Operations, safety role

Percentage of correct answers during periodic unannounced tests administered to people in key process safety roles (line operations and management) X ... 

At present, the pharmaceutical industry regulatory requirements refer to isolators specifically in the context of the manufacture of sterile products. There is no reference to their role in broader areas of crosscontamination and operator safety control. Within Europe, the current EU GMP clearly states that isolators might produce improvements in sterility assurance of sterile products, and that aseptic processing manufacturing isolators should be placed in at least a Grade D surrounding environment. The Food and Drug Administration (FDA) requirements are less well defined, but it is likely that in equivalent circumstances, they would like to see an isolator located in a class 100,000 or M6.5 environment In Operation. ... 

Couturier concluded, not surprisingly, that most of the FDAAA changes are useful and will have the intended effects. He also determined that a few may be counterproductive and others need to be added. The added ones come from the fact that the lOM recommendations and the FDAAA focus on a single component of the system (the FDA). The FDA does not operate in a vacuum, and the proposed changes do not take into account the safety role played by other components in the system, particularly physicians. As a result, the pressures that led to the erosion of the overall system safety controls were left unaddressed and are likely to lead to changes in the system static and dynamic safety controls that will undermine the improvements implemented by FDAAA. See Couturier [43] for the complete results. 

Several types of assumptions are relevant. One is the assumptions under which the system will be used and the environment in which the system will operate. Not only will these assumptions play an important role in system development, but they also provide part of the basis for creating the operational safety control structure and other operational safety controls such as creating feedback loops to ensure the assumptions underlying the system design and the safety analyses are not violated during operations as the system and its environment change over time. 

Hindsight bias and focusing only on the operator s role in accidents prevents us from fuUy learning from accidents and making significant progress in improving safety. 

Staff functions typically operate in a supportive role by offering advice to the Une personnel. The line can accept or reject the advice based on the rationale provided, because the line has the true authority. There are often exceptions to this relationship, but this is how most companies operate. Safety usually emanates primarily from a staff... 

AH structures and equipment required to fulfil level FI safety functions shall be seismic category I. Such structures and equipment shall be qualified to withstand the effects of a design basis earthquake (DBF) (i.e. to remain structurally intact, leaktight in the case of fluid retaining equipment, and functionally operable to the extent required by its safety role). 

Since early nineties of the last century, PSA methods have been used as a complementary approach to common deterministic analyses within the process of ensuring acceptable level of nuclear power plant operation safety in Czech Republic. More recently, PSA concept has become a fi eestanding decision-making tool for controlling both instantaneous and permanent plant risk level. Since human factor has been playing a fairly significant role in plant risk profile, special HRA methods had to be adopted as a part of worldwide know-how transfer and used to address human related specifics of Czech NPPs operation, in order to keep the corresponding PSA models as realistic as possible. 

Explanation for interrelationship between survey questions Good procedures are supposed to be helpful in the work (PI). It is assumed that procedures are more easily put into operational practice if the user has received training in how to understand and apply the procedures, and the safety role they play (P2). They are also assumed to be more workable if they reflect the reality of the working process. That is ensured through involving the crew in the development of procedures, and by paying attention to crews ejqierience (P3). If these factors (P2 P3) are not present, the procedural system may be perceived as confusing and difficult to relate to (P4 P5) (Reason, 2001). 

Certain active components and systems carry out functions which are likewise utilized for accident control Compared to the power reactors presently in operation, the role played by this equipment in assuring plant safety has been greatly reduced... 

A nuclear power plant embarking on an EOF project will need significant utility support during all phases of the EOF s development and implementation. The utility s support role is crucial because an EOF project is labour intensive, requires specialists and financial support and lasts for a number of years. Management should be fully committed to and supportive of EOF development and implementation because of the increase in operational safety that can be realized. 

In the example shown below in Figure 5, the asserted inference is that if all hazards are mitigated then the system is acceptably safe to operate. The role of the confidence argument for ACP 1 is to demonstrate why it should be believed that the two supporting claims of hazard mitigation are sufficient to draw the overall conclusion about system safety. We discuss how such a confidence argument may be constructed later. 

In industrial production, the temperature distribution in a batch mixing tank is sometimes a critical factor in process control for instance, in batch crystallization and in batch chemical reaction systems. In some processes, the solution temperature should follow a certain cooling or heating program, while in some other cases, heat removal should proceed in such a way that the temperature in the tank be kept constant in order to prevent temperature runaway. Therefore, heat transfer control is usually required during the batch and plays a crucial role in optimising the operation of the process in order to obtain the desired end-product and improve operational safety. 

De Voogt, A.J., Uitdewflligen, S. Eremenko, N., 2009. Safety in high-risk helicopter operations The role of additional crew in accident prevention. Safety Science, 47(5), pp.717-721. 

U. S. Congress. Senate. Committee on Government Operations. Federal Role in Traffic Safety. Hearings before a subcommittee on Executive Reorganization. 89th Congress, 1st Session, 1965, Part 1, p. 2. 

On this main line railway, the separation of the roles of infrastructure controller, train operator, and station operator, and the possibility of open access to the network for near operators, have the potential to raise doubt as to which railway management is responsible for each aspect of the safe operation of the railway. The respective safety cases should make this clear, and the hierarchy of safety case acceptance, with trmn and station operator safety cases being accepted by the infi-astructure controUer, and the infrastructure controller s safety case being accepted by the Health and Safety Executive (HSE), ensures a clear understanding of each party s respective safety responsibilities. 

The tolerance for safety risks affecting civil aviation during peacetime is likely to be very different from the tolerance of safety risks to military aircraft during conflict (operational safety criteria may be less severe). In accordance with DEF STAN 00-56 (Part 1 Para 7.3.2.c), some systems have a defensive role whereby inaction under hostile circumstances may constitute a hazard. Safety targets for such systems shall address the requirements to reduce, to a tolerable level, the risk resulting from inaction under hostile circumstances. 

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