In Part II of Food Safety Tech’s Q&A with Kathy Wybourn, Director Food & Beverage, USA & Canada at DNV-GL, we discuss FSMA preparedness and alignments of the regulation with GFSI.
Food Safety Tech: Now that we’re in the compliance phase, how prepared are food companies to meet FSMA requirements?
Read Part I: Embracing Big Data as an Asset to Your CompanyKathy Wybourn: It depends. Food companies must want to stay informed and make the necessary changes. What is critical in this change is the resources and organization, and not the size of a company. We still see large companies that are not ready for FSMA, same as with smaller companies. It comes down to what they have done proactively to keep up with the regulations, understanding the preventive pieces of that and the shift within their organization.
There are two pieces: It’s about being informed, plus the company’s culture for change. It comes down to management commitment. If you don’t have the management commitment to move an organization to being compliant with FSMA, you can be informed, but the culture isn’t there to support it.
FST: GFSI recently released Version 7.1 to incorporate more harmonization with FSMA. Any thoughts on this new version?
Wybourn: I was in the Technical Work Group for Version 7 guidance document. Adding in the food fraud and food defense components, and the new 7.1 Version brings the GFSI benchmark document closer to FSMA around suppliers and the use of non-approved suppliers.
It puts more requirements on the food manufacturer if they have supplier problems. For example, if there’s an interruption in the supply of a critical ingredient and you don’t have another supplier that’s going through the preventive hazard. It’s very important to know how to follow the requirements around non-approved suppliers. It all fits with the bigger picture of supply chain risks and transferring risks from a supplier (those things you don’t know about), understanding your suppliers and having a contingency plan. And if you don’t have that formal approval through your system, what are the requirements around using a non-approved supplier.
FST: How can the BRC FSMA Readiness Module help food companies with the Preventive Controls rule?
Wybourn: If you’re a BRC-certified site, it gives you guidance on what is needed to be FSMA ready. BRC benchmarked and identified what was missing in the standard and created a module that minimizes the gap. It gives you guidance and reference to the actual CFR and explains what’s needed.
Grande Produce has recalled papayas with the brand name Caribeña labeled on cartons.
One person has died (New York City), 12 people have been hospitalized and a total of 47 people have been infected with a strain of Salmonella Kiambu, according to the CDC. Epidemiological and lab evidence points to yellow Maradol papayas as the “likely” culprit of this multistate outbreak.
Thus far, one brand has been linked to the outbreak, Grande Produce, which has recalled its Caribeña brand Maradol papayas distributed between July 10 and July 19, 2017. The CDC will announce other brands once more information is available. During its investigation, an illness cluster was identified in Maryland.
Grande Produce, a distribution center located in Maryland, has stopped importing papayas from its grower and “is taking all precautionary measures to ensure the safety of its imported produce”, according to a company announcement on FDA’s website. According to Grande Produce, environmental microbial testing of its facilities has, to date, tested negative for Salmonella. “Specific sources of what health officials now believe may be two separate Salmonella outbreaks have not yet been determined,” the announcement states.
Six years ago, following FSMA being signed into law, Associated Wholesale Grocers, Inc. (AWG) knew it had to implement a supplier approval program to comply with the Preventive Controls rule. At the time, it had a manual process for managing the records of its 3000+ suppliers. The company needed an effective place, accessible any day of the year (and at any time), to collect and store all of its corporate and food safety documentation.
“I come from a manufacturing program where I was used to having a very robust supplier approval program,” says Shelly Stegner, director of food safety for AWG, a grocery co-op. “But in distribution companies such as AWG, food safety hasn’t necessarily been the culture, because we don’t do any reprocessing or repacking, or touch the product. When we had to comply with [FSMA], it was a whole new thing for AWG, and we knew we had to roll something out.”
AWG spent about two-and-a-half years looking for a company that could help not only manage documentation but could also give them control over the documents from a visibility perspective. After conducting thorough research, AWG selected Repositrak Inc.’s cloud-based Compliance Management solution. The product was recently launched to help companies during the sourcing process, assisting them with supplier qualification, order negotiation and on-boarding a new supplier. The solution also highlights compliant vendors based on business and safety requirements.
