quality. Based on accreditation standards structure and needs of different potential users, it was concluded that software backbone should be a database containing all accreditation standards, self assessment and external assessment details. In this article we will present the development of standardized software for self and external evaluation of quality of service in family medicine, as well as plans for the future development of this software package. Conclusion Electronic data gathering and storing enhances the management, access and overall use of information. During this project we came to conclusion that software for self assessment and external assessment is ideal for accreditation standards distribution, their overview by the family medicine team members, their self assessment and external assessment. PMID:24109157

Continuous quality improvement using intelligent infusion pump data analysis.

PubMed

Breland, Burnis D

2010-09-01

The use of continuous quality-improvement (CQI) processes in the implementation of intelligent infusion pumps in a community teaching hospital is described. After the decision was made to implement intelligent i.v. infusion pumps in a 413-bed, community teaching hospital, drug libraries for use in the safety software had to be created. Before drug libraries could be created, it was necessary to determine the epidemiology of medication use in various clinical care areas. Standardization of medication administration was performed through the CQI process, using practical knowledge of clinicians at the bedside and evidence-based drug safety parameters in the scientific literature. Post-implementation, CQI allowed refinement of clinically important safety limits while minimizing inappropriate, meaningless soft limit alerts on a few select agents. Assigning individual clinical care areas (CCAs) to individual patient care units facilitated customization of drug libraries and identification of specific CCA compliance concerns. Between June 2007 and June 2008, there were seven library updates. These involved drug additions and deletions, customization of individual CCAs, and alterations of limits. Overall compliance with safety software use rose over time, from 33% in November 2006 to over 98% in December 2009. Many potentially clinically significant dosing errors were intercepted by the safety software, prompting edits by end users. Only 4-6% of soft limit alerts resulted in edits. Compliance rates for use of infusion pump safety software varied among CCAs over time. Education, auditing, and refinement of drug libraries led to improved compliance in most CCAs.

Guidance and Control Software Project Data - Volume 1: Planning Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the planning documents from the GCS project. Volume 1 contains five appendices: A. Plan for Software Aspects of Certification for the Guidance and Control Software Project; B. Software Development Standards for the Guidance and Control Software Project; C. Software Verification Plan for the Guidance and Control Software Project; D. Software Configuration Management Plan for the Guidance and Control Software Project; and E. Software Quality Assurance Activities.

16 CFR 1211.8 - Secondary entrapment protection requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... device shall comply with the Standard for Safety for Software in Programmable Components, UL 1998, Second... on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov...

16 CFR 1211.8 - Secondary entrapment protection requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... device shall comply with the Standard for Safety for Software in Programmable Components, UL 1998, Second... on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov...

16 CFR 1211.8 - Secondary entrapment protection requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... device shall comply with the Standard for Safety for Software in Programmable Components, UL 1998, Second... on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov...

16 CFR 1211.8 - Secondary entrapment protection requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... device shall comply with the Standard for Safety for Software in Programmable Components, UL 1998, Second... on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov...

Analysis of Software Development Methodologies to Build Safety Software Applications for the SATEX-II: A Mexican Experimental Satellite

NASA Astrophysics Data System (ADS)

Aguilar Cisneros, Jorge; Vargas Martinez, Hector; Pedroza Melendez, Alejandro; Alonso Arevalo, Miguel

2013-09-01

Mexico is a country where the experience to build software for satellite applications is beginning. This is a delicate situation because in the near future we will need to develop software for the SATEX-II (Mexican Experimental Satellite). SATEX- II is a SOMECyTA's project (the Mexican Society of Aerospace Science and Technology). We have experienced applying software development methodologies, like TSP (Team Software Process) and SCRUM in other areas. Then, we analyzed these methodologies and we concluded: these can be applied to develop software for the SATEX-II, also, we supported these methodologies with SSP-05-0 Standard in particular with ESA PSS-05-11. Our analysis was focusing on main characteristics of each methodology and how these methodologies could be used with the ESA PSS 05-0 Standards. Our outcomes, in general, may be used by teams who need to build small satellites, but, in particular, these are going to be used when we will build the on board software applications for the SATEX-II.

16 CFR § 1211.8 - Secondary entrapment protection requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... device shall comply with the Standard for Safety for Software in Programmable Components, UL 1998, Second... on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov...

A methodology for model-based development and automated verification of software for aerospace systems

NASA Astrophysics Data System (ADS)

Martin, L.; Schatalov, M.; Hagner, M.; Goltz, U.; Maibaum, O.

Today's software for aerospace systems typically is very complex. This is due to the increasing number of features as well as the high demand for safety, reliability, and quality. This complexity also leads to significant higher software development costs. To handle the software complexity, a structured development process is necessary. Additionally, compliance with relevant standards for quality assurance is a mandatory concern. To assure high software quality, techniques for verification are necessary. Besides traditional techniques like testing, automated verification techniques like model checking become more popular. The latter examine the whole state space and, consequently, result in a full test coverage. Nevertheless, despite the obvious advantages, this technique is rarely yet used for the development of aerospace systems. In this paper, we propose a tool-supported methodology for the development and formal verification of safety-critical software in the aerospace domain. The methodology relies on the V-Model and defines a comprehensive work flow for model-based software development as well as automated verification in compliance to the European standard series ECSS-E-ST-40C. Furthermore, our methodology supports the generation and deployment of code. For tool support we use the tool SCADE Suite (Esterel Technology), an integrated design environment that covers all the requirements for our methodology. The SCADE Suite is well established in avionics and defense, rail transportation, energy and heavy equipment industries. For evaluation purposes, we apply our approach to an up-to-date case study of the TET-1 satellite bus. In particular, the attitude and orbit control software is considered. The behavioral models for the subsystem are developed, formally verified, and optimized.

Software safety - A user's practical perspective

NASA Technical Reports Server (NTRS)

Dunn, William R.; Corliss, Lloyd D.

1990-01-01

Software safety assurance philosophy and practices at the NASA Ames are discussed. It is shown that, to be safe, software must be error-free. Software developments on two digital flight control systems and two ground facility systems are examined, including the overall system and software organization and function, the software-safety issues, and their resolution. The effectiveness of safety assurance methods is discussed, including conventional life-cycle practices, verification and validation testing, software safety analysis, and formal design methods. It is concluded (1) that a practical software safety technology does not yet exist, (2) that it is unlikely that a set of general-purpose analytical techniques can be developed for proving that software is safe, and (3) that successful software safety-assurance practices will have to take into account the detailed design processes employed and show that the software will execute correctly under all possible conditions.

Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

NASA Astrophysics Data System (ADS)

Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

2013-09-01

There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

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.

Safe and Secure Partitioning with Pikeos: Towards Integrated Modular Avionics in Space

NASA Astrophysics Data System (ADS)

Almeida, J.; Prochazka, M.

2009-05-01

This paper presents our approach to logical partitioning of spacecraft onboard software. We present PikeOS, a separation micro-kernel which applies the state-of-the- art techniques and widely recognised standards such as ARINC 653 and MILS in order to guarantee safety and security properties of partitions executing software with different criticality and confidentiality. We provide an overview of our approach, also used in the Securely Partitioning Spacecraft Computing Resources project, an ESA TRP contract, which shifts spacecraft onboard software development towards the Integrated Modular Avionics concept with relevance for dual-use military and civil missions.

Infusing Reliability Techniques into Software Safety Analysis

NASA Technical Reports Server (NTRS)

Shi, Ying

2015-01-01

Software safety analysis for a large software intensive system is always a challenge. Software safety practitioners need to ensure that software related hazards are completely identified, controlled, and tracked. This paper discusses in detail how to incorporate the traditional reliability techniques into the entire software safety analysis process. In addition, this paper addresses how information can be effectively shared between the various practitioners involved in the software safety analyses. The author has successfully applied the approach to several aerospace applications. Examples are provided to illustrate the key steps of the proposed approach.

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 the system to be built. Shortly thereafter, as the system requirements are being defined, the second iteration of hazard analyses takes place, the systems hazard analysis (SHA). During the systems requirements phase, decisions are made as to what functions of the system will be the responsibility of software. This is the most critical time to affect the safety of the software. From this point, software safety analyses as well as software engineering practices are the main focus for assuring safe software. While many of the steps proposed in this paper seem like just sound engineering practices, they are the best technical and most cost effective means to assure safe software within a safe system.

Software system safety

NASA Technical Reports Server (NTRS)

Uber, James G.

1988-01-01

Software itself is not hazardous, but since software and hardware share common interfaces there is an opportunity for software to create hazards. Further, these software systems are complex, and proven methods for the design, analysis, and measurement of software safety are not yet available. Some past software failures, future NASA software trends, software engineering methods, and tools and techniques for various software safety analyses are reviewed. Recommendations to NASA are made based on this review.

Software Design Improvements. Part 2; Software Quality and the Design and Inspection Process

NASA Technical Reports Server (NTRS)

Lalli, Vincent R.; Packard, Michael H.; Ziemianski, Tom

1997-01-01

The application of assurance engineering techniques improves the duration of failure-free performance of software. The totality of features and characteristics of a software product are what determine its ability to satisfy customer needs. Software in safety-critical systems is very important to NASA. We follow the System Safety Working Groups definition for system safety software as: 'The optimization of system safety in the design, development, use and maintenance of software and its integration with safety-critical systems in an operational environment. 'If it is not safe, say so' has become our motto. This paper goes over methods that have been used by NASA to make software design improvements by focusing on software quality and the design and inspection process.

Assessment of the Draft AIAA S-119 Flight Dynamic Model Exchange Standard

NASA Technical Reports Server (NTRS)

Jackson, E. Bruce; Murri, Daniel G.; Hill, Melissa A.; Jessick, Matthew V.; Penn, John M.; Hasan, David A.; Crues, Edwin Z.; Falck, Robert D.; McCarthy, Thomas G.; Vuong, Nghia;

49 CFR 238.105 - Train electronic hardware and software safety.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Train electronic hardware and software safety. 238... and General Requirements § 238.105 Train electronic hardware and software safety. The requirements of this section apply to electronic hardware and software used to control or monitor safety functions in...

49 CFR 238.105 - Train electronic hardware and software safety.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Train electronic hardware and software safety. 238... and General Requirements § 238.105 Train electronic hardware and software safety. The requirements of this section apply to electronic hardware and software used to control or monitor safety functions in...

49 CFR 238.105 - Train electronic hardware and software safety.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Train electronic hardware and software safety. 238... and General Requirements § 238.105 Train electronic hardware and software safety. The requirements of this section apply to electronic hardware and software used to control or monitor safety functions in...

49 CFR 238.105 - Train electronic hardware and software safety.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Train electronic hardware and software safety. 238... and General Requirements § 238.105 Train electronic hardware and software safety. The requirements of this section apply to electronic hardware and software used to control or monitor safety functions in...

78 FR 47804 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

..., ``Configuration Management Plans for Digital Computer Software used in Safety Systems of Nuclear Power Plants... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants.'' This...

Software-Based Safety Systems in Space - Learning from other Domains

NASA Astrophysics Data System (ADS)

Klicker, M.; Putzer, H.

2012-01-01

Increasing complexity and new emerging capabilities for manned and unmanned missions have been the hallmark of the past decades of space exploration. One of the drivers in this process was the ever increasing use of software and software-intensive systems to implement system functions necessary to the capabilities needed. The course of technological evolution suggests that this development will continue well into the future with a number of challenges for the safety community some of which shall be discussed in this paper. The current state of the art reveals a number of problems with developing and assessing safety critical software which explains the reluctance of the space community to rely on software-based safety measures to mitigate hazards. Among others, usually lack of trustworthy evidence of software integrity in all foreseeable situations and the difficulties to integrate software in the traditional safety analysis framework are cited. Experience from other domains and recent developments in modern software development methodologies and verification techniques are analysed for the suitability for space systems and an avionics architectural framework (see STANAG 4626) for the implementation of safety critical software is proposed. This is shown to create among other features the possibility of numerous degradation modes enhancing overall system safety and interoperability of computerized space systems. It also potentially simplifies international cooperation on a technical level by introducing a higher degree of compatibility. As software safety cannot be tested or argued into a system in hindsight, the development process and especially the architecture chosen are essential to establish safety properties for the software used to implement safety functions. The core of the safety argument revolves around the separation of different functions and software modules from each other by minimal coupling of functions and credible separation mechanisms in the architecture combined with rigorous development methodologies for the software itself.

Guidance and Control Software Project Data - Volume 2: Development Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the development documents from the GCS project. Volume 2 contains three appendices: A. Guidance and Control Software Development Specification; B. Design Description for the Pluto Implementation of the Guidance and Control Software; and C. Source Code for the Pluto Implementation of the Guidance and Control Software

The Role and Quality of Software Safety in the NASA Constellation Program

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor R.; Zelkowitz, Marvin V.

2010-01-01

In this study, we examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Obtaining an accurate, program-wide picture of software safety risk is difficult across multiple, independently-developing systems. We leverage one source of safety information, hazard analysis, to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. The goal of this research is two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to quantify the level of risk presented by software in the hazard analysis. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. To quantify the importance of software, we collected metrics based on the number of software-related causes and controls of hazardous conditions. To quantify the level of risk presented by software, we created a metric scheme to measure the specificity of these software causes. We found that from 49-70% of hazardous conditions in the three systems could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. Furthermore, 10-12% of all controls were software-based. There is potential for inaccuracy in these counts, however, as software causes are not consistently scoped, and the presence of software in a cause or control is not always clear. The application of our software specificity metrics also identified risks in the hazard reporting process. In particular, we found a number of traceability risks in the hazard reports may impede verification of software and system safety.

Guidance and Control Software Project Data - Volume 3: Verification Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the verification documents from the GCS project. Volume 3 contains four appendices: A. Software Verification Cases and Procedures for the Guidance and Control Software Project; B. Software Verification Results for the Pluto Implementation of the Guidance and Control Software; C. Review Records for the Pluto Implementation of the Guidance and Control Software; and D. Test Results Logs for the Pluto Implementation of the Guidance and Control Software.

Guidance and Control Software Project Data - Volume 4: Configuration Management and Quality Assurance Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes configuration management and quality assurance documents from the GCS project. Volume 4 contains six appendices: A. Software Accomplishment Summary for the Guidance and Control Software Project; B. Software Configuration Index for the Guidance and Control Software Project; C. Configuration Management Records for the Guidance and Control Software Project; D. Software Quality Assurance Records for the Guidance and Control Software Project; E. Problem Report for the Pluto Implementation of the Guidance and Control Software Project; and F. Support Documentation Change Reports for the Guidance and Control Software Project.

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

2010-01-01

We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

PubMed

Ronquillo, Jay G; Zuckerman, Diana M

2017-09-01

Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety. Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices. © 2017 Milbank Memorial Fund.

Mitigating Motion Base Safety Issues: The NASA LaRC CMF Implementation

NASA Technical Reports Server (NTRS)

Bryant, Richard B., Jr.; Grupton, Lawrence E.; Martinez, Debbie; Carrelli, David J.

2005-01-01

The NASA Langley Research Center (LaRC), Cockpit Motion Facility (CMF) motion base design has taken advantage of inherent hydraulic characteristics to implement safety features using hardware solutions only. Motion system safety has always been a concern and its implementation is addressed differently by each organization. Some approaches rely heavily on software safety features. Software which performs safety functions is subject to more scrutiny making its approval, modification, and development time consuming and expensive. The NASA LaRC's CMF motion system is used for research and, as such, requires that the software be updated or modified frequently. The CMF's customers need the ability to update the simulation software frequently without the associated cost incurred with safety critical software. This paper describes the CMF engineering team's approach to achieving motion base safety by designing and implementing all safety features in hardware, resulting in applications software (including motion cueing and actuator dynamic control) being completely independent of the safety devices. This allows the CMF safety systems to remain intact and unaffected by frequent research system modifications.

Cellular Radio Telecommunication for Health Care: Benefits and Risks

PubMed Central

Sneiderman, Charles A.; Ackerman, Michael J.

2004-01-01

Cellular radio telecommunication has increased exponentially with many applications to health care reported. The authors attempt to summarize published applications with demonstrated effect on health care, review briefly the rapid evolution of hardware and software standards, explain current limitations and future potential of data quality and security, and discuss issues of safety. PMID:15298996

Modeling and Hazard Analysis Using STPA

NASA Astrophysics Data System (ADS)

Ishimatsu, Takuto; Leveson, Nancy; Thomas, John; Katahira, Masa; Miyamoto, Yuko; Nakao, Haruka

2010-09-01

A joint research project between MIT and JAXA/JAMSS is investigating the application of a new hazard analysis to the system and software in the HTV. Traditional hazard analysis focuses on component failures but software does not fail in this way. Software most often contributes to accidents by commanding the spacecraft into an unsafe state(e.g., turning off the descent engines prematurely) or by not issuing required commands. That makes the standard hazard analysis techniques of limited usefulness on software-intensive systems, which describes most spacecraft built today. STPA is a new hazard analysis technique based on systems theory rather than reliability theory. It treats safety as a control problem rather than a failure problem. The goal of STPA, which is to create a set of scenarios that can lead to a hazard, is the same as FTA but STPA includes a broader set of potential scenarios including those in which no failures occur but the problems arise due to unsafe and unintended interactions among the system components. STPA also provides more guidance to the analysts that traditional fault tree analysis. Functional control diagrams are used to guide the analysis. In addition, JAXA uses a model-based system engineering development environment(created originally by Leveson and called SpecTRM) which also assists in the hazard analysis. One of the advantages of STPA is that it can be applied early in the system engineering and development process in a safety-driven design process where hazard analysis drives the design decisions rather than waiting until reviews identify problems that are then costly or difficult to fix. It can also be applied in an after-the-fact analysis and hazard assessment, which is what we did in this case study. This paper describes the experimental application of STPA to the JAXA HTV in order to determine the feasibility and usefulness of the new hazard analysis technique. Because the HTV was originally developed using fault tree analysis and following the NASA standards for safety-critical systems, the results of our experimental application of STPA can be compared with these more traditional safety engineering approaches in terms of the problems identified and the resources required to use it.

OSI for hardware/software interoperability

NASA Astrophysics Data System (ADS)

Wood, Richard J.; Harvey, Donald L.; Linderman, Richard W.; Gardener, Gary A.; Capraro, Gerard T.

1994-03-01

There is a need in public safety for real-time data collection and transmission from one or more sensors. The Rome Laboratory and the Ballistic Missile Defense Organization are pursuing an effort to bring the benefits of Open System Architectures (OSA) to embedded systems within the Department of Defense. When developed properly OSA provides interoperability, commonality, graceful upgradeability, survivability and hardware/software transportability to greatly minimize life cycle costs, integration and supportability. Architecture flexibility can be achieved to take advantage of commercial accomplishments by basing these developments on vendor-neutral commercially accepted standards and protocols.

77 FR 50723 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., ``Verification, Validation, Reviews, and Audits for Digital Computer Software used in Safety Systems of Nuclear... NRC regulations promoting the development of, and compliance with, software verification and...

Autonomous Real Time Requirements Tracing

NASA Technical Reports Server (NTRS)

Plattsmier, George I.; Stetson, Howard K.

2014-01-01

One of the more challenging aspects of software development is the ability to verify and validate the functional software requirements dictated by the Software Requirements Specification (SRS) and the Software Detail Design (SDD). Insuring the software has achieved the intended requirements is the responsibility of the Software Quality team and the Software Test team. The utilization of Timeliner-TLX(sup TM) Auto-Procedures for relocating ground operations positions to ISS automated on-board operations has begun the transition that would be required for manned deep space missions with minimal crew requirements. This transition also moves the auto-procedures from the procedure realm into the flight software arena and as such the operational requirements and testing will be more structured and rigorous. The autoprocedures would be required to meet NASA software standards as specified in the Software Safety Standard (NASASTD- 8719), the Software Engineering Requirements (NPR 7150), the Software Assurance Standard (NASA-STD-8739) and also the Human Rating Requirements (NPR-8705). The Autonomous Fluid Transfer System (AFTS) test-bed utilizes the Timeliner-TLX(sup TM) Language for development of autonomous command and control software. The Timeliner- TLX(sup TM) system has the unique feature of providing the current line of the statement in execution during real-time execution of the software. The feature of execution line number internal reporting unlocks the capability of monitoring the execution autonomously by use of a companion Timeliner-TLX(sup TM) sequence as the line number reporting is embedded inside the Timeliner-TLX(sup TM) execution engine. This negates I/O processing of this type data as the line number status of executing sequences is built-in as a function reference. This paper will outline the design and capabilities of the AFTS Autonomous Requirements Tracker, which traces and logs SRS requirements as they are being met during real-time execution of the targeted system. It is envisioned that real time requirements tracing will greatly assist the movement of autoprocedures to flight software enhancing the software assurance of auto-procedures and also their acceptance as reliable commanders

Autonomous Real Time Requirements Tracing

NASA Technical Reports Server (NTRS)

Plattsmier, George; Stetson, Howard

2014-01-01

One of the more challenging aspects of software development is the ability to verify and validate the functional software requirements dictated by the Software Requirements Specification (SRS) and the Software Detail Design (SDD). Insuring the software has achieved the intended requirements is the responsibility of the Software Quality team and the Software Test team. The utilization of Timeliner-TLX(sup TM) Auto- Procedures for relocating ground operations positions to ISS automated on-board operations has begun the transition that would be required for manned deep space missions with minimal crew requirements. This transition also moves the auto-procedures from the procedure realm into the flight software arena and as such the operational requirements and testing will be more structured and rigorous. The autoprocedures would be required to meet NASA software standards as specified in the Software Safety Standard (NASASTD- 8719), the Software Engineering Requirements (NPR 7150), the Software Assurance Standard (NASA-STD-8739) and also the Human Rating Requirements (NPR-8705). The Autonomous Fluid Transfer System (AFTS) test-bed utilizes the Timeliner-TLX(sup TM) Language for development of autonomous command and control software. The Timeliner-TLX(sup TM) system has the unique feature of providing the current line of the statement in execution during real-time execution of the software. The feature of execution line number internal reporting unlocks the capability of monitoring the execution autonomously by use of a companion Timeliner-TLX(sup TM) sequence as the line number reporting is embedded inside the Timeliner-TLX(sup TM) execution engine. This negates I/O processing of this type data as the line number status of executing sequences is built-in as a function reference. This paper will outline the design and capabilities of the AFTS Autonomous Requirements Tracker, which traces and logs SRS requirements as they are being met during real-time execution of the targeted system. It is envisioned that real time requirements tracing will greatly assist the movement of autoprocedures to flight software enhancing the software assurance of auto-procedures and also their acceptance as reliable commanders.

How Safe Is Control Software

NASA Technical Reports Server (NTRS)

Dunn, William R.; Corliss, Lloyd D.

1991-01-01

Paper examines issue of software safety. Presents four case histories of software-safety analysis. Concludes that, to be safe, software, for all practical purposes, must be free of errors. Backup systems still needed to prevent catastrophic software failures.

Software development for safety-critical medical applications

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

There are many computer-based medical applications in which safety and not reliability is the overriding concern. Reduced, altered, or no functionality of such systems is acceptable as long as no harm is done. A precise, formal definition of what software safety means is essential, however, before any attempt can be made to achieve it. Without this definition, it is not possible to determine whether a specific software entity is safe. A set of definitions pertaining to software safety will be presented and a case study involving an experimental medical device will be described. Some new techniques aimed at improving software safety will also be discussed.

49 CFR 238.105 - Train electronic hardware and software safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and software system safety as part of the pre-revenue service testing of the equipment. (d)(1... safely by initiating a full service brake application in the event of a hardware or software failure that... 49 Transportation 4 2010-10-01 2010-10-01 false Train electronic hardware and software safety. 238...

A Formal Application of Safety and Risk Assessment in Software Systems

DTIC Science & Technology

2004-09-01

characteristics of Software Engineering, Development, and Safety...against a comparison of planned and actual schedules, costs, and characteristics . Software Safety is focused on the reduction of unsafe incidents...they merely carry out the role for which they were anatomically designed.55 Software is characteristically like an anatomical cell as it merely

A Case Study of Measuring Process Risk for Early Insights into Software Safety

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

2011-01-01

In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

SafetyAnalyst : software tools for safety management of specific highway sites

DOT National Transportation Integrated Search

2010-07-01

SafetyAnalyst provides a set of software tools for use by state and local highway agencies for highway safety management. SafetyAnalyst can be used by highway agencies to improve their programming of site-specific highway safety improvements. SafetyA...

Resilience Engineering in Critical Long Term Aerospace Software Systems: A New Approach to Spacecraft Software Safety

NASA Astrophysics Data System (ADS)

Dulo, D. A.

Safety critical software systems permeate spacecraft, and in a long term venture like a starship would be pervasive in every system of the spacecraft. Yet software failure today continues to plague both the systems and the organizations that develop them resulting in the loss of life, time, money, and valuable system platforms. A starship cannot afford this type of software failure in long journeys away from home. A single software failure could have catastrophic results for the spaceship and the crew onboard. This paper will offer a new approach to developing safe reliable software systems through focusing not on the traditional safety/reliability engineering paradigms but rather by focusing on a new paradigm: Resilience and Failure Obviation Engineering. The foremost objective of this approach is the obviation of failure, coupled with the ability of a software system to prevent or adapt to complex changing conditions in real time as a safety valve should failure occur to ensure safe system continuity. Through this approach, safety is ensured through foresight to anticipate failure and to adapt to risk in real time before failure occurs. In a starship, this type of software engineering is vital. Through software developed in a resilient manner, a starship would have reduced or eliminated software failure, and would have the ability to rapidly adapt should a software system become unstable or unsafe. As a result, long term software safety, reliability, and resilience would be present for a successful long term starship mission.

An Assessment of Software Safety as Applied to the Department of Defense Software Development Process

DTIC Science & Technology

1992-12-01

provide program 5 managers some level of confidence that their software will operate at an acceptable level of risk. A number of structured safety...safety within the constraints of operational effectiveness, schedule, and cost through timely application of system safety management and engineering...Master of Science in Software Systems Management Peter W. Colan, B.S.E. Robert W. Prouhet, B.S. Captain, USAF Captain, USAF December 1992 Approved for

77 FR 50724 - Developing Software Life Cycle Processes for Digital Computer Software Used in Safety Systems of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Developing Software Life Cycle Processes for Digital... Software Life Cycle Processes for Digital Computer Software used in Safety Systems of Nuclear Power Plants... clarifications, the enhanced consensus practices for developing software life-cycle processes for digital...

Space Station: NASA's software development approach increases safety and cost risks. Report to the Chairman, Committee on Science, Space, and Technology, House of Representatives

NASA Astrophysics Data System (ADS)

1992-06-01

The House Committee on Science, Space, and Technology asked NASA to study software development issues for the space station. How well NASA has implemented key software engineering practices for the station was asked. Specifically, the objectives were to determine: (1) if independent verification and validation techniques are being used to ensure that critical software meets specified requirements and functions; (2) if NASA has incorporated software risk management techniques into program; (3) whether standards are in place that will prescribe a disciplined, uniform approach to software development; and (4) if software support tools will help, as intended, to maximize efficiency in developing and maintaining the software. To meet the objectives, NASA proceeded: (1) reviewing and analyzing software development objectives and strategies contained in NASA conference publications; (2) reviewing and analyzing NASA, other government, and industry guidelines for establishing good software development practices; (3) reviewing and analyzing technical proposals and contracts; (4) reviewing and analyzing software management plans, risk management plans, and program requirements; (4) reviewing and analyzing reports prepared by NASA and contractor officials that identified key issues and challenges facing the program; (5) obtaining expert opinions on what constitutes appropriate independent V-and-V and software risk management activities; (6) interviewing program officials at NASA headquarters in Washington, DC; at the Space Station Program Office in Reston, Virginia; and at the three work package centers; Johnson in Houston, Texas; Marshall in Huntsville, Alabama; and Lewis in Cleveland, Ohio; and (7) interviewing contractor officials doing work for NASA at Johnson and Marshall. The audit work was performed in accordance with generally accepted government auditing standards, between April 1991 and May 1992.

Driving Innovation in Health Systems through an Apps-Based Information Economy

PubMed Central

Mandel, Joshua C.; Kohane, Isaac S.

2015-01-01

Healthcare data will soon be accessible using standard, open software interfaces. Here, we describe how these interfaces could lead to improved healthcare by facilitating the development of software applications (apps) that can be shared across physicians, health care organizations, translational researchers, and patients. We provide recommendations for next steps and resources for the myriad stakeholders. If challenges related to efficacy, accuracy, utility, safety, privacy, and security can be met, this emerging apps model for health information technology will open up the point of care for innovation and connect patients at home to their healthcare data. PMID:26339683

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

77 FR 50722 - Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Unit Testing for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1208, ``Software Unit Testing for Digital Computer Software used in Safety Systems of Nuclear Power Plants.'' The DG-1208 is proposed...

A performance improvement plan to increase nurse adherence to use of medication safety software.

PubMed

Gavriloff, Carrie

2012-08-01

Nurses can protect patients receiving intravenous (IV) medication by using medication safety software to program "smart" pumps to administer IV medications. After a patient safety event identified inconsistent use of medication safety software by nurses, a performance improvement team implemented the Deming Cycle performance improvement methodology. The combined use of improved direct care nurse communication, programming strategies, staff education, medication safety champions, adherence monitoring, and technology acquisition resulted in a statistically significant (p < .001) increase in nurse adherence to using medication safety software from 28% to above 85%, exceeding national benchmark adherence rates (Cohen, Cooke, Husch & Woodley, 2007; Carefusion, 2011). Copyright © 2012 Elsevier Inc. All rights reserved.

Spinoff 2013

NASA Technical Reports Server (NTRS)

2014-01-01

Topics covered include: Innovative Software Tools Measure Behavioral Alertness; Miniaturized, Portable Sensors Monitor Metabolic Health; Patient Simulators Train Emergency Caregivers; Solar Refrigerators Store Life-Saving Vaccines; Monitors Enable Medication Management in Patients' Homes; Handheld Diagnostic Device Delivers Quick Medical Readings; Experiments Result in Safer, Spin-Resistant Aircraft; Interfaces Visualize Data for Airline Safety, Efficiency; Data Mining Tools Make Flights Safer, More Efficient; NASA Standards Inform Comfortable Car Seats; Heat Shield Paves the Way for Commercial Space; Air Systems Provide Life Support to Miners; Coatings Preserve Metal, Stone, Tile, and Concrete; Robots Spur Software That Lends a Hand; Cloud-Based Data Sharing Connects Emergency Managers; Catalytic Converters Maintain Air Quality in Mines; NASA-Enhanced Water Bottles Filter Water on the Go; Brainwave Monitoring Software Improves Distracted Minds; Thermal Materials Protect Priceless, Personal Keepsakes; Home Air Purifiers Eradicate Harmful Pathogens; Thermal Materials Drive Professional Apparel Line; Radiant Barriers Save Energy in Buildings; Open Source Initiative Powers Real-Time Data Streams; Shuttle Engine Designs Revolutionize Solar Power; Procedure-Authoring Tool Improves Safety on Oil Rigs; Satellite Data Aid Monitoring of Nation's Forests; Mars Technologies Spawn Durable Wind Turbines; Programs Visualize Earth and Space for Interactive Education; Processor Units Reduce Satellite Construction Costs; Software Accelerates Computing Time for Complex Math; Simulation Tools Prevent Signal Interference on Spacecraft; Software Simplifies the Sharing of Numerical Models; Virtual Machine Language Controls Remote Devices; Micro-Accelerometers Monitor Equipment Health; Reactors Save Energy, Costs for Hydrogen Production; Cameras Monitor Spacecraft Integrity to Prevent Failures; Testing Devices Garner Data on Insulation Performance; Smart Sensors Gather Information for Machine Diagnostics; Oxygen Sensors Monitor Bioreactors and Ensure Health and Safety; Vision Algorithms Catch Defects in Screen Displays; and Deformable Mirrors Capture Exoplanet Data, Reflect Lasers.

Automated Reuse of Scientific Subroutine Libraries through Deductive Synthesis

NASA Technical Reports Server (NTRS)

Lowry, Michael R.; Pressburger, Thomas; VanBaalen, Jeffrey; Roach, Steven

1997-01-01

Systematic software construction offers the potential of elevating software engineering from an art-form to an engineering discipline. The desired result is more predictable software development leading to better quality and more maintainable software. However, the overhead costs associated with the formalisms, mathematics, and methods of systematic software construction have largely precluded their adoption in real-world software development. In fact, many mainstream software development organizations, such as Microsoft, still maintain a predominantly oral culture for software development projects; which is far removed from a formalism-based culture for software development. An exception is the limited domain of safety-critical software, where the high-assuiance inherent in systematic software construction justifies the additional cost. We believe that systematic software construction will only be adopted by mainstream software development organization when the overhead costs have been greatly reduced. Two approaches to cost mitigation are reuse (amortizing costs over many applications) and automation. For the last four years, NASA Ames has funded the Amphion project, whose objective is to automate software reuse through techniques from systematic software construction. In particular, deductive program synthesis (i.e., program extraction from proofs) is used to derive a composition of software components (e.g., subroutines) that correctly implements a specification. The construction of reuse libraries of software components is the standard software engineering solution for improving software development productivity and quality.

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...

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].

Computing Q-D Relationships for Storage of Rocket Fuels

NASA Technical Reports Server (NTRS)

Jester, Keith

2005-01-01

The Quantity Distance Measurement Tool is a GIS BASEP computer program that aids safety engineers by calculating quantity-distance (Q-D) relationships for vessels that contain explosive chemicals used in testing rocket engines. (Q-D relationships are standard relationships between specified quantities of specified explosive materials and minimum distances by which they must be separated from persons, objects, and other explosives to obtain specified types and degrees of protection.) The program uses customized geographic-information-system (GIS) software and calculates Q-D relationships in accordance with NASA's Safety Standard For Explosives, Propellants, and Pyrotechnics. Displays generated by the program enable the identification of hazards, showing the relationships of propellant-storage-vessel safety buffers to inhabited facilities and public roads. Current Q-D information is calculated and maintained in graphical form for all vessels that contain propellants or other chemicals, the explosiveness of which is expressed in TNT equivalents [amounts of trinitrotoluene (TNT) having equivalent explosive effects]. The program is useful in the acquisition, siting, construction, and/or modification of storage vessels and other facilities in the development of an improved test-facility safety program.

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Stephen B.

2010-01-01

Software plays an increasingly larger role in all aspects of NASA's science missions. This has been extended to the identification, management and control of faults which affect safety-critical functions and by default, the overall success of the mission. Traditionally, the analysis of fault identification, management and control are hardware based. Due to the increasing complexity of system, there has been a corresponding increase in the complexity in fault management software. The NASA Independent Validation & Verification (IV&V) program is creating processes and procedures to identify, and incorporate safety-critical software requirements along with corresponding software faults so that potential hazards may be mitigated. This Specific to Generic ... A Case for Reuse paper describes the phases of a dependability and safety study which identifies a new, process to create a foundation for reusable assets. These assets support the identification and management of specific software faults and, their transformation from specific to generic software faults. This approach also has applications to other systems outside of the NASA environment. This paper addresses how a mission specific dependability and safety case is being transformed to a generic dependability and safety case which can be reused for any type of space mission with an emphasis on software fault conditions.

Development and analysis of the Software Implemented Fault-Tolerance (SIFT) computer

NASA Technical Reports Server (NTRS)

Goldberg, J.; Kautz, W. H.; Melliar-Smith, P. M.; Green, M. W.; Levitt, K. N.; Schwartz, R. L.; Weinstock, C. B.

1984-01-01

SIFT (Software Implemented Fault Tolerance) is an experimental, fault-tolerant computer system designed to meet the extreme reliability requirements for safety-critical functions in advanced aircraft. Errors are masked by performing a majority voting operation over the results of identical computations, and faulty processors are removed from service by reassigning computations to the nonfaulty processors. This scheme has been implemented in a special architecture using a set of standard Bendix BDX930 processors, augmented by a special asynchronous-broadcast communication interface that provides direct, processor to processor communication among all processors. Fault isolation is accomplished in hardware; all other fault-tolerance functions, together with scheduling and synchronization are implemented exclusively by executive system software. The system reliability is predicted by a Markov model. Mathematical consistency of the system software with respect to the reliability model has been partially verified, using recently developed tools for machine-aided proof of program correctness.

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.

Assessment of Literature Related to Combustion Appliance Venting Systems

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

Rapp, V. H.; Less, B. D.; Singer, B. C.

In many residential building retrofit programs, air tightening to increase energy efficiency is often constrained by safety concerns with naturally vented combustion appliances. Tighter residential buildings more readily depressurize when exhaust equipment is operated, making combustion appliances more prone to backdraft or spill combustion exhaust into the living space. Several measures, such as installation guidelines, vent sizing codes, and combustion safety diagnostics, are in place with the intent to prevent backdrafting and combustion spillage, but the diagnostics conflict and the risk mitigation objective is inconsistent. This literature review summarizes the metrics and diagnostics used to assess combustion safety, documents theirmore » technical basis, and investigates their risk mitigations. It compiles information from the following: codes for combustion appliance venting and installation; standards and guidelines for combustion safety diagnostics; research evaluating combustion safety diagnostics; research investigating wind effects on building depressurization and venting; and software for simulating vent system performance.« less

APMS: An Integrated Suite of Tools for Measuring Performance and Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C.; Lynch, Robert E.; Connors, Mary M. (Technical Monitor)

1997-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data. The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data-analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions. APMS will offer to the air transport community an open, voluntary standard for flight-data-analysis software, a standard that will help to ensure suitable functionality, and data interchangeability, among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs of air crews in mind. APMS tools must serve the needs of the government and air carriers, as well as air crews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the air crew.

The Aviation Performance Measuring System (APMS): An Integrated Suite of Tools for Measuring Performance and Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C.; Connor, Mary M. (Technical Monitor)

1998-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data, The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions. APMS offers to the air transport community an open, voluntary standard for flight-data-analysis software; a standard that will help to ensure suitable functionality and data interchangeability among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs-of aircrews in mind. APMS tools must serve the needs of the government and air carriers, as well as aircrews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but also through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the aircrew.

