The past year has tested and stressed the food system, putting tremendous pressure on worker safety and supply chain resilience. Despite the challenges, the industry continued to work day in and day out to meet the needs of Americans. “Consumers could still go then and now to their favorite supermarket or online platform and have access to thousands of food SKUs that are available,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “We have the people in the food and agriculture sector to thank, and that’s you.”
Last week Yiannas gave his third Food Safety Consortium keynote address as deputy commissioner, reflecting on the past year and recognizing the progress and the work ahead. “I appreciate the larger conversation that the Consortium facilitates on food safety.” The Spring program of the Food Safety Consortium Virtual Conference Series takes place every Thursday in May.
Since the Fall of 2020, FDA has made advances in several areas, all of which take steps to advance the agency’s New Era of Smarter Food Safety initiative. The goals set as part of the New Era aim to help the agency more efficiently and efficiently respond to outbreaks and contamination, and other food safety challenges. The intent is to go beyond creating food safety programs into fostering a culture of food safety and truly bending the curve of foodborne illness, said Yiannas. In September the FDA issued the proposed FSMA rule on food traceability with the intent on laying the groundwork for meaningful harmonization. Nearly 6200 comments were submitted to the docket on the Federal Register, and the agency held three public meetings about the proposed rule in the fall, hosting more than 1800 people virtually. Yiannas anticipates the final rule will be published in early 2022.
The pandemic has shown how enhanced traceability might have helped prevent supply chain disruptions during a public health emergency, and the FDA continues its efforts to establish greater transparency and traceability. It is supporting the development of low-cost traceability technology solutions that are accessible to companies of all sizes. The agency also continues to explore the role of predictive analytics via the use of artificial intelligence. It has moved its AI program involving imported seafood from proof of concept into the field. Based on the results, it is expected that AI will help the FDA better manage the ever-increasing amount of imported foods by targeting inspectional resources in a more informed manner.
Efforts to strengthen food safety culture within organizations include collaborating with partners, industry, academia and consumers to define food safety culture in a transparent way. The agency will also be developing and launching internal training modules for FDA inspectional staff to introduce them to important concepts such as behavioral sciences. “We want to make food safety culture part of the dialogue and part of the social norm,” said Yiannas.
The agency will also be proposing new agricultural water requirements, a move as a result of feedback that FDA received in response to the Produce Rule. “Produce safety is one of the last frontiers because of product being grown outside,” said Yiannas.
In addition, FDA continues to review and evaluate feedback from proposed lab accreditation rule. It is expected that the FDA will issue the final rule early next year.
“We just lived through a historic year and historic challenges. These have been the most difficult of times in my profession. We have been able to move forward nonetheless,” said Yiannas. “We’re going to get through this stronger and more resilient than ever.”
Phase one of the pilot looked at using machine learning to find violative seafood shipments. “The pilot program will help the agency not only gain valuable experience with new powerful AI-enabled technology but also add to the tools used to determine compliance with regulatory requirements and speed up detection of public health threats,” FDA stated in a news release. “Following completion of the pilot, FDA will communicate on our findings to promote transparency and facilitate dialogue on how new and emerging technologies can be harnessed to solve complex public health challenges.”
Over the past 9 years, the Food Safety Consortium Conference & Expo has built a reputation for delivering perspectives and insights from the most knowledgeable and influential experts in food safety. As a result of the COVID-19 pandemic, last year’s event was converted from an in-person event into a 14-week series of virtual themed-episodes during the fall. Continuing the momentum from 2020, the 2021 Food Safety Consortium Virtual Conference Series will take place as a four-week Spring and five-week Fall program. Both the Spring and Fall programs will feature critical thinking topics that are for industry veterans and knowledgeable newcomers.
“As you know, the online experience is very different than in-person, so last year we deconstructed our in-person program and re-engineered it for virtual. Instead of having a virtual conference for three straight days, we set up our program in short 2.5-hour themed episodes that ran every Thursday in the fall. We received great feedback from attendees, speakers and sponsors. I think we were one of the few conferences that successfully pulled off the pivot to virtual,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium.
Building on the strong success of the 2020 Food Safety Virtual Conference Series, the 2021 Consortium will be presented into two seasonal programs. “This will allow us to continue the conversation throughout the year, while also taking into consideration the busy lives of food safety professionals,” Biros adds.
Food Safety Tech is the media sponsor and will feature exclusive content from the event.
