The Low-Acid Canned Foods regulation in 21 CFR Part 113.40(a) states the following:
(1) Temperature-indicating device. Each retort shall be equipped with at least one temperature indicating device that accurately indicates the temperature during processing. Each temperature indicating device shall have a sensor and a display. Each temperature-indicating device and each reference device that is maintained by the processor shall be tested for accuracy against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology (NIST), or other national metrology institute, standard reference device by appropriate standard procedures, upon installation and at least once a year thereafter, or more frequently if necessary, to ensure accuracy during processing. Each temperature-indicating device and each reference device that is
maintained by the processor shall have a tag, seal, or other means of identity.
Processors of low-acid canned foods have the option of replacing the mercury-in-glass thermometer with another instrument of equivalent accuracy, and many are doing so simply because they do not want mercury or glass on the processing floor. Processors should adopt the requirements highlighted above for their own calibration programs—i.e., maintaining records of the accuracy checks and tagging the instrument so that it is clear when the instrument was last tested for accuracy. This applies to all instruments including recorder charts, handheld devices, infrared thermometers, and any others. Calibration may be done internally or by a competent metrics company and, in some cases, must be done by regulatory agencies.
The next step is to make sure that any person assigned to monitor temperature understands not only how to do the job, but also why they are doing it and why it is important. Educating personnel requires that procedures be developed and properly documented and that the educational process focuses on the written procedures. It is a bad idea to conduct training or education programs without using documented protocols. Why? The session may miss a point or fail to emphasize something important.
Remember the old parlor game in which someone whispers something to someone in a group, and that person passes it on to the next person, and so on around the table. The message received by the last person is usually vastly different from the original message.
The educational sessions should also include hands-on work on the floor. These sessions often employ more experienced and/or longer-employed staff as mentors and evaluators. Programs often mandate that the more experienced staff “sign off” on the trainee’s competence. The procedures and training sessions should emphasize the following:
- Records should be recorded immediately on the form or electronically. Results should never be recorded on a separate piece of paper for transfer at a later time.
- If using hard copy forms, neatly record results and the time of the observation. Sign or initial the records neatly.
- The operator should check the recorder chart at regular intervals and neatly sign or initial the form and note the time of the observation. It is important to routinely check the recorder charts for several reasons. If the temperature begins to drop, then the operator may be able to make an adjustment, thereby preventing a deviation. Regular checks will also let the operator know that the chart recorder still has ink. If the recorder runs out of ink, then any time period that is blank would be deemed a deviation.
References:
i. U.S. Food and Drug Administration (FDA). Code of Federal Regulations. Title 21, Ch. I, Subpart B, Part 117. “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.
ii. FDA. Code of Federal Regulations. Title 21, Ch. I, Subpart B, Part 113.40. “Equipment and Procedures.”
iii. Falkenstein, Drew. “The 2007 Castleberry Farms Botulism Outbreak.” Food Poison Journal. February 25, 2015
iv. Centers for Disease Control and Prevention (CDC). “Botulism Associated with Commercially Canned Chili Sauce—Texas and Indiana, July 2007
Article by: By Richard F. Stier, M.S.