The person-in-charge: Is exempt from this regulation if: They meet the definition of a qualified facility in 21 CFR §117.3; or They meet the qualifications defined in: 21 CFR §§117.5—117.8; 21 CFR §117.201; 21 CFR §§117.251—117.287; and 21 CFR §117.315(a)(2); Shall ensure that a food safety plan: Is prepared, implemented, and managed by one or more individuals qualified in preventative controls; Is signed and dated by the owner, operator, or agent in charge: Upon initial completion; When any modification takes place; and At least once every 3 years; Includes a written hazard analysis that identifies all known and reasonably likely to occur biological, chemical, and physical hazards associated with each type of food manufactured in the plant; Includes written procedures for: Preventive controls; Process controls with parameters and values; Allergen controls; Sanitation controls; Other controls necessary as identified in the hazard analysis; Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard; Corrective actions that: Identify and correct the problem; Reduce the likelihood the problem will recur; Evaluate all affected food for safety; and Prevent all affected food from entering commerce; Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards; Validation for process controls; A supply chain program that complies with 21 CFR §§117.405—117.475 if the receiving facility has identified a hazard requiring a supply-chain-applied control; and A recall plan for a food with a hazard requiring a preventive control, that includes: Maintaining accurate records to identify the initial distribution of the food; Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food; Public notification about any hazard presented by the food when appropriate to protect public health; and Effectiveness checks to account for all products affected; Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards; Includes records that document implementation of: The food safety plan monitoring; Corrective actions; and Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor; Includes that records of monitoring and corrective actions are reviewed by a preventive controls qualified individual within 7 working days after the records are created, or within a reasonable time frame; and Includes that records of verification activities are reviewed within a reasonable time by a preventive controls qualified individual; and Shall ensure that a processing plant complies with the 21 CFR §§117.136—117.137 and 117.335 if results of the hazard analysis determine the facility is not required to implement preventive controls for a food item.