Current events and external threats to food and agriculture
Case studies and lessons learned in food defense
Insider threat mitigation
Resources for food and beverage manufacturers
Featured speakers include Jason Bashura, PepsiCo (session moderator); April Bishop, Treehouse Foods; Ben Miller, The Acheson Group; Frank Pisciotta, BPS, Inc.; Joel Martin, Cargill; James Nasella, Tate & Lyle; Scott Mahloch, Cassandra Carter, and Kevin Spradlin, FBI; Rob Odell – National Insider Threat Task Force; Sarah Miller – Carnegie Mellon/CERT; Rebecca Morgan, Center for the Development of Security Excellence
The event begins at 12 pm ET on Thursday, November 12. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.
Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].
The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.
Global food supply chains are complex and therefore quite vulnerable to errors or fraudulent activity. A company in Chile repackaged and falsely labeled cheap raspberries from China, reselling them as top-level organic Chilean raspberries in Canada. These raspberries were linked to a norovirus outbreak in Canada, sickening hundreds of people. A whistleblower complaint helped to uncover this fraudulent scheme that posed a significant risk to human health.
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.
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.
Figure 1. A schematic representation of some of the requirements of ISO/IEC 17025:2017 compliance. (Figure courtesy CloudLIMS)
Traceability
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.
Figure 2. A preconfigured food LIMS to manage instrument calibration and maintenance data. (Figure courtesy of CloudLIMS)
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.
Data Integrity
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.
Sampling
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.
Document Control
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.
Figure 3. A software solution for food labs helps manage documents, track their revision history, and ensure document control. (Figure courtesy of CloudLIMS)
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.
Conclusion
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.
Perry Johnson Laboratory Accreditation (2019). An Overview of Changes Between 17025:2005 and 17025:2017. ISO/IEC 17025:2017 Transition. https://www.pjlabs.com/downloads/17025-Transition-Book.pdf
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.
Fake honey is an enormous economical burden on beekeepers and consumers around the world. Adulteration methods are becoming more and more sophisticated. Besides the old-fashioned scams of real honey getting diluted or replaced by syrup, new tricks show up, for example pollen getting blended into syrup, chemical alteration of syrup to confuse tests, fake honey traveling through a number of countries to mask its country of origin, or a combination of these methods. Since the adulterated honey does not pose a risk to consumer’s health, government enforcement to detect and punish honey adulteration has not been very strong. So far, authenticity tests are mostly left to the private sector and the honey industry.
If global supply chains were considered complex before COVID-19, it’s hard to imagine what we’d call them now. Is there a single business operating exactly as it did before the pandemic?
All the more surprising, when survival would seem to be the top priority, pre-pandemic risk factors are not only alive and well, but they also actually outweigh coronavirus as strategic business concerns. In fact, COVID-19 didn’t even make the top five risk factors in the World Economic Forum’s 2020 Risk Report.
“While the risk of a pandemic was noted as important in the report, and something for which we are unprepared globally, it was not identified as one of the top five risks in terms of likelihood or impact in the 2020 survey. High-impact and highly probable risks, such as climate change, biodiversity loss and water crises, are just as present now as they were before the pandemic started . . .”
In our experience, some pre-pandemic business trends have actually gone from “warm and fuzzy” to red hot in spite of, or perhaps even due to, the COVID chaos. One prime example is in the case of social audits.
Social audits have been increasingly used over the past decade to evaluate corporate social responsibility and, indeed, the ethical conduct of entire supply chains. We’ve worked extensively with some of the biggest names in consumer electronics to conduct hundreds of social audits among component suppliers of all sizes. These assessments are mandatory, not by law, but by business policy. The vast scope reflects the importance—and business value—of operational factors that go beyond pure economics, whether it’s related to labor practices, health and safety, or environment.
A growing number of organizations strongly believe that social responsibility and profits are not mutually exclusive; they are in fact enablers of one another—but only if you commit to mining the full value of these programs. Think of it like data mining. Within any large body of information, you can almost always find hidden value. If you know how to look and have the proper tools. In the case of social auditing, the tools are the insights and methods employed by the auditing teams.
This is such a vital concept that we have designed its social auditing process to exceed even what the Responsible Business Alliance requires in its code of conduct. As a baseline, like every other auditor, we first look for nonconformities, which are the most serious issues requiring immediate attention. We also report “observations”, a second level of findings that speaks to things that are suboptimal but are not out of compliance, per se. That’s where it usually stops. This is the mentality of fault finding. And it has defined social auditing for a long time.
