Bob Pudlock, Gulf Stream Search
FST Soapbox

Architect the Perfect Food Safety Team: How to Assess the Candidate

By Bob Pudlock
No Comments
Bob Pudlock, Gulf Stream Search

If there’s anything to take away from our three-part series on Architecting the Perfect Food Safety Team, it’s to be thoughtful and cognizant of what behavior and end results you’re looking for from your team.

When you enter the ASSESS phase, it’s important to arm yourself with questions that elicit responses that give you an indication of whether the person CAN perform well and who will thrive in your company’s culture.

Additionally, you want that behavior and end result to be synced and aligned against the broader organization’s mission.

Bob Pudlock will be moderating the panel discussion, “Food Safety Leadership: Earning Respect”, at the 2019 Food Safety Consortium | October 1–3 | Schaumburg, ILAs a director or VP, that’s an important distinction. A company that’s in M&A mode is much different than one that’s under pressure from a major customer to get in compliance with their supplier guidelines. The ideal candidate for one is not necessarily the best fit for the other.

Let’s say you’re a director or VP at a company who has just acquired a smaller company certified under a different GFSI scheme. For the next year to two, other integration efforts have been prioritized over folding the acquired company’s scheme into the parent company. For the foreseeable future, that means there will be a disconnect in some protocols, reporting and expectations between the parent and acquired company.

In this scenario, we brainstorm with our client and bring forward themes or dynamics that will be present.

  • Transition -> Change -> Ambiguity
  • Gray area -> Open loops not immediately resolved -> Discomfort
  • Acquisition / Integration -> power/influence/reporting structure transition -> Ambiguity

Two themes that come out of this brainstorm are “dealing with ambiguity” and managing discomfort associated with a GFSI certification or being downgraded as a priority while the company pushes other objectives forward.

For these themes, now we look to construct questions that elicit how one has behaved in past. We can also construct a hypothetical scenario to see how an individual would strategize and act moving forward.

As you look at potential hires into the organization at this stage, you’re going to be presented with a range of candidates that exhibit varying degrees of emotional flexibility.

Emotional flexibility is the ability to identify, assess and adjust responses to events, circumstances or triggers as they arise.

If a candidate in this scenario is rigid or exhibits a black and white “compliance or bust” mentality, that’s going to be a source of constant friction for the individual and those with whom they interact. During the integration efforts, that person is going to have a hard time calibrating their feeling of incompleteness or disconnect from the broader organization.

A candidate that exhibits a low degree of emotional flexibility will have a harder time “rolling with the punches” and will make those around them uncomfortable—they’ll push and work towards a set of expectations that is not consistent with the broader organization’s timeline. Now there is certainly an opportunity to manage that individual’s expectations, but the less we have to do that as leaders, the better—hence, the importance of accurately assessing and pegging the attributes early and often in the interview process.

So, how do we do that?

We advocate for what we call “layered” interview questions. In simple terms, it’s asking a question a number of different ways and in different contexts to elicit responses that offer an accurate prediction of how someone will react in the future.

The first question might be (one layer): How do you deal with ambiguity?

Another question would be: How have you dealt with a situation in the past where your boss was not on site but your plant manager took on day-to-day supervising and reporting? The hiring team can shade in specifics to make the scenario more realistic. The core of the question is to create an image of an ambiguous environment.

And yet another question would be (this is hypothetical): Let’s say you’re alone and have been put on the spot to solve this food safety problem. Your boss is not available for the next two days and you believe that there might be a disconnect between how the plant manager might solve the problem and how your boss would solve it. What would you do?

Asking a question three different ways will ferret out canned, stale answers. Additionally it will test a candidate’s ability to “connect the dots” between past experience and current/future challenges in the workplace. Asking these questions and observing the responses is a significant improvement over what’s typically done.

Taking it a step further will give you an even more accurate prediction of whether a candidate will thrive or perish in this environment. To test this, drill down further on the candidate’s responses to each layered question to the point where you determine what toll, if any, these situations took on them; in other words, how does ambiguity and discomfort in the workplace make them “feel”? Just because someone has experience in ambiguous climates or has managed “transitional” situations like a company’s M&A phase doesn’t mean they thrive on it. For some people, it’s a constant stressor, and if they’re not emotionally resilient, at some point they will break or wear down.

