SQF Audit Allergen Validation NC

Our company allergen management program identifies site allergens as soy, wheat, fish, egg and milk. The company validates the program using Neogen 3-D reveal kits (ten in a box) When we started the allergen management program, we considered the cost of the kits and number of swabs in a kit (10), we are a small USDA facility. We tested for soy, as this is the most commonly used out of the 5 allergens on site currently. We tested food contact services after the soy clean up for 6 consecutive weeks and found allergen cleaning effective and opted to continue validating the program quarterly with the 4 swabs left in the kit. When it is time to purchase another allergen test kit we will use the next most used allergen on site. We received this NC: Allergen cleaning validation did not include allergen specific swab for egg, milk, fish and wheat. Does the fact that these allergens are on schedule to be validated in rotation with purchasing the next kit weigh in on this non-conformance? 

First there is a difference between Validated and Verification.

Next - you have these other allergens but do not test for them?

Only Soy?

Was this a Major finding or was the auditor overly nice to your company with a minor?

Does your product includes/declares the 5 allergens on the label?

If not, and you are producing based on schedule, what is your evidence that the other allergens are removed during cleaning when validation is not done using the specific swab?

Our company allergen management program identifies site allergens as soy, wheat, fish, egg and milk. The company validates the program using Neogen 3-D reveal kits (ten in a box) When we started the allergen management program, we considered the cost of the kits and number of swabs in a kit (10), we are a small USDA facility. We tested for soy, as this is the most commonly used out of the 5 allergens on site currently. We tested food contact services after the soy clean up for 6 consecutive weeks and found allergen cleaning effective and opted to continue validating the program quarterly with the 4 swabs left in the kit. When it is time to purchase another allergen test kit we will use the next most used allergen on site. We received this NC: Allergen cleaning validation did not include allergen specific swab for egg, milk, fish and wheat. Does the fact that these allergens are on schedule to be validated in rotation with purchasing the next kit weigh in on this non-conformance? 

Hi 3560lynne,

To chime in here on this one, Using a Neogen 3-D kit is not a validation. This would be considered a verification. Having your finished goods and/or your swabs sent to Neogen's lab for quantification would be a validation task. You would need to validate all of your allergens because every protein is different. 

Aside from that, I would strongly suggest using Neogen 3-D kits after each sanitation from allergen changeover. I'd also go so far as to recommending some ATP swabs along with the allergen protein swabs to play it safe.

Hi 3560lynne,

 

To chime in here on this one, Using a Neogen 3-D kit is not a validation. This would be considered a verification. Having your finished goods and/or your swabs sent to Neogen's lab for quantification would be a validation task. You would need to validate all of your allergens because every protein is different. 

 

Aside from that, I would strongly suggest using Neogen 3-D kits after each sanitation from allergen changeover. I'd also go so far as to recommending some ATP swabs along with the allergen protein swabs to play it safe.

Hi QAGB,

I hypothesise that OP's title/text illustrates some confusion with "Cleaning Validation and Verification" ,The relevant SQF requirement was maybe  -

2.8.1.5  Based on risk assessment, procedures for validation and verification of the effectiveness of the cleaning and sanitation of areas and equipment in which allergens are used shall be effectively implemented.

 

(Better not further discuss SQF's infamous interpretation of Va/Ve. )

Thanks for the insight. Corrective action: validate cleaning procedures are effective for all allergens on site using allergen specific testing. 

Verify effective allergen control via inspections of program; segregation, color coding, scheduling, PPE change over, ATP swabbing and finished product testing.

on the allergen program i have used the same kit for over 7years now its a change. Anybody have any ideal for me !! 

on the allergen program i have used the same kit for over 7years now its a change. Anybody have any ideal for me !! 

Hi tini,

Can you supply some specific context/details as to yr requirements ?