Tag Archives: auditors

Rick Biros
Biros' Blog

The Rising FSQA Phoenix

By Rick Biros
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Rick Biros

Last month, the Food Safety Tech team wrapped up a very successful Food Safety Consortium Conference. While I could name drop many of the who’s who of food safety who presented this year, Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, gave a great keynote address in tandem with Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS. Erik stayed for the full conference and participated in two additional panel discussions, one on Succession Planning and the second on Recalls. Sandy stayed for two days and made herself accessible to the delegates.

As the conference director I’m also the emcee. I introduce the speakers and panelists, but I also have the opportunity to be a participant and observe the interplay between delegates. What I observed at the Consortium was great networking, conversations and mentoring but what really stood out was a real energy among the delegates, something I haven’t seen at any food safety conference in the last few years. I believe that energy is an indicator that FSQA (food safety and quality assurance) is coming back from the devastation and impact of the Covid-19 pandemic.

For example, on the topic of FSQA auditing and inspections, Covid significantly reduced the amount and type of internal and supplier audits as well as FDA inspections. Many auditors who were independent contractors just quit. They moved on because there was no work. This left a huge void in trained and experienced auditors.

Our session on Succession Planning for Inspectors and Auditors included panelists from government, academia, industry and industry associations. They discussed the increase in inspections and audits coming in 2024 and thus, the real need to fill the void in inspectors and auditors left from the pandemic, as well as the need to train and nurture those folks.

Another theme at the Consortium was the continued evolution of Food Safety Culture. Delegates were looking for ways to take Food Safety Culture to the next level and apply metrics to it. We did a post conference survey, and the feedback we received supports this. Here are some of the direct responses:

Q: What were your top takeaways from the Food Safety Consortium?

  • Transparency from regulators and ways to foster growth and culture.
  • Food Safety Culture is in the forefront, as evidenced by the numerous panels. I attended nearly every one pertaining to this subject. It is a difficult subject because it is subjective and difficult to measure and quantify.
  • Food Safety Culture is ever evolving and becoming a more important factor every year. We need a new system but are unwilling to scrap or majorly overhaul the current one … FSMA was supposed to drastically reduce foodborne illness incidents. It doesn’t seem to be working, and we are nearing the time for FSMA 2.0. While it doesn’t appear that we are getting better at reducing the number of incidents, we are getting better at detecting them.

Q: What Topics should we plan for next year’s Food Safety Consortium?

  • Updates from the FDA and USDA on current projects
  • How to demonstrate Food Safety Culture. How to build a program and maintain momentum was discussed this year. But how do we show results to auditors? We need guidance and expertise on proving a solid FSC to auditors.

My takeaway from this year’s Food Safety Consortium is that the FSQA community is on the cusp of a resurgence in activity, training and investments—like a Phoenix rising from the ashes of Covid. But even before the pandemic, there was an overall sense of FSMA and GFSI fatigue. I am seeing a collective increase in FSQA activity that has not been present in many years, and that’s a good thing!

In 2024, we will see accelerated digital transformation. Data analytics will play a greater role in FSQA strategies. Getting an entire industry and supply chain ready for FSMA 204 in two years will be a huge undertaking. Also, Food Safety Culture will evolve to provide metrics and data for accountability.

Food Safety Tech continues to publish original weekly articles on these emerging trends. We are introducing a new FSQA Auditor Training program in Q1, and next year’s Food Safety Consortium conference will be held October 20-22, 2024, in Washington, DC, continuing the conversations, debates and discussions.

You can be part of this new wave of FSQA energy by contributing an article to Food Safety Tech or submitting an abstract for the 2024 Food Safety Consortium conference.

This new wave of energy has inspired me. It’s been a while since I last wrote this column, way too long. And FSMA 2.0, that will be the subject of a future column. Also, I’ll share my thoughts on the new food safety agency, our new podcast partners from Don’t Eat Poop and many other topics. Until next time…

All the best!

Rick Biros, Founder, Publisher, Conference Director

 

 

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.

Michele Pfannenstiel, Dirigo Food Safety
FST Soapbox

Quality Assurance and Food Safety in Cannabis-Infused Products

By Michele Pfannenstiel, DVM
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Michele Pfannenstiel, Dirigo Food Safety

The legal cannabis-infused products industry is growing with impressive and predictable rapidity. But because the rollout of new regulations occurs in an awkward and piecemeal fashion, with stark differences from one state to another, and sometimes even one county to another, uncertainty reigns.1 Many entrepreneurs are diving headlong into the nascent industry, hoping to take advantage of an uncertain regulatory environment where government audits and inspections are rare. These business owners will see quality assurance and product safety as burdens—costs to be avoided to the greatest extent possible.

I have seen this time and time again, even in the comparatively well-regulated food industry, and it is always a mistake.

