To add on to what everyone said above, the intent of the Risk Management Plan is to “Differentiate most critical product features related to safety/harm, Quantify and determine acceptability of risk, Provide focus and priority for product development and lifecycle activities (such as V&V, CAPA, etc.)”. The Risk Management Plan includes: assignment of responsibilities and authorities, risk acceptability criteria, risk verification, production and post production activity data collection and review. As some people stated above, risk is not necessarily very bad but it is the level of the risk that is important. The Risk Management Plan helps identify these risk and the level of it to determine the course of action.

More information on this can be found at pda.org under risk management