Revisit initial risk assessment-what is the likelihood of allergen in the environment being a potential source of allergen contamination in final product?
Contamination unlikely
Repeat validation exercise(total of at least 3 times)
See Scenario l
Contamination likely
Cleaning regime is not effective
Can allergen level in the environment be reduced?
Investigate approaches to remove allergen in the environment e.g.
-Cleaning
-Physical separation
-Scheduling
Implement changes
Repeat validation exercise
(total of at least 3 times)
Test results below acceptable level
See Scenario l
Test results above acceptable level
See Scenario 2