15 replies to this topic

[Sarahb3339]

Hello, we are an SQF company and we just closed out our 2021 audit. We had a few minors, one involving a foreign supplier and obtaining a certification. We receive the product , test it against the suppliers CoA to ensure it meets FDA , GMP standards . Reprocess the material and test again before release. Are there other ways to certify this supplier without obtaining a GMP cert ?  We have been working with this company for many years and we have never had a problem with testing, CoA etc.  We ensure that the product meets specification.  If we cannot obtain a GFSI cert in time for the audit corrections due date, what happens?

[Setanta]

I am sorry I didn't understand, but was your minor because the supplier did not have a GFSI cortication?

[Sarahb3339]

Essentially , yes.  The auditor wanted to know how we know certified or approved them as a supplier without it.

[Setanta]

YOU can do your own Audit of their facilities.  If you use SQF as a starting point, you can go there and audit them. 

[Sarahb3339]

Hm .  Thank you! That is what I thought.  Is it possible to do if from the US though???

[Setanta]

Is the other facility is the US?  

[Sarahb3339]

The importer is. It is just a company that serves as a repacker/relabeler then it gets sent to us.  However, the company does not have any certs or audit to provide me from the foreign supplier.  I have been testing against the foreign supplier CoA for a decade and reprocessing and testing again and it has never come up before.  I'm not sure what to do in this scenerio.  Historically, no issues at all.

[olenazh]

I have suppliers who're not GFSI certified. I've been sending them Supplier Questionnaire with questions about their FSMS, GMP, PRPs, etc. you know what I mean. My auditors never had any problem with that. BTW, we're FSSC22000.

[Setanta]

And they have no audit of any kind to send you?  That's a bit surprising, this is for a food ingredient?  Hmmmm

[Sarahb3339]

They have flow charts etc.  Just no GSI scheme.  They are also registered with FDA etc but the auditor was stuck on a GFSI scheme.

[olenazh]

And they have no audit of any kind to send you?  That's a bit surprising, this is for a food ingredient?  Hmmmm

Correct. For example, bacterial culture supplier - I've been working with them for 10 years, and all these years just Questionnaire. But they provide COAs of course.

[SQFconsultant]

What kind of certification?

 

First, I'd be looking at my own supplier approval procedures - as in what do I say I require from the supplier and do I actually get all that from each one.

 

Next, this is not a contract manufacturer in that you purchase the item and process it - thus, a standard 3rd party would be fine, unless of course your own requirements calls for a GFSI cert.

 

Then again, this is a foreign supplier - you did not say it, I can only assume that the auditor may be talking about (if not talking about a GFSI Cert) prove of FSVP, if applicable.

 

So, your message did not contain enough info but I've attempted an answer here anyway.

[Sarahb3339]

Perfect.   I have a questionaiire that I use for all of my suppliers.  My survey asks about GMP's, FSMA Rule etc.   This should be suffice I would think!  

[SQFconsultant]

Perfect.   I have a questionaiire that I use for all of my suppliers.  My survey asks about GMP's, FSMA Rule etc.   This should be suffice I would think!  

 

If that is the case Sarah, I am surprized the  Auditor did not write you up for (since I don't know what etc means in this case) Suffice, I don't know - I'd be reviewing the SQF code book right now to ensure that my requirements are in alignment.

[Sarahb3339]

It is a Foreign Supplier Verification Survey.  They are not certified, but do follow GMP's and meet FDA requirements.  The survey should reflect this plus the testing and historical testing results from verifying the CoA's from the supplier.  I would assume.  

[SQFconsultant]

you need to determine if the FSVP is applicable to this supplier and if this is the case, they are required to comply and show proof.   This is plain and simple stuff.