Validation. It’s not a word that piques most people’s interest when they first hear it. But if your occupation involves any food safety responsibilities you probably know validation is one of the most important things you do. Proper validation helps ensure the integrity of your company’s food safety programs. It’s one of the most common areas where non-conformities occur in food safety audits, and if not done properly can potentially lead to a recall, consumer illness, or death.
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Initial validation of food safety systems and its controls help make sure that each program works effectively. Revalidation acts as a secondary check on systems. During this process, employees and systems can be redirected if issues arise before they become serious concerns. Validation protects the company, its employees, customers, and consumers. Additionally, proper validation is an important part of developing a food safety culture—ensuring what we are doing is effective rather than just going through the motions because we think it’s what we’re supposed to do.
Learning from Recalls
The industry can learn a lot from companies that experienced recalls and regulatory action. One of the most well-known and widely-discussed cases of “what not to do” is the Peanut Corp. of America outbreak and recall in 2008-2009. The company made some bad choices, such as reportedly shipping product known to contain Salmonella, and having a facility ridden with pest activity, holes in the roof, and other food safety issues. One key mistake was not validating its programs. The company used its roaster as a control for biological hazards, and yet had not conducted any sort of validation to establish suitable process parameters to achieve a 5-log reduction of the target pathogen species. It’s also fairly obvious the company didn’t validate the effectiveness of its pest control and maintenance programs. If Peanut Corp. of America had process validation in place, it would have seen the gaps in its system and reacted accordingly.
In another example, Death Wish Coffee recalled its products in 2017. The company determined that although nobody had gotten ill at the time of the recall, there was a possibility of botulism from its nitrogen-infused product. The risk was due to the product’s formulation and lack of a process for eliminating the risk of Clostridium botulinum growth.
These instances show that any one company can have a very real impact on the entire food industry. In 1996, Odwalla was involved in a recall caused by improper validation. The company sold products containing apple juice that wasn’t pasteurized and had E. coli 0157:H7. More than 65 individuals became ill from the products and one child passed away. As a result, the FDA interjected itself into industry practices and shortly thereafter created regulations requiring all juice be pasteurized through a valid system.
There are other relevant outbreaks and recalls in the industry in which processes were not validated and consumers suffered the repercussions. Suffice it to say, the importance of validation in a food safety program cannot be overstated.
FDA’s View on Validation
The FDA applies validation in a relatively limited way for the food industry. According to the Food Safety Modernization Act’s Preventive Control Qualified Individual (PCQI) course, of the four kinds of preventive controls, only process preventive controls are required to be validated. In the PCQI training, Lead Trainers also discuss how a company may, in some cases, validate an allergen preventive control. In this instance, think of a clean-in-place (CIP) system, where process parameters such as time, temperature, fluid flow rate, and chemical concentration can be consistently managed, allowing the process parameters to be validated as effective.