Tag Archives: Testing

In the Food Lab

New Dynamics in Environmental Testing

By Erin Dreyling, Ph.D
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Recent recalls and outbreaks associated with Listeria coupled with FDA’s finalization of the FSMA preventive controls rule have heightened the industry’s need to focus on environmental testing programs. The need for a preventive control program with higher resolution is especially highlighted by the government’s increasing use of whole genome sequencing data to more rapidly link human illness to food processing establishments. I work with many customers who simply do not recognize all of the factors that influence their ability to detect Listeria in environmental samples. For many, an environmental sample is collected, shipped to a third-party lab, results are received within two to four days, and few questions asked. Most companies have not invested the time and resources needed to truly understand how each component of an environmental sample impacts their ability to detect Listeria. So what factors should be considered to maximize Listeria detection in the plant environment?

Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREListeria is a True Survivor

Listeria is inherently a hearty organism that can withstand highly adverse conditions in the plant environment. It is able to survive and grow across a wide range of temperatures, including refrigeration, and it is more tolerant to heat than Salmonella and E. coli. Additionally, the organism survives across a wide pH range, including extended periods in highly acidic conditions, and can survive food processing and preservation with up to 25.5% salt. These traits may result in highly injured Listeria being collected in environmental samples, and requires optimization of the sample collection and analysis process in order for detection and culture confirmation to occur.

Sanitation Programs May Not Destroy Listeria

Sanitation practices are intended to destroy Listeria in the plant environment, but not all sanitizers will be 100% effective. In some cases, sanitizers may not fully kill Listeria, leaving highly injured Listeria that may require an extended lag phase in order for growth and detection during testing. Sub-lethally injured Listeria remains a food safety concern, as the bacteria maintain the ability to recover and flourish in a nutritive environment. Additionally, Listeria readily forms biofilms in the plant environment, which many traditional sanitizers do not effectively remove. Biofilms in the plant environment may maintain low levels of Listeria that may be challenging to detect without the use of a sensitive detection method.

Sample Collection: Choose the Right Tool for the Job

The neutralizing and nutritive capacity of the collection media used with the collection device can have a significant impact on the ability to resuscitate, detect and culture stressed Listeria. When selecting a collection media, it is important to ensure that the media will effectively neutralize the sanitizers used in the plant environment. For instance, peroxyacetic acid and quaterinary ammonia-based sanitizers will not be neutralized well by commonly used collection media such as Neutralizing Buffer or Letheen Broth. Neutralization of the sanitizer in environmental samples is important in order for resuscitation and growth of any Listeria present within the sample. Additionally, use of a collection media that contains nutrients to begin the resuscitation process for Listeria immediately upon collection is also important for detection and culture confirmation of Listeria in samples. Collection media such as Neutralizing Buffer contains monopatassium phosphate, sodium thiosulfate, and aryl sulfonate complex intended only to neutralize sanitizers. Conversely, D/E Broth and HiCap Broth have components to nourish Listeria and facilitate resuscitation in addition to neutralizing sanitizers.

Enrichment Media Determines Recovery & Growth

Enrichment media plays a major role in the speed of recovery and growth of Listeria in environmental samples. Medias that facilitate faster recovery of injured Listeria allow for shortened lag phases facilitating more rapid growth. Enrichment media that facilitate faster recovery and growth allow Listeria to reach the limit of detection for screening tools more quickly. When paired with a highly sensitive method, enrichment media, which foster greater Listeria growth and recovery, can allow for significant reductions in time to results for screening methods. Additionally, faster recovery and growth of Listeria due to enrichment media can increase the likelihood of culturally confirming Listeria found at low levels pre-enrichment.

Not All Detection Methods are the Same

The ability of a detection method to find Listeria in an environmental sample is impacted by two factors: 1) method sensitivity and 2) method robustness in the presence of sanitizers. The more sensitive a rapid test method, the greater the chance of finding low levels of Listeria in an environmental sample. Low levels of Listeria in environmental samples are likely due to the injured state of Listeria in the plant environment post sanitization. Immuno-based rapid methods have a sensitivity of 105–106, DNA-based methods have a sensitivity of 104–105 and RNA based methods have a sensitivity of 102–103. Using an RNA-based method offers 1 to 2 logs greater sensitivity and greatly increases the chance of finding low-level Listeria.1 This can be particularly true when sampling conditions such as collection media or enrichment media are less than optimal for the neutralization of sanitizers and growth and recovery of Listeria.

