With FSMA’s Preventive Controls rule in full effect for all except small and very small facilities, FDA is conducting inspections according to the new rules. But, while facilities should expect a very regulatory approach to be taken with a primary focus on environmental swabbing and records review, facilities that have undergone the new inspections are verifying that the FDA “investigators” (terminology that FDA is beginning to emphasize instead of inspectors) are following the agency’s principle to “educate before and while we regulate.”
FROM THE PLANT FLOOR. “What we’ve heard is that FDA is being very consistent with what they said they would do and what they are doing,” said Hogan Lovells Counsel Elizabeth Fawell in a presentation at the GMA Science Forum in April. Expect the investigators to take a very regulatory approach to the inspection, and be sure your food safety plan is written, well-designed, defensible, and implemented, she said. “FDA is asking for records — if you don’t have the records, it is a deficiency.” Additionally, the investigators are expecting the plant manager to be able to explain and justify the plan.
McCormick has had two Preventive Controls inspections, said co-presenter McCormick Americas Senior Quality Systems Manager Jill Hoffman; one at its primary facility in Hunt Valley, Md., and one at a smaller Mohave Foods plant in California where FDA conducted a “FSMA-lite” inspection. Both were relatively amicable, with the investigators being easy to work with. “If you can ever describe an FDA inspection as pleasant, this would be the closest to that,” she said.
Hoffman affirmed Fawell’s statement that the investigators followed the guidance document for the inspection, with a key focus on the hazard analysis tables. “They used Appendix 1 extensively in their inspection,” she said. The investigators also had gone through the Preventive Controls Qualified Individual (PCQI) training that is required of facilities, so they also referenced that at times.
The investigators did ask some somewhat strange questions considering McCormick’s spice business, she said, such as “Do you have any types of animal feeds?” and “Do you ship any materials under temperature controls?” But Hoffman saw it as an aspect of the learning curve with investigators ensuring that they understood the facility’s food safety controls. The investigators also reached out to fellow subject matter experts from time to time, but, Hoffman said, they always explained why when they did so.
In addition to reviewing records, the investigators collected lots of records, she said. In fact, rather than trying to list the records they took, it would be easier to say what they didn’t take. But, she added, it seemed that these were being collected primarily for FDA’s later review to help the agency determine how well the industry is understanding the rule and how well facilities are following its provisions.
This expectation was verified by FDA Senior Science Advisor Mickey Parish in a separate presentation who said that the initial PC inspections are focused on education, training, and technical assistance so that FDA can understand where the gaps lie and how to move forward with inspections and enforcement. “We are working with the industry to create the food safety culture that we’ve heard so much about in the last few years,” Parish said.
While there was a strong focus on recordkeeping and review, the investigators were flexible with the food safety plan, but they will be more critical on a second inspection. “It really was an educate and regulate session; the commitment to that really did resonate,” Hoffman said.
One caution put forth by PepsiCo Legal Senior Director of Food Safety and Regulatory Cindy Kruger is that large companies should not assume that the food safety programs they had in place meet (or exceed) the requirements of FSMA. PepsiCo is the largest food company in the U.S. and had a strong food safety program in existence. But even with more than 300 people working on FSMA preparation for the past year — many full time — and 630 people PCQI trained, there were still areas which needed work. Her team continues to conduct mock audits to determine compliance, she said. “Every time you do a mock audit, you will find issues and improvements needed.”
As such, PepsiCo holds regular meetings to keep FSMA top of mind, has sent letters to suppliers reminding them of FSMA requirements, and asks that all workers follow the maxim: “See something; say something.”
With the Preventive Controls rule firmly in place, FDA investigators are asking plenty of questions during inspections in order to understand the facility’s practices and food safety controls.
FROM THE FDA. Also speaking at the session was FDA CFSAN Division of Enforcement Supervisory Consumer Safety Officer Priya Rathnam, who explained that FDA is conducting two types of inspections: the Preventive Controls (PC) inspection and a modernized GMP inspection — what Fawell referred to as PC Lite.
“We can’t do full PC inspections at all facilities, or even the 750 targeted for the first year,” Rathnam said. So while the GMP inspection also is training based, it is conducted primarily to find red flags for pathogen or allergen controls. Of the 190 GMP inspections conducted thus far, 185 were “No Action Indicated (NAI)”; that is, no objectionable conditions or practices were found or did not justify further actions.
