Tag Archives: automation

Randy Fields, Repositrak
FST Soapbox

Sanitary Transportation Rule: Ignore at Your Own Peril

By Randy Fields
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Randy Fields, Repositrak

FDA posted the FSMA rule on the Sanitary Transportation of Human and Animal Food in April. The majority of retailers, wholesalers, suppliers and carriers will have one year to comply with this new rule. The sanitary transportation rule sets out to prevent practices that would introduce contamination risk during the transportation of food through the supply chain.

For retailers, wholesalers, suppliers and carriers, the final rule is really the sleeper regulation among the new FSMA laws. You probably have your HAACP plans and preventative control procedures in place, but do you have the necessary documents in place with your carriers to meet the FDA’s requirements?  And, are those documents easily accessible?

Under FSMA, you must address all FDA record inquiries within 24 hours, and these inquiries can go back two years, plus 12 months beyond the expiration of related service agreements. Failure to respond to an FDA records inquiry is considered a “prohibited act” and can land you in hot water with both the FDA and Department of Justice, which acknowledged they will enforce FSMA through civil and criminal penalties. That’s a game changer.

You are now required to ensure that transportation equipment does not cause the food it is carrying to become unsafe. You must also maintain adequate temperatures throughout your portion of the supply chain and prevent cross contamination. And, you must train your personnel in sanitary practices. All of these factors—processes and procedures, agreements and formal training of personnel—must be documented and made available to the FDA. Put simply, compliance with FSMA is proven through documentation because according to the FDA, if it is not documented, it did not happen!

So what’s the best way to comply with the new rules? Having the information on paper in filing cabinets simply won’t do. Can you imagine searching for specific confirmation that an employee received the proper training in a bank of file cabinets? Even with an efficient system, that could be like looking for a needle in a haystack. Collecting the information in spreadsheets is only slightly better, as it simply digitizes the disorganization.

Retailers, wholesalers, suppliers and carriers need to start their compliance process by reviewing and understanding all of the FSMA rules, guidance procedures and responsibilities. You ignore them at your own peril.

Then, consider automating your recording keeping system.  It is really the only way to efficiently collect and manage the documentation needed to comply with the new law.  When reviewing technology options, make sure you choose a system that is not only easy to use by frontline workers, but also provides sophisticated reporting and alerts to point out potential problems in real time. And, if possible, the solution should do more than just report on food safety activities. As long as you’re investing in a technology to meet FSMA requirements, you might as well implement a system that can potentially save money in other areas such as managing business or training documentation, new vendor approvals, or carrier optimization.

The bottom line is that the sanitary transportation rule will require that you devote additional resources to make the entire extended grocery channel more risk free for consumers and companies alike. And the best way to do that is to implement new technology that gives visibility to product transfers from point of production or processing to the point of purchase, and documents each step along the way.

Stack of papers and folders

Supplier Documentation: To Automate or Not to Automate

By Maria Fontanazza
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Stack of papers and folders

Q&A Part I: Hiring and Training, Understanding FSMA Remain Big Industry ChallengesIn part two of Food Safety Tech’s Q&A with TraceGains, Anthony Arocha (customer success consultant), Rajan Gupta (vice president of customer success), and Jason Ulrich (customer success manager) explain the factors at play surrounding the lack of supplier documentation in the food industry.

Food Safety Tech: Just 44% of respondents said they automate supplier documents. What information can you glean from this? Why aren’t more companies automating?

Arocha: Companies understand that using technology is essential to manage the increasing demands on accurate food safety documentation and verification. For many companies, it is likely to be just a timing and resource issue as to why they have not yet adopted automation—timing as in they have not yet reached the pain threshold required to justify the new cost to implement and to have a resource to support or focus on it. As companies grow and new budgets get created, it is just a matter of time before they will have to include automation help if they have not already.

Gupta: I believe lack of internal respect for QA and thus lack of education and funding are key contributors to this area. Most of the quality staff is stuck doing daily activities with limited time to explore options to make their processes better. Lack of empowerment to make business process changes is also a large factor in not adopting technology. Marc states that the companies have silos as indicated by the transparency gains from technology—while that is true, the root cause of this may be that the various groups within an organization have never really paid attention to FSQA areas and thus never envisioned having access to information that can help the organization proactively manage risk and increase food safety awareness.

