ABSTRACT
Quality risk management should include systematic processes designed to coordinate, facilitate, and improve science-based decision making with respect to risk. Once a quality risk management process has been initiated, that process should continue to be used for events that might impact the original quality risk management decision, whether these events are planned or unplanned. The frequency of any review should be based upon the level of risk. Risk review might include reconsideration of risk acceptance decisions. Quality risk management supports a scientific and practical approach to decision making. It provides documented, transparent, and reproducible methods to accomplish steps of the quality risk management process based on knowledge about assessing the probability, severity, and sometimes detectability of the risk. Traditionally, risks to quality have been assessed and managed in a variety of informal ways based on, for example, compilation of observations, trends, and other information.
