Who would have even thought to put the topic of a pandemic in your business continuity plan? I know, I sure never thought of it, even as a senior auditor. I think that most of us are familiar with the typical subjects of tornados, floods, power outages and disgruntled employees, to name a few. We now need to focus on adding a pandemic to the to-do list of your plan, as this global issue has become a reality since early 2020.
It is quite likely that your plant has been affected by COVID-19 in some way, therefore your site has put into place actions to mitigate the risks posed by the pandemic. What may not be likely, is that any of these actions have been documented. I have currently seen plants evolve actions based on the severity of the pandemic in their locations. Travel restrictions, reduced work force, changing employee personal protective equipment, additional employee monitoring, and remote work environments are some of the examples directly affecting sites that I have witnessed during the first half of this year. As plants learn and experience more issues, they tend to adapt to how they are mitigating the risks in their facilities.
Capturing what actions went smoothly and what has gone astray will aid in strengthening your business continuity plan. Pandemics as well as other extraordinary events are handled by a multi-step approach that needs organization and good communication. That is why it is imperative to build and document actions, then verify how those steps are to be used. Involving key personnel–not just the quality manager–at the site is a best practice in getting a full grasp on what needs to happen during an emergency. In several instances, I have witnessed that key personnel are not informed about where a site’s business continuity plan is located; or the plan was updated right before an audit and after goes back on the shelf for the next 12 months, collecting dust. Employees should be trained on the contents of the plan, their responsibilities (if they are part of the business continuity team), current contacts, updates, and ways to initiate proper channels, if or when a time comes to do so. Hopefully, it never does, but it sure does not hurt to be prepared.
The business continuity plan is not a “one-size-fits-all” approach for plants. An important consideration, when defining what actions to take, if your area has been plagued by a pandemic includes determining what risks are brought by employees, visitors (i.e., contractors), location, and type of product being produced. Plant A making a high-risk open product may implement additional hand washing and sanitation, whereas Plant B making a low-risk closed product may implement additional health screening (i.e., temperature checks) for employees. You should ensure that it makes sense, and it is beneficial for your site and your interested parties, such as customers, consumers and stakeholders.
Your business continuity plan should be built to be a great resource to you in the time of need. And in return, you will have to put some elbow grease into shaping the document in a way that fits the ever-changing food environment. Keeping your plant current will assist your business to quickly respond to a negative event. In consequence, not having a plan that works for your site, or any at all, could lead to closed doors.
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne
Counterfeit alcoholic beverages keep claiming lives, like in this latest case in the state of Punjab in India. To curb the consumption of alcohol, the Indian government has imposed high taxes on alcoholic beverages, with the effect of increased illegal alcohol production. Often, the alcohol is from a variety of sources like nuts and sugar cane and of poor quality, posing a health hazard. Officials raided numerous operations and arrested multiple suspects, including police officers and customs officials.
To say that COVID-19 has been disruptive would be putting it mildly. The pandemic’s sudden and seismic impact has brought major upheaval across industries—the food industry and its supply chain included.
There was the initial panic buying that drove upticks in consumer demand for which few manufacturers and grocers were prepared, resulting in widespread product shortages. With restaurants closed, distributors and suppliers were left with considerable excess inventory—most of which ended up as waste and losses. Inside production sites and plants, many had to try and maintain their output with a reduced workforce, even as demand continued to climb. Meanwhile, some plants unfortunately have had to shut down operations on account of employees testing positive for COVID-19.
In the time since the outbreak, the food supply chain has stabilized to an extent. Store shelves are continuously being replenished with products. Restaurants have started reopening with new health and safety measures. Yet even as the industry takes gradual steps toward recovery, the underlying problem that led to the magnitude of COVID-19’s impact persists: Lack of visibility. There was lack of visibility into supply and demand and what was happening upstream and downstream across the supply chain, which prevented timely, proactive action to optimize operations in face of disruption.
