Design controls are required by the FDA and are implemented to ensure traceability on released products. The idea is that if the released product has a defect which interferes with its function and effects the consumer, all history is traced from raw materials used in the construction of the device to the manufacturing of it. If there is an adjustment within a procedure or process; the adjustment should be noted within the revision of the document. In addition, one of the most important design controls in my opinion are verification and validation, these procedures, although independent, are used together to ensure that a product meets requirements and specification, while fulfilling its intended purpose. Validation incorporates the concept of qualification to establish quality assurance and scientific evidence that the overall process is capable of consistently delivering quality product or performance. Verification, on the other hand, can be a considered a form of quality control in which processes, services or documents conform to specified requirements or regulations, which may also be attributed within Installation qualification, which ensures that equipment that is installed meets all specifications, and is installed correctly, this can be a day to day task, while validation is looked upon as the overall process.

Chris