Corrective and preventive action (CAPA) consists of improvements to an organization's
processes taken to eliminate causes of non-conformities or other undesirable situations. It
is set of actions that laws/regulations require an organization to take in manufacturing,
documentation, procedures, or systems to rectify and eliminate recurring non-performance.
Non-conformance identified after systematic evaluation and analysis of the root cause of the
non-conformance. Non-conformance may be a market complaint or customer complaint or failure
of machinery or a quality management system, or misinterpretation of written instructions to
carry out work. A team that includes QA personnel involvement in the actual observation
point of non-conformance designs the corrective and preventive action.
Corrective action: Action taken to eliminate the causes of
non-conformities or other undesirable situations.
Preventive action: Action taken to prevent further reoccurrence of such non-conformities.
CAPA may be required as part of the quality management system in Medical Devices and
Pharmaceutical industries. CAPA is use to bring about improvements to an organization's
processes, and is often undertaken to eliminate causes of non-conformities or other
undesirable situations. CAPA is a concept within good manufacturing practice (GMP) and
focuses on the systematic investigation of the root causes of identified problems/risks in
an attempt to prevent their recurrence or to prevent occurrence.
Corrective actions can implement 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. Preventive actions can implement in
response to the identification of potential sources of non-conformity.