Data breaches, ransomware attacks and now, operational shutdowns. Recent events bear out that cyber strikes are not reserved solely to data breaches and IT systems but now include Operational Technology (OT) and industrial controls to disrupt operations, distribution and the entire food supply chain.
JBS Foods, the one of the world’s largest meat producers, was leveled by a cyberattack in early June, affecting U.S. and Australia operations. In a public statement, the organization revealed that it paid the equivalent of $11 million in ransom in response to the criminal hack against its operations. “At the time of payment, the vast majority of the company’s facilities were operational. In consultation with internal IT professionals and third-party cybersecurity experts, the company made the decision to mitigate any unforeseen issues related to the attack and ensure no data was exfiltrated,” according to company documents.
There’s a security divide that shouldn’t be there—distinct lines between Cyber, OT and physical security teams that has resulted in disjointed and ineffective detection, mitigation and response to risk—forged by years of siloed departments.
It’s not a new problem—in fact the vulnerability of the critical infrastructure has been a discussion for decades. Moving to a converged approach across all departments, including HR, IT/cyber and OT/SCADA can effectively secure our most critical food production and distribution resources while actively enforcing compliance and company policies. Identity and Access is at the center of it all and the best way to holistically protect the enterprise.
In the example of high-profile enterprise Molson-Coors, a cyberattack in March centered on ransomware. In its SEC filing after the event, the beverage giant stated that the attack “has caused and may continue to cause a delay or disruption to parts of the company’s business,” which includes brewery operations, production and shipping.
The February attack on a Florida Water Treatment plant, hacked by compromise to a remote access software program on a facility computer, is still another stark reminder of the growing dangers of cyber-physical threats and that even employees can be part of the problem.
You can see just how fragile and vulnerable our supply chains and critical business processes have become. Cybercriminals now realize how disruptive and lucrative attacks targeting these systems can be so they will continue unabated without immediate stop-gaps.
Because these attacks have become blended and omni-present on every part of the critical infrastructure, executives need to move beyond IT-centric cybersecurity to minimize supply threats. This emergence of new attack vectors has other implications. It highlights the dire need to transition from siloed IT, OT, HR and physical security to a converged approach, yet executives remain at odds with how to execute this while working in their own bubbles.
The threat has become even greater than the organization itself. According to predictions by Gartner liability for cyber-physical security incidents will “pierce the corporate veil to personal liability,” for 75% of CEOs by 2024.
Security Convergence Key Ingredient to Digital Transformation
As the food industry continues to digitally transform, systems and processes move to rapidly connect. Security convergence, centered around identity and access governance, links all these separate departments and operations, so communications and processes actively and collectively address and shore up risk preemptively. Events, exceptions, alerts, alarms and targeted attacks on all points, including the network, control systems and physical security can be integrated for a coordinated and cohesive response.
Securing our most important critical resource—the food supply chain—means correlating threats across underlying HR, IT, physical security and OT used in production and processing. Physical access control and identity now links to specialized plant applications like manufacturing execution systems (MES), plant historians and demand management from ERP that can deliver information directly to production. Monitoring insider and contractor access to modifying batch recipes provides alerts and detection when the addition of a preservative has been suppressed, causing a contaminated batch to be produced, for example.
Integrating seamlessly with HR applications, converged software further prevents insider threat by automating background checks and risk analysis during the on-boarding and off-boarding process for employees and contractors.
The threat landscape today demands a single solution to manage operational risk and security. The following just one example of how this converged approach works.
A fictitious company named Big Food was dealing with disgruntled production foreman Tom. Tom not only had physical access to the production floor, but was intimately familiar with the control system settings to configure recipes for the MES.
Security software’s real-time link to SAP SuccessFactors HCM provided critical real-time data that identified Tom’s history of workplace issues. When Tom accessed the plant area after his normal shift hours, the security platform detected that he was making unusual changes to the production settings to eliminate the addition of preservatives. An alert was immediately sent to security operations staff as well as the plant manager. Incident prevented, with huge savings from avoided downtime and protection from loss of reputation to the company brand.
The food and beverage industry must meet high quality standards and adhere to rapid production cycles to preserve nutrition value and freshness. Convergence and automation are the keys to achieving these goals. As OT and IT networks become increasingly interconnected, OT environments become more exposed to cyber-physical attacks, which can result in tainted products, downtime and revenue losses. Security solutions secure enterprise IT applications and plant applications deliver continuous monitoring that prevents sabotage, acts of terrorism and other malicious acts. There’s also the ability to manage other supply chain risks, including changes to master data and transactions as well as the movement of goods and arrival notifications requirements by the FDA.
Today’s malicious actors don’t think in silos but most companies still do. As security and technology leaders we are compelled to rise and meet the challenge. It’s clear that only a converged approach, beyond IT-centric cybersecurity, is the way forward.
The recent cyberattack that shut down meat supplier JBS should be a wakeup call to the food industry. These attacks are on the rise across industries, and food operations both large and small need to be prepared. In a Q&A with Food Safety Tech, Brent Johnson, partner at Holland & Hart, breaks down key areas of vulnerability and how companies in the food industry can take proactive steps to protect their operations and ultimately, the consumer.
Food Safety Tech: Given the recent cyberattack on JBS, how vulnerable are U.S. food companies, in general, to this type of attack? How prepared are companies right now?
Brent Johnson: Food companies are in the same boat as other manufacturers. Cyber threats are constantly evolving and hackers are developing increasingly sophisticated delivery systems for ransomware. Food companies are obviously focused on making and delivering safe and compliant products and getting paid for them. Cybersecurity is important, but it’s difficult for manufacturers to devote the resources necessary to make their systems bulletproof when it’s an ancillary part of their overall operations and a cost driver. Unfortunately, hackers only have one job.
