Tracking and tracing made simple

New requirements for manufacturing IT usually come from new business processes or new manufacturing processes, but sometimes they come from new laws and regulations. Two new laws, the USA Bioterrorism Act "USA Public Law 107-188" and the European Health and Consumer Protection Directorate 178/2002 will require new or expanded manufacturing IT systems.

04/01/2005


New requirements for manufacturing IT usually come from new business processes or new manufacturing processes, but sometimes they come from new laws and regulations. Two new laws, the USA Bioterrorism Act "USA Public Law 107-188" and the European Health and Consumer Protection Directorate 178/2002 will require new or expanded manufacturing IT systems.

These regulations mandate the ability to rapidly trace the origins of foods and food additives to combat risks to the public's health and safety. The basic concept of the regulation is that it should be possible to identify every ingredient in any food, trace the ingredients back to their sources, and have the tracing information readily available. This requires food producers to maintain records that identify ingredients for each product and sources for each ingredient that goes into a product.

The Bioterrorism Act requires traceability known as "one up and one down." This means that food producers must keep track of where they obtained their raw materials and where they shipped their product. This is complicated because of the splitting and combining of material lots that occurs during food production.

For example, the end product in a box on the store shelf will probably have had several different raw material lots from several sources. Usually, recipes and production schedules do not specify which raw material lots to use, and it is at the discretion of operators to pick the appropriate material lot for each batch. Common practice today is to record this information manually, if it is recorded at all. Early U.S. FDA guidelines stated that, in case of a problem with the product, the FDA can request exactly what was in a product, where the raw materials came from, and the manufacturer must reply within four hours of the request (this has since been changed to 24 hours, but that's still a quick turnaround for such specific data). A related EU directive says information must be made available to competent authorities "on demand." Timing is critical; in the case of food contamination it can mean the difference between a safe recall and a disaster.

Fortunately, product traceability is a mainstream manufacturing requirement and is used in multiple industries. Material traceability has always been a regulatory requirement in the pharmaceutical and biotech industries and has recently become a requirement in consumer products due to product litigation concerns.

These industries have implemented MES (manufacturing execution systems) to automatically collect and manage tracing information. However, an MES is often expensive, complex, and hard to justify in many situations, especially if the only requirement is traceability. This situation is changing because of the new reference model for MES, defined in the ANSI/ISA 95.03 Manufacturing Operations Management Standard. It provides a clear definition of requirements for product traceability and most vendors are now using it to model their MES software. Systems following the model should allow implementation of production tracking, without requiring other MES functions.

In some cases, production tracking also can be accomplished through an ERP system, depending on its material tracking capabilities. Technology required for production tracking is not exotic or advanced. It only requires a database and bar-code input from shop-floor operators to identify material lots as they are added to products. Expensive solutions are not needed, but appropriate information technology must be applied to meet on-demand information requirements.

Changes such as those required by current and forthcoming regulations will require more information technology to be applied on the shop floor and increased integration of business and manufacturing systems. As a result, the modern control engineer must become familiar with basic information technologies and be ready to apply them to these new challenges.


Author Information
Dennis Brandl, dbrandl@brlconsulting.com , is the president of BR&L Consulting, a consulting firm focusing on manufacturing IT solutions, based in Cary, N.C.




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