8 replies to this topic

[Kubramilller]

Hey everyone, has anyone had a GFCO audit before? if yes, what are they looking the most? Also do I have to make new forms for gluten or can I  just show them during audit our regular procedures for allergen producers/ management? Thank you.

[SQFconsultant]

YES.

 

you should have a gluten-free food safety management system documentation binder separate from your GFSI or standard one.

 

it needs to include testing information, your protocols on how you ascertain that ingredients will not introduce gluten, etc.

 

These inputs include things like ensuring the glue on packaging for instance does not contribute to the GLUTEN content, etc.

 

It's a good overall intensive audit on systems, documentation and of course facility with heavy concentration on testing.

[umabansal]

Hi Kuberamilller,

 

Below ids the list of documents required for GFCO Audit.

 

• Production lot information
• Manufacturing permit or license to manufacture
• Customer Complaint program
• CAPA policy
• Org Chart
• Gluten free program
• Internal audit schedule that includes allergen management
• Gluten training program
• Gluten testing program
• GMP policy
• SSOP for equipment
• Supplier approval process document/program
• Procedure/documentation for incoming raw materials/outgoing finished goods
• Procedure/description for gluten free manufac
• Production record to show ingred lot identification, batched correctly, etc.
• Any re-work policy
• Policy for handling waste materials from production
• Dust control policy
• Recall process, results of mock recall
• Procedure for handling incoming materials that are contaminated
• Policy for handling out of spec product
• Policy/procedure for mis-labeled or packaged product
• Gluten test method currently in use
• Policy for storing gluten free materials
• Copy of final packaging with GFCO logo
• Processing flow chart or diagram

Thanks

[Kubramilller]

Thank you Umabansal for your answer and your time, it will help me a lot.

Our food safety plan covers cGMP, allergen control program, hazard analysis and I can use them to show during the audit, am I correct?

Or should I make a different file under the subjects you sent, just for Gluten free procedures?

[poof]

Hi Kubramiller, 

 

I am at a GFCO certified plant, however we are a designated gluten-free facility, so we don't have gluten in house at all. I do not have a separate binder/storage for my GFCO related documents- Do you keep seperate binders for each allergen you have in your plant, and all their related programs?. I include some specific information about gluten intolerance/celiac under my allergen management program. The GFCO audit was pretty simple in my experience- similar to a GMP audit. However, my experience may be different since we do not have gluten anywhere in our facility. 

[Kubramilller]

Hi,

Thank you for your answer Gballard

No, we are not a designated gluten-free facility, we will have gluten and gluten free production on the same line.

Our plan is scheduled production like having the gluten free production right after our cleaning day.

And also having a different cleaning-sanitizing procedure just for gluten.

Do you have any other suggestions? I am also looking for templates to use to create a Gluten free production program.

Thank you again

[poof]

I apologize Kubramiller, I do not have a gluten-free production program, I include most of it under my allergen management program since we have none in house. 

[emportllc]

Hi Kubramiller - 

 

The 2021 guidance for the GFCO Standard is available online here: https://gfco.org/wp-content/uploads/2021/01/GFCO-Manual-2021.pdf 

 

The audit agenda (including document review) is on page 15 but if you scroll towards the end of the file you'll also see a detailed explanation of the rationale behind everything included in the standard. Absolutely worth the time to go through it line by line but I'll call out #13 on p51 for you:

 

 

The Plant must have an appropriate collection of written procedures in place that specifically address gluten control, which will be referred to as the Plant’s “Gluten Program.” This Gluten Program does not need to be a unique, stand-alone set of documents, although it may be. The Gluten Program may be comprised of policies and procedures located in other management system documents, as long as those documents clearly refer to, and correctly define, gluten. The Gluten Program must include a current copy of the GFCO Standard.

Rationale: An essential part of managing gluten risks is a clear set of policies and procedures for gluten management. Written policies and procedures are also necessary for the continuity of the plant’s gluten control system in the event of staffing changes.

Evidence: A collection of written policies and procedures that cover the requirements of this Standard, and any other policies and procedures deemed essential for gluten control by the plant. The gluten program does not need to be a separate set of policies and procedures – the gluten management processes can be included within the plant’s other documentation. But the policies and procedures must name and specifically address gluten and its risks.

 

The good news is: they want you to do well at your audit! So I'd encourage you to check in with them with any specific questions that come up as you're going through the document checklist.

[Kubramilller]

Hi Emportllc,

 

Thank you for your answer. I already have gone trough the GFCO Manual, it has been little overwhelming, however all the pieces are getting together.

Thank you for your answer again.