Tag Archives: verification

Food Safety Consortium

2020 FSC Episode 6 Preview: Sanitation Issues

By Food Safety Tech Staff
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Food Safety Consortium

The integration of sanitation is a critical part of the food manufacturing process. This week’s episode of the 2020 Food Safety Consortium Virtual Conference Series will focus on effective approaches, best practices and lessons learned. The following are some highlights:

  • Sanitation Methods, Day-to-Day Operations and Applying It to a Pandemic (Now and Future Outbreaks), with Elise Forward, Forward Food Solutions; David Shelep, Paramount Sciences; and Bill Leverich, Microbiologics, Inc.
  • The Critical Nature of a Good Environmental Program: The Story Behind Sabra’s Recall, Experience with the FDA, and Environmental Monitoring Journey, with Rob Mommsen, Sabra Dipping Company
  • Surrogates & Emerging Applications: Their Role in Validation, Verification and Compliance, with Laure Pujol, Ph.D. and Vidya Ananth, Novolyze
  • Tech Talks from Sterilex and Romer Labs

The event begins at 12 pm ET. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Checklist

2020 FSC Episode 3 Wrap: Does Your Company Have a COVID Czar?

By Maria Fontanazza
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Checklist

Navigating the murky waters that COVID-19 presents has been no easy task for food companies. Being part of America’s critical infrastructure has meant that adapting to the pandemic has been unavoidable, and the industry has directly taken on the challenges to ensure the nation has a reliable food supply. But what about the frontline workers, their safety and how this ties into operational continuity as a whole? During last week’s episode of the 2020 Food Safety Consortium Virtual Conference Series, an expert panel discussed the practices that food companies have put in place during the pandemic and offered advice on managing the entire scope of COVID-19 challenges including screening employees and preventing infection transmission, safeguarding workers and the facility, administrative and engineering controls, education and training, and risk management.

“No doubt that it is a concert of controls and interventions that have allowed our industry to effectively combat this over the past several months,” said Sanjay Gummalla, senior vice president of scientific affairs at the American Frozen Foods Institute. “By and large, the industry has taken charge of this situation in a way that could not have been predicted.” Gummalla was joined by Trish Wester, founder of the Association for Food Safety Auditing Professionals and Melanie Neumann, executive vice president and general counsel for Matrix Sciences International.

First up, the COVID Czar—what is it and does your company have one? According to Neumann, this is a designated person, located both within a production facility as well as at the corporate location, who manages the bulk of the requirements and precautions that companies should be undertaking to address the pandemic. “We’re not trained in people safety—we’re trained in food safety,” said Neumann. “And it’s a lot to ask, especially on top of having to manage food safety.”

Some of the takeaways during the discussion include:

  • Administrative controls that must be managed: Appropriate cleaning, disinfection and sanitation; PPE; employee hygiene; shift management; and surveillance mechanisms
  • PPE: “It’s really clear now that face masks and coverings are critical in managing source control—it prevents the spread and protects other employees,” said Gummalla. “All employees wearing masks present the highest level of protection.” When the attendees were polled about whether face coverings are mandatory where they work, 91% answered ‘yes’.
  • Engineering controls within facility: Physical distancing measures such as plexiglass barriers, six-foot distance markings, traffic movement, limited employees, and hand sanitizer stations. “Engineering controls in a facility involve isolation from the virus,” said Gummalla. “In this case, controlling [and] reducing the exposure to the virus without relying on specific worker behavior. This is where facilities have implemented a great amount of thoughtful intervention, probably at a high capital cost as well.” Companies should also consider airflow management, which can involving bringing in an outside professional with expertise in negative and positive air pressure, advised Wester.
  • Verification activities and enterprise risk management: Neumann emphasized the importance of documentation as well as advising companies to apply a maturity model (similar to a food safety culture maturity model) to a COVID control program. The goal is to ensure that employees are following certain behaviors when no one is watching. “We want to be able to go from ‘told’ to ‘habit’,” she said.
  • Education and training: Using posters, infographics, brochures and videos, all of which are multilingual, to help emphasize that responsibility lies with every employee. “It is important to recognize the transmission is predominately is person to person,” said Gummalla. Do you have a daily huddle? Neumann suggests having a regular dialogue with employees about COVID.
  • The future, 2021 and beyond: Does your company have a contingency, preparedness or recovery plan? “The next six months are going to be critical; in many parts of the world, the worse is not over yet,” said Gummalla. “There will be a lot more innovation in our industry, and communication will be at the heart of all of this.”

