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DOE OSTI2025

Emerging Tools to Support DILI Assessment in Clinical Trials with Abnormal Baseline Serum Liver Tests or Pre-existing Liver Diseases

Abstract Based on the late Dr. Hyman Zimmerman’s observation that hepatocellular drug-induced liver injury (DILI) leading to jaundice carries a ≥ 10% fatality risk (coined as Hy’s law by others), evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) continues to play a central role in the assessment of a study drug’s liability for acute hepatocellular DILI. The eDISH identifies drugs in clinical trials with DILI fatality (death or transplant) risk that may be unacceptable in a post-market setting. As a two-dimensional graph that plots peak total bilirubin (TB) versus peak serum aminotransferase levels for each patient during study drug or comparator treatment, eDISH identifies potential cases of acute, modest, and serious hepatocellular DILI for in-depth analysis of liver tests (LT) and clinical course so that the likelihood of causal association with the study drug can be determined. Unfortunately, the generalizable utility of this tool only pertains to trials enrolling patients with normal or near normal (NNN) baseline (BL) serum LTs. The eDISH does not necessarily apply to trials of patients with abnormal baseline (ABN-BL) LTs that often coincide with underlying liver disorders. Because drug development programs being reviewed by the FDA increasingly target liver disorders, we are often challenged to evaluate DILI risk in trials of patients with ABN-BL LTs. Also, the high background prevalence of metabolic dysfunction associated steatotic liver disease (MASLD) means patients with LTs above NNN may need to be enrolled in trials treating non-liver disorders to reflect the target population. Such study populations create challenges for industry and regulators because eDISH may not reliably categorize or identify potential cases of DILI for further analysis, as it so efficiently does in NNN-BL trials. We describe the main functionalities of eDISH in NNN-BL trials to understand what should be emulated by new tools or eDISH modifications. We then discuss non-eDISH–based plots that may be useful in ABN-BL trials.

Amirzadegan, Jasmine↗

NASA NTRSDate not supplied

Simulating Microwave and Radar Signals in Severe Weather Conditions

The development of radiative transfer simulators for radar and microwave signals, spanning a range of frequencies from 10 to 800 GHz, is paramount for enhancing weather forecasting accuracy, particularly for severe weather events. These tools facilitate the assimilation of microwave and radar observations into numerical weather prediction models, thereby improving accuracy of weather forecasts. Additionally, they directly simulate radar signals crucial for autonomous vehicle operation, with frequencies commonly used in radar systems such as 24, 74, 77, and 79 GHz. However, these frequencies are susceptible to weather phenomena like severe rain and snow, which can significantly impact vehicle safety and performance. These simulation tools, including radiative transfer simulators, serve a dual purpose. Firstly, they enhance forecasts for severe weather events, contributing to autonomous vehicle safety by providing early warnings and risk assessments. Secondly, they enable the direct simulation of radar signals in autonomous vehicle driving systems, allowing researchers and engineers to evaluate radar system performance under various weather conditions. In addition to the radar signal simulator, this abstract discusses the incorporation of advanced scattering properties developed using the discrete dipole approximation (DDA). The DDA technique enhances scattering calculations for frozen hydrometeors at microwave frequencies, thereby improving the accuracy of radar signal simulations and enabling more accurate assessments of radar system performance in adverse weather conditions. In summary, this abstract explores the development and utilization of comprehensive simulation tools, emphasizing their significance in simulating microwave and radar signals and improving weather forecasts. Special attention is given to the simulation of radar signals at critical frequencies for autonomous vehicle sensing and navigation, addressing challenges posed by severe weather phenomena and their effects on signal propagation and detection

Isaac Moradi↗

NASA NTRS2023

Exploration Medical Capability IMPACT Medical Database – Medical Item Database (MedID) Content Development Methods

