Tag Archives: traceability

FDA

FDA Releases More Resources for Food Traceability Proposed Rule, Risk-Ranking Model for Food Tracing

By Food Safety Tech Staff
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FDA

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.

Other resources include a flowchart to assist with determining who is subject to the rule and a glossary of key terms.

Arun Apte, CloudLIMS
In the Food Lab

Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?

By Arun Apte
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Arun Apte, CloudLIMS

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:

  1. A revision to the scope to include testing, calibration and sampling associated with subsequent calibration and testing performed by a laboratory.3
  2. An emphasis on the results of a process instead of focusing on prescriptive procedures and policies.4
  3. The introduction of the concept of a risk-based approach used in production quality management systems.2
  4. 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.

ISO 17025 requirements
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.

Software, LIMS
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.

References

  1. Spink, J. (2014). Safety of Food and Beverages: Risks of Food Adulteration. Encyclopedia of Food Safety (413-416). Academic Press.
  2. International Organization for Standardization (October 2017). ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories. Retrieved from: https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100424.pdf
  3. 17025 Store (2018). Transitioning from ISO 17025:2005 to ISO/IEC 17024:2017. Standards Store.
  4. 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
  5. Analytical Laboratory Accreditation Criteria Committee. (2018). AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025. Oxford, England: Oxford University Press.
  6. Cokakli, M. (September 4, 2020). Transitioning to ISO/IEC 17025:2017. New Food Magazine.
  7. ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories.
  8. Bell, S. (1999). A Beginner’s Guide to Uncertainty of Measurement. Measurement Good Practice Guide. 11 (2).
  9. 17025Store (2018). Clause 7: Process requirements. Standards Store.
  10. Dell’Aringa, J. (March 27, 2017). Best Practices for ISO 17025 Accreditation: Preparing for a Food Laboratory Audit (Part I). Food Safety Tech.
  11. Apte, A. (2020). Preparing for an ISO 17025 Audit: What to Expect from a LIMS?
Mikael Bengtsson, Infor

As COVID-19 Stresses Food Suppliers, Technology Steps In

By Maria Fontanazza
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Mikael Bengtsson, Infor

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?

Mikael Bengtsson, Infor
Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor

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.

Checklist

2020 FSC Episode 4 Wrap: FDA: There’s a Strong Business and Public Health Case for Better Traceability

By Maria Fontanazza
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Checklist

One year ago the FDA held an at-capacity public meeting to discuss its latest initiative, the New Era of Smarter Food Safety. At the time, the agency was planning to release the blueprint for the New Era in the spring of 2020. In fact, the FDA was just days away from unveiling it when the COVID-19 pandemic hit in March. The blueprint was put aside and it was all hands on deck, as the agency worked with the food industry to ensure companies continued operating, as they were deemed a part of America’s critical infrastructure. From there, the agency navigated through uncharted waters with the food industry and its stakeholders. It signed an MOU with USDA in an effort to prevent disruptions at FDA-regulated food facilities and address shortages of PPE, disinfection and sanitation supplies. It announced that it would conduct remote inspections and extended the comment period for the Laboratory Accreditation Program Proposed Rule. It released a COVID-19 food safety checklist with OSHA to help guide companies through employee health, social distancing, and the operational issues that have entered into play as a result of the pandemic. Food companies and the supply chain were facing an enormous challenge.

“I always thought we had one of the best food systems in the world… by and large we have an amazing food system,” said Frank Yiannas deputy commissioner for food policy and response during last week’s keynote address at the 2020 Food Safety Consortium Virtual Conference Series. “We just experienced the biggest test on the food system in 100 years. Have we passed the test? I don’t think anyone would say we scored 100%… but by and large we passed the test.” Yiannas added that COVID-19 has exposed some strengths and weaknesses in the food system as well. He also emphasized a point that he has been driving home throughout the pandemic: “The virus that causes COVID-19 is not a virus that is transmitted by food. It is a respiratory virus and generally transmitted in very different ways.”

The FDA released the blueprint for the New Era of Smarter Food Safety, which incorporated some lessons learned from COVID-19, in July. Traceability is a big part of agency’s new era initiative, and the pandemic further put a spotlight on the need for better tracking and tracing in the food industry. And under FSMA, FDA is required to “establish a system that will enhance its ability to track and trace both domestic and imported foods”. In working to meet this requirement, FDA proposed the FSMA rule on food traceability last month.

