Tag Archives: FSMA

Megan Nichols
FST Soapbox

How Will AR and VR Improve Safety in the Food Industry?

By Megan Ray Nichols
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Megan Nichols

The food and beverage sector is a huge presence in the U.S. economy. As of 2017, the industry employed 1.46 million people across 27,000 different establishments. Total food and beverage sales stand at around $1.4 trillion and add $164 billion in value to the economy as a whole.1 This presents significant opportunities and risks alike. Companies that trade in food products are held to some of the highest regulatory standards. With globalization ongoing and a higher demand than ever for variety and niche products, companies find they need to expand the mobility of their services. They must also broaden their product choices without missing a beat when it comes to quality.

Augmented reality (AR) and virtual reality (VR) have emerged as unlikely allies in that quest. These technologies are already having a positive impact on food and worker safety in the industry.

Improves New Employee Training

Onboarding and training new employees is a costly and time-consuming endeavor in any industry. Moreover, failure by companies to impart the necessary skills, and failure by employees to retain them, can have ghastly consequences. Errors on assembly lines may result in faulty products, recalls, worker and customer injuries, and worse.

The stakes in the food and beverage sector are just as high as they are in other labor- and detail-oriented industries. VR provides an entirely new kind of training experience for employees, whether they’re working on mastering their pizza cutting technique or brewing the perfect cappuccino. Other times, “getting it right” is about much more than aesthetic appeal and immediate customer satisfaction.

Animal slaughtering and processing facilities represent some of the more extreme examples of potentially dangerous workplaces in the larger food and beverage industry. Between 2011 and 2015, this U.S. sector experienced 73 fatal workplace injuries. Excepting poultry processing, 2015 saw 9,800 recordable incidents in animal processing, or 7.2 cases for every 100 full-time employees.

Some adopters of VR-based employee training claim that virtual reality yields up to an 80% retention rate one year after an employee has been trained. This compares extremely favorably to the estimated 20% retention rate of traditional training techniques.

Training via VR headset can help companies get new hires up to speed faster in a safe, detailed and immersive environment. Food processing and service are high-turnover employment sectors. The right training technology can help workers feel better prepared and more engaged with their work, potentially reducing employee churn.

Helps Eliminate Errors in Food Processing

Augmented reality is already demonstrating great promise in manufacturing, maintenance and other sectors. For instance, an AR headset can give an assembly line worker in an automotive plant detailed, step-by-step breakdowns of their task in their peripheral vision through a digital overlay.

The same goes for food and beverage manufacturing. AR headsets can superimpose a list of inspection or processing tasks for workers to follow as they prepare food items in a manufacturing or distribution facility.

In 2018, there was an estimated 382 recalls involving food products. Augmented reality alone won’t bring that number down to zero. However, it does help reduce instances of line workers and inspectors missing critical steps in processing or packaging that might result in contamination or spoilage.

Eases the Learning Curve in Food Preparation

There are lots of food products in the culinary world that are downright dangerous if they’re not prepared properly and by following specific steps. Elderberries, various species of fish, multiple root vegetables, and even cashews and kidney beans can all induce illness and even death if the right steps aren’t taken to make them fit for consumption.

In early 2019, inspectors descended on a Michelin-starred and highly respected restaurant in Valencia, Spain. The problem? A total of 30 patrons reported falling ill after eating at El País, one of whom lost her life. Everyone reported symptoms similar to food poisoning.

The common element in each case appeared to be morel mushrooms. These are considered a luxury food item, but failure to cook them properly can result in gastric problems and worse. Augmented reality could greatly reduce the likelihood of incidents like this in the future by providing ongoing guidance and reminders to new and veteran chefs alike, without taking the bulk of their attention away from work.

Brings New Efficiencies to Warehousing and Pick-and-Pack

Consumers around the globe are getting used to ordering even highly perishable foodstuffs over the internet—and there’s no putting that genie back in the bottle. Amazon’s takeover of Whole Foods is an indicator of what’s to come: Hundreds of freezer-equipped and climate-controlled warehouses located within a stone’s throw from a majority of the American population.

Ensuring smooth operations in perishable food and beverage supply chains is a major and ongoing struggle. It’s not just a practical headache for companies—it’s something of a moral imperative, too. The World Health Organization finds that around 600 million individuals worldwide fall ill each year due to foodborne illnesses.

Augmented reality won’t completely solve this problem, but it may greatly reduce a major source of potential spoilage and contamination: Inefficiencies in picking and packing operations. Order pickers equipped with AR headsets can:

  • Receive visual prompts to quickly find their way to designated stow locations in refrigerated warehouses after receiving refrigerated freight.
  • Locate pick locations more efficiently while retrieving single items or when they already have a partial order of perishable goods picked.

In both cases, the visual cues provided by AR help employees navigate warehousing locations much more quickly and efficiently. This substantially lowers the likelihood that food products are stuck in limbo in unrefrigerated areas, potentially coming into contact with noncompliant temperatures or pathogens. The FDA recognizes mispackaged and mislabeled food products as a major public health risk.

For food and beverage companies, AR should be a welcome development and a worthy investment. FSMA recognized that 48 million Americans get sick each year from compromised foods. The act required these entities to be much more proactive in drawing up prevention plans for known sources of contamination and to be more deliberate in standardizing their processes for safety’s sake.

AR and VR Boost Food, Worker and Customer Safety

Augmented and virtual reality may seem like an unusual ally in an industry where most consumers are primarily focused on the aesthetic and sensory aspects of the experience. However, there’s a whole world that lives and dies according to the speed and attention to detail of employees and decision-makers alike. Augmented realities, and entirely new ones, point the way forward.

Reference

  1. Committee for Economic Development of The Conference Board. (March 2017). “Economic Contribution of the Food and Beverage Industry. Retrieved from https://www.ced.org/pdf/Economic_Contribution_of_the_Food_and_Beverage_Industry.pdf.
Susanne Kuehne, Decernis
Food Fraud Quick Bites

Keeping Food Safe, the U.S. Way

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.