“We’re trying to get away from issuing 483s unless there are really significant findings,” she said. (Form 483s are issued when the observed conditions or practices indicate that a product may violate FDA requirements.) Rather, she said, to “educate before and while we regulate,” investigators are asking open-ended questions during this initial phase to provide mutual education.
The standard timeframe for a full PC inspection is 22 hours, with a for-cause inspection likely to be longer. So, inspections are averaging about a week, she said, or more if environmental swabbing is conducted. (See Pathogen: Pet or a Pest?, for more on FDA’s environmental swabbing.) Investigators are undergoing PCQI training as well as shadowing – which means you may have several investigators in your facility at one time — those conducting the inspection and those who are shadowing them to learn.
Rathman also confirmed that the investigators are using the Appendix 1 Guidance document, particularly the first five chapters. Inspections are not yet focusing in on supply chain provisions, but the investigators will look at facility supplier programs.
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
Schooling for the Future
Features - Plant Management
Public and private sectors take action to fill expected workforce shortages.
With the food industry’s technological advances, increased regulatory requirements, and pressures of population growth which are increasing the need for agricultural efficiencies and sustainability, the Bureau of Labor Statistics has projected employment opportunities in agriculture and the food sciences to grow at a rate of five percent into the 2020s. While this percentage is similar to the average of all occupations in the U.S., the industry has the added factor of extensive job vacancies projected because of the number of scientists expected to retire within the next 10 years.
Although this should be good news for the industry, the bad news is that there are not enough prospective employees in the pipeline to fill all the projected openings for those food scientists or even production workers. The additional good news, however, is that the schools — from the elementary to the university levels — are not only aware of the need, but are taking action to educate and interest students in the food sciences and the many opportunities for a career in food production.
In this article, QA explores the issues and what is being done to find solutions before they significantly impact the industry.
INDUSTRY CHANGE. Over the last 25 years, there has been a great deal of change in food culture, science, and policy, said Darin Detwiler, Northeastern University College of Professional Studies assistant dean of graduate academic and faculty affairs. This has increased the need for higher level training in multiple areas of food law and regulation as well as food science. Additionally, the educational programs need to be more focused on the specific needs of the industry and its differences — from large to small and very small businesses; farms to manufacturers and distributors; dairy to bakery and ready-to-eat; etc. “We need to have programs that prepare those people to work at multiple levels in the industry,” Detwiler said.
It is a focus about which Detwiler is passionate, and for which he received a 2016 excellence in teaching award, nominated by students in his Master’s in Regulatory Affairs of Food and Food Industries program who called him an “outstanding and engaging” instructor who “shares an enormous passion for his discipline that he instills in others.”
The Northeastern program is designed to have multiple levels of experiential learning to include case studies, plant procedural elements, food safety or food defense plan writing, business mission statement development, as well as opportunities for internships. Not only do the students conduct research to develop the papers, they submit them to industry personnel. For example, the memo on page 24 is the result a student’s case study on recommendations for GMO labeling, which was submitted to chief executives of major food companies. (The full case study is available here.)
While many of the students are from the industry, most did not come from a food or food science background. “A common thread is that they’ve been in the industry for five, 10, or 20 years. They started off doing X, then someone retired or left, and they took over their position,” Detwiler said. But it didn’t take long for many to realize that they could not move higher without further food science or regulatory education. Others simply wanted a change in position or company.
Production plant internships are one initiative being taken to address the industry’s expected worker shortage.
As it turns out, all except one of his former students has been promoted or taken a higher level job at another company following their graduation from the program.
Detwiler feels that it is the experiential learning of the program that contributes most strongly to the students’ careers, which is substantiated by the fact that it was by showing the portfolio of work they did in the program that effected many of the students’ promotion or hiring.
GLOBAL ISSUES AND INITIATIVES. Following are just a few other initiatives taken by the public and private sectors to address the issues.
