Safety Case
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Safety Case
One definition of a Safety Case is that it is a structured argument, supported by evidence, intended to justify that a system is acceptably safe for a specific application in a specific operating environment. Safety cases are often required as part of a regulatory process, a certificate of safety being granted only when the regulator is satisfied by the argument presented in a safety case. Industries regulated in this way include transportation (such as aviation, the automotive industry and railways) and medical devices. As such there are strong parallels with the formal evaluation of risk used to prepare a Risk Assessment, although the result will be case specific. A vehicle safety case may show it to be acceptably safe to be driven on a road, but conclude that it may be unsuited to driving on rough ground, or with an off-center load for example, if there would then be a greater risk of danger e.g. a loss of control or an injury to the occupant. The information used to compile the ...
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Argument
An argument is a statement or group of statements called premises intended to determine the degree of truth or acceptability of another statement called conclusion. Arguments can be studied from three main perspectives: the logical, the dialectical and the rhetorical perspective. In logic, an argument is usually expressed not in natural language but in a symbolic formal language, and it can be defined as any group of propositions of which one is claimed to follow from the others through deductively valid inferences that preserve truth from the premises to the conclusion. This logical perspective on argument is relevant for scientific fields such as mathematics and computer science. Logic is the study of the forms of reasoning in arguments and the development of standards and criteria to evaluate arguments. Deductive arguments can be valid, and the valid ones can be sound: in a valid argument, premisses necessitate the conclusion, even if one or more of the premises is false ...
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Evidence
Evidence for a proposition is what supports this proposition. It is usually understood as an indication that the supported proposition is true. What role evidence plays and how it is conceived varies from field to field. In epistemology, evidence is what justifies beliefs or what makes it rational to hold a certain doxastic attitude. For example, a perceptual experience of a tree may act as evidence that justifies the belief that there is a tree. In this role, evidence is usually understood as a private mental state. Important topics in this field include the questions of what the nature of these mental states is, for example, whether they have to be propositional, and whether misleading mental states can still qualify as evidence. In phenomenology, evidence is understood in a similar sense. Here, however, it is limited to intuitive knowledge that provides immediate access to truth and is therefore indubitable. In this role, it is supposed to provide ultimate justifications for ...
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System Safety
The system safety concept calls for a risk management strategy based on identification, analysis of hazards and application of remedial controls using a systems-based approach. This is different from traditional safety strategies which rely on control of conditions and causes of an accident based either on the epidemiological analysis or as a result of investigation of individual past accidents. The concept of system safety is useful in demonstrating adequacy of technologies when difficulties are faced with probabilistic risk analysis. The underlying principle is one of synergy: a whole is more than sum of its parts. Systems-based approach to safety requires the application of scientific, technical and managerial skills to hazard identification, hazard analysis, and elimination, control, or management of hazards throughout the life-cycle of a system, program, project or an activity or a product. "Hazop" is one of several techniques available for identification of hazards. Syst ...
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Transportation
Transport (in British English), or transportation (in American English), is the intentional movement of humans, animals, and goods from one location to another. Modes of transport include air, land (rail and road), water, cable, pipeline, and space. The field can be divided into infrastructure, vehicles, and operations. Transport enables human trade, which is essential for the development of civilizations. Transport infrastructure consists of both fixed installations, including roads, railways, airways, waterways, canals, and pipelines, and terminals such as airports, railway stations, bus stations, warehouses, trucking terminals, refueling depots (including fueling docks and fuel stations), and seaports. Terminals may be used both for interchange of passengers and cargo and for maintenance. Means of transport are any of the different kinds of transport facilities used to carry people or cargo. They may include vehicles, riding animals, and pack animals. Vehicl ...
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Aviation
Aviation includes the activities surrounding mechanical flight and the aircraft industry. ''Aircraft'' includes fixed-wing and rotary-wing types, morphable wings, wing-less lifting bodies, as well as lighter-than-air craft such as hot air balloons and airships. Aviation began in the 18th century with the development of the hot air balloon, an apparatus capable of atmospheric displacement through buoyancy. Some of the most significant advancements in aviation technology came with the controlled gliding flying of Otto Lilienthal in 1896; then a large step in significance came with the construction of the first powered airplane by the Wright brothers in the early 1900s. Since that time, aviation has been technologically revolutionized by the introduction of the jet which permitted a major form of transport throughout the world. Etymology The word ''aviation'' was coined by the French writer and former naval officer Gabriel La Landelle in 1863. He derived the term from the v ...