Another important factor that influences a test method’s ability to detect Listeria in an environmental sample is the method’s ability to amplify and detect the organism in the presence of sanitizers. Most molecular-based methods do not include a sample clean up step resulting in sanitizer being present during the amplification step. For some methods, sanitizers may inhibit amplification, resulting in indeterminate or false negative results.

Confirmation Requires Optimization of the Sampling Process

The ability to culturally confirm a Listeria sample that screens positive is influenced by the entire environmental sampling process. In order to culture confirm samples with highly injured, low-level Listeria, it is necessary to optimize the sample collection media, enrichment media, and confirmation process to provide the greatest likelihood of culture recovery. If Listeria is not adequately resuscitated and able to achieve sufficient growth, the level of Listeria present in the sample post-enrichment may be below the limit of detection for culture. The likelihood of culture confirmation can be increased by incorporating steps such as a secondary enrichment or concentration via IMS capture. Culture confirmation for samples that screen positive on a rapid method can be especially challenging if a highly sensitive test method is used for screening that may detect Listeria at lower levels than culture. Thus, optimizing the environmental sample program is especially important if confirmation of screening results for highly sensitive methods is desired.

Method Sensitivity and Increased Positivity

Employing a highly sensitive screening tool for environmental samples provides a better lens to view risk within the food safety processing environment. Many companies fear that a more sensitive method will result in significant increases in positivity and cost for increased sanitation. In working with customers who have moved from immune-based methods to a highly sensitivity molecular method, I’ve observed an initial increase in positivity followed by a leveling off of low-level positivity after enhanced interventions are taken in the plant. Companies that proactively seek out and destroy Listeria in their plants are then able to maintain low level rates of positivity with routine cleaning measures, while also maintaining the confidence that they are using the best tool available for Listeria monitoring.

Understand Your Risk & Establish a Culture of Food Safety

It is important for food safety professionals to fully consider the hidden risks that may exist in their plant environment due to the environmental sample process masking the true presence of Listeria. Each component of the environmental monitoring process, sanitizer, collection media, enrichment media, detection method and culture process plays an important role in a company’s ability to be able to detect and culture confirm Listeria in the plant environment. Optimizing each step within the environmental sample process allows a company to be proactive instead of reactive. This approach creates a company culture of food safety that can seek out, detect and destroy Listeria in the plant environment, can significantly mitigate risk. The good news is that by incorporating the right food safety culture and making data-driven choices, today’s manufacturer can achieve both short-term dividends of risk reduction as well as a long-term elevation of control of its process.

Reference

  1. Culture Shift: The New Dynamics of Listeria Environmental Control and Testing. Roka Bioscience, Webinar.
FST Soapbox

Intelligent Algorithms Shape Food Safety

By Steven Burton
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The North American food safety testing market is projected to reach $16 billion by 2020, according to a recent study by Markets and Markets. In just a few short years, it’s safe to say that purchasing a software solution to create and manage food safety programs will become ubiquitous, equivalent to that of employing any other software tool such as Microsoft Excel.

However, there is a broad range of capabilities for food safety software, and some solutions are much more complex than others. Many types of HACCP software operate as part of an ERP system, merely managing documents online under IT administration. But the technological capabilities of a food safety management system are endless in terms of value-driven innovation. Any competitive software on the market should go further, and be flexible and agile enough to meet and contain the challenges of a changing regulatory landscape and aggressive market space.

One of the ways food safety management can take things further is through the use of intelligent algorithms that can help food safety professionals get the most out of their software—and their HACCP plan. For example, instead of manually searching for all the physical, chemical and biological hazards (as well as radiological hazards under HARPC), intelligent algorithms can use data from other HACCP plans to suggest hazards. By comparing facility types, process flows, ingredients and more, a sophisticated algorithm can make smart suggestions that give food safety professionals a significant leg up, cutting down research time and providing a context of learning since it’s much easier to learn by example than starting from scratch. As such, suggestions can equip food safety professionals with the right mindset to discover potential hazards.

There are core benefits to searching for software technologies that have intelligent algorithms in place to analyze and retrieve data for those food businesses looking to get the most long-term value out of their vendor purchase.

Facilities with High-Risk Products and Complex Process Steps

High-risk foods are defined by the FDA as foods that “may contain pathogenic microorganisms and will normally support formation of toxins or growth of pathogenic microorganisms.” High-risk foods include raw meat, poultry, fish, dairy, fresh fruit, and vegetables, and processors working with these products handle more hazards and process steps in general than processors making low-risk foods. Instead of sorting through hundreds of hazards, facilities with high-risk products and complex process steps are able to skip much of the manual grunt work and simply select automatically generated hazards and process steps suggested to them at their fingertips.

