Enhancing Food Safety: The Impact of FSMA’s Traceability Rule on the Supply Chain

By Jacob Olson
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The FDA’s Food Safety Modernization Act (FSMA) is designed to enhance food safety by establishing and regulating traceability requirements. The act mandates that all parties in the supply chain share critical information to address potential food safety issues. This article discusses FSMA requirements for comprehensive recordkeeping, including defining Critical Tracking Events (CTEs) and Key Data Elements (KDEs). It highlights the crucial role of Electronic Data Interchange (EDI) in meeting compliance and optimizing food traceability. EDI automates data exchange, improves visibility, simplifies compliance, and enables rapid outbreak response. By investing in EDI technology, organizations can establish a strong foundation for complying with FSMA regulations and ensuring food safety.

The Food & Drug Administration’s (FDA) final ruling for the Food Safety Modernization Act has introduced new stringent regulations that organizations who manufacture, process, pack, or hold foods must follow. The final rule mandates that all parties in the supply chain, from suppliers to retailers, share critical information to promptly address potential food safety issues. This ruling underscores the critical role of technology in maintaining compliance and ensuring safety throughout the food supply chain.

The latest FSMA updates require comprehensive recordkeeping for businesses involved in food production and distribution. Companies must now document key data elements (KDEs) tied to critical tracking events (CTEs) in the food supply chain. This includes manufacturing, processing, packing, and distribution activities for foods listed on the Food Traceability List (FTL). Organizations must provide this data to the FDA within a timely manner and in compliance with accepted standards.

Defining Critical Tracking Events (CTEs)

Critical Tracking Events (CTEs) are key checkpoints that mark the movement of food products from their origin to the retailer or consumer. These milestones offer visibility into the product’s journey through the supply chain. CTEs represent significant points in the food supply chain where specific actions occur, such as:

  • Receiving raw materials from suppliers
  • Processing and manufacturing food products
  • Packaging and labeling items for distribution
  • Shipping products to distribution centers
  • Receiving products by retailers or food service establishments
  • Selling products to consumers

Defining Key Data Elements (KDEs)

The FDA identifies Key Data Elements (KDEs) as crucial details linked to specific CTEs. This information provides essential insights into food products and their journey through the supply chain. KDEs may include:

  • Product Identifiers: Lot numbers, batch numbers, and serial numbers
  • Key Data Attributes: Ingredients, packaging materials, production and expiration dates, storage conditions
  • Chain of Custody: Records of entities handling and transporting products
  • Contact Information: Details of organizations responsible for food safety and emergency responses

Record Keeping Requirements

FSMA’s updated guidelines include specific requirements for the format and duration of recordkeeping. These records must also be available within 24 hours of an FDA inquiry and must be preserved for at least two years. The FDA mandates documentation be preserved in its original format and readily searchable electronically. Consequently, your organization must establish protocols for recordkeeping, product identification, and traceability lot code allocation.

Role of Electronic Data Interchange in Food Traceability

Electronic Data Interchange (EDI) is vital for meeting FSMA compliance and recording critical information such as CTEs and KDEs. EDI automates the exchange of traceability data by integrating with and extracting information from enterprise resource planning (ERP) or warehouse management system (WMS) solutions. EDI can ensure accuracy in KDEs to adhere to critical and time sensitive regulations. EDI also reduces potential manual data entry errors and ensures timely data management. Your suppliers and customers will have different levels of technical aptitude so remember; all types of EDI can be leveraged to achieve these outcomes, including traditional X12 EDI, EDIFACT EDI, and TRADACOMS EDI, along with other electronic data like APIs, JSON or XML, Flat Files, Spreadsheets, and web portals.

This technology streamlines the management of lot information, including its reception, translation, and distribution, and even enables direct integration of lot numbers into ERP systems. This integrated approach enables compliance and benefits all supply chain stakeholders by providing critical data for swift responses to any FDA inquiries regarding food traceability and safety.

EDI is crucial for optimizing food traceability within the supply chain by facilitating the accurate and efficient collection of KDEs and CTEs through the following:

  • Automation: EDI automates data exchanges, reducing manual input errors and facilitating efficient data management. It ensures precise tracking of food products with details such as purchase orders, invoices, and shipment notices.
  • Visibility: EDI is the foundation to providing real-time insights into product movement across the supply chain. Coupled with a modern integration platform, this enables businesses to track products from their origin to the end consumer.
  • Compliance: EDI simplifies compliance with food safety regulations by enabling the electronic recording and transmission of critical traceability data, streamlining the audit process.

Benefits of EDI Technology in Achieving FSMA Compliance

EDI offers several advantages beyond enhancing food traceability. It also positions your organization to proactively adapt to evolving regulatory landscapes. By investing in a modern, scalable EDI platform, you can establish a strong foundation for complying with upcoming FSMA regulations. To meet FSMA requirements, businesses need adaptable processes and procedures supported by technology that seamlessly integrates and automates critical data exchange. EDI integration specifically contributes to FSMA compliance by enabling:

  • Rapid Outbreak Response: EDI facilitates the quick exchange of standardized documents, simplifying the tracking of food movement and enabling a swift response to contamination outbreaks.
  • Efficient Recordkeeping: EDI automates the generation, storage, and sharing of electronic records, ensuring data accuracy and accessibility.
  • Improved Supplier and Customer Management: EDI supports real-time communication with suppliers, customers, carriers, and the other key components of your supply chain, enhancing management and simplifying compliance.
  • Risk Management: EDI integrates with other systems to enable data-driven risk assessments, monitoring critical control points, shelf life, and temperature controls to mitigate foodborne hazards.
  • Audit Readiness: EDI simplifies the capture, retrieval, and presentation of records, ensuring companies are always prepared for FDA inspections and can demonstrate compliance.

The cornerstone of food traceability under FSMA hinges on accurately identifying and documenting CTEs and KDEs. These regulations mandate electronically accessible and readily searchable records, underscoring the need for automated B2B integration technologies like EDI. EDI systems optimize data collection, minimizing errors and ensure real-time access to critical information. By automating these processes, EDI not only facilitates compliance but also enhances operational efficiency and responsiveness to potential food safety incidents.

The FSMA food traceability rules represent a pivotal advancement in safeguarding the food supply chain. By enforcing meticulous recordkeeping and rapid data retrieval, the regulation empowers authorities to swiftly identify and address food safety risks, protecting public health. Implementing advanced technologies such as EDI is essential for both compliance and operational excellence. These systems automate data sharing, improve transparency, and foster a connected supply chain all leading to improved business partner relationships, increasing revenue, and higher profitability.

As the industry navigates these rigorous standards, embracing technology will not only ensure compliance but also cultivate a more resilient and responsive food system capable of effectively managing food safety challenges.

Construction, food safety

Food Safety Things to Consider When Renovating a Facility

By Matt Inniger
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Construction, food safety

When food and beverage manufacturers aim to increase total throughput, they often face facility size constraints. Manufacturers can either expand their current facility or move operations to a larger building.

Due to property dimension limitations and the need for substantial additional square footage, procuring a new facility is the most common approach. Due to the difficulties associated with converting an industrial facility not previously used for food processing into a space suitable for food processing, it’s important to be considerate when selecting a new facility to minimize conversion time and costs.

Product Category and Risk

Before even looking at any specific facility, it’s important to consider the category of product you manufacture and what your specific production process requires of a facility, as well as what aspects of a facility might make manufacturing easier. For instance, rigid packaging necessitates substantial dry storage, while refrigerated finished goods benefit from pre-existing walk-in architecture. Conversely, confectionery or baking does not require extensive floor drainage or water supply.

The risk level associated with the product also plays a pivotal role. Facilities for dry mixes can be older or less pristine since contamination risks are minimal, controlled primarily by production equipment. However, ice cream production facilities demand extensive environmental risk mitigation, implying higher renovation costs if starting from a subpar condition.

Floor Plan

Arguably the most important consideration when looking at a facility is, to no one’s surprise, floor plan. It’s important that the shape, size, and orientation of rooms is suitable for how people, products, and materials need to flow through the building.

It’s sounds uselessly simple, but an excellent way to quickly gauge floor plan efficiency is to take a printout of the floor plan drawing, label each room for its potential purpose (i.e. production, offices, garb-up, warehouse, QA, etc) and draw arrows color coordinated to the movement of different types of employees and different types of materials.

