Implementing an effective CAPA program that is capable of satisfying quality assurance and regulatory documentation
requirements can be achieved by following these steps:
1. Identification of the potential or actual problem, nonconformity or incident
2. Evaluation of the extent of the problem and potential impact on the company
3. Availability of an investigation procedure that includes responsibilities
4. Analysis of the problem with appropriate data capture
5. Creating an Action Plan that lists all tasks to be completed in order to correct and/or prevent the problem
6. Implementation of the Action Plan
7. Follow-up with verification of the completion of all tasks, and an assessment of the appropriateness and effectiveness of
the actions taken.
