Tag Archives: verification

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.”

Continue to page 2 below.

Sequencing pattern, pathogens

Build Stronger Food Safety Programs With Next-Generation Sequencing

By Akhila Vasan, Mahni Ghorashi
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Sequencing pattern, pathogens

According to a survey by retail consulting firm Daymon Worldwide, 50% of today’s consumers are more concerned about food safety and quality than they were five years ago. Their concerns are not unfounded. Recalls are on the rise, and consumer health is put at risk by undetected cases of food adulteration and contamination.

While consumers are concerned about the quality of the food they eat, buy and sell, the brands responsible for making and selling these products also face serious consequences if their food safety programs don’t safeguard against devastating recalls.

A key cause of recalls, food fraud, or the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, continues to be an issue for the food safety industry. According to PricewaterhouseCoopers, food fraud is estimated to be a $10–15 billion a year problem.

Some of the more notorious examples include wood shavings in Parmesan cheese, the 2013 horsemeat scandal in the United Kingdom, and Oceana’s landmark 2013 study, which revealed that a whopping 33% of seafood sold in the United States is mislabeled. While international organizations like Interpol have stepped up to tackle food fraud, which is exacerbated by the complexity of globalization, academics estimate that 4% of all food is adulterated in some way.

High-profile outbreaks due to undetected pathogens are also a serious risk for consumers and the food industry alike. The United States’ economy alone loses about $55 billion each year due to food illnesses. The World Health Organization estimates that nearly 1 in 10 people become ill every year from eating contaminated food. In 2016 alone, several high-profile outbreaks rocked the industry, harming consumers and brands alike. From the E. coli O26 outbreak at Chipotle to Salmonella in live poultry to Hepatitis A in raw scallops to the Listeria monocytogenes outbreak at Blue Bell ice cream, the food industry has dealt with many challenges on this front.

What’s Being Done?

Both food fraud and undetected contamination can cause massive, expensive and damaging recalls for brands. Each recall can cost a brand about $10 million in direct costs, and that doesn’t include the cost of brand damage and lost sales.

Frustratingly, more recalls due to food fraud and contamination are happening at a time when regulation and policy is stronger than ever. As the global food system evolves, regulatory agencies around the world are fine-tuning or overhauling their food safety systems, taking a more preventive approach.

At the core of these changes is HACCP, the long implemented and well-understood method of evaluating and controlling food safety hazards. In the United States, while HACCP is still used in some sectors, the move to FSMA is apparent in others. In many ways, 2017 is dubbed the year of FSMA compliance.

There is also the Global Food Safety Initiative (GFSI), a private industry conformance standard for certification, which was established proactively by industry to improve food safety throughout the supply chain. It is important to note that all regulatory drivers, be they public or private, work together to ensure the common goal of delivering safe food for consumers. However, more is needed to ensure that nothing slips through the food safety programs.

Now, bolstered by regulatory efforts, advancements in technology make it easier than ever to update food safety programs to better safeguard against food safety risks and recalls and to explore what’s next in food.

Powering the Food Safety Programs of Tomorrow

Today, food safety programs are being bolstered by new technologies as well, including genomic sequencing techniques like NGS. NGS, which stands for next-generation sequencing, is an automated DNA sequencing technology that generates and analyzes millions of sequences per run, allowing researchers to sequence, re-sequence and compare data at a rate previously not possible.

The traditional methods of polymerase chain reaction (PCR) are quickly being replaced by faster and more accurate solutions. The benefit of NGS over PCR is that PCR is targeted, meaning you have to know what you’re looking for. It is also conducted one target at a time, meaning that each target you wish to test requires a separate run. This is costly and does not scale.

Next-generation sequencing, by contrast, is universal. A single test exposes all potential threats, both expected and unexpected. From bacteria and fungi to the precise composition of ingredients in a given sample, a single NGS test guarantees that hazards cannot slip through your supply chain.  In the not-too-distant future, the cost and speed of NGS will meet and then quickly surpass legacy technologies; you can expect the technology to be adopted with increasing speed the moment it becomes price-competitive with PCR.

Applications of NGS

Even today’s NGS technologies are deployment-ready for applications including food safety and supplier verification. With the bottom line protected, food brands are also able to leverage NGS to build the food chain of tomorrow, and focus funding and resources on research and development.

Safety Testing. Advances in NGS allow retailers and manufacturers to securely identify specific pathogens down to the strain level, test environmental samples, verify authenticity and ultimately reduce the risk of outbreaks or counterfeit incidents.

