Risk-based prioritizations

Deciding which risk-reduction method to use maybe difficult. In many instances, appropriate decisions can be made without resorting to quantitative techniques. However, in some cases, particularly when the options are costly, quantitative risk analysis (QRA) and risk-based decision-making approaches may be an effective basis for measuring the improvement in safety arising from the proposed options. These approaches can also be used in prioritizing safety improvements and balancing cost and production issues. 

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. 

U.S. Department of Health and Human Services (2004), Risk-based method for prioritizing cGMP inspections of pharmaceutical manufacturing sites—A pilot risk ranking model, Food and Drug Administration, Rockville, MD. 

Ranking The qualitative estimation of risk from severity and likelihood levels, in order to provide a prioritizing of risk based it s magnitude (refer to corporate risk matrix for ranking based on severity and likelihood levels). 

Chronic health or ecological impacts are often not immediately evident and may therefore require evaluation of long-term, future exposure patterns in order to establish appropriate site cleanup standards. Under a risk-based approach, response actions are prioritized at near-term, high-risk sites, and remedial measures are designed to minimize health/environmental risks by preventing exposure to harmful levels of site constituents. 

Risk Based—where the potential consequence and hkelihood are used to prioritize... 

XYZ Chemical has similar operations consisting primarily of pesticide and herbicide manufacturing operations in the United States, Europe, Asia, and South America. Since the operations are similar, the prioritization process (illustrated in Table 3.4) consists of cataloging all chemicals in transit (in and out of their facilities), modes of transport, qnantities, and nnmber of annual shipments. Specifically, the prioritization process is a combination of the hazards- and consequence-based prioritization processes illnstrated in Figure 3.4. If this process were expanded to a likelihood- or risk-based process, then additional factors (e.g., the number of shipment, length of shipment) may have been included in the prioritization. With this data collected, the hazards of each chemical and the potential impacts are docnmented based on the chemical physical properties and quantities in transit. With all of the information collected, the following qualitative ranking is nsed to prioritize issnes for escalation and identification of countries and operations that will need to condnct more detailed risk analyses ... 

In Chapter 3, XYZ Chemical conducted a corporate-level identification and prioritization of all worldwide hazardous material transportation activities. Based on this hazard-based prioritization activity, the chemicals listed in Table 4.3 were identified as potentially higher risk and escalated for further facilily/operational-level reviews. Facility review means the inbound and outbound hazardous material transportation activities for each XYZ Chemical plant moving these chemicals. 

In Chapter 3, a corporate-level identification and prioritization of all worldwide hazardons material transportation activities was condncted by XYZ Chemical. The chemicals listed in Table 6.6 were identified as potentially high risk based on the possible impacts of a chemical release along the transit ronte. 

The management of pressure systems equipment integrity can be risk-based or time-based however, risk-based is preferable in order to prioritize and optimize the resources. The risk-based inspection schemes can be either quantitative, semiquantitative, or qualitative, depending on the inspection and corrosion historical data available for risk assessment that will be used where necessary to derive inspection schemes and provide the foundation for planned integrity activities. 

The enterprise shall mitigate system-level risks to include products risks that were assessed to be critical to system development during concept selection. For critical risks associated with products, the enterprise utilizes simulation, scale-model tests, or prototype tests to demonstrate mitigation of risks to an acceptable level. The enterprise should assess subsystem risks and prioritize critical risks based upon probabihty of occurrence and related consequences to cost, schedule, and/or performance. 

Identified risks are prioritized based upon criticality to the successful development of the system. Acceptable levels of risk should be identified, depending on the stage of development, to provide a basis for establishing and monitoring risk reduction activities and mitigating unacceptable risks. 

A prioritization may be required to manage effectively safety control programs. Thus a structured industrial area is suitable to experiment a risk based approach in inspection and surveillance program. It could enable safety authorities to concentrate resources on establishments at a higher risk level, thus reducing efforts... 

The risk based approach has been widely applied for a decade in many industries for mechanical integrity or functionality controls, hut it is not yet very usual for occupational safety. In a few cases more risk industries are prioritized, but priority does not discriminate single firms. As in this matter there is a general lack of good practices or standards, it is essential to avoid too discretionary decisions. 

Applying risk-based decision-making tools for prioritizing risk management options (biological agents, heat)... 

Applying a risk-based approach to prioritize experiments to imderstand the effect of method and sample preparation parameters (mobile phase composition, temperature, dissolving solvent, etc.) on chromatographic behavior and results. 

Risk analysis refers to techniques for identifying, characterizing, and evaluating hazards. The identification of risk, defined in Eq. (12.1), and risk analysis found their way into many applications where they can add value in prioritization and management processes. The application of general risk analysis principles to help prioritize and manage the inspection program for plant equipment, now commonly referred to as risk-based inspection (RBI), is one of the newest applications of risk principles [3]. Some examples of risk criteria and associated units are shown in Table 12.1. 

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