Ulrich: This is all about people money, and time. The industry as a whole doesn’t have enough in quality departments. The lack of qualified individuals available in QA departments has always been an issue. The money is usually used to improve production and other departments except quality. That leaves the limited resources in the department with very little time to review and implement new processes or software.

Food Safety ad Quality Assurance Survey, TraceGains
2016 Annual TraceGains Food Safety & Quality Assurance (FSQA) Professional Survey (Figure courtesy of TraceGains)

FST: Regarding supplier documentation management, where are companies falling short?

Arocha: Supplier document management is not easy. You are at the mercy of your vendors. I think the biggest issue is trying to do everything too fast versus having a risk-based approach and focusing on the top priority items first. Build on success. If you try to do too much too fast, it is hard to pick out the success stories easily and can become overwhelming.

Gupta: Anthony is right but he is also stating the obvious problem – “mercy of vendors”. We believe that technology such as TraceGains Network can improve efficiency greatly in sharing documentation and risk-based data, but lack of education and rapid acceptance within the industry of new approaches hinders innovation and limits already stretched resources to take shortcuts that may not be the best course of action long-term.

Ulrich:  In addition to what Marc, Anthony and Raj stated most are afraid to challenge the supplier. There is a fear of making them angry or asking for too much.

How Automated Inventory Tracking Systems Contribute to Food Safety

By Ryan Hardy
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When a business decides to invest in technology, the primary driver is usually to save money over the long term. As with most automated systems, inventory management tools can reduce costs by saving time and resources used to manage inventory.

But the benefits that automated inventory tracking can provide through traceability (of lots, batches, and even individual items) go beyond the financial. These systems can also be used in every aspect of your food safety program from helping with compliance, to improving your quality controls.

Exchange knowledge about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MORE

In a nutshell, having an automated system that allows full visibility into the supply chain—that is, one that identifies in real time where items are being used and where they are sent, while retaining a historical record of that flow through the chain—makes it much simpler and faster to implement procedures to ensure the safety of the food you produce.

All about Accuracy and Speed

Speed and accuracy make a huge difference when it comes to dealing with potentially contaminated food. Being faster and more accurate than a manual inventory method is the most immediate benefit that an automated system brings to your food safety program.

The most compelling reason for having accurate and readily accessible track-and-trace data is to handle food recalls and to comply with requests for documentation from government agencies such as the FDA. In cases where consumer health is at risk, that information needs to be delivered quickly to prevent further harm, and it must be accurate to enable investigators to move in the right direction. Responding to requests for detailed documentation within a 24-hour timeframe can be nearly impossible if you are not using an automated system.

Even when the situation doesn’t involve a federal investigation, once a situation in which possible contamination or mislabeling arises, the faster you have accurate and detailed data, the faster your internal processes can move forward.

If the issue is identified through your quality control process, you will be more likely to be able to prevent contaminated product from reaching the retail outlet and thus getting into the hands of the consumer. Having traceability built into your inventory management systems provides immediate knowledge about whether a product using ingredients from the same batch have entered the distribution chain, and if so, where they are going. This greatly improves the likelihood of limiting the cost and scope of a recall.

Depending on the specific technology you employ, an automated system can provide immediate access to the track and trace information for specific ingredients at least one step backward and one step forward, as required by the Bioterrorism Act of 2002. A supply chain that integrates the most sophisticated technology, such as DNA tracking, can trace an item all the way from the farm or border to the individual consumer or restaurant kitchen.

This traceability means that if an ingredient was already contaminated before it entered your production line, the inventory tracking system can identify all products using that ingredient from the contaminated lot and thus will help you define the scope of the problem. This automation can go a step further by identifying where the ingredient lot originated, and thus help trace the ingredient at least one step backward to the vendor. If the vendor (whether a distribution company or a direct supplier) has traceability in an automated system, or if you are using a system hosted by a distribution partner, tracing the source farther back than one step is possible.

Such information can help you respond more quickly to FDA requests for product information and support the agency’s efforts in product traceability.

Protect Your Reputation

Just as using tracing technology can help identify potential contamination sources quickly, it can also be used to eliminate sources more quickly and accurately, thereby speeding up investigations into food contamination incidents. The faster a company can be eliminated from an investigation, the less time is taken away from normal production. In addition, quick exclusion can protect a company’s reputation from harm.