Small Business Owners or Basic Food Safety Professionals

It’s common for small food businesses to put the bulk of their food safety duties on the shoulders of the owner. For many who have no previous background in food safety, there can be an unexpected and frustrating learning curve to overcome before you can pay the sweat equity required to develop a HACCP plan, and not for lack of trying. Similarly, junior food safety employees in new facilities can find established food safety practices challenging to navigate. Through intelligent algorithms, a software system can reinforce food safety hazards and process steps that might have been missed or forgotten by making them instantly available for retrieval and selection.

Giving Back Time

Recordkeeping is an essential component to an excellent food safety culture. In the grand scheme of things, managing resources to allocate time to high-level tasks that require human expertise on the production floor is a critical activity that most food safety professionals prioritize. Having more time to correct potential risk actions is crucial to ensuring the lowest possible likelihood of a recall. Smart software systems facilitate better employee time management practices so they can maximize their hours for meaningful, rather than menial, work. By taking back the time that would have been spent researching hazards, smart suggestions provide food safety professionals with a starting point that allows them to choose from a curated selection without delay.

Experimental Facilities with Changing Product Portfolio

Facilities that have a tendency to experiment with product development (i.e., food startups) are prone to using a significant amount of ingredients and formulas. When it comes time to present the right information for inspections and audits, this translates into a substantial amount of additional work in maintaining a HACCP plan. Intelligent algorithms enable a clear and organized focus, eliminating the minutiae surrounding information management of experimental product development.

New Regulations and International Compliance

Around the world new regulations surrounding acceptable food safety documentation are coming into effect; notably, FSMA even adds to the traditional hazards included under HACCP. For foreign exporters as well as American businesses, regulatory expectations for a more comprehensive approach to hazards and critical control points are higher than in the past. In the face of new regulatory demands, smart algorithms help food businesses lay out a common framework so that they can build internationally compliant programs

Extra Safeguard Check

Human error is inevitable. The beauty of technology is that it acts as a safeguard to ensure there are no glaring omissions that may have an impact on food safety duties. As a final once-over before sending in the HACCP plan, it makes good sense to have smart suggestions to cover all the bases.

Intelligent algorithms allow food safety professionals to do more with their time. By selecting from suggestions related to ingredients, materials, packing and process steps, a considerable amount of time is restored to the work day compared to the time-consuming exercise of manually assembling lists. The main benefit to a food safety software solution with intelligent algorithms is to reinforce the right mindset for listing physical, chemical and biological hazards for ingredients, material, processes and beyond. While smart suggestions should always be verified by a food safety professional familiar with the internal operations of a facility, for companies that aim to work smarter but not harder, smart algorithms are a key feature to keep in mind when researching software vendors.

Counting Food Laboratories

By Robin Stombler
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What We Think We Know

Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.

More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”  In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.

There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.

To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:

  • The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
  • Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
  • It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
  • There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
  • In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.

With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.

Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:

But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…

Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.

Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.

To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?”  The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.

A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?”  Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.

ISO 17025

What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.

What We Need Now

FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.

Steven Guterman, InstantLabs
In the Food Lab

Save Seafood with Digital Tracking

By Steven Guterman, Sarah McMullin, Steve Phelan
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Steven Guterman, InstantLabs

The combination of improved digital tracking along the food supply chain, as well as fast, accurate DNA testing will provide modern, state-of-the-art tools essential to guarantee accurate labeling for the ever-increasing quantities of foods and ingredients shipped globally.

The sheer scale of the international food supply chain creates opportunities for unscrupulous parties to substitute cheaper products with false labels. We know fraud is obviously a part of the problem. Some suppliers and distributors engage in economically motivated substitution. That is certain.

It’s equally true, however, that some seafood misidentification is inadvertent. In fact, some species identification challenges are inevitable, particularly at the end of the chain after processing. We believe most providers want to act in an ethical manner.

Virtually all seafood fraud involves the falsification or manipulation of documents created to guarantee that the label on the outside of the box matches the seafood on the inside. Unfortunately, the documents are too often vague, misleading or deliberately fraudulent.

Oceana, an international non-profit focused solely on protecting oceans and ocean resources, has published extensively on seafood fraud and continues to educate the public and government through science-based campaigns.

Seafood fraud is not just an economic issue. If the product source is unknown, it is possible to introduce harmful contamination into the food supply. By deploying two actions simultaneously, we can help address this problem and reduce mistakes and mishandling:

  • Improved digital tracking technologies deployed along the supply chain
  • Faster, DNA-based in-house testing to generate results in hours

Strategic collaborations can help industry respond to broad challenges such as seafood fraud. We partner with the University of Guelph to develop DNA-based tests for quick and accurate species identification. The accuracy and portability produced by this partnership allow companies to deploy tests conveniently at many points in the supply chain and get accurate species identification results in hours.

