Like many large food companies, Dean Foods Co. operates a dedicated, centralized analytical lab, which is housed in the Dean Foods Technical Center in Rockford, IL. The main charge for Lab Director and Chief Chemist Ray Marsili and his co-workers is supporting the company’s food technologists in their product development work, though the lab also performs considerable support work for corporate quality control.

“One major problem we face is establishing analytical priorities,” Marsili says. “We have more requests than ever but our staff hasn’t increased—and today’s poor economic environment prevents us from hiring additional staff and has shrunk our capital budget for new time-saving instruments.” The upshot of this divergence of more work and fewer resources is that “We can’t afford to work on analytical problems that are of low priority,” Marsili says. “We constantly have to ask ourselves the question, ‘Are we spending time on the problems that are going to have the biggest payoff for the company?’”

Dean Foods, a 75-year-old company that was acquired by Suiza Foods late last year, is not alone in contending with a difficult economic environment, one that has the food processing industry, a very high-volume, low-margin business in even the best of times, searching for ways to improve cost efficiencies. One focus of these efforts is a company’s analytical capabilities and facilities—significant budget items that prompt the sort of prioritization that lab directors such as Marsili face on a daily basis, and that shape the outsourcing strategies employed by large and small processors alike.

There is no question that operating a laboratory or outsourcing analyses are expensive propositions, but they are critically necessary to providing safe foods that consistently meet expectations and perform well in a fickle consumer marketplace. Savvy firms recognize that good quality assurance adds value and protects brands, but there are many roads to achieving this end—no one approach works across the board. One issue that remains constant, however, is that most companies don’t have a good understanding of what their analytical expenses are. The true “sharp edge of the knife,” says Alan Parker, Managing Partner and Vice President of Consulting Services with Strasburger & Siegel in Hanover, MD, is that companies “don’t accurately figure the cost of operating their labs. Typically, it is underestimated, because corporate or manufacturing absorbs much of the overhead. The true cost of running the lab often is hard to pinpoint.”

Two Types of People Make Efficiency
The two primary cost centers in any laboratory are the high capital investments required for instrumentation, and the ongoing resources needed to train and retain qualified personnel. Observers agree that “Despite all the automation and information technology we have today, it’s still very labor-intensive work,” says Russell Flowers, President and CEO of Silliker Laboratories Group in Homewood, IL. “A lab’s biggest asset and expense are its people.”

Flowers and others name two dynamics currently shaping the labor market: one, an acute need for support work that doesn’t require degreed analysts, such as sample preparation and administrative activities; and two, the increasing specialization of degreed, highly skilled scientists. Each of these present their own challenges. For the former group, training in and reinforcement of basic principles of laboratory quality assurance and operation must be well structured and carried out continuously. And, as turnover among these personnel is very high, Flowers says “it is imperative for labs to provide an environment in which individuals can grow their careers.”

Marsili adds, “We have very little employee turnover in our research chemistry lab because we avoid giving our chemists just one or two tasks to perform. We tend to do a lot of cross-training, which makes the chemists’ jobs more interesting, and we also encourage them to develop their own areas of expertise, such as protein or carbohydrate testing, or flavor/off-flavor analysis.”

Specialization can be a double-edged sword in that it can lend to a laboratory’s expertise and detract from staffing flexibility and the capacity to handle a broader range of analyses. “Bringing in qualified people is a difficult balancing act particularly in finding managers,” Parker adds. “The true microbiologist is being asked to take on a more managerial role, and many of them don’t have the training or interest in this. It’s tough to find a person with the right scientific and people skills.”

Parker notes that standard operating procedures (SOPs) and a solid quality assurance (QA) program make it easier to bring people with less sophisticated backgrounds up to speed. These fundamental elements also foster efficient laboratory operation. “When you’re increasing volumes, you’re creating turbulence,” he says, “and the more you can do to create an organizational setting to regulate growth and smooth the turbulence, the better you’ll be able to maintain a high level of service quality.”

