I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices, a well-defined CAPA program provides a framework for quality and effectiveness, whether in product, process, or people. That’s why getting the CAPA quality fundamentals right is so important.

Let’s take a look at the five foundational steps of the CAPA quality process.

1. Identify potential CAPA quality cases
CAPA is the heart of your QMS and indicates its overall health. So, monitoring the inputs to the CAPA process is essential to ensure you’re promptly identifying any potential quality issues. The U.S. Food and Drug Administration (FDA) agrees because 21 CFR 820 includes a requirement for manufacturers to have processes to analyze input data.

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