Food traceability provides comprehensive information about a product’s history and origin, facilitating efficient recalls and supply chain management. However, distinct types of food fraud, such as concealment, counterfeit, and mislabelling, pose significant challenges. The integration of Artificial Intelligence (AI) and new regulatory measures, like the FDA’s traceability rule, enhance food safety and authenticity, fostering a more transparent and reliable food supply chain.
In the intricate web of the global food supply chain, ensuring the safety and authenticity of consumables stands as a paramount concern. Food traceability, defined as the ability to provide comprehensive information about the history and origin of a product throughout its journey, emerges as a cornerstone in this endeavour. This meticulous documentation not only facilitates supply chain management but also empowers swift actions such as recalls in the event of safety or quality breaches.
Beyond its logistical benefits, food traceability assumes a pivotal role in safeguarding consumer interests. By serving as a fundamental component of food safety and quality assurance, traceability ensures transparency and accountability at every stage of production and distribution. However, the efficacy of a traceability system is inherently tied to the credibility of its origins, paving the way for the convergence of food traceability and authentication.
Unveiling the Shadows: The Challenge of Food Adulteration
In an era plagued by instances of food adulteration and mislabelling, the imperative for robust authentication mechanisms becomes increasingly apparent. Reports from international and national research bodies shed light on a myriad of cases spanning various food categories, from wine and spirits to olive oil, fish, meat, and beyond. This pervasive challenge underscores the need for stringent standards and regulatory frameworks to combat fraudulence and uphold consumer trust.
Food fraud manifests in several forms, each presenting unique challenges for detection and prevention. For example:
Concealment involves hiding inferior or harmful ingredients within a product to avoid detection. An example of this is the addition of melamine in milk to falsely increase protein content readings, which led to a major scandal in China.
Counterfeit products replicate and sell a product under the guise of a well-known brand, often with substandard quality. These fake products can range from everyday items like bottled water to high-end goods like wines and spirits. Counterfeiting not only deceives consumers but also damages brand reputations and violates intellectual property rights.
Botanical Authentication ensures that plant-based products are derived from the claimed species and not substituted with cheaper alternatives. This is particularly important for products like herbal supplements, teas, and spices. For instance, saffron, one of the most expensive spices in the world, is often adulterated with less expensive substances such as dyed corn stigmas or safflower.
Geographical Origin fraud involves misrepresenting the region from which a product originates. Certain regions are known for producing specific high-quality foods and beverages, such as Champagne from France or Parmigiano Reggiano cheese from Italy. Mislabelling products to benefit from these reputations deceives consumers and undermines genuine producers.
Substitution entails replacing a high-value ingredient with a lower-cost one. This is common in products like olive oil, honey, and seafood. For example, extra virgin olive oil might be diluted with cheaper oils, or expensive fish species like tuna might be replaced with less costly ones like escolar. This not only cheats consumers but can also pose health risks.
Mislabelling involves incorrectly listing ingredients or nutritional information on labels. An example is claiming a product is organic when it is not.
Dilution involves adding water or other substances to increase the volume of a product. For instance, diluting fruit juices with water and not declaring it.
Unapproved Enhancements involve using unauthorized substances to enhance the appearance or quality of a product. An example is adding unauthorized dyes to make a product look fresher or more appealing.
Theft and Resale refers to stealing products and reintroducing them into the market through unauthorized channels. For example, reselling stolen goods without proper storage conditions.
Artificial Additives involves using artificial ingredients to mimic the qualities of a natural product. For example, adding synthetic vanilla flavor instead of natural vanilla extraction
The New Traceability Rule of FDA
The Food and Drug Administration (FDA) has introduced a new traceability rule aimed at enhancing the ability to trace the origin of foods throughout the supply chain more efficiently. This rule mandates that companies maintain more rigorous records of their supply chains, focusing on high-risk foods. The implementation of this rule is expected to significantly improve the speed and accuracy of traceability in the event of a foodborne illness outbreak or contamination incident, thus ensuring faster recalls and reducing the risk to public health.
The Dawn of a New Era: Advancements in Food Fraud
As the spectre of food fraud looms large, there arises an urgent demand for sophisticated analytical techniques to authenticate foodstuffs with precision and reliability. Here, the advent of Artificial Intelligence (AI) heralds a new era of innovation. AI-driven algorithms can sift through vast datasets, identifying patterns and anomalies that elude traditional methods. Machine learning models can analyse complex chemical compositions, flagging deviations indicative of adulteration or mislabelling. By harnessing the power of AI, authorities can fortify their efforts in safeguarding consumer interests and preserving the integrity of the global food market.
Charting the Course Ahead: Toward a Safer, More Authentic Future
In the pursuit of food safety and quality, the symbiotic relationship between traceability and fraud, bolstered by AI technologies, emerges as a beacon of hope. By fortifying supply chain transparency and deploying cutting-edge analytical methods, stakeholders can navigate the complexities of the modern food landscape with confidence and integrity. The integration of the FDA’s new traceability rule further strengthens this endeavour, ensuring a safer and more reliable food supply chain for all.
Many food suppliers are investigating and making early investments in the adoption of digital technology to aid and automate their food safety programs. One area of intense interest has been the increasing application of digital automation within food safety testing programs. As a data and technology leader and practitioner across multiple industries for the past 30 years, I have had the privilege of working with organizations as they seek to build the appropriate plans and business justification for taking on digital transformation initiatives.
The following are the top three questions I am continually asked and the answers that, over time, have provided the information and support needed to help companies through this important transition. Perhaps these are similar to the questions that your leadership is asking you?
Featured Expert: David Hatch, VP Digital Solutions Marketing, Neogen Analytics
What are the actual benefits that digitizing our food safety testing program will yield?
David: During the past six years, I have witnessed the implementation and deployment of approximately 500 digital food safety testing programs across the globe. This is always one of the first questions I am asked, and there is inevitably a challenge in the question… namely – “Our program is solid, we pass our certification and customer audits, so tell me how this will be better than what we are doing today.”
The most tangible benefit, of which there are many, boils down to two metrics of success that I have witnessed consistently, over time and across three decades of work, deliver real, measurable change: Time and Trending.
Time, metrics within food safety scenarios, is characterized as having three components:
“Time-to-information” – reducing the time between an event occurring, and information about that event being communicated to those in need of this knowledge.
“Time-to-decision” – reducing the time from when information is known to the moment when a decision can be made to affect the outcome of whatever the information indicates as needing to be addressed.
“Time-to-Action” – reducing the time from when a decision is made to when the enactment of that decision is carried out.
In the world of food safety, the diagnostic information, policy- and compliance-driven decisions, and the corrective and preventative actions (CAPA) that are mandated by regulation and driven by policy compliance standards, define the effectiveness of a food safety testing program.
Therefore, the ability to decrease these timeframes immediately produces a risk reduction result. When the time between an occurrence of a food safety issue and the completion of a corrective action is reduced, so too is risk reduced. Especially when the issue is deemed to be impacting public safety, brand value, and operational continuity… all of which can yield very costly results if not addressed quickly and accurately.