If these arrows intersect too much, double back on themselves, or are just generally too long, try swapping room designations. If you can’t find a layout that works, the building probably isn’t a good fit.

Walls and Ceilings

As discussed previously, this consideration depends on your product category. But for certain products, the integrity of walls and ceilings is very important to mitigate environmental risk.. Certain walls and ceiling materials like dairy brick don’t require covering, if they are minimally porous and easily cleanable.

Also, other panel materials like PVC provide alternatives to FRP that may be more inexpensive, easier to mount, or both. It’s important to examine more than just surfaces, as the internals of walls and ceiling can sometimes harbor mold or other microorganisms. Mold mitigation is an expensive proposition.

Utilities

Utility service is arguably the most important consideration when looking at a building. While adding a new utility or increasing service isn’t typically an outrageously expensive endeavor, it can be time- and energy-intensive due to long lead times on utility equipment and the hassle of working with local officials.

It’s a similar story for utility access points. While relocating electrical hookups in a single room is inexpensive and straightforward, running a three-phase line across a quarter million square foot building is not. Oversized utility service is worth its weight in gold. It offers a ton of flexibility in scaling up operations at a given facility

Truck Traffic and Docks

We’ve already discussed how important it is for people and materials to be able to move through a facility for optimal production output. But, it’s equally important, perhaps moreso, that people and materials be able to move into and out of a facility quickly and easily.

Acquiring a facility with an inadequate number of docks or poorly positioned docks can quickly become a new production bottleneck, and unlike other bottlenecks, this one can be impossible to fix.

This is why it’s important not just to carefully consider the number and placement of docks, but also the traffic pattern for trucks to get there. How long does it take a truck to maneuver into the dock? Can incoming and outgoing trucks pass each other? Are there tight turns in the road leading up to the facility that could be difficult for trucks to navigate? If there are problems upstream that aren’t on the facilities property, they could become catastrophic to growth.

Plumbing and Drainage

Finally, for product categories that require floor drainage due to process or sanitation concerns, having adequate plumbing in place from the get-go is incredibly key, as adding it is often the largest line item in a renovation budget.

This is why renovating a space that hasn’t been previously used for food production of some fashion is so rarely done. Installing plumbing and re-doing floors can balloon into six or seven figures for really large facilities.

So, for all of the readers who came into this article expecting validation for your preliminary decision to convert your warehouse space into production space, hopefully I’ve given you some things to think about first.

Conclusion

All this being said, careful consideration of these factors can prevent a food or beverage manufacturer from buying themselves a shiny new bottleneck. Proper planning and evaluation are key to ensuring a smooth and cost-effective renovation process.

Audit

Ensuring Food Safety from the farm to the table is crucial. How inspections and audits play a key role

By Don Abbott
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Audit

Food safety is an issue that is critical to millions of people’s health every year worldwide. Maintaining a high standard of hygiene is essential in preventing contamination and ensuring all people receive the safest quality food products every time. Inspections and audits are the key components to the industry’s effort to maintain these standards. These processes help identify potential risks and hazards, ensuring companies are compliant with regulatory requirements, and to ultimately protect all people’s health.

Audits and Inspections both verify the facility’s compliance with regulatory and procedural compliance, but in different ways. According to ISO definition, an audit is “systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” An inspection is the “determination of conformity to specific requirements,” such as FDA or USDA regulations.

The Importance of Inspections and Audits

Inspections and audits are vital in the food industry for many reasons:

  1. Preventing Foodborne Illnesses: Regular inspections and audits help the industry identify and mitigate risks that have the potential to lead to foodborne illnesses. This is a very crucial task in preventing outbreaks that can cause severe health issues and even fatalities.
  2. Regulatory Compliance: The food industry is subject to stringent regulations set by governmental and international bodies. Inspections and audits help to ensure companies are complying with these regulations consistently, avoiding any legal penalties and maintaining consumer trust.
  3. Quality Assurance: Inspections and audits help ensure food products meet quality standards also, which is very important and essential for companies maintaining brand reputation and customer satisfaction.
  4. Risk Management: Identifying personal hazards and implementing corrective actions during inspections and audits helps the companies manage and reduce risks associated with food production and distribution.

Inspection Process

Food inspections and audits involve a thorough examination of facilities, processes, and products. The process typically includes the following steps:

  1. Preparation: Inspectors will review relevant documents, any previous inspection reports, SOPs, and compliance records, to better understand the facility’s history and operations.
  2. On-site Inspections: Inspectors will visit the facility in order to observe operations, interview staff, and inspect all equipment and outside premises.
  3. Sampling and Testing: Samples of food products may be collected for laboratory testing to detect contaminants or verify compliance with safety and quality standards.
  4. Documentation and Reporting: Inspectors will document their findings and provide a detailed report outlining any observations of non-conformances.
  5. Follow-up: A follow-up inspection may be conducted to ensure all non-conformances have been closed and corrective actions have been implemented and the facility is compliant with all regulations.

Audit Process

Audits are systematic and independent examinations of records, processes, and systems to ensure compliance with specific standards. There are several types of audits in the food industry, including internal audits, supplier audits, and third-party audits. The audit process generally involves the following steps:

  1. Planning: The audit scope, objectives, and criteria are defined. An audit plan is developed, detailing the audit schedule and then areas to be examined.
  2. Execution: Auditors will review documents, conduct interviews, and observe operations to gather evidence. They assess compliance with regulatory requirements, industry standards, and company policies.
  3. Analysis: Auditors analyze the evidence collected to identify areas of non-compliance, potential risks, and opportunities for improvement.
  4. Reporting: A comprehensive audit report is prepared, highlighting findings, conclusions, and recommendations for corrective actions.
  5. Follow-up: Auditors may conduct follow-up audits to verify all corrective actions have been implemented and compliance has been achieved.

Food Recalls

Food recalls are an integral part of the food safety system, initiated when a product is found to be contaminated or mislabeled. They are often the result of inspections and audits that identify serious issues. Here are a few notable statistics.

  • There were 547 Food and Drug Administration (FDA) food recalls in 2023, a five-year high for the industry and 19.6% more events than were recorded in 2022. FDA recalls are on track in 2024 to be consistent with 2023. U.S. Department of Agriculture (USDA) recalls also increased, rising 31% from 2022. The volume of units recalled also increased a more notable 132.8% from 2022 to 2023.
  • In 2023, 313 food products (224 from FDA, 89 from USDA) were recalled, over 1,100 people were sickened and 6 people died from foodborne illness recalls (based on data collected). The two largest recalls, lead-tainted applesauce sickened 519 children in 44 states, and Salmonella contaminated cantaloupe sickened over 400 people. CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.
  • 2% of all FDA recalls stemmed from undeclared allergens, a 27% increase from 2022. One reason for the increase in allergen recalls is as of Jan. 1, 2023, manufacturers had to disclose sesame in their foods. The most common undeclared allergens — wheat, shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans — account for 90% of all food allergic reactions. Listeria was listed as second and Salmonella third for the most recalls.
  • Unsurprisingly, as the nation’s largest producer of food, California was found to be responsible for the largest share of all recalls. Over 16.3% of recalls originate from California products. Followed by New York at 8.1% and Texas at 6.5%. California customers are also most frequently affected by recalls. 39.8% of all recalls nationally impact residents in California, followed by New York at 36.4% and Pennsylvania at 35.8%.

The Role of Technology in Inspections and Audits

Advancements in technology have significantly enhanced the effectiveness of inspections and audits in the food industry. Some key innovations include:

  1. Data Analytics: Big data analytics enable companies to identify trends and potential risks by analyzing large volumes of data from various source, such as inspection reports, consumer complaints, and laboratory results.
  2. Blockchain: Blockchain technology provides a transparent and immutable record of the entire food supply chain, making it easier to trace the origin of products and detect potential issues quickly.
  3. IoT Devices: Internet of Things (IoT) devices, such as sensors and RFID tags, provide real-time monitoring of conditions like temperature and humidity, ensuring that products are stored and transported under optimal conditions.
  4. Mobile Inspection Tools: Mobile applications and digital platforms streamline the inspection process by allowing inspectors to record findings, take photos, and generate reports on-site, reducing paperwork and improving efficiency.

