10 replies to this topic

[Nemo's Friend]

I have been tasked to find out how we could get certified in SQF, with only "certifying" one machine. 

 

My response to our leadership today was that my belief is we would need to implement all required programs under Section 2 for the site and maybe then some of Section 13 would fall under just the machine but some also for the overall site. 

 

Any guidance with this would be very helpful. Thanks!

[kingstudruler1]

I have been tasked to find out how we could get certified in SQF, with only "certifying" one machine. 

 

My response to our leadership today was that my belief is we would need to implement all required programs under Section 2 for the site and maybe then some of Section 13 would fall under just the machine but some also for the overall site. 

 

Any guidance with this would be very helpful. Thanks!

 

 

Yes, you would need all of 2 and 13 for food packaging.  You can have exemptions on your certification (parts of the operation that are not certified).    My advise to you would be for you to contact a a few certification bodies  (the people that conduct the audits) and discuss your situation with them.  

[Nemo's Friend]

Thanks for your advice!

[SQFconsultant]

Yes, you can create exclusions, however as noted above and also keep in mind that even thought the other machines/areas are excluded that they are still subject to inspection by an SQF Auditor to ensure their us no shared/bleed over from the certified machine area to the excluded area. 

 

Frankly. I've found over the years that it is better most cases to get everything certified with no exclusions.

[Nemo's Friend]

Yes, you can create exclusions, however as noted above and also keep in mind that even thought the other machines/areas are excluded that they are still subject to inspection by an SQF Auditor to ensure their us no shared/bleed over from the certified machine area to the excluded area.

Frankly. I've found over the years that it is better most cases to get everything certified with no exclusions.

How would we implement section 2? And 13 with only one machine? Storage and transport? Supplier program? Food defense and fraud program? Chemical control? Sanitation? HACCP? GMPs? Could we all tailor those programs specific to just the food packaging?

I agree with you 100% and my recommendation to my executive team would be to implement SQF without exclusions - I just need some more details behind why to provide a business case. This is mainly due to costs and ROI as food packaging is only about 10% of our product mix.

[jfrey123]

My buddy and I got paid pretty well consulting specific businesses in this area.  It's hard to cover the full spread of considerations in a single forum post, but the biggest thing is that everything in Module 2 and 13 will apply to that specific machine, and unless the machine and raw/finished product is fully encapsulated, will apply to the building.  I've written and defended mixed use spaces for food production, and it's difficult, but can be done.

 

Looking at that code, a few examples come to mind (and to be fair, I've never worked in a packaging manufacturing plant):

 

2.3 Specs and Supplier Approval:  You'll need to prove your package is suitable for its specified use, and the materials you're purchasing for that use are food grade coming from proper suppliers.

 

2.6 Traceability:  Making whatever package will need to record input and output lots in case there's ever a problem in your process requiring a recall.

 

2.8 Allergen Mgmt:  Not sure how relaxed your warehouse is, but now any employee with a milk chocolate bar in their pocket is a violation of allergen controls.

 

13.1 Site Location/Premises and 13.2 Site Operation:  This is a biggie.  I created maps showing our "in scope" and "out of scope" areas, demonstrating where we kept goods and did our processing wholly separate from the non-SQF side of the business within a single warehouse suite.  SOP's prohibited comingling of products and personnel.  You'll need to address how you don't let the guy making whatsits across the production area from approaching your food grade whozits line.

 

13.6 Storage and Transport:  Another biggie.  You can't generally defend storing your food grade stuff next to non-food grade stuff, they'll want to see dedicated and segregated storage because you'd be hard pressed to justify how your non-food packages aren't contamination risks next to the food grade ones.

 

All of this needs to be codified in your SOP's, reinforced with training, and proper record keeping to boot.  Without going on and on, I hope that paints a bit of a picture for where you need to start taking the discussions.

[Scotty_SQF]

I feel it will be more difficult to have one machine/area under the scope then have the whole facility.  Just my opinion.  I worked at a place once where maybe only half the equipment was designated food contact and the other wasn't.  The first year I told the quality manager just to get the whole place under the scope and not claim exemptions.  They didn't listen and it was more of a struggle trying to show and tell the auditor how it was, I had to step in a lot.  The next year they listened to me and during the audit when the auditor came to one of the non-food grade machines, we would say this only runs non-food grade.  They would look, but not too in depth and the audit went easier.  I will point out that all our film and supplies that touched any film were all food grade regardless.  So much easier to do this when everything you bring in is basically already food grade.  We did have separate racks for food grade and non.

[SQFconsultant]

It's interesting, but in 15 years or so of SQF I've only seen a sprinkling of companies that did exclusions and what happens is that a customer comes along and it works out they want SQF too but now the partially certified company has to start dancing until changes with CB, etc can be made - having SQF is a great marketing tool if used correctly.

 

I'd suggest going ahead and skipping the dance and just get everything done at one time. Since you have to do everything in the modules apply anyway. It's really not saving any money, time, etc. 

 

We just had one where I had to have a chat with owners of a company to get them to put everything under scope. It was like playing whack a mole!

Edited by SQFconsultant, 04 January 2024 - 08:58 PM.

[Tony-C]

I have been tasked to find out how we could get certified in SQF, with only "certifying" one machine. 

