Frank Yiannas, a world-recognized food safety expert, and Aquatiq, an international provider of food safety solutions, are joining forces to advance global expertise in the establishment of food safety cultures in industry and government.
Yiannas, a former deputy commissioner at the U.S. Food and Drug Administration and principal of Smarter FY Solutions, has long championed the importance of establishing food safety cultures to fuel and support food safety management at all levels of the global food chain. He created this workshop to provide a greater understanding of how to use organizational and behavioral science principles to influence behavior and enhance employee compliance.
“This partnership marks a significant step in making food safety culture practical and impactful for companies worldwide. Together with Aquatiq, we aim to empower organizations with the tools and knowledge to prioritize food safety at every level,” said Yiannas.
Aquatiq’s program will include a rigorous train-the-trainer process, certification, and an emphasis on measurable outcomes, ensuring high standards of training and education.
“At Aquatiq, we believe that food safety culture is the cornerstone of sustainable and responsible food production.” said Eirik Bugge, CEO of Aquatiq. “Partnering with Frank Yiannas allows us to leverage his unparalleled expertise to deliver world-class training and solutions that empower companies to embed food safety into their core values and operations.”
Before joining the FDA in December 2018 as Deputy Commissioner of Food Policy and Response, Yiannas spent more than 30 years in leadership roles with Walmart and the Walt Disney Company. And he wrote two books on food safety culture: “Food Safety Culture: Creating a Behavior-Based Food Safety Management System,” published in 2008, and “Food Safety = Behavior: 30 Proven Techniques to Enhance Employee Compliance,” published in 2015. After leaving FDA, Yiannas established Smarter FY Solutions to advise on food safety and supply chain issues.
Aquatiq provides food safety solutions across every stage of the food production value chain. With a focus on enhancing sustainability and reducing costs, Aquatiq is dedicated to helping businesses achieve excellence in food safety and operational efficiency.
When you think about today’s cyber threats, ransomware and data breaches are among the first things that come to mind. However, there are also risks associated with our physical safety, including the integrity of global food supplies.
Cyberattacks, specifically those that target food supply chains, can pose a significant risk to our health and safety. Considering how dependent modern society has become on food production and distribution channels, major breaches in any of these areas can have critical long-term impacts on society as a whole.
Whether disrupting automated farming equipment or manipulating integrated industrial controls, it’s important to understand the ongoing risks to our food defense systems and how to better protect them going forward.
Understanding the Cyber Threat Landscape in Food Defense
Food supply chains are operated using a variety of interconnected systems and processes. While these create more opportunities for improvised agricultural development and larger distribution networks, they also create more entry points for cyber attackers.
Below are some of the areas where vulnerabilities that are currently present in food distribution sectors:
Farming and Food Production – Over the years, farming equipment and food production facilities have adopted a number of new technologies to make their processes more efficient. These include automated irrigation systems, livestock monitoring equipment, and other agricultural solutions. Due to their constant connectivity, they can become vulnerable to attacks that can not only manipulate data but could even damage crops or harm livestock.
Processing and Manufacturing – Most food processing plants leverage the use of industrial control systems and temperature monitoring devices to ensure quality control of stored products. The accuracy of these monitoring solutions is critical to minimize the development of harmful bacteria and to ensure the integrity of the products being sold. If these systems become compromised, it can lead to product contamination or major backlogs in production.
Packing and Distribution – Warehouse management systems are used to help food suppliers and distributors manage their logistics processes effectively to ensure timely deliveries to retail outlets. Logistics platforms and transportation networks rely on GPS solutions and temperature controls during transit to ensure transported goods maintain their quality. Hackers can compromise these systems in an effort to misroute products or cause delays in critical delivery networks.
What are the Impacts of Cyber Threats on Food Defense?
Cyber threats against global food production facilities and supporting supply chain networks are more than just inconvenient or financially draining; they can also pose a question of health and safety.
Food Safety Risks
Cyberattacks can directly impact the safety of the food distributed and consumed. For example, a breach in a manufacturing facility could change certain ingredient ratios or tamper with temperature controls that keep food from spoiling or having certain contaminants.
If a cyber attacker gains access to cold storage facilities or delivery systems, they could make changes in operating temperatures that can directly impact the shelf life of large volumes of food.
Economic Issues
The economic impacts of cyberattacks on the food industry can also be significant. Supply chain disruptions caused by attacks on logistics or transportation systems can create shortages, drive up prices, and impact end users.
When considering the extensive recovery costs associated with a cyberattack, including system restoration or legal fees due to breaching certain data security or compliance standards, the long-term damage could be substantial. The cumulative effect of these disruptions can also lead to significant increases in food prices and impact both businesses and consumers.
Public Health Concerns
One of the most concerning impacts of cyberattacks on food defense is the potential for widespread illness. Contaminated or spoiled food can lead to outbreaks of foodborne illnesses, affecting large numbers of people. In severe cases, these outbreaks can result in hospitalizations and even deaths.
The potential for large-scale food recalls triggered by cyberattacks is another issue that can have public health implications. These recalls not only disrupt the supply chain but also create significant costs for businesses and inconvenience for consumers.
Effective Strategies for Mitigating Cyber Threats in Food Defense
Protecting the food supply chain from cyberattacks requires a strategic approach involving a variety of preventative measures. This includes:
1. Implementing Strict Cybersecurity Measures
Having a strong cybersecurity foundation is critical for industries. This includes implementing network security measures like firewalls and intrusion detection systems to prevent unauthorized access. This includes:
Employing firewalls, intrusion detection/prevention systems, and virtual private networks (VPNs) to control network traffic and prevent unauthorized access.
Implementing data encryption at rest and in transit.
Regularly scanning for vulnerabilities and applying software patches and updates as quickly as possible.
Educating employees about cybersecurity best practices, practicing good password hygiene, and following established security protocols.
2. Strengthening Supply Chain Collaboration
Effective information sharing and threat intelligence with all supply chain stakeholders is essential. This includes establishing various cybersecurity standards and protocols across the supply chain to ensure that all partners work from the same baseline level of security preparedness.
