Dry Operations & Recalls
Dry operations are tricky. They are called dry operations not only because the finished product may indeed be dry, but also because water is the enemy of the products. Water creates a greater risk for the pathogen Salmonella in the environment. When I think of dry operations, I think of dry ingredients: powders, spices, gums, thickeners, vitamin and mineral blends, flour, salt, and sugar. All food companies have dry storage for these dry ingredients; I am not addressing storage here, but processing and manufacturing of these ingredients. For every dry ingredient purchased by a food facility, there is a food company making that dry ingredient.
Being from America’s Dairyland (Wisconsin), I have been in five different spray-dry facilities in the past two and a half years that were producing spray-dried milk or whey – or both. Dry. Nut roasting is dry. Peanut butter operations are dry. Chocolate – as an ingredient and chocolate manufacturing – are dry. Water is the enemy and creates an environment where the risk of Salmonella is greater.
This brings us to cleaning and sanitizing. For most of dry operations, production does not stop. (Everyone working in a wet-clean operation just gasped!) It’s true. If the equipment can keep running, it does. There may be short shutdowns for minor repairs or adjustments, but the equipment keeps running. Most of these dry-ingredient manufacturers do business on a small profit margin and can’t afford to shut down. When the equipment does go down for cleaning, it is a big deal and may take days or a week to clear the lines, make repairs, clean, sanitize, completely dry, and start back up. Most companies discard a substantial portion of the first product out in case a pathogen in the lines was cleared at start up. The cost to the company is significant.
Then there is the equipment that is never cleaned. In some operations, it is just not possible during a normal shutdown to take apart and open certain pieces of equipment for cleaning. In the event of a recall, it means that there never was truly a clean break. FDA looks to companies to inform them on when the last clean break occurred. With a clean break, a company has evidence to shorten the span of a recall back to that last clean break. This reminds me of a company I was in that had four large tanks of melted chocolates, and the different chocolates were drizzled on the top of the product. It was heaven for this chocoholic, until I learned that the large tanks were never emptied. Never. This is standard practice throughout industry. The company had a clever way of cleaning the equipment that dispensed the chocolate, but not the mother tanks. The question becomes: in the event of a recall, would the company recall all product in market with that particular chocolate?
Without a clean break, how does a company determine how far back to go for a recall? One way to determine the cut-off date is to stop production, call in a consultant to investigate, and collect hundreds of swabs for the determination of root cause. This takes time, and the company has an obligation to inform customers of the recall and may not have enough time.
My suggestion to owners of dry operations is to schedule an annual shutdown for repairs and complete cleaning and sanitizing. I know this is a huge cost. Your CFO can calculate the ultimate cost for this shutdown of production. Then calculate the cost of a recall. In addition to the cost of recalling all product from the market, what is the cost of loss of customers? This Cheesehead is going to continue to learn from clients of dry operations and formulate best practices for cleaning and sanitizing of dry operations. Please share your thoughts with me. Food safety is not competitive.
Matthew Botos, CEO of connectfood.com agrees, saying: “Dr. Knutson makes excellent points in this post. When dealing with any good manufacturing operation you must understand the hazards. This is why FSMA plans require a hazard analysis. Dry plants, as pointed out, have moisture as a concern for potential human health issues.”
The ConnectFood website has free resources, and the folks at ConnectFood are here to help! The online service allows you to complete a facility hazard analysis. Contact us.
About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd