Definition
The United States Government agency responsible for food and pharmaceutical regulation.
In detail
The U.S. Food and Drug Administration (FDA) is a government agency that regulates food, drugs, medical devices, and other products in the United States. In the DBS system, FDA-related requirements are external constraints that regulated businesses must comply with, influencing process design and improvement activities. It differs from internal quality tools and serves as an external regulatory benchmark. Typical outputs include compliance documents, audit preparation, and product registration records.
Example in practice
A medical device manufacturing company introduced DBS but needed to ensure all improvement activities complied with FDA quality system regulations. During Kaizen weeks, teams had to update validation documents in parallel when optimizing production processes to ensure compliance. Ultimately, the improvement results passed FDA audits smoothly, demonstrating that DBS and regulatory compliance can go hand in hand.