Employing penetration testing services to simulate real-world attacks is another important way to ensure that newly adopted security policies and procedures can withstand the latest attack methods. Simulated attacks can also help organizations prioritize their initiatives and collaborate to close critical gaps across interconnected supply infrastructure.
3. Developing Incident Response Plans
Even with the best preventative measures in place, cyberattacks can still occur. This is why developing comprehensive incident response plans is so important for improving food defense. These plans should outline clear procedures for handling cyberattacks, including identifying the incident, containing the damage, and recovering any impacted systems and data.
Creating backup and recovery systems is critical for minimizing downtime in the event of an attack. These systems should be regularly tested to ensure that they can be quickly and effectively deployed.
Effective communication strategies during a crisis should also be defined ahead of time. This includes notifying customers, suppliers, and regulatory agencies about the incident and keeping them informed about the steps being taken to resolve it.
Protecting Our Critical Infrastructure
Cyberattacks targeting the food supply chain can pose a significant threat to agricultural businesses and consumers. By implementing effective cybersecurity measures and strengthening supply chain collaboration, companies can take the necessary steps to protect critical infrastructure while ensuring the continued safety of our food supply.
Maintenance management in a food production facility is a formidable challenge. Managing machines and people across multiple sites, ensuring compliance with health, safety and environment (HSE) regulations, driving efficiency and preventing costly downtime: the challenges are manifold. With stringent audit requirements and the constant threat of product recalls or facility shutdowns, asset managers in the food sector must embrace strategic and data-driven maintenance strategies.
According to the Enterprise Asset Management (EAM) Trend Report, uptime is the most crucial performance indicator for asset managers in industrial businesses such as food and beverage manufacturing. Yet, a lack of communication remains one of the biggest risks to uptime. With the cost of downtime exceeding $22,000 per minute (or over $1M per hour)1 it’s an issue that no-one can afford to ignore. Effective collaboration, digital transformation and proactive maintenance practices are the key answer to the five biggest challenges for food sector asset managers.
1. Enhancing Collaboration for Optimized Asset Management
Asset managers must align maintenance KPIs with overarching business goals. Effective collaboration between maintenance teams, operations, and HSE professionals creates compound benefits such as improving productivity, efficiency, communication, and data integrity.
The Circle of Collaboration is a theory that fosters alignment between departments and facilitates a seamless flow of information. To achieve this, a centralized EAM system empowers teams to share data, analyze trends, and embrace a proactive maintenance culture. This approach helps eliminate the traditional “we use, you fix” mentality and shifts the focus toward shared objectives.
By leveraging a single-source-of-truth platform, food manufacturers can move away from blame-based working cultures and embrace interdepartmental cooperation, ultimately reducing downtime and enhancing workplace safety.
2. Protecting Uptime with Proactive Maintenance
Unplanned downtime is one of the most significant threats to food manufacturing operations. It leads to production delays, financial losses, and potential food safety risks. Given the perishable nature of food products, even minor disruptions can have catastrophic consequences.
Implementing proactive maintenance strategies helps mitigate these risks. By transitioning from reactive maintenance to predictive and risk-based approaches, organizations can optimize asset reliability and reduce costly breakdowns.
The Maintenance Maturity Model illustrates how companies can evolve from reactive repairs to predictive analytics-driven strategies, leveraging IoT technologies to monitor asset health in real time. With data-driven insights, asset managers can anticipate failures, schedule maintenance more efficiently, and extend the lifespan of critical equipment.
3. Controlling Costs Through Data-Driven Decisions
Maintenance budgets must be managed meticulously to ensure cost efficiency without compromising safety or productivity. However, relying on offline data records makes it challenging to understand how budgets are spent and which assets cost the most to maintain. Optimizing asset performance then becomes a guessing game.
A robust EAM system provides reliable data on asset operation and service history, allowing asset managers to make confident decisions. By automating maintenance tracking, organizations can pinpoint underperforming assets, identify inefficient maintenance practices, and allocate resources effectively.
With full visibility into maintenance costs, food manufacturers can get the most value out of their assets by spending the budget in the most impactful manner. In doing so, they optimize asset utilization and achieve greater financial control.
4. Simplifying HSE Compliance
Ensuring regulatory compliance is a top priority for food manufacturers. With ever-evolving safety regulations and stringent hygiene standards, food production facilities must integrate asset management and HSE processes effectively.
An EAM system supports this by enabling real-time monitoring of asset health and maintenance history, as well as providing a transparent record of compliance. It also aids in enforcing safety protocols, streamlining maintenance actions, and ensuring documentation is readily available for audits or investigations.
By centralizing data, organizations can reduce the risk of regulatory breaches, making it easy to confidently demonstrate compliance, avoid penalties, and maintain food safety standards.
5. Building Resilience with Digital Transformation
Resilience in food manufacturing is more critical than ever, especially in the wake of global disruptions such as COVID-19. Organizations with well-planned maintenance processes, remote capabilities, and digital management strategies hold a significant competitive advantage.
Innovative solutions, such as mobile-enabled EAM systems, provide real-time access to maintenance data, ensuring continuity even during disruptions. By digitizing maintenance workflows, companies can streamline operations, enhance decision-making, and improve overall agility.
The lessons learned from pandemic-related shutdowns underscore the importance of digital transformation in asset management. Investing in connected maintenance solutions not only improves operational efficiency but also strengthens business resilience against future uncertainties.
Case Study: Agristo’s Digital Maintenance Transformation
Agristo, a leading manufacturer of frozen potato products, faced significant challenges in managing maintenance across multiple production sites. The company struggled with operational inefficiencies due to a lack of structured maintenance processes and digital records.
By implementing the Ultimo EAM system, Agristo transformed its maintenance operations, achieving full visibility over maintenance tasks and asset health. In 2020 alone, the company logged over 53,695 maintenance jobs, ensuring proactive asset management and minimizing downtime.
Crisp conveyor
Agristo’s adoption of a centralized maintenance platform resulted in a 5 percent increase in uptime, improved data-driven decision-making, and enhanced compliance. According to Steven Volckaert, Group Maintenance Manager at Agristo, “Being able to show in a clear and structured way how the essential maintenance and safety processes are managed and stored can be a selling point to new customers.”