In the United States, the FDA is responsible for regulations and recommendations to protect public health, which includes the prevention of any type of food adulteration (unintentional contamination, intentional adulteration, and food fraud – or “economically motivated adulteration”). FSMA (the Food Safety Modernization Act) resulted in new regulations and guidance with strategies to reduce all types of risks in food facilities. It was the most comprehensive reform of FDA’s food safety regulations in more than 70 years.

Resource

  1. FSMA Rules & Guidance for Industry.

 

Data protection, security

The Digital Transformation of Global Food Security

By Katie Evans
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Data protection, security

Modern food supply chains are inherently complex, with products typically passing through multiple suppliers and distributors, as well as countries and continents, before they end up on the supermarket shelf. While global supply chains offer consumers greater choice and convenience, they also make protecting the security of food products more challenging. With additional stakeholders between farm and fork, products are exposed to an elevated risk of biological or chemical contamination, as well as food counterfeiting and adulteration challenges—potentially putting consumer health and brand reputation in jeopardy.

Given the importance of maintaining the safety, quality and provenance of food products, global regulatory bodies are placing the integrity of supply chains under increased scrutiny. In the United States, for example, the adoption of FSMA moved the focus from responding to foodborne illnesses to preventing them by prioritizing comprehensive food testing measures, enforcing inspections and checks, and enabling authorities to react appropriately to safety issues through fines, recalls or permit suspensions.1 Similarly, China’s revised Food Safety Law (known as FSL 2015) is widely considered to be the strictest in the country’s history, and seeks to drive up quality standards by empowering regulators, and enhancing traceability and accountability through robust record-keeping. 2 The European Union continues to closely regulate and monitor food safety through its General Food Law, which is independently overseen by the European Food Safety Authority from a scientific perspective.

Achieving the Highest Standards of Food Security, Integrity and Traceability

For producers, manufacturers and distributors, the heightened regulatory focus on the security and integrity of the food supply chain has placed additional emphasis on accurate record-keeping, transparent accountability and end-to-end traceability. To meet the needs of the modern regulatory landscape, food chain stakeholders require robust systems and tools to manage their quality control (QC), environmental monitoring and chain of custody data. Despite this, many businesses still handle this information using paper-based approaches or localized spreadsheets, which can compromise operational efficiency and regulatory compliance.

The fundamental flaw of these traditional data management approaches is their reliance on manual data entry and transcription steps, leaving information vulnerable to human error. To ensure the accuracy of data, some companies implement resource-intensive verification or review checks. However, these steps inevitably extend workflows and delay decision-making, ultimately holding up the release of products at a high cost to businesses. Moreover, as paper and spreadsheet-based data management systems must be updated by hand, they often serve merely as a record of past events and are unable to provide insight into ongoing activities. The time lag associated with recording and accessing supply chain information means that vital insight is typically unavailable until the end of a process, and data cannot be used to optimize operations in real-time.

Furthermore, using traditional data management approaches, gathering information in the event of an audit or food safety incident can be extremely challenging. Trawling through paperwork or requesting information contained in spreadsheets saved on local computers is time-consuming and resource-intensive. When it comes to establishing accountability for actions, these systems are often unable to provide a complete audit trail of events.

Digital Solutions Transform Food Security and Compliance

Given the limitations of traditional workflows, food supply chain stakeholders are increasingly seeking more robust data management solutions that will allow them to drive efficiency, while meeting the latest regulatory expectations. For many businesses, laboratory information management systems (LIMS) are proving to be a highly effective solution for collecting, storing and sharing their QC, environmental monitoring and chain of custody data.

One of the most significant advantages of managing data using LIMS is the way in which they bring together people, instruments, workflows and data in a single integrated system. When it comes to managing the receipt of raw materials, for example, LIMS can improve overall workflow visibility, and help to make processes faster and more efficient. By using barcodes, radiofrequency identification (RFID) tags or near-field communication, samples can be tracked by the system throughout various laboratory and storage locations. With LIMS tracking samples at every stage, ingredients and other materials can be automatically released into production as soon as the QC results have been authorized, streamlining processes and eliminating costly delays.

By storing the standard operating procedures (SOPs) used for raw material testing or QC centrally in a LIMS, worklists, protocols and instrument methods can be automatically downloaded directly to equipment. In this way, LIMS are able to eliminate time-consuming data entry steps, reducing the potential for human error and improving data integrity. When integrated with laboratory execution systems (LES), these solutions can even guide operators step-by-step through procedures, ensuring SOPs are executed consistently, and in a regulatory compliant manner. Not only can these integrated solutions improve the reliability and consistency of data by making sure tests are performed in a standardized way across multiple sites and testing teams, they can also boost operational efficiency by simplifying set-up procedures and accelerating the delivery of results. What’s more, because LIMS can provide a detailed audit trail of all user interactions within the system, this centralized approach to data management is a robust way of ensuring full traceability and accountability.

This high level of operational efficiency and usability also extends to the way in which data is processed, analyzed and reported. LIMS platforms can support multi-level parameter review and can rapidly perform calculations and check results against specifications for relevant customers. In this way, LIMS can ensure pathogens, pesticides and veterinary drug residues are within specifications for specific markets. With all data stored centrally, certificates of analysis can be automatically delivered to enterprise resource planning (ERP) software or process information management systems (PIMS) to facilitate rapid decision-making and batch release. Furthermore, the sophisticated data analysis tools built into the most advanced LIMS software enable users to monitor the way in which instruments are used and how they are performing, helping businesses to manage their assets more efficiently. Using predictive algorithms to warn users when principal QC instruments are showing early signs of deterioration, the latest LIMS can help companies take preventative action before small issues turn into much bigger problems. As a result, these powerful tools can help to reduce unplanned maintenance, keep supply chains moving, and better maintain the quality and integrity of goods.

