Tag Archives: risk

FST Soapbox

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

By David Hatch
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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.

Visit Corvium at the 2019 Food Safety Consortium Conference & Expo | Booth 204Define 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.

Chelle Hartzer, Orkin
Bug Bytes

Stay Audit-Ready, Anytime with Integrated Pest Management

By Chelle Hartzer
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Chelle Hartzer, Orkin

The unlimited supply of food sources that manufacturing facilities provide can make pest management a daunting task, especially with the scrutiny of third-party auditors, government regulators and customers. These high standards, along with yours, mean that diligence is a key ingredient in the recipe for pest management success.

Why is this important? The steps you take to prevent pests, and how issues are resolved if pest activity is detected, affects the overall credibility of your business. After all, pest management can account for up to 20% of an audit score.

Auditors look for an integrated pest management (IPM) plan, which includes prevention, monitoring, trend reports and corrective actions. If you want to stay audit-ready, all the time, implement the following five principles.

Open Lines of Communication

A successful pest management partnership is just that: A partnership. Create an open dialogue for ongoing communication with your pest management provider. Everyone has a role to play from sanitation to inspection to maintenance. For example, if there are any changes in your facility, such as alteration of a production line, let your provider know during their next service visit. During each visit, it’s important to set aside time to discuss what was found and done during the visit, including new pest sightings and concerns.

Communication shouldn’t be limited to the management team; your entire staff should be on board. During their day-to-day duties, employees should know what to look for, and most importantly, what to do if they notice pests or signs of pests. Reporting the issue right away can make a huge difference in solving a pest problem before it gets out of hand. Also, most pest management providers offer staff training sessions. These can be an overview of the basics during your next staff meeting or a specialized training on a pertinent issue.

Inspect Regularly

A thorough inspection can tell you a lot about your facility and the places most at risk for pests. Your pest management provider will be doing inspections every visit, but routine inspections should be done by site personnel as well. Everyone at the site has a set of eyes, so why not use them? This way, you can identify hot spots for pests and keep a closer eye on them. Pests are small and can get in through the tiniest of gaps, so some potential entry points to look out for are:
• Windows and doors. Leaving them propped open is an invitation for all sorts of pests. Don’t forget to check the bottom door seal and ensure it is sealed tight to the ground.

  • Floor drains. Sewers can serve as a freeway system for cockroaches, and drains can grant them food, water and shelter.
  • Dock plates. A great entry point for pests, as there are often gaps surrounding dock plates.
  • Ventilation intakes. These are a favorite spot for perching, roosting or nesting birds, as well as entry points for flying insects.
  • Roof. You can’t forget about the roof, as it serves as a common entry point for birds, rodents and other pests.

Another thing to look for is conducive conditions, such as sanitation issues and moisture problems. These are areas where there may not be pests yet, but they provide a perfect situation that pests could take advantage of if they aren’t dealt with. Make sure to take pictures of deficiencies so that can be shared with the maintenance department or third-party who can fix it. You can also take a picture of the work when it has been finished, showing the corrective action!

Keep It Clean

Proper sanitation is key to maintaining food safety and for preventing and reducing pests. You need a written sanitation plan to keep your cleaning routine organized and ensure no spots are left unattended for too long. The following are some additional steps consider:

  • Minimize and contain production waste. While it’s impossible to clean up all the food in a food processing site (you are producing said food!), it’s important to clean up spills quickly and regularly remove food waste.
  • Keep storage areas dry and organized.
  • Remember FIFO procedures (first in, first out) when it comes to raw ingredients and finished products.
  • Clean and maintain employee areas such as break rooms and locker rooms.
  • Ensure the outside of your facility stays clean and neat with all garbage going into trash cans with fitted lids.
  • Make sure dumpsters are emptied regularly and the area around them kept clean.

Monitoring

Monitoring devices for many pests will be placed strategically around your facility. Some common ones are insect light traps (ILTs), rodent traps and bait stations, insect pheromone traps and glue boards. It’s important to let employees know what these are there for and to respect the devices (try not to run them over with a fork lift or unplug them to charge a cell phone). These devices will be checked on a regular basis and the type of pest and the number of pests will be recorded. This data can then be analyzed over time to show trends, hot spots, and even seasonal issues. Review this with your pest management provider on a regular basis and establish thresholds and corrective actions to deal with the issues when they reach your threshold. The pest sighting log can also be considered a monitoring tool. Every time someone writes down an issue they have seen, this can be quickly checked and dealt with.

