You are probably already familiar with grading nonconformities as “Major” and “minor,” but the Global Harmonization Task Force (GHTF) introduced a new system in 2012 using a numbered scale of 1 to 5. The “new” GHTF number scale was adopted as the required method for MDSAP audits, but you can use either method internally and for supplier audits. Which method should you use?
Should you change the way you grade CAPAs and nonconforming products too?
Link to GHTF guidance on grading nonconformities:
www.imdrf.org/...
MDSAP = medical device single audit program (no OFIs are permitted)
Major = A major NC represents a systemic quality issue. I define it as a quality issue where one of the escalation rules from the GHTF grading system apply. Specifically, the issue is: 1) a repeat problem, 2) absence of a process or procedure, 3) absence of records for a process or procedure, and 4) shipping of NC products.
Minor = Any NC can be minor (i.e., anything that is not a major). Even a single lapse, such as forgetting to sign and date a correction on a record.
Some companies use a third definition: "critical". Often this will be used if the nonconformity could result in an FDA 483. I don't agree with this approach, because I think it sends an incorrect message that regulatory infractions are more serious that failing to follow your own procedures.
Many people wonder about OFIs: "Opportunity for improvement". The FDA does not allow MDSAP auditors to use the OFI designation, because they feel this is consulting. However, internal auditors and supplier auditors are allowed to "consult" or give advice. Therefore, I encourage internal and supplier auditors to issue OFIs. However, the company must show that they are addressing those OFIs and not ignoring them.
We are now using the MDSAP numerical system for grading NCs, CAPAs, and Internal auditing. What do you think about expanding that concept?