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.

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.

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.

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.

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.

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 reliability through fault-avoidance and fault-tolerance

NASA Technical Reports Server (NTRS)

Vouk, Mladen A.; Mcallister, David F.

1993-01-01

Strategies and tools for the testing, risk assessment and risk control of dependable software-based systems were developed. Part of this project consists of studies to enable the transfer of technology to industry, for example the risk management techniques for safety-concious systems. Theoretical investigations of Boolean and Relational Operator (BRO) testing strategy were conducted for condition-based testing. The Basic Graph Generation and Analysis tool (BGG) was extended to fully incorporate several variants of the BRO metric. Single- and multi-phase risk, coverage and time-based models are being developed to provide additional theoretical and empirical basis for estimation of the reliability and availability of large, highly dependable software. A model for software process and risk management was developed. The use of cause-effect graphing for software specification and validation was investigated. Lastly, advanced software fault-tolerance models were studied to provide alternatives and improvements in situations where simple software fault-tolerance strategies break down.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those requirements. This allows the projects leeway to meet these requirements in many forms that best suit a particular project's needs and safety risk. In other words, it tells the project what to do, not how to do it. This update also incorporated advances in the state of the practice of software safety from academia and private industry. It addresses some of the more common issues now facing software developers in the NASA environment such as the use of Commercial-Off-the-Shelf Software (COTS), Modified OTS (MOTS), Government OTS (GOTS), and reused software. A team from across NASA developed the update and it has had both NASA-wide internal reviews by software engineering, quality, safety, and project management. It has also had expert external review. This presentation and paper will discuss the new NASA Software Safety Standard, its organization, and key features. It will start with a brief discussion of some NASA mission failures and incidents that had software as one of their root causes. It will then give a brief overview of the NASA Software Safety Process. This will include an overview of the key personnel responsibilities and functions that must be performed for safety-critical software.

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).

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.

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.

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.

Projected Impact of Compositional Verification on Current and Future Aviation Safety Risk

NASA Technical Reports Server (NTRS)

Reveley, Mary S.; Withrow, Colleen A.; Leone, Karen M.; Jones, Sharon M.

2014-01-01

The projected impact of compositional verification research conducted by the National Aeronautic and Space Administration System-Wide Safety and Assurance Technologies on aviation safety risk was assessed. Software and compositional verification was described. Traditional verification techniques have two major problems: testing at the prototype stage where error discovery can be quite costly and the inability to test for all potential interactions leaving some errors undetected until used by the end user. Increasingly complex and nondeterministic aviation systems are becoming too large for these tools to check and verify. Compositional verification is a "divide and conquer" solution to addressing increasingly larger and more complex systems. A review of compositional verification research being conducted by academia, industry, and Government agencies is provided. Forty-four aviation safety risks in the Biennial NextGen Safety Issues Survey were identified that could be impacted by compositional verification and grouped into five categories: automation design; system complexity; software, flight control, or equipment failure or malfunction; new technology or operations; and verification and validation. One capability, 1 research action, 5 operational improvements, and 13 enablers within the Federal Aviation Administration Joint Planning and Development Office Integrated Work Plan that could be addressed by compositional verification were identified.

Practical Issues in Implementing Software Reliability Measurement

NASA Technical Reports Server (NTRS)

Nikora, Allen P.; Schneidewind, Norman F.; Everett, William W.; Munson, John C.; Vouk, Mladen A.; Musa, John D.

1999-01-01

Many ways of estimating software systems' reliability, or reliability-related quantities, have been developed over the past several years. Of particular interest are methods that can be used to estimate a software system's fault content prior to test, or to discriminate between components that are fault-prone and those that are not. The results of these methods can be used to: 1) More accurately focus scarce fault identification resources on those portions of a software system most in need of it. 2) Estimate and forecast the risk of exposure to residual faults in a software system during operation, and develop risk and safety criteria to guide the release of a software system to fielded use. 3) Estimate the efficiency of test suites in detecting residual faults. 4) Estimate the stability of the software maintenance process.

System Risk Balancing Profiles: Software Component

NASA Technical Reports Server (NTRS)

Kelly, John C.; Sigal, Burton C.; Gindorf, Tom

2000-01-01

The Software QA / V&V guide will be reviewed and updated based on feedback from NASA organizations and others with a vested interest in this area. Hardware, EEE Parts, Reliability, and Systems Safety are a sample of the future guides that will be developed. Cost Estimates, Lessons Learned, Probability of Failure and PACTS (Prevention, Avoidance, Control or Test) are needed to provide a more complete risk management strategy. This approach to risk management is designed to help balance the resources and program content for risk reduction for NASA's changing environment.

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.

Risk-Significant Adverse Condition Awareness Strengthens Assurance of Fault Management Systems

NASA Technical Reports Server (NTRS)

Fitz, Rhonda

2017-01-01

As spaceflight systems increase in complexity, Fault Management (FM) systems are ranked high in risk-based assessment of software criticality, emphasizing the importance of establishing highly competent domain expertise to provide assurance. Adverse conditions (ACs) and specific vulnerabilities encountered by safety- and mission-critical software systems have been identified through efforts to reduce the risk posture of software-intensive NASA missions. Acknowledgement of potential off-nominal conditions and analysis to determine software system resiliency are important aspects of hazard analysis and FM. A key component of assuring FM is an assessment of how well software addresses susceptibility to failure through consideration of ACs. Focus on significant risk predicted through experienced analysis conducted at the NASA Independent Verification & Validation (IV&V) Program enables the scoping of effective assurance strategies with regard to overall asset protection of complex spaceflight as well as ground systems. Research efforts sponsored by NASAs Office of Safety and Mission Assurance (OSMA) defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs and allowing queries based on project, mission type, domain/component, causal fault, and other key characteristics. Vulnerability in off-nominal situations, architectural design weaknesses, and unexpected or undesirable system behaviors in reaction to faults are curtailed with the awareness of ACs and risk-significant scenarios modeled for analysts through this database. Integration within the Enterprise Architecture at NASA IV&V enables interfacing with other tools and datasets, technical support, and accessibility across the Agency. This paper discusses the development of an improved workflow process utilizing this database for adaptive, risk-informed FM assurance that critical software systems will safely and securely protect against faults and respond to ACs in order to achieve successful missions.

Risk-Significant Adverse Condition Awareness Strengthens Assurance of Fault Management Systems

NASA Technical Reports Server (NTRS)

Fitz, Rhonda

2017-01-01

As spaceflight systems increase in complexity, Fault Management (FM) systems are ranked high in risk-based assessment of software criticality, emphasizing the importance of establishing highly competent domain expertise to provide assurance. Adverse conditions (ACs) and specific vulnerabilities encountered by safety- and mission-critical software systems have been identified through efforts to reduce the risk posture of software-intensive NASA missions. Acknowledgement of potential off-nominal conditions and analysis to determine software system resiliency are important aspects of hazard analysis and FM. A key component of assuring FM is an assessment of how well software addresses susceptibility to failure through consideration of ACs. Focus on significant risk predicted through experienced analysis conducted at the NASA Independent Verification Validation (IVV) Program enables the scoping of effective assurance strategies with regard to overall asset protection of complex spaceflight as well as ground systems. Research efforts sponsored by NASA's Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs and allowing queries based on project, mission type, domaincomponent, causal fault, and other key characteristics. Vulnerability in off-nominal situations, architectural design weaknesses, and unexpected or undesirable system behaviors in reaction to faults are curtailed with the awareness of ACs and risk-significant scenarios modeled for analysts through this database. Integration within the Enterprise Architecture at NASA IVV enables interfacing with other tools and datasets, technical support, and accessibility across the Agency. This paper discusses the development of an improved workflow process utilizing this database for adaptive, risk-informed FM assurance that critical software systems will safely and securely protect against faults and respond to ACs in order to achieve successful missions.

Safety Metrics for Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Leveson, Nancy G; Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems.This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

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.

ORAM-SENTINEL{trademark} demonstration at Fitzpatrick. Final report

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

Lee, L.K.; Anderson, V.M.; Mohammadi, K.

1998-06-01

New York Power Authority, in cooperation with EPRI, installed the ORAM-SENTINEL{trademark} software at James A. Fitzpatrick (JAF) Nuclear Power Plant. This software incorporates models of safety systems and support systems that are used for defense-in-depth in the plant during outage and on-line periods. A secondary goal was to include some pre-analyzed risk results to validate the methodology for quantitative assessment of the plant risks during proposed on-line maintenance. During the past year, New York Power Authority personnel have become familiar with the formal computerized Safety Assessment process associated with on-line and outage maintenance. The report describes techniques and lessons learnedmore » during development of the ORAM-SENTINEL model at JAF. It overviews the systems important to the Safety Function Assessment Process and provides details on development of the Plant Transient Assessment process using the station emergency operating procedures. The assessment results are displayed by color (green, yellow, orange, red) to show decreasing safety conditions. The report describes use of the JAF Probabilistic Safety Assessment within the ORAM-SENTINEL code to calculate an instantaneous core damage frequency and the criteria by which this frequency is translated to a color indicator.« less

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

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

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

2004-01-01

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

Assess/Mitigate Risk through the Use of Computer-Aided Software Engineering (CASE) Tools

NASA Technical Reports Server (NTRS)

Aguilar, Michael L.

2013-01-01

The NASA Engineering and Safety Center (NESC) was requested to perform an independent assessment of the mitigation of the Constellation Program (CxP) Risk 4421 through the use of computer-aided software engineering (CASE) tools. With the cancellation of the CxP, the assessment goals were modified to capture lessons learned and best practices in the use of CASE tools. The assessment goal was to prepare the next program for the use of these CASE tools. The outcome of the assessment is contained in this document.

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.

Certification Processes for Safety-Critical and Mission-Critical Aerospace Software

NASA Technical Reports Server (NTRS)

Nelson, Stacy

2003-01-01

This document is a quick reference guide with an overview of the processes required to certify safety-critical and mission-critical flight software at selected NASA centers and the FAA. Researchers and software developers can use this guide to jumpstart their understanding of how to get new or enhanced software onboard an aircraft or spacecraft. The introduction contains aerospace industry definitions of safety and safety-critical software, as well as, the current rationale for certification of safety-critical software. The Standards for Safety-Critical Aerospace Software section lists and describes current standards including NASA standards and RTCA DO-178B. The Mission-Critical versus Safety-Critical software section explains the difference between two important classes of software: safety-critical software involving the potential for loss of life due to software failure and mission-critical software involving the potential for aborting a mission due to software failure. The DO-178B Safety-critical Certification Requirements section describes special processes and methods required to obtain a safety-critical certification for aerospace software flying on vehicles under auspices of the FAA. The final two sections give an overview of the certification process used at Dryden Flight Research Center and the approval process at the Jet Propulsion Lab (JPL).

Automated Theorem Proving in High-Quality Software Design

NASA Technical Reports Server (NTRS)

Schumann, Johann; Swanson, Keith (Technical Monitor)

2001-01-01

The amount and complexity of software developed during the last few years has increased tremendously. In particular, programs are being used more and more in embedded systems (from car-brakes to plant-control). Many of these applications are safety-relevant, i.e. a malfunction of hardware or software can cause severe damage or loss. Tremendous risks are typically present in the area of aviation, (nuclear) power plants or (chemical) plant control. Here, even small problems can lead to thousands of casualties and huge financial losses. Large financial risks also exist when computer systems are used in the area of telecommunication (telephone, electronic commerce) or space exploration. Computer applications in this area are not only subject to safety considerations, but also security issues are important. All these systems must be designed and developed to guarantee high quality with respect to safety and security. Even in an industrial setting which is (or at least should be) aware of the high requirements in Software Engineering, many incidents occur. For example, the Warshaw Airbus crash, was caused by an incomplete requirements specification. Uncontrolled reuse of an Ariane 4 software module was the reason for the Ariane 5 disaster. Some recent incidents in the telecommunication area, like illegal "cloning" of smart-cards of D2GSM handies, or the extraction of (secret) passwords from German T-online users show that also in this area serious flaws can happen. Due to the inherent complexity of computer systems, most authors claim that only a rigorous application of formal methods in all stages of the software life cycle can ensure high quality of the software and lead to real safe and secure systems. In this paper, we will have a look, in how far automated theorem proving can contribute to a more widespread application of formal methods and their tools, and what automated theorem provers (ATPs) must provide in order to be useful.

A Model-based Framework for Risk Assessment in Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems. This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions. Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

SureTrak Probability of Impact Display

NASA Technical Reports Server (NTRS)

Elliott, John

2012-01-01

The SureTrak Probability of Impact Display software was developed for use during rocket launch operations. The software displays probability of impact information for each ship near the hazardous area during the time immediately preceding the launch of an unguided vehicle. Wallops range safety officers need to be sure that the risk to humans is below a certain threshold during each use of the Wallops Flight Facility Launch Range. Under the variable conditions that can exist at launch time, the decision to launch must be made in a timely manner to ensure a successful mission while not exceeding those risk criteria. Range safety officers need a tool that can give them the needed probability of impact information quickly, and in a format that is clearly understandable. This application is meant to fill that need. The software is a reuse of part of software developed for an earlier project: Ship Surveillance Software System (S4). The S4 project was written in C++ using Microsoft Visual Studio 6. The data structures and dialog templates from it were copied into a new application that calls the implementation of the algorithms from S4 and displays the results as needed. In the S4 software, the list of ships in the area was received from one local radar interface and from operators who entered the ship information manually. The SureTrak Probability of Impact Display application receives ship data from two local radars as well as the SureTrak system, eliminating the need for manual data entry.

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

NASA has developed guidelines for development and analysis of safety-critical software. These guidelines have been documented in a Guidebook for Safety Critical Software Development and Analysis. The guidelines represent a practical 'how to' approach, to assist software developers and safety analysts in cost effective methods for software safety. They provide guidance in the implementation of the recent NASA Software Safety Standard NSS-1740.13 which was released as 'Interim' version in June 1994, scheduled for formal adoption late 1995. This paper is a survey of the methods in general use, resulting in the NASA guidelines for safety critical software development and analysis.

Food Safety Attitudes in College Students: A Structural Equation Modeling Analysis of a Conceptual Model

PubMed Central

Booth, Rachelle; Hernandez, Magaly; Baker, Erica L.; Grajales, Tevni; Pribis, Peter

2013-01-01

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. PMID:23364131

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.

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.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2005-01-01

NASA (National Aeronautics and Space Administration) relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft (manned or unmanned) launched that did not have a computer on board that provided vital command and control services. Despite this growing dependence on software control and monitoring, there has been no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Led by the NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard (STD-18l9.13B) has recently undergone a significant update in an attempt to provide that consistency. This paper will discuss the key features of the new NASA Software Safety Standard. It will start with a brief history of the use and development of software in safety critical applications at NASA. It will then give a brief overview of the NASA Software Working Group and the approach it took to revise the software engineering process across the Agency.

Implementation and Simulation Results using Autonomous Aerobraking Development Software

NASA Technical Reports Server (NTRS)

Maddock, Robert W.; DwyerCianciolo, Alicia M.; Bowes, Angela; Prince, Jill L. H.; Powell, Richard W.

2011-01-01

An Autonomous Aerobraking software system is currently under development with support from the NASA Engineering and Safety Center (NESC) that would move typically ground-based operations functions to onboard an aerobraking spacecraft, reducing mission risk and mission cost. The suite of software that will enable autonomous aerobraking is the Autonomous Aerobraking Development Software (AADS) and consists of an ephemeris model, onboard atmosphere estimator, temperature and loads prediction, and a maneuver calculation. The software calculates the maneuver time, magnitude and direction commands to maintain the spacecraft periapsis parameters within design structural load and/or thermal constraints. The AADS is currently tested in simulations at Mars, with plans to also evaluate feasibility and performance at Venus and Titan.

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.

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.

NASA Software Safety Standard

NASA Technical Reports Server (NTRS)

Rosenberg, Linda

1997-01-01

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

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.

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

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.

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

[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.).

Object-Oriented Bayesian Networks (OOBN) for Aviation Accident Modeling and Technology Portfolio Impact Assessment

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Ancel, Ersin; Jones, Sharon M.

2012-01-01

The concern for reducing aviation safety risk is rising as the National Airspace System in the United States transforms to the Next Generation Air Transportation System (NextGen). The NASA Aviation Safety Program is committed to developing an effective aviation safety technology portfolio to meet the challenges of this transformation and to mitigate relevant safety risks. The paper focuses on the reasoning of selecting Object-Oriented Bayesian Networks (OOBN) as the technique and commercial software for the accident modeling and portfolio assessment. To illustrate the benefits of OOBN in a large and complex aviation accident model, the in-flight Loss-of-Control Accident Framework (LOCAF) constructed as an influence diagram is presented. An OOBN approach not only simplifies construction and maintenance of complex causal networks for the modelers, but also offers a well-organized hierarchical network that is easier for decision makers to exploit the model examining the effectiveness of risk mitigation strategies through technology insertions.

Assurance of Fault Management: Risk-Significant Adverse Condition Awareness

NASA Technical Reports Server (NTRS)

Fitz, Rhonda

2016-01-01

Fault Management (FM) systems are ranked high in risk-based assessment of criticality within flight software, emphasizing the importance of establishing highly competent domain expertise to provide assurance for NASA projects, especially as spaceflight systems continue to increase in complexity. Insight into specific characteristics of FM architectures seen embedded within safety- and mission-critical software systems analyzed by the NASA Independent Verification Validation (IVV) Program has been enhanced with an FM Technical Reference (TR) suite. Benefits are aimed beyond the IVV community to those that seek ways to efficiently and effectively provide software assurance to reduce the FM risk posture of NASA and other space missions. The identification of particular FM architectures, visibility, and associated IVV techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. The role FM has with regard to overall asset protection of flight software systems is being addressed with the development of an adverse condition (AC) database encompassing flight software vulnerabilities.Identification of potential off-nominal conditions and analysis to determine how a system responds to these conditions are important aspects of hazard analysis and fault management. Understanding what ACs the mission may face, and ensuring they are prevented or addressed is the responsibility of the assurance team, which necessarily should have insight into ACs beyond those defined by the project itself. Research efforts sponsored by NASAs Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs, and allowing queries based on project, mission type, domain component, causal fault, and other key characteristics. The repository has a firm structure, initial collection of data, and an interface established for informational queries, with plans for integration within the Enterprise Architecture at NASA IVV, enabling support and accessibility across the Agency. The development of an improved workflow process for adaptive, risk-informed FM assurance is currently underway.

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

Tenney, J.L.

SARS is a data acquisition system designed to gather and process radar data from aircraft flights. A database of flight trajectories has been developed for Albuquerque, NM, and Amarillo, TX. The data is used for safety analysis and risk assessment reports. To support this database effort, Sandia developed a collection of hardware and software tools to collect and post process the aircraft radar data. This document describes the data reduction tools which comprise the SARS, and maintenance procedures for the hardware and software system.

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...

The Application of Software Safety to the Constellation Program Launch Control System

NASA Technical Reports Server (NTRS)

Kania, James; Hill, Janice

2011-01-01

The application of software safety practices on the LCS project resulted in the successful implementation of the NASA Software Safety Standard NASA-STD-8719.138 and CxP software safety requirements. The GOP-GEN-GSW-011 Hazard Report was the first report developed at KSC to identify software hazard causes and their controls. This approach can be applied to similar large software - intensive systems where loss of control can lead to a hazard.

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.

Software safety

NASA Technical Reports Server (NTRS)

Leveson, Nancy

1987-01-01

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

Health, safety and environmental risk of a gas pipeline in an oil exploring area of Gachsaran.

PubMed

Kalatpoor, Omid; Goshtasp, Kambiz; Khavaji, Solieman

2011-01-01

The purpose of this study was assessing health, safety and environmental risk of a gas transfer pipeline in an oily area of Gachsaran. In this method, we used the Kent's pipeline risk assessment method except that to facilitate using the method more practically some changes were exerted into Kent's method. A pipeline with 16 kilometers length was selected considering surrounding nature of the pipeline. It was divided into two sections. Analogous to Kent's method, in this method, parameters included: interested party's injuries, corrosion, design factor, incorrect operation index and consequence scoring. The difference here was that for consequence scoring we used ALOHA 5.6 software instead of Kent's pattern. Results showed that health, safety and environmental risks of section 2 (the next 13 kilometers of outgoing pipeline from gas station after the first 3 kilometers) were greater. It seems the main cause of gaining a bigger risk number was related to more activities of interested parties around section 2. Because all figures gathered from indexes are almost close to gather except third parties activity.

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.

Planning the Unplanned Experiment: Assessing the Efficacy of Standards for Safety Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2015-01-01

We need well-founded means of determining whether software is t for use in safety-critical applications. While software in industries such as aviation has an excellent safety record, the fact that software aws have contributed to deaths illustrates the need for justi ably high con dence in software. It is often argued that software is t for safety-critical use because it conforms to a standard for software in safety-critical systems. But little is known about whether such standards `work.' Reliance upon a standard without knowing whether it works is an experiment; without collecting data to assess the standard, this experiment is unplanned. This paper reports on a workshop intended to explore how standards could practicably be assessed. Planning the Unplanned Experiment: Assessing the Ecacy of Standards for Safety Critical Software (AESSCS) was held on 13 May 2014 in conjunction with the European Dependable Computing Conference (EDCC). We summarize and elaborate on the workshop's discussion of the topic, including both the presented positions and the dialogue that ensued.

TH-A-12A-01: Medical Physicist's Role in Digital Information Security: Threats, Vulnerabilities and Best Practices

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

McDonald, K; Curran, B

I. Information Security Background (Speaker = Kevin McDonald) Evolution of Medical Devices Living and Working in a Hostile Environment Attack Motivations Attack Vectors Simple Safety Strategies Medical Device Security in the News Medical Devices and Vendors Summary II. Keeping Radiation Oncology IT Systems Secure (Speaker = Bruce Curran) Hardware Security Double-lock Requirements “Foreign” computer systems Portable Device Encryption Patient Data Storage System Requirements Network Configuration Isolating Critical Devices Isolating Clinical Networks Remote Access Considerations Software Applications / Configuration Passwords / Screen Savers Restricted Services / access Software Configuration Restriction Use of DNS to restrict accesse. Patches / Upgrades Awareness Intrusionmore » Prevention Intrusion Detection Threat Risk Analysis Conclusion Learning Objectives: Understanding how Hospital IT Requirements affect Radiation Oncology IT Systems. Illustrating sample practices for hardware, network, and software security. Discussing implementation of good IT security practices in radiation oncology. Understand overall risk and threats scenario in a networked environment.« less

Geotechnical approach for occupational safety risk analysis of critical slope in open pit mining as implication for earthquake hazard

NASA Astrophysics Data System (ADS)

Munirwansyah; Irsyam, Masyhur; Munirwan, Reza P.; Yunita, Halida; Zulfan Usrina, M.

2018-05-01

Occupational safety and health (OSH) is a planned effort to prevent accidents and diseases caused by work. In conducting mining activities often occur work accidents caused by unsafe field conditions. In open mine area, there is often a slump due to unstable slopes, which can disrupt the activities and productivity of mining companies. Based on research on stability of open pit slopes conducted by Febrianti [8], the Meureubo coal mine located in Aceh Barat district, on the slope of mine was indicated unsafe slope conditions, it will be continued research on OSH for landslide which is to understand the stability of the excavation slope and the shape of the slope collapse. Plaxis software was used for this research. After analyzing the slope stability and the effect of landslide on OSH with Job Safety Analysis (JSA) method, to identify the hazard to work safety, risk management analysis will be conducted to classified hazard level and its handling technique. This research aim is to know the level of risk of work accident at the company and its prevention effort. The result of risk analysis research is very high-risk value that is > 350 then the activity must be stopped until the risk can be reduced to reach the risk value limit < 20 which is allowed or accepted.

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...

78 FR 47014 - Configuration Management Plans for Digital Computer Software Used in Safety Systems of Nuclear...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION... Computer Software Used in Safety Systems of Nuclear Power Plants.'' This RG endorses, with clarifications... Electrical and Electronic Engineers (IEEE) Standard 828-2005, ``IEEE Standard for Software Configuration...

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.

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.

Design and Development of a Clinical Risk Management Tool Using Radio Frequency Identification (RFID)

PubMed Central

Pourasghar, Faramarz; Tabrizi, Jafar Sadegh; Yarifard, Khadijeh

2016-01-01

Background: Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process. Objective: This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. Methods: The proposed clinical error management system (CEMS) is consisted of a reader device, a transfer/receiver device, a database and managing software. The reader device works using radio waves and is wireless. The reader sends and receives data to/from the database via the transfer/receiver device which is connected to the computer via USB port. The database contains data about patients’ medication orders. Results: The CEMS has the ability to identify the clinical errors before they occur and then warns the care-giver with voice and visual messages to prevent the error. This device reduces the errors and thus improves the patient safety. Conclusion: A new tool including software and hardware was developed in this study. Application of this tool in clinical settings can help the nurses prevent medical errors. It can also be a useful tool for clinical risk management. Using this device can improve the patient safety to a considerable extent and thus improve the quality of healthcare. PMID:27147802

Design and Development of a Clinical Risk Management Tool Using Radio Frequency Identification (RFID).

PubMed

Pourasghar, Faramarz; Tabrizi, Jafar Sadegh; Yarifard, Khadijeh

2016-04-01

Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process. This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. The proposed clinical error management system (CEMS) is consisted of a reader device, a transfer/receiver device, a database and managing software. The reader device works using radio waves and is wireless. The reader sends and receives data to/from the database via the transfer/receiver device which is connected to the computer via USB port. The database contains data about patients' medication orders. The CEMS has the ability to identify the clinical errors before they occur and then warns the care-giver with voice and visual messages to prevent the error. This device reduces the errors and thus improves the patient safety. A new tool including software and hardware was developed in this study. Application of this tool in clinical settings can help the nurses prevent medical errors. It can also be a useful tool for clinical risk management. Using this device can improve the patient safety to a considerable extent and thus improve the quality of healthcare.

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

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...

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...

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2015-10-01

RAVEN is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncertainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters that need tomore » be perturbed are accessible by inputs files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused toward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN has started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assessment capability to RELAP-7, currently under development at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activaties are currently ongoing for coupling RAVEN with software such as RELAP5-3D, etc. The aim of this document is the explanation of the input requirements, focalizing on the input structure.« less

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2016-02-01

RAVEN is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncertainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters that need tomore » be perturbed are accessible by input files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused toward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assessment capability to RELAP-7, currently under development at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activates are currently ongoing for coupling RAVEN with software such as RELAP5-3D, etc. The aim of this document is the explanation of the input requirements, focusing on the input structure.« less

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.

RAVEN Theory Manual

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

Alfonsi, Andrea; Rabiti, Cristian; Mandelli, Diego

2016-06-01

RAVEN is a software framework able to perform parametric and stochastic analysis based on the response of complex system codes. The initial development was aimed at providing dynamic risk analysis capabilities to the thermohydraulic code RELAP-7, currently under development at Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose stochastic and uncertainty quantification platform, capable of communicating with any system code. In fact, the provided Application Programming Interfaces (APIs) allow RAVEN to interact with any code as long as all the parameters that need to be perturbed are accessible by input filesmore » or via python interfaces. RAVEN is capable of investigating system response and explore input space using various sampling schemes such as Monte Carlo, grid, or Latin hypercube. However, RAVEN strength lies in its system feature discovery capabilities such as: constructing limit surfaces, separating regions of the input space leading to system failure, and using dynamic supervised learning techniques. The development of RAVEN started in 2012 when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework arose. RAVEN’s principal assignment is to provide the necessary software and algorithms in order to employ the concepts developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just to identify the frequency of an event potentially leading to a system failure, but the proximity (or lack thereof) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. peak pressure in a pipe) is exceeded under certain conditions. Most of the capabilities, implemented having RELAP-7 as a principal focus, are easily deployable to other system codes. For this reason, several side activates have been employed (e.g. RELAP5-3D, any MOOSE-based App, etc.) or are currently ongoing for coupling RAVEN with several different software. The aim of this document is to provide a set of commented examples that can help the user to become familiar with the RAVEN code usage.« less

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

Improved modified pressure imaging and software for egg micro-crack detection and egg quality grading

USDA-ARS?s Scientific Manuscript database

Cracks in the egg shell increase a food safety risk. Especially, eggs with very fine, hairline cracks (micro-cracks) are often undetected during the grading process because they are almost impossible to detect visually. A modified pressure imaging system was developed to detect eggs with micro-crack...

Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

PubMed

Badri, Adel; Nadeau, Sylvie; Gbodossou, André

2012-09-01

Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

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...

Research on non-direct reflection columnar microstructure

NASA Astrophysics Data System (ADS)

Wu, B. Q.; Wang, X. Z.; Dong, L. H.

2015-10-01

To minimize the risk of laser accidents, especially those involving eye and skin injuries, it is crucial to pay more attention to laser safety. To control the risk of injury, depending on the laser power and wavelength, a number of required safety measures have been put forward, such as specific protection walls, and wearing safety goggles when operating lasers. The direct reflection columnar microstructure can also be used for laser safety. Based on mathematical foundations , a columnar microstructure is designed by the optical design software LightTools. Simulation showed that there is a tilt angle between the emergent and incident light, the incident light being perpendicular to the microstructure, as well as the phenomenon of no direct reflection happened. A novel testing platform was built for the columnar microstructure after it was machined. The applied testing method can measure the angle between the emergent and incident light. The method lays the condition for the further research. It is shown that the columnar microstructure with no direct reflection can be utilized in laser protection systems.

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.).

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...

78 FR 47011 - Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Unit Testing for Digital Computer Software... revised regulatory guide (RG), revision 1 of RG 1.171, ``Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants.'' This RG endorses American National Standards...

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.

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.

Risk-based Classification of Incidents

NASA Technical Reports Server (NTRS)

Greenwell, William S.; Knight, John C.; Strunk, Elisabeth A.

2003-01-01

As the penetration of software into safety-critical systems progresses, accidents and incidents involving software will inevitably become more frequent. Identifying lessons from these occurrences and applying them to existing and future systems is essential if recurrences are to be prevented. Unfortunately, investigative agencies do not have the resources to fully investigate every incident under their jurisdictions and domains of expertise and thus must prioritize certain occurrences when allocating investigative resources. In the aviation community, most investigative agencies prioritize occurrences based on the severity of their associated losses, allocating more resources to accidents resulting in injury to passengers or extensive aircraft damage. We argue that this scheme is inappropriate because it undervalues incidents whose recurrence could have a high potential for loss while overvaluing fairly straightforward accidents involving accepted risks. We then suggest a new strategy for prioritizing occurrences based on the risk arising from incident recurrence.

PharmARTS: terminology web services for drug safety data coding and retrieval.

PubMed

Alecu, Iulian; Bousquet, Cédric; Degoulet, Patrice; Jaulent, Marie-Christine

2007-01-01

MedDRA and WHO-ART are the terminologies used to encode drug safety reports. The standardisation achieved with these terminologies facilitates: 1) The sharing of safety databases; 2) Data mining for the continuous reassessment of benefit-risk ratio at national or international level or in the pharmaceutical industry. There is some debate about the capacity of these terminologies for retrieving case reports related to similar medical conditions. We have developed a resource that allows grouping similar medical conditions more effectively than WHO-ART and MedDRA. We describe here a software tool facilitating the use of this terminological resource thanks to an RDF framework with support for RDF Schema inferencing and querying. This tool eases coding and data retrieval in drug safety.

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.

Managing Risk in Safety Critical Operations - Lessons Learned from Space Operations

NASA Technical Reports Server (NTRS)

Gonzalez, Steven A.