While LIMS are very effective at building more resilient supply chains and preventing food security issues, they also make responding to potential threats much faster, easier and more efficient. With real-time access to QC, environmental monitoring and chain of custody data, food contamination or adulteration issues can be detected early, triggering the prompt isolation of affected batches before they are released. And in the event of a recall or audit, batch traceability in modern LIMS enables the rapid retrieval of relevant results and metadata associated with suspect products through all stages of production. This allows the determination of affected batches and swift action to be taken, which can be instrumental in protecting consumer safety as well as brand value.

Using LIMS to Protect Security and Integrity of the Food Supply Chain

Increasingly, LIMS are helping businesses transform food security by bringing people, instruments and workflows into a single integrated system. By simplifying and automating processes, providing end-to-end visibility across the food supply chain, and protecting the integrity of data at every stage, these robust digital solutions are not only helping food supply chain stakeholders to ensure full compliance with the latest regulations; they are enabling businesses to operate more efficiently, too.

References

  1. FDA. (2011). FDA Food Safety Modernization Act. Accessed October 3, 2019. Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma.
  2. Balzano, J. (2015). “Revised Food Safety Law In China Signals Many Changes And Some Surprises”. Forbes. Accessed October 3, 2019. Retrieved from https://www.forbes.com/sites/johnbalzano/2015/05/03/revised-food-safety-law-in-china-signals-many-changes-and-some-surprises/#624b72db6e59.
John McPherson, rfxcel
FST Soapbox

End-to-End Supply Chain Traceability Starts with High-Quality Data

By John McPherson
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John McPherson, rfxcel

End-to-end traceability technology across the food and beverage (F&B) supply chain has many benefits for companies at all nodes of the chain, not least of which is the ability to act to prevent problems such as irreversible damage, loss, and theft. For these technologies to best deliver on their promise, however, they need standardized and quality-assured data. F&B supply chain stakeholders need to take steps to achieve effective data management to truly take advantage of the benefits of traceability and real-time monitoring technologies.

Since FSMA was introduced in 2011, actors across the F&B supply chain have had to change their behavior. Prior to FSMA, companies tended to react to events; today, proactive and preemptive measures are the norm. This is in line with what the legislation was designed to do: Encourage the prevention of foodborne illness instead of responding after their occurrance.

F&B manufacturers and distributors rely on technology to help predict potential obstacles and mitigate issues along their supply chains. But expressing a desire to embrace technologies such as real-time monitoring solutions and predictive analytics isn’t enough to achieve ultimate supply chain efficiency. Only by taking the necessary steps can companies get on track to ensure results.

Any company that is thinking about deploying a traceability solution has a lot to consider. Foremost, data must be digitized and standardized. This might seem challenging, especially if you’re starting from scratch, but it can be done with appropriate planning.

Let’s examine what F&B companies stand to gain by adopting new, innovative technologies and how they can successfully maximize data to achieve end-to-end supply chain traceability.

New Technologies Hold Huge Potential for F&B Supply Chains

The advantages of adopting new technologies far outweigh the time and effort it takes to get up and running. To smooth the process, F&B companies should work with solution providers that offer advisory services and full-service implementation. The right provider will help define your user requirements and create a template for the solution that will help ensure product safety and compliance. Furthermore, the right provider will help you consider the immediate and long-term implications of implementation; they’ll show you how new technologies “future-proof” your operations because they can be designed to perform and adapt for decades to come.

Burgeoning technologies such as the Internet of Things (IoT), artificial intelligence (AI) and blockchain are driving end-to-end traceability solutions, bridging the gap between different systems and allowing information to move seamlessly through them.

For example, real-time tracking performed by IoT-enabled, item-level sensors allows companies to detect potential damage or negative events such as theft. These devices monitor and send updates about a product’s condition (e.g., temperature, humidity, pressure, motion and location) while it is in transit. They alert you as soon as something has gone wrong and give you the power to take action to mitigate further damage.

This is just one example of how data from a fully implemented real-time, end-to-end traceability platform can yield returns almost immediately by eliminating blind spots, identifying bottlenecks and threats, and validating sourcing requirements. Such rich data can also change outcomes by, for example, empowering you to respond to alerts, intercept suspect products, extend shelf life, and drive continuous improvement.

As for AI technologies, they use data to learn and predict outcomes without human intervention. Global supply chains are packed with diverse types of data (e.g., from shippers and suppliers, information about regulatory requirements and outcomes, and public data); when combined with a company’s internal data, the results can be very powerful. AI is able to identify patterns through self-learning and natural language, and contextualize a single incident to determine if a larger threat can be anticipated or to make decisions that increase potential. For example, AI can help automate common supply chain processes such as demand forecasting, determine optimal delivery routes, or eliminate unforeseeable threats.

Blockchain has garnered a lot of buzz this year. As a decentralized and distributed data network, it’s a technology that might help with “unknowns” in your supply chain. For example, raw materials and products pass through multiple trading partners, including suppliers, manufacturers, distributors, carriers and retailers, before they reach consumers, so it can be difficult to truly know—and trust—every partner involved in your supply chain. The immutable nature of blockchain data can build trust and secure your operations.

To date, many F&B companies have been hesitant to start a blockchain initiative because of the capital risks, complexity and time-to-value cost. However, you don’t have to dive in head-first. You can start with small pilot programs, working with just a few stakeholders and clearly defining pilot processes. If you choose the right solution provider, you can develop the right cultural shift, defining governance and business models to meet future demands.

To summarize, new technologies are not disruptive to the F&B industry. If you work with an experienced solution provider, they will be constructive for the future. Ultimately, it’s worth the investment.

So how can the F&B industry start acting now?

How to Achieve End-to-End Traceability

Digitize Your Supply Chain. We live in a digital world. The modern supply chain is a digitized supply chain. To achieve end-to-end traceability, every stakeholder’s data must be digitized. It doesn’t matter how big your company is—a small operation or a global processor—if your data isn’t digitized, your supply chain will never reach peak performance.