The Informing Mission Planning via Analysis of Complex Tradespaces (IMPACT) project encompasses a suite of computational tools that are used to inform systematic trade study evaluations and research prioritizations regarding the optimization of spaceflight medical systems, including the provision of risk assessment metrics, for a given design reference mission (DRM). The IMPACT Medical Database (IMPACT-MD) is the component that virtually houses the clinical and engineering data for medical conditions, capabilities, and resources used to support these analyses. In addition, IMPACT-MD also provides data to the associated SysML model to support the Level 2, Level 3, and Level 4 requirements development needed for IMPACT. IMPACT-MD contains an internal Evidence Library (EL) sub-component that hosts the clinical evidence, treatment and outcome metric data, and incidence data for each medical condition identified for exploration-class missions. Furthermore, a separate Medical Item Database (MedID) sub-component hosts the engineering data and physical attributes (e.g., mass, volume, power, etc.) associated with each medical resource item identified to address the requisite medical conditions. The IMPACT project is conducted under the Exploration Medical Capability (ExMC) element of the Human Research Program (HRP) within NASA's Space Operations Mission Directorate (SOMD). The reader is referred to the documents in Appendix A for a more complete overview of the IMPACT tool suite and functionality as well as further detail on any associated aspects of the project. The primary purpose of this document is to describe the methods utilized in the collection and verification of engineering data content during the project development phase for the MedID sub-component of the IMPACT-MD project. Engineering content data (both existing and new/future) will be stored in IMPACT-MD for use by the IMPACT project. This document will detail the content development and data credibility for the engineering data housed within the MedID subcomponent of IMPACT-MD, which is used to inform the IMPACT 1.0 project deliverables.

Exploration Medical Capability↗

DOE OSTI2022

Guide to the Distributed Energy Resource Risk Management Framework

The emergence of distributed energy resources (DERs) has transformed the electric power sector and will likely have even more profound impacts on the future evolution of the United States energy sector as it modernizes and becomes more reliant upon complex informatics programming and systems to ensure that our power grid remains safe from malicious interference. To mitigate risks associated with the increased and diversified use of DERs, the Distributed Energy Resource Cybersecurity Framework (DER-CF) was developed in 2019. The National Renewable Energy Laboratory extended the scope of the DER-CF to include the RMF. To address the challenges faced by federal energy managers and energy system stakeholders in applying the RMF to DER systems, the Distributed Energy Resource Risk Manager (DER-RM) is a six-step process to proactively manage cybersecurity risk in a methodical manner. The DER-RM is independent of the DER-CF's existing assessment, allowing users to focus specifically on the RMF steps. The tools are targeted to different processes - DER-CF enables organizations to perform self-assessments to improve their cybersecurity posture, while DER-RM assists organizations in achieving compliance with specific requirements. This document provides an overview of the DER-RM. The RMF process outlined in this report serves as a guide to diagnose information and operational system threats, gather required materials to comply with industry standards, and document plans for achieving Authority to Operate. Using the DER-RM, federal agencies and other organizations can easily and intuitively follow the RMF process, manage the risks to their grid-edge infrastructure through the integration of their on-site DERs, and comply with appropriate requirements.

24 POWER TRANSMISSION AND DISTRIBUTION↗

NASA NTRSDate not supplied

IMPACTing Medical System Design with a Risk Analysis Tool

Background: Following the success of Artemis I, NASA is preparing for human extended duration missions. Ongoing efforts are focused on mitigating mission-related risks, including those affecting crew health and performance. Communication latency, logistics of resupply and time frame of medical evacuation are barriers to provision of healthcare for these missions, especially with respect to constraints in mass, volume, and crew training. An in-depth assessment of medical risks, capabilities and resources for a specific mission design is necessary to determine an optimal balance that maximizes likelihood of mission success. Overview: IMPACT (Informed Mission Planning via Analysis of Complex Tradespaces) is a dynamic tool designed to estimate medical risk and outcomes for a specific mission design. In its current iteration, a list of medical conditions selected based on likelihood of occurrence and/or consequence was linked to a set of clinical capabilities and resources necessary for diagnosis and management. A probabilistic risk analysis tool was then used to identify and estimate the likelihood and consequence of risks through the following outcome metrics: loss of crew life (inflight mortality due to medical conditions), need for medical evacuation (return to definitive care), and crew disability (task time affected based on how medical conditions influence the ability to perform specific exploration mission crew tasks). Finally, the model’s optimization algorithm provides recommendations for medical capabilities that maximize risk mitigation relative to mass and volume constraints. In the Spring of 2023, IMPACT was utilized to estimate outcome metrics for a design reference mission that would be representative of an extended duration Artemis mission. Notional data generated were then used to determine a recommended set of medical capabilities and resources relative to user-defined mass and volume constraints. A multidisciplinary team has also been updating IMPACT to strengthen the model’s fidelity. Figure 1 shows how updates to outcome metric inputs for the conditions resulted in different capability and resource allocation recommendations. Discussion: This presentation will discuss the IMPACT tool and share the latest data generated for a representative extended duration Artemis mission. Efforts to improve the fidelity of data generated by the model’s algorithm will also be discussed.