2002-01-01

The Mission Control Center (MCC) at Johnson Space Center (JSC) has a rich legacy of supporting Human Space Flight operations throughout the Apollo, Shuttle and International Space Station eras. Through the evolution of ground operations and the Mission Control Center facility, NASA has gained a wealth of experience of what it takes to manage the risk in Safety Critical Operations, especially when human life is at risk. The focus of the presentation will be on the processes (training, operational rigor, team dynamics) that enable the JSC/MCC team to be so successful. The presentation will also share the evolution of the Mission Control Center architecture and how the evolution was introduced while managing the risk to the programs supported by the team. The details of the MCC architecture (e.g., the specific software, hardware or tools used in the facility) will not be shared at the conference since it would not give any additional insight as to how risk is managed in Space Operations.

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...

On the Safety of Machine Learning: Cyber-Physical Systems, Decision Sciences, and Data Products.

PubMed

Varshney, Kush R; Alemzadeh, Homa

2017-09-01

Machine learning algorithms increasingly influence our decisions and interact with us in all parts of our daily lives. Therefore, just as we consider the safety of power plants, highways, and a variety of other engineered socio-technical systems, we must also take into account the safety of systems involving machine learning. Heretofore, the definition of safety has not been formalized in a machine learning context. In this article, we do so by defining machine learning safety in terms of risk, epistemic uncertainty, and the harm incurred by unwanted outcomes. We then use this definition to examine safety in all sorts of applications in cyber-physical systems, decision sciences, and data products. We find that the foundational principle of modern statistical machine learning, empirical risk minimization, is not always a sufficient objective. We discuss how four different categories of strategies for achieving safety in engineering, including inherently safe design, safety reserves, safe fail, and procedural safeguards can be mapped to a machine learning context. We then discuss example techniques that can be adopted in each category, such as considering interpretability and causality of predictive models, objective functions beyond expected prediction accuracy, human involvement for labeling difficult or rare examples, and user experience design of software and open data.

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].

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 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.

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

NASA Technical Reports Server (NTRS)

Wetherholt, Martha

2016-01-01

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

Prediction of rodent carcinogenic potential of naturally occurring chemicals in the human diet using high-throughput QSAR predictive modeling

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

Valerio, Luis G.; Arvidson, Kirk B.; Chanderbhan, Ronald F.

2007-07-01

Consistent with the U.S. Food and Drug Administration (FDA) Critical Path Initiative, predictive toxicology software programs employing quantitative structure-activity relationship (QSAR) models are currently under evaluation for regulatory risk assessment and scientific decision support for highly sensitive endpoints such as carcinogenicity, mutagenicity and reproductive toxicity. At the FDA's Center for Food Safety and Applied Nutrition's Office of Food Additive Safety and the Center for Drug Evaluation and Research's Informatics and Computational Safety Analysis Staff (ICSAS), the use of computational SAR tools for both qualitative and quantitative risk assessment applications are being developed and evaluated. One tool of current interest ismore » MDL-QSAR predictive discriminant analysis modeling of rodent carcinogenicity, which has been previously evaluated for pharmaceutical applications by the FDA ICSAS. The study described in this paper aims to evaluate the utility of this software to estimate the carcinogenic potential of small, organic, naturally occurring chemicals found in the human diet. In addition, a group of 19 known synthetic dietary constituents that were positive in rodent carcinogenicity studies served as a control group. In the test group of naturally occurring chemicals, 101 were found to be suitable for predictive modeling using this software's discriminant analysis modeling approach. Predictions performed on these compounds were compared to published experimental evidence of each compound's carcinogenic potential. Experimental evidence included relevant toxicological studies such as rodent cancer bioassays, rodent anti-carcinogenicity studies, genotoxic studies, and the presence of chemical structural alerts. Statistical indices of predictive performance were calculated to assess the utility of the predictive modeling method. Results revealed good predictive performance using this software's rodent carcinogenicity module of over 1200 chemicals, comprised primarily of pharmaceutical, industrial and some natural products developed under an FDA-MDL cooperative research and development agreement (CRADA). The predictive performance for this group of dietary natural products and the control group was 97% sensitivity and 80% concordance. Specificity was marginal at 53%. This study finds that the in silico QSAR analysis employing this software's rodent carcinogenicity database is capable of identifying the rodent carcinogenic potential of naturally occurring organic molecules found in the human diet with a high degree of sensitivity. It is the first study to demonstrate successful QSAR predictive modeling of naturally occurring carcinogens found in the human diet using an external validation test. Further test validation of this software and expansion of the training data set for dietary chemicals will help to support the future use of such QSAR methods for screening and prioritizing the risk of dietary chemicals when actual animal data are inadequate, equivocal, or absent.« less

Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach.

PubMed

Lazic, Stanley E; Edmunds, Nicholas; Pollard, Christopher E

2018-03-01

Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict clinical outcomes and continue to invest in new assays to improve predictions. However, there are many open questions about how to make the best use of available data, combine diverse data, quantify risk, and communicate risk and uncertainty to enable good decisions. The costs of suboptimal decisions are clear: resources are wasted and patients may be put at risk. We argue that Bayesian methods provide answers to all of these problems and use hERG-mediated QT prolongation as a case study. Benefits of Bayesian machine learning models include intuitive probabilistic statements of risk that incorporate all sources of uncertainty, the option to include diverse data and external information, and visualizations that have a clear link between the output from a statistical model and what this means for risk. Furthermore, Bayesian methods are easy to use with modern software, making their adoption for safety screening straightforward. We include R and Python code to encourage the adoption of these methods.

Measuring and improving patient safety through health information technology: The Health IT Safety Framework

PubMed Central

Singh, Hardeep

2016-01-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings. PMID:26369894

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.

Planning the Unplanned Experiment: Towards Assessing the Efficacy of Standards for Safety-Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. M.

2015-01-01

Safe use of software in safety-critical applications requires well-founded means of determining whether software is fit for such use. While software in industries such as aviation has a good safety record, little is known about whether standards for software in safety-critical applications 'work' (or even what that means). It is often (implicitly) argued that software is fit for safety-critical use because it conforms to an appropriate standard. Without knowing whether a standard works, such reliance is an experiment; without carefully collecting assessment data, that experiment is unplanned. To help plan the experiment, we organized a workshop to develop practical ideas for assessing software safety standards. In this paper, we relate and elaborate on the workshop discussion, which revealed subtle but important study design considerations and practical barriers to collecting appropriate historical data and recruiting appropriate experimental subjects. We discuss assessing standards as written and as applied, several candidate definitions for what it means for a standard to 'work,' and key assessment strategies and study techniques and the pros and cons of each. Finally, we conclude with thoughts about the kinds of research that will be required and how academia, industry, and regulators might collaborate to overcome the noted barriers.

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.

Tools Ensure Reliability of Critical Software

NASA Technical Reports Server (NTRS)

2012-01-01

In November 2006, after attempting to make a routine maneuver, NASA's Mars Global Surveyor (MGS) reported unexpected errors. The onboard software switched to backup resources, and a 2-day lapse in communication took place between the spacecraft and Earth. When a signal was finally received, it indicated that MGS had entered safe mode, a state of restricted activity in which the computer awaits instructions from Earth. After more than 9 years of successful operation gathering data and snapping pictures of Mars to characterize the planet's land and weather communication between MGS and Earth suddenly stopped. Months later, a report from NASA's internal review board found the spacecraft's battery failed due to an unfortunate sequence of events. Updates to the spacecraft's software, which had taken place months earlier, were written to the wrong memory address in the spacecraft's computer. In short, the mission ended because of a software defect. Over the last decade, spacecraft have become increasingly reliant on software to carry out mission operations. In fact, the next mission to Mars, the Mars Science Laboratory, will rely on more software than all earlier missions to Mars combined. According to Gerard Holzmann, manager at the Laboratory for Reliable Software (LaRS) at NASA's Jet Propulsion Laboratory (JPL), even the fault protection systems on a spacecraft are mostly software-based. For reasons like these, well-functioning software is critical for NASA. In the same year as the failure of MGS, Holzmann presented a new approach to critical software development to help reduce risk and provide consistency. He proposed The Power of 10: Rules for Developing Safety-Critical Code, which is a small set of rules that can easily be remembered, clearly relate to risk, and allow compliance to be verified. The reaction at JPL was positive, and developers in the private sector embraced Holzmann's ideas.

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...

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.

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.

Technology and Tool Development to Support Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2017-01-01

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

Application of predictive modelling techniques in industry: from food design up to risk assessment.

PubMed

Membré, Jeanne-Marie; Lambert, Ronald J W

2008-11-30

In this communication, examples of applications of predictive microbiology in industrial contexts (i.e. Nestlé and Unilever) are presented which cover a range of applications in food safety from formulation and process design to consumer safety risk assessment. A tailor-made, private expert system, developed to support safe product/process design assessment is introduced as an example of how predictive models can be deployed for use by non-experts. Its use in conjunction with other tools and software available in the public domain is discussed. Specific applications of predictive microbiology techniques are presented relating to investigations of either growth or limits to growth with respect to product formulation or process conditions. An example of a probabilistic exposure assessment model for chilled food application is provided and its potential added value as a food safety management tool in an industrial context is weighed against its disadvantages. The role of predictive microbiology in the suite of tools available to food industry and some of its advantages and constraints are discussed.

Value of Responsive Launch Safety Toolsets

NASA Astrophysics Data System (ADS)

Devoid, Wayne E.

2013-09-01

This paper will discuss the advantages and disadvantages of all-in-one risk assessment toolsets as they are applied to a wide variety of orbital, suborbital, lander, and unmanned vehicles. Toolsets like APT's SafeLab and Horizon, that are designed from the ground up specifically to address ever- changing vehicle and mission parameters, reduce the need for additional software development costs for launch ranges and vehicle manufacturers.

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

Determining the explosion risk level and the explosion hazard area for a group of natural gas wells

NASA Astrophysics Data System (ADS)

Gligor, A.; Petrescu, V.; Deac, C.; Bibu, M.

2016-11-01

Starting from the fact that the natural gas engineering profession is generally associated with a high occupational risk, the current paper aims to help increase the safety of natural gas wells and reduce the risk of work-related accidents, as well as the occurrence of professional illnesses, by applying an assessment method that has proven its efficiency in other industrial areas in combination with a computer-aided design software. More specifically, the paper focuses on two main research directions: assessing the explosion risk for employees working at natural gas wells and indicating areas with a higher explosion hazard by using a modern software that allows their presentation in 3D. The appropriate zoning of industrial areas allows to group the various functional areas function of the probability of the occurrence of a dangerous element, such as an explosive atmosphere and subsequently it allows also to correctly select the electrical and mechanical equipment that will be used in that area, since electrical apparatuses that are otherwise found in normal work environments cannot generally be used in areas with explosion hazard, because of the risk that an electric spark, an electrostatic discharge etc. ignites the explosive atmosphere.

Willingness to use mobile application for smartphone for improving road safety.

PubMed

Cardamone, Angelo Stephen; Eboli, Laura; Forciniti, Carmen; Mazzulla, Gabriella

2016-01-01

In the last few years mobile devices have reached a large amount of consumers in both developed and high-growth world economies. In 2013, 97% of the Italian population owns a mobile phone, and 62% owns a smartphone. Application software for mobile devices is largely proposed to consumers, and several mobile applications were oriented toward the improvement of road safety and road accident risk reduction. In this paper, we describe the results of a survey oriented to preventively investigate on the willingness to receive and/or to give information about road condition by means of mobile devices. Road users were informed about the characteristics of a mobile application, and then they were invited to complete a questionnaire. Experimental data were used for capturing road user attitudes toward the use of the smartphone to improve road safety, and to establish the preferences for the different features of the proposed mobile application. To this end, we choose to use the ordered probit model methodology. We demonstrate that the adopted methodology accounts for the differential impacts of the willingness to receive and/or to give information about road conditions on the overall willingness to receive and/or to give information through an application software for mobile devices.

New risk metrics and mathematical tools for risk analysis: Current and future challenges

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

Skandamis, Panagiotis N., E-mail: pskan@aua.gr; Andritsos, Nikolaos, E-mail: pskan@aua.gr; Psomas, Antonios, E-mail: pskan@aua.gr

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) themore » Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total ‘failure’ that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and “momentary” expressed spoilage and safety level.« less

New risk metrics and mathematical tools for risk analysis: Current and future challenges

NASA Astrophysics Data System (ADS)

Skandamis, Panagiotis N.; Andritsos, Nikolaos; Psomas, Antonios; Paramythiotis, Spyridon

2015-01-01

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total `failure' that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and "momentary" expressed spoilage and safety level.

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.

Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

PubMed

Singh, Hardeep; Sittig, Dean F

2016-04-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Exploring the sociotechnical intersection of patient safety and electronic health record implementation

PubMed Central

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-01-01

Objective The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). Methods We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). Results The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human–computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. Discussion We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Conclusions Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology. PMID:24052536

Exploring the sociotechnical intersection of patient safety and electronic health record implementation.

PubMed

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-02-01

The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology.

Prevalence and predictors of problematic alcohol use, risky sexual practices and other negative consequences associated with alcohol use among safety and security employees in the Western Cape, South Africa.

PubMed

Harker Burnhams, Nadine; Parry, Charles; Laubscher, Ria; London, Leslie

2014-03-04

Harmful alcohol use can compromise worker health and productivity. Persons employed in safety-sensitive occupations are particularly vulnerable to hazardous alcohol use and its associated risks. This study describes the patterns of harmful alcohol use, related HIV risks and risk factors for the harmful use of alcohol among a sample of employees in South Africa working in the safety and security sector. A cross-sectional study that formed the baseline for a clustered randomized control trial was undertaken in 2011. A random sample of 325 employees employed within a safety and security sector of a local municipality in the Western Cape Province of South Africa participated in the study. Data were collected by means of an 18-page self-administered structured questionnaire and analyzed using SAS/STAT software version 9.2. For all significance testing, the F-statistic and p-values are reported. Three hundred and twenty-five employees were surveyed. Findings suggest that more than half (76.1%) of the 78.9% of participants who consumed alcohol engaged in binge drinking, with close to a quarter reporting a CAGE score greater than the cut-off of 2, indicating potentially hazardous drinking patterns. The study further found that employees who use alcohol are more likely to engage in risky sexual practices when under the influence. A favorable drinking climate (p < 0.001) and poor levels of group cohesion (p = 0.009) were significantly correlated to binge drinking. This study identifies alcohol-related behaviors and associated risks in the context of safety-sensitive occupations at the workplace. It suggests that persons employed within such positions are at high risk for developing alcohol-related disorders and for contracting HIV. This study highlights the need for testing a comprehensive package of services designed to prevent hazardous alcohol use among safety and security employees.

International Space Station (ISS) Risk Reduction Activities

NASA Technical Reports Server (NTRS)

Fodroci, Michael

2011-01-01

As the assembly of the ISS nears completion, it is worthwhile to step back and review some of the actions pursued by the Program in recent years to reduce risk and enhance the safety and health of ISS crewmembers, visitors, and space flight participants. While the ISS requirements and initial design were intended to provide the best practicable levels of safety, it is always possible to reduce risk -- given the determination and commitment to do so. The following is a summary of some of the steps taken by the ISS Program Manager, by our International Partners, by hardware and software designers, by operational specialists, and by safety personnel to continuously enhance the safety of the ISS. While decades of work went into developing the ISS requirements, there are many things in a Program like the ISS that can only be learned through actual operational experience. These risk reduction activities can be divided into roughly three categories: (1) Areas that were initially noncompliant which have subsequently been brought into compliance or near compliance (i.e., Micrometeoroid and Orbital Debris [MMOD] protection, acoustics) (2) Areas where initial design requirements were eventually considered inadequate and were subsequently augmented (i.e., Toxicity Level 4 materials, emergency hardware and procedures) (3) Areas where risks were initially underestimated, and have subsequently been addressed through additional mitigation (i.e., Extravehicular Activity [EVA] sharp edges, plasma shock hazards) Due to the hard work and cooperation of many parties working together across the span of nearly a decade, the ISS is now a safer and healthier environment for our crew, in many cases exceeding the risk reduction targets inherent in the intent of the original design. It will provide a safe and stable platform for utilization and discovery.

How technology megatrends are shaping the future of safety, health, and environmental monitoring.

PubMed

Brauch, Rob

2015-05-01

The Safety, Health and Environmental professional will soon be able to choose from a wider number of solutions that incorporate the latest developments in electronics, cellular and wireless communication, sensors, and software, all of which are driven by and are essential components of three "megatrends"--IoT, Big Data, and Social Networking. This will fundamentally alter the way in which we go about collecting information for risk assessment, exposure assessment, and thus how we implement better and more cost-effective solutions for protecting workers' lives and well-being. The more we become aware of these trends and developments, the better we will be able to integrate them into our sampling strategies and analysis methods, which creates greater value from our daily work as safety and health professionals.

Characterizing the nature of home care work and occupational hazards: a developmental intervention study.

PubMed

Markkanen, Pia; Quinn, Margaret; Galligan, Catherine; Sama, Susan; Brouillette, Natalie; Okyere, Daniel

2014-04-01

Home care (HC) aide is the fastest growing occupation, yet job hazards are under-studied. This study documents the context of HC aide work, characterizes occupational safety and health (OSH) hazards, and identifies preventive interventions using qualitative methods. We conducted 12 focus groups among aides and 26 in-depth interviews comprising 15 HC agency, union, and insurance company representatives as well as 11 HC recipients in Massachusetts. All focus groups and interviews were audio-recorded, transcribed, and coded with NVIVO software. Major OSH concerns were musculoskeletal disorders from client care tasks and verbal abuse. Performing tasks beyond specified job duties may be an OSH risk factor. HC aides' safety and clients' safety are closely linked. Client handling devices, client evaluation, care plan development, and training are key interventions for both aides' and clients' safety. Promoting OSH in HC is essential for maintaining a viable workforce. © 2013 Wiley Periodicals, Inc.

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

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.

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.

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

Draugen HSE-case - occupational health risk management

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

Glas, J.J.P.; Kjaer, E.

1996-12-31

The Draugen HSE-Case serves as a risk management tool. Originally, risk management included only major safety hazards to personnel, environment and assets. Work Environment risks such as ergonomics, psycho-social factors and exposure to chemicals and noise, was not given the same attention. The Draugen HSE-Case addresses this weakness and extends all work environment risks. In order to promote line responsibility and commitment, relevant personnel is involved in the Case development. {open_quotes}THESIS{degrees}, a software application, is used to systematize input and to generate reports. The Draugen HSE-case encompasses: HSE risk analyses related to specific activities; Control of risk related to workmore » environment; Established tolerability criteria; Risk reducing measures; Emergency contingency measures; and Requirements for Competence and Follow-up. The development of Draugen HSE-Case is a continuous process. It will serve to minimize the potential of occupational illnesses, raise general awareness, and make occupational health management more cost-effective.« less

The development of a 3D risk analysis method.

PubMed

I, Yet-Pole; Cheng, Te-Lung

2008-05-01

Much attention has been paid to the quantitative risk analysis (QRA) research in recent years due to more and more severe disasters that have happened in the process industries. Owing to its calculation complexity, very few software, such as SAFETI, can really make the risk presentation meet the practice requirements. However, the traditional risk presentation method, like the individual risk contour in SAFETI, is mainly based on the consequence analysis results of dispersion modeling, which usually assumes that the vapor cloud disperses over a constant ground roughness on a flat terrain with no obstructions and concentration fluctuations, which is quite different from the real situations of a chemical process plant. All these models usually over-predict the hazardous regions in order to maintain their conservativeness, which also increases the uncertainty of the simulation results. On the other hand, a more rigorous model such as the computational fluid dynamics (CFD) model can resolve the previous limitations; however, it cannot resolve the complexity of risk calculations. In this research, a conceptual three-dimensional (3D) risk calculation method was proposed via the combination of results of a series of CFD simulations with some post-processing procedures to obtain the 3D individual risk iso-surfaces. It is believed that such technique will not only be limited to risk analysis at ground level, but also be extended into aerial, submarine, or space risk analyses in the near future.

Chicago Sanitary and Ship Canal (CSSC) Marine Safety Risk Assessment

DTIC Science & Technology

2013-12-01

calculation of the rate of loss events and the associated consequences. Further, the selected tool supports a clear understanding of the drivers of failures...spreadsheet software. The event tree has a series of events stated in a success mode, or simply as the occurrence of a phenomenological condition. The...Public | December 2013 of a “transit” (when applicable). As subsequent events occur, there is a branch point, one branch representing success and the

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

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.

Command and Control Software Development Memory Management

NASA Technical Reports Server (NTRS)

Joseph, Austin Pope

2017-01-01

This internship was initially meant to cover the implementation of unit test automation for a NASA ground control project. As is often the case with large development projects, the scope and breadth of the internship changed. Instead, the internship focused on finding and correcting memory leaks and errors as reported by a COTS software product meant to track such issues. Memory leaks come in many different flavors and some of them are more benign than others. On the extreme end a program might be dynamically allocating memory and not correctly deallocating it when it is no longer in use. This is called a direct memory leak and in the worst case can use all the available memory and crash the program. If the leaks are small they may simply slow the program down which, in a safety critical system (a system for which a failure or design error can cause a risk to human life), is still unacceptable. The ground control system is managed in smaller sub-teams, referred to as CSCIs. The CSCI that this internship focused on is responsible for monitoring the health and status of the system. This team's software had several methods/modules that were leaking significant amounts of memory. Since most of the code in this system is safety-critical, correcting memory leaks is a necessity.

Long-Term International Space Station (ISS) Risk Reduction Activities

NASA Astrophysics Data System (ADS)

Fodroci, M. P.; Gafka, G. K.; Lutomski, M. G.; Maher, J. S.

2012-01-01

As the assembly of the ISS nears completion, it is worthwhile to step back and review some of the actions pursued by the Program in recent years to reduce risk and enhance the safety and health of ISS crewmembers, visitors, and space flight participants. While the initial ISS requirements and design were intended to provide the best practicable levels of safety, it is always possible to further reduce risk - given the determination, commitment, and resources to do so. The following is a summary of some of the steps taken by the ISS Program Manager, by our International Partners, by hardware and software designers, by operational specialists, and by safety personnel to continuously enhance the safety of the ISS, and to reduce risk to all crewmembers. While years of work went into the development of ISS requirements, there are many things associated with risk reduction in a Program like the ISS that can only be learned through actual operational experience. These risk reduction activities can be divided into roughly three categories: Areas that were initially noncompliant which have subsequently been brought into compliance or near compliance (i.e., Micrometeoroid and Orbital Debris [MMOD] protection, acoustics) Areas where initial design requirements were eventually considered inadequate and were subsequently augmented (i.e., Toxicity Hazard Level- 4 [THL] materials, emergency procedures, emergency equipment, control of drag-throughs) Areas where risks were initially underestimated, and have subsequently been addressed through additional mitigation (i.e., Extravehicular Activity [EVA] sharp edges, plasma shock hazards) Due to the hard work and cooperation of many parties working together across the span of more than a decade, the ISS is now a safer and healthier environment for our crew, in many cases exceeding the risk reduction targets inherent in the intent of the original design. It will provide a safe and stable platform for utilization and discovery for years to come.

Long-Term International Space Station (ISS) Risk Reduction Activities

NASA Technical Reports Server (NTRS)

Forroci, Michael P.; Gafka, George K.; Lutomski, Michael G.; Maher, Jacilyn S.

2011-01-01

As the assembly of the ISS nears completion, it is worthwhile to step back and review some of the actions pursued by the Program in recent years to reduce risk and enhance the safety and health of ISS crewmembers, visitors, and space flight participants. While the initial ISS requirements and design were intended to provide the best practicable levels of safety, it is always possible to further reduce risk given the determination, commitment, and resources to do so. The following is a summary of some of the steps taken by the ISS Program Manager, by our International Partners, by hardware and software designers, by operational specialists, and by safety personnel to continuously enhance the safety of the ISS, and to reduce risk to all crewmembers. While years of work went into the development of ISS requirements, there are many things associated with risk reduction in a Program like the ISS that can only be learned through actual operational experience. These risk reduction activities can be divided into roughly three categories: Areas that were initially noncompliant which have subsequently been brought into compliance or near compliance (i.e., Micrometeoroid and Orbital Debris [MMOD] protection, acoustics) Areas where initial design requirements were eventually considered inadequate and were subsequently augmented (i.e., Toxicity hazard level-4 materials, emergency procedures, emergency equipment, control of drag-throughs) Areas where risks were initially underestimated, and have subsequently been addressed through additional mitigation (i.e., Extravehicular Activity [EVA] sharp edges, plasma shock hazards). Due to the hard work and cooperation of many parties working together across the span of more than a decade, the ISS is now a safer and healthier environment for our crew, in many cases exceeding the risk reduction targets inherent in the intent of the original design. It will provide a safe and stable platform for utilization and discovery for years to come.

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

Rapid Risk Evaluation (ER2) Using MS Excel Spreadsheet: a Case Study of Fredericton (new Brunswick, Canada)

NASA Astrophysics Data System (ADS)

McGrath, H.; Stefanakis, E.; Nastev, M.

2016-06-01

Conventional knowledge of the flood hazard alone (extent and frequency) is not sufficient for informed decision-making. The public safety community needs tools and guidance to adequately undertake flood hazard risk assessment in order to estimate respective damages and social and economic losses. While many complex computer models have been developed for flood risk assessment, they require highly trained personnel to prepare the necessary input (hazard, inventory of the built environment, and vulnerabilities) and analyze model outputs. As such, tools which utilize open-source software or are built within popular desktop software programs are appealing alternatives. The recently developed Rapid Risk Evaluation (ER2) application runs scenario based loss assessment analyses in a Microsoft Excel spreadsheet. User input is limited to a handful of intuitive drop-down menus utilized to describe the building type, age, occupancy and the expected water level. In anticipation of local depth damage curves and other needed vulnerability parameters, those from the U.S. FEMA's Hazus-Flood software have been imported and temporarily accessed in conjunction with user input to display exposure and estimated economic losses related to the structure and the content of the building. Building types and occupancies representative of those most exposed to flooding in Fredericton (New Brunswick) were introduced and test flood scenarios were run. The algorithm was successfully validated against results from the Hazus-Flood model for the same building types and flood depths.

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2017-03-01

RAVEN is a generic software framework to perform parametric and probabilistic analy- sis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncer- tainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters thatmore » need to be perturbed are accessible by inputs files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused to- ward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN has started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is in- terested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assess- ment capability to RELAP-7, currently under develop-ment at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activates are currently ongoing for coupling RAVEN with soft- ware such as RELAP5-3D, etc. The aim of this document is the explaination of the input requirements, focalizing on the input structure.« less

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

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.

Spinoff 2011

NASA Technical Reports Server (NTRS)

2012-01-01

Topics include: Bioreactors Drive Advances in Tissue Engineering; Tooling Techniques Enhance Medical Imaging; Ventilator Technologies Sustain Critically Injured Patients; Protein Innovations Advance Drug Treatments, Skin Care; Mass Analyzers Facilitate Research on Addiction; Frameworks Coordinate Scientific Data Management; Cameras Improve Navigation for Pilots, Drivers; Integrated Design Tools Reduce Risk, Cost; Advisory Systems Save Time, Fuel for Airlines; Modeling Programs Increase Aircraft Design Safety; Fly-by-Wire Systems Enable Safer, More Efficient Flight; Modified Fittings Enhance Industrial Safety; Simulation Tools Model Icing for Aircraft Design; Information Systems Coordinate Emergency Management; Imaging Systems Provide Maps for U.S. Soldiers; High-Pressure Systems Suppress Fires in Seconds; Alloy-Enhanced Fans Maintain Fresh Air in Tunnels; Control Algorithms Charge Batteries Faster; Software Programs Derive Measurements from Photographs; Retrofits Convert Gas Vehicles into Hybrids; NASA Missions Inspire Online Video Games; Monitors Track Vital Signs for Fitness and Safety; Thermal Components Boost Performance of HVAC Systems; World Wind Tools Reveal Environmental Change; Analyzers Measure Greenhouse Gasses, Airborne Pollutants; Remediation Technologies Eliminate Contaminants; Receivers Gather Data for Climate, Weather Prediction; Coating Processes Boost Performance of Solar Cells; Analyzers Provide Water Security in Space and on Earth; Catalyst Substrates Remove Contaminants, Produce Fuel; Rocket Engine Innovations Advance Clean Energy; Technologies Render Views of Earth for Virtual Navigation; Content Platforms Meet Data Storage, Retrieval Needs; Tools Ensure Reliability of Critical Software; Electronic Handbooks Simplify Process Management; Software Innovations Speed Scientific Computing; Controller Chips Preserve Microprocessor Function; Nanotube Production Devices Expand Research Capabilities; Custom Machines Advance Composite Manufacturing; Polyimide Foams Offer Superior Insulation; Beam Steering Devices Reduce Payload Weight; Models Support Energy-Saving Microwave Technologies; Materials Advance Chemical Propulsion Technology; and High-Temperature Coatings Offer Energy Savings.

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...

Stochastic Modeling of Radioactive Material Releases

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

Andrus, Jason; Pope, Chad

2015-09-01

Nonreactor nuclear facilities operated under the approval authority of the U.S. Department of Energy use unmitigated hazard evaluations to determine if potential radiological doses associated with design basis events challenge or exceed dose evaluation guidelines. Unmitigated design basis events that sufficiently challenge dose evaluation guidelines or exceed the guidelines for members of the public or workers, merit selection of safety structures, systems, or components or other controls to prevent or mitigate the hazard. Idaho State University, in collaboration with Idaho National Laboratory, has developed a portable and simple to use software application called SODA (Stochastic Objective Decision-Aide) that stochastically calculatesmore » the radiation dose associated with hypothetical radiological material release scenarios. Rather than producing a point estimate of the dose, SODA produces a dose distribution result to allow a deeper understanding of the dose potential. SODA allows users to select the distribution type and parameter values for all of the input variables used to perform the dose calculation. SODA then randomly samples each distribution input variable and calculates the overall resulting dose distribution. In cases where an input variable distribution is unknown, a traditional single point value can be used. SODA was developed using the MATLAB coding framework. The software application has a graphical user input. SODA can be installed on both Windows and Mac computers and does not require MATLAB to function. SODA provides improved risk understanding leading to better informed decision making associated with establishing nuclear facility material-at-risk limits and safety structure, system, or component selection. It is important to note that SODA does not replace or compete with codes such as MACCS or RSAC, rather it is viewed as an easy to use supplemental tool to help improve risk understanding and support better informed decisions. The work was funded through a grant from the DOE Nuclear Safety Research and Development Program.« less

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.

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.

Radioactive dispersion analysis for hypothetical nuclear power plant (NPP) candidate site in Perak state, Malaysia

NASA Astrophysics Data System (ADS)

Shamsuddin, Shazmeen Daniar; Basri, Nor Afifah; Omar, Nurlyana; Koh, Meng-Hock; Ramli, Ahmad Termizi; Saridan Wan Hassan, Wan Muhamad

2017-10-01

Malaysia is planning to build a nuclear power plant (NPP) by 2030 to diversify the national electricity supply and resources. Selection of an NPP site must consider various factors, especially nuclear safety consideration to fulfil the nuclear safety objectives. Environmental Risk Assessment Analysis is a part of safety requirements by the International Atomic Energy Agency (IAEA) prior to the NPP commissioning process. Risk Assessments Analysis (RIA) is compulsory for the NPP site evaluation. One of RIA methods are Radioactive Dispersion Analysis using probabilistic risk analysis software. It is also important to perform studies to estimate the impact to the neighbouring population in the case of a nuclear accident at the power plant. In the present work, aimed to study the impact of a hypothetical nuclear accident by simulating the dispersion pattern of radionuclides originated from a candidate site at Manjung, Perak. The work has been performed using the HotSpot Health Physics codes. Two types of radionuclides have been considered namely 137Cs and 131I. In calculations, the initial concentration of radioactive materials of Fukushima Daiichi accident data are used which are 2.06 x 1016 Bq and 1.68 x 1017 Bq respectively for the two radionuclides. The result shows that the dispersion distance obtained from both software are not the same. It shows that 137Cs and 131I can be dispersed as far as 16 km and 80 km away from the site during radiological accident respectively, reaching major towns in Perak. Using HOTSPOT, the estimated total effective dose equivalent (TEDE) for 137Cs and 131I at major towns in Perak such as Lumut and Sitiawan are 1.2 mSv and 9.9 mSv. As for Taiping, Ipoh, Kampar, and Teluk Intan the estimated TEDE is around 0.2 mSv and 1.6 mSv respectively. In conclusion, the dispersion can reach as far as 80 km from the site. However, estimated annual effective dose is not more than 1 mSv limit, which is considered acceptable in the point of view of radiological health risk for human and the environment.