Additional Benefits

Through their ability to store specific data that can be used to identify potential risks, automated track and trace systems contribute to many preventive food safety measures as well as to the following corrective responses:

  • For perishable products, automated traceability can identify how long specific perishables have been in supply chain. This allows you to avoid using ingredients close to spoilage and to remove overdue products from the distribution chain.
  • During mock recalls, automated tracking systems reduce the time spent away from regular production and allow you consistent information throughout the organization, eliminating wasted effort due to miscommunications.
  • Automated systems reduce the time needed for notifications both internally and externally in the case of an incident affecting food quality or safety. This leads to faster line clearance and faster isolation of the possibly contaminated product.
  • With more effective accounting for possibly affected batches, you can better identify where to apply cleanup measures in the production chain.

In short, automated tracking can improve implementation of preventive controls to stop the contaminated product from reaching the marketplace, and in cases in which corrective actions are required, the automated system can help you respond more quickly and can reduce the scope of risk.

Not just Foodstuffs

Although raw ingredients and food products obviously require traceability, they aren’t the only traceable inventory that can impact food safety. Automated lot tracking can enhance food safety efforts related to all inventory items used in food processing/manufacturing:

  • Packaging. A sub-standard packaging lot can allow incursion of harmful substances or the growth of harmful bacteria. Leakers can contaminate an entire batch of meat or poultry product. Automated lot tracking can help you rapidly isolate the bad lot and know which production lines have already used the sub-standard materials.
  • Labeling. If an inferior adhesive has been applied to a batch of labels, you can identify which product lots to pull from the distribution chain. You can do the same if your quality controls find a batch of inaccurate labels.
  • Protective equipment and clothing. Gloves, masks and other protective gear must function properly to ensure the safety of your workers and also to prevent contamination from being introduced on the production line. An inferior batch of protective gloves that tear during use, for example, could violate your food safety practices. Identifying the bad batch quickly and removing it from the operations area immediately can save potential contamination.
  • Cleaning solutions. Even a batch of cleaning solution can be sub-par. If tests show that cleaning has not eliminated the targeted bacteria, for example, you can more quickly take measures to determine whether the root cause of the problem was a procedural issue or a quality issue with the batch of cleaner.

Beyond the Production Line

The benefits of automated tracking systems to your food safety program extend beyond the production line. They can also enhance decision-making, vendor management and communications functions.

When it comes to potential contamination, decision making needs to be both timely and based on the best information available. Automated systems can provide you with accurate information quickly to help you answer these and other key questions, so that the decision on what actions to take can be based on good information:

  • How widespread is the potential contamination?
  • Where is the product in the production and distribution chains?
  • Have we already exposed consumers?

These systems can put the answers to these questions in front of the appropriate decision makers early in the process. The technology can be configured to allow access to the data via a browser, so if those who make the final decisions are located elsewhere, they can see in real time the same information that you are seeing in the plant. This makes communication about potential contamination more effective and clear, since everyone can see the same thing at the same time, and it can eliminate the potential for miscommunication up the chain of command.

By identifying where bad lots entered your supply chain, automated track-and-trace can enhance supplier accountability. You can accurately see if you have vendors with recurring issues in the quality of the supplies they are providing.

Automated Inventory Tracking Technologies

An automated inventory tracking system depends on three components:

  • A physical component, such as a label or tag, which contains detailed information identifying the specific lot or item.
  • A database, where each discrete data item is stored.
  • A reporting interface that allows people to access and use the identification information. This is the programming code that performs searches, retrieves the data, and formats the information in a formatted report, which is then presented on the screen, saved to a file, or sent to a printer.

The most common physical components used by automated inventory tracking systems rely on barcode or RFID technology, or a combination of both. The choice of which technology to use to integrate into the inventory management database layer of the system depends on a number of factors, but both have been proven extremely accurate (some sources say up to 99%). What is more important than the choice of tracking tools is the quality of the data encoded in them.

The latest in tracking technology uses an engineered DNA marker, in the form of an edible spray. When applied to produce, this DNA marker can track the individual item (i.e., an apple, head of lettuce or onion), along the entire food supply chain, identifying where it was farmed, the date it was picked, and where it was processed.

