Tag Archives: recalls

FST Soapbox

A Digital Approach to Environmental Monitoring: Let’s Get Proactive!

Technology and automation for safety and surveillance have already impacted nearly every industry in the world. For example, in the United States and many other developed regions, we have just lived through the transformation to electronic health records within the healthcare industry. Prior to that, we lived through the digital transformation of all of our banking information to an online banking platform—now the norm across the world.

However, the food and beverage industry is still learning how technology can improve their organizations. The food safety segment of this market is particularly in need of a digital transformation, as the risk associated with foodborne illness is potentially catastrophic to food companies, and moreso, to the end consumers who are impacted by preventable pathogenic outbreaks.

Along with regulation advancements, such as the timed roll-out of FSMA, the industry continues to work towards a more effective approach to food safety. But most regulations, and advancements in the industry are pointed toward a reactive stance to food safety issues, rather than a preventive stance. For example, although traceability is important in leading investigations to the source and taking remediation steps sooner, a more proactive approach to prevention should be considered when investing in food safety programs.

This is where the importance of an automated environmental monitoring program comes in. To be proactive requires a commitment to embracing data and digital technology. Knowing where to start to effectively pivot your digital approach can be a challenge.

Understanding the following thought process can help you to recognize areas of potential improvement and growth within your environmental monitoring program.

  • Define Your Business Objectives. Ask how profitability and production uptime is connected to food safety issues.
  • Verify Suppliers. Establish protocols for incoming product from external suppliers and validate their food safety performance and ability to maintain a clean facility.
  • Modernize Your Environmental Monitoring Program (EMP). Are you able to confirm that your EMP is being executed consistently? Across all facilities?
  • Understand Data Exhaust. See how your organization’s valuable data can be used to identify trends and accelerate root cause analysis that impact decision-making processes.

Define Your Business Objectives

Food companies large and small are being challenged to implement required processes and procedures to meet the demands of FSMA, and ultimately achieve a more proactive and preventative food safety stance. Transformation in this arena, led by government regulation, and enhanced by standards certification requirements, has highlighted the responsibility of suppliers and manufacturers to protect consumers.

Many organizations are not aware that a single failure in their food safety program could actually be the most devastating profitability risk that the organization faces today. When your organization is focused on production uptime and profitability, it can be easy to overlook the details involved in maintaining a strong food safety program. In reality, though, food safety and profitability are inextricably linked due to the risk of production interruptions that can be caused by safety issues.

Whenever a food recall occurs, it has the potential to start the dominoes falling, with major implications regarding costs, reputational damage, compliance penalties, supply chain interruption, and sales declines. Worse yet, these impacts can last for years after the actual event. By delaying both the importance of recognizing the seriousness of this risk as well as taking necessary steps to prevent it, your organization’s reputation could be on the line.

Unfortunately, planning is often sacrificed when managers fail to implement the proper technological solutions. Fulfilling fundamental documentation requirements involves a smart, automated approach. This is the best way to optimize recall prevention. By incorporating an automated EMP process, a supplier management system, and other FSMA Preventive Controls measures, suppliers ultimately improve the strength of the entire chain for their partners, consumers and themselves.

There are many other facets to food safety, but the EMP is where inspectors and auditors will look to see the indicators of contamination and the efficacy of your sanitation controls. Therefore, it is critical that your organization exhibit not only that you are on top of things and are following your EMP procedures consistently, but that you can analyze and pinpoint issues as they arise, and that you have a track record of corrective actions in response to those issues. This, in-turn, allows you to see where your business objectives are most at-risk.

Regardless of which specific food industry segment your company operates in, or which governing body it reports to, it’s essential to stay informed and compliant with changing regulations in order to reduce the risk of experiencing a recall. In a strategic operational role, intelligent environmental monitoring allows companies to not only proactively work to avoid public health issues, but is vital to retaining a consistent bottom line.

Verify Suppliers

Earlier this year, the FDA heralded what they call a “New Era of Smarter Food Safety”. As technology becomes increasingly accessible, more and more companies are investigating how technology can be used to harness and control the growing complexity of supply chain implications.

The challenge of making sure your organization is doing its due diligence to prevent recalls is further complicated when incorporating outside suppliers. For example, 15% of the United State’s overall food supply is imported from more than 200 other countries, according to the FDA. Making sure the product coming into a facility is also meeting your standards is vital to preventing pathogens from entering your supply chain either through containers, people, or the incoming product itself.

The complexity grows exponentially when we contemplate what this means for tracking food safety across a supply chain of this scope. Generally suppliers are asked to provide verification for the cleanliness of the product they are bringing into your facility. However, by going a step further and establishing test points for the product when it comes in, you will be better equipped to catch pathogens before they can enter into your own supply chain and potentially contaminate other products. While you may already have a good relationship with your suppliers, being able to independently verify the safety of their products and that their own processes are working, creates a mutually beneficial relationship.

