Report incidents and risks to regulatory bodies

Trigger: A critical incident, return, or product recall is identified that meets the threshold for mandatory regulatory notification.

1. Identify the reportable incident or recall event
2. Gather incident details, risk assessments, and supporting data
3. Draft the regulatory notification and internal stakeholder briefs
4. Review the reports with legal and compliance teams
5. Submit the formal notification to the appropriate regulatory bodies
6. Archive the submitted reports and regulatory acknowledgments

Outcome: Stakeholders and regulatory bodies are formally notified, and compliance documentation is successfully filed and archived.