Case Study: AVO-Werke
AVO-Werke August Beisse GmbH is a market-leading spice specialist, serving many major food manufacturers, B2B operators in the food trade, and artisan butchers across Europe. The company produces approximately 50,000 tonnes of raw herbs and spices annually and boasts a portfolio of around 8,000 products, including organic and processed spices, spice blends, marinades, seasoning sauces, and dressings as well as food processing products such as nets and casings for ham and sausages.
AVO wanted a solution that would cover all vital asset management processes but also offer a simple user interface to allow quick uptake amongst employees and enable a mobile and largely paperless operation.
Previously, the technical department relied on various Excel spreadsheets for an overview of files, spare parts and the maintenance status. Switching to Ultimo has revolutionized the process. “Simple order management, visibility over the availability of spare parts, and access to key documentation on mobile devices are just some of the improvements that make our daily work significantly easier. During audits, we are able to provide the requested information very quickly.”
“All our maintenance processes from order management and reporting to cost control, procurement, and the management of spare parts are much better organized with Ultimo,” says Dr Kurt Höfelmann, Technical Manager, AVO-Werke. “We get an excellent overview of the condition of our plants, which enables us to reduce downtime. Everything runs more efficiently, and that has a positive impact on our employees’ motivation.”
“The new EAM solution allows us to be more flexible, working on the computer and processing orders on mobile devices using the Ultimo Go+ app,” explains project manager Denis Roor, Technical Purchasing, AVO-Werke. “It’s ingenious how you can create an order on the go, process it, and then report it as completed. It eliminates many steps and phone calls, the time saved can be used more productively.”
Cover all vital asset management processes
Food sector asset managers face immense pressure to maintain uptime, ensure regulatory compliance, and control costs while ensuring asset availability and food safety. By fostering collaboration, embracing digital asset management solutions, and transitioning to proactive maintenance strategies, organizations can navigate these challenges effectively.
Investing in EAM technology enables food manufacturers to streamline maintenance processes, enhance data-driven decision-making, and build resilience in an increasingly complex industry landscape. Implementing a robust EAM system is the first step toward sustainable, long-term success.
As the new administration moves to make regulatory changes, food recalls remain a constant, with donuts, potato chips, chocolate, chicken nuggets, and more being recalled in the first few months of 2025. In fact, recalls are at a five-year high. Tech-driven recall readiness will prepare food businesses and supply chains for an uncertain future.
Digital solutions are transforming recall management, helping food businesses reduce response times, improve information-sharing, and ultimately protect public health. Automation, real-time monitoring, and cloud-based platforms provide the agility needed to adapt to regulatory shifts while ensuring an effective recall process. Companies that adopt tech solutions will not only mitigate risk but also be better equipped to handle whatever policy changes lie ahead.
Communities that are resilient, even amid uncertain regulatory and political climates. Tech solutions are central to this effort. Here’s how to build a tech-driven Recall Ready Community with your supply chain:
Prioritize food safety
Strong food safety protocols should always be the foundation of your recall strategy, even as policies evolve. Using traceability software and predictive analytics helps you detect risks early and act swiftly when a recall is necessary. Ensure your team is trained and prepared, with clear procedures in place, knowing that a recall could happen at any time.
Work collaboratively with your supply chain
Align with your trading partners to improve speed and accuracy – streamlining the recall process for smoother, more effective responses. Use interoperable systems, supplier verification platforms, and cloud-based communication platforms to elevate data-sharing, transparency, and accuracy. Share expectations for action, and practice your recall process with your supply chain to reduce delays and confusion when a recall occurs.
Standardize data and processes
Standardized data sets ensure all stakeholders (e.g., regulators, trading partners, consumers, the media) have access to accurate, actionable information. Traceability and recall management platforms should use standard data sets (like GS1 standard), and your team should be trained on clean and secure data practices.
Practice in advance
Conduct recall simulations so your team knows exactly what to do in a real-world recall situation. Recall management platforms that allow mock recall simulations and VR training tools create lifelike sample scenarios ideal for effective practice with your supply chain. These simulations help identify and close gaps (like whether you have current contact information for your stakeholders), so you can reduce confusion, build confidence, and ensure preparedness for actual recalls.
Communicate clearly
Even as Federal health agencies paused communication, you can proactively alert consumers and other key stakeholders about recalls. Use automated notification systems and customer loyalty programs to quickly disseminate key messages about recalls to your customers. Provide clear, actionable messaging about what happened, why it happened, and what to do next.
Conclusion
By embracing digital solutions, food businesses can stay agile, respond quickly, and maintain consumer confidence. Don’t wait for Congressional decisions or court rulings around food safety and recalls. Be proactive to protect your brand and consumers, no matter what the future holds. Today’s tech solutions are affordable, accessible, and user-friendly. Now is the time to invest in technology that strengthens your recall strategy and builds a more resilient industry.
Supply chain stability has a great deal of influence over food safety and security across global markets. When food networks experience disruptions, the consequences affect production, distribution, storage conditions, and consumer well-being. Recent events, such as the COVID-19 pandemic, have demonstrated the urgency of developing adaptable food supply systems that maintain strict safety standards under pressure.
Modern food supply chains must balance operational excellence with strategic planning to respond to market shifts and evolving safety requirements. An ideal approach integrates vendor partnerships, technological solutions, and risk management practices to create robust networks that protect business value and public health. Successful food supply networks blend time-tested operational practices with smart innovation, maintaining quality standards through every market shift and challenge.
Streamlining Operations for Efficiency
Food supply networks depend on seamless coordination between multiple moving parts, from initial production to final delivery. Each step in the process — from cold storage management to transportation scheduling — requires precise timing and careful quality control. Optimizing these operations demands attention to two critical areas: building strong vendor partnerships and integrating smart technology solutions.