Modernize Your Environmental Monitoring Program

Food experts at the World Health Organization headquarters in Geneva discussed the critical nature of ensuring food safety across geographic boundaries, as it is an issue that affects everyone. Incidents of pathogen outbreaks around the world have a direct impact on the health of global citizens, with one in 10 people falling ill due to food contamination.

A traditional EMP allows organizations to continuously verify that their sanitation programs are working by scheduling testing, monitoring results for any signs of pathogens, and maintaining compliance with regulatory bodies. Historically, this type of program is documented in spreadsheets and three-ring binders, but today the acceptance of new tools being offered by vendors and labs are expanding offerings to modernize the monitoring process.

Food safety professionals, many of whom are trained microbiologists, should have better tools at their disposal than spreadsheets that force them to manually sift through data. All regulatory bodies in the food industry have guidelines when it comes to where, what, and when you should be testing in your facilities. Ensuring that this is happening is a basic requirement for meeting regulatory mandates.

By choosing an automated EMP, FSQA teams are able to schedule testing plans including randomization and test point coverage rules, see what testing is being performed when, and obtain all testing data in one system for ease of access before or during an audit. This offers an “always-on” source of audit data and more importantly, trending and root-cause analysis capabilities to find and define actions to remediate recurring problems.

Further, an automated EMP that is integrated with your food safety plan allows you to set up workflows and automatically notify appropriate team members according to your organization’s policies. Each remediation step can be recorded and time stamped as the corrective action moves towards completion.

Understand Data Exhaust

A dominant theme pushed forward by FSMA is the need to document all aspects of your food safety plan, from the written outline to the records indicating proper implementation. Today’s manufacturers face a time of heightened regulation, and with stricter enforcement comes greater requirements for documentation. Automated EMPs not only provide your organization insight into what is happening within your facilities for documentation, it also gives time back to your FSQA team who, instead of spending their days with three ring binders, can analyze and investigate recurring issues in your facility to look for new, innovative ways for the organization to maintain a high standard of quality.

However, effective testing also means reading, understanding and responding to results. It is not enough to simply meet the required volume and frequency of environmental testing metrics. You need to use the resulting information to effect change and improvements by lowering the likeliness of pathogens, allergens and contaminants from entering the food supply chain. The more data collected, the more it leads to true understandings. What testing might show is just the symptoms of the problem—not the root cause of a far bigger problem. As more data is available, it becomes more valuable through the insights that can be gained through trend analysis. This, in turn, moves the conversation to higher levels within the organization who care about ensuring productivity and reducing avoidable risk.

Incorporating your lab into the equation is essential. Find a lab partner that offers an automated testing program that is integrated with their LIMS. Your organization will then be in a better position to ensure results are being responded to in an appropriate time frame.

There are many diagnostic tools in use today, both in-plant and at the lab. Each of these tools generates “data exhaust” in the form of a diagnostic result. But are your data streams being integrated and analyzed to find correlations and potential cause/effect relationships? Or does your ATP device simply record its data to a dedicated laptop or spreadsheet?

Testing, combined with an automated EMP, can allow you to combine data from various diagnostic systems (on-premise or from your lab partner) to identify trends and therefore a more holistic path to remediation. For this to occur, data must be accessible, aggregated and actionable, which an automated EMP achieves.

Forward-thinking companies and facility managers are leveraging valuable software solutions to improve processes, protect reputations, minimize inefficiencies, and simplify multifaceted compliance and audit tasks. Over the next three to five years, numerous organizations will reduce their risk of food recalls by combining their EMPs with analytics capabilities to reduce food risk and improve quality using diagnostic solutions and data assets. This change will be arduous, as all digital transformations in other industries have shown. But, in the end, they have shown the value and long-term success that the food industry now needs to experience.

Home food delivery, food safety

Home Food Delivery: “It’s Kind of a Wild West Out There”

By Maria Fontanazza
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Home food delivery, food safety

As the popularity of home delivery services for food (i.e., online grocery shopping, prepared meals from restaurants, meal kits) continues to gain traction, the industry has been grappling with clear-cut guidance on how to ensure food safety during what is known as the “last mile” of delivery to the consumer. For example, how do third-party delivery services address concerns such as maintaining the right temperature of food during transit? How are allergen risks controlled? Do the people who deliver the food undergo any food safety training?

“It’s kind of a wild west out there,” said Donald Schaffner, Ph.D., professor at Rutgers University during a panel discussion on the topic of home food delivery at the IAFP annual meeting last week in Louisville, Kentucky.

In April, Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas acknowledged that there are food safety challenges presented by “evolving business models” such as e-commerce, and stated that the agency will be looking at ways to work with federal, state and local stakeholders to address the issues. During the IAFP panel, food safety professionals from Amazon, Uber Eats, The Kroger Company and FSIS shed some light on how their respective organizations are handling the food safety risks associated with home delivery.

