Development.Directing safety

The comprehensive and detailed assessment of the risks required for a safety-case can only be satisfactorily carried out for major installations with the aid of computer software. Suites of programmes for quantitative risk analysis have been developed over the past decade by consulting firms specializing in safety and environmental protection. Typical of the software available is the SAFETI (Suite for Assessment of Flammability Explosion and Toxic Impact) suite of programs developed by DNV Technica Ltd. These programs were initially developed for the authorities in the Netherlands, as a response to the Seveso Directives of the EU (which requires the development of safety cases and hazard reviews). The programs have subsequently been developed further and extended, and are widely used in the preparation of safety cases see Pitblado el al. (1990). 

The efforts to develop a harmonized system concerning direct safety, efficacy, and quality go back to 1965, when the first harmonized directive was issued [95]. Ten years later, the Committee for Proprietary Medicinal Products (CPMP) was established [96]. In 1989, the International Conference on Flarmonization (ICFI) was founded, and the EMEA began operation on January 1,1995 [97]. The EMEA serves as an advisory board, but is responsible for coordinating the approval, manufacturing, and inspection of medical products between the CPMP and member states regulatory bodies [98]. 

The development of antibodies to therapeutic proteins can have direct safety consequences in addition to the impact on pharmacokinetics as addressed in this chapter. Provided the antibody response itself does not have direct safety issues, in some cases it is possible to continue dosing the therapeutic protein in the presence of antibody, provided efficacious levels of the therapeutic protein can be maintained. In this case, it is important to fully understand how the antibody response impacts active concentrations of the therapeutic protein so that it is possible to design dosing regimens that minimize the impact of the antibody response. In the... 

The culture, formation and development of safety culture idea directly affect the process of safety production and relate the survival and development of enterprises. Therefore, in the process of coal production, to establish the safety concept is the first. Only the formation of safety concept correctly, can effectively promote the safety production of enterprises. 

The quality of indicators or performance data has been an issue at stake. According to Fleming (2010), good indicators are accurate (with direct relationship to system status, and difficult to manipulate), productive (related to future system states and performance) and current (giving real-time information). Skogdalen et al. (2010, 121-122) refer to the work of the American Petroleum Institute (API) about developing Process Safety Performance Indicators for the Refining and Petrochemical Industries, and finds that the success of indicators is related to the extent to which they are ... 

As a response to the obvious need for clarification about the risk level and as a first step measure to turn the development of safety in a positive direction, the authorities, here represented by the NPD, launched the first RNNS pilot proj ect. The project was done in cooperation with external research institutions and the expressed purpose was to establish a methodology to assess trends in the risk level and safety work at the Norwegian continental shelf (Ministry of work and administration 2001). This pilot project, which included extensive interviews with some of the key actors in the industry, documented the conflicts discussed above (Norwegian Petroleum Directorate 2000). Generally speaking, it became evident that some of the actors had very different views of the risk picture and development, and expressed different perceptions of reality. As a result, the trust among the partners in the industry was low. 

In order to pursue efforts to establish a single market for rail transport services, initiated by Council Directive 91/440/EEC of 29 July 1991 on the development of the Community s railways, it has been necessary to establish a common regulatory fi-amework for railway safely. Member States have developed their safety rules and standards mainly on national lines, based on national technical and operational concepts. Simultaneously, differences in principles, approach and culture have made it difficult to break through the technical barriers and estabhsh international transport operations. 

The lADC structure is directed toward MODUs (Mobile Offshore Drilling Units, including jackups, semisubmersibles, and submersibles). However, this document can be used to help develop a Safety Case for a much wider range of technologies. The lADC structure is summarized in Figure 8.1, which is derived... 

There are a number of specialized texts which consider in more detail some of the topics raised in this chapter. P.Bennett (ed.). Safety Aspects of Computer Control (Butterworth-Heinemann, 1993), discusses a number of general issues involved in the development of safety-related computer systems, including le liability and regulatoiy issues. Redmill Anderson (eds). Directions in Safety-Critical Systems (Springer-Verlag 1993), is the 1993 proceedings of the Safety Critical Symposium and contains a collection of papers on more specific aspects of the subject. 

The most efficient approach in developing any safety management system is to just listen to what employees have to say. This is the most direct way you can learn about the effectiveness of your safety management system. However, this approach can be difficult for various levels of management who have not had the opportunity to experience the true meaning of employee involvement. The culture of the organization may have a value system that reduces or prevents direct involvement of employees. The leadership team may... 

Sometimes success comes in small steps. Accomplishing field compliance using tools such as an effective inspection and audit program will likely come in small steps. These tools are all part of a developing safety culture. Each step that is made in the development of safety culture is a step in the right direction. 

As a conclusion to this paper it is worth considering the likely direction safety standards development will take within the eHealth software sector. 

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