Yiannas said the proposed rule has the potential to lay the foundation for meaningful harmonization and called aspects of the proposed rule game changing. It establishes two critical components that are the leading edge of food traceability: It defines critical tracking events (i.e., what are the types of events in the food system that required those events to be kept) and key data elements (i.e., the data elements that must be captured at those critical tracking events). “These two things are big ideas for traceability,” said Yiannas. “They will allow us to harmonize how traceability is to be done, allow us to scale and allow for greater interoperability.” The proposed rule also creates a traceability list that identifies foods based on a risk-ranking model for food tracing.

FDA is encouraging comments on the proposed rule and is holding three meetings (November 6, November 18 and December 2) to discuss the proposed traceability rule. “We are going to create the final rule together,” said Yiannas.

As part of a special offering, Episode 4 has been made available for viewing on demand for free. Register to view the on-demand recording.

Food Safety Consortium

2020 FSC Episode 4 Preview: FDA’s Frank Yiannas to Discuss Proposed FSMA Traceability Rule, Updates on New Era of Smarter Food Safety

By Food Safety Tech Staff
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Food Safety Consortium

Episode 4 of the 2020 Food Safety Consortium Virtual Conference Series features more important conversations about COVID-19 and its impact on the food industry. The event kicks off with a special presentation by FDA’s Frank Yiannas. Highlights include:

  • FDA Keynote Address by Frank Yiannas, deputy commissioner for food policy and response
  • COVID-19 Lessons Learned Panel Discussion with Mitzi Baum, STOP Foodborne Illness; Stephanie Dragatsis, Feeding America; Carletta Ooten, Amazon; Spir Marinakis, Maple Leaf Foods; and Craig Wilson, Costco Wholesale
  • Rumor vs. Reality: How to Cope with the Trends of Food Safety During a Pandemic, with Ge Song, Benjamin L. England & Associates, LLC
  • Tech Talk by sponsor Rizepoint and program partner AOAC

As part of a special offering, Episode 4 has been made available for viewing on demand for free. Register to view the on-demand recording.

Frank Yiannas, FDA, Rick Biros, Innovative Publishing, Food Safety Tech, Food Safety Consortium
Although there will be no physical handshaking this year, Frank Yiannas, deputy commission for food policy and response at FDA (left), will join Rick Biros, president of the Food Safety Consortium, for this year’s Virtual Conference Series on October 1. (Photo credit: amyBcreative)
FDA

FDA Proposes FSMA Rule on Food Traceability

By Food Safety Tech Staff
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FDA

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).

Foods on the proposed traceability list have been selected based on a risk-ranking model for food tracing and include:

  • Cheese
  • Shell eggs
  • Nut butter
  • Cucumbers
  • Herbs
  • Leafy greens
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fresh-cut fruits and vegetables
  • Finfish
  • Crusteaceans
  • Mollusks
  • Ready-to-eat deli salads

The requirements of the proposed rule pertain to the above-foods as a standalone product as well as when an ingredient in a product.

 

Daniel Erickson, ProcessPro
FST Soapbox

Recall Risk Reduction: An ERP’s Role

By Daniel Erickson
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Daniel Erickson, ProcessPro

Consumer safety is of paramount importance and product recalls are a necessary means to this end. Product recalls are a serious, complex, and costly issue affecting the food and beverage industry in the United States. The FDA estimates that there are around 48 million cases of foodborne illness each year—causing one in six Americans to get sick from contaminated food. In addition to affecting public health, recalls have a dramatic effect on manufacturers by creating economic problems, damaging a company’s reputation, and imposing potential legal penalties and liabilities. In the search for a business management solution to better prepare themselves for and reduce the risk of recalls in their operations, many food manufacturers have discovered that technology, specifically ERP software, is key to lowering the risk of food and beverage product recalls.

An industry-specific ERP solution is a centralized business system with key industry features providing a system of record-keeping, with the tools to support the preparation and reduction of recall risks. While a manufacturer is ultimately responsible for a product recall, an ERP solution is essential in supporting and championing overall recall readiness and reduction. With the streamlined and automated inventory, manufacturing, and quality control processes managed within the software, critical steps and data that assist in recall mitigation are documented—including supplier verification records, audit logs, receipt records, quality testing, lot tracking, and shipment logs. The key to prevention of a product recall is preparation, which can be handled efficiently through an ERP’s functionality specifically in the following areas.

