A Quality Event or Quality Incident (QE/QI) is a documented occurrence that indicates a potential or confirmed quality issue affecting trial processes, data integrity, or compliance.
Examples include recurring data errors, missed safety reporting timelines, system access failures, consent documentation gaps, or protocol process breakdowns. QE/QI reporting creates a traceable record that supports triage, investigation, and trending to identify systemic risks. These events often lead to root cause analysis and CAPA when impact is meaningful or patterns emerge. A strong QE/QI program strengthens quality culture by ensuring issues are captured early and resolved in a controlled, auditable way.