Appropriate design, risk assessment

Appropriate design, risk assessment, 91 Arkansas warehouse incident, 159 Audience, training and communication, 110 Audits, management practices, 70,114-115 Augusta, Georgia incident, 164-165 Auxiliary system sizing, risk assessment, 95... 

Capital Project Review and Design Procedures (for new or existing plants, expansions, and acquisitions) Appropriation request procedures Risk assessment for investment purposes Hazards review (including worst credible cases)... 

The approach described is appropriate for assuring process safety for the preliminary design and is commonly used in industry where hazardous materials are handled. The committee further notes that a full-scale quantitative risk assessment (QRA) will be required in conjunction with the completion of the final design to assure that all process safety issues have been fully addressed. 

The benefit of applying a fire risk assessment as a decision tool will vary between companies and projects. In many cases, a formalized fire risk assessment is not necessary because the solution is relatively obvious based on design standards and appropriate fire protection is either applied or not applied. Fire risk assessments may be necessary ... 

The above aspects are covered in more detail in Table 16.3.1 It should be kept in mind that Table 16.3 discusses general facility designs to consider when developing a containment strategy for highly potent compounds. However, each consideration is subject to rigorous risk assessment. Practically, this means a determination of whether the consideration or practice is required or is a nice extra to control exposures to an appropriate level. 

The remainder of the document is organized as follows. The next two sections lay the foundations for the terminology used in the document section 2 defines data in the context of exposure assessments and section 3 introduces a broader concept of data quality characterized by the four hallmarks or measures of quality mentioned above— appropriateness, accuracy, integrity and transparency. Section 4 discusses how these hallmarks might be applied to the design or evaluation of an exposure assessment to ensure its quality. The final section concludes with a broader perspective on the role of data quality in exposure assessment and its importance to risk assessment and risk management decisions. 

The risk assessment process can be conducted by examining record types to see if they are GxP or non-GxP, and then applying severity checks, likelihood, and probability of detection criteria, as illustrated in Figure 15.2. The most severe scenarios shonld be linked to direct patient/consnmer impact. GxP noncompliance and broken license conditions are severe in their own right bnt not as critical as patient/consumer health in this analysis." Its likelihood will be influenced by the degree of human error in how the record is input and used. The probability of detection needs to take into account the probability of the impacted record being used. Once failure modes are understood, then the appropriate design controls can be introduced. These should be documented and validated as part of the computer system life cycle discussed earher in this book. 

Due to the importance of safety in process industries various safety and risk assessment methods have been developed to provide the opportunity of considering safety issues in early design stages. Meanwhile several studies have been undertaken to create appropriate implementation tools for developed assessment methodologies (Palaniappan et al, 2002a, Khan and Amyotte, 2004 and 2005). In this paper, inherent safety method and Petri nets modelling have been selected as the safety assessment and implementation tool, respectively. 

These properties are especially important in the design, data analysis, and interpretation of multispecies toxicity tests, field studies, and environmental risk assessment and will be discussed in the appropriate sections. This alternate approach rejects the smooth transition of effects and recognizes that ecosystems have fundamentally different properties and are expected to react unexpectedly to contaminants. 

Last note that the proper use of these QSAR models designed for molecules with a specific MOA requires that we can assign a molecule to its appropriate class. This task represents a major hurdle in ecological risk assessment, since incorrect mode-of-action-based QSAR selections can result in 10- to 1000-fold errors in toxicity predictions [66], Solutions have been proposed to overcome this problem [65,67-71], but in practice, none is entirely satisfying. The different modeling strategies proposed to solve this crucial problem are presented in the next section. 

There is little question at this point that a better understanding of mammalian metabolism of pesticides can minimize pesticide risk. There remains, however, considerable concern about the effectiveness of the use of metabolism data in this regard and of the lack of coordinated efforts to improve the design of metabolism studies to more appropriately address the issue of risk assessment. 

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