Inspections and audits are indispensable components of the food industry’s efforts to ensure safety, quality, and compliance. They play a crucial role in preventing foodborne illnesses, managing risks, and maintaining consumer trust. As the technology continues to advance with properly trained and calibrated auditors, the effectiveness and efficiency of inspections and audits will only improve, further safeguarding the food supply chain from the farm to the table.

By understanding the crucial role inspections and audits play, stakeholders in the food industry can better prepare to meet the high standards necessary to ensure that food products are safe for consumption. The continued evolution of these processes, bolstered by technological advancements, promises a safer future for consumers worldwide.

Reference:

  1. Trace One analysis of 2020–2024 FDA and USDA data

Measuring and Improving Food Safety Culture

By Michael Ciepiela
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Although there is no definitive method to certify compliance with food safety culture, numerous approaches exist to demonstrate that a facility and its employees are thoroughly engaged in proper food safety practices.

Regardless of whether your facility is GFSI (Global Food Safety Initiative) certified, working towards certification, or newly established, it is essential to maintain a strong food safety culture. So how exactly is food safety culture defined? This seems to be an ongoing topic or even debate on how a facility can meet compliance for this requirement. Although there is no definitive method to certify compliance with food safety culture, numerous approaches exist to demonstrate that a facility and its employees are thoroughly engaged in proper food safety practices. This is achieved not only by adhering to these practices but also by actively contributing to their improvement. A key principle consistently emphasized from the leadership is that food safety culture is not the responsibility of a single individual or department. While the quality assurance department typically leads these efforts, ensuring the safety of the food produced is a collective responsibility shared by all employees.

Employee Engagement

When launching any initiative or project related to food safety culture, the first challenge is often gaining employee buy-in. As a leader, it is crucial to communicate the importance of food safety culture to your staff. Why is it important? How does it affect each individual? Why should an employee care if they perceive their role as simple?

In reality, no job is ever just ‘simple.’ This is where education and training become essential for both the individual and the entire team. Complacency can lead to a diminished sense of importance in one’s work, making it vital to emphasize the significance of each role in maintaining a robust food safety culture.

Allocating proper resources to employee training as part of continuous improvement initiatives boosts individual morale and benefits the company’s overall outlook. Investing in training demonstrates a commitment to employee development, fostering a culture of growth and engagement. Well-trained employees perform tasks more efficiently and accurately, leading to higher quality products and services. This investment enhances customer satisfaction and gives the company a competitive edge.

Benchmarking Food Safety Culture

Being able to measure the ‘Level of Health’ for your food safety culture can be tricky but not impossible. Food safety professionals will often delve more into quantifiable traits when establishing Key Performance Indicators (KPIs), but when it comes to measuring culture, qualifiable traits should be utilized as well. These qualifiable traits include employee attitudes, beliefs, and behaviors regarding food safety, which can be assessed through methods like employee surveys, interviews, and focus groups. Additionally, observing day-to-day interactions and the general atmosphere regarding food safety practices can provide valuable insights. It’s also beneficial to evaluate the level of engagement in food safety training sessions, the frequency and nature of internal food safety communications, and the willingness of employees to report issues and suggest improvements.

Quantifiable and Qualifiable Traits

Companies typically maintain key performance indicators (KPIs) as quantifiable metrics to gauge the success of their facilities and operations. These KPIs can range from simple measures like employee attendance or customer complaints to more detailed metrics like Overall Equipment Effectiveness (OEE), which considers availability, performance, and quality.

But how do quantifiable measures work with qualitative measures in relation to food safety culture? These two types of measures often work in conjunction. Quantitative metrics provide concrete data, allowing companies to track performance and identify areas for improvement. Qualitative measures, on the other hand, offer context and insight into the company’s food safety culture, capturing aspects such as employee attitudes towards food safety, adherence to protocols, and overall awareness.

Integrating both types of measures is crucial for a holistic understanding of organizational health. For instance, while high OEE scores indicate efficient production processes, qualitative feedback from employees can reveal underlying issues affecting food safety practices and morale. By balancing quantitative data with qualitative insights, companies can create a more comprehensive strategy for continuous improvement and a robust food safety culture.

Striving for Continuous Improvement

Getting your company to achieve a strong food safety culture is just the beginning of the journey. At times, it can feel like an uphill battle until you, as an individual or part of a collective team, reach the pinnacle of compliance. As leaders in your facility driving these initiatives, it’s crucial to maintain a high level of food safety culture and awareness while also striving for continuous improvement.

Engaging employees in ongoing education about their roles and responsibilities related to both their job functions and food safety and quality is essential. Too often, production employees might say, “Well, I’m not in quality assurance, so I don’t have to worry about that.” This mindset underscores the importance of consistent reminders and education for the entire team. By doing so, you can drive and maintain high standards of food safety culture expectations while also providing employees with a sense of fulfillment in their roles.

Continuous improvement in a culture, especially one as critical as food safety, may not always be easy. It requires persistent effort, regular training sessions, and clear communication about the importance of food safety at all levels of the organization. Recognizing and rewarding adherence to food safety practices can also motivate employees to stay committed to these standards. By fostering a sense of collective responsibility and ownership, you can create a robust and resilient food safety culture that benefits the entire organization.

Ensuring Long-term Success

Ultimately, a strong food safety culture is about more than just compliance; it’s about creating an environment where every employee understands their role in maintaining food safety and feels empowered to take action. By focusing on both quantitative and qualitative measures, engaging employees at all levels, and striving for continuous improvement, companies can develop and sustain a food safety culture that ensures the safety and quality of their products.

To ensure long-term success, it is vital to embed food safety principles into the core values of the organization. This means fostering an open and transparent communication channel where employees can voice concerns and suggest improvements without fear of repercussions. Regular audits and reviews should be conducted to assess the effectiveness of food safety practices and identify areas for enhancement.

Leadership must also lead by example, demonstrating a commitment to food safety in their daily actions and decisions. This top-down approach reinforces the importance of food safety across all levels of the organization. Additionally, celebrating successes and recognizing employees who exemplify excellent food safety practices can motivate the entire team to uphold these standards.

By integrating food safety culture into the organizational fabric, companies can not only meet regulatory requirements but also build a reputation for reliability and excellence in the industry. This proactive approach not only protects consumers but also strengthens the brand, ensuring long-term success and sustainability in the market.

Women in Food Safety

A Journey Of Growth And Resilience: Life Is A Cycle, Follow The Flow

By Melody Ge
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It’s WIFS’s (Women In Food Safety ) pleasure to meet with Rochelly Serrano, a seasoned professional in food safety and quality (FSQ). During the conversation, Rochelly shares her career journey, insights, and reflections. From unexpected beginnings to becoming a VP, her story is a testament to perseverance, growth, and the importance of staying true to one’s values.

Rochelly’s career in food safety and quality has been marked by growth, resilience, and an unwavering commitment to her values. Her story serves as an inspiration for aspiring professionals, especially women in FSQ. As she continues to navigate her journey, she remains dedicated to her passion for quality and her belief in the power of relationships and integrity.

Starting Out: From Uncertainty to Opportunity

Rochelly’s career began with a pivotal moment shortly before her college graduation. “Dr. Elliott asked me about my plans after graduation, and I had no idea,” she recalls. She considered various paths, including veterinary medicine, sales, and pharmacy, but none resonated with her. As an introvert, she found these options unappealing. However, a fortuitous connection through Dr. Elliotte led to an interview with the VP of HR at Tysons Foods, a major meat manufacturing company. This opportunity set her on an unexpected path.

Despite lacking industry knowledge, Rochelly began as a production supervisor. Reflecting on her early days, she admits, “I wasn’t mentally prepared for managing people. I had to manage 85 people on the beef patties production line.” She humorously likened her experience to a scene from the classic TV show “I Love Lucy,” where she struggled to keep up with the production line. “It was a humbling experience,” she says, recalling the chaos and the valuable lessons she learned about leadership and management.

