Tag Archives: facilities

By Benjamin Schreiber

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.

January 13, 2020

FST Soapbox

Importance of Flooring for Food Processing Plant Hygiene

By Kevin Smedley

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Food processing is a multi-trillion dollar industry that encompasses facilities such as bakeries, meat and poultry plants, bottling lines, dairies, canneries and breweries. For all of these food processing plants a commercial flooring system is essential for maintaining a hygienic environment. Few areas of a plant provide as much opportunity for the spread of bacteria, mold, fungi and dust as the floor. Hazardous materials from a contaminated floor can easily be spread from worker’s shoes and mobile equipment. Food processing plants present a unique set of challenges that require careful consideration of floor properties and installation.

Food processing plants floors are subjected to constant, high concentrations of salt, alkaline and oil compounds that substantially degrade the floor and thereby risk food contamination and facility shutdown. These compounds can come from common food production by-products like oils, fats, dairy products, sugar solutions, blood, and natural acids or from harsh cleaners and disinfectants. Even with frequent and thorough cleaning these substances can—and will—result in microbial growth and the spread of bacteria in untreated concrete or poorly installed resinous flooring.

Food processing plant hygiene, flooring — A commercial flooring system is critical to maintaining a hygienic environment in a food processing plant. (Image courtesy of High Performance Systems)

Cleaning floors is an essential part of maintaining food processing operations to keep up with government standards. A proper floor coating is a necessity for dealing with the vigorous, harsh cleaning procedures that typically include very hot water and aggressive cleaning chemicals. Depending on the exposure to corrosive, temperature and moisture conditions a thin film coating may suffice; however, in most cases, a thick, durable floor coating is needed to endure the cleaning operations. If too thin of a coating is used the repeated barrage of high pressure, high-temperature hot water and steam will strip the floor coating. Only an experienced flooring professional can determine the proper floor coating for a facility.

In addition to the properties of the floor coating, proper installation is essential for maintaining a hygienic, safe facility. If a floor is not seamless even the best floor coatings are vulnerable to germ buildup within gaps and cracks. To prevent harmful substance accumulation, a seamless coving transition from the floor to the wall is needed. Not only does that make the floors unsanitary, but it also can spread to other parts of the facility, equipment and product. Coving also aids in the cleaning process by allowing for hosing around the sides and corners of the room where germ buildup is most common.

An often-overlooked—yet critical—aspect of floor installation is having the proper pitch to promote water drainage. Having pools of water is not only dangerous for workers but for product safety. Such an examples of this issue is the Listeria outbreak at cantaloupe producer Jensen Farms, which led to 33 fatalities, 143 hospitalized victims, and ultimately, the end of their business. In the 2011 FDA released a report that focused on “Factors Potentially Contributing to the Contamination of Fresh, Whole Cantaloupe Implicated in the Multi-State Listeria monocytogenes Foodborne Illness Outbreak”. The conclusion was reached that the leading cause of Listeria spreading was due to a poorly constructed packing facility floor that was difficult to clean and allowed water to pool. The best way to prevent a similar situation at your plant is to make sure you get an experienced flooring expert, who understands your facility’s needs, to choose a floor with the right properties and to properly install it.

December 10, 2019

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part II)

By Frank Pisciotta, Spence Lane

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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. To further assist facilities with reviewing old or conducting new VAs, Part II will touch on access, subject matter experts, mitigation strategies and community drinking water through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 6: Utilization of Card Access. The FDA costs of implementing electronic access control, as reported in the Regulatory Impact Analysis document (page 25) are shown in Table 1.

Average Cost Per Covered Facility	Initial	Recurring	Total Annualized
Prohibit after hours key drop deliveries of raw materials	$	$1070	$1070
Electronic access controls for employees	$1122	$82	$242
Secured storage of finished products	$1999	$–	$285
Secured storage of raw materials	$3571	$–	$508
Cameras with video recording in storage rooms	$3144	$–	$448
Peer monitoring of access to exposed product (not used)	$47	$1122	$1129
Physical inspection of cleaned equipment	$–	$303	$22
Prohibit staff from bringing personal equipment	$157	$–	$22
Total	$9993	$1455	$2878
Table I. Costs of Mitigation

In our opinion, these costs may be underreported by a factor of five or more. A more realistic number for implementing access control at an opening is $5,000 or more depending on whether the wire needs to be run in conduit, which it typically would. While there are wireless devices available, food and beverage organizations should be mindful that the use of wireless devices may in some cases result in the loss of up to 50% of electronic access control benefits. This happens because doors using this approach may not result in monitored-for-alarm conditions, such as when doors are held open too long or are forced open. Some wireless devices may be able to report these conditions, but not always as reliable as hardwired solutions. Using electronic access control without the door position monitoring capability is a mistake. From a cost standpoint, even a wireless access control device would likely be upwards of $2,000 per opening.

Lesson 7: In the interest of time, and in facilities with more complex processes (which increases the work associated with the VA), plan to have quality, food safety and physical security personnel present for the duration of the VA. But also bring in operational specialists to assess each point, step or procedure for the respective operational areas. You may wish to have a quick high-level briefing for each operational group when it’s their turn to deliberate on their portion of the manufacturing operation. Proper planning can get a hybrid style VA done in one-and-a-half to three days maximum for the most complex of operations.

