Safety cases performance standards

The company should have set standards for all employees to indicate the quality/safety performance expected of them. The quality manual, improvement plan and performance standards should be available to be seen by all employees. Check that this is the case... 

The leading decision under the FHSA applying this concept of tmreasona-hle risk is Forester v. Consumer Product Safety Commission, 559 F.2d 774 (D.C. Cir. 1977). This case involved the validity of CPSC regulations prescribing design and performance standards for bicycles and determining... 

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. 

In this paper we want to show, how we perform safety programmes for our voice communication systems, how we try to reduce our efforts with maximum output in spite of the difficulties of different business areas with different standards (which occasionally change quite substantially over time). This includes the presentation of our safety management system, hazard log, internal trainings, safety analyses and the production of safety cases. 

One very essential question at a safety case is always, what level of detail is to be chosen regarding the documentation, the reports, the analyses and generally with respect to the exact fulfilment of the requirements of the standards. If the work is performed too extensively, broken down into too much detail it would be commercially unfeasible. For large, sophisticated systems the safety case can become a tremendous conpilation of documents, which is very difficult to be put into a clear, readable structure and to be kept consistent and up to date. This becomes even more a burning issue as the considered systems get more and more con lex. 

SEMP is very similar to the Process Safety Management standard (OSHA 1992) issued for onshore facilities in 1992 and which was widely hailed as being a good example of a performance-based, nonprescriptive standard. SEMP provided the basis of the SEMS rule, which was then supplemented by SEMS II. Therefore the combination of SEMS and SEMS II does create a performance-based system, although different in detail and application from the Safety Case approach. 

Although a Safety Case can and should cover aU aspects of safety (occupational, process, and technical, as described in Chapter 1) the focus tends to be on identifying and avoiding what are known as Major Accident Events (MAE), i.e., catastrophic events such as fires, explosions, and the release of toxic chemicals. Associated with Major Accident Events are Safety Critical Elements and Performance Standards. 

Although a Safety Case is fundamentally nonprescriptive and performance-based, this does not mean that it will not call out industrial standards and codes—many of which are quite detailed. Not only will API standards be referred to, particularly those in the Recommended Practices 14 group, but documents from other professional bodies such as the American Society of Mechanical Engineers (ASME) and the Institute of Electrical and Electronics Engineers (IEEE) are also likely to be cited. 

The safety case approach to safety certification may be contrasted with the standards-based approach, where the applicant is recommended or reqnired to follow certain gnidelines and standards. These generally specify the development and assurance processes that shonld be nsed, the intermediate artifacts to be produced (requirements, specifications, test plans etc.), the kinds of reviews, tests, and analyses that shonld be performed, and the documentation that should record all of these. 

The ASA (now ANSI) performance code for Safety Glazing Materials was revised in 1966 to incorporate these improvements in windshield constmction. The addition of test no. 26 requiring support of a 2.3-kg ball dropped from 3.7 m defined this level of improvement. It was based on a correlation estabUshed between 10-kg, instmmented, head-form impacts on windshields, on 0.6 x 0.9-m flat laminates, and the standard 0.3 x 0.3-m laminate with the 2.3-kg ball (28). Crash cases involving the two windshield interlayer types were matched for car impact speeds and were compared (29). The improved design produced fewer, less extensive, and less severe facial lacerations than those produced in the pre-1966 models. 

Where an effective informal system exists and is followed, the issue is one of style, not substance. A facility or unit may have a strong safety culture and sound safety practices, but its managers lack the habit of form documentation, or simply don t think it is important. Assuming that safety performance meets applicable standards, you will probably assign cases like these a relatively low priority, compared with other noncompliance situations. Cases like these are also often the easiest to fix since the fundamentals are already in place, what s required is simply to formalize the informal system by preparing and implementing documentation procedures. 

A No. We have a long-established project approval system which applies to all projects. We prioritize our investments based on the return they will bring to the company. In the case of safety and environmental projects they would receive priority treatment only if we b>elieved our current performance fell short of the standards expected of us. 

Beyond perfonnance optimization, issues relative to packaging and the need for compliance with certain safety and electronics regulatory codes are cited as reasons for a customized solution. In the latter case, a systems approach is required, especially when attempting to meet the code or performance requirements for compliance with European Certification (CE) mark or electrical and fire safety codes such as National Eire Prevention Association (NFPA) and CENELEC (European Committee for Electrotechiucal Standardization). Off-the-shelf electronics may provide the necessary performance characteristics for generic applications, and their use eliminates large expenses related to product development, plus the associated time delays. Photonics-related components are solely addressed in this section because they are used to customize instruments for application-specific systems. 

Cost-minimisation analysis are performed when the clinical outcomes (e.g. efficacy and safety) of the comparator groups are virtually identical and for all practical purposes can be considered to be equal. Because no decision can be made based on differences in the clinical endpoints, decisions are based on the incremental costs of the treatment pathways. Such was the case in a study that assessed the cost-effectiveness of treating proximal deep vein thromboses (DVT) at home with low molecular weight heparin versus standard heparin in hospital therapy. A cost-minimisation approach was chosen for this analysis because the results from a comparative clinical trial confirmed that there were no statistically significant differences in safety or efficacy between the two treatment groups. The study authors concluded that for patients with acute proximal DVTs, treatment at home with low molecular weight heparin was less costly than hospital treatment with standard heparin. ... 

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