Home food delivery, food safetyTraining the People Who Deliver Your Food

The overarching consensus among panelists was that there is not a one-size-fits all approach to training the people who deliver food to the consumer, because there are so many different business models out there. The key to developing successful training will be to first understand the risks associated with each of those different models.

“Everyone needs training, but we don’t want to over-engineering it—not everyone needs ServeSafe training,” said Schaffner. For example, training the person who is simply putting food in the car and delivering it to an address should be different from the training necessary for an employee selecting food in the grocery store versus the warehouse employee packing food. “Figuring out the right-size training and what kind is currently available is one of the things that we’re trying to figure out on the [Conference for Food Protection] committee.” (Note, the Conference for Food Protection committee is developing guidance that addresses home food delivery.) Schaffner indicated that training surrounding time and temperature, allergens and product tampering are important considerations.

Howard Popoola, vice president, corporate food technology and regulatory compliance at The Kroger Company provided the retailer perspective. “Our challenge is multiple in nature,” he said, emphasizing that stores try to keep labor at a minimum. Designing training for workers who are getting a $.25-per-hour raise presents a different hurdle. “What we’re doing in the store today is something we’ve never done before, and [we’re] asking individuals to do things they’ve never done before,” said Popoola. “The training we’ve done before is slowly becoming obsolete.” He said that The Kroger Company is evaluating its current basic food safety training and is looking at building on the segments of its stores that are involved in picking, packing and preparing food—especially the fresh items that are more susceptible to potential microbial contamination.

The Allergen Risk

A question was raised about whether delivery services use the same bags over and over, introducing the potential for cross-contamination. As part of its restaurant community guidelines, UberEats encourages restaurants to put food in tamper-resistant packaging. According to Joseph Navin, senior manager of global safety at the company, in order to reduce the possibility of cross contamination, all food should be placed in a bag before it is put in the insulated bag for transport. UberEats also has guidelines for how those bags should be cleaned. Further addressing the allergen risk: “How do we optimize the way that consumers can disclose that they have a food allergy? We don’t want to have food allergies going in the same free form text [box] that says ‘send extra napkins’,” said Navin. He added that UberEats is developing ways in which dealing with allergens is more conspicuous for restaurants when their employees are preparing food.

Allison Jennings, director food safety and compliance North America at Amazon, said the company has experimented with multiple types of packaging, but there isn’t one perfect set of variables and inputs. Amazon currently uses single-use bags for delivery to mitigate risks with re-cleaning, she said.

Consumer Complaints

As a best practice, integrating relevant information from consumer complaints should become part of a company’s food safety program, said Schaffner. An important role of technology will be its ability to collect feedback that allows companies to generate actionable insights related to food safety, identify any gaps, strengthen controls and be able to develop ways to mitigate risks, said Navin. Amazon currently monitors customer feedback using automatic detection for keywords related to food safety and quality that arrives via the phone, online chats with customer service and social media outlets. When necessary, the method can prompt an investigation, look for trends or help engage in continuous improvement processes. “We are constantly looking for any potential blind spots with our processes,” said Jennings. “We also mystery shop ourselves and make sure we’re meeting our requirements.”

The most common consumer complaints reported among the panelists were not related to food safety, but rather food quality—the product was crushed, didn’t look appealing, etc. “Since we rely on third party partners, we’ve walked through with them on those processes…[and are] challenging our third party partners on who they hire to deliver food, training, etc. and taking caution on delivering food,” said Popoola.

Schaffner said common complaints noted during a study conducted by Rutgers University and Tennessee State University were the following: The product was received out of temperature control; there was evidence of packages leaking (meat, poultry, and fish); a lack of cooking directions; and no mechanism to provide feedback to the company if you have a complaint.

According to Navin, among the top complaints that UberEats receives is missing food or a replacement for items that might be out of stock.

Recalls

In general, recalls in the home delivery segment would apply to products that are received via online grocery shopping services. Since consumers must sign up for these services by providing either an email or phone number, companies can contact customers in the event of a recall. For example, Amazon requires an email account, so it directly emails customers when there is recall or known safety risk associated with a product purchased. Similarly, when a customer uses a loyalty card at a grocery store such as Kroger, the retailer can use its robocall system to notify customers if they purchased an item that is subject to a recall or is associated with an outbreak.

Colleen Costello, VitalVio
FST Soapbox

Shining New Light on Preventing Food Recalls

By Colleen Costello
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Colleen Costello, VitalVio

Recalls have become an unfortunate reality for the food and beverage industry. It seems every month, another grocer pulls inventory from its shelves due to contaminated products that are potentially harmful for consumers.

Last month, it was Kroger that was forced to remove beef products from stores in Ohio, Kentucky and Indiana as part of Aurora Packing Company’s recall of more than 62,000 pounds of meat that may have been infected with E. coli. Not only do these situations hurt the reputation and bottom line of companies across the food supply chain—from the manufacturer to the retail store—there is the potential for these issues to become deadly.