Food Safety Tech: What are the advantages and drawbacks to using an automated solution like Repositrak?
Shelly Stegner: It’s an easy way to keep track and retain all the records that you’ve never been able to retain before. And not only can you retain them, but there are also visual statistics behind the documents (which you don’t have when with hard copies). It’s not just having the documents—it’s actual usable data when you use [Repositrak] that helps drive efficiencies within our company, and it helps decrease our risk and liability with vendors—for example, we know that their certificate of insurance has expired, whereas before [using Repositrak], we didn’t know that.
The drawbacks are cost. Is it the cheapest option out there? No. But is it the most efficient option that we found? Yes. A lot of the companies may have been cheaper, but we would have had to hire an individual to do all the work. There is a cost associated with it, so [some] vendors are hesitant. The other drawback is that the industry overall has many different solutions, so if the supplier is not using Repositrak for their supplier approval program, it’s another point of entry. Maybe it only takes 30 minutes to do it, but it’s still something else that they have to do.
I think it’s becoming easier for vendors with Repositrak as we get more traction and as it becomes more of an industry-known [product]. Suppliers only have to upload documents once, and it automatically reaches all their customers. So for them, the more [suppliers] that are on one system, the easier it is for the whole industry.
FST: What are the challenges to implementing this type of system?
Stegner: For a company that was completely in the Stone Ages, we didn’t even have a list of all of our active vendors—so we thought we had 6000 active vendors, and we only had a little more than 3000. Just getting the information to Repositrak about active vendors and contacts proved to be the most difficult thing for us. Once we got Repositrak the key information, they ran with it.
FST: From time management perspective, what are the savings?
Stegner: Before we had nothing in place. Now, during my third-party audits or when FDA arrives, I can show them where we are in compliance when they ask about our supplier program. It saves me a ton of time in that regard.
Now when I have a recall, I can go into the system and look up a contact, versus waiting to get a contact from a category manager. If I need to issue a recall, I can see if [the vendors] have reviewed our recall program and issue it without waiting on that either.
As far as the time it takes to approve documents, there’s an increased time, but there’s also an awareness that we never had before. So not only are we collecting the documents, but now we are building a whole food safety culture that also has a new awareness and understanding of what it means to distribute safe food.
FST: What are the general challenges you see companies facing, especially in the area of compliance and having visibility throughout their supply chain?
Stegner: I think there’s a challenge with some companies on keeping information confidential because they simply don’t want to share information.
As far as traceability goes, our company is challenged with technology. [There’s] the financial need of upgrading our technology to have the true traceability that has so increasingly become required by consumers from farm to fork. A great deal of technology is needed to understand that in real time.
The farmer has their traceability, and the supplier has their traceability, we have ours, and then there’s the retailer—it’s tying all those together that proves to be a bit of challenge.
On Saturday the USDA announced a Class I nationwide recall of 7,196,084 pounds of hot dog products from Marathon Enterprises, Inc. Produced between March 17, 2017 and July 4, 2017, the certain beef and pork hot dog and sausage items may contain bone fragments.
The issue was uncovered via the FSIS Complaint Monitoring System on July 10, which stated that pieces of bone were found in the product. No injuries have been reported yet.
USDA Recall Classification of Class I Recall: “This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.”
As companies are hit with a massive amount of information as a result of new technology, proper management of data intelligence can be difficult. The key is to be able to translate the data into useable information to drive improvements in processes, products and business operations. A new tool aims to do just that—help companies boost operational margins using real-time data intelligence, from supplier performance to trends to safety and quality processes, across an organization.
Launched earlier this week, SafetyChain Analytics can also help companies spot problems before they balloon into larger issues that affect product quality. Barry Maxon, CEO of SafetyChain, explains why the company developed the tool and how it can help food companies save money by being more efficient.
Food Safety Tech: What was the impetus behind developing this tool?
