ChallengesSimilarly, Green Bay Cheese Co. faced significant challenges due to government regulations and customer-compliance issues. Green Bay Cheese needed an enterprise resource planning (ERP) software package that could:
HR Nicholson faced other specific quality challenges from strong continued growth and, as a Platinum U.S. food service supplier, the company must access the kind of tracking and reporting required to meet government’s stringent requirements.
Food manufacturers and the bioterrorism act
Green Bay Cheese and HR Nicholson were required to meet the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These regulations enforce requirements regarding the establishment and maintenance of records by persons (excluding farms, restaurants and a few others) who manufacture, process, pack, transport, distribute, receive, hold or import food. The records facilitate the identification of immediate previous sources and immediate subsequent recipients of food, including its packaging, to address credible threats of serious adverse health consequences or death to humans or animals. This regulation implements the recordkeeping authority in the bioterrorism act. According to the Bioterrorism Act, failure to establish and maintain the required records or failure to make them available to the Food and Drug Administration, is forbidden and can trigger serious consequences. All food manufacturers must be compliant by the end of 2006.
Because lot-traceability documentation for food manufacturers is required by law, inventory control may be the most important function to consider. An integrated system is critical to justify the cost of the food ERP acquisition and achieve a rapid return on investment. With an ERP implementation, Green Bay Cheese Co. and HR Nicholson are better equipped to serve their customers.
FDA 21 CFR Part 11 drives lean choices
Created by the FDA in 1997, 21 CFR Part 11 requires FDA-regulated companies to adhere to a specific set of requirements for computerized systems, electronic records and electronic signatures. The scope of the regulation includes requirements for storing, transmitting and verifying electronic signatures. The regulation also dictates what conditions are needed to maintain data integrity of electronic information stored and modified in business management software packages or computer systems.
Compliance is required for any company involved in the development, manufacturing and distribution of products governed by FDA regulations. Examples include life-sciences products such as drugs, diagnostics and medical devices, chemical manufacturers, or food and beverage manufacturers. It’s also required of all companies operating under good manufacturing practice (GMP), good laboratory practice (GLP), or good clinical practice (GCP) guidelines.
Rebecca Gill, vice president of Toledo-based TGI, noted that companies must meet the following criteria to comply with the FDA 21 CFR Part 11 requirements:
The FDA specifically states that the “agency expects the magnitude of these benefits should significantly outweigh the costs of making these systems.” In other words, the cost of purchasing an FDA-compliant system is easily obtained in the system’s return on investment (ROI). The benefits of adhering to 21 CFR part 11 regulations include:
Lean technology solutions
Shaffer noted, “We first selected Technology Group International’s (TGI) Enterprise 21 because it takes the lean concept beyond manufacturing and extends it throughout the entire organization. A competitive edge is obtained by including the factory floor in the lean model, not by focusing solely on the plant floor for the continuous improvement efforts.”
Some of the key lean functionalities achieved included:
Enterprise 21 also delivers:
HR Nicholson has achieved lean efficiency with co-packaging partners—the purchasing and distribution transaction is seamless and invisible to their customers. Regional managers now have real-time access to viewing data, product availability and production capacity. Similarly, the lot-tracking feature available in their technology is central to HR Nicholson’s role as a United States Department of Agriculture audit partner. This lean technology has made Shaffer confident as the company will soon have more than seven distribution centers and has grown domestically and internationally.
Gill said, “Green Bay Cheese was able to address their requirements by electronically storing womb-to-tomb lot tracking of cheese so that a given lot of cheese can be traced to all customers who received material produced from that particular lot; interactively calculating online customer pricing based upon cheese market price and customer pricing factors; and automatically generating customer-specific labels, which included not only customer logos and barcodes, but also the retail customer’s price to the consumer."
Lean technology is required in the food sector
From HACCP to the Bioterrorism ACT to FDA 21 CFR Part 11 Compliance, to mention just a few regulatory compliance requirements, the rigors imposed to manufacturers and distributors of food products make lean technology solutions rather axiomatic and deeply valuable to continued operations, as well as the fundamental lean principle of continued process improvement.
Thomas R. Cutler is the president & CEO of Fort Lauderdale, Florida-based, TR Cutler Inc., (www.trcutlerinc.com). Cutler is the founder of the Manufacturing Media Consortium including more than 4,000 journalists, editors, and economists writing about trends in manufacturing, industry, material handling, and process improvement. Cutler is a member of the Society of Professional Journalists, Online News Association, American Society of Business Publication Editors, and the Committee of Concerned Journalists. He writes more than 500 feature articles annually regarding the manufacturing sector.
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