Supplier Management

An ERP facilitates best practices for supplier management and risk assessment within the solution to assure the acquisition of quality raw materials from trusted vendors. Its role is to maintain an approved supplier list for each product ingredient, documenting detailed supplier information, quality control test results, and risk level to ensure in-house and customer-specific standards are met. For approved or activated suppliers, information regarding materials that can be purchased through the vendor, applicable certifications, quality control results, and other pertinent supplier information is stored within the centralized data system of the ERP. A risk assessment for each vendor is also documented to ensure that any potential inherent risk(s) from vendor-issued recalls and to finished goods are limited.

In addition to activated suppliers, an ERP solution also assigns and manages qualified alternates to provide vetted selections should a primary supplier’s materials become unavailable. This positions a company well in the supply chain, as the investigative work has already been conducted on other suppliers, limiting the need and risk associated with onboarding an unknown supplier in a moment of crisis. Vendors are recorded within the system and ranked in order of preference and/or risk level so that they can be identified and put into use quickly if a supplier becomes unavailable—providing the preparation and leverage that companies need to mitigate the risk to safety in the supply chain. In a product recall situation, when a supplier notifies a customer of a contaminated ingredient, the supplier management feature within the ERP solution provides for a qualified replacement vendor that can fulfill the needed raw material quickly and efficiently.

Inventory Control

An ERP system offers end-to-end traceability, maintaining a comprehensive record that tracks raw ingredients, work-in-progress, and final products throughout the supply chain using barcode scanning to link product and lot information to batch tickets, QC testing results, shipping documents, and labels. This full forward and backward lot traceability is necessary to provide a documented audit trail imperative to locating raw materials or finished goods quickly within the initial 24-hour time period of a product recall. With full manufacturing, inventory, and reporting integrations, the ERP supports sound manufacturing practices that assist with recall preparedness – maintaining current Good Manufacturing Practices (cGMP), FDA reporting, GFSI compliance, and other industry-specific regulations to provide a documented audit trail with the ability to adapt as compliance requirements change.

Managing protocols to ensure the quality of inbound and outbound materials is essential in minimizing recall risk across the entire supply chain—from raw materials to the delivered final product. With an industry-specific ERP solution, formulas, recipes and instructions are maintained, scaled and verified to ensure consistency of products within the manufacturing process. This instills preventative measures throughout the production cycle in the form of process steps and quality control test specifications to bolster safety and quality. Quality features such as quarantine status and other status capabilities permit the isolating, removing and disposing of raw ingredients and finished goods that fail to meet quality control standards—triggering an alert to notify the purchasing department to investigate the issue. Having the ability to remove ingredients and finished goods from inventory or production prevents contaminated items from reaching store shelves and consumers, which reduces overall recall risk.

Inventory control practices are an important part of the functionality within an ERP solution that help to reduce overall recall risk. This includes managing and reporting of shelf life and expiration dates to maintain precise and lean control of inventory and reduce variances. Automated inventory transactions with the use of an ERP’s warehouse management solution (WMS) follow industry best practices and improve efficiency to ensure the accuracy of shipments, transfers, and material returns. This real-time visibility allows for the maintenance of FIFO inventory practices necessary to reduce the risk of spoilage.

One of the leading causes of contamination for food and beverage manufacturers that results in a recall event is a lack of allergen control throughout the supply chain and production process. An ERP system helps to track, manage and record the handling, storage and batch steps of raw materials from farm-to-fork. This includes stringent sanitary practices, lot tracking, raw material segregation and process controls to avoid allergen contamination or cross-contamination. Accurate product labeling is also a significant factor in reducing risk and an automated system that generates nutritional and product package labels plays a key role in a company’s recall prevention. To meet the needs of consumers and regulators, an ERP solution automates label creation to include accurate ingredient and allergen statements, nutrient analysis, expiration dates, lot and batch numbers, and regulatory specifications. The labeling history documented in the software allows products to be identified and located quickly in the event of a recall.

Reporting

Utilizing the recall functionality in the ERP solution allows companies to plan and test their recall process in advance. Performing mock recalls permits regular measurement and improvement of procedures to ensure rapid, accurate, and thorough responses by all company stakeholders in the event of a recall. A successful simulated exercise identifies 100% of recalled ingredients/products and notifies appropriate entities in a timely manner. Evaluation and documentation of mock recall exercises help expose inefficiencies, process gaps and procedural adjustments, which are designed to improve recall readiness and minimize consumer exposure to potentially dangerous contaminants.

