(A) Whenever a deviation from a critical limit occurs, a processor 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) If a written corrective action plan is developed, it shall become part of the HACCP plans in accordance with rule 901:3-23-04(B)(5) of the Adminstrative Code, by which they predetermine the corrective actions that they will take whenever there is a deviation form a critical limit. A corrective action plan shall 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 processor does not have a corrective action plan that is appropriate for that deviation, the processor 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;
(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;
(5) Perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with rule 901:3-23-08 of the Administrative Code, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan an necessary.
(D) All corrective actions taken in accordance with this rule shall be fully documented in records that are subject to verification in accordance with rule 901:3-23-06 of the Administrative Code and the record keeping requirements of rule 901:3-23-07 of the Administrative Code.
Prior History: (Five Year Review (FYR) Dates:
Promulgated Under: 119.03
Statutory Authority: 3715.02; 3715.021
Rule Amplifies: 3715.27
Prior Effective Dates: 4/28/2003)