Deviation Management

Deviation management is a quality measure to make sure the root cause of any problem is addressed so that non-conformances will be alleviated and problems prevented. FDA systems-based inspections increasingly emphasize areas of corrective and preventive action. Corrective and preventive action requires the highest levels of accuracy, methodology and flexibility.

• Deviation management systems: manual and automated systems, deviation classification (major, minor), threshold setting, tracking and trending

• Investigation: performance, documentation, immediate action

• Root causes determination: practical problem-solving techniques and quality tools

• Nonconforming materials and products: processes for controlling and evaluating nonconformances, material review board

• Deviation management action and follow-up: corrective and preventive action; effectiveness evaluation