If information is collected and recorded manually, and is stored in individual paper and spreadsheet files, it is, by definition, made ineffective. The time it takes to manually record the data, or retrieve it when needed, works against the requirement that information be on-tap in real time as issues arise. Digitizing a food safety testing program means, beyond merely putting data into spreadsheets, that information be collected and stored in a data base, whether that is data coming from on-premises testing, or a 3rd-party lab. And that database must be connected to a system that enables immediate access, auto-alerts, and data-driven triggers to enact corrective actions without having to wait for a human to think where to look, or how to combine data from various manual storage files.
Trending is equally important. While speed, as highlighted above, is critical, so too is the continuous collection and analysis of data. The ability to trend your diagnostic results goes further than merely seeing a time series report of testing results. If constructed properly, a trending analysis can provide your team with the ability to become far more preventative than ever before.
Trends allow you to see reoccurrences of issues, and as these grow, an alert engine can offer recommended actions that can prevent the future need for full CAPA scenarios, or worse, response to a regulatory inquiry. As illustrated below, when combined together, Time and Trending can yield significant benefit that, as a result, reduce a significant portion of the risk and costs associated with slow response to manually managed food safety testing data. Further, a digitized system can put your data to work for you, creating a scenario that enables the data itself to find the right person at the right time when thresholds and triggers deem this action to be necessary (see figure below).
How can we measure Return-on-Investment (ROI) on the cost of moving to a digitally managed program?
David: If the question and answer above are not yet enough to justify the move to a digitally managed testing program, there are three more factors to consider when assessing the return on a digital investment:
Reduction of production downtime: The occurrence and frequency of food safety issues increases the risk of system downtime. If a pathogen detection occurs, a machine, conveyor system or other equipment may need to be temporarily shut down for unplanned cleaning, or in extreme cases, torn down altogether for deep cleaning. Our interactions with over 500 implementations have shown that:
Downtime can reach an astounding 500 hours annually, leading to overall costs that some studies put in the range of $20,000 to $30,000 per hour, on average.
The financial impact of reducing production downtime by just 90 minutes per week can be dramatic once you’ve added up the week-after-week results. For example, a company operating two facilities with a $30,000/hour downtime cost can gain back $90,000 per week with just 90 minutes regained at each location weekly.
Reduction of Waste/Scrap and Rework: A pathogen positive diagnostic result in a Zone 1 or food contact surface location, or worse yet, within a finished product test, will result in the need to scrap and rework production lots. Each pound of finished product that is scrapped will require rework to make up for lost order fulfillment for customers. It is therefore imperative that when issues are detected, the associated corrective actions quickly and accurately address the situation. In my experience, we show that digital trending and time-to-action improvements can drive business impact – specifically, gaining back just 10% of scrapped food per week can yield significant results. For example:
An organization operates two facilities where 500 lbs. of finished product are scrapped each week.
The value per pound of finished product, when factoring in all the labor, energy costs and materials, is valued at a conservative cost of $1 per pound.
Annually, by reducing time-to-information by just 4 hours per sanitation cycle, the organization was able to realize $400,000 reduction in waste-related costs.
Improve Overall Efficiency: Over the course of several months, we partnered with a large dairy producer to explore how automating a manual EMP process could help drive increased efficiencies, reduce pathogen positives, and ultimately, improve the bottom line (see figure below).
Over time, the analysis gained from automated data gathering enabled new sanitation procedures to implemented, leading to significant efficiency gains:
A new baseline of testing volume, test types and correlated sanitation procedures were refined and implemented.
A revamped remediation program yielded new corrective action steps that have been proven through the study’s data to be more effective.
The FSQA team gained back 25% of their time by eliminating the need for manual reporting, analysis, and spreadsheet-based data preparation.
The organization improved corrective action completion time by 50%.
What are the resources and time required for the transition to a digitally automated program?
David: There can be a high degree of ‘fear of change’ involved in any digital transformation initiative. This is not unfounded fear, as horror stories abound regarding large enterprise system implementations and the havoc they can cause. The main consideration in avoiding these outcomes is to ensure the initiative has leadership buy-in and support. This is why the answers to the first two questions above are so important. The path to gaining leadership buy-in is through the ability to connect food safety digitization and automation to tangible business results. If a successful business case can be made utilizing the concepts described above, then the battle for assigning resources and the appropriate implementation timeframes can be achieved.
I started working with food safety teams in 2018, when the existence of food safety testing automation was still at a relatively low adoption rate. In the intervening six years, as adoption has increased, the complexity and timeframes of implementation have decreased significantly. This remains a key area of concern, however, as organizations are struggling to keep up with ongoing staffing shortages and resulting resource constraints. There are two key areas where a digital solution provider must be challenged to prove their ability to support your digital transformation:
Proof of delivery: Due to the relatively recent emergence of digital food safety testing platforms, we have not yet reached a state of maturity where tens of thousands of implementations have defined a standard of known implementation and adoption processes to exist. Therefore, it is critical that you find and work with a provider who will deliver a fully functioning trial of their system, preferably free of charge, for a significant amount of time. This will enable you and your team to experience the full range of capabilities offered, including the onboarding and training program, the length of time it takes, the level of technical acumen your team will be expected to have, and the overall delivery of the benefits described above.
Focus on requirements: Commonly, digital solutions are designed to work within fairly rigid processes and workflows as designed into the system. If you’re lucky, you may find a solution that aligns to your own existing workflows, but all too often, the largest stumbling block is the realization that your new system is not just a digital transformation but also requires a full business process reengineering project in order to conform to the way the software works. Challenge your providers to demonstrate how their solution is flexible enough to enable your team to reduce any process changes to the lowest degree possible. While some new processes will always be inevitable (and potentially helpful!), it should be the hallmark of any provider’s customer support/success team to understand your requirements and configure their solution to enable them without too much drastic change.
To learn more about how digitizing food safety programs can impact business ROI, download our EMP ROI white paper today.
With the effective date for updated traceability recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.
On November 21, 2022, the Food and Drug Administration (FDA) published the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). With the effective date for updated recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.
Most produce companies are no strangers to the importance of traceability. In fact, the Produce Traceability Initiative (PTI) was created over 15 years ago as a voluntary, industry-wide effort designed to help the industry maximize the effectiveness of current track and trace procedures, while developing a standardized industry approach to enhance the speed and efficiency of traceability systems for the future. The PTI has set dozens of companies throughout North America—ranging from small farms to international retailers—on the path to enhanced traceability and compliance with the FDA’s Food Traceability Rule.[i]
The following steps can help any produce company, whether it currently follows the PTI or not, prepare to meet FDA’s traceability requirements:
Understand the Food Traceability Rule.
While the FDA has had traceability requirements in the past, the FSMA Food Traceability Rule is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one step forward, one step back” traceback approach. The objective of the Rule is to help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.[ii]
In comparing the FSMA Rule to the PTI, a recent PTI press release states that the requirements of the PTI for case-level traceability are aligned with the Final Rule and cover approximately 90-95% of the requirements, with major differences stemming from the Traceability Lot Code Source and Traceability Lot Code Source Reference.[iii]
The key elements of the FDA Rule are built into several acronyms:
FTL (Food Traceability List): This list identifies the categories of high-risk foods that require additional traceability records under the Food Traceability Rule. The FTL currently comprises the following produce commodities: cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, and fresh cut fruits and vegetables. Other non-produce foods on the FTL include cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads.