These core elements create reliable, efficient systems that maintain food safety while reducing operational costs. Success begins with cultivating strong partnerships throughout the vendor network and amplifying these relationships through strategic technology adoption. Striking this balance requires careful attention to supplier relationships and smart implementation of digital monitoring tools.
Building Strong Vendor Networks
Strong vendor relationships start with clear performance standards and consistent communication practices. Regular quality assessments and collaborative planning sessions help create lasting partnerships built on mutual success. These relationships become especially valuable during supply chain challenges when quick responses and flexible solutions matter most.
Effective vendor invoice processing reduces costs through automated systems and standardized procedures. This streamlined approach eliminates common error sources while freeing staff to prioritize strategic improvements. Well-managed vendor documentation also supports compliance efforts by maintaining clear records of all transactions and quality verifications.
Technology Integration for Safety and Efficiency
Advanced digital systems monitor food safety throughout storage and transportation, offering precise control over environmental conditions and product tracking. Modern IoT-driven sensor networks provide continuous updates on temperature, humidity, and other critical factors that affect food quality. These systems also utilize AI technology to analyze and formulate rapid responses to potential issues before they affect product safety.
Digital platforms also improve communication across the supply chain, connecting vendors, transporters, and facility managers through unified data systems. Real-time updates and automated alerts help maintain product integrity while reducing waste. Supply chain managers use this precise, real-time data to reinforce both immediate decisions and strategic planning.
Risk Mitigation and Flexibility in the Supply Chain
Food distribution networks face persistent challenges from multiple sources. Seasonal storms disrupt transportation routes, equipment failures compromise cold storage systems, and sudden demand spikes strain production capacity. Each type of disruption presents unique challenges to food safety and quality control, requiring specific strategies and response protocols.
Effective risk management combines two essential capabilities: systematic vulnerability assessment and operational flexibility. Organizations must develop methods to spot potential problems before affecting product quality. They then need adaptable systems that can quickly adjust to changing conditions without compromising safety standards.
Identifying and Addressing Vulnerabilities
Effective risk prevention begins with regular assessment of potential weak points. Transportation delays, equipment malfunctions, and storage complications can all threaten product integrity. Maintaining food safety during disruptions requires systematic monitoring and clear response protocols. Organizations particularly benefit from detailed contingency plans that anticipate various scenarios and outline specific actions for each situation.
Quality control teams must stay alert to subtle indicators that might signal developing problems. This vigilance includes monitoring supplier performance metrics, tracking delivery patterns, and analyzing temperature control data. Early detection of potential issues allows swift intervention before minor concerns escalate into significant disruptions.
Building Adaptable Systems
Flexible distribution networks accommodate sudden changes without sacrificing safety standards or operational efficiency. This adaptability stems from strategic redundancy in critical areas, including backup supplier relationships and alternative transportation routes. Cross-trained staff members provide additional flexibility, allowing quick reallocation of resources when specific areas need extra support.
Clear communication channels prove essential during periods of adjustment. Team members at every level need accurate, current information about changing conditions and modified procedures. Staff training drills sharpen emergency response skills and build team confidence. Well-prepared personnel protect food quality standards while smoothly executing needed process adjustments.
Branding and Consumer Trust in Food Safety
Consumer confidence grows from consistent safety practices paired with open communication. Food producers and distributors sharing detailed information about quality control measures build lasting market relationships. Today’s consumers look beyond basic safety claims — they want to understand specific handling procedures, storage protocols, and quality certifications. This heightened interest in food safety creates opportunities for meaningful dialogue with customers about quality assurance practices.
Meeting these expectations takes a coordinated approach that spans internal operations and external communications. Organizations can build consumer trust by creating clear, accessible messages about safety standards and fostering active participation in safety practices across all stakeholder groups. From employee training programs to consumer education initiatives, each element of safety communication plays a vital role in building and maintaining market confidence.
Communicating Safety Commitments
Clear messaging about food safety practices builds credibility with consumers and retail partners. Documentation of safety protocols, quality certifications, and handling procedures demonstrates dedication to product quality. Promotional products highlight your brand values while educating consumers about specific safety measures, from temperature monitoring to contamination prevention. If possible, tailor your materials to match the relationship in question.
Safety communication involves more than standard product packaging and labels. Websites, social media, and print materials collaborate to share detailed quality control processes and safety innovations. Using multiple communication methods helps consumers find accurate safety information wherever they look. Generally speaking, it’s better to have more information available than you need than to be too opaque.
Engaging Stakeholders in Safety Culture
Food safety excellence starts in warehouses and continues through every delivery route. Quality control teams conduct hands-on training sessions, from temperature monitoring to contamination prevention, to simulate real-world challenges. Staff members contribute valuable insights through structured feedback programs, often identifying practical improvements to daily operations. Employee recognition programs celebrate exceptional safety practices, spurring healthy competition and innovative approaches to quality control.
Safety education has far-reaching effects throughout the distribution network. Distribution centers conduct specialized training sessions for retail partners, teaching proper handling techniques for various food categories. Store staff learn optimal storage methods for different products and then pass this knowledge to customers through clear guidelines and practical tips. Local food safety workshops bring together warehouse teams, retail staff, and consumers, creating collaborative learning environments.
Final Thoughts
Strong food supply networks emerge from careful attention to three core elements: operational precision, risk readiness, and stakeholder engagement. Organizations that excel at vendor management while integrating advanced monitoring systems create reliable distribution channels that withstand market pressures. Clear safety protocols and quick-response capabilities maintain food quality through unexpected challenges.
Safety-focused communication strengthens every link in the food supply chain. Informed employees can spot potential issues early, trained vendors can follow precise handling procedures, and educated consumers can make smarter storage decisions. When each participant understands their role in maintaining food safety, the entire system benefits through consistent quality, reduced waste, and increased market confidence.
In the dynamic and complex food industry landscape, the role of a food safety consultant is crucial. They provide expert guidance, advice, and assistance to ensure food safety, hygiene, and compliance with industry standards and regulatory requirements. Below are essential inquiries to ask your food safety consultant to ensure optimal results and mitigate potential risks and challenges.
