Today there's more emphasis than ever on keeping the food produced and the people who make it safe while maintaining compliance with shifting regulations.
We checked in with Jessie Leal, a food safety auditor with AIB International, who spoke to TraceGains about the latest plant sanitation practices.
“One of the things I’m seeing is that we’re consistent with training, but the knowledge of how chemicals work and which chemicals to use for sanitation is lacking,” Leal said.
Origins of Food Safety
“The first food regulations emerged in the United States in 1906. Over the years, there have been numerous changes, with some of the most recent changes in 2011 with the Food Safety and Modernization Act and 2016-17 with essential contamination rules. But the importance of these,” Leal stressed, “is the what, the why, and the how.”
The what of clean and safe food.
The why is that companies have both a legal and moral responsibility when it comes to safe food.
The how of understanding and complying with established regulations.
“One of the things we have to understand and get better at is complying with established prerequisite programs,” Leal said. “It’s not that companies only had to worry about 402(a) (3) of the Food, Drug, and Cosmetic Act when it came to plant inspections in the past. Under that rule, investigators had to find credible and verifiable contamination or adulteration.”
“What that means is, if you had a customer complaint, the regulatory folks would come in and have to find the foreign material or the contamination in the product,” Leal explained. “Now, under 402(a) (4), auditors only have to find conditions present that could lead to contamination or adulteration. So, what that means is they don't have to find contamination in your product, they only need to find conditions that may indicate adulteration or contamination may exist,” Leal added.
CDC Regulations Raise the Bar
But even these new, stricter standards might not be enough to address the latest CDC requirements aimed at COVID-19 concerns in food plants.
“I can tell you, based on several inspections I've done in the last several weeks, that plants are already ramping up their programs and inspectors are already leveraging the new guidelines and regulations from the CDC,” Leal said. “They're starting to look at what plants are doing to mitigate COVD-19, like observing and verifying that employees are properly washing their hands. I say ‘properly’ because, unfortunately, we probably need to do a better job of training our employees on the proper washing and sanitizing of their hands.”
The other thing inspectors are looking at is sanitation procedures and verifying that the plant can defend their food safety programs and sanitation programs, so Leal urges companies to prepare.
“There’s going to be some changes in the future. They’re going to be looking at what companies are doing to manage employee symptoms of illness,” Leal said.
From 2006 to 2018, Leal outlined items in the top five list of issues FDA inspectors found during food plant visits:
Personnel violations, such as handwashing and not hairnet usage.
Screening for pests, which goes along with pest exclusion.
Sanitation of floors, walls, and ceilings has been in the top five for the last 16 years except 2019.
“How do we measure good sanitation programs?” Leal asked. “We can’t rely on the old visual approach of observing equipment and contact surfaces. We have to make sure sanitation programs are comprehensive.”
Signs of a good sanitation program include a lack of recalls, fewer customer complaints, and a favorable regulatory history.
Leal outlined the steps in an effective sanitation program, which include:
Assess the needs.
Assess the risks.
Review available resources.
Implement the program.
Review the program.
Continually refine and improve the program.
Leal pointed to a few GMPs and the roles they play in food safety:
117.10: Personnel practices. How employees handle products and the personnel practices of hairnet usage, snacking, and eating.
117.20: Plant, grounds, and sanitary facilities and operations.
117.35: Sanitary operations of the facility.
How and what to clean.
Are you using the right chemicals for cleaning and sanitizing?
Are you sanitizing, or are you just cleaning?
Cleaning is the removal of dirt accumulation.
Sanitizing is the killing of bacteria and microbes.
117.40: Equipment and utensils.
"These aren't the only regulations," Leal pointed out. "These are the ones with the most direct impact on sanitation, and, ironically, these are some of the easiest ones to resolve."
"It's essential for everyone at your company to understand the financial impact of not maintaining the facility properly. I often ask students in my classes what product integrity means to them," Leal recalled. "And once a student said that product integrity is doing it right even when nobody's looking. That's the right answer."