TLC (Traceability Lot Code): This descriptor, often containing a combination of letters and numbers, is used as a unique identifier for product as it moves through the supply chain. The TLC is to be established by entities that originate, transform, or create food on the FTL. Once a food has been assigned a TLC, the TLC must be included in traceability program records collected at each Critical Tracking Event (CTE) and as a part of all Key Data Elements (KDEs) (see below). The TLC remains the same throughout the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
CTE (Critical Tracking Event): CTEs are the events in the food supply chain that require additional recordkeeping. These include harvesting, cooling before initial packing, packing, transforming, shipping, and receiving. At each CTE, the responsible entity must record the TLC.
KDE (Key Data Element): KDEs comprise the information associated with a CTE for which a record, including a TLC, must be maintained. Examples of KDEs include location description of the food being harvested; name of the field or growing area where the produce was harvested; date of harvest; quantity and unit of measure of the produce; date when the produce went from harvest, to cooling, to packing, to shipping, etc.
Interpret the Rule and Determine its Applicability.
To determine the Rule’s applicability, it is important to first take an inventory of your operations and products:
Do you grow cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, or tropical tree fruits?
Do you process fresh cut fruits, leafy greens, or vegetables other than leafy greens?
Do you manufacture a product that contains any of the foods listed above?
If the Rule applies (i.e., you answered yes to any of the three questions above), you must:
Maintain specific data records (i.e., KDEs) for at least two years.
Keep records of all CTEs.
Maintain an approved, updated Traceability Plan.
Ensure all data is easily accessible so it can be provided to the FDA within 24 hours of a request.
Note that there are a few nuanced exemptions that apply to farms, as noted on this FDA flow chart.[iv]
Perform a Gap Assessment.
Most produce companies are likely capturing at least some of the information needed to comply with the Food Traceability Rule, particularly if they already implement the PTI requirements. Conducting a gap assessment will help identify missing elements that may be required for compliance with FDA’s Rule. The following questions can help guide this assessment:
Does your organization already capture data that may be considered a KDE? For example, do you apply lot codes to your products? Do you collect location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information or data points you are missing and how you can gather that data.
Do you have a sufficient Traceability Plan? Does it cover all the elements required in the Food Traceability Rule?
Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Having a good document/records management system is essential for maintaining and sharing the data required by the Food Traceability Rule.
What collaborative activities can you and your suppliers/buyers perform to ensure that data is shared efficiently and encourage compliance?
Create a Plan of Implementation.
The gap assessment will identify elements that you need to implement to help ensure compliance. Use that information to create a game plan, working backwards from the Rule’s January 20, 2026 effective date. Doing so now affords time to test solutions, see how they work in practice, problem solve, and find the right solutions for your organization.
At a minimum the implementation plan must include two key elements that will be vital for compliance:
Traceability Plan. Every organization must develop a new (or update an existing) Traceability Plan for collecting the KDEs that are required by the Rule, as outlined in the CFR[v] (see also the FDA example of a Traceability Plan for Farms[vi]). The Traceability Plan must be updated annually, and old plans must be maintained for at least two years. The Traceability Plan must include:
Description of the procedures used to maintain required records, as well as how to format and where to store those records.
Description of how TLCs 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.
Document/Records Management System. Produce companies who manufacture, process, pack, or hold foods on the FTL will need to implement a document/records management system to fulfill the Food Traceability Rule’s recordkeeping requirements. While hard copies in binders can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data.
As produce companies work through this process, it is important to remember the objective of the Food Traceability Rule. Ultimately, the Rule will allow the food industry to quickly remove potentially harmful foods from the supply chain and make the entire recall process more efficient. Even if the FTL list does not apply to all your products, your customers may still require that all produce they purchase meet the same requirements as foods listed on the FTL. Creating this end-to-end traceability will save time, money, and most importantly, human lives.
[ii] Food and Drug Administration. What you need to know about the Food Traceability Rule: Recordkeeping Information for Produce Farms. June 2023. https://www.fda.gov/media/169510/download.
Minimizing the risk of contamination is a must if you work in food manufacturing. Accidentally including allergens in your products can cause harm to consumers, undermine your brand image, and lead to hefty lawsuits.
Even major food industry brands like McDonald’s fall foul of food safety laws from time to time. Recently, a man with a dairy allergy was allegedly served cheese in his Big Mac1, resulting in anaphylactic shock. This caused a large lawsuit and could damage the global food giant’s reputation.
You can take steps to stay in line with regulations and best practices by training your staff and implementing proper procedures. This will reduce the risk of human error and help you produce food that is both tasty and safe for consumers.
Food Safety Modernization Act
Most people think of food contamination as a thing of the past. However, 1 in 6 Americans2 fell ill due to foodborne diseases last year. This led to 128,000 hospitalizations and 3,000 deaths. The FDA’s Food Safety Modernization Act (FSMA) seeks to end this issue by bringing food manufacturing standards into the modern age. This means you may need to revise your approach to manufacturing to stay on the right side of changing guidelines. At its core, the FSMA includes:
Preventive Controls for Human Foods: Since 2015, food manufacturers have been required to produce a food safety plan. This plan should include key details like potential hazards and risk-mitigation strategies that are currently in place.
Third-Party Accreditation: Receiving a third-party authentication can keep you up to date with changing guidelines. Similarly, only working with suppliers who have been verified via third parties who work to ISO/IEC standards ensures that allergens don’t enter your facility from suppliers.
Preventing Intentional Adulteration: No employer wants to believe that their employees would intentionally harm consumers — but it does happen. The FSMA ruling against intentional adulteration means that you can seek support from the intelligence community if you suspect that a stakeholder is intentionally contaminating your supply.
These FSMA regulations aren’t exhaustive and should be seen as the bare minimum. You’ll still need to take proactive steps to improve communication on the food plant floor3 and should implement policies like proper labeling to keep contaminants and allergens separated.
Proper Labeling
If you’re producing food for public consumption, you must properly label your food. Failing to declare that allergens may enter a certain product will land you in legal trouble and will put consumers at risk. Rather than risking an allergic reaction, follow FDA labeling guidelines4 which include:
Clearly labeling the eight major allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans).
Including the source name of foods (for example, the source name of whey is milk, meaning your label should include “whey (milk)”).
Provide advisory statements like “may contain [allergen]” and “produced in a facility that also uses [allergen].”
Conduct regular testing and monitoring of products and processes to ensure that allergens have not entered the batch.
Taking these steps minimizes the risk of labeling errors and protects consumers. This is particularly important if you want to produce a product that is specifically allergen-free (for example, gluten-free or dairy-free). Failing to declare ingredients properly puts consumers at risk and will land you in hot legal water.
Segregating Allergens
Managing potential allergens is crucial if you work in a food manufacturing plant that produces multiple products. Failing to properly segregate allergens undermines your labeling system and increases the risk of cross-contamination between workstations.
You can minimize the risk of allergens entering the system by using simulations to improve business processes5. Virtual simulations are capable of generating scenarios that you may not have thought of but are likely to occur. You can also use constructive simulations to visualize what might happen should an allergen make its way into the supply. This is particularly important when onboarding new employees who may not understand the risk that allergens present to the food production process.
