CAPA prioritization scorer
A 1–5 SOD product (max 125). Your SOP defines the real thresholds and when a correction is enough.
27
Priority 2 — CAPA or documented justification
How to use the CAPA priority scorer
Score a complaint or nonconformance on severity, occurrence, and detectability, then read the priority band as a prompt for your CAPA procedure, not a replacement for it. Cross-check the hazard in the ISO 14971 risk matrix, see how CAPA fits your wider QMS with the ISO 13485 gap self-score, and when the fix changes the device or process, run it through the change-control classifier.
Want a CAPA process that holds up in an inspection?
A priority score only helps if your procedure defines what it triggers. Book a Consultation with our quality engineering team to align CAPA intake, thresholds, investigation, and effectiveness checks with ISO 13485 and FDA’s QMSR.
Book a ConsultationFAQ
- What do ISO 13485 and FDA’s QMSR require for CAPA?
- Since February 2, 2026, FDA’s Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference, and the former standalone CAPA section, 820.100, is reserved. Corrective action is covered by ISO 13485 clause 8.5.2 and preventive action by clause 8.5.3. Clause 8.5.2 calls for a documented procedure for reviewing nonconformities (including complaints), determining causes, evaluating the need for action, planning and implementing action, verifying that the action does not adversely affect regulatory compliance or device safety and performance, and reviewing its effectiveness, with records kept.
- Does ISO 13485 require an RPN or a severity × occurrence × detectability score?
- No. ISO 13485 requires corrective actions to be taken without undue delay and to be proportionate to the effects of the nonconformities encountered, but it does not prescribe a scoring method. A severity × occurrence × detectability product is a common convention borrowed from FMEA; the scales, thresholds, and what each priority band triggers belong in your CAPA procedure.
- What is the difference between a correction, a corrective action and a preventive action?
- Using the ISO 9000:2015 vocabulary that FDA’s QMSR also incorporates: a correction is action to eliminate a detected nonconformity, a corrective action is action to eliminate the cause of a nonconformity and prevent recurrence, and a preventive action is action to eliminate the cause of a potential nonconformity. Many low-priority items are closed with a correction and trended, with a documented justification for not opening a CAPA.
- Should a serious complaint wait for its CAPA score?
- No. Whether an event must be reported to a regulator is a separate decision from CAPA priority. ISO 13485 clause 8.2.3 requires documented procedures for notifying regulatory authorities, and complaints need to be evaluated against Medical Device Reporting requirements (21 CFR Part 803) in the US and serious-incident reporting under EU MDR Article 87. Run that evaluation in parallel with CAPA triage.
- How does CAPA priority connect to ISO 14971 risk management?
- Complaints and nonconformities are production and post-production information that ISO 14971 expects you to review against the risk management file. If a problem shows a hazard, hazardous situation, or probability of harm that the file does not reflect, update the risk analysis, and check under ISO 13485 clause 8.5.2 that the corrective action does not introduce new risks.
- Why is detectability scored with 1 as “always caught”?
- In this scorer, a higher detectability number means the problem is more likely to escape your controls and reach users, so it raises the priority. Severity and occurrence work the same way (higher is worse), giving a product from 1 to 125. Match the direction and anchors to the scales in your own procedure.
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. CAPA priority scorer does not submit to FDA, Notified Bodies, or IRBs.
Related regulatory & QMS tools
Want a CAPA process that holds up in an inspection?
A priority score only helps if your procedure defines what it triggers. Book a Consultation with our quality engineering team to align CAPA intake, thresholds, investigation, and effectiveness checks with ISO 13485 and FDA’s QMSR.
Book a Consultation