Risk-based development approach

Given the versatility of current amorphous characterization techniques, it is clear that a range of resolutions and data can be generated on amorphous dispersions. As discussed previously, within a risk-based development approach, it becomes possible to triage testing to yield the appropriate balance of resolution and resource utilization so that the extmded product can be successfully positioned for commercialization. 

The Department of the Interior should develop a proactive, risk-based performance approach specific to individual facilities, operations and environments, similar to the safety case approach in the North Sea. 

Risk-Based Inspection. Inspection programs developed using risk analysis methods are becoming increasingly popular (15,16) (see Hazard ANALYSIS AND RISK ASSESSMENT). In this approach, the frequency and type of in-service inspection (IS I) is determined by the probabiUstic risk assessment (PRA) of the inspection results. Here, the results might be a false acceptance of a part that will fail as well as the false rejection of a part that will not fail. Whether a plant or a consumer product, false acceptance of a defective part could lead to catastrophic failure and considerable cost. Also, the false rejection of parts may lead to unjustified, and sometimes exorbitant, costs of operation (2). Risk is defined as follows ... 

For companies to make risk-based decisions from risk screening or quantitative risk assessments, company-specific risk tolerance criteria or methodologies should be developed for both individual risk and aggregate risk. Chapter 4 provides a discussion of risk criteria and methodologies, and offers guidance for companies to consider in developing their own approaches to risk tolerability. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

The risk-based approach introduced by the FDA focuses the pharmaceutical companies and regulatory authorities resources into addressing potential risk areas based on the scientific approach. The aim is to ensure pharmaceutical companies adopt new scientific developments and equipment for manufacturing safe, effective, pure, and consistent products. 

Weisman, W. 1998. Analysis of Petroleum Hydrocarbons in Environmental Media. Total Petroleum Hydrocarbons Criteria Working Group Series, Vol. 1. Amherst Scientific Publishers, Amherst, MA.(See also Vol. 2, Composition of Petroleum Mixtures, 1998 Vol. 3, Selection of Representation Total Petroleum Hydrocarbons Fractions Based on Fate and Transport Considerations, 1997 Vol. 4, Development of Fraction-Specific Reference Doses and Reference Concentrations for Total Petroleum Hydrocarbons, 1997 and Vol. 5, Human Health Risk-Based Evaluation of Petroleum Contaminated Sites, Implementation of the Working Group Approach, 1999.)... 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

Proponents of the risk-based approach emphasize that decisions should be made on the basis of what is known. There must be clear evidence that harm of a specified nature may be caused by a technology, harm of sufficient severity to justify the proposed restrictions on that technology. In contrast, it is less clear what a precautionary approach involves.1 2 It is often presented as being the taking of restrictive action when there is a lack of clear evidence or of scientific certainty. Principle 15 of the 1992 Rio Declaration on the Environment and Development puts it as follows ... 

Finally, another major area of focus continues to be the characterization of intrinsic bioremediation as the most cost-effective cleanup alternative. As part of this strategy further work will need to be conducted on developing risk-based cleanup standards using environmentally acceptable endpoints , including the potential applicability of biostabilization. These approaches are being developed to... 

In the most straightforward risk-based approach, epidemiologic studies have developed exposure-response relationships based on biomarker measurements in hair, blood, urine, or other matrices (e.g., mercury, lead) (see Figure 5-2a). The relationships can be applied directly to new biomonitoring data to determine where on the exposure-response curve any person is. That may facilitate an understanding of risk, but it does not analyze sources of exposure, so other techniques (such as environmental sampling and behavioral surveys) may be needed to assess where the exposure came from. 

This Report presents the foundations and technical principles for development of a generally applicable and risk-based hazardous waste classification system. Recommendations on suitable approaches to establishing boundaries of different waste classes are discussed these boundaries could be expressed, for example, in terms of limits on concentrations of hazardous substances. However, a particular implementation of the proposed waste classification system in terms of quantifying the boundaries of different waste classes is not presented. 

NCRP s approach to addressing these difficulties is to develop a single hazardous waste classification system that is comprehensive and risk-based. 

In developing a risk-based approach to waste classification, NCRP has focused exclusively on the potential for significant adverse health effects in humans. However, there are other potential adverse impacts... 

---