Nutritional supplements occupy a murky middle-ground between food and pharmaceutical production, and the heightened scrutiny they are under should serve as a warning to mainstream food and beverage processors.
A coalition of three states’ attorneys general and their Puerto Rican counterparts has served notice that lax quality control in supplement production no longer will be tolerated. Spearheading the effort is Eric Schneiderman, New York’s attorney general, who recently announced that barely one in five herbal supplements tested contained DNA from the plants listed on the product labels.
The announcement triggered a recall of specific products from several retail chains, including GNC, which denied the allegation but announced it would expand testing “deeper into its supply chain” and begin screening products for the presence of eight common allergens.
Herbal supplements may be the Wild West of human consumables, but ingredient testing and supply-chain monitoring are emerging priorities in mainstream food and beverage production, as well. That is giving rise to a new breed of software designed specifically to manage the thousands of audit certifications, certificates of analysis (CoA) and other documents associated suppliers and their shipments.
Quality assurance includes food-safety activities, of course, but it is much broader, and documenting compliance can easily outstrip the capabilities of Xcel spreadsheets and paper logs. Manufacturers are under increasing pressure to verify both in-plant procedures and the purity of raw materials, ingredients and primary packaging materials, exponentially expanding the document-management task.
For example, Costco Wholesale Corp., which takes the position that food safety is a component of quality assurance, requires suppliers to document hourly checks of metal detectors and X-ray machines to verify that they are operating correctly. The firm also requires suppliers to have an approved vendor program that includes HACCP certification.
ERP systems often are promoted as one-stop solutions to the challenge, but unless a specialized module is integrated with the business system, they cannot satisfy today’s QA documentation needs, maintains Gary Nowacki, formerly of the now-defunct ERP vendor CDC Software, which included the Ross ERP system.
“In the ERP world, we worked really hard and still had dissatisfied customers” when it came to QA, says Nowacki, now CEO of TraceGains Inc., Westminster, Colo. “An ERP system doesn’t know the difference between a kosher certification and a CoA,” but independent auditors and manufacturers’ customers do. A traceability exercise might involve either variable. Customers like Costco expect manufacturers to account for all product involving either quality dimension within two hours.
Software for track and trace is useful for managing a recall, but those systems are largely reactive and difficult to cost justify unless there is a recall event, suggests Barbara Levin, vice president and cofounder of San Francisco-based SafetyChain Software. Most home security systems are purchased after a break-in, and track-and-trace software is similarly reactive, Levin says. Heading off noncompliance issues before they trigger a recall underpinned the creation of her solution in 2011, the year preventive controls became the law of the land under the Food Safety Modernization Act.
While FDA’s nonprescriptive approach to how food companies meet regulatory requirements precludes requiring electronic records, the case for moving away from manual and spreadsheet solutions has been building since passage of the Bioterrorism Act of 2002.
FSMA and independent audit standards under the Global Food Safety Initiative make the value of electronic records more compelling, although the cost of automation solutions remains a barrier to implementation. So-called cloud-based, software-as-a-service solutions like SafetyChain and TraceGains short-circuit the system integration and licensing costs to make software a realistic option for small and mid-sized food companies.
Optical character recognition (OCR) is used in both firms’ solutions, augmented by additional methods to pull data from paper CoAs and other documents into the program. OCR has come a long way, allows Levin, yet as anyone who has deposited checks in an ATM can attest, exceptions still are common.
Asking suppliers to download data in xML files is a better approach; even better is data entry in a web portal. Both Levin's and Nowacki’s systems accept portal transmission at no cost, a shift from prevailing practices. Suppliers “love the opportunity to go into a portal and enter the information,” says Levin, although “all that manual entry on their end is a lot of work, too.”
Mobile apps are another emerging simplification tool for data capture and transmission. Dole Food QA personnel have replaced clipboards with tablets for preharvest inspections, she reports. “Before and after photos can be part of the record,” she adds, providing a visual record that is just as applicable for in-plant inspections to verify that prerequisite requirements for sanitation, pest control and other programs are being met.
In the case of medical devices, it is not enough that suppliers verify their HACCP and other safety processes; they must be able to document compliance by their suppliers and their suppliers’ suppliers. The food industry is in the early stages of a similar journey.
Based on system-integration work at 300 customer sites, “most food companies had some processes in place for their internal documents, and they thought that was sufficient,” notes Nowacki. “But suppliers were a black box.”
Verification requires records, whether manual or electronic. As documentation requirements move upstream and downstream in the supply chain, food manufacturers are experiencing exponential growth in the volume they must manage. Regulators won’t dictate how they manage them, but a shift to electronic records is a question not of whether but when.