K A Shair↗

NASA NTRS2008

Designing a Composable Geometric Toolkit for Versatility in Applications to Simulation Development

Conceived and implemented through the development of probabilistic risk assessment simulations for Project Constellation, the Geometric Toolkit allows users to create, analyze, and visualize relationships between geometric shapes in three-space using the MATLAB computing environment. The key output of the toolkit is an analysis of how emanations from one "source" geometry (e.g., a leak in a pipe) will affect another "target" geometry (e.g., another heat-sensitive component). It can import computer-aided design (CAD) depictions of a system to be analyzed, allowing the user to reliably and easily represent components within the design and determine the relationships between them, ultimately supporting more technical or physics-based simulations that use the toolkit. We opted to develop a variety of modular, interconnecting software tools to extend the scope of the toolkit, providing the capability to support a range of applications. This concept of simulation composability allows specially-developed tools to be reused by assembling them in various combinations. As a result, the concepts described here and implemented in this toolkit have a wide range of applications outside the domain of risk assessment. To that end, the Geometric Toolkit has been evaluated for use in other unrelated applications due to the advantages provided by its underlying design.

Reed, Gregory S.↗

DOE OSTI2025

A Software/Hardware Framework for Efficient and Safe Emergency Response in Post-Crash Scenarios of Battery Electric Vehicles

The adoption rate of battery electric vehicles (EVs) is rapidly increasing. Electric vehicles differ significantly from conventional internal combustion engine vehicles and vary widely across different manufacturers. Emergency responders (ERs) and recovery personnel may have less experience with EVs and lack timely access to critical information such as the extent of the stranded energy present, high-voltage safety hazards, and post-crash handling procedures in a user-friendly manner. This paper presents a software/hardware interactive tool named Electric Vehicle Information for Incident Response Solutions (EVIRS) to aid in the quick access to emergency response and recovery information. The current prototype of EVIRS identifies EVs using the VIN or Make, Model, and Year, and offers several useful features for ERs and recovery personnel. These features include integration and easy access to emergency response procedures tailored to an identified EV, vehicle structural schematics, the quick identification of battery pack specifications, and more. For EVs that are not severely damaged, EVIRS can perform calculations to estimate stranded energy in the EV’s battery and discharge time for various power loads using either EV dashboard information or operational data accessed through the CAN interface. Knowledge of this information may be helpful in the post-crash handling, management, and storage of an EV. The functionality and accuracy of EVIRS were demonstrated through laboratory tests using a 2021 Ford Mach-E and associated data acquisition system. The results indicated that when the remaining driving range was used as an input, EVIRS was able to estimate the pack voltage with an error of less than 3 V. Conversely, when pack voltage was used as an input, the estimated state of charge (SOC) error was less than 5% within the range of 30–90% SOC. Additionally, other features, such as retrieving emergency response guides for identified EVs and accessing lessons learned from archived incidents, have been successfully demonstrated through EVIRS for quick access. EVIRS can be a valuable tool for emergency responders and recovery personnel, both in action and during offline training, by providing crucial information related to assessing EV/battery safety risks, appropriate handling, de-energizing, transport, and storage in an integrated and user-friendly manner.

