Quality Control, Safe Food Rely on People and Technology

A September Gallup revealed that 27% of U.S. adults have little to no confidence in the safety of U.S. foods at the grocery store. Is it any wonder with recalls like the recent Boar’s Head announcement? So what good is a QC program if it doesn’t include food safety?

The recent closure of Boar’s Head’s Jarratt, Virginia liverwurst plant—due to a serious outbreak of Listeria Monocytogenes (Lm)—is not the first facility over the years to have a resident strain of the bacteria, which caused a recall of several products and/or closed a facility—sometimes permanently. In October BrucePac recalled 11,765,285 pounds of RTE chicken due to possible Lm contamination, affecting a large number of manufacturers’ products (USDA update on 10-17-24).

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

While a facility may have a quality control program that inspects packaging or product defects, perhaps the more appropriate question to ask is whether a processor has an all-encompassing QC program that places a priority on not only food quality but also food safety. USDA’s FSIS found several insanitary conditions at the Boar’s Head facility, potentially causing or harboring Lm infestations.¹ Situations like this can be avoided with an extensive QC program that includes food safety measures and procedures. This article concerns itself with the food safety aspects of quality control. More can be found on defect control at the FDA’s “Food Defect Levels Handbook,” online.²

In establishing a QC program to ensure food quality and safety, it 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 HACCP and food safety/QC programs, adherence to FDA’s FSMA Preventive Controls and more.

Prerequisite programs

Personal hygiene
Food defense and food fraud
Housekeeping and hygiene
Chemical and physical product contamination
Product control
Process control
Traceability
Product flow and segregation
Production risk zoning
Staff training
Pest control
Cleaning and sanitation
Allergen management
Waste management
Utilities: water, ice, air and other gasses
Construction and layout of buildings
Maintenance
Storage and transport

— Hein Timmerman, Diversey – A Solenis Company; EHEDG

The Basics Start with People

How does a processor evaluate if 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 Control System Integrators Association (CSIA) member. “Even with all of the best tools in place such as QC programs that require photo evidence, explicit check sheets, 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 that speak up about infractions or safety concerns, not admonish them. Many companies focus on the bottom line by cutting corners to save costs at the expense of long-term breakdowns in procedure, which ultimately lead to loss in profits, which require more cost and corner cutting.”

Testing and standards only go so far, but 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,” says Richards. “The prerequisites that accompany a healthy HACCP program include—but are not 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 they’re associated with and how they can minimize their impact. Creating a food safety culture is prevalent as you set the expectations up front and hold your employees accountable for finished goods results.”

Diagram of FDA preventative controls — FDA had linked together HACCP and HARPC programs, but has renamed HARPC to “preventive controls.” Today, if a hazard 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 a HACCP plan, says Ana Lozano, Neogen Food Safety technical services and specialist manager. While HACCP is a foundational component, ensuring 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, these steps alone are insufficient without a strong food safety culture, adds Lozano. 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.

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

Remove or Replace Equipment and Structures?

The decision to remove a structure or replace equipment depends on thoroughly analyzing the facility and its specific challenges. Food safety is ultimately about validation, cross-functional collaboration and careful data-driven decision-making.

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 may reside and spread. By regularly monitoring and tracking these trends, a processor can better understand which areas or equipment may present risks.

Corrective actions for problematic sites or equipment might involve modifying cleaning procedures, modification or modernization of machinery, or even replacing equipment if it’s too difficult to clean properly. This is where having a solid food safety culture becomes essential. A company with a robust food safety culture is more likely to invest in the necessary resources and make smart decisions based on the data, helping to ensure long-term operational safety and compliance.

A collective review of the building’s integrity, hygiene monitoring data, and its impact on food safety is essential in determining whether a structure is beyond repair. This review should involve cross-functional teams from engineering, maintenance, and food safety, ensuring that decisions are based on validated evidence and focused on long-term sustainability.

— Taylor Lecy and Ana Lozano, Neogen Food Safety

In addition to HACCP plans, maintenance management software can also be employed to support regular maintenance activities for both plant and equipment. Additionally, compliance manager software plays a pivotal role in supporting documentation and actions related to food safety standards such as the Safe Quality Food (SQF) and British Retail Consortium (BRC). Compliance systems may be utilized to guide and document a structured audit program to help verify the housekeeping, safety and quality requirements.

Other risk analysis tools, such as a Failure Modes and Effects Analysis (FMEA), may also be utilized to elevate a quality program’s effectiveness. In this context, a robust quality management system (QMS), such as Plex QMS by Rockwell Automation, is often required to bring together the multiple tools used to manage food quality and safety into a harmonized framework that provides consistency and accountability while driving a mindset of continuous improvement.

