Quality Management system

At time of manufacturing, we need to do some changes in process, please guide us how to trigger through QMS?

Hello Ganesh!

If the change to the process is done at the time of manufacturing or β€œon the go”, I will assume that the change was not planned beforehand, and all changes to the manufacturing process that were not planned or were not as part of an established procedure (e.g. in-process contorl) are considered process deviations that could have an impact on product quality. QMS is triggered by the issuance of a proess deviation.

If you consider making a change to the process, either a one time event or establishing an in-process control, this should be triggered and handled via the change control system, which is part of the QMS. This change control allows you to identify any potential risks and mitigate them, so that the change achieves its purpose without putting any other element at risk.

I hope this is helpful.

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