Here is the finding:
Non-conformance description:
Risk management process and documentation are inadequately established
Requirement:
ISO 13485:2016
- 7.1-d) "records needed to provide evidence that the realization processes and resulting product meet requirements"
- 4.2.4-a) "review and approve documents for adequacy prior to issue
Objective Evidence:
- Not all processes/products have documented risk management files.
- Risk Management File 536571 Ferrite Holder include irrelevant information related to
PFMEA and Control Plan dated 10 Sep 2019 for 530581 Rev H Molded, 543631 Rev B Foam Pads Installed.
In the audit while looking for obj evidence we found a couple files with the wrong part number in the file name, the files were in the correct folders (electronic) but it looked like the file creator had modified an existing file for a new part but forgot to change the file name.
Our procedures have PFMEA and CP done during NPI processes and then updated whenever there is a rev change to the part.