Frederic Blais, PhD

Safety monitoring generates substantial signal volume across risk-based quality management tools, but only 30% to 36% of signals correspond to confirmed issues, suggesting the need for better prioritization, signal consolidation, and alignment between detection and proportional action.

Quality tolerance limits work best as a small set of focused guardrails that prompt rapid investigation and documented action, not as documentation exercises, with early breaches expected when sample sizes are small.