Storeroom Practices For Highly Regulated Industries (HRIs), Traceability Is Crucial
For HRIs from motor vehicle manufacture to medical equipment and pharmaceuticals—where environmental and/or public health and safety are at risk—the stakes are incredibly high, and failure to ensure safety can be disastrous. To meet strict regulations imposed on HRIs and reduce liability, companies must closely track inventory and its components—and maintain readily available records that document their oversight.
Although traceability is often required across the entire value chain, one area that is prone to system breakdown without rigorous management is the storeroom, from parts and materials warehouses to finished inventory storage. As an example, consider the pharmaceutical industry, which is one of the most highly regulated industries of all, for good reason.
With drug manufacture, the issues that make headlines— someone becomes ill from consuming a mislabeled drug or expired materials leak into a waterway—often occur far from the site of manufacture. Nevertheless, the chain of control must be demonstrable through every stage of a product’s lifecycle, from materials storage through inventory warehousing. To ensure rigorous tracking, companies must use detailed traceability systems, including unique serial numbers for products and lots.
Because storerooms are often seen as a “safe haven” where materials and products only reside but no person or process interacts with them, firms often overlook the importance of best-practice storeroom management. This can be a grave error, because lax storeroom management is proven to be an impetus for product or material contamination. Equally important, a well-organized, maintained and documented storeroom also provides credibility for manufacturers, supporting their claim of best practices when the source of containment or leakage is unclear.