My company makes many products of which some contain allergens and some do not. We have always performed a full wash-down between production runs with allergen verification swabs after an allergen containing production run to validate the cleanliness of random food contact areas. It has recently been decided to start performing these allergen swabs using a "Neogen Brand" test kit instead of sending swabs to an outside lab source due to financial reasons. Since this year will be the first year we are audited by the new BRC version that concentrates more on allergen control is am concerned of unforeseen issues of proper documentation or validation in the eyes of the auditor. The Neogen test kit will produce either a "negative" or "positive" test result based on if the ppm of the certain allergen was detectable or not however the 3rd party lab would give a quantitative ppm result. A validation study has been performed in which an allergen compound such as milk was diluted to a certain ppm ratio and swabbed with both Neogen swab and separate swab for 3rd party lab analysis by our sister company's lab (consider it in-house but accredited lab). My concerns are as follows:
1. Are there unforeseen questions about the possible variability with the validation study? example: proving the ppm dilution was conducted properly or one swab absorbing more allergen residue based on different type of study type.
2. Is a Pass/Fail (negative/positive) test result sufficient in the auditor's eyes? I understand that this could be based on the results from the Validation study
3. Is there a certain requirement to result reporting? currently the 3rd party lab creates the result report and I know according to that lab's protocol, they have a separate person perform test, separate person, double check interpretation of result, and different person either enter or approve final report. Is this a requirement?
4. Would a frequency or number of test points per swabbing program increase for in-house testing? current program states 1 CIP swab and 1 other random food contact area swab per allergen type per month.
I apologize for the long post but the decision was made within my company and I want to make sure we aren't missing any potential issues.