APMS: An Integrated Suite of Tools for Measuring Performance and Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C. (Technical Monitor)

1997-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data. The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data-analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions . APMS will offer to the air transport community an open, voluntary standard for flight-data-analysis software, a standard that will help to ensure suitable functionality, and data interchangeability, among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs of air crews in mind. APMS tools must serve the needs of the government and air carriers, as well as air crews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the air crew.

APMS: An Integrated Set of Tools for Measuring Safety

NASA Technical Reports Server (NTRS)

Statler, Irving C.; Reynard, William D. (Technical Monitor)

1996-01-01

This is a report of work in progress. In it, I summarize the status of the research and development of the Aviation Performance Measuring System (APMS) for managing, processing, and analyzing digital flight-recorded data. The objectives of the NASA-FAA APMS research project are to establish a sound scientific and technological basis for flight-data analysis, to define an open and flexible architecture for flight-data-analysis systems, and to articulate guidelines for a standardized database structure on which to continue to build future flight-data-analysis extensions. APMS will offer to the air transport community an open, voluntary standard for flight-data-analysis software, a standard that will help to ensure suitable functionality, and data interchangeability, among competing software programs. APMS will develop and document the methodologies, algorithms, and procedures for data management and analyses to enable users to easily interpret the implications regarding safety and efficiency of operations. APMS does not entail the implementation of a nationwide flight-data-collection system. It is intended to provide technical tools to ease the large-scale implementation of flight-data analyses at both the air-carrier and the national-airspace levels in support of their Flight Operations and Quality Assurance (FOQA) Programs and Advanced Qualifications Programs (AQP). APMS cannot meet its objectives unless it develops tools that go substantially beyond the capabilities of the current commercially available software and supporting analytic methods that are mainly designed to count special events. These existing capabilities, while of proven value, were created primarily with the needs of air crews in mind. APMS tools must serve the needs of the government and air carriers, as well as air crews, to fully support the FOQA and AQP programs. They must be able to derive knowledge not only through the analysis of single flights (special-event detection), but through statistical evaluation of the performance of large groups of flights. This paper describes the integrated suite of tools that will assist analysts in evaluating the operational performance and safety of the national air transport system, the air carrier, and the air crew.

Automatic Certification of Kalman Filters for Reliable Code Generation

NASA Technical Reports Server (NTRS)

Denney, Ewen; Fischer, Bernd; Schumann, Johann; Richardson, Julian

2005-01-01

AUTOFILTER is a tool for automatically deriving Kalman filter code from high-level declarative specifications of state estimation problems. It can generate code with a range of algorithmic characteristics and for several target platforms. The tool has been designed with reliability of the generated code in mind and is able to automatically certify that the code it generates is free from various error classes. Since documentation is an important part of software assurance, AUTOFILTER can also automatically generate various human-readable documents, containing both design and safety related information. We discuss how these features address software assurance standards such as DO-178B.

Putting Safety in the Software

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Berens, Kalynnda M.; Hardy, Sandra (Technical Monitor)

2001-01-01

Software is a vital component of nearly every piece of modern technology. It is not a 'sub-system', able to be separated out from the system as a whole, but a 'co-system' that controls, manipulates, or interacts with the hardware and with the end user. Software has its fingers into all the pieces of the pie. If that 'pie', the system, can lead to injury, death, loss of major equipment, or impact your business bottom line, then software safety becomes vitally important. Learning to think about software from a safety perspective is the focus of this paper. We want you to think of software as part of the safety critical system, a major part. This requires 'system thinking' - being able to grasp the whole picture. Software's contribution to modern technology is both good and potentially bad. Software allows more complex and useful devices to be built. It can also contribute to plane crashes and power outages. We want you to see software in a whole new light, see it as a contributor to system hazards, and also as a possible fix or mitigation to some of those hazards.

14 CFR 417.123 - Computing systems and software.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Computing systems and software. 417.123... systems and software. (a) A launch operator must document a system safety process that identifies the... systems and software. (b) A launch operator must identify all safety-critical functions associated with...

14 CFR 417.123 - Computing systems and software.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Computing systems and software. 417.123... systems and software. (a) A launch operator must document a system safety process that identifies the... systems and software. (b) A launch operator must identify all safety-critical functions associated with...

14 CFR 415.123 - Computing systems and software.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Computing systems and software. 415.123... Launch Vehicle From a Non-Federal Launch Site § 415.123 Computing systems and software. (a) An applicant's safety review document must describe all computing systems and software that perform a safety...

14 CFR 415.123 - Computing systems and software.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Computing systems and software. 415.123... Launch Vehicle From a Non-Federal Launch Site § 415.123 Computing systems and software. (a) An applicant's safety review document must describe all computing systems and software that perform a safety...

14 CFR 417.123 - Computing systems and software.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Computing systems and software. 417.123... systems and software. (a) A launch operator must document a system safety process that identifies the... systems and software. (b) A launch operator must identify all safety-critical functions associated with...

14 CFR 417.123 - Computing systems and software.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Computing systems and software. 417.123... systems and software. (a) A launch operator must document a system safety process that identifies the... systems and software. (b) A launch operator must identify all safety-critical functions associated with...

14 CFR 417.123 - Computing systems and software.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Computing systems and software. 417.123... systems and software. (a) A launch operator must document a system safety process that identifies the... systems and software. (b) A launch operator must identify all safety-critical functions associated with...

14 CFR 415.123 - Computing systems and software.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Computing systems and software. 415.123... Launch Vehicle From a Non-Federal Launch Site § 415.123 Computing systems and software. (a) An applicant's safety review document must describe all computing systems and software that perform a safety...

14 CFR 415.123 - Computing systems and software.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Computing systems and software. 415.123... Launch Vehicle From a Non-Federal Launch Site § 415.123 Computing systems and software. (a) An applicant's safety review document must describe all computing systems and software that perform a safety...

14 CFR 415.123 - Computing systems and software.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Computing systems and software. 415.123... Launch Vehicle From a Non-Federal Launch Site § 415.123 Computing systems and software. (a) An applicant's safety review document must describe all computing systems and software that perform a safety...

Analyzing Software Errors in Safety-Critical Embedded Systems

NASA Technical Reports Server (NTRS)

Lutz, Robyn R.

1994-01-01

This paper analyzes the root causes of safty-related software faults identified as potentially hazardous to the system are distributed somewhat differently over the set of possible error causes than non-safety-related software faults.

Development of a Nevada Statewide Database for Safety Analyst Software

DOT National Transportation Integrated Search

2017-02-02

Safety Analyst is a software package developed by the Federal Highway Administration (FHWA) and twenty-seven participating state and local agencies including the Nevada Department of Transportation (NDOT). The software package implemented many of the...

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

Code of Federal Regulations, 2010 CFR

2010-10-01

... system (all its elements including hardware and software) must be designed to assure safe operation with... unsafe errors in the software due to human error in the software specification, design, or coding phases... (hardware or software, or both) are used in combination to ensure safety. If a common mode failure exists...

Generalized implementation of software safety policies

NASA Technical Reports Server (NTRS)

Knight, John C.; Wika, Kevin G.

1994-01-01

As part of a research program in the engineering of software for safety-critical systems, we are performing two case studies. The first case study, which is well underway, is a safety-critical medical application. The second, which is just starting, is a digital control system for a nuclear research reactor. Our goal is to use these case studies to permit us to obtain a better understanding of the issues facing developers of safety-critical systems, and to provide a vehicle for the assessment of research ideas. The case studies are not based on the analysis of existing software development by others. Instead, we are attempting to create software for new and novel systems in a process that ultimately will involve all phases of the software lifecycle. In this abstract, we summarize our results to date in a small part of this project, namely the determination and classification of policies related to software safety that must be enforced to ensure safe operation. We hypothesize that this classification will permit a general approach to the implementation of a policy enforcement mechanism.

Development and evaluation of a web-based software for crash data collection, processing and analysis.

PubMed

Montella, Alfonso; Chiaradonna, Salvatore; Criscuolo, Giorgio; De Martino, Salvatore

2017-02-05

First step of the development of an effective safety management system is to create reliable crash databases since the quality of decision making in road safety depends on the quality of the data on which decisions are based. Improving crash data is a worldwide priority, as highlighted in the Global Plan for the Decade of Action for Road Safety adopted by the United Nations, which recognizes that the overall goal of the plan will be attained improving the quality of data collection at the national, regional and global levels. Crash databases provide the basic information for effective highway safety efforts at any level of government, but lack of uniformity among countries and among the different jurisdictions in the same country is observed. Several existing databases show significant drawbacks which hinder their effective use for safety analysis and improvement. Furthermore, modern technologies offer great potential for significant improvements of existing methods and procedures for crash data collection, processing and analysis. To address these issues, in this paper we present the development and evaluation of a web-based platform-independent software for crash data collection, processing and analysis. The software is designed for mobile and desktop electronic devices and enables a guided and automated drafting of the crash report, assisting police officers both on-site and in the office. The software development was based both on the detailed critical review of existing Australasian, EU, and U.S. crash databases and software as well as on the continuous consultation with the stakeholders. The evaluation was carried out comparing the completeness, timeliness, and accuracy of crash data before and after the use of the software in the city of Vico Equense, in south of Italy showing significant advantages. The amount of collected information increased from 82 variables to 268 variables, i.e., a 227% increase. The time saving was more than one hour per crash, i.e., a 36% reduction. The on-site data collection did not produce time saving, however this is a temporary weakness that will be annihilated very soon in the future after officers are more acquainted with the software. The phase of evaluation, processing and analysis carried out in the office was dramatically shortened, i.e., a 69% reduction. Another benefit was the standardization which allowed fast and consistent data analysis and evaluation. Even if all these benefits are remarkable, the most valuable benefit of the new procedure was the reduction of the police officers mistakes during the manual operations of survey and data evaluation. Because of these benefits, the satisfaction questionnaires administrated to the police officers after the testing phase showed very good acceptance of the procedure. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparison of methods for quantitative evaluation of endoscopic distortion

NASA Astrophysics Data System (ADS)

Wang, Quanzeng; Castro, Kurt; Desai, Viraj N.; Cheng, Wei-Chung; Pfefer, Joshua

2015-03-01

Endoscopy is a well-established paradigm in medical imaging, and emerging endoscopic technologies such as high resolution, capsule and disposable endoscopes promise significant improvements in effectiveness, as well as patient safety and acceptance of endoscopy. However, the field lacks practical standardized test methods to evaluate key optical performance characteristics (OPCs), in particular the geometric distortion caused by fisheye lens effects in clinical endoscopic systems. As a result, it has been difficult to evaluate an endoscope's image quality or assess its changes over time. The goal of this work was to identify optimal techniques for objective, quantitative characterization of distortion that are effective and not burdensome. Specifically, distortion measurements from a commercially available distortion evaluation/correction software package were compared with a custom algorithm based on a local magnification (ML) approach. Measurements were performed using a clinical gastroscope to image square grid targets. Recorded images were analyzed with the ML approach and the commercial software where the results were used to obtain corrected images. Corrected images based on the ML approach and the software were compared. The study showed that the ML method could assess distortion patterns more accurately than the commercial software. Overall, the development of standardized test methods for characterizing distortion and other OPCs will facilitate development, clinical translation, manufacturing quality and assurance of performance during clinical use of endoscopic technologies.

Survey of safety practices among hospital laboratories in Oromia Regional State, Ethiopia.

PubMed

Sewunet, Tsegaye; Kebede, Wakjira; Wondafrash, Beyene; Workalemau, Bereket; Abebe, Gemeda

2014-10-01

Unsafe working practices, working environments, disposable waste products, and chemicals in clinical laboratories contribute to infectious and non-infectious hazards. Staffs, the community, and patients are less safe. Furthermore, such practices compromise the quality of laboratory services. We conducted a study to describe safety practices in public hospital laboratories of Oromia Regional State, Ethiopia. Randomly selected ten public hospital laboratories in Oromia Regional State were studied from Oct 2011- Feb 2012. Self-administered structured questionnaire and observation checklists were used for data collection. The respondents were heads of the laboratories, senior technicians, and safety officers. The questionnaire addressed biosafety label, microbial hazards, chemical hazards, physical/mechanical hazards, personal protective equipment, first aid kits and waste disposal system. The data was analyzed using descriptive analysis with SPSS version16 statistical software. All of the respondents reported none of the hospital laboratories were labeled with the appropriate safety label and safety symbols. These respondents also reported they may contain organisms grouped under risk group IV in the absence of microbiological safety cabinets. Overall, the respondents reported that there were poor safety regulations or standards in their laboratories. There were higher risks of microbial, chemical and physical/mechanical hazards. Laboratory safety in public hospitals of Oromia Regional State is below the standard. The laboratory workers are at high risk of combined physical, chemical and microbial hazards. Prompt recognition of the problem and immediate action is mandatory to ensure safe working environment in health laboratories.

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

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

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

NASA space station software standards issues

NASA Technical Reports Server (NTRS)

Tice, G. D., Jr.

1985-01-01

The selection and application of software standards present the NASA Space Station Program with the opportunity to serve as a pacesetter for the United States software in the area of software standards. The strengths and weaknesses of each of the NASA defined software standards issues are summerized and discussed. Several significant standards issues are offered for NASA consideration. A challenge is presented for the NASA Space Station Program to serve as a pacesetter for the U.S. Software Industry through: (1) Management commitment to software standards; (2) Overall program participation in software standards; and (3) Employment of the best available technology to support software standards

Testing of Hand-Held Mine Detection Systems

DTIC Science & Technology

2015-01-08

ITOP 04-2-5208 for guidance on software testing . Testing software is necessary to ensure that safety is designed into the software algorithm, and that...sensor verification areas or target lanes. F.2. TESTING OBJECTIVES. a. Testing objectives will impact on the test design . Some examples of...overall safety, performance, and reliability of the system. It describes activities necessary to ensure safety is designed into the system under test

Items Supporting the Hanford Internal Dosimetry Program Implementation of the IMBA Computer Code

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

Carbaugh, Eugene H.; Bihl, Donald E.

2008-01-07

The Hanford Internal Dosimetry Program has adopted the computer code IMBA (Integrated Modules for Bioassay Analysis) as its primary code for bioassay data evaluation and dose assessment using methodologies of ICRP Publications 60, 66, 67, 68, and 78. The adoption of this code was part of the implementation plan for the June 8, 2007 amendments to 10 CFR 835. This information release includes action items unique to IMBA that were required by PNNL quality assurance standards for implementation of safety software. Copie of the IMBA software verification test plan and the outline of the briefing given to new users aremore » also included.« less

Web Implementation of Quality Assurance (QA) for X-ray Units in Balkanic Medical Institutions.

PubMed

Urošević, Vlade; Ristić, Olga; Milošević, Danijela; Košutić, Duško

2015-08-01

Diagnostic radiology is the major contributor to the total dose of the population from all artificial sources. In order to reduce radiation exposure and optimize diagnostic x-ray image quality, it is necessary to increase the quality and efficiency of quality assurance (QA) and audit programs. This work presents a web application providing completely new QA solutions for x-ray modalities and facilities. The software gives complete online information (using European standards) with which the corresponding institutions and individuals can evaluate and control a facility's Radiation Safety and QA program. The software enables storage of all data in one place and sharing the same information (data), regardless of whether the measured data is used by an individual user or by an authorized institution. The software overcomes the distance and time separation of institutions and individuals who take part in QA. Upgrading the software will enable assessment of the medical exposure level to ionizing radiation.

Software Assurance Challenges for the Commercial Crew Program

NASA Technical Reports Server (NTRS)

Cuyno, Patrick; Malnick, Kathy D.; Schaeffer, Chad E.

2015-01-01

This paper will provide a description of some of the challenges NASA is facing in providing software assurance within the new commercial space services paradigm, namely with the Commercial Crew Program (CCP). The CCP will establish safe, reliable, and affordable access to the International Space Station (ISS) by purchasing a ride from commercial companies. The CCP providers have varying experience with software development in safety-critical space systems. NASA's role in providing effective software assurance support to the CCP providers is critical to the success of CCP. These challenges include funding multiple vehicles that execute in parallel and have different rules of engagement, multiple providers with unique proprietary concerns, providing equivalent guidance to all providers, permitting alternates to NASA standards, and a large number of diverse stakeholders. It is expected that these challenges will exist in future programs, especially if the CCP paradigm proves successful. The proposed CCP approach to address these challenges includes a risk-based assessment with varying degrees of engagement and a distributed assurance model. This presentation will describe NASA IV&V Program's software assurance support and responses to these challenges.

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.

Software for the occupational health and safety integrated management system

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

Vătăsescu, Mihaela

2015-03-10

This paper intends to present the design and the production of a software for the Occupational Health and Safety Integrated Management System with the view to a rapid drawing up of the system documents in the field of occupational health and safety.

Software System Safety and the NASA Aeronautics Blueprint

NASA Technical Reports Server (NTRS)

Holloway, C. Michael; Hayhurst, Kelly J.

2002-01-01

NASA's Aeronautics Blueprint lays out a research agenda for the Agency s aeronautics program. The word software appears only four times in this Blueprint, but the critical importance of safe and correct software to the fulfillment of the proposed research is evident on almost every page. Most of the technology solutions proposed to address challenges in aviation are software dependent technologies. Of the fifty-two specific technology solutions described in the Blueprint, forty-one depend, at least in part, on software for success. For thirty-five of these forty-one, software is not only critical to success, but also to human safety. That is, implementing the technology solutions will require using software in such a way that it may, if not specified, designed, and implemented properly, lead to fatal accidents. These results have at least two implications for the research based on the Blueprint: (1) knowledge about the current state-of-the-art and state-of-the-practice in software engineering and software system safety is essential, and (2) research into current unsolved problems in these software disciplines is also essential.

Systems Engineering and Integration (SE and I)

NASA Technical Reports Server (NTRS)

Chevers, ED; Haley, Sam

1990-01-01

The issue of technology advancement and future space transportation vehicles is addressed. The challenge is to develop systems which can be evolved and improved in small incremental steps where each increment reduces present cost, improves, reliability, or does neither but sets the stage for a second incremental upgrade that does. Future requirements are interface standards for commercial off the shelf products to aid in the development of integrated facilities; enhanced automated code generation system slightly coupled to specification and design documentation; modeling tools that support data flow analysis; and shared project data bases consisting of technical characteristics cast information, measurement parameters, and reusable software programs. Topics addressed include: advanced avionics development strategy; risk analysis and management; tool quality management; low cost avionics; cost estimation and benefits; computer aided software engineering; computer systems and software safety; system testability; and advanced avionics laboratories - and rapid prototyping. This presentation is represented by viewgraphs only.

Testing of Safety-Critical Software Embedded in an Artificial Heart

NASA Astrophysics Data System (ADS)

Cha, Sungdeok; Jeong, Sehun; Yoo, Junbeom; Kim, Young-Gab

Software is being used more frequently to control medical devices such as artificial heart or robotic surgery system. While much of software safety issues in such systems are similar to other safety-critical systems (e.g., nuclear power plants), domain-specific properties may warrant development of customized techniques to demonstrate fitness of the system on patients. In this paper, we report results of a preliminary analysis done on software controlling a Hybrid Ventricular Assist Device (H-VAD) developed by Korea Artificial Organ Centre (KAOC). It is a state-of-the-art artificial heart which completed animal testing phase. We performed software testing in in-vitro experiments and animal experiments. An abnormal behaviour, never detected during extensive in-vitro analysis and animal testing, was found.

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258

Effectiveness of an intervention package on knowledge, attitude, and practices of food handlers in a tertiary care hospital of north India: A before and after comparison study.

PubMed

Dudeja, Puja; Singh, Amarjeet; Sahni, Nancy; Kaur, Sukhpal; Goel, Sonu

2017-01-01

Food-borne illnesses have been a recognized hazard for decades. Recent promulgation of Food Safety and Standards Act (FSSA), 2006, indicates the concern of our Govt. for food safety. Research on effectiveness of food safety interventions in our country is remarkably scarce. Hence, the present study was conducted in a tertiary care hospital of north India to create evidence-based results for food safety interventions. The study was before and after intervention trial which was registered with CTRI. Data collection was paperless using a software. All food handlers ( n  = 280) working inside the hospital were recruited. Intervention package comprised Self-Instructional Manual in Hindi for food handlers, short film for sensitization of food handlers on food safety titled 'Gravy Extra', and a documentary titled 'Food Safety from farm to Fork'. Chi square test, paired t test, and Wilcoxon sign rank test were used. The mean age of food handlers was 35 ± 2 years. Majority (61.7%) of food handlers were educated less than 10th standard. Nearly 60% of them had up to five years of experience. At base line majority (68.9%) had a fair knowledge about food safety issues. There was a significant improvement in food safety knowledge and practice score of food handlers after the intervention ( p  < 0.05). Their attitude toward food safety changed in a positive direction ( p  < 0.05). The intervention package was useful in improving the knowledge, creating a positive attitude and enhancing the food safety practices of food handlers working inside a tertiary care hospital.

Knowledge, Attitude and Practice of Healthcare Managers to Medical Waste Management and Occupational Safety Practices: Findings from Southeast Nigeria.

PubMed

Anozie, Okechukwu Bonaventure; Lawani, Lucky Osaheni; Eze, Justus Ndulue; Mamah, Emmanuel Johnbosco; Onoh, Robinson Chukwudi; Ogah, Emeka Onwe; Umezurike, Daniel Akuma; Anozie, Rita Onyinyechi

2017-03-01

Awareness of appropriate waste management procedures and occupational safety measures is fundamental to achieving a safe work environment, and ensuring patient and staff safety. This study was conducted to assess the attitude of healthcare managers to medical waste management and occupational safety practices. This was a cross-sectional study conducted among 54 hospital administrators in Ebonyi state. Semi-structured questionnaires were used for qualitative data collection and analyzed with SPSS statistics for windows (2011), version 20.0 statistical software (Armonk, NY: IBM Corp). Two-fifth (40%) of healthcare managers had received training on medical waste management and occupational safety. Standard operating procedure of waste disposal was practiced by only one hospital (1.9%), while 98.1% (53/54) practiced indiscriminate waste disposal. Injection safety boxes were widely available in all health facilities, nevertheless, the use of incinerators and waste treatment was practiced by 1.9% (1/54) facility. However, 40.7% (22/54) and 59.3% (32/54) of respondents trained their staff and organize safety orientation courses respectively. Staff insurance cover was offered by just one hospital (1.9%), while none of the hospitals had compensation package for occupational hazard victims. Over half (55.6%; 30/54) of the respondents provided both personal protective equipment and post exposure prophylaxis for HIV. There was high level of non-compliance to standard medical waste management procedures, and lack of training on occupational safety measures. Relevant regulating agencies should step up efforts at monitoring and regulation of healthcare activities and ensure staff training on safe handling and disposal of hospital waste.

Software IV and V Research Priorities and Applied Program Accomplishments Within NASA

NASA Technical Reports Server (NTRS)

Blazy, Louis J.

2000-01-01

The mission of this research is to be world-class creators and facilitators of innovative, intelligent, high performance, reliable information technologies that enable NASA missions to (1) increase software safety and quality through error avoidance, early detection and resolution of errors, by utilizing and applying empirically based software engineering best practices; (2) ensure customer software risks are identified and/or that requirements are met and/or exceeded; (3) research, develop, apply, verify, and publish software technologies for competitive advantage and the advancement of science; and (4) facilitate the transfer of science and engineering data, methods, and practices to NASA, educational institutions, state agencies, and commercial organizations. The goals are to become a national Center Of Excellence (COE) in software and system independent verification and validation, and to become an international leading force in the field of software engineering for improving the safety, quality, reliability, and cost performance of software systems. This project addresses the following problems: Ensure safety of NASA missions, ensure requirements are met, minimize programmatic and technological risks of software development and operations, improve software quality, reduce costs and time to delivery, and improve the science of software engineering

Software Formal Inspections Standard

NASA Technical Reports Server (NTRS)

1993-01-01

This Software Formal Inspections Standard (hereinafter referred to as Standard) is applicable to NASA software. This Standard defines the requirements that shall be fulfilled by the software formal inspections process whenever this process is specified for NASA software. The objective of this Standard is to define the requirements for a process that inspects software products to detect and eliminate defects as early as possible in the software life cycle. The process also provides for the collection and analysis of inspection data to improve the inspection process as well as the quality of the software.

78 FR 47805 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

... Documents Access and Management System (ADAMS): You may access publicly available documents online in the... Management Plans for Digital Computer Software used in Safety Systems of Nuclear Power Plants,'' issued for... Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Revision...

Make safety awareness a priority: Use a login software in your research facility

DOE PAGES

Camino, Fernando E.

2017-01-21

We report on a facility login software, whose objective is to improve safety in multi-user research facilities. Its most important safety features are: 1) blocks users from entering the lab after being absent for more than a predetermined number of days; 2) gives users a random safety quiz question, which they need to answer satisfactorily in order to use the facility; 3) blocks unauthorized users from using the facility afterhours; and 4) displays the current users in the facility. Besides restricting access to unauthorized users, the software keeps users mindful of key safety concepts. In addition, integration of the softwaremore » with a door controller system can convert it into an effective physical safety mechanism. Depending on DOE approval, the code may be available as open source.« less

Make safety awareness a priority: Use a login software in your research facility

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

Camino, Fernando E.

We report on a facility login software, whose objective is to improve safety in multi-user research facilities. Its most important safety features are: 1) blocks users from entering the lab after being absent for more than a predetermined number of days; 2) gives users a random safety quiz question, which they need to answer satisfactorily in order to use the facility; 3) blocks unauthorized users from using the facility afterhours; and 4) displays the current users in the facility. Besides restricting access to unauthorized users, the software keeps users mindful of key safety concepts. In addition, integration of the softwaremore » with a door controller system can convert it into an effective physical safety mechanism. Depending on DOE approval, the code may be available as open source.« less

A Validation Metrics Framework for Safety-Critical Software-Intensive Systems

DTIC Science & Technology

2009-03-01

so does its definition, tools, and techniques, including means for measuring the validation activity, its outputs, and impact on development...independent of the SDLP. When considering the above SDLPs from the safety engineering team’s perspective, there are also large impacts on the way... impact . Interpretation of any actionable metric data will need to be undertaken in the context of the SDLP. 2. Safety Input The software safety

A strategy to establish Food Safety Model Repositories.

PubMed

Plaza-Rodríguez, C; Thoens, C; Falenski, A; Weiser, A A; Appel, B; Kaesbohrer, A; Filter, M

2015-07-02

Transferring the knowledge of predictive microbiology into real world food manufacturing applications is still a major challenge for the whole food safety modelling community. To facilitate this process, a strategy for creating open, community driven and web-based predictive microbial model repositories is proposed. These collaborative model resources could significantly improve the transfer of knowledge from research into commercial and governmental applications and also increase efficiency, transparency and usability of predictive models. To demonstrate the feasibility, predictive models of Salmonella in beef previously published in the scientific literature were re-implemented using an open source software tool called PMM-Lab. The models were made publicly available in a Food Safety Model Repository within the OpenML for Predictive Modelling in Food community project. Three different approaches were used to create new models in the model repositories: (1) all information relevant for model re-implementation is available in a scientific publication, (2) model parameters can be imported from tabular parameter collections and (3) models have to be generated from experimental data or primary model parameters. All three approaches were demonstrated in the paper. The sample Food Safety Model Repository is available via: http://sourceforge.net/projects/microbialmodelingexchange/files/models and the PMM-Lab software can be downloaded from http://sourceforge.net/projects/pmmlab/. This work also illustrates that a standardized information exchange format for predictive microbial models, as the key component of this strategy, could be established by adoption of resources from the Systems Biology domain. Copyright © 2015. Published by Elsevier B.V.

A simple tool for preliminary hazard identification and quick assessment in craftwork and small/medium enterprises (SME).

PubMed

Colombini, Daniela; Occhipinti, E; Di Leone, G

2012-01-01

During the last Congress of the International Ergonomics Association (IEA), Beijing, August 2009, an international group was founded aimed at developing a "toolkit for MSD prevention" within IEA and in collaboration with World Health Organization (WHO). Possible users of toolkits are: members of health and safety committees, health and safety representatives, line supervisors; labor inspectors; health workers implementing basic occupational health services; occupational health and safety specialists.According to ISO standard 11228 series and the new Draft CD ISO 12259-2009: Application document guides for the potential user, a computer software ( in Excel®) was create dealing with hazard "mapping" in handicraft The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazard identification and risk estimation. Thus it makes possible to decide for which professional hazards a more exhaustive risk assessment will be necessary and which professional consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).

Development of a methodology for assessing the safety of embedded software systems

NASA Technical Reports Server (NTRS)

Garrett, C. J.; Guarro, S. B.; Apostolakis, G. E.

1993-01-01

A Dynamic Flowgraph Methodology (DFM) based on an integrated approach to modeling and analyzing the behavior of software-driven embedded systems for assessing and verifying reliability and safety is discussed. DFM is based on an extension of the Logic Flowgraph Methodology to incorporate state transition models. System models which express the logic of the system in terms of causal relationships between physical variables and temporal characteristics of software modules are analyzed to determine how a certain state can be reached. This is done by developing timed fault trees which take the form of logical combinations of static trees relating the system parameters at different point in time. The resulting information concerning the hardware and software states can be used to eliminate unsafe execution paths and identify testing criteria for safety critical software functions.

Surrogate Safety Assessment Model (SSAM)--software user manual

DOT National Transportation Integrated Search

2008-05-01

This document presents guidelines for the installation and use of the Surrogate Safety Assessment Model (SSAM) software. For more information regarding the SSAM application, including discussion of theoretical background and the results of a series o...

An intelligent maximum permissible exposure meter for safety assessments of laser radiation

NASA Astrophysics Data System (ADS)

Corder, D. A.; Evans, D. R.; Tyrer, J. R.

1996-09-01

There is frequently a need to make laser power or energy density measurements when determining whether radiation from a laser system exceeds the Maximum Permissible Exposure (MPE) as defined in BS EN 60825. This can be achieved using standard commercially available laser power or energy measurement equipment, but some of these have shortcomings when used in this application. Calculations must be performed by the user to compare the measured value to the MPE. The measurement and calculation procedure appears complex to the nonexpert who may be performing the assessment. A novel approach is described which uses purpose designed hardware and software to simplify the process. The hardware is optimized for measuring the relatively low powers associated with MPEs. The software runs on a Psion Series 3a palmtop computer. This reduces the cost and size of the system yet allows graphical and numerical presentation of data. Data output to other software running on PCs is also possible, enabling the instrument to be used as part of a quality system. Throughout the measurement process the opportunity for user error has been minimized by the hardware and software design.

Problem of unity of measurements in ensuring safety of hydraulic structures

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

Kheifits, V.Z.; Markov, A.I.; Braitsev, V.V.

1994-07-01

Ensuring the safety of hydraulic structures (HSs) is not only an industry but also a national and global concern, since failure of large water impounding structures can entail large losses of lives and enormous material losses related to destruction downstream. The main information on the degree of safety of a structure is obtained by comparing information about the actual state of the structure obtained on the basis of measurements in key zones of the structure with the predicted state on basis of the design model used when designing the structure for given conditions of external actions. Numerous, from hundreds tomore » thousands, string type transducers are placed in large HSs. This system of transducers monitor the stress-strain rate, seepage, and thermal regimes. These measurements are supported by the State Standards Committee which certifies the accuracy of the checking methods. To improve the instrumental monitoring of HSs, the author recommends: Calibration of methods and means of reliable diagnosis for each measuring channel in the HS, improvements to reduce measurement error, support for the system software programs, and development of appropriate standards for the design and examination of HSs.« less

Physiological approach to optimal stereographic game programming: a technical guide

NASA Astrophysics Data System (ADS)

Martens, William L.; McRuer, Robert; Childs, C. Timothy; Viirree, Erik

1996-04-01

With the advent of mass distribution of consumer VR games comes an imperative to set health and safety standards for the hardware and software used to deliver stereographic content. This is particularly important for game developers who intend to present this stereographic content via head-mounted display (HMD). The visual discomfort that is commonly reported by the user of HMD-based VR games presumably could be kept to a minimum if game developers were provided with standards for the display of stereographic imagery. In this paper, we draw upon both results of research in binocular vision and practical methods from clinical optometry to develop some technical guidelines for programming stereographic games that have the end user's comfort and safety in mind. This paper will provide generate strategies for user- centered implementation of 3D virtual worlds, as well as pictorial examples demonstrating a natural means for rendering stereographic imagery more comfortable to view in games employing first-person perspective.

Cyber Security Threats to Safety-Critical, Space-Based Infrastructures

NASA Astrophysics Data System (ADS)

Johnson, C. W.; Atencia Yepez, A.

2012-01-01

Space-based systems play an important role within national critical infrastructures. They are being integrated into advanced air-traffic management applications, rail signalling systems, energy distribution software etc. Unfortunately, the end users of communications, location sensing and timing applications often fail to understand that these infrastructures are vulnerable to a wide range of security threats. The following pages focus on concerns associated with potential cyber-attacks. These are important because future attacks may invalidate many of the safety assumptions that support the provision of critical space-based services. These safety assumptions are based on standard forms of hazard analysis that ignore cyber-security considerations This is a significant limitation when, for instance, security attacks can simultaneously exploit multiple vulnerabilities in a manner that would never occur without a deliberate enemy seeking to damage space based systems and ground infrastructures. We address this concern through the development of a combined safety and security risk assessment methodology. The aim is to identify attack scenarios that justify the allocation of additional design resources so that safety barriers can be strengthened to increase our resilience against security threats.

Software Safety Assurance of Programmable Logic

NASA Technical Reports Server (NTRS)

Berens, Kalynnda

2002-01-01

Programmable Logic (PLC, FPGA, ASIC) devices are hybrids - hardware devices that are designed and programmed like software. As such, they fall in an assurance gray area. Programmable Logic is usually tested and verified as hardware, and the software aspects are ignored, potentially leading to safety or mission success concerns. The objective of this proposal is to first determine where and how Programmable Logic (PL) is used within NASA and document the current methods of assurance. Once that is known, raise awareness of the PL software aspects within the NASA engineering community and provide guidance for the use and assurance of PL form a software perspective.

Advanced Software V&V for Civil Aviation and Autonomy

NASA Technical Reports Server (NTRS)

Brat, Guillaume P.

2017-01-01

With the advances in high-computing platform (e.g., advanced graphical processing units or multi-core processors), computationally-intensive software techniques such as the ones used in artificial intelligence or formal methods have provided us with an opportunity to further increase safety in the aviation industry. Some of these techniques have facilitated building safety at design time, like in aircraft engines or software verification and validation, and others can introduce safety benefits during operations as long as we adapt our processes. In this talk, I will present how NASA is taking advantage of these new software techniques to build in safety at design time through advanced software verification and validation, which can be applied earlier and earlier in the design life cycle and thus help also reduce the cost of aviation assurance. I will then show how run-time techniques (such as runtime assurance or data analytics) offer us a chance to catch even more complex problems, even in the face of changing and unpredictable environments. These new techniques will be extremely useful as our aviation systems become more complex and more autonomous.

Introduction of software tools for epidemiological surveillance in infection control in Colombia

PubMed Central

Motoa, Gabriel; Vallejo, Marta; Blanco, Víctor M; Correa, Adriana; de la Cadena, Elsa; Villegas, María Virginia

2015-01-01

Introduction: Healthcare-Associated Infections (HAI) are a challenge for patient safety in the hospitals. Infection control committees (ICC) should follow CDC definitions when monitoring HAI. The handmade method of epidemiological surveillance (ES) may affect the sensitivity and specificity of the monitoring system, while electronic surveillance can improve the performance, quality and traceability of recorded information. Objective: To assess the implementation of a strategy for electronic surveillance of HAI, Bacterial Resistance and Antimicrobial Consumption by the ICC of 23 high-complexity clinics and hospitals in Colombia, during the period 2012-2013. Methods: An observational study evaluating the introduction of electronic tools in the ICC was performed; we evaluated the structure and operation of the ICC, the degree of incorporation of the software HAI Solutions and the adherence to record the required information. Results: Thirty-eight percent of hospitals (8/23) had active surveillance strategies with standard criteria of the CDC, and 87% of institutions adhered to the module of identification of cases using the HAI Solutions software. In contrast, compliance with the diligence of the risk factors for device-associated HAIs was 33%. Conclusions: The introduction of ES could achieve greater adherence to a model of active surveillance, standardized and prospective, helping to improve the validity and quality of the recorded information. PMID:26309340

Introduction of software tools for epidemiological surveillance in infection control in Colombia.

PubMed

Hernández-Gómez, Cristhian; Motoa, Gabriel; Vallejo, Marta; Blanco, Víctor M; Correa, Adriana; de la Cadena, Elsa; Villegas, María Virginia

2015-01-01

Healthcare-Associated Infections (HAI) are a challenge for patient safety in the hospitals. Infection control committees (ICC) should follow CDC definitions when monitoring HAI. The handmade method of epidemiological surveillance (ES) may affect the sensitivity and specificity of the monitoring system, while electronic surveillance can improve the performance, quality and traceability of recorded information. To assess the implementation of a strategy for electronic surveillance of HAI, Bacterial Resistance and Antimicrobial Consumption by the ICC of 23 high-complexity clinics and hospitals in Colombia, during the period 2012-2013. An observational study evaluating the introduction of electronic tools in the ICC was performed; we evaluated the structure and operation of the ICC, the degree of incorporation of the software HAI Solutions and the adherence to record the required information. Thirty-eight percent of hospitals (8/23) had active surveillance strategies with standard criteria of the CDC, and 87% of institutions adhered to the module of identification of cases using the HAI Solutions software. In contrast, compliance with the diligence of the risk factors for device-associated HAIs was 33%. The introduction of ES could achieve greater adherence to a model of active surveillance, standardized and prospective, helping to improve the validity and quality of the recorded information.

A web-based information system for management and analysis of patient data after refractive eye surgery.

PubMed

Zuberbuhler, Bruno; Galloway, Peter; Reddy, Aravind; Saldana, Manuel; Gale, Richard

2007-12-01

The aim was to develop a software tool for refractive surgeons using a standard user-friendly web-based interface, providing the user with a secure environment to protect large volumes of patient data. The software application was named "Internet-based refractive analysis" (IBRA), and was programmed with the computer languages PHP, HTML and JavaScript, attached to the opensource MySQL database. IBRA facilitated internationally accepted presentation methods including the stability chart, the predictability chart and the safety chart; it was able to perform vector analysis for the course of a single patient or for group data. With the integrated nomogram calculation, treatment could be customised to reduce the postoperative refractive error. Multicenter functions permitted quality-control comparisons between different surgeons and laser units.