25 ENERGY STORAGE↗

NASA NTRS2005

Business Intelligence Modeling in Launch Operations

This technology project is to advance an integrated Planning and Management Simulation Model for evaluation of risks, costs, and reliability of launch systems from Earth to Orbit for Space Exploration. The approach builds on research done in the NASA ARC/KSC developed Virtual Test Bed (VTB) to integrate architectural, operations process, and mission simulations for the purpose of evaluating enterprise level strategies to reduce cost, improve systems operability, and reduce mission risks. The objectives are to understand the interdependency of architecture and process on recurring launch cost of operations, provide management a tool for assessing systems safety and dependability versus cost, and leverage lessons learned and empirical models from Shuttle and International Space Station to validate models applied to Exploration. The systems-of-systems concept is built to balance the conflicting objectives of safety, reliability, and process strategy in order to achieve long term sustainability. A planning and analysis test bed is needed for evaluation of enterprise level options and strategies for transit and launch systems as well as surface and orbital systems. This environment can also support agency simulation .based acquisition process objectives. The technology development approach is based on the collaborative effort set forth in the VTB's integrating operations. process models, systems and environment models, and cost models as a comprehensive disciplined enterprise analysis environment. Significant emphasis is being placed on adapting root cause from existing Shuttle operations to exploration. Technical challenges include cost model validation, integration of parametric models with discrete event process and systems simulations. and large-scale simulation integration. The enterprise architecture is required for coherent integration of systems models. It will also require a plan for evolution over the life of the program. The proposed technology will produce long-term benefits in support of the NASA objectives for simulation based acquisition, will improve the ability to assess architectural options verses safety/risk for future exploration systems, and will facilitate incorporation of operability as a systems design consideration, reducing overall life cycle cost for future systems. The future of business intelligence of space exploration will focus on the intelligent system-of-systems real-time enterprise. In present business intelligence, a number of technologies that are most relevant to space exploration are experiencing the greatest change. Emerging patterns of set of processes rather than organizational units leading to end-to-end automation is becoming a major objective of enterprise information technology. The cost element is a leading factor of future exploration systems.

Bardina, Jorge E.↗

NASA NTRS2017

High-Fidelity Multi-Rotor Unmanned Aircraft System Simulation Development for Trajectory Prediction Under Off-Nominal Flight Dynamics

The NASA Unmanned Aircraft System (UAS) Traffic Management (UTM) project is conducting research to enable civilian low-altitude airspace and UAS operations. A goal of this project is to develop probabilistic methods to quantify risk during failures and off nominal flight conditions. An important part of this effort is the reliable prediction of feasible trajectories during off-nominal events such as control failure, atmospheric upsets, or navigation anomalies that can cause large deviations from the intended flight path or extreme vehicle upsets beyond the normal flight envelope. Few examples of high-fidelity modeling and prediction of off-nominal behavior for small UAS (sUAS) vehicles exist, and modeling requirements for accurately predicting flight dynamics for out-of-envelope or failure conditions are essentially undefined. In addition, the broad range of sUAS aircraft configurations already being fielded presents a significant modeling challenge, as these vehicles are often very different from one another and are likely to possess dramatically different flight dynamics and resultant trajectories and may require different modeling approaches to capture off-nominal behavior. NASA has undertaken an extensive research effort to define sUAS flight dynamics modeling requirements and develop preliminary high fidelity six degree-of-freedom (6-DOF) simulations capable of more closely predicting off-nominal flight dynamics and trajectories. This research has included a literature review of existing sUAS modeling and simulation work as well as development of experimental testing methods to measure and model key components of propulsion, airframe and control characteristics. The ultimate objective of these efforts is to develop tools to support UTM risk analyses and for the real-time prediction of off-nominal trajectories for use in the UTM Risk Assessment Framework (URAF). This paper focuses on modeling and simulation efforts for a generic quad-rotor configuration typical of many commercial vehicles in use today. An overview of relevant off-nominal multi-rotor behaviors will be presented to define modeling goals and to identify the prediction capability lacking in simplified models of multi-rotor performance. A description of recent NASA wind tunnel testing of multi-rotor propulsion and airframe components will be presented illustrating important experimental and data acquisition methods, and a description of preliminary propulsion and airframe models will be presented. Lastly, examples of predicted off-nominal flight dynamics and trajectories from the simulation will be presented.