The CDC counts 3,000 deaths, 128,000 hospitalizations and 48 million foodborne illness cases every year. While the food industry has put stricter guidelines into place for recalling contaminated products, the key to preventing illness is to take an even more proactive stance toward making food free of harmful pathogens before it reaches consumers’ plates.

Unfortunately, this is easier said than done.

The 2019 Food Safety Consortium Conference & Expo features an entire track on sanitation | October 1–3 | Schaumburg, ILComplexities of the Food Supply Chain

The food industry faces unique supply chain challenges. First, consider that the industry is dealing with products that come from the ocean or earth. Once obtained, these products are boxed, sent, in many cases long distances, to a facility via truck or cargo ship, where our foods undergo a number of processing mechanisms before being put back in a shipping container and sent off to a store. When they finally make it in-store, they’re moved from the backroom to the store floor. After all this, these products go into our mouths and through our digestive systems.

There are often many complex steps food has to go through before it makes it into our homes—and with each level of the food supply chain comes a new opportunity for things to go wrong and contamination to happen. What makes the food supply chain even more frightening is that pinpointing the root cause of harmful pathogens—such as E. coli or Listeria—by retracing all the potential contacts points is very challenging given their microscopic nature. All in all, the germs are beating us.

Old Disinfection Techniques Aren’t Cutting It

To mitigate the issue of contamination and avoid those dreaded recalls, food companies have prioritized disinfection. Most often, techniques include manually washing processing equipment with chemicals to keep them sanitized, and even spraying food products with antibiotics to directly kill harmful germs. However, these solutions have many limitations and are either intermittent in their use or insufficient to tackle the complexity of challenges associated with the food processing environment.

First, the tide is beginning to turn on the use of chemicals on food products, with consumers having growing concerns with introducing antibiotics in their food. There’s heightened and justified skepticism over the use of antibiotics and fears over the potential impact on resistance through overuse. In other words, consumers are afraid of the potential side effects from ingesting these chemicals on a daily basis and the alternative resistance bacteria they promote.

The truth is that the excessive use of antibiotics makes them less effective. This is due to frequently exposed bacteria developing resistance to antibiotics over time. The result is that antibiotics are no longer as effective at killing these germs, which is at the heart of great concern for the public’s health.

Resistant bacteria can be passed from food-producing animals to humans in a number of ways. If an animal is carrying resistant bacteria, it can be passed on through meat that is not handled or cooked properly. Plus, food crops are regularly sprayed with fertilizers, which can contain animal manure with resistant bacteria. Once spread to humans, resistant bacteria can stay in the human gut and spread between individuals. The consequences of the introduction of these germs and the subsequent consumption of them include infections that would not have happened otherwise.

Second, cleaning equipment with chemicals and disinfectants is important, but only intermittently effective. While someone working in a food processing plant uses chemicals to clean off a surface or container before food touches it, there’s still an opportunity for harmful bacteria to land on the space in between washes from many sources including the air, packaging, other food, etc. Not to mention there is a wide variety of different surfaces and nodes that food touches as it moves throughout a plant and across the supply chain. Every single surface is a distinct and new opportunity for germs to live, and simply scrubbing these areas a few times a day (or once a day in some cases) simply isn’t enough to keep these germs away. By solely relying on the intermittent use of chemicals to sanitize, it seems virtually impossible to ensure contamination is not ever introduced along the way to your table.

The Introduction of Continuous Disinfection Using Light

Intermittent sanitization hasn’t been disproven to be a wholly effective way to kill germs—it’s simply not a strong enough line of defense in and of itself. Perhaps, one of the best ways to protect our food from harmful bacteria and prevent expensive recalls altogether is to introduce and layer in a new breed of “continuous disinfection” technology using bacteria-killing visible LED lighting directly into the process.

Going back to more than a century ago, scientists have known that certain wavelengths of light are highly effective at destroying bacteria. Ultraviolet (UV) light is extremely powerful, but it is also especially dangerous to humans and causes things like plastics to become brittle and crack. UV light directly impacts the DNA in people, animals and plants, along with bacterial cells.

There is, however, a very human-friendly frequency of light (405 nanometers), which is in the visible spectrum of light, that is completely harmless to humans, but just as devastating to bacteria. It activates the porphyrin molecules that exist only within unicellular organisms such as bacteria and fungi. Humans, animals and plants do not have these particular molecules. Exposure to 405 nm light directly activates these molecules and essentially rusts bacteria from the inside out destroying any bacteria that is exposed to this human-friendly light. The ability of this new LED tool to be safely used around the clock allows for it to be acting continuously. This continuous nature goes above and beyond the existing limitations of intermittent cleaning.

With the advent of LED lighting, it is now possible to “tune” the frequency of light with extreme precision. The significant breakthrough of isolating light to this specific frequency of violet-blue light has now begun to enter the food processing industry. It is taking its place as a critical component to the layered defenses against harmful bacteria entering the food chain. When left on, this light continuously kills bacteria, preventing any germ colonies from forming and replicating. This has now become the perfect complement to the proper cleaning and sanitizing of all surfaces used in food processing and preparation—intermittent chemical cleaning working together with continuous disinfection from light.