Are you familiar with our specific segment within the food industry? The food industry encompasses various sectors, each with unique challenges. Familiarity with your specific sector, such as dairies, bakeries, meat, confectionery, or packaging, will prove advantageous, allowing the food safety consultant to tailor their advice and solutions to your specific needs.
Can you help develop and implement a robust food safety management system (FSMS)? An effective FSMS is key to ensuring the safety and quality of food products. You can gauge the consultant’s potential effectiveness by evaluating their ability to design and implement an FSMS based on relevant standards like HACCP or ISO 22000.
How well-versed are you in risk analysis and hazard identification? The food chain has various potential hazards, from raw material sourcing to processing and distribution. The consultant needs expert knowledge in identifying potential risks and implementing measures to control them.
How do you approach problem-solving when a food safety issue arises? Every consultant should have a systematic approach to mitigating food safety crises. This approach may incorporate principles from Six Sigma, Lean Manufacturing, or Kaizen, which are methodologies for problem-solving and continuous improvement.
Selecting a food safety consultant requires careful consideration. By using some of these questions as a framework for objectively assessing potential candidates, you can confidently select a consultant who will provide the knowledge, expertise, and strategic guidance your operation requires. This proactive approach to food safety ensures the well-being of consumers, compliance with regulatory standards and the longevity and reputation of your brand.
Do you have a pressing issue but don’t know where to start? Let SGS help you meet customer expectations with our tailored solutions.
Labeling of food and dietary supplements in the United States involve several aspects and each must be approached with careful consideration. Regulatory, scientific, and business decisions need to be considered when working on labels’ mandatory elements and claims. The FDA released in December 2024 and January 2025 a few new proposed and final rules on several issues that will impact food and dietary supplement labeling. 1,2,3,4 However, it is unclear at this time whether these rules will be approved by the new federal administration. 5 Stay tuned into these topics over the next few months to obtain information on the final requirements.
Mandatory elements of the label declared on the principal display panel (or front-of-package) include the statement of identity and net content of the product. Other elements such as warnings might also be required depending on the product. One of the newly proposed rules by the FDA is the inclusion of an abbreviated version of the nutrition information (“Nutrition Info Box”) to be placed on the front of the package of most packaged foods. 1 If approved, companies will have 3 to 4 years (depending on business size) to implement the new label. Although editing a label is not very challenging, some companies might decide to reformulate the entire product in order to avoid a potential drop in sales. The nutrition info box will include clear information of product’s level as low, medium, or high of saturated fats, sodium, and added sugars on the front-of-package. In addition, the FDA released a draft guidance (nonbinding recommendations) on the statement of identity of plant-based foods. Coming up with the statement of identity of non-standardized foods can be tricky. This FDA guidance provides examples of how to name plant-based foods such as “soy-based cheddar cheese,” “chickpea and lentil-based fish sticks,” and “chia and flaxseed egg-less scramble.” This draft guidance is open to receive comments. The period for comments ends on May 7, 2025, and can be submitted online. 2
The other mandatory elements of the label are declared in the information panel. This is the panel located immediately to the right of the principal display panel and includes the Nutrition/Supplement Facts panel, the list of other ingredients (including allergen declaration), and the name and place of business. One of the FDA’s newly proposed rules that will impact the information panel if approved is the ban on Red No. 3 color additive. 3 Prohibiting the use FD&C Red No.3 will cause companies to reformulate their products. Food companies will have until January 15, 2027 to comply. Imported foods will also have to comply. This rule came into decision due to data that Red No.3 dye might induce cancer. The FDA also released a final guidance for industry regarding food allergen labeling. This guidance provides several new questions and answers on allergens such as shellfish and fish species as well as on allergen-free claims. Although this is a final guidance, comments can be submitted any time. 4
Claims are another important piece of the labeling. Claims inform consumers of the intended use of the product as well as add product marketability. However, as with the other components of the label, ensuring compliance with the correct claims wording and claims substantiation will keep companies out of trouble. The new FDA rule that will affect product claims if approved is on the term “healthy.” In December 2024, the FDA released a final rule on the eligibility for use of the term “healthy” as it relates to nutrient content claims in food and dietary supplements. This rule is set to be effective on February 25, 2025 with compliance until February 25, 2028. However, again it is unclear if this final rule will remain after the new federal administration. In general, the term “healthy” will only be allowed when products meet the criteria of containing a certain amount of healthy nutrients (i.e., fruits, vegetables, grains, fat-free and low-fat dairy and proteins) as well as staying under the limit for unhealthy nutrients including added sugars, saturated fat and sodium. 5
Food safety remains a vital concern for public health and consumer trust. Every decision in risk assessment can protect lives and prevent contamination. Adopting data-driven methods offers a clear advantage over traditional practices prone to human bias. Today, predictive analytics, digital collaboration, and Industry 4.0 innovations provide much of the evidence needed to secure the food supply.
However, biases can still affect these advanced technologies. To maximize their benefits, it’s vital to be mindful of these potential issues so you can prevent them from occurring and overcome them if they do.
Understanding Cognitive Bias in Food Safety Risk Assessments
Cognitive biases distort decision-making. Confirmation bias leads experts to favor data that supports familiar ideas. The availability heuristic overemphasizes recent or vivid events.
Information bias encourages reliance on incomplete or misleading data. Each bias weakens the risk assessment process and can result in missed hazards.
Recent research shows that biased evaluations have contributed to significant safety failures. In several cases, incomplete data led to overlooked risks, causing contamination events and product recalls. The industry now embraces objective, data-based methods to reduce errors. Using comprehensive datasets clarifies risk factors and improves evaluations, building a more resilient food safety system.
Food safety professionals now seek methodologies that replace subjective judgment with measurable evidence. They commit to processes that rely on hard data, ensuring every decision reflects the true risk level. This change promises clearer assessments, stronger preventive measures, and a safer food supply chain.
Leveraging Predictive Analytics for Objective Decision-Making
Predictive analytics transform risk assessments by forecasting hazards before they occur. Advanced models examine historical data alongside real-time information to identify emerging risks. These algorithms reveal patterns that traditional methods may miss, empowering teams to act before incidents occur.