1. Too Few Students to Meet Demand. Thousands of jobs in the fields of food, energy, and the environment are going unfilled in the U.S. today. These applied biological disciplines are vital to our national and global security and economy, but graduate too few students to meet current and projected workforce demands. (Michigan State University [MSU])
What is being done. An MSU research team landed a $1 million National Science Foundation STEM scholarship grant to recruit, nurture and graduate students prepared for careers in animal science, crop and soil sciences, forestry, entomology, fisheries and wildlife, food science or horticulture. The cohorts include Lansing School District high school students, Lansing Community College students and MSU students who haven’t declared a major. “Too few students are entering these disciplines — a problem that can be addressed by an effective, multifaceted, experiential and interactive recruitment program that engages students,” said Eunice Foster, MSU crop physiologist and the grant’s principal investigator. “Though many people want to know where their food comes from, there seems to be a disconnect in recognizing that science, technology, engineering and math are integral to the careers associated with food production, processing, packaging and delivery.” (http://bit.ly/2kpwi9s)
2. Unfilled Agricultural Jobs. Each year, approximately 25,000 agricultural jobs go unfilled due to a lack of qualified applicants. Modern agriculture encompasses more than farming, and represents a convergence that demands a variety of skills. (The Ohio State University [OSU])
What is being done. An NCES Statistical Analysis Report (SAR) presents an examination of students’ college attrition from science, technology, engineering, and math (STEM) fields over the course of six years to gain a better understanding of the attrition by determining rates of attrition from STEM and non-STEM fields; identifying characteristics of students who leave STEM fields; comparing STEM course taking and performance of STEM leavers and persisters; and examining the strength of various factors’ associations with STEM attrition. (http://bit.ly/2rbvl8w)
3.Students Leaving STEM Studies. A total of 48% of bachelor’s degree students and 69% of associate’s degree students who entered STEM fields in the U.S. between 2003 and 2009 had left these fields by spring 2009. Producing sufficient numbers of graduates who are prepared for STEM occupations has become a national priority in the United States. (National Center for Education Statistics [NCES])
What is being done. To encourage the pursuit of careers in STEM fields and agriculture, Monsanto awarded scholarships totaling $250,000 to 10 students through the Monsanto Graduate Student Scholarship program. “Many graduate and undergraduate students, especially high achievers from underrepresented communities, are unaware that their career paths could include jobs in agriculture or related industries,” said Steve Mizell, executive vice president of human resources for Monsanto. “These scholarships reinforce Monsanto’s commitment to building an innovative workforce that is able to meet the demands of feeding a growing global population of nine billion people by 2050.” (http://bit.ly/2pG78at)
4. It’s Not Just the U.S. The food and drink industry is the UK’s largest manufacturing sector, with about 400,000 employees, yet it will require 109,000 new recruits by 2022. Prospects.ac.uk
What is being done. Among UK initiatives detailed by Prospects are those of the Food and Drink Federation (FDF) which have included initiatives such as a “Taste Success — A Future in Food” careers campaign encouraging young people, parents and teachers to recognize the opportunities in the industry; an attempt to grow female participation by supporting the government’s “Your Life” campaign and pledging to attract women into STEM careers in food and drink; and the commissioning of Sheffield Hallam University’s BEng/MEng Food Engineering multidisciplinary program designed and developed in conjunction with more than 40 major food and drink companies. (http://bit.ly/2qnpVGz)
While such programs are advantageous to the industry and the students involved, the benefits go well beyond that to impact food safety and public health. With a goal to help students understand not only the many facets of the industry, but also the many levels of concern — of the company, stakeholders, and consumers, “we want our students to know enough to understand regulatory compliance, and we want our students to be able to care through the understanding,” Detwiler said. “I may never see or hear from them again, but I may eat food their company makes.”
The author is Editor of QA. She can be reached at llupo@gie.net.
Taking it to the School
Hands On program gives kids real world lessons on foodborne illness.
By James William Swart
Hands On: Real World Lessons for Middle School Classrooms is an experiential curriculum which improves behavior related to food safety, personal hygiene and food preparation to reduce risks of foodborne illness. Shown to catalyze students’ interest in science, technology, engineering, and math (STEM) programs in later years, this interdisciplinary curriculum is designed to provide classroom teachers with ready-to-use lesson plans that focus on providing students with instruction aligned to state content standards while teaching them the importance of proper handwashing, food cookery, and foodborne illnesses.
Hands On began in 2008 under the guidance of Jennifer Richards of the University of Tennessee (UT) with the support of the USDA and the Grocery Manufacturers Association Science and Education Foundation (GMA SEF). As a middle school teacher prior to attending UT, Richards saw a gap in food safety education programs for 6th, 7th, and 8th grades. She envisioned this program as influencing a previously unreached audience — and influence those students it did.
Students from Heritage Middle School in Blount County, Tenn., observe the results of the “Hands On” bacteria growth experiment.
Hands On is organized into sets of week-long lesson plans that cover state content standards in math, science, social studies, and English/language arts. Within these units, students take part in activities, including inoculating petri plates and observing bacterial growth, modeling cell division, and creating press releases related to disease outbreaks. The lessons and activities are designed to complement what is being taught in the classroom, and to give students a real-world connection to what they are learning.