If you haven’t begun transitioning to a digitalized supply chain, you should start now. Even though transforming processes can be a long journey, it’s worth the effort. You’ll have peace of mind knowing that your data is timely and accurate, and that you can utilize it to remain compliant with regulations, meet your customer’s demands, interact seamlessly with your trading partners, and be proactive about every aspect of your operations. And, of course, you’ll achieve true end-to-end supply chain traceability.

Standardize Your Data. As the needs of global F&B supply chains continue to expand and become more complex, the operations involved in managing relevant logistics also become more complicated. Companies are dealing with huge amounts of non-standardized data that must be standardized to yield transparency and security across all nodes of the supply chain.

Many things can cause inconsistencies with data. Data are often siloed or limited. Internal teams have their own initiatives and unique data needs; without a holistic approach, data can be missing, incomplete or exist in different systems. For example, a quality team may use one software solution to customize quality inspections and manage and monitor remediation or investigations, while a food safety team may look to a vendor management platform and a supply chain or operations team may pull reports from an enterprise resource planning (ERP) system to try and drive continuous improvement. Such conflict between data sources is problematic—even more so when it’s in a paper-based system.

Insights into your supply chain are only as good as the data that have informed them. If data (e.g., critical tracking events) aren’t standardized and quality-assured, companies cannot achieve the level and quality of information they need. Data standards coming from actors such as GS1 US, an organization that standardizes frameworks for easy adoption within food supply chains, can help with this.

There are many solutions to ensure data are standardized and can be shared among different supply chain stakeholders. With recent increases in recalls and contamination issues in the United States, the need for this level of supply chain visibility and information is even more critical.

Data Security. Data security is crucial for a successful digital supply chain with end-to-end traceability, so you must plan accordingly—and strategically. You must ensure that your data is safe 24/7. You must be certain you share your data with only people/organizations who you know and trust. You must be protected against hacks and disruptions. Working with the right solution provider is the best way to achieve data security.

Incentive Structures. Incentives to digitize and standardize data are still lacking across some parts of the F&B supply chain, increasing the chances for problems because all stakeholders are not on the same page.

Companies that continue to regard adopting traceability as a cost, not an investment in operations and brand security, will most likely do the minimum from both fiscal and regulatory standpoints. This is a strategic mistake, because the benefits of traceability are almost immediate and will only get bigger as consumers continue to demand more transparency and accuracy. Indeed, we should recognize that consumers are the driving force behind these needs.

Being able to gather rich, actionable data is the key to the future. Industry leaders that recognize this and act decisively will gain a competitive advantage; those that wait will find themselves playing catch-up, and they may never regain the positions they’ve lost. We can’t overstate the value of high-quality digitized and standardized data and the end-to-end traceability it fuels. If companies want to achieve full visibility and maximize their access to information across all nodes of their supply chains, they must embrace the available technologies and modernize their data capabilities. By doing so, they will reap the benefits of a proactive and predictive approach to the F&B supply chain.

Sean O'Leary, FoodLogiQ

The Value of a One Percent Improvement

By Food Safety Tech Staff
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Sean O'Leary, FoodLogiQ

During the past year, the headlines have been filled with stories of foodborne illness, product recalls, and consumers becoming sick from tainted food. In a Q&A with Food Safety Tech, Sean O’Leary, CEO at FoodLogiQ, talks food safety, traceability, and how small percentages can translate into big victories for the food industry and for the people they serve.

Food Safety Tech: From your perspective, what is the current sentiment of consumers with regard to food safety?

Sean O’Leary: Over the last few years, the consumer mindset has changed about food in general. We’ve watched fad diets come and go; however, the interest in healthy ingredients and the concern about where food comes from has graduated from a passing trend to a full shift into the public consciousness. Consumers are much more discerning about what they eat; they also demand to know where their food comes from, how it was produced, and how it got to their table. We are living in the age of transparency, and consumer expectations are high.

And who can blame them? CDC statistics tell us that approximately 48 million people get sick every year from foodborne illnesses—and that’s just in the United States; 128,000 of them end up in the hospital. When a person is admitted to the hospital, it affects more than just that one individual. If the patient is the sole breadwinner of their family, their illness affects the entire family. If the person who gets sick is a child, there can be long-term consequences that trickle down to his or her whole community. And when you consider that 3,000 people die every year from foodborne illness—that’s one 9/11 every year. That’s unacceptable, because this is a preventable issue, and unfortunately, these illnesses are an underreported public health problem.

My challenge to the food industry is simple: What if we made just a 1% improvement in the number of cases of foodborne illness? That seems like such a small percentage, but when you do that math, that’s 480,000 people who don’t get sick this year; 1,280 people who aren’t admitted to the hospital; and 30 people who don’t die. Those are significant numbers.

Sean O'Leary, FoodLogiQ
Sean O’Leary joined FoodLogiQ as CEO in January 2019 with more than 25 years of experience in the technology industry.

FST: To help shed additional light on this subject, FoodLogiQ conducted a national survey to tap into how U.S. consumers feel about issues related to food transparency. What did you learn from those consumer responses?

O’Leary: We polled more than 2,000 people to gauge their sentiment around food traceability and their expectations for food companies regarding foodborne illness and product recalls. The survey also posed questions around consumer preferences regarding their food sources and how they are identified on food labels and menus. The results were enlightening, to say the least.

We learned that a brand or restaurant will pay a high price in terms of customer loyalty if they experience a food recall due to consumer illness. And those customers have some strong opinions regarding how quickly the brand or restaurant should address a food safety issue.

  • 35% of survey respondents told us they would avoid an affected brand or restaurant for a few months, and maybe they would return after the issue had been resolved. Meanwhile, nearly 25% admitted they would never use the brand or visit the restaurant again.
  • Of the respondents who say they care about the quality of the food they eat, 55% say they expect a recall to be executed within 24 to 48 hours.

