1.16 The Supplier shall develop control plans at the system, subsystem, and/or material level for the product supplied, including those for processes producing bulk material, and the control plan shall take into account outputs from the process FMEA. The control plan shall list the controls used for the manufacturing process control, include the methods for monitoring of control, include the customer-required information, if any, and initiate the specified reaction plan when the process becomes unstable or not statistically capable.