[Relevance of the hemovigilance regional database for the shared medical file identity server].

PubMed

Doly, A; Fressy, P; Garraud, O

2008-11-01

The French Health Products Safety Agency coordinates the national initiative of computerization of blood products traceability within regional blood banks and public and private hospitals. The Auvergne-Loire Regional French Blood Service, based in Saint-Etienne, together with a number of public hospitals set up a transfusion data network named EDITAL. After four years of progressive implementation and experimentation, a software enabling standardized data exchange has built up a regional nominative database, endorsed by the Traceability Computerization National Committee in 2004. This database now provides secured web access to a regional transfusion history enabling biologists and all hospital and family practitioners to take in charge the patient follow-up. By running independently from the softwares of its partners, EDITAL database provides reference for the regional identity server.

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

Improving Software Engineering on NASA Projects

NASA Technical Reports Server (NTRS)

Crumbley, Tim; Kelly, John C.

2010-01-01

Software Engineering Initiative: Reduces risk of software failure -Increases mission safety. More predictable software cost estimates and delivery schedules. Smarter buyer of contracted out software. More defects found and removed earlier. Reduces duplication of efforts between projects. Increases ability to meet the challenges of evolving software technology.

Protection of Workers and Third Parties during the Construction of Linear Structures

NASA Astrophysics Data System (ADS)

Vlčková, Jitka; Venkrbec, Václav; Henková, Svatava; Chromý, Adam

2017-12-01

The minimization of risk in the workplace through a focus on occupational health and safety (OHS) is one of the primary objectives for every construction project. The most serious accidents in the construction industry occur during work on earthworks and linear structures. The character of such structures places them among those posing the greatest threat to the public (referred to as “third parties”). They can be characterized as large structures whose construction may involve the building site extending in a narrow lane alongside previously constructed objects currently in use by the public. Linear structures are often directly connected to existing objects or buildings, making it impossible to guard the whole construction site. However, many OHS problems related to linear structures can be prevented during the design stage. The aim of this article is to introduce a new methodology which has been implemented into a computer program that deals with safety measures at construction sites where work is performed on linear structures. Based on existing experience with the design of such structures and their execution and supervision by safety coordinators, the basic types of linear structures, their location in the terrain, the conditions present during their execution and other marginal conditions and influences were modelled. Basic safety information has been assigned to this elementary information, which is strictly necessary for the construction process. The safety provisions can be grouped according to type, e.g. technical, organizational and other necessary documentation, or into sets of provisions concerning areas such as construction site safety, transport safety, earthworks safety, etc. The selection of the given provisions takes place using multiple criteria. The aim of creating this program is to provide a practical tool for designers, contractors and construction companies. The model can contribute to the sufficient awareness of these participants about technical and organizational provisions that can help them to meet workplace safety requirements. The software for the selection of safety provisions also contains module that can calculate necessary cost estimates using a calculation formula chosen by the user. All software data conform to European standards harmonized for the Czech Republic.

Using software to predict occupational hearing loss in the mining industry.

PubMed

Azman, A S; Li, M; Thompson, J K

2016-01-01

Powerful mining systems typically generate high-level noise that can damage the hearing ability of miners. Engineering noise controls are the most desirable and effective control for overexposure to noise. However, the effects of these noise controls on the actual hearing status of workers are not easily measured. A tool that can provide guidance in assigning workers to jobs based on the noise levels to which they will be exposed is highly desirable. Therefore, the Pittsburgh Mining Research Division (PMRD) of the U.S. National Institute for Occupational Safety and Health (NIOSH) developed a tool to estimate in a systematic way the hearing loss due to occupational noise exposure and to evaluate the effectiveness of developed engineering controls. This computer program is based on the ISO 1999 standard and can be used to estimate the loss of hearing ability caused by occupational noise exposures. In this paper, the functionalities of this software are discussed and several case studies related to mining machinery are presented to demonstrate the functionalities of this software.

Concept Development for Software Health Management

NASA Technical Reports Server (NTRS)

Riecks, Jung; Storm, Walter; Hollingsworth, Mark

2011-01-01

This report documents the work performed by Lockheed Martin Aeronautics (LM Aero) under NASA contract NNL06AA08B, delivery order NNL07AB06T. The Concept Development for Software Health Management (CDSHM) program was a NASA funded effort sponsored by the Integrated Vehicle Health Management Project, one of the four pillars of the NASA Aviation Safety Program. The CD-SHM program focused on defining a structured approach to software health management (SHM) through the development of a comprehensive failure taxonomy that is used to characterize the fundamental failure modes of safety-critical software.

Autonomy Software: V&V Challenges and Characteristics

NASA Technical Reports Server (NTRS)

Schumann, Johann; Visser, Willem

2006-01-01

The successful operation of unmanned air vehicles requires software with a high degree of autonomy. Only if high level functions can be carried out without human control and intervention, complex missions in a changing and potentially unknown environment can be carried out successfully. Autonomy software is highly mission and safety critical: failures, caused by flaws in the software cannot only jeopardize the mission, but could also endanger human life (e.g., a crash of an UAV in a densely populated area). Due to its large size, high complexity, and use of specialized algorithms (planner, constraint-solver, etc.), autonomy software poses specific challenges for its verification, validation, and certification. -- - we have carried out a survey among researchers aid scientists at NASA to study these issues. In this paper, we will present major results of this study, discussing the broad spectrum. of notions and characteristics of autonomy software and its challenges for design and development. A main focus of this survey was to evaluate verification and validation (V&V) issues and challenges, compared to the development of "traditional" safety-critical software. We will discuss important issues in V&V of autonomous software and advanced V&V tools which can help to mitigate software risks. Results of this survey will help to identify and understand safety concerns in autonomy software and will lead to improved strategies for mitigation of these risks.

The Blue Dog: evaluation of an interactive software program to teach young children how to interact safely with dogs.

PubMed

Schwebel, David C; Morrongiello, Barbara A; Davis, Aaron L; Stewart, Julia; Bell, Melissa

2012-04-01

Pre-post-randomized design evaluated The Blue Dog, a dog safety software program. 76 children aged 3.5-6 years completed 3 tasks to evaluate dog safety pre- and postintervention: (a) pictures (recognition of safe/risky behavior), (b) dollhouse (recall of safe behavior via simulated dollhouse scenarios), and (c) live dog (actual behavior with unfamiliar live dog). Following preintervention evaluation, children were randomly assigned to dog or fire safety conditions, each involving 3 weeks of home computer software use. Children using Blue Dog had greater change in recognition of risky dog situations than children learning fire safety. No between-group differences emerged in recall (dollhouse) or engagement (live-dog) in risky behavior. Families enjoyed using the software. Blue Dog taught children knowledge about safe engagement with dogs, but did not influence recall or implementation of safe behaviors. Dog bites represent a significant pediatric injury concern and continued development of effective interventions is needed.

Improving hospital weekend handover: a user-centered, standardised approach.

PubMed

Mehra, Avi; Henein, Christin

2014-01-01

Clinical Handover remains one of the most perilous procedures in medicine (1). Weekend handover has emerged as a key area of concern with high variability in handover processes across hospitals (1,2,4, 5-10). Studying weekend handover processes within medicine at an acute teaching hospital revealed huge variability in documented content and structure. A total of 12 different pro formas were in use by the medical day-team to handover to the weekend team on-call. A Likert-survey of doctors revealed 93% felt the current handover system needed improvement with 71% stating that it did not ensure patient safety (Chi-squared, p-value <0.001, n=32). Semi-structured interviews of doctors identified common themes including "a lack of consistency in approach" "poor standardization" and "high variability". Seeking to address concerns of standardization, a standardized handover pro forma was developed using Royal College of Physician (RCP) guidelines (2), with direct end-user input. Results following implementation revealed a considerable improvement in documented ceiling of care, urgency of task and team member assignment with 100% uptake of the new proforma at both 4-week and 6-month post-implementation analyses. 88% of doctors surveyed perceived that the new proforma improved patient safety (p<0.01, n=25), with 62% highlighting that it allowed doctors to work more efficiently. Results also revealed that 44% felt further improvements were needed and highlighted electronic solutions and handover training as main priorities. Handover briefing was subsequently incorporated into junior doctor induction and education modules delivered, with good feedback. Following collaboration with key stakeholders and with end-user input, integrated electronic handover software was designed and funding secured. The software is currently under final development. Introducing a standardized handover proforma can be an effective initial step in improving weekend handover. Handover education and end-user involvement are key in improving the process. Electronic handover solutions have been shown to significantly increase the quality of handover and are worth considering (9, 10).

Issues in Software System Safety: Polly Ann Smith Co. versus Ned I. Ludd

NASA Technical Reports Server (NTRS)

Holloway, C. Michael

2002-01-01

This paper is a work of fiction, but it is fiction with a very real purpose: to stimulate careful thought and friendly discussion about some questions for which thought is often careless and discussion is often unfriendly. To accomplish this purpose, the paper creates a fictional legal case. The most important issue in this fictional case is whether certain proffered expert testimony about software engineering for safety critical systems should be admitted. Resolving this issue requires deciding the extent to which current practices and research in software engineering, especially for safety-critical systems, can rightly be considered based on knowledge, rather than opinion.

SafetyAnalyst

DOT National Transportation Integrated Search

2009-01-01

This booklet provides an overview of SafetyAnalyst. SafetyAnalyst is a set of software tools under development to help State and local highway agencies advance their programming of site-specific safety improvements. SafetyAnalyst will incorporate sta...

Computer Programs.

ERIC Educational Resources Information Center

Anderson, Tiffoni

This module provides information on development and use of a Material Safety Data Sheet (MSDS) software program that seeks to link literacy skills education, safety training, and human-centered design. Section 1 discusses the development of the software program that helps workers understand the MSDSs that accompany the chemicals with which they…

Building Safer Systems With SpecTRM

NASA Technical Reports Server (NTRS)

2003-01-01

System safety, an integral component in software development, often poses a challenge to engineers designing computer-based systems. While the relaxed constraints on software design allow for increased power and flexibility, this flexibility introduces more possibilities for error. As a result, system engineers must identify the design constraints necessary to maintain safety and ensure that the system and software design enforces them. Safeware Engineering Corporation, of Seattle, Washington, provides the information, tools, and techniques to accomplish this task with its Specification Tools and Requirements Methodology (SpecTRM). NASA assisted in developing this engineering toolset by awarding the company several Small Business Innovation Research (SBIR) contracts with Ames Research Center and Langley Research Center. The technology benefits NASA through its applications for Space Station rendezvous and docking. SpecTRM aids system and software engineers in developing specifications for large, complex safety critical systems. The product enables engineers to find errors early in development so that they can be fixed with the lowest cost and impact on the system design. SpecTRM traces both the requirements and design rationale (including safety constraints) throughout the system design and documentation, allowing engineers to build required system properties into the design from the beginning, rather than emphasizing assessment at the end of the development process when changes are limited and costly.System safety, an integral component in software development, often poses a challenge to engineers designing computer-based systems. While the relaxed constraints on software design allow for increased power and flexibility, this flexibility introduces more possibilities for error. As a result, system engineers must identify the design constraints necessary to maintain safety and ensure that the system and software design enforces them. Safeware Engineering Corporation, of Seattle, Washington, provides the information, tools, and techniques to accomplish this task with its Specification Tools and Requirements Methodology (SpecTRM). NASA assisted in developing this engineering toolset by awarding the company several Small Business Innovation Research (SBIR) contracts with Ames Research Center and Langley Research Center. The technology benefits NASA through its applications for Space Station rendezvous and docking. SpecTRM aids system and software engineers in developing specifications for large, complex safety critical systems. The product enables engineers to find errors early in development so that they can be fixed with the lowest cost and impact on the system design. SpecTRM traces both the requirements and design rationale (including safety constraints) throughout the system design and documentation, allowing engineers to build required system properties into the design from the beginning, rather than emphasizing assessment at the end of the development process when changes are limited and costly.

Fault Tree Analysis Application for Safety and Reliability

NASA Technical Reports Server (NTRS)

Wallace, Dolores R.

2003-01-01

Many commercial software tools exist for fault tree analysis (FTA), an accepted method for mitigating risk in systems. The method embedded in the tools identifies a root as use in system components, but when software is identified as a root cause, it does not build trees into the software component. No commercial software tools have been built specifically for development and analysis of software fault trees. Research indicates that the methods of FTA could be applied to software, but the method is not practical without automated tool support. With appropriate automated tool support, software fault tree analysis (SFTA) may be a practical technique for identifying the underlying cause of software faults that may lead to critical system failures. We strive to demonstrate that existing commercial tools for FTA can be adapted for use with SFTA, and that applied to a safety-critical system, SFTA can be used to identify serious potential problems long before integrator and system testing.

Product-based Safety Certification for Medical Devices Embedded Software.

PubMed

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

Four Pillars for Improving the Quality of Safety-Critical Software-Reliant Systems

DTIC Science & Technology

2013-04-01

Studies of safety-critical software-reliant systems developed using the current practices of build-then-test show that requirements and architecture ... design defects make up approximately 70% of all defects, many system level related to operational quality attributes, and 80% of these defects are

Range Safety for an Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Lanzi, Raymond J.; Simpson, James C.

2010-01-01

The Range Safety Algorithm software encapsulates the various constructs and algorithms required to accomplish Time Space Position Information (TSPI) data management from multiple tracking sources, autonomous mission mode detection and management, and flight-termination mission rule evaluation. The software evaluates various user-configurable rule sets that govern the qualification of TSPI data sources, provides a prelaunch autonomous hold-launch function, performs the flight-monitoring-and-termination functions, and performs end-of-mission safing

Open Source, Open Standards, and Health Care Information Systems

PubMed Central

2011-01-01

Recognition of the improvements in patient safety, quality of patient care, and efficiency that health care information systems have the potential to bring has led to significant investment. Globally the sale of health care information systems now represents a multibillion dollar industry. As policy makers, health care professionals, and patients, we have a responsibility to maximize the return on this investment. To this end we analyze alternative licensing and software development models, as well as the role of standards. We describe how licensing affects development. We argue for the superiority of open source licensing to promote safer, more effective health care information systems. We claim that open source licensing in health care information systems is essential to rational procurement strategy. PMID:21447469

Open source, open standards, and health care information systems.

PubMed

Reynolds, Carl J; Wyatt, Jeremy C

2011-02-17

Recognition of the improvements in patient safety, quality of patient care, and efficiency that health care information systems have the potential to bring has led to significant investment. Globally the sale of health care information systems now represents a multibillion dollar industry. As policy makers, health care professionals, and patients, we have a responsibility to maximize the return on this investment. To this end we analyze alternative licensing and software development models, as well as the role of standards. We describe how licensing affects development. We argue for the superiority of open source licensing to promote safer, more effective health care information systems. We claim that open source licensing in health care information systems is essential to rational procurement strategy.

NASA Software Documentation Standard

NASA Technical Reports Server (NTRS)

1991-01-01

The NASA Software Documentation Standard (hereinafter referred to as "Standard") is designed to support the documentation of all software developed for NASA; its goal is to provide a framework and model for recording the essential information needed throughout the development life cycle and maintenance of a software system. The NASA Software Documentation Standard can be applied to the documentation of all NASA software. The Standard is limited to documentation format and content requirements. It does not mandate specific management, engineering, or assurance standards or techniques. This Standard defines the format and content of documentation for software acquisition, development, and sustaining engineering. Format requirements address where information shall be recorded and content requirements address what information shall be recorded. This Standard provides a framework to allow consistency of documentation across NASA and visibility into the completeness of project documentation. The basic framework consists of four major sections (or volumes). The Management Plan contains all planning and business aspects of a software project, including engineering and assurance planning. The Product Specification contains all technical engineering information, including software requirements and design. The Assurance and Test Procedures contains all technical assurance information, including Test, Quality Assurance (QA), and Verification and Validation (V&V). The Management, Engineering, and Assurance Reports is the library and/or listing of all project reports.

Plutonium Critical Mass Curve Comparison to Mass at Upper Subcritical Limit (USL) Using Whisper

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

Alwin, Jennifer Louise; Zhang, Ning

Whisper is computational software designed to assist the nuclear criticality safety analyst with validation studies with the MCNP ® Monte Carlo radiation transport package. Standard approaches to validation rely on the selection of benchmarks based upon expert judgment. Whisper uses sensitivity/uncertainty (S/U) methods to select relevant benchmarks to a particular application or set of applications being analyzed. Using these benchmarks, Whisper computes a calculational margin. Whisper attempts to quantify the margin of subcriticality (MOS) from errors in software and uncertainties in nuclear data. The combination of the Whisper-derived calculational margin and MOS comprise the baseline upper subcritical limit (USL), tomore » which an additional margin may be applied by the nuclear criticality safety analyst as appropriate to ensure subcriticality. A series of critical mass curves for plutonium, similar to those found in Figure 31 of LA-10860-MS, have been generated using MCNP6.1.1 and the iterative parameter study software, WORM_Solver. The baseline USL for each of the data points of the curves was then computed using Whisper 1.1. The USL was then used to determine the equivalent mass for plutonium metal-water system. ANSI/ANS-8.1 states that it is acceptable to use handbook data, such as the data directly from the LA-10860-MS, as it is already considered validated (Section 4.3 4) “Use of subcritical limit data provided in ANSI/ANS standards or accepted reference publications does not require further validation.”). This paper attempts to take a novel approach to visualize traditional critical mass curves and allows comparison with the amount of mass for which the k eff is equal to the USL (calculational margin + margin of subcriticality). However, the intent is to plot the critical mass data along with USL, not to suggest that already accepted handbook data should have new and more rigorous requirements for validation.« less

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.

Mount control system of the ASTRI SST-2M prototype for the Cherenkov Telescope Array

NASA Astrophysics Data System (ADS)

Antolini, Elisa; Tosti, Gino; Tanci, Claudio; Bagaglia, Marco; Canestrari, Rodolfo; Cascone, Enrico; Gambini, Giorgio; Nucciarelli, Giuliano; Pareschi, Giovanni; Scuderi, Salvo; Stringhetti, Luca; Busatta, Andrea; Giacomel, Stefano; Marchiori, Gianpietro; Manfrin, Cristiana; Marcuzzi, Enrico; Di Michele, Daniele; Grigolon, Carlo; Guarise, Paolo

2016-08-01

The ASTRI SST-2M telescope is an end-to-end prototype proposed for the Small Size class of Telescopes (SST) of the future Cherenkov Telescope Array (CTA). The prototype is installed in Italy at the INAF observing station located at Serra La Nave on Mount Etna (Sicily) and it was inaugurated in September 2014. This paper presents the software and hardware architecture and development of the system dedicated to the control of the mount, health, safety and monitoring systems of the ASTRI SST-2M telescope prototype. The mount control system installed on the ASTRI SST-2M telescope prototype makes use of standard and widely deployed industrial hardware and software. State of the art of the control and automation industries was selected in order to fulfill the mount related functional and safety requirements with assembly compactness, high reliability, and reduced maintenance. The software package was implemented with the Beckhoff TwinCAT version 3 environment for the software Programmable Logical Controller (PLC), while the control electronics have been chosen in order to maximize the homogeneity and the real time performance of the system. The integration with the high level controller (Telescope Control System) has been carried out by choosing the open platform communications Unified Architecture (UA) protocol, supporting rich data model while offering compatibility with the PLC platform. In this contribution we show how the ASTRI approach for the design and implementation of the mount control system has made the ASTRI SST-2M prototype a standalone intelligent machine, able to fulfill requirements and easy to be integrated in an array configuration such as the future ASTRI mini-array proposed to be installed at the southern site of the Cherenkov Telescope Array (CTA).

A Guide to the Application of Probability Risk Assessment Methodology and Hazard Risk Frequency Criteria as a Hazard Control for the Use of the Mobile Servicing System on the International Space Station

NASA Astrophysics Data System (ADS)

D'silva, Oneil; Kerrison, Roger

2013-09-01

A key feature for the increased utilization of space robotics is to automate Extra-Vehicular manned space activities and thus significantly reduce the potential for catastrophic hazards while simultaneously minimizing the overall costs associated with manned space. The principal scope of the paper is to evaluate the use of industry standard accepted Probability risk/safety assessment (PRA/PSA) methodologies and Hazard Risk frequency Criteria as a hazard control. This paper illustrates the applicability of combining the selected Probability risk assessment methodology and hazard risk frequency criteria, in order to apply the necessary safety controls that allow for the increased use of the Mobile Servicing system (MSS) robotic system on the International Space Station. This document will consider factors such as component failure rate reliability, software reliability, and periods of operation and dormancy, fault tree analyses and their effects on the probability risk assessments. The paper concludes with suggestions for the incorporation of existing industry Risk/Safety plans to create an applicable safety process for future activities/programs

[A preliminary mapping methodology for occupational hazards and biomechanical risk evaluation: presentation of a simple, computerized tool kit for ergonomic hazards identification and risk assessment].

PubMed

Colombini, Daniela; Occhipinti, E; Di Leone, G

2011-01-01

During the last Congress of the International Ergonomics Association (IEA), Beijing, August 2009, an international group was founded with the task of developing a "toolkit for MSD prevention" under the IEA and in collaboration with the World Health Organization. The possible users of toolkits are: members of health and safety committees; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers providing basic occupational health services; occupational health and safety specialists. According to the ISO standard 11228 series and the new Draft CD ISO 12259-2009: Application document guides for the potential user, our group developed a preliminary "mapping" methodology of occupational hazards in the craft industry, supported by software (Excel). The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazards identification and risk estimation to be made. It is thus possible to decide for which occupational hazards a more exhaustive risk assessment will be necessary and which occupational consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).

Statistical modelling of software reliability

NASA Technical Reports Server (NTRS)

Miller, Douglas R.

1991-01-01

During the six-month period from 1 April 1991 to 30 September 1991 the following research papers in statistical modeling of software reliability appeared: (1) A Nonparametric Software Reliability Growth Model; (2) On the Use and the Performance of Software Reliability Growth Models; (3) Research and Development Issues in Software Reliability Engineering; (4) Special Issues on Software; and (5) Software Reliability and Safety.

Applying formal methods and object-oriented analysis to existing flight software

NASA Technical Reports Server (NTRS)

Cheng, Betty H. C.; Auernheimer, Brent

1993-01-01

Correctness is paramount for safety-critical software control systems. Critical software failures in medical radiation treatment, communications, and defense are familiar to the public. The significant quantity of software malfunctions regularly reported to the software engineering community, the laws concerning liability, and a recent NRC Aeronautics and Space Engineering Board report additionally motivate the use of error-reducing and defect detection software development techniques. The benefits of formal methods in requirements driven software development ('forward engineering') is well documented. One advantage of rigorously engineering software is that formal notations are precise, verifiable, and facilitate automated processing. This paper describes the application of formal methods to reverse engineering, where formal specifications are developed for a portion of the shuttle on-orbit digital autopilot (DAP). Three objectives of the project were to: demonstrate the use of formal methods on a shuttle application, facilitate the incorporation and validation of new requirements for the system, and verify the safety-critical properties to be exhibited by the software.

NASA software documentation standard software engineering program

NASA Technical Reports Server (NTRS)

1991-01-01

The NASA Software Documentation Standard (hereinafter referred to as Standard) can be applied to the documentation of all NASA software. This Standard is limited to documentation format and content requirements. It does not mandate specific management, engineering, or assurance standards or techniques. This Standard defines the format and content of documentation for software acquisition, development, and sustaining engineering. Format requirements address where information shall be recorded and content requirements address what information shall be recorded. This Standard provides a framework to allow consistency of documentation across NASA and visibility into the completeness of project documentation. This basic framework consists of four major sections (or volumes). The Management Plan contains all planning and business aspects of a software project, including engineering and assurance planning. The Product Specification contains all technical engineering information, including software requirements and design. The Assurance and Test Procedures contains all technical assurance information, including Test, Quality Assurance (QA), and Verification and Validation (V&V). The Management, Engineering, and Assurance Reports is the library and/or listing of all project reports.

PT-SAFE: a software tool for development and annunciation of medical audible alarms.

PubMed

Bennett, Christopher L; McNeer, Richard R

2012-03-01

Recent reports by The Joint Commission as well as the Anesthesia Patient Safety Foundation have indicated that medical audible alarm effectiveness needs to be improved. Several recent studies have explored various approaches to improving the audible alarms, motivating the authors to develop real-time software capable of comparing such alarms. We sought to devise software that would allow for the development of a variety of audible alarm designs that could also integrate into existing operating room equipment configurations. The software is meant to be used as a tool for alarm researchers to quickly evaluate novel alarm designs. A software tool was developed for the purpose of creating and annunciating audible alarms. The alarms consisted of annunciators that were mapped to vital sign data received from a patient monitor. An object-oriented approach to software design was used to create a tool that is flexible and modular at run-time, can annunciate wave-files from disk, and can be programmed with MATLAB by the user to create custom alarm algorithms. The software was tested in a simulated operating room to measure technical performance and to validate the time-to-annunciation against existing equipment alarms. The software tool showed efficacy in a simulated operating room environment by providing alarm annunciation in response to physiologic and ventilator signals generated by a human patient simulator, on average 6.2 seconds faster than existing equipment alarms. Performance analysis showed that the software was capable of supporting up to 15 audible alarms on a mid-grade laptop computer before audio dropouts occurred. These results suggest that this software tool provides a foundation for rapidly staging multiple audible alarm sets from the laboratory to a simulation environment for the purpose of evaluating novel alarm designs, thus producing valuable findings for medical audible alarm standardization.

Colossal Tooling Design: 3D Simulation for Ergonomic Analysis

NASA Technical Reports Server (NTRS)

Hunter, Steve L.; Dischinger, Charles; Thomas, Robert E.; Babai, Majid

2003-01-01

The application of high-level 3D simulation software to the design phase of colossal mandrel tooling for composite aerospace fuel tanks was accomplished to discover and resolve safety and human engineering problems. The analyses were conducted to determine safety, ergonomic and human engineering aspects of the disassembly process of the fuel tank composite shell mandrel. Three-dimensional graphics high-level software, incorporating various ergonomic analysis algorithms, was utilized to determine if the process was within safety and health boundaries for the workers carrying out these tasks. In addition, the graphical software was extremely helpful in the identification of material handling equipment and devices for the mandrel tooling assembly/disassembly process.

Survey of Cancer Patient Safety Culture: A Comparison of Chemotherapy and Oncology Departments of Teaching Hospitals of Tehran

PubMed Central

Raeissi, Pouran; Sharifi, Marziye; Khosravizadeh, Omid; Heidari, Mohammad

2017-01-01

Background: Patient safety culture plays an important role in healthcare systems, especially in chemotherapy and oncology departments (CODs), and its assessment can help to improve quality of services and hospital care. Objective: This study aimed to evaluate and compare items and dimensions of patient safety culture in the CODs of selected teaching hospitals of Iran and Tehran University of Medical Sciences. Materials and Methods: This descriptive-analytical cross-sectional survey was conducted during a six-month period on 270 people from chemotherapy and oncology departments selected through a cluster sampling method. All participants answered the standard questionnaire for “Hospital Survey of Patient Safety Culture” (HSOPSC). Statistical analyses were performed using SPSS/18 software. Results: The average score for patient safety culture was three for the majority of the studied CODs. Statistically significant differences were observed for supervisor actions, teamwork within various units, feedback and communications about errors, and the level of hospital management support. (p<0.05). Relationships between studied hospitals and patient safety culture were not statistically significant (p>0.05). Conclusion: Our results showed that the overall status of patient safety culture is not good in the studied CODs. In particular, teamwork across different units and organizational learning with continuous improvement were the only two properly operating items among 12 dimensions of patient safety culture. Therefore, systematic interventions are strongly required to promote communication. PMID:29072411

Public safety answering point readiness for wireless E-911 in New York State.

PubMed

Bailey, Bob W; Scott, Jay M; Brown, Lawrence H

2003-01-01

To determine the level of wireless enhanced 911 readiness among New York's primary public safety answering points. This descriptive study utilized a simple, single-page survey that was distributed in August 2001, with telephone follow-up concluding in January 2002. Surveys were distributed to directors of the primary public safety answering points in each of New York's 62 counties. Information was requested regarding current readiness for providing wireless enhanced 911 service, hardware and software needs for implementing the service, and the estimated costs for obtaining the necessary hardware and software. Two directors did not respond and could not be contacted by telephone; three declined participation; one did not operate an answering point; and seven provided incomplete responses, resulting in usable data from 49 (79%) of the state's public safety answering points. Only 27% of the responding public safety answering points were currently wireless enhanced 911 ready. Specific needs included obtaining or upgrading computer systems (16%), computer-aided dispatch systems (53%), mapping software (71%), telephone systems (27%), and local exchange carrier trunk lines (42%). The total estimated hardware and software costs for achieving wireless enhanced 911 readiness was between 16 million and 20 million dollars. New York's primary public safety answering points are not currently ready to provide wireless enhanced 911 service, and the cost for achieving readiness could be as high as 20 million dollars.

Isolating the Effects of a Mobile Phone on the Usability and Safety of eHealth Software Applications.

PubMed

Borycki, Elizabeth M; Griffith, Janessa; Monkman, Helen; Reid-Haughian, Cheryl

2017-01-01

Mobile phones are used in conjunction with mobile eHealth software applications. These mobile software applications can be used to access, review and document clinical information. The objective of this research was to explore the relationship between mobile phones, usability and safety. Clinical simulations and semi-structured interviews were used to investigate this relationship. The findings revealed that mobile phones may lead to specific types of usability issues that may introduce some types of errors.

Reliability, Safety and Error Recovery for Advanced Control Software

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2003-01-01

For long-duration automated operation of regenerative life support systems in space environments, there is a need for advanced integration and control systems that are significantly more reliable and safe, and that support error recovery and minimization of operational failures. This presentation outlines some challenges of hazardous space environments and complex system interactions that can lead to system accidents. It discusses approaches to hazard analysis and error recovery for control software and challenges of supporting effective intervention by safety software and the crew.

A survey of quality assurance practices in biomedical open source software projects.

PubMed

Koru, Günes; El Emam, Khaled; Neisa, Angelica; Umarji, Medha

2007-05-07

Open source (OS) software is continuously gaining recognition and use in the biomedical domain, for example, in health informatics and bioinformatics. Given the mission critical nature of applications in this domain and their potential impact on patient safety, it is important to understand to what degree and how effectively biomedical OS developers perform standard quality assurance (QA) activities such as peer reviews and testing. This would allow the users of biomedical OS software to better understand the quality risks, if any, and the developers to identify process improvement opportunities to produce higher quality software. A survey of developers working on biomedical OS projects was conducted to examine the QA activities that are performed. We took a descriptive approach to summarize the implementation of QA activities and then examined some of the factors that may be related to the implementation of such practices. Our descriptive results show that 63% (95% CI, 54-72) of projects did not include peer reviews in their development process, while 82% (95% CI, 75-89) did include testing. Approximately 74% (95% CI, 67-81) of developers did not have a background in computing, 80% (95% CI, 74-87) were paid for their contributions to the project, and 52% (95% CI, 43-60) had PhDs. A multivariate logistic regression model to predict the implementation of peer reviews was not significant (likelihood ratio test = 16.86, 9 df, P = .051) and neither was a model to predict the implementation of testing (likelihood ratio test = 3.34, 9 df, P = .95). Less attention is paid to peer review than testing. However, the former is a complementary, and necessary, QA practice rather than an alternative. Therefore, one can argue that there are quality risks, at least at this point in time, in transitioning biomedical OS software into any critical settings that may have operational, financial, or safety implications. Developers of biomedical OS applications should invest more effort in implementing systemic peer review practices throughout the development and maintenance processes.

Identification of Patient Safety Risks Associated with Electronic Health Records: A Software Quality Perspective.

PubMed

Virginio, Luiz A; Ricarte, Ivan Luiz Marques

2015-01-01

Although Electronic Health Records (EHR) can offer benefits to the health care process, there is a growing body of evidence that these systems can also incur risks to patient safety when developed or used improperly. This work is a literature review to identify these risks from a software quality perspective. Therefore, the risks were classified based on the ISO/IEC 25010 software quality model. The risks identified were related mainly to the characteristics of "functional suitability" (i.e., software bugs) and "usability" (i.e., interface prone to user error). This work elucidates the fact that EHR quality problems can adversely affect patient safety, resulting in errors such as incorrect patient identification, incorrect calculation of medication dosages, and lack of access to patient data. Therefore, the risks presented here provide the basis for developers and EHR regulating bodies to pay attention to the quality aspects of these systems that can result in patient harm.

Software technology insertion: A study of success factors

NASA Technical Reports Server (NTRS)

Lydon, Tom

1990-01-01

Managing software development in large organizations has become increasingly difficult due to increasing technical complexity, stricter government standards, a shortage of experienced software engineers, competitive pressure for improved productivity and quality, the need to co-develop hardware and software together, and the rapid changes in both hardware and software technology. The 'software factory' approach to software development minimizes risks while maximizing productivity and quality through standardization, automation, and training. However, in practice, this approach is relatively inflexible when adopting new software technologies. The methods that a large multi-project software engineering organization can use to increase the likelihood of successful software technology insertion (STI), especially in a standardized engineering environment, are described.

Design, implementation and evaluation of an independent real-time safety layer for medical robotic systems using a force-torque-acceleration (FTA) sensor.

PubMed

Richter, Lars; Bruder, Ralf

2013-05-01

Most medical robotic systems require direct interaction or contact with the robot. Force-Torque (FT) sensors can easily be mounted to the robot to control the contact pressure. However, evaluation is often done in software, which leads to latencies. To overcome that, we developed an independent safety system, named FTA sensor, which is based on an FT sensor and an accelerometer. An embedded system (ES) runs a real-time monitoring system for continuously checking of the readings. In case of a collision or error, it instantaneously stops the robot via the robot's external emergency stop. We found that the ES implementing the FTA sensor has a maximum latency of [Formula: see text] ms to trigger the robot's emergency stop. For the standard settings in the application of robotized transcranial magnetic stimulation, the robot will stop after at most 4 mm. Therefore, it works as an independent safety layer preventing patient and/or operator from serious harm.

SU-E-P-43: A Knowledge Based Approach to Guidelines for Software Safety

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

Salomons, G; Kelly, D

Purpose: In the fall of 2012, a survey was distributed to medical physicists across Canada. The survey asked the respondents to comment on various aspects of software development and use in their clinic. The survey revealed that most centers employ locally produced (in-house) software of some kind. The respondents also indicated an interest in having software guidelines, but cautioned that the realities of cancer clinics include variations, that preclude a simple solution. Traditional guidelines typically involve periodically repeating a set of prescribed tests with defined tolerance limits. However, applying a similar formula to software is problematic since it assumes thatmore » the users have a perfect knowledge of how and when to apply the software and that if the software operates correctly under one set of conditions it will operate correctly under all conditions Methods: In the approach presented here the personnel involved with the software are included as an integral part of the system. Activities performed to improve the safety of the software are done with both software and people in mind. A learning oriented approach is taken, following the premise that the best approach to safety is increasing the understanding of those associated with the use or development of the software. Results: The software guidance document is organized by areas of knowledge related to use and development of software. The categories include: knowledge of the underlying algorithm and its limitations; knowledge of the operation of the software, such as input values, parameters, error messages, and interpretation of output; and knowledge of the environment for the software including both data and users. Conclusion: We propose a new approach to developing guidelines which is based on acquiring knowledge-rather than performing tests. The ultimate goal is to provide robust software guidelines which will be practical and effective.« less

Health management and controls for Earth-to-orbit propulsion systems

NASA Astrophysics Data System (ADS)

Bickford, R. L.

1995-03-01

Avionics and health management technologies increase the safety and reliability while decreasing the overall cost for Earth-to-orbit (ETO) propulsion systems. New ETO propulsion systems will depend on highly reliable fault tolerant flight avionics, advanced sensing systems and artificial intelligence aided software to ensure critical control, safety and maintenance requirements are met in a cost effective manner. Propulsion avionics consist of the engine controller, actuators, sensors, software and ground support elements. In addition to control and safety functions, these elements perform system monitoring for health management. Health management is enhanced by advanced sensing systems and algorithms which provide automated fault detection and enable adaptive control and/or maintenance approaches. Aerojet is developing advanced fault tolerant rocket engine controllers which provide very high levels of reliability. Smart sensors and software systems which significantly enhance fault coverage and enable automated operations are also under development. Smart sensing systems, such as flight capable plume spectrometers, have reached maturity in ground-based applications and are suitable for bridging to flight. Software to detect failed sensors has reached similar maturity. This paper will discuss fault detection and isolation for advanced rocket engine controllers as well as examples of advanced sensing systems and software which significantly improve component failure detection for engine system safety and health management.

Intelligent Hardware-Enabled Sensor and Software Safety and Health Management for Autonomous UAS

NASA Technical Reports Server (NTRS)

Rozier, Kristin Y.; Schumann, Johann; Ippolito, Corey

2015-01-01

Unmanned Aerial Systems (UAS) can only be deployed if they can effectively complete their mission and respond to failures and uncertain environmental conditions while maintaining safety with respect to other aircraft as well as humans and property on the ground. We propose to design a real-time, onboard system health management (SHM) capability to continuously monitor essential system components such as sensors, software, and hardware systems for detection and diagnosis of failures and violations of safety or performance rules during the ight of a UAS. Our approach to SHM is three-pronged, providing: (1) real-time monitoring of sensor and software signals; (2) signal analysis, preprocessing, and advanced on-the- y temporal and Bayesian probabilistic fault diagnosis; (3) an unobtrusive, lightweight, read-only, low-power hardware realization using Field Programmable Gate Arrays (FPGAs) in order to avoid overburdening limited computing resources or costly re-certi cation of ight software due to instrumentation. No currently available SHM capabilities (or combinations of currently existing SHM capabilities) come anywhere close to satisfying these three criteria yet NASA will require such intelligent, hardwareenabled sensor and software safety and health management for introducing autonomous UAS into the National Airspace System (NAS). We propose a novel approach of creating modular building blocks for combining responsive runtime monitoring of temporal logic system safety requirements with model-based diagnosis and Bayesian network-based probabilistic analysis. Our proposed research program includes both developing this novel approach and demonstrating its capabilities using the NASA Swift UAS as a demonstration platform.

