A September 2024 Gallup poll revealed that nearly 30% of U.S. adults have little to no confidence in the safety of U.S. foods at the grocery store. Considering recent recalls, is it any wonder? What good is a quality control program if it doesn’t include food safety?

Boar’s Head’s Jarratt, Virginia, liverwurst plant—closed recently due to a serious outbreak of Listeria monocytogenes (Lm)—isn’t the first facility to have a resident strain of the bacteria that caused a recall of several products and/or closed the facility (in some cases, permanently). In October 2024, BrucePac recalled 11,765,285 pounds of ready-to-eat chicken due to possible Lm contamination, which affected a large number of manufacturers’ products (USDA update 10-17-24).

In June 2024, Totally Cool recalled all its ice cream products due to an outbreak of Lm. In 2015, Blue Bell shut down its Broken Arrow, Oklahoma, facility—and Food Engineering reported issues at other plants going back to 2013. Today, after many repairs, Blue Bell facilities are back in operation.

Although a facility might have a quality control program that inspects packaging or product defects, perhaps the better question is whether a processor has an all-encompassing QC program that places priority on food safety.

The U.S. Department of Agriculture’s Food Safety and Inspection Services (FSIS) found several unsanitary conditions at the Boar’s Head facility, potentially causing or harboring Lm infestations. Situations like this can be avoided with an extensive QC program that includes food safety measures and procedures. Although this article concerns itself with the food safety aspects of quality control, more can be found on defect control in the U.S. Food and Drug Administration’s “Food Defect Levels Handbook” online.

In establishing a QC program to ensure food quality and safety, organizations should include, among other considerations: appropriate building and structure cleanliness/maintenance; employee training; proper equipment cleaning and maintenance; regular testing of product throughout the production cycle; well-documented Hazard Analysis and Critical Control Point (HACCP) and food safety/QC programs; and adherence to FDA’s FSMA preventive controls.

The basics: Start with people

How does a processor evaluate whether it has a sufficient QC program in place? Are HACCP programs alone sufficient to establish an effective QC program? Can automation help fix the problem?

“One place that automation will never be able to replace humans is in managing company culture,” says Aaron Pfeifer, principal at Atlas OT, a member of the Control System Integrators Association (CSIA). “Even with all of the best tools in place, such as QC programs that require photo evidence, explicit check sheets, and QR and bar code scanning of equipment, a company culture of turning a blind eye will always find a way around mandates and procedures.

“Companies need to drive a culture of constant improvement and reward employees who speak up about infractions or safety concerns, not admonish them,” Pfeifer says. “Many companies focus on the bottom line by cutting corners to save costs at the expense of long-term breakdowns in procedure, ultimately leading to loss in profits, which require more cost and corner cutting.”

Testing and standards only go so far. According to Adam Richards, food safety engineer at Gray Solutions, a CSIA member, it’s people that matter. “Finished goods and environmental test results are key to understanding how robust your quality control program is,” he says. “The prerequisites that accompany a healthy HACCP program include—but aren’t limited to—quality standards, internal audits, training and competency, sanitation and environmental monitoring program (EMP), pest control, food defense, management review, and continuous improvement. The key to a great food safety program is training your employees to know what hazards [their jobs entail] and how they can minimize their impact. Creating a food safety culture is prevalent as you set the expectations upfront and hold your employees accountable for finished goods results.”

The FDA had linked HACCP and Hazard Analysis and Risk-Based Preventive Controls (HARPC) programs, but has renamed HARPC “preventive controls.” Today, if an analysis reveals a potential hazard, then a preventive control must be defined and implemented to prevent a food safety issue. A food safety program works like a feedback loop, periodically requiring a reevaluation and reanalysis to discover any changes to any part of the process. Image courtesy of FDA.

What constitutes a good QC program

“To evaluate whether a processor has a sufficient QC program in place, it’s important to go beyond just having an HACCP plan,” says Ana Lozano, Neogen Food Safety technical services and specialist manager. While HACCP is a foundational component, ensuring that the program is effective requires validation, monitoring, and verification steps.

Validation ensures that the preventive controls and critical limits defined in the HACCP plan are scientifically and technically reliable, and will prevent or control the identified hazards. This could involve microbiological testing or environmental monitoring to confirm that the controls are working.

Monitoring involves continuous or periodic checks during production to ensure that the preventive measures are being followed consistently. It’s key to catching potential issues before they lead to a larger problem.

Verification ensures that the system is working as intended over time. It includes reviewing records, conducting audits, and product testing to confirm the effectiveness of the controls.

