Description:
This CAPA form standardises how we document and close corrective and preventive actions with clear traceability and objective evidence.

• Assign a unique CAPAYYYY-XXX and record the Type of CAPA (Corrective Action / Preventive action).

• Capture a durable Description of the problem and Traceability to devices involved (lot/batch/SN).

• Complete Risk Assessment for safety, performance, and regulatory compliance (ISO 13485).

• Document Investigation scope (DHF/DHR/DMR/QMS, testing, suppliers) and Health Hazard Evaluation applicability.

• Perform Root-Cause Analysis using Ishikawa Diagram (6M) and 5 Why.

• Define Containment Item and action items with owners, dates, and evidence.

• Run Effectiveness Review with Acceptance Criteria and record outcomes.

• Finalise Closure with Approval stage, signature, and dates.

Your needs:

• CAPA form

• CAPA form for ISO 13485, MDR compliance

• Reduce rework, control timelines, and lower repeat audit findings.

Use this form when nonconformities, complaints, PMS signals, or audit findings require documented containment, root cause, and corrective/preventive actions.

It covers the full CAPA lifecycle. Root-cause analysis identifies why the issue happened so actions prevent recurrence. Effectiveness review verifies outcomes against acceptance criteria so closure is evidence-based.

• Assign CAPA ID and origin record for traceability.

• Evaluate recurrence sources (complaints, audits, PMS, suppliers).

• Complete safety/performance/compliance impact assessment.

• Document investigation need and HHE rationale.

• Record containment and CAPA actions with evidence.

• Confirm adverse impact assessment for changes.

• Close with approval, signature, and archiving.

At Lexqara, we align CAPA workflows with complaint handling, audits, and risk management, and support training and inspection-ready documentation. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 13485 [https://www.iso.org/standard/59752.html]. Download the template or request a short gap assessment.