In short, avoiding outbreaks and infection crises is all about smart prevention. Recalls are a reactionary solution to the problem. The key to preventing these potentially deadly (and costly) situations is to make sure that all facilities that process and handle food are continuously disinfected. The good news is that tech startups are at the helm of developing these new tools for killing germs before they even have a chance to have a seat at our tables.

2019 Food Safety Consortium Conference & Expo

Mark Your Calendars: 2019 Food Safety Consortium Includes Panels on Recalls, Food Defense and Supply Chain Transparency

By Maria Fontanazza
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2019 Food Safety Consortium Conference & Expo

The 2019 Food Safety Consortium Conference & Expo kicks off on Tuesday, October 1 and is packed with two-and-a-half days of informative sessions on a variety of topics that are critical to the food safety industry. We invite you to check out the full agenda on the event website, but below are several event highlights that you should plan on attending.

  • Opening Keynote: Frank Yiannas, Deputy Commissioner for Food Policy and Response, FDA
  • Recalls Panel Discussion: Led by Rob Mommsen, Director of Global Quality & Food Safety, Sabra Dipping Company
  • Food Defense Panel: Led by Steven Sklare, REHS, CP-FS, LEHP. Invited Panelists include Jason P. Bashura, MPH, RS, Sr. Mgr., Global Food Defense, PepsiCo and Jill Hoffman, Director, Global Quality Systems and Food Safety at McCormick & Company and Clint Fairow, M.S. Global Food Defense Manager, Archer Daniels Midland Company
  • “Validation Considerations and Regulations for Processing Technologies”: General Session presented by Glenn Black, Ph.D., Associate Director for Research, Division of Food Processing Science and Technology (DFPST), Office of Food Safety (OFS), CFSAN, FDA
  • “Food Safety Leadership: Earning respect – real-life examples of earning and maintaining influence as a Food Safety leader”: Panel Discussion moderated by Bob Pudlock, President, Gulf Stream Search
  • Supply Chain Transparency Panel Discussion: Led by Jeanne Duckett of Avery Dennison
  • Taking an Aggressive Approach to Sanitation: Planning for a Contamination Event: Presented by Elise Forward, President, Forward Food Safety
  • Three Breakout Tracks: Food Safety Leadership; Food Testing & Analysis and Sanitation and Operations

Register by September 13, 2019 for a special discount!

Frank Yiannas, VP of Food Safety, Walmart
Watch this video from when Frank Yiannas was the vice president of food safety at Walmart. He presented at the 2015 Food Safety Consortium.

Steven Sklare, USP, Aaron Biros, Food Safety Tech
Watch this video of Steven Sklare speaking with Aaron Biros of Cannabis Industry Journal at the 2017 Food Safety Consortium.

Bob Pudlock, Gulf Stream Search
Read Bob Pudlock’s exclusive series on Food Safety Tech, Architect the Perfect Food Safety Team.

Elise Forward, Forward Food Solutions
Elise Forward discusses how to take food defense beyond the four walls of your business.
Daniel Erickson, ProcessPro
FST Soapbox

Establishing Preparedness Initiatives to Mitigate the Effects of Recalls

By Daniel Erickson
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Daniel Erickson, ProcessPro

Despite manufacturers’ best intentions to provide safe products for consumers, notifications about recalled products appear in news headlines with increasing regularity. The CDC reports that each year, 48 million Americans experience foodborne illnesses, resulting in a reported 128,000 hospitalizations and 3,000 deaths. Behind these statistics are recall trends that can lead to operational and financial instability, and a loss of reputation for companies in the marketplace. Proactive measures and tools adopted by experienced food and beverage manufacturers can help mitigate the potentially harmful effects of these product recalls by establishing preparedness initiatives.

Recall Essential Facts

A recall is defined as a request for the return of a product from the market due to a defect or safety concern resulting from a variety of issues including improper labeling or contamination, which places the manufacturer at risk of legal action. Product recalls can be issued by either the manufacturer or a governmental agency, but it is the sole responsibility of the company to properly recall and notify consumers of unsafe products. Recalls are categorized as either voluntary or mandatory, with the majority falling under the voluntary classification. In the case of a voluntary recall, a manufacturer has greater control over the process with less stringent procedures, review and paperwork. While both have the same potential for negative effects and significant legal costs, a voluntary recall is preferred by manufacturers. Implementing an industry-specific ERP solution with a documented recall preparedness plan and mock recall capabilities provide the necessary tools for either scenario, as recalls are inevitable in today’s manufacturing environment.

