(A) Whenever a deviation from a critical limit occurs, a frozen dessert manufacturer shall take corrective action either by:
(1) Following a corrective action plan that is appropriate for the particular deviation; or,
(2) Following the procedures in paragraph (C) of this rule.
(B) A frozen dessert manufacturer may develop written corrective action plans, which become part of their HAACP plans in accordance with paragraph (C)(2)(e) of rule 901:11-3-06 of the Administrative Code, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:
(1) No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and,
(2) The cause of the deviation is corrected.
(C) When a deviation from a critical limit occurs and the frozen dessert manufacturer does not have a corrective action plan that is appropriate for that deviation, the manufacturer shall:
(1) Segregate and hold the affected product, at least until the requirements of paragraphs (C)(2) and (C)(3) of this rule are met;
(2) Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual who is qualified in accordance with rule 901:11-3-11 of the Administrative Code;
(3) Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;
(4) Take corrective action, when necessary, to correct the cause of the deviation; and,
(5) Perform or obtain a timely reassessment to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.
(D) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with paragraph (A)(3)(b) of rule 901:11-3-08 of the Administrative Code and the recordkeeping requirements of rule 901:11-3-09 of the Administrative Code.