Does anyone have any experience on change control?

R

Richard W

Dear all.

Does anyone have any experience on change control.

I don't want anything to complicated and was actually thinking of a simple process in the form of a FMEA. Obviously the FMEA will cover off the potential consequences well, but it doesn't cover off everything like the provision of resources and the control of them .

Any help would be great

Richard
 
S

Sentinel

Hi Richard,

In my experience, FMEA is used more as a tool to analyse risk and the prevention and detection controls you have in place for any particular failure mode. It is a very effective tool when used properly. You could use the format to conduct an exercise on a proposed change process potentially.

A good change control process to me, is something that details exactly what is being changed and the reason for that change. Our process has an imapct analysis section to understand what is impacted as a result of the change in the form of documentation, customer approval, production processing, gauging, packaging, labelling, etc. It also assesses any impact on interchangeability and maintainability. We also consider disposition of existing product within the realisation process, i.e. supply chain, WIP, finished goods, goods in transit and then a point of embodiment of the change.
 

Kronos147

Trusted Information Resource
Does anyone have any experience on change control.

I'll bet you do.

Do you have a document control system? That is change control.



Let's back up: Remember process approach. What are the changes that happens to the processes defined in your system?

Production Changes - measured by some production metric, no?
QMS changes - measured by Management Review, no?
Design Changes - measured by the design process, no?


Don't overthink it.

Cheers,
Kronos
 
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