However, Lozano says these steps alone are insufficient without a strong food safety culture. A processor must promote a culture where employees at all levels understand the importance of food safety and feel empowered to report issues or take corrective actions.

An HACCP plan paired with mandatory software enforcement and a single, digital source of truth for capturing required testing results provides greater support for quality control programs, says Jim Bresler, Plex director of product management, food and beverage. An HACCP plan should also cover building and structure cleanliness, ensure the use of safety materials (like rat traps), and conduct proper enforcement of these standards through mandatory check sheets.

Facilities and equipment: Replace or repair?

“Quality control often hinges on the facilities and environments where work takes place,” says John Robertson, vice president of food and beverage and consumer packaged goods at Life Cycle Engineering. Companies must regularly assess their facilities to ensure they meet the necessary quality standards for both the plant and the products being produced. This means identifying potential risks and pinpointing areas that could lead to noncompliance, especially in older facilities.

A strong hygiene monitoring program, which includes tools like ATP testing and indicator organism testing, is critical for identifying trends and pinpointing potential hot spots where bacteria might reside and spread, says Taylor Lecy, Neogen field application scientist. By regularly monitoring and tracking these trends, a processor can better understand which areas or equipment could present risks.

The first line of defense is a dedicated quality assurance team that actively evaluates risk levels and stays current with best practices, says Robertson. Inspectors for regulatory bodies such as the USDA and FDA provide another layer of oversight. Additionally, hiring independent experts specializing in a specific food industry to conduct a preemptive risk assessment can offer valuable insights before official inspections. If a facility continues to face significant compliance failures, it may be time to consider a comprehensive redesign or even relocation.

Design for reliability

Reliability starts at the design phase of any food and beverage production facility. Equipment must be designed and selected not just for initial performance but also for its long-term reliability to ensure quality control. When new equipment is purchased, or when facilities are expanded, reliability considerations should be integral to the decision-making process. Design for reliability (DfR) ensures that the equipment chosen is durable, easy to maintain, and resistant to the rigors of continuous production.

“This approach also extends to the physical layout of a production facility,” says Robertson. “For example, designing a facility with easy access to equipment for operations and maintenance activities, or with proper environmental controls to avoid equipment degradation, can significantly improve long-term reliability, ensure that maintenance becomes manageable, and maintain both food safety and production uptime.”

If the facility and equipment can’t be cleaned to a satisfactory level, or if the facility/equipment has degraded, then changes must be made, says Richards. These changes could be procedural, chemical, or  financial. Food safety inspectors or structural engineers would be a good resource when deciding whether a facility is beyond repair. Equipment built 20-plus years ago likely has hollow tubing for the framework, a red flag for an auditor because it’s one of the most common infractions regarding harborage. There should be no holes in the hollow framework to allow pest intrusion or water to gain entry, which could allow bacteria to grow.

“An ‘easy fix’ in a legacy building, where persistent bacteria are harboring, such as Listeria or Salmonella, isn’t an easy task,” says Timmerman. “Razing an existing structure would seem like the most efficient approach, but it is very capital expenditure-intensive and would be very disruptive for the total operation. Based on the findings of a gap assessment, the deficiencies need to be addressed, while also considering the requirements for food-safety management system documentation, staff training, and upgrading buildings, equipment, and infrastructure.”

“All structures that require repair should be prepared and properly treated in full isolation of adjacent lines that are still in production, so that all possible cross-contamination routes are controlled,” Timmerman says. “This will require careful planning, including for timing, specialized teams and  contractors, and the requirements of hygienic building design.”  

Testing and sampling for bacteria

Environmental monitoring programs (EMP) are integral in ensuring product safety and regulatory compliance for food manufacturers, says Timmerman. They involve systematic sampling and testing of the production environment for potential sources of contamination, such as pathogens, allergens, and other contaminants.

Essentially, an EMP is a scientific method of validating the effectiveness of food safety systems. EMPs for food safety also facilitate compliance with regulatory requirements set by agencies like the FDA and USDA, align with the standards of the Global Food Safety Initiative (GFSI) benchmarked food safety certification platforms, and help maintain product quality and brand reputation.

Food processors must perform a risk assessment for their EMP, says Annie Simmons, Neogen Food Safety field application scientist. This starts with mapping out their zones and identifying all testing sites within each zone. A risk-based approach is then used to rate each sample location to determine the testing frequency.

Some risk factors that should be considered while rating each sample site location include:
• Proximity to food
• Accessibility to cleaning and testing
• Equipment age, material, and condition of surface
• Potential for cross-contamination
• History of area that is testing positive

The harder the area is to clean and the closer it is to food, the greater the risk, says Simmons. High-risk areas are put on a high testing frequency, such as daily. Lower-risk areas (those that are farther away from food and easiest to clean) will be put on a lower testing frequency, such as monthly.

