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CAPA Process Flow Chart

Corrective and Preventive Actions

Fact: The only subsystem of a facility Quality System that the FDA always examines is the Corrective and Preventive Action program.

CAPA Facilitator™

CAPA Facilitator™ Start screen

CAPA Facilitator is an integrated software solution that manages the entire Corrective / Preventive Action process. Using a logical and intuitive approach, the program guides the user through initiating, investigating, resolving and documenting corrective or preventive actions. It will benefit any quality system by providing the tools needed to establish and support an effective corrective / preventive action program.

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CAPA Training Programs

The key to establishing a successful program is to make sure that it is fully understood by those who use it. CAPA training is a slide presentation intended to complement CAPA Facilitator and CAPA Guidelines. The training includes the essential aspects of corrective / preventive actions and can be used to increase employee awareness and understanding of the process.

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CAPA Guidelines Documents

A Corrective / Preventive Action policy is essential to an effective quality assurance system. CAPA Guidelines describes the specific steps that are required to implement a successful CAPA program. It contains valuable information for completing and documenting corrective and preventive actions as well as sample forms that can be used or modified.

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Why a CAPA Program is essential:

Continuous quality improvement is an important goal for most businesses and troubleshooting and resolving problems is a typical activity in that process. The reason is obvious: problems have a financial impact on the company. A Corrective / Preventive Action system (CAPA) is an essential management tool that should be a part of every quality system. It can help assure continuous quality improvement and customer satisfaction.

CAPA is also a major area of regulatory concern for both the FDA and ISO. They have recognized that how a quality system is maintained and monitored is critical to its effectiveness. Their risk-based CAPA requirements demand a well documented system. The Corrective / Preventive Action (CAPA) subsystem of a company’s quality system is nearly always examined during FDA and ISO regulatory compliance audits. Unfortunately, many companies do not implement CAPA as effectively as they could and 30 to 50 percent of non-conformances cited are directly due to CAPA violations.