Corrective and preventive action

It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance.

In this case, failure to adhere to proper CAPA handling is considered a violation of US Federal regulations on good manufacturing practices.

[citation needed] CAPA is used to bring about improvements to an organization's processes, and is often undertaken to eliminate causes of non-conformities or other undesirable situations.

Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, as well as adverse or unstable trends in product and process monitoring such as would be identified by statistical process control (SPC).

A root cause is the identification and investigation of the source of the problem where the person(s), system, process, or external factor is identified as the cause of the nonconformity.

To comply with the United States Food and Drug Administration's code FDA 21 CFR 820.100[5] medical device companies need to establish a CAPA process[6] within their QMS.

To have an FDA-compliant QMS system required the ability to capture, review, approve, control, and retrieve closed-loop processes.

[9] An example is the pharmaceutical company Avanos Medical, which in 2022 conducted a voluntary field correction after reports of 60 injuries and 23 patient deaths related to misplaced nasogastric feeding tubes while using their CORTRAK* 2 Enteral Access System.