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The purpose of the Corrective Action Preventative Action (CAPA) is to collect information,

analyze information, identify and investigate product and quality problems, and take appropriate
and effective corrective and/or preventive action to prevent their recurrence.

CAPA is the core of any quality system, but it’s especially key for life sciences companies and
other sectors doing business in regulatory environments.

CAPA is the result of a U.S. Food and Drug Administration (FDA) requirement, FDA 21 CFR
820.100 – a regulation that requires corrective and preventive procedures to be documented in
medical device manufacturing facilities. The CAPA requirement compels manufacturers of
medical devices 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.

The proper management of CAPA involves correcting quality issues to prevent recurrence. This
is vital for not only achieving regular compliance but also to assure overall product quality.

Identifying the root cause of failure is a key tenet of any effective QMS. When a problem
occurs, it is often just a symptom of the real issue. Symptoms can be treated but finding out why
the symptom is experienced is the true purpose for implementing CAPA. Failure to implement
an effective Corrective Action Preventive Action process is a violation of FDA regulations
defining Good Manufacturing Practice (GMP).

Once implemented, the CAPA system must exhibit 10 objectives to meet the intent of the FDA
21 CFR 820.100 requirement.

Learn about these CAPA objectives and more in Tonex’s CAPA Management Training, a 4-day
course that covers the rationale, concepts, tools, techniques, and practices of RCA and
Corrective and Preventive Action (CAPA) management in FDA field.

Additionally, Tonex offers nearly three dozen other courses in Root Cause Analysis Training.
For more information, questions, comments, contact us.

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