Risk assessment operational aspects

Performance-influencing factors analysis is an important part of the human reliability aspects of risk assessment. It can be applied in two areas. The first of these is the qualitative prediction of possible errors that could have a major impact on plant or personnel safety. The second is the evaluation of the operational conditions under which tasks are performed. These conditions will have a major impact in determining the probability that a particular error will be committed, and hence need to be systematically assessed as part of the quantification process. This application of PIFs will be described in Chapters 4 and 5. 

The hazards identification procedures presented in chapter 10 include some aspects of risk assessment. The Dow F EI includes a calculation of the maximum probable property damage (MPPD) and the maximum probable days outage (MPDO). This is a form of consequences analysis. However, these numbers are obtained by some rather simple calculations involving published correlations. Hazard and operability (HAZOP) studies provide information on how a particular accident occurs. This is a form of incident identification. No probabilities or numbers are used with the typical HAZOP study, although the experience of the review committee is used to decide on an appropriate course of action. 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

Essential vahdation work must therefore be identified to prove control of the critical aspects of the operations. A risk assessment approach should be used to determine the scope and extent of validation. 

This describes the principles of qualification and validation which are applicable to the manufacturer of medical products. It is a GMP requirement that manufacturers identify the validation work needed to prove control of the critical aspects of their particular operations. Significant changes for the facility, the equipment and the processes which may affect the quality of the product should be validated. A risk assessment approach should be used to determine the scope and extent of validation. 

You should make yourself aware of the particular safety aspects that operate in your own laboratory. This includes the position of fire safety equipment, the methods of hazard and risk assessments for the chemicals... 

For workplace design, management and operations, and task performance aspects of safety, application of hazard analysis and risk assessment methods are vital to achieving an acceptable risk level. 

In conclusion, validity assessments of the currently available QSARs in environmental sciences indicate that there are models for predicting some of the properties of potential contaminants reliably. If operated in accordance with their limitations, they can be valuable tools to fill data gaps. However, a complete coverage of all parameters and endpoints relevant to the hazard and risk assessment of chemicals has not yet been achieved. To improve and extend the techniques for estimating the intrinsic properties of environmental chemicals, experimental as well as theoretical aspects of these parameters need further elaboration. 

The objective of this section is to elucidate some of the current literature findings of environmental and health/safety issues with airborne nanoparticles. The Uterature review of the most recent articles in this area includes topics related to the multiple components of the risk assessment framework. This includes such important aspects as particle characteristics effecting toxicity, their fate and transport throughout the environment, the routes of exposure and the metrics by which exposure ought to be measured and the mechanisms of translocation to different parts of the body. In addition, recent studies are presented that involve the characterization of nanoparticles in the workplace during different operations and conditions. 

Release of a GMO in the waste stream could be construed to be a deliberate release although it falls within the remit of the contained use regulations. Nevertheless, information from studies on deliberate releases of GMOs could be usefully deployed for contained use operations. The IBP is seeking to collate relevant information for risk assessment purposes. The Royal Commission on Environmental Protection adapted the HAZOP technique as a practical and systematic technique to consider, assess and control possible risks from GMO release to the environment. The technique, termed GENHAZ, has also been tested by the IBP for contained use assessments. We developed an integrated approach to assess the operational aspects of the plant and equipment (as described in section 11.4.5) and the environmental aspects of possible GMO releases. We concluded that a more rigorous environmental risk assessment could be developed than had hitherto been provided by companies. 

In the previous chapter, it was established that in industry, plant hazards can cause harm to property (plant—machinery, asset), people, or the environment. So, it is important to develop some means of analyzing these and come up with a solution. Unfortunately, it is not as straightforward as it sounds. There are plenty of plant hazard analysis (PHA) techniques and each of them has certain strengths and weaknesses. Also each specific plant and associated hazard has specific requirements to be matched so that hazard analysis will be effective. In this chapter, various hazards (in generic terms) will be examined to judge their importance, conditions, quality, etc. so that out of so many techniques available for PHA it is possible to select which one is better (not the best because that needs to be done by experts specifically for the concerned plant) suited for the type of plant. So, discussion will be more toward evaluation of PHA techniques. Some PHA is more suited for process safety management (PSM) and is sometimes more applicable for internal fault effects [e.g., hazard and operability study (HAZOP)]. In contrast, hazard identification (HAZID) is applicable for other plants, especially for the identification of external effects and maj or incidents. HAZID is also covered in this chapter. As a continuation of the same discussion, it will be better to look at various aspects of risk analysis with preliminary ideas already developed in the previous chapter. In risk analysis risk assessment, control measures for safety management systems (SMSs) will be discussed to complete the topic. 

The risk assessment process applies to all aspects of operational risk management—occupational safety, occupational health, environmental matters, product safety, all aspects of transportation safety, safety of the public, health physics, system safety, fire protection engineering, property damage and business interruption avoidance, and the like. 

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