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Managing Research in a Risk World

The Office of Chief Medical Officer (OCHMO) owns all human health and performance risks managed by the Human System Risk Board (HSRB). While the HSRB manages the risks, the Human Research Program (HRP) manages the research portion of the overall risk mitigation strategy for these risks. The HSRB manages risks according to a process that identifies and analyzes risks, plans risk mitigation and tracks and reviews the implementation of these strategies according to its decisions pertaining to the OCHMO risk posture. HRP manages risk research work using an architecture that describes evidence-based risks, gaps in our knowledge about characterizing or mitigating the risk, and the tasks needed to produce deliverables to fill the gaps and reduce the risk. A planning schedule reflecting expected research milestones is developed, and as deliverables and new evidence are generated, research progress is tracked via the Path to Risk Reduction (PRR) that reflects a risk's research plan for a design reference mission. HRP's risk research process closely interfaces with the HSRB risk management process. As research progresses, new deliverables and evidence are used by the HSRB in conjunction with other operational and non-research evidence to inform decisions pertaining to the likelihood and consequence of the risk and risk posture. Those decisions in turn guide forward work for research as it contributes to overall risk mitigation strategies. As HRP tracks its research work, it aligns its priorities by assessing the effectiveness of its contributions and maintaining specific core competencies that would be invaluable for future work for exploration missions.

Anton, W.↗

HRP's Healthcare Spin-Offs Through Computational Modeling and Simulation Practice Methodologies

Spaceflight missions expose astronauts to novel operational and environmental conditions that pose health risks that are currently not well understood, and perhaps unanticipated. Furthermore, given the limited number of humans that have flown in long duration missions and beyond low Earth-orbit, the amount of research and clinical data necessary to predict and mitigate these health and performance risks are limited. Consequently, NASA's Human Research Program (HRP) conducts research and develops advanced methods and tools to predict, assess, and mitigate potential hazards to the health of astronauts. In this light, NASA has explored the possibility of leveraging computational modeling since the 1970s as a means to elucidate the physiologic risks of spaceflight and develop countermeasures. Since that time, substantial progress has been realized in this arena through a number of HRP funded activates such as the Digital Astronaut Project (DAP) and the Integrated Medical Model (IMM). Much of this success can be attributed to HRP's endeavor to establish rigorous verification, validation, and credibility (VV&C) processes that ensure computational models and simulations (M&S) are sufficiently credible to address issues within their intended scope. This presentation summarizes HRP's activities in credibility of modeling and simulation, in particular through its outreach to the community of modeling and simulation practitioners. METHODS: The HRP requires all M&S that can have moderate to high impact on crew health or mission success must be vetted in accordance to NASA Standard for Models and Simulations, NASA-STD-7009 (7009) [5]. As this standard mostly focuses on engineering systems, the IMM and DAP have invested substantial efforts to adapt the processes established in this standard for their application to biological M&S, which is more prevalent in human health and performance (HHP) and space biomedical research and operations [6,7]. These methods have also generated substantial interest by the broader medical community though institutions like the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to develop similar standards and guidelines applicable to the larger medical operations and research community. DISCUSSION: Similar to NASA, many leading government agencies, health institutions and medical product developers around the world are recognizing the potential of computational M&S to support clinical research and decision making. In this light, substantial investments are being made in computational medicine and notable discoveries are being realized [8]. However, there is a lack of broadly applicable practice guidance for the development and implementation of M&S in clinical care and research in a manner that instills confidence among medical practitioners and biological researchers [9,10]. In this presentation, we will give an overview on how HRP is working with the NIH's Interagency Modeling and Analysis Group (IMAG), the FDA and the American Society of Mechanical Engineers (ASME) to leverage NASA's biomedical VV&C processes to establish a new regulatory standard for Verification and Validation in Computational Modeling of Medical Devices, and Guidelines for Credible Practice of Computational Modeling and Simulation in Healthcare.