Whatever form of technology you employ, ensuring that your data is complete and accurate and can be integrated into both your supply and distribution chain is critical to realizing the benefits of that system in supporting your food safety efforts.

The WDS Food Safety Team also contributed to this article.

HACCP and HARPC Plan Management Demands Automation

By Food Safety Tech Staff
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Manual management of HACCP and HARPC plans is often a resource-intensive and inefficient process that can create a data rich vs. information poor sentiment. Next week Dan Bernkopf, vice president of food safety applications at SafetyChain, will share insights on how companies can use automation to help assess risks to effectively create critical control points and preventive controls, during a webinar, “Conquering HACCP/HARPC Plan Management: The Power of Automation”. He will also share insights to help companies learn how automation can ensure that HACCP and HARPC plan components are scheduled, monitored and documented.

How else can automation help companies with their HACCP and HARPC plans?

  • Provide real-time non-conformance reports for CAPAs, minimizing waste and rework
  • Leverage mobile technology to collect food safety data at the source
  • Conduct meaningful trend analysis for continuous improvement with accessible, actionable data
  • Be audit ready for USDA, FDA and customer inquiries

Register for “Conquering HACCP/HARPC Plan Management: The Power of Automation“
Thursday, August 6
1 pm ET / 10 am PDT
The webinar is part of SafetyChain’s FSQA Tech Talk series

Why Should Food Manufacturers Consider Lab Automation?

By Dr. Christine Paszko
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Food manufacturers that think strategically understand that labor efficiency is a measure of how effectively a workforce completes a task in comparison to industry. Companies frequently access efficiency and other metrics to identify weak points in their operations, with the end goal of enhancing data quality and streamlining costs. This approach has led many food and beverage manufacturers to embrace lean manufacturing and six sigma programs in their organizations. These leaders have a clear understanding that labor is money (or money is stored labor), and money equals margins. Food and beverage manufacturers often acquire several raw materials and convert them into finished products for consumers to purchase. These manufacturers have found that robotics and automation have greatly increased productivity and enhanced product quality while maximizing resources and profitability.

LIMS offer a variety of benefits. Image courtesy of ATL
LIMS offer a variety of benefits. Image courtesy of ATL

Ease Operations with Automation

Analytical testing laboratories within food manufacturing firms leverage LIMS to realize automation savings. LIMS is an acronym for Laboratory Information Management System, which can also be a manual paper/Excel based solution, however, this article will focus on completely automated, computerized, enterprise, software solutions. Manual systems are cumbersome, costly, and lack efficiency.

Just as automation and robotics have transformed the food manufacturing process, intelligent laboratory operations leverage LIMS, because it enables increased quality and faster turnaround, while providing significant cost savings. LIMS are computerized systems that organize, manage and communicate all of the laboratory test data and related information such as Standard Operating Procedures (SOPs) and Certificates of Analysis (COAs), final analysis reports, invoices, nutritional labels, formulations and information to support an organization’s operations and meet regulatory compliance goals.

Traditional LIMS facilitate overall laboratory organization, from sample management to test data to final reporting and disposal. LIMS begin with sample management and typically the generation of barcoded labels (of a unique identification number), testing is automatically assigned based on project or sample type (Note: Additional tests can be added or deleted, and ad hoc samples can also be logged). Some laboratories test all raw materials that arrive to confirm acceptance criteria against the COA, in addition to in-process, final product testing and environmental testing. Once samples are logged into the system, worklists are created in the LIMS of the samples to be run and the information is scanned via barcode and sent to the instrument controller. Tests that include associated quality control data are run by loading instruments. Results are electronically imported back into the LIMS from instrumentation (this is the most common and most efficient method). For manual, subjective tests that require interpretation, results must be entered into the LIMS by hand. Managers can also manage and track samples that have been subcontracted to other laboratories (i.e., for testing capabilities that do not exist internally). Once the subcontracted data is submitted back to the laboratory in an electronic format, it can be directly imported into the LIMS, and all data related to the sample is stored in a single, secure database.

