CAPA (Corrective and Preventive Actions) und NC (Non-Conformity) Management

Definition

CAPA aims to correct deviations and prevent future errors, while NC management deals with managing non-conformities to ensure products meet established standards.

Importance in medical device manufacturing

Both processes play a crucial role in identifying errors, resolving them, and preventing future problems. This is essential to meet the high requirements of medical device manufacturing and to ensure the safety and effectiveness of the products.

CAPA process

The CAPA process begins with identifying errors or deviations. Effective corrective and preventive measures are then implemented. The effectiveness of these measures is carefully monitored to ensure that they have the desired effect.

NC management

NC management focuses on the systematic identification of non-conformities, whether in production processes or in the product quality itself. Once identified, appropriate corrective actions are taken to ensure that products meet the required standards. Regular monitoring and reporting of these measures is crucial to ensure transparent quality control and drive the continuous improvement process.