Fundamentals for a Robust CAPA System

“Quality is not an act, it is a Habit.” - Aristotle

Author: Mayra I. Rosa-Pagán, Lead Consultant

One of the pillars for an effective Quality Management System is to have implemented a robust Corrective and Preventive Action program, which we normally call it “the CAPA system”.

The CAPA system is not only considered the heart of well-efficient management system but it also provides enormous inputs to the continuous improvement efforts towards Quality. 

What are the fundamentals for a robust CAPA System?

1. Well-defined investigation procedure

Your procedure on how to conduct effective investigations is a basic requirement for the solid results and clear action plans needed within your CAPA System.

2. Data trending for prompt detection of potential issues

Have a comprehensive mechanism to collect data and perform periodic data and trend analyses. It will show you the current issues but most important is to identify potential problems that you can prevent.

3. Effective implementation to prevent recurrence

Confirm that the root cause for the identified problem has been eradicated, so that you will not have the same issues again. This is the core purpose of your investigations and must be confirmed by objective evidence upon completion of all planned activities.

An effective CAPA System is not only a regulatory requirement that you must meet but it is the primary management system to guarantee quality of your processes, products and services.

If your need additional information related to all the regulatory compliance requirements, you may review this course available for you: CAPA & Effective Investigations

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