(a) Whenever the actual process is less than the process schedule or when any critical factor does not comply with the requirements for that factor as specified in the process schedule, it must be considered a deviation in processing.

(b) Deviations in processing (or process deviations) must be handled according to:

(1) A HACCP plan for canned product that addresses hazards associated with microbial contamination; or,

(2) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or

(3) Paragraph (c) of this section.

(c) Procedures for handling process deviations where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.

(1) Deviations identified in-process. If a deviation is noted at any time before the completion of the intended process schedule, the establishment must:

(i) Immediately reprocess the product using the full process schedule; or

(ii) Use an appropriate alternate process schedule provided such a process schedule has been established in accordance with § 431.3(a) and (b) and is filed with the inspector in accordance with § 431.3(c); or

(iii) Hold the product involved and have the deviation evaluated by a processing authority to assess the safety and stability of the product. Upon completion of the evaluation, the establishment must provide the inspector the following:

(A) A complete description of the deviation along with all necessary supporting documentation;

(B) A copy of the evaluation report; and

(C) A description of any product disposition actions, either taken or proposed.

(iv) Product handled in accordance with paragraph (c)(1)(iii) of this section must not be shipped from the establishment until the Program has reviewed all of the information submitted and approved the product disposition actions.

(v) If an alternate process schedule is used that is not on file with the inspector or if an alternate process schedule is immediately calculated and used, the product must be set aside for further evaluation in accordance with paragraphs (c)(1)(iii) and (iv) of this section.

(vi) When a deviation occurs in a continuous rotary retort, the product must be handled in accordance with paragraphs (c)(1)(iii) and (iv) of this section or in accordance with the following procedures:

(A) Emergency stops. (1) When retort jams or breakdowns occur during the processing operations, all containers must be given an emergency still process (developed per § 431.3(b)) before the retort is cooled or the retort must be cooled promptly and all containers removed and either reprocessed, repacked and reprocessed, or destroyed. Regardless of the procedure used, containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or breakdown must be removed and either reprocessed, repacked and reprocessed and or destroyed. Product to be destroyed must be handled as “U.S. Inspected and Condemned,” as defined in § 301.2 of this chapter, or as “U.S. Condemned,” as defined in § 381.1(b) of this chapter, and disposed of in accordance with part 314 of this chapter or with § 381.95 of this chapter, as applicable.

(2) The time the retort reel stopped and the time the retort is used for an emergency still retort process must be noted on the temperature/time recording device and entered on the other production records required in § 431.7.

(B) Temperature drops. When the retort temperature drops below the temperature specified in the process schedule, the reel must be stopped and the following actions must be taken:

(1) For temperature drops of less than 10 °F (or 5.5 °C) either:

(i) All containers in the retort must be given an emergency still process (developed per § 431.3(b)) before the reel is restarted;

(ii) Container entry to the retort must be prevented and an emergency agitating process (developed per § 431.3(b)) must be used before container entry to the retort is restarted; or

(iii) Container entry to the retort must be prevented and the reel restarted to empty the retort. The discharged containers must be reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed must be handled as “U.S. Inspected and Condemned,” as defined in § 301.2 of this chapter, or as “U.S. Condemned,” as defined in § 381.1(b) of this chapter, and disposed of in accordance with part 314 of this chapter or with § 381.95 of this chapter, as applicable.

(2) For temperature drops of 10 °F (or 5.5 °C) or more, all containers in the retort must be given an emergency still process (developed per § 431.3(b)). The time the reel was stopped and the time the retort was used for a still retort process must be marked on the temperature/time recording device by the establishment and entered on the other production records required in § 431.7. Alternatively, container entry to the retort must be prevented and the reel restarted to empty the retort. The discharged containers must be either reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed must be handled as “U.S. Inspected and Condemned,” as defined in § 301.2 of this chapter, or as “U.S. Condemned,” as defined in § 381.1(b) of this chapter, and disposed of in accordance with part 314 of this chapter or with § 381.95 of this chapter, as applicable.

(2) Deviations identified through record review. Whenever a deviation is noted during review of the processing and production records required by § 431.8(a) and (b), the establishment must hold the product involved and the deviation must be handled in accordance with paragraphs (c)(1)(iii) and (iv) of this section.

(d) Process deviation file. The establishment must maintain full records regarding the handling of each deviation. Such records must include, at a minimum, the appropriate processing and production records, a full description of the corrective actions taken, the evaluation procedures and results, and the disposition of the affected product. Such records must be maintained in a separate file or in a log that contains the appropriate information. The file or log must be retained in accordance with § 431.8(e) and must be made available to Program employees upon request.