To add to the discussion I believe that a complete Design Control System maintains the established feedback loop where the product is documented adequately while providing room for improvement along the development stages. The FDA, as previously mentioned, looks to see that the company adheres to their procedures and that they do not stray away from them. Incorrect documentation of stages along the process can result in possible findings. One example I can think of where the process needs to be full proof is during remediation of a product/product line. Although every level within the process should be full proof, remediation must have documentation, personnel, and adherence to procedure otherwise findings can occur.