Hello Everyone,
I am working on changing some procedures related to how my company conducts quantity checks for packaging final product.
We manually weigh out all final product batches into their individual packaging containers, so there is always an operator that is ensuring each container is weighed out to the correct minimum amount. There are times when one operator may only be weighing and packaging 1 container for a batch of product or may have to weigh and package over 100 containers for a batch as we make everything to order and batch sizes can vary greatly. Currently we operate quantity checks as if we had an automated system by conducting checks every 15 minutes during a packaging run for each product, however I feel like this is unnecessary and overkill at times with our manual system.
My question is: Can I justify having a set amount of documented quantity checks per product batch, regardless of the amount of containers being packed or time taken to pack? Justification would be what I mentioned above about having each container manually filled and checked by an operator, we also do a twice daily verification of all scales in facility with calibrated check weights, and I have documented trainings and competency checks with all operators that would be packing product showing they can properly read scales and package product. My biggest worry here is with batches that require a large number (50-100) of containers to be packed having the same amount of documented weight checks as a batch that only has 1-2 containers to be packed. BRCGS clause 6.3.1 is very vague and I haven't been able to track down any specific FDA legislation about quantity checking.
Any help or thoughts would be greatly appreciated!