When your quality assurance manager authors a book on quality systems, your own processes had best be up to par.
At Turtle Mountain, the Oregon-based manufacturer of dairy-free and allergen-free dessert products, whose Quality Assurance Manager, Mark Clute, wrote Food Quality Control Systems (CRC Press, 2009), however, par is not good enough.
At Turtle Mountain, the goal is perfection.
And through employee training and empowerment, double-check testing, a no-tolerance allergen program, and intensive supplier assessments and in-house processes, the manufacturer comes as close to perfect as is humanly possible. “We rely on our production people to manufacture perfect products,” Clute said. “My role is to make sure that what we do is perfect.”
Food Quality Control Systems. As described in its preface, “This book captures the big picture of a company’s quality control systems and outlines the basic methods of establishing a thorough quality control program.…[It] provides the basis for a hazard analysis critical control point (HACCP) program plan development to be used as the foundation of the entire quality control system.”
The programs defined in the book and in place at Turtle Mountain are, in fact, one and the same—though with continual improvements at the plant since publication. Clute developed the quality systems for Turtle Mountain, then turned those documents into an instructional book. With an update already planned, the company’s systems continue to provide a quality foundation for the industry.
Clute was brought in to Turtle Mountain in 2005. Prior to that, said Plant Manager Ted McElroy, the company was strictly a co-packing plant. Because the owner wanted to launch new products and was becoming unsatisfied with the quality of some of the co-packing, the company brought the manufacturing in-house and hired Clute to lead its quality control efforts. “We wanted to regain control of our products,” McElroy said.
The company still works with co-manufacturers for some of its products, but under the same strict specifications and quality programs as the in-plant processes. “A lot of them had to change the way they were looking at things,” McElroy said.
Risk Elimination. As with a HACCP program, the quality systems are developed through risk assessment and management. “That’s what we do; we eliminate the risk,” Clute said. “When Ted designs a process, he’s thinking, ‘What risks are we potentially running into? How do we eliminate them? And if we can’t eliminate them, what can we do?’”
As is evidenced by the chapters ranging from “The Role of Quality” to “Kosher Program”—and everything in between, Clute’s expertise encompasses all aspects of quality systems. But to limit the scope of this article (to less than the 500-plus pages of the book), my visit to Turtle Mountain focused primarily on the industry-leading, no-tolerance allergen program.
With certain aspects applicable to every system, following the allergen program through the plant provides a representative look at the company as a whole.
Take, for example, Turtle Mountain’s standard that all laboratory tests are checked and validated by two people; two sets of eyes. “That’s the way our entire quality system runs,” Clute said. “There are always two sets of eyes—changeovers, solids, allergens—all are validated twice.”
The Allergen Program. Knowing that any trace amount of an allergen can kill an allergic person, Turtle Mountain tests to available limits; implements double checks on every test; has an in-depth supplier approval process (that can take weeks for new suppliers); incorporates systems through every aspect of receiving, processing and finished goods; validates those systems and methods at each step; and implements training so every employee is part of the solution.
As such, the program is designed to prevent any unwanted allergens in the product and to validate the absence of undeclared food allergens. While there is debate about sensitivity and how low the body can detect, Turtle Mountain’s policy is to test to the lowest level possible.
“When we say it’s free, it’s free down to a level of five parts per million,” Clute said. “We have allergen tests for every allergen we use in the plant. All tests are antibody based and our corporate standard is five parts per million for any allergen.”
This is true whether the label says the product is dairy-free, gluten-free, allergen-free or GMO-free (non-genetically modified). In fact, the company has gone as far as commissioning the development of a test for coconut when it was added to the 2006 FDA allergenic tree nut list—even though it is technically a seed, not a nut.
In addition to its low-level testing, the company checks and validates every test with two sets of eyes; if a product is co-manufactured, tests are run both at that plant and at Turtle Mountain.
Most processors will plate-test finished product, but here, Clute said, every mix or batch is plate-tested every day; all finished product and every lot of co-packed refrigerated product are tested every week.
For speed and ease of use, the company is moving toward lateral flow and immunoassay tests, with technicians conducting tests on the floor and the CIP crew able to quickly assess rinse water to ensure all allergens or contaminants are clear prior to a new run. For example, Clute said, “if we had made a soy product yesterday, we would have run a complete clean up afterward and tested samples of the rinse water.” When the water runs clear and all tests read negative, the line is signed off as cleared for a run.