Mulugeta, Lealem↗

Human Reliability and the Cost of Doing Business

Most businesses recognize that people will make mistakes and assume errors are just part of the cost of doing business, but does it need to be? Companies with high risk, or major consequences, should consider the effect of human error. In a variety of industries, Human Errors have caused costly failures and workplace injuries. These have included: airline mishaps, medical malpractice, administration of medication and major oil spills have all been blamed on human error. A technique to mitigate or even eliminate some of these costly human errors is the use of Human Reliability Analysis (HRA). Various methodologies are available to perform Human Reliability Assessments that range from identifying the most likely areas for concern to detailed assessments with human error failure probabilities calculated. Which methodology to use would be based on a variety of factors that would include: 1) how people react and act in different industries, and differing expectations based on industries standards, 2) factors that influence how the human errors could occur such as tasks, tools, environment, workplace, support, training and procedure, 3) type and availability of data and 4) how the industry views risk & reliability influences ( types of emergencies, contingencies and routine tasks versus cost based concerns). The Human Reliability Assessments should be the first step to reduce, mitigate or eliminate the costly mistakes or catastrophic failures. Using Human Reliability techniques to identify and classify human error risks allows a company more opportunities to mitigate or eliminate these risks and prevent costly failures.

DeMott, Diana↗

Probe-And-Socket Fasteners For Robotic Assembly

Self-alignment and simplicity of actuation make mechanism amenable to robotic assembly. Includes socket, mounted on structure at worksite, and probe, mounted on piece of equipment to be attached to structure at socket. Probe-and-socket mechanism used in conjunction with fixed target aiding in placement of end effector of robot during grasping, and with handle or handles on structure. Intended to enable robot to set up workstation in hostile environment. Workstation then used by astronaut, aquanaut, or other human, spending minimum time in environment. Human concentrates on performing quality work rather than on setting up equipment, with consequent reduction of risk.

Nyberg, Karen↗

The International Space Station (ISS) Port 1 (P1) External Active Thermal Control System (EATCS) Ammonia Leak

From 2011 to 2017, the crew onboard the International Space Station (ISS) was at risk of dire consequences due to an external ammonia leak. Ammonia is used in the External Active Thermal Control System (EATCS) to cool the pressurized modules and external electrical systems. Engineers at NASA's Johnson Space Center (JSC) initially detected the leak in one of two cooling loops by monitoring the system ammonia inventory decay over time. White flakes seen on High Definition (HD) cameras were also thought to be associated with the leakage but not confirmed. Initially, the leak was small enough that the ammonia inventory and system operations were not in jeopardy. However, the leak began to accelerate to the point where troubleshooting and corrective action were vital to the sustainability of the ISS. Therefore, it became imperative that the leak be located and repaired for ISS operations to continue. No tools were readily available on the ISS to locate such a leak when it was initially detected, however NASA engineers were already in the process of developing a new device for this purpose called the Robotic External Leak Locator (RELL). The RELL is a robotic instrument package with a mass spectrometer and an ion pressure gauge. Initial checkout operations with RELL happened to coincide with the increasing leak, and ammonia vapors were measured around the P1 EATCS Radiator #3 flexible jumper hoses. The leak stopped after the radiator and its flexible hoses were remotely isolated from the loop and the ammonia from the isolated segment was vented to space. Astronauts conducted a spacewalk that successfully removed the hoses, which were returned to ground for further investigation. The purpose of this paper is to review the leak detection and isolation efforts, investigation results, lessons learned and the recovery plan.

Cowan, Darnell T.↗

The International Space Station (ISS) Port 1 (P1) External Active Thermal Control System (EATCS) Ammonia Leak

From 2011 to 2017, the crew onboard the International Space Station (ISS) was at risk of dire consequences due to an external ammonia leak. Ammonia is used in the External Active Thermal Control System (EATCS) to cool the pressurized modules and external electrical systems. Engineers at NASA's Johnson Space Center (JSC) initially detected the leak in one of two cooling loops by monitoring the system ammonia inventory decay over time. White flakes seen on High Definition (HD) cameras were also thought to be associated with the leakage but not confirmed. Initially, the leak was small enough that the ammonia inventory and system operations were not in jeopardy. However, the leak began to accelerate to the point where troubleshooting and corrective action were vital to the sustainability of the ISS. Therefore, it became imperative that the leak be located and repaired for ISS operations to continue. No tools were readily available on the ISS to locate such a leak when it was initially detected, however NASA engineers were already in the process of developing a new device for this purpose called the Robotic External Leak Locator (RELL). The RELL is a robotic instrument package with a mass spectrometer and an ion pressure gauge. Initial checkout operations with RELL happened to coincide with the increasing leak, and ammonia vapors were measured around the P1 EATCS Radiator #3 flexible jumper hoses. The leak stopped after the radiator and its flexible hoses were remotely isolated from the loop and the ammonia from the isolated segment was vented to space. Astronauts conducted a spacewalk that successfully removed the hoses, which were returned to ground for further investigation. The purpose of this paper is to review the leak detection and isolation efforts, investigation results, lessons learned and the recovery plan.