Maintain Proper Documentation

Pest management isn’t a one-time thing but a cycle of ongoing actions and reactions. Capturing the process is extremely important for many reasons. It allows you to analyze, refine and re-adjust for the best results. It’s a great way to identify issues early. Also, it’s a critical step for auditors. Appropriate documentation must be kept on hand and up-to-date. There’s lots of documentation to keep when it comes to pest management and your provider should be keeping all of that ready—from general documentation like your annual facility assessment and risk assessment to training and certification records, pest sighting reports, safety data sheets and more.

The documentation aspect may seem like a lot at first, but a pest management provider can break it down and make it easier. It’s absolutely necessary for food and product safety and will become second nature over time.

FDA

FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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FDA

Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
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AFSAP

The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.

Reason

“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA

Charge

“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.

Threat of Cyberattacks to Food Safety on the Rise

By Food Safety Tech Staff
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A new report released by the University of Minnesota’s Food Protection and Defense Institute warns that the food industry is vulnerable to cyberattacks, suggesting that food companies need to beef up their security and IT systems. According to the report, “Adulterating More Than Food: The Cyber Risk to Food Processing and Manufacturing”, the systems that food companies use for processing and manufacturing could be the most vulnerable and as such, serve as an attractive target for an attack—especially as industries that are currently common targets improve their cybersecurity.

“The food industry has not been a target of costly cyberattacks like financial, energy, and health care companies have,” said Stephen Streng, lead author of the FPDI report, in a news release. “However, as companies in those sectors learn to harden their defenses, the attackers will begin looking for easier victims. This report can help food companies learn about what could be coming their way and how to begin protecting themselves.”

The report calls out that in 2011, researchers and manufacturers found more than 200 vulnerabilities in industrial control systems. In addition to the fact that these vulnerabilities are in many components from different vendors, many of these systems have obsolete operating systems and passwords that are easy to hack. Compounding this issue, “Companies often lack knowledge about how their industrial control systems and IT systems interact and lack awareness about cyber risks and threats,” the FPDI release notes.

And if you’re a small company, don’t think you’re immune, the report cautions. It cites that 74% of U.S. food manufacturers have fewer than 20 employees—yet software company Symantec Corp. points out that small companies have been targeted as often, or sometimes even more, than large companies.

How can food companies address this risk? The report recommends the following “critical” steps all companies should take:

  • Bridge the gap and facilitate more communication between OT (operational technology) and IT (information technology) personnel
  • Conduct risk assessments of inventory control systems and IT systems
  • Ensure that staff with the cybersecurity knowledge is involved in procuring and deploying inventory control system devices
  • Incorporate cybersecurity into your food safety and food defense culture.

FPDI’s full report is available on the organization’s website.

Alert

Flooding and Food Safety: A Two-Part Plan for Extreme Weather Season

By Paula Herald
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Alert

The spring of 2019 saw record rain fall across North America, causing historic, severe flooding in the Great Plains, parts of the Midwest, and the Southern United States. That above-normal precipitation doesn’t look to be ending, either. The National Oceanic and Atmospheric Administration’s Climate Prediction Center predicts that wide swaths of the United States could face above normal precipitation for the remainder of 2019.

In addition to disrupting power to critical equipment and damaging property, when food businesses flood, food safety is put at risk. Flood waters can be contaminated with debris, sewage, chemicals, pests and more. In a restaurant or foodservice operation, any product, object or surface that flood waters touch becomes contaminated.

Pre-Flood Preparation

Having a documented flood emergency plan in place can give location staff a step-by-step course of action to follow in times of increased stress and panic. It can also help minimize losses for a business.

For national chains in particular, it can be harder to ensure that all locations have the resources and tools available in their area. Corporate operations can assist by identifying vendors and resources ahead of time.

  • Designate roles and responsibilities. Having a clearly outlined plan with designated roles and responsibilities can prevent confusion and extra work during the crisis. Have an updated phone contact list of key contacts available for those with designated roles and responsibilities.
  • Sandbags. Placing sandbags in front of doors or other openings may help limit flood damage.
  • Vital records. Both paper and digital/electronic records can be at risk. Businesses using electronic records should ensure that files are automatically backed up regularly. Businesses using paper records should ensure that vital records are secured in such a way that they can be quickly removed to a safe place or elevated to prevent damage.
  • Equipment. Flood waters can damage or destroy expensive equipment. Have a plan in place to remove equipment to a safe place.
  • Food storage. If flood waters contact food supplies, many may need to be destroyed. Arranging for food storage in a secure place away from flood waters can help minimize losses. This may require refrigeration storage.
  • Turn off electric and gas. Turning off natural gas lines can prevent devastating damage and contamination from occurring. Turning off and unplugging equipment that uses electricity can help protect the safety of rescue workers or staff returning for cleanup.
  • Refrigeration. If it is not possible to remove food, be certain that all refrigerated units are equipped with accurate thermometers. If possible, monitor the temperature in the units during the disaster situation.