The Spring Program will run every Thursday in May, with each episode starting at 12 pm ET. The weekly episodes will tackle a range of critical topics in foods safety, including FSMA and traceability, food protection strategies, COVID-19’s lasting impact on the food industry by segment, audits and supply chain management. Frank Yiannas, FDA deputy commissioner for food policy and response, is the confirmed keynote speaker for Thursday, May 6.
The Fall Program will run every Thursday beginning on October 7 at 12 pm ET through November 4. Episode topics include food safety hazards (emerging threats and new technologies), food defense strategies, an FDA update, and personal development, training and mentorship.
Companies that are interested in sponsoring a 10-minute technical presentation during the series can contact Sales Director RJ Palermo for more details.
About Food Safety Tech
Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.
Since 2012, Food Safety Tech audiences have learned to respect and expect our high-quality content—via FoodSafetyTech.com, our weekly newsletter and by attending our educational programs. Food Safety Tech keeps professionals current with the latest information about technology, best practices and regulations, and how innovative solutions and approaches can be leveraged to further advance food safety across the globe.
About the Food Safety Consortium Conference
The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in sessions that are critical for advancing careers and organizations alike. Over the past 9 years the Food Safety Consortium has built a reputation for delivering the most knowledgeable and influential perspectives in food safety. The speaker line-up has driven key food safety decision-makers to the event (both in-person and virtually)—facilitating an environment for vendors, suppliers, food industry professionals, and consultants to network and build long-lasting business relationships.
Due to COVID-19, the 2020 Food Safety Consortium was converted to a virtual conference series that featured specific topics in a weekly episode series. The 2021 Food Safety Consortium Virtual Conference Series will feature a Spring and Fall program, running in May and October, respectively.
Earlier this week FSMA celebrated its 10-year anniversary, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas reflected on the progress and accomplishments as a result of this legislation, and the path forward. As we round out the first week of 2021, Yiannas is looking back at the achievements of 2020 in the face of the historic COVID-19 pandemic.
“I’m struck by how tirelessly our team members have worked together to help ensure the continuity of the food supply chain and to help keep food workers and consumers alike safe during the COVID-19 pandemic,” said Yiannas on the FDA Voices blog. “Their commitment has not wavered in a time when we’re all dealing personally with the impact of the pandemic on our families, schooling our children from home and taking care of elderly parents.”
Response to COVID-19. FDA addressed the concern of virus transmission, assuring consumers that COVID-19 cannot be transmitted via food or its packaging. The agency also worked with CDC and OSHA on resources to help promote worker safety and supply chain continuity.
New protocol for developing and registering antimicrobial treatments for pre-harvest agricultural water
Enhanced foodborne outbreak investigation processes and established the outbreak investigation table (via the CORE Network) to disseminate information about an outbreak right when the agency begins its investigation
It may be hard to believe that 10 years have passed since FSMA became law. The risk-based preventive approach to growing, manufacturing and processing, packing, storing and transporting food has transformed the industry and the nation’s food system. Today, on the anniversary of FSMA, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas takes a look at where it all began and walks us through progress, accomplishments and what the future holds.
Seven foundational rules established, and the proposed Food Traceability Rule (September 2020) positioned to harmonized traceability
Global partnerships (Canada, Mexico, Europe, and China) to strengthen safety of imported food
Investment in cooperative agreement programs to support compliance with FSMA rules at the state level
Looking forward: New Era of Smarter Food Safety, with blueprint released in July 2020 creates a 10-year roadmap for a more “digital, traceable and safer food system”
Incentivizing industry to adopt new technologies that facilitate full traceability
Emphasis on food safety culture on farms and in food facilities
Improving root cause analysis when preventive control measures fail
“Have we accomplished everything we wanted to help ensure that the food you serve your family is safe? The honest answer is that we’re still working on that. We are working diligently to ensure that remaining FSMA rules and related guidance documents are finalized and implemented,” said Yiannas in the FDA Voices blog. “But even when we have reached all of those milestones, we will always be working with industry on continuous improvement based on the latest science and the application of new technologies. Every day we will do our utmost to make our nation’s food as safe as it can be.”