In reality, it sometimes takes weeks for a product to be pulled from the store or restaurant. This is frequently due to communication issues, since everyone along the supply chain—the grower, supplier, packing and distribution centers, corporate office, and the retailer or restaurant—all must be notified, and a recall plan must be set in motion. Unfortunately, that communication process takes time. When that communication takes place via email or by phone call, the people responsible for pulling product may not have the information they need or may have received misinformation. This can result in lag time, and potentially unsafe product can still get into the hands of consumers.

The faster a food company can address a recall situation and return to business as usual, the faster customers will come back. But comprehensive supply chain transparency is needed to be able to make swift, accurate decisions during this time of crisis. By having a robust end-to-end traceability program and technology that provides real-time data and visibility, companies facing a recall can isolate and surgically withdraw the tainted product out of the supply chain without recalling more items than necessary. That limits the disruption and the waste of good food, which saves the company money.

FST: You recently attended the FDA’s “A New Era of Smarter Food Safety” public meeting in Maryland. What do you think this new campaign will mean for the food industry?

O’Leary: FoodLogiQ was honored to have the opportunity to share our intricate knowledge of the food supply chain, as well as best practices regarding whole chain traceability during this monumental meeting with the FDA with more than 250 food industry leaders.

In retrospect, one thing is clear—we’re in the midst of a pivotal time of change for the world’s food supply chain. In the United States, the food industry remained status quo for decades, but the introduction of FSMA has brought increased scrutiny and accountability; I think it’s made every food company pause and evaluate where they are with regard to food safety, and that’s a good thing. And now, with the launch of the “New Era” campaign, we’re coming together in a collaborative fashion to map out how technology tools, prevention measures, new business models, and an evolving culture of food safety can be merged as a framework for a long term food safety solution. I agree with the FDA; ‘Smarter Food Safety’ is people-led, FSMA-based, and technology-enabled. It will take all of us working together to reach that goal.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

By Frank Pisciotta, Spence Lane
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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.

Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.

A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.

Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.

Class OSHA Workplace Violence Offender Description Motivation Translated to the Food and Beverage Industry
1 The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame. Behavioral Health Patient *
Social Media Fame Seeker *
Copycat *
Extortion *
Economic motivation *
2 The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category. My load isn’t ready, you are costing me money
3 The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace. I am upset with a coworker and adulterate to create problems for that person *
I am upset with the company and adulterate as retribution and to harm the brand *
Youthful stupidity
I am not paid enough *
4 The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim. I am upset with an intimate partner/ coworker and adulterate to create problems for that person
5 Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs. Radicalized Insider
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.

A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.

Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.

Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”

The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.

Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more. Read Part II of this series on intentional adulteration.

FDA

FDA Receives Record Turnout As Industry Eager to Discuss New Era of Smarter Food Safety

By Maria Fontanazza
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FDA

Industry from the public and private sector joined for a record turnout during the FDA public meeting yesterday to discuss the agency’s initiative, a new era of smarter food safety. The meeting, which was at maximum capacity for both in-person as well as webcast attendance, began with a call to action from FDA Deputy Commissioner, Office of Food Policy and Response, Frank Yiannas on the importance of all stakeholders in the industry to work together to drive the change. As Yiannas has previously commented, the food industry is in the midst of a revolution. The world is changing faster than ever, and the FDA is challenged with not just creating a safer, more technology-centric and traceable food system, but also getting there faster and more effectively. “I’ve always believed that words we use are important,” he said. As the day’s various discussions would be around the new era of smarter food safety, Yiannas gave the audience a definition to consider: “A new era is a memorable or important date or event, especially one that begins with a new period in our history.”

FDA held breakout sessions centered on areas critical to the initiative:

  • Tech-enabled traceability and outbreak response
  • Smarter tools and approaches for prevention
  • Adapting to new business models and retail modernization
  • Food safety culture

During each session, FDA facilitators asked the audience questions. The following are some key points brought out during the breakouts.

Tech-Enabled Traceability and Outbreak Response

  • FDA should consider all parts of the supply chain when thinking about traceability
  • Take into account considerations for sharing sensitive data along the supply chain
  • Speaking a common language and creating data standards, along with necessary minimum data elements for traceability is critical
  • Better communication related to data sharing as well as more meetings with FDA and stakeholders, especially during outbreaks
  • Show industry the ROI of the data
  • Provide a roadmap or recommendation for companies on where they can begin on their traceability journey
  • Request for unity across government agencies (i.e., FDA, USDA), as it would provide more clarity during an outbreak

Smarter Tools and Approaches for Prevention

  • Trust and transparency are key
  • Safeguards that address privacy concerns and liability
  • Data
    • Data sharing: Concern about retroactive investigations
    • Types of data: With the “treasure trove” of existing data out there, which is the most important and helpful in improving food safety?
  • Environmental assessments and root cause analysis—more dialogue between FDA and industry

Adapting to New Business Models and Retail Food Safety Modernization

  • More need for collaboration
  • Globalization and use of best practices
  • Establishing a common standard to level the playing field
  • Establish best practices for tamper resistance
  • The last mile: Food safety training for food delivery personnel as well as harmonization for last mile delivery
  • More consumer education

Food Safety Culture

  • Emphasis on behavior and humanizing the work: Focusing on what happens within organizations at all levels
  • Clarity and communication are important
  • Leveraging current food safety culture best practices as well as any relevant existing standards (i.e., ISO, Codex)
  • Partnerships are critical, finding the balance between compliance and collaboration

Other Factors FDA Must Consider

The FDA meeting also included panel discussions that drew out the realities FDA must consider in this rapidly changing environment. “These are exciting times and this initiative is recasting our thinking in a whole new light,” said CFSAN Director Susan Mayne, adding, “We need to get ahead of these challenges and not be in reactive mode.”

Consumer awareness and demands for healthy, locally sourced and minimally processed food, for example, are creating increased pressures on food companies and retailers. In addition, the digital savvy and diverse Generation Z (the population born between 1990 and 2010, which will comprise nearly 40% of the U.S. population by 2020) has buying habits and a strong desire for transparency that is shifting how food companies will need to do business, according to Mary Wagner, president of MX Wagner & Associates.