Foster, John V.↗

NASA NTRS2019

Standard Component Commodity Usage Guides (CUGs) for Charge-Coupled Devices (CCDs)

Communicating risk and reliability information within NASA Goddard’s missions is crucial to continuing the development of new technology and ensuring GSFC missions achieve their science objectives. The Reliability and Risk Assessment Branch (Code 371) within the SMA directorate is one of GSFC’s leaders in communicating this information to missions, and one tool 371 engineers use to provide this information is the Commodity Usage Guides (CUGs). CUGs are helpful in compiling various critical parameters and heritage information for standard payload components, ensuring project personnel inherit the lessons learned from previous experiences. The purpose of this project was to create CUGs for CCDs used within GSFC missions. To formulate a CUG applicable data was aggregated into the CUG template for Charge-Coupled Devices (CCDs)--electro-optical components used to convert photons into digital images and data. CCDs can easily be adapted to a variety of mission requirements making them widely used at GSFC, and therefore suitable for CUGs. Once the CUGs for CCDs are completed the information can be distributed to engineers, scientists and other project members to ensure the lessons learned are passed on to the next mission.

Christman, Jerika H.↗

NASA NTRS2015

Integrated Medical Model (IMM) Project Verification, Validation, and Credibility (VVandC)

The Integrated Medical Model (IMM) Project supports end user requests by employing the Integrated Medical Evidence Database (iMED) and IMM tools as well as subject matter expertise within the Project. The iMED houses data used by the IMM. The IMM is designed to forecast relative changes for a specified set of crew health and mission success risk metrics by using a probabilistic model based on historical data, cohort data, and subject matter expert opinion. A stochastic approach is taken because deterministic results would not appropriately reflect the uncertainty in the IMM inputs. Once the IMM was conceptualized, a plan was needed to rigorously assess input information, framework and code, and output results of the IMM, and ensure that end user requests and requirements were considered during all stages of model development and implementation, as well as lay the foundation for external review and application. METHODS: In 2008, the Project team developed a comprehensive verification and validation (VV) plan, which specified internal and external review criteria encompassing 1) verification of data and IMM structure to ensure proper implementation of the IMM, 2) several validation techniques to confirm that the simulation capability of the IMM appropriately represents occurrences and consequences of medical conditions during space missions, and 3) credibility processes to develop user confidence in the information derived from the IMM. When the NASA-STD-7009 (7009) [1] was published, the Project team updated their verification, validation, and credibility (VVC) project plan to meet 7009 requirements and include 7009 tools in reporting VVC status of the IMM. Construction of these tools included meeting documentation and evidence requirements sufficient to meet external review success criteria. RESULTS: IMM Project VVC updates are compiled recurrently and include updates to the 7009 Compliance and Credibility matrices. Reporting tools have evolved over the lifetime of the IMM Project to better communicate VVC status. This has included refining original 7009 methodology with augmentation from the HRP NASA-STD-7009 Guidance Document working group and the NASA-HDBK-7009 [2]. End user requests and requirements are being satisfied as evidenced by ISS Program acceptance of IMM risk forecasts, transition to an operational model and simulation tool, and completion of service requests from a broad end user consortium including operations, science and technology planning, and exploration planning. IMM v4.0 is slated for operational release in the FY015 and current VVC assessments illustrate the expected VVC status prior to the completion of customer lead external review efforts. CONCLUSIONS: The VVC approach established by the IMM Project of incorporating Project-specific recommended practices and guidelines for implementing the 7009 requirements is comprehensive and includes the involvement of end users at every stage in IMM evolution. Methods and techniques used to quantify the VVC status of the IMM Project represented a critical communication tool in providing clear and concise suitability assessments to IMM customers. These processes have not only received approval from the local NASA community but have also garnered recognition by other federal agencies seeking to develop similar guidelines in the medical modeling community.

