Risk-based thinking in IATF 16949

Answer:

When it comes to risk-based thinking or addressing risks and opportunities, IATF 16949 has addition to requirements of ISO 9001. IATF 16949 requires risk analysis to include, at minimum, product recalls, product audits, returns and repairs, complaints, scraps and rework. The evidence of the risks-based thinking would be FMEA (Failure Mode Effect Analysis) conducted for processes with appropriate actions taken to address the risks. As far as the staff operating the processes is concerned, the best approach is to focus primarily on the risks emerging from their processes and what has to be done to avoid the risks. For example, how to perform the activities and avoid the nonconformities.