Barry Maxon, CEO of SafetyChain
Barry Maxon: The food and beverage industry historically is a business that has tight operating margins. At the same time, companies spend a tremendous amount of money every year collecting compliance data. If you walk through any food and beverage facility, you’ll see people writing down data on paper and putting it in filing cabinets or a spreadsheet. There’s already a tremendous amount of data being collected. We wanted to help companies go beyond collecting compliance data to satisfy their records for their auditors; we wanted to harness that data so they can begin to use it to drive operational excellence. That’s what’s going to make the difference in moving the needle on a company’s bottom line and their operating margins—the ability to leverage all the data they’re collecting to gain insights into how their business is operating and use it to improve their processes, products and operations.
FST: How does it address challenges that food businesses experience? How does it streamline their workflow?
Maxon: Companies are being squeezed from all directions—they need to do more with less, perform at the speed of business today, and remain up to date with all the different compliance standards—be it regulatory, industry standards from GFSI, and even down to customer specific compliance level. There’s a tremendous amount of demand being put on food companies. Yet at the same time, all of these demands typically require greater cost, and they’re being challenged to do more with less and achieve greater economy with their businesses to actually improve their bottom line. It’s a double whammy—improve your bottom while also having greater demand placed on your business—competitively, and from a regulatory and compliance perspective.
There are a lot of processes that have been fundamentally manual in the past, on paper and spreadsheets and in filing cabinets. We’ve talked to companies that say they have people spending hours a day just billing out paperwork and putting numbers into spreadsheets. And we have multi-billion-dollar industries still running on spreadsheets. As nice as a spreadsheet is, it’s a 40-year old software technology that came out in 70s. We’re trying to use new and innovative tools so companies can perform in this new era of technology and use it to benefit their business in multiple ways.
Food Safety Tech: Who are the main product users?
Maxon: Your user base is anyone in the organization who touches safety, quality or compliance from an operational standpoint.
Often the front-end users are collecting and reviewing the sets of data. One of the key elements of the tool is to deliver the right data to the right user in real time. In the past, one of biggest challenges for food companies is that they may run for many hours before realizing they are out of compliance. The idea is to give front-line users have an immediate access to data that prompts them when they’re trending into a direction where they need to take preventive action.
At the same time, managers and executives have access to the tool so they can mine the data, run the reports, and see process control charts.
Screenshot of SafetyChain Analytics tool. “One of the key elements of the tool is to deliver the right data to the right user in real time.” – Barry Maxon
FST: Are there different security controls for this software?
Maxon: Absolutely. You can organize it so users only see what matters to them. That’s really the key to keeping it simple. Data can very quickly become overwhelming. We’re trying to deliver prebuilt dashboards and reports, and organize the data to make it intuitive. We’re also trying to leverage data on an exception-based management principle. It used to be, in more manual paper-based processes, that a supervisor had to review every single record and sign off on it. Here, with automation in software, everything that passes compliance goes through the system; you don’t need to look at it—it will immediately highlight where you have exceptions in your process so you can quickly take corrective action and make sure everything is resolved before it gets further downstream.
This year’s annual Food Safety Consortium will take place November 29 at 1 pm until December 1, concluding at noon. The main conference kicks off on Wednesday, November 29 at 1 pm with a plenary presentation by Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by a town hall meeting where he will answer audience questions. General sessions for the afternoon include a presentation on food defense given by Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI.
During the final session of the day, industry experts will gather for an engaging reflection on Food Safety: Past, Present and Future. Stay tuned for more details on this special event.
On Thursday, attendees will be treated to an interactive court case:
Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham, represented by Shawn Stevens vs. Food Safety victims, represented by Bill Marler. Stevens and Marler will be present their case to the honorable Judge Steve Sklare
In addition to the general event, there will be pre- and post-conference workshops. Pre-conference workshops take place on Tuesday, November 28, beginning at 9 am and run for the first half of the morning on Wednesday, November 29. Post-conference workshops take place during the afternoon of Friday, December 1, following the conclusion of the main event.
Big data has become a fairly common term used across industries. It refers to large, complex volumes of data that are generated from multiple sources. The challenge may not be so much in gathering the data but more so in what to do with the information. Although it can be a bear to manage, if able to harness data correctly, food companies could have a leg up on their competition.