Cowan, Darnell T.↗

Mitigation of High Lateral Asymmetry Rates Due to Loss of a Cruise Motor on the X-57 Mod III Aircraft

The X-57 Mod III aircraft utilizes wingtip electric motors to generate thrust. The potential benefit of wingtip propulsion is a reduction in induced drag because wingtip vortices are interrupted. Wingtip propulsors, however, pose the risk of dangerous thrust asymmetry if one of the motors abruptly stops producing full thrust. This paper examines the effects of a full-power, single-motor failure at various phases of flight for the X-57 Mod III aircraft design by way of piloted-in-the-loop simulations conducted by two National Aeronautics and Space Administration test pilots. After determining that a failure during takeoff potentially poses the highest risk of catastrophic consequences, possible mitigations to the failure were explored and evaluated through pilot simulation data, Cooper-Harper ratings, and pilot comments. The preferred mitigation was found to be an automated power reduction system that allowed for a lower pilot workload and quick reduction of the asymmetric thrust.

Ryan Wallace↗

Managing the Risk of Command File Errors

Command File Error (CFE), as defined by the Jet Propulsion Laboratory's (JPL) Mission Operations Assurance (MOA) is, regardless of the consequence on the spacecraft, either: an error in a command file sent to the spacecraft, an error in the process for developing and delivering a command file to the spacecraft, or the omission of a command file that should have been sent to the spacecraft. The risk consequence of a CFE can be mission ending and thus a concern to space exploration projects during their mission operations. A CFE during space mission operations is often the symptom of some kind of imbalance or inadequacy within the system that comprises the hardware & software used for command generation and the human experts involved in this endeavour. As we move into an era of enhanced collaboration with other NASA centers and commercial partners, these systems become more and more complex and hence it is all the more important to formally model and analyze CFEs in order to manage the risk of CFEs. Here we will provide a summary of the ongoing efforts at JPL in this area and also explain some more recent developments in the area of developing quantitative models for the purpose of managing CFE's.

Bayesian Belief Networks↗

Risk of Adverse Cognitive or Behavioral Conditions and Psychiatric Disorders

The NASA commitment to human space flight includes continuing to fly astronauts on the ISS until it is decommissioned as well as possibly returning astronauts to the moon or having astronauts venture to an asteroid or Mars. As missions leave low Earth orbit and explore deeper space, BHP supports and conducts research to enable a risk posture that considers the risk of adverse cognitive or behavioral conditions and psychiatric disorders “acceptable given mitigations,” for pre-, in, and post-flight.The Human System Risk Board (HSRB) determines the risk of various mission scenarios using a likelihood (per person per year) by consequences matrix examining those risks across two categories—long term health and operational (within mission). Colors from a stoplight signal are used by HSRB and quickly provide a means of assessing overall perceived risk for a particular mission scenario. Risk associated with the current six month missions on the ISS are classified as “accepted with monitoring” while planetary missions, such as a mission to Mars, are recognized to be a “red” risk that requires mitigation to ensure mission success.Currently, the HSRB deems that the risk of adverse cognitive or behavioral conditions and psychiatric outcomes requires mitigation for planetary missions owing to long duration isolation and radiation exposure (see Table 1). While limited research evidence exists from spaceflight, it is well known anecdotally that the shift from the two week shuttle missions to the six month ISS missions renders the psychological stressors of space as more salient over longer duration missions. Shuttle astronauts were expected just to tolerate any stressors that arose during their mission and were successful at doing so (Whitmire et al, 2013). While it is possible to deal with stressors such as social isolation and to live with incompatible crewmembers for two weeks on shuttle, “ignoring it” is much less likely to be a successful coping mechanism on station. For the longer missions of the ISS, astronauts require a larger, more robust set of coping skills and more psychological support. Evidence of this are the number of BHP’s Operational Psychology (Op Psy) staff who have been awarded silver Snoopys by long duration astronauts†, in the statements of praise for the Op Psy and Family Support Office teams, and in the written and oral statements from flown astronauts regarding difficulty of longer missions and how much Op Psy helped.