Automated Transfer Vehicle Proximity Flight Safety Overview

NASA Astrophysics Data System (ADS)

Cornier, Dominique; Berthelier, David; Requiston, Helene; Zekri, Eric; Chase, Richard

2005-12-01

The European Automated Transfer Vehicle (ATV) is an unmanned transportation spacecraft designed to contribute to the logistic servicing of the ISS. The ATV will be launched by ARIANE 5 and, after phasing and rendezvous maneuvers, it autonomously docks to the International Space Station (ISS).The ATV control is nominally handled by the Guidance, Navigation and Control (GNC) function using computers, software, sensors and actuators. During rendezvous operations, in order to cover the extreme situations where the GNC function fails to ensure a safe trajectory with respect to the ISS, a segregated Proximity Flight Safety (PFS) function is activated : this function will initiate a collision avoidance maneuver which will place the ATV on a trajectory ensuring safety with respect to the ISS. The PFS function relies on segregated computers, the Monitoring and Safing Units (MSUs) running specific software, on four dedicated thrusters, on dedicated batteries and on specific interfaces with ATV gyrometers.The PFS function being the ultimate protection to ensure ISS safety in case of ATV malfunction, specific rules have been applied to its implementation, in particular for the development of the MSU software, which is critical since any failure of this software may result in catastrophic consequences.This paper provides an overview of the ATV Proximity Flight Safety function. After a short description of the overall ATV avionics architecture and its rationale, the second part of the paper presents more details on the PFS function both in terms of hardware and software implementation. The third part of the paper is dedicated to the MSU software validation method that is specific considering its criticality. The last part of the paper provides information on the different operations related to the use of the PFS function during an ATV flight.

Streamlining Software Aspects of Certification: Report on the SSAC Survey

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.; Dorsey, Cheryl A.; Knight, John C.; Leveson, Nancy G.; McCormick, G. Frank

1999-01-01

The aviation system now depends on information technology more than ever before to ensure safety and efficiency. To address concerns about the efficacy of software aspects of the certification process, the Federal Aviation Administration (FAA) began the Streamlining Software Aspects of Certification (SSAC) program. The SSAC technical team was commissioned to gather data, analyze results, and propose recommendations to maximize efficiency and minimize cost and delay, without compromising safety. The technical team conducted two public workshops to identify and prioritize software approval issues, and conducted a survey to validate the most urgent of those issues. The SSAC survey, containing over two hundred questions about the FAA's software approval process, reached over four hundred industry software developers, aircraft manufacturers, and FAA designated engineering representatives. Three hundred people responded. This report presents the SSAC program rationale, survey process, preliminary findings, and recommendations.

SafetyAnalyst Testing and Implementation

DOT National Transportation Integrated Search

2009-03-01

SafetyAnalyst is a software tool developed by the Federal Highway Administration to assist state and local transportation agencies on analyzing safety data and managing their roadway safety programs. This research report documents the major tasks acc...

An approach for the semantic interoperability of ISO EN 13606 and OpenEHR archetypes.

PubMed

Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

2010-10-01

The communication between health information systems of hospitals and primary care organizations is currently an important challenge to improve the quality of clinical practice and patient safety. However, clinical information is usually distributed among several independent systems that may be syntactically or semantically incompatible. This fact prevents healthcare professionals from accessing clinical information of patients in an understandable and normalized way. In this work, we address the semantic interoperability of two EHR standards: OpenEHR and ISO EN 13606. Both standards follow the dual model approach which distinguishes information and knowledge, this being represented through archetypes. The solution presented here is capable of transforming OpenEHR archetypes into ISO EN 13606 and vice versa by combining Semantic Web and Model-driven Engineering technologies. The resulting software implementation has been tested using publicly available collections of archetypes for both standards.

Traveler Trustworthy Autonomy

NASA Technical Reports Server (NTRS)

Skoog, Mark A.

2016-01-01

NASAs Armstrong Flight Research Center has been engaged in the development of highly automatic safety systems for aviation since the mid 80s. For the past three years under Seedling and Center Innovation funding this work has moved toward the development of a software architecture applicable to autonomous safety. This work is now broadening and accelerating to address the airworthiness issues surrounding making a case for trustworthy autonomy. This software architecture is called the expandable variable-autonomy architecture (EVAA) and utilizes a run-time assurance approach to safety assurance.

The image-guided surgery toolkit IGSTK: an open source C++ software toolkit.

PubMed

Enquobahrie, Andinet; Cheng, Patrick; Gary, Kevin; Ibanez, Luis; Gobbi, David; Lindseth, Frank; Yaniv, Ziv; Aylward, Stephen; Jomier, Julien; Cleary, Kevin

2007-11-01

This paper presents an overview of the image-guided surgery toolkit (IGSTK). IGSTK is an open source C++ software library that provides the basic components needed to develop image-guided surgery applications. It is intended for fast prototyping and development of image-guided surgery applications. The toolkit was developed through a collaboration between academic and industry partners. Because IGSTK was designed for safety-critical applications, the development team has adopted lightweight software processes that emphasizes safety and robustness while, at the same time, supporting geographically separated developers. A software process that is philosophically similar to agile software methods was adopted emphasizing iterative, incremental, and test-driven development principles. The guiding principle in the architecture design of IGSTK is patient safety. The IGSTK team implemented a component-based architecture and used state machine software design methodologies to improve the reliability and safety of the components. Every IGSTK component has a well-defined set of features that are governed by state machines. The state machine ensures that the component is always in a valid state and that all state transitions are valid and meaningful. Realizing that the continued success and viability of an open source toolkit depends on a strong user community, the IGSTK team is following several key strategies to build an active user community. These include maintaining a users and developers' mailing list, providing documentation (application programming interface reference document and book), presenting demonstration applications, and delivering tutorial sessions at relevant scientific conferences.

Agile Methods for Open Source Safety-Critical Software

PubMed Central

Enquobahrie, Andinet; Ibanez, Luis; Cheng, Patrick; Yaniv, Ziv; Cleary, Kevin; Kokoori, Shylaja; Muffih, Benjamin; Heidenreich, John

2011-01-01

The introduction of software technology in a life-dependent environment requires the development team to execute a process that ensures a high level of software reliability and correctness. Despite their popularity, agile methods are generally assumed to be inappropriate as a process family in these environments due to their lack of emphasis on documentation, traceability, and other formal techniques. Agile methods, notably Scrum, favor empirical process control, or small constant adjustments in a tight feedback loop. This paper challenges the assumption that agile methods are inappropriate for safety-critical software development. Agile methods are flexible enough to encourage the right amount of ceremony; therefore if safety-critical systems require greater emphasis on activities like formal specification and requirements management, then an agile process will include these as necessary activities. Furthermore, agile methods focus more on continuous process management and code-level quality than classic software engineering process models. We present our experiences on the image-guided surgical toolkit (IGSTK) project as a backdrop. IGSTK is an open source software project employing agile practices since 2004. We started with the assumption that a lighter process is better, focused on evolving code, and only adding process elements as the need arose. IGSTK has been adopted by teaching hospitals and research labs, and used for clinical trials. Agile methods have matured since the academic community suggested they are not suitable for safety-critical systems almost a decade ago, we present our experiences as a case study for renewing the discussion. PMID:21799545

Agile Methods for Open Source Safety-Critical Software.

PubMed

Gary, Kevin; Enquobahrie, Andinet; Ibanez, Luis; Cheng, Patrick; Yaniv, Ziv; Cleary, Kevin; Kokoori, Shylaja; Muffih, Benjamin; Heidenreich, John

2011-08-01

The introduction of software technology in a life-dependent environment requires the development team to execute a process that ensures a high level of software reliability and correctness. Despite their popularity, agile methods are generally assumed to be inappropriate as a process family in these environments due to their lack of emphasis on documentation, traceability, and other formal techniques. Agile methods, notably Scrum, favor empirical process control, or small constant adjustments in a tight feedback loop. This paper challenges the assumption that agile methods are inappropriate for safety-critical software development. Agile methods are flexible enough to encourage the rightamount of ceremony; therefore if safety-critical systems require greater emphasis on activities like formal specification and requirements management, then an agile process will include these as necessary activities. Furthermore, agile methods focus more on continuous process management and code-level quality than classic software engineering process models. We present our experiences on the image-guided surgical toolkit (IGSTK) project as a backdrop. IGSTK is an open source software project employing agile practices since 2004. We started with the assumption that a lighter process is better, focused on evolving code, and only adding process elements as the need arose. IGSTK has been adopted by teaching hospitals and research labs, and used for clinical trials. Agile methods have matured since the academic community suggested they are not suitable for safety-critical systems almost a decade ago, we present our experiences as a case study for renewing the discussion.

Using software to predict occupational hearing loss in the mining industry

PubMed Central

Azman, A.S.; Li, M.; Thompson, J.K.

2017-01-01

Powerful mining systems typically generate high-level noise that can damage the hearing ability of miners. Engineering noise controls are the most desirable and effective control for overexposure to noise. However, the effects of these noise controls on the actual hearing status of workers are not easily measured. A tool that can provide guidance in assigning workers to jobs based on the noise levels to which they will be exposed is highly desirable. Therefore, the Pittsburgh Mining Research Division (PMRD) of the U.S. National Institute for Occupational Safety and Health (NIOSH) developed a tool to estimate in a systematic way the hearing loss due to occupational noise exposure and to evaluate the effectiveness of developed engineering controls. This computer program is based on the ISO 1999 standard and can be used to estimate the loss of hearing ability caused by occupational noise exposures. In this paper, the functionalities of this software are discussed and several case studies related to mining machinery are presented to demonstrate the functionalities of this software. PMID:28596700

Making the Implicit Explicit: Towards an Assurance Case for DO-178C

NASA Technical Reports Server (NTRS)

Holloway, C. Michael

2013-01-01

For about two decades, compliance with Software Considerations in Airborne Systems and Equipment Certification (DO-178B) has been the primary means for receiving regulatory approval for using software on commercial airplanes. A new edition of the standard, DO-178C, was published in December 2011, and regulatory bodies have started the process towards recognizing this edition. The stated purpose of DO-178C remains unchanged from its predecessor: providing guidance “for the production of software for airborne systems and equipment that performs its intended function with a level of confidence in safety that complies with airworthiness requirements.” Within the text of the guidance, little or no rationale is given for how a particular objective or collection of objectives contributes to achieving this purpose. Thus the assurance case for the document is implicit. This paper discusses a current effort to make the implicit explicit. In particular, the paper describes the current status of the research seeking to identify the specific arguments contained in, or implied by, the DO-178C guidance that implicitly justify the assumption that the document meets its stated purpose.

Standardized development of computer software. Part 2: Standards

NASA Technical Reports Server (NTRS)

Tausworthe, R. C.

1978-01-01

This monograph contains standards for software development and engineering. The book sets forth rules for design, specification, coding, testing, documentation, and quality assurance audits of software; it also contains detailed outlines for the documentation to be produced.

Development and validation of techniques for improving software dependability

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

A collection of document abstracts are presented on the topic of improving software dependability through NASA grant NAG-1-1123. Specific topics include: modeling of error detection; software inspection; test cases; Magnetic Stereotaxis System safety specifications and fault trees; and injection of synthetic faults into software.

[Development of a software standardizing optical density with operation settings related to several limitations].

PubMed

Tu, Xiao-Ming; Zhang, Zuo-Heng; Wan, Cheng; Zheng, Yu; Xu, Jin-Mei; Zhang, Yuan-Yuan; Luo, Jian-Ping; Wu, Hai-Wei

2012-12-01

To develop a software that can be used to standardize optical density to normalize the procedures and results of standardization in order to effectively solve several problems generated during standardization of in-direct ELISA results. The software was designed based on the I-STOD method with operation settings to solve the problems that one might encounter during the standardization. Matlab GUI was used as a tool for the development. The software was tested with the results of the detection of sera of persons from schistosomiasis japonica endemic areas. I-STOD V1.0 (WINDOWS XP/WIN 7, 0.5 GB) was successfully developed to standardize optical density. A serial of serum samples from schistosomiasis japonica endemic areas were used to examine the operational effects of I-STOD V1.0 software. The results indicated that the software successfully overcame several problems including reliability of standard curve, applicable scope of samples and determination of dilution for samples outside the scope, so that I-STOD was performed more conveniently and the results of standardization were more consistent. I-STOD V1.0 is a professional software based on I-STOD. It can be easily operated and can effectively standardize the testing results of in-direct ELISA.

John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety.

PubMed

Heget, Jeffrey R; Bagian, James P; Lee, Caryl Z; Gosbee, John W

2002-12-01

In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities. To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond. NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.

Health, safety and environment conditions in primary schools of Northern Iran.

PubMed

Behzadkolaee, Seyed Mohammad Asadi; Mirmohammadi, Seyed Taghi; Yazdani, Jamshid; Gorji, Ali Morad Heidari; Toosi, Ameneh; Rokni, Mohammad; Gorji, Mohammad Ali Heidari

2015-01-01

People spend a considerable part of their childhood time in the schools, a phase that coincides with their physical and mental growth. A healthy educational environment is vital to student's health and wellbeing. This study is a descriptive study conducted in 100 primary schools (both state and nonprofit schools) from Sari's Districts 1 and 2 in Iran. Sampling was performed by census and data were collected using the standard questionnaire by direct interview. Data were analyzed by Excel and SPSS software (Version 20.0. IBM Corp, Armonk), NY: IBM Corp using independent numerical T2 testing. Significant relationship was observed between the kind of schools (P = 0.045) and their locations (P = 0.024), however the health, safety and environment (HSE) ratings among boys only versus girls only schools were similar (P = 0.159). Interestingly private and nongovernment schools and primary schools from Sari's districts one had consistently higher HSE ratings. The differential and higher HSE ratings in primary schools run by Private organizations and primary schools from Sari's districts one could be due to manager's awareness and implementation of recommended HSE standards, schools neglecting and overlooking these standards had lower HSE ratings. It is necessary that schools with lower HSE ratings are made aware of the guidelines and necessary infrastructures allocated to improve their HSE ratings.

JPL Space Telecommunications Radio System Operating Environment

NASA Technical Reports Server (NTRS)

Lux, James P.; Lang, Minh; Peters, Kenneth J.; Taylor, Gregory H.; Duncan, Courtney B.; Orozco, David S.; Stern, Ryan A.; Ahten, Earl R.; Girard, Mike

2013-01-01

A flight-qualified implementation of a Software Defined Radio (SDR) Operating Environment for the JPL-SDR built for the CoNNeCT Project has been developed. It is compliant with the NASA Space Telecommunications Radio System (STRS) Architecture Standard, and provides the software infrastructure for STRS compliant waveform applications. This software provides a standards-compliant abstracted view of the JPL-SDR hardware platform. It uses industry standard POSIX interfaces for most functions, as well as exposing the STRS API (Application Programming In terface) required by the standard. This software includes a standardized interface for IP components instantiated within a Xilinx FPGA (Field Programmable Gate Array). The software provides a standardized abstracted interface to platform resources such as data converters, file system, etc., which can be used by STRS standards conformant waveform applications. It provides a generic SDR operating environment with a much smaller resource footprint than similar products such as SCA (Software Communications Architecture) compliant implementations, or the DoD Joint Tactical Radio Systems (JTRS).

SU-E-T-524: Web-Based Radiation Oncology Incident Reporting and Learning System (ROIRLS)

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

Kapoor, R; Palta, J; Hagan, M

Purpose: Describe a Web-based Radiation Oncology Incident Reporting and Learning system that has the potential to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: The VA National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and near miss data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. Software used for this program is deployed on the VAs intranet as a Website. All data entry forms (adverse event or near missmore » reports, work product reports) utilize standard causal, RT process step taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting (AAPM Work Group Report on Prevention of Errors and ASTROs safety is no accident report). All reported incidents are investigated by the radiation oncology domain experts. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The operational workflow is similar to that of the Aviation Safety Reporting System. This system is also synergistic with ROSIS and SAFRON. Results: The ROIRLS facilitates the collection of data that help in tracking adverse events and near misses and develop new interventions to prevent such incidents. The ROIRLS electronic infrastructure is fully integrated with each registered facility profile data thus minimizing key strokes and multiple entries by the event reporters. Conclusions: OIRLS is expected to improve the quality and safety of a broad spectrum of radiation therapy patients treated in the VA and fulfills our goal of Effecting Quality While Treating Safely The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations Inc. and is deployed on the VA intranet as a Website. The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations Inc. and is deployed on the VA intranet as a Website.« less

Transportation systems safety hazard analysis tool (SafetyHAT) user guide (version 1.0)

DOT National Transportation Integrated Search

2014-03-24

This is a user guide for the transportation system Safety Hazard Analysis Tool (SafetyHAT) Version 1.0. SafetyHAT is a software tool that facilitates System Theoretic Process Analysis (STPA.) This user guide provides instructions on how to download, ...

The Dangers of Failure Masking in Fault-Tolerant Software: Aspects of a Recent In-Flight Upset Event

NASA Technical Reports Server (NTRS)

Johnson, C. W.; Holloway, C. M.

2007-01-01

On 1 August 2005, a Boeing Company 777-200 aircraft, operating on an international passenger flight from Australia to Malaysia, was involved in a significant upset event while flying on autopilot. The Australian Transport Safety Bureau's investigation into the event discovered that an anomaly existed in the component software hierarchy that allowed inputs from a known faulty accelerometer to be processed by the air data inertial reference unit (ADIRU) and used by the primary flight computer, autopilot and other aircraft systems. This anomaly had existed in original ADIRU software, and had not been detected in the testing and certification process for the unit. This paper describes the software aspects of the incident in detail, and suggests possible implications concerning complex, safety-critical, fault-tolerant software.

Putting the Power of Configuration in the Hands of the Users

NASA Technical Reports Server (NTRS)

Al-Shihabi, Mary-Jo; Brown, Mark; Rigolini, Marianne

2011-01-01

Goal was to reduce the overall cost of human space flight while maintaining the most demanding standards for safety and mission success. In support of this goal, a project team was chartered to replace 18 legacy Space Shuttle nonconformance processes and systems with one fully integrated system Problem Reporting and Corrective Action (PRACA) processes provide a closed-loop system for the identification, disposition, resolution, closure, and reporting of all Space Shuttle hardware/software problems PRACA processes are integrated throughout the Space Shuttle organizational processes and are critical to assuring a safe and successful program Primary Project Objectives Develop a fully integrated system that provides an automated workflow with electronic signatures Support multiple NASA programs and contracts with a single "system" architecture Define standard processes, implement best practices, and minimize process variations

The Elements of an Effective Software Development Plan - Software Development Process Guidebook

DTIC Science & Technology

2011-11-11

standards and practices required for all XMPL software development. This SDP implements the <corporate> Standard Software Process (SSP). as tailored...Developing and integrating reusable software products • Approach to managing COTS/Reuse software implementation • COTS/Reuse software selection...final selection and submit to change board for approval MAINTENANCE Monitor current products for obsolescence or end of support Track new

NASA's Aviation Safety and Modeling Project

NASA Technical Reports Server (NTRS)

Chidester, Thomas R.; Statler, Irving C.

2006-01-01

The Aviation Safety Monitoring and Modeling (ASMM) Project of NASA's Aviation Safety program is cultivating sources of data and developing automated computer hardware and software to facilitate efficient, comprehensive, and accurate analyses of the data collected from large, heterogeneous databases throughout the national aviation system. The ASMM addresses the need to provide means for increasing safety by enabling the identification and correcting of predisposing conditions that could lead to accidents or to incidents that pose aviation risks. A major component of the ASMM Project is the Aviation Performance Measuring System (APMS), which is developing the next generation of software tools for analyzing and interpreting flight data.

A Predictive Safety Management System Software Package Based on the Continuous Hazard Tracking and Failure Prediction Methodology

NASA Technical Reports Server (NTRS)

Quintana, Rolando

2003-01-01

The goal of this research was to integrate a previously validated and reliable safety model, called Continuous Hazard Tracking and Failure Prediction Methodology (CHTFPM), into a software application. This led to the development of a safety management information system (PSMIS). This means that the theory or principles of the CHTFPM were incorporated in a software package; hence, the PSMIS is referred to as CHTFPM management information system (CHTFPM MIS). The purpose of the PSMIS is to reduce the time and manpower required to perform predictive studies as well as to facilitate the handling of enormous quantities of information in this type of studies. The CHTFPM theory encompasses the philosophy of looking at the concept of safety engineering from a new perspective: from a proactive, than a reactive, viewpoint. That is, corrective measures are taken before a problem instead of after it happened. That is why the CHTFPM is a predictive safety because it foresees or anticipates accidents, system failures and unacceptable risks; therefore, corrective action can be taken in order to prevent all these unwanted issues. Consequently, safety and reliability of systems or processes can be further improved by taking proactive and timely corrective actions.

[Expert investigation on food safety standard system framework construction in China].

PubMed

He, Xiang; Yan, Weixing; Fan, Yongxiang; Zeng, Biao; Peng, Zhen; Sun, Zhenqiu

2013-09-01

Through investigating food safety standard framework among food safety experts, to summarize the basic elements and principles of food safety standard system, and provide policy advices for food safety standards framework. A survey was carried out among 415 experts from government, professional institutions and the food industry/enterprises using the National Food Safety Standard System Construction Consultation Questionnaire designed in the name of the Secretariat of National Food Safety Standard Committee. Experts have different advices in each group about the principles of food product standards, food additive product standards, food related product standards, hygienic practice, test methods. According to the results, the best solution not only may reflect experts awareness of the work of food safety standards situation, but also provide advices for setting and revision of food safety standards for the next. Through experts investigation, the framework and guiding principles of food safety standard had been built.

Safety Characteristics in System Application Software for Human Rated Exploration

NASA Technical Reports Server (NTRS)

Mango, E. J.

2016-01-01

NASA and its industry and international partners are embarking on a bold and inspiring development effort to design and build an exploration class space system. The space system is made up of the Orion system, the Space Launch System (SLS) and the Ground Systems Development and Operations (GSDO) system. All are highly coupled together and dependent on each other for the combined safety of the space system. A key area of system safety focus needs to be in the ground and flight application software system (GFAS). In the development, certification and operations of GFAS, there are a series of safety characteristics that define the approach to ensure mission success. This paper will explore and examine the safety characteristics of the GFAS development.

Space Telecommunications Radio System (STRS) Architecture Standard. Release 1.02.1

NASA Technical Reports Server (NTRS)

Reinhart, Richard C.; Kacpura, Thomas J.; Handler, Louis M.; Hall, C. Steve; Mortensen, Dale J.; Johnson, Sandra K.; Briones, Janette C.; Nappier, Jennifer M.; Downey, Joseph A.; Lux, James P.

2012-01-01

This document contains the NASA architecture standard for software defined radios used in space- and ground-based platforms to enable commonality among radio developments to enhance capability and services while reducing mission and programmatic risk. Transceivers (or transponders) with functionality primarily defined in software (e.g., firmware) have the ability to change their functional behavior through software alone. This radio architecture standard offers value by employing common waveform software interfaces, method of instantiation, operation, and testing among different compliant hardware and software products. These common interfaces within the architecture abstract application software from the underlying hardware to enable technology insertion independently at either the software or hardware layer.

21 CFR 882.1440 - Neuropsychiatric interpretive electroencephalograph assessment aid.

Code of Federal Regulations, 2014 CFR

2014-04-01

... described in detail in the software requirements specification and software design specification... the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness. (i) Hardware specifications must be provided. Appropriate...

Software engineering standards and practices

NASA Technical Reports Server (NTRS)

Durachka, R. W.

1981-01-01

Guidelines are presented for the preparation of a software development plan. The various phases of a software development project are discussed throughout its life cycle including a general description of the software engineering standards and practices to be followed during each phase.

Automated Transfer Vehicle (ATV) Critical Safety Software Overview

NASA Astrophysics Data System (ADS)

Berthelier, D.

2002-01-01

The European Automated Transfer Vehicle is an unmanned transportation system designed to dock to International Space Station (ISS) and to contribute to the logistic servicing of the ISS. Concisely, ATV control is realized by a nominal flight control function (using computers, softwares, sensors, actuators). In order to cover the extreme situations where this nominal chain can not ensure safe trajectory with respect to ISS, a segregated proximity flight safety function is activated, where unsafe free drift trajectories can be encountered. This function relies notably on a segregated computer, the Monitoring and Safing Unit (MSU) ; in case of major ATV malfunction detection, ATV is then controlled by MSU software. Therefore, this software is critical because a MSU software failure could result in catastrophic consequences. This paper provides an overview both of this software functions and of the software development and validation method which is specific considering its criticality. First part of the paper describes briefly the proximity flight safety chain. Second part deals with the software functions. Indeed, MSU software is in charge of monitoring nominal computers and ATV corridors, using its own navigation algorithms, and, if an abnormal situation is detected, it is in charge of the ATV control during the Collision Avoidance Manoeuvre (CAM) consisting in an attitude controlled braking boost, followed by a Post-CAM manoeuvre : a Sun-pointed ATV attitude control during up to 24 hours on a safe trajectory. Monitoring, navigation and control algorithms principles are presented. Third part of this paper describes the development and validation process : algorithms functional studies , ADA coding and unit validations ; algorithms ADA code integration and validation on a specific non real-time MATLAB/SIMULINK simulator ; global software functional engineering phase, architectural design, unit testing, integration and validation on target computer.

Improving hospital weekend handover: a user-centered, standardised approach

PubMed Central

Mehra, Avi; Henein, Christin

2014-01-01

Clinical Handover remains one of the most perilous procedures in medicine (1). Weekend handover has emerged as a key area of concern with high variability in handover processes across hospitals (1,2,4, 5–10). Studying weekend handover processes within medicine at an acute teaching hospital revealed huge variability in documented content and structure. A total of 12 different pro formas were in use by the medical day-team to handover to the weekend team on-call. A Likert-survey of doctors revealed 93% felt the current handover system needed improvement with 71% stating that it did not ensure patient safety (Chi-squared, p-value <0.001, n=32). Semi-structured interviews of doctors identified common themes including “a lack of consistency in approach” “poor standardization” and “high variability”. Seeking to address concerns of standardization, a standardized handover pro forma was developed using Royal College of Physician (RCP) guidelines (2), with direct end-user input. Results following implementation revealed a considerable improvement in documented ceiling of care, urgency of task and team member assignment with 100% uptake of the new proforma at both 4-week and 6-month post-implementation analyses. 88% of doctors surveyed perceived that the new proforma improved patient safety (p<0.01, n=25), with 62% highlighting that it allowed doctors to work more efficiently. Results also revealed that 44% felt further improvements were needed and highlighted electronic solutions and handover training as main priorities. Handover briefing was subsequently incorporated into junior doctor induction and education modules delivered, with good feedback. Following collaboration with key stakeholders and with end-user input, integrated electronic handover software was designed and funding secured. The software is currently under final development. Introducing a standardized handover proforma can be an effective initial step in improving weekend handover. Handover education and end-user involvement are key in improving the process. Electronic handover solutions have been shown to significantly increase the quality of handover and are worth considering (9, 10). PMID:26734248

Impact of software and hardware technologies on occupational health and safety policies in Saudi Arabian oil refineries.

PubMed

Idreis, Hany M; Siqueira, Carlos E; Levenstein, Charles C

2006-01-01

This article seeks to examine the impact of technology importation on occupational health and safety in both Saudi Arabian and U.S. oil refining industries. Technologies imported to the Saudi oil industry take two forms: hardware (sophisticated equipment to run oil facilities) and software (policies and regulations pertaining to workers' health and safety, and employment rights installed by Aramco's founding multinational companies). This study utilizes qualitative, historically oriented, cross-national case studies to compare and assess workers' health, safety, and rights in Saudi Aramco with its U.S. counterpart, Motiva Enterprises. Two facilities were chosen to conduct field research: the Saudi Aramco oil refinery at Jeddah and Motiva's refinery at Port Arthur, Texas. The Jeddah refinery is fully owned by Saudi Aramco, thus, representing Aramco's health and safety policies and regulations. The Port Arthur refinery serves as a reference case study for U.S. oil refining facilities. The aspects of occupational health and safety in Saudi Aramco--ExxonMobil's joint ventures SAMREF and LUBREF--also are discussed to examine workers' health policies in both companies. The American oil industry made a significant contribution in establishing the Saudi oil industry, with the cooperation of the Saudi government. Despite having outstanding employment benefits schemes in Saudi Aramco, the presence of an organized work force better serves employee participation in Motiva than in Aramco. Safety systems such as Process Safety Management (PSM)--applied in Motiva--partially exist in Aramco to operate hardware technologies safely. Motiva training systems are better through PACE's Triangle of Prevention (TOP). Both companies follow the same pattern of handling occupational injuries and diseases; however, Saudi government agencies (GOSI) are responsible for compensating and treating injured workers. Saudi workers expressed conditional support for the worker committee program proposed by the Ministry of Labor. American and Saudi workers are concerned about the quality and sufficiency of health and safety training, employment promotion, work pressure, and job uncertainty due to continuous downsizing. This article recommends that Saudi social actors increase safety and health awareness in the work environment by providing intensive occupational safety training to the employees (as demanded by Saudi and American workers), improve labor-management relations through establishing strong cooperative contacts with regional and international trade unions, and establish uniform and standard occupational health and safety regulations for Saudi Aramco and its subsidiaries in order to provide an equal level of protection for Saudi workers.

Verification and Validation in a Rapid Software Development Process

NASA Technical Reports Server (NTRS)

Callahan, John R.; Easterbrook, Steve M.

1997-01-01

The high cost of software production is driving development organizations to adopt more automated design and analysis methods such as rapid prototyping, computer-aided software engineering (CASE) tools, and high-level code generators. Even developers of safety-critical software system have adopted many of these new methods while striving to achieve high levels Of quality and reliability. While these new methods may enhance productivity and quality in many cases, we examine some of the risks involved in the use of new methods in safety-critical contexts. We examine a case study involving the use of a CASE tool that automatically generates code from high-level system designs. We show that while high-level testing on the system structure is highly desirable, significant risks exist in the automatically generated code and in re-validating releases of the generated code after subsequent design changes. We identify these risks and suggest process improvements that retain the advantages of rapid, automated development methods within the quality and reliability contexts of safety-critical projects.

Software Defined Radio Standard Architecture and its Application to NASA Space Missions

NASA Technical Reports Server (NTRS)

Andro, Monty; Reinhart, Richard C.

2006-01-01

A software defined radio (SDR) architecture used in space-based platforms proposes to standardize certain aspects of radio development such as interface definitions, functional control and execution, and application software and firmware development. NASA has charted a team to develop an open software defined radio hardware and software architecture to support NASA missions and determine the viability of an Agency-wide Standard. A draft concept of the proposed standard has been released and discussed among organizations in the SDR community. Appropriate leveraging of the JTRS SCA, OMG's SWRadio Architecture and other aspects are considered. A standard radio architecture offers potential value by employing common waveform software instantiation, operation, testing and software maintenance. While software defined radios offer greater flexibility, they also poses challenges to the radio development for the space environment in terms of size, mass and power consumption and available technology. An SDR architecture for space must recognize and address the constraints of space flight hardware, and systems along with flight heritage and culture. NASA is actively participating in the development of technology and standards related to software defined radios. As NASA considers a standard radio architecture for space communications, input and coordination from government agencies, the industry, academia, and standards bodies is key to a successful architecture. The unique aspects of space require thorough investigation of relevant terrestrial technologies properly adapted to space. The talk will describe NASA's current effort to investigate SDR applications to space missions and a brief overview of a candidate architecture under consideration for space based platforms.

AstroBus On-Board Software

NASA Astrophysics Data System (ADS)

Biscarros, D.; Cantenot, C.; Séronie-Vivien, J.; Schmidt, G.

AstroBus on-board software is a customisable software for ERC32 based avionics implementing standard ESA Packet Utilization Standard functions. Its architecture based on generic design templates and relying on a library providing standard PUS TC, TM and event services enhances its reusability on various programs. Finally, AstroBus on-board software development and validation environment is based on last generation tools providing an optimised customisation environment.

Improvements to NASA's Debris Assessment Software

NASA Technical Reports Server (NTRS)

Opiela, J.; Johnson, Nicholas L.

2007-01-01

NASA's Debris Assessment Software (DAS) has been substantially revised and expanded. DAS is designed to assist NASA programs in performing orbital debris assessments, as described in NASA s Guidelines and Assessment Procedures for Limiting Orbital Debris. The extensive upgrade of DAS was undertaken to reflect changes in the debris mitigation guidelines, to incorporate recommendations from DAS users, and to take advantage of recent software capabilities for greater user utility. DAS 2.0 includes an updated environment model and enhanced orbital propagators and reentry-survivability models. The ORDEM96 debris environment model has been replaced by ORDEM2000 in DAS 2.0, which is also designed to accept anticipated revisions to the environment definition. Numerous upgrades have also been applied to the assessment of human casualty potential due to reentering debris. Routines derived from the Object Reentry Survival Analysis Tool, Version 6 (ORSAT 6), determine which objects are assessed to survive reentry, and the resulting risk of human casualty is calculated directly based upon the orbital inclination and a future world population database. When evaluating reentry risks, the user may enter up to 200 unique hardware components for each launched object, in up to four nested levels. This last feature allows the software to more accurately model components that are exposed below the initial breakup altitude. The new DAS 2.0 provides an updated set of tools for users to assess their mission s compliance with the NASA Safety Standard and does so with a clear and easy-to-understand interface. The new native Microsoft Windows graphical user interface (GUI) is a vast improvement over the previous DOS-based interface. In the new version, functions are more-clearly laid out, and the GUI includes the standard Windows-style Help functions. The underlying routines within the DAS code are also improved.

[Exploration of the Association Between Workplace Bullying and Attitudes Toward Patient Safety in Female Nurses].

PubMed

Lin, Yuh-Hsuan; Hsiao, Shu-Tai Sheen; Lin, Chiou-Fen; Yang, Chyn-Yng; Chung, Min-Huey

2018-02-01

Workplace bullying is known to have a significant and detrimental effect on the physical and psychological outcomes of its victims. The reactions of victims to bullying may decrease clinical care outcomes and patient safety. To explore the relationship between workplace bullying and the attitudes of female nurses toward the safety of their patients. This cross-sectional survey study used convenience sampling. Participants included female nurses from a regional teaching hospital. The research tool was a three-part, structured questionnaire that included a basic personal information datasheet, negative behavior scale, and patient safety attitude scale. The researcher distributed 420 questionnaires and collected 329 valid samples (valid return rate: 78.3%). Data were analyzed using SPSS software version 22.0. The analysis found that 29.8% of the participants had suffered from various degrees of workplace bullying. The mean score for patient safety attitudes was 3.58 (standard deviation = 0.55). Workplace bullying and patient safety attitudes were negatively correlated (p < .1), and being a recipient of workplace bullying was identified as a significant predictor of attitudes toward patient safety. Based on the results, we suggest that supervisors should take the initiative to care for their nursing staffs and to provide them with training in conflict-oriented skills. Organization managers should set up relevant committee-notification mechanisms that construct the safe working environment necessary to reduce workplace bullying and to enhance the patient safety attitudes of nurses, which will indirectly improve the quality of patient care.

NASA Tech Briefs, June 2011

NASA Technical Reports Server (NTRS)

2011-01-01

Topics covered include: Wind and Temperature Spectrometry of the Upper Atmosphere in Low-Earth Orbit; Health Monitor for Multitasking, Safety-Critical, Real-Time Software; Stereo Imaging Miniature Endoscope; Early Oscillation Detection Technique for Hybrid DC/DC Converters; Parallel Wavefront Analysis for a 4D Interferometer; Schottky Heterodyne Receivers With Full Waveguide Bandwidth; Carbon Nanofiber-Based, High-Frequency, High-Q, Miniaturized Mechanical Resonators; Ultracapacitor-Based Uninterrupted Power Supply System; Coaxial Cables for Martian Extreme Temperature Environments; Using Spare Logic Resources To Create Dynamic Test Points; Autonomous Coordination of Science Observations Using Multiple Spacecraft; Autonomous Phase Retrieval Calibration; EOS MLS Level 1B Data Processing Software, Version 3; Cassini Tour Atlas Automated Generation; Software Development Standard Processes (SDSP); Graphite Composite Panel Polishing Fixture; Material Gradients in Oxygen System Components Improve Safety; Ridge Waveguide Structures in Magnesium-Doped Lithium Niobate; Modifying Matrix Materials to Increase Wetting and Adhesion; Lightweight Magnetic Cooler With a Reversible Circulator; The Invasive Species Forecasting System; Method for Cleanly and Precisely Breaking Off a Rock Core Using a Radial Compressive Force; Praying Mantis Bending Core Breakoff and Retention Mechanism; Scoring Dawg Core Breakoff and Retention Mechanism; Rolling-Tooth Core Breakoff and Retention Mechanism; Vibration Isolation and Stabilization System for Spacecraft Exercise Treadmill Devices; Microgravity-Enhanced Stem Cell Selection; Diagnosis and Treatment of Neurological Disorders by Millimeter-Wave Stimulation; Passive Vaporizing Heat Sink; Remote Sensing and Quantization of Analog Sensors; Phase Retrieval for Radio Telescope and Antenna Control; Helium-Cooled Black Shroud for Subscale Cryogenic Testing; Receive Mode Analysis and Design of Microstrip Reflectarrays; and Chance-Constrained Guidance With Non-Convex Constraints.

Perceptions of health care professionals on the safety and security at Odi District Hospital, Gauteng, South Africa

PubMed Central

Okeke, Sunday O.