Looking ahead, participants across the food supply chain will need enhanced end-to-end visibility so that they can work together to get ahead of the curve. As part of gaining this visibility, they will need the transparent exchange of information and cohesive collaboration to adapt especially as the food industry continues to see shifts in consumer behavior and the marketplace in the wake of COVID-19—particularly in the following three key areas.
Food Distribution
While food producers have been working tirelessly to keep grocery store shelves and restaurant kitchens well stocked, there continues to be fluctuating availability on certain products, such as eggs, dairy, poultry and meat. This has led distributors and suppliers to increase their prices when selling these goods to stores and restaurants, who have had to then pass the additional costs on to consumers through their own price increases and surcharges, respectively. One report from CoBank, a cooperative bank part of the Farm Credit System, notes there could be as much as a 20% increase in the price of pork and beef this year due to supply issues.1 Many grocers have also implemented purchase limitations on consumers to combat shortages.
These downstream implications stem largely to uncertainty in the supply chain, with stores and restaurants unsure about available supply upstream and when they can expect to receive shipments. But if there was clearer visibility and transparency between production, distribution, transportation, food service and retail, then all parties could better anticipate and plan for supply shortages or delays. For instance, if a meat processing plant has to temporarily close due to cases of COVID-19, they can immediately communicate to the rest of the supply chain so that parties downstream can readily find alternative sources and minimize any necessary price inflations or other implications to consumers.
Consumer Demand
Even with the reopening of restaurants, people will likely choose to cook more of their meals at home. It was a trend that began with restaurant closures and will continue for the foreseeable future as consumers remain cautious of dining out. While this may bring tough times ahead for the food service industry, the grocery sector is seeing a huge lift in business. Research from restaurant management platform Crunchtime shows that, towards the end of June, restaurants were only seeing 64.5% of their pre-COVID-19 sales levels.2 At the same time, a study by Brick Meets Click and Mercatus reveals U.S. online grocery sales reached a record $7.2 billion in June, up nearly 10% over May.3
For food companies and brands, growth in the grocery sector has presented a challenge in the way of demand planning and forecasting. I’ve personally spoken with several company executives who have seen significant upticks in orders from their grocery channel partners—an increase for which they didn’t forecast—and are now struggling to adjust production levels accordingly to avoid the risk of excess production that would lead to unnecessary costs, wastes and losses. In such instances, real-time visibility into transactional activity and stock levels at the retail level would help production planners improve the accuracy of their forecasts and enable them to think steps ahead before orders come in and thereby optimally balance supply with demand. Stores would remain well stocked and the supply chain could flow in a more efficient and profitable way for all participants.
Food Handling
Without question, public health is the number one priority right now. Participants at each point in the food supply chain today need to communicate with each other, as well as to consumers, that they’re following best practices for social distancing, disinfecting and other precautions. It’s not to prevent the possible transfer of the virus via actual products, as the FDA notes there is currently no evidence of transmission through food or packaging. But rather, it’s to build greater confidence in the food supply chain—that everyone is doing their part to support individual and collective health and safety, which in turn prevents possible facility closures or other case-related bottlenecks that would inhibit consistent supply to the market.
There also has to be confidence that, amid these countermeasures for COVID-19, companies are still upholding their commitments to food safety, integrity and proper handling. What can support that confidence is data—shared data from every point in a product’s journey from source to shelf. The data should be transparent and available to all supply chain participants as well as immutable so that it is tamperproof and fully traceable should there be any problem, such as mislabeling or a foodborne illness. The data ultimately holds everyone accountable for their role in ensuring a safe food supply chain.
To achieve the level of visibility outlined above, the food industry will have to break away from legacy processes involving the siloed management of operational systems and databases. Instead, the disruption seen during COVID-19 and ongoing shifts in the marketplace should encourage companies to consider digital transformation and technologies that can enable a more cohesive and nimble food supply chain. These are technologies like blockchain, which provides a decentralized, distributed ledger to publish and share data in real time. Moreover, artificial intelligence that can leverage incoming real-time data to guide next-best actions, even when the unexpected occurs. Personally, I always return to the notion that the supply chain is a team sport. You need visibility to know what each team member is doing on the field and how to align everyone on a gameplay. The digital solutions available today offer that visibility and insight, as well as the agility to pivot as needed to obstacles along the journey from source to shelf.
Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.
Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.
Safeguarding Food Quality to Meet Industry Standards
Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.
Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.
In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.
The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.
To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.
From Hazard Analysis to Record-Keeping: A Data-Led Approach
Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.
The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.
LIMS can be used to visualize control points for HACCP analysis according to set limits. Graphic courtesy of Thermo Fisher Scientific.
The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:
Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.
As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.
How LIMS Enable Clear Compliance and Optimal Control
Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.
The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.
Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.
Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.
Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.
Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.
LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.
With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.
Conclusion
To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.
With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne
Sulfites and sulfur dioxide can make meats look fresher than they truly are, and therefore are banned by the FDA The Australia New Zealand Food Standards Code also prohibits the addition of sulfites to raw meat. Not only is there a risk of meat past its prime getting into the food supply, sulfites may also pose a danger to allergy and asthma sufferers. More than 23 tons of ground beef were freshened up illegally with sulfites and sold in New Zealand to consumers. The manufacturer was recently sentenced to a fine in this two-year old case.
The 2020 Food Safety Consortium Virtual Series features an episode on Food Integrity & Food Fraud. The episode takes place on Thursday, October 22. Learn more about 2020 FSC now!
Consumer safety is of paramount importance and product recalls are a necessary means to this end. Product recalls are a serious, complex, and costly issue affecting the food and beverage industry in the United States. The FDA estimates that there are around 48 million cases of foodborne illness each year—causing one in six Americans to get sick from contaminated food. In addition to affecting public health, recalls have a dramatic effect on manufacturers by creating economic problems, damaging a company’s reputation, and imposing potential legal penalties and liabilities. In the search for a business management solution to better prepare themselves for and reduce the risk of recalls in their operations, many food manufacturers have discovered that technology, specifically ERP software, is key to lowering the risk of food and beverage product recalls.
An industry-specific ERP solution is a centralized business system with key industry features providing a system of record-keeping, with the tools to support the preparation and reduction of recall risks. While a manufacturer is ultimately responsible for a product recall, an ERP solution is essential in supporting and championing overall recall readiness and reduction. With the streamlined and automated inventory, manufacturing, and quality control processes managed within the software, critical steps and data that assist in recall mitigation are documented—including supplier verification records, audit logs, receipt records, quality testing, lot tracking, and shipment logs. The key to prevention of a product recall is preparation, which can be handled efficiently through an ERP’s functionality specifically in the following areas.
Supplier Management
An ERP facilitates best practices for supplier management and risk assessment within the solution to assure the acquisition of quality raw materials from trusted vendors. Its role is to maintain an approved supplier list for each product ingredient, documenting detailed supplier information, quality control test results, and risk level to ensure in-house and customer-specific standards are met. For approved or activated suppliers, information regarding materials that can be purchased through the vendor, applicable certifications, quality control results, and other pertinent supplier information is stored within the centralized data system of the ERP. A risk assessment for each vendor is also documented to ensure that any potential inherent risk(s) from vendor-issued recalls and to finished goods are limited.
In addition to activated suppliers, an ERP solution also assigns and manages qualified alternates to provide vetted selections should a primary supplier’s materials become unavailable. This positions a company well in the supply chain, as the investigative work has already been conducted on other suppliers, limiting the need and risk associated with onboarding an unknown supplier in a moment of crisis. Vendors are recorded within the system and ranked in order of preference and/or risk level so that they can be identified and put into use quickly if a supplier becomes unavailable—providing the preparation and leverage that companies need to mitigate the risk to safety in the supply chain. In a product recall situation, when a supplier notifies a customer of a contaminated ingredient, the supplier management feature within the ERP solution provides for a qualified replacement vendor that can fulfill the needed raw material quickly and efficiently.
