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.
Explore this issueFebruary/March 2005
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.”