When measuring student gains from the program, Hands On looks at three categories: total knowledge gain, reported self-efficacy in dealing with issues related to food safety, and attitudes/behaviors in food safety. The data for this analysis were collected from schools that have implemented the curriculum using a pre, post, and follow-up testing structure. Students were assessed prior participation to determine their base knowledge, behavior, and self-efficacy levels. After completing the curriculum, students were given the same assessment. Then, six weeks after the post-assessment, students were given the post assessment again to measure their retention.
Based on analysis of that data, students see an increase in each of the categories. The data also show that these students retain information from the curriculum when tested six weeks after implementation.
As of May 1, 2017, Hands On has impacted more than 55,000 students in 24 states. More than 160 schools have been served by the program, with 44% of teachers choosing to implement the program more than once. Presently, the program provides classroom teachers with all supplies needed to implement the curriculum free of charge. This is possible through GMA SEF funding in collaboration with the Partnership for Food Safety Education.
Hands On will be expanded to all 50 states by 2025 and is being promoted internationally. With this expansion, the curriculum will be revised and aligned to content standards for each new state, but the underlying messages of the curriculum will remain the same. Hands On is essentially a curriculum platform which is being used for a number of topics including road safety and transportation and will soon include a nutrition focused curriculum/module. This new module will focus on understanding the importance of proper nutrition, reading food labels, and being a healthy individual while still tying the content to what teachers are covering in the classroom.
The success of Hands On is heavily dependent on the ability of teachers and students to receive the curriculum and all instructional materials at no cost since classroom teachers often have very small budgets for classroom supplies. At just under two dollars per student, Hands On is an extremely cost effective way to engage future consumers and food scientists. The program relies exclusive on voluntary contributions and federal grants. If you are interested in becoming a supporting partner by making a donation to the program, or if you know of a school district that would like to adopt Hands On, contact handson@utk.edu, or visit www.handsonclassrooms.org for more information.
The author is a Master’s candidate at the University of Tennessee in the field of curriculum development. He is transitioning to the position of Hands On program manager over the next year.
Consistent Quality in Comfort Foods
Features - Cover Profile
The Legacy of Bob Evans lives on in BEF refrigerated sides.
“Evans
complained that he could not get good sausage for the restaurant he
started after World War II in Gallipolis in southeast Ohio. Starting
with $1,000, a couple of hogs, 40 pounds of black pepper, 50 pounds of
sage and other secret ingredients, he opted to make his own, relying on
the hog’s best parts as opposed to the scraps commonly used in sausage.” – from the Legacy.com obituary of Bob Evans (May 30, 1918 – June 21, 2007)
By Lisa Lupo
Photos by Vicki Jeromos-Blayney
Senior Quality Assurance Manager Carrie Hart and Director of
Manufacturing Operations Alan Paige keep the quality focused and
consistent at the BEF Foods Lima, Ohio, plant.From Bob Evans’ 1948 founding of a 12-stool diner in Gallipolis, Ohio; through the opening of the original Bob Evans Restaurant in 1962 on his Chillicothe, Ohio, farm (which expanded into more than 500 restaurants); to the 2017 split of Bob Evans Restaurants and Bob Evans Farms (BEF) Foods businesses, consistent quality has been the essential driver and key to success.
In April 2017, the company sold its restaurants to San Francisco-based Golden Gate Capital to enable it to focus on its BEF Foods business and its fastest growing category, refrigerated sides. The two businesses do, however, continue to work together, with Bob Evans Restaurants being a key customer of BEF Foods. BEF Foods also acquired Pineland Farms Potato Company (PFPC), which not only provides an in-house source of potatoes for its refrigerated mashed potatoes, but also enabled the company to acquire additional production capacity and business, as it had customers to which BEF had not been selling.
Refrigerated side dishes is a relatively new business segment for the food industry, and it is continuing to emerge and evolve. Currently it has only about a 20% national household penetration, of which BEF Foods holds more than half, said CEO Mike Townsley. “We’re the leading brand. We are developing the category.”
The company continues to make its legacy sausage, but it sees that segment as a mature business, with little potential for significant growth. About eight years ago, the company asked itself: “Are we a sausage company or a food company?” said Senior Vice President of Retail Business Development Chris Lambrix. “It was very easy to see that we would sell a lot more sides in the very near future.”
