Elements and Performance Criteria
- Identify non-conformance
- Identify causes of non-conformance
- Review processes to minimise risk of recurrence
- Assess and select solutions to eliminate or minimise the risk of recurrence
- Develop an implementation plan for risk minimisation solutions
- Conduct CAPA effectiveness checks according to GMP requirements and workplace procedures
- Establish consultative mechanisms and communicate implementation plan to support continuous improvement according to GMP requirements and workplace procedures