If you are in the food, beverage, chemical or pharmaceutical industries, one measure of success is how well you cope with their ever-evolving complexity of regulatory requirements. Product safety and quality assurance compliance is essential in avoiding fines and penalties as well as the lost sales, market share and public confidence that attend every contamination scare and product recall. Not surprisingly, companies are turning to technology to help them implement best practices for all their mandated business process modifications. ERP software system providers can deliver solutions that are not only especially well suited to the specialized needs of process manufacturers and their distributors but that also essentially automate compliance and reporting requirements of government regulations.

ERP System

How the right ERP system can help automate FDA and USDA compliance. (Part 1)

The principal areas of functionality that the latest ERP systems bring to product safety and lot traceability for food, beverage, chemical or pharmaceutical companies are so compelling that, if you don’t have them, a strong business case can be made for scrapping your existing ERP system for one that does have these features.

This series explores the critical requirements an ERP system must have to absorb most of the burden of FDA and USDA compliance.

Forward and backward lot traceability. Process manufacturers and their distributors sit in the middle, between ingredient suppliers and the ultimate consumer. Contamination and product safety issues can arise at either end of that spectrum, with a supplier whose own quality control procedures uncover a problem, or with a wave of salmonella or e.coli cases tied back to a specific product or even an entire class of products. In either case, manufacturers need to have bullet-proof, near-instantaneous lot traceability up and down the supply chain. In fact, the Bioterrorism Act of 2002 requires that all companies that manufacture, distribute, import, pack, process, receive or hold products that are consumed by humans or animals must be able to track their products and prove to the FDA that they can.  

An ERP system with robust backward and forward traceability actually assigns lot numbers as an automated part of receiving ingredients or processing the product. It expands the lot number when ingredients are received, when they are consumed by the manufacturing process, or as part of an intermediate step assigned its own lot number, and when the finished goods lot was shipped and to whom. Complete traceability, step by step. At each stage of the distribution process, when product is received, picked and shipped, lot numbers are recorded and associated with the corresponding order number. There is complete visibility into which vendor supplied a specific lot and which customers received a specific finished good lot.

Rather than mass, indiscriminate—and costly-- recalls, should a problem arise at the ingredient level, manufacturers can forward-trace offending lots and ask  distributors and/or retailers to return them, or alert the public to not consume them. If a product problem arises at the consumer end of the supply chain, a manufacturer can begin the detective process armed with specific information about date of manufacture and ingredients consumed, knowing instantly, for example, all other customers who were shipped product from the same lot.

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tracey boxer