2020 has taken a lot away from us, but it has also taught us the importance of being able to quickly adapt (can you say…“pivot”?) to rapidly changing, dire circumstances. For Food Safety Tech, that meant shifting our in-person annual Food Safety Consortium to a virtual event. I really look forward to the Consortium each year, because we are a virtual company, and this is the one time of year that most of the Food Safety Tech and Innovative Publishing Company team are together. When we made the decision to move the event online, we really wanted to be considerate of our attendees, who more than likely were quickly developing webinar and Zoom fatigue. So we created a series of 14 Episodes that spanned from September until last week. I am not going to single out one episode or speaker/session in particular, because I think that all of our speakers and sponsors brought a tremendous amount of education to the food safety community. Thank you.
With that, the following are my top 10 takeaways from the 2020 Food Safety Consortium Virtual Conference Series—and this simply scratches the surface. Feel free to leave a comment on what you learned from our speakers and the discussions this fall.
COVID-19 has served as the springboard for digital transformation, more of which we have seen in the past nine months than in the last several years or even decade. Tech advances are increasing efficiencies, adding the ability to be more predictive, giving more visibility and traceability in the supply chain and offering increased accessibility. These include: IoT; Advanced analytics; Artificial intelligence (FDA has been piloting AI technology); Graph technology used in supply chain visibility; blockchain; mixed reality; and remote monitoring.
There are new responsibilities that come with being a part of America’s critical infrastructure and protecting essential frontline workers.
Companies must have a strong relationship (or work to build one) with local health departments and authorities
Name a COVID Czarat your company: This is a designated person, located both within a production facility as well as at the corporate location, who manages the bulk of the requirements and precautions that companies should be undertaking to address the pandemic.
Every company should have an emergency risk management plan that centers around good communication.
The COVID-19 pandemic is a reminder to us that the threat for viruses is always lurking beneath the surface. There is still work to be done on the food labs side regarding more rapid assays, leveling the playing field regarding conducting viral testing, and technology that enables labs to get safe, effective and consistent results.
Lessons in sanitation: Investment in sanitation is critical, there are no shortcuts, and empower your sanitation employees, give them the tools they need to effectively do their jobs.
The FDA’s FSMA Proposed Traceability rule is expected to be a “game changer”. It will lay the foundation for meaningful harmonization. FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said the pandemic really put a spotlight on the fact that the U.S. food industry needs better tracking and tracing.
Know your suppliers, know your suppliers, know your suppliers!
Biofilms are ubiquitous, and the process of detecting and eliminating Listeria in your facility is a marathon with no finish line.
Food Safety Culture is a profit center, not an overhead department.
“If I’m not well, I can’t do well.” Making sure your needs are met personally and professionally plays an important role in being a better contributor to your company’s success.
As part of a special offering, we are making four episodes of the 2020 Food Safety Consortium Virtual Conference Series available on demand for free. Head to our Events & Webinars page to register to view the sessions on or after January 2021.
While COVID-19 exposed disconnects in the food supply chain, it also served as an overdue catalyst for rapid technology adoption. Food manufacturers, distributors and retailers were forced to grapple with consumer behaviors that—previously expected to occur over five years— changed within about five weeks. Faced with unprecedented demand, channel shifts and rapidly changing consumer purchasing behaviors, forward-looking brands and retailers have started to transform their business models to become highly responsive and agile.
A new approach called “programmatic commerce” may be the key to faster market insights and pivots. Taking cues from past attempts to digitize the supply chain from end-to-end, programmatic commerce uses artificial intelligence (AI) and machine learning (ML) to connect and unify critical business data across food manufacturers, distributors and retailers using common retail portals, BI and CRM tools as well as other data resources and platforms.
With a real-time unified view of channels and activity, programmatic commerce has the potential to create fully automated trade processes to optimize production, inventory management, logistics, promotions and more for both upstream and downstream supply chain activities.
To achieve the potential of programmatic commerce, real-time or near real-time data sources must be easily integrated, unified and displayed. This is in stark contrast to previous attempts to create end-to-end supply chain visibility, which often required custom or manual integrations, had costly and lengthy implementation requirements and necessitated custom reporting.
The programmatic approach is already gaining traction, enabling retailers to leverage AI and ML technology to optimize supply chains. But the real value is in taking it one step further—to tap into rich customer data, understand rapidly changing consumer behaviors and ultimately—to predict and personalize shopping experiences at scale.
Tracking and Adapting to Evolving Consumer Journeys
Consumers increasingly demand greater choice, control, personalization and transparency and companies must continuously create, track and manage a 360º view of customers’ shopping journeys to stay ahead of these trends. Fortunately, real-time data and analytical capabilities are available to supply the critical information they need to implement a programmatic commerce approach.