We tend to think of big tech and financial services companies as the prime targets for ransomware attacks because of the critical nature of their technology and data, but food companies are really no different. Plus, unlike tech companies and the financial services industry, food companies haven’t, as a general matter, developed the robust defenses necessary to thwart attacks, so they’re easier targets.
Food Safety Tech: What is the overall impact of a cyberattack on a food company, from both a business as well as a consumer safety perspective?
Johnson: It may come as a bit of a surprise to those who don’t work in the food industry, but food production (from slaughterhouses to finished products) is highly automated and data driven. That’s one of the lessons of the JBS ransomware attack. The attack shut down meat processing facilities across the United States and elsewhere. I work in Utah and the JBS Beef Plant in Hyrum was temporarily shut down. JBS cancelled two shifts at its meatpacking operation in Greeley, Colorado where my firm has a large presence as well, because of the ransomware attack. So, the impact on a food company’s business from a successful ransomware attack is dramatic.
On the consumer safety side, a ransomware attack that impacts automated safety systems would cause significant problems for a food manufacturer. Software controls much of the food industry’s safety systems—from sanitation (equipment washdowns and predictive maintenance) to traceability (possible pathogen contamination and recalls) to ingredient monitoring (including allergen detection). Every part of a food company’s production system is traced, tracked, and verified electronically. A ransomware attack on a food maker would very likely compromise the company’s ability to produce safe products.
Food Safety Tech:What proactive steps should food companies be taking to protect themselves against a cyberattack?
Johnson: I wish there was an easy and foolproof system for food companies to implement to protect against cyber attacks, but there isn’t. The threats are always changing. The Biden Administration’s recent memorandum to corporate executives and business leaders on strengthening cyber defenses is a good starting point, however. The White House’s Deputy National Security Adviser for Cyber and Emerging Tech, Anne Neuberger, reiterated the following “Five Best Practices” from President Biden’s executive order. These practices are multifactor authentication, endpoint detection and response, aggressive monitoring for malicious activities on the company’s networks and blocking them, data encryption, and the creation of a skilled cyber security team with the ability to train employees, detect threats and patch system vulnerabilities.
Food Safety Tech: Are there specific companies within the food industry that are especially susceptible?
Johnson: Not really. Hackers are opportunistic and look for the paths of least resistance. That said, as can be seen from the recent Colonial Pipeline and JBS ransomware attacks, hackers have transitioned from the early days of going after individuals and small businesses to whale hunting. The money is better.
It’s important to observe that the recent attacks have been directed at industries that present national infrastructure concerns (oil, the food supply). There’s no evidence of any involvement by a foreign government in these attacks, but it’s a fair question as to whether the hackers, themselves, expect that the federal government will step in at some point to assist the victims of cyber attacks financially due to their critical importance.
Food Safety Tech:Where do you see the issue of cybersecurity and cyberattacks related to the food industry headed in the future?
Johnson: Other than the certainty that the attacks will increase in both intensity and sophistication, I have no prediction. It’s not a time for complacency.
Q: What leads a company to decide a quality management solution is necessary?
Bryce Romney: For many companies, the catalyst for beginning the procurement process is needing to better integrate with data across the brand. Safety and quality checks have traditionally been managed with clipboards, spreadsheets, and email. While these may have their place in a modern quality model, fully manual processes make it difficult to aggregate, visualize, and use data effectively as a company grows.
Companies may also start looking to a quality management software when:
Their supply chain is expanding and it’s no longer possible to track suppliers and vendors manually.
Specific certification bodies require digital audit submission and converting from manual to digital has become too time consuming.
Corrective actions are not being effectively tracked as a part of the continuous improvement process.
Other departments have begun modernizing and integrating data across the company has become difficult.
In essence, many companies look to quality management software when it becomes difficult to track quality with more traditional processes as the company grows.
Q: What common missteps do companies make when selecting a vendor?
Romney: One of the biggest issues I see companies make is believing the right quality management software will give them an effective quality model. No software will fix a broken quality system or create a good system where one doesn’t exist. It’s critical, then, to ensure you go into the procurement process with a good quality and safety model in place. If there are things that aren’t working now, automating them won’t help. Get consensus from your team on what the quality and safety framework should be before streamlining it with quality management software.
Something else I frequently see is having the wrong people involved in procurement, or not ensuring the correct teams have a voice in the process. Narrowing your vendor selection to the final choice involves more than the director of operations or head of supply chain. Ultimately, the stakeholders that should get involved include whichever executive will give final approval, someone from the IT team who will head implementation, the team that will have to manage the software, representatives from any departments who may interface with quality, and someone to represent the needs of any suppliers, factories, or other partners who may have to use it.
Finally, I see that often people try to begin without a clear idea of their goals and desired outcomes in mind when bringing in new software. When you assemble the correct group of stakeholders, it’s critical to work on creating a specific list of goals, and a corresponding list of necessary features and functions. Having specific needs is key to narrowing an initial broad selection to the shortlist to your final selection. It allows you to avoid emotional decision making and focus on which vendor can meet your company’s needs. After all, as the Cheshire Cat in “Alice in Wonderland” says, “If you don’t know where you want to go, then it doesn’t really matter which path you take.”
Q: Quality management systems are increasingly integrated with external partners, vendors, and suppliers. How do you ensure the vendor of choice is able to accommodate all the needs of a local and/or global brand?