Get access to the presentations and points discussed during this exclusive session by registering for the 2020 Food Safety Consortium Conference Virtual Series. Attendees will have also access to upcoming sessions as well as the recordings of all sessions.

Manuel Orozco, AIB International
FST Soapbox

Detecting Foreign Material Will Protect Your Customers and Brand

By Manuel Orozco
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Manuel Orozco, AIB International

During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.

As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.

The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.

The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.

To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.

But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.

Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.

It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.

Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.

The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.

The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.

Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.

There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.

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.

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.

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.

Melody Ge, Corvium
FST Soapbox

Changes in the Food Safety Industry: Face Them or Ignore Them?

By Melody Ge
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Melody Ge, Corvium

“A new era of smarter food safety is coming,” said Frank Yiannas, FDA’s deputy commissioner of food policy and response, at the GFSI Conference 2019 in Nice, France. He went on to explain, “a smarter food safety is people-led, FSMA-based and technology-enabled.” Afterwards, Yiannas announced the need for a greater budget for the FDA to invest in modern food safety for 2020 and beyond.

Now the question is, when this new era comes, are you ready?

The food industry is relatively behind on technology compared to other industries, or even within our daily lives. Take a look at the cell phone you have now compared to what you had 10 years ago; it has come a long way with all of its handy and useful features. Why can’t the food industry also benefit from technology? Of course, every coin has two sides, but no one would deny that technology played a significant role in bringing the world closer and making it more efficient nowadays.

The scary part of change is that it’s hard to predict what and when they will come to us, however, they also force us think outside of the box. Instead of debating whether incorporating advanced technology into our daily operations makes sense, why don’t we take a look at our current processes in place and see where technology can truly help us? We now have the opportunity to take advantage of technology to enhance our food safety and quality culture at our own facility. Here are some thoughts to share.

1. Identify what can be automated in your current process with technology

Certain things just can’t be replaced by technology, such as risk assessment or hazard identification (at least for now). However, inventory, temperature checking, testing results recording, or anything executing a command from you or implementing a part of your SOPs can potentially be automated. Execution is also the part where the most error could occur, and technology can help improve accuracy and consistency. Identify those steps systematically and understand what data needs to be captured to help your food safety management system.

2. Work with your technology developer to build technical requirements

Explain to the technology developer exactly how you want the program to operate daily. List the operating steps along with responsibilities step-by-step, and identify what requirements are needed for each step. Translating the paper SOP to a computer program plays an important role in this transition. Not only does it set the foundation for your future daily operation, but it also ensures that the control parameter is not lost during the transition.

3. Keep the integrity of the food safety management system through verification and validation

Once processing steps are done by technology, it doesn’t mean that we no longer have to do anything. We need to verify and validate the technology with certain frequency to ensure the steps are controlled as intended. Confirming that the software or system is capturing the right data at the right time becomes key to ensure the integrity of control risks is not compromised.

4. Utilize “preventative maintenance” on all technology used on site

Just like all equipment, food safety technology needs a preventive maintenance schedule. Check whether it is properly functioning on a certain frequency based on the safety impact in your process flow and take actions proactively.

5. Learn from your own records

The time saved from traditional ways allows us to have more time for looking at control points and records received to identify areas for continuous improvement. There are many ways of studying the data with modeling and trend analysis based on your own facility situation. Either way, those records are your own supporting documents of any changes or modifications to your food safety management system, as well as strong support to your risk assessment for justifications.

Just like Yiannas said, a smarter food safety system is still FSMA based. The goal has never changed; we want to produce sustainable, safe and high-quality products to our consumers, whether we use traditional or advanced approaches. After all, we are utilizing technology as a modern way to help us enhance and simplify our food safety management system; the outcome from the automated technology is still controlled by us.

So when the era comes, we all want to be ready for it.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Method Acting: Comparing Different Analytical Methods for Allergen Testing and Verification

By Gabriela Lopez-Velasco, Ph.D.
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Gabriela Lopez, 3M Food Safety

Every day, food industries around the world work to comply with the food labeling directives and regulations in place to inform consumers about specific ingredients added to finished products. Of course, special attention has been placed on ensuring that product packaging clearly declares the presence of food allergens including milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy, sesame and mustard. (Additional food allergens may also be included in other regions.)