2017-01-01

Background For optimum delivery of service, an establishment needs to ensure a safe and secure environment. In 2011, the South African government promulgated the National Core Standards for Health Establishments for safety and security for all employees in all establishments. Little is known about whether these standards are being complied to. Aim and setting: To assess the perceptions of health care professionals (HCPs) on safety and security at Odi District Hospital. Methodology A sample of 181 out of a total of 341 HCPs was drawn through a systematic sampling method from each HCP category. Data were collected through a self-administered questionnaire. The SPSS® statistical software version 22 was used for data analysis. The level of statistical significance was set at < 0.05. Results There were more female respondents than male respondents (136; 75.10%). The dominant age group was 28–47 years (114; 57.46%). Perceptions on security personnel, their efficiency and the security system were significantly affirmed (p = 0.0001). The hospital infrastructure, surroundings and plan in emergencies were perceived to be safe (p < 0.0001). The hospital lighting system was perceived as inadequate (p = 0.0041). Only 36 (20.2%) HCPs perceived that hospital authorities were concerned about employees’ safety (p < 0.0001). Conclusion HCPs had positive perceptions regarding the hospital’s security system. Except for the negative perceptions of the lighting system and the perceived lack of hospital authorities’ concern for staff safety, perceptions of the HCPs on the hospital working environment were positive. The hospital authorities need to establish the basis of negative perceptions and enforce remedial measures to redress them. PMID:29113444

48 CFR 227.7203-5 - Government rights.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Software and Computer Software Documentation 227.7203-5 Government rights. The standard license rights in computer software that a licensor grants to the Government are unlimited rights, government purpose rights, or restricted rights. The standard license in computer software documentation conveys unlimited...

48 CFR 227.7203-5 - Government rights.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Software and Computer Software Documentation 227.7203-5 Government rights. The standard license rights in computer software that a licensor grants to the Government are unlimited rights, government purpose rights, or restricted rights. The standard license in computer software documentation conveys unlimited...

48 CFR 227.7203-5 - Government rights.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Software and Computer Software Documentation 227.7203-5 Government rights. The standard license rights in computer software that a licensor grants to the Government are unlimited rights, government purpose rights, or restricted rights. The standard license in computer software documentation conveys unlimited...

48 CFR 227.7203-5 - Government rights.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Software and Computer Software Documentation 227.7203-5 Government rights. The standard license rights in computer software that a licensor grants to the Government are unlimited rights, government purpose rights, or restricted rights. The standard license in computer software documentation conveys unlimited...

48 CFR 227.7203-5 - Government rights.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Software and Computer Software Documentation 227.7203-5 Government rights. The standard license rights in computer software that a licensor grants to the Government are unlimited rights, government purpose rights, or restricted rights. The standard license in computer software documentation conveys unlimited...

Integrated Functional and Executional Modelling of Software Using Web-Based Databases

NASA Technical Reports Server (NTRS)

Kulkarni, Deepak; Marietta, Roberta

1998-01-01

NASA's software subsystems undergo extensive modification and updates over the operational lifetimes. It is imperative that modified software should satisfy safety goals. This report discusses the difficulties encountered in doing so and discusses a solution based on integrated modelling of software, use of automatic information extraction tools, web technology and databases.

78 FR 47012 - Developing Software Life Cycle Processes Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Developing Software Life Cycle Processes Used in... revised regulatory guide (RG), revision 1 of RG 1.173, ``Developing Software Life Cycle Processes for... Developing a Software Project Life Cycle Process,'' issued 2006, with the clarifications and exceptions as...

75 FR 16817 - Meeting for Software Developers on the Technical Specifications for Common Formats for Patient...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Software Developers on the Technical Specifications for Common Formats for Patient Safety Data Collection... software developers can provide input on these technical specifications for the Common Formats Version 1.1... specifications, which provide direction to software developers that plan to implement the Common Formats...

76 FR 16785 - Meeting for Software Developers on the Technical Specifications for Common Formats for Patient...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... Software Developers on the Technical Specifications for Common Formats for Patient Safety Data Collection... designed as an interactive forum where PSOs and software developers can provide input on these technical... updated event descriptions, forms, and technical specifications for software developers. As an update to...

Automated Translation of Safety Critical Application Software Specifications into PLC Ladder Logic

NASA Technical Reports Server (NTRS)

Leucht, Kurt W.; Semmel, Glenn S.

2008-01-01

The numerous benefits of automatic application code generation are widely accepted within the software engineering community. A few of these benefits include raising the abstraction level of application programming, shorter product development time, lower maintenance costs, and increased code quality and consistency. Surprisingly, code generation concepts have not yet found wide acceptance and use in the field of programmable logic controller (PLC) software development. Software engineers at the NASA Kennedy Space Center (KSC) recognized the need for PLC code generation while developing their new ground checkout and launch processing system. They developed a process and a prototype software tool that automatically translates a high-level representation or specification of safety critical application software into ladder logic that executes on a PLC. This process and tool are expected to increase the reliability of the PLC code over that which is written manually, and may even lower life-cycle costs and shorten the development schedule of the new control system at KSC. This paper examines the problem domain and discusses the process and software tool that were prototyped by the KSC software engineers.

A feasibility study for Arizona's roadway safety management process using the Highway Safety Manual and SafetyAnalyst : final report.

DOT National Transportation Integrated Search

2016-07-01

To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...

NASA's SDR Standard: Space Telecommunications Radio System

NASA Technical Reports Server (NTRS)

Reinhart, Richard C.; Johnson, Sandra K.

2007-01-01

A software defined radio (SDR) architecture used in space-based platforms proposes to standardize certain aspects of radio development such as interface definitions, functional control and execution, and application software and firmware development. NASA has charted a team to develop an open software defined radio hardware and software architecture to support NASA missions and determine the viability of an Agency-wide Standard. A draft concept of the proposed standard has been released and discussed among organizations in the SDR community. Appropriate leveraging of the JTRS SCA, OMG s SWRadio Architecture and other aspects are considered. A standard radio architecture offers potential value by employing common waveform software instantiation, operation, testing and software maintenance. While software defined radios offer greater flexibility, they also poses challenges to the radio development for the space environment in terms of size, mass and power consumption and available technology. An SDR architecture for space must recognize and address the constraints of space flight hardware, and systems along with flight heritage and culture. NASA is actively participating in the development of technology and standards related to software defined radios. As NASA considers a standard radio architecture for space communications, input and coordination from government agencies, the industry, academia, and standards bodies is key to a successful architecture. The unique aspects of space require thorough investigation of relevant terrestrial technologies properly adapted to space. The talk will describe NASA s current effort to investigate SDR applications to space missions and a brief overview of a candidate architecture under consideration for space based platforms.

Epistemic Questions and Answers for Software System Safety

NASA Technical Reports Server (NTRS)

Holloway, C. M.; Johnson, Chris W.

2010-01-01

System safety is primarily concerned with epistemic questions, that is, questions concerning knowledge and the degree of confidence that can be placed in that knowledge. For systems with which human experience is long, such as roads, bridges, and mechanical devices, knowledge about what is required to make the systems safe is deep and detailed. High confidence can be placed in the validity of that knowledge. For other systems, however, with which human experience is comparatively short, such as those that rely in part or in whole on software, knowledge about what is required to ensure safety tends to be shallow and general. The confidence that can be placed in the validity of that knowledge is consequently low. In a previous paper, we enumerated a collection of foundational epistemic questions concerning software system safety. In this paper, we review and refine the questions, discuss some difficulties that attend to answering the questions today, and speculate on possible research to improve the situation.

Final Technical Report on Quantifying Dependability Attributes of Software Based Safety Critical Instrumentation and Control Systems in Nuclear Power Plants

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

Smidts, Carol; Huang, Funqun; Li, Boyuan

With the current transition from analog to digital instrumentation and control systems in nuclear power plants, the number and variety of software-based systems have significantly increased. The sophisticated nature and increasing complexity of software raises trust in these systems as a significant challenge. The trust placed in a software system is typically termed software dependability. Software dependability analysis faces uncommon challenges since software systems’ characteristics differ from those of hardware systems. The lack of systematic science-based methods for quantifying the dependability attributes in software-based instrumentation as well as control systems in safety critical applications has proved itself to be amore » significant inhibitor to the expanded use of modern digital technology in the nuclear industry. Dependability refers to the ability of a system to deliver a service that can be trusted. Dependability is commonly considered as a general concept that encompasses different attributes, e.g., reliability, safety, security, availability and maintainability. Dependability research has progressed significantly over the last few decades. For example, various assessment models and/or design approaches have been proposed for software reliability, software availability and software maintainability. Advances have also been made to integrate multiple dependability attributes, e.g., integrating security with other dependability attributes, measuring availability and maintainability, modeling reliability and availability, quantifying reliability and security, exploring the dependencies between security and safety and developing integrated analysis models. However, there is still a lack of understanding of the dependencies between various dependability attributes as a whole and of how such dependencies are formed. To address the need for quantification and give a more objective basis to the review process -- therefore reducing regulatory uncertainty -- measures and methods are needed to assess dependability attributes early on, as well as throughout the life-cycle process of software development. In this research, extensive expert opinion elicitation is used to identify the measures and methods for assessing software dependability. Semi-structured questionnaires were designed to elicit expert knowledge. A new notation system, Causal Mechanism Graphing, was developed to extract and represent such knowledge. The Causal Mechanism Graphs were merged, thus, obtaining the consensus knowledge shared by the domain experts. In this report, we focus on how software contributes to dependability. However, software dependability is not discussed separately from the context of systems or socio-technical systems. Specifically, this report focuses on software dependability, reliability, safety, security, availability, and maintainability. Our research was conducted in the sequence of stages found below. Each stage is further examined in its corresponding chapter. Stage 1 (Chapter 2): Elicitation of causal maps describing the dependencies between dependability attributes. These causal maps were constructed using expert opinion elicitation. This chapter describes the expert opinion elicitation process, the questionnaire design, the causal map construction method and the causal maps obtained. Stage 2 (Chapter 3): Elicitation of the causal map describing the occurrence of the event of interest for each dependability attribute. The causal mechanisms for the “event of interest” were extracted for each of the software dependability attributes. The “event of interest” for a dependability attribute is generally considered to be the “attribute failure”, e.g. security failure. The extraction was based on the analysis of expert elicitation results obtained in Stage 1. Stage 3 (Chapter 4): Identification of relevant measurements. Measures for the “events of interest” and their causal mechanisms were obtained from expert opinion elicitation for each of the software dependability attributes. The measures extracted are presented in this chapter. Stage 4 (Chapter 5): Assessment of the coverage of the causal maps via measures. Coverage was assessed to determine whether the measures obtained were sufficient to quantify software dependability, and what measures are further required. Stage 5 (Chapter 6): Identification of “missing” measures and measurement approaches for concepts not covered. New measures, for concepts that had not been covered sufficiently as determined in Stage 4, were identified using supplementary expert opinion elicitation as well as literature reviews. Stage 6 (Chapter 7): Building of a detailed quantification model based on the causal maps and measurements obtained. Ability to derive such a quantification model shows that the causal models and measurements derived from the previous stages (Stage 1 to Stage 5) can form the technical basis for developing dependability quantification models. Scope restrictions have led us to prioritize this demonstration effort. The demonstration was focused on a critical system, i.e. the reactor protection system. For this system, a ranking of the software dependability attributes by nuclear stakeholders was developed. As expected for this application, the stakeholder ranking identified safety as the most critical attribute to be quantified. A safety quantification model limited to the requirements phase of development was built. Two case studies were conducted for verification. A preliminary control gate for software safety for the requirements stage was proposed and applied to the first case study. The control gate allows a cost effective selection of the duration of the requirements phase.« less

Data systems and computer science: Software Engineering Program

NASA Technical Reports Server (NTRS)

Zygielbaum, Arthur I.

1991-01-01

An external review of the Integrated Technology Plan for the Civil Space Program is presented. This review is specifically concerned with the Software Engineering Program. The goals of the Software Engineering Program are as follows: (1) improve NASA's ability to manage development, operation, and maintenance of complex software systems; (2) decrease NASA's cost and risk in engineering complex software systems; and (3) provide technology to assure safety and reliability of software in mission critical applications.

Diversification and Challenges of Software Engineering Standards

NASA Technical Reports Server (NTRS)

Poon, Peter T.

1994-01-01

The author poses certain questions in this paper: 'In the future, should there be just one software engineering standards set? If so, how can we work towards that goal? What are the challenges of internationalizing standards?' Based on the author's personal view, the statement of his position is as follows: 'There should NOT be just one set of software engineering standards in the future. At the same time, there should NOT be the proliferation of standards, and the number of sets of standards should be kept to a minimum.It is important to understand the diversification of the areas which are spanned by the software engineering standards.' The author goes on to describe the diversification of processes, the diversification in the national and international character of standards organizations, the diversification of the professional organizations producing standards, the diversification of the types of businesses and industries, and the challenges of internationalizing standards.

Structural Statics Analysis and Optimization Design of Regulating Device for Air Conveyer Outlet in Coal Mine

NASA Astrophysics Data System (ADS)

Gong, Xiaoyan; Li, Ying; Zhang, Yongqiang

2018-06-01

In view of the enlargement of fully mechanized face excavation and long distance driving, gas emission and dust production increase greatly. However, the current ventilation device direction angle, caliber and front-back distance cannot change dynamically at any time, resulting in the serious accumulation in the dead zone. In this paper, a new device were proposed that can solve above problems. Finite element ANSYS software were used to simulate and optimize the structural safety of the control device' key components. The optimization results showed that the equivalent stress decreases by 49%; after the optimization of deformation and mass are 0.829mm and 0.548kg, which were 21% and 10% lower than before.The quality, safety, reliability and cost of the control device reach the expected standards perfectly, which can meet the requirements of safe ventilation and down-dusting of fully mechanized face.

Safety self-efficacy and safety performance: potential antecedents and the moderation effect of standardization.

PubMed

Katz-Navon, Tal; Naveh, Eitan; Stern, Zvi

2007-01-01

The purpose of this paper is to suggest a new safety self-efficacy construct and to explore its antecedents and interaction with standardization to influence in-patient safety. The paper used a survey of 161 nurses using a self-administered questionnaire over a 14-day period in two large Israeli general hospitals. Nurses answered questions relating to four safety self-efficacy antecedents: enactive mastery experiences; managers as safety role models; verbal persuasion; and safety priority, that relate to the perceived level of standardization and safety self-efficacy. Confirmatory factor analysis was used to assess the scale's construct validity. Regression models were used to test hypotheses regarding the antecedents and influence of safety self-efficacy. Results indicate that: managers as safety role models; distributing safety information; and priority given to safety, contributed to safety self-efficacy. Additionally, standardization moderated the effects of safety self-efficacy and patient safety such that safety self-efficacy was positively associated with patient safety when standardization was low rather than high. Hospital managers should be aware of individual motivations as safety self-efficacy when evaluating the potential influence of standardization on patient safety. Theoretically, the study introduces a new safety self-efficacy concept, and captures its antecedents and influence on safety performance. Also, the study suggests safety self-efficacy as a boundary condition for the influence of standardization on safety performance. Implementing standardization in healthcare is problematic because not all processes can be standardized. In this case, self-efficacy plays an important role in securing patient safety. Hence, safety self-efficacy may serve as a "substitute-for-standardization," by promoting staff behaviors that affect patient safety.

Highway Safety Manual applied in Missouri - freeway/software.

DOT National Transportation Integrated Search

2016-06-01

AASHTOs Highway Safety Manual (HSM) facilitates the quantitative safety analysis of highway facilities. In a 2014 : supplement, freeway facilities were added to the original HSM manual which allows the modeling of highway : interchanges. This repo...

Space Station Software Recommendations

NASA Technical Reports Server (NTRS)

Voigt, S. (Editor)

1985-01-01

Four panels of invited experts and NASA representatives focused on the following topics: software management, software development environment, languages, and software standards. Each panel deliberated in private, held two open sessions with audience participation, and developed recommendations for the NASA Space Station Program. The major thrusts of the recommendations were as follows: (1) The software management plan should establish policies, responsibilities, and decision points for software acquisition; (2) NASA should furnish a uniform modular software support environment and require its use for all space station software acquired (or developed); (3) The language Ada should be selected for space station software, and NASA should begin to address issues related to the effective use of Ada; and (4) The space station software standards should be selected (based upon existing standards where possible), and an organization should be identified to promulgate and enforce them. These and related recommendations are described in detail in the conference proceedings.

What is Clinical Safety in Electronic Health Care Record Systems?

NASA Astrophysics Data System (ADS)

Davies, George

There is mounting public awareness of an increasing number of adverse clinical incidents within the National Health Service (NHS), but at the same time, large health care projects like the National Programme for IT (NPFIT) are claiming that safer care is one of the benefits of the project and that health software systems in particular have the potential to reduce the likelihood of accidental or unintentional harm to patients. This paper outlines the approach to clinical safety management taken by CSC, a major supplier to NPFIT; discusses acceptable levels of risk and clinical safety as an end-to-end concept; and touches on the future for clinical safety in health systems software.

Open Architecture Standard for NASA's Software-Defined Space Telecommunications Radio Systems

NASA Technical Reports Server (NTRS)

Reinhart, Richard C.; Johnson, Sandra K.; Kacpura, Thomas J.; Hall, Charles S.; Smith, Carl R.; Liebetreu, John

2008-01-01

NASA is developing an architecture standard for software-defined radios used in space- and ground-based platforms to enable commonality among radio developments to enhance capability and services while reducing mission and programmatic risk. Transceivers (or transponders) with functionality primarily defined in software (e.g., firmware) have the ability to change their functional behavior through software alone. This radio architecture standard offers value by employing common waveform software interfaces, method of instantiation, operation, and testing among different compliant hardware and software products. These common interfaces within the architecture abstract application software from the underlying hardware to enable technology insertion independently at either the software or hardware layer. This paper presents the initial Space Telecommunications Radio System (STRS) Architecture for NASA missions to provide the desired software abstraction and flexibility while minimizing the resources necessary to support the architecture.

Teaching and Assessment of Mathematical Principles for Software Correctness Using a Reasoning Concept Inventory

ERIC Educational Resources Information Center

Drachova-Strang, Svetlana V.

2013-01-01

As computing becomes ubiquitous, software correctness has a fundamental role in ensuring the safety and security of the systems we build. To design and develop software correctly according to their formal contracts, CS students, the future software practitioners, need to learn a critical set of skills that are necessary and sufficient for…

Program Helps Standardize Documentation Of Software

NASA Technical Reports Server (NTRS)

Howe, G.

1994-01-01

Intelligent Documentation Management System, IDMS, computer program developed to assist project managers in implementing information system documentation standard known as NASA-STD-2100-91, NASA STD, COS-10300, of NASA's Software Management and Assurance Program. Standard consists of data-item descriptions or templates, each of which governs particular component of software documentation. IDMS helps program manager in tailoring documentation standard to project. Written in C language.

Evidence Arguments for Using Formal Methods in Software Certification

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh

2013-01-01

We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former.

Methodology for assessing the safety of Hydrogen Systems: HyRAM 1.1 technical reference manual

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

Groth, Katrina; Hecht, Ethan; Reynolds, John Thomas

The HyRAM software toolkit provides a basis for conducting quantitative risk assessment and consequence modeling for hydrogen infrastructure and transportation systems. HyRAM is designed to facilitate the use of state-of-the-art science and engineering models to conduct robust, repeatable assessments of hydrogen safety, hazards, and risk. HyRAM is envisioned as a unifying platform combining validated, analytical models of hydrogen behavior, a stan- dardized, transparent QRA approach, and engineering models and generic data for hydrogen installations. HyRAM is being developed at Sandia National Laboratories for the U. S. De- partment of Energy to increase access to technical data about hydrogen safety andmore » to enable the use of that data to support development and revision of national and international codes and standards. This document provides a description of the methodology and models contained in the HyRAM version 1.1. HyRAM 1.1 includes generic probabilities for hydrogen equipment fail- ures, probabilistic models for the impact of heat flux on humans and structures, and computa- tionally and experimentally validated analytical and first order models of hydrogen release and flame physics. HyRAM 1.1 integrates deterministic and probabilistic models for quantifying accident scenarios, predicting physical effects, and characterizing hydrogen hazards (thermal effects from jet fires, overpressure effects from deflagrations), and assessing impact on people and structures. HyRAM is a prototype software in active development and thus the models and data may change. This report will be updated at appropriate developmental intervals.« less

Microhydration of caesium compounds: Cs, CsOH, CsI and Cs₂I₂ complexes with one to three H₂O molecules of nuclear safety interest.

PubMed

Sudolská, Mária; Cantrel, Laurent; Cernušák, Ivan

2014-04-01

Structure and thermodynamic properties (standard enthalpies of formation and Gibbs free energies) of hydrated caesium species of nuclear safety interest, Cs, CsOH, CsI and its dimer Cs₂I₂, with one up to three water molecules, are calculated to assess their possible existence in severe accident occurring to a pressurized water reactor. The calculations were performed using the coupled cluster theory including single, double and non-iterative triple substitutions (CCSD(T)) in conjunction with the basis sets (ANO-RCC) developed for scalar relativistic calculations. The second-order spin-free Douglas-Kroll-Hess Hamiltonian was used to account for the scalar relativistic effects. Thermodynamic properties obtained by these correlated ab initio calculations (entropies and thermal capacities at constant pressure as a function of temperature) are used in nuclear accident simulations using ASTEC/SOPHAEROS software. Interaction energies, standard enthalpies and Gibbs free energies of successive water molecules addition determine the ordering of the complexes. CsOH forms the most hydrated stable complexes followed by CsI, Cs₂I₂, and Cs. CsOH still exists in steam atmosphere even at quite high temperature, up to around 1100 K.

Modular Software for Spacecraft Navigation Using the Global Positioning System (GPS)

NASA Technical Reports Server (NTRS)

Truong, S. H.; Hartman, K. R.; Weidow, D. A.; Berry, D. L.; Oza, D. H.; Long, A. C.; Joyce, E.; Steger, W. L.

1996-01-01

The Goddard Space Flight Center Flight Dynamics and Mission Operations Divisions have jointly investigated the feasibility of engineering modular Global Positioning SYSTEM (GPS) navigation software to support both real time flight and ground postprocessing configurations. The goals of this effort are to define standard GPS data interfaces and to engineer standard, reusable navigation software components that can be used to build a broad range of GPS navigation support applications. The paper discusses the GPS modular software (GMOD) system and operations concepts, major requirements, candidate software architecture, feasibility assessment and recommended software interface standards. In additon, ongoing efforts to broaden the scope of the initial study and to develop modular software to support autonomous navigation using GPS are addressed,

Safety assessment of Cracked K-joint Structure Based on Fracture Mechanics

NASA Astrophysics Data System (ADS)

Wang, Xin; Pengyu, Yan; Jianwei, Du; Fuhai, Cai

2017-05-01

The K-joint is the main bearing structure of lattice jib crane. During frequent operation of the crane, surface cracks often occur at its weld toe, and then continue to expand until failure. The safety of the weak structure K-joint of the crane jib can be evaluated by BS7910 failure assessment standard in order to improve its utilization. The finite element model of K-joint structure with cracks is established, and its mechanical properties is analyzed by ABAQUS software, the results show that the crack depth has a great influence on the bearing capacity of the structure compared with the crack length. It is assumed that the K-joint with the semi-elliptical surface crack under the action of the tension propagate stably under the condition that the c/a (ratio of short axis to long axis of ellipse) is about 0.3. The safety assessment of K-joint with different lengths crack is presented according to the 2A failure assessment diagram of BS7910, and the critical crack of K-joint under different loads can be obtained.

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

Space Telecommunications Radio Architecture (STRS)

NASA Technical Reports Server (NTRS)

Reinhart, Richard C.

2006-01-01

A software defined radio (SDR) architecture used in space-based platforms proposes to standardize certain aspects of radio development such as interface definitions, functional control and execution, and application software and firmware development. NASA has charted a team to develop an open software defined radio hardware and software architecture to support NASA missions and determine the viability of an Agency-wide Standard. A draft concept of the proposed standard has been released and discussed among organizations in the SDR community. Appropriate leveraging of the JTRS SCA, OMG's SWRadio Architecture and other aspects are considered. A standard radio architecture offers potential value by employing common waveform software instantiation, operation, testing and software maintenance. While software defined radios offer greater flexibility, they also poses challenges to the radio development for the space environment in terms of size, mass and power consumption and available technology. An SDR architecture for space must recognize and address the constraints of space flight hardware, and systems along with flight heritage and culture. NASA is actively participating in the development of technology and standards related to software defined radios. As NASA considers a standard radio architecture for space communications, input and coordination from government agencies, the industry, academia, and standards bodies is key to a successful architecture. The unique aspects of space require thorough investigation of relevant terrestrial technologies properly adapted to space. The talk will describe NASA s current effort to investigate SDR applications to space missions and a brief overview of a candidate architecture under consideration for space based platforms.

Space Telecommunications Radio Architecture (STRS): Technical Overview

NASA Technical Reports Server (NTRS)

Reinhart, Richard C.

2006-01-01

A software defined radio (SDR) architecture used in space-based platforms proposes to standardize certain aspects of radio development such as interface definitions, functional control and execution, and application software and firmware development. NASA has charted a team to develop an open software defined radio hardware and software architecture to support NASA missions and determine the viability of an Agency-wide Standard. A draft concept of the proposed standard has been released and discussed among organizations in the SDR community. Appropriate leveraging of the JTRS SCA, OMG s SWRadio Architecture and other aspects are considered. A standard radio architecture offers potential value by employing common waveform software instantiation, operation, testing and software maintenance. While software defined radios offer greater flexibility, they also poses challenges to the radio development for the space environment in terms of size, mass and power consumption and available technology. An SDR architecture for space must recognize and address the constraints of space flight hardware, and systems along with flight heritage and culture. NASA is actively participating in the development of technology and standards related to software defined radios. As NASA considers a standard radio architecture for space communications, input and coordination from government agencies, the industry, academia, and standards bodies is key to a successful architecture. The unique aspects of space require thorough investigation of relevant terrestrial technologies properly adapted to space. The talk will describe NASA's current effort to investigate SDR applications to space missions and a brief overview of a candidate architecture under consideration for space based platforms.

Standard practices for the implementation of computer software

NASA Technical Reports Server (NTRS)

Irvine, A. P. (Editor)

1978-01-01

A standard approach to the development of computer program is provided that covers the file cycle of software development from the planning and requirements phase through the software acceptance testing phase. All documents necessary to provide the required visibility into the software life cycle process are discussed in detail.

Standardization: Hardware and Software Standardization Can Reduce Costs and Save Time

ERIC Educational Resources Information Center

Brooks-Young, Susan

2005-01-01

Sadly, technical support doesn't come cheap. One money-saving strategy that's gained popularity among school technicians is equipment and software standardization. When it works, standardization can be very effective. However, standardization has its drawbacks. This article discusses the advantages and disadvantages of standardization.

[Pregnant women's food safety and nutritional status in Cartagena, Colombia 2011].

PubMed

López-Sáleme, Rossana; Díaz-Montes, Carmen E; Bravo-Aljuriz, Leidy; Londoño-Hio, Nataly P; Salguedo-Pájaro, Maireng del Carmen; Camargo-Marín, Casandra C; Osorio-Espitia, Eider

2012-01-01

Establishing an association between food safety and nutritional status in pregnant women in Cartagena. This was a cross-sectional study, using a sample of 413 pregnant women living in urban areas who were affiliated to healthcare-providing companies in Cartagena. A 95 % confidence level, 5 % error and 0.41 prevalence were used. they were stratified by proportional allocation; nutritional status was identified by anthropometric indicators plotted on a Rosso-Mardones nomogram and food safety was determined by a national survey of the situation. Stata 9.2 statistical software was used for a descriptive analysis of the data using frequencies, percentages, averages and standard deviations. The odds ratio (OR)* and p <0.05 significance level were estimated in bivariate analysis. Mean age was 24.3 years-old, 72.2 % were living with a partner and 52 % belonged to stratum 1; it was determined that 70.2 % had food safety. Regarding nutritional status, it was observed that 42 % had maintained appropriate weight during pregnancy. Food safety was not associated with nutritional status (OR 0.8; 0.5-1.3 95 %CI). A high percentage of pregnant women had altered nutritional status, tending towards deficit or towards increase reported as having food safety. This may have been because this study assessed food safety in relation to even though the pregnant women may have had food available, this did not guarantee that they consumed it in suitable quantities and/or quality, such aspects not having been evaluated in this study.

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

Soubies, B.; Henry, J.Y.; Le Meur, M.

1300 MWe pressurised water reactors (PWRs), like the 1400 MWe reactors, operate with microprocessor-based safety systems. This is particularly the case for the Digital Integrated Protection System (SPIN), which trips the reactor in an emergency and sets in action the safeguard functions. The softwares used in these systems must therefore be highly dependable in the execution of their functions. In the case of SPIN, three players are working at different levels to achieve this goal: the protection system manufacturer, Merlin Gerin; the designer of the nuclear steam supply system, Framatome; the operator of the nuclear power plants, Electricite de Francemore » (EDF), which is also responsible for the safety of its installations. Regulatory licenses are issued by the French safety authority, the Nuclear Installations Safety Directorate (French abbreviation DSIN), subsequent to a successful examination of the technical provisions adopted by the operator. This examination is carried out by the IPSN and the standing group on nuclear reactors. This communication sets out: the methods used by the manufacturer to develop SPIN software for the 1400 MWe PWRs (N4 series); the approach adopted by the IPSN to evaluate the safety software of the protection system for the N4 series of reactors.« less

Software Reviews.

ERIC Educational Resources Information Center

Wulfson, Stephen, Ed.

1988-01-01

Reviews seven instructional software packages covering a variety of topics. Includes: "Science Square-Off"; "The Desert"; "Science Courseware: Physical Science"; "Odell Lake"; "Safety First"; "An Experience in Artificial Intelligence"; and "Master Mapper." (TW)

49 CFR 385.5 - Safety fitness standard.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Safety fitness standard. 385.5 Section 385.5... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.5 Safety fitness standard. A motor carrier must meet the safety fitness standard set forth...

49 CFR 385.5 - Safety fitness standard.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Safety fitness standard. 385.5 Section 385.5... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.5 Safety fitness standard. A motor carrier must meet the safety fitness standard set forth...

Contracting for Computer Software in Standardized Computer Languages

PubMed Central

Brannigan, Vincent M.; Dayhoff, Ruth E.

1982-01-01

The interaction between standardized computer languages and contracts for programs which use these languages is important to the buyer or seller of software. The rationale for standardization, the problems in standardizing computer languages, and the difficulties of determining whether the product conforms to the standard are issues which must be understood. The contract law processes of delivery, acceptance testing, acceptance, rejection, and revocation of acceptance are applicable to the contracting process for standard language software. Appropriate contract language is suggested for requiring strict compliance with a standard, and an overview of remedies is given for failure to comply.

Texas curve margin of safety.

DOT National Transportation Integrated Search

2013-01-01

This software can be used to assist with the assessment of margin of safety for a horizontal curve. It is intended for use by engineers and technicians responsible for safety analysis or management of rural highway pavement or traffic control devices...

Formal Safety Certification of Aerospace Software

NASA Technical Reports Server (NTRS)

Denney, Ewen; Fischer, Bernd

2005-01-01

In principle, formal methods offer many advantages for aerospace software development: they can help to achieve ultra-high reliability, and they can be used to provide evidence of the reliability claims which can then be subjected to external scrutiny. However, despite years of research and many advances in the underlying formalisms of specification, semantics, and logic, formal methods are not much used in practice. In our opinion this is related to three major shortcomings. First, the application of formal methods is still expensive because they are labor- and knowledge-intensive. Second, they are difficult to scale up to complex systems because they are based on deep mathematical insights about the behavior of the systems (t.e., they rely on the "heroic proof"). Third, the proofs can be difficult to interpret, and typically stand in isolation from the original code. In this paper, we describe a tool for formally demonstrating safety-relevant aspects of aerospace software, which largely circumvents these problems. We focus on safely properties because it has been observed that safety violations such as out-of-bounds memory accesses or use of uninitialized variables constitute the majority of the errors found in the aerospace domain. In our approach, safety means that the program will not violate a set of rules that can range for the simple memory access rules to high-level flight rules. These different safety properties are formalized as different safety policies in Hoare logic, which are then used by a verification condition generator along with the code and logical annotations in order to derive formal safety conditions; these are then proven using an automated theorem prover. Our certification system is currently integrated into a model-based code generation toolset that generates the annotations together with the code. However, this automated formal certification technology is not exclusively constrained to our code generator and could, in principle, also be integrated with other code generators such as RealTime Workshop or even applied to legacy code. Our approach circumvents the historical problems with formal methods by increasing the degree of automation on all levels. The restriction to safety policies (as opposed to arbitrary functional behavior) results in simpler proof problems that can generally be solved by fully automatic theorem proves. An automated linking mechanism between the safety conditions and the code provides some of the traceability mandated by process standards such as DO-178B. An automated explanation mechanism uses semantic markup added by the verification condition generator to produce natural-language explanations of the safety conditions and thus supports their interpretation in relation to the code. It shows an automatically generated certification browser that lets users inspect the (generated) code along with the safety conditions (including textual explanations), and uses hyperlinks to automate tracing between the two levels. Here, the explanations reflect the logical structure of the safety obligation but the mechanism can in principle be customized using different sets of domain concepts. The interface also provides some limited control over the certification process itself. Our long-term goal is a seamless integration of certification, code generation, and manual coding that results in a "certified pipeline" in which specifications are automatically transformed into executable code, together with the supporting artifacts necessary for achieving and demonstrating the high level of assurance needed in the aerospace domain.

Applications of Formal Methods to Specification and Safety of Avionics Software

NASA Technical Reports Server (NTRS)

Hoover, D. N.; Guaspari, David; Humenn, Polar

1996-01-01

This report treats several topics in applications of formal methods to avionics software development. Most of these topics concern decision tables, an orderly, easy-to-understand format for formally specifying complex choices among alternative courses of action. The topics relating to decision tables include: generalizations fo decision tables that are more concise and support the use of decision tables in a refinement-based formal software development process; a formalism for systems of decision tables with behaviors; an exposition of Parnas tables for users of decision tables; and test coverage criteria and decision tables. We outline features of a revised version of ORA's decision table tool, Tablewise, which will support many of the new ideas described in this report. We also survey formal safety analysis of specifications and software.

Microprocessor-controlled, wide-range streak camera

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

Amy E. Lewis, Craig Hollabaugh

Bechtel Nevada/NSTec recently announced deployment of their fifth generation streak camera. This camera incorporates many advanced features beyond those currently available for streak cameras. The arc-resistant driver includes a trigger lockout mechanism, actively monitors input trigger levels, and incorporates a high-voltage fault interrupter for user safety and tube protection. The camera is completely modular and may deflect over a variable full-sweep time of 15 nanoseconds to 500 microseconds. The camera design is compatible with both large- and small-format commercial tubes from several vendors. The embedded microprocessor offers Ethernet connectivity, and XML [extensible markup language]-based configuration management with non-volatile parameter storagemore » using flash-based storage media. The camera’s user interface is platform-independent (Microsoft Windows, Unix, Linux, Macintosh OSX) and is accessible using an AJAX [asynchronous Javascript and XML]-equipped modem browser, such as Internet Explorer 6, Firefox, or Safari. User interface operation requires no installation of client software or browser plug-in technology. Automation software can also access the camera configuration and control using HTTP [hypertext transfer protocol]. The software architecture supports multiple-simultaneous clients, multiple cameras, and multiple module access with a standard browser. The entire user interface can be customized.« less

Microprocessor-controlled wide-range streak camera

NASA Astrophysics Data System (ADS)

Lewis, Amy E.; Hollabaugh, Craig

2006-08-01

Bechtel Nevada/NSTec recently announced deployment of their fifth generation streak camera. This camera incorporates many advanced features beyond those currently available for streak cameras. The arc-resistant driver includes a trigger lockout mechanism, actively monitors input trigger levels, and incorporates a high-voltage fault interrupter for user safety and tube protection. The camera is completely modular and may deflect over a variable full-sweep time of 15 nanoseconds to 500 microseconds. The camera design is compatible with both large- and small-format commercial tubes from several vendors. The embedded microprocessor offers Ethernet connectivity, and XML [extensible markup language]-based configuration management with non-volatile parameter storage using flash-based storage media. The camera's user interface is platform-independent (Microsoft Windows, Unix, Linux, Macintosh OSX) and is accessible using an AJAX [asynchronous Javascript and XML]-equipped modem browser, such as Internet Explorer 6, Firefox, or Safari. User interface operation requires no installation of client software or browser plug-in technology. Automation software can also access the camera configuration and control using HTTP [hypertext transfer protocol]. The software architecture supports multiple-simultaneous clients, multiple cameras, and multiple module access with a standard browser. The entire user interface can be customized.

Bar Coding and Tracking in Pathology.

PubMed

Hanna, Matthew G; Pantanowitz, Liron

2016-03-01

Bar coding and specimen tracking are intricately linked to pathology workflow and efficiency. In the pathology laboratory, bar coding facilitates many laboratory practices, including specimen tracking, automation, and quality management. Data obtained from bar coding can be used to identify, locate, standardize, and audit specimens to achieve maximal laboratory efficiency and patient safety. Variables that need to be considered when implementing and maintaining a bar coding and tracking system include assets to be labeled, bar code symbologies, hardware, software, workflow, and laboratory and information technology infrastructure as well as interoperability with the laboratory information system. This article addresses these issues, primarily focusing on surgical pathology. Copyright © 2016 Elsevier Inc. All rights reserved.

Bar Coding and Tracking in Pathology.

PubMed

Hanna, Matthew G; Pantanowitz, Liron

2015-06-01

Bar coding and specimen tracking are intricately linked to pathology workflow and efficiency. In the pathology laboratory, bar coding facilitates many laboratory practices, including specimen tracking, automation, and quality management. Data obtained from bar coding can be used to identify, locate, standardize, and audit specimens to achieve maximal laboratory efficiency and patient safety. Variables that need to be considered when implementing and maintaining a bar coding and tracking system include assets to be labeled, bar code symbologies, hardware, software, workflow, and laboratory and information technology infrastructure as well as interoperability with the laboratory information system. This article addresses these issues, primarily focusing on surgical pathology. Copyright © 2015 Elsevier Inc. All rights reserved.

Designing and Implementation a Lab Testing Method for Power Cables Insulation Resistance According with STAS 10411-89, SR EN ISO/CEI/17025/2005

NASA Astrophysics Data System (ADS)

Dobra, R.; Pasculescu, D.; Marc, G.; Risteiu, M.; Antonov, A.

2017-06-01

Insulation resistance measurement is one of the most important tests required by standards and regulations in terms of electrical safety. Why these tests are is to prevent possible accidents caused by electric shock, damage to equipment or outbreak of fire in normal operating conditions of electrical cables. The insulation resistance experiment refers to the testing of electrical cable insulation, which has a measured resistance that must be below the imposed regulations. Using a microcontroller system data regarding the insulation resistance of the power cables is acquired and with SCADA software the test results are displayed.