Food safety teams use predictive models to monitor trends and allocate resources effectively. Early intervention prevents potential outbreaks and minimizes losses. Predictive analytics shifts the focus from reacting to problems to anticipating them. This proactive approach leads to more precise, measurable outcomes and reinforces public confidence in food safety systems.
The power of predictive analytics inspires a forward-thinking mindset across the industry. Professionals apply data-driven tools to predict challenges and implement timely countermeasures. In doing so, they turn vast amounts of data into actionable intelligence, which strengthens the overall safety framework.
Using Collaborative Tools to Reduce Bias
Collaboration plays a crucial role in achieving unbiased risk assessments. Modern digital platforms enable experts from various fields to work together. Online whiteboards and collaborative software create an environment where data becomes visible and ideas exchange freely. These tools foster real-time discussions that help challenge assumptions and examine data thoroughly.
Team members organize and annotate information to reveal inconsistencies. They review data collectively, which reduces individual biases and refines overall judgments. Structured group analysis enhances transparency and leads to more accurate evaluations.
Key benefits of digital collaboration include:
Real-time brainstorming sessions
Clear, visual organization of complex data
Collective review processes that minimize personal bias
These collaborative platforms promote an atmosphere of open dialogue and mutual accountability. They encourage professionals to use every available data point to build well-rounded risk assessments. In turn, this approach improves decision-making and strengthens the safety net across the food industry.
The Role of Industry 4.0 and Data Analytics in Food Safety
Industry 4.0 technologies revolutionize food safety by streamlining data collection and analysis. Sensors placed throughout production lines capture real-time data on temperature, humidity, and pressure. Automated systems record this information and feed it directly into analytical models. Machine learning algorithms process the data and detect anomalies with impressive speed.
This technological integration minimizes human error. It ensures consistency in monitoring and sharpens the accuracy of risk assessments. Automated systems and smart devices provide continuous feedback, ensuring quick interventions as required. Such precision proves indispensable for upholding strict safety standards.
Industry 4.0 innovations drive a transformation that enhances efficiency and strengthens consumer confidence. The use of interconnected devices and advanced analytics creates a transparent environment where every step in the production process receives constant scrutiny. This proactive system ensures that potential concerns are spotted and handled before they become larger problems.
Data Analytics in Food Safety Compliance
These tools can overhaul risk management strategies using advanced data analytics. Teams can integrate real-time monitoring with predictive models to examine a wide range of risk factors. This allows detection of the early warning signs of contamination that traditional methods often miss. Swift action could prevent a potential outbreak and avoid a costly product recall.
When professionals embrace analytics, they can achieve significant improvements in compliance. They can detect risks earlier and implement targeted measures that maintain high safety standards. Ongoing success confirms that investment in data analytics translates into improved operational efficiency and better protection of public health.
The potential positive outcomes from this use case drive home the value of advanced risk assessments. They demonstrate that data-centric strategies help shift reactionary processes into anticipatory systems. Industry professionals must adopt similar methods and continuously refine their safety practices.
Scientific Perspectives on Data-Driven Risk Assessments
Recent scientific studies support the benefits of data-driven risk assessments. Researchers have found that objective data and advanced models lead to more accurate, reproducible evaluations. Comprehensive datasets help uncover subtle risk factors that traditional methods often overlook. The evidence demonstrates that objective analysis reduces the influence of human bias.
Peer-reviewed research validates the need for measurable, data-based strategies in food safety. Scientists conclude that integrating robust analytics improves decision accuracy. Empirical studies reveal that evidence-based approaches lead to better identification of hazards. This research reinforces the importance of transitioning away from subjective methods toward data-driven protocols.
The scientific community’s findings promote a clear path forward. Food safety professionals receive encouragement to adopt advanced analytics in their work. They gain assurance that objective, data-driven practices enhance every aspect of risk management, leading to safer food systems and greater public trust.
Embracing the Human Element in Data-Driven Food Safety
Technology and data form the backbone of modern food safety, but human expertise remains essential. Skilled professionals interpret complex datasets and translate numerical insights into practical safety measures. Their deep understanding of food systems ensures that advanced analytics enhance, rather than replace, expert judgment.
These professionals scrutinize every data point, validate the accuracy of algorithms, and adjust protocols based on real-world conditions. Their critical analysis turns raw data into clear, actionable strategies. Human insight and analytical tools work together to refine risk assessments continuously.
Integrating human expertise with data-driven solutions builds a resilient safety culture. Food safety teams commit to continuous improvement, ensuring that every risk assessment reflects the latest insights and technologies. The combination of precise analytics and expert judgment ultimately strengthens the industry’s resolve to protect public health.
Conclusion
Data-driven decision-making is revolutionizing food safety risk assessments, replacing guesswork with objective, measurable evidence. Predictive analytics, collaborative digital tools, and Industry 4.0 innovations all work together to empower professionals to identify and mitigate risks before they escalate. Every sensor reading and algorithmic prediction strengthens transparency and ensures a proactive approach to safety.
This shift represents more than a technological upgrade. It is a commitment to public health and trust. Clear, accurate risk assessments reduce cognitive bias and reinforce industry accountability. By embracing data-driven methodologies, food safety professionals create a resilient system that adapts to new challenges, safeguards consumers, and upholds the highest standards of excellence.
“Oh no, not another audit!” This is a phrase most professionals in Quality have either heard uttered in staff meetings and huddles or have actually spoken themselves. Audits, whether you embrace them or not, are a staple of every regulatory environment, and how you conduct and handle audits can impact all aspects of your business. When viewed as a means of continuous improvement and preparation, audits can also provide deep, meaningful understanding of your systems and expose gaps when they are embraced as a Quality tool to utilize.
Audits come in a variety of types, but the three main audit types that will be covered here are Regulatory Audits, Internal Audits, and Mock Audits. The ways a company handles, conducts and views these three categories of inspections will set them up for success.
Regulatory Audits – Know Your Regulations to Best Your Regulations
Regulatory audits are some of the most common audits to be had in regulated industries and therefore are also the most common type to need to be prepared for. There are several steps involved with being prepared for a Regulatory audit: Knowing the regulations, having a process, and having people assigned to that process.