But labeling only covers the ingredients deliberately added to foods and beverages. In reality, food manufacturers have two jobs when it comes to serving the needs of their allergic consumers:

  1. Fully understand and clearly declare the intentional presence of allergenic foods
  2. Prevent the unintended presence of allergenic foods into their product

Almost half of food recalls are the result of undeclared allergens, and often these at-fault allergens were not only undeclared but unintended. Given such, the unintended presence of allergenic foods is something that must be carefully considered when establishing an allergen control plan for a food processing facility.

How? It starts with a risk assessment process that evaluates the likelihood of unintentionally present allergens that could originate from raw materials, cross-contact contamination in equipment or tools, transport and more. Once the risks are identified, risk management strategies should then be established to control allergens in the processing plant environment.
It is necessary to validate these risk management strategies or procedures in order to demonstrate their effectiveness. After validation, those strategies or procedures should then be periodically verified to show that the allergen control plan in place is continually effective.

In several of these verification procedures it may be necessary to utilize an analytical test to determine the presence or absence of an allergenic food or to quantify its level, if present. Indeed, selecting an appropriate method to assess the presence or the level of an allergenic food is vitally important, as the information provided by the selected method will inform crucial decisions about the safety of an ingredient, equipment or product that is to be released for commercialization.

A cursory review of available methods can be daunting. There are several emerging methods and technologies for this application, including mass spectroscopy, surface plasmon resonance, biosensors and polymerase chain reaction (PCR). Each of these methods have made advancements, and some of them are already commercialized for food testing applications. However, for practical means, we will discuss those methods that are most commonly used in the food industry.

In general, there are two types of analytical methods used to determine the presence of allergenic foods: Specific and non-specific methods.

Specific tests

Specific methods can detect target proteins in foods that contain the allergenic portion of the food sample. These include immunoassays, in which specific antibodies can recognize and bind to target proteins. The format of these assays can be quantitative, such as an enzyme-linked immunosorbent assay (ELISA) that may help determine the concentration of target proteins in a food sample. Or they can be qualitative, such as a lateral flow device, which within a few minutes and with minimum sample preparation can display whether a target protein is or is not present. (Note: Some commercial formats of ELISA are also designed to obtain a qualitative result.)

To date, ELISA assays have become a method of choice for detection and quantification of proteins from food allergens by regulatory entities and inspection agencies. For the food industry, ELISA can also be used to test raw ingredients and final food products. In addition, ELISA is a valuable analytical tool to determine the concentration of proteins from allergenic foods during a cleaning validation process, as some commercial assay suppliers offer methods to determine the concentration of target proteins from swabs utilized to collect environmental samples, clean-in-place (CIP) final rinse water or purge materials utilized during dry cleaning.

ELISA methods often require the use of laboratory equipment and technical skills to be implemented. Rapid-specific methods such as immunoassays with a lateral flow format also allow detection of target specific proteins. Given their minimal sample preparation and short time-to-result, they are valuable tools for cleaning validation and routine cleaning verification, with the advantage of having a similar sensitivity to the lowest limit of quantification of an ELISA assay.

The use of a specific rapid immunoassay provides a presence/absence result that determines whether equipment, surfaces or utensils have been cleaned to a point where proteins from allergenic foods are indiscernible at a certain limit of detection. Thus, equipment can be used to process a product that should not contain a food allergen. Some commercial rapid immunoassays offer protocols to use this type of test in raw materials and final product. This allows food producers to analyze foods and ingredients for the absence of a food allergen with minimum laboratory infrastructure and enables in-house testing of this type of sample. This feature may be a useful rapid verification tool to analyze final product that has been processed shortly after the first production run following an equipment cleaning.

Non-Specific Tests

While non-specific testing isn’t typically the best option for a cleaning validation study, these tests may be used for routine cleaning verification. Examples of non-specific tests include total protein or ATP tests.

Tests that determine total protein are often based on a colorimetric reaction. For example, commercial products utilize a swab format that, after being used to survey a defined area, is placed in a solution that will result in a color change if protein is detected. The rationale is that if protein is not detected, it may be assumed that proteins from allergenic foods were removed during cleaning. However, when total protein is utilized for routine verification, it is important to consider that the sensitivity of protein swabs may differ from the sensitivity of specific immunoassays. Consequently, highly sensitive protein swabs should be selected when feasible.