Automation significantly reduces cost, enhances quality and provides a means to rapidly scale production. This image shows a cheese processing plant. Image courtesy of ATL
Automation significantly reduces cost, enhances quality and provides a means to rapidly scale production. This image shows a cheese processing plant. Image courtesy of ATL

This approach offers a major advantage, especially to global operations, due to the ability to deliver real-time data across an enterprise. End-users can leverage the technology to make intelligent buying decisions based on product specifications of incoming raw materials, customer demand, specification criteria and blending simulations.

Managers can view a variety of metrics, including the number of samples that have been run for a particular product, statistical process control charts, instruments in service for workload management, and supplier performance in any given period. Complete product traceability is possible.

LIMS has evolved to manage many additional functions, such as communications with ERP/SAP systems, shelf life studies, performing skip lot testing, formulations, and field and plant data collection by integration with tablets and smartphones for real-time updates, managing competitive analysis data as well as special projects. A few of the major areas in which LIMS are leveraged include:

  1. Sample management of all testing initiated
  2. Quality assurance (including in process quality checks)
  3. Workflow management (optimization of processes)
  4. Regulatory compliance (FSMA, GFSI, HACCP, FDA)
  5. Specification management, formulations and blending
  6. Dashboards for real-time updates (in a single site or across operations)
  7. Customer relationship management (organizing and responding to customer inquiries)
  8. Reporting (COA, final analysis and invoice reports)
  9. Inventory management and product release

Enabling Standardization

A LIMS not only enhances communication across a laboratory, but also across a global organization with multiple sites, ensuring effective cooperation and relationships between suppliers, production and customers. A LIMS promotes standardization in global firms and gives management teams real-time data access from site to site, so that data is readily available for better management and resource allocation decisions. Standardization makes business and financial sense, as organizations can realize cost savings in buying testing equipment and supplies in larger quantities, exchanging staff to different sites (potentially reducing training costs), and managing a user-friendly, single secure database that supports localization (each site can implement LIMS in its native language). Standardization does not mean that systems must be ridged; each facility can leverage its own unique workflows and terminology while saving data to a standard database format.

A LIMS can manage an entire organization’s laboratory SOPs or work instructions, and documents associated with the following:
  • Laboratory testing
  • Assets
  • Inventory
  • Laboratory chemicals
  • Supplies
  • Formulations
  • Blending
  • Automated calculations
  • Customer interactions
  • Employee training records
  • Laboratory instrumentation
  • Purchase orders
  • Sample storage
  • Reporting
  • Invoicing
  • Facilitating governmental laboratory compliance requirements

Today, LIMS’ have expanded to manage all aspects of laboratory operations and have significant overlap with ERP, SAP systems and other enterprise solutions. The goal is to move away from multiple separate databases and distinct islands to one centralized data management solution. Amazingly, some laboratories do not make the investment in new LIMS technology and continue use in-house created database systems, manual paper systems and Excel spreadsheets (or a combination of these systems) to manage portions of the critical product testing data. These systems are often costly, labor intensive, subject to data loss, and difficult to manage and maintain.

A LIMS ensures that analytical resources have been best utilized to maximize productivity and efficiency to generate high-quality data to support operations, while facilitating regulatory compliance goals. Organizations that embrace quality often leverage technology such as LIMS, and typically hold ISO 17025 certification and embrace six sigma, lean manufacturing and other best practices.

Robotics has transformed food manufacturing to allow greater volumes of final product to be produced, with an emphasis on speed, standardization, consistent product quality and volume, with increased efficiency and cost savings. LIMS’ have transformed the manufacturing process and the laboratory analysis process from raw material testing to in-process /environmental testing and finished product testing. For example, on-line monitors can feed data into an LIMS (i.e. flow, temperature from freezers or incubators), and if there are any alarming data points, instant notification is provided to the team via email or a phone call. This rapid response saves time for a corrective action to be put into place. Within the laboratory, if a shelf life study is underway and the incubator fails, an alert can be sent after one out-of-range temperature measurement, allowing the problem to be corrected and the study saved, versus having to start over.

The analytical testing group in any food and beverage testing facility generates hundreds, thousands, even millions of data points a year. They gather data on raw materials (based on COAs), in-process manufacturing (quality checks, statistical process control and specification confirmation), environmental monitoring, and finished product testing as well as performing competitive analysis. These are some of the main areas that are impacted by sample collection and testing. LIMS and laboratory automation have transformed the way that data is collected, monitored and analyzed. Today’s LIMS’ are based on modern technology, providing a valuable tool to ensure that product is within specification, and collected and disseminated in real-time to improve efficiency, reduce costs, increase profitability.