Post-Flood Recovery

Even with a rock-solid pre-storm plan in place, Mother Nature’s extreme weather events can wreak havoc on facilities. In the wake of a storm, sorting out what needs to be done to restore order to operations can be a hefty task.

Post-storm recovery can be an extensive task, especially if flooding is involved. It may require work of many staff members or outside vendors, such as remediation specialists. Safety should be absolutely paramount. No one should enter a space that has been flooded without confirmation that there are no electrical shock hazards, gas leaks or debris that could harm people. Structural damage that could lead to collapse or other injury is possible. Mold is also a risk following floods. All personnel involved in flood clean-up must wear personal protective equipment—eye protection, gloves, disposable aprons, rubber boots, and masks or respirators, etc.

The following guidelines can help prioritize steps to ensure food safety won’t be a factor holding back a location from re-opening.

  • Safe water. Facilities cannot prepare food without a clean, potable water supply. If the water system was affected by flood or the local water supply was unsafe, the local health department should be involved in clearing re-opening.
  • Disinfection of equipment. Any food equipment that was exposed to flood water or other non-potable water must be disinfected prior to use, including ice machines, which are often overlooked. Discard any ice already present in a machine. Thoroughly clean and sanitize the machine before turning it on. Once the machine is running again, discard the first two cycles of ice.
  • Disinfection of surfaces. Any surface (countertops, walls, ceilings, floors, equipment surface, etc.) that was contacted by floodwaters must be disinfected before reopening.
    • Use a commercial disinfectant with effectiveness against norovirus or make a chlorine bleach solution to disinfect affected areas.
    • Use unscented bleach and wear gloves.
    • Make fresh bleach solutions daily.
    • Food contact surfaces that are disinfected must be rinsed with clean, potable water, and sanitized before use.
    • Discard any mop heads or absorbent materials used to clean flooded areas.
  • What to discard. Inevitably, there will be items that cannot be salvaged following a flood event. The following items should be discarded if they have come into contact with floodwater or non-potable water or were subjected to temperature abuse due to power outages. If there is any doubt, throw it out.
    • Unpackaged food (examples: fruits, vegetables)
    • Food in permeable packaging (examples: flour in bags, produce in cardboard boxes)
    • Food packaging materials
    • Refrigerated food in a refrigerated unit where the temperature rose above 41°F for more than four hours
    • Any refrigerated product that was not temperature-controlled for more than four hours
    • Frozen food product that has thawed to a temperature of above 41°F for more than four hours
    • Canned items with damaged seams, swelling or dents
    • Items with screw tops, twist-off caps, or other semi-permeable packaging
    • Single service/use items
    • Any linens that contacted floodwaters that cannot be laundered with bleach and dried in a mechanical dryer
  • What can be safely kept. Not everything will need to be discarded.
    • Canned foods free of dents or rust can be kept after labels are removed, they are disinfected, washed, rinsed in clean water, and sanitized; cans with any signs of bulging or leaking must be discarded; canned foods should be also be relabeled with the name of the food product, as well as the expiration date
    • Linens that can be safely laundered with bleach and dried in a mechanical dryer
    • Dishes, utensils, pots and pans, and other service items that are free of rust and can be disinfected, washed, and sanitized

As climate change continues to advance, the threat of extreme weather and flooding situations may soon be a reality for areas of the United States that have never experienced them before. In the Congress-mandated Fourth National Climate Assessment, compiled by the U.S. Global Change Research Program, the authors warn of the future of severe weather events.

“More frequent and intense extreme weather and climate-related events, as well as changes in average climate conditions, are expected to continue to damage infrastructure, ecosystems, and social systems that provide essential benefits to communities.” – Fourth National Climate Assessment

Even for businesses that have not had to consider flooding before, it may be time to sit down and develop a flooding and food safety plan of action. The time invested in training and educating staff members may help to protect investments and keep food safe in the event of flooding and weather emergencies.

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.

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

Your Supply Chain in 2019: Top Considerations

By Maria Fontanazza
No Comments
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

Technology Helps Your Food Safety Employees Work Smarter, Not Harder

By Maria Fontanazza
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As the use of technology in manufacturing and quality continues to expand, there are many opportunities to help food companies streamline operations and enhance efficiencies. During a brief chat with Food Safety Tech, Melody Ge, head of compliance at Corvium, Inc. talks about the benefits of using technology in manufacturing and why some companies may be hesitant to take the leap.

