QA Has a New Role in Bioterrorism Act Compliance

More than half of all quality assurance (QA) managers in food manufacturing do not currently interface with their company’s Enterprise Resource Planning (ERP) system. The Bioterrorism Act, passed in 2002 to ensure the safety of the U.S. food supply from a terrorist attack, is quickly changing the role that food quality professionals play in the selection and utilization of ERP software.

ERP selection was often left to a small committee that included the CEO, CFO, operations and purchasing managers. ERP packages were designed to integrate all departments and functions across a company onto a single computer system that can serve all department needs. ERP software, at its best, combines the enterprise into a single, integrated solution that runs off a single database so various departments can easily share information and communicate. When running at an optimum, this integrated approach has a tremendous payback. Until regulations were mandated by the government, QA managers were rarely considered in the ERP selection process or even utilization of the integrated system.

Section 306 of the Bioterrorism Act mandates strict record-keeping requirements for manufacturing, processing, packing, transporting, distributing, receiving, holding or importing food to the United States. In December 2004, FDA published a final rule requiring food firms to establish and maintain records that would allow inspectors to conduct a trace investigation to protect the food and animal feed supply. FDA estimated that about 420,000 food facilities were required to register under the act, and increasingly QA managers are looking to technology resources (existing in-house or acquirable) that will assist in meeting this compliance requirement.

ERP vendors have responded to these regulatory requirements in a myriad of different ways. Some vendors have simply added a lot traceability feature and suggest that, “voila” they are now able to address the Bioterrorism Act. Other ERP vendors have been proactive since the passage of the law to develop tools to provide the reporting mechanisms required beyond simple lot traceability; while other vendors are simply adding a new tab to their Web sites called “food and beverage” in hopes that a generic ERP system will suffice.

Lot traceability: A good place to start

The Bioterrorism Act makes lot traceability documentation a requirement by law, not merely an option or desirable ERP feature.

According to Rebecca Gill, vice president of Enterprise 21, TGI Ltd., a software development house (Toledo, Ohio) compliance with the Bioterrorism Act means full tracking of raw material lots through manufacturing and of finished good lots through shipment to customer.

Gill says complete reporting on lot genealogy, showing all usage of lots from vendor to manufacturing to end user is also a must. The system should also provide the ability to query end-user sales orders and see all raw material and finished good lots used for specific shipment; evaluate lots from vendors or manufacturing to see all the end-users who received shipments; and track lot properties with allowable “criteria” for each lot.

There are other functionalities that support food manufacturing audits and quality assurance concerns without being a direct response to Bioterrorism Act compliance. Those functionalities include automatic quality assurance of incoming products; various product grades with or without usage/holds; tracking of original country for raw materials; and complete data warehouse for 24/7 ad hoc reporting.

Sage Software Inc.’s ERP contains food safety and nutritional labeling features, warning of the increasingly litigious and regulated environment. Rather than the Bioterrorism Act, Sage, a division of The Sage Group PLC (London), focuses on tools for high product quality standards include powerful computerized formulation laboratory, comparative physical properties analysis, comprehensive vendor quality analysis, multiple lot tracking methodologies, quarantine and expiration date control and complete QC data history maintenance. Obviously some of these features are useful for FDA Bioterrorism Act compliance.