CAPA & Complaint Handling
Corrective and Preventive Action (CAPA)
A robust CAPA system is a core requirement of NOM-241-SSA1-2025 and is fundamental to maintaining GMP compliance. COFEPRIS inspectors specifically assess the effectiveness of the CAPA system.
CAPA inputs
| Source | Description |
|---|---|
| Customer complaints | Device malfunction, labelling issues, performance concerns |
| Adverse event reports | Serious incidents triggering technovigilance reporting |
| Internal audits | Non-conformities identified during self-inspections |
| Process data | Out-of-specification results, process deviations |
| Management review | Trends identified at periodic management review |
| Regulatory changes | NOMs, guidance, or COFEPRIS directives requiring process updates |
CAPA process
- Detection — identify and document the non-conformity or potential non-conformity.
- Root cause analysis — investigate the true underlying cause (not just the symptom).
- Action plan — define specific corrective/preventive actions with owners and deadlines.
- Implementation — execute the actions.
- Effectiveness check — verify the actions resolved the root cause and the problem has not recurred.
- Closure — document closure with evidence of effectiveness.
Documentation requirements
All CAPAs must be documented in the CAPA log with:
- Date of detection.
- Description of non-conformity.
- Root cause analysis method and conclusion.
- Actions taken.
- Responsible person.
- Target and actual completion dates.
- Effectiveness verification outcome.
Complaint handling
What constitutes a complaint?
A complaint is any written, electronic, or oral communication alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance of a marketed medical device.
All complaints must be:
- Received and logged in a complaint register.
- Assessed for whether they meet adverse event reporting criteria under NOM-240.
- Investigated to determine the root cause and appropriate response.
- Responded to (customer response where appropriate).
- Archived with all investigation records.
Complaints that are adverse events
If a complaint describes a device malfunction, serious injury, or death, it must be escalated as an adverse event through the technovigilance system for CNFV reporting. The complaint and the adverse event records should be cross-referenced.
Technovigilance Report at renewal
The CAPA log and complaint records feed directly into the Technovigilance Report required for registration renewal. Maintaining complete, well-organised records throughout the registration period makes renewal significantly easier.