MDSAP Audit Findings - Document change orders

I could really use some help from everyone on some audit findings. The first one is on document change orders. We were unable to produce all of the records requested (because the person responsible didn't complete them). They requested 3 DCO's and we only had 1. Yet this was marked as a major. We do have a process in place which was reflected in both written procedure, form, and the record produced. It's an initial audit and not a repeated finding. It doesn't to me directly impact quality of the product, can I argue this or do I not have a valid point?

Last edited:


Staff member
Super Moderator
Are you wanting to argue that it's not a major? Clearly you had nonconformities. Based on the auditor's sampling (3 records), 2 were nonconforming. Would probably be reasonable for an auditor to conclude it's systemic. Maybe some of the auditing experts can weigh in on whether they agree it's major or not.
Oh yes systemic and we had problems no doubt. But it's still not repeat offense and indirect on QMS which is why MDSAP grade of 1. I'm wondering why a major on ISO. I have friend in notified body that thinks it is a minor. But I'm also looking for insight from other experts.
I don't have the current version of ISO 17021, but from what I see in section 9.1.15(b) a major means:

1) failure to fulfil one or more requirements of the management system standard, or

2) a situation that raises significant doubt about the ability of the client's management system to achieve its intended outputs;

If I may speculate... the reason you got a major and not a minor is the auditor's lack of confidence in the QMS. It's difficult to argue against that and saying that it doesn't directly effect the quality of the product won't help you, and you can't prove it.
If you should appeal, aim to regain his confidence in your process.

I hope it makes sense.

It seems to me that you do not have a process in place, or the person responsible for the process would have in fact completed all the records.

Uncontrolled changes to documents can definitely affect the quality of the product in the narrow sense (whether it continues to meet lot release criteria) and in the broader sense (whether it remains safe and effective for its intended use).

I do not think major vs minor should have anything to do with whether it is a first, second, or third offense, but should reflect the risk it represents, not to the manufacturer, but to patients. What MDSAP auditors think, I cannot say.

Top Bottom