Compared to legacy PCR methods, brands leveraging NGS are able to test for multiple pathogens with a single test, at a lower cost and higher accuracy. This universality is key to protecting brands against all pathogens, not just the ones for which they know to look.

Supplier Verification. NGS technologies can be used to combat economically motivated food fraud and mislabeling, and verify supplier claims. Undeclared allergens are the number one reason for recalls.

As a result of FSMA, the FDA now requires food facilities to implement preventative controls to avoid food fraud, which today occurs in up to 10% of all food types. Traditional PCR-based tests cannot distinguish between closely related species and have high false-positive rates. NGS offers high-resolution, scalable testing so that you can verify suppliers and authenticate product claims, mitigating risk at every level.

R&D. NGS-based metagenomics analysis can be used in R&D and new product development to build the next-generation of health foods and nutritional products, as well as to perform competitive benchmarking and formulation consistency monitoring.

As the consumer takes more and more control over what goes into their food, brands have the opportunity to differentiate not only on transparency, but on personalization, novel approaches and better consistency.

A Brighter Future for Food Safety

With advances in genomic techniques and analysis, we are now better than ever equipped to safeguard against food safety risks, protect brands from having to issue costly recalls, and even explore the next frontier for food. As the technology gets better, faster and cheaper, we are going to experience a tectonic shift in the way we manage our food safety programs and supply chains at large.

We will be discussing this topic, “Building Stronger Food Safety Programs through Next-Generation Sequencing”, during a live conversation on June 7, 2017 at 2:00 pm ET. Microbiologists, testing personnel, food industry management, and anyone interested in how to leverage these new technologies to fortify their food safety programs will learn how NGS is going to transform the future of food safety.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include 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 microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include 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. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

AOAC Neogen

Neogen’s AccuPoint Advanced receives AOAC approval

AOAC Neogen

Neogen recently received approval from the AOAC Research Institute for its rapid and accurate AccuPoint Advanced ATP Sanitation Verification System.

Neogen’s AccuPoint Advanced is the first sanitation verification system to receive an AOAC approval, and this approval follows a recent study by NSF International that showed AccuPoint Advanced exceeded the performance of competitive systems.

“Each time we receive a validation from an independent third party on any of our tests, it provides further assurance to the food production and processing industry that our tests perform as expected,” said Ed Bradley, Neogen’s vice president of Food Safety. “The performance of our AccuPoint Advanced system in recent independent evaluations by AOAC and NSF is very gratifying. We developed the product with the goal of creating a new sanitation verification system that is superior to anything else on the market.”

The results in the AOAC validation report (Performance Tested MethodSM 091601) provided evidence that AccuPoint Advanced produces consistent and reliable data for evaluating sanitation program effectiveness in food processing and food services facilities.

AccuPoint Advanced is an enhanced version of its earlier AccuPoint test system. Improvements with AccuPoint Advanced include: improved sampler chemistry to produce more consistent results with even greater sensitivity; an enhanced instrument to produce even faster results (less than 20 seconds); and advanced Data Manager software to easily streamline the testing process by creating test plans and syncing important data, while keeping a permanent record of sanitation test results.

AOAC International is a globally recognized, independent forum for finding appropriate science-based solutions through the development of microbiological and chemical standards. The Applied Research Center at NSF International is a not-for-profit global research group that provides product development support to manufacturers and developers of products in the food safety, agriculture, clinical and life science markets.

Tim Curran, Sample6
FST Soapbox

Putting FSMA Into Practice

By Tim Curran
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Tim Curran, Sample6

High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.

Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?

FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.

Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:

  • Preventive controls
  • Inspection and compliance
  • Imported food safety
  • Response
  • Enhanced partnerships

I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.

Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.

Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.

Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.

Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.

Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.

The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.

Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.

Compliance fail

Senior Execs in for a Rude Awakening Regarding Supply Chain Compliance

By Maria Fontanazza
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Compliance fail

In previous years, supplier compliance was oftentimes built on trust. With FSMA tightening the reigns on compliance via auditing and documentation requirements and unannounced inspections, a higher level of accountability is being placed on companies, from the employees on the manufacturing floor all the way up to the C-suite. However, when senior executives start digging into the level of compliance maintained by their suppliers, they might not like what they find. In fact, they might be downright shocked, according to Randy Fields, chairman and CEO of Park City Group. “Instead of maintaining control over these issues of compliance, by delegating it and not properly supervising it, they’ve [senior management] lost visibility,” Fields says. “They have to be more involved than in the past, because they’re on the hook for it. But, they’re going to discover that their supply chain is nowhere near as compliant as they imagined.” In a Q&A with Food Safety Tech, Fields discusses how FSMA is changing the game for executives in the food business.