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Automotive Industry
The automotive industry comprises a wide range of company, companies and organizations involved in the design, Business development, development, manufacturing, marketing, and selling of motor vehicles. It is one of the world's largest industry (economics), industries by revenue (from 16 % such as in France up to 40 % to countries like Slovakia). It is also the industry with the highest spending on research & development per firm. The word ''automotive'' comes from the Greek language, Greek ''autos'' (self), and Latin ''motivus'' (of motion), referring to any form of self-powered vehicle. This term, as proposed by Elmer Ambrose Sperry, Elmer Sperry (1860-1930), first came into use with reference to automobiles in 1898. History The automotive industry began in the 1860s with hundreds of manufacturers that pioneered the Brass Era car, horseless carriage. For many decades, the United States led the world in total automobile production. In 1929, before the Great Depression, ...
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Railways
Rail transport (also known as train transport) is a means of transport that transfers passengers and goods on wheeled vehicles running on rails, which are incorporated in tracks. In contrast to road transport, where the vehicles run on a prepared flat surface, rail vehicles (rolling stock) are directionally guided by the tracks on which they run. Tracks usually consist of steel rails, installed on sleepers (ties) set in ballast, on which the rolling stock, usually fitted with metal wheels, moves. Other variations are also possible, such as "slab track", in which the rails are fastened to a concrete foundation resting on a prepared subsurface. Rolling stock in a rail transport system generally encounters lower frictional resistance than rubber-tyred road vehicles, so passenger and freight cars (carriages and wagons) can be coupled into longer trains. The operation is carried out by a railway company, providing transport between train stations or freight customer facil ...
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Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (F ...
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Risk Assessment
Broadly speaking, a risk assessment is the combined effort of: # identifying and analyzing potential (future) events that may negatively impact individuals, assets, and/or the environment (i.e. hazard analysis); and # making judgments "on the tolerability of the risk on the basis of a risk analysis" while considering influencing factors (i.e. risk evaluation). Put in simpler terms, a risk assessment determines possible mishaps, their likelihood and consequences, and the tolerances for such events. The results of this process may be expressed in a quantitative or qualitative fashion. Risk assessment is an inherent part of a broader risk management strategy to help reduce any potential risk-related consequences. Need Individual risk assessment Risk assessment are done in individual cases, including patient and physician interactions. Individual judgements or assessments of risk may be affected by psychological, ideological, religious or otherwise subjective factors, which impa ...
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ALARP
ALARP ("as low as reasonably practicable"), or ALARA ("as low as reasonably achievable"), is a principle in the regulation and management of safety-critical and safety-involved systems. The principle is that the residual risk shall be reduced as far as reasonably practicable. In UK and NZ Health and Safety law, it is equivalent to SFAIRP ("so far as is reasonably practicable"). In the US, ALARA is used in the regulation of radiation risks. For a risk to be ALARP, it must be possible to demonstrate that the cost involved in reducing the risk further would be grossly disproportionate to the benefit gained. The ALARP principle arises from the fact that infinite time, effort and money could be spent in the attempt of reducing a risk to zero; not the fact that reducing the risk in half would require a finite time, effort and money. It should not be understood as simply a quantitative measure of benefit against detriment. It is more a best common practice of judgement of the balance of r ...
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Goal Structuring Notation
Goal structuring notation (GSN) is a graphical diagram notation used to show the elements of an argument and the relationships between those elements in a clearer format than plain text. Often used in safety engineering, GSN was developed at the University of York during the 1990s to present safety cases. The notation gained popularity as a method of presenting safety assurances but can be applied to any type of argument and was standardized in 2011. GSN has been used to track safety assurances in industries such as clinical care aviation, automotive, rail, traffic management and nuclear power and has been used in other contexts such as security cases, patent claims, debate strategy, and legal arguments. History The goal structuring notation was first developed at the University of York during the ASAM-II (A Safety Argument Manager II) project in the early 1990s, to overcome perceived issues in expressing safety arguments using the Toulmin method. The notation was further develop ...
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Agile Software Development
In software development, agile (sometimes written Agile) practices include requirements discovery and solutions improvement through the collaborative effort of self-organizing and cross-functional teams with their customer(s)/ end user(s), adaptive planning, evolutionary development, early delivery, continual improvement, and flexible responses to changes in requirements, capacity, and understanding of the problems to be solved. Popularized in the 2001 ''Manifesto for Agile Software Development'', these values and principles were derived from and underpin a broad range of software development frameworks, including Scrum and Kanban. While there is much anecdotal evidence that adopting agile practices and values improves the effectiveness of software professionals, teams and organizations, the empirical evidence is mixed and hard to find. History Iterative and incremental software development methods can be traced back as early as 1957, Gerald M. Weinberg, as quoted in " ...
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