Recall Trends

In the USDA- and FDA-regulated markets, comparatively, there have been a slightly higher number of recall incidents in the beginning months of 2019 versus 2018. Mispackaging is identified as one of the primary recall issues, involving packaging a finished good into the wrong container. Another trending recall cause involves not properly identifying an ingredient on the packaging label. Both of these manufacturing errors resulted in the labels not providing an accurate reflection of the product, which could be potentially harmful to consumers if the undeclared ingredient(s) include one of the common allergens. Well-documented and properly executed internal manufacturing processes, in addition to an automated ERP solution, create checks and balances and assist in generating accurate, compliant packaging and nutrition fact panels to meet the requirements of consumers and regulatory bodies.

A third recall trend of 2019 is being driven by consumer complaints in regards to foreign materials such as metal fragments, plastics or rubber pieces in finished goods. This is caused by incomplete testing, lack of or faulty material detection equipment, including metal detectors, x-rays and other devices used during manufacturing. Due to an increasing number of these types of incidents, the USDA has issued a guidance document requiring manufacturers to maintain updated documentation of their internal procedures in their hazard analysis and critical control point (HACCP) plan. This guidance necessitates follow up with federal inspectors regarding any adjustments made to the plan. HACCP information recorded within an ERP solution helps to identify and control potential hazards before food safety is compromised—providing quality, consistent and safe consumables for the public.

Progress towards fewer FDA food and beverage recalls continues due to an increase in FDA inspections as well as manufacturers’ success in proactive measures to stay abreast of FDA requirements. However, bacterial pathogenic concerns including Listeria, Salmonella and E. coli continue to be prevalent recall culprits. This has resulted in the FDA utilizing the Whole Genome Sequencing (WGS) Program in an attempt to protect consumers from foodborne illness. By swabbing manufacturing environments and sending samples to WGS, the DNA strains are documented in a centralized public database—holding manufacturer’s accountable for processing and sanitation control. When an outbreak occurs, the database is able to locate possible matches that help health officials identify the source of contamination, and stop outbreaks more quickly, thereby avoiding additional widespread illnesses. As the database grows in size, so will the speed of investigations to determine the root causes of illnesses. This program has the potential to not only stop outbreaks from spreading but also includes proactive applications for increasing the safety of the food and beverage industry as a whole.

ERP’s Role in Recall Preparedness

An industry-specific ERP’s real-time forward and backward lot traceability, detailed record keeping, allergen/attribute tracking and efficient, documented processes support end-to-end recall management functionality to maintain compliance. With preventative measures such as establishing supplier relationships, conducting quality control testing and documenting quarantine procedures, an ERP solution works to identify gaps and prevent future recalls. Accurate product labeling is one of the key factors of recall prevention and food and beverage ERP software handles the intricacies of packaging and label creation, such as ingredient and allergen statements, nutrient analysis, expiration dates and lot and batch numbers—creating an audit trail that allows items to be located promptly in the event of a recall. As part of a sound food safety plan, mock recalls conducted regularly encourages familiarity with internal recall processes, as well as allows for adjustments to be made as needed. With a comprehensive ERP to generate lot tracking reports, manufacturers are able to identify and locate contaminated products in order to notify clients, vendors, consumers and government agencies quickly in the event of a recall—helping to minimize harmful effects in the marketplace as well as legal action.

The trends identified in recent recalls issued by the FDA and the USDA, thus far in 2019, demonstrate that manufacturers need to be proactive in how they respond in order to mitigate the detrimental effects that recalls can have on companies and to public health. With the increasing scrutiny from the FDA and USDA, along with an aware consumer base, it’s important for forward-thinking businesses to address the eventuality of a product recall with sound food safety and HACCP plans and an industry-focused ERP software solution that promotes, supports and helps manage preparedness and responsive action, if needed.

Food Safety Consortium - October 1-3, 2019 - Schaumburg, IL

Food Safety Consortium Early Bird Discount Expires This Week

By Food Safety Tech Staff
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Food Safety Consortium - October 1-3, 2019 - Schaumburg, IL

View the range of content associated with the Food Safety ConsortiumThe 2019 Food Safety Consortium Conference & Expo attracts some of the most influential stakeholders in the industry. This year’s event, which runs October 1–3, will not disappoint, with several features that provide a maximum networking and educational benefit to attendees.

The following is a snapshot of just a few of the benefits of attending this year’s Food Safety Consortium:

  • The Food Defense Consortium Meeting. This pre-conference workshop is open to all participants of the Food Safety Consortium
  • FSSC 22000 North American Information Day. This pre-conference workshop takes place on the morning of Tuesday, October 1 and is open to all Food Safety Consortium participants
  • A complimentary Sanitation Pre-conference Workshop (Tuesday, October 1)
  • Keynote Plenary Session by Frank Yiannas, FDA deputy commissioner for food policy and response
  • Recalls panel led by Rob Mommsen, director of global quality & food safety, Sabra Dipping Company
  • Food defense panel led by Steven Sklare, president of The Food Safety Academy; participants include Jason Bashura, senior manager of global food defense at PepsiCo
  • Focused breakout tracks on food safety leadership, food testing & analysis, and sanitation and operations

Don’t miss the opportunity to have access to the premier industry event at a significant value. The super early bird discount expires this Friday, June 28.

