You failed to evaluate suppliers of components and other materials used to assemble the WatchChildTM device. You had not documented your decisions to use the approved vendors on the approved vendor list. While you have a written procedure for supplier certification and recertification, it was not being followed. The type and extent of control to be exercised over the suppliers has not been defined. You failed to perform incoming inspection of your components to verify that they conform to your specifications. You also failed to perform in-process and final inspection of components (software) manufactured at your firm. The acting operations manager was not familiar with the written procedures for receiving, in-process and finished device acceptance. He indicated that the firm never followed these procedures.

You failed to have a Device Master Record for the WatchChildTM device. Records of the WatchChildTM software validation were incomplete.

SoftwareCPR Keywords: vendor qualification