Multi miller damaged in pharma …and the iron particles mixed with material …how to investigate this incident as QA person
First and foremost is do not call iron particles.
The investigation steps
- Assembly procedure was available? SOP.
- Operator was trained? Training docs
- Was there any foreign particle introduced like tools, scoop etc? The safety screen was in place?
- pre startup checks completed? Noise can be heard if not assembled or likely to get loose.
- Excessive material poured?
Based on these investigation you have to proceed