Laura Lombard, IMEPIK
FST Soapbox

Is Your Facility Properly Prepared to Ensure Preventive Controls are Met?

By Laura Lombard
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Laura Lombard, IMEPIK

Under FSMA, you are required to have at least one Preventive Control Qualified Individual (PCQI) on your staff at all times to build and manage your food safety plan(s) for your manufacturing facilities. Per the regulation, PCQIs “have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system.” (Subpart C Section 117.180 (c) (1))

First and foremost, have you met the basic requirement of having at least one trained PCQI? There are now both online and in-person options to ensure your that food safety or quality assurance manager has had the proper training. Most online options require set times and dates like the in-person version to complete the training. Only one PCQI training currently on the market is completely self-paced and available 24-7. No matter which option you choose, it is a baseline that you ensure you have checked that regulatory box before the FDA comes to inspect your facility.

But what if your PCQI needs to take extended medical leave or moves on to another job? It is a proactive and smart move to have a back-up PCQI trained to both help support your PCQI under regular circumstances and be ready to step in if your quality assurance manager becomes unavailable. For a relatively small investment, you can ensure your company is meeting the regulatory requirement and has the training to provide a safe, quality product.

The FSMA regulation does not require you to have a PCQI for every facility but does require an individual food safety plan per location. Depending on how many facilities your particular company has, you may want to consider more than one PCQI to ensure that food safety plans are regularly updated and properly implemented. Many companies are now training the entire quality assurance department or a facility cross-functional team to be PCQIs and participate on the food safety team. Again, the relatively small investment in properly training personnel can save your company hundreds of thousands or millions of dollars in costly recalls, lost revenue due to negative brand reputation, and FDA fines. The average recall costs $10 million, not including brand damage and lost customers.

It is simply prudent to invest in PCQI training beyond the basic requirement of the FSMA regulation. Companies should train their quality assurance or food safety staff at the PCQI level to protect a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more that can be saved in costly recalls, loss of current or potential customers, and brand reputation. Lastly, a company with a robust safety culture has a competitive advantage over competitors who are less inclined to invest sufficiently in their food safety training and may suffer financial repercussions and damage to reputation as a result of recalls and customer quality assurance complaints.

Third party certification program, FDA, audits, Food Safety Supply Chain Conference

Your Supply Chain in 2019: Top Considerations

By Maria Fontanazza
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Third party certification program, FDA, audits, Food Safety Supply Chain Conference

Last week industry gathered for the Food Safety Supply Chain conference at USP in Rockville, MD. The following are some quick highlights of insights they shared.

Most Common Form 483 Observations

Following FSVP inspections, the most common Form 483 observation was a company’s failure to develop an FSVP. From FY 2017 to present, the observation was cited 552 times, outweighing any other observation and underscoring the need for an educational component. – AJ Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA

FDA, Food Safety Supply Chain Conference
(left to right) AJ Seaborn, Lisa Ross and Priya Rathnam of FDA share an update on FSMA implementation at the 2019 Food Safety Supply Chain Conference

Top Citations for FY 2018

  • Hazard analysis (when a facility is not identifying a hazard that requires a preventive control)
  • Lack of a food safety plan. “There’s still work to be done on the education and outreach on this one.”
  • Equipment and utensils (GMP deficiency)
  • Allergen controls monitoring
  • Sanitation control verification procedures
  • Personnel (usually, this is related to a repeated issue)
    Priya Rathnam, supervisory consumer safety officer, CFSAN, FDA

Critical Supplier Questions Must Be Asked

  • How do you choose and approve your suppliers?
  • What must be done to ensure that we aren’t receiving hazards from suppliers?
  • What requirements must be defined?
  • Does every supplier need to be audited?
  • Should we treat all suppliers equally? (No, it depends on their risk profile)
  • How do we ensure that our program is effective?
  • When working with suppliers, it’s important that your decisions are reproducible and that you apply the same risk methodology across the board. – Erika Miller, food safety specialist, D.L. Newslow & Associates, Inc.

“Before you can do anything to transform your business, you have to have visibility in your supply chain.” – George Dyche, senior director, innovations & solutions, Avery Dennison

“’Compliance’ should be replaced in industry with ‘commitment’…when you’re committed, compliance will follow.” – Felix Amiri, food sector chair, Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP)

Putting the “P” in CAPA = Getting out in front of issues before they happen. “Don’t wait for the consumer to get sick… if you have a recall, it means you haven’t done your work on the CAPA side.” – Andrew Kennedy, director, Global Traceability Center, IFT

Food Safety Supply Chain Conference
(left to right) Felix Amiri, Lucy Angarita and Andy Kennedy discusss supply chain vulnerabilities and solutions.

