Hi there,
We recently had a gluten free audit where the auditor gave us a non conformance for our allergen cleaning validation procedure. We produce nutrition bars and have most of the allergens (soy, milk, peanut, tree nut, wheat/gluten, sulfites) in our facility. there is no dedicated line so cleaning is our procedure for controlling cross contamination.
Our current procedure for validation is to send out allergen specific swabs to a third party lab for testing. the swab samples are taken on each type of surface (plastic, stainless steel, etc) after cleaning is conducted post production. All our products have some allergen so naturally these allergens would transfer on the production equipment. The results from validation were within the detection limit of the test. this showed that there was no allergen residue on the production equipment/surfaces after cleaning.
According to the auditor this is verification, not validation. we have been asked to show proof that allergens were present on the surface originally. therefore we have to do allergen specific swab before cleaning and another set after cleaning to show that those allergens were removed. Is this accurate? I have not come across any literature that prescribes allergen cleaning validation in this way. Has anyone else come across such a requirement?
Any help will be appreciated. Also, this increases the validation cost 2x and management is not onboard unless i can provide guidance/ specific industry standard that requires this. the gluten free standard does not prescribe how to do validation either.