Inventory Control
An ERP system offers end-to-end traceability, maintaining a comprehensive record that tracks raw ingredients, work-in-progress, and final products throughout the supply chain using barcode scanning to link product and lot information to batch tickets, QC testing results, shipping documents, and labels. This full forward and backward lot traceability is necessary to provide a documented audit trail imperative to locating raw materials or finished goods quickly within the initial 24-hour time period of a product recall. With full manufacturing, inventory, and reporting integrations, the ERP supports sound manufacturing practices that assist with recall preparedness – maintaining current Good Manufacturing Practices (cGMP), FDA reporting, GFSI compliance, and other industry-specific regulations to provide a documented audit trail with the ability to adapt as compliance requirements change.
Managing protocols to ensure the quality of inbound and outbound materials is essential in minimizing recall risk across the entire supply chain—from raw materials to the delivered final product. With an industry-specific ERP solution, formulas, recipes and instructions are maintained, scaled and verified to ensure consistency of products within the manufacturing process. This instills preventative measures throughout the production cycle in the form of process steps and quality control test specifications to bolster safety and quality. Quality features such as quarantine status and other status capabilities permit the isolating, removing and disposing of raw ingredients and finished goods that fail to meet quality control standards—triggering an alert to notify the purchasing department to investigate the issue. Having the ability to remove ingredients and finished goods from inventory or production prevents contaminated items from reaching store shelves and consumers, which reduces overall recall risk.
Inventory control practices are an important part of the functionality within an ERP solution that help to reduce overall recall risk. This includes managing and reporting of shelf life and expiration dates to maintain precise and lean control of inventory and reduce variances. Automated inventory transactions with the use of an ERP’s warehouse management solution (WMS) follow industry best practices and improve efficiency to ensure the accuracy of shipments, transfers, and material returns. This real-time visibility allows for the maintenance of FIFO inventory practices necessary to reduce the risk of spoilage.
One of the leading causes of contamination for food and beverage manufacturers that results in a recall event is a lack of allergen control throughout the supply chain and production process. An ERP system helps to track, manage and record the handling, storage and batch steps of raw materials from farm-to-fork. This includes stringent sanitary practices, lot tracking, raw material segregation and process controls to avoid allergen contamination or cross-contamination. Accurate product labeling is also a significant factor in reducing risk and an automated system that generates nutritional and product package labels plays a key role in a company’s recall prevention. To meet the needs of consumers and regulators, an ERP solution automates label creation to include accurate ingredient and allergen statements, nutrient analysis, expiration dates, lot and batch numbers, and regulatory specifications. The labeling history documented in the software allows products to be identified and located quickly in the event of a recall.
Reporting
Utilizing the recall functionality in the ERP solution allows companies to plan and test their recall process in advance. Performing mock recalls permits regular measurement and improvement of procedures to ensure rapid, accurate, and thorough responses by all company stakeholders in the event of a recall. A successful simulated exercise identifies 100% of recalled ingredients/products and notifies appropriate entities in a timely manner. Evaluation and documentation of mock recall exercises help expose inefficiencies, process gaps and procedural adjustments, which are designed to improve recall readiness and minimize consumer exposure to potentially dangerous contaminants.
As proof or documentation of adherence to specific processes, reporting is essential to demonstrate that these processes have been completed—without it, an integral component is missing. Across the supply chain and throughout the manufacturing process, documentation and reporting accentuate steps that have been taken to prepare and reduce recall risk. Risk-based assessments in supplier management, lot traceability reports, and mock recall reporting all provide a starting point of analysis to allow for adjustments to be made across the business. In a recall situation, the system is able to create lot tracking reports that encompass raw ingredients through shipped finished goods. These reports can be produced in minutes, rather than the hours it takes if data is stored within separate software programs.
Due to the amount of time and money that food and beverage companies invest in getting their products to market, it is imperative that preventative measures are taken in order to avoid a product recall. Forward-thinking manufacturers can help prepare for and reduce recall risks by utilizing several important features in ERP software—including supplier management, inventory control, and reporting. Using the tools at their disposal, a company can mitigate liabilities and protect their brand to turn a potential crisis into a future filled with opportunities.
