Safety cases risk management system

Safety management safety case C. Make rules for safety cases SHE management systems and how they control risks D. Check the structure and functioning of SHE management systems... 

A common feature of management activities is drat diey may be defined in terms of a set of processes. This is clearly the case for a safety (or quality) management system. Thus, an initial attempt to create a mediod could usefully be aimed at the risk analysis of such a system, using a process model. 

The Health and Safety at Work etc. Act (HSW Act), 1974, instituted a system of enforced self-regulation which placed primary responsibility for health and safety with industry. It charged companies with risk management responsibilities which ideally involved companies in developing risk management systems and rules to secure compliance and also entailed worker participation (Ch. 6). But, as Dawson et al. (1988 44) warn, the creation of health and safety structures and procedures within a company is an imperfect measure which does not in itself indicate an improvement in health and safety. Indeed their own case studies demonstrated that compliance with the formalities did not necessarily indicate a serious and established concern to improve standards of health and safety (1988 87). There is therefore a need to consider the impact of these structures in terms of the difference they make at an everyday level. As Stone (1975) comments, the key task is to make bureaucracies think like responsible individuals, so the systems and decision-making processes they institute are critical. 

A Safety Case is not just an analytical or discussion document. It results in a risk-management system that has to be implemented. Such a system generally is structured on the following lines ... 

In situation one, the organization to which the safety professional gives counsel has OSHA incident and lost-workday case rates (DART rates) three times that of its industry averages. Much needs to be done to bring operational risks down to acceptable levels. Leading indicators selected would be for the basics of an operational risk management system and a measurement system could be established with suitable and attainable goals. 

Secondary prevention and mitigation, by themselves, are unable to eliminate the risk of serious or catastrophic chemical accidents, although improved process safety management can reduce their probability and severity. Most chemical production involves transformation processes, which are inherently complex and tightly coupled. Normal accidents are an unavoidable risk of systems with these characteristics [11]. However, the risk of serious, or catastrophic, consequences need not be. Specific industries use many different processes. In many cases, alternative chemical processes exist which completely or almost completely eliminate the use of highly toxic, volatile, or flammable chemicals [12]. 

Advanced Railway Safety Case Production Tool of Railway Research Centre (http //www.railway.bham.ac.uk/advanced.htm)—the research addressed the requirements for a Safety Case Automated Production Tool (SCAPT) environment integrating systems engineering processes and tools, modeling, risk management and domain knowledge. 

Where extension of use is conducted as part of a controlled roll out it should be subject to the usual change management procedures which will have been established in the in SMS. Essentially a set of safety activities will need to take place on the product to determine whether the new operating environment introduces any new hazards and the safety case updated accordingly. The analysis will need to be able to justify operating the system outside of the intended purpose and set out the evidence to support the claim that the risk remains acceptable. 

When used to accurately summarise risk, communicate controls and contribute to a safety culture, the safety case is an invaluable tool in assuring a HIT system. However, the value of the safety case can quickly be eroded should it be seen as an administrative exercise or a simple means to an end to satisfy management, a regulator or contractual requirement. All too often the potential hazards associated with a system are only thought about when development of the safety case begins. This... 

Note that in defining the system one should be careful not to use overly commercial language. The safety case is not the place to extol the virtues of efficiency gains, improved productivity, return on investment, etc. These are all important facets of product management, the business case and marketing but in the safety case these factors could be perceived as being an ill-informed means of justifying the clinical risk. Any text which is reused from other materials should have subjective elements removed so that a plain and factual system description is articulated. 

Systems for controlling risk should concentrate on management systems rather than just on hardware and instrumentation. Therefore, the safety case must show that the correct management systems for controlling safety are in place. 

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