“The food industry is behind. As an example, the aerospace industry has the ability to monitor engines on a transatlantic flight to ensure they are operating at the optimal conditions. This data is being used by engineers within different organizations to make improvements,” says Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL. “Just having the ability to collect information in real time will shift the industry from reactive to proactive. This will require the industry to fit the pieces together to collect information. As an example, you could reject a product at the supplier site, even before it leaves the supplier—you would have all that information at the tips of your fingers.” In a Q&A with Food Safety Tech, Wybourn discusses how the food industry can benefit from the proper use of big data.
Food Safety Tech: What does the term “big data” mean to the food industry?
Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL
Kathy Wybourn: Large volumes of data that is collected from both internal and external sources, used to make smarter business decisions. The supply chain in the food industry is very complex—receiving supplies from all over the globe. [Big data can identify] trends in different regions of the world and assist food companies make better risk decisions about their supply chain. Big data will ultimately improve the safety and quality of products for consumers. Improved supply chain management [and] traceability of products will also lower the risk of food fraud.
We’ve moved from an analog to digital age. The internet has provided the connectivity to link data from raw materials to end users. Using social media data, GPS, photos, videos and data sensors can provide real-time data about raw materials through manufacturing, distribution and retail, which will allow an organization to have better insights into information and decision making along the entire supply chain.
DNV GL recently conducted a survey called “ViewPoint” about the application of Big data. The survey found that 50% of the respondents already have been doing something with Big Data in different ways. Interesting enough, Big Data has different meanings and importance to the respondents, but what is common, is the fact that data will be used differently in the future than what is currently in their tool box. Big Data will allow better insight and enable companies to make fact-based decisions and better manage both performance and risks. The respondents may have different definitions for Big Data, but they all agree that data will be used differently than today for making both internal and external business decisions.
“A higher number of food and beverage companies indicate that big data will have a high or fairly high impact on their business in the next 2¬–3 years. The companies in this industry indicate fewer barriers, even today, in taking advantage of big data concepts. Already, 21% say that their management team is preparing for the new reality and seemingly more food and beverage companies plan to invest in big data.” – DNV-GL Viewpoint Report
FST: How can the industry use big data to make food safer and more sustainable?
Wybourn: Big data will allow the food industry to become even more transparent, which will help improve food safety. Big data will improve supply chain management and allow organizations to make more informed decisions regarding processes, both internally and externally. Food manufacturers can improve efficiency and quality of their own manufacturing processes: Increasing output and solving operational problems faster, which will both have a positive effect on an organization’s bottom line.
Non-conformity data is powerful and can be collected through advanced analytics throughout the supply chain. This data can be further sorted by regions of the world, which will improve knowledge and insight about suppliers. Big data brings further insight beyond what is gained from one audit, which will allow organizations to be confident about making better risk decisions.
Additionally, big data can be used to assess your organization’s performance by benchmarking against other companies’ performance in the areas of nonconformities to food safety standards in their own or different regions.
FST: Can you give some examples of where food companies are or should be leveraging big data to help them in the compliance phase of FSMA?
Wybourn: Both large as well as small companies are struggling with FSMA preventive controls. FSMA mandates that a manufacturing facility have a risk-based supply chain program for raw materials and ingredients for hazards that require a supply chain applied control. Manufacturing sites may rely on a supplier or customer to control a hazard. An organization’s ability to manage big data to improve the organization’s tools to capture, store and analyze this data can greatly improve the monitoring of hazards and lower risk to the supply chain.
FST: Do you have examples of how some companies are leveraging technology to make the best use of their data?
Wybourn: DNV GL has new digital platforms, which can be used to benchmark your own organization to the performance of others.
eAdvantage is a customer portal that provides customers with a complete overview of their former and future audit activities. Through the portal they can see upcoming activities, work with findings and close non-conformities, communicate with an auditor, share audit information, access certificates and monitor their overall progress.
Lumina is a set of tools that provides better insight into a company’s management system. It analyses information hidden in the company’s audit data and allows to benchmark that company against thousands of others worldwide based on more than 1.6 million audit findings. It allows an organization to obtain an overview of their own sites performance, spot warning signs at an early stage and see how they compare to similar companies in the industry, giving confidence to make the right decisions.