“Trust represents safety, quality and commitment on a much more personal level to our consumers,” said Dirk Herdes, senior vice president at the Nielsen Company, emphasizing the need to communicate with authenticity. “Consumers have never been more informed, but never have been more overwhelmed with information. It’s not data—it’s trust. Trust is the new currency with which we’ll operate.”

FDA and USDA also remain committed to building a stronger relationship between the agencies, said Mindy Brashears, Ph.D., deputy undersecretary for food safety at USDA. “As science moves forward, we have to allow our policies to move forward to keep consumers safe,” she added.

The comments shared during yesterday’s meeting, along with written and electronic comments (with a deadline of November 20), will be considered as FDA puts together its blueprint document for a new era of smarter food safety. More information about providing comments can be found on the Federal Register page.

Megan Nichols
FST Soapbox

Tips to Train Employees and Maintain FSMA Compliance

By Megan Ray Nichols
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Megan Nichols

Eight years ago, the government passed FSMA. As a manufacturer, training new and existing employees to remain compliant with legislation is paramount. The goal isn’t to make life harder for business owners—it’s to protect American consumers from unsafe food handling and transportation practices.

The following are five tips to help warehouse managers train employees while maintaining FSMA compliance.

Understand FSMA Final Rules

It’s essential for everyone in the facility, from the CEO to the newest hire, to understand the FSMA rules. According to current Good Manufacturing Practices (cGMP), everyone who works in manufacturing, processing or packaging of food is required to train in food hygiene and safety. Managers can offer training in one of two ways—through on the job experience or via an FSMA-accredited classroom curriculum.

For individuals with specialized jobs, such as quality auditors or preventative controls qualified individuals (PCQI), the training option that allows compliance with FSMA rules is an accredited curriculum.

Utilize Warehouse Management Systems

FSMA gives the FDA authority to issue mandatory recalls for any food products if deemed necessary. To meet FSMA standards, record keeping and lot tracking is a necessity. If a product type is linked to a disease outbreak, the FDA wants to know where each product in that lot is within 24 hours. Having the ability to track and trace 100% of the products ensures that the company is FSMA compliant.

A warehouse management system (WMS) can track products, but only if you train employees in its use. While the average employee won’t be responsible for tracing a production lot in the event of a recall, each worker needs to know how to enter data into the system correctly, and how to retrieve the information if necessary. Include training in your WMS to ensure compliance.

Warehouse management systems, when paired with IoT sensors, can prevent recalls and ensure compliance by monitoring temperature fluctuations in climate-controlled areas. According to the Department of Agriculture, frozen food stored at temperatures at or below -0.4° F is always safe. A comprehensive WMS can monitor the temperature inside a facility’s freezers and alert workers or management if there are dramatic fluctuations that may result in a recall.

Seek Out Alliances

Warehouse managers are not alone when it comes to creating a compliant workplace. The FDA has established and funded three alliances—Produce Safety, Food Safety Preventative Controls, and Sprout Safety—each with their own standardized curriculum designed to help those who fall under FSMA rules.These alliances work for the majority of those in the food production industry, though they may not work for everyone.

Seek out the applicable food safety alliance and see if their training curriculums apply to your facility. Even if they don’t fit directly, these alliances can give managers an excellent place to start creating their training curriculum.

Create a Culture of Compliance

FSMA isn’t designed to make life harder for warehouse managers. Its goal is to keep people safe when buying their weekly groceries. Don’t just focus on training to meet FSMA standards. Instead, create a culture of compliance throughout the facility. Make FSMA everyone’s responsibility, and make it easier for employees to communicate with management if they notice a problem that normal channels don’t address.

As part of this culture of compliance, create incentives that reward employees for reporting problems, maintaining compliance levels and completing accredited training. Sometimes incentives can be the best way to motivate employees, whether you’re offering money, paid vacation or other benefits. Walk employees through the process of how to spot a problem and report it to management.

Continue Education Throughout Employment

FSMA compliance training isn’t something you should restrict to an employee’s onboarding. It’s something you should continue throughout their time at your facility. Make FSMA education a priority for every worker in your facility. While you want to start their training with onboarding, it shouldn’t stop there. Offer new training courses once a month or every three months—as often as you’d like without compromising productivity.

As the day-to-day grind continues, most workers forget about rules and regulations. Continuing education ensures FSMA compliance is at the forefront of everyone’s mind throughout their careers. Continuing your employee’s education is also shown to increase loyalty and reduce turnover, keeping things running smoothly and preventing warehouse managers from training new workers every quarter.

Looking Forward

The FDA oversees food safety and can issue a recall when a problem occurs. Yes, as a whole, it’s the responsibility of every single person working in the food production industry—from the highest-paid CEO to the newest employee on the production floor—to maintain compliance. It’s not enough to review guidelines with new employees during onboarding.

Training is essential to ensure everyone in a facility maintains the rules laid down by FSMA. Seek out assistance in the form of the FDA-funded alliances, continue employee education and make it a point to create a culture of compliance from the moment employees walk through the door. Offer continuous training opportunities and you’ll never have to worry about breaking FSMA rules.

Food Safety Consortium, Frank Yiannas, FDA

Industry in Midst of a Revolution, Tech Must Help Advance Food Safety, Says FDA

By Maria Fontanazza
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Food Safety Consortium, Frank Yiannas, FDA

The industry has evolved quite a bit since FSMA was passed eight years ago, and there’s been an overarching recognition that more modern methods to addressing food safety challenges—especially traceability—are essential. “The agency is at the threshold of a sea change in how we’re going to oversee food safety in the nation’s food supply,” said Frank Yiannas, deputy commissioner for food policy & response at FDA at the 2019 Food Safety Consortium. The first driver is the FDA’s new initiative announced earlier this year, coined the “New Era of Smarter Food Safety”. The agency will be looking at how new and emerging technologies can help advance food safety.

