Import risk analysis process

To this point in the risk analysis process, XYZ Chemical commissioned a separate study to review the bulk pesticide operation and all potential risk reduction options and combination of options that could be implemented to manage the risk of this operation. This study determined that the combination of several risk reduction options reduced the bulk pesticide risk from higher risk to lower risk. While management thought it was important to reduce identified risks, the costs of the available options were not justifiable and so the movement of bulk pesticide from this Asian facility was stopped. 

Another informal comparison was made in the ITA (Independent Technical Authority) analysis described in section 8.6. An informal review of the risks identified by using STPA showed that they included all the risks identified by the informal NASA risk analysis process using the traditional method common to such analyses. The additional risks identified by STPA appeared on the surface to be as important as those identified by the NASA analysis. As noted, there is no way to determine whether the less formal NASA process identified additional risks and discarded them for some reason or simply missed them. 

Acceptable Risk An acceptable level of risk for regulations and special permits is established by consideration of risk, cost/benefit and public comments. Relative or comparative risk analysis is most often used where quantitative risk analysis is not practical or justified. Public participation is important in a risk analysis process, not only for enhancing the public s understanding of the risks associated with hazardous materials transportation, but also for insuring that the point of view of all major segments of the population-at-risk is included in the analyses process. 

Risk analysis is the process in which risks are examined at various degrees of detail to determine the extent of the risks, how risk elements are related to each other, and which ones are the most important to deal with. This may not necessarily involve any consideration of the significance of the estimated risks (DNV 1996). The main stages of the risk analysis are (1) preparations for analysis, (2) risk analysis process and (3) conclusions and recommendations. These main stages consist of a number of steps and sub-steps or tasks, which are identified and further developed for ready application in the risk analysis of the maritime transport of PDG based on combination of the literature study (DETRA 1999 DNV 1995 HSE 1991, 1999, 2001 lEC 1995 IMO 1997, 2004, 2006 ISO 1999 OECD 2000, 2001 USCG 2001 Weigkricht and Fedra 1993) and the author s research experiences (Mullai and Paulsson 2002 Mullai 2004, 2006, 2007). 

Table 12.2 The import risk analysis (IRA) process (based on the Australian and New Zealand published IRA procedures)...

The Chemical Process Industry (CPI) uses various quantitative and qualitative techniques to assess the reliability and risk of process equipment, process systems, and chemical manufacturing operations. These techniques identify the interactions of equipment, systems, and persons that have potentially undesirable consequences. In the case of reliability analyses, the undesirable consequences (e.g., plant shutdown, excessive downtime, or production of off-specification product) are those incidents which reduce system profitability through loss of production and increased maintenance costs. In the case of risk analyses, the primary concerns are human injuries, environmental impacts, and system damage caused by occurrence of fires, explosions, toxic material releases, and related hazards. Quantification of risk in terms of the severity of the consequences and the likelihood of occurrence provides the manager of the system with an important decisionmaking tool. By using the results of a quantitative risk analysis, we are better able to answer such questions as, Which of several candidate systems poses the least risk Are risk reduction modifications necessary and What modifications would be most effective in reducing risk ... 

It is most important that the whole life cycle of a process plant can be evaluated on safety. Safety and risk analyses evaluate the probability of a risk to appear, and the decisions of necessary preventative actions are made after results of an analysis. The aim of the risk estimation is to support the decision making on plant localization, alternative processes and plant layout. Suokas and Kakko (1993) have introduced steps of a safety and risk analysis in Figure 2. The safety and risk analysis can be done on several levels. The level on which the analysis is stopped depends on the complexity of the object for analysis and the risk potential. 

Risk is defined as a measure of human injury, environmental damage, or economic loss in terms of both the incident likelihood (probability) and the magnitude of the loss or injury (consequence) (AICHE/CCPS, Guidelines for Chemical Process Quantitative Risk Analysis, 2d ed., American Institute of Chemical Engineers, New York, 2000, pp. 5-6). It is important that both likelihood and consequence be included in risk. For instance, seat belt use is based on a reduction in the consequences of an accident. However, many people argue against seat belts based on probabilities, which is an incorrect application of the risk concept. 