Food Safety Tech: In the context of supply chain accountability, increased interaction is now essential between food safety managers and executives. What level of awareness is required in the C-suite?

Randy Fields
Randy Fields, chairman and CEO of Park City Group, says the C-suite is not ready for what it is going to discover in terms of lack of compliance in the supply chain.

Randy Fields: Given the change in the law (FSMA), the regulatory world, and increasingly, the world of tort, the unfortunate reality is that the C-suite in nowhere near as aware of the issues of accountability in the supply chain as they need to be. It breaks down into two pieces: First, they have entrusted supply chain compliance to other people in the business; it’s been dropped down too far within the organization without the proper oversight.

Second, they don’t have a good way of measuring compliance—it’s been based on trust. Compliance has become more complex and as a function of the complexity, [senior management] doesn’t have a good set of tools by which they can stay on top of compliance and measure it.

With the change in the law, accountability has legally moved up to the C-suite, because FSMA, for all intents and purposes, brings Sarbanes–Oxley to the FDA. Between FSMA and tort, the way that it’s been is about to change very dramatically, but the surprises are all downside surprises. The consequence of trust without verification is now likely to lead both to litigation and possible criminal conviction. This is a different world.

The basic level of compliance in the global supply chain is far worse than anyone ever imagined. It will be not unlike turning over stones in your backyard in terms of what’s going to crawl out.

“Personal liability is probably the ultimate determinate of whether or not the C-suite starts to pay attention.” –FieldsFST: Is there a larger responsibility on the part of food safety managers to translate the compliance message to the C-suite?

Fields: I think it’s now both the appropriate responsibility and potentially the legal responsibility of food safety managers to insist that their C-suite become aware and provide them both the oversight and the tools by which compliance can be continually and professionally supervised and managed. I think failure to do that represents negligence.

Tort claims are getting more frequent and larger for foodborne illness problems. And now with both civil and criminal penalties potentially being applied by the FDA, it’s a game changer. It cannot be business as usual. This changes the world for food safety managers, and it changes the world for their bosses. We live in a world now where, whether we like it or not, the concept of accountability is about to be more legally enforceable.

The Peanut Corporation of America sentences are exemplary. But strict liability means that there can be a criminal prosecution without intent or even conceptually gross negligence. It is only a matter of fact that you supervised the function that was involved.

There’s a set of issues here that food safety managers should be bringing to the attention of senior executives. It’s beholden on them to say to these guys, ‘you have to pay more attention to this because you’re legally, civilly and criminally on the hook.’

FST: Do these factors have an impact on the type of professionals that are needed within food businesses?

Fields: Yes. I suspect that what will happen over the long term is that food safety will not be as much [about] science as it is compliance. In many companies, the food safety people tend to be the scientists who may not be as interested in the whole compliance problem. Increasingly, it’s the whole problem of compliance, not just the problem of food science.

We typically see within a company that someone manages the insurance part of the supply chain; someone else manages the food safety part of the supply chain, and someone else manages some other part of it: All of that fits under the rubric of compliance. We’re seeing more and more companies beginning to address this holistically.

Using ATP-based Methods for Cleaning and Sanitation Verification

By Camila Gadotti, M.S., Michael Hughes
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There are several factors that must be considered when selecting a reliable and accurate system for detecting adenosine triphosphate.

A common way to assess the effectiveness of cleaning and sanitation programs in food manufacturing facilities is through the use of methods that detect adenosine triphosphate (ATP). Methods based on ATP detection are inexpensive and rapid, and provide the ability to perform onsite in real-time. There are several manufacturers of ATP-based methods, but choosing the most reliable one can be a daunting task. This article will discuss how these methods work and which factors should be considered to make an informed purchasing decision.

ATP is the universal energy currency in all living cells. It is present in all viable microorganisms (with the exception of viruses) and in foodstuffs. High amounts of ATP can be found in some fresh foods like vegetables, while other foods, especially highly processed foods such as fats, oils or sugar, contain very low amounts of this molecule. It is also important to know that ATP can be found in the environment in its free form hours after a cell has died.1 An ATP bioluminescence assay operates on the principle that ATP in food/food residues and microorganisms, in the presence of a luciferin/luciferase complex, leads to light emission. This light can be measured quantitatively by a luminometer (light-detecting instrument), with results available in 10–40 seconds. The amount of light emitted is proportional to the amount of ATP on a surface and hence its cleanliness. The light emitted is typically measured in relative light units (RLUs), calibrated for each make of instrument and set of reagents. Therefore, the readings obtained from assessing the cleaning of food manufacturing facilities need to be compared with baseline data representing acceptable clean values.

