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


What does Capa involve?

CAPA involves:

  • Analyzing quality data to identify existing and potential causes of nonconforming products or other quality issues
  • Investigating the root cause of the nonconformity
  • Identifying actions needed to correct and prevent reoccurrence of the nonconformity
  • Verifying and validating the corrective and preventive action to ensure effectiveness
  • Implementing and recording changes in procedures to correct the problem and prevent it from reoccurring
  • Disseminating information related to the identified problem and CAPAs to all key stakeholders

*Source: pharmaceuticalonline.com

What is an example of corrective action?
What is the purpose of CAPA?

The purpose of CAPA is to identify the root cause of product nonconformities or quality issues and implement the appropriate corrective and/or preventive measures to prevent their reoccurrence.

*Source: fda.gov


Medical device companies must have a compliant Corrective Action Preventive Action (CAPA) process in place to comply with FDA 21 CFR 820.100. Learn the essential elements of a CAPA system.