You can also use emerging technology to improve production6 and reduce the risk of contamination. For example, as your firm grows, you may want to invest in AI and advanced robotics. Robotics can react quickly to changing demand and are less likely to inadvertently spread allergens throughout your supply. This is particularly important when carrying out repetitive tasks, like filling pre-packaged sandwiches or seasoning foods. Automated robots can take care of these mundane tasks, leaving human workers to focus on more creative tasks.
Some food manufacturers, like Walmart, are also using blockchain technology to trace and track contamination. This can improve your crisis management plan7 and bolster operational resilience. Your crisis management team leader can tap into tech to improve communications and simulate potential breaches. This will help you practice your crisis management plan and will ensure that you’re able to pinpoint errors to learn from in the future.
Sanitation Procedures
Regularly sanitizing your workspace is crucial if you want to produce clean, allergen-free goods. This applies to your people, too, who may inadvertently bring allergens in with them when they arrive at work or move between stations.
However, you can’t expect regular handwashing to be enough. Instead, embrace the digital revolution and use data8 to clean up your production line. This will improve reporting and ensure that compliance guidelines are followed at all times. For example, if you suspect that your employees are not washing their hands thoroughly enough, you can use digital products to track employee handwashing and time folks while they apply hot, soapy water.
Digital tracking can also alert you to potentially unclean workstations. For example, if you work in a bakery and typically produce most of your dough before dawn, a digital program can track the contaminants that have entered the workspace in order to produce your bread or baked goods. This will alert you to potential allergen risks and ensure that any workstation that has used an ingredient like gluten is properly sanitized in a timely fashion.
Staff Training
Properly training your employees is key to minimizing contamination risk and staying on the right side of regulatory compliance laws. A proper approach to training will empower employees and help them understand the potential risks involved with food manufacturing.
However, proper training doesn’t mean that you should force your workers to sit through hours of PowerPoint. Instead, train smarter, not harder9 by conducting training that is:
Legitimate. Before asking folks to engage in further training, ask yourself whether or not you are qualified to speak on the subject. If not, consider bringing in a speaker who is well-respected in the food safety industry.
Authentic. Build a culture of trust and engagement at your workplace by working with speakers and programs that are accredited and up to date with compliance law. This will convince folks that your speakers are worth listening to and that your training programs are worth completing.
Engaging. Don’t force your employees to sit through lengthy seminars without an opportunity to engage. Instead, encourage participation by creating engaging training programs that help folks learn skills as they go.
Simplistic. Food safety can be complex. Cut through this complexity by giving folks simple, actionable steps to take. This will minimize the risk of folks forgetting your policies and will empower employees who want to improve safety at work.
These training principles are well-established in the food production and safety world. Even simple changes, like including a quiz or mock preparation test, will pique people’s interest and ensure that employees are engaged when receiving training. If you fail to run engaging, intelligent training, you put yourself at greater risk of contamination during production.
Conclusion
Following FDA guidelines should keep your consumers safe by minimizing the risk of an allergen entering your workspace. However, you’ll need to go above and beyond minimum requirements if you want to completely eliminate the risk of contamination. Get the ball rolling by embracing the digital revolution and using automation or robotics to handle more mundane tasks. This empowers employees and reduces the risk of human errors during production.
Food is essential for human life, but ironically, it can also be a source of harm. Unsafe food, contaminated with pathogens or chemical hazards, is estimated to cause millions of illnesses and thousands of deaths globally each year. According to the World Health Organization (WHO), 1 in 10 people get sick because of contaminated food and 420,000 people die due to foodborne illnesses every year around the world (WHO, Food Safety, 2022). However, the impact of unsafe food extends far beyond individual health, creating a significant financial burden on individuals, healthcare systems, and national economies.
Food safety is a critical issue that impacts both public health and the economy, especially in areas where there is not enough food, no clean water, open defecation, poor hygiene, lack of electricity and lack of cooling system, weak food safety education and loose regulatory systems. In addition to its impact on public health, food safety also affects economies, resulting in the cost of recalls, lost businesses, damaged reputations, lost lives, and lost working hours. Here, we explore the challenges that countries face in ensuring safe food and its economic impacts and the potential solutions to these challenges.
Financial Impact of Unsafe Food
The financial cost of unsafe food encompasses various direct and indirect expenses. These costs arise from both the immediate impacts of foodborne illnesses and the long-term consequences on public health, productivity, and economic well-being. Here are some key components of the financial cost of unsafe food:
Healthcare Costs:
Treatment Expenses: Individuals affected by foodborne illnesses often require medical attention, leading to costs associated with hospitalization, medication, doctor visits, and diagnostic tests.
Emergency Response: Public health agencies and emergency services may incur significant expenses in responding to outbreaks, conducting investigations, and implementing control measures.
Product Recalls and Market Loss:
Recall Costs: When contaminated or unsafe food products are identified, manufacturers may have to recall the products from the market. The costs associated with the retrieval, disposal, and destruction of the affected products can be substantial.
Market Loss: Companies may suffer financial losses due to the damage to their reputation and the decline in consumer trust, leading to reduced sales and market share.
Workforce Productivity Loss:
Absenteeism: Foodborne illnesses can lead to increased absenteeism in the workforce as employees may need time off to recover or seek medical treatment.
Reduced Productivity: Even employees who are present at work may experience reduced productivity due to illness-related fatigue and discomfort.
Government and Regulatory Costs:
Inspection and Enforcement: Governments invest resources in inspecting food production facilities, enforcing regulations, and monitoring compliance with food safety standards.
Legal Proceedings: Legal actions, such as lawsuits against companies responsible for unsafe food, can result in additional costs for both businesses and the legal system.
Insurance Costs:
Liability Insurance: Businesses in the food industry may face increased premiums for liability insurance to cover potential legal claims resulting from foodborne illnesses.
Product Recall Insurance: Companies may also invest in product recall insurance to mitigate the financial impact of recalling unsafe products.
Loss of Trade and Tourism:
International Trade: Countries exporting food products may face trade restrictions and bans if their products are associated with safety concerns, resulting in economic losses.
Tourism: Foodborne illness outbreaks can negatively impact the tourism industry if destinations are perceived as unsafe.
Long-term Health Costs:
Chronic Health Conditions: Some foodborne illnesses can lead to chronic health conditions, imposing ongoing healthcare costs and reducing individuals’ long-term productivity.
The most immediate financial impact of unsafe food is incurred through direct medical expenses associated with treating foodborne illnesses. These costs encompass doctor visits, hospital stays, medications, and laboratory tests. A 2018 World Bank study estimated that foodborne illnesses cost low- and middle-income countries around $110 billion annually in medical expenses alone. In the U.S., the Centers for Disease Control and Prevention (CDC) estimates the annual cost of foodborne illnesses at $78 billion, with hospitalizations accounting for a significant portion.
Recalls can result in significant financial losses for food producers and retailers. For example, in 2006, a spinach contaminated with E. coli recall cost the industry $350 million (Kudashkina, Corradini, Thirunathan, Yada, & Fraser, 2022). In developing countries, where food safety regulations may be weak or nonexistent, the cost of recalls can be even higher, as the risk of contamination and outbreaks is greater.