Slack, Kelley J.↗

Pitfalls and Precautions When Using Predicted Failure Data for Quantitative Analysis of Safety Risk for Human Rated Launch Vehicles

Launch vehicle reliability analysis is largely dependent upon using predicted failure rates from data sources such as MIL-HDBK-217F. Reliability prediction methodologies based on component data do not take into account risks attributable to manufacturing, assembly, and process controls. These sources often dominate component level reliability or risk of failure probability. While consequences of failure is often understood in assessing risk, using predicted values in a risk model to estimate the probability of occurrence will likely underestimate the risk. Managers and decision makers often use the probability of occurrence in determining whether to accept the risk or require a design modification. Due to the absence of system level test and operational data inherent in aerospace applications, the actual risk threshold for acceptance may not be appropriately characterized for decision making purposes. This paper will establish a method and approach to identify the pitfalls and precautions of accepting risk based solely upon predicted failure data. This approach will provide a set of guidelines that may be useful to arrive at a more realistic quantification of risk prior to acceptance by a program.

Hatfield, Glen S.↗

Human Systems Risk Network - A Ranking Analysis of Risks

INTRODUCTION The Human Systems Risk Board (HSRB) is responsible for understanding, managing, and mitigating the risks associated with spaceflight. For a particular mission, the HSRB assigns each human system risk a rating on a 5x5 grid assessing its likelihood and consequence, which is ultimately used to compare and rank the risks. The HSRB approaches risk management by primarily establishing the context of each human system risk individually with the understanding that mitigating one risk might affect the likelihood, consequence, and mitigation approaches of another. To support this effort the HSRB, subject matter experts, and risk custodian teams created directed acyclic graphs (DAG), often called a causal graph, for the twenty-nine risks. In this presentation, we propose a new ranking algorithm for the risks which includes the downstream influence of each risk according to the information in the DAGs and provide an application of graph theoretic tools. METHODS In 2014, Mindock and Klaus proposed a taxonomy for human system risk influences which we have adopted to categorize the nodes in each DAG. Analyzing the nodes that correspond to the risks in this taxonomy allows us to analyze and understand how each risk influences the others. We construct an auxiliary network, which we call the Primary Risk Network (PRN), where the nodes are the twenty-nine space flight risks and, a directed edge connects Risk A to Risk B if Risk A has some influence on the likelihood or consequence of Risk B as described in the DAGS. We perform a variety of graph theoretic ranking methods on the nodes (or risks) in the PRN, including Katz centrality. RESULTS We rank the nodes in the PRN using the Katz centrality score. The ten risks with the highest score are pictured in Figure 1, colored (light to dark) according to their score. We analyze other centrality measures like betweenness centrality, eigenvector centrality, and the Estrada index, and provide the meaning of the corresponding rankings in terms of the risks. Future work includes analyzing the other categories in the taxonomy defined by Mindock and Klaus [1]. For example, we are interested in analyzing the nodes that are labeled as countermeasures or capabilities and perform similar analysis to measure their effect on certain medical conditions.

dag↗

Alignment of NASA’s Human System Risks with Technological Capability Gaps to Enable Integrated Research and Technology Development Strategic Planning

BACKGROUND: Radiation, reduced gravity, distance from earth, isolation and confinement, and habitation within artificially created and controlled life support environments are hazards that present risk to human space explorers. NASA’s Human System Risk Board (HSRB) maintains a set of twenty-nine different Human System Risks with subject matter experts from across the agency providing regular updates to the estimated likelihood and consequence associated with each risk. The Human Research Program (HRP) has historically used these risk classifications as a primary basis for identifying and prioritizing human research investments aimed at characterizing and/or mitigating the respective human system risks. In many cases, technology development is required to mature and validate risk mitigation strategies, however, NASA’s primary technology development programs have not typically used Human System Risks as a basis for strategic planning. A primary function of the Environmental Control and Life Support Systems (ECLSS) – Crew Health and Performance (CHP) System Capability Leadership Team (SCLT) is to continually identify, review, and update technological capability gaps and to establish and oversee multiyear strategic roadmaps aimed at guiding NASA’s technology development priorities in these areas. These roadmaps are intended to be agency-wide and independent of any program, directorate, or other organization within NASA. DESCRIPTION: The SCLT and HRP collaborated to establish a set of Human System Capability Gaps, which establish a formal linkage between the capability gaps used to prioritize investments across much of NASA, and the Human System Risks that are primarily used to inform and prioritize human research. This set of twenty-eight gaps was developed by subject matter experts, and each gap mapped to the primary associated Human System Risks. The gaps and risk mapping were then reviewed and approved via the HSRB, thereby formally aligning the research-focused Human System Risks with the technology-focused capability gaps. DISCUSSION: This effort has enabled development of integrated roadmaps and budget coordination with research and technology development activities that are formally linked to agency-recognized capability gaps and Human System Risks. Close and ongoing coordination between the SCLT, HRP, Mars Campaign Office, and the Health & Medical Technical Authority (HMTA) is essential to ensure alignment and prioritization of CHP-related research and technology development to enable NASA’s future exploration missions.