Food Safety Tech: Your recent Food Safety Tech article, “Changes in the Food Safety Industry: Face Them or Ignore Them”, highlighted the role of technology in improving efficiency. What are the top areas in which companies are challenged to streamline processes?

Melody Ge, Corvium
Melody Ge, head of compliance at Corvium, Inc.

Melody Ge: When talking about a company’s production process, the challenge usually comes from where to start. A company may have difficulty figuring out which areas in the processing line can either be automated or how they can use technology as an advantage.

The challenge could also come from the fact that only parts of the process can be automated with the current technology. For example, with hazard analysis or risk assessment—those processes still need the human brain. So within a process, part of it can be automated, and part of it can’t—that could be another challenge.

FST: What technologies can food companies use to better help them manage risk in manufacturing?

Ge: It depends on what’s out there and what products a company is producing. From a manufacturing perspective, they can use supply chain management software or document management software to help them manage their approved supplier program. Using technology can make it easier and more efficient for companies to manage the risks from incoming goods and suppliers as it centralizes their documentation to make it easy to access.

Technology also helps companies use online software to centralize training documents on one corporate site and deploy it to all employees at different levels.

And from a HACCP and Preventive Controls perspective, companies can use digital technology to document temperature, pH Value, humidity, pathogen testing results, etc.—all the types of data that help execute a HACCP plan can be automated and help manage risk. After all the information is centralized and digitalized, you can see the data and easily translate that to help manage risk.

FST: What are the current technology adoption hurdles, and how are you helping companies understand the value of technology versus a paper-based system?

Ge: I think some hurdles come from fear: What’s going to happen as a result of technology is unknown, and especially at this stage, how FDA will respond is unknown. FDA already announced that this smarter food safety era is coming, but no one knows whether there will be new requirements as a result. Will requirements change because manufacturers are using new technology? Those unknowns make manufacturers fearful about what’s going to happen.

Another fear factor is job loss. For example, if processes are automated, or AI is used to capture data, or record keeping is automated, then what am I going to do? Does the company still need me as a QA professional or supervisor? I think those can stand in the way of making changes. However, [companies or employees] shouldn’t think that way. Technology is not replacing QA professionals, but [rather it] helps them do higher-level jobs. For example, in the time saved by technology, QA professionals can read and digest the data results, and study the trends and recommend best practices to continuously improve their food safety management system. It makes their time more valuable to the company.

Another hurdle is understanding which steps in processes can be automated. There are so many technologies out there that have pros and cons, and whether it will fit with the manufacturer or the facility—there’s an overwhelming amount of information, and the QA technician needs time to digest and understand the process at the facility as well as the technology out there to then select the most suitable technology for a process.

As far as helping companies understand the ROI of technology, there are four areas where I think technology can add value:

  1. It provides increased efficiencies and accuracy of daily operations and data collection. It reduces human error. Let the technology help the food safety professionals document daily operational data.
  2. It streamlines the food safety management system for continuous improvement. Because technology helps the food safety professional do the job of daily data collection, the time saved can be used wisely to study the data and outcomes, and truly understand how they can bring their food safety management system to another level.
  3. It centralizes all the documents and records for management. Using technology, the food safety professional can see their SOPs, records and any related documents in one place. They don’t have to physically go to several places to see what’s happening operationally. This can also help increase efficiency during the audit process.
  4. Centralized data helps the food safety professional more easily see where the deficiencies are located.

Ultimately, the ROI is that advanced technology can help the food safety professional increase operational efficiency, reduce product waste and production downtime.

FST: Any additional comments about the role of technology in food manufacturing?

Ge: In echoing on FDA’s announcement, although the smarter food safety era comes with using advanced technology, the mentality has not changed as all—it’s always FSMA based and people led. We need people to use the technology, and that foundation isn’t changing. We are protecting our consumers from any potential food safety risk. We’re just using a more efficient way to help all of us achieve this goal. I believe in the future, all food facilities will use at least one technology out there to help them automate one or more processing steps. And if you start with one step at a time, it will generally take over the entire production process.

Visit Corvium at next week’s Food Safety Supply Chain Conference at USP in Rockville, MD. Unable to travel? Attend the program virtually!

Steve Ardagh, Eagle Protect
FST Soapbox

Glove Polymers: The Unregulated Food Safety Threat

By Steve Ardagh
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Steve Ardagh, Eagle Protect

Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.1

Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.

Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.2

There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.

As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!

References

  1. Bhutta, M. and Santhakumar, A. (March 2016). In Good Hands. Tackling labor rights concerns in the manufacture of medical gloves. British Medical Association. Retrieved from https://www.bma.org.uk/collective-voice/influence/international/global-justice/fair-medical-trade/medical-gloves-report.
  2. Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report

The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.