How Does FDA Train its Inspectors to Investigate Your CAPA Processes?

One of the most important quality system elements is the corrective and preventive action subsystem. Corrective action taken to address an existing product or quality problem should include action to:

• Correct the existing product nonconformity or quality problems and;
• Prevent the recurrence of the problem

Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.

The U.S. FDA publishes these checklists and guidelines to help the industry to know how its investigators will conduct CAPA audits. Adhering to these is not only a good idea but also aligns well with the published standards that any life sciences company should adhere to.