Tag Archives: Preventive Controls

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.

Alex Kinne, Thermo Fisher Scientific
In the Food Lab

Ensuring Food Safety in Meat Processing Through Foreign Object Detection

By Alex Kinne
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Alex Kinne, Thermo Fisher Scientific

The USDA estimates that foodborne illnesses cost more than $15.6 billion each year. However, biological contamination isn’t the only risk to the safety and quality of food. Food safety can also be compromised by foreign objects at virtually any stage in the production process, from contaminants in raw materials to metal shavings from the wear of equipment on the line, and even from human error. While the risk of foreign object contamination may seem easy to avoid, in 2019 alone the USDA reported 34 food recalls, impacting 17 million pounds of food due to ‘extraneous material’ which can include metal, plastic and even glass.

When FSMA went into effect, the focus shifted to preventing food safety problems, necessitating that food processors implement preventive controls to shift the focus from recovery and quarantine to proactive risk mitigation. Food producers developed Hazard Analysis and Critical Control Point (HACCP) plans focused on identifying potential areas of risk and placement of appropriate inspection equipment at these key locations within the processing line.

Metal detection is the most common detection technology used to find ferrous, non-ferrous, and stainless steel foreign objects in food. In order to increase levels of food safety and better protect brand reputation, food processors need detection technologies that can find increasingly smaller metal foreign objects. Leading retailers are echoing that need and more often stipulate specific detection performance in their codes of practice, which processors must meet in order to sell them product.

As food processors face increased consumer demand and continued price-per-unit pressures, they must meet the challenges of greater throughput demands while concurrently driving out waste to ensure maximum operational efficiencies.

Challenges Inherent in Meat Metal Detection

While some food products are easier to inspect, such as dry, inert products like pasta or grains, metal foreign object detection in meat is particularly challenging. This is due to the high moisture and salt content common in ready-to-eat, frozen and processed, often spicy, meat products that have high “product effect.” Bloody whole muscle cuts can also create high product effect.

The conductive properties of meat can mimic a foreign object and cause metal detectors to incorrectly signal the presence of a physical contaminant even when it is nonexistent. Food metal detectors must be intelligent enough to ignore these signals and recognize them as product effect to avoid false rejection. Otherwise, they can signal metal when it is not present, thus rejecting good product and thereby increasing costs through scrap or re-work.

Equipping for Success

When evaluating metal detection technologies, food processors should request a product test, which allows the processor to see how various options perform for their application. The gold standard is for the food processor to send in samples of their product and provide information about the processing environment so that the companies under consideration can as closely as possible simulate the manufacturing environment. These tests are typically provided at no charge, but care should be taken upfront to fully understand the comprehensiveness of the testing methodologies and reporting.

Among the options to explore are new technologies such as multiscan metal detection, which enables meat processors to achieve a new level of food safety and quality. This technology utilizes five user-adjustable frequencies at once, essentially doing the work of five metal detectors back-to-back in the production line and yielding the highest probability of detecting metal foreign objects in food. When running, multiscan technology allows inspectors to view all the selected frequencies in real time and pull up a report of the last 20 rejects to see what caused them, allowing them to quickly make appropriate adjustments to the production line.

Such innovations are designed for ease of use and to meet even the most rigorous retailer codes of practice. Brands, their retail and wholesale customers, and consumers all benefit from carefully considered, application-specific, food safety inspection.

Ensuring Safety

The food processing industry is necessarily highly regulated. Implementing the right food safety program needs to be a top priority to ensure consumer safety and brand protection. Innovative new approaches address these safety concerns for regulatory requirements and at the same time are designed to support increased productivity and operational efficiency.

Ben Schreiber, ActiveSense
Bug Bytes

How ERM Can Simplify Pest Management

By Benjamin Schreiber
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Ben Schreiber, ActiveSense

Whether you work in food manufacturing, distribution or retail, pests are both a fact of life as well as a regulatory disruption. At the same time, pest management solutions aren’t always clear-cut: While there are a variety of effective strategies employed by pest management professionals (PMPs) servicing the food industry, industry challenges—shifting regulatory standards, a lack of proper documentation and more—can complicate the process. For these reasons, short-term rodent problems can become long-term logistical nightmares, leaving food manufacturers in an undesirable situation when a third-party food plant auditor arrives.