ATP swab tests are also commonly utilized by the food industry as a non-specific tool for hygiene monitoring and cleaning verification. However, the correlation between ATP and protein is not always consistent. Because the ATP present in living somatic cells varies with the food type, ATP should not be considered as a direct marker to assess the removal of allergenic food residues after cleaning. Instead, an analytical test designed for the detection of proteins should be used alongside ATP swabs to assess hygiene and to assess removal of allergenic foods.

Factors for Using One Test Versus Another

For routine testing, the choice of using a specific or a non-specific analytical method will depend on various factors including the type of product, the number of allergenic ingredients utilized for one production line, whether a quantitative result is required for a particular sample or final product, and, possibly, the budget that is available for testing. In any case, it is important that when performing a cleaning validation study, the method used for routine testing also be included to demonstrate that it will effectively reflect the presence of an allergenic food residue.

Specific rapid methods for verification are preferable because they enable direct monitoring of the undesirable presence of allergenic foods. For example, they can be utilized in conjunction with a non-specific protein swab and, based on the sampling plan, specific tests can then be used periodically (weekly) for sites identified as high-risk because they may be harder to clean than other surfaces. In addition, non-specific protein swabs can be used after every production changeover for all sites previously defined in a sampling plan. These and any other scenarios should be discussed while developing an allergen control plan, and the advantages and risks of selecting any method(s) should be evaluated.

As with all analytical methods, commercial suppliers will perform validation of the methods they offer to ensure the method is suitable for testing a particular analyte. However, given the great diversity of food products, different sanitizers and chemicals used in the food industry, and the various processes to which a food is subjected during manufacturing, it is unlikely that commercial methods have been exhaustively tested. Thus, it is always important to ensure that the method is fit-for-purpose and to verify that it will recover or detect the allergen residues of interest at a defined level.

Food Safety Supply Chain panel 2017

Registration Open for 4th Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Supply Chain panel 2017

Do you trust your suppliers? What about your supplier’s suppliers? Strengthening the links within your supply chain can be a challenging task, but it is necessary with FDA, and FSMA, recognizing the risk that exists.

Key topics, including vulnerabilities, inspections & audits, traceability, supplier verification, transportation, and recalls will be addressed at the 4th Food Safety Supply Chain conference from June 12–13 in Rockville, MD. The event will be held at the U.S. Pharmacopeial Convention.

This year’s agenda will be posted by March 1. In the meantime, the following are some topics covered at last year’s event:

Industry Experts Weigh in on Supply Chain Issues

Import Safe Food, Stay Out of Trouble with FDA

 

Robert Rogers
FST Soapbox

Validating Your Foreign Material Inspection System

By Robert Rogers
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Robert Rogers

The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing companies identify potential hazards within their production systems and then:

  • Put in place preventive controls to address those hazards,
  • Monitor those preventive controls to ensure their effectiveness &
  • Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying potential food safety hazards and preventive controls to counter them, and to establish the monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe food enters the market enables food manufacturers and processors to meet the specific regulatory standards mandated by the countries where they operate and sell. This enables them to avoid product recalls that are costly and that severely damage brand identity. But these processes, in addition to satisfying regulators, also play a valuable part in protecting the companies from potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are inspection systems (checkweighers and metal detection, X-ray and machine vision inspection systems) that quickly and efficiently detect non-standard and contaminated products and defective packaging and reject them from production lines before they can enter the marketplace. The performance of these systems must be validated, verified and monitored on an ongoing basis to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating confusion within organizations and across industries because people interpret and use these terms in different ways. In fact, each term identifies a distinct process that has a clear purpose and role to play at different points throughout the equipment lifecycle. It is important to understand the purpose of each process to make sure that validation, verification and routine performance monitoring tests are performed to comply with regulatory requirements, particularly where the equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food manufacturing or processing production line, is conducting an objective, data-based confirmation that the system does what it was designed, manufactured and installed to do. The International Featured Standards (IFS) organization defines validation as “confirmation through the provision of objective evidences, that the requirements for the specific intended use or application have been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.” An important part of the validation procedure is the production of detailed data that demonstrates to line managers and to regulators that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing it with generic products and packaging similar to what the customer will be producing. But that is only the beginning of the validation process. Onsite, that same system needs to be validated when inspecting the specific products that the production line where it will operate will be processing and/or packaging. This is ideally done at the time the system is originally installed in a production line, and then becomes one element of a complete program of validation, periodic verification and ongoing monitoring that will keep the system operating as intended and ensure that products are adequately and accurately inspected, and that accurate records of those inspections are kept.