Drilling down to this level will give you a more accurate feel to how resilient and tolerant one will be in your company’s current and future culture. Additionally, you’ll determine whether or not their level of emotional flexibility will allow them to thrive or cause a constant stressor that will ultimately wear them down.

This is just one example of how to use a layered question. There may be three to four key themes that you want to dig into for each role in your organization. Pairing the layered questions (same question, multiple contexts) with eliciting feeling-based responses will give you an even more accurate predictor of who will thrive on your team. It will also isolate and disqualify individuals who have canned responses to interview questions and/or who can’t think on their feet, or struggle to tie past experiences to current state challenges.

This might “feel” like a lot of effort, but it’s an immense time and energy saver when you balance it against the aggravation, time and energy-suck you experience with a poor or mediocre hire.

Read on to Part III of this series: Architect the Perfect Food Safety Team: Capture Your Ideal Candidate and Set Them Up for Success

Susanne Kuehne, Decernis
Food Fraud Quick Bites

In Wine, There Is Not Always Truth

By Susanne Kuehne
No Comments
Susanne Kuehne, Decernis
Wine
Records involving wine fraud can be found in the Food Fraud Database. Image credit: Susanne Kuehne

Three arrests were made and at least 11,000 bottles of red wine labeled high-quality IGT Toscana wines have been seized in Italy for containing lower quality wines and fraudulent labeling, misrepresenting the wine’s geographic origin. The investigation was taken to the Europol level in conjunction with German and Italian law enforcement authorities.

Resource

Authorities shutdown international wine fraud operation; three in Italy arrested. Food Safety News. Accessed February 19, 2019.

Matthew Botos, ConnectFood
FST Soapbox

Food Entrepreneurial Trends

By Matthew Botos
No Comments
Matthew Botos, ConnectFood

Over the last two decades I have had the utmost privilege to work with food manufacturers from every sector. From dried goods, meats, poultry, school lunches programs, etcetera. I have seen almost everything. The leading trend I have seen over the last 20 years is the steady rise of beverage companies. Everyone likes a different type of beverage: Water, juice, cold coffee, teas, energy drinks, kombucha… the list goes on. The two most important things a small company entering the market needs to remember is to make sure that first, you can comply with the regulators, and second, that the people you are selling your products to also understand their market (buyers and retailers).

The marketplace loves new and innovative products. We need, as an industry, to continue to support innovation in the beverage industry. Healthcare trends, nutraceuticals, supplements, and “fresh” are some of the many things consumers are looking for in a product. We often have questions such as, “I have the perfect recipe for a new beverage product—how do we get it out into the market?” The first question to ask yourself is: Do you understand your product and its intended use? And, second: Do you understand how the physical properties of this product impact how it will need to be transported as well as stored and used by the final consumer? Both of these questions come back to—and can be answered by—food safety. Companies can have the greatest product ideas; however, if you do not have the ability to make sure it has a safety factor during transportation, as well as the ability to communicate your food safety plan, an entrepreneur can jeopardize the future of their company before it is even allowed to begin.

I have used the analogy that food safety best practices are like a sport—the more you train, practice and focus on the “basics done well,” the better your plan will be on a day-to-day basis. Bottom line: The focus is making the food supply safer. Please take note the transition to new practices does not mean that an existing HACCP plan (Hazard Analysis and Critical Control Points) is invalid! As a matter of fact, HACCP and Good Manufacturing Practices (GMP’s) should be looked at as the foundation of FSMA’s Preventive Controls for Human Food. Local departments of public health still rely on HACCP as their main line of defense for the food safety industry. We have seen so many small processors and restaurants that have inspections where HACCP is still the focus, even though Preventive Controls has some more advanced techniques for protection. Both HACCP and Preventive Controls focus on making sure you have good sanitation practices, employee training, and have done a hazard analysis for biological, chemical and physical hazards. I believe the lines are blurring a bit—companies, academics and regulators don’t often understand the differences between the two and, to be honest, the differences are not that substantial from a fundamental level. Ultimately, companies are responsible for their own food safety best practices.