Software Graphics Processing Unit (sGPU) for Deep Space Applications

NASA Technical Reports Server (NTRS)

McCabe, Mary; Salazar, George; Steele, Glen

2015-01-01

A graphics processing capability will be required for deep space missions and must include a range of applications, from safety-critical vehicle health status to telemedicine for crew health. However, preliminary radiation testing of commercial graphics processing cards suggest they cannot operate in the deep space radiation environment. Investigation into an Software Graphics Processing Unit (sGPU)comprised of commercial-equivalent radiation hardened/tolerant single board computers, field programmable gate arrays, and safety-critical display software shows promising results. Preliminary performance of approximately 30 frames per second (FPS) has been achieved. Use of multi-core processors may provide a significant increase in performance.

ESSAA: Embedded system safety analysis assistant

NASA Technical Reports Server (NTRS)

Wallace, Peter; Holzer, Joseph; Guarro, Sergio; Hyatt, Larry

1987-01-01

The Embedded System Safety Analysis Assistant (ESSAA) is a knowledge-based tool that can assist in identifying disaster scenarios. Imbedded software issues hazardous control commands to the surrounding hardware. ESSAA is intended to work from outputs to inputs, as a complement to simulation and verification methods. Rather than treating the software in isolation, it examines the context in which the software is to be deployed. Given a specified disasterous outcome, ESSAA works from a qualitative, abstract model of the complete system to infer sets of environmental conditions and/or failures that could cause a disasterous outcome. The scenarios can then be examined in depth for plausibility using existing techniques.

Software Formal Inspections Guidebook

NASA Technical Reports Server (NTRS)

1993-01-01

The Software Formal Inspections Guidebook is designed to support the inspection process of software developed by and for NASA. This document provides information on how to implement a recommended and proven method for conducting formal inspections of NASA software. This Guidebook is a companion document to NASA Standard 2202-93, Software Formal Inspections Standard, approved April 1993, which provides the rules, procedures, and specific requirements for conducting software formal inspections. Application of the Formal Inspections Standard is optional to NASA program or project management. In cases where program or project management decide to use the formal inspections method, this Guidebook provides additional information on how to establish and implement the process. The goal of the formal inspections process as documented in the above-mentioned Standard and this Guidebook is to provide a framework and model for an inspection process that will enable the detection and elimination of defects as early as possible in the software life cycle. An ancillary aspect of the formal inspection process incorporates the collection and analysis of inspection data to effect continual improvement in the inspection process and the quality of the software subjected to the process.

48 CFR 52.250-5 - SAFETY Act-Equitable Adjustment.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., engineering services, software development services, software integration services, threat assessments... security, i.e., it will perform as intended, conforms to the seller's specifications, and is safe for use...

48 CFR 52.250-5 - SAFETY Act-Equitable Adjustment.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., engineering services, software development services, software integration services, threat assessments... security, i.e., it will perform as intended, conforms to the seller's specifications, and is safe for use...

48 CFR 52.250-5 - SAFETY Act-Equitable Adjustment.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., engineering services, software development services, software integration services, threat assessments... security, i.e., it will perform as intended, conforms to the seller's specifications, and is safe for use...

48 CFR 52.250-5 - SAFETY Act-Equitable Adjustment.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., engineering services, software development services, software integration services, threat assessments... security, i.e., it will perform as intended, conforms to the seller's specifications, and is safe for use...

A Generic Software Safety Document Generator

NASA Technical Reports Server (NTRS)

Denney, Ewen; Venkatesan, Ram Prasad

2004-01-01

Formal certification is based on the idea that a mathematical proof of some property of a piece of software can be regarded as a certificate of correctness which, in principle, can be subjected to external scrutiny. In practice, however, proofs themselves are unlikely to be of much interest to engineers. Nevertheless, it is possible to use the information obtained from a mathematical analysis of software to produce a detailed textual justification of correctness. In this paper, we describe an approach to generating textual explanations from automatically generated proofs of program safety, where the proofs are of compliance with an explicit safety policy that can be varied. Key to this is tracing proof obligations back to the program, and we describe a tool which implements this to certify code auto-generated by AutoBayes and AutoFilter, program synthesis systems under development at the NASA Ames Research Center. Our approach is a step towards combining formal certification with traditional certification methods.

77 FR 50720 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Test Documentation for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1207, ``Test Documentation for Digital... practices for test documentation for software and computer systems as described in the Institute of...

Earthern embankment overtopping analysis using the WinDAM B software

USDA-ARS?s Scientific Manuscript database

Over 11,000 small watershed dams have been constructed with USDA involvement over an eighty year period. WinDAM B software has been developed to help engineers address dam safety concerns relative to potential overtopping of these earthen embankments. The primary function of the software is threef...

An empirical evaluation of software quality assurance practices and challenges in a developing country: a comparison of Nigeria and Turkey.

PubMed

Sowunmi, Olaperi Yeside; Misra, Sanjay; Fernandez-Sanz, Luis; Crawford, Broderick; Soto, Ricardo

2016-01-01

The importance of quality assurance in the software development process cannot be overemphasized because its adoption results in high reliability and easy maintenance of the software system and other software products. Software quality assurance includes different activities such as quality control, quality management, quality standards, quality planning, process standardization and improvement amongst others. The aim of this work is to further investigate the software quality assurance practices of practitioners in Nigeria. While our previous work covered areas on quality planning, adherence to standardized processes and the inherent challenges, this work has been extended to include quality control, software process improvement and international quality standard organization membership. It also makes comparison based on a similar study carried out in Turkey. The goal is to generate more robust findings that can properly support decision making by the software community. The qualitative research approach, specifically, the use of questionnaire research instruments was applied to acquire data from software practitioners. In addition to the previous results, it was observed that quality assurance practices are quite neglected and this can be the cause of low patronage. Moreover, software practitioners are neither aware of international standards organizations or the required process improvement techniques; as such their claimed standards are not aligned to those of accredited bodies, and are only limited to their local experience and knowledge, which makes it questionable. The comparison with Turkey also yielded similar findings, making the results typical of developing countries. The research instrument used was tested for internal consistency using the Cronbach's alpha, and it was proved reliable. For the software industry in developing countries to grow strong and be a viable source of external revenue, software assurance practices have to be taken seriously because its effect is evident in the final product. Moreover, quality frameworks and tools which require minimum time and cost are highly needed in these countries.

Supporting the Use of CERT (registered trademark) Secure Coding Standards in DoD Acquisitions

DTIC Science & Technology

2012-07-01

Capability Maturity Model IntegrationSM (CMMI®) [Davis 2009]. SM Team Software Process, TSP, and Capability Maturity Model Integration are service...STP Software Test Plan TEP Test and Evaluation Plan TSP Team Software Process V & V verification and validation CMU/SEI-2012-TN-016 | 47...Supporting the Use of CERT® Secure Coding Standards in DoD Acquisitions Tim Morrow ( Software Engineering Institute) Robert Seacord ( Software

Research on the management and endorsement of nuclear safety standards in the United States and its revelation for China

NASA Astrophysics Data System (ADS)

Liu, Ting; Tian, Yu; Yang, Lili; Gao, Siyi; Song, Dahu

2018-01-01

This paper introduces the American standard system, the Nuclear Regulatory Commission (NRC)’s responsibility, NRC nuclear safety regulations and standards system, studies on NRC’s standards management and endorsement mode, analyzes the characteristics of NRC standards endorsement management, and points out its disadvantages. This paper draws revelation from the standard management and endorsement model of NRC and points suggestion to China’s nuclear and radiation safety standards management.The issue of the “Nuclear Safety Law”plays an important role in China’s nuclear and radiation safety supervision. Nuclear and radiation safety regulations and standards are strong grips on the implementation of “Nuclear Safety Law”. This paper refers on the experience of international advanced countriy, will effectively promote the improvement of the endorsed management of China’s nuclear and radiation safety standards.

Software archeology: a case study in software quality assurance and design

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

Macdonald, John M; Lloyd, Jane A; Turner, Cameron J

2009-01-01

Ideally, quality is designed into software, just as quality is designed into hardware. However, when dealing with legacy systems, demonstrating that the software meets required quality standards may be difficult to achieve. As the need to demonstrate the quality of existing software was recognized at Los Alamos National Laboratory (LANL), an effort was initiated to uncover and demonstrate that legacy software met the required quality standards. This effort led to the development of a reverse engineering approach referred to as software archaeology. This paper documents the software archaeology approaches used at LANL to document legacy software systems. A case studymore » for the Robotic Integrated Packaging System (RIPS) software is included.« less

A Probabilistic Software System Attribute Acceptance Paradigm for COTS Software Evaluation

NASA Technical Reports Server (NTRS)

Morris, A. Terry

2005-01-01

Standard software requirement formats are written from top-down perspectives only, that is, from an ideal notion of a client s needs. Despite the exactness of the standard format, software and system errors in designed systems have abounded. Bad and inadequate requirements have resulted in cost overruns, schedule slips and lost profitability. Commercial off-the-shelf (COTS) software components are even more troublesome than designed systems because they are often provided as is and subsequently delivered with unsubstantiated validation of described capabilities. For COTS software, there needs to be a way to express the client s software needs in a consistent and formal manner using software system attributes derived from software quality standards. Additionally, the format needs to be amenable to software evaluation processes that integrate observable evidence garnered from historical data. This paper presents a paradigm that effectively bridges the gap between what a client desires (top-down) and what has been demonstrated (bottom-up) for COTS software evaluation. The paradigm addresses the specification of needs before the software evaluation is performed and can be used to increase the shared understanding between clients and software evaluators about what is required and what is technically possible.

Addressing software security risk mitigations in the life cycle

NASA Technical Reports Server (NTRS)

Gilliam, David; Powell, John; Haugh, Eric; Bishop, Matt

2003-01-01

The NASA Office of Safety and Mission Assurance (OSMA) has funded the Jet Propulsion Laboratory (JPL) with a Center Initiative, 'Reducing Software Security Risk through an Integrated Approach' (RSSR), to address this need. The Initiative is a formal approach to addressing software security in the life cycle through the instantiation of a Software Security Assessment Instrument (SSAI) for the development and maintenance life cycles.

Integrated Functional and Executional Modelling of Software Using Web-Based Databases

NASA Technical Reports Server (NTRS)

Kulkarni, Deepak; Marietta, Roberta

1998-01-01

NASA's software subsystems undergo extensive modification and updates over the operational lifetimes. It is imperative that modified software should satisfy safety goals. This report discusses the difficulties encountered in doing so and discusses a solution based on integrated modelling of software, use of automatic information extraction tools, web technology and databases. To appear in an article of Journal of Database Management.

Proceedings of the Center for National Software Studies Workshop on Trustworthy Software

DTIC Science & Technology

2004-05-10

just the de - velopment cost) to achieve a sustained level of software trustworthiness. • Reforming the procurement process. We could reform the...failure or breach of security. Some examples include software used in safety systems of nuclear power plants, transportation systems, medical devices...issue in many vital systems, including those found in transportation , telecommunications, utilities, health care, and financial services. Any lack of

16 CFR 1205.1 - Scope of the standard.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY... subpart A of part 1205 is a consumer product safety standard which prescribes safety requirements for... the standard are subject to the requirements of this standard if they are “consumer products”. “Walk...

16 CFR 1205.1 - Scope of the standard.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY... subpart A of part 1205 is a consumer product safety standard which prescribes safety requirements for... the standard are subject to the requirements of this standard if they are “consumer products”. “Walk...

16 CFR 1205.1 - Scope of the standard.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY... subpart A of part 1205 is a consumer product safety standard which prescribes safety requirements for... the standard are subject to the requirements of this standard if they are “consumer products”. “Walk...

Design, Simulation, Software Development, and Testing of a Compact Aircraft Tracking Payload for the CanX-7 Nanosatellite Mission

NASA Astrophysics Data System (ADS)

Bennett, Ian Graham

Automatic Dependent Surveillance-Broadcast (ADS-B) is quickly becoming the new standard for more efficient air traffic control, but as a satellite/ground-based hybrid system it faces limitations on its usefulness over oceans and remote areas. Tracking of aircraft from space presents many challenges that if overcome will greatly increase the safety and efficiency of commercial air travel in these areas. This thesis presents work performed to develop a flight-ready ADS-B receiver payload for the CanX-7 technology demonstration satellite. Work presented includes a simulation of payload performance and coverage area, the design and testing of a single-feed circularly polarized L-band antenna, the design of software to control the payload and manage its data, and verification of the performance of the hardware prior to integration with the satellite and launch. Also included is a short overview of results from the seven-month aircraft tracking campaign conducted with the spacecraft.

Preparing Florida for deployment of SafetyAnalyst for all roads.

DOT National Transportation Integrated Search

2012-05-01

SafetyAnalyst is an advanced software system designed to provide the state and local highway agencies with a comprehensive set of tools to enhance their programming of site-specific highway safety improvements. As one of the 27 states that sponsored ...

GCS programmer's manual

NASA Technical Reports Server (NTRS)

Lowman, Douglas S.; Withers, B. Edward; Shagnea, Anita M.; Dent, Leslie A.; Hayhurst, Kelly J.

1990-01-01

A variety of instructions to be used in the development of implementations of software for the Guidance and Control Software (GCS) project is described. This document fulfills the Radio Technical Commission for Aeronautics RTCA/DO-178A guidelines, 'Software Considerations in Airborne Systems and Equipment Certification' requirements for document No. 4, which specifies the information necessary for understanding and programming the host computer, and document No. 12, which specifies the software design and implementation standards that are applicable to the software development and testing process. Information on the following subjects is contained: activity recording, communication protocol, coding standards, change management, error handling, design standards, problem reporting, module testing logs, documentation formats, accuracy requirements, and programmer responsibilities.

Computer-based mechanical design of overhead lines

NASA Astrophysics Data System (ADS)

Rusinaru, D.; Bratu, C.; Dinu, R. C.; Manescu, L. G.

2016-02-01

Beside the performance, the safety level according to the actual standards is a compulsory condition for distribution grids’ operation. Some of the measures leading to improvement of the overhead lines reliability ask for installations’ modernization. The constraints imposed to the new lines components refer to the technical aspects as thermal stress or voltage drop, and look for economic efficiency, too. The mechanical sizing of the overhead lines is after all an optimization problem. More precisely, the task in designing of the overhead line profile is to size poles, cross-arms and stays and locate poles along a line route so that the total costs of the line's structure to be minimized and the technical and safety constraints to be fulfilled.The authors present in this paper an application for the Computer-Based Mechanical Design of the Overhead Lines and the features of the corresponding Visual Basic program, adjusted to the distribution lines. The constraints of the optimization problem are adjusted to the existing weather and loading conditions of Romania. The outputs of the software application for mechanical design of overhead lines are: the list of components chosen for the line: poles, cross-arms, stays; the list of conductor tension and forces for each pole, cross-arm and stay for different weather conditions; the line profile drawings.The main features of the mechanical overhead lines design software are interactivity, local optimization function and high-level user-interface

45 CFR 156.1110 - Establishment of patient safety standards for QHP issuers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... STANDARDS RELATED TO EXCHANGES Quality Standards § 156.1110 Establishment of patient safety standards for QHP issuers. (a) Patient safety standards. A QHP issuer that contracts with a hospital with greater... 45 Public Welfare 1 2014-10-01 2014-10-01 false Establishment of patient safety standards for QHP...

The Goddard Space Flight Center (GSFC) robotics technology testbed

NASA Technical Reports Server (NTRS)

Schnurr, Rick; Obrien, Maureen; Cofer, Sue

1989-01-01

Much of the technology planned for use in NASA's Flight Telerobotic Servicer (FTS) and the Demonstration Test Flight (DTF) is relatively new and untested. To provide the answers needed to design safe, reliable, and fully functional robotics for flight, NASA/GSFC is developing a robotics technology testbed for research of issues such as zero-g robot control, dual arm teleoperation, simulations, and hierarchical control using a high level programming language. The testbed will be used to investigate these high risk technologies required for the FTS and DTF projects. The robotics technology testbed is centered around the dual arm teleoperation of a pair of 7 degree-of-freedom (DOF) manipulators, each with their own 6-DOF mini-master hand controllers. Several levels of safety are implemented using the control processor, a separate watchdog computer, and other low level features. High speed input/output ports allow the control processor to interface to a simulation workstation: all or part of the testbed hardware can be used in real time dynamic simulation of the testbed operations, allowing a quick and safe means for testing new control strategies. The NASA/National Bureau of Standards Standard Reference Model for Telerobot Control System Architecture (NASREM) hierarchical control scheme, is being used as the reference standard for system design. All software developed for the testbed, excluding some of simulation workstation software, is being developed in Ada. The testbed is being developed in phases. The first phase, which is nearing completion, and highlights future developments is described.

V&V Within Reuse-Based Software Engineering

NASA Technical Reports Server (NTRS)

Addy, Edward A.

1996-01-01

Verification and Validation (V&V) is used to increase the level of assurance of critical software, particularly that of safety-critical and mission-critical software. V&V is a systems engineering discipline that evaluates the software in a systems context, and is currently applied during the development of a specific application system. In order to bring the effectiveness of V&V to bear within reuse-based software engineering, V&V must be incorporated within the domain engineering process.

Imaging and quantification of endothelial cell loss in eye bank prepared DMEK grafts using trainable segmentation software.

PubMed

Jardine, Griffin J; Holiman, Jeffrey D; Stoeger, Christopher G; Chamberlain, Winston D

2014-09-01

To improve accuracy and efficiency in quantifying the endothelial cell loss (ECL) in eye bank preparation of corneal endothelial grafts. Eight cadaveric corneas were subjected to Descemet Membrane Endothelial Keratoplasty (DMEK) preparation. The endothelial surfaces were stained with a viability stain, calcein AM dye (CAM) and then captured by a digital camera. The ECL rates were quantified in these images by three separate readers using trainable segmentation, a plug-in feature from the imaging software, Fiji. Images were also analyzed by Adobe Photoshop for comparison. Mean times required to process the images were measured between the two modalities. The mean ECL (with standard deviation) as analyzed by Fiji was 22.5% (6.5%) and Adobe was 18.7% (7.0%; p = 0.04). The mean time required to process the images through the two different imaging methods was 19.9 min (7.5) for Fiji and 23.4 min (12.9) for Adobe (p = 0.17). Establishing an accurate, efficient and reproducible means of quantifying ECL in graft preparation and surgical techniques can provide insight to the safety, long-term potential of the graft tissues as well as provide a quality control measure for eye banks and surgeons. Trainable segmentation in Fiji software using CAM is a novel approach to measuring ECL that captured a statistically significantly higher percentage of ECL comparable to Adobe and was more accurate in standardized testing. Interestingly, ECL as determined using both methods in eye bank-prepared DMEK grafts exceeded 18% on average.

Quality and standardization of telecommunication switching system software

NASA Astrophysics Data System (ADS)

Ranko, K.; Hivensaio, J.; Myllykangas, A.

1981-12-01

The purpose of this paper has been to illustrate quality and standardization of switching system software from the authors point of view with the aim of developing standardization in the user environment.

10 CFR 851.23 - Safety and health standards.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Safety and health standards. 851.23 Section 851.23 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Specific Program Requirements § 851.23 Safety and health standards. (a) Contractors must comply with the following safety and health standards that are...

29 CFR 1925.2 - Safety and health standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 7 2014-07-01 2014-07-01 false Safety and health standards. 1925.2 Section 1925.2 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH STANDARDS FOR FEDERAL SERVICE CONTRACTS § 1925.2 Safety and health standards...

10 CFR 851.23 - Safety and health standards.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Safety and health standards. 851.23 Section 851.23 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Specific Program Requirements § 851.23 Safety and health standards. (a) Contractors must comply with the following safety and health standards that are...

29 CFR 1925.2 - Safety and health standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 7 2010-07-01 2010-07-01 false Safety and health standards. 1925.2 Section 1925.2 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH STANDARDS FOR FEDERAL SERVICE CONTRACTS § 1925.2 Safety and health standards...

10 CFR 851.23 - Safety and health standards.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Safety and health standards. 851.23 Section 851.23 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Specific Program Requirements § 851.23 Safety and health standards. (a) Contractors must comply with the following safety and health standards that are...

29 CFR 1925.2 - Safety and health standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 7 2012-07-01 2012-07-01 false Safety and health standards. 1925.2 Section 1925.2 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH STANDARDS FOR FEDERAL SERVICE CONTRACTS § 1925.2 Safety and health standards...

29 CFR 1925.2 - Safety and health standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 7 2011-07-01 2011-07-01 false Safety and health standards. 1925.2 Section 1925.2 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH STANDARDS FOR FEDERAL SERVICE CONTRACTS § 1925.2 Safety and health standards...

10 CFR 851.23 - Safety and health standards.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Safety and health standards. 851.23 Section 851.23 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Specific Program Requirements § 851.23 Safety and health standards. (a) Contractors must comply with the following safety and health standards that are...

29 CFR 1925.2 - Safety and health standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 7 2013-07-01 2013-07-01 false Safety and health standards. 1925.2 Section 1925.2 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH STANDARDS FOR FEDERAL SERVICE CONTRACTS § 1925.2 Safety and health standards...

10 CFR 851.23 - Safety and health standards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Safety and health standards. 851.23 Section 851.23 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Specific Program Requirements § 851.23 Safety and health standards. (a) Contractors must comply with the following safety and health standards that are...

WTEC monograph on instrumentation, control and safety systems of Canadian nuclear facilities

NASA Technical Reports Server (NTRS)

Uhrig, Robert E.; Carter, Richard J.

1993-01-01

This report updates a 1989-90 survey of advanced instrumentation and controls (I&C) technologies and associated human factors issues in the U.S. and Canadian nuclear industries carried out by a team from Oak Ridge National Laboratory (Carter and Uhrig 1990). The authors found that the most advanced I&C systems are in the Canadian CANDU plants, where the newest plant (Darlington) has digital systems in almost 100 percent of its control systems and in over 70 percent of its plant protection system. Increased emphasis on human factors and cognitive science in modern control rooms has resulted in a reduced workload for the operators and the elimination of many human errors. Automation implemented through digital instrumentation and control is effectively changing the role of the operator to that of a systems manager. The hypothesis that properly introducing digital systems increases safety is supported by the Canadian experience. The performance of these digital systems has been achieved using appropriate quality assurance programs for both hardware and software development. Recent regulatory authority review of the development of safety-critical software has resulted in the creation of isolated software modules with well defined interfaces and more formal structure in the software generation. The ability of digital systems to detect impending failures and initiate a fail-safe action is a significant safety issue that should be of special interest to nuclear utilities and regulatory authorities around the world.

ANOPP programming and documentation standards document

NASA Technical Reports Server (NTRS)

1976-01-01

Standards defining the requirements for preparing software for the Aircraft Noise Prediction Program (ANOPP) were given. It is the intent of these standards to provide definition, design, coding, and documentation criteria for the achievement of a unity among ANOPP products. These standards apply to all of ANOPP's standard software system. The standards encompass philosophy as well as techniques and conventions.

46 CFR 80.25 - Notification of safety standards.

Code of Federal Regulations, 2014 CFR

2014-10-01

... standards, except the 1966 fire safety standards. (ii) This vessel complies with international safety standards developed prior to 1960. There is (or, is not) an automatic sprinkler system fitted in the... international safety standard. There is (or, is not) an automatic sprinkler system fitted in the passenger...

46 CFR 80.25 - Notification of safety standards.

Code of Federal Regulations, 2012 CFR

2012-10-01

... standards, except the 1966 fire safety standards. (ii) This vessel complies with international safety standards developed prior to 1960. There is (or, is not) an automatic sprinkler system fitted in the... international safety standard. There is (or, is not) an automatic sprinkler system fitted in the passenger...

46 CFR 80.25 - Notification of safety standards.

Code of Federal Regulations, 2013 CFR

2013-10-01

... standards, except the 1966 fire safety standards. (ii) This vessel complies with international safety standards developed prior to 1960. There is (or, is not) an automatic sprinkler system fitted in the... international safety standard. There is (or, is not) an automatic sprinkler system fitted in the passenger...

46 CFR 80.25 - Notification of safety standards.

Code of Federal Regulations, 2011 CFR

2011-10-01

... standards, except the 1966 fire safety standards. (ii) This vessel complies with international safety standards developed prior to 1960. There is (or, is not) an automatic sprinkler system fitted in the... international safety standard. There is (or, is not) an automatic sprinkler system fitted in the passenger...

The Safety Analysis of Shipborne Ammunition in Fire Environment

NASA Astrophysics Data System (ADS)

Ren, Junpeng; Wang, Xudong; Yue, Pengfei

2017-12-01

The safety of Ammunition has always been the focus of national military science and technology issues. And fire is one of the major safety threats to the ship’s ammunition storage environment, In this paper, Mk-82 shipborne aviation bomb has been taken as the study object, simulated the whole process of fire by using the FDS (Fire Detection System) software. According to the simulation results of FDS, ANSYS software was used to simulate the temperature field of Mk-82 carrier-based aviation bomb under fire environment, and the safety of aviation bomb in fire environment was analyzed. The result shows that the aviation bombs under the fire environment can occur the combustion or explosion after 70s constant cook-off, and it was a huge threat to the ship security.

Hazard identification and pre-map with a simple specific tool: synthesis of application experience in handicrafts in various productive sectors.

PubMed

Colombini, Daniela; Occhipinti, Enrico; Peluso, Raffaele; Montomoli, Loretta

2012-01-01

In August 2009, an international group was founded with the task of developing a "toolkit for MSD prevention" under the IEA and in collaboration with the World Health Organization.According to the ISO standard 11228 series and the new Draft ISO TR 12259 "Application document guides for the potential user", our group developed a preliminary "mapping" methodology of occupational hazards in the craft industry, supported by software (Excel®, free download on: www.epmresearch.org).The possible users of toolkits are: members of health and safety committees; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers providing basic occupational health services; occupational health and safety specialists.The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazards identification and risk estimation to be made. It is thus possible to decide for which occupational hazards a more exhaustive risk assessment will be necessary and which occupational consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).The methodology has been applied in different situations of small and medium craftsmanship Italian enterprises: leather goods, food, technical dental work, production of artistic ceramics and stained glass, beekeeping activities. The results are synthetically reported and discussed in this paper.

Commercial-off-the-shelf (COTS) hardware and software for train control applications : system safety considerations.

DOT National Transportation Integrated Search

2003-04-01

The objective of this study was to assess the feasibility of using commercial off-the-shelf(COTS)processor-based systems for safety- related railroad applications. From the safety perspective,the fundamental challenges of using COTS products are most...

Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach.

PubMed

Haase, Rocco; Wunderlich, Maria; Dillenseger, Anja; Kern, Raimar; Akgün, Katja; Ziemssen, Tjalf

2018-04-01

For safety evaluation, randomized controlled trials (RCTs) are not fully able to identify rare adverse events. The richest source of safety data lies in the post-marketing phase. Real-world evidence (RWE) and observational studies are becoming increasingly popular because they reflect usefulness of drugs in real life and have the ability to discover uncommon or rare adverse drug reactions. Areas covered: Adding the documentation of psychological symptoms and other medical disciplines, the necessity for a complex documentation becomes apparent. The collection of high-quality data sets in clinical practice requires the use of special documentation software as the quality of data in RWE studies can be an issue in contrast to the data obtained from RCTs. The MSDS3D software combines documentation of patient data with patient management of patients with multiple sclerosis. Following a continuous development over several treatment-specific modules, we improved and expanded the realization of safety management in MSDS3D with regard to the characteristics of different treatments and populations. Expert opinion: eHealth-enhanced post-authorisation safety study may complete the fundamental quest of RWE for individually improved treatment decisions and balanced therapeutic risk assessment. MSDS3D is carefully designed to contribute to every single objective in this process.

Determining the status quo of infection prevention and control standards in the hospitals of iran: a case study in 23 hospitals.

PubMed

Shojaee, Jalil; Moosazadeh, Mahmood

2014-02-01

Applying Prevention and Control of Infection (PCI) standards in hospitals reduces probable risks to patients, staff and visitors; it also increases efficiency, and ultimately improves productivity of hospitals. The current study aimed to determine the status quo of international standards of PCI in hospitals located in the north of Iran. This cross-sectional study was conducted in 23 hospitals. Data collection tool was a questionnaire with confirmed validity and reliability. . In this regard, 260 managers, section supervisors and infection control nurses participated in the study according to census basis. SPSS software version 16 was employed to analyze the data through descriptive and analytical statistics. Among the studied hospitals, 18 hospitals were public. Hospitals enjoyed 77.2% of leadership and programming, 80.8% of focus of programs, 67.4% of isolating methods, 88.2% of hand health and protection techniques, 78.8% of improving patient's safety and quality, 90.3% of training personnel, and 78.7% of the average status quo of PCI standards. This study revealed that PCI standards were significantly observed in the studied hospitals and that there were necessary conditions for full deployment of nosocomial infection surveillance.

Alternative Fuels Data Center: Biodiesel Codes, Standards, and Safety

Science.gov Websites

Codes, Standards, and Safety to someone by E-mail Share Alternative Fuels Data Center: Biodiesel Codes, Standards, and Safety on Facebook Tweet about Alternative Fuels Data Center: Biodiesel Codes , Standards, and Safety on Twitter Bookmark Alternative Fuels Data Center: Biodiesel Codes, Standards, and

Space Station Software Issues

NASA Technical Reports Server (NTRS)

Voigt, S. (Editor); Beskenis, S. (Editor)

1985-01-01

Issues in the development of software for the Space Station are discussed. Software acquisition and management, software development environment, standards, information system support for software developers, and a future software advisory board are addressed.

Space and Missile Systems Center Standard: Software Development

DTIC Science & Technology

2015-01-16

maintenance , or any other activity or combination of activities resulting in products . Within this standard, requirements to “develop,” “define...integration, reuse, reengineering, maintenance , or any other activity that results in products ). The term “developer” encompasses all software team...activities that results in software products . Software development includes new development, modification, reuse, reengineering, maintenance , and any other

41 CFR 50-204.2 - General safety and health standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 1 2010-07-01 2010-07-01 true General safety and health... Public Contracts PUBLIC CONTRACTS, DEPARTMENT OF LABOR 204-SAFETY AND HEALTH STANDARDS FOR FEDERAL SUPPLY CONTRACTS General Safety and Health Standards § 50-204.2 General safety and health standards. (a) Every...

77 FR 76005 - Submission for OMB Review; Comment Request-Safety Standard for Walk-Behind Power Lawn Mowers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... Request--Safety Standard for Walk-Behind Power Lawn Mowers AGENCY: Consumer Product Safety Commission... with the Commission's safety standard for walk- behind power lawn mowers. DATES: Written comments on... of approval of the collection of information required in the Safety Standard for Walk-Behind Power...

The research and practice of spacecraft software engineering

NASA Astrophysics Data System (ADS)

Chen, Chengxin; Wang, Jinghua; Xu, Xiaoguang

2017-06-01

In order to ensure the safety and reliability of spacecraft software products, it is necessary to execute engineering management. Firstly, the paper introduces the problems of unsystematic planning, uncertain classified management and uncontinuous improved mechanism in domestic and foreign spacecraft software engineering management. Then, it proposes a solution for software engineering management based on system-integrated ideology in the perspective of spacecraft system. Finally, a application result of spacecraft is given as an example. The research can provides a reference for executing spacecraft software engineering management and improving software product quality.

Software Certification - Coding, Code, and Coders

NASA Technical Reports Server (NTRS)

Havelund, Klaus; Holzmann, Gerard J.

2011-01-01

We describe a certification approach for software development that has been adopted at our organization. JPL develops robotic spacecraft for the exploration of the solar system. The flight software that controls these spacecraft is considered to be mission critical. We argue that the goal of a software certification process cannot be the development of "perfect" software, i.e., software that can be formally proven to be correct under all imaginable and unimaginable circumstances. More realistically, the goal is to guarantee a software development process that is conducted by knowledgeable engineers, who follow generally accepted procedures to control known risks, while meeting agreed upon standards of workmanship. We target three specific issues that must be addressed in such a certification procedure: the coding process, the code that is developed, and the skills of the coders. The coding process is driven by standards (e.g., a coding standard) and tools. The code is mechanically checked against the standard with the help of state-of-the-art static source code analyzers. The coders, finally, are certified in on-site training courses that include formal exams.

Evolution of International Space Station Program Safety Review Processes and Tools

NASA Technical Reports Server (NTRS)

Ratterman, Christian D.; Green, Collin; Guibert, Matt R.; McCracken, Kristle I.; Sang, Anthony C.; Sharpe, Matthew D.; Tollinger, Irene V.

2013-01-01

The International Space Station Program at NASA is constantly seeking to improve the processes and systems that support safe space operations. To that end, the ISS Program decided to upgrade their Safety and Hazard data systems with 3 goals: make safety and hazard data more accessible; better support the interconnection of different types of safety data; and increase the efficiency (and compliance) of safety-related processes. These goals are accomplished by moving data into a web-based structured data system that includes strong process support and supports integration with other information systems. Along with the data systems, ISS is evolving its submission requirements and safety process requirements to support the improved model. In contrast to existing operations (where paper processes and electronic file repositories are used for safety data management) the web-based solution provides the program with dramatically faster access to records, the ability to search for and reference specific data within records, reduced workload for hazard updates and approval, and process support including digital signatures and controlled record workflow. In addition, integration with other key data systems provides assistance with assessments of flight readiness, more efficient review and approval of operational controls and better tracking of international safety certifications. This approach will also provide new opportunities to streamline the sharing of data with ISS international partners while maintaining compliance with applicable laws and respecting restrictions on proprietary data. One goal of this paper is to outline the approach taken by the ISS Progrm to determine requirements for the new system and to devise a practical and efficient implementation strategy. From conception through implementation, ISS and NASA partners utilized a user-centered software development approach focused on user research and iterative design methods. The user-centered approach used on the new ISS hazard system utilized focused user research and iterative design methods employed by the Human Computer Interaction Group at NASA Ames Research Center. Particularly, the approach emphasized the reduction of workload associated with document and data management activities so more resources can be allocated to the operational use of data in problem solving, safety analysis, and recurrence control. The methods and techniques used to understand existing processes and systems, to recognize opportunities for improvement, and to design and review improvements are described with the intent that similar techniques can be employed elsewhere in safety operations. A second goal of this paper is to provide and overview of the web-based data system implemented by ISS. The software selected for the ISS hazard systemMission Assurance System (MAS)is a NASA-customized vairant of the open source software project Bugzilla. The origin and history of MAS as a NASA software project and the rationale for (and advantages of) using open-source software are documented elsewhere (Green, et al., 2009).

System integration test plan for HANDI 2000 business management system

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

Wilson, D.

This document presents the system integration test plan for the Commercial-Off-The-Shelf, PassPort and PeopleSoft software, and custom software created to work with the COTS products. The PP software is an integrated application for AP, Contract Management, Inventory Management, Purchasing and Material Safety Data Sheet. The PS software is an integrated application for Project Costing, General Ledger, Human Resources/Training, Payroll, and Base Benefits.

78 FR 37706 - Safety Standards for Infant Walkers and Infant Swings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... Danny Keysar Child Product Safety Notification Act, if ASTM revises the underlying voluntary standard... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1216 and 1223 Safety Standards for Infant Walkers... the Danny Keysar Child Product Safety Notification Act, the U.S. Consumer Product Safety Commission...

49 CFR 385.5 - Safety fitness standard.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 5 2012-10-01 2012-10-01 false Safety fitness standard. 385.5 Section 385.5... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.5 Safety fitness standard. The satisfactory safety rating is based on the degree of...

49 CFR 385.5 - Safety fitness standard.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false Safety fitness standard. 385.5 Section 385.5... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.5 Safety fitness standard. The satisfactory safety rating is based on the degree of...

49 CFR 385.5 - Safety fitness standard.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Safety fitness standard. 385.5 Section 385.5... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.5 Safety fitness standard. The satisfactory safety rating is based on the degree of...

76 FR 43743 - Pipeline Safety: Meetings of the Technical Pipeline Safety Standards Committee and the Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2011-0127] Pipeline Safety: Meetings of the Technical Pipeline Safety Standards Committee and the Technical Hazardous Liquid Pipeline Safety Standards Committee AGENCY: Pipeline and Hazardous Materials...

NASA Software Assurance's Roles in Research and Technology

NASA Technical Reports Server (NTRS)

Wetherholt, Martha

2010-01-01

This slide presentation reviews the interactions between the scientist and engineers doing research and technology and the software developers and others who are doing software assurance. There is a discussion of the role of the Safety and Mission Assurance (SMA) in developing software to be used for research and technology, and the importance of this role as the technology moves to the higher levels of the technology readiness levels (TRLs). There is also a call to change the way the development of software is developed.

The IEEE Software Engineering Standards Process

PubMed Central

Buckley, Fletcher J.

1984-01-01

Software Engineering has emerged as a field in recent years, and those involved increasingly recognize the need for standards. As a result, members of the Institute of Electrical and Electronics Engineers (IEEE) formed a subcommittee to develop these standards. This paper discusses the ongoing standards development, and associated efforts.

Software Quality Evaluation Models Applicable in Health Information and Communications Technologies. A Review of the Literature.

PubMed

Villamor Ordozgoiti, Alberto; Delgado Hito, Pilar; Guix Comellas, Eva María; Fernandez Sanchez, Carlos Manuel; Garcia Hernandez, Milagros; Lluch Canut, Teresa

2016-01-01

Information and Communications Technologies in healthcare has increased the need to consider quality criteria through standardised processes. The aim of this study was to analyse the software quality evaluation models applicable to healthcare from the perspective of ICT-purchasers. Through a systematic literature review with the keywords software, product, quality, evaluation and health, we selected and analysed 20 original research papers published from 2005-2016 in health science and technology databases. The results showed four main topics: non-ISO models, software quality evaluation models based on ISO/IEC standards, studies analysing software quality evaluation models, and studies analysing ISO standards for software quality evaluation. The models provide cost-efficiency criteria for specific software, and improve use outcomes. The ISO/IEC25000 standard is shown as the most suitable for evaluating the quality of ICTs for healthcare use from the perspective of institutional acquisition.

Standard Populations (Millions) for Age-Adjustment - SEER Population Datasets

Cancer.gov

Download files containing standard population data for use in statististical software. The files contain the same data distributed with SEER*Stat software. You can also view the standard populations, either 19 age groups or single ages.

