IATF 16949:2016 - Quality Management System for Automotive Production 8.5.1.1: Control Plan

What does 8.5.1.1 require?

The organization develops control plans that conform to Annex A at system, subsystem, component or material level for the manufacturing site and for all product it supplies, bulk material processes included; family control plans are allowed for bulk material and for similar parts made on a shared process. Pre-launch and production control plans link to and draw on the design risk analysis (where the customer provides one), the process flow diagram and the outputs of the manufacturing process risk analysis (such as the process FMEA). Where the customer requires it, the organization supplies the measurement and conformity data gathered while the control plan (pre-launch or production) is carried out. The control plan includes: controls applied to the manufacturing process, including verification of job set-up; validation of the first and last piece produced, as applicable; methods for monitoring control of special characteristics defined by the customer and by the organization; information the customer requires; and a stated reaction plan for when nonconforming product is found or the process goes unstable or loses capability. Control plans are reviewed and, where needed, updated when shipped nonconforming product comes to light; when any change touches product, manufacturing process, measurement, logistics, sources of supply, production volume or the risk analysis; after a customer complaint and the corrective action that follows; and at a frequency that risk analysis sets. If the customer requires it, the organization gains customer approval once the plan has been reviewed or revised.