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by Mark A. DeSorbo
Under-the-hood technologies like electronic record-keeping software will not only boost HACCP's horsepower, the platforms will also provide food companies better handling when it comes to easily identifying recurring trends and taking corrective actions. That means greater visibility to upper management, a transparency throughout the company and, ultimately, compliance with forthcoming federal regulations.
The tired old Cadillac Fleetwood couldn't get out of its own 4,000-pound way, but once in the hands of Jesse James and the boys of the Discovery Channel's Monster Garage, it was transformed into a muscular dragster that burns up the tarmac. Pick any one of those reality make-over shows and you're bound to see how the same kind of formula could transform a dilapidated, ineffective HACCP program or fumbling food plant into a finely tuned machine that swiftly negotiates the winding corners of compliance. Compliance has indeed forced the pharmaceutical industry to conform. That regulatory influence has caught the eyes and ears of the food industry, which is under increasing pressure to beef up its performance capabilities and provide accountability, traceability and security at every step of the supply chain, especially at a time when the food supply is a potential terrorist target. These prominent issues are addressed in Title 21 CFR Part 11, a federal regulation allowing companies to use electronic records and signatures. The regulation is perhaps the kind of under-the-hood platform to boost HACCP horsepower, thus turbo charging an operation's ability to quickly identify recurring trends, take corrective actions and, ultimately, improve overall efficiency. "Not only will it boost their horsepower, but it will give them control, too," says KR Karu, director of sales for Sparta Systems Inc., a Holmdel, N.J.-based developer of regulatory-compliant database software. Sparta Systems has enjoyed success in the pharmaceutical and biotech industries with its software platforms, namely TrackWise; a quality management system that Karu claims is used by 110 life science companies and "19 of the top 20 pharmaceutical companies." "It has not only made them compliant with federal regulations, but it has also made their plants more efficient," Karu says. "We are looking to duplicate that in the food industry because there are a lot of similarities." Several food industry experts agree, saying that while very few manufacturers and retailers have jumped on the bandwagon, many are aware of the high-octane impact that regulatory compliance has had on the pharmaceutical industry, and it is only a matter of time before the food industry will have to cross the 21 CFR Part 11 bridge. "There is no question that this is coming," says Rob Wiersma, industry director of consumer packaged goods for SSA Global, a Chicago, Ill.-based developer of enterprise resource planning (ERP) software. "It's just a matter of how fast will it get here. Once the FDA is finished helping the pharma people with complying with Part 11, they will then turn to food companies that are importing food into the U.S." John Blanchard, director of research for the food and beverage industries for consulting firm ARC Advisory Group LLC (Dedham, Mass.), agrees, and says the industry is beginning to realize that HACCP is just one small part of a food safety program and that food safety has become paramount not only in the minds of regulators, but in the minds of consumers as well. Although Blanchard isn't sure the industry has completely made the connection between good business practices, Part 11 and the Bioterrorism Act, food companies are doing more to bolster accountability in the supply chain. "There are already pilot programs that Starbucks is using to track and trace coffee beans from Central America all the way to Seattle. They know where it is all the time," he says. "Meatco is taking meat out of central Africa and bringing it to the U.K. The technology exists to track the product from the ground, or the farm, to the fork."
Bolting on Part 11
These "pilot plans" used by the retail coffee chain and the Namibia meat company as Blanchard described essentially apply many aspects of what 21 CFR Part 11 is all about. The regulation, unveiled by the FDA in 1997, was part of an agency-wide effort to decrease the amount of paper generated by such record-keeping activities. It allows companies to keep electronic records and use electronic signatures through the use of Web- or local area network-geared database software. While Part 11 is the proverbial catalytic converter for such life science industries as pharmaceutical and biotech companies, it remains merely an option for the straight-pipe running food industry, says Sebastian Cianci, an FDA policy analyst and spokesman. "We don't have a preference one way or the other," he says. "It's up to the company. We do, however, want the records to be true and accurate and be presented to us when requested. Now just because we don't express a preference, it doesn't mean [a company] won't find benefits in one [method] or the other." When presented with the belief that Part 11 would become a food industry regulation once the FDA finished helping life science industries comply, Cianci replied, "That may be the feeling, but I couldn't speculate one way or the other." However, if a food company or food service operation does decide to keep electronic records, there are guidelines on how to do so, he adds. The guidelines provide specifics on definitions for electronic records and signatures; appropriate controls for closed and open systems; signature manifestation and record linking and controls for signatures, identification and passwords. (Part 11 guidelines can be found at www.access.gpo.gov/nara/cfr/waisidx_04/21cfr11_04.html.) An electronic record, for example, is defined by the agency as "any combination of text, graphics, data, audio, pictorial or other information represented in a digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system." Electronic signatures are just that; the legally binding equivalent of an individual's handwritten signature. The agency deems open systems as environments in which system access is not controlled by workers responsible for the content of the electrical records on that system. Access to a closed system, on the other hand, is controlled by persons responsible for electronic record content. The remainder of the guidelines deals strictly with maintaining the authenticity and integrity of those records by way of who has access to records and how they are maintained for audit trail purposes. "Part 11 deals with automated processes and how you go about validating that everything works," says Bill Freitag, president Agile Technologies LLC, a Bridgewater, N.J-based consulting firm that assists life science companies in developing IT platforms. "The FDA is most interested in retention and how easy it is to access information, and how to make it easier to collect information so that it's more accurate." The agency, he explains, is equally concerned with maintaining the audit trial. "Say you don't have a back-up strategy and your network crashes. Companies should not be losing data. [The FDA] wants to see ways of backing up and restoring that information." Federal regulators also want validation when it comes to authenticating signatures, or how is it determined that people using the record-keeping system are who they say they are. "You have to make sure that only the people who need to have access have access," Freitag says. "Some people should only be able to read the information, and some people should be able to edit or update it. You need to define who those people are and what they need access to. If everyone has access to the same information, there's no audit trail."
