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Risk management
Published in Marie B. Teixeira, Design Controls for the Medical Device Industry, 2019
Given the definition above, we can now look at some other key terms: “Risk analysis” is the process of collecting and examining information/data in order to identify real and potential hazards associated with the use and misuse of a device and then estimating the risk associated with those hazards.“Risk estimation” is the process used to assign values to the probability of occurrence of harm and the severity of that harm.“Risk evaluation” is the process of determining whether a risk is acceptable based on the risk analysis.“Risk control” is the process through which decisions are reached and protective measures are implemented to reduce risks to, or maintain risks within, specified levels.“Risk management” includes risk analysis as well as the processes of evaluating the individual risks and the overall risk for acceptability, controlling any unacceptable risks or justifying them, and then managing risks through post-market experience.
Hydraulic Structures
Published in David Stephenson, Water resources management, 2003
Without hydraulic structures we could not control water. Something is needed to contain or transport water. Usually a man made structure is needed to meet human requirements. Despite objections, without structures in or across rivers we would not be able to access water except by primitive means of traveling to the source at the correct time. Our purpose should be to reach a balance between utility and acceptability. Structures are built on rivers and at water sources for many purposes. These may include: Measuring structures such as weirs, flumes, orifices or installation of measurement devices for measuring water depth or flow.Storage structures such dams, barrages for storing water from periods of excess to periods of shortage.Transfer conduits. These can include tunnels, pipelines and channels.Control structures. Gates, valves and constrictions to control flow rate, pressure or volume.Abstraction or diversion. Intakes on rivers or wells are for drawing out water.Protection or rehabilitation such as erosion control.
Introduction
Published in Roger T. Haug, of Compost Engineering, 2018
Once the quality and characteristics of the substrates are defined, attention shifts to the compost quality expected from the facility. Product standards are necessary to protect public and environmental health and to assure a measure of commercial acceptability. Public health risks associated with composting facilities come from exposure to human pathogens, aerospores and vectors. Primary pathogens exist in the materials to be composted and secondary pathogens grow during the composting process. The secondary pathogens of greatest concern are spore forming fungi that can inhabit some composting environments. Pathogens of concern, conditions for heat inactivation, suggested product standards, and requirements for personnel protection are discussed in Chapters 4 and 5.
SAPIUM: A Generic Framework for a Practical and Transparent Quantification of Thermal-Hydraulic Code Model Input Uncertainty
Published in Nuclear Science and Engineering, 2020
Jean Baccou, Jinzhao Zhang, Philippe Fillion, Guillaume Damblin, Alessandro Petruzzi, Rafael Mendizábal, Francesc Reventos, Tomasz Skorek, Mathieu Couplet, Bertrand Iooss, Deog-Yeon Oh, Takeshi Takeda, Nils Sandberg
The analysis of the validation results is based on an acceptability checking to evaluate if the quantified input uncertainties are suitable for the intended use. This requires the introduction of acceptability criteria. In particular, it involves the choice of acceptability thresholds that are related to the problem of interest and to the risk tolerance of the decision maker. This process cannot be formalized in a generic approach, such as the SAPIUM one. However, it is worth mentioning that the thresholds depend on the type of validation indicators. In the case of the unit-less indicators coming from the hypothesis-testing framework, significance thresholds are available in the statistical literature to be able to reject the tested hypothesis. Their limitation to interpret validation results is that their use relies on strong assumptions on the number or independence of the validation data that are not always fulfilled in practice. In the case of the area metric, since it is expressed in the SRQ physical unit, the scale is based on expert judgment.
Designing acceptable emerging technologies: what contribution from ergonomics?
Published in Theoretical Issues in Ergonomics Science, 2021
Situated acceptance holds that adoption of technology is accomplished within and through activity (Bobillier Chaumon 2016). From this perspective, acceptability is to be determined in the actual use of a technology and in the concrete experience of users. Situated acceptance is interested in the ways that users adopt and use technology as they go about their activity (Benedetto-Meyer and Chevallet 2008).