Indirect costs include lost business and damaged reputations. In 2017, a listeria outbreak in South Africa linked to processed meat products resulted in the closure of several food processing plants, leading to job losses and economic damage to the industry and the deaths of 216 people (Tchatchouang, et al., 2020). Similarly, in 2011, an E. coli outbreak linked to sprouts in Germany led to a significant decline in demand for sprouts across Europe, resulting in lost revenue for farmers and producers (Buchholz, Bernard, Werber, Böhmer, & Remschmidt, 2011).
Beyond direct medical expenses, unsafe food leads to significant indirect costs for the consumer through lost productivity. Individuals suffering from foodborne illnesses miss work or school, leading to lost wages and reduced economic output. Additionally, families may incur childcare costs or lost productivity due to caring for sick individuals. The CDC estimates that lost productivity due to foodborne illnesses costs the U.S. economy around $55 billion annually.
Disproportionate Burden on Vulnerable Populations
It is crucial to recognize that the financial burden of unsafe food is not evenly distributed. Low- and middle-income countries are disproportionately affected due to limited access to clean water, sanitation, and robust food safety regulations. Children, pregnant women, and the elderly are also more vulnerable to foodborne illnesses due to weaker immune systems. This unequal impact exacerbates existing inequalities and hinders economic development in vulnerable communities.
Challenges for Developing Countries
One of the most significant challenges in developing countries is the lack of access to clean water. According to WHO, in 2020 only 74% the global population had safe water (Bhagwat, 2019; WHO, Drinking Water, 2022), which is essential for maintaining proper hygiene and preventing the spread of foodborne illnesses (Marino, 2007). In many countries, access to clean water is limited and this accounts for around 282 million people, and around 368 million people may be forced to rely on contaminated or unprotected water sources, such as rivers or wells (WHO, Drinking Water, 2022). This can lead to the contamination of food products, as people may use contaminated water to irrigate crops, wash fruits and vegetables, or clean utensils.
Another challenge is the lack of access to electricity and cooling systems (Vipham, Chaves, & Trinetta, 2018), which makes it difficult to store and preserve food products. In many developing countries, electricity is not available in rural areas, and people may not have access to refrigeration or other cooling systems. This can lead to the spoilage of food products, which can cause foodborne illnesses (CDC, 2022) and result in economic losses for consumers, farmers and producers because food that requires refrigeration or freezing has to be thrown away after four hours if not kept at the recommended temperature (USDA, 2021).
Poor food safety education and regulatory systems are also significant challenges in various countries (Medeiros, Hillers, Kendall, & Mason, 2001). Many people in these countries may not be aware of the risks associated with consuming contaminated food or how to prevent foodborne illnesses. Additionally, regulatory systems may be weak or nonexistent, and food products may not be adequately monitored or tested for contaminants or pathogens. In addition, regulatory system costs cannot be prioritized over other pressing issues in many countries. The cost of food safety regulation can be between 4% and 20% per half kg of food (Ollinger & Moore, 2009).
In addition to the financial costs, food safety issues in developing countries can also result in lost lives and lost working hours. Based on WHO’s estimate globally there is $110 billion losses due in lost working hours and medical cost. Foodborne illnesses can cause severe illness and death, especially in vulnerable populations such as children and the elderly. Children carry 40% of the death burden from unsafe food (WHO, Food Safety, 2022).
Overcoming The Challenges
To address these challenges, a comprehensive integrated approach is needed that involves government, industry, and consumers. One potential solution is to improve access to clean water in rural areas. Governments can invest in water treatment facilities, establish regulations for the use of water sources in agriculture, and provide education and awareness campaigns on the importance of clean water for food safety.
Another potential solution is to promote the use of alternative cooling systems in areas where electricity is not available. This can include the use of solar-powered refrigerators or evaporative coolers, which can help to preserve food products and prevent spoilage. Governments and NGOs can also provide education and training on proper food storage and preservation techniques, such as canning or drying, to reduce food waste and improve food safety.
Another potential solution is to invest in food safety education and awareness campaigns. Governments, industry, and NGOs can work together to develop and implement educational programs on food safety such as proper handwashing, cooking, and storage techniques, and avoiding cross-contamination. These programs can be targeted at schools, community groups, and the general public to promote safe food practices and raise awareness of the risks associated with consuming contaminated food, and the importance of reporting illnesses to health authorities.
Another potential solution is to strengthen food safety regulations and monitoring systems in developing countries. Governments can establish and enforce regulations for food safety, including requirements for testing and monitoring of food products. They can also establish regulatory bodies responsible for overseeing the safety of the food supply, and provide training and resources to ensure that food producers and retailers comply with safety standards.
Finally, the promotion of sustainable agriculture practices can also contribute to food safety in developing countries. The use of chemical fertilizers and pesticides in agriculture can contaminate food products and harm human health. Governments can promote the use of sustainable agriculture practices, such as organic farming, which reduces the use of harmful chemicals and promotes the use of natural fertilizers and pest control methods.
This review provides a broad overview of the financial cost of unsafe food. Further research is needed to:
Refine cost estimates to better understand the true economic burden of unsafe food in different regions and demographics.
Evaluate the cost-effectiveness of different prevention and intervention strategies.
Develop innovative financing mechanisms to support improved food safety measures in low- and middle-income countries.
Investigate the link between unsafe food and malnutrition, considering the broader economic and social costs.
Unsafe food poses a significant and multifaceted financial burden on individuals, healthcare systems, and national economies. While the direct costs associated with medical treatment are substantial, the indirect costs of lost productivity and broader economic consequences create an even greater financial strain. By recognizing the disproportionate impact on vulnerable populations, continuing research and implementing proactive measures, we can build a safer, more sustainable, and economically sound food system for everyone.
References:
Bhagwat, V. (2019). Safety of Water Used in Food Production. doi:10.1016/B978-0-12-816333-7.00009-6
Buchholz, U., Bernard, H., Werber, D., Böhmer, M., & Remschmidt, C. (2011). German Outbreak of Escherichia coli O104:H4 Associated with Sprouts. New England Journal of Medicine, 365, 1763-1770.
Kudashkina, K., Corradini, M., Thirunathan, P., Yada, R., & Fraser, E. (2022). Artificial Intelligence technology in food safety: A behavioral approach. Trends in Food Science & Technology, 123, 376-381.
Marino, D. (2007). Water and Food Safety in the Developing World: Global Implications for Health and Nutrition of Infants and Young Children. Journal of the Academy of Nutrition and Dietitics, 107(11), 1930-1934.
Medeiros, L., Hillers, V., Kendall, P., & Mason, A. (2001). Food safety education: what should we be teaching to consumers? Journal of Nutrition Education, 33(2), 108-103. doi:10.1016/s1499-4046(06)60174-7
Ollinger, M., & Moore, D. (2009). The Direct and Indirect Costs of Food-Safety Regulation. Review of Agricultural Economics, 31(2), 247-265.
Tchatchouang, C.-D., Fri, J., Santi, M., Brandi, G., Schiavano, G., Amagliani, G., & Ateba, C. (2020). Listeriosis Outbreak in South Africa: A Comparative Analysis with Previously Reported Cases Worldwide. Microorganisms, 8(1), 18.
Vipham, J., Chaves, B., & Trinetta, V. (2018). Mind the gaps: how can food safety gaps be addressed in developing nations? Animal Frontiers, 8(4), 16–25.
