The recorder is not the official monitoring device. A now-defunct business named Castleberry’s had a botulism issue a number of years ago.3,4 Missing temperature monitoring devices on retorts was one of the problems that contributed to the botulism outbreak. In total, 14 people in seven U.S. states contracted botulism poisoning from consumption of the company’s “Hot Dog Chili Sauce” and other products that were under-processed. The outbreak ultimately led to the closure of the company’s Georgia canning operations in in March 2008.
Recordkeeping forms should be designed for ease of use. Ensure there is adequate space to record all results so that they are easily visible to reviewers and auditors. If an incorrect result is inadvertently entered on a form, that number should be lined out, initialled, and dated, and the correct value should be entered. The operator should then make a note on the form explaining the correction. The incorrect entry should never be erased or covered up. Such an action would be deemed a falsified record. Another useful addition to any recordkeeping form for temperature monitoring is to include the target temperatures and what to do in the event of a deviation. If those values are on the form and easily visible, then there should be no question about what is and is not an acceptable value.
Part of the educational process must include how the operator should handle deviations. How a deviation is handled depends upon the product and process. For products that are processed using high-temperature/short-time processes such as pasteurized foods and beverages, aseptic puddings,
juices, and sauces, temperature drops are detected and diverted by a flow diversion valve. The low temperature product usually goes back to a surge tank, from which it circulates until the proper temperature is achieved. If a system has a flow diversion valve, then the startup process should include a test while running water through the system. If the temperature drops below the target, it will divert, indicating that the flow diversion valve is functioning. Any procedure that addresses how to handle deviations should include notification of management. The management team is ultimately responsible for making the decision on the product in question.
The bottom line is that temperature monitoring is more than writing numbers on a form or entering data into a spreadsheet. Operators and recorders must be properly educated on not only how to do the work, but also why it is important—as well as the ramifications of failing to properly do the work. Remember Castleberry. Where would the growth continue – would the use of rapid microbiological method use in commercial labs continue to drive, or if a plateau is likely to occur? Will rapid microbiological method technology evolve to the point where it may be acceptable to bring back the analysis to an in-house lab? Look for answers to those questions and others with us as the industry continues to grow and evolve
with the everchanging times.
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.