As proof or documentation of adherence to specific processes, reporting is essential to demonstrate that these processes have been completed—without it, an integral component is missing. Across the supply chain and throughout the manufacturing process, documentation and reporting accentuate steps that have been taken to prepare and reduce recall risk. Risk-based assessments in supplier management, lot traceability reports, and mock recall reporting all provide a starting point of analysis to allow for adjustments to be made across the business. In a recall situation, the system is able to create lot tracking reports that encompass raw ingredients through shipped finished goods. These reports can be produced in minutes, rather than the hours it takes if data is stored within separate software programs.

Due to the amount of time and money that food and beverage companies invest in getting their products to market, it is imperative that preventative measures are taken in order to avoid a product recall. Forward-thinking manufacturers can help prepare for and reduce recall risks by utilizing several important features in ERP software—including supplier management, inventory control, and reporting. Using the tools at their disposal, a company can mitigate liabilities and protect their brand to turn a potential crisis into a future filled with opportunities.

Are Traasdahl, Crisp
FST Soapbox

How a History of Slow Technology Adoption Across Food Supply Chains Nearly Broke Us

By Are Traasdahl
1 Comment
Are Traasdahl, Crisp

The COVID-19 crisis has exacerbated existing disconnects between food supply and demand. While some may be noticing these issues on a broader scale for the first time, the reality is that there have been challenges in our food supply chains for decades. A lack of accurate data and information sharing is the core of the problem and had greater impact due to the pandemic. Outdated technologies are preventing advancements and efficiencies, resulting in the paradox of mounting food insecurity and food waste.

To bridge this disconnect, the food industry needs to implement innovative AI and machine learning technologies to prevent shortages, overages and waste as COVID-19 subsides. Solutions that enable data sharing and collaboration are essential to build more resilient food supply chains for the future.

Data-sharing technologies that can help alleviate these problems have been under development for decades, but food supply chains have been slow to innovate compared to other industries. By reviewing the top four data-sharing technologies used in food industry and the year they were introduced to food supply chains, it’s evident that the pace of technology innovation and adoption needs to accelerate to advance the industry.

A History of Technology Adoption in the Food Industry

The Barcode – 19741
We’re all familiar with the barcode—that assemblage of lines translated into numbers and letters conveying information about a product. When a cashier scans a barcode, the correct price pops up on the POS, and the sale data is recorded for inventory management. Barcodes are inexpensive and easy to implement. However, they only provide basic information, such as a product’s name, type, and price. Also, while you can glean information from a barcode, you can’t change it or add information to it. In addition, barcodes only group products by category—as opposed to radio-frequency identification (RFID), which provides a different code for every single item.

EDI First Multi-Industry Standards – 19812
Electronic data interchange (EDI) is just what it sounds like—the concept of sharing information electronically instead of on paper. Since EDI standardizes documents and the way they’re transferred, communication between business partners along the supply chain is easier, more efficient, and human error is reduced. To share information via EDI, however, software is required. This software can be challenging for businesses to implement and requires IT expertise to handle updates and maintenance.

RFID in the Food Supply Chain – 20033
RFID and RFID tags are encoded with information that can be transmitted to a reader device via radio waves, allowing businesses to identify and track products and assets. The reader device translates the radio waves into usable data, which then lands in a database for tracking and analysis.

RFID tags hold a lot more data than barcodes—and data is accessible in remote locations and easily shared along the supply chain to boost transparency and trust. Unlike barcode scanners, which need a direct line of sight to a code, RFID readers can read multiple tags at once from any direction. Businesses can use RFID to track products from producer to supplier to retailer in real time.

In 2003, Walmart rolled out a pilot program requiring 100 of its suppliers to use RFID technology by 2005.3 However, the retail giant wasn’t able to scale up the program. While prices have dropped from 35–40 cents during Walmart’s pilot to just 5 cents each as of 2018, RFID tags are still more expensive than barcodes.4 They can also be harder to implement and configure. Since active tags have such a long reach, businesses also need to ensure that scammers can’t intercept sensitive data.

Blockchain – 20175
A blockchain is a digital ledger of blocks (records) used to record data across multiple transactions. Changes are recorded in real-time, making the history unfalsifiable and transparent. Along the food supply chain, users can tag food, materials, compliance certificates and more with a set of information that’s recorded on the blockchain. Partners can easily follow the item through the physical supply chain, and new information is recorded in real-time.