Fortunately, emerging technologies in pest management practices are helping facility managers streamline their food and beverage quality assurance processes, reducing the risk of product loss, regulatory action, improper brand management and more. Specifically, electronic remote monitoring (ERM) allows PMPs to detect and monitor rodents in real time, providing you with important information to help reduce risk and increase audit compliance. As such, the value of food safety pest management strategies that incorporate ERM systems is only growing. Seeking out PMPs who use ERM allows you to invest in technologies that protect your margins, ensure the quality of your product and, ultimately, safeguard your most important asset—your reputation.

Modernizing Pest Management With ERM

At first glance, it might seem like pest management practices haven’t drastically changed since they were first implemented in the food manufacturing industry. Many rodent trapping systems remain similar to their original design: Devices designed to trap or kill that must be individually inspected and serviced by professional technicians. Technicians must then relay any risks to facility managers, who have to determine if additional resources are needed to avoid product loss or audit-based infractions.

Upon closer examination, it’s clear that while pests themselves have not significantly changed, both the pest management industry and the modern food supply chain have become increasingly complex. Food facility managers must contend with increasingly stringent food safety standards, and PMPs must rise to meet these needs with evolving pest management strategies.

In many ways, ERM technologies are the structural pest control industry’s response to these challenges, providing technicians with real-time notifications about rodent behavior and allowing them to make risk-based assessments that identify and treat problems before infestations occur. Unlike pest control strategies that rely on periodic service visits from technicians, PMPs who utilize ERM technology can monitor pest activity around the clock, 24/7/365, in virtually any environment. Instead of monitoring individual traps, PMPs can use ERM technology to know exactly when and where pest activity occurs, including in hard-to-monitor areas such as drop ceilings, crawlspaces, shelving undersides and other traditionally overlooked spaces. Technicians then receive valuable analytics from each trap they install, as well as documentation and reporting, that help managers achieve audit and regulatory compliance.

FSMA and ERM

In 2015, the FDA issued the final component of preventative control for human food under FSMA, officially enacting legislation that requires food safety plants to focus on risk-based pest prevention instead of reactive pest control strategies. As a result, quality assurance professionals and facility managers are often tasked with reallocating personnel toward proactive pest control activities in addition to their day-to-day responsibilities.

In many ways, ERM systems go hand-in-hand with FSMA and GFSI regulations. While preparing for a situation that hasn’t yet occurred can be a costly and time-consuming process, ERM has helped PMPs develop custom pest management strategies that assess and control situations in accordance with FSMA and other auditing firm guidelines. In many ways, ERM can provide all parties—PMPs, in-house auditors and third-party regulators—with a track record of pest history that all parties can cross-reference when assessing a facility.

From Risk-Averse to Risk-Based

When it comes to food safety rules and regulations, the only constant is change. In the structural pest control industry, auditors have historically implemented strict guidelines about trap placement that are frequently changing: For instance, traps should be placed every 10, 15, or 20 feet, regardless of facility susceptibility to various pest conditions. Failure to comply with regulations can result in point deductions on audits, even if the conditions that might lead to an infestation are not present. As such, food processing plants often choose to abide by the most stringent audit guidelines imposed upon them by other parties, such as retailers. By utilizing ERM technologies, food safety and quality assurance professionals can use additional pest monitoring analytics to focus on specific compliance issues, rather than spending additional time and money on other strategies.

Additionally, ERM allows PMPs to focus their efforts not only on weekly service visits and station checks, but also on important tasks, including assessing facility vulnerabilities, tracking rodent access points, and providing consultation and additional management strategies to their client—you.

Approaching the Audit with ERM

Food plant managers and retailers alike know that auditor approval is everything. Because ERM is a fast-developing technology, many quality assurance managers and facility owners are curious to know if ERM is audit approved. In truth, there are many kinds of audits, each with different goals, assessment techniques and regulatory standards. When it comes to audits, the gold standard is not necessarily the assessment of the facility and production line itself, but rather how well the assessment matches records kept by the food production plant.