Gear It Up
Knowing the ins and outs of Part 11 is probably the first step to boosting the performance of a flaccid HACCP program or quality management system, Freitag says. "You need to identify what's important to your operation and you have to look at the cost of maintaining [this]because it can be pretty rigorous," he adds. "One also has to believe that automation controls your environment and creates transparency." Freitag's firm has mainly dealt with pharmaceutical companies, but it has begun working with Thinkage LLC, a Bridgewater, N.J.-based food industry consulting firm, in developing and tailoring Part 11-based record keeping platforms for the food industry.
"Information is now part of the product and that electronic information can be bundled with a food product so that your end users, the restaurateurs and retailers, have the confidence in the product," says Mark Grace, president of Thinkage. But what to do with the data is perhaps the biggest issue, and Grace suggests that food companies know the basics of what they want to track. "You are going to have to know basic questions: Why you are measuring something? If you are doing HACCP, you have to set up the 'why'? But that's not all. You're going to also have to establish corrective actions," he says. Thinkage helps its clientele through this by constructing "decision models" that takes data through appropriate actions steps. Take for example, temperature monitoring in a HACCP program. "If there's an issue with temperature, say at meat a processing company, and the cooking temperature is too low, an alarm goes off," Grace explains. "Then, an alarm goes off that says that throughput is higher than normal. The decision is to slow the line down and let the heating device catch up. You will also need a system that ensures that personnel are carrying out those decisions." Karu from Sparta Systems echoes this same sentiment, saying a food company must find the root causes of problems and try to prevent such events from happening again. "When a company has a problem, they log it into the system. This way, they have a consistent way of evaluating an issue, which, later on, allows them to do trending and analysis over various sites to identify reoccurring [problems]," he says. "If somebody found that problem and recorded it, it's not going to go away. It's all about the quality of the product and safety." Also, a quality management system, Karu says, gives upper management greater visibility of what's going on throughout company departments. "It creates a transparency throughout the company, meaning you can't hide," he says. "There is no place to hide and that sometimes frightens people because everyone answers to somebody. So in the end, it actually creates a much better environment because people know these regulations need to be followed., and it creates a better, safer product going to market."
Modifying the Machine
With Part 11 bolted on and an evaluation of what kinds of performance upgrades are desired, the machine, the HACCP program or quality management system, can be hopped up with horsepower. While Sparta Systems' clientele is predominantly life sciences companies, like drug makers, it is looking to diversify into the food industry. "We are talking to a number of them," Karu says of food companies Sparta has targeted. Many, he says, could easily install Sparta's Part 11-compliant TrackWise, a quality management software platform that monitors a host of functions, including audits, corrective and preventive actions (CAPA), validation, complaints, training, safety incidents as well as events and supplier management. "A quality management system will not allow any balls to be dropped," he adds. And accountability is what it boils down to, says Terri Bringgold, marketing communications manager for Ecolab's Food and Beverage Division (St. Paul, Minn). Ecolab's Quadexx is an allocation and formulation system for sanitation chemicals, and she says the onus ultimately falls upon personnel. The system is leased to meat and poultry processors as well as breweries, Bringgold says. Sanitation managers log onto myecolab.com and gain access to a Web site constructed specifically for that company. That site documents every transaction. For example, when a worker pulls a product to clean a particular area, they have to put in a password or use a swipe card to gain access to the Quadexx system. The system will then record the transaction so that plant management can track what's going on," Bringgold says. "It cuts down on waste and improves efficiency. And if there is a problem, as in someone didn't clean a particular piece of equipment, the sanitation manager can look and see what the problem. It takes the guess work out." Like Sparta Systems' TrackWise, SSA's ERP LX and LN software allows companies to manage manufacturer-to-customer demands; high volume order and fulfillment; product development and documentation control; supply chains; and overall performance. SSA claims to serve 11 of the top 15 consumer packaged goods/food and beverage companies with its SSA ERP LX and LN software platforms. Along with RFID and Web-based tools, emerging DNA-based technologies also take the guess work out, says SSA Global's Wiersma, adding that managing the supply chain is a key factor. "If you think about how to trace from farm to fork, one of the best ways to do that is DNA, especially for a cow or pig that is pulled apart into many pieces and shipped in many different directions," he says. DNA samples of an animal are taken before it is slaughtered so that it can be traced all the way through the supply chain. "That's the route that I'm following. As a manufacturer, we could be a couple of steps away from where the product is coming from, and I have to rely on everyones record keeping. That is a key component of this. You are one supply chain of many supply chains," he adds. "I could be testing meat as it comes into the door or as it goes through processing, [but] the DNA stays the same. If you can't localize the problem, production is hindered." In the bigger picture, however, Grace of Thinkage believes that using technology to power up HACCP programs and quality management systems surpasses the benefits of conventional, if not archaic paper-based methods. "It's still an economic way to collect data, but there are a number of errors associated with that method," he says. "It is also very difficult to calibrate a pencil." One thing is for sure, the apparent contest between electronic- and paper-based could turn out like the tale of the tortoise and the hare. Food companies will ultimately decide whether to stay on the slow and steady or power up and put the proverbial pedal to the metal. -FQ