As we trend toward new and innovative beverage concepts, we need to be partners with both our regulators and our customers. There is so much information across the United States and companies that are in emerging markets will only grow and develop if they have proper food safety plans as a foundation. Emerging companies should get connected early and learn from other companies and organizations, and become more proactively involved in the food safety element of their product.

I believe 2019 will be an incredible year for the rise of food and beverage startups. We have already seen much growth in the knowledge of food supply due to easily accessible information about products. Keeping a transparent conversation with regulatory personnel and customers is key to the success of any food or beverage company.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Bee Careful What You Eat

By Susanne Kuehne
No Comments
Susanne Kuehne, Decernis
Food Fraud, honey
These types of records can be found in the Food Fraud Database
Image credit: Susanne Kuehne

One of China’s most famous health brands has been banned from making honey and issued a steep fine in China after selling expired honey. For a long time, the brand’s “Premium” honey was a supposedly safe alternative in China compared to “fake” honey, mixed with sugar syrup.

Resource

Executives of TCM company in trouble over honey
Wen, X. (February 13, 2019). Executives of TCM company in trouble over honey. Accessed February 13, 2019. Retrieved from http://www.chinadaily.com.cn/a/201902/13/WS5c635b26a3106c65c34e8fba.html

Karen Everstine, Decernis
Food Fraud Quick Bites

How Food Fraud Happens

By Karen Everstine, Ph.D.
No Comments
Karen Everstine, Decernis

The food industry has been hard at work over the past few years implementing food fraud mitigation plans in response to Global Food Safety Initiative (GFSI) certification program requirements. GFSI defines food fraud as:

“A collective term encompassing the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information or false or misleading statements made about a product for economic gain that could impact consumer health.” (GFSI Benchmarking Requirements, 2017)

GFSI then further defines the terminology of food fraud by citing seven categories (shown in the following diagram).

GFSI, Food Fraud
Used with permission from GFSI

In the Food Fraud Database, we categorize food fraud records using the following terminology (with examples):

  • Dilution/substitution
    • Substitution of an entire fish fillet or partial dilution of olive oil with another oil
  • Artificial enhancement
    • Addition of melamine to artificially increase the apparent protein content of milk or the addition of coloring agents to spices
  • Use of undeclared, unapproved, or banned biocides
    • The use of chloramphenicol in honeybee populations (where not permitted) or the addition of hydrogen peroxide to milk
  • Removal of authentic constituents
    • The sale of “spent” spice powder (used in the production of an oleoresin) as a whole spice powder
  • Misrepresentation of nutritional value
    • Infant formula that does not contain the required nutritional content
  • Fraudulent labeling claims
    • Misrepresentation of label attributes related to production method (organic, kosher, halal, etc.)
  • Formulation of an entirely fraudulent product (using multiple adulterants and methods)
    • The sale of “100% apple juice” that consists of sugar, water, malic acid, flavor, and color
  • Other
    • This includes counterfeits, theft, overruns, etc.

Harmonization of food fraud terminology is frequently discussed, so I thought it might be useful to provide information on how our definitions relate to the GFSI terminology:

GFSI category “Dilution”: This category maps directly to our category dilution/substitution. The reason we combine these into one category is that the intent is the same: To replace the weight or volume of a product. This can occur either through partial or full substitution of a liquid product, a granulated product, or swapping an entire intact product such as a fish filet. One of the GFSI examples for substitution is “sunflower oil partially substituted with mineral oil”, which could just as accurately be described as dilution.

GFSI category “Substitution”: As noted above, this category maps directly to our category dilution/substitution. However, we would not consider the use of hydrolyzed leather protein in milk (one of the cited examples) to be dilution/substitution because it is not used to replace weight or volume. We would view that as artificial enhancement of the protein content of milk.

