"7.1.4Change control
The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation."

In this clause ,it means that we should assess ,and verification and validation on the change control.
By now,i have known what's the mean of verification and validation and how to do these through the ISO9000:2005.but i don't know the "assess",who can help me ?thanks inadvance!:thanks:

"7.1.4Change control
The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation."

In this clause ,it means that we should assess ,and verification and validation on the change control.
By now,i have known what's the mean of verification and validation and how to do these through the ISO9000:2005.but i don't know the "assess",who can help me ?thanks inadvance!:thanks:

Hi zhuoyz2003.

Perhaps this will help you...
If you look at the attached Product/Process Change Notification form, you will see that at the bottom of the 1st page, there is an Yellow area titled, "Impact of Change Implementation" (and which continues on Page 2 of the form).

In this area, champions of the various functional areas review the proposed/approved change and are required to assess it's likely, or known impact on their specific areas. Before implementation can begin, all functions must assess and coordinate implementation efforts and identify implementation targets to ensure a successful transition. At the bottom, individual Managers sign off indicating their consideration, review and consensus of the impact of the change.

Patricia Ravanello

Can this be done with at ECR (Engineer Change Request) Form

Can this be done with at ECR (Engineer Change Request) Form

I suppose that depends on what your "Engineer Change Request Form" looks like...and what scope of activities it covers.

Without seeing your ECR form, only you can answer that question...is there a place on your ECR form that asks and records, "How does this change impact on...Design, Fit, Form, Function, Safety, Ergonomics, resources, training...and so on?" Is the impact of the change assessed by various areas/departments?

Patricia Ravanello

:bigwave:Patricia
We go directly in to the ECO and yes there are places in this to check for
inpact locations

:bigwave:Patricia
We go directly in to the ECO and yes there are places in this to check for
inpact locations

I think you've answered your own question. Some companies initiate an Engineering Change Request with a separate form. If it is rejected, that's the end of the process and the form. If it is accepted, and its viability verified, it escalates to an Engineering Change Implementation Form.

If you can do it all in one form...that's great...fewer forms to maintain:agree1:!

Patricia