Walton, M.↗

NASA NTRS2003

System Risk Assessment and Allocation in Conceptual Design

As aerospace systems continue to evolve in addressing newer challenges in air and space transportation, there exists a heightened priority for significant improvement in system performance, cost effectiveness, reliability, and safety. Tools, which synthesize multidisciplinary integration, probabilistic analysis, and optimization, are needed to facilitate design decisions allowing trade-offs between cost and reliability. This study investigates tools for probabilistic analysis and probabilistic optimization in the multidisciplinary design of aerospace systems. A probabilistic optimization methodology is demonstrated for the low-fidelity design of a reusable launch vehicle at two levels, a global geometry design and a local tank design. Probabilistic analysis is performed on a high fidelity analysis of a Navy missile system. Furthermore, decoupling strategies are introduced to reduce the computational effort required for multidisciplinary systems with feedback coupling.

Mahadevan, Sankaran↗

NASA NTRS2014

Persistent Expression Changes of Fibrosis-Related Genes in the Lung Tissues of Rats Exposed to Lunar Dust Particles

The Moon's surface is covered by a layer of fine, potential reactive dust. Lunar dust contain about 1‐2% of very fine respirable dust (less than 3 micrometers). The habitable area of any lunar landing vehicle and outpost would inevitably be contaminated with lunar dust that could pose a health risk. The purpose of the study is to evaluate the toxicity of Apollo moon dust in rodents to assess the health risk of dust exposures to humans. One of the particular interests in the study is to evaluate dust‐induced changes of the expression of fibrosis‐related genes, and to identify specific signaling pathways involved in lunar dustinduced toxicity. F344 rats were exposed for 4 weeks (6h/d; 5d/wk) in nose‐only inhalation chambers to concentrations of 0 (control air), 2.1, 6.8, 21, and 61 milligrams per cubic meters of lunar dust. Five rats per group were euthanized at 1 day, 1 week, 1 month, and 3 months after the last inhalation exposure. The bronchoalveolar lavage fluid (BALF) was collected by lavaging with phosphate‐buffered saline (PBS). A zymosan‐induced luminolbased chemiluminescence assay was used to assess the activity of BAL cells. The lavaged lung tissue was snap frozen in LN2 and total RNA was isolated using the Qigen RNeasy kit. The expression of 84 fibrosisrelated genes were analyzed using the RT2 Profiler PCR Array technique. The expression of 18 genes of interest were further measured using real‐time PCR technique in all the samples. 10 out of 18 genes of interest showed persistently significant expression changes in the local lung tissue exposed to lunar dust, indicating a prolonged proinflammatory response. The expressions of several of these genes were dose‐ and time‐dependent and were significantly correlated with other pathological parameters. The potential signaling pathways and upstream regulators were further analyzed using IPA pathway analysis tool based on the gene expression data. The data presented in this study, for the first time, explore the molecular mechanisms of lunar dust induced toxicity, contributing not only the risk assessment for future space exploration, but also understandings of the dust‐induced toxicity in humans on earth.

Zhang, Ye↗

NASA NTRS2011

Probabilistic Risk Assessment Procedures Guide for NASA Managers and Practitioners (Second Edition)

Probabilistic Risk Assessment (PRA) is a comprehensive, structured, and logical analysis method aimed at identifying and assessing risks in complex technological systems for the purpose of cost-effectively improving their safety and performance. NASA's objective is to better understand and effectively manage risk, and thus more effectively ensure mission and programmatic success, and to achieve and maintain high safety standards at NASA. NASA intends to use risk assessment in its programs and projects to support optimal management decision making for the improvement of safety and program performance. In addition to using quantitative/probabilistic risk assessment to improve safety and enhance the safety decision process, NASA has incorporated quantitative risk assessment into its system safety assessment process, which until now has relied primarily on a qualitative representation of risk. Also, NASA has recently adopted the Risk-Informed Decision Making (RIDM) process [1-1] as a valuable addition to supplement existing deterministic and experience-based engineering methods and tools. Over the years, NASA has been a leader in most of the technologies it has employed in its programs. One would think that PRA should be no exception. In fact, it would be natural for NASA to be a leader in PRA because, as a technology pioneer, NASA uses risk assessment and management implicitly or explicitly on a daily basis. NASA has probabilistic safety requirements (thresholds and goals) for crew transportation system missions to the International Space Station (ISS) [1-2]. NASA intends to have probabilistic requirements for any new human spaceflight transportation system acquisition. Methods to perform risk and reliability assessment in the early 1960s originated in U.S. aerospace and missile programs. Fault tree analysis (FTA) is an example. It would have been a reasonable extrapolation to expect that NASA would also become the world leader in the application of PRA. That was, however, not to happen. Early in the Apollo program, estimates of the probability for a successful roundtrip human mission to the moon yielded disappointingly low (and suspect) values and NASA became discouraged from further performing quantitative risk analyses until some two decades later when the methods were more refined, rigorous, and repeatable. Instead, NASA decided to rely primarily on the Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA) methods for system safety assessment.