To this end, ERM might be the answer to a streamlined audit process. No matter what kind of audit a plant is currently undergoing, ERM allows PMPs to provide records auditors need to verify that all systems are working properly. ERM can mean the difference between a streamlined process and a laborious audit, acting as a documentation system that helps officials conduct a PMP-verified “second-check.” This kind of verification is invaluable in an industry where there are already more than enough regulatory categories to consider without having to further worry about potential pest infestations.

ERM-Oriented Solutions

Thanks to the many advantages they offer, ERM and other remote pest monitoring technologies are growing in popularity. Many facility managers appreciate that ERM allows them to assess pest activity, prevent infestations before they occur, gather data that helps them remain industry-compliant, and acquire and share information with additional parties. If you’re a facility manager, quality assurance professional or other food safety decision-maker interested in the opportunities ERM technologies provide, consider starting the conversation about your pest prevention system with your PMP and how ERM might help improve it.

Trust, But Verify

There is an overwhelming consensus in the pest control industry that technology should be developed to provide end-users with more information. ERM systems are a natural extension of this belief, providing each component of the food production and distribution supply chain—manufacturers, distributors, retailers, quality assurance officials, technicians and others—with more data about how pest control decisions are made. Without data, it can be difficult to ensure technician service visits end in greater transparency about the issues facility owners will face as they prepare for an audit.

Fortunately, ERM can help provide the level of trust and assurance plant managers need to feel confident in their day-to-day operations. ERM is an important step forward for manufacturer-regulator relations, which require a strong combination of data, trust and transparency to ensure that communication systems don’t break down. After all, there are many industries in which miscommunication can lead to catastrophic consequences, and food production is no exception.

While each manufacturing facility, processing plant, distribution center, storage warehouse and retail outlet is different, none are insusceptible to pest infestations, and none can avoid audits required to keep them compliant. Because rigorous oversight is crucial for food producers and consumers alike, working with your PMP to develop pest monitoring strategies that utilize ERM systems and other cutting-edge technologies should be part of your larger pest control consideration process.

In the end, the pest infestation that causes the least damage to your product, profit potential and industry reputation is the infestation that never occurs.

Audit

Webinar Series: Improve Your Hazard Analysis

By Food Safety Tech Staff
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Audit
Patricia Wester, PA Wester Consulting
Patricia Wester, PA Wester Consulting and Founder, The Association for Food Safety Auditing Professionals

The most commonly cited observation during a Preventive Controls inspection is an incomplete or incorrect hazard analysis, according to FDA data. Food Safety Tech is hosting a special complimentary webinar series, instructed by Patricia Wester, founder of The Association for Food Safety Auditing Professionals, that will provide attendees with important tips on conducting and documenting a thorough hazard analysis. During the one-hour event, Wester will help participants understand how to recognize gaps in a hazard analysis as well as share best practices for closing those gaps. The content is geared toward food safety professionals and auditors who develop, manage or review food safety plans in a Preventive Controls landscape.

What: “Did You Know?” Tips on Improving Your Hazard Analysis
Date: Wednesday, September 18, 2019
Time: 12pm – 1pm ET
Register for the webinar

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Top Tips for PCQI Training Success

By Maria Fontanazza
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In a recent exclusive column on Food Safety Tech, Laura Lombard, CEO of ImEPIK, discusses why food companies should be investing in PCQI training beyond basic FSMA requirements. During the following Q&A, she expands on these insights further to shed light on some of the misunderstandings companies have when it comes to the PCQI requirements under FSMA as well as tips for how to approach PCQI training itself.

Food Safety Tech: What are some of the misconceptions with the FSMA PCQI requirements?

Laura Lombard, IMEPIK
Is Your Facility Properly Prepared to Ensure Preventive Controls Are Met? Read this exclusive column by Laura Lombard.