On critical success factors to establish a traceability program: Technology will never fix a company’s data quality or process issues. If you don’t already have it defined, you won’t get there. And after you understand the KPIs and goals, don’t give up. This doesn’t happen overnight. Engage your leadership, because the vision has to be from the top for others to also allocate the time and effort. “It’s a journey, not a destination. If you take your eyes off data quality, data quality goes down.” – Lucy Angarita, director, supply chain traceability, IPC/Subway

In 2018, 47% of recalls were allergen related, and this rate has increased. “People still don’t get [allergen labeling]”.  – Barry Parsons, senior consultant, PTI Consulting Group (Division of Paster Training)

On the significance of teaching truck drivers the importance of food safety risks: “They are part of our supply chain, and we need to incorporate them. It shouldn’t be out of sight, out of mind.” – Holly Mockus, senior industry analyst, Alchemy

Third party certification program, FDA, audits, Food Safety Supply Chain Conference
Trish Wester, chair of The Association of Food Safety Auditing Professionals, leads an FDA panel discussion about the Third-Party Certification Program. (left to right) Doriliz De Leon, program coordinator, accredited third-party certification program, FDA; Marla Keller, biologist, FDA; Marianne Fatica, policy analyst, Office of Compliance, FDA; Clinton Priestley, consumer safety officer, audit staff, human and animal food operations, ORA, FDA
Karen Everstine, Decernis
Food Fraud Quick Bites

Food Fraud: Where Do I Start?

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

I attended the Safe Food California Conference last week in Monterey, California. Food fraud was not the main focus of the conference, but there was some good food fraud-related content. Craig Wilson gave a plenary session about the past, present and future of food safety at Costco. As part of that presentation, he discussed their supplier ingredient program. This program was implemented in response to the 2008 Salmonella Typhimurium outbreak in peanut paste but has direct applicability to food fraud prevention.

Food Fraud: Problem Solved? Learn more at the 2019 Food Safety Supply Chain Conference | May 29–30, 2019 | Attend in Rockville, MD or virtually Jeanette Litschewski from SQFI gave a breakout presentation on the most common SQF non-conformities in 2018. She presented data from 7,710 closed audits that cited 44,439 non-conformities. Of those, 756 were related to food fraud requirements. While this presentation was not focused on the specifics of the food fraud non-conformities, Jeanette did mention that many of them were related to broad issues such as not having completed a food fraud vulnerability assessment or appropriately documenting that each of the required factors was addressed in an assessment.

I was invited to give a breakout presentation with an overview of food fraud issues globally and a brief outline of some of the tools currently available to assist with conducting vulnerability assessments. Although many of the attendees had already began implementation of food fraud measures, there was a lot of interest in this list of tools and resources. Therefore, I am recreating the list in Table I. The focus is on resources that are either complimentary or affordable for small- and medium-sized businesses, with recognition that “full-service” and tailored consulting services are always an option.

Food Fraud Resources (Table I)
Food Fraud Mitigation Training Food Fraud Vulnerability Assessments Food Fraud Data/Records
Michigan State Massive Open Online Courses for Food Fraud SSAFE/PwC Decernis Food Fraud Database
Food Fraud Advisors Online Training Courses USP FFMG FPDI Food Adulteration Incidents Registry
Food Fraud Advisors Vulnerability Assessment Tools (downloadable spreadsheets):

The USP Food Fraud Mitigation Guidance referenced in Table I is a great source of general information on food fraud mitigation, as is the “Food Fraud Prevention” document created by Nestle. Many of the GFSI Certification Programme Owners have also released guidance documents about vulnerability assessments, such as BRC, FSSC 22000, and SQF.

The Decernis Food Fraud Database and the FPDI Food Adulteration Incidents Registry (see Table I) are two sources of historical food fraud data that are referenced specifically in the SSAFE/PwC tool. Companies can also track official information about food safety recalls and alerts (including related to food fraud) from public sources such as the FDA Recalls, Market Withdrawals, & Safety Alerts; Import Refusals; Warning Letters; USDA Recalls and Public Health Alerts; EU RASFF, and many others.

Of course, there are quite a few companies that offer tailored tools, training and consulting services. Companies that offer courses in food fraud mitigation and assistance in creating a vulnerability assessment (or FDA-required food safety plan) include NSF, Eurofins, AIB International, SGS, and The Acheson Group.

Also available are services that compile food safety recalls and alerts (including those resulting from food fraud) from multiple official sources, such as FoodAKAI and HorizonScan. EMAlert is a proprietary tool that merges public information with user judgment to inform food fraud vulnerability. Horizon Scanning is a system that can monitor emerging issues, including food fraud, globally.

Food fraud mitigation, vulnerability assessment
Vulnerability assessments should help focus resources towards those ingredients truly at risk of fraudulent adulteration.

In short, there are many resources available to help support your food fraud vulnerability assessments and mitigation plans. If I have unintentionally missed mentioning any resources you have found to be helpful, please let us know in the comments.

FDA

FDA Final Guidance Informs Companies on When to Notify Public about Food Recalls

By Food Safety Tech Staff
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FDA

FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.

In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.

“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA

In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.