SafetyChain Software

Six Steps to Getting a Handle on Cost of Quality

By Barbara Levin
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SafetyChain Software

The importance of food safety is understood and hopefully, unquestioned. It is industry’s responsibility to protect consumers and of course, a major food safety event can ruin a company’s brand and financial health.

Yet when it comes to food quality management, the complexities and overall economics of quality are often underestimated. While lapses in food safety can destroy a brand, it is the consistent adherence to food quality attributes that build brand loyalty. This is why that brand of bread always has that certain softness, or why that French fry always has the same taste regardless of where you buy it. And that is why manufacturers continue to purchase, or decide not to purchase, ingredients from certain suppliers.

Food quality management can often be more complex than food safety. Think 3 CCPs vs. 30 quality attributes, for example. And, Cost of Quality can have the biggest impact on a food company’s overall key performance indicators (KPIs), profitability and brand reputation. Non-conformances in food quality often cause the most rework and the most customer rejections, which has a significant impact on what can be referred to as the Economics of Food Quality Management.

Since most food safety and quality assurance (FSQA) operations are often “data rich and information poor” — meaning they don’t have an effective way to do trending and benchmarking on the volume of quality data they collect — it can be difficult to fully understand, and therefore reduce, Cost of Quality.

Getting a handle on Cost of Quality is a process. These six steps are a good place to start:

  • Define quality in your organization
  • Determine the right metrics for a better understanding of Cost of Quality
  • Improve transparency and visibility of your processes, products and supplier quality requirements
  • Fully understand where your quality risks come from
  • Make your quality data both accessible and actionable for continuous improvement to reduce Cost of Quality
  • Understand what tools are available, such as automation technologies, that can improve performance and lower Cost of Quality

SafetyChain is hosting a complimentary webinar, “The Economics of Food Quality Management: Understanding and Reducing Cost of Quality,” on June 25. The event features Lamont Rumbers, president and founder of Fully Integrated Quality Solutions, and former senior director of quality for Sam’s Club. Rumbers will discuss these six steps and much more. Learn more about the webinar and register.

Randy Fields, Repositrak
FST Soapbox

Despite FSMA Exemptions, Compliance Will Not Be Optional For Small Suppliers

By Randy Fields
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Randy Fields, Repositrak

The product recall at Blue Bell Creameries earlier this year is yet another example of food safety issues negatively impacting food marketers, growers, processers and manufacturers. We all remember the Peanut Corporation of America’s salmonella outbreak in 2008 and the Jensen Farms listeria outbreak in 2011. Salmonella-tainted eggs in 2010, E. coli in strawberries in 2011, and listeria in caramel apples last Halloween combined with dozens of others during the last six years, have sickened thousands and killed dozens of people.

The brand reputation impact from the incidents at Peanut Corporation of America and Jensen Farms was terminal—both companies went bankrupt. The effect on Blue Bell, while likely not fatal, is expected by industry experts to be substantial and include loss of revenue and market share. The company has already announced plans to lay off more than 1,000 workers as a result of the recall.

In addition, growers saw cantaloupe consumption take a nosedive after the Jensen Farms listeria outbreak, which was one of the worst foodborne illness outbreaks in U.S. history in terms of number of deaths. They are only now seeing sales levels return to those before the incident. And because the farm itself went out of business, personal injury lawyers went after the companies that sold the disease-ridden cantaloupes—the retailers. By virtue of last year’s out-of-court settlement by Walmart on the Jensen Farms lawsuit, both suppliers and retailers are now responsible for everything they sell.

Enter the Food Safety Modernization Act, signed in 2011 and about to begin finalization in August. FSMA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection. Add these records to the business relationship records that retailers and suppliers should already be maintaining (including indemnifications and certificates of insurance that help manage brand risk), and you’d think our risk of foodborne illness is about be eradicated.

