Prescription standardization

In turn, reminders at the moment of prescribing may be more administrative than educational in nature, their impact disappearing when the intervention ceases, although their reference to previously agreed prescription standards is of especial relevance. Little is known about whether mechanisms of this type might help to relieve pharmaceutical-related problems derived from pressure exerted either by colleagues or by patients. 

Three key issues for codes and standards include better synchronization of codes and standards development with RD D, performance- versus design-based (or prescriptive) standards, and coordinating national codes and standards development with international standards development. For all the three issues, the critical need is to establish a scientific foundation for requirements incorporated in codes and standards. If the science underlying these requirements can be established, harmonization of requirements and consensus among international experts can be more readily achieved, and the DOE can focus on the critical RD D needs as identified in the Roadmap to facilitate harmonization and consensus. 

Design-based, or prescriptive, standards, however, specify the materials and design for components, subsystems, and systems that are covered by the standard. An example of such standards are those found in the ASME s Boiler and Pressure Vessel Code, which specify the materials, design, fabrication, installation, testing and inspection, and operation and maintenance that boilers and pressure vessels must meet. Such prescriptive standards are common for stationary components and systems that must be approved by state and local code officials. Most of these requirements are based on historical practice and safety experience and have served the affected industries well. 

A performance standard states requirements in terms of required results with criteria for verifying compliance but without stating the methods of achieving required results. A performance standard may define the functional requirements for the item, operational requirements, and/or interface and interchangeability characteristics. A performance standard may be viewed in juxtaposition to a prescriptive standard, which may specify design requirements, such as materials to be used, how a requirement is to be achieved, or how an item is to be fabricated or constructed (Office of Management and Budget 1998). 

In North America, all plywood manufactures used to follow the prescriptive standard PSl (APA, 1995). However, since the introduction of performance-based standards such as PS2 (NIST, 2004) and PRP-108 (APA, 2001) in 1990s other structural panel products, such as OSB, can and have been used interchangeably in structural panel applications. 

Risk management programs can be divided into two broad categories prescriptive and nonprescrip-tive. Prescriptive standards, in which a set of detailed standards are developed, usually by a regulator or industry standards-setting body, are what most people think of when safety is discussed, are often associated with traditional occupational safety standards. To pick an example almost at random, OSHA has the following rule to do with ladders ... 

Another example of prescriptive standards for offshore facilities regarding the design of systems to prevent overpressure of vessels comes from API Recommended Practice 14C which states... 

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 operation of modem process facilities involves the use sophisticated management systems. Once more, it is difficult to write prescriptive standards to address aU the nuances of such systems. 

SEMP (the voluntary standard for offshore safety) is quite prescriptive because it refers to a large number of prescriptive standards. It is also self-regulated, and so is in the bottom left square. 

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... 

Many employers and manufacturers in the United States will use both approaches concurrently. The latter emphasizes a comprehensive analysis of hazards and a clear definition of which controls should be in place. Prescriptive standards and regulations may not always cover the unique situations of specific employers, manufacturers, and processes. 

However there are many questions that arise about these properties of evidence and in particular how we measure them either qualitatively or quantitatively. Currently, a large amount of the consideration of relevance occurs on a case-by-case basis using subjective judgement. Conceptual frameworks for assessing relevance, trustworthiness and independence methodically and the presentation of this information in the safety case would improve our understanding of the role the evidence plays. This problem is not specific to goal-based standards and is equally applicable to evidence generated to satisfy prescriptive standards. 

Another fiction relating to SoS safety cases is that the adoption of Def Stan 00-56 Issue 4 will make it difficult to construct a safety case because the onus is on the designers to argue that the right evidence has been produced in support of the safety case. However, the fact is that Def Stan 00-56 Issue 4, being a goal-based rather than a prescriptive standard, allows potentially greater flexibility in the types of evidence that can be presented in order to support the safety case and demonstrate that the system of systems is acceptably safe. Therefore the outputs of novel safety analysis techniques can be used as evidence to support the SoS safety case. 

The use of prescriptive standards does, however, offer a number of advantages. First, given that the standards were developed by experts in the field, then-use will ensure that high levels of safety will be achieved even if the persons designing and running the platform are not themselves industry experts. 

Second, the use of prescriptive standards increases efficiency and reduces design time. Rather than having to develop safety concepts and standards from scratch, the designers and operators of a platform can quickly and efficiently apply recognized rules. 

Although each facility is unique, many operations, such as starting a pump or training a contract worker, are really quite similar from site-to-site and from company-to-company. Therefore it is possible to develop high-quality, generic systems that can be used in a wide variety of situations. Doing so saves time and money, and improves quality. It is this philosophy that lies behind the creation of RP 75 and the many prescriptive standards that it calls on. 

It can be concluded, therefore, that The Cullen Report did call for a paradigm shift one that moved the industry away from prescriptive standards toward performance-based programs and regulatory standards. It can also be concluded that the offshore oil and gas industry worked toward achieving that paradigm shift, although different approaches were used in different locations. 

In practice, most nonprescriptive regulations also incorporate many prescriptive standards. For example, the SEMS mie that is described in Chapter 5 is basically nonprescriptive, but it does make reference to standards such as API RP 14C that are quite prescriptive in nature and that are often a legal requirement. For example, paragraph 4.2.1.1.4 of the SEMS rule states ... 

From a regulator s point of view it is fairly simple to measure compliance against a prescriptive standard. A facility is either following that standard, or it is not. For example, with regard to the API RP 14C standard quoted above, either a system has two levels of protection, or it does not. In the case of the OSHA ladder standard, either the rungs of a ladder have a minimum diameter of a % inch, or they do not. There is no need for judgment. 

ASSE through the ASSE Foundation is paying the Rand Corporation 100,000 to research the risk-based regulatory systems in the UK and Europe because there is evidence (significantly lower fatality rates) to suggest the risk-based system may be more effective than prescriptive standards. 

Instead of a tug of war over compliance to prescriptive standards that cannot address each workplace, this nation s approach to workplace safety must encourage a specific dialogue about the most important risks in each workplace that engages employers, workers and OSHA in a cooperative effort to address those risks, supported not only enforcement but by NIOSH research and education resources."... 

Increasing complexity and prescriptive standards were the topic of discussion at two technical committees of Lloyd s Register in 2011 [2]. It was agreed that goal based standards convert a culture of passive compliance to one of active ownership. 

The purpose of this procedure is to enable XYZ Ltd to provide in-house expertise in functional safety such as to meet the requirements of lEC 61508. Since lEC 61508 is not a prescriptive standard, the issue is of providing a risk-based safety argument that is acceptable to one s regulator/auditor/HSE. A functional safety assessment consists of evidence showing that the areas of the standard have been adequately addressed and that the results are compatible with the current state of the art... 

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