Romney: Start with identifying which partners or suppliers will use audits or corrective actions within the software. Are there certifications they use that are already integrated with any of the vendors you’re considering? Do you need to be able to import audits from disparate systems into a single system, and can the new software vendor accommodate that?
When working with a global supply chain, you should also consider the complexities of how the system will be used. Will you be able to get Wi-Fi or data connection in the farms or factories you’re monitoring, and can the software work offline? Do you have vendors with complex business hierarchies that the software will need to work with? Is a trained auditor using the software or will different locations need to have the usability to perform self-assessments?
Once you have a clear idea of what the answers to questions like these are, you can begin to understand which platform will best help you meet those needs. While you may not be able to find a single vendor who can meet all of your business needs, as well as those of your partners, the more you can accommodate in a single system the better. This will reduce the amount of work needed to integrate data between systems and build integrity across the quality team.
Bryce Romney is Director of Product at RizePoint. People, problems and solutions. That’s what keeps Bryce excited about moving the RizePoint platform forward. New customer journeys toward solutions for real problems is where he loves to focus. With the world moving as fast as it does, technology enhancements making leaps every year, Bryce enjoys chasing big visions, while remembering to focus on real people and the problems they still face today in their jobs and lives.
COVID-19 has been a sharp wake-up call for many food manufacturers in the need for resilient production environments that can readily respond to large and sudden changes, including fluctuations in demand and disruptive external events. This means being able to optimize operations for the following:
Efficiency: Where you can achieve constant output even when given fewer inputs—such as in workforce availability or resources. This was especially important when the pandemic caused widespread supply shortages, as well as staffing shortages due to social distancing measures.
Productivity: When you can ensure that, given the amount of available input (i.e., raw ingredients, manpower, equipment availability), you can maintain a consistent output to meet demand in the marketplace.
Flexibility: Where you can rapidly and intelligently adapt your processes in the face of change, in ways that are in the best interest of your business, the supply chain, and the consumers who purchase and trust in your products.
That trust is paramount, as manufacturers must continue to uphold quality and safety standards—especially during a time when public health is of the upmost importance. But between operational challenges and managing product quality, that’s a lot for manufacturers to wade through during a crisis.
To navigate the current COVID reality and improve response to future events, more organizations are looking to harness the power of data to enable agile decision-making and, in turn, build more resilient production environments.
Harnessing the Power of Data
The key to harnessing data for agile decisions is to aggregate end-to-end process information and make it available in real time. When you can achieve that, it’s possible to run analytics and derive timely insights into every facet of production. Those insights can be used to increase efficiency, productivity and flexibility—as well as ensure product quality and safety—even amidst upheaval.
When looking at solutions to aggregate data from a single site—or better yet, multiple sites—all roads lead to the cloud. Namely, cloud-based quality intelligence solutions can decouple the data from physical locations—such as paper checklists, forms, or supervisory control and data acquisition (SCADA) and human-machine interfaces (HMI) systems—and centralize what’s collected digitally in a unified repository. The data can then be accessed, analyzed, and consumed by those who need actionable insights from anywhere, at any time, and on any device, making cloud an ideal solution for connecting on-site operators and remote employees.
An Opportunity for Broader Transformation
In migrating to the cloud, manufacturers open the opportunity to break away from the legacy, manual processes of yesterday and transition to more nimble, digitally enabled environments of tomorrow. For example, manual processes are often highly dependent on individual operator knowledge, experience and judgement. As the pandemic has shown, such institutional knowledge can be lost when employees become ill, or are unavailable due to self-isolation or travel restrictions, presenting a risk to operational efficiency and productivity. But if that valuable institutional knowledge were captured and codified in a quality intelligence solution as predefined workflows and prescriptive instructions, then a manufacturer could more easily move their resources and personnel around as necessary and find comfort knowing that processes will be executed according to best practices.
For many organizations, this would be a remarkable transformation in the ways of working, where data and digital technologies can augment human capacity and flexibility. Take for instance, in traditional production environments, a lot of human effort is spent on monitoring lines to catch process deviations or events like machine anomalies or quality issues. Using real-time data, next-generation solutions can take on that burden and continuously monitor what’s happening on the plant floor—only alerting relevant teams when an issue arises and they need to intervene. Manufacturers can thereby redeploy people to other tasks, while minimizing the amount of resources necessary to manage product quality and safety during daily production and in the event of disruption.
Ensuring Quality Upstream and Downstream
One company that has succeeded in digital transformation is King & Prince, a manufacturer of breaded, battered and seasoned seafood. When the company digitized its manufacturing processes, it centralized the quality data from all points of origin in a single database. The resulting real-time visibility enables King & Prince to monitor quality on more than 100 processes across three U.S. plants, as well as throughout a widespread network of global suppliers.
With this type of real-time visibility, a company can work with suppliers to correct any quality issues before raw materials are shipped to the United States, which directly translates to a better final product. This insight also helps plant-based procurement managers determine which suppliers to use. Within its own plants, operators receive alerts during production if there are any variations in the data that may indicate inconsistencies. They can thereby stop the process, make necessary adjustments, and use the data again to confirm when everything is back on track.
During finished product inspections, the company can also review the captured data to determine if they need to finetune any processes upstream and respond sooner to prevent issues from making it downstream to the consumer level. Overall, the company is able to better uphold its quality and safety standards, with the number of customer complaints regarding its seafood products dropping to less than one per million pounds sold year over year—and that’s all thanks to the harnessing of data in a digitally enabled production environment.
