Article | October 13, 2017

How To Recognize Effective CAPAs And A Culture Of Quality

Source: Flexan/FMI, Inc.
How To Recognize Effective CAPAs And A Culture Of Quality

The FDA can’t physically be at every medical device manufacturing facility every day to ensure the safety and reliability of products. What it can do is enforce a system of continuous self-improvement at each facility — known as Corrective And Preventive Action (CAPA). When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.