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Bayesian Framework For Bioburden Density Calculations To Perform Planetary Protection Probabilistic Risk Assessment

The planetary protection discipline aims to minimize the microbial contamination on spacecraft to prevent the inadvertent contamination of other planetary bodies, known as forward planetary protection (PP). Planetary protection probabilistic risk assessment (PRA) relies on two core methodologies-the contamination probability event tree analysis and statistical parameter estimation. Planetary protection engineers combine several techniques to estimate the bioburden present on spacecraft components. A direct assay to enumerate CFU (colony forming units) is the preferred methodology, but given a similar processing environment the bioburden present on certain components is inferred using: (1) a NASA defined bioburden estimate based upon the biological cleanliness of the manufacturing/assembly environment or (2) sampled data from a similar spacecraft component. The paper presents an empirical Bayesian framework to systematically treat bioburden estimation and its uncertainties on different levels starting with measurement procedures to combining different components to subsystems and whole spacecraft. It is shown that the Bayesian approach can effectively handle estimations and their uncertainties at different levels and produce a reliable estimate for bioburden to be used to evaluate the probability of contamination.

Seuylemezian, Arman↗

Human Reliability Assessments: Using the Past (Shuttle) to Predict the Future (ORION)

NASA uses two HRA assessment methodologies. The first is a simplified method which is based on how much time is available to complete the action, with consideration included for environmental and personal factors that could influence the human's reliability. This method is expected to provide a conservative value or placeholder as a preliminary estimate. This preliminary estimate is used to determine which placeholder needs a more detailed assessment. The second methodology is used to develop a more detailed human reliability assessment on the performance of critical human actions. This assessment needs to consider more than the time available, this would include factors such as: the importance of the action, the context, environmental factors, potential human stresses, previous experience, training, physical design interfaces, available procedures/checklists and internal human stresses. The more detailed assessment is still expected to be more realistic than that based primarily on time available. When performing an HRA on a system or process that has an operational history, we have information specific to the task based on this history and experience. In the case of a PRA model that is based on a new design and has no operational history, providing a "reasonable" assessment of potential crew actions becomes more problematic. In order to determine what is expected of future operational parameters, the experience from individuals who had relevant experience and were familiar with the system and process previously implemented by NASA was used to provide the "best" available data. Personnel from Flight Operations, Flight Directors, Launch Test Directors, Control Room Console Operators and Astronauts were all interviewed to provide a comprehensive picture of previous NASA operations. Verification of the assumptions and expectations expressed in the assessments will be needed when the procedures, flight rules and operational requirements are developed and then finalized.

DeMott, Diana L.↗

Human Reliability Assessments: Using the Past (Shuttle) to Predict the Future (Orion)

NASA (National Aeronautics and Space Administration) Johnson Space Center (JSC) Safety and Mission Assurance (S&MA) uses two human reliability analysis (HRA) methodologies. The first is a simplified method which is based on how much time is available to complete the action, with consideration included for environmental and personal factors that could influence the human's reliability. This method is expected to provide a conservative value or placeholder as a preliminary estimate. This preliminary estimate or screening value is used to determine which placeholder needs a more detailed assessment. The second methodology is used to develop a more detailed human reliability assessment on the performance of critical human actions. This assessment needs to consider more than the time available, this would include factors such as: the importance of the action, the context, environmental factors, potential human stresses, previous experience, training, physical design interfaces, available procedures/checklists and internal human stresses. The more detailed assessment is expected to be more realistic than that based primarily on time available. When performing an HRA on a system or process that has an operational history, we have information specific to the task based on this history and experience. In the case of a Probabilistic Risk Assessment (PRA) that is based on a new design and has no operational history, providing a "reasonable" assessment of potential crew actions becomes more challenging. To determine what is expected of future operational parameters, the experience from individuals who had relevant experience and were familiar with the system and process previously implemented by NASA was used to provide the "best" available data. Personnel from Flight Operations, Flight Directors, Launch Test Directors, Control Room Console Operators, and Astronauts were all interviewed to provide a comprehensive picture of previous NASA operations. Verification of the assumptions and expectations expressed in the assessments will be needed when the procedures, flight rules, and operational requirements are developed and then finalized.

DeMott, Diana L.↗

Human Reliability Assessments: Using the Past (Shuttle) to Predict the Future (Orion)

NASA (National Aeronautics and Space Administration) Johnson Space Center (JSC) Safety and Mission Assurance (S&MA) uses two human reliability analysis (HRA) methodologies. The first is a simplified method which is based on how much time is available to complete the action, with consideration included for environmental and personal factors that could influence the human's reliability. This method is expected to provide a conservative value or placeholder as a preliminary estimate. This preliminary estimate or screening value is used to determine which placeholder needs a more detailed assessment. The second methodology is used to develop a more detailed human reliability assessment on the performance of critical human actions. This assessment needs to consider more than the time available, this would include factors such as: the importance of the action, the context, environmental factors, potential human stresses, previous experience, training, physical design interfaces, available procedures/checklists and internal human stresses. The more detailed assessment is expected to be more realistic than that based primarily on time available. When performing an HRA on a system or process that has an operational history, we have information specific to the task based on this history and experience. In the case of a Probabilistic Risk Assessment (PRA) that is based on a new design and has no operational history, providing a "reasonable" assessment of potential crew actions becomes more challenging. In order to determine what is expected of future operational parameters, the experience from individuals who had relevant experience and were familiar with the system and process previously implemented by NASA was used to provide the "best" available data. Personnel from Flight Operations, Flight Directors, Launch Test Directors, Control Room Console Operators and Astronauts were all interviewed to provide a comprehensive picture of previous NASA operations. Verification of the assumptions and expectations expressed in the assessments will be needed when the procedures, flight rules and operational requirements are developed and then finalized.