Blockchain is more secure and transparent, less vulnerable to fraud, and more scalable than technologies like RFID. When paired with embedded sensors and RFID tags, the tech offers easier record-keeping and better provenance tracking, so it can address and help solve traceability problems. Blockchain boosts trust by reducing food falsification and decreasing delays in the supply chain.6

On the negative side, the cost of transaction processing with blockchain is high. Not to mention, the technology is confusing to many, which hinders adoption. Finally, while more transparency is good news, there’s such a thing as too much transparency; there needs to be a balance, so competitors don’t have too much access to sensitive data.

Cloud-Based Demand Forecasting – 2019 to present7
Cloud-based demand forecasting uses machine learning and AI to predict demand for various products at different points in the food supply chain. This technology leverages other technologies on this list to enhance communication across supply chain partners and improve the accuracy of demand forecasting, resulting in less waste and more profit for the food industry. It enables huge volumes of data to be used to predict demand, including past buying patterns, market changes, weather, events and holidays, social media input and more to create a more accurate picture of demand.

The alternative to cloud-based demand forecasting that is still in use today involves Excel or manual spreadsheets and lots of number crunching, which are time-intensive and prone to human error. This manual approach is not a sustainable process, but AI, machine learning and automation can step in to resolve these issues.

Obtaining real-time insights from a centralized, accurate and accessible data source enables food suppliers, brokers, distributors, brands and retailers to share information and be nimble, improving their ability to adjust supply in response to factors influencing demand.8 This, in turn, reduces cost, time and food waste, since brands can accurately predict how much to produce down to the individual SKU level, where to send it and even what factors might impact it along the way.

Speeding Up Adoption

As illustrated in Figure 1, the pace of technology change in the food industry has been slow compared to other industries, such as music and telecommunications. But we now have the tools, the data and the brainpower to create more resilient food supply chains.

Technology adoption, food industry
Figure 1. The pace of technology change in the food industry has been slow compared to other industries. Figure courtesy of Crisp.

Given the inherent connectivity of partners in the food supply chain, we now need to work together to connect information systems in ways that give us the insights needed to deliver exactly the rights foods to the right places, at the right time. This will not only improve consumer satisfaction but will also protect revenue and margins up and down food supply chains and reduce global waste.

References

  1. Weightman, G. (2015). The History of the Bar Code. Smithsonian Magazine.
  2. Locken, S. (2012). History of EDI Technology. EDI Alliance.
  3. Markoff, R, Seifert, R. (2019). RFID: Yesterday’s blockchain. International Institute for Management Development.
  4. Wollenhaupt, G. (2018). What’s next for RFID? Supply Chain Dive.
  5. Tran, S. (2019). IBM Food Trust: Cutting Through the Complexity of the World’s Food Supply with Blockchain. Blockchain News.
  6. Galvez, J, Mejuto, J.C., Simal-Gandara, J. (2018). Future Challenge on the use of blockchain for food traceability analysis. Science Direct.
  7. (2019). Crisp launches with $14.2 million to cut food waste using big data. Venture Beat.
  8. Dixie, G. (2005). The Impact of Supply and Demand. Marketing Extension Guide.
Mike Edgett, Sage

COVID-19 Leads Food Companies and Meat Processors to Explore AI and Robotics, Emphasize Sanitation, and Work from Home

By Maria Fontanazza
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Mike Edgett, Sage

The coronavirus pandemic has turned so many aspects of businesses upside down; it is changing how companies approach and execute their strategy. The issue touches all aspects of business and operations, and in a brief Q&A with Food Safety Tech, Mike Edgett of Sage touches on just a few areas in which the future of food manufacturing looks different.

Food Safety Tech: How are food manufacturers and meat processors using AI and robotics to mitigate risks posed by COVID-19?

Mike Edgett: Many food manufacturers and meat processors have had to look to new technologies to account for the disruptions caused by the COVID-19 pandemic. While most of these measures have been vital in preventing further spread of the virus (or any virus/disease that may present itself in the future), they’ve also given many food manufacturers insight into how these technologies could have a longer-term impact on their operations.

For instance, the mindset that certain jobs needed to be manual have been reconsidered. Companies are embracing automation (e.g., the boning and chopping of meat in a meatpacking plant) to replace historically manual processes. While it may take a while for innovations like this to be incorporated fully, COVID-19 has certainly increased appetite amongst executives who are trying to avoid shutdowns and expedited the potential for future adoption.

FST: What sanitation procedures should be in place to minimize the spread of pathogens and viruses?

