Prioritization risk assessment

Because the validation of computerized systems is time consuming, expensive and resource intensive, many organizations are challenged to identify and prioritize which systems will be validated. There are organizational and system specific risk factors to consider in the regulated environment. Each organization must establish its own risk assessment process. 

The results of the risk assessment prioritization can be reflected in an organizational validation master plan. Therefore, an organization can demonstrate the sequence in which they intend to address validation activities from a scheduling point of view. 

Risk assessment constitutes a cornerstone for the control of chemicals for both scientific and management purposes. Environmental risk management deals with regulatory measures based on risk assessment [3], Strategies such as the prioritization of chemicals represent a useful tool to optimize efforts for both regulatory and monitoring purposes [4, 5]. 

Combating Terrorism Threat and Risk Assessments Can Help Prioritize and Target Program Investments. Washington, D.C. U.S. Government Accounting Office (NSIAD-98-74, April 9) 1998.. 

Besse JP, Garric J (2010) Environmental risk assessment and prioritization stratagies for human pharmaceuticals review and discussion. In Benoit R (ed) Pharmaceuticals in the environment current knowledge and need assessment to reduce presence and impact. IWA Publishing, London... 

Process Hazard Analysis— An organized effort to identify and evaluate hazards associated with chemical processes and operations to enable their control. This review normally involves the use of qualitative techniques to identify and assess the significance of hazards. Conclusions and appropriate recommendations are developed. Occasionally, quantitative methods are used to help prioritize risk reduction measures. 

The first draft of the risk assessment reports are written by the Member States, which act as rapporteurs . Generally, one Member State acts as rapporteur for a prioritized substance or group of substances however, for some prioritized substances, more than one Member State can act as rapporteurs. The risk assessment process is coordinated by the ECB. Stakeholders are involved in the process through the Technical Committee for New and Existing Substances (TC NES). The Commission mediates the meetings, which attempt to reach consensus on the conclusions of the risk assessments. During the risk assessment process, the Scientific Committee on Health and Environmental Risks (SCHER) is requested to provide an opinion. 

In the EU, 141 of existing high production volume chemical substances have been prioritized for an in-depth risk assessment, see Section 2.4.1.4 for details. 

The TGD has been revised and the second edition was published in 2003 (EC 2003). However, the human health risk characterization part was not included in this second edition. A final draft version of the human health risk characterization part was released in 2005 with a detailed guidance on, among others, the main issues to be included in derivation of the reference MOS (MOSref), which is analogous to an overall assessment factor. The individual factors contributing to the MOSref are described separately and guidance is given on how to combine these into the MOSref. The guidance provided in this draft version has been extensively used in relation to the risk assessment of prioritized substances carried out since the draft version was released however, this version is not publicly available. 

As risk assessment becomes more sophisticated and is extended to more chemicals, it will also be extended to smaller and smaller risks. Since it is not possible to regulate all risks, an important use of risk analysis must be to decide which chemicals should be regulated and to what degree. Under the Tbxic Substances Control Act (TOSCA), all new chemicals must be considered. The prioritization scheme for chemical testing is based upon a set of dichotomous criteria, toxicity, chemical reactivity, etc., which involve qualitative rather than quantitative risk analysis. As procedures for more quantitative analysis become available, the prioritization scheme will become more precise, (NAS/NRC, 1984). 

The PAT guidance clearly states that industrial implementations should be risk based. Soon after the PAT team and objective have been identified, the project should commence with a formal risk assessment. The risk assessment should be focused on identifying and characterizing the failure modes which present risks to product quality the outcome of the risk assessment will provide a means prioritizing the allocation of PAT resources and a baseline for review of the effect of PAT in mitigating risks to quahty. 

A number of in vitro developmental systems have been used to investigate the morphological and biochemical basis of normal and abnormal development. Examples include cell, organ and whole embryo culture. Although it is unlikely that in vitro systems will ever be able to replace whole animal systems for risk assessment, in vitro tests are very useful when used in addition to in vivo studies (Stahlmann et al., 1993). In particular, they are useful to study the mechanisms of normal and abnormal development, to determine dose-response, to identify organ toxicity and perhaps to screen or prioritize chemicals for further in vivo studies. However, most in vitro tests focus on a narrow range of developmental events thus, some researchers feel that in vitro studies should be based on previously characterized results from in vivo studies (Schwetz, 1993). 

The flowchart in Figure 3.1 describes the typical role of (Q)SARs for risk assessment and prioritization of further experimental requirements, especially in the absence or paucity of experimental results, where (Q)SARs will play a significant role. 

Russom CL, Breton RL, Walker JD, Bradbury SP. 2003. An overview of the use of quantitative structure-activity relationships for ranking and prioritizing large chemical inventories for environmental risk assessments. Environ Toxicol Chem 22 ... 

Salvito DT, Senna RJ, Federle TW. 2002. A framework for prioritizing fragrance materials for aquatic risk assessment. Environ Toxicol Chem 21 1301-1308. 

In December 2006, the Canadian federal government announced a new Chemical Substances Plan to prioritize chemicals targeted for risk assessment and risk management.103 The aim of this new Plan is to use science-based information to protect our health and the environment by... 

The proposed NCP recognizes the statutory mandate in Section 105(8) to develop risk assessment criteria and a National Priority List by limiting "remedial" actions to releases on the National Priority List ( 300.67(a)). This will put teeth in the mandate of Section 105(8) and will assure the importance of the risk analy-sis/prioritization process. 

Selection of Remedy. Risk assessment under the Section 105 scheme for the NCP is explicitly required only in connection with the prioritization process under Section 105(8). After prioritization on the basis of risk, the key issue is selection of remedy. 

Thus, once risk is taken into account in the prioritization process, the EPA has considerable latitude in devising methods and criteria for remedy selection, with the major substantive requirement being cost effectiveness under Section 105(7). Nevertheless, in many cases the Mitre Model will not produce a risk assessment adequate for remedy selection, and a more detailed assessment will be necessary. 

In Superfund s Section 105 requirement for a Revised NCP, Congress mandated a scheme for responding to releases of hazardous materials. For old dump sites response starts with a survey and prioritization of sites based on risk assessment. After prioritization the focus turns to selection of cost-effective remedies which will adequately protect the public health and welfare and the environment. In revising the NCP, EPA is engaged in a pioneering effort to develop a practical and effective site assessment model. After prioritization additional assessment will often... 

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