Risk factors, mitigation

Implicit to our recommendation for IMBPs is that viral expression system derived DNA or excipient derived contaminant carcinogens are no longer an issue. Although, for example, host cell DNA can be a risk factor for neoplasia [3], the current stringent biochemical characterization, purification, and virus inactivation steps taken with all well-characterized biopharmaceuticals adequately mitigate any potential risk from these sources. 

H. Cyclosporine immunosuppression mitigates immunologic risk factors in renal allotransplantation. Transplant. Proc. 15, 2469-2478 (1983). 

Rice and Caniato, (2003b) Review Supply risk, transportation risk, facilities risk, communication risk, human resources risk. Proposes actions to mitigate risk factors and discusses their advantages/disadvantages. Discusses and groups actions to take for risk mitigation at four different levels... 

To mitigate extra risks to the limb and skin, it is recommended that methylene blue infusion be delivered via CVC and that extra care be given to patients with risk factors for extravasation, such as sedation, presence of systemic disease, proximal intravenous puncture sites and improperly placed catheters. 

A safety feature is a special and intentional feature in the design of a system or product employed specifically for the purpose of eliminating or mitigating the risk presented by an identified hazard. A safety feature may not be necessary for system function, but it is necessary for saifety (i.e., risk reduction). A safety feature can be any device, technique, method, or procedure incorporated into the design to specifically eliminate or reduce the risk factors comprising a hazard. 

The SSHA technique is a safety analysis tool for identifying hazards, their associated causal factors, effects, level of risk, and mitigating design measures. 

It is thus critical for global supply chains to be aware of the relevant risk factors and build in suitable mitigation strategies. Table 6-3 contains a categorization of supply chain risks and their drivers that must be considered during network design. 

Proceedings of the International Conference on Hazard Identification and Risk Analysis, Human Factors, and Human Reliability in Process Safety, 1992 Proceedings of the International Conference/Workshop on Modeling and Mitigating the Consequences of Accidental Releases of Hazardous Materials, 1991... 

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