KANSAS CITY, MO — Day-to-day, the responsibility for staying on top of shifting audit requirements lands on the quality assurance team. Legally, however, the food safety buck stops with senior leadership as determined by the Responsible Corporate Officer (RCO) Doctrine, also known as the Park Doctrine, which dates back to a 1975 US Supreme Court ruling.
“The first questions the FDA will ask when it comes into a facility is, ‘Who is the chief operating officer?’ and ‘Who is the president?’” said Gale Prince, founder of Sage Food Safety Consultants.
Bakeries with air-tight internal food safety management systems — the key to acing third-party audits and government inspections — have a few things in common. First, they have an organization-wide culture of food safety led by the c-suite. That means they hold every employee accountable for understanding — and following — food safety requirements and best practices. Additionally, they view their internal programs through the lens of continuous improvement vs. something that must be done solely for compliance purposes.
“When you’re doing internal audits, your list should be longer than the auditor’s,” said Jim McBride, VP of quality assurance at Chicago-based Schulze & Burch Biscuit Co. “If you can find it and correct it, then that doesn’t leave anything for them to find.”
Establishing a top-down culture of food safety requires a significant investment of time from the senior leadership team. At Schulze & Burch, the first 15 minutes of weekly senior management meetings are set aside for food safety.
“We plug in a different program every week,” McBride said. “Senior management can hear what we’re focusing on internally and see the trends and charts. It gives them a platform where they can ask questions. We do it all virtually, which allows us to roll in our remote sites. We’ve found that doing it ‘bite-size’ like this allows focus and interaction.”
At Thomasville, GA-based Flowers Foods, leadership created a food safety mission that recognizes and upholds the importance of a food safety culture.
“Food safety culture is about more than simply following a checklist of regulations and standards; it’s a way for bakery teams to know what’s right, what’s wrong, and how to focus as a team on a solution through shared practices and solutions,” said Molly Schmidt, senior VP of food safety, quality and regulatory at Flowers Foods. “Our network of food safety champions across the organization provides consistent messaging and reinforcement and helps us identify opportunities for ongoing training and awareness of food safety principles.”
Beyond meetings and mission statements, however, visible engagement from the leadership team is essential.
“CEOs need to show interest and involvement,” Prince said. “Sometimes you need to show up at two o’clock in the morning when the sanitation crew is there.”
Food safety is just one reason why bakery leadership isn’t a 9-to-5 role.
“The time for senior management to walk through the plant is not when they follow the auditor around,” McBride echoed. “The time for senior management to walk through the plant is the month before the auditor arrives.”
Engagement also means allocating capital to infrastructure upgrades, including equipment that meets food safety certification standards.
“Hygienically designed equipment is fundamental to food safety,” noted Jon Anderson, managing consultant with Bakery Equipment Assessment Group (BEAG). “When a bakery equipment manufacturer follows the BEAG equipment certification process and conforms to the ANSI/ASB/Z50.2-2015 standard, they provide the baker with an essential advantage in establishing an effective product safety program and compliance with regulatory and certification inspection requirements.”
Keeping tabs on what may be coming down the pike in terms of government regulations and audit requirements is just as important as staying on top of internal audits. Industry organizations such as the American Bakers Association (ABA) serve as conduits of information between bakers and regulatory bodies.
One rule ABA and industry consultants are keeping their eye on is the food traceability rule.
“It’s the last of the series of the Food Safety Modernization Act regulations, often referred to as the FSMA Section 204 rule,” said Rasma Zvaners, VP of regulatory and technical services for the ABA. “The compliance date for this is January 20, 2026, so this is one we’re continuing to monitor.”
As the date draws closer, Ranjeet Klair, a food safety director at The Acheson Group said at least one retailer is requesting stricter traceability requirements than what the rule will require.
“Where the industry wants a traceability exercise to be done once a year, this retailer wants it done two times a year,” she shared.
Zvaners added that bakers can also expect to feel the impact of the US Food and Drug Administration (FDA)’s restructuring plans, announced earlier this year. The latest progress was the late-August appointment of Jim Jones as the first deputy commissioner for human foods.
“That’s something that will likely play a role in how the agency moves forward with compliance,” Zvaners said. “There are several moving pieces, and we’re going to monitor that to see how it impacts our industry, both in food safety and nutrition policy.”
Also on the audit horizon is the likelihood of more FDA inspections.
“We can anticipate the FDA is going to be doing more plant inspections, and they’re going to be in far greater detail than we’ve ever seen before because of FSMA and the training the FDA has done with its inspection staff,” Prince said.
Bakers should also prepare for the return of unannounced government audits. When the COVID-19 public health emergency expired in May, FDA ended its pandemic-era policy of pre-announced full-scope inspections for FSMA.
While meeting additional audit requirements can add yet another layer of complexity to the daily challenges that come with food production, Prince encourages bakers to consider the benefits, especially in terms of continuous improvement.
“A third-party auditor evaluates your operation with a fresh set of eyes and a broad knowledge of what they are seeing in other facilities,” Prince said. “It becomes a training tool for not only the managers, supervisors and vice presidents but also for the people working on the line. It’s another piece of your food safety culture.”
This story has been adapted from the October | Q4 2023 issue of Commercial Baking. Read the full story in the digital edition here.