GFSI category “Concealment”: We do not include a category focused on concealment because all food fraud involves concealing some aspect of the true contents of the food. One of the examples cited in this category is “poultry injected with hormones to conceal disease.” The use of antibiotics, anti-fungal agents or other substances to reduce bacterial load or mask deterioration would be classified, in our system, as the use of undeclared, unapproved or banned biocides. The use of coloring agents on fruit to improve appearance would also be classified as artificial enhancement.

GFSI category “Mislabeling”: Since all food fraud is, to some extent, mislabeling, we reserve the use of the term fraudulent labeling claims to those label attributes that describe production processes (organic, kosher, etc.). With the exception of falsification of expiration dates, the other examples cited would not be classified by us as mislabeling. The sale of Japanese star anise, which is potentially toxic, as Chinese star anise (a different species) is dilution/substitution and a health risk to consumers. The sale of cooking oil that has been recovered from waste streams and illegally produced is also a form of substitution that poses a potential health risk to consumers.

GFSI category “Unapproved enhancements”: This GFSI category aligns nicely with our category artificial enhancement, and both examples cited are nicely illustrative of the concept, which involves the fraudulent addition of a substance specifically for its function (not as a replacement for weight or volume).

GFSI Category “Gray market production/theft/diversion”: The production and sale of food products through unregulated channels would all be classified in our category called other. Because these forms of food fraud involve the sale of food outside of regulatory control, prevention measures will generally be substantially different from the prevention of fraud within legitimate supply chains.

GFSI Category Counterfeiting: This GFSI category is similar to the gray market production/theft/diversion category in that it involves intellectual property infringement and production outside of regulatory control. It would similarly be classified in our other category.

Shawna Wagner, DNV GL
FST Soapbox

How to Strengthen Your Audit Score

By Shawna Wagner
No Comments
Shawna Wagner, DNV GL

It is one week before your scheduled audit. Are you running around from department to department crossing the T’s and dotting the I’s, or are you cool, calm and collected, as it is just another audit? More than likely you have been in both cases, but how does one finally get to the collected stage? It is not about being nervous—even as a lead auditor I get nervous (I am human, too)— it is about being ready!

Believe it or not, I can generally gage if the audit is going to flow well within the first hour of arrival. My questions from audit to audit of course change, but overall, I am asking for the same materials and results. If the team is getting baffled by questions in the beginning stages of the audit, I know I am in for a long ride. Why does this happen? If the situation has gone down hill rather quickly, I find that whomever at the plant is responsible for the implementation of the audit standard, has never taken the time to read or review it. That, my friends, is one of the most critical mistakes you can make. I know these standards are not world-class bestselling books that you are dying to binge read by the fireplace with a glass of wine—if this was your view, you would be an auditor already. HA! The standards are not always black and white as far as requirements, but just taking the time to read the standard will enhance your understanding of where the auditor is coming from.

Now you have read the standard, you understand it and are comfortable. You have a 200,000 square-foot facility, 200 employees and four different HACCP plans to watch over. How could you possibly score an excellent, “A”, pass, whatever the top score may be defined as? I am sure you have heard the expression, it is not all about you, and that holds true for audits. So many times I have witnessed that the quality manager (or equivalent) try to undertake the entire audit from start to finish and answer all the questions. This is not a best-practice approach. A good example here would be that many audits now talk about annual objectives and key performance indicators. As an auditor, I expect that your plant manager (or equivalent key person responsible) come talk about these with their senior management. Too often I see the quality department commit to answering these questions, but as an auditor, I am interested in your system and how it works throughout your entire facility. I do not just want to know about the quality department. Get all departments involved. They, too, then get firsthand experience of understanding what the audit requirements are, instead of just reading endless emails of what needs to be accomplished.

