Preventative Action Defined

The second ‘half’ of CAPA is “Preventive Action.” This is triggered when nonconformities are LIKELY to occur if actions aren’t taken to prevent them.

CFR 21 Part 820 vs. ISO 13485

In 820, CA and PA aren’t presented as separate / unique entities. In 13485, they are!

Preventative Actions Happen Frequently!

As noted earlier, Preventive Actions are taken all the time. This is inherent in product Risk Management, project risk management, activities such as design (review) for manufacturing, preventive maintenance, etc. The challenge is to know when to enter something in the “PA” process.