What is a Corrective and Preventive Action (CAPA)?

Corrective and Preventive Action Definition

Corrective and preventive action (CAPA) is a good manufacturing practice (GMP) concept in which product failures are investigated to determine their root cause in an effort to eliminate occurrences of nonconformity (corrective action) and prevent similar occurrences from happening in the future (preventive action). Whereas a corrective action can be thought of as a reaction to a nonconformance, preventive action is a proactive approach aimed at preventing future occurrences of nonconformance before they happen.

CAPA software helps address these processes and should include the following capabilities:

  1. Organize all documents and processes around the product’s bill of materials
  2. Manage the CAPA process, including tasks, assignments, deadlines, all connected to affected products and documents
  3. Connect quality processes with the engineering change process and product record
  4. Provide analytics for measure and improve related processes
What is a Corrective and Preventive Action