 

My response to our leadership today was that my belief is we would need to implement all required programs under Section 2 for the site and maybe then some of Section 13 would fall under just the machine but some also for the overall site. 

 

Any guidance with this would be very helpful. Thanks!

 

Hi Nemo's Friend,

 

I don’t see that would work unless you have a separate area manufacturing food packaging.

 

You will also need to apply food packaging standards to common areas such as warehousing. It seems to me like it would be more difficult to control and more confusing than applying a common standard across the whole facility?

 

Kind regards,

 

Tony

[Nemo's Friend]

My buddy and I got paid pretty well consulting specific businesses in this area.  It's hard to cover the full spread of considerations in a single forum post, but the biggest thing is that everything in Module 2 and 13 will apply to that specific machine, and unless the machine and raw/finished product is fully encapsulated, will apply to the building.  I've written and defended mixed use spaces for food production, and it's difficult, but can be done.

 

Looking at that code, a few examples come to mind (and to be fair, I've never worked in a packaging manufacturing plant):

 

2.3 Specs and Supplier Approval:  You'll need to prove your package is suitable for its specified use, and the materials you're purchasing for that use are food grade coming from proper suppliers.

 

2.6 Traceability:  Making whatever package will need to record input and output lots in case there's ever a problem in your process requiring a recall.

 

2.8 Allergen Mgmt:  Not sure how relaxed your warehouse is, but now any employee with a milk chocolate bar in their pocket is a violation of allergen controls.

 

13.1 Site Location/Premises and 13.2 Site Operation:  This is a biggie.  I created maps showing our "in scope" and "out of scope" areas, demonstrating where we kept goods and did our processing wholly separate from the non-SQF side of the business within a single warehouse suite.  SOP's prohibited comingling of products and personnel.  You'll need to address how you don't let the guy making whatsits across the production area from approaching your food grade whozits line.

 

13.6 Storage and Transport:  Another biggie.  You can't generally defend storing your food grade stuff next to non-food grade stuff, they'll want to see dedicated and segregated storage because you'd be hard pressed to justify how your non-food packages aren't contamination risks next to the food grade ones.

 

All of this needs to be codified in your SOP's, reinforced with training, and proper record keeping to boot.  Without going on and on, I hope that paints a bit of a picture for where you need to start taking the discussions.

How did you address the GMPs? Such as hair nets and lockers? 

 

We have a large facility and only a few machines will be running food packaging products - though food packaging is only 10% of our product mix and so we do not run it often. My thoughts are to complete a full risk assessment of the entire facility not having to use hair protection but when we do run the products that the operators of those machines follow a rigourous cleaning and hair nets policy. 

 

We also have lockers placed all around the production floor, not in a central location but we do have a lunch room which employees store their food their prior to entering production. Is this a problem?

Edited by Nemo's Friend, 25 January 2024 - 02:16 AM.

[jfrey123]

How did you address the GMPs? Such as hair nets and lockers? 

 

We have a large facility and only a few machines will be running food packaging products - though food packaging is only 10% of our product mix and so we do not run it often. My thoughts are to complete a full risk assessment of the entire facility not having to use hair protection but when we do run the products that the operators of those machines follow a rigourous cleaning and hair nets policy. 

 

We also have lockers placed all around the production floor, not in a central location but we do have a lunch room which employees store their food their prior to entering production. Is this a problem?

 

We addressed by making the area where food operations happened our GMP controlled area.  This was a small operation doing dry steam sterilization/pasteurization, so the part of the warehouse with our food storage and heat chambers was partitioned off and GMPs were enforced in this area.  Only cross hazard was where we drove from the GMP area to the loading dock, and our policies dictated that no other loading/unloading was to occur at this shared dock space while we were moving food, and the food had dedicated dock doors.  Believe me, there was always a lot of "we're doing our best with limited space and business needs" type statements to the auditors, and it took them time to accept it but they never found fault when they poked and prodded our programs.

 

When I say small operation, I mean one production employee, one plant manager, and me a shared QA role between this building and the one next door (family run operation).  Our breakroom and employee storage was in an office directly leading to the GMP area, handwash sink and smocks kept immediately outside that office leading into the processing area.

 

From what you're describing, I'd want the entire area around these food machines regulated as a GMP area.  If packages can be sealed inside this area after production, I'd argue all day long that it's fine to then transport the goods through the rest of your non-GMP production on the way to storage.  But you'll need to establish and risk assess your traffic flows, to make sure the employees traveling to the GMP area aren't picking up environmental hazards on the way (or mitigate those hazards once they enter the GMP area: handwash, smocks, shoe coverings, etc).

 

As for the lockers, I'd recommend removing them.  Auditors are going to argue that any employee storage in the production area is a risk, because you can't say for sure your non-GMP employees aren't storing things like food in their non-GMP area lockers.  Auditors are free to examine the non-GMP areas to determine if they find a risk to the food operations you're trying to perform, even if the area is out-of-scope they're going to argue certain parts of the program must be enforced to protect the GMP area.

 

As I hinted earlier, it's not impossible but you're going to have your work cut out for you...

Edited by jfrey123, 25 January 2024 - 05:29 PM.