Risk Assessment for ISO 13485:2016 section 7??

[Dofolo]

Against what specific clause is the NC raised? An auditor cannot go 'meh this is wrong' and then not name the specific clause, and just have some subjective evidence.

If you do not have this information, raise the issue with the CB and ask for it.

The objective evidence was against the process and computer system validation assessment performed for one of our QMS tools (not related to product realisation), the auditor felt because we were using the tool for the QMS, we needed a detailed assessment of all potential process hazards across the QMS.

Ah puzzle pieces That's a 4.1.6 NC, not a 7.1 one imho.

And I can see where 4.1.6 becomes a royal pain in the behind when you are a SAMD developer. Because you obviously are going to drag 4.1.6 into 7.1 & 7.3 and vice versa. And then that's where I can see the 7.1 coming into play ...

What a really complicated way to write a NC against 4.1.6. And also kinda odd to raise it against 7.1 ... Maybe the auditor wasn't familiar with a SAMD company and their typical processes.

What do you have defined for 4.1.6, and 7.1? What do you have defined for software tool validation, for QMS, for development and for 'other' ? That validation should have a risk assessment part, based on the (potential) influence on your QMS, day to day business and SAMD products. You could also probably class the software tools you use into categories based on risk for the above mentioned items, and have validation plans based upon the defined risk.

Also on a personal side note, screw 4.1.6 :/

 

[AliceQA]

Thanks Dofolo, you see this is where my confusion with the NC comes from because the auditor was ok with what we had for 4.1.6 with the SOP and objective evidence we provided.
The concern seemed to be with the fact that we didn't have a process risk assessment for all our product realisation processes, and the NC/CAPA tool was the example provided as it had some risk assessment but 'not enough detail'.

Thanks to everyone who has posted with ideas, it has helped me steer the conversation with the CB.