At that point, a push through of the soy-free product would be run and tested. If clear, the run would begin. Throughout the process, random samples would continue to be taken to ensure the product is clear and free of allergens as well as pathogens.
While general procedure is to run non-allergen products first, then allergen-containing products, there are times that changeover occurs mid-day in the other direction, Clute said. But when that happens, changeover takes two to three hours, with all the complete cleaning and testing processes described above.
Consumer Information. A key component of Turtle Mountain’s allergen program is label accuracy and consumer information. “If it’s in there, it’s declared. If it’s not declared, it’s not in there,” Clute said. This is applicable not only to the label of each specific product, but is also a main component of the company’s Website (www.sodeliciousdairyfree.com).
The site’s Allergen page includes a 1,700-word overview of the company’s allergen program, links to resources for more information, and allergen identification tables listing every flavor of every product, with a 10-column listing noting presence of almond, coconut, corn, dairy, egg, gluten, peanut, pecan, soy or walnut. Similar tables are also included for chocolate, gluten and phenylalanine. In addition, all Turtle Mountain products are dairy free and non-GMO.
Supplier Management. Turtle Mountain requires that all ingredient suppliers provide a letter of guarantee as to the allergen content of the ingredient and whether the ingredient was processed on a line or in a facility that contains allergens.
In addition, every ingredient considered for a product undergoes a very strict risk analysis before it is approved for use. Not only is the raw material tested, but any subcomponents and supplier suppliers are also checked. The program includes a supplier audit and review of the facility and process; Certificates of Analysis are required and validated; and food safety requirements undergo review and approval.
“It can take five hours to approve an ingredient—if I have everything in front of me,” Clute said. “It can take 16 hours, or even weeks, to approve a new supplier.
“We don’t want to accept anyone else’s issues, so we try to exclude all risk.”
In Production. To aid in their responsibility for the manufacture of perfect products, every worker in the plant has a process step, Clute said, explaining, “Everyone on the floor has a process they make from start to finish.” With this responsibility is also empowerment, not only for quality and allergen control, but also for profitability. “We don’t like to waste anything, so everyone has the power to shut the line down at any time,” he said.
Test samples are pulled every half hour during a run and at the end of each shift. At that time, line workers from the shift participate in an evaluation, conducting a cut of the product for color, texture and taste. This enables employees to see how they did on their shift and have a better feel for process quality by understanding what was done right or not. “We want the people who are actually making the product to know—as it is coming down the line—if it is right and how to fix it,” Clute said. “They are a valuable part of the process.”
Turtle Mountain is also developing a full sensory training for employees, including cross-functional instruction on key quality attributes. “Our teams work very closely together,” Clute said. “We develop a lot of programs cross-functionally.”
But, at Turtle Mountain, quality is not a function of operations. Rather, he said, “the quality department is a completely separate department. I report to the senior vice president of marketing and technology.”
The separation creates a unique relationship, Clute said. “It improves our quality because it’s almost like having an outside organization right here in the plant.” The quality group can have more of an outsider’s objectivity while having an insider’s knowledge.
Innovation. The teamwork also provides a strong foundation for innovation, not only in quality and allergen control, but in all aspects of production. “We are innovators in quality, new product marketing, technology and equipment,” Clute said. “That all comes together to make us successful as a team.”
On my visit, the extent of the company’s advanced equipment and technological innovation was in evidence. Not only in the equipment built by or for Turtle Mountain for which the company representatives gave full explanation, but also in that which was so proprietary it was covered by dark plastic sheeting during the visit. Explaining both as key to Turtle Mountain quality and uniqueness, Clute said, “A lot of times you have need for equipment that doesn’t exist, so you have to make it yourself.”
As it moves into the future continuing to perfect its quality, innovate enhancements, and grow business, Turtle Mountain sees itself not as having reached its goals, but as continually striving for better and more.
As McElroy said, “Every time I think we’re done, I realize we’re just starting.”
The author is Managing Editor of QA magazine. She can be reached at llupo@giemedia.com.
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Fast Facts of Turtle Mountain Production
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