What does CAPA mean?
CAPA stands for Corrective and Preventive Action and is a process from the QMS (Quality Management System) and a part of GMP-compliant work (Good Manufacturing Practice). The CAPA-process includes, on the one hand, the identification and analysis of occurring errors and, on the other hand, the implementation of solutions and preventive actions. The aim is to improve the quality of processes and products and to increase customer satisfaction.
What are the two parts of CAPA?
CAPA is composed of corrective and preventive actions. The goal of corrective actions is to solve problems and correct errors. The goal of preventive measures is to identify potential sources of errors so that they can be corrected before errors occur.
What is a CAPA-process?
A CAPA-process begins with the error description, in which the problem is documented in detail. The cause of the error is then analyzed in order to determine the corrective measures. Preventive measures are also defined to avoid future errors. After validation and verification of the defined measures, the measures are implemented. At the end of the CAPA process, an effectiveness review is conducted to evaluate whether the actions have corrected the problem. If the measures were successful, the CAPA process is completed. If the measures have not had the hoped-for effect, the process starts again.
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Maintenance Plan and Why it is Important
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