CAPACorrective Action and Preventive Action
CAPA (corrective and preventive action) is the quality-system process for investigating problems, removing their causes and preventing them from happening. Drug guidance (ICH Q10, EU GMP Chapter 1) and device rules (ISO 13485 via FDA's QMSR) each expect it in their own terms.
On this page · 5 sections
How does CAPA apply to your shop floor?
Pick your industry and scale — Ask V5 rewrites the definition in your context, gives a worked example, and shows what V5 does on day one.
01What CAPA is
A correction fixes the immediate problem (rework a label, quarantine a lot). A corrective action removes the cause so the same problem does not recur. A preventive action removes the cause of a potential problem that has not happened yet. A CAPA system ties these to investigations, records who decided what, and checks afterwards that the actions worked.
ICH Q10 3.2.2 says a pharmaceutical company should have a system for implementing corrective and preventive actions resulting from complaints, product rejections, nonconformances, recalls, deviations, audits, inspections and trends — with investigation effort proportionate to risk, and effectiveness evaluated.
02Where the expectation comes from
| Sector / market | Source | Status |
|---|---|---|
| Drugs, US | 21 CFR 211.192 requires investigation of unexplained discrepancies and failures; 'CAPA' as a system is described in ICH Q10 guidance | Regulation + nonbinding guidance |
| Drugs, EU | EU GMP Chapter 1, 1.4(xiv): root cause analysis and appropriate CAPA, effectiveness monitored | GMP guideline applied through EU law |
| Devices, US | QMSR incorporates ISO 13485:2016 corrective and preventive action clauses; legacy 820.100 no longer current | Regulation (since 2 Feb 2026) |
03Worked example
Two complaints in a month report a missing allergen statement on a sauce label. Correction: the affected lots are placed on hold and relabelled after a person approves the disposition. Investigation finds the label template was edited without review. Corrective action: label templates move under change control with a second-person check. Preventive action: the same control is applied to two other product families that use the same template workflow. Effectiveness check: after three months, label audits show no further errors, and the quality lead signs off closure.
04Common failure modes and checks
- Root cause recorded as 'human error' without checking process, procedure or system causes — EU GMP Chapter 1 asks for that justification.
- Actions closed on completion, with no effectiveness check.
- Every issue forced into a full CAPA, burying the important ones; effort should follow risk.
- CAPA records not linked to the deviation, complaint or audit that raised them.
05Where V5 fits
V5 includes CAPA records with a root-cause workflow, links to deviations, complaints, audits and change control, and electronic signatures. Its Quality AI can suggest a classification or draft text for an investigation; a person reviews, edits and decides. Your procedures set the approval steps, and closing a CAPA or judging effectiveness remains a human decision.
Frequently asked questions
Q.Is CAPA a legal requirement for drug makers in the US?+
21 CFR 211.192 requires investigations of unexplained discrepancies and failures. The term CAPA system comes mainly from ICH Q10, which is guidance.
Q.What is the difference between correction and corrective action?+
A correction fixes the immediate problem; a corrective action removes its cause.
Q.Does every deviation need a CAPA?+
No. Guidance expects effort proportionate to risk; procedures define when a CAPA is opened.
Q.Is 21 CFR 820.100 still the device CAPA rule?+
No. Since 2 February 2026, QMSR relies on ISO 13485:2016's corrective and preventive action clauses.
Primary sources
Further reading
Explore this topic
CAPA sits inside 3 overlapping topic clusters in our glossary. Every neighbour is one click away.
Drug-product cGMP rules, ICH Q-series, and the regulators that enforce them.
Root-cause toolkit, SPC, capability and the rest of the QA practitioner's bench.
HCT/Ps, blood cGMP, donor eligibility, ISBT 128 labeling and forward-tracing lookback.
Want to see how CAPA could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.