Although FSMA represents the most sweeping change to our food safety laws in the last 70 years, it may not have the greatest impact where the supply chain is most vulnerable. Today the largest suppliers that sell the majority of our food have very sophisticated systems to ensure safe food production and transportation. This group will have the easiest path to compliance with FSMA, and they most likely already hold themselves to a higher standard. It’s actually the smaller suppliers, which likely do not have the available resources or sophistication to comply with FSMA requirements, that will be exempt from certain documentation under FSMA based on their size. This group of suppliers is growing rapidly to meet consumer desire for fresh food that is locally grown and produced. Unfortunately for them, it’s only a matter of time before wholesalers and retailers decide that the risk is too great to continue to do business with these small suppliers.

The good news is that technology exists that can help small suppliers reduce risk in their extended supply chains. Affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation. Suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall. This move to automation will help all suppliers not only meet the demands of FSMA, but also establish a base for retailer and consumer demands for transparency in the supply chain going forward.

Having a comprehensive food safety system is quickly becoming a competitive advantage. Retailers and consumers are looking for those suppliers that have an unblemished safety record and are transparent about their safety processes, so the time is now for small suppliers to hold themselves to a higher standard than FSMA requires for future business opportunities. The stakes are just too high for retailers and wholesalers to not verify that everything they sell to consumers is produced and transported safely.

Ask the Experts – Automation Pathogen Detection

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An ideal pathogen detection solution should provide increased confidence in results, high reproducibility and robustness to routine testing labs, fit seamlessly in laboratory workflow without disrupting it, and work well for medium-to high-throughput testing laboratories. This Q&A provides some insights.

Q: How can an automation system help safeguard against false negative pathogen results?

Pathogen testing can typically be broken up into three categories:

  1. Raw material testing;
  2. Finished product testing; and
  3. Environmental monitoring.

Regardless of the type of testing that is done, it is clear that pathogen detection is an important component of any hazard analysis and risk-based preventative control program. Verification of results is crucial, particularly negative results. When performing pathogen testing with a real-time PCR based assay, the presence of an internal amplification control is critical. When present for each individual sample, the internal control monitors for inhibition, which can be common with matrices such as spices and chocolate. When a negative result is obtained, it is important to know if that sample is truly negative because the pathogen of interest is not present or if the reaction was inhibited.

Another potential for false negative results can come from technician error. If a sample is not actually added to the reaction block, tube or strip for testing, the result will be negative. Therein lies the power of an automation system. The iQ-Check Prep automation system employs a liquid level sensing volume verification step at the beginning of the run. Utilizing monitored air displacement technology and conductive pipette tips, users are alerted if a sample was missed in the setup. The user then has the option to add the sample or skip it and continue the run. If the sample is not added, the result is flagged as invalid. Combining the internal control of iQ-Check real-time PCR detection kits with the verification of the iQ-Check Prep automation system, users can be confident in their results and safeguard against false negatives.

Q: How can an automation system be incorporated into a laboratory without disrupting existing workflow?

Incorporating an automation system into a laboratory can greatly increase efficiency, traceability and throughput…if it is the right solution for the lab. Many factors need to be taken into consideration, for example batch processing. Examining time intervals at which samples finish incubation can determine how batch processing fits into the lab workflow. Technician responsibilities also play a part. Does the system require monitoring and continuous feeding of samples or is it a walk away system that frees technicians up to perform other lab duties? Another important consideration is maintenance. The scheduled upkeep of the system needs to be evaluated not only for the amount of time required but for the cost associated with the maintenance.

The iQ-Check Prep system was designed with efficiency in mind. Samples are processed in batches (plates of 94 samples at a time) for a throughout of >500 samples per instrument per eight hour shift. The system is a true walk away system that does not require constant monitoring or continuous feeding. The maintenance is self-contained and completed by the instrument in 5 minutes. These are just a few questions to ask when considering an automation system for the laboratory. The chosen system should fit effortlessly into the laboratory workflow and increase throughput and efficiency without causing major disruptions.

For more information, visit Bio-rad.com. 

Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific
In the Food Lab

Molecular Diagnostics – Generation 3: 2005 to Present

By Ravi Ramadhar
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Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific

In my previous blog, I covered the first two generations of Molecular Diagnostics: Generation one, was the advent of these tests prior to 1995, while the second generation saw the evolution of molecular diagnostics with the emergence of standardized food molecular and method workflow.

The advent of automated DNA sequencing and use of multiple fluorescent dyes by companies like Applied Biosystems and Roche led to the development of multiple fluorescent dyes and real- time quantitative PCR systems (qPCR). At first these qPCR systems were only used in the research environment, but quickly found their way to the food industry.