There’s No Time Like the Present
In truth, technologies like the cloud and quality intelligence solutions, and even the concept of digital transformation, aren’t new. They’ve been on many company agendas for some time, but just haven’t been a high priority. But when the pandemic hit, organizations were suddenly faced with the vulnerabilities of their long-held operational processes and legacy technologies. Now, with the urgency surrounding the need for resilient production environments, these same companies are thinking about how to tactically achieve digital transformation in the span of a few weeks or months rather than years.
Yet while digital transformation may sound like a tremendous initiative with high risks and expenses, it’s more tangible than some may think. For example, cloud-based Software-as-a-Service (SaaS) solutions offer flexible subscription-based models that keep costs low on top of rapid scalability. Digital transformation doesn’t have to be an all-or-nothing endeavor either. In fact, it can be better to progress incrementally, starting first with the manufacturing areas that are most in need or have the most issues. This minimizes unnecessary risk, makes digital transformation more achievable and realistic over short timeframes, and avoids overwhelming already maxed out operational and IT teams.
All things must pass. The pandemic will eventually be over. But in its wake will be a permanent legacy on not just society, but also on the manufacturing sector. In my opinion, digital transformation is a fundamental basis for building resilience into the modern food production environment. Now, more than ever, is the time to address that opportunity head on.
For a long time, companies could effectively run food safety programs using only manual methods of quality management, such as pen, paper, spreadsheets and emails. Those practices have served the food industry well, but it was only a matter of time before food safety and quality management systems became mostly an exercise of technology.
Even before COVID-19, industry trends and government requirements (e.g., FSMA, the FDA’s New Era of Smarter Food Safety) were setting roadmaps for modernizing food safety and quality management with technology. Additionally, the food industry is thirsty for better performance, more insights and data-based decisions—all things that need more sophistication than manual systems.
As we continue through the throes of the pandemic, it’s abundantly clear that the tech-based future we were planning for five to ten years in the future is happening now. It’s both unavoidable and imperative for the food industry to quickly adapt to the new landscape in front of us. It’s as the CEO of Airbnb, Brain Chesky, recently said: Because of the pandemic, he had to make “10 years’ worth of decisions in 10 weeks.”
From my viewpoint, I see at least seven additional trends that are also expediting modernization in our industry.
1. A shift toward proactive mindset versus reactive habits. Always reacting to what’s happening around you is precarious and makes it difficult to mitigate risks, for you as well as your location employees. The benefits of being more strategic and prepared for different scenarios can shore up your foundation, making you more ready for crises at the corporate and location level. Gathering, combining and analyzing data with technology gives you more insights, so you can make data-based decisions quickly and with more confidence.
2. Empowerment of employees to act as chief quality officers. This comes down to the difference between training employees versus coaching them. Giving employees rules (training) is one thing but showing them the reason why a rule exists (coaching) is another. In other words, when you add more coaching, you’re empowering employees to identify and act on the right thing to do for themselves—which is chief quality officer behavior.
It is important to reassure employees during coaching that honest assessments will result in managers’ support rather than punishment when things go wrong. When all employees proactively watch for quality and compliance issues and get the right support when bringing up these issues, you’re more likely to catch (and fix) small issues before they become huge liabilities.
3. An increase in virtual audits and self-assessments. I don’t believe the corporate audit will ever go away, but our customer data is showing a marked increase in location self-assessments and virtual audits before the pandemic, and even more since March.
Right now, these audit types are a necessary stopgap while the health and safety of auditors is in question. However, I’m also confident that virtual audits and self-assessments will continue to rise. The reason? These audits can start giving you a continuous view of food safety initiatives instead of a single point-in-time view.
Even though corporate audits are still part of best practices, shorter self-assessments and other evaluations can help you glean more data and gain more visibility on a continual basis, especially if you use technology to store and analyze your data in one place.
4. Continuous quality monitoring is overtaking point-in-time audits. Let’s expand on this trend. Manual processes may provide some valuable data, but it’s impossible to build real-time, integrated views into your business with only a yearly audit. It merely shows you a single (but important) point in time rather than what’s going on at each location right now. Additionally, since everyone is watching every employee at all store locations due to COVID-19, it is critical to have a checks and balances system to continually correct small issues and to find coaching opportunities.
Again, it’s virtually impossible to do this with paper checklists and email blasts because the daily-gathered data can easily be misfiled, deleted or otherwise lost. Many quality management software systems are built to integrate, store and analyze your data in a continuous manner.
5. Consolidation of multiple programs into single software solutions. As you think about updating your programs and systems from manual processes, it is important to remember that you don’t need a different solution for every activity. For example, you don’t necessarily have to invest in an auditing app, an analytics platform, and a document storage solution (and still probably manage many spreadsheets). There are many quality management software companies that have solutions built to combine and streamline all the activities you need to manage food safety or other quality management programs.
6. Innovations to share costs with suppliers. Budgets have not likely increased due to COVID-19, so investing in modernization may seem like a pipe dream. But many companies are offsetting their costs in a new way. They are requiring suppliers to use a specific software system to submit their qualifying documents, and then these companies are charging reasonable fees for suppliers’ use of the software.
Additionally, there more benefits to managing suppliers within your quality management system. First, it can streamline document collection and storage, and second, it gives you an opportunity to communicate and collaborate with your suppliers on a deeper level.
7. Standards bodies are accelerating plans to update requirements. As seen with GLOBAL.G.A.P. this year, some standards bodies are updating their digital submission requirements to streamline certification submissions as well as start building up sharable industry data so certification bodies can do their jobs better. Additionally, GLOBALG.A.P has already partnered with existing quality management software companies to make the integration and submission process even easier, and other standards bodies are sure to follow.