Lesson 8: Conduct a thorough site tour during the assessment process; do not limit your vulnerability activity to a conference room. Both internal and external tours are important in the assessment process by all members of the team. The external tour is needed to evaluate existing measures and identify vulnerabilities by answering questions such as:

Is the perimeter maintained?
Are cameras pointed correctly?
Are doors secure?
Are vehicles screened?
Are guards and guard tours effective?
Internal tours are important to validate documented HACCP points, steps or procedures.A tour also helps to validate process steps that are in multiple parts and may need to be further assessed as a KAT, for public health impact, accessibility and feasibility or to identify issues that have become “invisible” to site employees which might serve a security purpose.
Properly conducted tours measure the effectiveness of a variety of potential internal controls such as:
- Access control
- Visitor controls
- Use of identification measures
- Use of GMP as a security measure (different colors, access to GMP equipment and clean rooms)
- Effectiveness of buddy systems
- Employee presence

Lesson 9: Do not forget the use of community drinking water in your processes. This is an easy way to introduce a variety of contaminants either in areas where water is being treated on site (even boiler rooms) or where water may sit in a bulk liquid tank with accessibility through ladders and ports. In our experience, water is listed on about half of the HACCP flow charts we assessed in the VA process.

Lesson 10: Some mitigation strategies may exist but may not be worth taking credit for in your food defense plan. Due to the record keeping requirements being modeled after HACCP, monitoring, corrective action and verification records are required for each mitigation strategy associated with an APS. This can often create more work than it is worth or result in a requirement to create a new form or record. Appropriate mitigation strategies should always be included in your food defense plan, but sometimes it produces diminishing returns if VA facilitators try to get too creative with mitigation strategies. Also, it is usually better to be able to modify an existing process or form than having to create a new one.

Lesson 11: In cases of multi-site assessments, teams at one plant may reach a different conclusion than another plant on whether an identical point, set or procedure is an APS. This is not necessarily a problem, as there may be different inherent conditions from one site to the next. However, we strongly suggest that there be a final overall review from a quality control standpoint to analyze such inconsistencies adjudicate accordingly where there is no basis for varying conclusions.

Lesson 12: If there is no person formally responsible for physical security at your site, you may have a potential gap in a critical subject matter area. Physical security measures will make at least a partial contribution to food defense. Over 30 years, we have seen many organizations deploy electronic access control, video surveillance and lock and key control systems ineffectively, which provides a false sense of security and results in unidentified vulnerability. It is as important to select the right physical security measures to deploy, but also critical to administer them in a manner that meets the intended outcome. Most companies do not have the luxury of a full-time security professional, but someone at the plant needs to be provided with a basic level of competency in physical security to optimize your food defense posture. We have developed several online training modules that can help someone who is new to security on key food defense processes and security system administration.

Lesson 13: As companies move into ongoing implementation and execution of the mitigation strategies, it is important to check that your mitigation strategies are working correctly. You will be required to have a monitoring component, correction action and verification intended for compliance assurance. However, one of the most effective programs we recommend for our clients’ food defense and physical security programs is the penetration test. The penetration test is intended to achieve continuous improvement when the program is regularly challenged. The Safe Quality Food (SQF) Institute may agree with this and now requires facilities that are SQF certified to challenge their food defense plan at least once annually. We believe that frequency should be higher. Simple challenge tests can be conducted in 10 minutes or less and provide substantial insight into whether your mitigation strategies are properly working or whether they represent food defense theater. For instance, if a stranger were sent through the plant, how long would it take for employees to recognize and either challenge or report the condition? Another test might include placing a sanitation chemical in the production area at the wrong time. Would employees recognize, remove and investigate that situation? Challenge tests are easy high impact activities; and regardless of the outcome, can be used to raise awareness and reinforce positive behaviors.

Whether training a new security officer, reviewing existing security plans or preparing for an upcoming vulnerability assessment (due July 26, 2020), these lessons learned from experienced security consultants should help to focus efforts and eliminate unnecessary steps at your facility. The final installment in this series will address broad mitigation strategies, the “Three Element” approach and food defense plan unification. Read the final installment of this series on Lessons Learned from Intentional Adulteration Vulnerability Assessments, Part III.

October 29, 2019

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

By Frank Pisciotta, Spence Lane

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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.

Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.

A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.

Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.

Class	OSHA Workplace Violence Offender Description	Motivation Translated to the Food and Beverage Industry
1	The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame.	Behavioral Health Patient * Social Media Fame Seeker * Copycat * Extortion * Economic motivation *
2	The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category.	My load isn’t ready, you are costing me money
3	The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace.	I am upset with a coworker and adulterate to create problems for that person * I am upset with the company and adulterate as retribution and to harm the brand * Youthful stupidity I am not paid enough *
4	The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim.	I am upset with an intimate partner/ coworker and adulterate to create problems for that person
5	Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs.	Radicalized Insider
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.

A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.

Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.

Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”

The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.

Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more. Read Part II of this series on intentional adulteration.

January 5, 2017

FBI to Food Companies: Insider Threat Should Be Big Concern

By Maria Fontanazza

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SA Scott Mahloch will present FBI’s Role in Food Defense on November 29 at the 2017 Food Safety Consortium | Learn moreIn most cases, contamination that occurs within a food facility is unintentional. However, it’s been documented that terrorists are interested in targeting the food sector, and as lone wolf attacks gain popularity, companies need to be able to identify and protect themselves against the insider threat, said Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI, at the 2016 Food Safety Consortium.

In the following video, Mahloch talks about FBI’s role in the food industry, explains how food companies can protect themselves against terrorism by identifying the insider threat, and discusses some of the FBI’s initiatives surrounding food defense. “One of the biggest concerns that we have is the disgruntled employee and the FBI really isn’t in the position to identify these people,” says Mahloch. “That’s going to be the frontline supervisors, the coworkers that can see somebody’s behavior that maybe deviates outside anything that they would recognize as being baseline behavior.”

Read the article: FBI Says Terrorists May Target Food Sector

Modernizing Pest Management With ERM

FSMA and ERM

From Risk-Averse to Risk-Based

Approaching the Audit with ERM

ERM-Oriented Solutions

Trust, But Verify

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