PROCESS MANAGEMENT GLOSSARY

What does CAPA stand for?

Corrective Action Preventive Action (CAPA) refers to a process in which an organization investigates and solves problems in order to correct non-compliance with regulation and/or non-conformity with best codes of practice.

It also aims to detect and prevent the root cause of non-compliace issues and ensure that the problem is never experienced again. 

Functions of 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).

CAPA is split between two distinct but related functions.

  1. 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.
  2. Preventive Action (PA) is similar to Lessons Learned / Read Across. PA resembles the replication activity of Design for Six Sigma (DFSS). Another example of PA in industry is Yokaten, a Japanese term used by Toyota, describing a sharing across the organization. The primary goal of PA is to inform an organization and prevent the problem from returning in other facilities lines or products.

Ten objectives of CAPA

The CAPA system must exhibit ten objectives to meet the intent of the FDA 21 CFR 820.100 requirement.  The 10 objectives of CAPA implementation are:

  1. Verification of a CAPA system procedure(s) that addresses the requirements of the quality system regulation. It must be defined and documented.
  2. Evidence that appropriate sources of product and quality problems have been identified.
  3. Tracking of Trends (which are unfavorable) are identified.
  4. Data sources for Corrective and Preventive Action are of appropriate quality and content.
  5. Verify that appropriate Statistical Process Control (SPC) methods are used to detect recurring quality problems.
  6. Verify the RCA work performed is aligned to the level of Risk the problem has been identified with.
  7. Actions address the root cause and preventive opportunities.
  8. CAPA process actions are effective and verified or validated prior to implementation.
  9. Corrective and preventive actions for product and quality problems are implemented and documented.
  10. Nonconforming product, quality problems and corrective / preventive actions have been properly shared and included in management review.

More Resources:

Case Study: When change processes lead to learning

Four problems that make management problems static


Source: Quality-One, Corrective Action Preventive Action (CAPA Meaning), Introduction to CAPA