Can our Supplier's Quality Mgr. conduct Supplier Audit on behalf of manufacturer?

[ryno fan]

Hello,

I work for an FDA-regulated medical device manufacturer. We have contracted suppliers that produce components for inclusion in our finished medical device. These suppliers only work for us.

My question is, is it allowable under FDA CFR 820.50 Purchasing Controls for my company (the device manufacturer) to have the supplier's Quality Manager conduct audits for my company (the manufacturer), using checklists we (the manufacturer) develop? Will these audits count as periodic supplier audits performed by the manufacturer? (We would define this setup in our Purchasing Controls SOP, and "qualify" the supplier's Quality Manager.)

 

[Mark Meer]

My feeling is that if this process accurately reflects what is in your SOP for supplier control, it is technically fine.

In practice, however, it might raise eyebrows. You are essentially getting your supplier to self-audit, in which case what's to stop said Quality Manager from simply filling out your checklist to give a glowing report everytime? Without additional controls, you'd be none the wiser...

 

[ryno fan]

I should have also explained that the supplier's Quality Manager would be one auditor on the manufacturer's behalf, but not the only one - the other auditors would be employees of the manufacturer...Does this change your perception?

Thanks

 

[Mark Meer]

...yes that makes a bit more sense...

...but why involve the supplier's Quality Manager at all? If manufacturer representatives are on-site with their own checklists, surely there is no need for the QM's own report as well? His/her capacity need only be to facilitate the inspection and help the manufacturer representatives complete their reports to their satisfaction...

That said, if your SOPs already have this supplier QM checklist in place, I see no reason to change it. Just some extra paper-work is all...

 

[ryno fan]

The supplier's Quality Manager does facilitate the audit, I agree. But the use of the supplier's Quality Mgr. in the audit capacity is seen by manufacturer's management as an efficient use of that resource. The manufacturer only has its employees at the supplier overseas site about 2x/year - and the manufacturer's employees are such high-ranking management that they are onsite to make management decisions - and really don't have time to do an in-depth audit. So it is an approach that is trying to maximize on "available resources"... The supplier's Quality Manager audit report would be reviewed by a knowledgeable manager at the manufacturer, so I am hoping this would be perceived as a check and balance on the supplier's Quality Mgr. remaining objective in his/her findings.