Trust

Maintaining consumer trust through the quality and safety of Abbott’s nutritional products are (from left) Susanne Roslon, divisional vice president, supply chain manufacturing; Bradd Eldridge, director, supply chain quality assurance; Sharon Bottock, Casa Grande plant quality assurance manager; Enrique Porras, Casa Grande plant manager; Diane Beno, divisional vice president, supply chain quality assurance.

Abbott manufactures Similac infant formula, as well as PediaSure, Ensure, and other pediatric and adult nutrition products, all of which can be a significant, if not the only, source of nutrition for their users.

Trust is particularly critical in the case of infant formulas, on which babies often subsist for their first six months of life. “The infant is at a very critical time of growth and development, and this is often its only source of nutrition,” said Divisional Vice President of Quality Assurance Diane Beno. It is for this reason that, she said, “Infant formula is probably the most tightly regulated food.” And it is for this reason that Abbott goes beyond the tight regulations to ensure every product is backed by science-based nutrition that consumers can trust.
 

Regulatory Requirements. Classified as a high-risk food product, there is an entire section of the Federal Food, Drug, and Cosmetic Act devoted to Requirements for Infant Formula (Section 412), to which manufacturers must comply. In addition to following all other applicable regulations, such as Thermal Processing of Low Acid Canned Foods, standard GMPs, and traditional quality and safety practices and testing, infant formula manufacturers must adhere to regulations such as:

• Registration as an infant formula manufacturer prior to introducing the formula into interstate commerce, as well as food facility registration.
• Notification to FDA at least 90 days prior to marketing a new infant formula detailing facility, product, package, and process information. The registration does not imply FDA approval of the product, Beno said, rather it provides assurance that the product meets the required quality and nutrition standards.
• Prior notification to FDA of process, formulation, or packaging changes once the product is commercialized. Continued monitoring and verification of microbial controls, labeling claims, specification tolerance data, and shelf-life testing and documentation—each of which has tighter specifications than most foods.
• Written documentation and retention of records demonstrating compliance with all GMPs and prescribed quality control procedures throughout the supply chain.
• Routine inspection and testing of finished product.
• Unannounced FDA inspections occurring at least once a year and routine sample pulls at anytime.
• Ingredient and nutrient content, quantity, and quality controls.
• Notification of out-of-specification results for commercial products that have left the manufacturer’s control.
   

Working at the tray forming line in the metal can line packaging area of Abbott’s nutrition manufactuing plant in Case Grande, Ariz., are (above) Crew Leader David Hale and (below, from left) Manufacturing Associate Sally Heet; Divisional Vice President, Supply Chain Manufacturing Susanne Roslon; Hale; and Manufacturing Associate Sheena Valdez.

In addition to these stringent regulations, infant formula is subject to the new standards of the Food Safety Modernization Act (FSMA), as are all food processors. While the Act has given FDA more authority and more access to documentation, said Director, Quality Assurance Bradd Eldridge, “It didn’t shatter our world because of what we already had established.” The greatest impact, he said, was the requirement for food safety prevention plans. “We had all the elements, but now we want to have a food safety book compiling it all into one.”

Abbott was also ahead of the curve because it had developed a Food Safety Program Team prior to passage of the Act. In the first quarter of 2011, the company created a global initiative to ensure its food safety programs were consistently applied around the world, share best practices among its facilities, and benchmark off each other, Eldridge said. The teams included cross-functional representation and focused on all aspects of the plant. “Food safety is everyone’s responsibility, and we stress that.”

Our visit was to the manufacturing plant in Casa Grande, Ariz., but this sharing of practices ensures that all Abbott facilities maintain the same high standards, with variation allowances for global operations which must meet the standards of their host countries. In addition to sharing between facilities, Eldridge said, “We are not keeping it within the walls of Abbott.” Rather the company is working with third-party manufacturers, suppliers, and distributors to share best practices and ensure FSMA compliance. “We don’t treat food safety as competitive,” he said.
 

Quality Through the System. Thus, to ensure all the standards are met and its products provide the quality and nutrition that mothers can trust, Abbott products and processes are developed through, and backed by, “science-based nutrition,” Beno said. “We have very robust validation requirements to ensure we can reproducibly produce the intended results.” This validation and reproducibility of results was in evidence throughout the process at the Casa Grande plant , which employs about 500 people and operates 24 hours a day, seven days a week, with three shifts.

One of the first things you notice in walking through the plant are the variously colored lines, boxes, and shapes on floors and pegboards. The basic tenet of the 5S system—A place for everything and everything in its place —is a key process control at all Abbott facilities.