Teamwork and understanding are now established—great! How strong are your programs? There are a few programs I want to touch on here, including your internal audit program and procedures. I can not write this article and tell you “X” is the solution, as there is not a one-size-fits-all approach. If you are spending two hours on an annual internal audit for a facility like the one mentioned above, it is possible that your program is lacking robustness. When conducting an internal audit and a requirement is in compliance, do you write what made it in compliance, what you reviewed, and with whom you spoke? This is a great way for you to compare what you see in your plant versus what an auditor sees in your plant, especially if you built your internal audit from an audit standard. How about your sanitation program? I came from a background of meat inspection, so maybe I am a bit biased, but your sanitation is encompassed with other pre-requisite programs in the facility. If your facility has untidy locker rooms, cafeterias and bathrooms, what motivates the employees to be tidy on the production floor? Sometimes it is the small things that go a very long way. In talking about sanitation, I have observed that many site managers never go in to watch your pre-operational inspections that may take place very early in the morning. Just because it is not on first shift, does not mean it is not important, and it also does not mean that it will not be audited. Likely, it will be audited!

Lastly, take all nonconformities that you have found either through internal or external audits, respond to them in a timely fashion, and get the root causes and preventative actions in place! Nothing pains me more then to see sites repeat a nonconformance, just to possibly get a major conformity. It’s like shooting yourself in the foot and your audit score takes an unnecessary plunge that could have been avoided.

Audits are not a fad and are not going away. It does take way more time to get to the cool, calm and collected stage for audits, but in the end, being audit ready all the time looks good on you and your site!

Kevin Payne, Zest Labs
FST Soapbox

2019 Food Safety and Transparency Trends

By Kevin Payne
2 Comments
Kevin Payne, Zest Labs

When it comes to addressing food safety, did the industry really make any progress in 2018? In 2019, what new approaches or technologies can be successfully applied to prevent problems before they occur and minimize the consumer risk, minimize the market impact, and speed up the identification, isolation and recall of contaminated products?

Field-packed produce offers a unique challenge to the fresh food supply chain, as it is not processed and is not required to adhere to an FDA mandated HACCP (Hazard Analysis and Critical Control Points) process. It has been a challenge for field-packed produce suppliers to proactively identify or prevent contaminated produce from entering the supply chain. As a result, during serious contamination incidents, the reaction is to pull and destroy all suspect product from store shelves and supply chain. Due to the lack of data isolating the source of the contamination, this is the safest approach, but it’s costing the industry millions of dollars. Ultimately, our inability to prevent or quickly isolate these events causes confusion among consumers who don’t know who to trust or what is safe to eat, resulting in a prolonged market impact.

In response to the latest E. coli outbreak involving romaine lettuce, the industry has proposed a voluntary item-level label that reflects the harvest location and date, to help identify safe product to the consumer. At best, this is a stop-gap solution, as it burdens the consumer to identify safe product.

I work in the fresh produce supply chain industry. When I go to the grocery store, I examine the produce, noting the brand and various other factors. I was aware of the romaine problem and the voluntary labeling program, so I knew what to look for. But I’m an exception. Most consumers don’t know romaine lettuce is grown during the summer and fall in northern California and further south during the winter in regions that include Arizona and Mexico. Most consumers don’t know what the “safe date” for harvest really means—nor should they be required to know this information. They look to the industry to manage this. If we buy a car or microwave oven that is found to be unsafe, the manufacturer and the government are responsible for identifying the problem and recalling the product. Yet, in the produce industry, that responsibility seems to be moving to the retailer and consumer.

It’s an unfair burden, as the retailer and consumer do not have the necessary information to make a definitive judgement regarding food safety. The responsibility needs to be shared across the entire fresh food supply chain. Records about the produce need to be shared and maintained from harvest to retail.

Will 2019 be the year that we realize we can address this challenge proactively to improve the safety of our fresh food?

We need a new approach that leverages innovative technology to provide a more reliable solution. For example, irrigation water is often identified as a culprit in spreading bacteria. Yet even with regular testing of irrigation water, the results do not currently guarantee food safety. We see emerging technology that will make regular testing more reliable, accurate and affordable to facilitate more proactive management of the water supply. This will be a critical part of an overall solution for proactive produce food safety.

Blockchain technology has been hailed as a savior of food safety and traceability. Early in 2018, it was all the rage, as various sources claimed that, by using blockchain, recall times could be cut from days or weeks to seconds. But was this an oversimplification? Perhaps so, as this early hype faded by the middle of the year amidst the various food safety outbreaks that went unresolved. Then last August, Gartner, a  market analyst firm, declared that blockchain had moved into the “trough of disillusionment” on its 2018 Hype Cycle for Emerging Technologies as a result of over-hyped expectations. The firm predicts that the technology may reach the “plateau of productivity” within the next decade. Can we wait another 10 years before being able to benefit from it? Should we?

