CAPA, short for Corrective Action, Preventive Action or Corrective and Preventive Action; is a set of processes an organization takes to set right nonconformities. It seeks to address the root causes of problems that may have contributed to nonconformity. It is a major regulatory problem area, since medical devices are very heavily regulated and need to conform to strict standards. It is hence a major aspect of GMP.

How big is the CAPA problem?

CAPA comes second among the FDA’s top ten 483 items under QSIT, at 30 percent, below 40 percent for management. This of course, is because many CAPA problems come under management. So, the point is that CAPA is a major factor in inviting 483s from the FDA. The FDA expects a medical device company to have a proactive CAPA system which will enhance the processes in your product.

How does a medical device company minimize the risk of inviting a 483 for its CAPA? It cannot always hold user error responsible. The two most important elements it must incorporate are a Human Factors Engineering and Product Redesign program.

Correction vs. corrective action

Two important aspects of CAPA need to be taken into consideration.

What is correction, and how is it different from corrective action? “Correction” refers to repair, rework or adjustment of an existing nonconformity.

Corrective action, on the other hand, is the elimination of the causes of nonconformity. This is a little like the difference between treating symptoms and curing in medicine.


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Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

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