Corrective and Preventive Action (CAPA)

One of the most important elements of a Quality Management System (QMS) is the Corrective and Preventive Action (CAPA) system. The purpose of the CAPA system is to identify, investigate, and correct or prevent product and quality nonconformities or other undesirable situations.

Corrective action is an action taken to eliminate the cause(s) of a detected nonconformity or other undesirable situation. Corrective action is taken to prevent recurrence. Preventive action is an action taken to eliminate the cause(s) of a potential nonconformity or other undesirable situation. Preventive action is taken to prevent occurrence. These terms are often confused because they are related to one another, but there is a key distinction in that one is reactive while the other is proactive.

The objectives of the CAPA system are the following:

  1. To collect and analyze information to identify actual and potential product and quality problems.
  2. To investigate product and quality problems and take appropriate and effective, corrective, or preventive action.
  3. To verify or validate the effectiveness of corrective and preventive actions.
  4. To communicate corrective and preventive actions to the appropriate people.
  5. To provide information for management review meetings to assess the state of the QMS.
  6. To document activities for future reference.

Most companies doing business in regulated industries could improve their CAPA processes by implementing better methods and applying effective risk-based approaches. Skilled resources and quality expertise are not always available within each organization to understand the regulatory requirements for developing and implementing a compliant CAPA system. Kymanox has broad expertise in implementing efficient, effective, and sustainable CAPA systems that fit within your overall QMS in order to meet the satisfaction of internal and external stakeholders.