We expect that blockchain trials will continue in 2019. But, while blockchain has shown promise in terms of being a secure and immutable data exchange, questions remain. What data about the produce will be entered into the blockchain? How is that data collected? Is the data validated? Bad, inaccurate or incomplete data makes blockchain relatively useless, or worse, as it undermines a trusted platform. Further, without broad agreement and adoption of data collection, blockchain can’t be successful.

For proactive management of food safety, we will also need to address both forward and backward supply chain traceability. One of the challenges realized from recent outbreaks is that it takes time to figure out what is happening. Identifying the source of the illness/outbreak isn’t easy. Once we identify a source (or multiple sources) of the contamination, blockchain—assuming that all of the necessary data has been collected—only helps to more quickly trace back produce to its origin. But, for growers, quickly understanding where all product shipped from a specific location or date is just as critical in understanding and minimizing consumer impact. Tracing product forward enables a grower to proactively inform retailers and restaurants that their product should be recalled.

Blockchain currently does not directly support this forward tracing, but can be augmented to do so. But blockchain can maintain a food safety data item, or items, that could quickly and reliably communicate product status at the pallet-level, providing instant food safety status to the current product owner, even if they didn’t have direct contact with the grower. As such, a hybrid blockchain approach, as espoused by ChainLink Research, is optimal for forward and backward traceability.

Equally important, we need to fully digitize the supply chain to enable blockchain. To make comprehensive data collection feasible, we need to automate data collection by utilizing IoT sensors at the pallet level, to properly reflect how distribution takes place through the supply chain. We need reliable data collection to properly reflect the location and condition of product distributed through a multi-tier distribution network. That level of product data visibility enables proactive management for food safety as well as quality and freshness— well beyond the current trailer-level monitoring that only monitors transit temperatures with no benefit to managing food safety. Effective data capture will define the next generation of fresh food management, as it embraces proactive food safety, quality and freshness management.

Goals for This Year

For 2019, our goals should be to embrace new approaches and technology that:

  1. Identify food contamination at its source and prevent contaminated food from ever entering the supply chain. We need to focus on developing new technologies that make this feasible and cost effective.
  2. Accurately and consistently track product condition and authenticity of fresh produce from the time it is harvested until it is delivered. IoT sensors and proactive fresh food supply chain management solutions provide this capability.
  3.  Make it cost-effective and practical for growers, suppliers and grocers to use solutions to improve the entire fresh food supply chain. If we make the process burdensome or without a reasonable ROI, implementation will lag, and the problems will persist. But if we demonstrate that these solutions offer value across the fresh food supply chain—through reduced waste and improved operational efficiency—growers, suppliers, shippers and grocers will embrace them.
Moira McGrath, OPUS International
FST Soapbox

We Need More Qualified Food Scientists

By Moira McGrath
1 Comment
Moira McGrath, OPUS International

I oversee an executive search firm that specializes in placing food scientists in the food industries. In many of our searches, we are asked specifically for individuals who have food science degrees versus other scientific degrees. When we asked the universities how many students were graduating in the 33 universities approved by IFT, we received a variety of answers. So, in 2006 we started our Food Science Student Survey, asking the chairs of each of the departments to provide the answers to three questions: How many students are in the program, how many are seniors, and how many are pursuing a graduate degree. The survey has been completed every other year since 2006.

The good news is that the numbers have doubled. In 2006, there were only 462 seniors in 33 U.S. universities in food science programs. In 2018, there were 931. The departments vary in size, from UC Davis being the largest program with 249 undergraduate students in their program, to the smallest, Tuskegee University with only 15. The total number of undergraduates in 2018 exceeded 3400. This is good news for the food industry, as there has been a shortage of food scientists for many years, especially due to the baby boomers retiring. With stronger food safety regulations, and a constant need to innovate, the food industry needs more qualified food scientists. We appreciate the efforts of the universities to expand their programs.