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.

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;

Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis.

PubMed

von Keyserlingk, Camilla; Hopkins, Robert; Anastasilakis, Athanasios; Toulis, Konstantinos; Goeree, Ron; Tarride, Jean-Eric; Xie, Feng

2011-10-01

Clinical trials indicate that denosumab could be a potential treatment for postmenopausal osteoporosis. The objective of this meta-analysis was to assess the clinical efficacy and safety of offering denosumab to postmenopausal women with low bone mass. Data sources included MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) from inception to February 3, 2010 and bibliographies of reviews. Randomized controlled trials comparing the efficacy and safety of denosumab to placebo for treatment of low bone mass (low bone mineral density or osteoporosis) in postmenopausal women were selected. Two reviewers independently abstracted data on study general characteristics and outcomes. Review Manager 5.0 software was used for data syntheses and meta-analysis. The database search revealed 4 studies (comprising 8864 patients randomized) that met the inclusion criteria and contributed to some or all of the meta-analysis outcomes. Relative risk (95% CI) of fractures for the denosumab compared with placebo group was 0.58 (0.52 to 0.66); relative risk (95% CI) of serious adverse events was 1.33 (0.83 to 2.14); relative risk (95% CI) of serious adverse events related to infection was 2.10 (0.64 to 6.90); relative risk (95% CI) of neoplasm was 1.11 (0.91 to 1.36); relative risk (95% CI) of study discontinuation due to adverse events was 1.10 (0.83 to 1.47); and relative risk (95% CI) of death was 0.78 (0.57 to 1.06). Findings remained robust to sensitivity analyses. Our analysis found a significant reduction in relative fracture risk in the denosumab compared with the placebo group. Copyright © 2011 Elsevier Inc. All rights reserved.

Risk Management Implementation Tool

NASA Technical Reports Server (NTRS)

Wright, Shayla L.

2004-01-01

Continuous Risk Management (CM) is a software engineering practice with processes, methods, and tools for managing risk in a project. It provides a controlled environment for practical decision making, in order to assess continually what could go wrong, determine which risk are important to deal with, implement strategies to deal with those risk and assure the measure effectiveness of the implemented strategies. Continuous Risk Management provides many training workshops and courses to teach the staff how to implement risk management to their various experiments and projects. The steps of the CRM process are identification, analysis, planning, tracking, and control. These steps and the various methods and tools that go along with them, identification, and dealing with risk is clear-cut. The office that I worked in was the Risk Management Office (RMO). The RMO at NASA works hard to uphold NASA s mission of exploration and advancement of scientific knowledge and technology by defining and reducing program risk. The RMO is one of the divisions that fall under the Safety and Assurance Directorate (SAAD). I worked under Cynthia Calhoun, Flight Software Systems Engineer. My task was to develop a help screen for the Continuous Risk Management Implementation Tool (RMIT). The Risk Management Implementation Tool will be used by many NASA managers to identify, analyze, track, control, and communicate risks in their programs and projects. The RMIT will provide a means for NASA to continuously assess risks. The goals and purposes for this tool is to provide a simple means to manage risks, be used by program and project managers throughout NASA for managing risk, and to take an aggressive approach to advertise and advocate the use of RMIT at each NASA center.

A qualitative investigation of Hispanic construction worker perspectives on factors impacting worksite safety and risk

PubMed Central

2011-01-01

Background Hispanic workers have higher rates of injury and death on construction worksites than workers of other ethnicities. Language barriers and cultural differences have been hypothesized as reasons behind the disparate rates. Methods We conducted two series of focus groups with union and non-union Hispanic construction workers to ask them about their perceptions of the causes for the unequal rates. Spanish transcripts were translated and coded in QSR NVivo software for common themes. Results Workers reported a difficult work environment characterized by supervisor pressure, competition for jobs and intimidation with regard to raising safety concerns. Language barriers or cultural factors were not strongly represented as causative factors behind the rates. Conclusion The results of this study have informed the development of an intervention trial that seeks to prevent falls and silica dust exposure by training contractors employing Hispanic construction workers in the elements of safety leadership, including building respect for their Hispanic workers and facilitating their participation in a safety program. PMID:21962128

77 FR 50726 - Software Requirement Specifications for Digital Computer Software and Complex Electronics Used in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Computer Software and Complex Electronics Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear...-1209, ``Software Requirement Specifications for Digital Computer Software and Complex Electronics used... Electronics Engineers (ANSI/IEEE) Standard 830-1998, ``IEEE Recommended Practice for Software Requirements...

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.

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.

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.

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.

Physical and numerical modeling of hydrophysical proceses on the site of underwater pipelines

NASA Astrophysics Data System (ADS)

Garmakova, M. E.; Degtyarev, V. V.; Fedorova, N. N.; Shlychkov, V. A.

2018-03-01

The paper outlines issues related to ensuring the exploitation safety of underwater pipelines that are at risk of accidents. The performed research is based on physical and mathematical modeling of local bottom erosion in the area of pipeline location. The experimental studies were performed on the basis of the Hydraulics Laboratory of the Department of Hydraulic Engineering Construction, Safety and Ecology of NSUACE (Sibstrin). In the course of physical experiments it was revealed that the intensity of the bottom soil reforming depends on the deepening of the pipeline. The ANSYS software has been used for numerical modeling. The process of erosion of the sandy bottom was modeled under the pipeline. Comparison of computational results at various mass flow rates was made.

Using mental mapping to unpack perceived cycling risk.

PubMed

Manton, Richard; Rau, Henrike; Fahy, Frances; Sheahan, Jerome; Clifford, Eoghan

2016-03-01

Cycling is the most energy-efficient mode of transport and can bring extensive environmental, social and economic benefits. Research has highlighted negative perceptions of safety as a major barrier to the growth of cycling. Understanding these perceptions through the application of novel place-sensitive methodological tools such as mental mapping could inform measures to increase cyclist numbers and consequently improve cyclist safety. Key steps to achieving this include: (a) the design of infrastructure to reduce actual risks and (b) targeted work on improving safety perceptions among current and future cyclists. This study combines mental mapping, a stated-preference survey and a transport infrastructure inventory to unpack perceptions of cycling risk and to reveal both overlaps and discrepancies between perceived and actual characteristics of the physical environment. Participants translate mentally mapped cycle routes onto hard-copy base-maps, colour-coding road sections according to risk, while a transport infrastructure inventory captures the objective cycling environment. These qualitative and quantitative data are matched using Geographic Information Systems and exported to statistical analysis software to model the individual and (infra)structural determinants of perceived cycling risk. This method was applied to cycling conditions in Galway City (Ireland). Participants' (n=104) mental maps delivered data-rich perceived safety observations (n=484) and initial comparison with locations of cycling collisions suggests some alignment between perception and reality, particularly relating to danger at roundabouts. Attributing individual and (infra)structural characteristics to each observation, a Generalised Linear Mixed Model statistical analysis identified segregated infrastructure, road width, the number of vehicles as well as gender and cycling experience as significant, and interactions were found between individual and infrastructural variables. The paper concludes that mental mapping is a highly useful tool for assessing perceptions of cycling risk with a strong visual aspect and significant potential for public participation. This distinguishes it from more traditional cycling safety assessment tools that focus solely on the technical assessment of cycling infrastructure. Further development of online mapping tools is recommended as part of bicycle suitability measures to engage cyclists and the general public and to inform 'soft' and 'hard' cycling policy responses. Copyright © 2015 Elsevier Ltd. All rights reserved.

Reducing Risk in DoD Software-Intensive Systems Development

DTIC Science & Technology

2016-03-01

intensive systems development risk. This research addresses the use of the Technical Readiness Assessment (TRA) using the nine-level software Technology...The software TRLs are ineffective in reducing technical risk for the software component development. • Without the software TRLs, there is no...effective method to perform software TRA or reduce the technical development risk. The software component will behave as a new, untried technology in nearly

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.

Automated Risk Assessment for Stroke in Atrial Fibrillation (AURAS-AF)--an automated software system to promote anticoagulation and reduce stroke risk: study protocol for a cluster randomised controlled trial.

PubMed

Holt, Tim A; Fitzmaurice, David A; Marshall, Tom; Fay, Matthew; Qureshi, Nadeem; Dalton, Andrew R H; Hobbs, F D Richard; Lasserson, Daniel S; Kearley, Karen; Hislop, Jenny; Jin, Jing

2013-11-13

Patients with atrial fibrillation (AF) are at significantly increased risk of stroke. Oral anticoagulants (OACs) substantially reduce this risk, with gains seen across the spectrum of baseline risk. Despite the benefit to patients, OAC prescribing remains suboptimal in the United Kingdom (UK). We will investigate whether an automated software system, operating within primary care electronic medical records, can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment. We will conduct a cluster randomised controlled trial, involving general practices using the Egton Medical Information Systems (EMIS) Web clinical system. We will randomise practices to use an electronic software tool or to continue with usual care. The tool will a) produce (and continually refresh) a list of patients with AF who are eligible for OAC therapy--practices will invite these patients to discuss therapy at the start of the trial--and b) generate electronic screen reminders in the medical records of those eligible, appearing throughout the trial. The software will run for 6 months in 23 intervention practices. A total of 23 control practices will manage their AF register in line with the usual care offered. The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months. Secondary outcomes are incidence of stroke, transient ischaemic attack, other major thromboembolism, major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample--those deemed eligible for OACs. We will conduct a process evaluation in parallel with the randomised trial. We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice, including its time implications. AURAS-AF will investigate whether a simple intervention, using electronic primary care records, can improve OAC uptake in a high risk group for stroke. Given previous concerns about safety, especially surrounding inappropriate prescribing, we will also examine whether electronic reminders safely impact care in this clinical area. http://ISRCTN 55722437.

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.

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.

Finite element analysis of container ship's cargo hold using ANSYS and POSEIDON software

NASA Astrophysics Data System (ADS)

Tanny, Tania Tamiz; Akter, Naznin; Amin, Osman Md.

2017-12-01

Nowadays ship structural analysis has become an integral part of the preliminary ship design providing further support for the development and detail design of ship structures. Structural analyses of container ship's cargo holds are carried out for the balancing of their safety and capacity, as those ships are exposed to the high risk of structural damage during voyage. Two different design methodologies have been considered for the structural analysis of a container ship's cargo hold. One is rule-based methodology and the other is a more conventional software based analyses. The rule based analysis is done by DNV-GL's software POSEIDON and the conventional package based analysis is done by ANSYS structural module. Both methods have been applied to analyze some of the mechanical properties of the model such as total deformation, stress-strain distribution, Von Mises stress, Fatigue etc., following different design bases and approaches, to indicate some guidance's for further improvements in ship structural design.

Vulnerabilities in GSM technology and feasibility of selected attacks

NASA Astrophysics Data System (ADS)

Voznak, M.; Prokes, M.; Sevcik, L.; Frnda, J.; Toral-Cruz, Homer; Jakovlev, Sergej; Fazio, Peppino; Mehic, M.; Mikulec, M.

2015-05-01

Global System for Mobile communication (GSM) is the most widespread technology for mobile communications in the world and serving over 7 billion users. Since first publication of system documentation there has been notified a potential safety problem's occurrence. Selected types of attacks, based on the analysis of the technical feasibility and the degree of risk of these weaknesses, were implemented and demonstrated in laboratory of the VSB-Technical University of Ostrava, Czech Republic. These vulnerabilities were analyzed and afterwards possible attacks were described. These attacks were implemented using open-source tools, software programmable radio USRP (Universal Software RadioPeripheral) and DVB-T (Digital Video Broadcasting - Terrestrial) receiver. GSM security architecture is being scrutinized since first public releases of its specification mainly pointing out weaknesses in authentication and ciphering mechanisms. This contribution also summarizes practically proofed and used scenarios that are performed using opensource software tools and variety of scripts mostly written in Python. Main goal of this paper is in analyzing security issues in GSM network and practical demonstration of selected attacks.

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

Comparison between herbal medicine and fluoxetine for depression: a systematic review of randomized controlled trials.

PubMed

Ren, Yi; Zhu, Chenjun; Wu, Jianjun; Zheng, Ruwen; Cao, Huijaun

2015-10-01

To evaluate the effectiveness and safety of Chinese herbal medicine (CHM) versus fluoxetine on depression. A systematic review of randomized controlled trials (RCTs). RCT with two parallel groups that compared CHM and fluoxetine on treatment of depression with reported decreased Hamilton Depression Scale (HAMD) and adverse events during treatment were included after searching through six electric-databases. The methodological quality of RCTs was assessed according to the Cochrane risk of bias tool. Meta-analysis was conducted using RevMan 5.3 software with pooled mean difference (MD) or risk ratio (RR) and their 95% confidence interval (CI) if no significant heterogeneity was detected. A SOF table was generated using GRADEPro software to evaluate the overall quality of the evidence. Twenty-six trials with 3294 participants were included in the review. Most of them had high risk of bias during conducting and reporting. The results achieved weak evidence which showed CHM had similar effect to fluoxetine (20mg/day) on relieving depression according to HAMD assessment (for primary depression: MD=-0.08, 95%CI -0.98-0.82; for secondary depression: MD=-0.36, 95%CI -1.55-0.83), but fewer incidences of adverse events than the drug (for primary depression: RR=0.31, 95%CI 0.17-0.59; for post-stroke depression: RR=0.04, 95%CI 0.00-0.25). No serious adverse event was found in neither CHM nor fluoxetine group. Due to the poor quality of included trials and the potential publication bias of this review, no confirmed conclusion could be draw to evaluate the effectiveness and safety of CHM for depression compared with fluoxetine. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Model for Assessing the Liability of Seemingly Correct Software

NASA Technical Reports Server (NTRS)

Voas, Jeffrey M.; Voas, Larry K.; Miller, Keith W.

1991-01-01

Current research on software reliability does not lend itself to quantitatively assessing the risk posed by a piece of life-critical software. Black-box software reliability models are too general and make too many assumptions to be applied confidently to assessing the risk of life-critical software. We present a model for assessing the risk caused by a piece of software; this model combines software testing results and Hamlet's probable correctness model. We show how this model can assess software risk for those who insure against a loss that can occur if life-critical software fails.

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

ASSIP Study of Real-Time Safety-Critical Embedded Software-Intensive System Engineering Practices

DTIC Science & Technology

2008-02-01

and assessment 2. product engineering processes 3. tooling processes 6 | CMU/SEI-2008-SR-001 Slide 1 Process Standards IEC/ ISO 12207 Software...and technical effort to align with 12207 IEC/ ISO 15026 System & Software Integrity Levels Generic Safety SAE ARP 4754 Certification Considerations...Process Frameworks in revision – ISO 9001, ISO 9004 – ISO 15288/ ISO 12207 harmonization – RTCA DO-178B, MOD Standard UK 00-56/3, … • Methods & Tools

Women's safety alerts in maternity care: is speaking up enough?

PubMed

Rance, Susanna; McCourt, Christine; Rayment, Juliet; Mackintosh, Nicola; Carter, Wendy; Watson, Kylie; Sandall, Jane

2013-04-01

Patients' contributions to safety include speaking up about their perceptions of being at risk. Previous studies have found that dismissive responses from staff discouraged patients from speaking up. A Care Quality Commission investigation of a maternity service where serious incidents occurred found evidence that women had routinely been ignored and left alone in labour. Women using antenatal services hesitated to raise concerns that they felt staff might consider irrelevant. The Birthplace in England programme, which investigated the quality and safety of different places of birth for 'low-risk' women, included a qualitative organisational case study in four NHS Trusts. The authors collected documentary, observational and interview data from March to December 2010 including interviews with 58 postnatal women. A framework approach was combined with inductive analysis using NVivo8 software. Speaking up, defined as insistent and vehement communication when faced with failure by staff to listen and respond, was an unexpected finding mentioned in half the women's interviews. Fourteen women reported raising alerts about safety issues they felt to be urgent. The presence of a partner or relative was a facilitating factor for speaking up. Several women described distress and harm that ensued from staff failing to listen. Women are speaking up, but this is not enough: organisation-focused efforts are required to improve staff response. Further research is needed in maternity services and in acute and general healthcare on the effectiveness of safety-promoting interventions, including real-time patient feedback, patient toolkits and patient-activated rapid response calls.

Aerospace safety advisory panel

NASA Technical Reports Server (NTRS)

1995-01-01

The Aerospace Safety Advisory Panel (ASAP) monitored NASA's activities and provided feedback to the NASA Administrator, other NASA officials and Congress throughout the year. Particular attention was paid to the Space Shuttle, its launch processing and planned and potential safety improvements. The Panel monitored Space Shuttle processing at the Kennedy Space Center (KSC) and will continue to follow it as personnel reductions are implemented. There is particular concern that upgrades in hardware, software, and operations with the potential for significant risk reduction not be overlooked due to the extraordinary budget pressures facing the agency. The authorization of all of the Space Shuttle Main Engine (SSME) Block II components portends future Space Shuttle operations at lower risk levels and with greater margins for handling unplanned ascent events. Throughout the year, the Panel attempted to monitor the safety activities related to the Russian involvement in both space and aeronautics programs. This proved difficult as the working relationships between NASA and the Russians were still being defined as the year unfolded. NASA's concern for the unique safety problems inherent in a multi-national endeavor appears appropriate. Actions are underway or contemplated which should be capable of identifying and rectifying problem areas. The balance of this report presents 'Findings and Recommendations' (Section 2), 'Information in Support of Findings and Recommendations' (Section 3) and Appendices describing Panel membership, the NASA response to the March 1994 ASAP report, and a chronology of the panel's activities during the reporting period (Section 4).

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.

Software Risk Identification for Interplanetary Probes

NASA Technical Reports Server (NTRS)

Dougherty, Robert J.; Papadopoulos, Periklis E.

2005-01-01

The need for a systematic and effective software risk identification methodology is critical for interplanetary probes that are using increasingly complex and critical software. Several probe failures are examined that suggest more attention and resources need to be dedicated to identifying software risks. The direct causes of these failures can often be traced to systemic problems in all phases of the software engineering process. These failures have lead to the development of a practical methodology to identify risks for interplanetary probes. The proposed methodology is based upon the tailoring of the Software Engineering Institute's (SEI) method of taxonomy-based risk identification. The use of this methodology will ensure a more consistent and complete identification of software risks in these probes.

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.

In silico toxicology for the pharmaceutical sciences

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

Valerio, Luis G., E-mail: Luis.Valerio@fda.hhs.go

2009-12-15

The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy ofmore » in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical prediction of human drug metabolism, mechanisms of action for pharmaceuticals, and newer models for predicting human adverse effects. How accurate are these approaches is both a statistical issue and challenge in toxicology. In this review, fundamental concepts and the current capabilities and limitations of this technology will be critically addressed.« less

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.

Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions

PubMed Central

Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R

2005-01-01

Background: Until recently, the preparation of paediatric parenteral nutrition formulations in our institution included re-transcription and manual compounding of the mixture. Although no significant clinical problems have occurred, re-engineering of this high risk activity was undertaken to improve its safety. Several changes have been implemented including new prescription software, direct recording on a server, automatic printing of the labels, and creation of a file used to pilot a BAXA MM 12 automatic compounder. The objectives of this study were to compare the risks associated with the old and new processes, to quantify the improved safety with the new process, and to identify the major residual risks. Methods: A failure modes, effects, and criticality analysis (FMECA) was performed by a multidisciplinary team. A cause-effect diagram was built, the failure modes were defined, and the criticality index (CI) was determined for each of them on the basis of the likelihood of occurrence, the severity of the potential effect, and the detection probability. The CIs for each failure mode were compared for the old and new processes and the risk reduction was quantified. Results: The sum of the CIs of all 18 identified failure modes was 3415 for the old process and 1397 for the new (reduction of 59%). The new process reduced the CIs of the different failure modes by a mean factor of 7. The CI was smaller with the new process for 15 failure modes, unchanged for two, and slightly increased for one. The greatest reduction (by a factor of 36) concerned re-transcription errors, followed by readability problems (by a factor of 30) and chemical cross contamination (by a factor of 10). The most critical steps in the new process were labelling mistakes (CI 315, maximum 810), failure to detect a dosage or product mistake (CI 288), failure to detect a typing error during the prescription (CI 175), and microbial contamination (CI 126). Conclusions: Modification of the process resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities. PMID:15805453

Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions.

PubMed

Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R E

2005-04-01

Until recently, the preparation of paediatric parenteral nutrition formulations in our institution included re-transcription and manual compounding of the mixture. Although no significant clinical problems have occurred, re-engineering of this high risk activity was undertaken to improve its safety. Several changes have been implemented including new prescription software, direct recording on a server, automatic printing of the labels, and creation of a file used to pilot a BAXA MM 12 automatic compounder. The objectives of this study were to compare the risks associated with the old and new processes, to quantify the improved safety with the new process, and to identify the major residual risks. A failure modes, effects, and criticality analysis (FMECA) was performed by a multidisciplinary team. A cause-effect diagram was built, the failure modes were defined, and the criticality index (CI) was determined for each of them on the basis of the likelihood of occurrence, the severity of the potential effect, and the detection probability. The CIs for each failure mode were compared for the old and new processes and the risk reduction was quantified. The sum of the CIs of all 18 identified failure modes was 3415 for the old process and 1397 for the new (reduction of 59%). The new process reduced the CIs of the different failure modes by a mean factor of 7. The CI was smaller with the new process for 15 failure modes, unchanged for two, and slightly increased for one. The greatest reduction (by a factor of 36) concerned re-transcription errors, followed by readability problems (by a factor of 30) and chemical cross contamination (by a factor of 10). The most critical steps in the new process were labelling mistakes (CI 315, maximum 810), failure to detect a dosage or product mistake (CI 288), failure to detect a typing error during the prescription (CI 175), and microbial contamination (CI 126). Modification of the process resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities.

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.

Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

PubMed

Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

2008-07-01

The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

Work-related stress risk assessment in Italy: a methodological proposal adapted to regulatory guidelines.

PubMed

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-06-01

Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

Work-Related Stress Risk Assessment in Italy: A Methodological Proposal Adapted to Regulatory Guidelines

PubMed Central

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-01-01

Background Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. Methods After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. Results We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. Conclusion This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons. PMID:23961332

Software And Systems Engineering Risk Management

DTIC Science & Technology

2010-04-01

RSKM 2004 COSO Enterprise RSKM Framework 2006 ISO/IEC 16085 Risk Management Process 2008 ISO/IEC 12207 Software Lifecycle Processes 2009 ISO/IEC...1 Software And Systems Engineering Risk Management John Walz VP Technical and Conferences Activities, IEEE Computer Society Vice-Chair Planning...Software & Systems Engineering Standards Committee, IEEE Computer Society US TAG to ISO TMB Risk Management Working Group Systems and Software

A CMMI-based approach for medical software project life cycle study.

PubMed

Chen, Jui-Jen; Su, Wu-Chen; Wang, Pei-Wen; Yen, Hung-Chi

2013-01-01

In terms of medical techniques, Taiwan has gained international recognition in recent years. However, the medical information system industry in Taiwan is still at a developing stage compared with the software industries in other nations. In addition, systematic development processes are indispensable elements of software development. They can help developers increase their productivity and efficiency and also avoid unnecessary risks arising during the development process. Thus, this paper presents an application of Light-Weight Capability Maturity Model Integration (LW-CMMI) to Chang Gung Medical Research Project (CMRP) in the Nuclear medicine field. This application was intended to integrate user requirements, system design and testing of software development processes into three layers (Domain, Concept and Instance) model. Then, expressing in structural System Modeling Language (SysML) diagrams and converts part of the manual effort necessary for project management maintenance into computational effort, for example: (semi-) automatic delivery of traceability management. In this application, it supports establishing artifacts of "requirement specification document", "project execution plan document", "system design document" and "system test document", and can deliver a prototype of lightweight project management tool on the Nuclear Medicine software project. The results of this application can be a reference for other medical institutions in developing medical information systems and support of project management to achieve the aim of patient safety.

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.

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

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...

Dynamic Positioning System (DPS) Risk Analysis Using Probabilistic Risk Assessment (PRA)

NASA Technical Reports Server (NTRS)

Thigpen, Eric B.; Boyer, Roger L.; Stewart, Michael A.; Fougere, Pete

2017-01-01

The National Aeronautics and Space Administration (NASA) Safety & Mission Assurance (S&MA) directorate at the Johnson Space Center (JSC) has applied its knowledge and experience with Probabilistic Risk Assessment (PRA) to projects in industries ranging from spacecraft to nuclear power plants. PRA is a comprehensive and structured process for analyzing risk in complex engineered systems and/or processes. The PRA process enables the user to identify potential risk contributors such as, hardware and software failure, human error, and external events. Recent developments in the oil and gas industry have presented opportunities for NASA to lend their PRA expertise to both ongoing and developmental projects within the industry. This paper provides an overview of the PRA process and demonstrates how this process was applied in estimating the probability that a Mobile Offshore Drilling Unit (MODU) operating in the Gulf of Mexico and equipped with a generically configured Dynamic Positioning System (DPS) loses location and needs to initiate an emergency disconnect. The PRA described in this paper is intended to be generic such that the vessel meets the general requirements of an International Maritime Organization (IMO) Maritime Safety Committee (MSC)/Circ. 645 Class 3 dynamically positioned vessel. The results of this analysis are not intended to be applied to any specific drilling vessel, although provisions were made to allow the analysis to be configured to a specific vessel if required.

Sun damage in ultraviolet photographs correlates with phenotypic melanoma risk factors in 12-year-old children.

PubMed

Gamble, Ryan G; Asdigian, Nancy L; Aalborg, Jenny; Gonzalez, Victoria; Box, Neil F; Huff, Laura S; Barón, Anna E; Morelli, Joseph G; Mokrohisky, Stefan T; Crane, Lori A; Dellavalle, Robert P

2012-10-01

Ultraviolet (UV) photography has been used to motivate sun safety in behavioral interventions. The relationship between sun damage shown in UV photographs and melanoma risk has not been systematically investigated. To examine the relationship between severity of sun damage in UV photographs and phenotypic melanoma risk factors in children. UV, standard visible and cross-polarized photographs were recorded for 585 children. Computer software quantified sun damage. Full-body nevus counts, skin color by colorimetry, facial freckling, hair and eye color were collected in skin examinations. Demographic data were collected in telephone interviews of parents. Among 12-year-old children, sun damage shown in UV photographs correlated with phenotypic melanoma risk factors. Sun damage was greatest for children who were non-Hispanic white and those who had red hair, blue eyes, increased facial freckling, light skin and greater number of nevi (all P values < .001). Results were similar for standard visible and cross-polarized photographs. Freckling was the strongest predictor of sun damage in visible and UV photographs. All other phenotypic melanoma risk factors were also predictors for the UV photographs. Differences in software algorithms used to score the photographs could produce different results. UV photographs portray more sun damage in children with higher risk for melanoma based on phenotype. Therefore sun protection interventions targeting those with greater sun damage on UV photographs will target those at higher melanoma risk. This study establishes reference ranges dermatologists can use to assess sun damage in their pediatric patients. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

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.

Newest Developments in the German Explosive Safety Quantitative Risk Analysis Software (ESQRA-GE)

DTIC Science & Technology

2010-07-01

Joule is shown if the density exceeds one over 56 m ². For both densities the fragments are considered that pass through a specified volume element. An...maximum velocity for each angle interval: ( , )fragN f m and 0 max ( ).fragv f  (5) We use a barrel filled with water to determine the...matrix. We employ characteristic quantities as mass, momentum and energy of the fragment matrix defined as , ijfm r c M m  , (6) , ij ifm r

NSR&D Program Fiscal Year 2015 Funded Research Stochastic Modeling of Radioactive Material Releases Final Report

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

Andrus, Jason P.; Pope, Chad; Toston, Mary

2016-12-01

Nonreactor nuclear facilities operating under the approval authority of the U.S. Department of Energy use unmitigated hazard evaluations to determine if potential radiological doses associated with design basis events challenge or exceed dose evaluation guidelines. Unmitigated design basis events that sufficiently challenge dose evaluation guidelines or exceed the guidelines for members of the public or workers, merit selection of safety structures, systems, or components or other controls to prevent or mitigate the hazard. Idaho State University, in collaboration with Idaho National Laboratory, has developed a portable and simple to use software application called SODA (Stochastic Objective Decision-Aide) that stochastically calculatesmore » the radiation dose distribution associated with hypothetical radiological material release scenarios. Rather than producing a point estimate of the dose, SODA produces a dose distribution result to allow a deeper understanding of the dose potential. SODA allows users to select the distribution type and parameter values for all of the input variables used to perform the dose calculation. Users can also specify custom distributions through a user defined distribution option. SODA then randomly samples each distribution input variable and calculates the overall resulting dose distribution. In cases where an input variable distribution is unknown, a traditional single point value can be used. SODA, developed using the MATLAB coding framework, has a graphical user interface and can be installed on both Windows and Mac computers. SODA is a standalone software application and does not require MATLAB to function. SODA provides improved risk understanding leading to better informed decision making associated with establishing nuclear facility material-at-risk limits and safety structure, system, or component selection. It is important to note that SODA does not replace or compete with codes such as MACCS or RSAC; rather it is viewed as an easy to use supplemental tool to help improve risk understanding and support better informed decisions. The SODA development project was funded through a grant from the DOE Nuclear Safety Research and Development Program.« less

NSR&D Program Fiscal Year 2015 Funded Research Stochastic Modeling of Radioactive Material Releases Final Report

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

Andrus, Jason P.; Pope, Chad; Toston, Mary

Nonreactor nuclear facilities operating under the approval authority of the U.S. Department of Energy use unmitigated hazard evaluations to determine if potential radiological doses associated with design basis events challenge or exceed dose evaluation guidelines. Unmitigated design basis events that sufficiently challenge dose evaluation guidelines or exceed the guidelines for members of the public or workers, merit selection of safety structures, systems, or components or other controls to prevent or mitigate the hazard. Idaho State University, in collaboration with Idaho National Laboratory, has developed a portable and simple to use software application called SODA (Stochastic Objective Decision-Aide) that stochastically calculatesmore » the radiation dose distribution associated with hypothetical radiological material release scenarios. Rather than producing a point estimate of the dose, SODA produces a dose distribution result to allow a deeper understanding of the dose potential. SODA allows users to select the distribution type and parameter values for all of the input variables used to perform the dose calculation. Users can also specify custom distributions through a user defined distribution option. SODA then randomly samples each distribution input variable and calculates the overall resulting dose distribution. In cases where an input variable distribution is unknown, a traditional single point value can be used. SODA, developed using the MATLAB coding framework, has a graphical user interface and can be installed on both Windows and Mac computers. SODA is a standalone software application and does not require MATLAB to function. SODA provides improved risk understanding leading to better informed decision making associated with establishing nuclear facility material-at-risk limits and safety structure, system, or component selection. It is important to note that SODA does not replace or compete with codes such as MACCS or RSAC; rather it is viewed as an easy to use supplemental tool to help improve risk understanding and support better informed decisions. The SODA development project was funded through a grant from the DOE Nuclear Safety Research and Development Program.« less

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.