Varying Optical Components

Luminometers have evolved over the years from very large and cumbersome in size to small handheld models that can be used anywhere within a manufacturing facility. Although several components are housed inside these instruments, the optical component is the most important part of a luminometer. Used to detect light coming from the ATP/luciferin/luciferase reaction, the optical component is the defining factor related to luminometer reliability, sensitivity and repeatability. Good luminometers use a photomultiplier tube (PMT) in the light detection system; however, as part of the drive toward cheaper and smaller instruments, some manufacturers have replaced PMTs with less-sensitive photodiode-based systems. When using photodiodes, the swab chemistry must be adapted to produce more intense light. This results in a shorter duration of light, decreasing the time window allotted to place the swab in the luminometer and obtain an accurate read. A PMT, however, multiplies the electrical current produced when light strikes it by millions of times, allowing this optical device to detect a single photon. This approach emits light over a longer period of time. Although the weight of the system is also dependent on factors such as the battery, case and the display screen, a luminometer constructed with a photodiode will generally weigh less than a luminometer constructed with a PMT, since the former is smaller than the latter.

Sensitivity Testing

When an ATP hygiene monitoring system has poor sensitivity or repeatability, there is substantial risk that the test result does not truly represent the hygienic status of the location tested. Therefore, it may provide false positives leading to unnecessary chemical and labor costs and production delays, or false negatives leading to the use of contaminated pieces of equipment. A system that is sensitive to low-level contamination of a surface by microorganisms and/or food residues allows sanitarians to more accurately understand the status of a test point. The ability of a system to repeat results gives one peace of mind that the result is reliable and the actions taken are appropriate. To test different ATP systems for sensitivity, one can run the following simple test using at least eight swabs per system:

•    Make at least four serial dilutions of a microbial culture and a food product in a sterile phosphate buffer solution.
•    Using an accurate pipette, dispense 20 μl of these dilutions carefully onto the tip of the swabs of each ATP system and read the swabs in the respective luminometer, following the manufacturer’s instructions.
•    Use caution when dispensing the inoculum onto the swab head to prevent any sample loss or spillage. In addition, it is very important the swabs are inoculated immediately prior to reading, which means that each swab should be inoculated one at a time and read in the respective luminometer. Repeat this process for all the swabs.

 

 
To test different ATP systems for sensitivity, one can run a simple test using at least eight swabs per system. Photo courtesy of 3M

The most sensitive system will be the one that results in the most “fail results” (using the manufacturers’ recommended pass/caution/fail limits).

One can also test different ATP systems for repeatability by the following test:

•    Prepare a dilution of a standard ATP positive control or a food product such as fluid milk in a sterile phosphate buffer. If using a standard ATP positive control, follow the manufacturer’s direction to prepare dilution. If using fluid milk, add 1 ml of milk into 99 ml of phosphate buffer.
•    Using an accurate pipette, dispense 20 μl of this standard onto the tip of the swabs of each ATP system and read these swabs in their respective luminometer, following the manufacturer’s instructions.
•    Prepare and read at least 10 swabs for each system you are evaluating, and capture the results on a digital spreadsheet.
•    Once all 10 swab results (for each system) are in the spreadsheet, calculate the mean (=average) and standard deviation (=stdev) for each system’s data set. Divide the standard deviation by the mean and transform the result in percentage; this value is called the coefficient of variation percentage (CV%).
The test with the lowest CV% is the most repeatable and will provide the most reliable information to help make the correct decisions for a food manufacturing facility.

Choosing the Right ATP System

There are many ATP systems available on the market to support cleaning and sanitation verification in manufacturing plants. Some systems are more reliable than others and will provide results that are meaningful, accurate and repeatable. Be sure, therefore, not to choose a system solely based on its price. Check for the quality of the instrument, ask the sales representative what kind of optical device is used in the construction of the instrument and, moreover, perform an evaluation running tests for both sensitivity and repeatability. It is also important to consider the functionality and usability of the software provided with the system to ensure that the software can be used to customize sample plans, store test results and produce reports and graphs.

Reference

  1. Jay, J. M., ‎Loessner, M. J., & Golden, D. A. (2008). Modern Food Microbiology.

 


About the Author:

Camila Gadotti, M.S., is a field technical service professional and Michael Hughes is a technical service professional with 3M Food Safety.