FDA Commissioner Stephen Hahn, M.D. recently announced that food safety inspections will resume in July, but inspectors will be given leeway to accommodate the coronavirus pandemic. Inspections will be prearranged by appointments. The agency suspended routine inspections in late March as a result of the pandemic response, which closed down much of the country.
The “White House Guidelines for Opening Up America Again” calls for the FDA to send out investigators for on-site inspections by the week of July 20, using the COVID-19 Advisory Rating system, which utilizes state and national data about infection rates to determine the regions where enforcement can resume.
In a July 10 FDA statement Hahn noted, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.”
One of the most significant modifications for domestic inspections in the announcement is that they will be pre-announced to FDA-regulated businesses. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said. Previously, most inspections were unannounced.
It’s not entirely clear how FDA will use the White House guidelines to determine where they can schedule inspections. There is mention of a prioritization mechanism that will identify high-risk operations, but that has traditionally been part of FDA’s approach to inspections.
The CDC published phased guidelines for states to follow in reopening, which are referred to in the announcement. The guidelines document outlines the gating criteria for states, but published versions do not mention inspection requirements. Many states began reopening without meeting all of the gateway criteria for Phase 1, and continued to accelerate reopening activities in a way that makes it unclear which phase criteria they may have actually met when compared to the phase under which they claim to be operating.
Further complicating the safety issue is the recent rising number of COVID-19 cases that is causing some states to pause or rollback reopening activities. Since publishing the announcement, several states have emerged as new COVID-19 hot spots, including Texas, Arizona and Florida; In addition, Florida has surpassed New York in total cases. California, another food producing state heavily affected by the pandemic, is seeing a significant increase in cases and is considering issuing new shelter-in-place orders. It was recently reported that CDC has identified 21 states as “Red Zones”, with at least 11 states on the verge of surging cases.
In other words, with the virus on the rise, there may not be a significant number of inspections actually performed, regardless of whether or not inspections have technically resumed, simply because there just isn’t a safe way to send inspectors out.
The FDA has also published the “New Era of Smarter Food Safety Blueprint”, which includes ways the agency could use technology to support compliance activities. There may be an opportunity for the FDA to implement new tools such as remote verification in lieu of onsite inspections, but that remains to be seen. Among such tools, remote audit pilots were recently completed and those results will be available for public presentation at the end of August.
In the short term, should FDA determine you are an inspection candidate, you will contacted in advance to schedule a day and time.
With significant clusters of COVID-19 infection among employees—16,000 cases and 86 deaths documented by the CDC through May 2020 — the food processing and distribution industry faces significant challenges in reopening their facilities and ramping up to full capacity. Technology for health and safety access governance and intelligence, along with guidelines from the CDC and OSHA, can help support food companies in the automation of certain compliance activities and a safe return-to-work strategy.
Designated part of the essential critical infrastructure by the federal government at the onset of the pandemic in the spring of 2020, the food supply chain needs active solutions to protect its workforce. But there’s more to this back-to-work transition. Workers need to feel safe and trust that new security, safety and compliance processes have their best interests in mind—transferring to an overall positive experience with their employer.
In the age of contagion, the food industry requires ways to communicate better with the workforce, identify and isolate areas of contagion and also deal with the lingering presence of potential bioterrorism, insider threat and cyber-attack. It’s a multi-faceted and complex workspace we’re reentering, one that takes coordination of technology, people and processes. Without it, food suppliers risk plant shutdowns and loss of business continuity.
Bioterrorism and insider threat remain an active part of the supply chain landscape. In fact, according to a June 2020 Wall Street Journal Pro Research Survey of cybersecurity executives at nearly 400 companies, 67% were concerned about malicious insiders. Remote workers and lax controls have exacerbated the situation and rising threats include malicious employees, accidental negligence, contractor or vendor misuse and account compromise.
The Landscape of Collaboration
The ongoing coordination between human resources (HR) and security is a collaborative effort that bolsters food defense in a COVID-19 world. Fueled by digital transformation, converged physical security and HR management solutions are wound together tightly in a coordinated and analytical approach to keep food industry employees safe and operations running smoothly.