Andrew F J Abercromby↗

Humans vs Hardware: The Unique World of NASA Human System Risk Assessment

Understanding spaceflight risks to crew health and performance is a crucial aspect of preparing for exploration missions in the future. The research activities of the Human Research Program (HRP) provide substantial evidence to support most risk reduction work. The Human System Risk Board (HSRB), acting on behalf of the Office of Chief Health and Medical Officer (OCHMO), assesses these risks and assigns likelihood and consequence ratings to track progress. Unfortunately, many traditional approaches in risk assessment such as those used in the engineering aspects of spaceflight are difficult to apply to human system risks. This presentation discusses the unique aspects of risk assessment from the human system risk perspective and how these limitations are accommodated and addressed in order to ensure that reasonable inputs are provided to support the OCHMO's overall risk posture for manned exploration missions.

Anton, W.↗

Behavioral Health and Performance (BHP) Work-Rest Cycles

BHP Program Element Goal: Identify, characterize, and prevent or reduce behavioral health and performance risks associated with space travel, exploration and return to terrestrial life. BHP Requirements: a) Characterize and assess risks (e.g., likelihood and consequences). b) Develop tools and technologies to prevent, monitor, and treat adverse outcomes. c) Inform standards. d) Develop technologies to: 1) reduce risks and human systems resource requirements (e.g., crew time, mass, volume, power) and 2) ensure effective human-system integration across exploration mission.

Leveton, Lauren B.↗

System Safety and the Unintended Consequence

The analysis and identification of risks often result in design changes or modification of operational steps. This paper identifies the potential of unintended consequences as an over-looked result of these changes. Examples of societal changes such as prohibition, regulatory changes including mandating lifeboats on passenger ships, and engineering proposals or design changes to automobiles and spaceflight hardware are used to demonstrate that the System Safety Engineer must be cognizant of the potential for unintended consequences as a result of an analysis. Conclusions of the report indicate the need for additional foresight and consideration of the potential effects of analysis-driven design, processing changes, and/or operational modifications.

Watson, Clifford↗

Risk Assessment: Evidence Base

Human systems PRA (Probabilistic Risk Assessment: a) Provides quantitative measures of probability, consequence, and uncertainty; and b) Communicates risk and informs decision-making. Human health risks rated highest in ISS PRA are based on 1997 assessment of clinical events in analog operational settings. Much work remains to analyze remaining human health risks identified in Bioastronautics Roadmap.

Johnson-Throop, Kathy A.↗

Demystification of Processes that Effect Prioritization of Space Radiation Element Research

In an effort to demystify how research funding priorities are established , the Space Radiation Element will present an introduction to the Human Space Risk Board (HSRB) framework that is that used to inform Human System Risk and can be found at https://humanresearchroadmap.nasa.gov/Risks/. These risks are based on the consequences of hazards (space radiation, altered gravity, isolation & confinement, distance from earth and hostile/closed environment) a human body is exposed to during spaceflight. The HSRB regularly evaluates risks to humans in space which includes updating the knowledge base to reflect emerging research, the development of effective countermeasures, and evolving operational approaches toward addressing those risks. To increase understanding and clarity, this talk will step through how risks (with the focus on Risk of Radiation Carcinogenesis) are assigned a rating (and color code) based on design reference missions, likelihood, and consequence. Further, The Space Radiation Element will discuss how risks, including the magnitude/rating, required technical deliverables, and expected products from current research efforts affect our element strategy and prioritization of research. In addition, navigation of the publicly available www.nasa.gov/hrp, will be demonstrated to inform principal investigators where this information can be readily accessed. Our primary objectives for this presentation/demonstration are to demystify The Space Radiation Element’s internal processes and to educate researchers concerning publicly available documents that can be used to better align their proposed objectives with Element priorities.

J A Zawaski↗