“We were well over 60% side dishes at the time of the acquisition. And if we are going to grow to a national business, it will be in growth of our side dishes, not sausage,” Townsley added.
“When people think of Bob Evans, they think comfort food,” he said. And that is exactly what the company offers in its refrigerated sides including mashed potatoes, oven-baked scalloped potatoes, macaroni and cheese, and other pasta dishes. But it is comfort food that focuses on today’s consumer-driven trends — calling out the fresh aspects of the products; cleaning up the ingredients (e.g., taking out hydrogenated oils); and listing the natural, fresh, and real aspects on the packaging. BEF Foods will even include gluten-free labeling on products that are naturally gluten-free to reassure concerned consumers that the products will fit into their diets.
“Consumers are moving away from the middle of the store and frozen foods to the perimeter foods which are deemed fresher options,” said Director of Marketing Thyme Hill. “So more and more brands are going to the perimeter because they are following the consumer.”
A LEGACY OF QUALITY. Although Bob Evans’ 2013-built corporate headquarters in New Albany, Ohio, (which continues to house both businesses in separate areas) is a far cry from Evans’ original 12-stool diner, the founder’s legacy lives on — both on the walls of the building’s Heritage Hallway and in the food produced in its four facilities.
With such founder’s philosophies as “We do it right or we don’t do it”; “Quality and service to every guest”; and “Quality is long remembered after price is forgotten” establishing the roots of the business, their application has evolved to fit the changing business, with “convenience without compromise” now a key quality mantra. “It is a high-quality product that can be prepared in five minutes with ingredients that you would use yourself,” said Vice President of Operational Business Development Terry Camp.
In fact, as we saw at the company’s most recently built plant in Lima, Ohio, where its refrigerated mashed potatoes and other potato and pasta sides are produced, BEF mashed potatoes contain just what home cooks have been putting in their mashed potatoes — likely since potatoes were first mashed; that is, 100% fresh potatoes, butter, milk, and seasonings. However, as is essential for food safety and shelf life, the company does add preservatives, but no artificial colors or flavors are included in the final product.
Even the production simulates homemade mashed potatoes — though, of course, at a much larger scale.
A FOOD-SAFETY FLOW. With few ingredients and simplified production, mashed potato production doesn’t require a lot of steps for food safety issues. This is particularly true at the BEF Lima plant which was built for flow-through: to augment food safety from receiving through cleaning, peeling, cutting, mixing, and cooking to packing and shipping. Each area and line of the plant is in a separate room, accessed from a hallway which runs the length of the building, and each room, set in order of production, has dedicated workers and specific food safety garment and processing requirements.
For example, the spices for the finished products are brought into the Spice Room where its workers review the schedule then repackage the ingredients into the amounts required for each recipe. Keeping supplier packaging out of productions rooms adds an extra layer of food safety protection. It also enables the plant to maintain the mix/fill area as a simulated clean room, further ensuring against potential outside contamination.
Lima’s Line 4 Room, which was commissioned in late 2016 to facilitate the continuing double-digit growth of BEF refrigerated sides, continues the in-to-out flow with an enter-only door. “You can get in this way, but you can’t get out this way,” said Lima Director of Operations Alan Paige.
The new flexible-use line incorporates fillers with high-speed weight-check technology, a dual sleever system, a robotic packaging unit, and x-ray technology. While all BEF lines have metal detectors, on Line 4, Paige said, “Every product goes through the x-ray to detect any changes in density as well as any metal fragments.”
The microwavable products are tested in a variety of ovens to simulate the home environment.
Additionally, at the front of the line is a diversicut cutter/slicer and visual, colorimetry inspection technology. As explained by Lima Line Lead Matthew Roode, once the potatoes are cut to the proper size for the mashed or scalloped oven-baked product, they are run under the camera which looks at everything that runs through it. In this case, if a black or brown spot, or other defect, is seen, the potato piece is automatically rejected off the line.
“The process flow is so smooth that, from a food safety aspect, it takes a lot of the risk out,” Camp said. “It’s very conducive to the process.”
IT’S ABOUT THE POTATOES. While a three-ingredient (plus seasonings) product may seem to have a simple recipe, complexity can arise because potatoes come in a range of varieties and from various sources. “Every potato is different depending on where it came from and whether it’s fresh or from storage,” Paige said.