Edgett: In the post-COVID-19 era, manufacturers must expand their view of sanitation requirements. It is more than whether the processing equipment is clean. Companies must be diligent and critical of themselves at every juncture—especially when it comes to how staff and equipment are utilized.

While working from home wasn’t a common practice in the manufacturing industry prior to March 2020, it will be increasingly popular moving forward. Such a setup will allow for a less congested workplace, as well as more space and time for bolstered sanitation practices to take place. Now and in the future, third-party cleaning crews will be used onsite and for machinery on a daily basis, with many corporations also experimenting with new ways to maintain the highest cleanliness standards.

This includes the potential for UV sterilization (a tactic that is being experimented with across industries), new ways to sterilize airflow (which is particularly important in meatpacking plants, where stagnant air is the enemy) and the inclusion of robotics (which could be used overnight to avoid overlap with human employees). These all have the potential to minimize the spread of pathogens and, ultimately, all viruses that may arise.

Mike Edgett, Sage
Mike Edgett is an enterprise technology and process manufacturing expert with 20+ years leading business strategy for brands such as Infor, Quaker Oats and Bunge Foods. At Sage, he leads the U.S. product marketing team focused on the medium segment.

FST: How is the food industry adjusting to the remote working environment?

Edgett: While the pandemic has changed the ways businesses and employees work across most industries, F&B manufacturers did face some unique challenges in shifting to a remote working environment.

Manufacturing as a whole has always relied on the work of humans, overseeing systems, machinery and technology to finalize production—but COVID-19 has changed who and how many people can be present in a plant at once. Naturally, at the start of the pandemic, this meant that schedules and shifts had to be altered, and certain portions of managerial oversight had to be completed virtually.

Of course, with employee and consumer safety of paramount concern, cleaning crews and sanitation practices have taken precedent, and have been woven effectively and efficiently into altered schedules.

While workers that are essential to the manufacturing process have been continuing to work in many facilities, there will likely be expanded and extended work-from-home policies for other functions within the F&B manufacturing industry moving forward. This will result in companies needed to embrace technology that can support this work environment.

FST: Can you briefly explain how traceability is playing an even larger role during the pandemic?

Edgett: The importance of complete traceability for food manufacturers has never been greater. While traceability is by no means a new concept, COVID-19 has not only made it the number one purchasing decision for your customers, but [it is also] a vital public health consideration.

The good news is that much of the industry recognizes this. In fact, according to a survey conducted by Sage and IDC, manufacturing executives said a key goal of theirs is to achieve 100% traceability over production and supply chain, which serves as a large part of their holistic digital mission.

Traceability was already a critical concern for most manufacturers—especially those with a younger customer base. However, the current environment has shone an even greater spotlight on the importance of having a complete picture of not only where our food comes from—but [also] the facilities and machinery used in its production. Major budget allocations will surely be directed toward traceability over the next 5–10 years.

FDA

FDA Unveils Blueprint for New Era of Smarter Food Safety

By Food Safety Tech Staff
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FDA

Today FDA released the New Era of Smarter Food Safety Blueprint. The much-anticipated document was originally scheduled for release in March but was delayed due to the agency’s response to COVID-19. Although the agency’s plan places a lot of focus on the use of new technology, FDA Commissioner Stephen Hahn, M.D., stressed that it is also about enabling more effective methods and processes.

FDA’s Blueprint for the Future breaks down the four core elements of the plan:

  • Tech-Enabled Traceability. A lesson learned during the coronavirus pandemic was that there is a need for greater traceability and visibility in the supply chain. “One of the challenges we’ve faced over the years is recurring outbreaks of illnesses associated with the consumption of certain foods,” said Hahn. “What this daunting problem underscores is the critical importance of the FDA working with industry so that we can rapidly trace a contaminated food to its source. And when I say rapidly, I mean minutes, not days, weeks, or even longer.
  • Smarter Tools and Approaches for Prevention and Outbreak Response. Here, the FDA is emphasizing the “power of data”. “The plans embraced by the blueprint include strengthening our procedures and protocols for conducting the root cause analyses that can identify how a food became contaminated and inform our understanding of how to help prevent that from happening again,” said Hahn.
  • New Business Models and Retail Modernization. This element address food production and delivery, as well as food safety in restaurants and the retail setting.
  • Food Safety Culture. “The pandemic has given us a new perspective on what we mean by food safety culture,” said Hahn. He stated that beyond influencing human behavior, food safety culture must also address worker safety and consumer education.

View the New Era of Smarter Food Safety: FDA’s Blueprint for the Future.