We can, and do, break that mold. Taking another critical step to ask, “what’s going right?”, provides an extra level of inquiry that probes for opportunities embedded in the fabric of the way things work. It could be an unrecognized best practice, something that people have been doing but nobody took the time, or had the awareness, to document and share. Often times, it’s something frontline workers have done as a response to an unexpected development, like a pandemic that makes you work from home.
In one service-based organization, we found that the sudden shift to working from home led to an unwelcomed rise in cases of domestic violence. We discovered this during audits of pay rates and working hours. The company was able to develop an innovative response, establishing a framework of verbal signals that workers now use to communicate stress or threat. In another instance, while auditing a large industrial company for workplace safety, we found that employees were using a shortcut to avoid a required safety measure. By probing and asking questions in a non-accusatory way, those same workers recommended a very simple workaround to the workaround—thereby restoring the safety measure without adding complexity to the task.
The key to all of this is mindset. Not just ours (the auditors), but the client organization’s as well. You must be willing to broaden the very idea of “compliance.” Sometimes, things that are out of spec are that way for a reason. Rather than lump every outlier as a flaw, you should look beneath the surface and see if there’s a good reason for it. That doesn’t automatically mean nonconformities are suddenly something else. But if you are only looking for problems, that’s all you’re going to find.
Keeping in line with commitments made under FDA’s New Era of Smarter Food Safety, the FDA has announced a food traceability proposed rule to create more recordkeeping requirements for specific foods. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods”, puts additional requirements on companies that manufacture, process, pack or hold foods on the Food Traceability List to establish and maintain records related to critical tracking events (i.e., growing, receiving, transforming, creating and shipping).
Food retailers and the entire food and beverage (F&B) industry are now operating very differently than they did some six months ago. The pandemic has brought immense shifts in supply chains, imposed new hazard controls, and—perhaps most importantly—turned consumer preferences upside down.
To accommodate these changes, food manufacturers, retailers, restaurants and others stepped up to innovate and secure the continuity of their services. But now, as many industries begin to drop the notion of ever going back to what once was, it’s time we started thinking about how many of the newly introduced processes will stick around for the long-term.
What will be the main trends defining the food industry as a whole post-COVID?
Adopted Habits Aren’t Going Anywhere
The pandemic brought radical changes to our everyday lives, and it’s clear that many of the newly adopted behaviors won’t disappear overnight. Consumers will continue to rely on grocery retailers to keep them both fed and healthy while expecting minimum disruptions and a high respect for safety regulations—both in terms of handling and the state of delivered products.
Take-home grocery sales grew by 17% between April and July, breaking the record for the fastest period of growth since 1994. Online grocery shopping also gained popularity while managing to engage entirely new demographics. Some 10% of baby boomers now say they would buy more groceries online once the pandemic is over—compared to 34% of Gen Xs and 40% of millennials.
Due to consumer hyper-awareness of safety and sanitation, the whole food industry will continue to be defined by safety practices. Sanitizing common surfaces like keyboards, door handles, tables and chairs regularly will remain the norm. Beyond “manual” rules such as the mandatory use of facemasks, requirements such as regular health checks could boost the adoption of technology across the industry—transforming not only customer-facing interactions but also the processes behind the curtain.
Technology as an Enabler
Every crisis sparks innovation, and the food industry has certainly proved this thesis. Technology has become the ultimate aide, enabling interactions that would otherwise be impossible. These include contactless ordering, payments and pickup—processes that are likely to stick around even beyond COVID-19.
At the same time, the pandemic accelerated the usage of innovations that previously struggled to become mainstream. This includes virtual tipping jars or mobile order-and-pay, such as the options introduced by fast-food giants including McDonald’s, Subway, KFC, and Burger King.
There’s an obvious appetite for F&B companies to further incorporate technology. For example, the Coca-Cola Company is rolling out a touchless fountain experience that can be used with a smartphone for contactless pouring. Heineken, on the other hand, turned to virtual tech to launch a new product—a cardboard topper for multipack beer that will eliminate plastic from millions of cans. With travel restrictions hindering the mobility of engineers, the company leveraged virtual technology to install the new machinery needed at its Manchester-based factory.
But it’s not just solitary innovations; the market has already seen new AI-based technologies that help food businesses better manage risk in their workforce. Food manufacturing, distribution and provision require many different touchpoints; by predicting, monitoring and testing the health and safety of the workers involved in these processes, companies can ensure they keep their operations running, even if another wave of COVID-19 hits. Solutions like these will be crucial when looking to add another layer of safety that goes beyond mandatory governmental regulations.
