(6) Any additional information needed to ensure appropriate monitoring of the preventive controls.
(b) The owner, operator, or agent in charge of a facility must monitor the preventive controls with sufficient frequency to provide assurance that the preventive controls are consistently performed.
(c) Monitoring of preventive controls in accordance with this section must be documented in records that are subject to verification in accordance with SEC 507.45(b)(1) and records review in accordance with SEC 507.45(c)(1)(i) and (c)(2).
SEC 507.42 Corrective actions.
(a) The owner, operator, or agent in charge of a facility must establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented. The corrective active procedures must describe the steps to be taken to ensure:
(1) Appropriate action is taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur;
(2) All affected animal food is evaluated for safety; and
(3) All affected animal food is prevented from entering into commerce if the owner, operator, or agent in charge of the facility cannot ensure the affected animal food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.
(b) If a preventive control is not properly implemented and a specific corrective action procedure has not been established, or a preventive control is found to be ineffective, the owner, operator, or agent in charge of a facility must:
(1) Take corrective action to identify and correct the problem to reduce the likelihood that the problem will recur;
(2) Evaluate all affected animal food for safety;
(3) As necessary, prevent affected animal food from entering commerce as would be done following the corrective action procedure under paragraph (a)(3) of this section; and
(4) Reanalyze the food safety plan in accordance with SEC 507.45(e) to determine whether modification of the food safety plan is required.
(c) When corrective actions are taken, they must be documented in written records. These records are subject to verification in accordance with SEC 507.45(b)(2) and records review in accordance with SEC 507.45(c)(1)(i) and (c)(2).
SEC 507.45 Verification.
(a) Except as provided by paragraph (a)(3) of this section, the owner, operator, or agent in charge of a facility must validate that the preventive controls identified and implemented in accordance with SEC 507.36 to control the hazards identified in the hazard analysis as reasonably likely to occur are adequate to do so. The validation of the preventive controls:
(1) Must be performed (or overseen) by a qualified individual:
(i) Prior to implementation of the food safety plan or, when necessary, during the first 6 weeks of production; and
(ii) Whenever a reanalysis of the food safety plan reveals the need to do so;
(2) Must include collecting and evaluating scientific and technical information (or, when such information is not available or is insufficient, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards that are reasonably likely to occur; and
(3) Need not address:
(i) The sanitation controls in SEC 507.36(d)(2); and
(ii) The recall plan in SEC 507.38.
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