The Transition to Food Safety

Rochelly’s transition into food safety was driven by her curiosity and desire for efficiency. While working as a production supervisor at a corndog product company, she was approached by the VP of Quality, who suggested she consider a QA position. Trusting her judgment, she accepted, marking the beginning of her career in FSQ. “Creating relationships with people is key,” she emphasizes, highlighting the importance of trust and collaboration.

Passion for Production and Quality

When asked whether she prefers production or quality, Rochelly expresses her love for both. “I am definitely a production person; I love to see products made from the beginning,” she says. As a Latina, she values the cultural importance of connecting with food and strives for perfection in quality. “Our consumers eating good quality products is satisfying to me,” she notes, underscoring her commitment to excellence.

Challenges and Growth: Learning from Mistakes

Rochelly acknowledges that starting her career, she wasn’t fully prepared for the realities of the job. “It doesn’t matter what the job is; honoring your values is key,” she explains. She emphasizes the importance of aligning one’s work with personal values for success. One of the biggest surprises in her career was realizing that things are rarely as easy as they seem. “Don’t take people’s expertise for granted. Trust your team and involve them in decision-making,” she advises.

She also discusses the inherent conflicts between FSQ and other departments. “I’ve had thousands of melting points,” she admits, but she emphasizes the importance of recognizing these as temporary challenges. “Everything in life has a beginning and end. Everything will pass,” she reminds us, encouraging resilience and perspective. Life is a cycle, good or bad things will all pass. Control what you can control, take the lesson given by life and learn from it. Everything in life happens for a reason, these lessons are here to help you grow.

Ethical Challenges and Integrity

Rochelly shares a memorable ethical dilemma from her career. At one point, she was asked to find a way to salvage moldy products. She refused to compromise on safety and quality, even though it led to tension with her superiors. “I learned to ask questions, gain more knowledge, and work with the team,” she reflects. This experience taught her the importance of exploring all options while maintaining integrity. It’s very easy to say no, but no is not always the right answer. Of course, there are times we have to say no to the business, but ultimately, is how we say no. Have we explored all options to the protect business? As a food safety and quality professional, it’s important to influence and engage other departments to align with your decision and direction.

Advice for Aspiring FSQ Professional Leaders

For those looking to enter the FSQ field, Rochelly offers practical advice. “Understand the business; you are the business owner, not just the quality owner,” she says. She encourages professionals to collaborate across departments and understand the broader business implications of their decisions.

Leadership and Gender in the Workplace

As a female executive, Rochelly provides a unique perspective on leadership. She believes that women bring valuable perspectives to the table, particularly in FSQ. “There are no weaknesses as female leaders. The only weakness exists in your mind,” she asserts, emphasizing the importance of authenticity and confidence.

She challenges the notion of a “glass ceiling,” suggesting that it’s often a mental construct. “Do your job so darn well and become so indispensable that there is a greater loss by not having you around,” she advises, stressing the importance of excellence and self-promotion. It’s what’s in your mind, if you think there is a glass ceiling, or negativity; then there is negativity and a glass ceiling.

Maintaining Confidence and Making Decisions

Rochelly credits one of her many mentors, Sharon Woods at HEB, for helping her build confidence. “She saw something in me that I didn’t see in myself,” she says. She also emphasizes the importance of aligning decisions with one’s values and being adaptable. “Every decision made at that point is the right decision,” she believes, underscoring the value of learning from every experience.

Reflections and Wisdom

Looking back, Rochelly has no regrets. She views every challenge and mistake as a learning opportunity. She advises others to avoid focusing on regrets and instead embrace life’s lessons. “If you focus on regrets, you will never win or learn,” she says.

Regarding unconscious bias, Rochelly acknowledges that life isn’t always fair. “Learn to live the life you are given. The way people talk to you has nothing to do with you, but how you react to it is about you,” she advises, encouraging resilience and positivity.

Reducing Food Contamination Risks in Healthcare Settings

By Ainsley Lawrence
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Protecting patients from contamination in healthcare facilities must be a priority for care providers and food service staff alike. Effective measures include tailored cleanliness and cross-contamination protocols, solid communication, and regular training, among other elements. With well-informed collaborations and clear guidance, there’s a better chance of enhancing everyone’s understanding of how to keep patients both nourished and safe.

Protecting patients from contamination is one of the duties of healthcare facilities. When companies provide in-patient services, this extends to how patients’ food might be present or be subject to risks. After all, unsafe food can have significant health consequences even for perfectly healthy people. Add the potential for patients to be vulnerable due to compromised immune systems or periods of recovery, and the need to be particularly vigilant is clear.

While some measures will be similar to most food service environments, others need to be more specific to the healthcare space. Professionals and managers need to account for the risks and challenges these spaces feature. We’re going to explore this concept a little further.

The Connection Between Food Safety and Quality Care

In healthcare settings, it’s easy to think of food service as a different sphere entirely from clinical care. Yet, the two aren’t mutually exclusive. Food is an important part of patient well-being. It provides nutrition and can aid in recovery from illnesses and surgeries. Importantly, when contamination occurs, there can be detrimental health impacts.

Therefore, it’s vital for those providing food service in these settings to understand the connection to and be actively involved in prioritizing quality healthcare1 above all else. By definition, quality healthcare is dependent on ensuring ongoing patient safety, centered on the patient’s needs, and timely, among other factors. There are simple steps service providers can take to enhance quality, including involving patients more in their care and offering a human touch. Additionally, your approach to minimizing food contamination can enhance quality standards.

  • Ensure communication between care providers and food services: Care providers will have the best understanding of patient needs and the circumstances within the facility. Therefore, they can provide food service staff with information regarding specific patient needs. This isn’t just about what foods are most nutritional, but also what contamination challenges may be present.

For instance, some patients may have specific dietary requirements related to the treatment they’re receiving. Cancer patients navigating chemotherapy are likely to have compromised immune systems, making consuming inadequately rinsed fruits or vegetables even riskier. Good communication of these specific risks enables food staff to take the most relevant additional steps.

  • Provide avenues for feedback between patients and food services: Patients may have their own preferences or concerns about the potential for their food to become contaminated in the medical space. There should be clear avenues for them to offer feedback to service providers, either through direct messaging or to delivery staff. Food service managers should then interact with patients either to provide solutions or to reassure them with details of cleanliness methods.

Another way to bolster the connection between quality care and preventing food contamination is to involve food service staff in key facility meetings. Even if it’s just food service managers or supervisors, this allows the department to better understand the current challenges and risks in the facility and how these impact patient needs.

Separation of Food and Waste

Perhaps the most obvious contamination risk for food in healthcare settings is biomedical waste. This waste can be present throughout most facilities and may include everything from bodily fluids to used gloves and other products. Minimizing the potential for this waste to come in contact with foodstuffs is one of the keys to maintaining patient well-being throughout their time in the facility.

Adhering to occupational health and safety (OSHA) waste disposal guidelines2 is a vital component of anti-contamination practices, not to mention in keeping facilities and staff OSHA compliant. These include:

a) Correct segregation

Biowaste must always be stored separately from other forms of waste. For instance, if patients with diabetes receive insulin injections, the used sharps and pharmaceuticals must be disposed of away from both food consumption areas and regular waste. This prevents cross-contamination when staff and patients are handling kitchen and food products.

Color coding waste containers is also an OSHA requirement, further minimizing the potential for workers to mistake which containers to handle. Wherever possible, though, it’s wise to store biowaste and food waste in separate areas. This provides an additional layer of security by minimizing food staff’s unnecessary access to hazardous materials.

b) Clear labeling

It’s important for everyone interacting with both food and biomedical waste to have knowledge of what they may be exposing patients and themselves to. After all, food services staff may be bringing patients’ or workers’ food to various areas of the facility. They need to be able to immediately see and understand what risky materials are present, so they can make informed decisions. Labeling on sample containers, trash units, and other items must be designed for easy reading. This starts with prominent biohazard symbols. Detailing in bold lettering the type of waste and what it contains is also wise. Food staff can then steer clear of these items and not place foodstuffs in the immediate vicinity of what could be wasted.

c) Inspections and Training

Knowledge is a powerful tool in the fight against food contamination risks in healthcare settings. Having a good understanding of the cleanliness gaps and risks empowers managers to make improvements. Additionally, having well-educated workers on hand with the knowledge and skills to respond to risks minimizes the potential for contamination arising. Therefore, inspection and training protocols must be a priority.