These departments, once siloed and co-existing without direct interaction, are benefiting from software’s move to the cloud and open operating platforms, which provides increased opportunity for real-time integration of HR, security and facilities technologies. Moving to a converged approach across all departments, including HR, IT/cyber and operational technology (OT)/SCADA—can effectively secure our most critical food production and distribution resources while actively enforcing compliance and company policies, including COVID-19 mandates. In addition, physical security access governance, in a holistic manner, protects food industry workers and processes from compromised identities, systems and insider threats.
HR and physical security now have the ability to share data-insights to prevent, detect and mitigate the spread of contagions. With this convergence, organizations have the information they need to actively defend and protect the workforce, focusing on the human side of security to yield a positive experience.
The ongoing coordination between human resources and security is a collaborative effort that bolsters food defense in a COVID-19 world. Shutterstock image courtesy of AlertEnterprise.
Enabling a Safe and Healthy Return to Work
This time of unprecedented change has triggered a tectonic shift in the way organizations have been dealing with the health, security and safety of their workforce. Sensing a coming tsunami, HR, corporate real estate and physical security leaders are realizing that they must stop operating in silos and embrace a holistic approach. Enterprise response and recovery plans have become a major catalyst for converged security, as it has proven to be the most effective way to manage workspace access, enforce workforce security, safety and privacy.
Reopening with Technology at Your Back
Physical identity access management (PIAM) software, including visitor identity management (VIM) are convergence platforms that deliver identity and access governance, health and safety intelligence and compliance validation across the enterprise. PIAM provides a safer work environment by managing physical, logical and operational technology access for employees and visitors, actively enforcing company policies, compliance and industry regulations with built-in best practices and regulatory controls. Automated policy-driven background checks yield real-time vetting of visitors, contractors and employees while validating and identifying any policy violations. PIAM and VIM keeps facilities and workers safe, making sure the employees and visitors only have access to the areas, data and assets they need, including vital food processing areas where deliberate sabotage needs to be kept at bay.
While prevention of bioterrorism and insider threat is ongoing at food distribution, production and processing facilities there’s been a notable shift during the pandemic that focuses on the health and safety of workers. Security is no longer simply about keeping the bad guys out; it’s about safety and protecting workers from unsafe behavior.
Workforce health and safety access governance software solutions help organizations open safely in a frictionless, controlled and secure way by automating and enforcing COVID-19 related policies and procedures. Automated batch email/text notifications with self-service links send requests to the remote workforce for self-attestation and self-reporting offsite and enable access by the worker to the facility based on health, travel and other company policies.
Here’s how it works: An employee completes the self-reporting health and travel questionnaire through a mobile app, which triggers automated workflows based on those answers. These health questionnaires collect data and document employee activity during lockdown, including infection, symptoms or exposure. The employee’s self-attestation request comes to the manager for action, and based on answers the worker is considered high risk and per policy their access to the facility is revoked for 14 days while they are in quarantine. A similar self-attestation and workflow then applies to reinstatement for the employee. This reporting and workflow can be configured specifically to the facility. Enterprises can further customize their visitor identity management to provide clear communication of current policies during the outbreak, reinforcing WHO best practices.
Focus on Health and Safety
Health and safety access governance and intelligence provides prescreening support of workforce site entry with automated policy enforcements. Pre-registered and onsite visitors/contractors check-in/check-out with prescreening, watch list and other checks prior to access. In the production or distribution facility, health and safety analytics track confirmed or potentially exposed COVID-19 workers, identify exposed areas for lockdown and/or sanitization, social distancing violation, location heat map and other actionable health & safety analytics.
PIAM also allows you to automate your communications and deliver clear expectations and procedures to your workforce, visitors and contractors pre-visit and onsite—adding to a seamless experience.
Security convergence delivers a comprehensive, holistic solution across the entire food value chain, from sourcing to production to retail distribution. Human resources and physical security have teamed up—yielding real-time data that can prevent, detect and mitigate the spread of contagions. With this convergence comes greater situational awareness that defends and protects the workforce, with a strong focus on safety and building trust between worker and employer.
