Safety specification, risk management planning

The Walkerton inquiry report notes that the decisions to remove the water safety controls in Ontario or to reduce their enforcement were taken without an assessment of the risks or the preparation of a risk-management plan. The report says there was evidence that those at the most senior levels of government who were responsible for the decisions considered the risks to be manageable, but there was no evidence that the specific risks were properly assessed or addressed. 

Cooper, A.J., Lettis, S., Chapman, C.L., Evans, S.J., Waller, P.C., Shakir, S., Pay vandi, N., and Murray, A.B. 2008. Developing tools for the safety specification in risk management plans Lessons learned from a pilot project. Phartmcoepidemiol Drug Safety, 17,445 54. 

Some progress in these directions has since been made - e.g. with the development of risk management plans which include a safety specification. There are also encouraging current initiatives towards a culture of scientific development in the EU with the emergence of collaborative research networks and new training programs. However, there is still quite a long way to go. 

All this is to say that worst-case scenario analyses can be extremely helpful, but they are difficult to perform and potentially difficult to understand. They are most useful when specific guidelines are followed and when they are used to enhance safety by developing safeguards against the accident scenarios developed. For the risk management plan described in Section 24.2.2. worst-case scenario analyses are required by regulation. 

The purpose of the safety specification is to explicitly consider the level of safety that has been demonstrated so far. It should identify what is and is not yet known about safety and the latter (i.e. what is not known) should be a major driver of the pharmacovigilance plan. The purpose of that plan is essentially to attempt to find out what is not yet known, largely because of the limitations of clinical trials. Risk minimisation plans are not invariably required - essentially they are needed when there are known or potential risks which cannot simply be managed through routine measures contained in the product information. 

A written emergency response plan for a site location should include, at a minimum, the following (Specific regulations, for example, Process Safety Management (PSM) or Risk Management Program (RMP) may require other elements.)... 

Each Gen-lV system requires challenging R D projects some are common to all whereas others are specific to the system. For example, the list of Gen-lV safety crosscut items comprises system optimization and safety assessment methodology, emergency planning methods, licensing and regulatory framework, radionuclide transport and dose assessment, and human factors. Additional R D areas of common interest are proposed as instrumentation and control, human machine interface, reactor physics and thermal-hydraulics, risk management, operation and maintenance. 

In the specific implementation of a safety audit project, safety audit project leader should be fully aware of the following circumstances, an initid assessment of the importance of this safety audit and audit risk (1) ask the audited entity related personnel and related management (2) access to the audited entity s operations manual, the internal control manual and other information (3) access to the audited entity annual production and safety plans, financial budget and other documents (4) check the safety activities or safety issues certificates and records (5) examine the audited unit production, business activities and the implementation of internal control (6) select the number of safety events to be tested. 

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