Inspections

While the facility might have clear procedures outlined in documentation, you can’t always assume these are always being followed to the letter. Not to mention that unexpected circumstances may arise to impact how procedures are carried out. Therefore, conducting regular inspections is essential. Some points to focus on include:

  • Patient eating spaces: Even the space between the plate and mouth can have the potential for contamination to occur. It is vital to ensure that there are regular inspections to ensure staff are implementing cleanliness measures for tables and bedsides before patients are served food. This may include disinfecting surfaces and ensuring any biohazardous materials are removed.
  • Food preparation areas: The spaces where food is being prepared can be points for contamination to occur. Foodborne pathogens, such as E.coli can be easily transmitted3, but you can minimize this through careful and clean preparation. Similarly, patients who have food allergies must have their meals prepared in spaces that minimize exposure to ingredients that are hazardous to their health. As a result, regular inspections of food preparation areas, including the processes for wiping surfaces and ingredient separation, is vital.
  • Routes between kitchens and wards: Another element to regularly inspect is the route food service staff take when delivering meals to patients. Areas of focus might include the human and biomedical hazards in each area they pass through. Reviewing how food is covered and protected throughout these journeys to minimize accidental contamination or unauthorized access and tampering.
Image Source: Pixels

Training

All staff that directly interact with patients’ food need to receive training on measures to minimize contamination. Head nurses4 are usually responsible for providing care staff with guidance on correct waste management, which should include keeping such items clear from patients’ meals. Facility catering managers must also ensure all food service staff receive certified courses and on-the-job guidance that address contamination in their roles.

Chefs and sous chefs need to recognize how cooking times and washing can minimize foodborne contaminants. Delivery staff must be able to identify hazards along the route to patients and protect foodstuffs accordingly. Training also needs to be reviewed for relevance and updated regularly.

References:

Roy Shaw (2022) How to Prioritize Quality Healthcare, from https://www.protrainings.com/blog/prioritize-quality-healthcare/

Abby Witt (2023) OSHA Biohazard Waste Disposal Guidelines, from https://www.medicalwastepros.com/blog/osha-biohazard-waste-disposal-guidelines/

Susan Assanasen, MD, Gonzalo M.L. Bearman, MD, MPHH (2018) Food: Considerations for Hospital Infection Control, from https://isid.org/guide/infectionprevention/hospital-food/

K.K. Padmanabhan and Debabrata Barik 2018) Health Hazards of Medical Waste and its Disposal, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7152398/

Beltway Beat

The Effectiveness of U.S. Food Laws Over Private Standards

By Sayed M Naim Khalid
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Introduction

The safety of our food supply is critical to public health, economic stability, and consumer confidence. The United States has developed a comprehensive regulatory framework for food safety that relies heavily on federal laws and oversight. This system involves multiple federal agencies, state and local governments, and numerous statutes designed to ensure food safety from farm to table. Private standards, such as those established by the Global Food Safety Initiative (GFSI), also play a role, but they are not a substitute for the regulatory power and public accountability inherent in U.S. food laws. This artilce argues that U.S. food laws are more effective than private standards and that businesses can achieve sufficient food safety by adhering to these laws without incurring additional costs associated with private standard implementation.

The Current U.S. Food Safety System

The U.S. food safety system is multifaceted, involving producers, processors, shippers, retailers, and consumers. The government, particularly through agencies like the FDA, USDA, EPA, and CDC, plays a critical role in establishing and enforcing food safety standards. These agencies work under numerous statutes and interagency agreements to ensure the safety of the food supply. The system, while complex and somewhat fragmented, is backed by legal enforcement, scientific research, and public accountability.

The Effectiveness of U.S. Food Safety Laws

The U.S. food safety regulatory system is extensive and multifaceted, involving numerous agencies with specialized roles. The Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the National Marine Fisheries Service (NMFS) of the Department of Commerce all play crucial roles in ensuring food safety. These agencies operate under a framework of more than 35 statutes overseen by 28 Congressional committees, reflecting the complexity and thoroughness of the system.

The FDA, for instance, regulates domestic and imported foods, except for meat and poultry products, ensuring they are safe, sanitary, and properly labeled. The agency has regulatory authority over more than $1 trillion in products sold annually—about 25 cents of every dollar spent by consumers, including surveillance, risk assessment, research, inspection, and education. Similarly, the FSIS is responsible for ensuring the safety of meat and poultry products, employing roughly 7,400 inspectors to oversee 6,200 slaughtering and processing plants through continuous and daily inspections.

The statutory mandates for these agencies are comprehensive. For example, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) enforces tolerances for pesticide residues, approves food additives, and ensures that food processing plants adhere to safety standards. The FSIS, by law, must conduct carcass-by-carcass inspection during slaughter, ensuring that meat and poultry products are safe for consumption. USDA) announced in 2021 that government will invest more than US$4 billion to improve the food system.

Government Enforcement and Public Accountability

U.S. food laws are enforced by federal agencies with the authority to conduct inspections, enforce regulations, and impose penalties for non-compliance. This legal backing ensures a high level of adherence to food safety standards. For example, the FDA and USDA conduct regular inspections and surveillance to ensure compliance with food safety laws. This system of oversight provides a level of public accountability that is essential for maintaining consumer trust and preventing foodborne illnesses.

Scientific Basis and Comprehensive Coverage

U.S. food laws are grounded in scientific research and are regularly updated to reflect the latest food safety information. These laws cover a wide range of food products and hazards, including microbiological contaminants, pesticides, and additives. This comprehensive approach ensures that all potential risks are addressed, providing a higher level of protection for consumers.

Economic and Consumer Protection

Effective food safety regulations prevent large-scale foodborne illness outbreaks, reducing healthcare costs and economic losses. By ensuring that food products meet safety standards, the government protects consumers from the dangers of contaminated or unsafe food. This protection is crucial for maintaining public health and economic stability.

Limitations of Private Standards

While private standards like those established by GFSI can complement public regulations, they are not a substitute for the robust framework provided by U.S. food laws. Private standards are voluntary and lack the enforcement power of government regulations. They often require third-party audits, which can be costly and lead to inconsistent implementation due to variability in auditor competency and interpretation of standards.

Cost and Market Pressure

Certification and compliance with private standards can be expensive, particularly for small and medium-sized enterprises. These costs can create barriers to market entry and place unnecessary financial burdens on businesses. Moreover, companies may feel pressured to adopt private standards to remain competitive, regardless of whether these standards offer additional safety benefits over existing regulations.

Transparency and Accountability

Private standards are enforced through independent third-party audits, which may lack the transparency and public accountability of government inspections. The results of these audits are not always made public, and there is less oversight to ensure that auditors maintain high standards of integrity and competence.

Limited Scope and Inequality

Private standards may not cover all aspects of food safety, especially those specific to local contexts or emerging threats. Additionally, smaller companies and producers in developing countries may face significant barriers to accessing certification due to costs and resource constraints, leading to inequality in market access and potentially restricting trade opportunities.

The Case for Relying on U.S. Food Laws

Given the comprehensive and enforceable nature of U.S. food laws, businesses can achieve sufficient food safety by adhering to these regulations without incurring additional costs associated with private standards. The legal framework provided by U.S. food laws is designed to protect consumers and ensure food safety across the entire supply chain. By focusing on compliance with these laws, businesses can avoid the complexities and expenses of private certification while still maintaining high standards of food safety.

HACCP Systems and FSMA

The implementation of Hazard Analysis Critical Control Point (HACCP) systems and the Food Safety Modernization Act (FSMA) has strengthened the U.S. food safety framework. HACCP systems focus on preventing hazards at critical points in the production process, while FSMA emphasizes proactive measures to prevent food safety issues. These regulatory approaches are widely recognized as effective means of ensuring food safety and can be more cost-effective than adhering to multiple private standards.

Comparison with Private Standards

Private food safety schemes, like those endorsed by GFSI, offer standardized protocols for food safety management across global supply chains. These schemes are often seen as more stringent and market-driven, providing a competitive edge and reassurance to consumers and business partners. However, these private standards come at a cost. Businesses must pay for certification, ongoing compliance audits, and the implementation of specific protocols that may overlap with existing regulatory requirements.

