As mentioned previously, the FDA considers the CAPA system a ‘single’ system. The process requires the following:
- Analysis – a thorough analysis of the issue
- Investigation – a determination of the root cause(s)
- Actions to correct and prevent – fix the problems and ensure they don’t happen again
- Verification or validation of effectiveness of the actions – did the changes have their desired effect (more than once) and did they have any adverse effects?
- Procedural changes – the means to institutionalize the changes
- Communicating the changes to those directly involved – making sure everyone is aware of the changes, understands the changes, and implements the changes
- Review at the management level – make management aware of and ensure they are on board with all the activities
- Document everything – provide that “audit trail” of everything done