According to the Centers for Disease Control and Prevention (CDC), one in six Americans fall ill after consuming contaminated food or beverages, resulting in approximately 3,000 fatalities from foodborne illnesses per year. This highlights the critical need for restaurant traceability systems to ensure food safety and maintain quality standards. Without proper transparency, it becomes difficult to identify the source of contamination and take necessary actions to prevent the spread of foodborne illness.
The Benefits of Traceability Systems
The primary reason restaurants implement traceability systems is to prevent the spread of foodborne illnesses. Traceability enables swift identification and removal of contaminated products from the supply chain.
Through detailed tracking of food production processes, including sourcing, processing, and distribution, traceability allows for targeted recalls, preventing the spread of harmful pathogens and ensuring consumer protection. Additionally, this system facilitates accountability among food producers, encourages adherence to stringent safety standards, and fosters trust and confidence in the food industry.
By tracking the origin of every ingredient and monitoring its handling and storage conditions, restaurants can ensure that all their products meet set quality criteria. This can include freshness, nutritional value, and sensory characteristics.
Effective Internal Communication
Traceability systems also allow for more effective communication within a restaurant’s internal organization. Using digital communication tools such as electronic logging devices (ELDS) and connected cameras, employees and managers can coordinate tasks efficiently and oversee global teams. These tools also offer real-time footage of food production processes, serving as visual records for audits. Efficient communication ensures all employees are adequately trained in technical processes, reducing the risk of errors, and boosting confidence in the system. Consequently, the establishment is better equipped to provide exceptional customer service, as they can pinpoint where ingredients or foods are in the distribution and production process.
Promoting Transparency
With the rise of food allergies and dietary restrictions, people want to know what ingredients are in their food and where they come from. Traceability enables precise identification of allergens by tracing the journey of ingredients from their source to the final product, allowing for accurate labeling and risk assessment.
For instance, a bakery can use traceability to track the origin of nuts used in its products, ensuring thorough allergen labeling and preventing cross-contamination for customers with nut allergies. This attention to detail helps to build trust and transparency with customers, who can then make informed decisions about what they consume.
These benefits make traceability systems an essential tool for restaurants looking to maintain food safety and quality standards while meeting consumer demands for accountability in the food industry.
Challenges in Implementing Traceability Systems
While applying traceability systems can significantly benefit restaurants, there are some hurdles that the food industry faces in maintaining them. This is why food industries need to implement food management systems to overcome challenges such as:
Cost: Implementing traceability systems can be costly, especially for small businesses. Audits, preparations, and maintenance require financial resources that may not always be readily available.
Keeping up with standards: The food industry must comply with various standards and regulations, which can be challenging for restaurants. Some standard guidelines include the Food Safety Modernization Act (FSMA) and the Global Food Safety Initiative (GFSI), which have strict requirements for record-keeping, documentation, and reporting.
Resistance to change: Many restaurants still rely on traditional manual processes for tracking and record-keeping, making it difficult to transition to automated systems. This may be due to a lack of awareness or reluctance to change ingrained practices that have existed for a long time.
Technical challenges: Some individuals may be intimidated by new technology, making implementation and training complex. Lack of technical support can cause confusion in understanding new systems, and resistance to digital tools.
Despite these obstacles, the benefits of traceability systems make it essential for foodservice businesses to address these challenges and ensure they meet current standards and regulatory requirements. Following are some of the key technologies to investigate as you work to a more effective traceability system.
Tools To Enhance Traceability
Smart Labeling Solutions. Smart labeling systems use data matrix codes or RFID technology to monitor products throughout the supply chain. The codes can be scanned at various checkpoints, providing real-time data on the product’s location and condition. This improves data collection, reduces human error, and enhances security by ensuring only authorized personnel handle the products.
Smart labels also enable restaurants to provide customers with detailed information about their food, such as allergens and nutritional content, promoting transparency and trust. Product tracing can also lessen restaurant product recall costs, as the affected products can be quickly identified and contained.
IoT Asset Tracking. The Internet of Things (IoT) technology can aid in safe distribution, visibility, and reliability in restaurants. Through vendor compliance monitoring, damage detection, theft reduction, and spoilage detection, IoT can enhance data collection and help prevent food safety issues. This technology also enables real-time monitoring of products’ temperature and conditions during transportation, reducing the risk of spoilage or contamination. Moreover, close monitoring of these conditions makes it easier to identify and address any guidelines or compliance violations.
With advanced technology, effective processes, and a focus on disclosing accurate information, restaurants can implement more effective traceability systems to meet consumer demands and encourage confidence in the food industry.
In the food production industry, being efficient is not just a goal, it is essential for success. Operations that produce top-quality products at the lowest costs come out on top. One key to staying efficient is cross training production workers and making sure they’re skilled in operating various machines. This way, anyone can step in to keep things running smoothly, avoiding costly delays. Another important strategy is using predictive maintenance to keep equipment in good shape and prevent unexpected breakdowns. This approach helps avoid interruptions and keeps production lines moving efficiently. This article will explore how predictive maintenance can enhance efficiency across food production operations.
Predictive maintenance represents a significant leap beyond traditional reactive and preventive maintenance practices. Instead of waiting for something to break down (reactive maintenance) or just checking machines on a regular maintenance schedule (preventive maintenance), predictive maintenance uses data to predict equipment failures before they happen. For example, ultrasonic monitoring can detect changes in bearing conditions; oil analysis evaluates lubricants to monitor the condition of gear systems, compressors, bearings, and other components; thermal infrared scanning can identify overheating electrical components; and vibration analysis can predict mechanical failures. These asset condition-monitoring diagnostics, when combined, provide a comprehensive view of equipment health.
Imagine if you could do a blood test that not only tells you what’s currently wrong but also predicts potential health issues before they become serious. Predictive maintenance in the factory setting works much like this advanced blood analysis, but for machinery. Just as a blood test can reveal hidden health issues by looking at various markers and indicators, predictive maintenance tools act as the diagnostics for machinery health. Ultrasonic testing, oil analysis, thermal infrared scans, and vibration analysis provide a detailed insight into the equipment’s condition, catching the smallest signs of wear and potential risks of malfunction. This allows maintenance teams to intervene early, ensuring that the machinery keeps operating smoothly without unexpected and costly downtimes.
Starting a Predictive Maintenance Program in Food Production
To effectively launch a predictive maintenance program within food production, consider this tailored approach:
Assess Current Maintenance Practices: Review existing maintenance activities, focusing on their effectiveness and areas where predictive insights could reduce failures and inefficiencies.
Set Clear Objectives: Establish goals specifically for predictive maintenance, such as minimizing unplanned downtime, predicting and preventing equipment failures, and optimizing maintenance costs. Ensure these goals align with overall business objectives.
Gather and Analyze Equipment Data: Collect detailed data on equipment performance, including historical maintenance records and operational data. This information will serve as the foundation for developing predictive models.
Implement Condition-Based Monitoring: Deploy appropriate monitoring technologies (like ultrasonic and thermal infrared scanning) that align with your equipment’s specific needs. Use these tools to continuously monitor equipment health and predict potential failures.
Develop a Predictive Maintenance Schedule: Utilize data and insights obtained from condition-based monitoring to schedule maintenance activities proactively, before failures are likely to occur.
Train Your Team: Provide specialized training for both maintenance and production teams on predictive maintenance techniques and the interpretation of data insights. This ensures they can effectively respond to predictive alerts and maintain equipment reliability.