It is critical for producers to remember, however, that the original onsite validation relates only to the specific products tested at the time. As new or additional sizes of products are developed and run on the production line, or packaging (including labeling) changes, the system will need to be re-validated for each change.

Verification

Verification is the process of periodically confirming that the inspection equipment continues to be as effective as when it was first validated. The verification process uses standard, established tests to determine whether the inspection system is still under control and continuing to operate as originally demonstrated. This verification process is conducted periodically at regular intervals to provide evidence-based confirmation that the system continues to be effective as specified. Formal performance verification is typically an annual process, to support audit requirements. It should continue throughout the productive life of the system.

Both validation of an installed system and periodic verification of operating systems can be conducted either internally by the end-user, or by the supplier of the equipment. Validation and verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as distinct from periodic verification, consists of a series of frequent, regular performance checks, during production, completed to determine whether processes are under control and to confirm that there has not been a significant change in the system’s performance level since the last successful test. The monitoring frequency may be as often as every two hours, depending on company standards, industry standards and/or retailer codes of practice.

If the monitoring process finds that a particular device is out of specification, all product that has passed through the production line since the last successful routine performance-monitoring event must be considered suspect and re-inspected.

In many cases, it is line operators that conduct online performance monitoring. However, many of today’s more sophisticated product inspection systems incorporate built-in performance monitoring software that automates this process and alerts operators when deviations occur. This valuable software feature removes any human error factor from the monitoring activity to help ensure that inspection processes are still being performed properly. It also provides documentation that will guide the end-user company’s QA groups in their continuous improvement efforts, and that will also be a valuable asset in the event of an inspection visit from regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE. Installing a system with built-in condition monitoring capability that automatically detects when the system may need correction and communicates that information directly to line operators reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable experts regarding their products, it is their equipment suppliers that are the experts on the capabilities and qualification procedures of their equipment. That expertise makes them the best source of reliable recommendations on questions from the most effective inspection equipment type for specific product needs, where to place that equipment on the production line for optimum results and how to validate, verify and monitor its performance.

Relying on these experts to conduct onsite validation and to advise on conducting periodic verification and ongoing performance monitoring can reduce both the time needed for the original onsite validation time and that needed for verification and ongoing monitoring procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on the most current food safety regulations and the technology that affect equipment validation. It is critical for their success that they stay current on those topics, and sharing that knowledge is a valuable part of their service.

The Validation Conversation

By Joy Dell’Aringa
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Our industry is in a perpetual food safety discussion. We are constantly mulling over the finer points of hazards, risk, preventive controls, training, sanitation, and regulations. Validation is also a key component of the food safety dialog. Here we will explore common themes industry professionals discuss in regard to validation in this era of food safety.

Definitions

In any good conversation, terms must be set and semantics agreed upon. It is helpful to start off with a simplistic definition of validation and verification that can be applied across industries and applications. We often return to these reductive definitions throughout conversations to recalibrate and ensure that all parties are on the same page.

  • Validation:  Are we using the correct system / method?
  • Verification: Are we using the system / method correctly?

From there, we narrow our focus. Using the FSMA backdrop, from the FDA’s “Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods” we find the following definitions:

Validation: Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

Validation and Verification: Semantics Matter.

Definitions for validation and verification are available from various standards organizations and regulatory bodies. What is most important, however, is that in this conversation there is a clear distinction between validation and verification—both in activities and objectives. These are not interchangeable terms. Further, validation and verification can be discussed from two general perspectives in the food safety landscape. Process validation addresses manufacturing activities and controls to prevent product hazard and contamination. Method validation addresses the analytical methods used to verify the physical, chemical or microbiological properties of a product.

Process Validation

Our industry is comprised of a variety of categorical segments. Each segment faces unique processing challenges, risks and requirements that must be addressed in the validation and verification conversation.

Some segments, such as the dairy industry, have long standing processes in place that have a robust scientific backbone and leave little room for guesswork, experimentation or modification. “Milk  processes were validated years ago and are part of the Pasteurized Milk Ordinance (PMO). The science is there,” states Janet Raddatz, vice president of quality & food safety systems at Sargento Foods, Inc. ” It is well established that when you pasteurize the product for the time and temperature that has been validated, then you simply verify the pasteurizer is working to the validated specifications.”

