IATF 16949:2016 - Quality Management System for Automotive Production
Clause 9: Performance evaluation – IATF 16949:2016 - Quality Management System for Automotive Production

IATF 16949:2016 - Quality Management System for Automotive Production 9.1.1.1: 9.1.1.1 Monitoring and measurement of manufacturing processes

Studies are run on every new manufacturing process, including assembly and sequencing, to confirm capability and to feed process control, special characteristics included; where capability cannot be shown, alternative methods such as conformance of each batch may be used. Capability or performance results are kept in the form the customer's part approval process requires. The organization confirms that its PFMEA, control plan and process flow diagram are actually applied, covering measurement techniques, sampling plans, acceptance criteria, recorded actual values for variable data, and the reaction and escalation steps taken when acceptance criteria are missed. Notable process events, for example a tool change or a machine repair, are recorded. For any characteristic that is unstable or not capable, the reaction plan in the control plan is started, with containment and full (100 percent) inspection as appropriate, and a corrective action plan stating the specific actions, timing and owners is drawn up to bring the process back to stability and capability; where the customer requires it, that plan is reviewed with the customer and approved by them. Records are kept of the dates on which process changes take effect.

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