Adopting Open Source Software to Address Software Risks during the Scientific Data Life Cycle

NASA Astrophysics Data System (ADS)

Vinay, S.; Downs, R. R.

2012-12-01

Software enables the creation, management, storage, distribution, discovery, and use of scientific data throughout the data lifecycle. However, the capabilities offered by software also present risks for the stewardship of scientific data, since future access to digital data is dependent on the use of software. From operating systems to applications for analyzing data, the dependence of data on software presents challenges for the stewardship of scientific data. Adopting open source software provides opportunities to address some of the proprietary risks of data dependence on software. For example, in some cases, open source software can be deployed to avoid licensing restrictions for using, modifying, and transferring proprietary software. The availability of the source code of open source software also enables the inclusion of modifications, which may be contributed by various community members who are addressing similar issues. Likewise, an active community that is maintaining open source software can be a valuable source of help, providing an opportunity to collaborate to address common issues facing adopters. As part of the effort to meet the challenges of software dependence for scientific data stewardship, risks from software dependence have been identified that exist during various times of the data lifecycle. The identification of these risks should enable the development of plans for mitigating software dependencies, where applicable, using open source software, and to improve understanding of software dependency risks for scientific data and how they can be reduced during the data life cycle.

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.

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, ...

Integration and Assessment of Component Health Prognostics in Supervisory Control Systems

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

Ramuhalli, Pradeep; Bonebrake, Christopher A.; Dib, Gerges

Enhanced risk monitors (ERMs) for active components in advanced reactor concepts use predictive estimates of component failure to update, in real time, predictive safety and economic risk metrics. These metrics have been shown to be capable of use in optimizing maintenance scheduling and managing plant maintenance costs. Integrating this information with plant supervisory control systems increases the potential for making control decisions that utilize real-time information on component conditions. Such decision making would limit the possibility of plant operations that increase the likelihood of degrading the functionality of one or more components while maintaining the overall functionality of the plant.more » ERM uses sensor data for providing real-time information about equipment condition for deriving risk monitors. This information is used to estimate the remaining useful life and probability of failure of these components. By combining this information with plant probabilistic risk assessment models, predictive estimates of risk posed by continued plant operation in the presence of detected degradation may be estimated. In this paper, we describe this methodology in greater detail, and discuss its integration with a prototypic software-based plant supervisory control platform. In order to integrate these two technologies and evaluate the integrated system, software to simulate the sensor data was developed, prognostic models for feedwater valves were developed, and several use cases defined. The full paper will describe these use cases, and the results of the initial evaluation.« less

Development and preliminary validation of an index for indicating the risks of the design of working hours to health and wellbeing.

PubMed

Schomann, Carsten; Giebel, Ole; Nachreiner, Friedhelm

2006-01-01

BASS 4, a computer program for the design and evaluation of workings hours, is an example of an ergonomics-based software tool that can be used by safety practitioners at the shop floor with regard to legal, ergonomic, and economic criteria. Based on experiences with this computer program, a less sophisticated Working-Hours-Risk Index for assessing the quality of work schedules (including flexible work hours) to indicate risks to health and wellbeing has been developed to provide a quick and easy applicable tool for legally required risk assessments. The results of a validation study show that this risk index seems to be a promising indicator for predicting risks of health complaints and wellbeing. The purpose of the Risk Index is to simplify the evaluation process at the shop floor and provide some more general information about the quality of a work schedule that can be used for triggering preventive interventions. Such a risk index complies with practitioners' expectations and requests for easy, useful, and valid instruments.

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.

Emission rate modeling and risk assessment at an automobile plant from painting operations

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

Kumar, A.; Shrivastava, A.; Kulkarni, A.

Pollution from automobile plants from painting operations has been addressed in the Clean Act Amendments (1990). The estimation of pollutant emissions from automobile painting operation were done mostly by approximate procedures than by actual calculations. The purpose of this study was to develop a methodology for calculating the emissions of the pollutants from painting operation in an automobile plant. Five scenarios involving an automobile painting operation, located in Columbus (Ohio), were studied for pollutant emission and concomitant risk associated with that. In the study of risk, a sensitivity analysis was done using Crystal Ball{reg{underscore}sign} on the parameters involved in risk.more » This software uses the Monte Carlo principle. The most sensitive factor in the risk analysis was the ground level concentration of the pollutants. All scenarios studied met the safety goal (a risk value of 1 x 10{sup {minus}6}) with different confidence levels. The highest level of confidence in meeting the safety goal was displayed by Scenario 1 (Alpha Industries). The results from the scenarios suggest that risk is associated with the quantity of released toxic pollutants. The sensitivity analysis of the various parameter shows that average spray rate of paint is the most important parameter in the estimation of pollutants from the painting operations. The entire study is a complete module that can be used by the environmental pollution control agencies for estimation of pollution levels and estimation of associated risk. The study can be further extended to other operations in an automobile industry or to different industries.« less

Wallops Ship Surveillance System

NASA Technical Reports Server (NTRS)

Smith, Donna C.

2011-01-01

Approved as a Wallops control center backup system, the Wallops Ship Surveillance Software is a day-of-launch risk analysis tool for spaceport activities. The system calculates impact probabilities and displays ship locations relative to boundary lines. It enables rapid analysis of possible flight paths to preclude the need to cancel launches and allow execution of launches in a timely manner. Its design is based on low-cost, large-customer- base elements including personal computers, the Windows operating system, C/C++ object-oriented software, and network interfaces. In conformance with the NASA software safety standard, the system is designed to ensure that it does not falsely report a safe-for-launch condition. To improve the current ship surveillance method, the system is designed to prevent delay of launch under a safe-for-launch condition. A single workstation is designated the controller of the official ship information and the official risk analysis. Copies of this information are shared with other networked workstations. The program design is divided into five subsystems areas: 1. Communication Link -- threads that control the networking of workstations; 2. Contact List -- a thread that controls a list of protected item (ocean vessel) information; 3. Hazard List -- threads that control a list of hazardous item (debris) information and associated risk calculation information; 4. Display -- threads that control operator inputs and screen display outputs; and 5. Archive -- a thread that controls archive file read and write access. Currently, most of the hazard list thread and parts of other threads are being reused as part of a new ship surveillance system, under the SureTrak project.

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.

Taking the Risk Out of Risk Assessment

NASA Technical Reports Server (NTRS)

2005-01-01

The ability to understand risks and have the right strategies in place when risky events occur is essential in the workplace. More and more organizations are being confronted with concerns over how to measure their risks or what kind of risks they can take when certain events transpire that could have a negative impact. NASA is one organization that faces these challenges on a daily basis, as effective risk management is critical to the success of its missions especially the Space Shuttle missions. On July 29, 1996, former NASA Administrator Daniel Goldin charged NASA s Office of Safety and Mission Assurance with developing a probabilistic risk assessment (PRA) tool to support decisions on the funding of Space Shuttle upgrades. When issuing the directive, Goldin said, "Since I came to NASA [in 1992], we've spent billions of dollars on Shuttle upgrades without knowing how much they improve safety. I want a tool to help base upgrade decisions on risk." Work on the PRA tool began immediately. The resulting prototype, the Quantitative Risk Assessment System (QRAS) Version 1.0, was jointly developed by NASA s Marshall Space Flight Center, its Office of Safety and Mission Assurance, and researchers at the University of Maryland. QRAS software automatically expands the reliability logic models of systems to evaluate the probability of highly detrimental outcomes occurring in complex systems that are subject to potential accident scenarios. Even in its earliest forms, QRAS was used to begin PRA modeling of the Space Shuttle. In parallel, the development of QRAS continued, with the goal of making it a world-class tool, one that was especially suited to NASA s unique needs. From the beginning, an important conceptual goal in the development of QRAS was for it to help bridge the gap between the professional risk analyst and the design engineer. In the past, only the professional risk analyst could perform, modify, use, and perhaps even adequately understand PRA. NASA wanted to change this by developing a PRA tool that would be friendlier, more understandable, and more useful to the broader engineering community. This concept ultimately led to the look, feel, and functionality that QRAS has today.

An exploratory study of the relationship between socioeconomic status and motor vehicle safety features.

PubMed

Girasek, Deborah C; Taylor, Brett

2010-04-01

The purpose of this study was to assess the association between motor vehicle owners' socioeconomic status (SES) and the safety of their motor vehicles. Truncated vehicle identification numbers (VINs) were obtained from the Maryland Motor Vehicle Administration office. ZIP code-level income and educational data were assigned to each VIN. Software was used to identify safety-related vehicle characteristics including crash test rating, availability of electronic stability control and side impact air bags, age, and weight. Correlations and analyses of variance were performed to assess whether a ZIP code's median household income and educational level were associated with its proportion of registered vehicles with safety features. For 13 of the 16 correlations performed, SES was significantly associated with the availability of vehicle safety features in a direction that favored upper-income individuals. Vehicle weight was not associated with income or education. When ZIP codes were divided into median household income quintiles, their mean proportions of safety features also differed significantly, in the same direction, for availability of electronic stability control, side impact air bags, vehicle age, and crash test ratings. Safer motor vehicles appear to be distributed along socioeconomic lines, with lower income groups experiencing more risk. This previously unidentified mechanism of disparity merits further study and the attention of policy makers.

Development of the Likelihood of Low Glucose (LLG) algorithm for evaluating risk of hypoglycemia: a new approach for using continuous glucose data to guide therapeutic decision making.

PubMed

Dunn, Timothy C; Hayter, Gary A; Doniger, Ken J; Wolpert, Howard A

2014-07-01

The objective was to develop an analysis methodology for generating diabetes therapy decision guidance using continuous glucose (CG) data. The novel Likelihood of Low Glucose (LLG) methodology, which exploits the relationship between glucose median, glucose variability, and hypoglycemia risk, is mathematically based and can be implemented in computer software. Using JDRF Continuous Glucose Monitoring Clinical Trial data, CG values for all participants were divided into 4-week periods starting at the first available sensor reading. The safety and sensitivity performance regarding hypoglycemia guidance "stoplights" were compared between the LLG method and one based on 10th percentile (P10) values. Examining 13 932 hypoglycemia guidance outputs, the safety performance of the LLG method ranged from 0.5% to 5.4% incorrect "green" indicators, compared with 0.9% to 6.0% for P10 value of 110 mg/dL. Guidance with lower P10 values yielded higher rates of incorrect indicators, such as 11.7% to 38% at 80 mg/dL. When evaluated only for periods of higher glucose (median above 155 mg/dL), the safety performance of the LLG method was superior to the P10 method. Sensitivity performance of correct "red" indicators of the LLG method had an in sample rate of 88.3% and an out of sample rate of 59.6%, comparable with the P10 method up to about 80 mg/dL. To aid in therapeutic decision making, we developed an algorithm-supported report that graphically highlights low glucose risk and increased variability. When tested with clinical data, the proposed method demonstrated equivalent or superior safety and sensitivity performance. © 2014 Diabetes Technology Society.

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.

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.

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...

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.

45 CFR 153.350 - Risk adjustment data validation standards.

Code of Federal Regulations, 2012 CFR

2012-10-01

... implementation of any risk adjustment software and ensure proper validation of a statistically valid sample of... respect to implementation of risk adjustment software or as a result of data validation conducted pursuant... implementation of risk adjustment software or data validation. ...

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...

An Integrated Fault Tolerant Robotic Controller System for High Reliability and Safety

NASA Technical Reports Server (NTRS)

Marzwell, Neville I.; Tso, Kam S.; Hecht, Myron

1994-01-01

This paper describes the concepts and features of a fault-tolerant intelligent robotic control system being developed for applications that require high dependability (reliability, availability, and safety). The system consists of two major elements: a fault-tolerant controller and an operator workstation. The fault-tolerant controller uses a strategy which allows for detection and recovery of hardware, operating system, and application software failures.The fault-tolerant controller can be used by itself in a wide variety of applications in industry, process control, and communications. The controller in combination with the operator workstation can be applied to robotic applications such as spaceborne extravehicular activities, hazardous materials handling, inspection and maintenance of high value items (e.g., space vehicles, reactor internals, or aircraft), medicine, and other tasks where a robot system failure poses a significant risk to life or property.

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 :...

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.

Incidence and Residual Risk of HIV, HBV and HCV Infections Among Blood Donors in Tehran.

PubMed

Saber, Hamid Reza; Tabatabaee, Seyed Morteza; Abasian, Ali; Jamali, Mostafa; SalekMoghadam, Ebadollah; Hajibeigi, Bashir; Alavian, Seyed Moayed; Mirrezaie, Seyed Mohammad

2017-09-01

Estimation of residual risk is essential to monitor and improve blood safety. Our epidemiologic knowledge in the Iranian donor population regarding transfusion transmitted viral infections (TTIs), is confined to a few studies based on prevalence rate. There are no reports on residual risk of TTIs in Iran. In present survey, a software database of donor records of Tehran Blood Transfusion Center (TBTC) was used to estimate the incidence and residual risk of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infections, by applying the incidence rate/window period (IR-WP) model. A total of 1,207,155 repeat donations was included in the analysis and represented a mean of 8.4 donations per donor over 6 years. The incidence amongst repeat donors was estimated by dividing the number of confirmed seroconverting donors by the total number of person-years at risk. The residual risk was calculated using the incidence/window period model. Incidence rate and residual risk for HBV, HCV and HIV infections were calculated for total (2005-2010) and two consecutive periods (2005-2007 and 2008-2010) of the study. According to the IR-WP model, overall residual risk for HIV and HCV in the total study period was 0.4 and 12.5 per million units, respectively and for HBV 4.57/100,000 donations. The incidence and residual risk of TTIs, calculated on TBTC's blood supply was low and comparable with developed countries for HIV infection but high for HCV and HBV infections. Blood safety may therefore be better managed by applying other techniques like nucleic acid amplification tests.

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

Integrating service user and practitioner expertise within a web-based system for collaborative mental-health risk and safety management.

PubMed

Buckingham, Christopher D; Adams, Ann; Vail, Laura; Kumar, Ashish; Ahmed, Abu; Whelan, Annie; Karasouli, Eleni

2015-10-01

To develop a decision support system (DSS), myGRaCE, that integrates service user (SU) and practitioner expertise about mental health and associated risks of suicide, self-harm, harm to others, self-neglect, and vulnerability. The intention is to help SUs assess and manage their own mental health collaboratively with practitioners. An iterative process involving interviews, focus groups, and agile software development with 115 SUs, to elicit and implement myGRaCE requirements. Findings highlight shared understanding of mental health risk between SUs and practitioners that can be integrated within a single model. However, important differences were revealed in SUs' preferred process of assessing risks and safety, which are reflected in the distinctive interface, navigation, tool functionality and language developed for myGRaCE. A challenge was how to provide flexible access without overwhelming and confusing users. The methods show that practitioner expertise can be reformulated in a format that simultaneously captures SU expertise, to provide a tool highly valued by SUs. A stepped process adds necessary structure to the assessment, each step with its own feedback and guidance. The GRiST web-based DSS (www.egrist.org) links and integrates myGRaCE self-assessments with GRiST practitioner assessments for supporting collaborative and self-managed healthcare. Copyright © 2015. Published by Elsevier Ireland Ltd.

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...

Safety huddles to proactively identify and address electronic health record safety

PubMed Central

Menon, Shailaja; Singh, Hardeep; Giardina, Traber D; Rayburn, William L; Davis, Brenda P; Russo, Elise M

2017-01-01

Objective: Methods to identify and study safety risks of electronic health records (EHRs) are underdeveloped and largely depend on limited end-user reports. “Safety huddles” have been found useful in creating a sense of collective situational awareness that increases an organization’s capacity to respond to safety concerns. We explored the use of safety huddles for identifying and learning about EHR-related safety concerns. Design: Data were obtained from daily safety huddle briefing notes recorded at a single midsized tertiary-care hospital in the United States over 1 year. Huddles were attended by key administrative, clinical, and information technology staff. We conducted a content analysis of huddle notes to identify what EHR-related safety concerns were discussed. We expanded a previously developed EHR-related error taxonomy to categorize types of EHR-related safety concerns recorded in the notes. Results: On review of daily huddle notes spanning 249 days, we identified 245 EHR-related safety concerns. For our analysis, we defined EHR technology to include a specific EHR functionality, an entire clinical software application, or the hardware system. Most concerns (41.6%) involved “EHR technology working incorrectly,” followed by 25.7% involving “EHR technology not working at all.” Concerns related to “EHR technology missing or absent” accounted for 16.7%, whereas 15.9% were linked to “user errors.” Conclusions: Safety huddles promoted discussion of several technology-related issues at the organization level and can serve as a promising technique to identify and address EHR-related safety concerns. Based on our findings, we recommend that health care organizations consider huddles as a strategy to promote understanding and improvement of EHR safety. PMID:28031286

A Research Roadmap for Computation-Based Human Reliability Analysis

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

Boring, Ronald; Mandelli, Diego; Joe, Jeffrey

2015-08-01

The United States (U.S.) Department of Energy (DOE) is sponsoring research through the Light Water Reactor Sustainability (LWRS) program to extend the life of the currently operating fleet of commercial nuclear power plants. The Risk Informed Safety Margin Characterization (RISMC) research pathway within LWRS looks at ways to maintain and improve the safety margins of these plants. The RISMC pathway includes significant developments in the area of thermalhydraulics code modeling and the development of tools to facilitate dynamic probabilistic risk assessment (PRA). PRA is primarily concerned with the risk of hardware systems at the plant; yet, hardware reliability is oftenmore » secondary in overall risk significance to human errors that can trigger or compound undesirable events at the plant. This report highlights ongoing efforts to develop a computation-based approach to human reliability analysis (HRA). This computation-based approach differs from existing static and dynamic HRA approaches in that it: (i) interfaces with a dynamic computation engine that includes a full scope plant model, and (ii) interfaces with a PRA software toolset. The computation-based HRA approach presented in this report is called the Human Unimodels for Nuclear Technology to Enhance Reliability (HUNTER) and incorporates in a hybrid fashion elements of existing HRA methods to interface with new computational tools developed under the RISMC pathway. The goal of this research effort is to model human performance more accurately than existing approaches, thereby minimizing modeling uncertainty found in current plant risk models.« less

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.

Software Reviews Since Acquisition Reform - The Artifact Perspective

DTIC Science & Technology

2004-01-01

Risk Management OLD NEW Slide 13Acquisition of Software Intensive Systems 2004 – Peter Hantos Single, basic software paradigm Single processor Low...software risk mitigation related trade-offs must be done together Integral Software Engineering Activities Process Maturity and Quality Frameworks Quality

[Prenatal risk calculation: comparison between Fast Screen pre I plus software and ViewPoint software. Evaluation of the risk calculation algorithms].

PubMed

Morin, Jean-François; Botton, Eléonore; Jacquemard, François; Richard-Gireme, Anouk

2013-01-01

The Fetal medicine foundation (FMF) has developed a new algorithm called Prenatal Risk Calculation (PRC) to evaluate Down syndrome screening based on free hCGβ, PAPP-A and nuchal translucency. The peculiarity of this algorithm is to use the degree of extremeness (DoE) instead of the multiple of the median (MoM). The biologists measuring maternal seric markers on Kryptor™ machines (Thermo Fisher Scientific) use Fast Screen pre I plus software for the prenatal risk calculation. This software integrates the PRC algorithm. Our study evaluates the data of 2.092 patient files of which 19 show a fœtal abnormality. These files have been first evaluated with the ViewPoint software based on MoM. The link between DoE and MoM has been analyzed and the different calculated risks compared. The study shows that Fast Screen pre I plus software gives the same risk results as ViewPoint software, but yields significantly fewer false positive results.

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…

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.

SCaN Testbed Software Development and Lessons Learned

NASA Technical Reports Server (NTRS)

Kacpura, Thomas J.; Varga, Denise M.

2012-01-01

National Aeronautics and Space Administration (NASA) has developed an on-orbit, adaptable, Software Defined Radio (SDR)Space Telecommunications Radio System (STRS)-based testbed facility to conduct a suite of experiments to advance technologies, reduce risk, and enable future mission capabilities on the International Space Station (ISS). The SCAN Testbed Project will provide NASA, industry, other Government agencies, and academic partners the opportunity to develop and field communications, navigation, and networking technologies in the laboratory and space environment based on reconfigurable, SDR platforms and the STRS Architecture.The SDRs are a new technology for NASA, and the support infrastructure they require is different from legacy, fixed function radios. SDRs offer the ability to reconfigure on-orbit communications by changing software for new waveforms and operating systems to enable new capabilities or fix any anomalies, which was not a previous option. They are not stand alone devices, but required a new approach to effectively control them and flow data. This requires extensive software to be developed to utilize the full potential of these reconfigurable platforms. The paper focuses on development, integration and testing as related to the avionics processor system, and the software required to command, control, monitor, and interact with the SDRs, as well as the other communication payload elements. An extensive effort was required to develop the flight software and meet the NASA requirements for software quality and safety. The flight avionics must be radiation tolerant, and these processors have limited capability in comparison to terrestrial counterparts. A big challenge was that there are three SDRs onboard, and interfacing with multiple SDRs simultaneously complicatesd the effort. The effort also includes ground software, which is a key element for both the command of the payload, and displaying data created by the payload. The verification of the software was an extensive effort. The challenges of specifying a suitable test matrix with reconfigurable systems that offer numerous configurations is highlighted. Since the flight system testing requires methodical, controlled testing that limits risk, a nearly identical ground system to the on-orbit flight system was required to develop the software and write verification procedures before it was installed and tested on the flight system. The development of the SCAN testbed was an accelerated effort to meet launch constraints, and this paper discusses tradeoffs made to balance needed software functionality and still maintain the schedule. Future upgrades are discussed that optimize the avionics and allow experimenters to utilize the SCAN testbed potential.

Continuous Risk Management: An Overview

NASA Technical Reports Server (NTRS)

Rosenberg, Linda; Hammer, Theodore F.

1999-01-01

Software risk management is important because it helps avoid disasters, rework, and overkill, but more importantly because it stimulates win-win situations. The objectives of software risk management are to identify, address, and eliminate software risk items before they become threats to success or major sources of rework. In general, good project managers are also good managers of risk. It makes good business sense for all software development projects to incorporate risk management as part of project management. The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to implement risk management. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This is an introductory tutorial to continuous risk management based on this course. The rational for continuous risk management and how it is incorporated into project management are discussed. The risk management structure of six functions is discussed in sufficient depth for managers to understand what is involved in risk management and how it is implemented. These functions include: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions.

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

The Pedestrian Evacuation Analyst: geographic information systems software for modeling hazard evacuation potential

USGS Publications Warehouse

Jones, Jeanne M.; Ng, Peter; Wood, Nathan J.

2014-01-01

Recent disasters such as the 2011 Tohoku, Japan, earthquake and tsunami; the 2013 Colorado floods; and the 2014 Oso, Washington, mudslide have raised awareness of catastrophic, sudden-onset hazards that arrive within minutes of the events that trigger them, such as local earthquakes or landslides. Due to the limited amount of time between generation and arrival of sudden-onset hazards, evacuations are typically self-initiated, on foot, and across the landscape (Wood and Schmidtlein, 2012). Although evacuation to naturally occurring high ground may be feasible in some vulnerable communities, evacuation modeling has demonstrated that other communities may require vertical-evacuation structures within a hazard zone, such as berms or buildings, if at-risk individuals are to survive some types of sudden-onset hazards (Wood and Schmidtlein, 2013). Researchers use both static least-cost-distance (LCD) and dynamic agent-based models to assess the pedestrian evacuation potential of vulnerable communities. Although both types of models help to understand the evacuation landscape, LCD models provide a more general overview that is independent of population distributions, which may be difficult to quantify given the dynamic spatial and temporal nature of populations (Wood and Schmidtlein, 2012). Recent LCD efforts related to local tsunami threats have focused on an anisotropic (directionally dependent) path distance modeling approach that incorporates travel directionality, multiple travel speed assumptions, and cost surfaces that reflect variations in slope and land cover (Wood and Schmidtlein, 2012, 2013). The Pedestrian Evacuation Analyst software implements this anisotropic path-distance approach for pedestrian evacuation from sudden-onset hazards, with a particular focus at this time on local tsunami threats. The model estimates evacuation potential based on elevation, direction of movement, land cover, and travel speed and creates a map showing travel times to safety (a time map) throughout a hazard zone. Model results provide a general, static view of the evacuation landscape at different pedestrian travel speeds and can be used to identify areas outside the reach of naturally occurring high ground. In addition, data on the size and location of different populations within the hazard zone can be integrated with travel-time maps to create tables and graphs of at-risk population counts as a function of travel time to safety. As a decision-support tool, the Pedestrian Evacuation Analyst provides the capability to evaluate the effectiveness of various vertical-evacuation structures within a study area, both through time maps of the modeled travel-time landscape with a potential structure in place and through comparisons of population counts within reach of safety. The Pedestrian Evacuation Analyst is designed for use by researchers examining the pedestrian-evacuation potential of an at-risk community. In communities where modeled evacuation times exceed the event (for example, tsunami wave) arrival time, researchers can use the software with emergency managers to assess the area and population served by potential vertical-evacuation options. By automating and managing the modeling process, the software allows researchers to concentrate efforts on providing crucial and timely information on community vulnerability to sudden-onset hazards.

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)

Towards a Food Safety Knowledge Base Applicable in Crisis Situations and Beyond

PubMed Central

Falenski, Alexander; Weiser, Armin A.; Thöns, Christian; Appel, Bernd; Käsbohrer, Annemarie; Filter, Matthias

2015-01-01

In case of contamination in the food chain, fast action is required in order to reduce the numbers of affected people. In such situations, being able to predict the fate of agents in foods would help risk assessors and decision makers in assessing the potential effects of a specific contamination event and thus enable them to deduce the appropriate mitigation measures. One efficient strategy supporting this is using model based simulations. However, application in crisis situations requires ready-to-use and easy-to-adapt models to be available from the so-called food safety knowledge bases. Here, we illustrate this concept and its benefits by applying the modular open source software tools PMM-Lab and FoodProcess-Lab. As a fictitious sample scenario, an intentional ricin contamination at a beef salami production facility was modelled. Predictive models describing the inactivation of ricin were reviewed, relevant models were implemented with PMM-Lab, and simulations on residual toxin amounts in the final product were performed with FoodProcess-Lab. Due to the generic and modular modelling concept implemented in these tools, they can be applied to simulate virtually any food safety contamination scenario. Apart from the application in crisis situations, the food safety knowledge base concept will also be useful in food quality and safety investigations. PMID:26247028

Towards a Food Safety Knowledge Base Applicable in Crisis Situations and Beyond.

PubMed

Falenski, Alexander; Weiser, Armin A; Thöns, Christian; Appel, Bernd; Käsbohrer, Annemarie; Filter, Matthias

2015-01-01

In case of contamination in the food chain, fast action is required in order to reduce the numbers of affected people. In such situations, being able to predict the fate of agents in foods would help risk assessors and decision makers in assessing the potential effects of a specific contamination event and thus enable them to deduce the appropriate mitigation measures. One efficient strategy supporting this is using model based simulations. However, application in crisis situations requires ready-to-use and easy-to-adapt models to be available from the so-called food safety knowledge bases. Here, we illustrate this concept and its benefits by applying the modular open source software tools PMM-Lab and FoodProcess-Lab. As a fictitious sample scenario, an intentional ricin contamination at a beef salami production facility was modelled. Predictive models describing the inactivation of ricin were reviewed, relevant models were implemented with PMM-Lab, and simulations on residual toxin amounts in the final product were performed with FoodProcess-Lab. Due to the generic and modular modelling concept implemented in these tools, they can be applied to simulate virtually any food safety contamination scenario. Apart from the application in crisis situations, the food safety knowledge base concept will also be useful in food quality and safety investigations.

Ensuring the Environmental and Industrial Safety in Solid Mineral Deposit Surface Mining

NASA Astrophysics Data System (ADS)

Trubetskoy, Kliment; Rylnikova, Marina; Esina, Ekaterina

2017-11-01

The growing environmental pressure of mineral deposit surface mining and severization of industrial safety requirements dictate the necessity of refining the regulatory framework governing safe and efficient development of underground resources. The applicable regulatory documentation governing the procedure of ore open-pit wall and bench stability design for the stage of pit reaching its final boundary was issued several decades ago. Over recent decades, mining and geomechanical conditions have changed significantly in surface mining operations, numerous new software packages and computer developments have appeared, opportunities of experimental methods of source data collection and processing, grounding of the permissible parameters of open pit walls have changed dramatically, and, thus, methods of risk assessment have been perfected [10-13]. IPKON RAS, with the support of the Federal Service for Environmental Supervision, assumed the role of the initiator of the project for the development of Federal norms and regulations of industrial safety "Rules for ensuring the stability of walls and benches of open pits, open-cast mines and spoil banks", which contribute to the improvement of economic efficiency and safety of mineral deposit surface mining and enhancement of the competitiveness of Russian mines at the international level that is very important in the current situation.

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.

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.

Security Risks: Management and Mitigation in the Software Life Cycle

NASA Technical Reports Server (NTRS)

Gilliam, David P.

2004-01-01

A formal approach to managing and mitigating security risks in the software life cycle is requisite to developing software that has a higher degree of assurance that it is free of security defects which pose risk to the computing environment and the organization. Due to its criticality, security should be integrated as a formal approach in the software life cycle. Both a software security checklist and assessment tools should be incorporated into this life cycle process and integrated with a security risk assessment and mitigation tool. The current research at JPL addresses these areas through the development of a Sotfware Security Assessment Instrument (SSAI) and integrating it with a Defect Detection and Prevention (DDP) risk management tool.

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...

Fears of violence during morning travel to school.

PubMed

Wiebe, Douglas J; Guo, Wensheng; Allison, Paul D; Anderson, Elijah; Richmond, Therese S; Branas, Charles C

2013-07-01

Children's safety as they travel to school is a concern nationwide. We investigated how safe children felt from the risk of being assaulted during morning travel to school. Children between 10 and 18 years old were recruited in Philadelphia and interviewed with the aid of geographic information system (GIS) mapping software about a recent trip to school, situational characteristics, and how safe they felt as they travelled based on a 10-point item (1 = very unsafe, 10 = very safe). Ordinal regression was used to estimate the probability of perceiving different levels of safety based on transportation mode, companion type, and neighborhood characteristics. Among 65 randomly selected subjects, routes to school ranged from 7 to 177 minutes (median = 36) and .1-15.1 street miles (median = 1.9), and included between 1-5 transportation modes (median = 2). Among students interviewed, 58.5% felt less than very safe (i.e., <10) at some point while traveling to school and one-third (32.5%) of the total person time was spent feeling less than very safe. Nearly a quarter of students, or 24.6%, felt a reduction in safety immediately upon exiting their home. The probability of reporting a safety of >8, for example, was .99 while in a car and .94 while on foot but was .86 and .87 when on a public bus or trolley. Probability was .98 while with an adult but was .72 while with another child and .71 when alone. Also, perceived safety was lower in areas of high crime and high density of off-premise alcohol outlets. Efforts that target situational risk factors are warranted to help children feel safe over their entire travel routes to school. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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.

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.

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...