Potatoes can have varying levels of water or sugar, be more or less starchy, or have greater or lesser salt tolerance for which tests need to be run — and that’s before the production even begins. Thus, each variety of potato, and potentially each batch, has a separate and specific recipe based on the characteristics of the incoming potatoes. “If you control what’s coming in, you can control what’s going out,” said Lima Operations Manager Kasey Patton.As such, tests are conducted on each incoming shipment to ensure it fits the accompanying certificate of analysis (COA).
Water is an essential component of the potato’s journey. Not only is it used to wash the incoming potatoes, it carries them along their journey to ensure a gentle ride. Think Lazy River: “We move potatoes with water,” Paige said. The Lima plant has 10 potato delivery bins, which, together, can hold a total of 432,000 pounds of incoming potatoes.
Bob Evan’s philosophies established the roots of the business and have evolved to fit the changing business.
Because potatoes are a raw agricultural product, temperature control and consistency during various aspects of production are critical for food safety and quality. For example, temperature abuse can sour potatoes and hot fill of the mashed potatoes is necessary to prevent mold growth. And whether talking potatoes or pasta, which also is used for side dishes produced in the plant, “it’s always about time and temperature,” Paige said. “The product is cooked at 210°F, which can pretty much handle any microbial growth.” After that, the hot fill of the mashed potatoes is a key lethality step with the CCP set as a temperature of at least 160°F, which provides instant kill even on the trays in which the product is packaged. If the temperature is set any lower, you will not effectively reduce the bacteria load and it can continue to grow, Paige said.
Once the mashed potatoes are heated and cooked at the high temperatures, they need to be chilled down to 38°F in the specified time, with each dwell time determined by the product. BEF uses two methods for chilling: air and water.
Tests also are run throughout the process, with set quality controls for viscosity, allergens, salt, pH, weight, and defects (e.g., lumps, packaging leaks, etc.) of finished product. To facilitate this, each production room of the facility has a quality control table at which tests are conducted on products directly off the line. Some of the tests run by Lima Quality Assurance Technician Bev Berelsman are leak detection in which packages are submerged in water and a vacuum is drawn, with any air bubbles arising from a package indicating a faulty seal. The process also provides a check to ensure package integrity is maintained at high altitudes. Another is the salt test in which finished mashed potatoes are blended with a set amount of water and run through a specialized strainer which detects salt levels.
“Bev has been doing this a long time — she can tell by taste where a potato came from and whether it’s fresh or from storage,” Paige said.
One of Paige’s primary responsibilities, and of the whole quality control team, is that of verification, he said. “On my trips around the facility, that’s what I do; I check all my touchpoints.” And those touchpoints hit about every point of the process from the temperatures of the hot fill and chill to accuracy of the labels and even alignment of the corrugated boxes: “I’ll check the boxes to make sure they line up right. If they don’t, I’ll have a discussion with the operator,” he said. “We’re here to help them verify that what they’re doing is correct.”
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The plant’s greatest opportunity, Paige said, is automation. All products except those run on the new Line 4 which has robotics, are packaged manually. “In some ways, it’s helpful to have more eyes on the product, but automation is definitely our opportunity.”
Once all is said and done and stored, the goal is to turn most finished product within a couple days. “I want to be in a position with logistics of ‘I make it, you take it,’” Paige said.
But with all that, mashed potatoes are still, at their heart, a fairly simple comfort food made with potatoes, dairy, and spices. “When I say it’s what you do at the house, it’s pretty much what you do at the house,” Paige said.
Additionally, BEF wants its mashed potatoes to be of the quality that can be passed off as being made in the house, should the home “cook” prefer … as one person mentioned was exactly what her aunt did every Thanksgiving.
CONSUMER FOCUS. The company’s quality mission seems to be working for more than just that woman’s aunt. With one of the greatest consumer challenges of this emerging market being consumer awareness, BEF Foods has been able to achieve a repeat-purchase rate of 62% on the top selling item, Original Mashed Potatoes — in an industry in which 35%-50% is considered to be good, Townsley said. “Our research shows us that if we can get someone to buy it, two out of three will buy it again.”
And that repeat rate isn’t a coincidence. With a QA kitchen located in the center — “at the heart” — of the corporate office, the company conducts a great deal of quality testing on both its retail and restaurant products. “We put the kitchen in the center of the building, philosophically and practically, because the kitchen is at the heart of any meal,” Townsley said.
