Corrective and Preventive Action (CAPA)

Corrective and Preventive Action (CAPA) is the structured data object and workflow that records identified quality problems, root-cause analyses, corrective actions (to fix what already happened), and preventive actions (to keep similar problems from recurring). CAPA is the backbone of FDA inspections in medical devices and a core requirement of every modern QMS standard.

What it covers

• Issue intake — from nonconformances, complaints, audit findings, supplier issues, and trends.
• Investigation and root-cause analysis — 5-Whys, fishbone, fault tree, 8D.
• Corrective actions to address the immediate cause and preventive actions to address systemic risk.
• Effectiveness verification — closed-loop check that the action actually worked.
• Linkage to ECOs, deviations, and SOP revisions — most CAPAs trigger downstream changes.

Relationships (see sidebar)

• Conforms to ISO 9001 §10.2, ISO 13485 §8.5, and 21 CFR 820.100.
• Supports Quality Management, Warranty and Field Feedback, and Change Management (ECO/ECN).
• Implemented by PLM/QMS platforms including Siemens Teamcenter, PTC Windchill, Aras Innovator, and PTC Arena.