Enhancing requirements engineering for patient registry software systems with evidence-based components.

PubMed

Lindoerfer, Doris; Mansmann, Ulrich

2017-07-01

Patient registries are instrumental for medical research. Often their structures are complex and their implementations use composite software systems to meet the wide spectrum of challenges. Commercial and open-source systems are available for registry implementation, but many research groups develop their own systems. Methodological approaches in the selection of software as well as the construction of proprietary systems are needed. We propose an evidence-based checklist, summarizing essential items for patient registry software systems (CIPROS), to accelerate the requirements engineering process. Requirements engineering activities for software systems follow traditional software requirements elicitation methods, general software requirements specification (SRS) templates, and standards. We performed a multistep procedure to develop a specific evidence-based CIPROS checklist: (1) A systematic literature review to build a comprehensive collection of technical concepts, (2) a qualitative content analysis to define a catalogue of relevant criteria, and (3) a checklist to construct a minimal appraisal standard. CIPROS is based on 64 publications and covers twelve sections with a total of 72 items. CIPROS also defines software requirements. Comparing CIPROS with traditional software requirements elicitation methods, SRS templates and standards show a broad consensus but differences in issues regarding registry-specific aspects. Using an evidence-based approach to requirements engineering for registry software adds aspects to the traditional methods and accelerates the software engineering process for registry software. The method we used to construct CIPROS serves as a potential template for creating evidence-based checklists in other fields. The CIPROS list supports developers in assessing requirements for existing systems and formulating requirements for their own systems, while strengthening the reporting of patient registry software system descriptions. It may be a first step to create standards for patient registry software system assessments. Copyright © 2017 Elsevier Inc. All rights reserved.

CAD/CAE Integration Enhanced by New CAD Services Standard

NASA Technical Reports Server (NTRS)

Claus, Russell W.

2002-01-01

A Government-industry team led by the NASA Glenn Research Center has developed a computer interface standard for accessing data from computer-aided design (CAD) systems. The Object Management Group, an international computer standards organization, has adopted this CAD services standard. The new standard allows software (e.g., computer-aided engineering (CAE) and computer-aided manufacturing software to access multiple CAD systems through one programming interface. The interface is built on top of a distributed computing system called the Common Object Request Broker Architecture (CORBA). CORBA allows the CAD services software to operate in a distributed, heterogeneous computing environment.

Towards Real-time, On-board, Hardware-Supported Sensor and Software Health Management for Unmanned Aerial Systems

NASA Technical Reports Server (NTRS)

Schumann, Johann; Rozier, Kristin Y.; Reinbacher, Thomas; Mengshoel, Ole J.; Mbaya, Timmy; Ippolito, Corey

2013-01-01

Unmanned aerial systems (UASs) can only be deployed if they can effectively complete their missions and respond to failures and uncertain environmental conditions while maintaining safety with respect to other aircraft as well as humans and property on the ground. In this paper, we design a real-time, on-board system health management (SHM) capability to continuously monitor sensors, software, and hardware components for detection and diagnosis of failures and violations of safety or performance rules during the flight of a UAS. Our approach to SHM is three-pronged, providing: (1) real-time monitoring of sensor and/or software signals; (2) signal analysis, preprocessing, and advanced on the- fly temporal and Bayesian probabilistic fault diagnosis; (3) an unobtrusive, lightweight, read-only, low-power realization using Field Programmable Gate Arrays (FPGAs) that avoids overburdening limited computing resources or costly re-certification of flight software due to instrumentation. Our implementation provides a novel approach of combining modular building blocks, integrating responsive runtime monitoring of temporal logic system safety requirements with model-based diagnosis and Bayesian network-based probabilistic analysis. We demonstrate this approach using actual data from the NASA Swift UAS, an experimental all-electric aircraft.

Use of Unified Modeling Language (UML) in Model-Based Development (MBD) For Safety-Critical Applications

DTIC Science & Technology

2014-12-01

appears that UML is becoming the de facto MBD language. OMG® states the following on the MDA® FAQ page: “Although not formally required [for MBD], UML...a known limitation [42], so UML users should plan accordingly, especially for safety-critical programs. For example, “models are not used to...description of the MBD tool chain can be produced. That description could be resident in a Plan for Software Aspects of Certification (PSAC) or Software

Software for occupational health and safety risk analysis based on a fuzzy model.

PubMed

Stefanovic, Miladin; Tadic, Danijela; Djapan, Marko; Macuzic, Ivan

2012-01-01

Risk and safety management are very important issues in healthcare systems. Those are complex systems with many entities, hazards and uncertainties. In such an environment, it is very hard to introduce a system for evaluating and simulating significant hazards. In this paper, we analyzed different types of hazards in healthcare systems and we introduced a new fuzzy model for evaluating and ranking hazards. Finally, we presented a developed software solution, based on the suggested fuzzy model for evaluating and monitoring risk.

76 FR 10246 - Updating Fire Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Parts 17 and 59 RIN 2900-AN57 Updating Fire Safety Standards... regulations and update the standards for VA approval of such facilities, including standards for fire safety... to ``RIN 2900-AN57--Updating Fire Safety [[Page 10247

Treatment delivery software for a new clinical grade ultrasound system for thermoradiotherapy.

PubMed

Novák, Petr; Moros, Eduardo G; Straube, William L; Myerson, Robert J

2005-11-01

A detailed description of a clinical grade Scanning Ultrasound Reflector Linear Array System (SURLAS) applicator was given in a previous paper [Med. Phys. 32, 230-240 (2005)]. In this paper we concentrate on the design, development, and testing of the personal computer (PC) based treatment delivery software that runs the therapy system. The SURLAS requires the coordinated interaction between the therapy applicator and several peripheral devices for its proper and safe operation. One of the most important tasks was the coordination of the input power sequences for the elements of two parallel opposed ultrasound arrays (eight 1.5 cm x 2 cm elements/array, array 1 and 2 operate at 1.9 and 4.9 MHz, respectively) in coordination with the position of a dual-face scanning acoustic reflector. To achieve this, the treatment delivery software can divide the applicator's treatment window in up to 64 sectors (minimum size of 2 cm x 2 cm), and control the power to each sector independently by adjusting the power output levels from the channels of a 16-channel radio-frequency generator. The software coordinates the generator outputs with the position of the reflector as it scans back and forth between the arrays. Individual sector control and dual frequency operation allows the SURLAS to adjust power deposition in three dimensions to superficial targets coupled to its treatment window. The treatment delivery software also monitors and logs several parameters such as temperatures acquired using a 16-channel thermocouple thermometry unit. Safety (in particular to patients) was the paramount concern and design criterion. Failure mode and effects analysis (FMEA) was applied to the applicator as well as to the entire therapy system in order to identify safety issues and rank their relative importance. This analysis led to the implementation of several safety mechanisms and a software structure where each device communicates with the controlling PC independently of the others. In case of a malfunction in any part of the system or a violation of a user-defined safety criterion based on temperature readings, the software terminates treatment immediately and the user is notified. The software development process consisting of problem analysis, design, implementation, and testing is presented in this paper. Once the software was finished and integrated with the hardware, the therapy system was extensively tested. Results demonstrated that the software operates the SURLAS as intended with minimum risk to future patients.

A Predictive Approach to Eliminating Errors in Software Code

NASA Technical Reports Server (NTRS)

2006-01-01

NASA s Metrics Data Program Data Repository is a database that stores problem, product, and metrics data. The primary goal of this data repository is to provide project data to the software community. In doing so, the Metrics Data Program collects artifacts from a large NASA dataset, generates metrics on the artifacts, and then generates reports that are made available to the public at no cost. The data that are made available to general users have been sanitized and authorized for publication through the Metrics Data Program Web site by officials representing the projects from which the data originated. The data repository is operated by NASA s Independent Verification and Validation (IV&V) Facility, which is located in Fairmont, West Virginia, a high-tech hub for emerging innovation in the Mountain State. The IV&V Facility was founded in 1993, under the NASA Office of Safety and Mission Assurance, as a direct result of recommendations made by the National Research Council and the Report of the Presidential Commission on the Space Shuttle Challenger Accident. Today, under the direction of Goddard Space Flight Center, the IV&V Facility continues its mission to provide the highest achievable levels of safety and cost-effectiveness for mission-critical software. By extending its data to public users, the facility has helped improve the safety, reliability, and quality of complex software systems throughout private industry and other government agencies. Integrated Software Metrics, Inc., is one of the organizations that has benefited from studying the metrics data. As a result, the company has evolved into a leading developer of innovative software-error prediction tools that help organizations deliver better software, on time and on budget.

[Study on the reorganization of standards related to food contact ceramics and porcelains].

PubMed

Zhang, Jianbo; Zhu, Lei; Zhang, Hong; Liu, Shan; Wang, Zhutian

2014-07-01

To solve the problem of overlap, iterance and conflict among current standards related to food contact ceramics and porcelains. To collect all the current standards related to food contact ceramics and porcelains and reorganize them following the settled principles and method and list the standards that need to be revoked, revised, incorporated, or keep valid and excluded from the food safety standard system. 19 standards were collected in this study and reorganized. The main food safety indexes in these standards were the limits for lead and cadmium that released from food contact ceramics and porcelains. There were released limits for lead and cadmium in 10 standards, including 4 horizontal standards and 6 commodity standards. The provisions in these 10 standards were in conflict. And as a result of this, the 4 horizontal standards were suggested to be incorporated and revised to one food safety standard, while the 6 commodity standards were suggested to be revised and exclude the lead and cadmium provisions. Another 7 commodity standards only referenced provisions for lead and cadmium limits from horizontal standards, and these 7 standards were suggested to be excluded from food safety standard system. There were no food safety indexes in 2 standards of the 19 standards, these standards were considered not related to food safety and no need to be reorganized. There were conflicts about the released limits of lead and cadmium among the current standards related to food contact ceramics and porcelains. So, it is necessary to a set up a new food safety standard for released lead and cadmium permissible limits which can apply to all food contact ceramics and porcelains. This food safety standard should be based on food safety risk assessment and the actual situations of manufacture and usage of food contact ceramics and porcelains. The provisions in international standards and relative standards from other countries can also provide references to this standard.

Software database creature for investment property measurement according to international standards

NASA Astrophysics Data System (ADS)

Ponomareva, S. V.; Merzliakova, N. A.

2018-05-01

The article deals with investment property measurement and accounting problems at the international, national and enterprise levels. The need to create the software for investment property measurement according to International Accounting Standards was substantiated. The necessary software functions and the processes were described.

Non-developmental item computer systems and the malicious software threat

NASA Technical Reports Server (NTRS)

Bown, Rodney L.

1991-01-01

The following subject areas are covered: a DOD development system - the Army Secure Operating System; non-development commercial computer systems; security, integrity, and assurance of service (SI and A); post delivery SI and A and malicious software; computer system unique attributes; positive feedback to commercial computer systems vendors; and NDI (Non-Development Item) computers and software safety.

Information Extraction for System-Software Safety Analysis: Calendar Year 2007 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2008-01-01

This annual report describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis on the models to identify possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations; 4) perform discrete-time-based simulation on the models to investigate scenarios where these paths may play a role in failures and mishaps; and 5) identify resulting candidate scenarios for software integration testing. This paper describes new challenges in a NASA abort system case, and enhancements made to develop the integrated tool set.

A Comparison of Two Approaches to Safety Analysis Based on Use Cases

NASA Astrophysics Data System (ADS)

Stålhane, Tor; Sindre, Guttorm

Engineering has a long tradition in analyzing the safety of mechanical, electrical and electronic systems. Important methods like HazOp and FMEA have also been adopted by the software engineering community. The misuse case method, on the other hand, has been developed by the software community as an alternative to FMEA and preliminary HazOp for software development. To compare the two methods misuse case and FMEA we have run a small experiment involving 42 third year software engineering students. In the experiment, the students should identify and analyze failure modes from one of the use cases for a commercial electronic patient journals system. The results of the experiment show that on the average, the group that used misuse cases identified and analyzed more user related failure modes than the persons using FMEA. In addition, the persons who used the misuse cases scored better on perceived ease of use and intention to use.

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

NASA Software Engineering Benchmarking Study

NASA Technical Reports Server (NTRS)

Rarick, Heather L.; Godfrey, Sara H.; Kelly, John C.; Crumbley, Robert T.; Wifl, Joel M.

2013-01-01

To identify best practices for the improvement of software engineering on projects, NASA's Offices of Chief Engineer (OCE) and Safety and Mission Assurance (OSMA) formed a team led by Heather Rarick and Sally Godfrey to conduct this benchmarking study. The primary goals of the study are to identify best practices that: Improve the management and technical development of software intensive systems; Have a track record of successful deployment by aerospace industries, universities [including research and development (R&D) laboratories], and defense services, as well as NASA's own component Centers; and Identify candidate solutions for NASA's software issues. Beginning in the late fall of 2010, focus topics were chosen and interview questions were developed, based on the NASA top software challenges. Between February 2011 and November 2011, the Benchmark Team interviewed a total of 18 organizations, consisting of five NASA Centers, five industry organizations, four defense services organizations, and four university or university R and D laboratory organizations. A software assurance representative also participated in each of the interviews to focus on assurance and software safety best practices. Interviewees provided a wealth of information on each topic area that included: software policy, software acquisition, software assurance, testing, training, maintaining rigor in small projects, metrics, and use of the Capability Maturity Model Integration (CMMI) framework, as well as a number of special topics that came up in the discussions. NASA's software engineering practices compared favorably with the external organizations in most benchmark areas, but in every topic, there were ways in which NASA could improve its practices. Compared to defense services organizations and some of the industry organizations, one of NASA's notable weaknesses involved communication with contractors regarding its policies and requirements for acquired software. One of NASA's strengths was its software assurance practices, which seemed to rate well in comparison to the other organizational groups and also seemed to include a larger scope of activities. An unexpected benefit of the software benchmarking study was the identification of many opportunities for collaboration in areas including metrics, training, sharing of CMMI experiences and resources such as instructors and CMMI Lead Appraisers, and even sharing of assets such as documented processes. A further unexpected benefit of the study was the feedback on NASA practices that was received from some of the organizations interviewed. From that feedback, other potential areas where NASA could improve were highlighted, such as accuracy of software cost estimation and budgetary practices. The detailed report contains discussion of the practices noted in each of the topic areas, as well as a summary of observations and recommendations from each of the topic areas. The resulting 24 recommendations from the topic areas were then consolidated to eliminate duplication and culled into a set of 14 suggested actionable recommendations. This final set of actionable recommendations, listed below, are items that can be implemented to improve NASA's software engineering practices and to help address many of the items that were listed in the NASA top software engineering issues. 1. Develop and implement standard contract language for software procurements. 2. Advance accurate and trusted software cost estimates for both procured and in-house software and improve the capture of actual cost data to facilitate further improvements. 3. Establish a consistent set of objectives and expectations, specifically types of metrics at the Agency level, so key trends and models can be identified and used to continuously improve software processes and each software development effort. 4. Maintain the CMMI Maturity Level requirement for critical NASA projects and use CMMI to measure organizations developing software for NASA. 5.onsolidate, collect and, if needed, develop common processes principles and other assets across the Agency in order to provide more consistency in software development and acquisition practices and to reduce the overall cost of maintaining or increasing current NASA CMMI maturity levels. 6. Provide additional support for small projects that includes: (a) guidance for appropriate tailoring of requirements for small projects, (b) availability of suitable tools, including support tool set-up and training, and (c) training for small project personnel, assurance personnel and technical authorities on the acceptable options for tailoring requirements and performing assurance on small projects. 7. Develop software training classes for the more experienced software engineers using on-line training, videos, or small separate modules of training that can be accommodated as needed throughout a project. 8. Create guidelines to structure non-classroom training opportunities such as mentoring, peer reviews, lessons learned sessions, and on-the-job training. 9. Develop a set of predictive software defect data and a process for assessing software testing metric data against it. 10. Assess Agency-wide licenses for commonly used software tools. 11. Fill the knowledge gap in common software engineering practices for new hires and co-ops.12. Work through the Science, Technology, Engineering and Mathematics (STEM) program with universities in strengthening education in the use of common software engineering practices and standards. 13. Follow up this benchmark study with a deeper look into what both internal and external organizations perceive as the scope of software assurance, the value they expect to obtain from it, and the shortcomings they experience in the current practice. 14. Continue interactions with external software engineering environment through collaborations, knowledge sharing, and benchmarking.

Co Modeling and Co Synthesis of Safety Critical Multi threaded Embedded Software for Multi Core Embedded Platforms

DTIC Science & Technology

2017-03-20

computation, Prime Implicates, Boolean Abstraction, real- time embedded software, software synthesis, correct by construction software design , model...types for time -dependent data-flow networks". J.-P. Talpin, P. Jouvelot, S. Shukla. ACM-IEEE Conference on Methods and Models for System Design ...information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing   data sources, gathering and

Transit safety retrofit package development : applications requirements document.

DOT National Transportation Integrated Search

2014-05-01

This Application Requirements Document for the Transit Safety Retrofit Package (TRP) Development captures the system, hardware and software requirements towards fulfilling the technical objectives stated within the contract. To achieve the objective ...

76 FR 57635 - Restrictions on Operators Employing Former Flight Standards Service Aviation Safety Inspectors...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... Standards Service Aviation Safety Inspectors; Correction AGENCY: Federal Aviation Administration (FAA), DOT... ``Restrictions on Operators Employing Former Flight Standards Service Aviation Safety Inspectors'' (76 FR 52231... of, a Flight Standards Service Aviation Safety Inspector, and had direct responsibility to inspect...

Facial protection conferred by cycle safety helmets: use of digitized image processing to develop a new nondestructive test.

PubMed

Harrison, M; Shepherd, J P

1997-07-01

Cycle safety helmets are designed to prevent head injury. Although most commercially available helmets conform to one of several national and international standards, individual designs differ widely, particularly in relation to face coverage. A method was developed to assess the potential for the differing designs to protect the face from injury. A nonimpact test was assessed, using digitized image-processing software (Digithurst Ltd.) to measure the shadow cast by a helmet rim under a collimated plane light source onto the face of a mannequin headform. Twelve helmet designs available internationally were tested and ranked with respect to the direct protection conferred (area of the face directly covered by the helmet) and indirect protection (area of the face shaded). The three highest-ranking helmets for direct protection (Rosebank Stackhat, Asphalt Warrior, and Lazer Voyager) also ranked the highest for indirect protection. These helmets were more inferiorly extended and were of a more bulky construction. It was concluded that the dimensions of cycle helmets in relation to face coverage are crucial in influencing the extent to which facial protection is conferred. International test standards need urgent revision to ensure that face coverage is optimized. Lower-face protection could be achieved through incorporation of a lower-face bar to cycle helmets.

25 CFR 543.7 - What are the minimum internal control standards for bingo?

Code of Federal Regulations, 2011 CFR

2011-04-01

... software upgrades, data storage media replacement, etc.). The information recorded must be used when...., draw objects and back-up draw objects); and (ii) Random number generator software. (Additional information technology security standards can be found in § 543.16 of this part.) (2) The game software...

25 CFR 543.7 - What are the minimum internal control standards for bingo?

Code of Federal Regulations, 2012 CFR

2012-04-01

... software upgrades, data storage media replacement, etc.). The information recorded must be used when...., draw objects and back-up draw objects); and (ii) Random number generator software. (Additional information technology security standards can be found in § 543.16 of this part.) (2) The game software...

Future of Software Engineering Standards

NASA Technical Reports Server (NTRS)

Poon, Peter T.

1997-01-01

In the new millennium, software engineering standards are expected to continue to influence the process of producing software-intensive systems which are cost-effetive and of high quality. These sytems may range from ground and flight systems used for planetary exploration to educational support systems used in schools as well as consumer-oriented systems.

Evolution of Secondary Software Businesses: Understanding Industry Dynamics

NASA Astrophysics Data System (ADS)

Tyrväinen, Pasi; Warsta, Juhani; Seppänen, Veikko

Primary software industry originates from IBM's decision to unbundle software-related computer system development activities to external partners. This kind of outsourcing from an enterprise internal software development activity is a common means to start a new software business serving a vertical software market. It combines knowledge of the vertical market process with competence in software development. In this research, we present and analyze the key figures of the Finnish secondary software industry, in order to quantify its interaction with the primary software industry during the period of 2000-2003. On the basis of the empirical data, we present a model for evolution of a secondary software business, which makes explicit the industry dynamics. It represents the shift from internal software developed for competitive advantage to development of products supporting standard business processes on top of standardized technologies. We also discuss the implications for software business strategies in each phase.

Towards a global IT system for personalized medicine: the Medicine Safety Code initiative.

PubMed

Samwald, Matthias; Minarro-Giménez, José Antonio; Blagec, Kathrin; Adlassnig, Klaus-Peter

2014-01-01

The availability of pharmacogenomic data of individual patients can significantly improve physicians' prescribing behavior, lead to a reduced incidence of adverse drug events and an improvement of effectiveness of treatment. The Medicine Safety Code (MSC) initiative is an effort to improve the ability of clinicians and patients to share pharmacogenomic data and to use it at the point of care. The MSC is a standardized two-dimensional barcode that captures individual pharmacogenomic data. The system is backed by a web service that allows the decoding and interpretation of anonymous MSCs without requiring the installation of dedicated software. The system is based on a curated, ontology-based knowledge base representing pharmacogenomic definitions and clinical guidelines. The MSC system performed well in preliminary tests. To evaluate the system in realistic health care settings and to translate it into practical applications, the future participation of stakeholders in clinical institutions, researchers, pharmaceutical companies, genetic testing providers, health IT companies and health insurance organizations will be essential.

Towards a global IT system for personalized medicine: the Medicine Safety Code initiative.

PubMed

Samwald, Matthias; Minarro-Giménez, José Antonio; Blagec, Kathrin; Adlassnig, Klaus-Peter

2014-01-01

The availability of pharmacogenomic data of individual patients can significantly improve physicians' prescribing behavior, lead to a reduced incidence of adverse drug events and an improvement of effectiveness of treatment. The Medicine Safety Code (MSC) initiative is an effort to improve the ability of clinicians and patients to share pharmacogenomic data and to use it at the point of care. The MSC is a standardized two-dimensional barcode that captures individual pharmacogenomic data. The system is backed by a web service that allows the decoding and interpretation of anonymous MSCs without requiring the installation of dedicated software. The system is based on a curated, ontology-based knowledge base representing pharmacogenomic definitions and clinical guidelines. The MSC system performed well in preliminary tests. To evaluate the system in realistic health care settings and to translate it into practical applications, the future participation of stakeholders in clinical institutions, medical researchers, pharmaceutical companies, genetic testing providers, health IT companies and health insurance organizations will be essential.

Maternal worries, home safety behaviors, and perceived difficulties.

PubMed

Hendrickson, Sherry Garrett

2008-01-01

The aim of the study was to explore the worries, safety behaviors, and perceived difficulties in keeping children safe at home in a purposive sample of low-income, predominantly non-English speaking mothers as a foundation for later nursing interventions. This study was a qualitative, descriptive design with content analysis to identify maternal concerns, behaviors, and perceptions of home safety as part of a larger study. Eighty-two mothers, 64% of whom were monolingual Spanish-speakers, responded in writing to three semistructured interview questions. When mothers were unable to read and write the researcher wrote the responses, then read the content aloud for verification. A standardized probe for each question was posed to obtain richer responses. Data management included use of the software program NUD*IST and coding analyses following the Miles and Huberman guidelines (1994). Interpretations were translated into English for this report. The major worries were falling, health, kidnapping, and being hit by a car. The leading maternal behaviors were coded as being physically, verbally, and environmentally preventive. Mothers said that it was their role to provide safety, and that this role could be wearisome, such that constant supervision was difficult. Low-income mothers described their worries for their 1 to 4 year-old children, explored their behaviors for preventing injury, and discussed what made keeping children from harm difficult. Understanding how mothers keep children safe, the barriers to home safety, and effective safety behaviors are important to the health of children. The clinical relevance of this study includes building trust as clinicians plan assessment, intervention and evaluation of home safety to encourage dialog about concerns, safety behaviors, and barriers to keeping children from injury.

Towards a Clinical Trial Protocol to Evaluate Health Information Systems: Evaluation of a Computerized System for Monitoring Tuberculosis from a Patient Perspective in Brazil.

PubMed

Crepaldi, Nathalia Yukie; de Lima, Inacia Bezerra; Vicentine, Fernanda Bergamini; Rodrigues, Lídia Maria Lourençon; Sanches, Tiago Lara Michelin; Ruffino-Netto, Antonio; Alves, Domingos; Rijo, Rui Pedro Charters Lopes

2018-05-08

Assessment of health information systems consider different aspects of the system itself. They focus or on the professional who will use the software or on its usability or on the software engineering metrics or on financial and managerial issues. The existent approaches are very resources consuming, disconnected, and not standardized. As the software becomes more critical in the health organizations and in patients, becoming used as a medical device or a medicine, there is an urgency to identify tools and methods that can be applied in the development process. The present work is one of the steps of a broader study to identify standardized protocols to evaluate the health information systems as medicines and medical devices are evaluated by clinical trials. The goal of the present work was to evaluate the effect of the introduction of an information system for monitoring tuberculosis treatment (SISTB) in a Brazilian municipality from the patients' perspective. The Patient Satisfaction Questionnaire and the Hospital Consumer Assessment of Healthcare Providers and Systems were answered by the patients before and after the SISTB introduction, for comparison. Patients from an outpatient clinic, formed the control group, that is, at this site was not implanted the SISTB. Descriptive statistics and mixed effects model were used for data analysis. Eighty-eight interviews were conducted in the study. The questionnaire's results presented better averages after the system introduction but were not considered statistically significant. Therefore, it was not possible to associate system implantation with improved patient satisfaction. The HIS evaluation need be complete, the technical and managerial evaluation, the safety, the impact on the professionals and direct and/or indirect impact on patients are important. Developing the right tools and methods that can evaluate the software in its entirety, from the beginning of the development cycle with a normalized scale, are needed.

Integrating Data Sources for Process Sustainability ...

EPA Pesticide Factsheets

To perform a chemical process sustainability assessment requires significant data about chemicals, process design specifications, and operating conditions. The required information includes the identity of the chemicals used, the quantities of the chemicals within the context of the sustainability assessment, physical properties of these chemicals, equipment inventory, as well as health, environmental, and safety properties of the chemicals. Much of this data are currently available to the process engineer either from the process design in the chemical process simulation software or online through chemical property and environmental, health, and safety databases. Examples of these databases include the U.S. Environmental Protection Agency’s (USEPA’s) Aggregated Computational Toxicology Resource (ACToR), National Institute for Occupational Safety and Health’s (NIOSH’s) Hazardous Substance Database (HSDB), and National Institute of Standards and Technology’s (NIST’s) Chemistry Webbook. This presentation will provide methods and procedures for extracting chemical identity and flow information from process design tools (such as chemical process simulators) and chemical property information from the online databases. The presentation will also demonstrate acquisition and compilation of the data for use in the EPA’s GREENSCOPE process sustainability analysis tool. This presentation discusses acquisition of data for use in rapid LCI development.

SAFEGUARD: An Assured Safety Net Technology for UAS

NASA Technical Reports Server (NTRS)

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

2016-01-01

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

Field application of farm-food safety risk assessment (FRAMp) tool for small and medium fresh produce farms.

PubMed

Soon, J M; Davies, W P; Chadd, S A; Baines, R N

2013-02-15

The objective of this study was to develop a farm food safety-risk assessment tool (FRAMp) which serves as a self-assessment and educational tool for fresh produce farms. FRAMp was developed in Microsoft® Excel spreadsheet software using standard mathematical and logical functions and utilised a qualitative risk assessment approach for farmers to evaluate their food safety practices. The FRAMp tool has since been tested on 12 fresh produce farms throughout UK. All the farms determined that FRAMp was interesting but 17% found it too long while 25% of the farms felt the tool was too complicated. The instructions on FRAMp usage were revised and farmers were given the options to skip and select specific steps in the farm risk assessment. The end users (farmers/farm managers) determined that developing their own action plans and using it as proof of assessment for future third-party audits were most useful to them. FRAMp tool can be described as an illustrative risk ranking tool to facilitate farms to identify potential risk factors during their crop production. Copyright © 2012 Elsevier Ltd. All rights reserved.

Free and open-source software application for the evaluation of coronary computed tomography angiography images.

PubMed

Hadlich, Marcelo Souza; Oliveira, Gláucia Maria Moraes; Feijóo, Raúl A; Azevedo, Clerio F; Tura, Bernardo Rangel; Ziemer, Paulo Gustavo Portela; Blanco, Pablo Javier; Pina, Gustavo; Meira, Márcio; Souza e Silva, Nelson Albuquerque de

2012-10-01

The standardization of images used in Medicine in 1993 was performed using the DICOM (Digital Imaging and Communications in Medicine) standard. Several tests use this standard and it is increasingly necessary to design software applications capable of handling this type of image; however, these software applications are not usually free and open-source, and this fact hinders their adjustment to most diverse interests. To develop and validate a free and open-source software application capable of handling DICOM coronary computed tomography angiography images. We developed and tested the ImageLab software in the evaluation of 100 tests randomly selected from a database. We carried out 600 tests divided between two observers using ImageLab and another software sold with Philips Brilliance computed tomography appliances in the evaluation of coronary lesions and plaques around the left main coronary artery (LMCA) and the anterior descending artery (ADA). To evaluate intraobserver, interobserver and intersoftware agreements, we used simple and kappa statistics agreements. The agreements observed between software applications were generally classified as substantial or almost perfect in most comparisons. The ImageLab software agreed with the Philips software in the evaluation of coronary computed tomography angiography tests, especially in patients without lesions, with lesions < 50% in the LMCA and < 70% in the ADA. The agreement for lesions > 70% in the ADA was lower, but this is also observed when the anatomical reference standard is used.

Safe Software for Space Applications: Building on the DO-178 Experience

NASA Astrophysics Data System (ADS)

Dorsey, Cheryl A.; Dorsey, Timothy A.

2013-09-01

DO-178, Software Considerations in Airborne Systems and Equipment Certification, is the well-known international standard dealing with the assurance of software used in airborne systems [1,2]. Insights into the DO-178 experiences, strengths and weaknesses can benefit the international space community. As DO-178 is an excellent standard for safe software development when used appropriately, this paper provides lessons learned and suggestions for using it effectively.

Adverse drug event reporting systems: a systematic review

PubMed Central

Peddie, David; Wickham, Maeve E.; Badke, Katherin; Small, Serena S.; Doyle‐Waters, Mary M.; Balka, Ellen; Hohl, Corinne M.

2016-01-01

Aim Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. Methods We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full‐texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. Results We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). Conclusion We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. PMID:27016266

Adverse drug event reporting systems: a systematic review.

PubMed

Bailey, Chantelle; Peddie, David; Wickham, Maeve E; Badke, Katherin; Small, Serena S; Doyle-Waters, Mary M; Balka, Ellen; Hohl, Corinne M

2016-07-01

Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. © 2016 The British Pharmacological Society.

FAILSAFE Health Management for Embedded Systems

NASA Technical Reports Server (NTRS)

Horvath, Gregory A.; Wagner, David A.; Wen, Hui Ying; Barry, Matthew

2010-01-01

The FAILSAFE project is developing concepts and prototype implementations for software health management in mission- critical, real-time embedded systems. The project unites features of the industry-standard ARINC 653 Avionics Application Software Standard Interface and JPL s Mission Data System (MDS) technology (see figure). The ARINC 653 standard establishes requirements for the services provided by partitioned, real-time operating systems. The MDS technology provides a state analysis method, canonical architecture, and software framework that facilitates the design and implementation of software-intensive complex systems. The MDS technology has been used to provide the health management function for an ARINC 653 application implementation. In particular, the focus is on showing how this combination enables reasoning about, and recovering from, application software problems.

24 CFR 51.203 - Safety standards.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Safety standards. 51.203 Section 51... Conventional Fuels or Chemicals of an Explosive or Flammable Nature § 51.203 Safety standards. The following... from a hazard: (a) Thermal Radiation Safety Standard. Projects shall be located so that: (1) The...

41 CFR 50-204.2 - General safety and health standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... health standards. 50-204.2 Section 50-204.2 Public Contracts and Property Management Other Provisions Relating to Public Contracts PUBLIC CONTRACTS, DEPARTMENT OF LABOR 204-SAFETY AND HEALTH STANDARDS FOR FEDERAL SUPPLY CONTRACTS General Safety and Health Standards § 50-204.2 General safety and health...

75 FR 17641 - Updating Fire Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Parts 17 and 59 RIN 2900-AN57 Updating Fire Safety Standards... for VA approval of such facilities, including standards for fire safety and heating and cooling... submitted in response to ``RIN 2900-AN57--Updating Fire Safety Standards.'' Copies of comments received will...

24 CFR 51.203 - Safety standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Safety standards. 51.203 Section 51... Conventional Fuels or Chemicals of an Explosive or Flammable Nature § 51.203 Safety standards. The following... from a hazard: (a) Thermal Radiation Safety Standard. Projects shall be located so that: (1) The...

76 FR 8699 - Locomotive Safety Standards; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

.... FRA-2009-0094 and FRA-2009-0095, Notice No. 2] RIN 2130-AC16 Locomotive Safety Standards; Correction... notifying the public that the correct docket number for the Locomotive Safety Standards notice of proposed... locomotive safety standards. See 76 FR 2200. The NPRM established a public docket to receive comments in...

77 FR 23159 - Locomotive Safety Standards; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-18

.... FRA-2009-0094 and FR-2009-0095, Notice No. 4] RIN 2130-AC16 Locomotive Safety Standards; Correction... notifying the public that the correct docket number for the Locomotive Safety Standards final rule is FRA... rule related to locomotive safety standards. See 77 FR 21312. The final rule established a public...

46 CFR 80.25 - Notification of safety standards.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 3 2010-10-01 2010-10-01 false Notification of safety standards. 80.25 Section 80.25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PASSENGER VESSELS DISCLOSURE OF SAFETY STANDARDS AND COUNTRY OF REGISTRY § 80.25 Notification of safety standards. (a) Each owner, operator, agent...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2010 CFR

2010-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2011 CFR

2011-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2012 CFR

2012-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2014 CFR

2014-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2013 CFR

2013-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

78 FR 9623 - Federal Motor Vehicle Safety Standards; Air Brake Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... [Docket No. NHTSA-2013-0011] RIN 2127-AL11 Federal Motor Vehicle Safety Standards; Air Brake Systems... rule that amended the Federal motor vehicle safety standard for air brake systems by requiring... published a final rule in the Federal Register amending Federal Motor Vehicle Safety Standard (FMVSS) No...

50 CFR 600.355 - National Standard 10-Safety of Life at Sea.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 50 Wildlife and Fisheries 8 2010-10-01 2010-10-01 false National Standard 10-Safety of Life at Sea... Standards § 600.355 National Standard 10—Safety of Life at Sea. (a) Standard 10. Conservation and management measures shall, to the extent practicable, promote the safety of human life at sea. (b) General. (1...

Bayesian Software Health Management for Aircraft Guidance, Navigation, and Control

NASA Technical Reports Server (NTRS)

Schumann, Johann; Mbaya, Timmy; Menghoel, Ole

2011-01-01

Modern aircraft, both piloted fly-by-wire commercial aircraft as well as UAVs, more and more depend on highly complex safety critical software systems with many sensors and computer-controlled actuators. Despite careful design and V&V of the software, severe incidents have happened due to malfunctioning software. In this paper, we discuss the use of Bayesian networks (BNs) to monitor the health of the on-board software and sensor system, and to perform advanced on-board diagnostic reasoning. We will focus on the approach to develop reliable and robust health models for the combined software and sensor systems.

SAO mission support software and data standards, version 1.0

NASA Technical Reports Server (NTRS)

Hsieh, P.

1993-01-01

This document defines the software developed by the SAO AXAF Mission Support (MS) Program and defines standards for the software development process and control of data products generated by the software. The SAO MS is tasked to develop and use software to perform a variety of functions in support of the AXAF mission. Software is developed by software engineers and scientists, and commercial off-the-shelf (COTS) software is used either directly or customized through the use of scripts to implement analysis procedures. Software controls real-time laboratory instruments, performs data archiving, displays data, and generates model predictions. Much software is used in the analysis of data to generate data products that are required by the AXAF project, for example, on-orbit mirror performance predictions or detailed characterization of the mirror reflection performance with energy.

Visual Uav Trajectory Plan System Based on Network Map

NASA Astrophysics Data System (ADS)

Li, X. L.; Lin, Z. J.; Su, G. Z.; Wu, B. Y.

2012-07-01

The base map of the current software UP-30 using in trajectory plan for Unmanned Aircraft Vehicle is vector diagram. UP-30 draws navigation points manually. But in the field of operation process, the efficiency and the quality of work is influenced because of insufficient information, screen reflection, calculate inconveniently and other factors. If we do this work in indoor, the effect of external factors on the results would be eliminated, the network earth users can browse the free world high definition satellite images through downloading a client software, and can export the high resolution image by standard file format. This brings unprecedented convenient of trajectory plan. But the images must be disposed by coordinate transformation, geometric correction. In addition, according to the requirement of mapping scale ,camera parameters and overlap degree we can calculate exposure hole interval and trajectory distance between the adjacent trajectory automatically . This will improve the degree of automation of data collection. Software will judge the position of next point according to the intersection of the trajectory and the survey area and ensure the position of point according to trajectory distance. We can undertake the points artificially. So the trajectory plan is automatic and flexible. Considering safety, the date can be used in flying after simulating flight. Finally we can export all of the date using a key

Nasa-wide Standard Administrative Systems

NASA Technical Reports Server (NTRS)

Schneck, P.

1984-01-01

Factors to be considered in developing agency-wide standard administrative systems for NASA include uniformity of hardware and software; centralization vs. decentralization; risk exposure; and models for software development.

Highway Safety Manual applied in Missouri - freeway/software : research summary.

DOT National Transportation Integrated Search

2016-03-01

AASHTOs Highway Safety Manual (HSM) : includes models for freeway segments, speedchange : lanes (transitional area between mainline : and ramps), ramps, and interchange terminals. : These predictive models for freeway : interchanges need to be cal...