Model based verification of the Secure Socket Layer (SSL) Protocol for NASA systems

NASA Technical Reports Server (NTRS)

Powell, John D.; Gilliam, David

2004-01-01

The National Aeronautics and Space Administration (NASA) has tens of thousands of networked computer systems and applications. Software Security vulnerabilities present risks such as lost or corrupted data, information theft, and unavailability of critical systems. These risks represent potentially enormous costs to NASA. The NASA Code Q research initiative 'Reducing Software Security Risk (RSSR) Trough an Integrated Approach' offers formal verification of information technology (IT), through the creation of a Software Security Assessment Instrument (SSAI), to address software security risks.

Assessment of drug-induced arrhythmic risk using limit cycle and autocorrelation analysis of human iPSC-cardiomyocyte contractility

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

Kirby, R. Jason

2016-08-15

Cardiac safety assays incorporating label-free detection of human stem-cell derived cardiomyocyte contractility provide human relevance and medium throughput screening to assess compound-induced cardiotoxicity. In an effort to provide quantitative analysis of the large kinetic datasets resulting from these real-time studies, we applied bioinformatic approaches based on nonlinear dynamical system analysis, including limit cycle analysis and autocorrelation function, to systematically assess beat irregularity. The algorithms were integrated into a software program to seamlessly generate results for 96-well impedance-based data. Our approach was validated by analyzing dose- and time-dependent changes in beat patterns induced by known proarrhythmic compounds and screening a cardiotoxicitymore » library to rank order compounds based on their proarrhythmic potential. We demonstrate a strong correlation for dose-dependent beat irregularity monitored by electrical impedance and quantified by autocorrelation analysis to traditional manual patch clamp potency values for hERG blockers. In addition, our platform identifies non-hERG blockers known to cause clinical arrhythmia. Our method provides a novel suite of medium-throughput quantitative tools for assessing compound effects on cardiac contractility and predicting compounds with potential proarrhythmia and may be applied to in vitro paradigms for pre-clinical cardiac safety evaluation. - Highlights: • Impedance-based monitoring of human iPSC-derived cardiomyocyte contractility • Limit cycle analysis of impedance data identifies aberrant oscillation patterns. • Nonlinear autocorrelation function quantifies beat irregularity. • Identification of hERG and non-hERG inhibitors with known risk of arrhythmia • Automated software processes limit cycle and autocorrelation analyses of 96w data.« less

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

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

NASA Technical Reports Server (NTRS)

Anderson, Joel M.

2011-01-01

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

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 ...

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.

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.

Safe intravenous administration in pediatrics: A 5-year Pediatric Intensive Care Unit experience with smart pumps.

PubMed

Manrique-Rodríguez, S; Sánchez-Galindo, A C; Fernández-Llamazares, C M; Calvo-Calvo, M M; Carrillo-Álvarez, Á; Sanjurjo-Sáez, M

2016-10-01

To estimate the impact of smart pump implementation in a pediatric intensive care unit in terms of number and type of administration errors intercepted. Observational, prospective study carried out from January 2010 to March 2015 with syringe and great volumen infusion pumps available in the hospital. A tertiary level hospital pediatric intensive care unit. Infusions delivered with infusion pumps in all pediatric intensive care unit patients. Design of a drug library with safety limits for all intravenous drugs prescribed. Users' compliance with drug library as well as number and type of errors prevented were analyzed. Two hundred and eighty-three errors were intercepted during 62 months of study. A high risk drug was involved in 58% of prevented errors, such as adrenergic agonists and antagonists, sedatives, analgesics, neuromuscular blockers, opioids, potassium and insulin. Users' average compliance with the safety software was 84%. Smart pumps implementation has proven effective in intercepting high risk drugs programming errors. These results might be exportable to other critical care units, involving pediatric or adult patients. Interdisciplinary colaboration is key to succeed in this process. Copyright © 2016 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Preliminary stochastic model for managing Vibrio parahaemolyticus and total viable bacterial counts in a Pacific oyster (Crassostrea gigas) supply chain.

PubMed

Fernandez-Piquer, Judith; Bowman, John P; Ross, Tom; Estrada-Flores, Silvia; Tamplin, Mark L

2013-07-01

Vibrio parahaemolyticus can accumulate and grow in oysters stored without refrigeration, representing a potential food safety risk. High temperatures during oyster storage can lead to an increase in total viable bacteria counts, decreasing product shelf life. Therefore, a predictive tool that allows the estimation of both V. parahaemolyticus populations and total viable bacteria counts in parallel is needed. A stochastic model was developed to quantitatively assess the populations of V. parahaemolyticus and total viable bacteria in Pacific oysters for six different supply chain scenarios. The stochastic model encompassed operations from oyster farms through consumers and was built using risk analysis software. Probabilistic distributions and predictions for the percentage of Pacific oysters containing V. parahaemolyticus and high levels of viable bacteria at the point of consumption were generated for each simulated scenario. This tool can provide valuable information about V. parahaemolyticus exposure and potential control measures and can help oyster companies and regulatory agencies evaluate the impact of product quality and safety during cold chain management. If coupled with suitable monitoring systems, such models could enable preemptive action to be taken to counteract unfavorable supply chain conditions.

Decompression scenarios in a new underground transportation system.

PubMed

Vernez, D

2000-10-01

The risks of a public exposure to a sudden decompression, until now, have been related to civil aviation and, at a lesser extent, to diving activities. However, engineers are currently planning the use of low pressure environments for underground transportation. This method has been proposed for the future Swissmetro, a high-speed underground train designed for inter-urban linking in Switzerland. The use of a low pressure environment in an underground public transportation system must be considered carefully regarding the decompression risks. Indeed, due to the enclosed environment, both decompression kinetics and safety measures may differ from aviation decompression cases. A theoretical study of decompression risks has been conducted at an early stage of the Swissmetro project. A three-compartment theoretical model, based on the physics of fluids, has been implemented with flow processing software (Ithink 5.0). Simulations have been conducted in order to analyze "decompression scenarios" for a wide range of parameters, relevant in the context of the Swissmetro main study. Simulation results cover a wide range from slow to explosive decompression, depending on the simulation parameters. Not surprisingly, the leaking orifice area has a tremendous impact on barotraumatic effects, while the tunnel pressure may significantly affect both hypoxic and barotraumatic effects. Calculations have also shown that reducing the free space around the vehicle may mitigate significantly an accidental decompression. Numeric simulations are relevant to assess decompression risks in the future Swissmetro system. The decompression model has proven to be useful in assisting both design choices and safety management.

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.

CrossTalk. The Journal of Defense Software Engineering. Volume 23, Number 6, Nov/Dec 2010

DTIC Science & Technology

2010-11-01

Model of archi- tectural design. It guides developers to apply effort to their software architecture commensurate with the risks faced by...Driven Model is the promotion of risk to prominence. It is possible to apply the Risk-Driven Model to essentially any software development process...succeed without any planned architecture work, while many high-risk projects would fail without it . The Risk-Driven Model walks a middle path

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...

Using software security analysis to verify the secure socket layer (SSL) protocol

NASA Technical Reports Server (NTRS)

Powell, John D.

2004-01-01

nal Aeronautics and Space Administration (NASA) have tens of thousands of networked computer systems and applications. Software Security vulnerabilities present risks such as lost or corrupted data, information the3, and unavailability of critical systems. These risks represent potentially enormous costs to NASA. The NASA Code Q research initiative 'Reducing Software Security Risk (RSSR) Trough an Integrated Approach '' offers, among its capabilities, formal verification of software security properties, through the use of model based verification (MBV) to address software security risks. [1,2,3,4,5,6] MBV is a formal approach to software assurance that combines analysis of software, via abstract models, with technology, such as model checkers, that provide automation of the mechanical portions of the analysis process. This paper will discuss: The need for formal analysis to assure software systems with respect to software and why testing alone cannot provide it. The means by which MBV with a Flexible Modeling Framework (FMF) accomplishes the necessary analysis task. An example of FMF style MBV in the verification of properties over the Secure Socket Layer (SSL) communication protocol as a demonstration.

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.

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.

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

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.

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.

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

Nurses' experiences of using a smart mobile device application to assist home care for patients with chronic disease: a qualitative study.

PubMed

Chiang, Kuei-Feng; Wang, Hsiu-Hung

2016-07-01

To examine nurses' experiences regarding the benefits and obstacles of using a smart mobile device application in home care. The popularity of mobile phones and Internet technology has established an opportunity for interaction between patients and health care professionals. Line is an application allowing instant communication that is available for free globally. However, the literature relating to use of Line in this area is limited. A qualitative study involving individual in-depth interviews. Participants included community nurses (N = 17) from six home care facilities in southern Taiwan who had used Line for home care of chronically ill patients for at least six months. The study was conducted using semi-structured in-depth interviews, which were recorded and converted into transcripts for content analysis. Seven themes emerged from data analysis: reduction in medical care consumption and costs, reduction in workload and stress, facilitating improvement in the quality of care, promotion of the nurse-patient relationship, perceived risk, lack of organisational incentives and operating procedures and disturbance to personal life. Nurses considered Line valuable for use in home care. While this application has diverse functions, its video transfer function could in particular help nursing staff make prompt decisions about patients' problems and promote nurse-patient relationships. However, there might be hidden risks including legal consequences, safety risks to patients, possible violations of professionalism and increased risk of nurse burnout. Increasing nursing staff awareness of using mobile messaging software applications is necessary. This study provides relevant information about the benefits, disadvantages, risks and limitations of nurses' use of Line. The study also provides suggestions for software programmers and future organisational strategy and development. © 2016 John Wiley & Sons Ltd.

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.

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.

Rapid Response Risk Assessment in New Project Development

NASA Technical Reports Server (NTRS)

Graber, Robert R.

2010-01-01

A capability for rapidly performing quantitative risk assessments has been developed by JSC Safety and Mission Assurance for use on project design trade studies early in the project life cycle, i.e., concept development through preliminary design phases. A risk assessment tool set has been developed consisting of interactive and integrated software modules that allow a user/project designer to assess the impact of alternative design or programmatic options on the probability of mission success or other risk metrics. The risk and design trade space includes interactive options for selecting parameters and/or metrics for numerous design characteristics including component reliability characteristics, functional redundancy levels, item or system technology readiness levels, and mission event characteristics. This capability is intended for use on any project or system development with a defined mission, and an example project will used for demonstration and descriptive purposes, e.g., landing a robot on the moon. The effects of various alternative design considerations and their impact of these decisions on mission success (or failure) can be measured in real time on a personal computer. This capability provides a high degree of efficiency for quickly providing information in NASA s evolving risk-based decision environment

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.

Safety profile comparison between extemporaneous and a licensed preparation of caffeine citrate in preterm infants with apnea of prematurity.

PubMed

Vatlach, Scarlet; Arand, Joerg; Engel, Corinna; Poets, Christian F

2014-01-01

Given the lack of a licensed product (LP), extemporaneous caffeine citrate (ECC) has been used by many hospital pharmacies. Since July 2011, an LP has been available in Germany. We prospectively compared the safety profile of ECC and LP in preterm infants with apnea of prematurity. Between April 2010 and April 2013, selected side effects occurring with ECC or LP were documented in 6 German NICUs for infants ≤34 weeks' gestation using a longitudinal study design. The software developed for daily prescriptions in NICU residents requires entries if any of the following symptoms occurred during the last 24 h: tachycardia (resting heart rate >200/min), clinical or encephalographic seizures, gastric residuals, vomiting, or necrotizing enterocolitis (NEC). ECC and LP were administered at identical doses (20 mg/kg/day loading, 5-10 mg/kg/day maintenance) and in similar formulations either orally or intravenously. 562 infants with 14,590 treatment days on ECC and 538 infants with 12,813 treatment days on LP were evaluated. The mean gestational age was similar (29.20 weeks for ECC vs. 29.14 weeks for LP). No relevant differences were seen concerning tachycardia, gastric residuals, or vomiting, but ECC was associated with a higher risk of NEC (risk ratio: 2.68, 95% CI: 1.01-7.23, p = 0.047) and, albeit not significantly so, seizures (risk ratio: 1.91, 95% CI: 0.53-6.96, p = 0.35). This survey demonstrates a similar safety profile for both forms of caffeine citrate. The lower NEC and seizure rate seen with the LP is intriguing, but requires confirmation in a controlled study design. © 2013 S. Karger AG, Basel.

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 ...

Exploring approaches to patient safety: the case of spinal manipulation therapy.

PubMed

Rozmovits, Linda; Mior, Silvano; Boon, Heather

2016-06-02

The purpose of this study was to gain insight into the current safety culture around the use of spinal manipulation therapy (SMT) by regulated health professionals in Canada and to explore perceptions of readiness for implementing formal mechanisms for tracking associated adverse events. Fifty-six semi-structured telephone interviews were conducted with professional leaders and frontline practitioners in chiropractic, physiotherapy, naturopathy and medicine, all professions regulated to perform SMT in the provinces of Alberta and Ontario Canada. Interviews were digitally audio-recorded for verbatim transcription. Transcripts were entered into HyperResearch software for qualitative data analysis and were coded for both anticipated and emergent themes using the constant comparative method. A thematic, descriptive analysis was produced. The safety culture around SMT is characterized by substantial disagreement about its actual rather than putative risks. Competing intra- and inter-professional narratives further cloud the safety picture. Participants felt that safety talk is sometimes conflated with competition for business in the context of fee-for-service healthcare delivery by several professions with overlapping scopes of practice. Both professional leaders and frontline practitioners perceived multiple barriers to the implementation of an incident reporting system for SMT. The established 'measure and manage' approach to patient safety is difficult to apply to care which is geographically dispersed and delivered by practitioners in multiple professions with overlapping scopes of practice, primarily in a fee-for-service model. Collaboration across professions on models that allow practitioners to share information anonymously and help practitioners learn from the reported incidents is needed.

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

A software quality model and metrics for risk assessment

NASA Technical Reports Server (NTRS)

Hyatt, L.; Rosenberg, L.

1996-01-01

A software quality model and its associated attributes are defined and used as the model for the basis for a discussion on risk. Specific quality goals and attributes are selected based on their importance to a software development project and their ability to be quantified. Risks that can be determined by the model's metrics are identified. A core set of metrics relating to the software development process and its products is defined. Measurements for each metric and their usability and applicability are discussed.

Synthesis, molecular properties, toxicity and biological evaluation of some new substituted imidazolidine derivatives in search of potent anti-inflammatory agents

PubMed Central

Husain, Asif; Ahmad, Aftab; Khan, Shah Alam; Asif, Mohd; Bhutani, Rubina; Al-Abbasi, Fahad A.

2015-01-01

The aim of this study was to design and synthesize pharmaceutical agents containing imidazolidine heterocyclic ring in the hope of developing potent, safe and orally active anti-inflammatory agents. A number of substituted-imidazolidine derivatives (3a–k) were synthesized starting from ethylene diamine and aromatic aldehydes. The imidazolidine derivatives (3a–k) were investigated for their anticipated anti-inflammatory, and analgesic activity in Wistar albino rats and Swiss albino mice, respectively. Bioactivity score, molecular and pharmacokinetic properties of the imidazolidine derivatives were calculated by online computer software programs viz. Molinspiration and Osiris property explorer. The results of biological testing indicated that among the synthesized compounds only three imidazolidine derivatives namely 4-[1,3-Bis(2,6-dichlorobenzyl)-2-imidazolidinyl]phenyl-diethylamine (3g), 4-[1,3-Bis(3-hydroxy-4-methoxybenzyl)-2-imidazolidinyl]phenyl-diethylamine (3i) and 4-(1,3-Bis(4-methoxybenzyl)-4-methylimidazolidin-2-yl)-phenyl-diethylamine (3j) possess promising anti-inflammatory and analgesic actions. Additionally these derivatives displayed superior GI safety profile (low severity index) with respect to the positive control, Indomethacin. All synthesized compounds showed promising bioactivity score for drug targets by Molinspiration software. Almost all the compounds were predicted to have very low toxicity risk by Osiris online software. Compound number (3i) emerged as a potential candidate for further research as it obeyed Lipinski’s rule of five for drug likeness, exhibited promising biological activity in-vivo and showed no risk of toxicity in computer aided screening. PMID:26903774

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.

The efficacy and safety of tranexamic acid in revision total knee arthroplasty: a meta-analysis.

PubMed

Tian, Peng; Liu, Wen-Bin; Li, Zhi-Jun; Xu, Gui-Jun; Huang, Yu-Ting; Ma, Xin-Long

2017-06-21

There is no consistent conclusion regarding the efficacy and safety of the intravenous administration of tranexamic acid (TXA) for reducing blood loss in revision total knee arthroplasty (TKA). We performed a meta-analysis of comparative trials to evaluate the efficacy and safety of TXA in revision TKA. We conducted a search of PubMed, EMBASE, The Cochrane Library and Web of Science for randomized controlled trials (RCTs) and non-RCTs. Two authors selected the studies, extracted the data, and assessed the risk of bias independently. A pooled meta-analysis was performed using RevMan 5.3 software. Four non-RCTs met the inclusion criteria. The meta-analysis indicated that the use of TXA was related to significantly less transfusion requirements (RD = -0.25; 95% CI: -0.43 to -0.08; P = 0.005), drainage volume (MD = -321.07; 95% CI: -445.13 to -197.01, P = 0.005), hemoglobin reduction (MD = -0.52; 95% CI: -0.79 to -0.25, P = 0.0001), and length of hospital stay (MD = -2.36; 95% CI: -4.00 to -0.71, P = 0.005). No significant differences in the incidence of deep venous thrombosis (DVT) or pulmonary embolism (PE) were noted. The use of TXA for patients undergoing revision TKA may reduce blood loss and transfusion requirements without increasing the risk of postoperative venous thromboembolism. Due to the limited quality of the currently available evidence, more high-quality RCTs are required.

A research program in empirical computer science

NASA Technical Reports Server (NTRS)

Knight, J. C.

1991-01-01

During the grant reporting period our primary activities have been to begin preparation for the establishment of a research program in experimental computer science. The focus of research in this program will be safety-critical systems. Many questions that arise in the effort to improve software dependability can only be addressed empirically. For example, there is no way to predict the performance of the various proposed approaches to building fault-tolerant software. Performance models, though valuable, are parameterized and cannot be used to make quantitative predictions without experimental determination of underlying distributions. In the past, experimentation has been able to shed some light on the practical benefits and limitations of software fault tolerance. It is common, also, for experimentation to reveal new questions or new aspects of problems that were previously unknown. A good example is the Consistent Comparison Problem that was revealed by experimentation and subsequently studied in depth. The result was a clear understanding of a previously unknown problem with software fault tolerance. The purpose of a research program in empirical computer science is to perform controlled experiments in the area of real-time, embedded control systems. The goal of the various experiments will be to determine better approaches to the construction of the software for computing systems that have to be relied upon. As such it will validate research concepts from other sources, provide new research results, and facilitate the transition of research results from concepts to practical procedures that can be applied with low risk to NASA flight projects. The target of experimentation will be the production software development activities undertaken by any organization prepared to contribute to the research program. Experimental goals, procedures, data analysis and result reporting will be performed for the most part by the University of Virginia.

Continuous Risk Management Course. Revised

NASA Technical Reports Server (NTRS)

Hammer, Theodore F.

1999-01-01

This document includes a course plan for Continuous Risk Management taught by the Software Assurance Technology Center along with the Continuous Risk Management Guidebook of the Software Engineering Institute of Carnegie Mellon University and a description of Continuous Risk Management at NASA.

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.

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

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.

Information systems in food safety management.

PubMed

McMeekin, T A; Baranyi, J; Bowman, J; Dalgaard, P; Kirk, M; Ross, T; Schmid, S; Zwietering, M H

2006-12-01

Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with information on microorganisms pertinent to the identification of foodborne pathogens, response of microbial populations to the environment and characteristics of foods and processing conditions are the cornerstone of food safety management systems. Such databases find application in: Identifying pathogens in food at the genus or species level using applied systematics in automated ways. Identifying pathogens below the species level by molecular subtyping, an approach successfully applied in epidemiological investigations of foodborne disease and the basis for national surveillance programs. Predictive modelling software, such as the Pathogen Modeling Program and Growth Predictor (that took over the main functions of Food Micromodel) the raw data of which were combined as the genesis of an international web based searchable database (ComBase). Expert systems combining databases on microbial characteristics, food composition and processing information with the resulting "pattern match" indicating problems that may arise from changes in product formulation or processing conditions. Computer software packages to aid the practical application of HACCP and risk assessment and decision trees to bring logical sequences to establishing and modifying food safety management practices. In addition there are many other uses of information systems that benefit food safety more globally, including: Rapid dissemination of information on foodborne disease outbreaks via websites or list servers carrying commentary from many sources, including the press and interest groups, on the reasons for and consequences of foodborne disease incidents. Active surveillance networks allowing rapid dissemination of molecular subtyping information between public health agencies to detect foodborne outbreaks and limit the spread of human disease. Traceability of individual animals or crops from (or before) conception or germination to the consumer as an integral part of food supply chain management. Provision of high quality, online educational packages to food industry personnel otherwise precluded from access to such courses.

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

Efficacy and safety of regional citrate anticoagulation in critically ill patients undergoing continuous renal replacement therapy.

PubMed

Zhang, Zhongheng; Hongying, Ni

2012-01-01

Regional citrate anticoagulation (RCA) is an attractive anticoagulation mode in continuous renal replacement therapy (CRRT) because it restricts the anticoagulatory effect to the extracorporeal circuit. In recent years, several randomized controlled trials have been conducted to investigate its superiority over other anticoagulation modes. Thus, we performed a systematic review of available evidence on the efficacy and safety of RCA. A systematic review of randomized controlled trials investigating the efficacy and safety of RCA was performed. PubMed, Current Contents, CINAHL, and EMBASE databases were searched to identify relevance articles. Data on circuit life span, bleeding events, metabolic derangement, and mortality were abstracted. Mean difference was used for continuous variables, and risk ratio was used for binomial variables. The random effects or fixed effect model was used to combine these data according to heterogeneity. The software Review Manager 5.1 was used for the meta-analysis. Six studies met our inclusion criteria, which involved a total of 658 circuits. In these six studies patients with liver failure or a high risk of bleeding were excluded. The circuit life span in the RCA group was significantly longer than that in the control group, with a mean difference of 23.03 h (95% CI 0.45-45.61 h). RCA was able to reduce the risk of bleeding, with a risk ratio of 0.28 (95% CI 0.15-0.50). Metabolic stability (electrolyte and acid-base stabilities) in performing RCA was comparable to that in other anticoagulation modes, and metabolic derangements (hypernatremia, metabolic alkalosis, and hypocalcemia) could be easily controlled without significant clinical consequences. Two studies compared mortality rate between RCA and control groups, with one reported similar mortality rate and the other reported superiority of RCA over the control group (hazards ratio 0.7). RCA is effective in maintaining circuit patency and reducing the risk of bleeding, and thus can be recommended for CRRT if and when metabolic monitoring is adequate and the protocol is followed. However, the safety of citrate in patients with liver failure cannot be concluded from current analysis. The metabolic stability can be easily controlled during RCA. Survival benefit from RCA is still controversial due to limited evidence.

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...

Concerns of Capitol Hill staff workers after bioterrorism: focus group discussions of authorities' response.

PubMed

North, Carol S; Pollio, David E; Pfefferbaum, Betty; Megivern, Deborah; Vythilingam, Meena; Westerhaus, Elizabeth Terry; Martin, Gregory J; Hong, Barry A

2005-08-01

Systematic studies of mental health effects of bioterrorism on exposed populations have not been carried out. Exploratory focus groups were conducted with an exposed population to provide qualitative data and inform empirical research. Five focus groups of 28 political worker volunteers were conducted 3 months after the October 15, 2001, anthrax attack on Capitol Hill. More than 2000 transcribed focus group passages were categorized using qualitative software. The category with the most items was authorities' response (23% passages), and much of this discussion pertained to communication by authorities. The category with the fewest items was symptoms (4%). Identified issues were less within individuals and more between them and authorities. Risk communication by authorities regarding safety and medical issues was a prominent concern among Capitol Hill office staff workers regarding the anthrax incident on Capitol Hill. This suggests focus on risk communication in developing interventions, but more systematic investigation is needed.

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.

Risk reduction using DDP (Defect Detection and Prevention): Software support and software applications

NASA Technical Reports Server (NTRS)

Feather, M. S.

2001-01-01

Risk assessment and mitigation is the focus of the Defect Detection and Prevention (DDP) process, which has been applied to spacecraft technology assessments and planning, both hardware and software. DDP's major elements and their relevance to core requirement engineering concerns are summarized. The accompanying research demonstration illustrates DDP's tool support, and further customizations for application to software.

Performance Measures in Neurosurgical Patient Care: Differing Applications of Patient Safety Indicators.

PubMed

Moghavem, Nuriel; McDonald, Kathryn; Ratliff, John K; Hernandez-Boussard, Tina

2016-04-01

Patient Safety Indicators (PSIs) are administratively coded identifiers of potentially preventable adverse events. These indicators are used for multiple purposes, including benchmarking and quality improvement efforts. Baseline PSI evaluation in high-risk surgeries is fundamental to both purposes. Determine PSI rates and their impact on other outcomes in patients undergoing cranial neurosurgery compared with other surgeries. The Agency for Healthcare Research and Quality (AHRQ) PSI software was used to flag adverse events and determine risk-adjusted rates (RAR). Regression models were built to assess the association between PSIs and important patient outcomes. We identified cranial neurosurgeries based on International Classification of Diseases, Ninth Revision, Clinical Modification codes in California, Florida, New York, Arkansas, and Mississippi State Inpatient Databases, AHRQ, 2010-2011. PSI development, 30-day all-cause readmission, length of stay, hospital costs, and inpatient mortality. A total of 48,424 neurosurgical patients were identified. Procedure indication was strongly associated with PSI development. The neurosurgical population had significantly higher RAR of most PSIs evaluated compared with other surgical patients. Development of a PSI was strongly associated with increased length of stay and hospital cost and, in certain PSIs, increased inpatient mortality and 30-day readmission. In this population-based study, certain accountability measures proposed for use as value-based payment modifiers show higher RAR in neurosurgery patients compared with other surgical patients and were subsequently associated with poor outcomes. Our results indicate that for quality improvement efforts, the current AHRQ risk-adjustment models should be viewed in clinically meaningful stratified subgroups: for profiling and pay-for-performance applications, additional factors should be included in the risk-adjustment models. Further evaluation of PSIs in additional high-risk surgeries is needed to better inform the use of these metrics.

Efficacy and safety of stenting for elderly patients with severe and symptomatic carotid artery stenosis: a critical meta-analysis of randomized controlled trials.

PubMed

Ouyang, Yi-An; Jiang, Yugang; Yu, Mengqiang; Zhang, Yunze; Huang, Hao

2015-01-01

To investigate both short-term and long-term therapeutic efficacy and safety of carotid artery stenting (CAS) and carotid artery endarterectomy (CEA) for elderly patients with severe and symptomatic carotid artery stenosis. PubMed, EMBASE, Cochrane Library, Clinical Trials Register Centers, and Google Scholar were comprehensively searched. After identifying relevant randomized controlled trials, methodological quality was assessed by using Cochrane tools of bias assessment. Meta-analysis was performed by RevMan software, and subgroup analyses according to different follow-up periods were also conducted. Sixteen articles of nine randomized controlled trials containing 6,984 patients were included. Compared with CEA, CAS was associated with high risks of stroke during periprocedural 30 days (risk ratio [RR]=1.47, 95% confidence interval [CI]: 1.15-1.88), 48 months (RR=1.37, 95% CI: 1.11-1.70), and >48 months (RR=1.76, 95% CI: 1.34-2.31). There was no significant difference in the aspects of death, disabling stroke, or death at any time between the groups. For other periprocedural complications, CAS decreased the risk of myocardial infarction (RR=0.44, 95% CI: 0.26-0.75), cranial nerve palsy (RR=0.09, 95% CI: 0.04-0.22) and hematoma (RR=0.31, 95% CI: 0.14-0.68) compared with CEA, while it increased the risk of bradycardia or hypotension (RR=8.45, 95% CI 2.91-24.58). Compared with CEA, CAS reduced hematoma, periprocedural myocardial infarction, and cranial nerve palsy, while it was associated with higher risks of both short-term and long-term nondisabling stroke. And they seemed to be equivalent in other outcome measures. As regards to its minimal invasion, it should be applied only in specific patients.

Global review of open access risk assessment software packages valid for global or continental scale analysis

NASA Astrophysics Data System (ADS)

Daniell, James; Simpson, Alanna; Gunasekara, Rashmin; Baca, Abigail; Schaefer, Andreas; Ishizawa, Oscar; Murnane, Rick; Tijssen, Annegien; Deparday, Vivien; Forni, Marc; Himmelfarb, Anne; Leder, Jan

2015-04-01

Over the past few decades, a plethora of open access software packages for the calculation of earthquake, volcanic, tsunami, storm surge, wind and flood have been produced globally. As part of the World Bank GFDRR Review released at the Understanding Risk 2014 Conference, over 80 such open access risk assessment software packages were examined. Commercial software was not considered in the evaluation. A preliminary analysis was used to determine whether the 80 models were currently supported and if they were open access. This process was used to select a subset of 31 models that include 8 earthquake models, 4 cyclone models, 11 flood models, and 8 storm surge/tsunami models for more detailed analysis. By using multi-criteria analysis (MCDA) and simple descriptions of the software uses, the review allows users to select a few relevant software packages for their own testing and development. The detailed analysis evaluated the models on the basis of over 100 criteria and provides a synopsis of available open access natural hazard risk modelling tools. In addition, volcano software packages have since been added making the compendium of risk software tools in excess of 100. There has been a huge increase in the quality and availability of open access/source software over the past few years. For example, private entities such as Deltares now have an open source policy regarding some flood models (NGHS). In addition, leaders in developing risk models in the public sector, such as Geoscience Australia (EQRM, TCRM, TsuDAT, AnuGA) or CAPRA (ERN-Flood, Hurricane, CRISIS2007 etc.), are launching and/or helping many other initiatives. As we achieve greater interoperability between modelling tools, we will also achieve a future wherein different open source and open access modelling tools will be increasingly connected and adapted towards unified multi-risk model platforms and highly customised solutions. It was seen that many software tools could be improved by enabling user-defined exposure and vulnerability. Without this function, many tools can only be used regionally and not at global or continental scale. It is becoming increasingly easy to use multiple packages for a single region and/or hazard to characterize the uncertainty in the risk, or use as checks for the sensitivities in the analysis. There is a potential for valuable synergy between existing software. A number of open source software packages could be combined to generate a multi-risk model with multiple views of a hazard. This extensive review has simply attempted to provide a platform for dialogue between all open source and open access software packages and to hopefully inspire collaboration between developers, given the great work done by all open access and open source developers.

Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

PubMed

Valleé, Jean-Charles Le; Charlebois, Sylvain

2015-10-01

Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

Nuclear Cardiology: Are We Using the Right Protocols and Tracers the Right Way?

PubMed

Dondi, Maurizio; Pascual, Thomas; Paez, Diana; Einstein, Andrew J

2017-12-01

The field of nuclear cardiology has changed considerably over recent years, with greater attention paid to safety and radiation protection issues. The wider usage of technetium-99m (Tc-99m)-labeled radiopharmaceuticals for single-photon emission computed tomography (SPECT) imaging using gamma cameras has contributed to better quality studies and lower radiation exposure to patients. Increased availability of tracers and scanners for positron emission tomography (PET) will help further improve the quality of studies and quantify myocardial blood flow and myocardial flow reserve, thus enhancing the contribution of non-invasive imaging to the management of coronary artery disease. The introduction of new instrumentation such as solid state cameras and new software will help reduce further radiation exposure to patients undergoing nuclear cardiology studies. Results from recent studies, focused on assessing the relationship between best practices and radiation risk, provide useful insights on simple measures to improve the safety of nuclear cardiology studies without compromising the quality of results.

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.