Setting up a QC program: Some pointers from the experts

“Many startups begin by buying low-cost equipment individually from different manufacturers without considering how to fully integrate all the individual islands of automated equipment,” says Pfeifer. “Companies should be designing their facilities with a fully integrated data management and reporting system in mind. This could be an OEE, SCADA, ERP, or other system to aggregate important data such as equipment runtimes, product quality, maintenance schedules, operator actions, and QC data.”

“Automation vendors provide procedure management software that allows processors to electronically specify what needs to be done, enforce the execution of these requirements, and capture ample information to verify how these tasks had been performed,” says John Parraga, director at ECS Solutions. “The activities to be specified include those performed by the automation equipment as well as the many activities required to be performed by operators.”

“There are multiple online tools and trainings to help create a food safety program,” says Richards. “The FDA has a Food Safety Plan Builder that will guide users. Creating an HACCP plan to encompass all hazards associated with incoming ingredients, as well as process steps, is crucial when starting up a new facility. When discussing hazards associated with process steps, consider hazards that the employees could intentionally or inadvertently present as well.”

“Implementing a new quality program or enhancing current programs involves a strategic and multifaceted approach that takes into consideration production and maintenance planning, proactive shutdown, changeovers, and startup procedures,” says Robertson. “This strategy should also include design for reliability, employee training, and validation of skills and abilities in EHS and QC protocols.”

“Implementing a robust food safety and quality system is critical for any food processing facility, especially for startups looking to scale up their production,” says Lecy. “A great starting point would be to align with regulatory frameworks like the Food Safety Modernization Act (FSMA) preventive controls in the U.S. and Safe Food for Canadians Regulations (SFCR) preventive controls in Canada. These regulations provide a solid foundation for creating a QC program that addresses food safety and quality through preventive measures, hazard analysis, and critical control points.”

“Implementing an effective food safety management system can be challenging but is essential in the operation of a food processing facility,” says Timmerman. “It requires a dedicated team and support from senior management. This process involves planning, budgeting, management involvement, and ongoing performance monitoring. In all different prerequisite programs, some third parties like Diversey can offer services and dedicated tools to assist new startups.”

To determine what organisms to test for, food processors need to understand what components are at risk in their processing environment, incoming raw materials, and finished products. They also must understand industry regulations, because some tests are regulated and required. Food processors must learn what organisms their raw material suppliers test for; hire a private consultant; perform independent research, such as die-off studies; consult with their method vendors or third-party labs; and understand their customer testing requirements.

“History may determine what tests are implemented,” says Simmons. “For example, let’s say you join a company, and they indicated that in 2010 they had a Bacillus cereus outbreak in their RTE product. It is very likely that they will have implemented a Bacillus cereus-specific test for that product on their CoA.”

Solely relying on raw material suppliers’ certificate of analysis (CoA) is not a good practice, says Simmons. “The results listed on the CoA from a raw material supplier are a representation of the product while it was still in their controlled plant environment. Often, it doesn’t represent the product after it has undergone shipping and transport. Whenever time and temperature changes occur, you introduce fluctuations of bacteria counts. While it’s good to request CoAs from raw-material suppliers, it’s also best practice to test all incoming raw materials because they are your risk as soon as they arrive in your facility.”

When testing for bacteria, it’s important to swab framework, adjacent walls or equipment, floors, drains, ceilings, or anything in the near vicinity that could cause cross-contamination, says Richards. “The frequency of testing is driven by the severity of risk, as well as the results. If you keep getting Listeria hits on a specific drain, you’re likely going to test at a high frequency, but also increase the cleaning regime for that drain as well. For adjacent areas that rarely have positive swab results, you’re likely going to swab them more infrequently.

“For a new facility, treat everything as if it were dirty and swab for Listeria, Salmonella, and Enterobacteriaceae (EBAC),” he says. “If you have positive results, you’ll want to swab areas adjacent to the positive hits to figure out exactly where the issue is driven from. You can adjust the frequency as you collect more data and understand the likelihood of positive results.”

Resources
• “Revision of the Notice of Suspension (Boar’s Head).” USDA. July 31, 2024.
• “Food Defect Levels Handbook.” FDA website
• “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry (Draft Guidance),” FDA. January 2024, (PDF download)
• “Key Facts about Preventive Controls for Human Food,” FDA (PDF download)
• “Recalls, Market Withdrawals, & Safety Alerts,” FDA website
• “Recalls & Public Health Alerts,” USDA (FSIS) website

Published Dec. 19, 2024, by Food Engineering.