Safety risk reduction

By this we mean that the way the IT service is implemented and operated provides the safety risk reduction required. The updates to the controlling documents mentioned earlier are an example of this when combined with suitably trained and experienced staff they perform a mitigating function, reducing the safety risks in the service. ... 

System life cycle System subdivisions Functional safety Risk reduction SIL... 

A Software Safety Verification Method Based on System-Theoretic Process Analysis. This paper proposes a method for verifying software safety requirements derived at the system level in order to provide evidence of safety risk reduction. 

The book does not focus on occupational safety and health issues, although improved process safety can benefit each area. Detailed engineering designs are outside the scope of the book. This book intends to identify issues and concerns in batch reaction systems and provides potential solutions to address these concerns. This should be of value to process design engineers, operators, maintenance personnel, as well as members of process hazards analysis teams. While the book offers potential solutions to specific issues/concerns, ultimately the user needs to make the case for the solutions that best satisfy their company s requirements for a balance between risk reduction and cost. In many instances the book provides one or more sources of additional information on the subject which could be of value to the reader. 

Prioritize Safety Improvements. This uses the detailed analysis (2) to identify items having high risk importance. Engineering analysis identifies and costs candidate improvements which are selected on the bn. o of risk reduction for a given cost. ... 

The Safety of Tirofiban in Acute Ischemic Stroke (SaTIS) trial examined 250 patients 6-22 hours after stroke onset treated with tirohban infusion or placebo for 48 hours. No increase in ICH was reported in the active group. Although no beneht in early functional recovery was observed, 5-6-month mortality was lower in the tirohban-treated group (relative risk reduction (RRR) 27%, 95% Cl 0.08-0.95, p = 0.03). 

Five randomized primary and secondary prevention trials " have demonstrated the efficacy and safety of warfarin in preventing AF-related stroke. Pooled data from these trials demonstrated a 68% reduction in ischemic stroke (95% Cl 50-79) and an intracerebral hemorrhage rate of <1% per year. The data for aspirin suggested that it had a lesser effect, with a 36% risk reduction (95% Cl 4—57). 

Deciding which risk-reduction method to use maybe difficult. In many instances, appropriate decisions can be made without resorting to quantitative techniques. However, in some cases, particularly when the options are costly, quantitative risk analysis (QRA) and risk-based decision-making approaches may be an effective basis for measuring the improvement in safety arising from the proposed options. These approaches can also be used in prioritizing safety improvements and balancing cost and production issues. 

The what-if analysis method may simply generate a list of questions and answers about the process. However, it usually results in a tabular listing of hazardous situations, their consequences, safety levels, and possible options for risk reduction. 

Management can use a variety of criteria to select and prioritize corrective actions and safety improvements. They include costs, other competing priorities, implementation schedules, the effectiveness of risk reduction, and technical feasibility. These criteria, as well as management decisions about corrective actions, must be documented. If after evaluating an action item, management chooses to take no further action, that decision must also be documented. In addition to requiring documentation of management decisions, the PSM Rule requires a system to track implementation of corrective actions to be made. 

Safety instrumented function (SIF) A safety function allocated to the safety instrumented system with a safety integrity level necessary to achieve the desired risk reduction for an identified process hazard. 

The gap between the process risk and the owner/operator s risk criteria establishes the requirements for risk reduction. The risk gap can be managed by a single safety function or by multiple functions allocated to protection layers. The team defines the risk reduction that must be provided by each safety function and allocates the safety function to a protection layer that is designed and managed to achieve the allocated risk reduction. 

Subsequently, three methods indicating safety risks will be evaluated on these nine criteria discussed above whether indirect safety related operational deviations are used, general conclusions can be derived, detailed cause-effect relationships are available, the method is feasible, the results are reliable, only limited resources are needed, the results can be ranked, a clear link between risk reduction and operational benefit is present, and if all (root)cause areas are included. 

From this analysis it appears that a huge discrepancy exists between deviations prior to accidents, that can be found in normal operation and the pro-active safety indicators and methods in current use. The re-occurring indirect safety related deviations that are the dominant class of events causing accidents are therefore defined as the precursors for accidents, as stated in Chapter 1. Furthermore, from Table 5 it can be concluded that a clear link between risk reduction and the normal way of working is not explicitly present in one of the three methods. Finally, the feasibility of methods (except PRISMA) needs some attention additional expert knowledge is often necessary to apply the method. The focus of the method indicating safety risks developed in this thesis will lie especially on these three criteria. 

Apart from reduced yield, down-stream processing can cause minor or even bigger modifications in the structure of the biomolecule. Often, these modifications do not affect the activity of the product, but may change its antigenicity. Along with virus safety, the reduction of such risks is a main objective in the down-stream processing of such biomolecules. Chromatographic purification,... 

If a botanical is shown to reverse an abnormal test result, modify another drug s adverse event, or act synergistically with another modality, it will usually be best developed as a drug. This is especially true if the botanical provides a distinct benefit for a patient population, but would pose safety concerns if used by the general public. In contrast to prevention, risk-reduction, or health-maintenance trials, therapeutic studies are often able to demonstrate clinical benefit with smaller numbers of subjects and with more tangible measures of outcome. 

Exposure scenarios specify the conditions in which the chemical is to be used (including the protective equipment to be used, working practices, products it is incorporated into, how consumers use those products and how these are disposed), limiting the range of the conditions that must be considered in the exposure assessment. The exposure scenario is annexed to the chemical safety data sheet that is passed to downstream users of the chemical. Those downstream users are required to pass information back to their suppliers about their use of the substance, the exposure to the substance involved in that use and the practicality of specified risk reduction measures. If a use is significantly different from those identified in the CSA, the user must report this to the European Chemicals Agency and prepare its own CSA, or ask the manufacturer to revise the CSA to include that use. 

Once the severity and the probability corresponding to a scenario are estimated, that is, the risk is assessed, a decision can be made on the nature of the protection system to be implemented. If a safety instrumented system (SIS) is to be used, consisting of one or more independent protection levels (IPL), the required reliability of the protection system, constituting a so-called Safety Integrated Level (SIL) can be determined by using this risk assessment, respective of the required risk reduction. 

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