Quality Control Associate Michael DeVere tests grain in the quality control lab (at right), while (below) Mario Muraira monitors the processing system in the processing control room.

A second striking factor are the number of process control rooms guiding the process of the products. With the raw ingredients flowing through a controlled system right up to packaging, hands-on governance is maintained primarily through the central control rooms where trained operators monitor everything from flow through filling and retort, and even the slightest deviation from critical parameters sets off an alarm.

In the retort control room, for example, operators monitor all load parameters and can manually override the system to make corrections if needed. If anything is out of specification, a critical alarm will sound, and it is the operator’s role to assess the situation, decide if it is an isolated condition or if there is a product impact, determine if a system correction needs to be made, then make the necessary fix.

The processes monitored in the control rooms go through extensive validation to ensure they are always working properly, said Plant Quality Assurance Manager Sharon Bottock. Abbott maintains an in-house team of qualified engineers and maintenance and calibration technicians, who test, validate, calibrate, and maintain all equipment.
 

On the Floor. Such controls are in evidence from the time an ingredient arrives at the dock. For example, vitamins are weighed to exact specifications with the data entered into the system. But only ingredients that have an approved status will be allowed to move further. If QA has put any item on hold for any reason—even just seconds ago—the item will not be able to be used anywhere in the process and the process stopped. This same system enables detailed traceback, should that ever be needed.

Other practices the company implements to ensure its high standards in quality and safety are:

• All conveyors are closed or capped through the point at which the cans or bottles are completely sealed and capped. In addition, video cameras projected to big-screen TVs are used on the plant floor to monitor overhead conveyors.
• Although the finished product may be a powder or a liquid, everything, Beno said, starts as a liquid. The powdered formulas are derived as the liquid falls through a seven-story dryer system, which evaporate the liquid into an aerosol mist, converting it into the exact powder formulation by the time it reaches the tanks at the bottom. The powdered liquid is stored in a series of hoppers with the top four stories of the tower completely enclosed. “Think of the science that goes into that—so that the formulation starts as a liquid at the top and results in the correct formulated powder at the bottom,” Beno said.
• In powder, the headspace of the containers is injected with nitrogen in order to limit oxygen which can degrade nutrients.
• The caps of the recloseable bottles are heated prior to being placed on bottles to form a tight seal. Proactive trend analysis is conducted on an ongoing basis to indicate if caps are getting loose before any actually are. At the same time, the torque tests ensure that caps aren’t too tight, Bottock said, “so consumers don’t have trouble getting the cap off, but it’s not too loose, so it doesn’t leak.”
• Once filled, each bottle is rinsed so there is no product on the outside when it goes through retort. In addition, a process CCP is the heated, sterilizing retort of every product. This is critical for liquid products.
• At any point in the process, if a bottle or can touches the floor or is found off the line, it is never put back on the line. Rather it is to be given to a supervisor or taken to the lab to be discarded.
• In a single year, the plant will conduct environmental tests on 26,000 sites, from equipment to floors to restrooms. “If we can prevent bacteria on the floor of areas outside production, we can keep it from coming into the processing area,” said Divisional Vice President of Manufacturing Susanne Roslon, adding, “It’s all about prevention.”
• Abbott controls access in the plant, particularly in sensitive areas, through individual badge-specific entry. The system prevents the entry of unauthorized personnel, provides a record of who accessed a particular area at what time, and enables instant activation or deactivation of any badge’s access.
• One particularly high-risk, limited entry area is the enclosed powdered Similac filling room. In addition to having a different entry classification, the gowning procedure includes full coverage—from coveralls to face mask, and additional sanitation and sterilization requirements, such as shoe spray, alcohol hand wipes, and gloves.

Classified as a high-risk food product, there is an entire section  of the FD&C Act devoted to requirements for infant formula (top). Reclosable plastic bottles are fed into the sterilizer (bottom).