“I believe that we’re in the midst of a food revolution,” said Yiannas, pointing to the level of investment in food globally. “Products will be reformulated… new food sources and production approaches will be realized, and the food system will become increasingly digitized.” It will be the job of food safety professionals to adapt to this changing landscape and to ensure that innovation does in fact happen (and safely) in order to feed the growing population.

FDA is taking a new mindset that builds on the success of FSMA but also leverages a people-led, technology enabled method to get there. Just a few days ago the agency launched FDA-TRACK, a new food safety dashboard through which FDA intends to track and measure the performance of the seven FSMA rules—and these measurements will be publicized and available for all stakeholders. Initial available metrics will be tracking outcomes for the FSMA Preventive Controls and the Foreign Supplier Verification Program related to inspections and recalls.

The second driver of this sea change at the FDA involves a shift in its current approach to FSMA and the evolution of the regulation. While the agency continues to educate while it regulates, this past summer FDA took actions that are indicating a shift in its approach to FSMA compliance. On July 30, FDA issued its first warning letter using FSVP authorities to a tahini importer for lack of FSVP compliance. This was followed a month later by actions surrounding the most recent Salmonella outbreak linked to imported papaya. “If you pause and look back, there have been eight outbreaks in eight years,” said Yiannas. The outbreak involved 500 documented cases, 100 hospitalizations and two deaths. “I thought, enough is enough,” he added, and this prompted Acting FDA Commissioner Ned Sharpless, M.D. and Yiannas to issue a statement asking the papaya industry to do more—and urged them to work together to review their practices and make necessary changes to ensure that the papayas they’re offering to the public are safe. The FDA also issued a warning letter to the papaya importer, with the possibility of barring the company for the next five years. “When there’s a public health hazard, FDA will act decisively,” said Yiannas, stating that parity and oversight is important, and domestic and imported food must be safe. “We regulators, we’re going to strike the right balance, and are committed and as passionate as ever in trying to bend the foodborne illness curve.”

Yiannas added that over the next eight years, the trajectory of papaya-related illness will look very different from the last eight years, thanks to the adoption of better technologies—and that’s part of what the FDA’s New Era of Smarter Food Safety is about. “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency,” said Yiannas. There’s a lack of knowledge in where food comes from, where it’s produced, and the fact that many companies simply don’t know as much about their supply chains as they think. With FSMA, Congress anticipated the need to track and trace food, and now the agency is exploring how new technology can enhance tracking and tracing. With regards to tracking foodborne illnesses, the food industry has been in a race between detection and prevention. “We’re getting so good at finding the needle in the haystack, but we can’t find the haystack,” said Yiannas. “We have to provide the same level of investment for technologies for trace backs….we will do that together.”

Food Safety Consortium, Frank Yiannas, FDA
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium (Image Credit: amybcreative)

When looking at implementing smarter tools and approaches for prevention, the industry needs to work together at not just collecting the data but also converting this data into actionable information. Yiannas emphasized that the agency is not chasing the shiny object—new technology will not be a distraction; it will help solve industry problems and address the new issues that arise with the evolving food system (i.e., cell-cultured meat, plant-based meat, etc.). The agency is also holding a public meeting on October 21 to encourage discussion between the public and private sector, all surrounding this new initiative on smarter food safety.

“What’s become clear to me is [that] there’s so much we an do working together—the public and private sector… Think. Think about how you can do your work differently,” said Yiannas. “We’re all working for the same boss, the consumer. [We have the] same mission and they’re counting on us.”

FST Soapbox

A Digital Approach to Environmental Monitoring: Let’s Get Proactive!

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Technology and automation for safety and surveillance have already impacted nearly every industry in the world. For example, in the United States and many other developed regions, we have just lived through the transformation to electronic health records within the healthcare industry. Prior to that, we lived through the digital transformation of all of our banking information to an online banking platform—now the norm across the world.

However, the food and beverage industry is still learning how technology can improve their organizations. The food safety segment of this market is particularly in need of a digital transformation, as the risk associated with foodborne illness is potentially catastrophic to food companies, and moreso, to the end consumers who are impacted by preventable pathogenic outbreaks.

Along with regulation advancements, such as the timed roll-out of FSMA, the industry continues to work towards a more effective approach to food safety. But most regulations, and advancements in the industry are pointed toward a reactive stance to food safety issues, rather than a preventive stance. For example, although traceability is important in leading investigations to the source and taking remediation steps sooner, a more proactive approach to prevention should be considered when investing in food safety programs.

This is where the importance of an automated environmental monitoring program comes in. To be proactive requires a commitment to embracing data and digital technology. Knowing where to start to effectively pivot your digital approach can be a challenge.

Understanding the following thought process can help you to recognize areas of potential improvement and growth within your environmental monitoring program.

  • Define Your Business Objectives. Ask how profitability and production uptime is connected to food safety issues.
  • Verify Suppliers. Establish protocols for incoming product from external suppliers and validate their food safety performance and ability to maintain a clean facility.
  • Modernize Your Environmental Monitoring Program (EMP). Are you able to confirm that your EMP is being executed consistently? Across all facilities?
  • Understand Data Exhaust. See how your organization’s valuable data can be used to identify trends and accelerate root cause analysis that impact decision-making processes.

Define Your Business Objectives

Food companies large and small are being challenged to implement required processes and procedures to meet the demands of FSMA, and ultimately achieve a more proactive and preventative food safety stance. Transformation in this arena, led by government regulation, and enhanced by standards certification requirements, has highlighted the responsibility of suppliers and manufacturers to protect consumers.

Many organizations are not aware that a single failure in their food safety program could actually be the most devastating profitability risk that the organization faces today. When your organization is focused on production uptime and profitability, it can be easy to overlook the details involved in maintaining a strong food safety program. In reality, though, food safety and profitability are inextricably linked due to the risk of production interruptions that can be caused by safety issues.

Whenever a food recall occurs, it has the potential to start the dominoes falling, with major implications regarding costs, reputational damage, compliance penalties, supply chain interruption, and sales declines. Worse yet, these impacts can last for years after the actual event. By delaying both the importance of recognizing the seriousness of this risk as well as taking necessary steps to prevent it, your organization’s reputation could be on the line.