Stamatelatos,Michael↗

NASA NTRSDate not supplied

Human Systems Integration (HSI) Framework and Training - Shifting the View of HSI for Better Implementation

The Implementation of Human Systems Integration (HSI) presents challenges within the acquisition community for two reasons. The first is that misconceptions of HSI still exist, with many Program Managers (PMs) and leadership uncertain of the value or where to begin. The second is due to an unbalanced approach to HSI in its own framework. These implementation challenges lead to barriers in the early prevention of mishaps. Understanding HSI practices and how they should be implemented in the Acquisition Product Life Cycle (PLC) has been a challenge across the government, leaving the value of HSI unknown and misunderstood with Program Managers. In the case for many acquisition programs, HSI is not implemented in early design, losing the perspective on human capabilities and limitations, creating impacts on human-centered design. Expectations in human performance are not clearly set and operations are baselined with no margin for changes in technology and processes that will affect system performance. The HSI framework addresses total system performance holistically using collaboration as the primary tool. The goal is to create a system with efficiencies while minimizing risk to the operators, maintainers, and support personnel, as well as any collateral personnel and systems. To accomplish this, HSI should be implemented as part of preemptive measures to minimize potential human error and mishaps during the operation phase. Investigative and assessment tools exist that consider events, issues, and other outside influences of a system that may not fall under the current construct of the HSI domains, leaving gaps in early HSI implementation and affecting the prevention of human errors and mishaps. This presentation will outline what NASA HSI is doing to support Early HSI implementation and Operational Performance shifts that affect human performance.

Anthony T Thomas↗

NASA NTRS2011

The Role of Uncertainty in Aerospace Vehicle Analysis and Design

Effective uncertainty quantification (UQ) begins at the earliest phase in the design phase for which there are adequate models and continues tightly integrated to the analysis and design cycles as the refinement of the models and the fidelity of the tools increase. It is essential that uncertainty quantification strategies provide objective information to support the processes of identifying, analyzing and accommodating for the effects of uncertainty. Assessments of uncertainty should never render the results more difficult for engineers and decision makers to comprehend, but instead provide them with critical information to assist with resource utilization decisions and risk mitigation strategies. Success would be measured by the tools to enable engineers and decision makers to effectively balance critical project resources against system requirements while accounting for the impact of uncertainty.

Kenny, Sean P.↗

NASA NTRS1992

Structural reliability assessment capability in NESSUS

The principal capabilities of NESSUS (Numerical Evaluation of Stochastic Structures Under Stress), an advanced computer code developed for probabilistic structural response analysis, are reviewed, and its structural reliability assessed. The code combines flexible structural modeling tools with advanced probabilistic algorithms in order to compute probabilistic structural response and resistance, component reliability and risk, and system reliability and risk. An illustrative numerical example is presented.

Millwater, H.↗

NASA NTRS1999

Reliability/Risk Methods and Design Tools for Application in Space Programs

Since 1984 NASA has funded several major programs to develop Reliability/Risk Methods and tools for engineers to apply in the design and assessment of aerospace hardware. Two probabilistic software tools that show great promise for practical application are the finite element code NESSUS and the system risk analysis code QRAS. This paper examines NASA's past, present, and future directions in reliability and risk engineering applications, Both the NESSUS and QRAS software tools are detailed.

Townsend, John S.↗