How can a robust environmental monitoring program complement your prerequisites?
"You can't see microbial activity or pathogens with the naked eye. In some cases, you need environmental monitoring programs to test and swab, such as ATP, which confirms what's on the surface. That's invaluable information because then we know the level of sanitation."
How can employee cleaning practices, as well as personnel practices, impact microbial concerns?
"This is huge," Leal said. "If employees don't understand the chemicals they're using, and if they don't understand the temperatures required for certain chemicals to work, then effective cleaning and sanitation are at risk. Many plant employees also don't understand the difference between disinfecting, sanitizing, sterilizing, and cleaning."
Disinfecting depends on the chemicals used and how long the chemicals are left on a surface to kill germs.
Sanitizing is killing bacteria germs and reducing the amount of microbial life to a safe level.
Sterilizing is eliminating all microbial growth on a surface.
Cleaning is removing the soils from the surface.
Impact of Poor Sanitation
Infestation on equipment and overheads "Many plants have cleaning schedules within a two to three-week period. They do that to try and break the insect life cycle and prevent infestations from egg to larva to adult. If you find an infestation on equipment and overheads, you're not breaking those cycles, and you've missed something," Leal said.
Infestation in product spillage and storage areas “Product spillage isn“t necessarily what insects eat. The insect eggs could be in the product itself. And if you don’t get to that promptly, you’re going to allow insects to develop,” Leal added.
Infestation in electrical panels “Certain insects like the cigarette beetle or the warehouse beetle, like warmer areas, such as electrical panels,” Leal explained.
Product zones “Product zones might have a visual residue from a prior product made, which could even be an allergy concern,” Leal said.
Areas adjacent to product zones “It can be a problem when areas adjacent to product zones are not well-cleaned, and there’s a buildup of old residues,” Leal said.
Utensils and containers “Utensils and containers are very easy to miss and can show up as trouble spots in FDA inspections,” Leal shared.
“Except 2018 and 2019, finding pests was the top issue found in plants. They’re looking at this very closely. And what does the rule say? According to the FDA, plants should be free from pests, whether they’re alive or dead,” Leal said.
Other Requirements Impacting Sanitation
Chemical control programs “It’s incredibly important that your employees are using chemicals properly, and employees understand temperature requirements. For instance, caustics are more effective with hot water, but with acids, it doesn’t matter if you use cold or hot water,” Leal explained.
Benefits of proper equipment design “If you can’t get into the equipment to clean it, that's a problem. It would be best if you made sure equipment is designed for accessibility to allow proper sanitation. Equipment design has an impact on microbial and pest development,” Lead added.
Principles of Inspecting “You have to know what you’re looking for during an inspection. Do you know how to audit, inspect, and find these issues, and do you know how to correct the problems you uncover? You have to understand the conditions and the environment for microbial concerns. If you’re using allergens, you have to know what to do to ensure there's no cross-contact,” Leal explained.
“Are you practicing what you learn? Are you communicating with your employees and making sure they’re looking at the root cause to correct them? Finally, you have to focus on the entire facility – inside out. Remember, no one should know your plant as well as you do,” Leal said.
A Better Way
Many companies still manage quality assurance with clipboards and other manual processes, which makes preparing for audits challenging. Fortunately, there's a better way.
Quality Management helps companies drive continuous improvement to store and analyze quality control and safety data in a single system, providing immediate insight into plant floor and quality operations. Forms once kept in binders, and filing cabinets are digitized, so when data is gathered electronically on the plant floor, it’s automatically matched with compliance standards and critical benchmarks.
Audit Management automates and streamlines the entire audit process. Teams can schedule, conduct, and track audits on a single platform using a desktop or mobile device. Users can customize their audit checklists or use pre-loaded templates. Notifications, workflows, and task assignments help track audit teams’ progress, and real-time reporting flags key findings and corrective actions.