FENERIUM said:
Dear my colleagues,
Do you have any 8-D study example against to possible risk of quality system processes
Best Regards.
An
8D would probably not be the best tool to use to perform a risk assessment of the quality system. It is intended to take a specific failure that has already occurred, identify root cause and drive corrective action.
Since ISO 9001:2000 was released, your quality management system should be looked at as a series of quality or business
processes, which have been or could be shown on a process flow chart. You could then assess risk using a
PFMEA (Process Failure Mode Effects Analysis). This would identify the potential failure modes, effects, causes, and ratings of severity, occurence and detection.
This identifies the risks, and allows prioritization of improvement actions.