Along with regular employee sensory testing, BEF also employs home-use testing, through which it provides prototypes for select consumers to take home and test, then respond by survey on various aspects of the food. To further the use of its products, the company also regularly creates new home-use recipes which it posts on its website, such as the pork chimichanga with macaroni and cheese and a sweet potato parfait, which we tested at our lunch. Those recipes are not just tested in-house, however. Rather, they too, are first provided to employees and home-use testers, both for taste of the finished product as well as ease in understanding and following the directions.
BEF also is continuing to work to evolve its quality with a strong focus on incoming goods. For example, said Director of Food Products, Food Safety and QA Karrie Menz, “We are working with USDA AMS to get trained on grading potatoes.” Although the company does contract for the type and grade required, she said, “Now we will be able to verify it.”
In addition to requiring that all its suppliers go through an approval process and be GFSI certified, Menz’s team will personally visit suppliers when deemed applicable. For example, if a company provides a low-risk ingredient and maintains high audit scores, BEF will likely accept these as verification. But if the ingredient is high risk or there are issues with an audit or other questionable factors, a visit will be made. This not only ensures the supplier is providing the quality and food safety required by BEF, but, Menz said, “It provides eyes on the supplier and also gives us an idea of what else they may be able to do for us.”
The company also uses consumer complaints as a quality tool, with KPIs associated with complaint reduction at each plant. For any product for which a consumer files a complaint, especially those claiming presence of a foreign object, she said, “We work very hard to get the product returned, so we can find out what it was from.” Then, BEF follows up with the customer, providing feedback and telling him or her what was done to correct the problem.
A FOOD SAFETY CULTURE. Every production facility has a QA department which reports directly to corporate QA, which reports directly to the CEO. “We go straight up to Mike (Townsley); it has given us a good support system,” Menz said. Prioritized above operational efficiencies, employee safety, food safety, and food quality hold the greatest importance for BEF, she said. “There’s no compromise.” In fact, the ranking of commitment of BEF Foods’ executive team is:
Employee safety
Food safety
Food quality
Operational efficiencies
To ensure the top priorities are met, all quality department employees are required to be HACCP certified; conduct internal auditing; stay updated on BRC current versions and regulations, including FSMA; and have basic microbiology, sensory, label compliance, and advanced Listeria monocytogenes and environmental control training.
Additionally, every operator in the BEF Foods plants are trained to say, “That’s acceptable” or “That’s not,” Paige said. “Anybody on the line can shut a line down, but only the quality people can start it back up.”
While neither mashed potatoes nor macaroni and cheese are very complex foods, it can be difficult to make either perfectly at home, every time, without, at least sometimes, ending up with lumpy or runny potatoes or over- or undercooked pasta. Thus, the secret behind the quality that keeps consumers coming back for BEF refrigerated sides, according to Paige: “Consistent repetition, I think, is what makes us good at what we do.”
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
Mistakes happen. We’ve likely all said this at one time or another, but if you are using the phrase in your food facility to justify or side-step periodic or even potential contamination issues, you should probably take another look at your programs. Although mistakes certainly can happen; in the food industry, risks unmistakably increase when mistakes happen.
Contamination “mistakes” — that is, just about any unintended adulteration of food — are the very risks which food safety programs are intended and developed to prevent. However, based on CDC’s April 21 FoodNET report, it seems that even with the increased preventive controls that facilities are implementing, those mistakes and the resulting contamination of food are continuing to increase.
In fact, the report (Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food and the Effect of Increasing Use of Culture-Independent Diagnostic Tests [CIDT] on Surveillance) shows the incidences of infections as having increased for nearly all foodborne illness-causing bacteria.
That said, while there is no question that foodborne diseases represent a substantial public health concern in the U.S., CDC raises some doubt about the FoodNet data comparisons, asking the age-old question of whether foodborne illness is increasing or are we simply getting better at detecting it? In this case, the disproportionate numbers may be due in part to the increased use of Culture Independent Diagnostic Tests (CIDT) by clinical laboratories.
As CDC states, “CIDTs complicate the interpretation of surveillance data; testing for pathogens might occur more frequently because of changes in either health care provider behaviors or laboratory testing practices.” However, the report continues, “Some information about the bacteria causing infections, such as subtype and antimicrobial susceptibility, can only be obtained for CIDT positive specimens if reflex culture is performed. Increasing use of CIDTs affects the interpretation of public health surveillance data and ability to monitor progress toward prevention measures.”
But, regardless of how it is being detected and whether or not there is a significant increase, the data is clearly showing that there are still a significant number of cases of major foodborne pathogens:
Mistakes happen; but in the food industry, risks increase when mistakes happen.