The first step seems like it shouldn’t need to be stated out loud, but it does. Knowing the regulations, and more importantly, how those regulations apply to your business and how you can show compliance to those regulations is absolutely critical to ensuring your best chances of a smooth regulatory inspection when the time comes. Take the time to not only read the full text of the regulation you will be inspected against, but step through it clause by clause asking how the clause applies to the business and what would need to be shown documentation wise to an inspector to show compliance. Additionally, remember that regulations periodically update, so the first time you step through your regulation should NEVER be your last. Always keep up with how the regulation has updated year over year and ensure you are not behind the curve on a new or enhanced clause.
The second and third steps go hand in hand: Have a process and have people assigned to it. Having a written procedure on how to handle regulatory inspections will help ensure trained staff are consistent and prescriptive in how an inspection is handled. This goes a long way to showing an inspector, for many of whom it will be their first time in your business, that you are ready, willing and able to show compliance to the regulatory standards. The written process should cover every aspect of an inspection from greeting an inspector, opening meetings, facility tours, handling of documentation requests including roles and personnel for back action rooms for documentation review prior to entering the audit room, and inspection follow-up.
The procedure should describe for each of these steps who is responsible for executing the step in the process as well as list potential backup personnel for responsibility in order to ensure smooth and complaint execution of your procedure should personnel be unavailable due to vacation, illness, or other leave of absence. Once this process is in place, all staff should be trained on the process and procedure, including personnel not necessarily involved with the process as they will need at least an awareness of what will occur during the inspection.
Once you have completed a review of the applicable regulations, and written and completed training for a procedure to follow, remember that the core mission of agencies like the FDA is public safety, and that inspections, while potentially stressful, are opportunities to engage with the agency and mitigate gaps in compliance with regulations.
Mock Audits – Practice Makes as Perfect as Possible!
Mock Audits are, as the name implies, practice audits against the applicable regulations and implemented processes and procedures to ensure compliance. Mock audits follow the same cadence as a normal inspection would and should test each aspect of your procedure to ensure compliance. Mock audits, along with Internal Audits discussed next, are a great way to probe and test your Quality Management Systems and unit operational activities to expose and correct any compliance gaps before an actual inspection occurs. Conducting Mock Audits on a regular basis will also reduce anxiety and uncertainty among your staff in preparing them for an actual regulatory inspection and how normal inspector interactions flow, especially staff members who might be new to the regulatory landscape.
A difference with a Mock Audit versus an Internal Audit will be that the “inspector,” who is a staff member or person contracted by your firm, should be in character at all times during the audit, and should expect to receive responses and documents as if they were not an employee. You will want your auditor in this case to have experience with both the regulations they are auditing against as well as the normal cadence and flow of a regulatory inspection. The auditor should not rely on standardized checklists but instead focus on open ended questioning of processes and procedures and speaking with employees at length to have them talk through the process they are performing. Doing this will benefit everyone involved in that compliance gaps will be identified and addressed, and employees who might not normally spend large amounts of time in the presence of a regulatory auditor or inspector will have the opportunity to learn the best ways to engage questioning.
Internal Audits – Better Me Than Them!
Finally, let’s cover Internal Audits. Internal Audits and associated internal audit programs are not only a good idea to have in place they are a requirement of several regulatory standards. Like Mock Audits, Internal Audits are a great way to identify and address any regulatory gaps you may have in your processes and systems before an actual inspection takes place. The approach here can be simplified down to “Who would you rather find this compliance gap: Me the internal auditor, or a Regulatory Inspector?” Additionally, Internal Audits provide a clear path for deep, thorough analysis of processes and procedures, allowing for processes and systems to be evaluated from a variety of standpoints throughout the internal audit cycle.
For an Internal Audit program, there should be a written defined procedure that covers not only the scheduling and cadence of internal audits but also defines the areas to be covered under the schedule (including Quality!), the process for the issuance of observations, reporting timelines, and auditor qualifications (an item that is often overlooked!).
As internal audits are often a deeper, more meaningful dive into a subject, it is best if possible, to have audit teams for internal audits consisting of a member of Quality as well as various subject matter experts versus a single auditor. Caution must be taken in this team approach, however, to ensure that an auditor does not audit their own work. This is especially important when auditing Quality, including an inspection of the Internal Audit Program. It is also a good idea to utilize checklists for audits to ensure that every clause of the applicable standard is reviewed, leaving nothing overlooked to ensure full compliance.
In conclusion, audits and inspections in the various forms they come in are not a requirement to be feared or dreaded. Audits and inspections are a great tool that when utilized correctly via documented and implemented processes and procedure can help provide deep, meaningful insight into all aspects of a business and help prepare both a facility and the staff for complete compliance to any auditing situation that may arise.
In recent years, food recalls have become a concern for the food and beverage (F&B) industry, with regulatory bodies tightening oversight as the number of recall-related incidents continues to rise. The F&B industry is no stranger to recalls, but recent trends indicate a steady increase in frequency, with the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) issuing 313 recalls in 2023, an 8% increase from the previous year. This uptick can be attributed to various factors, including the detection of undeclared allergens, which made up almost half of food recalls last year, and contamination by harmful bacteria such as Listeria, Salmonella, and E. coli.
Consumers are taking notice of these continuous food recalls as a new Gallup poll revealed that Americans’ perspective of the grocery industry has turned negative due to inflation and food safety concerns. It also showed that, for the first time, Americans have more negative views (47%) than positive (33%) of the grocery industry. The growing number of recalls, plus consumer concerns, has intensified calls for stricter compliance and enhanced traceability within the food supply chain.
Major Changes Are Coming
These recalls have become a persistent public health problem, with over 1,100 Americans falling ill from foodborne illnesses linked to recalled products. However, significant steps are being taken to address these concerns in the next few years. To reduce the number of foodborne illnesses, the FDA introduced the Food Safety Modernization Act (FSMA) 204, a regulation requiring F&B businesses to provide detailed traceability information within 24 hours of a recall. Starting in January 2026, this rule will focus on tracking food inputs from suppliers, enabling companies to pinpoint the source of contamination more efficiently.