Monitor, Evaluate, and Adjust: Regularly assess the effectiveness of the predictive maintenance program, comparing actual outcomes against your objectives. Adjust strategies and techniques as needed to continuously improve maintenance efficiency and equipment performance.
Maximizing Efficiency and Reliability Through Predictive Maintenance
The success of a predictive maintenance program relies on the expertise and skills of the maintenance team. Essential training in predictive maintenance techniques and the proficient use of diagnostic tools equip maintenance personnel to preemptively identify and address equipment issues. Cross-training further empowers the team, enabling them to manage a wide range of equipment challenges, significantly enhancing the program’s overall effectiveness.
Shifting our focus to predictive maintenance in food production operations marks a significant step towards enhancing asset reliability and extending the life of machinery. This approach steers clear of the risks associated with running equipment to failure, promoting a more sustainable and efficient operational model. The financial advantages of adopting predictive maintenance are plentiful and include:
Enhanced energy efficiency: Equipment in optimal condition operates more efficiently, lowering energy consumption and costs.
Improved order fulfillment: Predictive maintenance minimizes unexpected downtime, ensuring smoother production flow and timely delivery of orders to meet demand.
Implementing predictive maintenance practices ensures continuous, high-quality production while cultivating a maintenance culture focused on reliability, cost savings, and operational excellence. This approach allows businesses to optimize the value and longevity of their equipment assets and enhance efficiency across food production operations.
With millions of people in the U.S. getting sick each year from foodborne illness, the FDA is continuing to transform the nation’s food safety system with more stringent rules and regulations. In 2011, the Food Safety Modernization Act (FSMA) was signed into law, and consequently, several rules have been finalized to implement the act and ensure food safety across different points in the global supply chain.
The FDA’s Requirements for Additional Traceability Records for Certain Foods, also known as the Food Traceability Final Rule or FSMA 204, establishes additional recordkeeping requirements for entities that manufacture, process, pack or hold foods on the Food Traceability List. The list includes specific foods, such as specific cheeses, eggs, cucumbers, herbs, leafy greens and more, for which extra recordkeeping requirements are reasonable and necessary to protect public health.
The rule was finalized by the FDA on November 15, 2022. It will be enforced beginning January 20, 2026, with routine inspections anticipated to start in 2027, meaning businesses must prepare now to comply with the new requirements.
The goals are to identify and remove potentially contaminated food from the market more quickly, and as a result, prevent the spread of foodborne illnesses and/or fatalities.
Understanding the Food Traceability List
The FDA’s identified foods can be found on the Food Traceability List (FTL). FSMA 204 uses an established set of metrics known as Key Data Elements (KDEs) that relate to various supply chain occurrences known as Critical Tracking Occurrences (CTEs). The CTEs are:
Harvesting
Cooling
Initial Packing (applies to Raw Agricultural Commodities not obtained from a fishing vessel)
First Land-Based Receiver (applies only to seafood)
Shipping
Receiving
Transformation
If an entity uses any of the above CTEs for any food on the FTL, as well as food that uses an ingredient that remains in the same form (e.g. fresh) on the list, it must comply with the additional recordkeeping requirements.
Preparing for FSMA 204
FSMA 204 became operative in January 2023, 60 days after the publication of the final rule in November 2022. While businesses have three years to become fully compliant (until January 20, 2026), starting the process early is highly recommended as several of the requirements, such as having an established food traceability system, take both time and effort. Meeting the deadline can be extremely challenging if preparations are put off until just before the compliance date.
To prepare for FSMA 204, first, take the time to thoroughly review and understand the rule. Carefully read through the FTL and its overview of ingredients and finished products. Then, make sure that you understand any exemptions that apply to your business.
The next step should be to consult the FDA’s reference guide on CTEs and KDEs to determine which KDEs you must record. Various sets of KDEs may need to be recorded depending on your specific business activities. For example, a food processor could fall under the categories of receiver, transformer, and shipper since it physically acquires products from a supplier, then combines, repackages, relabels, or otherwise transforms the food before shipping it to clients.
In addition to capturing the KDEs, businesses should:
Create and maintain a traceability plan.
Maintain records in the form of either the original printed records, electronic records, or true copies. (Records must be legible and stored to prevent loss or deterioration.)
Ensure traceability records are sent to the FDA within 24 hours of their request (or within a reasonable time to which the FDA has agreed), including any information required to comprehend the data or records. When required to assist during an outbreak, recall or other public health danger, you must deliver an electronic sortable spreadsheet containing pertinent traceability data to the FDA within 24 hours of a request (or within a reasonable timeframe to which the FDA has consented).
Traceability Plan Must-Haves
The food traceability plan should include all procedures used to maintain traceability records, including detailing the format and location of these records in the business. It should also include procedures used to identify foods on the FTL and the subsequent CTEs.
Other key items to include are a process on how traceability lot codes are assigned, points of contact for questions on the traceability system and its records, and supporting documents such as a farm map that indicates the location of the growers or raisers of the food on the FTL (other than eggs). The map must include the position and name of each field or growing area, as well as other details required to pinpoint the sites.
Next Steps
Preparing for FSMA 204 and meeting the requirements can be overwhelming. Several third-party organizations are offering support services. Additionally, the FDA has several resources located on its website, including Frequently Asked Questions, a webinar recording and more.
For businesses unsure about how the rule applies to them and their products, NSF offers an Initial Scoping Workshop that includes a virtual session, which involves reviewing the ingredients and finished products compared to the FTL, a document check (e.g. of the traceability plan), confirmation that all relevant stakeholders have been captured, and access to a video recording explaining the principles of FSMA 204’s traceability requirements. A recommendation will also be made if a FSMA 204 Readiness Assessment is needed.
Businesses who already know their products fall under the FTL can opt to start with a full FSMA 204 Readiness Assessment, which ensures you have taken all the steps necessary and helps you identify any corrective actions/controls needed to ensure compliance with the rule.
Effectively communicating the food traceability plan and coaching supply chain partners on new processes is a critical component to meeting compliance. Label harmonization must be completed to properly track and secure the required information from suppliers.
Though paper records are permitted under the rule, businesses should consider leveraging technology to assist them with complying with the requirements. Consider investing in a platform that can automate data gathering and securely save information so it can be easily retrieved if needed. On-demand traceback and trace forward features are especially important, as in the event of an investigation or recall, immediate product tracing capabilities are essential.
While FSMA 204 will require entities across the food industry to comply with the new requirements, it will contribute to a stronger and more resilient global food supply chain.
This past year, I was invited to participate in a risk assessment workshop led by a third-party consultant at a food safety event. During my 30+ year career, I have been through many different types of risk assessments across several industry segments. I have been a participant seeking to define and address risk at my own organization, as well as a consultant helping my clients perform their own risk assessments. Each time I experienced a risk assessment exercise, I learned something new, and this time was no different. The key learning for me in this case is encapsulated in the title of this blog: Food Safety Risk Assessments are “Data Hungry.”
What Does This Mean?
As we went through the workshop exercise, we explored the elements of risk. Specifically, risk is defined as a combination of three factors: Is something POSSIBLE, how PROBABLE is it to occur, and what is the potential SEVERITY if it were to occur?