Hazard analysis and preventative control diagram — As required by FDA’s Preventive Controls for Human Food: With a hazard analysis processors are required to identify any known or reasonably foreseeable (i.e., potential) biological, chemical, and physical hazards, and determine if any of those hazards require a preventive control. *Image courtesy of FDA*

Beyond software, says Bressler, certain workplace organization methods, such as 5S programs go beyond HACCP and place safety and cleanliness into everyone’s hands.

It’s good to keep in mind that a QC system is only a part of a full food safety management system, which should be the base of what is seen as a food safety culture and should be supported by all employees in a facility, says Hein Timmerman, global sector specialist - F&B at Diversey – a Solenis company and also president of EHEDG. A HACCP plan is only one component within many others such as:

Food safety policies, procedures, and work instructions
Prerequisite programs (See sidebar, “Prerequisite programs”)
An overall Hazard Analysis of Critical Control Points (HACCP)
Regular inspection and maintenance
Validation and verification
Training

Preventive controls, if then diagram — Per FDA’s Preventive Controls, If the hazard analysis identifies a hazard that requires a preventive control, processors are required to develop and implement a control to significantly minimize or prevent the hazard. *Image courtesy of FDA*

Facilities and Equipment: Replace or Repair

Quality control often hinges on the facilities and environments where work takes place, says John Robertson, vice president, food & 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 may 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 may 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 USDA and FDA provide another layer of oversight. Additionally, hiring independent experts who specialize 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 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. 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 maintenance becomes manageable and maintain both food safety and production uptime.

— John Robertson, Life Cycle Engineering

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

“An ‘easy fix’ in a legacy building, where persistent bacteria are harboring, such as Listeria or Salmonella, is not an easy task,” says Timmerman. “Razing an existing structure would seem like the most efficient approach, but 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 in the following manner, while considering the requirements for food safety management system documentation, staff training, and upgrading of buildings, equipment, and infrastructure.”

“All structures that are requiring repair should be well prepared and properly treated in full isolation of adjacent lines which are still in production, so that all possible cross-contamination routes are controlled. This will require careful planning, with strict timings and specialized and trained teams and skilled contractors, and an understanding of the requirements of hygienic building design,” adds Timmerman.

Testing and Sampling for Bacteria

Environmental monitoring programs are integral in ensuring product safety and regulatory compliance for food manufacturers, says Diversey’s Timmerman. They involve the 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 GFSI-benchmarked food safety certification platforms and help maintain product quality and brand reputation.

Food processors need to 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. Then a risk-based approach is 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 testing positive

The harder the area is to clean and the closer it is to food, the greater the risk, adds Simmons. High-risk areas are put on a high testing frequency, such as daily. Lower risk areas (those that are further 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. 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.

— Aaron Pfeifer, Atlas OT

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. The activities to be specified include those performed by the automation equipment as well as the many activities required to be performed by operators.

— John Parraga, Director, ECS Solutions, a CSIA certified member

There are multiple online tools and trainings to help create a food safety program. The FDA has a Food Safety Plan Builder which will guide users through building a food safety program. Creating a 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.

— Adam Richards, Gray Solutions

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. This strategy should also include design for reliability, employee training and validation of skills and abilities in EHS and QC protocols.

— John Robertson, Life Cycle Engineering

Implementing a robust food safety and quality system is critical for any food processing facility, especially for startups looking to scale up their production. A great starting point would be to align with regulatory frameworks like FSMA preventive controls in the U.S. and 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.

— Taylor Lecy, Neogen Food Safety

Implementing an effective food safety management system can be challenging but is essential in the operation of a food processing facility. 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.

— Hein Timmerman, Diversey; EHEDG

To determine what organisms to test for, food processors need to understand what organisms are of risk to their processing environment, incoming raw materials and finished products. They also need to understand industry regulations as some tests are regulated and required. Food processors 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, understand their customer testing requirements—and last, history may determine what tests are implemented, adds 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.”

Hygiene Academy screenshot — An important part of a QC program is having employees well-versed in food safety and hygiene. Diversey, a Solenis company, provides online its “Hygiene Academy,” which is a cloud-based learning environment for food and beverage professionals, and is credited by the Continuous Professional Development (CPD) Certification Service. The academy provides essential, application, process and specific microbe control courses. *Image courtesy of Diversey, a Solenis company*

As far as solely relying on raw material suppliers’ CoAs, this 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 does not represent the product after it has undergone shipping and transport. Whenever time and temperature changes occur, you introduce fluctuations of bacteria counts. While it is good to request CoA’s from raw material suppliers, it is also best practice to test all incoming raw materials as they are your risk as soon as they arrive in your facility. All these questions should be addressed when food processors perform an adequate risk assessment.”

When testing for bacteria, it is important to swab framework, adjacent walls or equipment, floors, drains, ceilings, or anything in the near vicinity that could cause cross contamination, says Gray’s 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). 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.”