Comparison of U.S. Food Laws vs. GFSI Standards

Pros and Cons of GFSI Standards

GFSI Standards

Pros

Cons
  1. Global Recognition: GFSI standards are recognized worldwide, facilitating international trade and ensuring global food safety.
  2. Flexibility: GFSI standards allow for flexibility and adaptability to new food safety practices and technologies.
  3. Market Competitiveness: Certification to GFSI standards can enhance a company’s reputation and market access.
  4. Private Sector Leadership: GFSI involves private sector stakeholders, fostering innovation and industry-driven solutions.
  5. Standard Harmonization: GFSI standards harmonize various private food safety schemes, reducing duplication and confusion.
  6. Risk-Based Approach: GFSI emphasizes a risk-based approach to food safety, focusing on critical control points and preventive measures.
  7. Continuous Improvement: The GFSI framework encourages continuous improvement and regular updates to standards.
  8. Third-Party Audits: Independent third-party audits provide an objective assessment of a company’s food safety practices.
  9. Training and Resources: GFSI offers extensive training and resources to help companies comply with standards.
  10. Consumer Confidence: Certification to GFSI standards can enhance consumer confidence in the safety and quality of food products.

 
  1. Cost: Certification and ongoing compliance with GFSI standards can be expensive, especially for small and medium-sized enterprises.
  2. Voluntary Nature: As a voluntary scheme, GFSI lacks the legal enforcement power of government regulations.
  3. Inconsistent Implementation: Variability in auditor competency and interpretation of standards can lead to inconsistent implementation.
  4. Complexity: The process of achieving and maintaining GFSI certification can be complex and resource-intensive.
  5. Overlap with Regulations: GFSI standards can overlap with existing government regulations, creating redundancy.
  6. Market Pressure: Companies may feel pressured to adopt GFSI standards to remain competitive, regardless of their actual necessity.
  7. Audit Fatigue: Frequent audits and certifications can lead to audit fatigue and a focus on passing audits rather than genuine food safety improvements.
  8. Limited Scope: GFSI standards may not cover all aspects of food safety, particularly those specific to local contexts or emerging threats.
  9. Transparency Issues: Private certification bodies may not be as transparent as government agencies in disclosing audit results and non-compliance.
  10. Access Inequality: Smaller companies, particularly in developing countries, may face barriers to accessing GFSI certification due to costs and resource constraints.

 

Pros and Cons of U.S. Food law

U.S. Food Laws

Pros

Cons
1.     Government Enforcement: U.S. food laws are enforced by federal agencies like the FDA and USDA, providing a robust and legally backed framework for food safety.

2.     Comprehensive Coverage: These laws cover a wide range of food products and hazards, including pesticides, additives, and microbiological contaminants.

3.     Public Accountability: Government agencies are accountable to the public, with transparent operations and public reporting of food safety issues.

4.     Standardization: U.S. food laws provide standardized regulations across the country, ensuring uniform food safety practices.

5.     Scientific Basis: The laws are based on scientific research and updated with the latest food safety information.

6.     Interagency Coordination: Multiple agencies collaborate, providing a multi-faceted approach to food safety.

7.     Consumer Protection: The primary goal is to protect consumers from foodborne illnesses and unsafe food products.

8.     Economic Impact: Government-regulated food safety can prevent large-scale foodborne illness outbreaks, reducing healthcare costs and economic losses.

9.     Legally Binding: Compliance is mandatory, with legal consequences for non-compliance, ensuring high levels of adherence.

10.   Educational Resources: Government agencies provide extensive educational resources and support to food businesses to help them comply with regulations.
  1. Bureaucracy: The complexity and fragmentation of the regulatory system can lead to inefficiencies and slow responses to emerging food safety issues.
  2. Resource Limitations: Federal and state agencies often face budget and staffing constraints, impacting their ability to perform inspections and enforce regulations.
  3. Inconsistencies: Variation in enforcement and standards across different states and localities can create inconsistencies in food safety practices.
  4. Regulatory Overlap: Overlapping jurisdictions between agencies can cause confusion and redundancy in regulatory efforts.
  5. Slow Adaptation: Government regulations can be slow to adapt to new food safety technologies and practices.
  6. Burden on Small Businesses: Compliance with complex regulations can be burdensome for small food businesses with limited resources.
  7. Limited Global Reach: U.S. laws apply primarily to domestic producers, potentially creating gaps in food safety for imported products.
  8. Focus on Compliance: The emphasis on regulatory compliance may sometimes overshadow the focus on innovative food safety improvements.
  9. Inspection Gaps: Resource limitations can lead to infrequent inspections, reducing the effectiveness of enforcement.
  10. Perceived Rigidity: Some stakeholders view government regulations as rigid and inflexible, stifling industry innovation.

 

Conclusion

While both U.S. food laws and GFSI standards have their strengths and weaknesses, their effectiveness depends on the specific context and needs of the food industry stakeholders. U.S. food laws provide a legally enforceable and standardized framework, ensuring a high level of consumer protection and public accountability. On the other hand, GFSI standards offer flexibility, global recognition, and industry-driven innovation, though they come with significant costs and may lack the enforcement power of government regulations.

The U.S. food safety system, despite its complexity and fragmentation, provides a robust and effective framework for ensuring the safety of the food supply. Federal regulations enforced by agencies like the FDA and USDA offer comprehensive coverage, scientific grounding, and legal enforcement, which are critical for protecting public health and consumer confidence. While private standards can play a supportive role, they cannot match the effectiveness and public accountability of government regulations. By adhering to U.S. food laws, businesses can achieve high standards of food safety without incurring the additional costs and complexities associated with private certification.

For optimal food safety, a balanced approach that leverages the strengths of both systems may be the most effective solution. This hybrid strategy would combine the stringent, enforceable standards of U.S. food laws with the flexibility and global perspective of private standards like GFSI, ensuring comprehensive protection for consumers while promoting innovation and international trade.

Further reading:

  1. (2023, July 13). FSMA Final Rule on Accredited Third-Party Certification. Retrieved July 18, 2024, from US Food and Drug Administration: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification
  2. Foulis, D. (2024, Feb 14). Four benefits of gaining GFSI certification. Retrieved July 18, 2024, from Ideagen: https://www.ideagen.com/thought-leadership/blog/four-benefits-gfsi-certification
  3. (2011, March). Enhancing Food Safety Through Third Party Certifications. Retrieved July 18, 2024, from Mygfsi.com: https://mygfsi.com/wp-content/uploads/2019/09/Third-Party-Certification-GFSI-White-Paper.pdf
  4. Kaylegian, K. (2021, April 13). The Food Safety Modernization Act (FSMA). Retrieved July 18, 2024, from PennState Extension: https://extension.psu.edu/the-food-safety-modernization-act-fsma
  5. Loucks, S. (2024, May 31). Why Should My Business Become GFSI Certified? Retrieved July 18, 2024, from FoodReady: https://foodready.ai/blog/why-should-my-business-become-gfsi-certified/
  6. Scott, J. (2023, Nov 8). FDA FSMA: Providing value beyond compliance. Retrieved July 18, 2024, from IBM: https://www.ibm.com/blog/fda-fsma-providing-value-beyond-compliance/
  7. Ng S, Shao S, Ling N. Food safety risk-assessment systems utilized by China, Australia/New Zealand, Canada, and the United States. J Food Sci. 2022 Nov;87(11):4780-4795. doi: 10.1111/1750-3841.16334. Epub 2022 Oct 26. PMID: 36285586; PMCID: PMC9828015.
  8. Halabi, Sam. 2016. The Battle between Public and Private Food Safety Standards. Yale Journal of Regulations. https://www.yalejreg.com/nc/the-battle-between-public-and-private-food-safety-standards/ (access on 6/29/2024)
  9. Soon JM, Baines RN. Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers? Laws. 2013; 2(1):1-19. https://doi.org/10.3390/laws2010001
  10. National Research Council (US) Committee on the Review of Food and Drug Administration’s Role in Ensuring Safe Food; Wallace RB, Oria M, editors. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington (DC): National Academies Press (US); 2010. 2, The Food Safety System: Context and Current Status. Available from: https://www.ncbi.nlm.nih.gov/books/NBK220410/
  11. Institute of Medicine (US) and National Research Council (US) Committee to Ensure Safe Food from Production to Consumption. Ensuring Safe Food: From Production to Consumption. Washington (DC): National Academies Press (US); 1998. 2, The Current US Food Safety System. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209121/

 

Addressing Foreign Material Contamination in Food Products

By Kurt Westmoreland
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I’ve seen it all when it comes to foreign material contamination — from electrical wire to welding slag to a folded-up $50 bill in a block of frozen protein. Physical foreign material contamination isn’t isolated to one type of material, phase of the manufacturing process or point in your supply chain. Physical contaminants can enter food product anywhere, anytime, making reliable detection and actionable traceability vital for producers to ensure safe food to market. We typically trace the issue back to one of three “stops” on a food product’s journey to the end consumer.

