Risk management involves determining the probability and impact of process failures and mitigating risks likely to occur with severe impacts. An acceptable risk is determined by evaluating options and consequences to select the most acceptable one. Risk severity is the probability of an event multiplied by its potential negative impact. Ways to deal with risk include proactive risk management to reduce probabilities and impacts, and reactive crisis management with constrained options. The CAPA system connects to risk management by using risk assessments to prioritize CAPAs and elevate issues. An annual product review examines manufacturing, quality, and post-market records over the previous year to support management decisions.