Among the shifts companies must track as a result of COVID-19 is the explosion in online grocery shopping. In November 2020, U.S. grocery delivery and pickup sales totaled $5.9 billion and a record high 83% of consumers intend to purchase groceries online again, signaling this trend continues as the pandemic lingers on.1 By 2025, online grocery sales are predicted to account for 21.5% of total grocery sales, representing more than a 60% increase over pre-pandemic estimates.2 A permanent shift toward online grocery shopping can be expected as consumers’ shopping and fulfillment experience continues to improve.
For consumers still shopping in stores, the pandemic also drove switches in primary physical store locations. In the United States, an estimated 17% of consumers shifted away from their primary store since the start of the pandemic.3 This was driven by increased work-from-home, which eliminated commuting routes and made different store locations more convenient, including ones closer to home.
Given the multitude of changes impacting consumer journeys during the pandemic, it is imperative that companies track relevant purchase drivers and considerations of each purchase occasion, while also taking into account their recent shopping experience. This creates the need for consistent, seamless and relevant experiences across both digital and physical channels that aligns all touchpoints with the consumer as part of their “total commerce experience.”
Multiple retailers are already pursuing this approach in the hope of retaining their “primary store” status across the totality of their consumers’ shopping experiences. Walmart recently launched a new store format to help achieve “seamless omni-shopping experiences” for its customers through a digitally enabled shopping environment. Customers can use the Walmart app to efficiently find what they’re looking for, discover new products, check pricing, and complete contactless checkout.4 Data tracked on these customers can eventually be used to create personalized recommendations and in-store activations and assistance based on their purchase history and in-store experience.
Conversely, the “digital store” is also being reimagined to align with consumers’ in-store experience to create a seamless shopping experience. For example, personalized meal planning service The Dinner Daily now offers the ability for its members to order recipe ingredients directly from Kroger and other Kroger-owned stores through The Dinner Daily app.5 Integrated data from multiple shopping platforms and consumer touchpoints can provide food manufacturers and retailers with shopper profiles, consumer experiences, and purchase history along with inventory status and other inputs to ultimately build personalized customer experiences and enhance shopper loyalty.
Applying Programmatic Commerce to Deliver Personalization to Consumers
Once armed with real-time data in a uniform format from sources ranging from consumer search analytics to retailer promotional pricing, a programmatic commerce approach can provide companies with predictive understanding of demand and supply to optimize decision making from raw materials through production through retail or direct-to-consumer.
Using online grocery shopping as an example, consumer personalization can be delivered through the accurate prediction and display of items relevant to each shopper based on shopping history, preferences, current cart selections, and other inputs such as real-time availability, marketing promotions and more.
Innovations are already in the market, including Halla, a data science company that developed a grocery-specific personalization algorithm that works with grocery retailer e-commerce platforms to create smart recommendations based on understanding of individual shoppers’ product usage and preferences.6 Another example is the Locai Solutions digital grocery platform, which applies AI to personalize recipe recommendations based on consumer preferences and purchase history and determines ingredients and quantities needed for easy incorporation into their shopping cart.7
The Path Ahead: Accelerating Technology Adoption in the Food Industry
AI and ML are already reducing waste across supply chains and enabling consumer personalization. However, currently only about 12% of retail decision-makers feel they are very effective at providing these experiences to customers and only 10% have access to the real-time data needed to achieve this goal.8
Modern programmatic commerce platforms (see Figure 1) can effectively bridge information gaps, improve inventory and distribution to prevent shortages or overages and help companies be data-ready to meet actual demand. Beyond this, a programmatic approach unlocks the next stage of customer satisfaction and loyalty, personalizing the experience during and after the pandemic.
Figure 1. Programmatic Commerce Platform visualization. (Courtesy of Crisp)
Food Safety Recalls – Digging Deeper into FDA, CDC, USDA & Food Industry Data, with Allen Sayler, EAS Consulting
Preparing for Blockchain in “A New Era of Smarter Food Safety”, with Kathy Barbeire, CAT Squared
The Road to Traceability is Paved with Standards, with Lucelena Angarita, IPC/Subway and Liz Serti, GS1 US
TechTalk from Controlant
The event begins at 12 pm ET on Thursday, December 10. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring 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.
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
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