A well-running continuous improvement process relies on:

1. Personnel understanding their role

2. Clearly defined procedures and standard work requirements for micro-tasks (think planning, resources etc)

3. Personnel feeling safe to raise issues or admit mistakes

4. Management letting go of micro-management and controlling practices.

So a continuous improvement program might tick an auditor's box. But does it demonstrate that your personnel are engaged? A strong improvement program also is one of the main generators of compliant efficiencies in a quality culture. It is so much more than a CAPA process! Do you agree?