SYSTEMS FRAMEWORK

Data collection for developing framework Framework evaluation 

Interviews RRS TGD and restrictions REACH legislation and RIPs RRS reports 

Actor roles and responsibilities for national and EU risk management Relevance and implications of actors for EU decision-making Identification of methods for supporting actor responsibilities Necessity for national versus EU action 

Problems with current regulatory processes What processes have been followed, why the problems may have occurred Identification of how regulatory processes may change under REACH What outcomes could result from using the framework 

Problems anticipated under REACH Potential obstacles with implementing the current TGD under REACH Potential solutions to obstacles Avoidance of potential obstacles and improvements to the TGD 

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S. K. Shum and co-workers, "A Knowledge-Based System Framework for Diagnosis in Process Plants," in Proceedings of the Seventh Power Plant Dynamics, ControlandTestingSymposiums Knoxville, Term., 1989. 

There are many different management system frameworks that can be used for integrating PSM and ESH. All the concepts presented in this book can be applied to other systems or templates, and the frameworks of different Quality Management systems can even be combined. For example, some one might wish to use the basic elements of ISO 9004 plus a management of change element as their template. 

As one of her first initiatives after being sworn in as FDA Commissioner, Dr. Jane Henney established a Task Force to evaluate the system for managing risks of FDA-approved medical products. The Task Force assessed risk-management practices within the overall healthcare-delivery system, focusing on the roles and responsibilities of each participant. The Task Force s report Managing the Risks from Medical Product Use Creating a Risk Management Framework found that a systems framework for medical product risk... 

To ensure that this team concept is institutionalized and for its continuous improvement, the PAT Team process will be under the FDA s Quality Systems Framework. This should also help in ensuring quality and consistency of reviews, inspections, and other regulatory activities. 

U.S. Department of Health and Human Services (2006), SMG 2020—FDA quality system framework for internal activities, Food and Drug Administration, Rockville, MD. 

The systems framework was also evaluated by considering how it meets actor demands and system constraints of EU decisionmaking. The process for developing and evaluating the framework is described in Chapters 5 and 6. 

The research findings were disseminated to the interviewees, certain members of the European Commission, and the relevant European Parliament committee reporters. The systems framework was formatted and submitted as a short document to the RIP responsible for developing TGD for restriction and authorisation. Responses received were considered in terms of the overall contribution of the research project. 

The Netherlands Highly developed national chemicals strategy - Dutch chemicals strategy available in English - Dutch strategy considered when devising the Systems Framework (Chapter 6)... 

Chapter 4 National approaches and Chapter 5 Systems framework ... 

The next Chapter exposes how without careful attention to particular issues during implementation the REACH legislative text is unlikely to deliver the recommendations identified in Table 4.6. Several examples are presented in Chapter 5 that illustrate how the strengths and weakness of the national approaches tend to hinder rather than facilitate EU decision-making. The proposed systems framework for decision-making under REACH then seeks to rectify these potential shortcomings of the legislation. 

Although many aspects of the SOMS or RCEP system can be readily integrated with REACH, neither appears to have been particularly influential in the European Commission legislative drafting (Table 5.2). The systems framework, which is presented in the next section of this Chapter, contains the key elements of the SOMS and RCEP proposals shown in Table 5.2. 

Figure 5.7 The proposed systems framework (structural differences between the framework and...

The categorisation process for the proposed systems framework is shown in Figure 5.9. A substance or group of similar substances (referred to as a chemical grouping ) would enter the systems... 

Although professional uses include chemical exposures resulting from occupational use, the systems framework proposes to make a clear distinction between professional and industrial applications, as explained in subsequent sections. 

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