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