SQF 11.6.5.1 nonconformance

Hello all, we have a minor SQF nonconformance for 11.6.5.1, pending technical review. It is for having several open cases of 1-lb finished good bags stored on racks in our finished goods warehouse. The bags are kept in corrugated boxes; 12 bags are in a case. This is an area where the shipping workers go through and pick the individual units for shipping to customers. The risk, according to the auditor, is that dust in the area could contaminate the bags since the boxes are open.

We believe that the warehouse is no more dusty than a retail store would be, and in such a store, they would not keep the individual units in closed cases; they would have the units open and exposed to the ambient air. Also, we have the warehouse on a cleaning schedule for ensuring the floors are swept, shelves are dusted, etc. We are selling through the product at a rate where, in our observation, we do not see significant dust accumulation on the outside of the bags.

This nonconformance seems to us to be out of proportion to the risk posed by the dust. I wanted to see if this is something we should push back on with the auditor, and if so, how should we do that? Would we refer to a risk assessment for the area to support how we know that the cases do not need to be closed?

It's not just about the bags but we have other products (mostly 250 cc, 1 oz, and 2 oz bottles) that are in open cases or are as individual bottles on our warehouse shelves; however, the auditor did not comment on the bottles. If they make us keep the bags in closed cases/containers, then they could make us do the same with bottles, too. Is that reasonable? It seems to us that that is an unreasonable demand that is out of proportion to the risk posed by the conditions of our storage.

We are regulated in the United States under 21 CFR Part 111 and 117 and we have SQF and NSF GMP certifications for manufacturing dietary supplements. 

Thank you,

Matthew

What type of racks?  If this is an open case with sealed bags inside on a pallet rack, with a bunch of stuff above, I'd say it's a crap finding but the auditor has a point.  Not just dust, but all sorts of crap could fall down onto the bags in an open case, and it's a better practice overall to keep cases closed when in the pallet racking.

Nothing wrong with going for a technical review, as 11.6.5.1 really only calls out loading/unloading/storage in general with regards to product integrity and cross-contamination.  Product in a sealed bag can't be contaminated by dust.  As long as your written warehousing SOP allowed for the practice as the auditor saw it, I think you've got at least enough to have the finding reviewed.

Don't worry the Auditor will pick up the bottles next time around if they are still exposed.

This is a minor, I'd skip the push-back, take the hit, do your corrective action submission and move on and thank you lucky stars you didn't get written up for the bottles and whatever else.

Have you ever received a complaint about dusty packages?

The amount of dust which can be generated, moved and settle in warehouses and be cleaned up on an irregular basis is not small in my view and much higher than retail stores.  I'd question that assumption.

Also it depends on the product and whether a consumer hands could become contaminated with outside dirt, dust etc which then could become a food safety risk if transferred.

Also while never acceptable, it's not infrequent that you will get the odd intruder into a warehouse.  If I had a guess of the percentage of pest sitings which were warehouse vs manufacturing area, I'd say it's 80% the former.  I'd want stuff with an extra layer of protection.

I agree with Glenn.  Suck it up.

We use slip sheets on top of all pallets with bags or bottles in cases with open tops to protect them from dust, but we also keep everything on pallets, no shelving.  We also do an EOD check of the pick aisles to ensure everything that should be, is covered.  It takes a bit for new employees to get used to it, but our guys who have been here for years are usually on top of it.  Slip sheets and doors being closed are things our older guys really get hot about if it's not done properly, but most have no problem throwing wrap trash or label backing on random pallets, or half cutting wrap and leaving it all hanging off the back cases.   :doh:

Hi Matthew,

It be interesting to know what you are packing into those bags and bottles. Normally packaging would be issued to production and when returned it should be in good condition and sealed.

It is considered good practice for all items to be sealed, to prevent contamination from the environment and pests but also as part of food fraud prevention/food defense procedures.

I’d also be interested to know how traceability works with your open case system?

Kind regards,

Tony