Our new collaboration with SAP, the largest global enterprise digital partner in the world, will help ensure that test results can be integrated with a company’s supply chain data for instant visibility and action throughout the enterprise. In fact, SAP provides enterprise-level software to customers who distribute 78% of the world’s food and accordingly its supply chain validation features have earned global acceptance.

The food fraud and safety digital tracking innovations being developed by SAP will be critical in attacking fraud. Linking paper documents with definitive test results at all points in the supply chain is no longer a realistic solution. Paper trails in use today do not go far enough. Product volume has rendered paper unworkable. Frustrated retailers voice concerns that their customers believe they are doing more testing and validation than they can actually undertake.

We must generate more reliable data and make it available everywhere in seconds in order to protect and strengthen the global seafood supply chain.

Catfish will become the first seafood species to be covered by United States regulations as a result of recent Congressional legislation. This change will immediately challenge the capability of supply chain accuracy. Catfish are but one species among thousands.

Increasingly, researchers and academics in the food industry recognize fast and reliable in-house and on-site testing as the most effective method to resolve the challenges of seafood authentication.

DNA-based analyses have proven repeatedly to be the most effective process to ensure accurate species identification across all food products. Unfortunately, verifying a species using DNA sequencing techniques typically takes one to two weeks to go from sample to result. With many products, and especially with seafood, speed on the production line is essential. In many cases, waiting two weeks for results is just not an acceptable solution.

Furthermore, “dipstick” or lateral-flow tests may work on unprocessed food at the species level, however, DNA testing provides the only accurate test method to differentiate species and sub-species in both raw and processed foods.

Polymerase chain reaction (PCR), which analyzes the sample DNA, can provide accurate results in two to three hours, which in turn enhances the confidence of producers, wholesalers and retailers in the products they sell and minimizes their risk of recalls and brand damage.

New technology eliminates multi-day delays for test results that slow down the process unnecessarily. Traditional testing options require sending samples to commercial laboratories that usually require weeks to return results. These delays can be expensive and cumbersome. Worse, they may prevent fast, accurate testing to monitor problems before they reach a retail environment, where brand and reputational risk are higher.

Rapid DNA-based testing conducted in-house and supported by sophisticated digital tracking technologies will improve seafood identification with the seafood supply chain. This technological combination will improve our global food chain and allow us to do business with safety and confidence in the accuracy and reliability of seafood shipments.

DuPont BAX System, Salmonella detection

PCR Assay for Salmonella Detection Gets AOAC-RI Certified

By Food Safety Tech Staff
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DuPont BAX System, Salmonella detection
DuPont BAX System, Salmonella detection
DuPont BAX System X5 PCR Assay for Salmonella detection

Today DuPont announced that the AOAC Research Institute (AOAC-RI) approved a method extension of Performance Tested Method #100201 to include the company’s BAX System X5 PCR Assay for Salmonella detection. Introduced this past July, the PCR assay provides next-day results for most sample types following a standard enrichment protocol and approximately 3.5 hours of automated processing. The lightweight system is smaller and designed to provide more flexibility in testing.

“Many customers rely on AOAC-RI and other third-party certifications as evidence that a pathogen detection method meets a well-defined set of accuracy and sensitivity requirements,” says Morgan Wallace, DuPont Nutrition & Health senior microbiologist and validations leader for diagnostics, in a company release. “Adopting a test method that has received these certifications allows them to use the method right away, minimizing a laboratory’s requirements for expensive, time-consuming in-house validation procedures before they can begin product testing.”

The validation covers a range of food types, including meat, poultry, dairy, fruits, vegetables, bakery products, pet food and environmental samples.

David Hammond, Eurofins, food fraud

Proactive Approach to Preventing Food Fraud

By Food Safety Tech Staff
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David Hammond, Eurofins, food fraud

Several different approaches can be used to verify authenticity of food, from a heteroduplex assay to microsatellite analysis. In part II of a presentation by fruit juice and authenticity expert David Hammond, Ph.D. of Eurofins Scientific at the 2015 Food Labs Conference, learn about the DNA methodologies as well as the proactive steps that companies should be taking to prevent food fraud or economically motivated adulteration of product.