Issues with the health of frontline workers, supply chain disruptions, and changes in consumer behavior are just a few vulnerabilities that the food industry is experiencing as a result of COVID-19. Food Safety Tech recently had a conversation with Jennifer van de Ligt, Ph.D., director of the University of Minnesota Integrated Food Systems Leadership Program and Food Protection and Defense Institute about the hurdles that the industry is experiencing and where we go from here.
Food Safety Tech: What challenges is the food system facing in light of the COVID-19 pandemic? Where are the vulnerabilities?
Jennifer van de Ligt, Ph.D.: The food system is facing primary, secondary and tertiary challenges right now. I see two main drivers as disruptors as a result of COVID-19. The health and safety of employees is the first primary driver. As COVID-19 has more broadly spread through the U.S., ensuring the health and safety of employees in the food system has become essential; however, the pandemic has shown us the food system has struggled with that.
The other big primary challenge facing the food system has been the swift change in consumer behavior. Pre-COVID-19, nearly half of food was consumed away from home. When restaurants closed, and stay-at-home orders were in place, it put extreme amounts of pressure on our food retail segment, causing supply and demand issues.
Regarding the health and safety of employees: We’ve seen meat processing struggle with production demands because the health of their employees has been impacted by the virus. In mid-April, the beef and pork capacity in this country went down by over 40%. They are making great improvements and are approaching normal harvest capacity range for both [beef and pork production]. Meat cuts being produced are slightly different than normal, as this part of the meat plants are very labor intensive. This has really highlighted the need to make sure that we keep the health and safety of our food system employees front and center.
During the 2020 Food Safety Consortium Virtual Conference Series, Jennifer Van de Ligt will participate in a panel discussion on November 5 about Professional Development and Women in Food Safety | Register NowNow that the meat supply chain is beginning to recover, we’re also beginning to see increasing effects on non-meat supply manufacturing. This isn’t isolated to food manufacturing; as we experience broader community spread, COVID-19 will impact all aspects of our food system.
On consumer behavior: As consumers shifted to food retail, immense pressure was quickly put on our food supply chain logistics, manufacturing timing and processes, the speed to warehouses and delivery, etc.
One example that demonstrates a challenge in manufacturing and consumer demand is the difference in volumes for food services versus retail. I like to use the example of shredded cheese. At a grocery store, you’ll find a one-pound pack, but shredded cheese in food service might be in a 10-pound bag. There are not a lot of consumers who want to buy a 10-pound bag of shredded cheese. Well, why can’t cheese manufacturers just package bulk product into one-pound packs? There are several reasons that don’t allow producers to pivot quickly: They may not have the machinery or packaging to do that. Also, changing packaging from food service to retail requires different labels and regulatory approvals. Examples like this led to many of the spot outages consumers found in grocery stores. In the produce sector, it led to produce being plowed under in fields because they didn’t have the distribution channels to go into retail instead of into food service.
In the Integrated Food System Leadership (IFSL) program, we’ve recently discussed food equity and food injustice as a result of COVID-19. As food retail became stressed and unemployment increased, we saw a huge demand for our food assistance networks. Because food retail is one of the primary contributors to the food assistance networks, there wasn’t enough volume being donated. In addition, food service foods are not appropriately packaged to go into the food assistance networks and food banks, similar to the issue in moving to food retail. This led to tremendous pressure and innovative solutions to source and distribute food to a newly vulnerable population.
As we look ahead into the coming months, many of the vulnerabilities in the food system will be the same. We have to continuously monitor the health and safety of our employees to keep our food system as a whole functional. There’s a growing recognition that our primary agriculture workers are also at risk—the people in fields harvesting and planting. There are many groups providing recommendations on how to protect agriculture employees and communities where they work and reside.
We’ll see continued adaptation in the food system to the new reality of how restaurants and food service engage with their consumers with the shift in behavior to limited restaurant dining and increases in online ordering.
