Safety cases standards

In the United Kingdom, the Health and Safety at Work Act (1974) and regulations made under it require occupiers to provide a safe plant and system of work and adequate instruction, training, and supervision. In the European community, occupiers of major hazard sites are required to produce a safety case, which describes how hazards have been assessed and are kept under control. Many other countries have similar legislation, though standards of enforcement vary. 

Note that the approach does not preclude compliance with any specific regulatory or standard requirements. Rather the SMS should ensure that compliance is achieved in the course of safety case development. Essentially, the safety case represents an information superset and knowledge base potentially facilitating compliance with any number of relevant safety standards. 

Safety cases are gradually being adopted in the HIT domain especially in the UK in order to comply with safety standards ISB 0129/0160 [7]. Outside the UK the term safety case is not widely used [8] but nevertheless reports which achieve the same purpose are becoming increasingly prevalent and may take other names such as a Safety Analysis Report. The safety case and its development has a number of benefits to manufacturers, healthcare organisations and ultimately to patients. These can be broadly categorised as [9] ... 

There are at least of a couple of other subtle benefits of the safety case. For manufacturers, products which are delivered along with a well thought-out safety case create a perception of quality, attention to detail and responsibility. The value which this adds to a product is very real and can generate a competitive edge over products from alternative suppliers. Manufacturers are quite justified in marketing the fact that a product has been subject to a safety assessment particularly where there is a statutory or regulatory requirement to comply with a standard. 

There is no right or wrong way to document the planning and execution of testing but a number of artefacts have become common over the years underpinned by the requirements in a number of different software testing standards. These artefacts are important inputs into the team developing the safety case. 

Readers need to have confidence in the safety case s claims. Whilst evidence of historical operation, conformance with standards and well-managed CRM workshops are non-specific controls they can add up to a rounded and convincing story. 

The safety case is only likely to be compelling if it is structured and logical. The SMS should contain a standard template for the safety case. 

The safety case documentation providing evidence that the applicable requirements of the design for safety have been met in the design and implementation of the refurbished I C systems important to safety will have the format and contents as per the US NRC Regulatory Guide 1.70 and Chapter 7 of the US NRC Standard Review Plan (year 1997 issue). 

In practice, all actual safety management programs combine a mix of prescriptive and nonprescrip-tive approaches. For example, many offshore Safety Cases make reference to the API s Recommended Practice 14C, a prescriptive standard. On the other hand, judgment will always be required when prescriptive standards are being applied—no rule or standard can cover every possible situation. It would be invidious to state that one approach is better than the other. 

The first safety cases prepared for the process industries were those developed for North Sea offshore oil and gas operations following the Piper Alpha disaster that occurred in the year 1988. The Cullen report (Cullen, 1990) that was written following that accident was highly critical of offshore operating practices and recommended that a safety case approach be implemented. The Seveso incident that occurred in Italy further prompted the increased use of safety cases. Since that time the use of safety cases has spread to other industries (such as mining and railway operations) and to other nations, primarily in Europe and Australasia. (It is notable that the safety case regime approach has not been taken up for offshore oil and gas operations in the Gulf of Mexico—instead a more prescriptive approach based on industry consensus standards is used.)... 

At the heart of the safety case approach lies an understanding that is the operator of a facility—not the regulator—who decides how to ensure safe operations. This nonprescriptive approach to the management of safety is similar to the manner in which most PSM programs are prepared and administered. The operator of the facility, known as the duty holder, develops a safety system that is pertinent to that particular facility. The duty holder s performance is then assessed against his or her own standard. 

The safety case procedures must define the objections of the program and must identify which procedures and standards are in place. 

In order to establish reliable quantification measures, a consistent set of terms and reporting standards is required. In the area of occupational safety, considerable standardization has already been achieved through the use of measmes such as the number of first-aid cases or recordable injuries. Although different organizations will apply these terms slightly differently from one another there is sufficient consensus to allow for their use across broad swathes of industry. For process safety it is much more difficult to come up with comparable yardsticks. Hence comparisons between different facilities may lack validity and credible trend lines are difficult to develop. 

As regards the enforcement of the regulations by the HSE, it is clear that insofar as so much detail is now produced by the duty holder rather than the regulator, it is not so much in the position of holding the regulated to standards that it has set, but rather of holding them to the procedures and arrangements described in the current safety case which may affect health or safety ."... 

This issue has come under particularly close scrutiny following the Deepwater Horizon incident in the Gulf of Mexico. At the time of the incident, the safety regulation in place for the offshore oil and gas industry in the United States took the form of a prescriptive, standards-based regime. The report of the National Commission on the Deepwater Horizon Blowout includes a summary of the development of the safety case approach in the nuclear, chemicals, aviation, and offshore oil and gas industry (National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling 2011b, 69) and points out that the fatality rate in the offshore oil and gas industry in the United States is at least four times the fatality rate in European jurisdictions that have operated for several decades under safety case... 

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