Sourcing Out the Routine
Like many independent laboratories, Strasburger & Siegel is in an expansion mode and needs to quickly and significantly ramp up its work force. Analytical expertise in particular areas or in particularly difficult procedures has long been one reason food companies turn to outside laboratories. Covance, for example, is expanding its food and nutraceutical labs in Madison, WI. Expected to be complete in the fourth quarter of this year, the project will add 20% capacity to Covance’s North American food and nutraceutical operations. “Much of the expansion is in response to demand for nutritional equivalency testing of bioengineered food products,” says Randy Smith, Vice President of Analytical Services. “Companies want to ensure that their products meet or beat baseline nutrient levels.”

While the typical food company has staff to support its quality control (QC) functions and to perform basic constituent analyses, the necessary expertise often isn’t there for more complicated testing. New situations or issues that call for additional or specialized testing—as occurred most recently when genetically modified organisms made headlines— also will generate work for contract labs, which generally are better equipped to react to such circumstances. Smith and others, however, say that the paradigm is shifting to one in which routine and support testing constitute the bulk of the work being farmed out to independent laboratories.

“Food companies in general are looking at focusing resources on their core competencies and outsourcing the ancillary services,” Smith says. “We’re also seeing companies interested in total out- source strategies, where we adopt their procedures and methods and operate as their internal analytical team. People are looking at ways to best utilize all the resources available to them to obtain most value.”

Flowers says the complexion of Silliker’s clientele has changed from five years ago, when most customers were small- to mid-size processing companies that either did not maintain in-house laboratories or that had only small labs equipped to do cursory analytical work. “Now we have many more of the larger companies, most of which have fairly extensive labs of their own,” he says. “But they are focusing on their core businesses and making larger investments in product development. So a lot of the work that is not essential to the company’s mission is outsourced.” This primarily encompasses routine quality control testing where, because of heightened legal liabilities, “companies are looking for objective data and third-party verification.” Independent analysis lends additional credence to nutrition label claims, as well.

One ramification of this is that “When big companies outsource, we gain a sophisticated customer, with good control programs and a good understanding of the processes and the results,” Parker says. “There’s not a lot of hand holding in defining analytical needs. But the expectations are very high. More customers require that we participate in proficiency testing and they conduct pretty sophisticated audits. So the bar is much higher.”

Testing that Makes a Difference
An outsourcing strategy that allows a company to focus its analytical resources on work that more visibly affects the bottom line is one facet of more widespread interest in organizationally, and even physically, delineating the routine from the value-added. For Marsili’s corporate research lab, for example, “It’s imperative that we work on important issues that are proprietary in nature or too sophisticated to send to an outside testing lab.”

Another common scenario is that a corporate lab will conduct more extensive analyses, which could identify trends or suspect ingredients or suppliers, of samples found to be contaminated by in-plant or QC labs. At Dean Foods, for example, S-Elisa test kits from Neogen are used to check for allergens in finished product. “The QC labs at the plant have the qualitative test kits, while our research chemistry lab uses the more expensive quantitative test kits with the colorimetric reader to check samples that QC testing has shown to be contaminated.”

A chief example of value-added sew- ices provided by the Dean Foods lab is off-flavor/flavor analysis. On several occasions the staff has related serious product off-flavor or malodors to the product’s packaging material, typically from contamination by residual packaging solvents. Another packaging problem encountered is scalping of important flavor ingredients from the food or beverage product either into or through the packaging material.

“Normally we find packaging suppliers very cooperative when we can identify problems related to their packaging,” Marsili says. “They work quickly to correct the problem and are careful in the future to make sure packaging is properly manufactured and inks are properly cured when they know we have testing capabilities to monitor food packaging quality.”

Essentially, the ability to perform sophisticated testing using gas chromatography coupled with mass spectrometry (GC/MS) to screen for off-flavors “keeps our ingredient and packaging suppliers on their toes,” Marsili says. “I am convinced that this type of analytical capability has inspired our suppliers to supply us with high quality ingredients and packaging.”

Investing in Better Results
Reliable instrumentation that brings an industrial, assembly-line approach to sophisticated test methods is sought across virtually every analytical discipline, and significant advancements continue to be made toward that end. However, these technologies are not inexpensive and high sample volumes often must exist to justify their purchase. Steep price tags on both instruments and consumables is a concern in microbiology, where great strides in instrumentation have been made during the past decade. Further, the pervasive heightened focus on pathogen testing, which drives ongoing demand for faster turnarounds and the use of rapid methodologies, makes microbiological services a significantly greater expense than it was some years ago.