It’s clear to me that these trends are of a long-term nature, and each one requires updating manual food safety and quality programs to quality management system software solutions. Acting on these trends in any number will require modernization and digital transformation to have a lasting impact on your programs and your business. The mode of “just keeping the doors open” is not sustainable and will not last forever, so now is the time to start building a better food safety future.
With the increasing globalization of the food industry, ensuring that products reaching consumers are safe has never been more important. Local, state and federal regulatory agencies are increasing their emphasis on the need for food and beverage laboratories to be accredited to ISO/IEC 17025 compliance. This complicated process can be simplified and streamlined through the adoption of LIMS, making accreditation an achievable goal for all food and beverage laboratories.
With a global marketplace and complex supply chain, the food industry continues to face increasing risks for both unintentional and intentional food contamination or adulteration.1 To mitigate the risk of contaminated products reaching consumers, the International Organization for Standardization (ISO), using a consensus-based approval process, developed the first global laboratory standard in 1999 (ISO/IEC 17025:1999). Since publication, the standard has been updated twice, once in 2005 and most recently in 2017, and provides general requirements for the competence of testing and calibration laboratories.2
In the recent revision, four key updates were identified:
A revision to the scope to include testing, calibration and sampling associated with subsequent calibration and testing performed by a laboratory.3
An emphasis on the results of a process instead of focusing on prescriptive procedures and policies.4
The introduction of the concept of a risk-based approach used in production quality management systems.2
A stronger focus on information technologies/management systems, specifically Laboratory Information Management System (LIMS).4
As modern-day laboratories reduce their reliance on hard copy documents and transition to electronic records, additional emphasis and guidance for ISO 17025 accreditation in food testing labs using LIMS was greatly needed. Food testing laboratories have increased reliance on LIMS to successfully meet the requirements of accreditation. Food and beverage LIMS has evolved to increase a laboratory’s ability to meet all aspects of ISO 17025.
Chain of Custody
A key element for ISO 17025 accredited laboratories is the traceability of samples from accession to disposal.5 Sometimes referred to as chain of custody, properly documented traceability allows a laboratory to tell the story of each sample from the time it arrives until the time it is disposed of.
LIMS software allows for seamless tracking of samples by employing unique sample accession numbers through barcoding processes. At each step of sample analysis, a laboratory technician updates data in a LIMS by scanning the sample barcode, establishing time and date signatures for the analysis. During an ISO 17025 audit, this information can be quickly obtained for review by the auditor.
Procurement and Laboratory Supplies
ISO 17025 requires the traceability of all supplies or inventory items from purchase to usage.6 This includes using approved vendors, documentation of receipt, traceability of supply usage to an associated sample, and for certain products, preparation of supply to working conditions within the laboratory. Supply traceability impacts multiple departments and coordinating this process can be overwhelming. A LIMS for food testing labs helps manage laboratory inventory, track usage of inventory items, and automatically alerts laboratory managers to restock inventory once the quantity falls below a threshold level.
A food LIMS can ensure that materials are ordered from approved vendors only, flagging items purchased outside this group. As supplies are inventoried into LIMS, the barcoding process can ensure accurate storage. A LIMS can track the supply through its usage and associate it with specific analytical tests for which inventory items are utilized. As products begin to expire, a LIMS can notify technicians to discard the obsolete products.
One unique advantage of a fully integrated LIMS software is the preparation and traceability of working laboratory standards. A software solution for food labs can assist a technician in preparing standards by determining the concentration of solvents needed based on the input weight from a balance. Once prepared, LIMS prints out a label with barcodes and begins the supply traceability process as previously discussed.
Quality Assurance of Test and Calibration Data
This section of ISO 17025 pertains to the validity of a laboratory’s quality system including demonstrating that appropriate tests were performed, testing was conducted on properly maintained and calibrated equipment by qualified personnel, and with appropriate quality control checks.
Laboratory Personnel Competency
Laboratory personnel are assigned to a specific scope of work based upon qualifications (education, training and experience) and with clearly defined duties.7 This process adds another layer to the validity of data generated during analysis by ensuring only appropriate personnel are performing the testing. However, training within a laboratory can be one of the most difficult components of the accreditation process to capture due to the rapid nature in which laboratories operate.
With a food LIMS, management can ensure employees meet requirements (qualifications, competency) as specified in job descriptions, have up-to-date training records (both onboarding and ongoing), and verify that only qualified, trained individuals are performing certain tests.
Calibration and Maintenance of Equipment
Within the scope of ISO 17025, food testing laboratories must ensure that data obtained from analytical instruments is reliable and valid.5 Facilities must maintain that instruments are in correct operating condition and that calibration data (whether performed daily, weekly, or monthly) is valid. As with laboratory personnel requirements, this element to the standard adds an additional layer of credibility that sample data is precise, accurate, and valid.
A fully integrated software solution for food labs sends a notification when instrument calibration is out of specification or expired and can keep track of both routine internal and external maintenance on instruments, ensuring that instruments are calibrated and maintained regularly. Auditors often ask for instrument maintenance and calibration records upon the initiation of an audit, and LIMS can swiftly provide this information with minimal effort.
Measurement of Uncertainty (UM)
Accredited food testing laboratories must measure and report the uncertainty associated with each test result.8 This is accomplished by using certified reference materials (CRM), or known spiked blanks. UM data is trended using control charts, which can be prepared using labor-intensive manual input or performed automatically using LIMS software. A fully integrated food LIMS can populate control data from the instrument into the control chart and determine if sample data analyzed in that batch can be approved for release.