The first element is a yes or no question. Anything that can possibly happen should be included in the assessment.
The second element, probability, is measured on a scale. In our exercise, we assigned probability to a scale of 1–5 (least to most probable). A subset of probability is the expected frequency. This is a tricky one. If something has been occurring over time, then the frequency is known and can be easily factored into the probability scale. If it is a newly discovered issue, then “expected frequency” becomes an exercise in guesswork — one that must be refined over time. In our exercise, frequency was measured on a scale of 1–5 (least to most frequent).
For the third element, severity, we also used a 1–5 scale (least to most severe).
The room then proceeded to use these elements and measurement techniques to assess risk across 10 different scenarios. These included descriptions of foodborne illness, food safety testing outcomes, discovery of allergens, labelling mishaps, chemical contamination, food fraud, supply chain disruptions, and other risks.
The risk assessment included a worksheet laid out as a table, where each scenario could be prioritized and scored according to the risk measurement elements (Figure 1).
Figure 1: Example Risk Scoring Table
The room was divided into three teams, and each was asked to prioritize the various scenarios in order of highest to lowest risk. Each group completed this task, and here is where things got interesting — each team had different results!
As shown in the example table, a lower priority may yield a risk score above that of something that was originally considered a higher priority. Each team’s tables looked significantly different from the others. To be clear, these were not strangers performing the exercise with no knowledge of each other’s priorities. In fact, the three teams comprised the global food safety leadership of one company — yet each team seemed to have very different ideas on risk prioritization. This unexpected result caused some lively discussion; meanwhile, the consultant leading the exercise was the only one in the room who was not surprised at all by the results. Here’s why:
There was one more factor to consider — one that was on the minds of each team, but not openly expressed as a factor for prioritizing risk: The TYPE of risk.
The consultant then asked the room to describe what type of risk they were thinking about from the following four categories:
Public Health
Reputation
Regulatory
Business Operations
The room concluded that the type of risk had a significant impact on how the risk was originally prioritized. Each team had set out their prioritization criteria based on a preconceived risk category, and it turned out that each team’s selected category was different. Depending on which of the four risk types or objectives was dominant, a different prioritization and risk scoring resulted.
This is where the “data hungry” concept factors in. The final analysis revealed that a risk scoring exercise conducted in this manner is capable of yielding only a “perceived risk” score. While perception is a good start, an actionable risk assessment should be based on actual outcomes and experiences. The availability of real-world data, collected over time, has a dramatic impact on validating perceptions.
For example, the availability of pathogen testing diagnostic data, along with the probability, frequency, and likeliness of occurrences, would allow a risk assessment score to be based on a historical trend, rather than a perceived level of frequency and probability. A risk assessment exercise would be informed by the data, and a score of 1–5 could be applied with far more confidence.
Data, in the words of one of the participants, “removes the guesswork and assumptions” within a risk assessment. I learned that data is the necessary element to transform risk perception into risk knowledge. While it is useful to perform a risk assessment based on perceived scoring and prioritization, it is essential that a risk assessment be validated with real data.
Inefficiencies and lack of oversight in cold storage monitoring of food can lead to product spoilage, high repair costs, and contamination concerns. The solution to many of these issues is to gain more visibility and control over these processes, and this is precisely what the Internet of Things (IoT) provides. Following are five ways food businesses can use IoT technology to improve their cold storage monitoring.
1. Accelerate Emergency Response
One of the best ways to use the IoT in the cold chain is to monitor refrigerated shipments in real time. IoT sensors can track a product’s condition, location, and temperature as it travels and alert relevant stakeholders when any of these factors deviate from expected or required levels. These notifications enable faster responses to mitigate unexpected disruptions.
Broken refrigeration units are an excellent example. IoT sensors can alert drivers and other supply chain partners when a shipment’s temperature has risen too much. Drivers can then adjust their route to temporarily store the items somewhere nearby while they address the issue, preventing spoilage in transit.
Immediate responses like this could help reduce the 30% to 40% of food that goes to waste in the U.S. Over time, data from this real-time monitoring may also reveal larger trends indicating the need to upgrade some equipment or reorganize supply chains.
2. Improve Long-Term Equipment Maintenance
Equipment maintenance is another ideal use case for IoT in cold storage monitoring. Refrigeration units in vehicles or warehouses benefit from real time alerts as well as long-term data analysis.
IoT sensors can analyze repeated repair issues to diagnose refrigeration equipment with larger underlying issues, informing more effective fixes. They can also alert organizations when it’s time to inspect or upgrade equipment. That is particularly important for refrigerated buildings built before 2010, which likely use the now-banned R22 and require replacement.
Predictive maintenance is another popular application under this umbrella. This practice uses IoT sensors to predict future repair needs based on past trends and current data. By forming repair schedules around these predictions, businesses prevent breakdowns while minimizing maintenance-related downtime.
3. Enhance Inventory Visibility
Food and beverage companies can use IoT systems to improve their inventory visibility. Up to 40% of food loss occurs between production and store shelves, often because of inefficient storage practices. More transparency is the solution.
IoT tracking solutions provide real-time data on the locations of products within a warehouse. They can also alert workers when items are nearing their expiration dates. With these insights, it becomes easier for companies to organize inventories and shipping schedules to prevent spoilage and product loss.
Storage facilities can use IoT monitoring to track temperatures throughout the warehouse as well. This data reveals if any spots are experiencing greater fluctuations in temperature or tend to be warmer than other areas. Brands can then address their refrigeration and storage practices to ensure everything stays at ideal temperatures.
4. Streamline Shipment Routes
Businesses can use IoT to refine their in-transit operations. The same cold storage monitoring systems that track shipments can reveal larger logistics trends to spur supply chain optimization.
For example, refrigerated shipments are often delicate and/or have short life spans, making inefficient routes risky. Over time, IoT data will help by revealing where the most stops or slowdowns occur. Organizations can analyze this information to uncover new, more efficient or less disruption-prone routes for more timely deliveries.
These insights are particularly valuable for food and beverage companies with international supply chains. Cross-border routes with multiple charge offs will have more opportunities for optimization, making them ideal IoT use cases.
5. Minimize Energy Costs
IoT sensors in cold storage can also reduce power consumption. By responding to current data, smart devices provide more precise, adaptable controls over energy-consuming processes, letting them operate on as little energy as possible.
Smart HVAC systems are the most familiar example. IoT-connected AC units stop or trigger cooling systems in response to temperature fluctuations, preventing unnecessary energy expenditures. Consequently, consumer versions can save $50 a year in cooling costs and industrial-scale equipment could see even more significant savings.
IoT tracking solutions also reduce supply chain energy consumption through more efficient routing practices. Vehicles traveling for less time consume less fuel, leading to lower diesel costs and related emissions.
Refrigerated transportation and storage can be difficult to get right. Food and beverage companies must ensure this equipment is reliable, but doing so often involves high operational costs. IoT technologies can improve cold storage processes and uncover opportunities to enhance related workflows.
Implementing IoT technologies in cold storage monitoring will involve some initial disruption and upfront costs. However, the long-term savings can compensate for these upfront expenses. Businesses that take this challenge head-on today can secure a far more efficient future.
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Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.
![Example Risk Scoring Table]](https://foodsafetytech.com/wp-content/uploads/2024/04/Figure1.jpg)