Laura Lombard: The FSMA rule allows for alternate PCQI training in addition to the original FSPCA training. PCQI trainings are accepted as long as they meet the standardized curriculum recognized by the FDA. The FDA never intended that one organization have a monopoly over PCQI training but equally wants to ensure that core competencies in preventive controls are met.

The FSMA regulation does not require you to have a different PCQI per facility. However, it does require a PCQI to be in charge of an individual food safety plan per location. Depending on how many facilities your particular company has, you may want to consider more than one PCQI to oversee these different food safety plans to ensure that food safety plans are regularly updated and properly implemented.

FST: How should food companies be investing in PCQI training beyond the basic FSMA requirements?

Lombard: It’s very important to have at least one back up PCQI in place to ensure you are always covered if your head PCQI is out sick, on family leave, departs from the company, etc. This isn’t only to meet the FDA requirement of having a PCQI on your team, but also to ensure you are keeping your brand, product, and customers safe. The more you can protect yourself from having to do a recall of your product, the better. Recalls cost an average of $10 million, and this does not including damage to your brand and customer retention.

ImEpik and Food Safety Tech have partnered to offer PCQI online training, with special pricing options for attendees of the 2019 Food Safety Consortium Conference & Expo | Learn moreFST: What are your top tips for companies regarding PCQI training?

Lombard: Be proactive in ensuring your employees are trained. The regulation is the minimum required, but for a small investment, you can ensure more of your food safety staff is current on best practices to ensure your products’ quality and safety.

Look for training that fits your individual or company needs and learning styles. Look for training that is interactive and going to test knowledge rather than just death by PowerPoint. Again, the goal shouldn’t be to check a regulatory box but to ensure that your staff has the knowledge needed to maintain your brands quality, reputation and customer base.

FST: What are some of the differences between the various PCQI trainings on the market?

Lombard: There are three types of trainings that all require 20-hours of content: 1) An in-person version where an instructor leads a 2 or 2.5 day training, 2) a blended-online version that has some content that is self-paced but also requires a set time and date for a webinar portion, and 3) a 100% self-paced online course that does not require a webinar. Some of the blended versions claim to be 100% online. It is true in the sense that both the self-paced content and webinar are computer-based, but it is not as convenient as being able to do the entire training on your schedule. All versions have their pros and cons, but doing the course online can save your company significant time and money by not requiring travel or set timeframes. We have learned that online versions allow learners more opportunity for mastering the material through regular assessments and remediation as needed. It is also an opportunity to practice knowledge through scenarios in a low-risk environment. Lastly, done correctly, online training can be more interactive through the use of games, videos and audio tools to keep learners engaged.

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FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Food Safety Tech’s FSMA Supply Chain IQ test series continues with Part II. The test was put together by the subject matter experts at Kestrel Management, LLC. Before taking Part II, let’s review the results from Part I below. (If you have not taken Part I, take the test now!)

  1.  FSMA requires all records for the reevaluation of cGMPs every three years.
    • FALSE. Only 28% knew this.
  2. Implementation records are required for every FSMA requirement.
    • TRUE. 74% got this right.
  3. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required.
    • TRUE. 90% answered correctly.
  4. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product.
    • FALSE. Respondents were almost evenly split. 51% answered correctly.
  5. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan.
    • TRUE. 92% answered on target.
  6. Written supply chain plans are not included in FSMA food safety plans.
    • FALSE. 81% answered correctly.
  7. Mandatory recalls are provided under FSMA as a new requirement.
    • TRUE. 63% answered correctly.
  8. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA.
    • FALSE. 74% got this right.
  9. cGMPs under FSMA require that outer garments be suitable to protect against allergen contamination.
    • TRUE. 77% answered correctly.
  10. You do not need to document records of all product testing under FSMA.
    • FALSE. 82% answered correctly.
  11. FSMA preventive controls does not require hazards be addressed under the HACCP plan.
    • FALSE. 69% got this right.
  12. The food safety plan does not require hazards that are unintentionally introduced within an operation’s processes.
    • FALSE. 82% answered correctly.

Surprised by the results? Provide feedback in the comments section.