Stop 1: Raw Materials

Let’s start from square one: raw materials pose a foreign contamination threat, especially in the case of meat/poultry and fruit/vegetable products. If livestock consume inorganic material like stone or plastic, or metal pieces from plant harvest machinery find their way into plant/organic matter, contamination is immediately a concern. If physical contaminants aren’t detected by a raw ingredient supplier, the risks they pose can be passed downstream in the supply chain to other producers.

Stop 2: Processing

Most raw materials go through an initial stage of processing to turn them into usable ingredients for later-stage producers. This processing stage can involve a higher activity level, leading to more machinery interaction. Perhaps bone debris remains in protein after deboning, or a maintenance failure leads to a lost screw in plant matter. The activity levels at this stage in the supply chain call for increased scrutiny of physical contamination detection and prevention.

Stop 3: Production

Last, these processed ingredients are often turned into prepared or packaged foods. These processes typically include a more refined level of machinery involvement, but also include unique foreign material risks. Machinery, packaging and product breakage are all common challenges at this stage. In the past, we’ve found broken jars, missing pens, lost eyeglasses and more. No producer, no product, no process is immune to this threat—particularly when human beings are involved.

The modern food production environment is highly mechanized, and no matter how new and improved technology may be, the risk of foreign material exists from the machinery used to produce at high throughput. Line extensions, wear and tear, new construction and routine maintenance all play a role in introducing the problem of foreign material in the job of feeding our customers.

Counting the Costs of Foreign Material Contamination

There are many downstream impacts of foreign material contamination. Some are quantifiable, some are not—but all of them hold weight in their own right. Missed orders lead to dissatisfied customers. Storage challenges lead to sunk costs at your facility. Downgraded product leads to lost value and smaller profit margins.

While it’s nearly impossible to sum up the potential effects of foreign material contamination, the image below serves as a point of reference for the many considerations producers have related to this issue.

73% of companies we surveyed in 2024 reported a foreign material incident at least quarterly, many of them citing weekly challenges. Last year, 70 recalls occurred due to foreign material contamination. That frequency is noteworthy, but it doesn’t have to be a crisis. Foreign material contamination can be managed and addressed within any food safety program.

Taking a Closer Look: Technology in Food Inspection

If there’s one thing we know about our industry, it’s that technology is always expanding. More than 50% of food producers use X-ray technology in some form, but there are many other inspection options available:

  • Metal Detection. Metal detectors use electric signal disruption to detect metal within a food product. They are of limited use when food contains high moisture, salt, or sugar. They are most effective for aluminum and ferrous metals.
  • Vision Systems. These systems use machine learning to “teach” the system but are more often used for qualitative analysis than for foreign material detection, as their examination is only surface-level. Foreign material can and does appear both on and in product.
  • Hyperspectral. Hyperspectral systems emit photons of various wavelengths and use spectroscopic sensors to evaluate the energy directed back to identify the material type. While this system type only works at the surface level, it is one of the most reliable detection systems for rubbers and plastics.
  • Microwave. While used sparingly in the food and beverage industry, these systems use microwaves and disturbances in the resulting electromagnetic field to detect foreign material. These systems are excellent at detection but haven’t yet reached mass adoption.
  • Computed Tomography (CT). CT systems create a 360-degree rotational view of the product, overcoming the positional constraints of a 2D system. Production speeds are too fast for this to work in-line, but these systems are very effective for use off-line.

Embracing technology allows food producers to tailor their contamination prevention and detection strategies to meet their operations’ unique challenges. No matter how physical contaminants are found, once they’re known, the question becomes: What do we do now?

What To Do With a Product Hold

Producers have options to address foreign material contamination incidents. The instinctive reaction may be product disposal, which eliminates the threat of physical contaminants entirely. The ripple effects are lost revenue, potentially damaged retailer relationships and a negative impact to sustainability goals.

In some cases, internal inspection is the best option. Manufacturers use in-house resources and equipment to re-inspect products for contamination, but this option has its limitations. Food manufacturers’ core competency is just that—manufacturing. Plants are equipped, and employees are trained to produce as much food as profitably possible and not to slowly reinspect food, which increases the cost of labor, downtime and overtime.

Third-Party Inspection: A Secret Weapon

Another option exists: third-party inspection. In the majority of cases, a third-party inspection company can find foreign material contamination and limit product loss to only product that is contaminated. This allows companies to recapture revenue that would otherwise be lost at an extremely competitive ROI. It avoids concerns about hidden internal costs of rework, protects brand reputations, protects relationships, ensures manufacturing efficiency, meets or grows sustainability compliance, and upholds product and supplier quality.

Third-party providers are also typically able to provide data that helps you make the best decisions possible for hold and release—and, in some cases, can provide the data that aids your team in tracking down the issues that are contributing to physical contamination in your supply chain or at your facility. It’s not about scrubbing product clean, it’s about detecting objects at small sizes and providing producers with the opportunity to make better, risk-based decisions.

The two key points of difference between in-house reinspection and third-party inspection are the process and the technology.

Process

  • Line Speed: third-party inspection line speeds average 4-5 feet per minute
  • Multiple Inspectors: third-party inspection services operate multiple, concurrent inspection lines
  • Multiple Facilities: larger third-party inspection services operate multiple facilities across the U.S.
  • Trained Inspectors: third-party inspectors are trained specifically to find foreign material, not produce food

Technology

  • X-Ray Type: typical inline machines use a linear diode x-ray configuration while leading third-party inspectors use flat panel configurations that enable greater contrast and depth
  • X-Ray Size: inline detection technology is typically fixed in place and customized to the product size at a specific stage of production, whereas third-party can inspect product in various sizes and configurations using customized equipment built for that purpose
  • X-Ray Sensitivity: inline detection technology is typically built to detect known foreign material types, while third-party technology is designed to detect foreign material of all types

Here’s the bottom line: foreign material contamination isn’t a possibility, it’s a promise. The good news is, producers aren’t powerless. By taking a careful look at their operations, they can determine what tools and methodology will help safeguard their product and their profits, both short and long term.

Food prep gloves

The Foundation of Food Safety: Addressing Glove Selection & Implementation

By Darin Detwiler, Ph.D.
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Food prep gloves

The review in the July 2024 Journal of Food Protection, “Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination,” sheds light on critical issues within the glove manufacturing industry and their implications for food safety. As food industry executives and professionals, it is crucial to understand these challenges and implement effective strategies to mitigate glove risks. Purchasing gloves with FDA “food compliance” alone may not be a sound food safety strategy. In this article, I provide five key pieces of advice on glove selection and implementation to ensure they remain the foundation of food safety.

  1. Prioritize Quality & Regulatory Compliance

The review highlights how the pandemic demand revealed shortcomings in glove manufacturing, emphasizing the need for stringent quality control. Food Safety professionals should prioritize sourcing gloves only from reputable manufacturers that adhere to enhanced regulatory requirements for Acceptable Quality Limits (AQL) and bioburden standards.

– Why This Matters: High-quality gloves are less likely to contain chemical, or microbiological contaminants that can compromise food and glove wearer safety. Gloves with improved durability are less likely to fail (rip) and cause foreign material contamination.

– Benefits: Ensures consistent protection for both food products and workers, reducing the risk of contamination and associated health hazards.