However, process validation challenges arise when novel applications, ingredients and processes are employed. Even in an established industry, reformulations of products such as sauces and dressings require fresh validation perspective and risk assessment. “You must assess the risk anytime there is a change. Properties such as pH, salt and water are critical variables to the safety and microbial stability of a product. Novel processing techniques aimed at ‘all natural’ or ‘minimal processing’ consumer demands should also be challenged.” Raddatz suggests conducting a full assessment to identify potential areas of risk. A challenge study may also be a critical piece to validate that a certain process or formulation is appropriate.

To help the food industry understand, design and apply good validation and verification practices, the Institute for Food Safety and Health (IFSH) published “Validation and Verification: A Practical, Industry-driven Framework Developed to Support the Requirement of the Food Safety Modernization Act (FSMA) of 2011.” This insightful document provides various definitions, guidance, practical advice, and offers several Dos and Don’ts on validation and verification activities.

Do:

  • Divide validation and verification into separate tasks
  • Think of validation as your scientific evidence and proof the system controls the hazards
  • Use science-based information to support the initial validation
  • Use management to participate in validation development and operations of verification
  • Use lessons from “near-misses” and corrections to adjust and improve the food safety system

Don’t:

  • Confuse the activities of verification with those of routine monitoring
  • Rely on literature or studies that are unlike your process/ product to prove controls are valid
  • Conduct audit processes and then not review the results
  • Perform corrective actions without determining if a system change may be needed to fix the problem
  • Forget, reanalysis is done every three years or sooner if new information or problems suggest

Method Validation

Analytical methods used to verify a validated food process must also be validated for the specific product and conditions under which they will be conducted. For example, a manufacturer that has their laboratory test a product for Salmonella to verify that a kill step in the manufacturing process worked, must ensure that the method the laboratory uses is both validated for that product and has been verified as appropriate for use in that laboratory. Three general considerations should be discussed with the laboratory:

  • Is the method validated for the product (matrix)?
    • Often, the method will carry several matrix validations that were previously conducted by the diagnostic provider, an industry organization or as a reference method.
    • If the matrix to be tested is not validated the laboratory should conduct a validation study before proceeding.
  • Has the laboratory verified this method on the product (matrix)?
    • The laboratory should demonstrate that they can indeed perform the validated method appropriately.
    • Verification activities typically involve a matrix specific spiked recovery.
  • Are there any modifications made to the validated method?
    • All method modifications should be validated and verified. Additionally, modification should be noted on the laboratory report or Certificate of Analysis issued.
    • Method modifications may include time and temperature alterations, media changes and sample preparation factors.

AOAC International is an organization that certifies the validation of methods to a specific prescribed standard. “Diagnostic companies seek AOAC approval, which entails rigorous validation protocol with the selected matrices,” says Ronald Johnson Ph.D., president of AOAC International and associate director of validation for bioMérieux, describes the importance of commercial standardization.  “The AOAC validation scheme ensures that the method is robust, rugged, inclusive and exclusive, stable and meets the sensitivity presented.” Standards such as these provide confidence to the user that the method is fit-for-purpose, a critical first step in method selection.

While many diagnostic companies will perform standardized validation as described above, how a laboratory validates and verifies a method is incredibly nuanced in the food industry. Currently, there is no standardized approach to study design and execution. Even ISO 17025 accredited laboratories are only required to have a validation and verification protocol—there is no dictation about what that protocol should look like.

“Currently, there is a lot of variation in the industry around [method] validation,” says Patrick Bird, microbiology R&D laboratory supervisor at Q Laboratories. Bird is a method validation expert who is on the U.S. ISO TAG TC34/SC9 working group 3 for the new ISO validation and verification standards, including ISO/DIS 16140-4 guidelines, “Microbiology of the food chain – Method Validation – Part 4: Protocol for single-laboratory (in-house) method validation.”

“Variables such as number of replicates, spike levels, and even acceptance criteria vary widely from lab to lab—both in manufacturing laboratories and contract testing laboratories. We hope the ISO guidelines will standardize that, ” says Bird. He goes on to discuss the importance of good laboratory stewardship in the industry. “While some look at validations as a proprietary or competitive advantage, the testing industry must realize that without standardization, poor validation and verification practices by a few can tarnish the great science done by the many, and ultimately jeopardize the safety of our food supply.” He stresses the importance of quality operations and open communications with laboratories, whether in house or third party. “Now that validation is highlighted as a required area in FSMA Preventive Controls, more and more companies are paying attention to the methods and associated validation/verification data their labs can provide.”

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