FST: In what areas do food manufacturers, processors or growers need to adapt moving forward in order to thrive?
Van de Ligt: There are several. First, I think this crisis has really brought worker health and welfare to the forefront, and there will be more emphasis on the essentiality of food system workers. They were previously a behind-the-scenes workforce. The issue of worker health and welfare is going to accelerate in many industries, but I also see a push to more automation. The human workforce is necessary, and people do a really wonderful job, but are there areas that might benefit from automation? I think those go hand in hand.
I also think the global food system needs to rethink how it remains resilient. In the past, there’s been a focus on resilience and efficiency through economy of scale. That still exists and may look different moving forward. Using the meat industry as an example, that economy of scale was also its biggest weakness that had gone unrecognized. Going forward, I think there are many companies that are going to consider alternative supply chains. Should multiple, smaller plants be utilized instead of one large plant to provide a more resilient framework for production? Other companies are going to think about installing equipment or processing lines that could more quickly pivot between food service and food retail. There’s also a huge opportunity now for local and smaller markets to really make an impact as people look for alternative supply chains and sources. We found that many of the local food markets and co-ops, especially those that provided into food service, pivoted pretty quickly to pop-up online marketplaces to provide food direct to consumer. I think we’ll see that trend increase as well.
In order to feed billions of people worldwide, it’s essential that the food industry take a broader systems approach versus the siloed approach path we’ve been using. The pandemic has highlighted how the food system is an intricately functioning balance and requires collaboration. Our food system will only be able to move forward faster with less disruption when we have food system leaders who understand the intricacies and the ripple effects of the challenges we face. Leaders who understand the impacts of decisions outside of their sphere will be essential to plan for impacts from natural disasters, another pandemic, etc.—and to create a more responsive and resilient food system in the future.
FST: Where does this leave folks who are either beginning or rising in their careers in food safety? Do you think the pandemic has changed food safety careers as they’ve historically functioned?
Van de Ligt: I like to say that ‘what got us here is not going to get us there.’ In general, if you think about where food safety careers have been in the past, the roles have been all about consistency, understanding regulations, making sure we do everything precisely right all of the time so we don’t have a food safety outbreak.
The focus on doing things precisely right all of the time will absolutely continue. What I think will shift is the need for food safety professionals to think more broadly than just the regulations that are required for compliance. Food safety professionals need to understand more about the system that is happening outside their facility; the impact of their work going backwards and forwards in the supply chain.
How things have worked historically in a food safety role has been having a consistent supplier network that provides the same type of product every time; you know what to expect, how to produce and distribute safe food for the customers you serve. In a situation like COVID-19, because of the disruptions from farm to fork, the suppliers you need to work with may be different and you need to quickly make decisions spontaneously as supply shifts. Having the knowledge and skills to navigate changes is essential to ensure the quality and safety of your product.
A highly technical focus that many professionals have when they start their career is often too narrow and won’t be enough for emerging food system leaders. Leadership skills are vital as well. In the IFSL program we teach food system professionals how to explore proactive viewpoints, not just managing people or responsibilities. Managers make sure things are done things correctly; leaders make sure we do the right thing. In order to learn how to do the right thing, we teach skills and tools on how to navigate uncertainty; practicing active listening, constructive feedback; and understanding the concerns of a supplier or customer are examples.
We emphasize and teach in the IFSL program that food system professionals and leaders need to be much more proactive. This means equipping them with the food system knowledge and leadership skills so they can predict and prepare for how decisions affect upstream and downstream. Having a broader viewpoint is critical to adaptivity, which will build resilience and help limit disruption.
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.
The ninth OPSON operation, a cooperation between Europol and Interpol, included 83 countries around the world. OPSON IX targeted organized crime groups involved in food and beverage fraud. The substandard and fraudulent products potentially pose significant risk for consumers. Animal feed and alcoholic beverages made the top of the list of seized products, followed by grains, coffee and tea, and condiments. The officials also ran special campaigns to uncover fraudulent dairy products, olive oil and horsemeat.
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