  1. Independent Supplier Audit Reports

Independent audits from your glove supplier will verify that manufacturers meet the necessary standards and employ robust quality control measures. These audits should include an evaluation of the manufacturing process, contamination control measures, and compliance with regulatory standards. With forced labor violations and U.S. Customs and Border Protection import bans against well-known companies, independent audits of ethical manufacturing standards are encouraged.

– Why This Matters: Identifies potential sources of contamination and ensures that suppliers maintain consistent high standards of hygiene and safety and robust workplace cultures over a focus on profit alone.

– Benefits: Builds a reliable supply chain, minimizes the risk of receiving contaminated gloves, and fosters trust in glove safety.

  1. Implement Comprehensive Training Programs

Proper glove use is critical in preventing contamination. Training programs should educate food handlers on the correct procedures for donning, using, and disposing of gloves. Emphasis should be placed on glove changing frequency, especially after tasks that involve raw food, meals and/or restroom breaks, or when gloves become damaged.

– Why This Matters: Prevents cross-contamination and ensures that gloves are used effectively to protect food and workers.

– Benefits: Enhances overall food safety, reduces the risk of foodborne illnesses, and promotes a culture of hygiene and safety within the organization.

  1. Utilize Gloves with Enhanced Performance

Advancements in glove technology have led to the development of gloves with improved durability and performance. Look for gloves manufactured with proven superior materials and quality systems and ensure commercial trials for proven resistance to punctures and tears.

–Why This Matters: Reduces the likelihood of physical failures that can lead to contamination.

– Benefits: Provides better protection for food products and workers, ensuring gloves perform effectively in various food handling tasks.

  1. Regularly Review & Update Safety Protocols

Food safety is an evolving field, and it’s crucial to stay updated with the latest research, regulations, and best practices. Regularly reviewing and updating safety protocols ensures that they reflect current knowledge and address emerging risks.

– Why This Matters: Keeps safety measures relevant and effective in protecting against new and evolving threats.

– Benefits: Ensures continuous improvement in food safety practices, enhances compliance with regulatory standards, and protects the organization’s reputation.

Conclusion

The review in the Journal of Food Protection underscores the importance of addressing the potential risks associated with glove use in food environments. By prioritizing quality and regulatory compliance, conducting thorough supplier audits, implementing comprehensive training programs, utilizing gloves with enhanced durability, and regularly reviewing and updating safety protocols, food industry executives can ensure that gloves remain a cornerstone of food safety.

As we continue to navigate the complexities of food safety, it is imperative to recognize that gloves are not a panacea but a critical component of a broader safety strategy. Ensuring their proper selection, use, and management will significantly contribute to the overall safety and quality of food products, protecting both consumers and workers in the process.

For further reading, I recommend reviewing the full article in the Journal of Food Protection to gain a deeper understanding of the issues and recommendations discussed. Together, we can build a safer food industry by staying informed and proactive in our approach to glove use and food safety.

Traceability in food manufacturing, Honeywell
Beltway Beat

Produce Traceability: Uncovering the Gaps in Your Program

By Samantha Humphrey
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Traceability in food manufacturing, Honeywell

The produce industry handles an estimated six billion cases of produce in the U.S. each year. [i] Because a significant portion of this produce travels through the supply chain to reach customers, many produce companies already have traceability program in place. With the finalization of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods [ii] (Food Traceability Rule), the question is whether these existing traceability programs, systems, and procedures meet new FDA requirements.

A gap assessment can do just that—determine what requirements your existing programs already meet and identify where improvements are needed to comply with the final Food Traceability Rule by the January 2026 deadline.

Steps for Conducting a Gap Assessment

Not surprisingly, many produce companies already have elements of a traceability program that fulfill some of the Final Rule’s requirements. A gap assessment serves as the starting point for:

  • Understanding your regulatory obligations compared to your current compliance status.
  • Determining if existing programs, procedures, and systems are good as is, need improvement, or are missing and need to be developed.

Performing a gap assessment will help you compare what you have to what you need. The following steps will get you started:

  1. Find the most current copy of the standard you will compare against your programs. You will likely want to use the Code of Federal Regulation (CFR) Title 21, Chapter 1, Subchapter A, Part 1, Subpart S [iii], as it outlines specific expectations for general provisions, Traceability Plan, records of Critical Tracking Events (CTEs), and more.
  2. After you are familiar with the rule, review the most current version of your own program. A systematic review over time may make conducting a gap analysis more manageable. Start by identifying which of your products are on the Food Traceability List (FTL) [iv], what CTEs you perform, and which Key Data Elements (KDEs) you are already collecting. Have you overlooked a CTE? Have you forgotten a KDE? Refer to the questions below as you conduct this gap assessment. Document all missing elements.
  3. Compare your Traceability Plan to what is required by the new rule. Document the items you have identified as missing from your Traceability Plan.
  4. Develop and document your strategy to address each gap identified in steps 2 and 3 above. There may be some items that can be addressed immediately, while others may require additional time and support. You may need to create new logs, enlist the help of other departments, or acquire approval from your supervisors to make the necessary changes. Set realistic goals to implement the required updates by the compliance date.
  5. Train or retrain employees. Tell them why the changes are happening, acknowledge the importance of compliance with the new rule, and empower them to make the necessary changes.
  6. Notify management, customers, and suppliers of changes to your program to ensure everyone involved is on the same page.

Turning Gaps into Opportunities: Key Questions to Ask

Asking the right questions is key to ensure your gap assessment identifies required missing elements in your programs compared to the rule. The following questions can help guide your food traceability gap assessment:

  • Do you manufacture, pack, process, or hold any of the foods found on the FTL? The FDA developed the FTL considering a few specific food safety factors, including frequency of outbreaks, occurrences of illness, severity of illness, likelihood of contamination, potential for pathogen growth, process contamination, consumption rate, and cost of illness. Comparing your products to the FTL may indicate the likelihood of your produce being implicated in a recall or outbreak event and will underscore the importance of your organization’s compliance with the Traceability Rule.
  • Are you performing CTEs? These include harvesting, cooling, initial packing, first land-based receiving (food obtained from a fishing vessel), shipping, receiving, or transforming any of the foods on the FTL. If so, specific data must be collected. Do you understand and are you meeting these data collection requirements?
  • Does your organization capture data that is considered a KDE? For example, do you apply lot codes to your products? Do you collect detailed location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information, data points, or additional KDEs you must capture and maintain to meet FDA requirements (e.g., date, harvest crew, common name of the commodity and variety, etc.). The data required is dependent on which of the CTEs you are performing. This guide from the FDA[v] can help determine whether you are collecting all the required data. Once you know what data you are missing, as identified by your gap assessment, you can determine how to best record it (e.g., developing new processes and procedures, implementing a new lot code sticker program).
  • Do you have a sufficient Traceability Plan? Does your Plan cover all the elements required in the Food Traceability Rule? The Traceability Plan must include the following, at a minimum:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how lot codes are assigned.
    • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
    • Map identifying the farms where FTL produce is grown.
    • Updates to reflect updated or new practices.
  • What recordkeeping system are you using? Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Can your system handle new requirements? Is required information readily retrievable? While hard copies in binders and Excel spreadsheets can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data. Your gap assessment can help you identify and better understand your needs and requirements prior to investing in an IT solution that helps streamline your traceability process and improve overall compliance efficiency.
  • How are you sharing data? What collaborative activities can you and your suppliers/buyers perform to ensure efficient data sharing? How do you communicate and with what frequency? What systems are your partners using? What is the best way to connect them to enable data sharing? It is important to ensure you have established processes, systems, and methods of communication throughout the supply chain to facilitate the required documentation, information sharing, and collaboration.

The answers to these questions will identify elements that you need to implement to help ensure compliance. Getting started on your gap assessment now affords time for produce companies to identify compliance program gaps, test protocols and verify their effectiveness, implement corrective actions, and ensure adequate traceability processes are in place before the January 2026 deadline.

[i] The Produce Traceability Initiative. https://producetraceability.org/.

[ii] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. June 27, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.

[iii] Code of Federal Regulation. Title 21, Chapter 1, Subchapter A, Part 1, Subpart S. July 3, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S?toc=1.

[iv] U.S. Food and Drug Administration. Food Traceability List. March 30, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.

[v] U.S. Food and Drug Administration. Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). https://www.fda.gov/media/163132/download?attachment.