Occupational Exposure to Carbon Nanotubes and Nanofibers

MedlinePlus

... Software Video Follow NIOSH Facebook Flickr Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health ... Review Plan Follow NIOSH Facebook Flickr Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health ...

Proceedings of the Twenty-Third Annual Software Engineering Workshop

NASA Technical Reports Server (NTRS)

1999-01-01

The Twenty-third Annual Software Engineering Workshop (SEW) provided 20 presentations designed to further the goals of the Software Engineering Laboratory (SEL) of the NASA-GSFC. The presentations were selected on their creativity. The sessions which were held on 2-3 of December 1998, centered on the SEL, Experimentation, Inspections, Fault Prediction, Verification and Validation, and Embedded Systems and Safety-Critical Systems.

Technology Infusion of CodeSonar into the Space Network Ground Segment (RII07)

NASA Technical Reports Server (NTRS)

Benson, Markland

2008-01-01

The NASA Software Assurance Research Program (in part) performs studies as to the feasibility of technologies for improving the safety, quality, reliability, cost, and performance of NASA software. This study considers the application of commercial automated source code analysis tools to mission critical ground software that is in the operations and sustainment portion of the product lifecycle.

A Human Reliability Based Usability Evaluation Method for Safety-Critical Software

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

Phillippe Palanque; Regina Bernhaupt; Ronald Boring

2006-04-01

Recent years have seen an increasing use of sophisticated interaction techniques including in the field of safety critical interactive software [8]. The use of such techniques has been required in order to increase the bandwidth between the users and systems and thus to help them deal efficiently with increasingly complex systems. These techniques come from research and innovation done in the field of humancomputer interaction (HCI). A significant effort is currently being undertaken by the HCI community in order to apply and extend current usability evaluation techniques to these new kinds of interaction techniques. However, very little has been donemore » to improve the reliability of software offering these kinds of interaction techniques. Even testing basic graphical user interfaces remains a challenge that has rarely been addressed in the field of software engineering [9]. However, the non reliability of interactive software can jeopardize usability evaluation by showing unexpected or undesired behaviors. The aim of this SIG is to provide a forum for both researchers and practitioners interested in testing interactive software. Our goal is to define a roadmap of activities to cross fertilize usability and reliability testing of these kinds of systems to minimize duplicate efforts in both communities.« less

A software upgrade method for micro-electronics medical implants.

PubMed

Cao, Yang; Hao, Hongwei; Xue, Lin; Li, Luming; Ma, Bozhi

2006-01-01

A software upgrade method for micro-electronics medical implants is designed to enhance the devices' function or renew the software if there are some bugs found, the software updating or some memory units disabled. The implants needn't be replaced by operations if the faults can be corrected through reprogramming, which reduces the patients' pain and improves the safety effectively. This paper introduces the software upgrade method using in-application programming (IAP) and emphasizes how to insure the system, especially the implanted part's reliability and stability while upgrading.

A Framework for Software Reuse in Safety-Critical System of Systems

DTIC Science & Technology

2008-03-01

environment.8 Pressman , on the other hand, defines a software component as a unit of composition with contractually specified and explicit context...2005, p654. 9 R.S. Pressman ., Software Engineering A Practitioner’s Approach, Sixth Edition, New York, NY.: McGraw-Hill, 2005, p817. 10 W.C. Lim...index.php. 79 Pressman , R.S., Software Engineering A Practitioner’s Approach, Sixth Edition, New York, NY.: McGraw-Hill, 2005. Radio Technical

NREL Provides First-of-its-Kind Guidance Promoting Safety Standards for

Science.gov Websites

Promoting Safety Standards for Natural Gas Vehicle Maintenance Facilities NREL Provides First-of-its-Kind Guidance Promoting Safety Standards for Natural Gas Vehicle Maintenance Facilities December 1, 2017 The U.S vehicle maintenance facilities with a new handbook and webinar that outline safety factors and standards

Software architecture standard for simulation virtual machine, version 2.0

NASA Technical Reports Server (NTRS)

Sturtevant, Robert; Wessale, William

1994-01-01

The Simulation Virtual Machine (SBM) is an Ada architecture which eases the effort involved in the real-time software maintenance and sustaining engineering. The Software Architecture Standard defines the infrastructure which all the simulation models are built from. SVM was developed for and used in the Space Station Verification and Training Facility.

78 FR 22432 - Airworthiness Directives; Airbus Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... electrical rudder], through Airbus Service Bulletin (SB) A330-27-3176, --software standard P12A/M21A on FCPC.... Since we issued that AD, we have determined that new software standards for the flight control primary.... This proposed AD would require that operators modify or replace all three FCPCs with new software...

ICESat (GLAS) Science Processing Software Document Series. Volume 2; Science Data Management Plan; 4.0

NASA Technical Reports Server (NTRS)

Jester, Peggy L.; Hancock, David W., III

1999-01-01

This document provides the Data Management Plan for the GLAS Standard Data Software (SDS) supporting the GLAS instrument of the EOS ICESat Spacecraft. The SDS encompasses the ICESat Science Investigator-led Processing System (I-SIPS) Software and the Instrument Support Facility (ISF) Software. This Plan addresses the identification, authority, and description of the interface nodes associated with the GLAS Standard Data Products and the GLAS Ancillary Data.

ICESat (GLAS) Science Processing Software Document Series. Volume 3; GLAS Science Software Requirements Document; Ver 2.1

NASA Technical Reports Server (NTRS)

Jester, Peggy L.; Lee, Jeffrey; Zukor, Dorothy J. (Technical Monitor)

2001-01-01

This document addresses the software requirements of the Geoscience Laser Altimeter System (GLAS) Standard Data Software (SDS) supporting the GLAS instrument on the EOS ICESat Spacecraft. This Software Requirements Document represents the initial collection of the technical engineering information for the GLAS SDS. This information is detailed within the second of four main volumes of the Standard documentation, the Product Specification volume. This document is a "roll-out" from the governing volume outline containing the Concept and Requirements sections.

Prevalence and determinants of non-standard motorcycle safety helmets amongst food delivery workers in Selangor and Kuala Lumpur.

PubMed

Kulanthayan, S; See, Lai Git; Kaviyarasu, Y; Nor Afiah, M Z

2012-05-01

Almost half of the global traffic crashes involve vulnerable groups such as pedestrian, cyclists and two-wheeler users. The main objective of this study was to determine the factors that influence standard of the safety helmets used amongst food delivery workers by presence of Standard and Industrial Research Institute of Malaysia (SIRIM) certification label. A cross sectional study was conducted amongst 150 food delivery workers from fast food outlets in the vicinity of Selangor and Kuala Lumpur. During observation, safety helmets were classified as standard safety helmet in the presence of SIRIM label and non-standard in the absence of the label. They were approached for questionnaire participation once consent was obtained and were requested to exchange their safety helmet voluntarily with a new one after the interview. Data analysis was carried out using SPSS. Chi square and logistic regression analysis was applied to determine the significance and odds ratio of the variables studied, respectively (penetration test, age, education level, knowledge, crash history, types of safety helmet, marital status and years of riding experience) against the presence of SIRIM label. The response rate for this study was 85.2%. The prevalence of non-standard helmets use amongst fast food delivery workers was 55.3%. Safety helmets that failed the penetration test had higher odds of being non-standard helmets compared with safety helmets passing the test. Types of safety helmet indicated half-shell safety helmets had higher odds to be non-standard safety helmets compared to full-shell safety helmets. Riders with more years of riding experience were in high odds of wearing non-standard safety helmets compared to riders with less riding experience. Non-standard (non-SIRIM approved) helmets were more likely to be half-shell helmets, were more likely to fail the standards penetration test, and were more likely to be worn by older, more experienced riders. The implications of these findings are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

48 CFR 50.201 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... requirements or such other requirements as defined and specified by the Secretary of Homeland Security: (1) Is... otherwise cause, for which a SAFETY Act designation has been issued. For purposes of defining a QATT..., engineering services, software development services, software integration services, threat assessments...

48 CFR 50.201 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... requirements or such other requirements as defined and specified by the Secretary of Homeland Security: (1) Is... otherwise cause, for which a SAFETY Act designation has been issued. For purposes of defining a QATT..., engineering services, software development services, software integration services, threat assessments...

48 CFR 50.201 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... requirements or such other requirements as defined and specified by the Secretary of Homeland Security: (1) Is... otherwise cause, for which a SAFETY Act designation has been issued. For purposes of defining a QATT..., engineering services, software development services, software integration services, threat assessments...

48 CFR 50.201 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... requirements or such other requirements as defined and specified by the Secretary of Homeland Security: (1) Is... otherwise cause, for which a SAFETY Act designation has been issued. For purposes of defining a QATT..., engineering services, software development services, software integration services, threat assessments...

48 CFR 50.201 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... requirements or such other requirements as defined and specified by the Secretary of Homeland Security: (1) Is... otherwise cause, for which a SAFETY Act designation has been issued. For purposes of defining a QATT..., engineering services, software development services, software integration services, threat assessments...

Information system life-cycle and documentation standards, volume 1

NASA Technical Reports Server (NTRS)

Callender, E. David; Steinbacher, Jody

1989-01-01

The Software Management and Assurance Program (SMAP) Information System Life-Cycle and Documentation Standards Document describes the Version 4 standard information system life-cycle in terms of processes, products, and reviews. The description of the products includes detailed documentation standards. The standards in this document set can be applied to the life-cycle, i.e., to each phase in the system's development, and to the documentation of all NASA information systems. This provides consistency across the agency as well as visibility into the completeness of the information recorded. An information system is software-intensive, but consists of any combination of software, hardware, and operational procedures required to process, store, or transmit data. This document defines a standard life-cycle model and content for associated documentation.

29 CFR 1910.5 - Applicability of standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.5 Applicability of standards. (a) Except as provided in... enforce standards or regulations affecting occupational safety or health. (c)(1) If a particular standard...

29 CFR 1910.5 - Applicability of standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.5 Applicability of standards. (a) Except as provided in... enforce standards or regulations affecting occupational safety or health. (c)(1) If a particular standard...

Training Children in Pedestrian Safety: Distinguishing Gains in Knowledge from Gains in Safe Behavior

PubMed Central

McClure, Leslie A.

2014-01-01

Pedestrian injuries contribute greatly to child morbidity and mortality. Recent evidence suggests that training within virtual pedestrian environments may improve children’s street crossing skills, but may not convey knowledge about safety in street environments. We hypothesized that (a) children will gain pedestrian safety knowledge via videos/software/internet websites, but not when trained by virtual pedestrian environment or other strategies; (b) pedestrian safety knowledge will be associated with safe pedestrian behavior both before and after training; and (c) increases in knowledge will be associated with increases in safe behavior among children trained individually at streetside locations, but not those trained by means of other strategies. We analyzed data from a randomized controlled trial evaluating pedestrian safety training. We randomly assigned 240 children ages 7–8 to one of four training conditions: videos/software/internet, virtual reality (VR), individualized streetside instruction, or a no-contact control. Both virtual and field simulations of street crossing at 2-lane bi-directional mid-block locations assessed pedestrian behavior at baseline, post-training, and 6-month follow-up. Pedestrian knowledge was assessed orally on all three occasions. Children trained by videos/software/internet, and those trained individually, showed increased knowledge following training relative to children in the other groups (ps < 0.01). Correlations between pedestrian safety knowledge and pedestrian behavior were mostly non-significant. Correlations between change in knowledge and change in behavior from pre- to post-intervention also were non-significant, both for the full sample and within conditions. Children trained using videos/software/internet gained knowledge but did not change their behavior. Children trained individually gained in both knowledge and safer behavior. Children trained virtually gained in safer behavior but not knowledge. If VR is used for training, tools like videos/internet might effectively supplement training. We discovered few associations between knowledge and behavior, and none between changes in knowledge and behavior. Pedestrian safety knowledge and safe pedestrian behavior may be orthogonal constructs that should be considered independently for research and training purposes. PMID:24573688

Formal Verification Toolkit for Requirements and Early Design Stages

NASA Technical Reports Server (NTRS)

Badger, Julia M.; Miller, Sheena Judson

2011-01-01

Efficient flight software development from natural language requirements needs an effective way to test designs earlier in the software design cycle. A method to automatically derive logical safety constraints and the design state space from natural language requirements is described. The constraints can then be checked using a logical consistency checker and also be used in a symbolic model checker to verify the early design of the system. This method was used to verify a hybrid control design for the suit ports on NASA Johnson Space Center's Space Exploration Vehicle against safety requirements.

Formal Modeling and Analysis of a Preliminary Small Aircraft Transportation System (SATS)Concept

NASA Technical Reports Server (NTRS)

Carrreno, Victor A.; Gottliebsen, Hanne; Butler, Ricky; Kalvala, Sara

2004-01-01

New concepts for automating air traffic management functions at small non-towered airports raise serious safety issues associated with the software implementations and their underlying key algorithms. The criticality of such software systems necessitates that strong guarantees of the safety be developed for them. In this paper we present a formal method for modeling and verifying such systems using the PVS theorem proving system. The method is demonstrated on a preliminary concept of operation for the Small Aircraft Transportation System (SATS) project at NASA Langley.

Bureaucracy, Safety and Software: a Potentially Lethal Cocktail

NASA Astrophysics Data System (ADS)

Hatton, Les

This position paper identifies a potential problem with the evolution of software controlled safety critical systems. It observes that the rapid growth of bureaucracy in society quickly spills over into rules for behaviour. Whether the need for the rules comes first or there is simple anticipation of the need for a rule by a bureaucrat is unclear in many cases. Many such rules lead to draconian restrictions and often make the existing situation worse due to the presence of unintended consequences as will be shown with a number of examples.

Simulation for Prediction of Entry Article Demise (SPEAD): An Analysis Tool for Spacecraft Safety Analysis and Ascent/Reentry Risk Assessment

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

For the purpose of performing safety analysis and risk assessment for a potential off-nominal atmospheric reentry resulting in vehicle breakup, a synthesis of trajectory propagation coupled with thermal analysis and the evaluation of node failure is required to predict the sequence of events, the timeline, and the progressive demise of spacecraft components. To provide this capability, the Simulation for Prediction of Entry Article Demise (SPEAD) analysis tool was developed. The software and methodology have been validated against actual flights, telemetry data, and validated software, and safety/risk analyses were performed for various programs using SPEAD. This report discusses the capabilities, modeling, validation, and application of the SPEAD analysis tool.

LEGOS: Object-based software components for mission-critical systems. Final report, June 1, 1995--December 31, 1997

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

NONE

1998-08-01

An estimated 85% of the installed base of software is a custom application with a production quantity of one. In practice, almost 100% of military software systems are custom software. Paradoxically, the marginal costs of producing additional units are near zero. So why hasn`t the software market, a market with high design costs and low productions costs evolved like other similar custom widget industries, such as automobiles and hardware chips? The military software industry seems immune to market pressures that have motivated a multilevel supply chain structure in other widget industries: design cost recovery, improve quality through specialization, and enablemore » rapid assembly from purchased components. The primary goal of the ComponentWare Consortium (CWC) technology plan was to overcome barriers to building and deploying mission-critical information systems by using verified, reusable software components (Component Ware). The adoption of the ComponentWare infrastructure is predicated upon a critical mass of the leading platform vendors` inevitable adoption of adopting emerging, object-based, distributed computing frameworks--initially CORBA and COM/OLE. The long-range goal of this work is to build and deploy military systems from verified reusable architectures. The promise of component-based applications is to enable developers to snap together new applications by mixing and matching prefabricated software components. A key result of this effort is the concept of reusable software architectures. A second important contribution is the notion that a software architecture is something that can be captured in a formal language and reused across multiple applications. The formalization and reuse of software architectures provide major cost and schedule improvements. The Unified Modeling Language (UML) is fast becoming the industry standard for object-oriented analysis and design notation for object-based systems. However, the lack of a standard real-time distributed object operating system, lack of a standard Computer-Aided Software Environment (CASE) tool notation and lack of a standard CASE tool repository has limited the realization of component software. The approach to fulfilling this need is the software component factory innovation. The factory approach takes advantage of emerging standards such as UML, CORBA, Java and the Internet. The key technical innovation of the software component factory is the ability to assemble and test new system configurations as well as assemble new tools on demand from existing tools and architecture design repositories.« less

A Standardized Shift Handover Protocol: Improving Nurses’ Safe Practice in Intensive Care Units

PubMed Central

Malekzadeh, Javad; Mazluom, Seyed Reza; Etezadi, Toktam; Tasseri, Alireza

2013-01-01

Introduction: For maintaining the continuity of care and improving the quality of care, effective inter-shift information communication is necessary. Any handover error can endanger patient safety. Despite the importance of shift handover, there is no standard handover protocol in our healthcare settings. Methods: In this one-group pretest-posttest quasi-experimental study conducted in spring and summer of 2011, we recruited a convenience sample of 56 ICU nurses. The Nurses’ Safe Practice Evaluation Checklist was used for data collection. The Content Validity Index and the inter-rater correlation coefficient of the checklist was 0.92 and 89, respectively. We employed the SPSS 11.5 software and the Mc Nemar and paired-samples t test for data analysis. Results: Study findings revealed that nurses’ mean score on the Safe Practice Evaluation Checklist increased significantly from 11.6 (2.7) to 17.0 (1.8) (P < 0.001). Conclusion: using a standard handover protocol for communicating patient’s needs and information improves nurses’ safe practice in the area of basic nursing care. PMID:25276725

29 CFR 505.6 - Safety and health standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Safety and health standards. 505.6 Section 505.6 Labor... HUMANITIES § 505.6 Safety and health standards. (a) Standards. Section 5(i)(2) and section 7(g)(2) of the Act... dangerous to the health and safety of the employees engaged in such project or production. Compliance with...

29 CFR 505.6 - Safety and health standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 3 2014-07-01 2014-07-01 false Safety and health standards. 505.6 Section 505.6 Labor... HUMANITIES § 505.6 Safety and health standards. (a) Standards. Section 5(i)(2) and section 7(g)(2) of the Act... dangerous to the health and safety of the employees engaged in such project or production. Compliance with...

29 CFR 505.6 - Safety and health standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 3 2011-07-01 2011-07-01 false Safety and health standards. 505.6 Section 505.6 Labor... HUMANITIES § 505.6 Safety and health standards. (a) Standards. Section 5(i)(2) and section 7(g)(2) of the Act... dangerous to the health and safety of the employees engaged in such project or production. Compliance with...

29 CFR 505.6 - Safety and health standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 3 2012-07-01 2012-07-01 false Safety and health standards. 505.6 Section 505.6 Labor... HUMANITIES § 505.6 Safety and health standards. (a) Standards. Section 5(i)(2) and section 7(g)(2) of the Act... dangerous to the health and safety of the employees engaged in such project or production. Compliance with...

29 CFR 505.6 - Safety and health standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 3 2013-07-01 2013-07-01 false Safety and health standards. 505.6 Section 505.6 Labor... HUMANITIES § 505.6 Safety and health standards. (a) Standards. Section 5(i)(2) and section 7(g)(2) of the Act... dangerous to the health and safety of the employees engaged in such project or production. Compliance with...

78 FR 73692 - Revisions to Safety Standards for Infant Bath Seats, Toddler Beds, and Full-Size Baby Cribs

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-09

... standard issued under the Danny Keysar Child Product Safety Notification Act was based, the revision... standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1215, 1217 and 1219 Revisions to Safety Standards...

48 CFR 1352.271-82 - Department of Labor occupational safety and health standards for ship repair.

Code of Federal Regulations, 2014 CFR

2014-10-01

... occupational safety and health standards for ship repair. 1352.271-82 Section 1352.271-82 Federal Acquisition... of Provisions and Clauses 1352.271-82 Department of Labor occupational safety and health standards... Occupational Safety and Health Standards for Ship Repair (APR 2010) The contractor, in performance of all work...

48 CFR 1352.271-82 - Department of Labor occupational safety and health standards for ship repair.

Code of Federal Regulations, 2011 CFR

2011-10-01

... occupational safety and health standards for ship repair. 1352.271-82 Section 1352.271-82 Federal Acquisition... of Provisions and Clauses 1352.271-82 Department of Labor occupational safety and health standards... Occupational Safety and Health Standards for Ship Repair (APR 2010) The contractor, in performance of all work...

48 CFR 1352.271-82 - Department of Labor occupational safety and health standards for ship repair.

Code of Federal Regulations, 2013 CFR

2013-10-01

... occupational safety and health standards for ship repair. 1352.271-82 Section 1352.271-82 Federal Acquisition... of Provisions and Clauses 1352.271-82 Department of Labor occupational safety and health standards... Occupational Safety and Health Standards for Ship Repair (APR 2010) The contractor, in performance of all work...

48 CFR 1352.271-82 - Department of Labor occupational safety and health standards for ship repair.

Code of Federal Regulations, 2012 CFR

2012-10-01

... occupational safety and health standards for ship repair. 1352.271-82 Section 1352.271-82 Federal Acquisition... of Provisions and Clauses 1352.271-82 Department of Labor occupational safety and health standards... Occupational Safety and Health Standards for Ship Repair (APR 2010) The contractor, in performance of all work...

30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

48 CFR 1352.271-82 - Department of Labor occupational safety and health standards for ship repair.

Code of Federal Regulations, 2010 CFR

2010-10-01

... occupational safety and health standards for ship repair. 1352.271-82 Section 1352.271-82 Federal Acquisition... of Provisions and Clauses 1352.271-82 Department of Labor occupational safety and health standards... Occupational Safety and Health Standards for Ship Repair (APR 2010) The contractor, in performance of all work...

Space Debris Modeling at NASA

NASA Technical Reports Server (NTRS)

Johnson, Nicholas L.

2001-01-01

Since the Second European Conference on Space Debris in 1997, the Orbital Debris Program Office at the NASA Johnson Space Center has undertaken a major effort to update and improve the principal software tools employed to model the space debris environment and to evaluate mission risks. NASA's orbital debris engineering model, ORDEM, represents the current and near-term Earth orbital debris population from the largest spacecraft to the smallest debris in a manner which permits spacecraft engineers and experimenters to estimate the frequency and velocity with which a satellite may be struck by debris of different sizes. Using expanded databases and a new program design, ORDEM2000 provides a more accurate environment definition combined with a much broader array of output products in comparison with its predecessor, ORDEM96. Studies of the potential long-term space debris environment are now conducted with EVOLVE 4.0, which incorporates significant advances in debris characterization and breakup modeling. An adjunct to EVOLVE 4.0, GEO EVOLVE has been created to examine debris issues near the geosynchronous orbital regime. In support of NASA Safety Standard 1740.14, which establishes debris mitigation guidelines for all NASA space programs, a set of evaluation tools called the Debris Assessment Software (DAS) is specifically designed for program offices to determine whether they are in compliance with NASA debris mitigation guidelines. DAS 1.5 has recently been released with improved WINDOWS compatibility and graphics functions. DAS 2.0 will incorporate guideline changes in a forthcoming revision to NASA Safety Standard 1740.14. Whereas DAS contains a simplified model to calculate possible risks associated with satellite reentries, NASA's higher fidelity Object Reentry Survival Analysis Tool (ORSAT) has been upgraded to Version 5.0. With the growing awareness of the potential risks posed by uncontrolled satellite reentries to people and property on Earth, the application of both DAS and ORSAT has increased markedly in the past two years.

Simple solution to the medical instrumentation software problem

NASA Astrophysics Data System (ADS)

Leif, Robert C.; Leif, Suzanne B.; Leif, Stephanie H.; Bingue, E.

1995-04-01

Medical devices now include a substantial software component, which is both difficult and expensive to produce and maintain. Medical software must be developed according to `Good Manufacturing Practices', GMP. Good Manufacturing Practices as specified by the FDA and ISO requires the definition and compliance to a software processes which ensures quality products by specifying a detailed method of software construction. The software process should be based on accepted standards. US Department of Defense software standards and technology can both facilitate the development and improve the quality of medical systems. We describe the advantages of employing Mil-Std-498, Software Development and Documentation, and the Ada programming language. Ada provides the very broad range of functionalities, from embedded real-time to management information systems required by many medical devices. It also includes advanced facilities for object oriented programming and software engineering.

Preparation guide for class B software specification documents

NASA Technical Reports Server (NTRS)

Tausworthe, R. C.

1979-01-01

General conceptual requirements and specific application rules and procedures are provided for the production of software specification documents in conformance with deep space network software standards and class B standards. Class B documentation is identified as the appropriate level applicable to implementation, sustaining engineering, and operational uses by qualified personnel. Special characteristics of class B documents are defined.

New Results in Software Model Checking and Analysis

NASA Technical Reports Server (NTRS)

Pasareanu, Corina S.

2010-01-01

This introductory article surveys new techniques, supported by automated tools, for the analysis of software to ensure reliability and safety. Special focus is on model checking techniques. The article also introduces the five papers that are enclosed in this special journal volume.

Software Reliability Issues Concerning Large and Safety Critical Software Systems

NASA Technical Reports Server (NTRS)

Kamel, Khaled; Brown, Barbara

1996-01-01

This research was undertaken to provide NASA with a survey of state-of-the-art techniques using in industrial and academia to provide safe, reliable, and maintainable software to drive large systems. Such systems must match the complexity and strict safety requirements of NASA's shuttle system. In particular, the Launch Processing System (LPS) is being considered for replacement. The LPS is responsible for monitoring and commanding the shuttle during test, repair, and launch phases. NASA built this system in the 1970's using mostly hardware techniques to provide for increased reliability, but it did so often using custom-built equipment, which has not been able to keep up with current technologies. This report surveys the major techniques used in industry and academia to ensure reliability in large and critical computer systems.

Assuring NASA's Safety and Mission Critical Software

NASA Technical Reports Server (NTRS)

Deadrick, Wesley

2015-01-01

What is IV&V? Independent Verification and Validation (IV&V) is an objective examination of safety and mission critical software processes and products. Independence: 3 Key parameters: Technical Independence; Managerial Independence; Financial Independence. NASA IV&V perspectives: Will the system's software: Do what it is supposed to do?; Not do what it is not supposed to do?; Respond as expected under adverse conditions?. Systems Engineering: Determines if the right system has been built and that it has been built correctly. IV&V Technical Approaches: Aligned with IEEE 1012; Captured in a Catalog of Methods; Spans the full project lifecycle. IV&V Assurance Strategy: The IV&V Project's strategy for providing mission assurance; Assurance Strategy is driven by the specific needs of an individual project; Implemented via an Assurance Design; Communicated via Assurance Statements.

Socio-technical issues and challenges in implementing safe patient handovers: insights from ethnographic case studies.

PubMed

Balka, Ellen; Tolar, Marianne; Coates, Shannon; Whitehouse, Sandra

2013-12-01

Ineffective handovers in patient care, including those where information loss occurs between care providers, have been identified as a risk to patient safety. Computerization of health information is often offered as a solution to improve the quality of care handovers and decrease adverse events related to patient safety. The purpose of this paper is to broaden our understanding of clinical handover as a patient safety issue, and to identify socio-technical issues which may come to bear on the success of computer based handover tools. Three in depth ethnographic case studies were undertaken. Field notes were transcribed and analyzed with the aid of qualitative data analysis software. Within case analysis was performed on each case, and subsequently, cross case analyses were performed. We identified five types of socio-technical issues which must be addressed if electronic handover tools are to succeed. The inter-dependencies of these issues are addressed in relation to arenas in which health care work takes place. We suggest that the contextual nature of information, ethical and medico-legal issues arising in relation to information handover, and issues related to data standards and system interoperability must be addressed if computerized health information systems are to achieve improvements in patient safety related to handovers in care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The Software Maturity Matrix: A Software Performance Metric

DTIC Science & Technology

2003-01-28

are for Managing n Use Them! n Unused measurements have the same value as last night’s unused hotel room or an empty airline seat. n Be Prepared to...standard measurements are implicit n Organization standard verification is implicit n Organization standard SMM training can be the basis of an

Determination of Slope Safety Factor with Analytical Solution and Searching Critical Slip Surface with Genetic-Traversal Random Method

PubMed Central

2014-01-01

In the current practice, to determine the safety factor of a slope with two-dimensional circular potential failure surface, one of the searching methods for the critical slip surface is Genetic Algorithm (GA), while the method to calculate the slope safety factor is Fellenius' slices method. However GA needs to be validated with more numeric tests, while Fellenius' slices method is just an approximate method like finite element method. This paper proposed a new method to determine the minimum slope safety factor which is the determination of slope safety factor with analytical solution and searching critical slip surface with Genetic-Traversal Random Method. The analytical solution is more accurate than Fellenius' slices method. The Genetic-Traversal Random Method uses random pick to utilize mutation. A computer automatic search program is developed for the Genetic-Traversal Random Method. After comparison with other methods like slope/w software, results indicate that the Genetic-Traversal Random Search Method can give very low safety factor which is about half of the other methods. However the obtained minimum safety factor with Genetic-Traversal Random Search Method is very close to the lower bound solutions of slope safety factor given by the Ansys software. PMID:24782679

Initial development of prototype performance model for highway design

DOT National Transportation Integrated Search

1997-12-01

The Federal Highway Administration (FHWA) has undertaken a multiyear project to develop the Interactive Highway Safety Design Model (IHSDM), which is a CADD-based integrated set of software tools to analyze a highway design to identify safety issues ...

29 CFR 1924.1 - Applicable safety standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 7 2011-07-01 2011-07-01 false Applicable safety standards. 1924.1 Section 1924.1 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY STANDARDS APPLICABLE TO WORKSHOPS AND REHABILITATION FACILITIES ASSISTED BY GRANTS § 1924...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2014 CFR

2014-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2011 CFR

2011-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2012 CFR

2012-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

49 CFR 212.213 - Motive power and equipment (MP&E) inspector.

Code of Federal Regulations, 2013 CFR

2013-10-01

... of determining compliance with all sections of the Freight Car Safety Standards (49 CFR part 215... maintenance standards accepted in the industry; and (ii) The Freight Car Safety Standards, Safety Glazing... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STATE SAFETY PARTICIPATION REGULATIONS State...

Software Design Improvements. Part 1; Software Benefits and Limitations

NASA Technical Reports Server (NTRS)

Lalli, Vincent R.; Packard, Michael H.; Ziemianski, Tom

1997-01-01

Computer hardware and associated software have been used for many years to process accounting information, to analyze test data and to perform engineering analysis. Now computers and software also control everything from automobiles to washing machines and the number and type of applications are growing at an exponential rate. The size of individual program has shown similar growth. Furthermore, software and hardware are used to monitor and/or control potentially dangerous products and safety-critical systems. These uses include everything from airplanes and braking systems to medical devices and nuclear plants. The question is: how can this hardware and software be made more reliable? Also, how can software quality be improved? What methodology needs to be provided on large and small software products to improve the design and how can software be verified?

Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Simpson, James

2010-01-01

The Autonomous Flight Safety System (AFSS) is an independent self-contained subsystem mounted onboard a launch vehicle. AFSS has been developed by and is owned by the US Government. Autonomously makes flight termination/destruct decisions using configurable software-based rules implemented on redundant flight processors using data from redundant GPS/IMU navigation sensors. AFSS implements rules determined by the appropriate Range Safety officials.

Health and safety management systems: liability or asset?

PubMed

Bennett, David

2002-01-01

Health and safety management systems have a background in theory and in various interests among employers and workplace health and safety professionals. These have resulted in a number of national systems emanating from national standard-writing centres and from employers' organizations. In some cases these systems have been recognized as national standards. The contenders for an international standard have been the International Organization of Standardization (ISO) and the International Labour Organization (ILO). The quality and environmental management systems of ISO indicate what an ISO health and safety management standard would look like. The ILO Guidelines on Safety and Health Management Systems, by contrast, are stringent, specific and potentially effective in improving health and safety performance in the workplace.

International Safety Regulation and Standards for Space Travel and Commerce

NASA Astrophysics Data System (ADS)

Pelton, J. N.; Jakhu, R.

The evolution of air travel has led to the adoption of the 1944 Chicago Convention that created the International Civil Aviation Organization (ICAO), headquartered in Montreal, Canada, and the propagation of aviation safety standards. Today, ICAO standardizes and harmonizes commercial air safety worldwide. Space travel and space safety are still at an early stage of development, and the adoption of international space safety standards and regulation still remains largely at the national level. This paper explores the international treaties and conventions that govern space travel, applications and exploration today and analyzes current efforts to create space safety standards and regulations at the national, regional and global level. Recent efforts to create a commercial space travel industry and to license commercial space ports are foreseen as means to hasten a space safety regulatory process.

Understanding the Perception of Very Small Software Companies towards the Adoption of Process Standards

NASA Astrophysics Data System (ADS)

Basri, Shuib; O'Connor, Rory V.

This paper is concerned with understanding the issues that affect the adoption of software process standards by Very Small Entities (VSEs), their needs from process standards and their willingness to engage with the new ISO/IEC 29110 standard in particular. In order to achieve this goal, a series of industry data collection studies were undertaken with a collection of VSEs. A twin track approach of a qualitative data collection (interviews and focus groups) and quantitative data collection (questionnaire) were undertaken. Data analysis was being completed separately and the final results were merged, using the coding mechanisms of grounded theory. This paper serves as a roadmap for both researchers wishing to understand the issues of process standards adoption by very small companies and also for the software process standards community.

Intellectual Dummies

NASA Technical Reports Server (NTRS)

2002-01-01

Goddard Space Flight Center and Triangle Research & Development Corporation collaborated to create "Smart Eyes," a charge coupled device camera that, for the first time, could read and measure bar codes without the use of lasers. The camera operated in conjunction with software and algorithms created by Goddard and Triangle R&D that could track bar code position and direction with speed and precision, as well as with software that could control robotic actions based on vision system input. This accomplishment was intended for robotic assembly of the International Space Station, helping NASA to increase production while using less manpower. After successfully completing the two- phase SBIR project with Goddard, Triangle R&D was awarded a separate contract from the U.S. Department of Transportation (DOT), which was interested in using the newly developed NASA camera technology to heighten automotive safety standards. In 1990, Triangle R&D and the DOT developed a mask made from a synthetic, plastic skin covering to measure facial lacerations resulting from automobile accidents. By pairing NASA's camera technology with Triangle R&D's and the DOT's newly developed mask, a system that could provide repeatable, computerized evaluations of laceration injury was born.

Reliability of Beam Loss Monitors System for the Large Hadron Collider

NASA Astrophysics Data System (ADS)

Guaglio, G.; Dehning, B.; Santoni, C.

2004-11-01

The employment of superconducting magnets in high energy colliders opens challenging failure scenarios and brings new criticalities for the whole system protection. For the LHC beam loss protection system, the failure rate and the availability requirements have been evaluated using the Safety Integrity Level (SIL) approach. A downtime cost evaluation is used as input for the SIL approach. The most critical systems, which contribute to the final SIL value, are the dump system, the interlock system, the beam loss monitors system and the energy monitor system. The Beam Loss Monitors System (BLMS) is critical for short and intense particle losses, while at medium and higher loss time it is assisted by other systems, such as the quench protection system and the cryogenic system. For BLMS, hardware and software have been evaluated in detail. The reliability input figures have been collected using historical data from the SPS, using temperature and radiation damage experimental data as well as using standard databases. All the data have been processed by reliability software (Isograph). The analysis ranges from the components data to the system configuration.

49 CFR 659.15 - System safety program standard.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program standard. 659.15 Section 659... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.15 System safety program standard. (a) General requirement. Each state...

29 CFR 1910.18 - Changes in established Federal standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 1910.18 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.18 Changes in established Federal standards. Whenever an occupational safety and health...

29 CFR 1910.18 - Changes in established Federal standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 1910.18 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.18 Changes in established Federal standards. Whenever an occupational safety and health...

Open Source Surrogate Safety Assessment Model, 2017 Enhancement and Update: SSAM Version 3.0 [Tech Brief

DOT National Transportation Integrated Search

2016-11-17

The ETFOMM (Enhanced Transportation Flow Open Source Microscopic Model) Cloud Service (ECS) is a software product sponsored by the U.S. Department of Transportation in conjunction with the Microscopic Traffic Simulation Models and SoftwareAn Op...

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

NASA Technical Reports Server (NTRS)

Fitz, Rhonda; Whitman, Gerek

2016-01-01

Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IVV) Program, with Software Assurance Research Program support, extracted FM architectures across the IVV portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IVV projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management.

Training survey -- educational profile for Hanford HANDI 2000 project

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

Wilson, D.

Fluor Daniel Hanford, Inc. (FDH) is currently adopting streamlined business processes through integrated software solutions. Replacing the legacy software (current/replacement systems, attached) also avoids significant maintenance required to resolve Year 2000 issues. This initiative is being referred to as `HANDI 2000`. The software being implemented in the first phase of this project includes Indus International`s PASSPORT Software, Peoplesoft and Primavera P3 Software. The project, which encompasses all the system replacements that will occur, has been named `HANDI 2000.` The PASSPORT applications being implemented are Inventory Management, Purchasing, Contract Management, Accounts Payable, and MSDS (Material Safety Data Sheets).

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

PubMed Central

2014-01-01

Background According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). Methods The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. Results The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. Conclusions The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers. PMID:24655818

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit.

PubMed

Höss, Angelika; Lampe, Christian; Panse, Ralf; Ackermann, Benjamin; Naumann, Jakob; Jäkel, Oliver

2014-03-21

According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.

Food safety attitudes in college students: a structural equation modeling analysis of a conceptual model.

PubMed

Booth, Rachelle; Hernandez, Magaly; Baker, Erica L; Grajales, Tevni; Pribis, Peter

2013-01-30

College students are one of the most at-risk population groups for food poisoning, due to risky food safety behaviors. Using the Likert Scale, undergraduate students were asked to participate in a Food Safety Survey which was completed by 499 students ages 18-25. Data was analyzed using SPSS and AMOS statistical software. Four conceptual definitions regarding food safety were defined as: general food safety, bacterial food safety, produce food safety, and politics associated with food safety. Knowledge seems to be an important factor in shaping students attitudes regarding general and bacterial safety. Ethnicity plays a role in how people view the politics of food safety, and the safety of organic foods.

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2014 CFR

2014-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal agency standards affecting occupational safety and health. (a) Where employees of different agencies...

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2013 CFR

2013-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal agency standards affecting occupational safety and health. (a) Where employees of different agencies...

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2012 CFR

2012-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal agency standards affecting occupational safety and health. (a) Where employees of different agencies...