Form for Managing Coating Process Parameter Changes during Production

QAengineer13

Quite Involved in Discussions
#1
Dear all,

Any advise on how to go about managing any process parameter change during the coating production process ( because of raw material issue, Environmental) with proper approval from Engineering / process Engineering team.

Although the process was validated and the machine extreme was tested and the tolerance was defined , due to some random raw material issue ( offcourse NCR can be created on the suppler) but in a situation you need to continue production and the process engineer is confident that by changing the machine parameter , the product performance is not compromised.

In this situation , what FORM can I out in place and how to control it?

Thanks.:thanx:
 
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W

Wilderness Woody

#2
If you are changing a parameter of the processing equipment not previously identified in the validation or are changing the settings outside of established (validated) range, then you probably need to re-validate to ensure (prove) that performance is not compromised.

You should be able to validate a process to cover certain variables such as condition or properties of inputs (raw material). Many processes are capable of manual or automatic adjustment during setup and run to ensure output meets specifications.

Without more detail about the coating and specific parameters and your validation scope, I can't offer much more insight.
 

John Broomfield

Staff member
Super Moderator
#3
Dear all,

Any advise on how to go about managing any process parameter change during the coating production process ( because of raw material issue, Environmental) with proper approval from Engineering / process Engineering team.

Although the process was validated and the machine extreme was tested and the tolerance was defined , due to some random raw material issue ( offcourse NCR can be created on the suppler) but in a situation you need to continue production and the process engineer is confident that by changing the machine parameter , the product performance is not compromised.

In this situation , what FORM can I out in place and how to control it?

Thanks.:thanx:
QAengineer,

Your form for controlling nonconforming product should be used when it is possible that the product is nonconforming.

This time it is because someone chose to use raw materials that changed the validated process.

The change in raw materials should have invoked re-validation of the process.

You may want to clarify the scope of your NCR form.

John
 
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