Valid Test Methods and Results
Accurate test and calibration results can only be obtained with methods that are validated for the intended use.5 Accredited food laboratories should use test methods that are current and contain embedded quality control standards.
A LIMS for food testing labs can ensure correct method selection by technicians by comparing data from the sample accession input with the test method selected for analysis. Specific product identifiers can indicate if methods have been validated. As testing is performed, a LIMS can track time signatures to ensure protocols are properly performed. At the end of the analysis, results of the quality control samples are linked to the test samples to ensure only valid results are available for clients. Instilling checks at each step of the process allows a LIMS to auto-generate Certificates of Analysis (CoA) knowing that the testing was performed accurately.
The foundation of a laboratory’s reputation is based on its ability to provide reliable and accurate data. ISO 17025:2017 includes specific references to data protection and integrity.10 Laboratories often claim within their quality manuals that they ensure the integrity of their data but provide limited details on how it is accomplished making this a high priority review for auditors. Data integrity is easily captured in laboratories that have fully integrated their instrumentation into LIMS software. Through the integration process, data is automatically populated from analytical instruments into a LIMS. This eliminates unintentional transcription errors or potential intentional data manipulation. A LIMS for food testing labs restricts access to changing or modifying data, allowing only those with high-level access this ability. To control data manipulation even further, changes to data auto-populated in LIMS by integrated instrumentation are tracked with date, time, and user signatures. This allows an auditor to review any changes made to data within LIMS and determine if appropriate documentation was included on why the change was made.
ISO 17025:2017 requires all food testing laboratories to have a documented sampling plan for the preparation of test portions prior to analysis. Within the plan, the laboratory must determine if factors are addressed that will ensure the validity of the testing, ensure that the sampling plan is available to the laboratory (or the site where sampling is performed), and identify any preparation or pre-treatment of samples prior to analysis. This can include storage, homogenization (grinding/blending) or chemical treatments.9
As sample information is entered into LIMS, the software can specify the correct sampling method to be performed, indicate appropriate sample storage conditions, restrict the testing to approved personnel and provide electronic signatures for each step.
Monitoring and Maintenance of the Quality System
Organization within a laboratory’s quality system is a key indicator to assessors during the audit process that the facility is prepared to handle the rigors that come with accreditation.10 Assessors are keenly aware of the benefits that a food LIMS provides to operators as a single, well-organized source for quality and technical documents.
An ISO 17025 accredited laboratory must demonstrate document control throughout its facility.6 Only approved documents are available for use in the testing facility, and the access to these documents is restricted through quality control. This reduces the risk of document access or modification by unauthorized personnel.
LIMS software efficiently facilitates this process in several ways. A food LIMS can restrict access to controlled documents (both electronic and paper) and require electronic signatures each time approved personnel access, modify or print them. This digital signature provides a chain of custody to the document, ensuring that only approved controlled documents are used during analyses and that these documents are not modified.
Corrective Actions/Non-Conforming Work
A fundamental requirement for quality systems is the documentation of non-conforming work, and subsequent corrective action plans established to reduce their future occurrence.5
A software solution for food labs can automatically maintain electronic records of deviations in testing, flagging them for review by quality departments or management. After a corrective action plan has been established, LIMS software can monitor the effectiveness of the corrective action by identifying similar non-conforming work items.
Food and beverage testing laboratories are increasingly becoming accredited to ISO 17025. With recent changes to ISO 17025, the importance of LIMS for the food and beverage industry has only amplified. A software solution for food labs can integrate all parts of the accreditation process from personnel qualification, equipment calibration and maintenance, to testing and methodologies.11 Fully automated LIMS increases laboratory efficiency, productivity, and is an indispensable tool for achieving and maintaining ISO 17025 accreditation.
The theme of better traceability and more transparency is a theme that will only grow stronger in the food industry. Just last week we heard FDA Deputy Commissioner for Food Policy and Response Frank Yiannas talk about the agency’s recently proposed FSMA rule on food traceability during the 2020 Food Safety Consortium Virtual Conference Series. In a recent Q&A with Food Safety Tech, Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor, explains yet another role that technology can play in helping companies maintain agility during changes that affect the supply chain such as the coronavirus pandemic.
Food Safety Tech: How can food suppliers mitigate the risks of foodborne illness outbreaks under the stress of the COVID-19 pandemic and with limited resources?
Mikael Bengtsson: Food safety must always be a top priority for any food and beverage company. The risks associated with contamination can have a severe impact for public health, brand and company reputation. Safety routines are therefore always of the highest priority. In today’s situation with COVID-19, the stress on safety is further increased. Now, it’s not only about keeping products safe but also keeping employees healthy. One progression and resource that all food suppliers must follow is the FDA [FSMA rules], which require suppliers to be diligent and document their compliance. Especially now, while suppliers are faced with limited resources and additional stress during the pandemic, they must rely on the basics—ensuring masks are worn in and out of the workplace, washing hands for at least 20 seconds prior to touching any food, and remaining six feet apart from co-workers. When it comes to a crisis like COVID, take solace in knowing suppliers can rely on the basics—even when conditions are strained.
This year we have seen many companies having to adapt and change quickly. Demand has shifted between products, ingredients have been in shortage and many employees have had to work from home. Some were better prepared than others in adapting to the new situation. Technology plays a big role when it comes to agility. Regarding food safety, there are many proactive measures to be taken. The industry leaders establish transparency in their supply chain both upstream and downstream, use big data analysis to identify inefficiencies, as well as couple IoT with asset management systems to foresee issues before they happen.