Veracity is an open industry data platform, ideal for integrating data in a secure way. The Veracity eco-system handles asset data, manages data quality and applies advanced analytics, connecting industry players for frictionless data aggregation, sharing and benchmarking. In the aquaculture industry, this will lay the foundation for predictive analyses, decision support, indication warning, and simulation capabilities unlocking substantial growth potential in the global aquaculture industry. All the while, we make sure fish farmers and other data providers retain ownership and control of their data.
I believe we are only at the tip of an iceberg of where big data can take the food & beverage Industry.
FST: Is it possible to get too much data? Are food companies going to be bombarded with too much info that they don’t know how to use?
Wybourn: The answer is simple, yes. We live in a world of data abundance and information overload each day. Data sets are growing rapidly, and the ability to store and analyze data is daunting. The tools we have today will become obsolete tomorrow. One only can sort through data with the tools he/she has today to understand even the simplest of processes.
As consumer preferences continue the shift toward organic food, Campbell Soup Co. announced its $700 million acquisition of Pacific Foods today. The cash deal will help Campbell Soup expand into the organic and functional food spaces, according to company president and CEO Denise Morrison.
“Pacific Foods is an excellent fit with Campbell — strategically, culturally and philosophically,” said Morrison in a company press release. “It advances our strategic imperatives around real food, transparency, sustainability and health and well-being. Culturally, Campbell and Pacific Foods share similar values and a commitment to a purpose-driven approach. Philosophically, both companies believe in making food that we are proud to serve at our own tables using simple, recognizable ingredients.”
Pacific Foods produces organic broth and soup, as well as shelf-stable plant-based beverages and other meals. The Oregon-based company, which employees 540 people, will become part of Campbell’s Americas Simple Meals and Beverages division. Pacific Foods CEO and co-founder Chuck Eggert will remain a supplier of key ingredients through his family farms, which will help the company continue its farm-to-table philosophy. “We’ve spent the past 30 years focused on making nourishing foods with an emphasis on simple, organic ingredients and authentic, rich flavors,” said Eggert. “Looking ahead, a future with Campbell means we can maintain what we value while accelerating growth of the brand in a way that we couldn’t do alone, reaching more people while increasing our impact on sustainable agriculture.”
Hygiena, LLC has launched an alkaline phosphatase (ALP) testing system that can verify pasteurization efficiency in short shelf life dairy products in five minutes. ZymoSnap ALP requires minimal equipment and can be used without special technical knowledge or testing facilities. It is also designed to provide repeat results at low levels (25–100 mU/L). Campden BRI independently validated the test.
“Manufacturers of dairy products are under constant pressure to demonstrate compliance with international safety and quality requirements. That’s why they need to regularly monitor and verify the efficiency of their pasteurisation process. With this in mind, we have developed ZymoSnap ALP to enable tests to be carried out rapidly allowing for an immediate pass/fail assessment and trend analysis. It has never been easier or quicker to ensure that pasteurisation processes are operating efficiently.” – Martin Easter, Ph.D., chief scientific officer, Hygiena
The Hygiena ZymoSnap ALP test
A 100% recyclable device, the ZymoSnap ALP Positive Control Kit provides a reference point for the regulatory limit of liquid milk and validation of other dairy products. It is compatible with the company’s EnSURE monitoring system, a luminometer that is used to detect indicators and bacteria, including coliform, E. coli and Enterobacteriaceae.
As global competition continues to grow and supply dwindles in many areas, food fraud is a major concern. The value of the food authenticity market, which was around $5 billion last year, is expected to reach $8.3 billion by 2023, achieving a compound annual growth rate (CAGR) of 7.7%, according to Allied Market Research.
Last year, polymerase chain reaction (PCR) technology took up about one third of the market and is expected to achieve a 8.3% CAGR from 2017 to 2023. Processed food (includes infant formula, packaged food, wine, and bakery and confectionary products) accounted for another third of the global market from a revenue standpoint. Meat speciation is expected to achieve the highest revenue growth, with a 8.2% CAGR.
According to Allied Market Research, Asia-Pacific is expected to experience the highest growth between 2017 and 2023, while Europe continues to lead the worldwide market in this area. North America, which is the second-leading revenue contributor worldwide, is anticipated to achieve a 7.4% CAGR in revenue.
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