Showing it from a training slide to help others out. There are similar slides available from multiple sources. This is the general information.
Depending on the clause the auditor must/chooses to write it up against it will be either considered indirect or direct (though the simplistic choice on this construction has been disputed, this is still the current state).
They must then verify whether in the past there were findings against the same clause (at the specific clause number level, though not at the itemized list level). To note: for us the recurrence was drawn from the two most recent (though non-MDSAP) ISO audits by the same certifying body. I think this one can get confusing depending on schemes, bodies etc, but simply count back 2 years.
You can get an additional increase to the grade for the absence of mandatory procedures and for the release of non-conforming product to the field (note that release under concessions, if done well, do not count as such).
Three or more grade 4's, or one or more grade 5's will result in expedited notification of relevant authorities. Any number of grade 4's already cuts down on the time you have to respond.
ISO is a different scheme, so to obtain ISO certification, relevant non-conformities will be graded minor or major as well (when they are written out against an ISO 13485 clause). We did not experience a write-up solely against an MDSAP step with only a regional requirement, but most auditors will default to a (distantly) related ISO 13485 clause anyway.
MDSAP has tighter timelines than ISO, counted in days (not work or weekdays). So tight that you should plan to:
- initiate CAPA's the day after the audit,
- and ensure you have the key personnel available for 3 months after the audit to implement.
- for grade 4's or higher to complete root cause analysis and action planning within 15 days (again days, not work or weekdays).
- complete implementation of grade 4's or higher within 30 days (to be doubly certain days, not work or weekdays).
- complete minors in the time that you used to prioritize only to majors.
- Luckily verification can extend beyond the period.
We went through it and this approach gave peace of mind, but might take a toll on your workforce (MDSAP don't care about school vacation or holidays).
I still believe that as truly critical NC's require real effort that cannot be compressed within a month, MDSAP will (for a period of time) result in some fake solutions within 30 days, and hopefully real solutions outside of it out of fear for the next time. But it is still odd to play it like that from the regulator's standpoint.