Correlation of Risk Analysis Method Results with Numerical and Limit Equilibrium Methods in Overall Slope Stability Analysis of Southern Wall of Chadormalu Iron Open Pit Mine-Iran / Korelacja wyników analizy ryzyka z wynikami obliczeń numerycznych oraz wynikami uzyskanymi w oparciu o metodę równowagi granicznej zastosowanych do badania stabilności wyrobiska pochyłego na południowej ścianie odkrywkowej kopalni rud żelaza w chadormalu w Iranie

NASA Astrophysics Data System (ADS)

Ahangari, Kaveh; Paji, Arman Gholinezhad; Behdani, Alireza Siami

2013-06-01

Slope stability analysis is one of the most important factors in designing open pit mines. Therefore an optimal slope design that supports both aspects of economy and safety is very significant. There are many different methods in slope stability analysis including empirical, limit equilibrium, block theory, numerical, and probabilistic methods. In this study, to analyze the overall slope stability of southern wall of Chadormalu iron open pit mine three numerical, limit equilibrium and probabilistic methods have been used. Software and methods that is used for analytical investigation in this study are FLAC software for numerical analysis, SLIDE software and circuit failure chart for limit equilibrium analysis and qualitative fault tree and semi-quantitative risk matrix for probabilistic analysis. The results of all above mentioned methods, was a circular failure occurrence in Metasomatite rock zone between 1405 to 1525 m levels. The main factors of failure occurrence in this range were heavily jointing and existing of faults. Safety factors resulted from numerical method; Circular chart method and SLIDE software are 1.16, 1.25 and 1.27 respectively. Regarding instability and safety factors in Metasomatite rock zone, in order to stabilize the given zone, some considerations such as bench angle and height reduction should be planned. In results of risk matrix method this zone was mentioned too as a high risk zone that numerical and limit equilibrium methods confirmed this. Badanie stabilności wyrobiska pochyłego jest jednym z najważniejszych czynników uwzględnianych przy projektowaniu kopalni odkrywkowych. Optymalne zaprojektowanie wyrobiska pochyłego z uwzględnieniem czynników ekonomicznych oraz bezpieczeństwa jest niezmiernie ważne. Istnieje wiele metod badania stabilności wyrobiska pochyłego, między innymi metody empiryczne, metoda równowagi granicznej, teoria bloków oraz metody numeryczne i probabilistyczne. W pracy tej omówiono zastosowanie trzech spośród tych metod: metody numerycznej, równowagi granicznej oraz metody probabilistycznej, do analizy stabilności wyrobiska pochyłego na południowej ścianie kopalni rud żelaza w Chadormalu w Iranie. Oprogramowanie wykorzystane w badaniach analitycznych to pakiet FLAK przy metodzie numerycznej, oprogramowanie SLIDE oraz wykresy kołowe przy metodzie równowagi granicznej oraz jakościowe drzewa określające występowanie uskoków i pół-jakościowe macierze ryzyka przy metodzie probabilistycznej. Wyniki uzyskane w oparciu o trzy wyżej wymienione metody wykazały wystąpienie zawalenia się skał metasomatycznych na poziomie od 1405 do 1525 m. Głównymi czynnikami warunkującymi zawalenie się skał w tym regionie była obecność licznych pęknięć oraz uskoków. Wskaźniki bezpieczeństwa uzyskane przy pomocy metod numerycznych, wykresu kołowego oraz oprogramowanie SLIDE wyniosły kolejno: 1.16, 1.25, 1.27. W odniesieniu do niestabilności w rejonie skał metasomatycznych, aby uczynić tę strefę bardziej stabilną należy uwzględnić takie czynniki jak kąt nachylenia ławy oraz obniżenie wysokości. Analiza przeprowadzona w oparciu o macierze ryzyka wykazała, że strefa ta jest strefą wysokiego ryzyka, zaś wyniki analizy numerycznej oraz wyników uzyskanych przy pomocy metody równowagi granicznej w pełni ten wniosek potwierdziły.

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

Software risk estimation and management techniques at JPL

NASA Technical Reports Server (NTRS)

Hihn, J.; Lum, K.

2002-01-01

In this talk we will discuss how uncertainty has been incorporated into the JPL software model, probabilistic-based estimates, and how risk is addressed, how cost risk is currently being explored via a variety of approaches, from traditional risk lists, to detailed WBS-based risk estimates to the Defect Detection and Prevention (DDP) tool.

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.

Modeling and Simulation of Shuttle Launch and Range Operations

NASA Technical Reports Server (NTRS)

Bardina, Jorge; Thirumalainambi, Rajkumar

2004-01-01

The simulation and modeling test bed is based on a mockup of a space flight operations control suitable to experiment physical, procedural, software, hardware and psychological aspects of space flight operations. The test bed consists of a weather expert system to advise on the effect of weather to the launch operations. It also simulates toxic gas dispersion model, impact of human health risk, debris dispersion model in 3D visualization. Since all modeling and simulation is based on the internet, it could reduce the cost of operations of launch and range safety by conducting extensive research before a particular launch. Each model has an independent decision making module to derive the best decision for launch.

Distributed Web-Based Expert System for Launch Operations

NASA Technical Reports Server (NTRS)

Bardina, Jorge E.; Thirumalainambi, Rajkumar

2005-01-01

The simulation and modeling of launch operations is based on a representation of the organization of the operations suitable to experiment of the physical, procedural, software, hardware and psychological aspects of space flight operations. The virtual test bed consists of a weather expert system to advice on the effect of weather to the launch operations. It also simulates toxic gas dispersion model, and the risk impact on human health. Since all modeling and simulation is based on the internet, it could reduce the cost of operations of launch and range safety by conducting extensive research before a particular launch. Each model has an independent decision making module to derive the best decision for launch.

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 ...

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?

HyRAM V1.0 User Guide

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

Groth, Katrina M.; Zumwalt, Hannah Ruth; Clark, Andrew Jordan

2016-03-01

Hydrogen Risk Assessment Models (HyRAM) is a prototype software toolkit that integrates data and methods relevant to assessing the safety of hydrogen fueling and storage infrastructure. The HyRAM toolkit integrates deterministic and probabilistic models for quantifying accident scenarios, predicting physical effects, and characterizing the impact of hydrogen hazards, including thermal effects from jet fires and thermal pressure effects from deflagration. HyRAM version 1.0 incorporates generic probabilities for equipment failures for nine types of components, and probabilistic models for the impact of heat flux on humans and structures, with computationally and experimentally validated models of various aspects of gaseous hydrogen releasemore » and flame physics. This document provides an example of how to use HyRAM to conduct analysis of a fueling facility. This document will guide users through the software and how to enter and edit certain inputs that are specific to the user-defined facility. Description of the methodology and models contained in HyRAM is provided in [1]. This User’s Guide is intended to capture the main features of HyRAM version 1.0 (any HyRAM version numbered as 1.0.X.XXX). This user guide was created with HyRAM 1.0.1.798. Due to ongoing software development activities, newer versions of HyRAM may have differences from this guide.« less

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.

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.

Real-time 3D radiation risk assessment supporting simulation of work in nuclear environments.

PubMed

Szőke, I; Louka, M N; Bryntesen, T R; Bratteli, J; Edvardsen, S T; RøEitrheim, K K; Bodor, K

2014-06-01

This paper describes the latest developments at the Institute for Energy Technology (IFE) in Norway, in the field of real-time 3D (three-dimensional) radiation risk assessment for the support of work simulation in nuclear environments. 3D computer simulation can greatly facilitate efficient work planning, briefing, and training of workers. It can also support communication within and between work teams, and with advisors, regulators, the media and public, at all the stages of a nuclear installation's lifecycle. Furthermore, it is also a beneficial tool for reviewing current work practices in order to identify possible gaps in procedures, as well as to support the updating of international recommendations, dissemination of experience, and education of the current and future generation of workers.IFE has been involved in research and development into the application of 3D computer simulation and virtual reality (VR) technology to support work in radiological environments in the nuclear sector since the mid 1990s. During this process, two significant software tools have been developed, the VRdose system and the Halden Planner, and a number of publications have been produced to contribute to improving the safety culture in the nuclear industry.This paper describes the radiation risk assessment techniques applied in earlier versions of the VRdose system and the Halden Planner, for visualising radiation fields and calculating dose, and presents new developments towards implementing a flexible and up-to-date dosimetric package in these 3D software tools, based on new developments in the field of radiation protection. The latest versions of these 3D tools are capable of more accurate risk estimation, permit more flexibility via a range of user choices, and are applicable to a wider range of irradiation situations than their predecessors.

There is more to risk and safety planning than dramatic risks: Mental health nurses' risk assessment and safety-management practice.

PubMed

Higgins, Agnes; Doyle, Louise; Downes, Carmel; Morrissey, Jean; Costello, Paul; Brennan, Michael; Nash, Michael

2016-04-01

Risk assessment and safety planning are considered a cornerstone of mental health practice, yet limited research exists into how mental health nurses conceptualize 'risk' and how they engage with risk assessment and safety planning. The aim of the present study was to explore mental health nurses' practices and confidence in risk assessment and safety planning. A self-completed survey was administered to 381 mental health nurses in Ireland. The findings indicate that nurses focus on risk to self and risk to others, with the risk of suicide, self-harm, substance abuse, and violence being most frequently assessed. Risk from others and 'iatrogenic' risk were less frequently considered. Overall, there was limited evidence of recovery-oriented practice in relation to risk. The results demonstrate a lack of meaningful engagement with respect to collaborative safety planning, the identification and inclusion of protective factors, and the inclusion of positive risk-taking opportunities. In addition, respondents report a lack of confidence working with positive risk taking and involving family/carers in the risk-assessment and safety-planning process. Gaps in knowledge about risk-assessment and safety-planning practice, which could be addressed through education, are identified, as are the implications of the findings for practice and research. © 2015 Australian College of Mental Health Nurses Inc.

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...

Software analysis handbook: Software complexity analysis and software reliability estimation and prediction

NASA Technical Reports Server (NTRS)

Lee, Alice T.; Gunn, Todd; Pham, Tuan; Ricaldi, Ron

1994-01-01

This handbook documents the three software analysis processes the Space Station Software Analysis team uses to assess space station software, including their backgrounds, theories, tools, and analysis procedures. Potential applications of these analysis results are also presented. The first section describes how software complexity analysis provides quantitative information on code, such as code structure and risk areas, throughout the software life cycle. Software complexity analysis allows an analyst to understand the software structure, identify critical software components, assess risk areas within a software system, identify testing deficiencies, and recommend program improvements. Performing this type of analysis during the early design phases of software development can positively affect the process, and may prevent later, much larger, difficulties. The second section describes how software reliability estimation and prediction analysis, or software reliability, provides a quantitative means to measure the probability of failure-free operation of a computer program, and describes the two tools used by JSC to determine failure rates and design tradeoffs between reliability, costs, performance, and schedule.

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).

Introduction to benchmark dose methods and U.S. EPA's benchmark dose software (BMDS) version 2.1.1

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

Davis, J. Allen, E-mail: davis.allen@epa.gov; Gift, Jeffrey S.; Zhao, Q. Jay

2011-07-15

Traditionally, the No-Observed-Adverse-Effect-Level (NOAEL) approach has been used to determine the point of departure (POD) from animal toxicology data for use in human health risk assessments. However, this approach is subject to substantial limitations that have been well defined, such as strict dependence on the dose selection, dose spacing, and sample size of the study from which the critical effect has been identified. Also, the NOAEL approach fails to take into consideration the shape of the dose-response curve and other related information. The benchmark dose (BMD) method, originally proposed as an alternative to the NOAEL methodology in the 1980s, addressesmore » many of the limitations of the NOAEL method. It is less dependent on dose selection and spacing, and it takes into account the shape of the dose-response curve. In addition, the estimation of a BMD 95% lower bound confidence limit (BMDL) results in a POD that appropriately accounts for study quality (i.e., sample size). With the recent advent of user-friendly BMD software programs, including the U.S. Environmental Protection Agency's (U.S. EPA) Benchmark Dose Software (BMDS), BMD has become the method of choice for many health organizations world-wide. This paper discusses the BMD methods and corresponding software (i.e., BMDS version 2.1.1) that have been developed by the U.S. EPA, and includes a comparison with recently released European Food Safety Authority (EFSA) BMD guidance.« less

Medication-use evaluation with a Web application.

PubMed

Burk, Muriel; Moore, Von; Glassman, Peter; Good, Chester B; Emmendorfer, Thomas; Leadholm, Thomas C; Cunningham, Francesca

2013-12-15

A Web-based application for coordinating medication-use evaluation (MUE) initiatives within the Veterans Affairs (VA) health care system is described. The MUE Tracker (MUET) software program was created to improve VA's ability to conduct national medication-related interventions throughout its network of 147 medical centers. MUET initiatives are centrally coordinated by the VA Center for Medication Safety (VAMedSAFE), which monitors the agency's integrated databases for indications of suboptimal prescribing or drug therapy monitoring and adverse treatment outcomes. When a pharmacovigilance signal is detected, VAMedSAFE identifies "trigger groups" of at-risk veterans and uploads patient lists to the secure MUET application, where locally designated personnel (typically pharmacists) can access and use the data to target risk-reduction efforts. Local data on patient-specific interventions are stored in a centralized database and regularly updated to enable tracking and reporting for surveillance and quality-improvement purposes; aggregated data can be further analyzed for provider education and benchmarking. In a three-year pilot project, the MUET program was found effective in promoting improved prescribing of erythropoiesis-stimulating agents (ESAs) and enhanced laboratory monitoring of ESA-treated patients in all specified trigger groups. The MUET initiative has since been expanded to target other high-risk drugs, and efforts are underway to refine the tool for broader utility. The MUET application has enabled the increased standardization of medication safety initiatives across the VA system and may serve as a useful model for the development of pharmacovigilance tools by other large integrated health care systems.

TU-FG-201-07: Development of SRS Conical Collimator Collision Prediction Software for Radiation Treatment Safety

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

Gutti, V; Morrow, A; Kim, S

Purpose: Stereotactic radiosurgery (SRS) treatments using conical collimators can potentially result in gantry collision with treatment table due to limited collision-clear spaces. An in-house software was developed to help the SRS treatment planner mitigate potential SRS conical collimator (Varian Medical System, Palo Alto, CA) collisions with the treatment table. This software was designed to remove treatment re-planning secondary to unexpected collisions. Methods: A BrainLAB SRS ICT Frameless Extension used for SRS treatments in our clinic was mathematically modelled using surface points registered to the 3D co-ordinate space of the couch extension. The surface points are transformed based on the treatmentmore » isocenter point and potential collisions are determined in 3D space for couch and gantry angle combinations. The distance between the SRS conical collimators and LINAC isocenter is known. The collision detection model was programmed in MATLAB (Mathwork, Natick, MA) to display graphical plots of the calculations, and the plotted data is used to avoid the gantry and couch angle combinations that would likely result in a collision. We have utilized the cone collision tool for 23 SRS cone treatment plans (8 retrospective and 15 prospective for 10 patients). Results: Twenty one plans strongly agreed with the software tool prediction for collision. However, in two plans, a collision was observed with a 0.5 cm margin when the software predicted no collision. Therefore, additional margins were added to the clearance criteria in the program to achieve a lower risk of actual collisions. Conclusion: Our in-house developed collision check software successfully avoided SRS cone re-planning by 91.3% due to a reduction in cone collisions with the treatment table. Future developments to our software will include a CT image data set based collision prediction model as well as a beam angle optimization tool to avoid normal critical tissues as well as previously treated lesions.« less

Evaluation of Key Factors Impacting Feeding Safety in the Neonatal Intensive Care Unit: A Systematic Review.

PubMed

Matus, Bethany A; Bridges, Kayla M; Logomarsino, John V

2018-06-21

Individualized feeding care plans and safe handling of milk (human or formula) are critical in promoting growth, immune function, and neurodevelopment in the preterm infant. Feeding errors and disruptions or limitations to feeding processes in the neonatal intensive care unit (NICU) are associated with negative safety events. Feeding errors include contamination of milk and delivery of incorrect or expired milk and may result in adverse gastrointestinal illnesses. The purpose of this review was to evaluate the effect(s) of centralized milk preparation, use of trained technicians, use of bar code-scanning software, and collaboration between registered dietitians and registered nurses on feeding safety in the NICU. A systematic review of the literature was completed, and 12 articles were selected as relevant to search criteria. Study quality was evaluated using the Downs and Black scoring tool. An evaluation of human studies indicated that the use of centralized milk preparation, trained technicians, bar code-scanning software, and possible registered dietitian involvement decreased feeding-associated error in the NICU. A state-of-the-art NICU includes a centralized milk preparation area staffed by trained technicians, care supported by bar code-scanning software, and utilization of a registered dietitian to improve patient safety. These resources will provide nurses more time to focus on nursing-specific neonatal care. Further research is needed to evaluate the impact of factors related to feeding safety in the NICU as well as potential financial benefits of these quality improvement opportunities.

Software Acquisition Risk Management Key Process Area (KPA) - A Guidebook Version 1.0.

DTIC Science & Technology

1997-08-01

Budget - Software Project Management Practices and Techniques. McGraw-Hill International (UK) Limited, 1992. [Boehm 81 ] Boehm, Barry . Software...Engineering Economics. Englewood Cliffs, N.J.: Prentice-Hall, Inc., 1981. [Boehm 89] Boehm, Barry . IEEE Tutorial on Software Risk Management. New York: IEEE...95] [Mayrhauser 90] [Moran 90] [Myers 96] [NRC 89] [Osborn 53] [Paulk 95] [ Pressman 92] [Pulford 96] [Scholtes 88] [Sisti 94] [STSC 96

Software Tools for Developing and Simulating the NASA LaRC CMF Motion Base

NASA Technical Reports Server (NTRS)

Bryant, Richard B., Jr.; Carrelli, David J.

2006-01-01

The NASA Langley Research Center (LaRC) Cockpit Motion Facility (CMF) motion base has provided many design and analysis challenges. In the process of addressing these challenges, a comprehensive suite of software tools was developed. The software tools development began with a detailed MATLAB/Simulink model of the motion base which was used primarily for safety loads prediction, design of the closed loop compensator and development of the motion base safety systems1. A Simulink model of the digital control law, from which a portion of the embedded code is directly generated, was later added to this model to form a closed loop system model. Concurrently, software that runs on a PC was created to display and record motion base parameters. It includes a user interface for controlling time history displays, strip chart displays, data storage, and initializing of function generators used during motion base testing. Finally, a software tool was developed for kinematic analysis and prediction of mechanical clearances for the motion system. These tools work together in an integrated package to support normal operations of the motion base, simulate the end to end operation of the motion base system providing facilities for software-in-the-loop testing, mechanical geometry and sensor data visualizations, and function generator setup and evaluation.

A Hazardous Gas Detection System for Aerospace and Commercial Applications

NASA Technical Reports Server (NTRS)

Hunter, G. W.; Neudeck, P. G.; Chen, L. - Y.; Makel, D. B.; Liu, C. C.; Wu, Q. H.; Knight, D.

1998-01-01

The detection of explosive conditions in aerospace propulsion applications is important for safety and economic reasons. Microfabricated hydrogen, oxygen, and hydrocarbon sensors as well as the accompanying hardware and software are being developed for a range of aerospace safety applications. The development of these sensors is being done using MEMS (Micro ElectroMechanical Systems) based technology and SiC-based semiconductor technology. The hardware and software allows control and interrogation of each sensor head and reduces accompanying cabling through multiplexing. These systems are being applied on the X-33 and on an upcoming STS-95 Shuttle mission. A number of commercial applications are also being pursued. It is concluded that this MEMS-based technology has significant potential to reduce costs and increase safety in a variety of aerospace applications.

A Hazardous Gas Detection System for Aerospace and Commercial Applications

NASA Technical Reports Server (NTRS)

Hunter, G. W.; Neudeck, P. G.; Chen, L.-Y.; Makel, D. B.; Liu, C. C.; Wu, Q. H.; Knight, D.

1998-01-01

The detection of explosive conditions in aerospace propulsion applications is important for safety and economic reasons. Microfabricated hydrogen, oxygen, and hydrocarbon sensors as well as the accompanying hardware and software are being, developed for a range of aerospace safety applications. The development of these sensors is being done using MEMS (Micro ElectroMechanical Systems) based technology and SiC-based semiconductor technology. The hardware and software allows control and interrocation of each sensor head and reduces accompanying cabling through multiplexing. These systems are being, applied on the X-33 and on an upcoming STS-95 Shuttle mission. A number of commercial applications are also being pursued. It is concluded that this MEMS-based technology has significant potential to reduce costs and increase safety in a variety of aerospace applications.

Estimating and controlling workplace risk: an approach for occupational hygiene and safety professionals.

PubMed

Toffel, Michael W; Birkner, Lawrence R

2002-07-01

The protection of people and physical assets is the objective of health and safety professionals and is accomplished through the paradigm of anticipation, recognition, evaluation, and control of risks in the occupational environment. Risk assessment concepts are not only used by health and safety professionals, but also by business and financial planners. Since meeting health and safety objectives requires financial resources provided by business and governmental managers, the hypothesis addressed here is that health and safety risk decisions should be made with probabilistic processes used in financial decision-making and which are familiar and recognizable to business and government planners and managers. This article develops the processes and demonstrates the use of incident probabilities, historic outcome information, and incremental impact analysis to estimate risk of multiple alternatives in the chemical process industry. It also analyzes how the ethical aspects of decision-making can be addressed in formulating health and safety risk management plans. It is concluded that certain, easily understood, and applied probabilistic risk assessment methods used by business and government to assess financial and outcome risk have applicability to improving workplace health and safety in three ways: 1) by linking the business and health and safety risk assessment processes to securing resources, 2) by providing an additional set of tools for health and safety risk assessment, and 3) by requiring the risk assessor to consider multiple risk management alternatives.

WinDAM C earthen embankment internal erosion analysis software

USDA-ARS?s Scientific Manuscript database

Two primary causes of dam failure are overtopping and internal erosion. For the purpose of evaluating dam safety for existing earthen embankment dams and proposed earthen embankment dams, Windows Dam Analysis Modules C (WinDAM C) software will simulate either internal erosion or erosion resulting f...

Coupled dam safety analysis using WinDAM

USDA-ARS?s Scientific Manuscript database

Windows® Dam Analysis Modules (WinDAM) is a set of modular software components that can be used to analyze overtopping and internal erosion of embankment dams. Dakota is an extensive software framework for design exploration and simulation. These tools can be coupled to create a powerful framework...

Improving Airline Safety

NASA Technical Reports Server (NTRS)

1998-01-01

Under a NASA-Ames Space Act Agreement, Coryphaeus Software and Simauthor, Inc., developed an Aviation Performance Measuring System (APMS). This software, developed for the aerospace and airline industry, enables the replay of Digital Flight Data Recorder (DFDR) data in a flexible, user-configurable, real-time, high fidelity 3D (three dimensional) environment.

Road Infrastructure Safety Management in Poland

NASA Astrophysics Data System (ADS)

Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

2017-10-01

The objective of road safety infrastructure management is to ensure that when roads are planned, designed, built and used road risks can be identified, assessed and mitigated. Road transport safety is significantly less developed than that of rail, water and air transport. The average individual risk of being a fatality in relation to the distance covered is thirty times higher in road transport that in the other modes. This is mainly because the different modes have a different approach to safety management and to the use of risk management methods and tools. In recent years Poland has had one of the European Union’s highest road death numbers. In 2016 there were 3026 fatalities on Polish roads with 40,766 injuries. Protecting road users from the risk of injury and death should be given top priority. While Poland’s national and regional road safety programmes address this problem and are instrumental in systematically reducing the number of casualties, the effects are far from the expectations. Modern approaches to safety focus on three integrated elements: infrastructure measures, safety management and safety culture. Due to its complexity, the process of road safety management requires modern tools to help with identifying road user risks, assess and evaluate the safety of road infrastructure and select effective measures to improve road safety. One possible tool for tackling this problem is the risk-based method for road infrastructure safety management. European Union Directive 2008/96/EC regulates and proposes a list of tools for managing road infrastructure safety. Road safety tools look at two criteria: the life cycle of a road structure and the process of risk management. Risk can be minimized through the application of the proposed interventions during design process as reasonable. The proposed methods of risk management bring together two stages: risk assessment and risk response occurring within the analyzed road structure (road network, road stretch, road section, junction, etc.). The objective of the methods is to help road authorities to take rational decisions in the area of road safety and road infrastructure safety and understand the consequences occurring in the particular phases of road life cycle. To help with assessing the impact of a road project on the safety of related roads, a method was developed for long-term forecasts of accidents and accident cost estimation as well as a risk classification to identify risks that are not acceptable risks. With regard to road safety audits and road safety inspection, a set of principles was developed to identify risks and the basic classification of mistakes and omissions. This work has added to the Polish experience of preparing and implementing such tools within the competent road authorities.

Qualitative Future Safety Risk Identification an Update

NASA Technical Reports Server (NTRS)

Barr, Lawrence C.

2017-01-01

The purpose of this report is to document the results of a high-level qualitative study that was conducted to identify future aviation safety risks and to assess the potential impacts to the National Airspace System (NAS) of NASA Aviation Safety research on these risks. Multiple external sources (for example, the National Transportation Safety Board, the Flight Safety Foundation, the National Research Council, and the Joint Planning and Development Office) were used to develop a compilation of future safety issues risks, also referred to as future tall poles. The primary criterion used to identify the most critical future safety risk issues was that the issue must be cited in several of these sources as a safety area of concern. The tall poles in future safety risk, in no particular order of importance, are as follows: Runway Safety, Loss of Control In Flight, Icing Ice Detection, Loss of Separation, Near Midair Collision Human Fatigue, Increasing Complexity and Reliance on Automation, Vulnerability Discovery, Data Sharing and Dissemination, and Enhanced Survivability in the Event of an Accident.

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

Towards A Comprehensive Consideration of Epistemic Questions in Software System Safety

NASA Technical Reports Server (NTRS)

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

2009-01-01

For any software system upon which lives depend, the most important question one can ask about it is, 'How do we know the system is safe?' Despite the critical importance of this question, no widely accepted, generally applicable answer exists. Instead, debate continues to rage over the question, with theorists and practitioners quarrelling with each other and amongst themselves. This paper suggests a possible way forward towards quelling the quarrels, based on refining the critical safety question into additional questions, which may be more likely to have answers on which a consensus can be reached.

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.

Advancing the integration of hospital IT. Pitfalls and perspectives when replacing specialized software for high-risk environments with enterprise system extensions.

PubMed

Engelmann, Carsten; Ametowobla, Dzifa

2017-05-17

Planning and controlling surgical operations hugely impacts upon productivity, patient safety, and surgeons' careers. Established, specialized software for this task is being increasingly replaced by "Operating Room (OR)-modules" appended to enterprise-wide resource planning (ERP) systems. As a result, usability problems are re-emerging and require developers' attention. Systematic evaluation of the functionality and social repercussions of a global, market-leading IT business control system (SAP R3, Germany), adapted for real-time OR process steering. Field study involving document analyses, interviews, and a 73-item survey addressed to 77 qualified (> 1-year system experience) senior planning executives (end users; "planners") working in surgical departments of university hospitals. Planners reported that 57% of electronic operation requests contained contradictory information. Key screens contained clinically irrelevant areas (36 +/- 29%). Compared to the legacy system, users reported either no improvements or worse performance, in regard to co-ordination of OR stakeholders, intra-day program changes, and safety. Planners concluded that the ERP-planning module was "non-intuitive" (66%), increased planning work (56%, p=0.002), and did not impact upon either organizational mishap spectrum or frequency. Interviews evidenced intra-institutional power shifts due to increased system complexity. Planners resented e.g. a trend towards increased personal culpability for mishap. Highly complex enterprise system extensions may not be directly suited to specific process steering tasks in a high risk/low error-environment like the OR. In view of surgeons' high primary task load, the repeated call for simpler IT is an imperative for ERP extensions. System design should consider a) that current OR IT suffers from an input limitation regarding planning-relevant real-time data, and b) that there are social processes that strongly affect planning and particularly ERP use beyond algorithms. Real improvement of clinical IT tools requires their independent evaluation according to standards developed for pharmaceutical subjects.

77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

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.

Certification of highly complex safety-related systems.

PubMed

Reinert, D; Schaefer, M

1999-01-01

The BIA has now 15 years of experience with the certification of complex electronic systems for safety-related applications in the machinery sector. Using the example of machining centres this presentation will show the systematic procedure for verifying and validating control systems using Application Specific Integrated Circuits (ASICs) and microcomputers for safety functions. One section will describe the control structure of machining centres with control systems using "integrated safety." A diverse redundant architecture combined with crossmonitoring and forced dynamization is explained. In the main section the steps of the systematic certification procedure are explained showing some results of the certification of drilling machines. Specification reviews, design reviews with test case specification, statistical analysis, and walk-throughs are the analytical measures in the testing process. Systematic tests based on the test case specification, Electro Magnetic Interference (EMI), and environmental testing, and site acceptance tests on the machines are the testing measures for validation. A complex software driven system is always undergoing modification. Most of the changes are not safety-relevant but this has to be proven. A systematic procedure for certifying software modifications is presented in the last section of the paper.

Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety Final Report

DOT National Transportation Integrated Search

2008-02-01

This Final Report describes the process and product from the project, Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety (OBMS), in which a prototypical suite of hardware and software on a class 8 truck was developed and tested. The...

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

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.

Element Load Data Processor (ELDAP) Users Manual

NASA Technical Reports Server (NTRS)

Ramsey, John K., Jr.; Ramsey, John K., Sr.

2015-01-01

Often, the shear and tensile forces and moments are extracted from finite element analyses to be used in off-line calculations for evaluating the integrity of structural connections involving bolts, rivets, and welds. Usually the maximum forces and moments are desired for use in the calculations. In situations where there are numerous structural connections of interest for numerous load cases, the effort in finding the true maximum force and/or moment combinations among all fasteners and welds and load cases becomes difficult. The Element Load Data Processor (ELDAP) software described herein makes this effort manageable. This software eliminates the possibility of overlooking the worst-case forces and moments that could result in erroneous positive margins of safety and/or selecting inconsistent combinations of forces and moments resulting in false negative margins of safety. In addition to forces and moments, any scalar quantity output in a PATRAN report file may be evaluated with this software. This software was originally written to fill an urgent need during the structural analysis of the Ares I-X Interstage segment. As such, this software was coded in a straightforward manner with no effort made to optimize or minimize code or to develop a graphical user interface.

Independent verification and validation for Space Shuttle flight software

NASA Technical Reports Server (NTRS)

1992-01-01

The Committee for Review of Oversight Mechanisms for Space Shuttle Software was asked by the National Aeronautics and Space Administration's (NASA) Office of Space Flight to determine the need to continue independent verification and validation (IV&V) for Space Shuttle flight software. The Committee found that the current IV&V process is necessary to maintain NASA's stringent safety and quality requirements for man-rated vehicles. Therefore, the Committee does not support NASA's plan to eliminate funding for the IV&V effort in fiscal year 1993. The Committee believes that the Space Shuttle software development process is not adequate without IV&V and that elimination of IV&V as currently practiced will adversely affect the overall quality and safety of the software, both now and in the future. Furthermore, the Committee was told that no organization within NASA has the expertise or the manpower to replace the current IV&V function in a timely fashion, nor will building this expertise elsewhere necessarily reduce cost. Thus, the Committee does not recommend moving IV&V functions to other organizations within NASA unless the current IV&V is maintained for as long as it takes to build comparable expertise in the replacing organization.