“Across the board we’re seeing more extensive use of rapid methods, and the cost of consumables for both PCR [polymerase chain reaction] tests and immunoassays are high compared to both classical microbiology and analytical chemistry,” Parker says. “Fifteen years ago about 6% of our overall costs were for microbiological consumables and that figure is now at about 25%.” There’s been an upward price adjustment in microbiological analyses during the past few years and, not surprisingly, “It’s hard for a lab to be profitable if you’re just doing microbiology,” Parker says.

Still, instrumental approaches, particularly those incorporating genetic-based testing, are critical as the food industry moves forward. “As much as possible you want an analytical or instrumental read as opposed to a subjective read. Enzyme immunoassays (EIA) and genetic-based tests for microbial pathogens provide an analytical result result rather than an individual looking at a petri dish and making a subjective reading,” Flowers says. From a slow initial uptake since their introduction in the mid 1980s, EIA- and DNA-based tests now account for as much as 80% to 90% of pathogen testing at Silliker Laboratories. Quantitative microbiological testing, however, has lagged in terms of the development of instrumental methods, with most of the tests in use essentially unchanged from 30 or 40 years ago.

In both microbiological and chemical analysis, despite instrumental advancements, a key time issue is sample preparation prior to chromatographic analysis. Technologies such as gas chromatographs, liquid chromatographs and autosamplers are reliable time savers, but the sample preparation steps necessary to concentrate and isolate analytes from the sample matrix and interferences prior to injection continue to be the rate determining steps in a chemical analysis. “Accurate, fast, efficient methods for sample preparation are needed. This is the only way we will be able to keep up with our increasing work demand,” Marsili says.

Data Handling and Access
Along with training and instrumentation, another major area of investment for many labs, one that hugely impacts efficiency, service and data quality, is information technology (IT). Flowers is a big proponent of IT systems because of the benefits they bring both internally and to relations with clients. “Within the lab, the bulk of errors occur in data handling, transcription and communication,” he says. “Our LIMS [laboratory information management system] not only automates data management and reduces this workload, it reduces the number of times people handle data. This is very important. With all of our North American labs on the same LIMS, we’ve seen a big improvement in data accuracy.” He adds, “You get more value from automation when instruments are linked together as part of a larger system. You don’t gain a lot of value in automating single steps.”

Extensive computerization, particularly for sample tracking, is an important part of the industrial psychology that many organizations apply to the physical layout and regulation of work flow in their laboratories. Covance’s facility, for example, will be purpose-built to match the process flow of a sample from accession to final reporting, leading to faster turnaround times and improved customer service, Smith says.

Silliker also has a system that enables communication with customers over the Internet, a functionality that few labs have in place but is a trend for the future in laboratory data communication and management. This facilitates a relationship that goes beyond a “one-time information transfer,” Flowers says. “They can collect and store their own data and conduct their own trend analyses right on the web interface. It’s a convenience for them and a means to manage their data instead of just sending it back and forth.”

Managing analytical data, and the means by which it is gathered, are key factors in the success of food products in the market. If safety and quality testing programs are not run efficiently, without due consideration given to operating expenses and the value they instill products and services, they are likely to be viewed as cost centers providing little tangible benefit to a company’s profitability.

Lab managers throughout the industry are careful to ensure that key analytical resources are not bogged down in routine QC, work that can be performed at in-plant labs and, if necessary, outsourced easily. Beyond the need for testing more samples, another challenge is testing for more and different kinds of analytes in an efficient, accurate manner. And, of course, there is the time factor:
almost without exception, people want results, from either an internal lab or contract partner, as soon as possible.

“Doing quality work is the base-line, and from there, you must be efficient and good at what you do,” Smith says. “For any lab, you’re only as good as your last data point. This is how you will be judged.”

Bruce Flickinger is a freelance writer specializing in the food and pharmaceutical industries.