CAPA vs Correction: What’s the Difference (with Examples)
Introduction
If you work in Quality, you’ve felt the tug-of-war between fixing something fast and fixing it for good. A mislabeled bottle is easy to reprint (correction), but the pattern of mislabels is a different beast that requires root-cause work (CAPA). Mixing these up clogs your system with either too many CAPAs or too many band‑aids. This article gives you practical rules, examples, and ready‑to‑use wording you can drop into SOPs and your eQMS.
Core definitions (plain English)
- Correction: An immediate fix to restore conformity. It addresses the symptom (e.g., rework, re‑label, scrap, resend CoA).
- CAPA (Corrective and Preventive Action): A structured process to find and eliminate the root cause so the issue does not happen again (and ideally doesn’t happen elsewhere).
Rule of thumb: If it’s likely to recur or the impact is significant, you need CAPA. Otherwise, a documented correction (with justification) may be enough.
Decision framework (fast triage)
- Impact: Could this affect patient/user safety, product quality, or data integrity? If Yes, escalate toward CAPA.
- Recurrence: Has it happened before, or could it happen again with reasonable likelihood? If Yes, CAPA.
- Systemic signal: Does it touch procedures, training, equipment, or suppliers? If Yes, CAPA.
- One‑off & contained? If it’s clearly isolated and low risk, a correction with a short investigation may suffice.
Examples you can reuse
- Correction only: A picker grabbed the wrong shipper carton; goods were still quarantined. Action: segregate, repack with correct carton, document as correction, note refresher tip in daily huddle.
- CAPA required: Repeated carton mix‑ups on Line 3 in the last quarter. Action: open CAPA; 5 Whys + Ishikawa; actions: relabel shelves, barcode verification at pick, weekly audit; verify effectiveness with three months zero mix‑ups.
- Correction + CAPA: Incorrect expiry printed. Contain by reprinting labels (correction). Open CAPA for print template governance and scanner maintenance.
Records to capture
- For Corrections: What happened, when, who fixed it, how product was contained, and why CAPA wasn’t needed (justification).
- For CAPA: Problem statement, scope, risk level; investigation (data, 5 Whys, fishbone); action plan (owners, due dates); verification of implementation; effectiveness check (measure proving it worked); closure approval.
Common mistakes (and alternatives)
- Everything becomes CAPA → overload and delays. Alternative: Use a triage form with impact/recurrence logic.
- No root-cause method → actions don’t stick. Alternative: Require a basic tool set: 5 Whys, Ishikawa, Pareto, and evidence links.
- Skipping effectiveness checks → same issue returns. Alternative: Define success metrics at CAPA initiation.
Metrics to watch
- CAPA lead time to closure
- % CAPAs reopened after effectiveness check
- Repeat deviations per area/equipment
- % events resolved with correction vs CAPA (trend and ratio)
How an eQMS like Complibued helps
- Structured intake with severity/recurrence gates
- Linked objects: events → investigations → CAPA → change control → training
- Reminders & escalations by due date/priority
- AI Assist: turns long notes into concise summaries and suggests fields/checklists so reviewers don’t leave the page
FAQ
Is a correction part of CAPA? Often yes—containment (correction) happens upfront, then CAPA pursues prevention.
Who approves CAPA closure? Typically QA/Approver; your SOP defines roles and signatures.
How long should CAPA stay open? Until actions are implemented and effectiveness is proven against a metric.
Conclusion
Use corrections to restore control fast; reserve CAPAs for prevention and systemic fixes. The clarity saves time, reduces audit findings, and helps teams focus on what really matters: preventing repeat issues.