Ascent/Descent Software

NASA Technical Reports Server (NTRS)

Brown, Charles; Andrew, Robert; Roe, Scott; Frye, Ronald; Harvey, Michael; Vu, Tuan; Balachandran, Krishnaiyer; Bly, Ben

2012-01-01

The Ascent/Descent Software Suite has been used to support a variety of NASA Shuttle Program mission planning and analysis activities, such as range safety, on the Integrated Planning System (IPS) platform. The Ascent/Descent Software Suite, containing Ascent Flight Design (ASC)/Descent Flight Design (DESC) Configuration items (Cis), lifecycle documents, and data files used for shuttle ascent and entry modeling analysis and mission design, resides on IPS/Linux workstations. A list of tools in Navigation (NAV)/Prop Software Suite represents tool versions established during or after the IPS Equipment Rehost-3 project.

Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases.

PubMed

Egbring, Marco; Kullak-Ublick, Gerd A; Russmann, Stefan

2010-01-01

To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.

Development of a tool for documenting, tracking, recording, and analyzing improvements to intersection sites and roadway departures in curve locations.

DOT National Transportation Integrated Search

2015-04-01

The principal objectives and scope of this project were to provide a software tracking tool to improve : decision-making for highway safety. A literature search revealed that purchasing and customizing : existing software was not feasible and a new s...

Are cellular phone blocking applications effective for novice teen drivers?

PubMed

Creaser, Janet I; Edwards, Christopher J; Morris, Nichole L; Donath, Max

2015-09-01

Distracted driving is a significant concern for novice teen drivers. Although cellular phone bans are applied in many jurisdictions to restrict cellular phone use, teen drivers often report making calls and texts while driving. The Minnesota Teen Driver Study incorporated cellular phone blocking functions via a software application for 182 novice teen drivers in two treatment conditions. The first condition included 92 teens who ran a driver support application on a smartphone that also blocked phone usage. The second condition included 90 teens who ran the same application with phone blocking but which also reported back to parents about monitored risky behaviors (e.g., speeding). A third control group consisting of 92 novice teen drivers had the application and phone-based software installed on the phones to record cellular phone (but not block it) use while driving. The two treatment groups made significantly fewer calls and texts per mile driven compared to the control group. The control group data also demonstrated a higher propensity to text while driving rather than making calls. Software that blocks cellular phone use (except 911) while driving can be effective at mitigating calling and texting for novice teen drivers. However, subjective data indicates that some teens were motivated to find ways around the software, as well as to use another teen's phone while driving when they were unable to use theirs. Cellular phone bans for calling and texting are the first step to changing behaviors associated with texting and driving, particularly among novice teen drivers. Blocking software has the additional potential to reduce impulsive calling and texting while driving among novice teen drivers who might logically know the risks, but for whom it is difficult to ignore calling or texting while driving. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

Fault Management Architectures and the Challenges of Providing Software Assurance

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

Fault Management Architectures and the Challenges of Providing Software Assurance

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

Do we see how they perceive risk? An integrated analysis of risk perception and its effect on workplace safety behavior.

PubMed

Xia, Nini; Wang, Xueqing; Griffin, Mark A; Wu, Chunlin; Liu, Bingsheng

2017-09-01

While risk perception is a key factor influencing safety behavior, the academia lacks specific attention to the ways that workers perceive risk, and thus little is known about the mechanisms through which different risk perceptions influence safety behavior. Most previous research in the workplace safety domain argues that people tend to perceive risk based on rational formulations of risk criticality. However, individuals' emotions can be also useful in understanding their perceptions. Therefore, this research employs an integrated analysis concerning the rational and emotional perspectives. Specifically, it was expected that the identified three rational ways of perceiving risk, i.e., perceived probability, severity, and negative utility, would influence the direct emotional risk perception. Furthermore, these four risk perceptions were all expected to positively but differently influence safety behavior. The hypotheses were tested using a sample of 120 construction workers. It was found that all the three rational risk perceptions significantly influenced workers' direct perception of risk that is mainly based on emotions. Furthermore, safety behavior among workers relied mainly on emotional perception but not rational calculations of risk. This research contributes to workplace safety research by highlighting the importance of integrating the emotional assessment of risk, especially when workers' risk perception and behavior are concerned. Suggested avenues for improving safety behavior through improvement in risk perception include being aware of the possibility of different ways of perceiving risk, promoting experience sharing and accident simulation, and uncovering risk information. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluating Predictive Models of Software Quality

NASA Astrophysics Data System (ADS)

Ciaschini, V.; Canaparo, M.; Ronchieri, E.; Salomoni, D.

2014-06-01

Applications from High Energy Physics scientific community are constantly growing and implemented by a large number of developers. This implies a strong churn on the code and an associated risk of faults, which is unavoidable as long as the software undergoes active evolution. However, the necessities of production systems run counter to this. Stability and predictability are of paramount importance; in addition, a short turn-around time for the defect discovery-correction-deployment cycle is required. A way to reconcile these opposite foci is to use a software quality model to obtain an approximation of the risk before releasing a program to only deliver software with a risk lower than an agreed threshold. In this article we evaluated two quality predictive models to identify the operational risk and the quality of some software products. We applied these models to the development history of several EMI packages with intent to discover the risk factor of each product and compare it with its real history. We attempted to determine if the models reasonably maps reality for the applications under evaluation, and finally we concluded suggesting directions for further studies.

Workplace bullying in risk and safety professionals.

PubMed

Brewer, Gayle; Holt, Barry; Malik, Shahzeb

2018-02-01

Previous research demonstrates that workplace bullying impacts the welfare of victimized employees, with further consequences for the organization and profession. There is, however, a paucity of information relating to the bullying directed at risk and safety professionals. The present study was conducted to address this issue. Risk and safety professionals (N=420) completed the Negative Acts Questionnaire - Revised and Brief Cope, and reported the extent to which they had been pressured to make or amend a risk or safety based decision. Those experiencing workplace bullying were more likely to engage in a range of coping behaviors, with exposure to work-related and personal bullying particularly influential. Workplace bullying also predicted pressure to make or change a risk or safety based decision. Work related and physically intimidating bullying were particularly important for this aspect of professional practice. Findings are discussed with regard to current practice and the support available to risk and safety professionals. Risk and safety professionals require additional support in relation to workplace bullying and specifically guidance to resist pressure to make or change a risk or safety based decision. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

CoNNeCT Antenna Positioning System Dynamic Simulator Modal Model Correlation

NASA Technical Reports Server (NTRS)

Jones, Tevor M.; McNelis, Mark E.; Staab, Lucas D.; Akers, James C.; Suarez, Vicente

2012-01-01

The National Aeronautics and Space Administration (NASA) developed an on-orbit, adaptable, Software Defined Radios (SDR)/Space Telecommunications Radio System (STRS)-based testbed facility to conduct a suite of experiments to advance technologies, reduce risk, and enable future mission capabilities on the International Space Station (ISS). The Communications, Navigation, and Networking reConfigurable Testbed (CoNNeCT) Project will provide NASA, industry, other Government agencies, and academic partners the opportunity to develop and field communications, navigation, and networking technologies in both the laboratory and space environment based on reconfigurable, software-defined radio platforms and the STRS Architecture. The CoNNeCT Payload Operations Nomenclature is "SCAN Testbed," and this nomenclature will be used in all ISS integration, safety, verification, and operations documentation. The SCAN Testbed (payload) is a Flight Releasable Attachment Mechanism (FRAM) based payload that will launch aboard the Japanese H-II Transfer Vehicle (HTV) Multipurpose Exposed Pallet (EP-MP) to the International Space Station (ISS), and will be transferred to the Express Logistics Carrier 3 (ELC3) via Extravehicular Robotics (EVR). The SCAN Testbed will operate on-orbit for a minimum of two years.

CoNNeCT Antenna Positioning System Dynamic Simulator Modal Model Correlation

NASA Technical Reports Server (NTRS)

Jones, Trevor M.; McNelis, Mark E.; Staab, Lucas D.; Akers, James C.; Suarez, Vicente J.

2012-01-01

The National Aeronautics and Space Administration (NASA) developed an on-orbit, adaptable, Software Defined Radios (SDR)/Space Telecommunications Radio System (STRS)-based testbed facility to conduct a suite of experiments to advance technologies, reduce risk, and enable future mission capabilities on the International Space Station (ISS). The Communications, Navigation, and Networking reConfigurable Testbed (CoNNeCT) Project will provide NASA, industry, other Government agencies, and academic partners the opportunity to develop and field communications, navigation, and networking technologies in both the laboratory and space environment based on reconfigurable, software-defined radio platforms and the STRS Architecture. The CoNNeCT Payload Operations Nomenclature is SCAN Testbed, and this nomenclature will be used in all ISS integration, safety, verification, and operations documentation. The SCAN Testbed (payload) is a Flight Releasable Attachment Mechanism (FRAM) based payload that will launch aboard the Japanese H-II Transfer Vehicle (HTV) Multipurpose Exposed Pallet (EP-MP) to the International Space Station (ISS), and will be transferred to the Express Logistics Carrier 3 (ELC3) via Extravehicular Robotics (EVR). The SCAN Testbed will operate on-orbit for a minimum of two years.

Virtual reality for mine safety training.

PubMed

Filigenzi, M T; Orr, T J; Ruff, T M

2000-06-01

Mining has long remained one of America's most hazardous occupations. Researchers believe that by developing realistic, affordable VR training software, miners will be able to receive accurate training in hazard recognition and avoidance. In addition, the VR software will allow miners to follow mine evacuation routes and safe procedures without exposing themselves to danger. This VR software may ultimately be tailored to provide training in other industries, such as the construction, agricultural, and petroleum industries.

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.

78 FR 53245 - Safety Zone; San Diego Bayfair; Mission Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

..., Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may...-AA00 Safety Zone; San Diego Bayfair; Mission Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION...

Software Assurance Competency Model

DTIC Science & Technology

2013-03-01

COTS) software , and software as a service ( SaaS ). L2: Define and analyze risks in the acquisition of contracted software , COTS software , and SaaS ...2010a]: Application of technologies and processes to achieve a required level of confidence that software systems and services function in the...

A Practical Approach to Modified Condition/Decision Coverage

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.; Veerhusem, Dan S.

2001-01-01

Testing of software intended for safety-critical applications in commercial transport aircraft must achieve modified condition/decision coverage (MC/DC) of the software structure. This requirement causes anxiety for many within the aviation software community. Results of a survey of the aviation software industry indicate that many developers believe that meeting the MC/DC requirement is difficult, and the cost is exorbitant. Some of the difficulties stem, no doubt, from the scant information available on the subject. This paper provides a practical 5-step approach for assessing MC/DC for aviation software products, and an analysis of some types of errors expected to be caught when MC/DC is achieved1.

Software Model Checking Without Source Code

NASA Technical Reports Server (NTRS)

Chaki, Sagar; Ivers, James

2009-01-01

We present a framework, called AIR, for verifying safety properties of assembly language programs via software model checking. AIR extends the applicability of predicate abstraction and counterexample guided abstraction refinement to the automated verification of low-level software. By working at the assembly level, AIR allows verification of programs for which source code is unavailable-such as legacy and COTS software-and programs that use features-such as pointers, structures, and object-orientation-that are problematic for source-level software verification tools. In addition, AIR makes no assumptions about the underlying compiler technology. We have implemented a prototype of AIR and present encouraging results on several non-trivial examples.

Staying Secure for School Safety

ERIC Educational Resources Information Center

Youngkin, Minu

2012-01-01

Proper planning and preventive maintenance can increase school security and return on investment. Preventive maintenance begins with planning. Through careful planning, education institutions can determine what is working and if any equipment, hardware or software needs to be replaced or upgraded. When reviewing a school's safety and security…

Operational improvements at traffic circles : safety analysis, final report, December 2008.

DOT National Transportation Integrated Search

2008-12-01

The purpose of this study was to improve the safety and operation at three traffic circles in New : Jersey. To do this, data were collected at the traffic circles to allow researchers to model the : circles using the PARAMICS software simulation pack...

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Risk-Based Object Oriented Testing

NASA Technical Reports Server (NTRS)

Rosenberg, Linda H.; Stapko, Ruth; Gallo, Albert

2000-01-01

Software testing is a well-defined phase of the software development life cycle. Functional ("black box") testing and structural ("white box") testing are two methods of test case design commonly used by software developers. A lesser known testing method is risk-based testing, which takes into account the probability of failure of a portion of code as determined by its complexity. For object oriented programs, a methodology is proposed for identification of risk-prone classes. Risk-based testing is a highly effective testing technique that can be used to find and fix the most important problems as quickly as possible.

Track train dynamics analysis and test program: Methodology development for the derailment safety analysis of six-axle locomotives

NASA Technical Reports Server (NTRS)

Marcotte, P. P.; Mathewson, K. J. R.

1982-01-01

The operational safety of six axle locomotives is analyzed. A locomotive model with corresponding data on suspension characteristics, a method of track defect characterization, and a method of characterizing operational safety are used. A user oriented software package was developed as part of the methodology and was used to study the effect (on operational safety) of various locomotive parameters and operational conditions such as speed, tractive effort, and track curvature. The operational safety of three different locomotive designs was investigated.

Acupuncture for common cold: A systematic review and meta-analyze protocol.

PubMed

Cheng, Ying; Gao, Bifeng; Jin, Yuhao; Xu, Na; Guo, Taipin

2018-03-01

The common cold (CC) is the most common syndromes of infection in human beings, but there is currently no special treatment. For this reason, acupuncture is used to relieve the symptoms of the CC. Acupuncture is a traditional Chinese medicine (TCM) therapy that has been used for over 2000 years to treat various diseases. However, few studies have provided evidence for the efficacy and safety of acupuncture for the CC. This study aims to evaluate the effectiveness and safety of acupuncture on CC periods and its symptoms. The following electronic databases will be searched for studies conducted through January 1, 2019: Web of Science, Cochrane Library, EBASE, World Health Organization International Clinical Trials Registry Platform, Springer, Wan-fang database, Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP), China National Knowledge Infrastructure (CNKI), and other sources. All randomized controlled trials on acupuncture for common cold will be included. Risk of bias will be assessed using the Cochrane risk of bias assessment tool, while RevMan V.5.3.5 software will be implemented for the assessment of bias risk, data synthesis, subgroup analysis, and meta-analyses if conditions are met. Continuous outcomes will be presented as mean difference (MD) or standard mean difference (SMD), while dichotomous data will be expressed as relative risk. A high-quality synthesis of current evidence of acupuncture for CC will be stated from several aspect using subjective reports and objective measures of performance. The reduction rate of common cold symptoms after initial treatment, resolved cold symptoms, and reduced cold duration will be collected. This protocol will present the evidence of whether acupuncture therapy is an effective intervention for CC.

Integrated Software Health Management for Aircraft GN and C

NASA Technical Reports Server (NTRS)

Schumann, Johann; Mengshoel, Ole

2011-01-01

Modern aircraft rely heavily on dependable operation of many safety-critical software components. Despite careful design, verification and validation (V&V), on-board software can fail with disastrous consequences if it encounters problematic software/hardware interaction or must operate in an unexpected environment. We are using a Bayesian approach to monitor the software and its behavior during operation and provide up-to-date information about the health of the software and its components. The powerful reasoning mechanism provided by our model-based Bayesian approach makes reliable diagnosis of the root causes possible and minimizes the number of false alarms. Compilation of the Bayesian model into compact arithmetic circuits makes SWHM feasible even on platforms with limited CPU power. We show initial results of SWHM on a small simulator of an embedded aircraft software system, where software and sensor faults can be injected.

77 FR 35852 - Safety Zones; Multiple Firework Displays in Captain of the Port, Puget Sound Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may... 1625-AA00 Safety Zones; Multiple Firework Displays in Captain of the Port, Puget Sound Zone AGENCY...

78 FR 39610 - Safety Zone; Big Bay Boom, San Diego Bay; San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

..., Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may...-AA00 Safety Zone; Big Bay Boom, San Diego Bay; San Diego, CA AGENCY: Coast Guard, DHS. ACTION...

The Secret of Safety Lies in Danger.

ERIC Educational Resources Information Center

Wildavsky, Aaron

In creating and maintaining public safety, risks which entail some amount of danger are necessary. These risks must be rated regarding the amount of benefit and danger they would bring in order to ascertain the worthiness of the risk. It is important to realize that risks can often bring greater safety, that many safety devices themselves involve…

75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

A survey of Canadian medical physicists: software quality assurance of in-house software.

PubMed

Salomons, Greg J; Kelly, Diane

2015-01-05

This paper reports on a survey of medical physicists who write and use in-house written software as part of their professional work. The goal of the survey was to assess the extent of in-house software usage and the desire or need for related software quality guidelines. The survey contained eight multiple-choice questions, a ranking question, and seven free text questions. The survey was sent to medical physicists associated with cancer centers across Canada. The respondents to the survey expressed interest in having guidelines to help them in their software-related work, but also demonstrated extensive skills in the area of testing, safety, and communication. These existing skills form a basis for medical physicists to establish a set of software quality guidelines.

Mass and Reliability System (MaRS)

NASA Technical Reports Server (NTRS)

Barnes, Sarah

2016-01-01

The Safety and Mission Assurance (S&MA) Directorate is responsible for mitigating risk, providing system safety, and lowering risk for space programs from ground to space. The S&MA is divided into 4 divisions: The Space Exploration Division (NC), the International Space Station Division (NE), the Safety & Test Operations Division (NS), and the Quality and Flight Equipment Division (NT). The interns, myself and Arun Aruljothi, will be working with the Risk & Reliability Analysis Branch under the NC Division's. The mission of this division is to identify, characterize, diminish, and communicate risk by implementing an efficient and effective assurance model. The team utilizes Reliability and Maintainability (R&M) and Probabilistic Risk Assessment (PRA) to ensure decisions concerning risks are informed, vehicles are safe and reliable, and program/project requirements are realistic and realized. This project pertains to the Orion mission, so it is geared toward a long duration Human Space Flight Program(s). For space missions, payload is a critical concept; balancing what hardware can be replaced by components verse by Orbital Replacement Units (ORU) or subassemblies is key. For this effort a database was created that combines mass and reliability data, called Mass and Reliability System or MaRS. The U.S. International Space Station (ISS) components are used as reference parts in the MaRS database. Using ISS components as a platform is beneficial because of the historical context and the environment similarities to a space flight mission. MaRS uses a combination of systems: International Space Station PART for failure data, Vehicle Master Database (VMDB) for ORU & components, Maintenance & Analysis Data Set (MADS) for operation hours and other pertinent data, & Hardware History Retrieval System (HHRS) for unit weights. MaRS is populated using a Visual Basic Application. Once populated, the excel spreadsheet is comprised of information on ISS components including: operation hours, random/nonrandom failures, software/hardware failures, quantity, orbital replaceable units (ORU), date of placement, unit weight, frequency of part, etc. The motivation for creating such a database will be the development of a mass/reliability parametric model to estimate mass required for replacement parts. Once complete, engineers working on future space flight missions will have access a mean time to failures and on parts along with their mass, this will be used to make proper decisions for long duration space flight missions

SU-E-I-10: Automatic Monitoring of Accumulated Dose Indices From DICOM RDSR to Improve Radiation Safety in X-Ray Angiography

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

Omar, A; Bujila, R; Nowik, P

2014-06-01

Purpose: To investigate the potential benefits of automatic monitoring of accumulated patient and staff dose indicators, i.e., CAK and KAP, from DICOM Radiation Dose Structured Reports (RDSR) in x-ray angiography (XA). Methods: Recently RDSR has enabled the convenient aggregation of dose indices and technique parameters for XA procedures. The information contained in RDSR objects for three XA systems, dedicated to different types of clinical procedures, has been collected and aggregated in a database for over one year using a system developed with open-source software at the Karolinska University Hospital. Patient weight was complemented to the RDSR data via an interfacemore » with the Hospital Information System (HIS). Results: The linearly approximated trend in KAP over a time period of a year for cerebrovascular, pelvic/peripheral vascular, and cardiovascular procedures showed a decrease of 12%, 20%, and 14%, respectively. The decrease was mainly due to hardware/software upgrades and new low-dose imaging protocols, and partially due to ongoing systematic radiation safety education of the clinical staff. The CAK was in excess of 3 Gy for 15 procedures, and exceeded 5 Gy for 3 procedures. The dose indices have also shown a significant dependence on patient weight for cardiovascular and pelvic/peripheral vascular procedures; a 10 kg shift in mean patient weight can result in a dose index increase of 25%. Conclusion: Automatic monitoring of accumulated dose indices can be utilized to notify the clinical staff and medical physicists when the dose index has exceeded a predetermined action level. This allows for convenient and systematic follow-up of patients in risk of developing deterministic skin injuries. Furthermore, trend analyses of dose indices over time is a valuable resource for the identification of potential positive or negative effects (dose increase/decrease) from changes in hardware, software, and clinical work habits.« less

The Integrated Hazard Analysis Integrator

NASA Technical Reports Server (NTRS)

Morris, A. Terry; Massie, Michael J.

2009-01-01

Hazard analysis addresses hazards that arise in the design, development, manufacturing, construction, facilities, transportation, operations and disposal activities associated with hardware, software, maintenance, operations and environments. An integrated hazard is an event or condition that is caused by or controlled by multiple systems, elements, or subsystems. Integrated hazard analysis (IHA) is especially daunting and ambitious for large, complex systems such as NASA s Constellation program which incorporates program, systems and element components that impact others (International Space Station, public, International Partners, etc.). An appropriate IHA should identify all hazards, causes, controls and verifications used to mitigate the risk of catastrophic loss of crew, vehicle and/or mission. Unfortunately, in the current age of increased technology dependence, there is the tendency to sometimes overlook the necessary and sufficient qualifications of the integrator, that is, the person/team that identifies the parts, analyzes the architectural structure, aligns the analysis with the program plan and then communicates/coordinates with large and small components, each contributing necessary hardware, software and/or information to prevent catastrophic loss. As viewed from both Challenger and Columbia accidents, lack of appropriate communication, management errors and lack of resources dedicated to safety were cited as major contributors to these fatalities. From the accident reports, it would appear that the organizational impact of managers, integrators and safety personnel contributes more significantly to mission success and mission failure than purely technological components. If this is so, then organizations who sincerely desire mission success must put as much effort in selecting managers and integrators as they do when designing the hardware, writing the software code and analyzing competitive proposals. This paper will discuss the necessary and sufficient requirements of one of the significant contributors to mission success, the IHA integrator. Discussions will be provided to describe both the mindset required as well as deleterious assumptions/behaviors to avoid when integrating within a large scale system.

Cybersecurity for Connected Diabetes Devices

PubMed Central

Klonoff, David C.

2015-01-01

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. PMID:25883162

Cybersecurity for Connected Diabetes Devices.

PubMed

Klonoff, David C

2015-04-16

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. © 2015 Diabetes Technology Society.

[Prospects of systemic radioecology in solving innovative tasks of nuclear power engineering].

PubMed

Spiridonov, S I

2014-01-01

A need of systemic radioecological studies in the strategy developed by the atomic industry in Russia in the XXI century has been justified. The priorities in the radioecology of nuclear power engineering of natural safety associated with the development of the radiation-migration equivalence concept, comparative evaluation of innovative nuclear technologies and forecasting methods of various emergencies have been identified. Also described is an algorithm for the integrated solution of these tasks that includes elaboration of methodological approaches, methods and software allowing dose burdens to humans and biota to be estimated. The rationale of using radioecological risks for the analysis of uncertainties in the environmental contamination impacts,at different stages of the existing and innovative nuclear fuel cycles is shown.

SU-E-T-421: Failure Mode and Effects Analysis (FMEA) of Xoft Electronic Brachytherapy for the Treatment of Superficial Skin Cancers

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

Hoisak, J; Manger, R; Dragojevic, I

Purpose: To perform a failure mode and effects analysis (FMEA) of the process for treating superficial skin cancers with the Xoft Axxent electronic brachytherapy (eBx) system, given the recent introduction of expanded quality control (QC) initiatives at our institution. Methods: A process map was developed listing all steps in superficial treatments with Xoft eBx, from the initial patient consult to the completion of the treatment course. The process map guided the FMEA to identify the failure modes for each step in the treatment workflow and assign Risk Priority Numbers (RPN), calculated as the product of the failure mode’s probability ofmore » occurrence (O), severity (S) and lack of detectability (D). FMEA was done with and without the inclusion of recent QC initiatives such as increased staffing, physics oversight, standardized source calibration, treatment planning and documentation. The failure modes with the highest RPNs were identified and contrasted before and after introduction of the QC initiatives. Results: Based on the FMEA, the failure modes with the highest RPN were related to source calibration, treatment planning, and patient setup/treatment delivery (Fig. 1). The introduction of additional physics oversight, standardized planning and safety initiatives such as checklists and time-outs reduced the RPNs of these failure modes. High-risk failure modes that could be mitigated with improved hardware and software interlocks were identified. Conclusion: The FMEA analysis identified the steps in the treatment process presenting the highest risk. The introduction of enhanced QC initiatives mitigated the risk of some of these failure modes by decreasing their probability of occurrence and increasing their detectability. This analysis demonstrates the importance of well-designed QC policies, procedures and oversight in a Xoft eBx programme for treatment of superficial skin cancers. Unresolved high risk failure modes highlight the need for non-procedural quality initiatives such as improved planning software and more robust hardware interlock systems.« less

Expecting the Unexpected: Radiation Hardened Software

NASA Technical Reports Server (NTRS)

Penix, John; Mehlitz, Peter C.

2005-01-01

Radiation induced Single Event Effects (SEEs) are a serious problem for spacecraft flight software, potentially leading to a complete loss of mission. Conventional risk mitigation has been focused on hardware, leading to slow, expensive and outdated on-board computing devices, increased power consumption and launch mass. Our approach is to look at SEEs from a software perspective, and to explicitly design flight software so that it can detect and correct the majority of SEES. Radiation hardened flight software will reduce the significant residual residual risk for critical missions and flight phases, and enable more use of inexpensive and fast COTS hardware.

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

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

Reassuring or risky: the presentation of seafood safety in the aftermath of the British Petroleum Deepwater Horizon Oil Spill.

PubMed

Greiner, Amelia L; Lagasse, Lisa P; Neff, Roni A; Love, David C; Chase, Rachel; Sokol, Natasha; Smith, Katherine Clegg

2013-07-01

The BP Deepwater Horizon Oil Spill was enormously newsworthy; coverage interlaced discussions of health, economic, and environmental impacts and risks. We analyzed 315 news articles that considered Gulf seafood safety from the year following the spill. We explored reporting trends, risk presentation, message source, stakeholder perspectives on safety, and framing of safety messages. Approximately one third of articles presented risk associated with seafood consumption as a standalone issue, rather than in conjunction with environmental or economic risks. Government sources were most frequent and their messages were largely framed as reassuring as to seafood safety. Discussions of prevention were limited to short-term, secondary prevention approaches. These data demonstrate a need for risk communication in news coverage of food safety that addresses the larger risk context, primary prevention, and structural causes of risk.

From Bridges and Rockets, Lessons for Software Systems

NASA Technical Reports Server (NTRS)

Holloway, C. Michael

2004-01-01

Although differences exist between building software systems and building physical structures such as bridges and rockets, enough similarities exist that software engineers can learn lessons from failures in traditional engineering disciplines. This paper draws lessons from two well-known failures the collapse of the Tacoma Narrows Bridge in 1940 and the destruction of the space shuttle Challenger in 1986 and applies these lessons to software system development. The following specific applications are made: (1) the verification and validation of a software system should not be based on a single method, or a single style of methods; (2) the tendency to embrace the latest fad should be overcome; and (3) the introduction of software control into safety-critical systems should be done cautiously.

Regulatory Science in Professional Education.

PubMed

Akiyama, Hiroshi

2017-01-01

In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

Bridging the Divide between Safety and Risk Management for your Project or Program

NASA Technical Reports Server (NTRS)

Lutomski, Mike

2005-01-01

This presentation will bridge the divide between these separate but overlapping disciplines and help explain how to use Risk Management as an effective management decision support tool that includes safety. Risk Management is an over arching communication tool used by management to prioritize and effectively mitigate potential problems before they concur. Risk Management encompasses every kind of potential problem that can occur on a program or project. Some of these are safety issues such as hazards that have a specific likelihood and consequence that need to be controlled and included to show an integrated picture of accepted) mitigated, and residual risk. Integrating safety and other assurance disciplines is paramount to accurately representing a program s or projects risk posture. Risk is made up of several components such as technical) cost, schedule, or supportability. Safety should also be a consideration for every risk. The safety component can also have an impact on the technical, cost, and schedule aspect of a given risk. The current formats used for communication of safety and risk issues are not consistent or integrated. The presentation will explore the history of these disciplines, current work to integrate them, and suggestions for integration for the future.

Risk assessment for consumer exposure to toluene diisocyanate (TDI) derived from polyurethane flexible foam.

PubMed

Arnold, Scott M; Collins, Michael A; Graham, Cynthia; Jolly, Athena T; Parod, Ralph J; Poole, Alan; Schupp, Thomas; Shiotsuka, Ronald N; Woolhiser, Michael R

2012-12-01

Polyurethanes (PU) are polymers made from diisocyanates and polyols for a variety of consumer products. It has been suggested that PU foam may contain trace amounts of residual toluene diisocyanate (TDI) monomers and present a health risk. To address this concern, the exposure scenario and health risks posed by sleeping on a PU foam mattress were evaluated. Toxicity benchmarks for key non-cancer endpoints (i.e., irritation, sensitization, respiratory tract effects) were determined by dividing points of departure by uncertainty factors. The cancer benchmark was derived using the USEPA Benchmark Dose Software. Results of previous migration and emission data of TDI from PU foam were combined with conservative exposure factors to calculate upper-bound dermal and inhalation exposures to TDI as well as a lifetime average daily dose to TDI from dermal exposure. For each non-cancer endpoint, the toxicity benchmark was divided by the calculated exposure to determine the margin of safety (MOS), which ranged from 200 (respiratory tract) to 3×10(6) (irritation). Although available data indicate TDI is not carcinogenic, a theoretical excess cancer risk (1×10(-7)) was calculated. We conclude from this assessment that sleeping on a PU foam mattress does not pose TDI-related health risks to consumers. Copyright © 2012 Elsevier Inc. All rights reserved.

Complexity and Safety (FAA)

DTIC Science & Technology

2016-10-27

Software Engineering Institute Carnegie Mellon University Pittsburgh, PA 15213 © 2016 Carnegie Mellon University [DISTRIBUTION STATEMENT A: This... Carnegie Mellon University [DISTRIBUTION STATEMENT A: This material has been approved for public release and unlimited distribution] Copyright 2016 Carnegie ... Carnegie Mellon University for the operation of the Software Engineering Institute, a federally funded research and development center sponsored by

Automated Source-Code-Based Testing of Object-Oriented Software

NASA Astrophysics Data System (ADS)

Gerlich, Ralf; Gerlich, Rainer; Dietrich, Carsten

2014-08-01

With the advent of languages such as C++ and Java in mission- and safety-critical space on-board software, new challenges for testing and specifically automated testing arise. In this paper we discuss some of these challenges, consequences and solutions based on an experiment in automated source- code-based testing for C++.

