CAPA FORM

Description

What is Corrective Action Preventive Action (CAPA)

Corrective Action Preventive Action (CAPA) is the result of a US FDA requirement, FDA 21 CFR 820.100. The CAPA requirement applies to manufacturers of medical devices and compels them to include CAPA in their Quality Management System (QMS).

https://www.fda.gov/iceci/inspections/inspectionguides/ucm170612.htm

Corrective and preventive action (CAPA, also called corrective action/preventive action or simply corrective action) consists of improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions that laws or regulations require an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring nonperformance. Non-conformance is 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 a failure of a machinery or a quality management system, or misinterpretation of written instructions to carry out a work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of nonconformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation.

CAPA is split between two distinct but related functions.

Corrective Action (CA) is an extension of Root Cause Analysis (RCA). The first goal of CA is to find the root cause, base event or error that preceded the problem. The second goal is to take action directed at the root cause or error.
Preventive Action (PA) is similar to Lessons Learned / Read Across. PA resembles the replication activity of Design for Six Sigma (DFSS).

The Corrective Action Preventive Action Form follows best practice guidelines and can be customized to fit the unique needs of each company and each industry

The form includes fields to capture:

• Basic CAPA information
• Nonconformance or defect
• Immediate action
• Root cause
• Corrective & preventive actions
• Evaluation & follow-up
• Procedural changes and documentation