Corrective and Preventative Action (CAPA) is a concept within the Food and Drug Administration’s (FDA) Good Manufacturing Practice (GMP). CAPA involves the systematic analysis of anomalies, defects, or inconsistencies in an attempt to prevent their recurrence. It is an elaborate system of processes used to ensure conformity with several U.S. laws and quality standards.
Without fail, CAPA systems are a focal point for FDA inspections, and quality system audits every year. The FDA continues to clamp down on food and beverage manufacturers with rigorous compliance, safety, and quality regulations. A comprehensive, well-documented, and implemented CAPA can make all the difference when it comes to compliance.
There’s a common misconception that CAPA systems are difficult to understand and implement. Let’s lay this misconception to rest. Here’s everything you need to know about CAPA to ready your business.
As mentioned, CAPAs are actions that correct, prevent and eliminate the recurrence of poor quality and are an essential tool in eliminating causes of non-conformities in manufacturing processes. As a result, CAPAs are an integral part of change control, risk management, and continuous improvement.
As a CAPA system evolves, it advances from more corrective actions to preventative actions. In the long haul, preventing quality issues saves time and money as there is progressively less need for rework.
CAPA systems are designed to simplify FDA regulatory requirements for corrective and preventative action processes.
Implementing CAPA in Quality Management Systems (QMS) simplifies the process of complying with FDA requirements. It provides a safeguard against regulatory risk by integrating with QMS systems for audits, non-conformances, and change control.
To ensure FDA compliance, manufacturers must ensure that their CAPA system can demonstrate the effectiveness of their quality system. A true CAPA system enables the identification of defects and problems as well as the implementation of effective and preventive actions.
A fundamental aspect of quality management is continuous improvement. A sound CAPA system ensures this by handling non-conformances quickly and efficiently, in addition to preventing future errors.
Regardless of industry or the size of your company, you should implement CAPA software systems as part of your quality management system if you want to reduce business risks and improve quality levels.
CAPA programs are most effective when they are approached and utilized as proactive systems as opposed to reactive ones. The benefits of this approach include:
To make the most of your CAPA system, you require an intimate understanding of the CAPA quality process.
Some organizations perceive CAPA as an onerous task they must complete to stay compliant. Well, this isn’t the best view. You should approach CAPA as a complete system made up of phases. A lifecycle program, if you will. One that provides the tools to identify and investigate a discrepancy and evaluate the effectiveness of a resolution.
The following phase-based system provides a systematic approach to quality management.
A phase-based approach to CAPA ensures events are dealt with promptly and the implemented actions are efficient.
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105 College Road East
Princeton, New Jersey 08540
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.
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