We invite you to take Part II below and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Create your own user feedback survey

Question mark

FSMA Supply Chain IQ Test (Part I)

By Food Safety Tech Staff
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Question mark

Food Safety Tech’s FSMA IQ test series continues with a two-part series that addresses supply chain considerations under FSMA. Once again, the test was put together by the subject matter experts at Kestrel Management, LLC. We invite you to take the 12-question test and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Results of Part I will be posted next week, at which point Part II will be available.

Create your own user feedback survey

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
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Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements

FDA

FDA Issues Guidance Document for Qualified Facilities Under FSMA Rules

By Food Safety Tech Staff
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FDA

Last week FDA released a guidance document to help facilities understand whether they are subject to the “qualified facility” definition under the FSMA preventive controls rules for human and animal food. Titled “Determination of Status as a Qualified Facility”, the guidance offers frequently asked questions about the requirements for facilities that manufacture, process, pack or hold human as well as animal food (defined separately—Part 117 for human food and Part 507 for animal food).

“Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.” – FDA

Facilities that fall under the PC Human Food rule must submit the first required attestation forms by December 17, 2018, and those subject to the PC Animal Food role must submit the first required attestation forms by December 16, 2019.

More information about the new guidance for industry is available on FDA’s website.

Chelle Hartzer, Orkin
Bug Bytes

Don’t Let Pests Wreck Your Supply Chain

By Chelle Hartzer
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Chelle Hartzer, Orkin

In today’s global marketplace, it has become necessary for facility managers to implement more detailed inspection and documentation policies for incoming shipments as part of the larger food safety plan. But plan as you might, pests are adept at infiltrating food products and contaminating shipments. Their resilience and persistence will make you pay, literally, if you’re not paying close attention.

Pest management is a key component of any facility manager’s food safety plan, but understanding how best to prevent pests from compromising shipments—and by extension the supply chain—takes diligence. An integrated pest management (IPM) program is the best way to ensure that insects and rodents are kept away from processing, packaging and storing food products. Again, this information shouldn’t be anything new if you’re a food processing facility manager, but it’s important to note that IPM focuses on proactive prevention of pests, to align with FSMA’s Hazard Analysis and Risk-Based Preventive Control (HARPC) regulations. These newer regulations shift the focus from reacting to potential contamination concerns to preventing as many issues as possible. Being proactive is a must.

Aside from the legal backlash a facility could face if found if violating these rules, pest issues can also have a major negative impact on a business’ bottom line. Imagine the cost of even one of your outgoing shipments being contaminated by cockroaches or stored product pests. Now, imagine the impact on your business from consumer backlash if the pest-ridden shipment travels further down the line. Simply put, it’s never good if the pest problems are traced back to your facility.

So, what’s the best way to protect your supply chain from potential pest issues and remain compliant under FSMA and HARPC?

All food safety plans should have considerations in place based on a review from a Preventive Controls Qualified Individual (PCQI). This individual is responsible for preparing the document, with the input of as many departments and people as possible, such as QA/QC, maintenance, production teams, and more. Since pests are a common potential hazard, a pest management program should be included in the plan.

That being said, it’s important to inspect all incoming shipments. Even if suppliers have implemented measures to help keep pests away from their sites and products, pests are tough to entirely prevent and it’s always a possibility some have slipped through the cracks (literally!). Pests are attracted by food, water and shelter, so a truck transporting products to your facility is going to be chock-full of attractants! Carefully inspecting incoming shipments will not only help ensure pests don’t enter your facility, but it will help you and your supply chain partners target exactly where problems may be occurring. Forming good relationships with your suppliers, and keeping communication open can help to manage any issues that may pop up.

The faster pest issues are detected, the better. It’s easier to address a pest problem and more accurately pinpoint where it originated if it can be caught early. Otherwise, pests can reproduce quickly and spread, making it harder to pin down the source of an infestation and to treat it. It’s tough to overstate the importance of open lines of communicated between supply chain partners!