3M Molecular detection assay for Listeria

Molecular Detection Assay for Listeria Promises Faster Results

By Food Safety Tech Staff
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3M Molecular detection assay for Listeria

A molecular detection assay for Listeria monocytogenes has been approved by the AOAC Performance Test Methods

3M Molecular detection assay for Listeria
The new test was developed in response to customer engagement and a desire to work with food processors to protect the world’s food supply, says 3M Food Safety.

(PTM) program. Developed by 3M Food Safety, the assay is based on isothermal DNA amplification and bioluminescence detection technologies. With a streamlined workflow that is 30% faster than the first generation assay, the new test is designed to provide expedited, simple and more accurate real-time pathogen detection.

Obtaining AOAC PTM status involved a thorough independent lab examination of the test method’s ability to accurately detect Listeria monocytogenes within a variety of foods. During the validation study, analyzed food samples included beef hot dogs, queso fresco cheese, vanilla ice cream, 4 % milk fat cottage cheese, 3% chocolate whole milk, romaine lettuce, bagged raw spinach, cold smoked salmon, deli turkey, raw chicken, cantaloupe, and various environmental surfaces (plastic, stainless steel, concrete). Achieving AOAC PTM approval certifies that the test kit is equivalent or better than standard reference methods, according to 3M Food Safety.

Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

Food Safety Testing Must Live Up to Higher Expectations

By Maria Fontanazza
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Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.

Key trends:

  • Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
  • Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
  • The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.

Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?

Tim Curran, CEO of Sample6, pathogen detection
Tim Curran, CEO of Sample6

Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].

Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.

Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.

“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.

These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.

Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.

Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.

Michael Koeris, Ph.D., founder and vice president of operations, Sample6, pathogen detection
Michael Koeris, Ph.D., founder and vice president of operations

Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.

FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?

Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.

Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.

Jim Godsey, vice president of research & development, Sample6, pathogen detection
Jim Godsey, vice president of research & development

There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.

FST: How do you expect the final FSMA rules and implementation process will impact industry?

Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.

FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.

Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.

More Food Labs Using Certified Reference Materials

By Karin Pauly
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A notable section of the Food Safety Modernization Act (FSMA) calls for the development and implementation of model laboratory standards.  To ascertain the level of laboratory standards currently employed by food laboratories, a laboratory testing services company commissioned a survey of laboratory directors, quality assurance managers and technical supervisors.  One area of questioning focused on certified reference materials (CRM).

According to a recent survey, more than 50% of laboratory directors, quality assurance managers and technical supervisors report using certified reference materials.
According to a recent survey, more than 50% of laboratory directors, quality assurance managers and technical supervisors report using certified reference materials. (Click to enlarge)

In response to whether their laboratory uses CRM, 65% of respondents said yes. Most of the remaining survey respondents (31%), volunteered that they sometimes use these materials, if required. Only 4% replied “No” (see Figure 1).

The responses are significant in that they provide a glimpse into current food laboratory quality practices.  FSMA tasks the U.S. Department of Health and Human Services with making certain that analytical procedures and quality systems are established and followed.  Yet, it is not clear what procedures and systems are currently employed.  This survey provides a baseline measure from a segment of the food laboratory community, indicating, that a majority of respondents use certified reference materials.

Quality Controls vs. CRM

A food laboratory aims to provide the correct result every time a test is performed. In order to achieve this consistency and reliability, laboratories should use standard measurements, known as quality controls. Quality controls are essentially the stable norm against which testing processes and instruments may be assessed. By using quality controls, it is possible to find areas in the testing process that may be weak or failing.

CRM, used as a form of quality control, are highly characterized, homogenous, authenticated control materials. Food laboratories often have options available for obtaining commercially sourced materials for quality controls, but not all of these options are well characterized or authenticated. CRM are used by laboratories to assess the quality of method validation as well as to trace to an established standard. In the food lab, CRM help provide a level of certainty in the results when instruments and processes are validated and verified. CRM may be obtained from accredited producers, as established under ISO Guide 34.

The survey also asked whether on-site and contract laboratories use quality controls. Interestingly, not all laboratories surveyed are using quality control materials as part of their testing processes and procedures.  For on-site laboratories, 81% of survey respondents acknowledged using quality control materials. For contract laboratories, the number slips to 67%.  For survey respondents not using quality control materials, it is unknown if or how their test results are validated and verified.

Quality control is a basic component of laboratory testing as well as a requirement for accreditation.  Whether CRM or non-certified reference materials are used, quality controls are important components needed to ensure test results are valid and reliable for food consumers and industry alike.  As future FSMA rules on model standards are likely to address this essential provision of laboratory testing, these survey results support the use of CRM.

The survey discussed in this article was commissioned by Microbiologics, Inc.

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.