The CAPA Conundrum

As a certification officer and lead auditor for a Notified Body (NB)/Certification Body (CB), I have come across a variety of challenging issues during the assessment of quality management systems. Controlling outsourced processes and evaluating suppliers, keeping current with applicable regulatory requirements and harmonized standards, verifying the effectiveness of just about anything and using Corrective Action and Preventive Action (CAPA) properly-the processes all seem to require improvement. While each deserves attention, lately I have noticed that CAPA is probably the system most in need of it.