Applications such as quantitation of GMOs and multiple pathogen targets became common. Real-time PCR systems permitted users to visualize amplification as it happened and enabled simultaneous detection of multiple targets. With the use of newer chemistries and improved enzymes, shorter amplification cycles – sometimes as low as 40 minutes – could be achieved. The real-time systems offered faster time-to-result with additional target probes and thus higher target specificity. As with most molecular methods, the workflow was sensitive to food matrix inhibition and required alternative sample preparation methods to meet the wide variety of food matrixes.

Within this generation of solutions, alternatives were introduced, that promised faster, easier or more sensitive results. These included alternative to either the detection method or enzymes utilized Iisothermal amplification, for example without need for multiplexing capability of qPCR or internal controls, as well as targeting alternative nucleic acid such as RNA were introduced to the food market. These incremental improvements did not lead to any significant new paradigms or improvements to the food testing workflow. Their emergence instead led to an explosion of additional and alternative molecular platforms for food, without any real innovation. Within this, solutions introduced to the food industry eventually brought us to where we are today.

Directly taking systems from the clinical diagnostics workflow and introducing these platforms and systems as food solutions. While these systems automate the entire workflow or automate the PCR setup it remains to be seen if with their higher complexity and high maintenance these systems can survive the food industry. The basic molecular workflow for food has remained intact since its introduction in the late 1990s with innovation more or less stagnant. What’s needed is for someone to truly develop a platform from the ground up with the food laboratory in mind.

Today’s landscape and what’s next

Today, there are some early signals of where innovations and changes for food labs will emerge. A recent poster by Nestle, for example, highlighted the uses of next-generation sequencing (NGS) and DNA sequencing to develop a DNA method to allow the identification of coffee varieties through the value chain, from the field to the finished product. The method is applied on routine basis to guarantee the purity and authenticity of raw material used by Nespresso.

Applications of NGS in outbreak response and trace back investigations are being used in parallel with existing technologies. Finally, availability of new sequencing data enables better assay design and development of adjacent technologies.

NGS was preceded by emulsion amplification and sequencing by synthesis. These developments led to the development and introduction of digital PCR. Within a digital PCR reaction, millions of simultaneous reactions from one sample occur. The advantages of dPCR include lower and absolute, not relative gene copy number. The data has high precision and has better tolerance to inhibitors. These characteristics can lead to better and more precise molecular tests in food. , Before dPCR wide spread adoption is seen, however, the limitations of high cost and limited dynamic range must be addressed.

It’s not only in the testing labs and adjacent technologies that NGS is having an impact. In the labs driving innovation in food and food ingredient development, applications of NGS are being used to develop targeted food ingredients.

Nestle is the leader in this convergence of food, health and nutrition and over the last three years, the company has acquired and formed partnerships targeting the space. In its formation of the Nestle Institute of Health Sciences, Emmanuel Baetge, head of NHIS, emphasized NHIS expertise and research capabilities using systems biology, next generation sequencing, and human genetics.

The world of food safety is as dynamic as the natural flora of food itself. Changing regulations, evolving organisms, technological change and consumers’ changing tastes require new solutions. The requirements of the food laboratory have not changed. They are the protectors of brands and the teams we trust to deliver safe and quality foods. However, how they do that has and will continue to change.

Next time… molecular serotyping.

References:

  1. Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program (GSP) Available at: www.genome.gov/sequencingcosts. Accessed 1/13/2014 [DOA 1/13/12014].
  2. Beilei Ge and Jianghong Meng , 2009 14: 235 Advanced Technologies for Pathogen and Toxin Detection in Foods: Current Applications and Future Journal of Laboratory Automation DOI: 10.1016/j.jala.2008.12.012.
  3. Morisset D, Sˇ tebih D, Milavec M, Gruden K, Zˇ el J (2013) Quantitative Analysis of Food and Feed Samples with Droplet Digital PCR. PLoS ONE 8(5):e62583. doi:10.1371/journal.pone.0062583.
  4. http://www.nestle-nespresso.com/asset-libraries/Related%20documents%20not%20indexed/Nespresso%20poster%20ASIC2012%20DNA%20traceability.pdf