Food Science Student Survey, OPUS International, IFT
Survey of Food Science Students in IFT-approved U.S.-based Universities (2018). Table courtesy of OPUS International, Inc.
Emily Kaufman, Emport, Allergens
Allergen Alley

Matrix Matters: Why Allergen Test Kits Are Only Half the Story

By Emily Kaufman
No Comments
Emily Kaufman, Emport, Allergens

On-site rapid tests for allergens are an important part of any manufacturing facility’s allergen control plan. Several companies offer allergen test kits for day-to-day use, and it can be hard to tell the differences between them or determine which is the best fit for a given facility. What’s a busy QA professional to do?

One of the most overlooked factors when choosing an allergen test kit actually has almost nothing to do with the test kit itself. Instead, it’s much closer to home: The matrices being tested are just as—if not more—important to consider than the test kit itself.

Before you commit to any allergen test kit, you should talk to someone extensively about the types of products you plan to test. There are a variety of surprising and counterintuitive ways that your matrices can impact the functionality of a test, and you’ll save time and money by understanding information BEFORE you start testing. Below, we’ll review some of the most common matrix challenges.

High Fat Matrices

fruit pops, allergensLet’s imagine a facility that makes ice cream and sorbet. Let’s assume they make a gourmet strawberry ice cream and a fat-free strawberry sorbet, both of which ought to be peanut-free—but since some of the ingredients come from a supplier who also works with peanuts, the QA team decides to run a rapid peanut test on the strawberry products.

Much to the team’s surprise, the sorbet tests positive for peanut but the ice cream does not. What could be happening? Of course, the simplest explanation is possible: The sorbet has peanut residue in it and the ice cream does not. However, there’s another, trickier possibility: They could have the same amount of peanut residue, but the full-fat ice cream could inhibit the test kit’s ability to detect the allergen.

In general, the higher the fat content of your matrices, the higher the detection limit on your test kit. It’s an imprecise spectrum: Using rapid tests to find traces of allergenic protein on an oil is nearly impossible, on fat-rich items like ice cream or cream-based soups it’s a challenge, on items with little or no fat it shouldn’t be an issue. That isn’t to say there couldn’t be other issues with low-fat items, as we’ll review below.

Matrices Processed with High Heat

peanuts, allergensLet’s say our ice cream facility starts making a peanut-butter-swirl flavor. Perhaps they will begin testing their rinsewater for peanut residue after running that flavor, to ensure satisfactory cleaning. The kit they use says it can detect peanut allergen to 5 ppm, and rinsewater is not a high-fat matrix, so they should be good, right?

In this exact example, it’s probably just fine. However, it’s important for the QA team to consider the temperature at which peanuts were roasted. While raw peanut might be detectable at 5 ppm, roasted peanuts could have a detection limit that is much higher. In fact, very strongly roasted peanuts could only be detectable at levels of 500 ppm or more. This doesn’t mean there is no reason to test—but it’s important to know that many antibody-based tests will respond differently to an allergen processed with high heat than one that is raw. The same detection challenge can sometimes be seen with canned or tinned items that are subjected to high heat in processing.

Fermented or Hydrolyzed Matrices

Two of the trickiest items when it comes to allergen detection are soy sauce and fish sauce. In both of these condiments—and many other common ingredients subjected to these types of processing—the allergenic material is subjected to heavy modification. As proteins get folded and broken in unpredictable ways, they become more challenging for antibody-based test kits to detect. In fact, soy sauce and fish sauce are nearly undetectable by most kits.

When validating a cleaning process after using one of these ingredients, often the safest thing to do is to test for a different allergen—formulated in a simpler way—that is also present. Sufficient cleaning after a product made with fish sauce and breadcrumbs, for example, could be proven with a gluten kit; that second allergen will be unaffected by the fermented allergens in the recipe.

Matrices without Multiple Proteins

Some kits look for a variety of proteins commonly found within one allergen. Other times, though, each test kit will be looking for one specific protein. It’s important to confirm that the allergenic protein your facility works with is in fact an allergenic protein that your test kit is trained to recognize.

