We hear it very often in industry that implements Quality Management System (QMS), if we don’t record or documented what we did, so it is not different from we did not do it “Documentation of what you do, and recorded what you did“. In QMS proofing is important to show that we did what we say. Documentation of quality management program and practices is very critical to effectiveness of quality management system.
According to latest publishes, and to the best of my experiences, below are top 3 of audit findings in section of Documentation and Record of Quality Management system
- Employee Training
- Corrective action plan
- Management Review and Change management