Which sources should feed a CAPA system?

Why

A CAPA system can only fix what reaches it. ICH Q10 names the sources it expects: complaints, product rejections, nonconformances, recalls, deviations, internal and external audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. FDA quality systems guidance lists similar inputs, adding returns, data and risk assessments and management review decisions.

The list matters because each source sees a different slice of reality. Deviations show what operators noticed. Complaints show what patients and pharmacists noticed after release.

Trends show what nobody noticed because each result passed. Audits show where systems drift from procedures. If a company feeds CAPA only from deviations, it will miss a slowly rising complaint rate for a hard-to-open blister, or an impurity creeping up across stability lots.

Preventive action depends on the trend and risk sources, because by definition there is no failure yet. Q10 also says CAPA should continue after a product is discontinued, considering product still on the market and other products that might be affected. The practical risk is overload.

If every input automatically opens a CAPA, the system floods and serious items drown, so a triage step that decides which inputs need a full CAPA, based on risk, is part of a healthy design.