Food Safety Revamped
Even though COVID-19 is transmitted through airborne respiratory droplets, and the risk of contracting the virus through food is low, people around the world are concerned about the possibility. After all, 40% of people are more careful about washing unpackaged fruit and vegetables than before the pandemic.
The pandemic has already made societies rethink various established concepts, such as wet markets or the consumption of wild animals. The pandemic could, therefore, lead to changed behaviors, and newly imposed rules such as formalizing small and micro food enterprises, provisions for direct sales by farmers, leveraging technology to ensure safety, and investments in a more robust food infrastructure altogether.
Such changes could also irreversibly affect street food—a sector that is bound to feel the hit of COVID-19. Particularly in countries with diverse street food culture, one of the emerging trends will be the rise of gourmet street food brands that can provide both great taste and high hygiene standards.
Food Sustainability to the Forefront
2020 will be a year of reckoning for the world’s food systems. The pandemic exposed the flaws of the global food supply chain that continues to be highly centralized and operating on a just-in-time basis. This is why we have seen panic food runs, urgent supply shortages and high amounts of food waste as many businesses were shut down overnight. In developing countries, several agencies expect that a “hunger pandemic” and a doubling of people starving could happen unless serious action is taken.
As we rethink the underlying principles of the food industry such as safety and supply, other concepts such as transparency and visibility into product sourcing and manufacturing also come into the spotlight. Consumers across the globe are more likely to prioritize offerings that are healthy and locally sourced than they were before COVID-19.
Food produced with the overuse of chemicals in monoculture cropping systems and large-scale animal farming significantly impact the availability of natural resources and cause substantial greenhouse gas emissions. Added to that, practices like industrial animal farming that operate with large numbers of livestock in confined spaces are a breeding ground for viruses, and have been linked to prior outbreaks such as the outbreak of swine flu in 2009. They also enable the spread of antibiotic-resistant organisms due to the common overuse of antibiotics administered to prevent infections caused by cramped living conditions.
Consumers are increasingly aware of this: Nearly 25% of Americans are now eating more plant-based food. As we move forward, diverse food companies are likely to tap into this trend, resulting in great opportunities for plant-based, nutritious, local, and even healthy DIY meals and products. For example, an Australian food producer has recently announced the launch of a new proprietary product range that will offer the first vegan ready-to-drink protein shakes on the Australian market.
A New Way of Dining
The restaurant market has been one of the direct victims of the pandemic but has shown impressive elasticity in adapting to the new realities. Many businesses have introduced service extensions such as deliveries and take-outs, as well as pop-up grocery stores. Enjoying great popularity, some of these options will stick around far beyond the pandemic.
However, there’s a counterforce hindering significant expansion: The simple fact that many consumers discovered a new joy in cooking. A recent study notes that 54% of Americans are now cooking more than they were before the pandemic, with 35% saying that they “enjoy cooking more now than ever.” But at the same time, 33% of consumers say they’re getting more takeout than before the pandemic. This implies that the post-pandemic normal will likely see a shift toward eating at home more often, whether that means cooking or takeout and delivery.
Therefore, restaurants are likely to continue diversifying their services, experiment with food bundles and DIY meal kits, or even luxurious in-home chef visit experiences as an alternative to high-end restaurant dining.
The past crises have shown that economic uncertainty is directly linked to changes in demand for private-label and value brands. After the 2008 financial crisis, 60% of U.S. consumers were more interested in reasonably priced products with core features than in higher-priced, cutting-edge products. So while luxury dining is not completely disappearing, it could take on other aspects.
In Denmark, for example, a two-Michelin star restaurant is moving to serve burgers. In China, a country that many look to as the model for the post-COVID world, there has also been a clear push toward more affordable dining as well. Hot pot and barbecue venues have been thriving, particularly among customers in their 20s and 30s. Many fine dining restaurants, on the other hand, have started offering affordable lunch menus or have cut prices to correspond to the current value-conscious behaviors.
It’s clear that the future of food retail and the F&B industry will be significantly marked by the pandemic. Its prolonged nature will also cause the newly adopted habits to become further solidified—and many processes will adapt to match them. For example, while contactless deliveries were accelerated in the past months, businesses are working hard to make them as efficient as convenient as possible, making it unlikely that such investments would be erased overnight, once COVID-19 is no longer a threat.
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.
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.
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