To avoid allowing pests into your facility or sending them to a supply chain partner, implement the following processes:

  • Inspect shipments for pest activity, especially incoming shipments. Some common signs include live or dead insects, droppings and damage to the product and packaging.
  • Ensure packaged products are properly sealed and undamaged before transport, and then check the transportation vehicle before loading product for shipping.
  • If there is a pest sighting, remove any compromised product to avoid allowing pests to spread to other goods or find a way into the facility. If it can’t be removed from the facility, isolate it in a contained area and call your pest management provider immediately.
  • Empower employees to call out pest issues as well by implementing a “see something, say something” policy. Don’t forget to have a pest sighting log, and let the employees know where it is and what to record.
  • Use monitoring devices to detect pest activity levels. Devices like insect light traps, pheromone monitors, and glue boards can be easily placed in shipping and receiving areas as an early warning sign of pest activity.

With an untrained eye, pest issues can be difficult to notice. Ask your pest control professional about a free training session for employees. Most pest management companies offer this service free of charge, and it can be a big help. There’s no reason you shouldn’t take advantage.

The pest pressure a facility faces is dependent on a variety of factors including location, geography and the type of product being produced and stored. No two facilities are the same, which is why every pest management program should be customized to meet the needs of the business.

As a start, the following pests are the most common to find in the food processing industry.

  • Rodents: Rats and mice can carry disease-causing pathogens that can be deposited onto other surfaces by simply making contact with equipment or products. Both are capable of fitting through tiny gaps (mice can fit through a hole the size of a dime, while rats can fit through a hole the size of a quarter), meaning any openings on the exterior of a building serve as a welcome mat to a curious rodent. To spot the signs of rodent activity, look for droppings and yellowish-brown grease marks around corners and along baseboards, as these marks can be caused as a rodent rubs against these areas. In addition, look for gnaw marks around any gaps or openings in walls and on products.
  • Cockroaches: Able to squeeze their bodies through miniscule gaps, cockroaches will feed on just about anything. With a good food source, they can reproduce quickly. A couple cockroaches can become an infestation in a matter of months, especially with an abundant food supply. Cockroaches are most active at night, so if you see one during the day it’s a good sign that it’s time to act quickly!
  • Flies: While less likely to find their way into packaged products, flies can spread dangerous, potentially disease-spreading pathogens on everything they touch. They usually don’t travel too far from their larval food source, but their ability to reproduce quickly can make them a nightmare to get rid of if steps aren’t taken to remove them immediately.
  • Stored Product Pests: There are numerous kinds of stored product pests, but all are adept at thriving in and around products undetected. The Indian meal moth, for example, is a moth with small, cream colored larvae that will eat just about anything. Stored product pests are some of the most likely pests you’ll find on incoming shipments and in storage areas, as they’re right at home breaking into and surviving within product packaging.

Keep these pests on the radar, and make sure to take note of where pests are found and how many are spotted. The more information, the better, as it helps pest management professionals get to the root of pest problems.

Documentation is always a major key. It shows an auditor that careful planning and proactive prevention are points of emphasis, which will be important. Although there are numerous documents to keep on hand, add the following to your list in order to more easily demonstrate compliance with pest related FSMA regulations:

  1. Supply chain program, including suppliers and ingredients.
  2. Receiving procedures, including the pest management program that helps prevent pests from entering the facility on products or through loading areas.
  3. Receiving records, or, in other words, documentation of shipments received from suppliers.
  4. Monitoring records of any captured pests in or around the facility and any corrective actions.
  5. Application records for treatments used in and around the facility.

If suppliers are located in another country, note the requirements differ from facilities located in the United States. The FDA breaks this down on their website, but importing products from another country means a facility must follow the Foreign Supplier Verification Program. This comes with a different set of compliance documents and means the importing facility must monitor foreign suppliers’ food safety plans.

Remember: Preventing pests needs to be a proactive process included in the food safety plan. If you want your supply chain to remain pest free, partner with a pest management company and talk to your supply partners to establish standards for documentation and communication. All will benefit, as you’ll be able to catch problems early and have a better chance of keeping pests from wrecking your supply chain.

Read on for more articles by Chelle Hartzer.

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