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Food Safety Command Center 20 items

Low-Acid Canned Food (21 CFR 113) Checklist

Verify thermally processed low-acid foods packaged in hermetically sealed containers are controlled to prevent Clostridium botulinum, covering scheduled processes and process controls.

21 CFR 113FDALACF

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Scheduled Process & Process Authority

  • Is a scheduled process established by a qualified process authority for each product, container size, and equipment? *
  • Are scheduled processes on file and available at the establishment? *
  • Are critical factors specified in the scheduled process (fill weight, consistency, headspace, pH) monitored and controlled? *
  • Is the plant registered and each process filed with FDA (FCE and SID)? *

Operator Training

  • Have retort and processing system operators completed a recognized Better Process Control School course? *
  • Is supervisor training current and documented? *
  • Are operators knowledgeable of the specific processing and container closure operations they conduct? *

Thermal Processing Equipment & Controls

  • Is each retort equipped with an accurate mercury-in-glass or equivalent master temperature indicating device? *
  • Are temperature-recording devices installed and their charts compared against the reference device? *
  • Are venting schedules for still steam retorts followed to remove air before timing begins? *
  • Recorded retort come-up and process temperature (°F)

Process Monitoring & Records

  • Are initial temperature, process time, and process temperature recorded for each retort load? *
  • Are processing and production records reviewed and signed by a qualified person within one working day? *
  • Are records retained for at least three years? *

Container Closure & Integrity

  • Are container closures examined at intervals and results recorded (double-seam or seal evaluations)? *
  • Are seam measurements within specification for the container type? *
  • Are cooling water and post-process container handling controlled to prevent recontamination? *

Deviations

  • Is there a written procedure for handling process deviations, including product hold and evaluation by a process authority? *
  • Is product involved in a deviation segregated pending evaluation of its safety? *
  • Are deviation records maintained showing corrective action and disposition? *

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