Identifying and managing product and process nonconformance and eliminating its cause is critical to an organization’s quality system. This is especially pertinent in the stringent FDA and ISO-compliant environments, where a non-conforming product, material, or component could lead to costly rework, or worse, a product recall. Our primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.