FSMA 204 will bring major changes to the F&B industry by enhancing traceability requirements for high-risk foods. The rule mandates that companies must improve tracking across the supply chain to ensure key data points are recorded at critical stages of food production, processing, and distribution. This means F&B businesses must implement more stringent record-keeping processes, invest in technology for real-time tracking, and increase collaboration with suppliers to ensure compliance.
However, many organizations aren’t prepared to undergo the data process transformations needed to align with this new traceability rule. Below are a few actionable steps companies can take to prepare their supply chains for FSMA 204:
Investing in Solutions to Streamline Reporting
Despite the wide scale impact FSMA 204 will have across the F&B industry, a main challenge for companies will be updating and investing in new systems and processes to comply with the rule. FSMA 204 mandates that F&B companies provide detailed, accurate traceability data within a 24-hour window during a recall, which requires modern technology capable of handling real-time information. Many existing systems are outdated or not equipped to meet this new level of compliance. As a result, suppliers will need to adopt new software, train staff, and overhaul data management processes. These changes are certain to be time-consuming and raise operational costs. The complexity of this process, especially in a global and multifaceted supply chain, can be overwhelming without the right tools in place.
In addition, suppliers face the challenge of integrating these new systems with their broader supply chain networks. Ensuring seamless communication between suppliers, manufacturers, and retailers is essential for meeting the strict reporting timelines under FSMA 204. The coordination required to share and track data effectively across multiple partners adds an additional layer of complexity. Suppliers must also ensure their traceability solutions are scalable to accommodate future growth and evolving regulations, all while maintaining business continuity and protecting their bottom line.
Investing in scalable technology not only ensures compliance but also enhances business resilience. It provides better visibility into the supply chain, helping businesses respond quickly to disruptions, recall situations, or emerging food safety threats. Furthermore, these solutions enable businesses to streamline their data-sharing processes with trading partners, improving collaboration and reducing the time and resources spent manually documenting transactions.
While this can be costly, investing in robust technology systems and implementing effective food safety quality programs for employees provides the benefit of demonstrating a commitment to food safety and helps ensure smoother operations.
A few solutions suppliers can consider include advanced technologies like supply chain control towers and blockchain. These solutions provide real-time insights into inventory, orders, and potential disruptions, allowing companies to trace food origins and pinpoint contamination sources quickly. Supply chain control towers centralize data collection, management, and analysis, streamlining reporting processes, while blockchain offers a secure, tamper-proof record that ensures data consistency and transparency across all participants in the supply chain. By leveraging these technologies, suppliers can enhance traceability, reduce contamination risks, and build greater consumer trust.
Enhancing Data Consistency
Data consistency works in tandem with the integration of new technologies. The success of any traceability system under FSMA 204 relies on the consistency and accuracy of data collected throughout the supply chain. However, one of the most significant challenges businesses face is ensuring that data is recorded uniformly across different suppliers and systems. Inconsistent or incomplete data can lead to gaps in traceability, making it difficult to track products effectively or respond quickly to a recall. With the new regulation requiring detailed traceability information within 24 hours of a recall, any discrepancies or gaps in data could lead to delays in identifying contamination sources.
To ensure data consistency, suppliers can implement standardized data collection practices and utilize integrated technologies, such as supply chain control towers and blockchain. By implementing uniform data entry protocols across the entire supply chain, suppliers can avoid errors, discrepancies, and miscommunication that often result from inconsistent or fragmented data. Standardization helps streamline reporting and ensures that all parties—from suppliers to distributors—are working from the same set of accurate, reliable information.
Bringing Employees Along on the Journey
Investing in technology and ensuring data consistency are vital steps in preparing for FSMA 204, but they are only part of the equation. For these initiatives to succeed, businesses must also invest in their employees through training and education. Compliance with FSMA 204 requires everyone involved in the food supply chain to understand their role in the traceability process and the importance of accurate data reporting.
Training programs can be implemented at all levels of the organization to educate employees on the new traceability requirements and how they affect day-to-day operations. This includes not only teaching staff how to use new software solutions but also fostering a culture of accountability and food safety awareness, including setting up conversations with employees at every stage of the supply chain. Employees must understand that even minor data collection or reporting lapses can have significant consequences, from costly recalls to legal penalties and damage to brand reputation.
Continuous education is also key to keeping up with the evolving regulatory landscape. As food safety regulations change and new technologies emerge, businesses must keep their teams informed and updated. This can be achieved through regular workshops, webinars, or online courses that keep employees engaged and equipped with the latest knowledge.
The Cost of Non-Compliance
Failure to comply with FSMA 204 can lead to serious consequences for both suppliers and retailers. The FDA has the authority to enforce various penalties, including civil or criminal actions in federal court. It’s important to remember that this rule is considered mandatory, and parties will be under real pressure from the government if they don’t take the necessary steps to ensure the traceability requirements under this act. Non-compliance can lead to legal repercussions for both companies and suppliers in the form of lawsuits and litigation. In addition, the FDA has the authority to impose significant fines, sanctions, and criminal penalties for non-compliance.
Suppliers that are unable to meet FSMA 204 requirements may also face financial loss and damage to the company’s reputation as retailers and manufacturers may decide to switch to more reliable partners. Compliance penalties can also result in lost sales and brand damage that can impact consumers’ decisions.
Operationally, non-compliance with FSMA 204 can disrupt supply chain processes, leading to delays in identifying and resolving contamination issues. The inability to quickly trace food inputs can result in prolonged and costly recalls. Furthermore, non-compliance can strain relationships with trading partners who rely on accurate traceability data for product safety.
Preparing for FSMA 204 requires a multifaceted approach that combines technology, data standardization, and employee engagement. By investing in solutions that streamline reporting, enhance data consistency, and bring employees along through training and education, F&B companies can position themselves for success. These actions will help ensure compliance with FSMA 204 and lead to more efficient, transparent, and resilient supply chains, ultimately improving food safety for consumers.
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