The largest number of confirmed or CIDT positive–only infections was reported for Campylobacter (8,547), followed by Salmonella (8,172), Shigella (2,913), STEC (1,845), Cryptosporidium (1,816), Yersinia (302), Vibrio (252), Listeria (127), and Cyclospora (55).
The proportion of infections that were CIDT positive without culture confirmation in 2016 was largest for Campylobacter (32%) and Yersinia (32%), followed by STEC (24%), Shigella (23%), Vibrio (13%), and Salmonella (8%).
The overall increase in CIDT positive–only infections for these six pathogens in 2016 was 114% compared with 2013–2015.
Among infections for which reflex culture was performed, the proportion of infections that were positive was highest for Salmonella (88%) and STEC (87%), followed by Shigella (64%), Yersinia (59%), Campylobacter (52%), and Vibrio (46%).
Similar arguments could, in fact, be made that there is an increase in pathogens being found in the food production facility because of the increased environmental monitoring required by FSMA, and that food illnesses are simply being more regularly linked to foods and production environments due to FDA’s increasing use of whole genome sequencing (WGS).
Again, however, whether there are more or we are detecting more, pathogens in the foods and the plant environment are undoubtedly the root cause of at least some of the infections — and are, now, a key factor of FDA Preventive Controls inspections. (See Pathogen: Pet or Pest, page 36, for more information on FDA inspection “swab-a-thons.”)
While it is likely that all the foodborne illnesses caused by the pathogens cited in the FoodNet report are due to unintended adulteration (rather than intentional terroristic, begrudged employee, or economically motivated adulteration), the food safety landscape is becoming more and more complex every day. At the same time, the detection of food safety issues is being heightened and the diagnosis of resulting foodborne illness increasing.
Food companies are being caught in the crosshairs of better diagnostic detection of illness in humans, linked, where possible, with whole genome sequencing; and, “pathogen mapping” of food plants by the regulators as part of “swab-a-thons.”
The bottom line is that the risks just keep going up and, without a solid food safety program and environmental controls, this complexity is likely to lead to increasing mistakes — which are not only more likely to be detected and cause for recall, but also increase the risks to consumers and your brand.
In years to come, 2011 will be heralded as the year in which was passed the first major piece of federal legislation addressing food safety since 1938. But, within the industry, it is likely that 2017 will be the year most remembered as the one in which FDA began its real enforcement of the “new” Food Safety Modernization Act (FSMA). It is the year in which inspections took a new turn, focused primarily on written food safety plans and environmental control “swab-a-thons” — but with a leniency and partnering tone focused on “educate before and while we regulate.”
In addition to a year of writing about these topics to educate the QA readers, 2017, for me, has been a year of food safety conferences. With a conference a month from March through July, I have been struck by the similarities of the session topics and speaker focus. While I would expect this to a certain extent, it is the repetition of phrases, objectives, and goals of both FDA and the industry that is particularly striking this year.
For example, while there always will be at least some “federalese” in a talk by a government official, when a phrase resounds from every podium at which an agency official speaks at every conference — as did FDA’s “educate before and while we regulate” — it becomes more than jargon. With such focus and repetition, how can it not be followed by the inspectors in the field? (Or, that is, by the “investigators,” the phrasing which was emphasized as the correct terminology by one official.)
After the anticipation, expectation, trepidation, and general air of “hurry up and wait” of the last six years, FDA is inspecting to FSMA’s Preventive Controls rule.
And it was both FDA officials and industry representatives who began using the term “swab-a-thon” to illustrate the vast extent to which the new Preventive Controls (PC) inspections are including environmental sampling. FDA also is conducting modernized GMP (or “PC Lite”) inspections at some plants with less swabbing included, and this is particularly the case when it is the state conducting the inspection through the new agency partnerships.
Learn more about what to expect with the new PC (and PC Lite) inspections in “Educate Before and While We Regulate” (page 32) and about FDA’s environmental “swab-a-thons” in “Pathogen: Pet or Pest?” (page 36).
FSMA was signed into law six and a half years ago. In that time there has been a great deal of anticipation, expectation, trepidation, and a general air of “hurry up and wait,” as FDA developed, wrote, rewrote, and issued the rules and provisions by which the Congressional orders would be implemented. Although the industry is still awaiting a few key provisions (such as the laboratory component and designation of high-risk foods requiring extra recordkeeping and traceability) along with a number of guidance documents, FSMA is in operation.... Are you?
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
