Official text controls
This overview is educational. Confirm the current official source, applicability and effective status.
Open primary official source ↗Orient the system
Define the lifecycle, ownership, required records, escalation rules and links to adjacent quality systems.
- Define scope and accountable owner.
- Link conclusions to evidence and documented rationale.
- Escalate uncertainty to appropriately qualified personnel.
Review the evidence
Distinguish immediate correction from systemic corrective and preventive work; document evidence and scientific rationale.
- Define scope and accountable owner.
- Link conclusions to evidence and documented rationale.
- Escalate uncertainty to appropriately qualified personnel.
Act through the QMS
Choose effectiveness measures before closure and trend outcomes for recurrence or unintended consequences.
- Define scope and accountable owner.
- Link conclusions to evidence and documented rationale.
- Escalate uncertainty to appropriately qualified personnel.