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CATÉGORIE: QUALITY SYSTEMS

Actions correctives et préventives (CAPA)

Un processus systématique d'investigation, d'identification des causes racines et de résolution des problèmes qualité. Le CAPA est un élément critique du SMQ.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

CAPA investigates systemic quality issues, implements corrections/preventive actions, and verifies effectiveness—required in device QMS frameworks worldwide.

PROCESS / STEPS

  1. Identify issue and contain product risk.
  2. Investigate root cause with evidence.
  3. Implement corrective and preventive actions.
  4. Verify effectiveness and close with management review visibility.

EXAMPLES

  • Recurring complaint codes trigger CAPA beyond one-off rework.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Système de management de la qualité (SMQ)ISO 13485Contrôles de conception