FST: How can technology help suppliers meet the growing consumer demand for transparency in an end-to-end supply chain and improve consumer trust?
Bengtsson: Communication with consumers is changing. It is not only about marketing products, but also to educate and interact with consumers. This requires a different approach. Of course, consumers are loyal to brands, but are also tempted to try something new when grocery shopping. After a new study is published or a new story is written, consumers are likely to shift their shopping preferences.
It is therefore important to build a closer connection with consumers. Companies who have full supply chain visibility, transparency and traceability have detailed stories to tell their consumers. One way they can build these stories is by including QR codes on their packages. The consumer can then easily scan the code and be brought to a website that shows more product details—e.g. who was the farmer, how were the animals cared for and what sustainability efforts were involved. These are all important aspects to build consumer trust. According to researchers at MIT Sloan School of Management, investing in supply chain visibility is the optimal way to gain consumer trust, and can lead to increased sales.
FST: What technologies should suppliers leverage to better collaborate with trading partners and ensure consistent food safety procedures?
Bengtsson: When a food safety problem arises, batches, lots, and shipments need to be identified within minutes. Manufacturers must be able to trace all aspects of products throughout the entire supply chain—with complete visibility at the ingredient level—from farm to table, and everything in-between. An efficient and transparent food supply chain requires extensive collaboration and coordination between stakeholders. New technologies can extend both amount of collaboration possibilities and the impact of those collaborations. In order to maintain a transparent, efficient food supply chain, companies need to invest in modern cloud-based ERP and supply chain systems that incorporate the increased visibility of the Internet of Things (IoT) with data sharing, supplier and customer portals, and direct links between systems—all aimed at facilitating joint awareness and coordinated decision-making. Modern technologies that enable transparency will also have the added benefits of meeting consumer demand for product information, identifying and responding to food safety issues, reducing food waste, and supporting sustainability claims.
Some impressive technologies are not only impacting the food industry right now but will also have a huge impact in the future. As their use grows to be more prevalent, the industry will change to be smarter and more efficient, with continued improvements across the board.
1. AI and Advanced Robotics
While artificial intelligence and advanced robotics are two distinct technologies, they are frequently paired together. AI, and the data it digests, is used to command robots, allowing them to be more precise, more intelligent and more aware.
Most robots on their own are capable of completing only repetitive and clearly defined tasks. Throw something unique into the mix and they’ll either fumble or fail. However, when governed by data-based intelligence solutions like AI or machine learning, those robots become something incredibly advanced.
In the food industry, machinery and robots are leveraged to improve operations, further maintaining quality and efficiency, at affordable costs. They often work alongside human laborers to augment or enhance processes. They come with several unexpected benefits as well, such as much-improved safety for workers, faster and higher product output and consistent, reliable quality.
For example, JBS, one of the world’s largest meatpacking firms, deployed robotic butchers within its plants. The robots were used to slice more challenging meats, which reduced workplace injuries.
Automation stands alongside AI and advanced robotics, even incorporating those technologies to create a streamlined system. As of 2017, 73% of surveyed companies in the food and beverage manufacturing industry either had or were in the process of establishing automation within their facilities.
Many systems are designed to replace or enhance repetitive tasks, boosting their speed and accuracy, to significantly improve output, without incurring a loss in quality. It’s not just about hardware, like swapping a human laborer for a robot. It’s also achieved through software. Think supply chain management solutions that help plan for various events and experiences without human input.
When many of these technologies are used side-by-side, it strengthens their application and usability. As is true of advanced robotics, for example, AI can also be used to create more intelligent automation platforms. Instead of carrying out rote or simple tasks, they can be programmed to react and engage through any number of parameters. The system might slow production, for instance, based on a decrease in product demand. Or, it might swap to an alternate component or ingredient because of a shortage somewhere.
With the right controls and support, automation technologies are game-changing. With the global population growing and demands increasing more with each year, food manufacturers will look to streamline their operations and boost output in any way possible, and automation will be a go-to.
3. Digital Twins
Digital twins in food manufacturing are essentially simulated copies or a virtual representation of a physical system. That definition might seem confusing, but think of it as a clone that can be manipulated for testing and analytics.In other words, it is a twin of the actual system and information, in every sense of the word, albeit one that is more versatile and less vulnerable. It allows manufacturers and distributors to run simulations by feeding specific information into the system to identify patterns, recognize outcomes and much more.
As the systems and controls supporting the field become smarter and more digitized, digital twins in food manufacturing will find their way into product development, testing, post-production, distribution and nearly every other facet of the industry. It will become an integral component to not only understand what’s happening in the market but also for keeping up with the ebb and flow of supply and demand.
Even well before the pandemic, people had become much more conscious about the foods they consume. They want to know the origin of their goods and whether they’ve been sourced using safe, healthy and environmentally friendly methods. The problem with such demands is that, until recently, there haven’t been many solutions for increased visibility within the food supply chain.
Growing concerns for health are now a priority, and visibility is an absolute must. Blockchain technology is the answer, providing precisely the kind of visibility, efficiency, controls and collaboration that consumers want.
With this food manufacturing technology in place, someone could trace a head of lettuce back to its initial seeding. They can see who grew the plants and where, and which methods they used to mature the crop. Then, they can follow its journey to the store shelf.
How is such a thing possible? It all has to do with the technology. In its simplest form, Blockchain is a digital ledger or complete and digitized record of a particular data set. The data that goes in is added to something called a block, and as more is added, it is tacked on to the end of that block to create a long, linked record. Every bit of information is visible across the entire chain, hence the name blockchain.