From those techniques given in Table 1 my personal preference is for failure mode, effects, and criticality analysis (FMECA). This technique can be applied to both equipment and facilities and can be used to methodically break down the analysis of a complex process into a series of manageable steps. It is a powerful tool for summarizing the important modes of failure, the factors that may cause these failures, and their likely effects. It also incorporates the degree of severity of the consequences, their respective probabilities of occurrence, and their detectability. It must be stressed, however, that the outcome of the risk assessment process should be independent of the tool used and must be able to address all of the risks associated with the instrument that is being assessed. 

The approach used in an FHA is to assume ignition of releases. In reality, not all releases result in afire. The likelihood of ignition can be addressed in the quantitative risk assessment process. However, in an FHA it is important to identify if ignition sources are present for the fire scenarios to occur. In some instances, fire scenarios can be eliminated from analysis because of the lack of a credible ignition source. 

Methodically devised and established methods (and criteria) of substance and process assessment and evaluation like risk analysis, toxicological and ecotoxi-cological analyses, life-cycle-analysis and cost-benefit analysis . But also much simpler approaches, which in practice play an important role for assessing formulations and snbstance properties (e.g. the nse of negative and/or positive lists). 

Furthermore, each cell division round has the potential danger of rearrangement of chromosome sections during mitosis and thus chromosome aberrations. A thorough theoretical and experimental analysis of the dose-effect relation of various canceroge-nic substances has shown that an increased cell division activity is an important risk factor for the creation of tumors (Cohen and Ellwein, 1990). All processes that lead to an increase in the rate of cell division will increase the probability of tumor formation, according to these investigations. 

One important aspect of the quality systems approach is the ongoing collection and analysis of quality data to continuously evaluate quality system effectiveness. Historical data, process knowledge, and risk analysis methods can be applied to identify specific data requirements. Trending and other data analysis methods can allow identification of actual and potential sources of nonconformity so that appropriate corrective and preventive actions can be taken in accordance with established change control procedures. 

The results of any risk analysis should be well documented as they become the key input into the qualification and validation process. They are the basis for defining tests in the IQ, OQ, and PQ phases. It is often impossible to say prior to a risk analysis what steps of qualification need to be performed. It depends on the risks and measurements defined during the risk analysis. Equally important, this procedure increases the efficiency of the qualification process. In the past, the decision on which qualification tests to perform was outlined by writing qualification protocols. These usually prompted long and expensive discus-... 

A risk analysis is not an objective by itself, but is one of the elements of the design of a technically and economically efficient chemical process [1]. In fact, risk analysis reveals the process inherent weaknesses and provides means to correct them. Thus, risk analysis should not be considered as a police action, in the sense that, at the last minute, one wants to ensure that the process will work as intended. Risk analysis rather plays an important role during process design. Therefore, it is a key element in process development, especially in the definition of process control strategies to be implemented. A well-driven risk analysis not only leads to a safe process, but also to an economic process, since the process will be more reliable and give rise to less productivity loss. 

The scope of the analysis aims to identify the process under consideration, in which plant it will take place, and with which chemicals it will be performed. The chemical reactions and unit operations must be clearly characterized. In this step, it is also important to check for interface problems with other plant units. As an example, when considering raw material delivery, it can be assumed that the correct raw material of the intended quantity and quality is delivered from a tank farm. Thus, it can be referred to the tank farm risk analysis, or the tank farm is to be included in the scope of the analysis. Similar considerations can be made for energy supply, to ensure that the appropriate energy is delivered. Nevertheless, loss of energy must be considered in the analysis, but it will be assumed that... 

The safety data used in risk analysis can be grouped into different categories, described in the following sections. The data should be provided for raw material, intermediates, and products, as well as for reaction mixtures or wastes as they are to be handled in the process. Missing data, important in risk analysis, may be marked with a letter I, to indicate that this information is missing or as a default by a letter C, if its value is unknown but judged to be critical. 

Another important activity is the process to evaluate new security technologies and their integration with computer systems. The procedural controls implemented as a result of a risk analysis provide a starting point to look for technologies that can replace procedural controls. These procedural controls are the result of security-related implementation requirements identified during the risk analysis. 

FMEA is focused on safety consequences of component failures. Identified failure modes of a component are analyzed case by case. The analysis process results in an explicit and documented decisions that take into account the risk associated with a given failure mode. The decision can be just the acceptance (supported by a convincing justification) of the consequences of the failure or it can suggest necessary design changes to remove (or mitigate) the consequences or causes of the failures. Documentation is an important output of FMEA. This documentation can be then referred to by a safety case for the considered system. 

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