Engineering Change Request (ECR) / Notice (ECN) - Seeking Example Forms

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C

Chris Willis

#5
#5
ECR forms

Hi,

these are the ones we currently use. Basically we say that each ECR is a program, and provide a list of associated documents, and let the ECR team decide which documents have to be reviewed and updated.

In addition these can also be used to approve VAVE programmes as well.

Chris
 

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J

Jonell

#7
#7
We use a Change Notice

We use a "Change Notice" here. This allows us to use one form for more than just engineering changes.

Here's a copy.

Jonell
 

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C

Cari Spears

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#8
#8
Jonell said:
We use a "Change Notice" here. This allows us to use one form for more than just engineering changes....
Click to expand...
Same here, ours is called a PO Change Notice. We use it for engineering changes, quantity changes, due dates...anything.
 
J

Jerry Schoen

#10
#10
I am looking for an Engineering Change Notice that I can use in the medical device industry. I have been looking at the posted samples of an ECN form, but do not see any the address the regulatory requirements of the FDA concerning safety, labeling and substantial equivalence.

Does anyone have a good sample?

Thanks,
Jerry Schoen
 
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