Walmart is using the technology to track potential food contamination outbreaks. It empowers them to not just find the source but also find the many branches involved — like where goods might have been shipped and who may have purchased them.
Food Manufacturing Technology for the Future
While each food manufacturing technology discussed here is incredibly influential and will have a direct impact on the future of the industry, they are not the only solutions making waves. Some additional examples include:
Drones and automated delivery vehicles
3-D printing for edible goods
Smart or precision agriculture
Smarter waste disposal and recycling
The takeaway is that technology is vastly improving the operational efficiency of the food supply chain, from farmers and manufacturers to the retail stores featuring goods on their shelves. There’s no right or wrong buy-in, as any one of these technologies can be used to streamline separate processes. The biggest challenge will be deciding what to upgrade first, especially when it comes to delivering high-quality, fresh goods in a prompt manner.
I don’t have to tell you that COVID-19 is a crisis, and the consequences have been immediate and difficult. But as I speak to clients and look beyond the immediacy of the problems the food industry is facing, I am seeing positive insights that can help us now and in the future.
Food safety culture hasn’t always been clearly defined, nor has it been a “must” in many food safety systems. But the reality is that food safety culture—and the buy-in that needs to happen in your entire organization—is a direct and important element for staying up to date with new rules and being consistent and compliant at every location.
Join Kari Hensien for a complementary webinar, “4 Solvable Challenges for Enhancing Your Food Safety Culture 2020” | October 28 | Register NowWhat Does Food Safety Culture Mean Now?
The definition I have liked most is “food safety culture is what you’re doing when no one is watching.” But with the coronavirus pandemic, everyone is always watching, so the definition must expand.
Customers are carefully watching every employee at every location to gain a feeling of safety and trust at restaurants and eateries. And if employees aren’t up to speed or don’t have buy-in to your food safety culture, or even food safety in general, a single incident can turn away customers for good.
As an example, I recently visited a favorite taco joint. After the cashier rang me up, he put hand sanitizer on his gloves and proceeded to put handfuls of chips into my takeaway bag with those same “sanitized” gloves. I will not be going back.
So, food safety culture is still about what you do when no one is watching and when everyone is watching, making participation from every member of your organization critical.
What Can You Do Now to Enhance Food Safety Culture?
Practices that enhance food safety culture should initiate a shift in perspective before you implement more tangible activities. These shifts will be more challenging because they require your entire organization to be on board.
Perspective Shifts for Food Safety Culture
One or more paradigm shifts may be necessary to make enhancing your food safety culture successful. Sometimes initiatives like food safety culture can feel more like another addition to your to-do list rather than an asset that ultimately makes the job of a quality manager easier. So, consider these suggested shifts as you move forward.
Food safety culture is part of your food safety system and your corporate social responsibility plans. With any crisis, not just the current pandemic, the values and expectations you instill in your employees can give you an immovable base, even if the surface is in constant fluctuation. And whether you’re dealing with an outbreak or a pandemic, showing you put customers and location employees first demonstrates good corporate citizenship.
Location employees can be your biggest asset or your biggest liability. Employees perform better when they know the purpose behind what they’re doing rather than following rules that may seem arbitrary if they don’t have a clear understanding of why.
Punitive systems encourage hiding problems; supportive systems encourage collaboration and trust. If employees feel safe reporting issues or problems at their location, the more likely they’ll catch small issues before they become huge liabilities.
Food safety culture can be a huge asset. In other words, instead of looking at food safety culture as another chore in your already crowded list, see it as an asset that improves food safety and creates better work environments, which inherently decreases risk and protects your brand.
In-Practice Shifts for Food Safety Culture
The paradigm shifts suggested above help build a support perspective for a strong food safety culture. The following shifts I suggest can help you implement tangible actions that benefit every level of your organization.
Take great care of location employees. These employees are in direct contact with customers the most, and they are truly your first line of defense. Which means they can be an incredible asset or the weakest link.
Consider audit and checklist software over laminated or paper checklists. The right software or app can instantly push new policies or standards to every location and employee at the same time, so everyone is always on the same page. Choose software or other tools that 1) makes it easy for all employees to get the information they need; 2) helps them quickly build behaviors that serve your quality and safety programs; and 3) empowers them to confidently share issues that need to be corrected so you get a true view of the health of any location.
Consider quality management system software. With a platform (there are many that include audit and checklist tools), you can collect data points more quickly and from more sources to create a single source of truth and deepen insights. Software can directly support food safety culture, helping you:
Find new insights and continually improve your processes
Systematically rollout new policies and procedures
Drive adoption of new policies and “build muscle memory” so employees build good habits
Validate that your policies and practices are followed in every location
Identify locations or policies that need increased focus while you reward areas of successful performance.
Look at your organization from a 30,000-foot perspective. This is not so easy to do if you are using manual processes such as paper, file cabinets or even spreadsheets. With those tools, you can see data points, but it takes a lot of work to build a big-picture view. Again, this is where software is invaluable. Many quality management system software options include built-in analytics and reporting, which means much of the work is done for you, saving you valuable time.
I hope your main takeaway from this article is that surviving a crisis requires a strong food safety culture. It helps unify employees across your organization, so everyone knows what’s expected of them and how their work affects the big picture. I see strong evidence that enhancing your food safety culture is more than the “next thing on your to-do list.” It’s a tool that you can put to work to decrease risk, increase compliance, and find small issues before they become huge problems.
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.
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.
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.
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.
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