Unfortunately, planning is often sacrificed when managers fail to implement the proper technological solutions. Fulfilling fundamental documentation requirements involves a smart, automated approach. This is the best way to optimize recall prevention. By incorporating an automated EMP process, a supplier management system, and other FSMA Preventive Controls measures, suppliers ultimately improve the strength of the entire chain for their partners, consumers and themselves.

There are many other facets to food safety, but the EMP is where inspectors and auditors will look to see the indicators of contamination and the efficacy of your sanitation controls. Therefore, it is critical that your organization exhibit not only that you are on top of things and are following your EMP procedures consistently, but that you can analyze and pinpoint issues as they arise, and that you have a track record of corrective actions in response to those issues. This, in-turn, allows you to see where your business objectives are most at-risk.

Regardless of which specific food industry segment your company operates in, or which governing body it reports to, it’s essential to stay informed and compliant with changing regulations in order to reduce the risk of experiencing a recall. In a strategic operational role, intelligent environmental monitoring allows companies to not only proactively work to avoid public health issues, but is vital to retaining a consistent bottom line.

Verify Suppliers

Earlier this year, the FDA heralded what they call a “New Era of Smarter Food Safety”. As technology becomes increasingly accessible, more and more companies are investigating how technology can be used to harness and control the growing complexity of supply chain implications.

The challenge of making sure your organization is doing its due diligence to prevent recalls is further complicated when incorporating outside suppliers. For example, 15% of the United State’s overall food supply is imported from more than 200 other countries, according to the FDA. Making sure the product coming into a facility is also meeting your standards is vital to preventing pathogens from entering your supply chain either through containers, people, or the incoming product itself.

The complexity grows exponentially when we contemplate what this means for tracking food safety across a supply chain of this scope. Generally suppliers are asked to provide verification for the cleanliness of the product they are bringing into your facility. However, by going a step further and establishing test points for the product when it comes in, you will be better equipped to catch pathogens before they can enter into your own supply chain and potentially contaminate other products. While you may already have a good relationship with your suppliers, being able to independently verify the safety of their products and that their own processes are working, creates a mutually beneficial relationship.

Modernize Your Environmental Monitoring Program

Food experts at the World Health Organization headquarters in Geneva discussed the critical nature of ensuring food safety across geographic boundaries, as it is an issue that affects everyone. Incidents of pathogen outbreaks around the world have a direct impact on the health of global citizens, with one in 10 people falling ill due to food contamination.

A traditional EMP allows organizations to continuously verify that their sanitation programs are working by scheduling testing, monitoring results for any signs of pathogens, and maintaining compliance with regulatory bodies. Historically, this type of program is documented in spreadsheets and three-ring binders, but today the acceptance of new tools being offered by vendors and labs are expanding offerings to modernize the monitoring process.

Food safety professionals, many of whom are trained microbiologists, should have better tools at their disposal than spreadsheets that force them to manually sift through data. All regulatory bodies in the food industry have guidelines when it comes to where, what, and when you should be testing in your facilities. Ensuring that this is happening is a basic requirement for meeting regulatory mandates.

By choosing an automated EMP, FSQA teams are able to schedule testing plans including randomization and test point coverage rules, see what testing is being performed when, and obtain all testing data in one system for ease of access before or during an audit. This offers an “always-on” source of audit data and more importantly, trending and root-cause analysis capabilities to find and define actions to remediate recurring problems.

Further, an automated EMP that is integrated with your food safety plan allows you to set up workflows and automatically notify appropriate team members according to your organization’s policies. Each remediation step can be recorded and time stamped as the corrective action moves towards completion.

Understand Data Exhaust

A dominant theme pushed forward by FSMA is the need to document all aspects of your food safety plan, from the written outline to the records indicating proper implementation. Today’s manufacturers face a time of heightened regulation, and with stricter enforcement comes greater requirements for documentation. Automated EMPs not only provide your organization insight into what is happening within your facilities for documentation, it also gives time back to your FSQA team who, instead of spending their days with three ring binders, can analyze and investigate recurring issues in your facility to look for new, innovative ways for the organization to maintain a high standard of quality.

However, effective testing also means reading, understanding and responding to results. It is not enough to simply meet the required volume and frequency of environmental testing metrics. You need to use the resulting information to effect change and improvements by lowering the likeliness of pathogens, allergens and contaminants from entering the food supply chain. The more data collected, the more it leads to true understandings. What testing might show is just the symptoms of the problem—not the root cause of a far bigger problem. As more data is available, it becomes more valuable through the insights that can be gained through trend analysis. This, in turn, moves the conversation to higher levels within the organization who care about ensuring productivity and reducing avoidable risk.

Incorporating your lab into the equation is essential. Find a lab partner that offers an automated testing program that is integrated with their LIMS. Your organization will then be in a better position to ensure results are being responded to in an appropriate time frame.

There are many diagnostic tools in use today, both in-plant and at the lab. Each of these tools generates “data exhaust” in the form of a diagnostic result. But are your data streams being integrated and analyzed to find correlations and potential cause/effect relationships? Or does your ATP device simply record its data to a dedicated laptop or spreadsheet?

Testing, combined with an automated EMP, can allow you to combine data from various diagnostic systems (on-premise or from your lab partner) to identify trends and therefore a more holistic path to remediation. For this to occur, data must be accessible, aggregated and actionable, which an automated EMP achieves.

Forward-thinking companies and facility managers are leveraging valuable software solutions to improve processes, protect reputations, minimize inefficiencies, and simplify multifaceted compliance and audit tasks. Over the next three to five years, numerous organizations will reduce their risk of food recalls by combining their EMPs with analytics capabilities to reduce food risk and improve quality using diagnostic solutions and data assets. This change will be arduous, as all digital transformations in other industries have shown. But, in the end, they have shown the value and long-term success that the food industry now needs to experience.