Perhaps the most common FALCPA allergen where this plays a role is milk. While there are a number of proteins in milk, casein is the most common and accounts for approximately 80% of the protein in milk, making it a common target for allergen test kits (both rapid and ELISA). The remaining 20% of protein is comprised of various whey proteins, most commonly beta-lactoglobulin.

In the case of our ice cream and sorbet facility mentioned above, a kit that detects casein OR beta-lactoglobulin OR both proteins together could be suitable for confirming that the sorbet is truly milk-free. However, there are other types of product that contain only whey proteins, which are a popular way to increase protein content in a variety of foods and beverages. If a facility that works exclusively with whey proteins uses a kit that only detects casein, they will never have a true understanding of their allergen contamination risk.

Another challenging FALCPA allergen is fish, as there are many different species of fish with quite divergent protein structures. If you are testing for fish contamination, it’s important to understand which species of fish the test you are considering can detect, and which species may pose a problem. If there is a mismatch between kit and matrix, then you’ll need to find a different way to ensure safety.

How to Troubleshoot Your Matrices

If you are beginning an allergen testing program, find time to talk with the manufacturers of any allergen kits you are considering. You may also want to talk with the representatives of any labs that are doing third party testing for you. Some questions to ask include:

  • What matrices have you validated your tests for?
  • Do you anticipate any issues with my matrices?
  • How should I validate your tests for my products?
  • What factors impact the sensitivity of this kit?
  • Does the detection limit change based on the matrix?

Your kit manufacturer (or third-party testing lab) should make you feel confident that they understand the quirks of your specific matrices—and they should have ideas for how to troubleshoot any challenges that they foresee. If a supplier tells you that their kit will work equally well across all matrices and declines to offer proof that corresponds to your needs, beware (or at least be prepared to conduct rigorous validation on your own). Allergen detection is complicated, and as with so much of life: If it sounds too good to be true, it probably is.

Laura Lombard, IMEPIK
FST Soapbox

The Business Case for PCQI Training

By Laura Lombard
No Comments
Laura Lombard, IMEPIK

Beyond reducing liability or checking a regulatory box, investing in robust training can reap measurable business impact. The FSMA regulation requires that Preventive Control Qualified Individuals (PCQIs) “have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system,” as per Subpart C Section 117.180 (c) (1). Even if the person serving in the role of PCQI is qualified through job experience, FDA investigators will expect adherence to development and application of risk-based controls as contained in the standardized PCQI curriculum material or the alternative training allowed in the regulation.

Let’s face it: Our employees serving in the role of PCQI come from a spectrum of food safety plan experience. In addition, many are mentoring new members as Qualified Individuals on the food safety team. Others are building a whole new team from scratch. Team members may be specialized department heads or hold several titles and job duties within a manufacturing facility. Your PCQI is charged with overseeing the development and analysis of the food safety plan. The PCQI needs a team that has had consistent training in the language of the new rules and how to comply to support the PCQI’s charge.

Beyond meeting the regulation, companies should train at the PCQI level to safeguard a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more you save in costly recalls, loss of current or potential customers, and your brand’s reputation. A company with a robust safety culture has a competitive advantage over competitors who are more lax in their food safety and may suffer financially and reputationally from recalls and customer quality assurance complaints. In an era when customers are seeking more information about the food they consume, being a trusted food safety brand can make your company stand above the crowd.

In addition, consistent training can help with internal culture change and worker productivity. Working on hazard analysis and defining preventive controls requires that employees show critical thinking and problem-solving skills. Team members taking a curriculum with standardized material and consistent learning objectives can reflect together to identify and document gaps and corrections to practices or processes. They can quickly apply their learning for more accurate analysis of the components of the food safety plan. This is the true impact from investment in high quality instruction—motivating employees to learn updated food safety practices, change their behavior, and make more efficient and effective decisions to keep the quality and safety of your products. Well-trained food safety employees are a key factor in the protection of your customers, your company’s brand and the prevention of costly food recalls. The investment in training at the PCQI level is strategic on all fronts.