If you find yourself thinking about quality assurance or food safety as a prohibitive cost, annoyance or distraction, I encourage you to change your thinking on this issue. The most successful businesses realize that product safety and quality assurance are inextricably linked with profitability. They are best thought of not as distractions, but as critical elements of an efficient and optimized process. Proper QA and safety are not costs, they are value.

Food safety and quality assurance should be seen as important elements of the process that you undertake to enforce the high standards and consistency that will win you repeat customers. The fact that they guard against costly recalls or satisfy meddlesome auditors is only a bonus. Realizing this will make your business smarter, faster and more profitable.

Learn more about the science, technology, regulatory compliance and quality management issues surrounding cannabis at the Food Labs / Cannabis Labs Conference | June 2–4, 2020If today you cannot clearly communicate your product standards to your employees and to your customers, then you have some work to do. That’s because quality assurance always begins with precise product specifications. (A good definition of “quality” is “conformance to specifications.”) How can you assess quality if you don’t have a definitive standard with which to evaluate it? My consulting firm works with food businesses both small and large, and this is where we begin every relationship. You might be surprised how often even a well-established business has a difficult time naming and describing every one of its products, let alone articulating objective standards for them.

This may be doubly difficult for fledgling businesses in the cannabis world. Because the market is so new, there are fewer agreed-upon standards to fall back on.

When we help businesses create specifications, we always look at the relevant regulations while keeping in mind customer expectations. In cannabis, the regulations just aren’t as comprehensive as they are for conventional food and agriculture. Laws and guidelines are still in flux, and different third-party standards are still competing for market dominance. Different states have entirely different standards, and don’t even agree, for example, whether cannabis edibles should be considered pharmaceuticals or food. To some extent, it’s the wild west of regulation, and as long as the federal government remains reluctant to impose national guidelines, it’s likely to remain so.

The wild west may be a good place for the unscrupulous, but it’s not good for business owners that care about the health of their customers and the long-term health of their brand. Don’t take advantage of confusing quality and safety standards by doing the least possible to get by. At some point there will be a scandal in this country when a novel cannabis product makes dozens of customers sick, or worse. You don’t want it to be yours.

With cannabis-infused products, there is a unique additional factor at play: The strength of THC and other psychoactive compounds. Again, there are few agreed-upon standards for potency testing, and relatively little oversight of the laboratories themselves. This allows labs to get sloppy, and even creates an incentive for them to return inflated THC counts; at the very least, results may hugely differ from one lab to another even for identical products.2 Some labs are ISO 17025 accredited, and some are not. Using an unaccredited laboratory may prevent your efforts to create consistent and homogeneous products.

Even in comparatively well-regulated states, such as Colorado, it is ultimately your responsibility to create products that are safe and consistent. And in the states where the politicians haven’t even figured out which department is regulating cannabis products, your standards should be tougher than whatever is officially required.

And so we look to the more established world of conventional food and agriculture as a guide for the best practices in the cannabis industry.

Hazards

The most constructive way to look at food safety, and the way your (eventual) auditors and regulators will view it, is to look at your product and process from the perspective of the potential hazards.

Some day, when regulation finally gets sorted out, you are likely to be asked to implement a Hazard Analysis and Critical Control Points (HACCP) safety system. HACCP framework recognizes three broad categories of hazards:

  • Physical hazards: Foreign material that is large enough to cause harm, such as glass or metal fragments.
  • Chemical hazards: Pesticides and herbicides, heavy metals, solvents and cleaning solutions.
  • Biological hazards: The pathogens that cause foodborne illness in your customers, such as E. coli, and other biological hazards, such as mycotoxins from molds.

All of these hazards are highly relevant to cannabis-infused product businesses.

The HACCP framework asks us to consider what steps in our process offer us the chance to definitively and objectively eliminate the risk of relevant hazards. In a cannabis cookie, for example, this might be a cooking step, a baking process that kills the Salmonella that could be lurking in your flour, eggs, chocolate or (just as likely!) the cannabis extracts themselves.

A good HACCP system is merely the capstone resting atop a larger foundational system of safety programs, including standard operating procedures, good manufacturing practices, and good agricultural practices. It’s important to use these agreed-upon practices and procedures in your own facility and to ensure that your suppliers and shippers are doing the same. Does your cultivator have a culture of safety and professionalism? Do they understand their own risks of hazards?

HACCP offers a rigorous perspective with which to look at a process, and to examine all of the places where it can go wrong. The safety system ultimately holds everything together because of its emphasis on scrupulous documentation. Every important step is written down, every time, and is always double-checked by a supervisor. It sounds like a lot of paperwork, but it is better viewed as an opportunity to enforce consistency and precision.

When you thoroughly document your process you’ll create a safer product, run a more efficient business, and make more money.

References

  1. Rough, L. (2016, March 4). Leafly’s State-by-State Guide to Cannabis Regulations. Retrieved from https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations
  2. Jikomes, N. & Zoorob, M. (2018, March 14). The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities and Popular Consumer Products. Retrieved from https://www.nature.com/articles/s41598-018-22755-2