DeMott, Diana↗

Risk of Bone Fracture due to Spaceflight-induced Changes to Bone

The Human Research Program (HRP) is taking a biomechanical approach to assessing subsequent fracture risk in active astronauts as a consequence of spaceflight exposure. Triennial testing of active and retired astronauts continues as Space Medicine monitors for a premature diagnosis of primary osteoporosis, which is associated with age-related bone loss and skeletal fragility. This updated 2023 Fracture Evidence Report has expanded the description of skeletal changes to capture the full effects of spaceflight on bone: • Recent analysis of fractures from health records of the full astronaut cohort, suggests an increased incidence rate of hip and spine fractures in astronauts following longer spaceflight duration flights compared to incident rates found in shorter duration flights. • Routine preflight-to-postflight surveillance by DXA (dual-energy x-ray absorptiometry) does not provide the full detection of loss and recovery in the long-duration (LD) astronaut nor the full recovery of hip trabecular bone. • The inclusion of hip quantitative computed tomography (QCT) in flight studies delineates effects of spaceflight, of countermeasures, and of post-flight recovery on cortical and trabecular bone parameters—some of which are verified predictors of hip fracture in the aged. • QCT detects and compares the distinct countermeasure effects of the pharmaceutical alendronate and of resistive exercise (on the Advanced Resistive Exercise Device, ARED) in specific cortical and trabecular bone sub-regions during spaceflight. • A published comparison of QCT-determined loss rates of hip trabecular bone in LD astronauts compared to terrestrial cohorts suggest that accelerated loss rates in trabecular volumetric BMD (vBMD) during spaceflight might be analogous to skeletal effects of accelerated loss rates in females due to menopause, potentially leading to disruptions in trabecular microarchitecture. • A dataset of finite element (FE) estimates of hip bone strength in aging terrestrial cohorts (spanning astronaut age-range) provides comparative context for changes in the FE of hip bone strength in LD astronauts, including comparison (force unit of newton) to percentiles (50th, 75th, and 100th) of sex-matched aged humans with hip fractures. • Risk of fracture, due to the mechanical overloading of bones, is being updated with IMPACT, the next-generation tool suite for probabilistic risk assessment (PRA) for exploration missions being created by the Exploration and Medical Capability Element (ExMC) at NASA. IMPACT is currently in development and will not be included in this 2024 update. The risk for fracture necessitates understanding the relationship between applied loads to bone and the biomechanical competence of bone. The Risk for Early Onset Osteoporosis focuses on the weakened condition of bone (including development of new technologies, measurements of novel skeletal attributes, translation of multiple measures to an index of bone fragility, and interpretations of data used to reflect a weakened bone), while the Risk for Fracture assesses factors that influence the probability an astronaut would encounter applied loads exceeding the biomechanical competence of bones, resulting in fracture. This Evidence Report combines the research gaps and tasks associated with both risks.

Fracture↗

Impact Outputs for A Representative Extended Duration Artemis Mission

BACKGROUND: As NASA and private industry begin preparation for long-duration spaceflight, quantifying the impact that potential human health and performance capabilities have on crew health outcomes is imperative for medical risk mitigation. NASA’s Informing Mission Planning via Analysis of Complex Tradespaces tool (IMPACT) applies Probabilistic Risk Assessment (PRA) methodology to estimate these outcomes. OVERVIEW: As NASA prepares to return to the Moon, medical system planning has already begun for extended Artemis missions, which will see humans spending months at a time in cis-lunar space and on the surface of the Moon. The Long Duration Lunar Orbital and Lunar Surface (LDLOLS) design reference mission (DRM) lasts 9 months, including 3 months on the lunar surface, and involves 2 male and 2 female crewmembers. LDLOLS assumes no extravehicular activities (EVAs) in orbit, but, while on the lunar surface, involves 2-4 EVAs/month in a pressurized rover and 2-4 EVAs/month in an unpressurized rover or on foot. This DRM assumes a physician level Crew Medical Officer with commensurate knowledge, skills, and abilities. The IMPACT tool was utilized to estimate in-flight medical risk for this mission. More specifically, 100,000 simulations of this DRM were modeled, and overall estimates for loss of crew life (LOCL), need for evacuation (RTDC; return to definitive care), and crew task time lost (TTL; a measure of disability) were calculated. A recommended medical capability set, with appropriate mass and volume constraints, was also generated. DISCUSSION: This abstract reviews the IMPACT-derived risk for these mission outcomes with and without treatment, a macroscopic look at the total mass and volume necessary for full diagnostic and treatment capability, and how these change with input mission parameters.

J G Steller↗

NASA System Safety Handbook: System Safety Framework and Concepts for Implementation - Volume 1

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.

Dezfuli, Homayoon↗