• The plant has three separate labs: microbiology, incoming, and analytical. Full gowning is required in the microbiology lab to ensure that contamination is not introduced into the testing. One section of the analytical lab, where nutrients are tested, has yellow lighting to reduce degradation to light-sensitive vitamins.
• To assess and correct issues, the plant uses teamwork and fishbone cause-and-effect diagrams, explained Project Coordinator Scott McKinney. In the example provided, it had been found that upstream bottle priming was one of the top causes of downtime. Following the fishbone process, it was determined that the type of wear strip being used was being damaged by the silicone spray, which was causing premature wear. Once the cause was found, a change was made—and the situation and solution communicated across the Abbott system. “We don’t just trouble shoot, we bring everyone together to review the situation and determine the real cause,” McKinney said.
• Abbott also uses corrective and preventive action (CAPA) proactively to chart and track trending. By doing so, potential issues can be addressed before they become problems. If an event does occur, the practice is initiated to determine the root cause and demonstrate proven action to ensure it doesn’t reoccur.
• Labeling is a key area of control for Abbott. All labels are kept in locked, wheeled cages, accessible only by authorized personnel, and brought to each line in the locked cage. Checks are conducted throughout the process to ensure correct labels are being used, and when a run is completed, a line clearance is conducted, with workers and supervisors walking the lines backward and forward to ensure no product remains on, under, or around any line. If a bottle or can is found, note is made of the location and assessment conducted to determine how or why. “It is a very important area for us,” Bottock said.
• In addition to being a high-risk product, infant formula has one of the highest risks of theft and diversion. To discourage this, an identification code is embossed on the bottom of each can of Similac. “You can’t easily cross that out,” Roslon explained.
• Although the Arizona plants ships out almost 200 trucks of product each week, before any finished product is released, it is placed in hold until release approval is granted by quality assurance.

Empowerment. Despite all the standards and controls required of and implemented at Abbott plants, the company recently shifted its plant procedures from a management-led plan to a self-directed, team-lead plan. With this change, employees are not only authorized to take ownership of the line and the quality of the product, it is an expectation that they will. “Line operators are very in-tune and empowered to shut down if there is a quality problem,” Bottock said. “We like to run our numbers, but quality is more important.”

Although the transition also includes training and education, there is the realization—and allowance for the fact—that mistakes may be made. However, results of the transition are showing many more positives than negatives, such as the perfect line led by Supervisor Andy Cortez and Crew Leader David Hale, who achieved a full year with perfect documentation, no destructs, no isolations, and no reworks.

“Quality systems are important,” Eldridge said. “But the people are what make it happen.”

Global Business Shawn Stiltz-Leeson performs torque tests in the reclosable plastic-bottle filler room. Complexity. Stringent U.S. regulations create a complexity for the manufacture of infant formula that is little found for other products, but what makes this—and the manufacture of nutritional products—even more complex is the range of global standards governing the products. Using Ensure as an example, Divisional Vice President of Quality Assurance Diane Beno said that although the U.S. considers the product to be a food, in Europe, it is classified and regulated as a medical product, and in Japan, it must be registered as a drug and can only be purchased by prescription. Over the last five years, Abbott has had international growth, Beno said. Much of this has been in countries such as China, India, and Vietnam, whose middle-class rise has increased the overall nutritional consciousness of their populations. Currently, Abbott’s nutrition supply chain organization has more than 5,000 workers in 14 plants which produce more than 4,000 SKUs. As in the U.S., many governments have country-specific regulations for infant formulas and nutritional products that go beyond that of other food products. Thus, Abbott’s growth has also given rise to a complexity that is even more involved than that of other international food companies. Abbott has nutrition manufacturing plants in seven countries, and markets products in more than 110 countries, which means it has a vast array of product-specific regulations which it must know, understand, follow, and stay updated on. It means that these products generally cannot be produced exactly the same in any two countries. And it means that the ingredients in a container of Similac purchased in England may not be exactly the same as that purchased in the U.S. or Japan. The variations in product focus primarily on government-mandated nutrient requirements for infant formulas. Each provides essential nutrients; the difference is the required adherence to the levels of vitamins and minerals defined as essential by the country in which the product is manufactured and sold.   Collaboration. The world is changing, and it is critical that companies have strong global connections, said Divisional Vice President of Manufacturing Susanne Roslon. In addition, it is important for companies to recognize that the U.S. is not the leader, or the best, in all things. As such, a company can derive significant benefit by working with global connections; conducting business in a collaborative manner; and being willing to learn from, work with, or follow the lead of whomever may be leading any specific area. There is no one country that holds the highest standards across all areas, Roslon said. Europe and the U.S. are fairly comparable; Japan leads in certain areas; and even China, specifically because of the food safety challenges it has faced, has escalated expectations in recent years. Thus, while a manufacturer needs to uphold its quality and safety standards no matter where it operates, it is also important to integrate the needs of emerging markets and cultures with this and be flexible in the means while focusing on the results. “Standardization may be a benefit in many areas, but not all,” Roslon said. Further complicating the global complexity are economic considerations, such as capacity, capability, and geographic constraints. Supply is driven by consumer preferences and government regulation, but not every line or plant can make every product, she said, so some product is necessarily imported into certain countries. However, some countries will not accept product that is made in certain countries, so Abbott needs to be aware of these and ensure it does not breach such regulatory or cultural restrictions. “We have to always be vigilant,” Roslon said.

The author is Editor of QA magazine. She can be reached at llupo@gie.net