4 replies to this topic

[Hoyle]

So we had a couple of non-conformances on our recent audit, one of which was not having supplier spec sheets on file for our bags.

I've been attempting to get it from the company which provides us with our packaging but they have only given me their FDA certification tests for the bags, and not the actual spec sheet.

I'm trying to give the company the benefit of the doubt, possibly there is an error in translation, or they are just busy with Lunar New year, but I only have a few more days to get this CAPA submitted.

So I got 2 questions:
1. Would that FDA certificate be adequate?

2. What further steps can I take beyond reaching out to multiple members of their team? Is there a pre-existing database of TDSs somewhere that I can't find?


Thanks in advance for any help you fine people can offer.

[Scampi]

Who issued the non conformance?  Regulatory or GFSI?

[Hoyle]

Non-conformance through SQF
Is there a big difference between nonconformances between the two?

Sorry if thats a noob question, but I am a noob (first audit)

Who issued the non conformance?  Regulatory or GFSI?

[SQFconsultant]

I go to the packaging company website and see if I can pull specs from there and then go to your in-house buyer or whoever is in charge of approving agreements to supply (contracts to purchases, purchase orders, etc) and see if there are specs available from another department in your company.

 

If all else fails based on all the info that you gather, you can make up your own spec sheets and indicate on the NC that supplier refused to directly provide.

 

Now the only issue with that is that if your Approved Supplier program requires specs (and I imagine it does) the question is going to be - how did this and that supplier get approved without submitting what you require?

[kingstudruler1]

Even if I receive them, I make my own.    They dont have to be very complicated, just a descrition of what you are purchasing.   Dimensions, construction, materials, meet regulatory requirements X, diagram or picture, etc.