RELAP-7 Development Updates

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

Zhang, Hongbin; Zhao, Haihua; Gleicher, Frederick Nathan

RELAP-7 is a nuclear systems safety analysis code being developed at the Idaho National Laboratory, and is the next generation tool in the RELAP reactor safety/systems analysis application series. RELAP-7 development began in 2011 to support the Risk Informed Safety Margins Characterization (RISMC) Pathway of the Light Water Reactor Sustainability (LWRS) program. The overall design goal of RELAP-7 is to take advantage of the previous thirty years of advancements in computer architecture, software design, numerical methods, and physical models in order to provide capabilities needed for the RISMC methodology and to support nuclear power safety analysis. The code is beingmore » developed based on Idaho National Laboratory’s modern scientific software development framework – MOOSE (the Multi-Physics Object-Oriented Simulation Environment). The initial development goal of the RELAP-7 approach focused primarily on the development of an implicit algorithm capable of strong (nonlinear) coupling of the dependent hydrodynamic variables contained in the 1-D/2-D flow models with the various 0-D system reactor components that compose various boiling water reactor (BWR) and pressurized water reactor nuclear power plants (NPPs). During Fiscal Year (FY) 2015, the RELAP-7 code has been further improved with expanded capability to support boiling water reactor (BWR) and pressurized water reactor NPPs analysis. The accumulator model has been developed. The code has also been coupled with other MOOSE-based applications such as neutronics code RattleSnake and fuel performance code BISON to perform multiphysics analysis. A major design requirement for the implicit algorithm in RELAP-7 is that it is capable of second-order discretization accuracy in both space and time, which eliminates the traditional first-order approximation errors. The second-order temporal is achieved by a second-order backward temporal difference, and the one-dimensional second-order accurate spatial discretization is achieved with the Galerkin approximation of Lagrange finite elements. During FY-2015, we have done numerical verification work to verify that the RELAP-7 code indeed achieves 2nd-order accuracy in both time and space for single phase models at the system level.« less

SNAPSHOT: A MODERN, SUSTAINABLE HOLDUP MEASUREMENT SYSTEM

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

Rowe, Nathan C; Younkin, James R; Smith, Steven E

2016-01-01

SNAPSHOT is a software platform designed to eventually replace Holdup Measurement System 4 (HMS 4), which is the current state-of-the-art for acquisition and analysis of nondestructive assay measurement data for in situ nuclear materials, holdup, in support of criticality safety and material control and accounting. HMS 4 is over 10 years old and is currently unsustainable due to hardware and software incompatibilities that have arisen from advances in detector electronics, primarily updates to multi-channel analyzers (MCAs), and both computer and handheld operating systems. SNAPSHOT is a complete redesign of HMS 4 that addresses the issue of compatibility with modern MCAsmore » and operating systems and that is designed with a flexible architecture to support long-term sustainability. It also provides an updated and more user friendly interface and is being developed under an NQA 1 software quality assurance (SQA) program to facilitate site acceptance for safety-related applications. This paper provides an overview of the SNAPSHOT project including details of the software development process, the SQA program, and the architecture designed to support sustainability.« less

Information Extraction for System-Software Safety Analysis: Calendar Year 2008 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2009-01-01

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 and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Using a quantitative risk register to promote learning from a patient safety reporting system.

PubMed

Mansfield, James G; Caplan, Robert A; Campos, John S; Dreis, David F; Furman, Cathie

2015-02-01

Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.

Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

PubMed

Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

2018-01-01

To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology used in this study may be useful for reevaluation of the safety of other traditional Chinese medicines.

Towards a better reliability of risk assessment: development of a qualitative & quantitative risk evaluation model (Q2REM) for different trades of construction works in Hong Kong.

PubMed

Fung, Ivan W H; Lo, Tommy Y; Tung, Karen C F

2012-09-01

Since the safety professionals are the key decision makers dealing with project safety and risk assessment in the construction industry, their perceptions of safety risk would directly affect the reliability of risk assessment. The safety professionals generally tend to heavily rely on their own past experiences to make subjective decisions on risk assessment without systematic decision making. Indeed, understanding of the underlying principles of risk assessment is significant. In this study, the qualitative analysis on the safety professionals' beliefs of risk assessment and their perceptions towards risk assessment, including their recognitions of possible accident causes, the degree of differentiations on their perceptions of risk levels of different trades of works, recognitions of the occurrence of different types of accidents, and their inter-relationships with safety performance in terms of accident rates will be explored in the Stage 1. At the second stage, the deficiencies of the current general practice for risk assessment can be sorted out firstly. Based on the findings from Stage 1 and the historical accident data from 15 large-scaled construction projects in 3-year average, a risk evaluation model prioritizing the risk levels of different trades of works and which cause different types of site accident due to various accident causes will be developed quantitatively. With the suggested systematic accident recording techniques, this model can be implemented in the construction industry at both project level and organizational level. The model (Q(2)REM) not only act as a useful supplementary guideline of risk assessment for the construction safety professionals, but also assists them to pinpoint the potential risks on site for the construction workers under respective trades of works through safety trainings and education. It, in turn, arouses their awareness on safety risk. As the Q(2)REM can clearly show the potential accident causes leading to different types of accident by trade of works, it helps the concerned safety professionals and parties to plan effective accident prevention measures with reference to the priority of the risk levels. Copyright © 2011 Elsevier Ltd. 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.

A software for managing chemical processes in a multi-user laboratory

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

Camino, Fernando E.

Here, we report a software for logging chemical processes in a multi-user laboratory, which implements a work flow designed to reduce hazardous situations associated with the disposal of chemicals in incompatible waste containers. The software allows users to perform only those processes displayed in their list of authorized chemical processes and provides the location and label code of waste containers, among other useful information. The software has been used for six years in the cleanroom of the Center for Functional Nanomaterials at Brookhaven National Laboratory and has been an important factor for the excellent safety record of the Center.

A software for managing chemical processes in a multi-user laboratory

DOE PAGES

Camino, Fernando E.

2016-10-26

Here, we report a software for logging chemical processes in a multi-user laboratory, which implements a work flow designed to reduce hazardous situations associated with the disposal of chemicals in incompatible waste containers. The software allows users to perform only those processes displayed in their list of authorized chemical processes and provides the location and label code of waste containers, among other useful information. The software has been used for six years in the cleanroom of the Center for Functional Nanomaterials at Brookhaven National Laboratory and has been an important factor for the excellent safety record of the Center.

Automating Nuclear-Safety-Related SQA Procedures with Custom Applications

DOE PAGES

Freels, James D.

2016-01-01

Nuclear safety-related procedures are rigorous for good reason. Small design mistakes can quickly turn into unwanted failures. Researchers at Oak Ridge National Laboratory worked with COMSOL to define a simulation app that automates the software quality assurance (SQA) verification process and provides results in less than 24 hours.

Space biology initiative program definition review. Trade study 2: Prototype utilization in the development of space biology hardware

NASA Technical Reports Server (NTRS)

Jackson, L. Neal; Crenshaw, John, Sr.; Schulze, Arthur E.; Wood, H. J., Jr.

1989-01-01

The objective was to define the factors which space flight hardware developers and planners should consider when determining: (1) the number of hardware units required to support program; (2) design level of the units; and (3) most efficient means of utilization of the units. The analysis considered technology risk, maintainability, reliability, and safety design requirements for achieving the delivery of highest quality flight hardware. Relative cost impacts of the utilization of prototyping were identified. The development of Space Biology Initiative research hardware will involve intertwined hardware/software activities. Experience has shown that software development can be an expensive portion of a system design program. While software prototyping could imply the development of a significantly different end item, an operational system prototype must be considered to be a combination of software and hardware. Hundreds of factors were identified that could be considered in determining the quantity and types of prototypes that should be constructed. In developing the decision models, these factors were combined and reduced by approximately ten-to-one in order to develop a manageable structure based on the major determining factors. The Baseline SBI hardware list of Appendix D was examined and reviewed in detail; however, from the facts available it was impossible to identify the exact types and quantities of prototypes required for each of these items. Although the factors that must be considered could be enumerated for each of these pieces of equipment, the exact status and state of development of the equipment is variable and uncertain at this time.

Reassuring or Risky: The Presentation of Seafood Safety in the Aftermath of the British Petroleum Deepwater Horizon Oil Spill

PubMed Central

Lagasse, Lisa P.; Neff, Roni A.; Love, David C.; Chase, Rachel; Sokol, Natasha; Smith, Katherine Clegg

2013-01-01

The BP Deepwater Horizon Oil Spill was enormously newsworthy; coverage interlaced discussions of health, economic, and environmental impacts and risks. We analyzed 315 news articles that considered Gulf seafood safety from the year following the spill. We explored reporting trends, risk presentation, message source, stakeholder perspectives on safety, and framing of safety messages. Approximately one third of articles presented risk associated with seafood consumption as a standalone issue, rather than in conjunction with environmental or economic risks. Government sources were most frequent and their messages were largely framed as reassuring as to seafood safety. Discussions of prevention were limited to short-term, secondary prevention approaches. These data demonstrate a need for risk communication in news coverage of food safety that addresses the larger risk context, primary prevention, and structural causes of risk. PMID:23678933

Performance of Compiler-Assisted Memory Safety Checking

DTIC Science & Technology

2014-08-01

software developer has in mind a particular object to which the pointer should point, the intended referent. A memory access error occurs when an ac...Performance of Compiler-Assisted Memory Safety Checking David Keaton Robert C. Seacord August 2014 TECHNICAL NOTE CMU/SEI-2014-TN...based memory safety checking tool and the performance that can be achieved with two such tools whose source code is freely available. The note then

Integrated Systems Health Management for Space Exploration

NASA Technical Reports Server (NTRS)

Uckun, Serdar

2005-01-01

Integrated Systems Health Management (ISHM) is a system engineering discipline that addresses the design, development, operation, and lifecycle management of components, subsystems, vehicles, and other operational systems with the purpose of maintaining nominal system behavior and function and assuring mission safety and effectiveness under off-nominal conditions. NASA missions are often conducted in extreme, unfamiliar environments of space, using unique experimental spacecraft. In these environments, off-nominal conditions can develop with the potential to rapidly escalate into mission- or life-threatening situations. Further, the high visibility of NASA missions means they are always characterized by extraordinary attention to safety. ISHM is a critical element of risk mitigation, mission safety, and mission assurance for exploration. ISHM enables: In-space maintenance and repair; a) Autonomous (and automated) launch abort and crew escape capability; b) Efficient testing and checkout of ground and flight systems; c) Monitoring and trending of ground and flight system operations and performance; d) Enhanced situational awareness and control for ground personnel and crew; e) Vehicle autonomy (self-sufficiency) in responding to off-nominal conditions during long-duration and distant exploration missions; f) In-space maintenance and repair; and g) Efficient ground processing of reusable systems. ISHM concepts and technologies may be applied to any complex engineered system such as transportation systems, orbital or planetary habitats, observatories, command and control systems, life support systems, safety-critical software, and even the health of flight crews. As an overarching design and operational principle implemented at the system-of-systems level, ISHM holds substantial promise in terms of affordability, safety, reliability, and effectiveness of space exploration missions.

Increasing the use of 'smart' pump drug libraries by nurses: a continuous quality improvement project.

PubMed

Harding, Andrew D

2012-01-01

The use of infusion pumps that incorporate "smart" technology (smart pumps) can reduce the risks associated with receiving IV therapies. Smart pump technology incorporates safeguards such as a list of high-alert medications, soft and hard dosage limits, and a drug library that can be tailored to specific patient care areas. Its use can help to improve patient safety and to avoid potentially catastrophic harm associated with medication errors. But when one independent community hospital in Massachusetts switched from older mechanical pumps to smart pumps, it neglected to assign an "owner" to oversee the implementation process. One result was that nurses were using the smart pump library for only 37% of all infusions.To increase pump library usage percentage-thereby reducing the risks associated with infusion and improving patient safety-the hospital undertook a continuous quality improvement project over a four-month period in 2009. With the involvement of direct care nurses, and using quantitative data available from the smart pump software, the nursing quality and pharmacy quality teams identified ways to improve pump and pump library use. A secondary goal was to calculate the hospital's return on investment for the purchase of the smart pumps. Several interventions were developed and, on the first of each month, implemented. By the end of the project, pump library usage had nearly doubled; and the hospital had completely recouped its initial investment.

Surface extra-vehicular activity emergency scenario management: Tools, procedures, and geologically related implications

NASA Astrophysics Data System (ADS)

Zea, Luis; Diaz, Alejandro R.; Shepherd, Charles K.; Kumar, Ranganathan

2010-07-01

Extra-vehicular activities (EVAs) are an essential part of human space exploration, but involve inherently dangerous procedures which can put crew safety at risk during a space mission. To help mitigate this risk, astronauts' training programs spend substantial attention on preparing for surface EVA emergency scenarios. With the help of two Mars Desert Research Station (MDRS) crews (61 and 65), wearing simulated spacesuits, the most important of these emergency scenarios were examined at three different types of locations that geologically and environmentally resemble lunar and Martian landscapes. These three platforms were analyzed geologically as well as topographically (utilizing a laser range finder with slope estimation capabilities and a slope determination software). Emergency scenarios were separated into four main groups: (1) suit issues, (2) general physiological, (3) attacks and (4) others. Specific tools and procedures were developed to address each scenario. The tools and processes were tested in the field under Mars-analog conditions with the suited subjects for feasibility and speed of execution.

Applying Formal Methods to NASA Projects: Transition from Research to Practice

NASA Technical Reports Server (NTRS)

Othon, Bill

2009-01-01

NASA project managers attempt to manage risk by relying on mature, well-understood process and technology when designing spacecraft. In the case of crewed systems, the margin for error is even tighter and leads to risk aversion. But as we look to future missions to the Moon and Mars, the complexity of the systems will increase as the spacecraft and crew work together with less reliance on Earth-based support. NASA will be forced to look for new ways to do business. Formal methods technologies can help NASA develop complex but cost effective spacecraft in many domains, including requirements and design, software development and inspection, and verification and validation of vehicle subsystems. To realize these gains, the technologies must be matured and field-tested so that they are proven when needed. During this discussion, current activities used to evaluate FM technologies for Orion spacecraft design will be reviewed. Also, suggestions will be made to demonstrate value to current designers, and mature the technology for eventual use in safety-critical NASA missions.

System for decision analysis support on complex waste management issues

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

Shropshire, D.E.

1997-10-01

A software system called the Waste Flow Analysis has been developed and applied to complex environmental management processes for the United States Department of Energy (US DOE). The system can evaluate proposed methods of waste retrieval, treatment, storage, transportation, and disposal. Analysts can evaluate various scenarios to see the impacts to waste slows and schedules, costs, and health and safety risks. Decision analysis capabilities have been integrated into the system to help identify preferred alternatives based on a specific objectives may be to maximize the waste moved to final disposition during a given time period, minimize health risks, minimize costs,more » or combinations of objectives. The decision analysis capabilities can support evaluation of large and complex problems rapidly, and under conditions of variable uncertainty. The system is being used to evaluate environmental management strategies to safely disposition wastes in the next ten years and reduce the environmental legacy resulting from nuclear material production over the past forty years.« less

RELAP-7 Software Verification and Validation Plan

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

Smith, Curtis L.; Choi, Yong-Joon; Zou, Ling

This INL plan comprehensively describes the software for RELAP-7 and documents the software, interface, and software design requirements for the application. The plan also describes the testing-based software verification and validation (SV&V) process—a set of specially designed software models used to test RELAP-7. The RELAP-7 (Reactor Excursion and Leak Analysis Program) code is a nuclear reactor system safety analysis code being developed at Idaho National Laboratory (INL). The code is based on the INL’s modern scientific software development framework – MOOSE (Multi-Physics Object-Oriented Simulation Environment). The overall design goal of RELAP-7 is to take advantage of the previous thirty yearsmore » of advancements in computer architecture, software design, numerical integration methods, and physical models. The end result will be a reactor systems analysis capability that retains and improves upon RELAP5’s capability and extends the analysis capability for all reactor system simulation scenarios.« less

University building safety index measurement using risk and implementation matrix

NASA Astrophysics Data System (ADS)

Rahman, A.; Arumsari, F.; Maryani, A.

2018-04-01

Many high rise building constructed in several universities in Indonesia. The high-rise building management must provide the safety planning and proper safety equipment in each part of the building. Unfortunately, most of the university in Indonesia have not been applying safety policy yet and less awareness on treating safety facilities. Several fire accidents in university showed that some significant risk should be managed by the building management. This research developed a framework for measuring the high rise building safety index in university The framework is not only assessed the risk magnitude but also designed modular building safety checklist for measuring the safety implementation level. The safety checklist has been developed for 8 types of the university rooms, i.e.: office, classroom, 4 type of laboratories, canteen, and library. University building safety index determined using risk-implementation matrix by measuring the risk magnitude and assessing the safety implementation level. Building Safety Index measurement has been applied in 4 high rise buildings in ITS Campus. The building assessment showed that the rectorate building in secure condition and chemical department building in beware condition. While the library and administration center building was in less secure condition.

Perception is reality: How patients contribute to poor workplace safety perceptions.

PubMed

McCaughey, Deirdre; McGhan, Gwen; DelliFraine, Jami L; Brannon, S Diane

2011-01-01

Nurses and aides are among the occupational subgroups with the highest injury rates and workdays lost to illness and injury in North America. Many studies have shown that these incidents frequently happen during provision of patient care. Moreover, health care workplaces are a source of numerous safety risks that contribute to worker injuries. These findings identify health care as a high-risk occupation for employee injury or illness. The purpose of this study was to examine the relationships among patient care, employee safety perceptions, and employee stress. Using the National Institute for Occupational Safety and Health Model of Job Stress and Health as a foundation, we developed and tested a conceptual workplace safety climate-stress model that explicates how caring for high-risk patients is a safety stressor that has negative outcomes for health care providers, including poor workplace safety perceptions and increasing stress levels. We introduced the concept of "high-risk patients" and define them as those who put providers at greater risk for injury or illness. Using a nonexperimental survey design, we examined patient types and safety perceptions of health care providers (nurses, aides, and allied health) in an acute care hospital. Health care providers who care for high-risk patients more frequently have poor safety climate perceptions and higher stress levels. Safety climate was found to mediate the relationship between high-risk patients and stress. These findings bring insight into actions health care organizations can pursue to improve health care provider well-being. Recognizing that different patients present different risks and pursuing staffing, training, and equipment to minimize employee risk of injury will help reduce the staggering injury rates experienced by these employees. Moreover, minimizing employee stress over poor workplace safety is achievable through comprehensive workplace safety climate programs that include supervisor, management, and organizational commitment to safety enhancement.

Patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature.

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

Patient safety risk in the homecare context and patient safety risk related to telecare are both emerging research areas. Patient safety issues associated with the use of telecare in homecare services are therefore not clearly understood. It is unclear what the patient safety risks are, how patient safety issues have been investigated, and what research is still needed to provide a comprehensive picture of risks, challenges and potential harm to patients due to the implementation and use of telecare services in the home. Furthermore, it is unclear how training for telecare users has addressed patient safety issues. A systematic review of the literature was conducted to identify patient safety risks associated with telecare use in homecare services and to investigate whether and how these patient safety risks have been addressed in telecare training. Six electronic databases were searched in addition to hand searches of key items, reference tracking and citation tracking. Strict inclusion and exclusion criteria were set. All included items were assessed according to set quality criteria and subjected to a narrative synthesis to organise and synthesize the findings. A human factors systems framework of patient safety was used to frame and analyse the results. 22 items were included in the review. 11 types of patient safety risks associated with telecare use in homecare services emerged. These are in the main related to the nature of homecare tasks and practices, and person-centred characteristics and capabilities, and to a lesser extent, problems with the technology and devices, organisational issues, and environmental factors. Training initiatives related to safe telecare use are not described in the literature. There is a need to better identify and describe patient safety risks related to telecare services to improve understandings of how to avoid and minimize potential harm to patients. This process can be aided by reframing known telecare implementation challenges and user experiences of telecare with the help of a human factors systems approach to patient safety.

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual basis but to consider measures of aggregate safety risk and to ensure wherever possible that there be quantitative measures for evaluating how effective the controls are in reducing these aggregate risks. The term aggregate risk, when used in this handbook, refers to the accumulation of risks from individual scenarios that lead to a shortfall in safety performance at a high level: e.g., an excessively high probability of loss of crew, loss of mission, planetary contamination, etc. Without aggregated quantitative measures such as these, it is not reasonable to expect that safety has been optimized with respect to other technical and programmatic objectives. At the same time, it is fully recognized that not all sources of risk are amenable to precise quantitative analysis and that the use of qualitative approaches and bounding estimates may be appropriate for those risk sources. Second, the handbook stresses the necessity of developing confidence that the controls derived for the purpose of achieving system safety not only handle risks that have been identified and properly characterized but also provide a general, more holistic means for protecting against unidentified or uncharacterized risks. For example, while it is not possible to be assured that all credible causes of risk have been identified, there are defenses that can provide protection against broad categories of risks and thereby increase the chances that individual causes are contained. Third, the handbook strives at all times to treat uncertainties as an integral aspect of risk and as a part of making decisions. The term "uncertainty" here does not refer to an actuarial type of data analysis, but rather to a characterization of our state of knowledge regarding results from logical and physical models that approximate reality. Uncertainty analysis finds how the output parameters of the models are related to plausible variations in the input parameters and in the modeling assumptions. The evaluation of unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that derive from the safety objectives of the organization. The safety claims are developed from a hierarchy of safety objectives and are therefore hierarchical themselves. Assurance that all the claims are true within acceptable risk tolerance limits implies that all of the safety objectives have been satisfied, and therefore that the system is safe. The acceptable risk tolerance limits are provided by the authority who must make the decision whether or not to proceed to the next step in the life cycle. These tolerances are therefore referred to as the decision maker's risk tolerances. In general, the safety claims address two fundamental facets of safety: 1) whether required safety thresholds or goals have been achieved, and 2) whether the safety risk is as low as possible within reasonable impacts on cost, schedule, and performance. The latter facet includes consideration of controls that are collective in nature (i.e., apply generically to broad categories of risks) and thereby provide protection against unidentified or uncharacterized risks.

EVALUATION OF VADOSE ZONE AND SOURCE MODELS FOR MULTI-MEDIA, MULTI-PATHWAY, MULTI-RECEPTOR RISK ASSESSMENT USING LARGE SOIL COLUMN EXPERIMENT DATA

EPA Science Inventory

The U.S. Environmental Protection Agency (EPA) is developing a comprehensive environmental exposure and risk analysis software system for agency-wide application using the methodology of a Multi-media, Multi-pathway, Multi-receptor Risk Assessment (3MRA) model. This software sys...

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.

Framework for Risk Analysis in Multimedia Environmental Systems: Modeling Individual Steps of a Risk Assessment Process

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

Shah, Anuj; Castleton, Karl J.; Hoopes, Bonnie L.

2004-06-01

The study of the release and effects of chemicals in the environment and their associated risks to humans is central to public and private decision making. FRAMES 1.X, Framework for Risk Analysis in Multimedia Environmental Systems, is a systems modeling software platform, developed by PNNL, Pacific Northwest National Laboratory, that helps scientists study the release and effects of chemicals on a source to outcome basis, create environmental models for similar risk assessment and management problems. The unique aspect of FRAMES is to dynamically introduce software modules representing individual components of a risk assessment (e.g., source release of contaminants, fate andmore » transport in various environmental media, exposure, etc.) within a software framework, manipulate their attributes and run simulations to obtain results. This paper outlines the fundamental constituents of FRAMES 2.X, an enhanced version of FRAMES 1.X, that greatly improve the ability of the module developers to “plug” their self-developed software modules into the system. The basic design, the underlying principles and a discussion of the guidelines for module developers are presented.« less

A Case for Developing a Ground Based Replication of the Earth, Moon and Mars Spaceflight Infrastructure

NASA Technical Reports Server (NTRS)

Bradford, Robert N.; Best, Susan L.

2006-01-01

When the systems are developed and in place to provide the services needed to operate en route and on the Lunar and Martian surfaces, an Earth based replication will need to be in place for the safety and protection of mission success. The replication will entail all aspects of the flight configuration end to end but will not include any closed loop systems. This would replicate the infrastructure from Lunar and Martian robots, manned surface excursions, through man and unmanned terrestrial bases, through the various types of communication systems and technologies, manned and un-manned space vehicles (large and small), to Earth based systems and control centers. An Earth based replicated infrastructure will enable checkout and test of new technologies, hardware, software updates and upgrades and procedures without putting humans and missions at risk. Analysis of events, what ifs and trouble resolution could be played out on the ground to remove as much risk as possible from any type of proposed change to flight operational systems. With adequate detail, it is possible that failures could be predicted with a high probability and action taken to eliminate failures. A major factor in any mission to the Moon and to Mars is the complexity of systems, interfaces, processes, their limitations, associated risks and the factor of the unknown including the development by many contractors and NASA centers. The need to be able to introduce new technologies over the life of the program requires an end to end test bed to analyze and evaluate these technologies and what will happen when they are introduced into the flight system. The ability to analyze system behaviors end to end under varying conditions would enhance safety e.g. fault tolerances. This analysis along with the ability to mine data from the development environment (e.g. test data), flight ops and modeling/simulations data would provide a level of information not currently available to operations and astronauts. In this paper we will analyze the beginnings of such a replication and what it could do in terms of reducing risk in the near term for development. We will analyze the Space Shuttle Main Engine (SSME) test lab which has to a large extent accomplished this replication for the SSME and has been highly successful in analyzing hardware and software problems and changes. The cost of replicating the flight system as proposed here could be very high if attempted as an afterthought. We will describe the initial steps for the development of a replication of this infrastructure starting with the communication infrastructure. The Constellation of Labs (CofL) under the Command, Control, Communication and Information (C3I) project for the NASA Exploration Initiative will provide the initial foundation upon which to base this replication. Simply put, there is very little margin for error in high latency situations e.g. en-route to/from Mars or in an autonomous process on the Lunar far side. Any thought out approach to reduce risk and increase safety needs to be accomplished end to end with the actual systems configuration.

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.

Physicians' and nurses' perceptions of patient safety risks in the emergency department.

PubMed

Källberg, Ann-Sofie; Ehrenberg, Anna; Florin, Jan; Östergren, Jan; Göransson, Katarina E

2017-07-01

The emergency department has been described as a high-risk area for errors. It is also known that working conditions such as a high workload and shortage off staff in the healthcare field are common factors that negatively affect patient safety. A limited amount of research has been conducted with regard to patient safety in Swedish emergency departments. Additionally, there is a lack of knowledge about clinicians' perceptions of patient safety risks. Therefore, the purpose of this study was to describe emergency department clinicians' experiences with regard to patient safety risks. Semi-structured interviews were conducted with 10 physicians and 10 registered nurses from two emergency departments. Interviews were analysed by inductive content analysis. The experiences reflect the complexities involved in the daily operation of a professional practice, and the perception of risks due to a high workload, lack of control, communication and organizational failures. The results reflect a complex system in which high workload was perceived as a risk for patient safety and that, in a combination with other risks, was thought to further jeopardize patient safety. Emergency department staff should be involved in the development of patient safety procedures in order to increase knowledge regarding risk factors as well as identify strategies which can facilitate the maintenance of patient safety during periods in which the workload is high. Copyright © 2017 Elsevier Ltd. All rights reserved.

Techniques for development of safety-related software for surgical robots.

PubMed

Varley, P

1999-12-01

Regulatory bodies require evidence that software controlling potentially hazardous devices is developed to good manufacturing practices. Effective techniques used in other industries assume long timescales and high staffing levels and can be unsuitable for use without adaptation in developing electronic healthcare devices. This paper discusses a set of techniques used in practice to develop software for a particular innovative medical product, an endoscopic camera manipulator. These techniques include identification of potential hazards and tracing their mitigating factors through the project lifecycle.

MODIS. Volume 1: MODIS level 1A software baseline requirements

NASA Technical Reports Server (NTRS)

Masuoka, Edward; Fleig, Albert; Ardanuy, Philip; Goff, Thomas; Carpenter, Lloyd; Solomon, Carl; Storey, James

1994-01-01

This document describes the level 1A software requirements for the moderate resolution imaging spectroradiometer (MODIS) instrument. This includes internal and external requirements. Internal requirements include functional, operational, and data processing as well as performance, quality, safety, and security engineering requirements. External requirements include those imposed by data archive and distribution systems (DADS); scheduling, control, monitoring, and accounting (SCMA); product management (PM) system; MODIS log; and product generation system (PGS). Implementation constraints and requirements for adapting the software to the physical environment are also included.

Automated workflows for modelling chemical fate, kinetics and toxicity.

PubMed

Sala Benito, J V; Paini, Alicia; Richarz, Andrea-Nicole; Meinl, Thorsten; Berthold, Michael R; Cronin, Mark T D; Worth, Andrew P

2017-12-01

Automation is universal in today's society, from operating equipment such as machinery, in factory processes, to self-parking automobile systems. While these examples show the efficiency and effectiveness of automated mechanical processes, automated procedures that support the chemical risk assessment process are still in their infancy. Future human safety assessments will rely increasingly on the use of automated models, such as physiologically based kinetic (PBK) and dynamic models and the virtual cell based assay (VCBA). These biologically-based models will be coupled with chemistry-based prediction models that also automate the generation of key input parameters such as physicochemical properties. The development of automated software tools is an important step in harmonising and expediting the chemical safety assessment process. In this study, we illustrate how the KNIME Analytics Platform can be used to provide a user-friendly graphical interface for these biokinetic models, such as PBK models and VCBA, which simulates the fate of chemicals in vivo within the body and in vitro test systems respectively. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Geographic Mapping as a Tool for Identifying Communities at High Risk for Fires.

PubMed

Fahey, Erin; Lehna, Carlee; Hanchette, Carol; Coty, Mary-Beth

2016-01-01

The purpose of this study was to evaluate whether the sample of older adults in a home fire safety (HFS) study captured participants living in the areas at highest risk for fire occurrence. The secondary aim was to identify high risk areas to focus future HFS interventions. Geographic information systems software was used to identify census tracts where study participants resided. Census data for these tracts were compared with participant data based on seven risk factors (ie, age greater than 65 years, nonwhite race, below high school education, low socioeconomic status, rented housing, year home built, home value) previously identified in a fire risk model. The distribution of participants and census tracts among risk categories determined how well higher risk census tracts were sampled. Of the 46 census tracts where the HFS intervention was implemented, 78% (n = 36) were identified as high or severe risk according to the fire risk model. Study participants' means for median annual family income (P < .0001) and median home value (P < .0001) were significantly lower than the census tract means (n = 46), indicating participants were at higher risk of fire occurrence. Of the 92 census tracts identified as high or severe risk in the entire county, the study intervention was implemented in 39% (n = 36), indicating 56 census tracts as potential areas for future HFS interventions. The Geographic information system-based fire risk model is an underutilized but important tool for practice that allows community agencies to develop, plan, and evaluate their outreach efforts and ensure the most effective use of scarce resources.

Using the Job Demands-Resources model to investigate risk perception, safety climate and job satisfaction in safety critical organizations.

PubMed

Nielsen, Morten Birkeland; Mearns, Kathryn; Matthiesen, Stig Berge; Eid, Jarle

2011-10-01

Using the Job Demands-Resources model (JD-R) as a theoretical framework, this study investigated the relationship between risk perception as a job demand and psychological safety climate as a job resource with regard to job satisfaction in safety critical organizations. In line with the JD-R model, it was hypothesized that high levels of risk perception is related to low job satisfaction and that a positive perception of safety climate is related to high job satisfaction. In addition, it was hypothesized that safety climate moderates the relationship between risk perception and job satisfaction. Using a sample of Norwegian offshore workers (N = 986), all three hypotheses were supported. In summary, workers who perceived high levels of risk reported lower levels of job satisfaction, whereas this effect diminished when workers perceived their safety climate as positive. Follow-up analyses revealed that this interaction was dependent on the type of risks in question. The results of this study supports the JD-R model, and provides further evidence for relationships between safety-related concepts and work-related outcomes indicating that organizations should not only develop and implement sound safety procedures to reduce the effects of risks and hazards on workers, but can also enhance other areas of organizational life through a focus on safety. © 2011 The Authors. Scandinavian Journal of Psychology © 2011 The Scandinavian Psychological Associations.