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

[gpainter]

Looking for some sample forms for ECN? I have a few but I do not think they are good. Thanks in advance for your help.

 

[Al Rosen]

Looking for some sample forms for ECN? I have a few but I do not think they are good. Thanks in advance for your help.

Look at this post https://elsmar.com/elsmarqualityforum/posts/79823/
and here (broken link removed)

 

[gpainter]

Thanks, those are better ones than I have.

 

[Bill Ryan - 2007]

Here's one we use

 

[Chris Willis]

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

 

[gheghe]

Change Form

Here is an example.

 

[Jonell]

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

 

[Cari Spears]

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

Same here, ours is called a PO Change Notice. We use it for engineering changes, quantity changes, due dates...anything.

 

[CarolX]

Here is my form.

 

[Jerry Schoen]

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