This a Major NC:
I think this unjust definition and un-stated-in-the-code change is due to SQF anticipating FDA reg changes coming down the pipe line, even when we use an FDA study as validation of our practices/methods: this is what re just got from our auditor via the C.B via SQFI, this hinges on the interpretation of validating "effective" cleaning measures of allergen cleaning.... (not verification).
______________________________________________________
2.8.2.1 vii
SQF Requirement: Cleaning and sanitation of product contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces, including aerosols as appropriate, to prevent cross contact.
Expectation: The SQF Code requires validation and verification of cleaning and sanitizing procedures for the product contact equipment. Therefore, the use of finished product testing for validation of cleaning is not considered adequate. A program of verification needs to be built on an initial validation study that identifies target allergens, threshold levels and the severity of contamination, and shows the cleaning process and testing used are effective to give the desired results consistently. Once the cleaning process has been validated as effective verification/monitoring program shall be established.
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen(s). This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence. The acceptable validation testing methods involve the use of a test method which uses an antigen and antibody test, such as the ELISA method. The ELISA method can be qualitative or quantitative and can be conducted in a laboratory or with test kits available for plant use. Most test kits have a sensitivity of 10 PPM.
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time. The verification must be documented by a responsible person from the facility who has been trained in the validated cleaning method. The most common method is the use of highly sensitive swabs that test for proteins (sensitivity 20 PPM).
When there is a mixture of different allergens in use, the acceptable method for confirming the effectiveness of cleaning is to test for the highest risk allergens, the highest concentration of allergens, or the ones that are most difficult to remove. Examples of difficult to remove allergens include milk proteins, such as in chocolates.
Nearly all of the allergens have specific test kits available. However, there are a few allergens that do not have a test kit. There are currently no test kits available for certain fish species and all tree nuts. In these cases the use of highly sensitive protein swabs may be an acceptable alternative.
Suppliers using whole or partial nuts such as muffin toppings have to verify removal of all the nut fragments from the equipment (based on visual inspection). Ground nuts and nut butters require the use of validated cleaning procedures and a recognized allergen specific cleaning test such as conveyors, augers and other product transfer devices.
Dry product processing facilities may use an inert product flush to remove allergens. In this case three product flushes may be required to assure removal of allergens.
______________________________________________________
........... So it seems if it is not the ELISA method, it is not "validation" (-10 as a Major NC).
I cant "validate" if this comes directly from SQFI but that is what the contract auditor is stating that is coming from the CB he is working with.
It seems NSF sent out a letter addressing this issue to its auditors and the clients BEFORE audits ensued (we did not get that luxury).
Dont know if this will impact other GFSI benchmarks...