QMSR Tip #3: 5 blind spots to check in your CAPA process
CAPA continues to be the top issue for most medical device manufacturers. Check these 5 blind spots in your CAPA process as you get ready for the QMSR.
Darrin Carlson contributed to this article.
FDA requires medical device manufacturers to establish and maintain procedures for implementing corrective and preventive action (CAPA) according to the current quality system regulation, 21 CFR 8201.
CAPA is one of the most critical processes of a quality system to ensure continued safety and effectiveness of a medical device. Yet, it continues to be significant compliance challenge for most medical device manufacturers. As shown in the Figure below, CAPA is the top category of FDA inspection observations2, accounting for an average 14% of the total observations issued in the last 5 years.
As you prepare your transition to the Quality Management System Regulation (QMSR), it is important to appreciate that FDA scrutiny on CAPA will only increase. One reason is that FDA will be able to apply the requirements of ISO 13485:2016 as this International Standard has now been included in the amended regulation as a normative reference. A key point to note here is that ISO 13485 treats corrective action (CA) and preventive action (PA) as two different concepts, and expects a risk-based approach to CAPA.
This article highlights 5 potential blind spots in your CAPA process you should check and fix as you prepare to transition to QMSR compliance. Although not a comprehensive list, we think these are the most important areas of opportunity based on our analysis of recent FDA warning letters.
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