Great post. Just to add onto what has been stated. Another risk management tool is:

Risk ranking and filtering- This method is used for comparing and ranking risks. Risk ranking of complex systems typically involves evaluation of multiple diverse quantitative and qualitative factors for each risk. The tool involves breaking down a basic risk question into as many components as needed to capture factors involved in the risk. These factors are combined into a single relative risk score that can then be used for ranking risks. “Filters,” in the form of weighting factors or cut-offs for risk scores, can be used to scale or fit the risk ranking to management or policy objectives. This tool can be used to prioritize manufacturing sites for inspection/audit by regulators or industry, for example.

http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073511.pdf