Skip to main content
QHSE Glossary

CAPA

Corrective and Preventive Action — a systematic approach to investigating root causes of non-conformances and implementing fixes.

CAPA

CAPA (Corrective and Preventive Action) is a critical concept in quality, health, safety, and environmental management.

What Is CAPA?

CAPA (Corrective and Preventive Action) is a systematic approach to investigating, addressing, and preventing the recurrence of quality problems, non-conformances, and undesirable situations. Corrective action eliminates the root cause of an existing problem. Preventive action eliminates the root cause of a potential problem. CAPA is required by ISO 9001 (Clause 10.2), ISO 13485, FDA 21 CFR Part 820, AS9100, and virtually every quality management standard. An effective CAPA system includes: identification, evaluation, investigation (root cause analysis), action planning, implementation, effectiveness verification, and closure.

CAPA Requirements Under UK Law

ISO 9001:2015 Clause 10.2 requires organisations to react to nonconformities, evaluate the need for action, implement corrective actions, review effectiveness, and update risks/opportunities. FDA 21 CFR 820.90 mandates CAPA procedures for medical device manufacturers with specific documentation requirements. AS9100 adds requirements for timely CAPA closure and trend analysis. Failure to maintain an effective CAPA system is the #1 FDA 483 observation — cited in 42% of all FDA inspections.

Key Components of CAPA

  • Corrective Action (fix existing problem)
  • Preventive Action (prevent potential problem)
  • 8D methodology
  • 5-Why analysis
  • Fishbone/Ishikawa diagram
  • Fault tree analysis
  • DMAIC

CAPA in Practice

An aerospace manufacturer receives a customer complaint about a dimensional non-conformance on 15 machined components. The Quality Engineer raises a CAPA in Q-Hub, classifying it as Major. Root cause analysis using 5-why reveals a worn cutting tool that wasn't replaced at the scheduled 500-unit interval. Corrective action: replace tool, rework 15 parts (cost £2,400). Preventive action: add automated tool-life counter alert in Q-Hub at 450 units. Effectiveness verified after 60 days — zero recurrences.

How to Manage CAPA with Q-Hub

Q-Hub provides comprehensive tools for CAPA management. The Capa Management module handles the core requirements. Combined with document control, audit scheduling, and training management, Q-Hub ensures your CAPA processes are audit-ready at all times.

Related Terms

Want to see how Q-Hub handles CAPA in practice? Book a demo or see pricing.

Related QHSE Terms

  • AS9100 — The aerospace quality management standard, based on ISO 9001 with additional requirements for aviati
  • Audit — A systematic, independent examination of processes, products, or systems to verify compliance with d
  • Bow-Tie Analysis — A visual risk assessment method that maps the causes of an event, the event itself, its consequences
  • COSHH — Control of Substances Hazardous to Health — UK regulations requiring employers to control exposure t
  • Calibration — The process of comparing measurement equipment against a known standard to ensure accuracy and trace
Bow-Tie Analysis Back to Glossary COSHH