How to close the circle QMS and ECO (Engineering Change Order)?

Q

QAMTY

#1
Hello to all

I want to share a question regarding how to ensure changes are
validated.

For Example in Design and development 7.3
Covers the design revision, verification and validation
under these points it is possible to close the circle form the start to the end.

But I wonder in ECO´s where this circle is closed?, I mean, where can be validated the change, because in most of the ECo´s procedure, mainly are focused in the control of the document and I think in this document it should not be included the verification.Will be needed other control, other document for this verification, as to how to close the circle?

Thanks
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#3
<snip> But I wonder in ECO´s where this circle is closed?, I mean, where can be validated the change, because in most of the ECo´s procedure, mainly are focused in the control of the document and I think in this document it should not be included the verification.Will be needed other control, other document for this verification, as to how to close the circle?

Thanks
Typically Engineering Change Orders are closed after the change has been implemented and the output is validated in the same way as it was in the design and development stage.

Some of the others here may have things to add.
 

Jim Wynne

Staff member
Admin
#4
Typically Engineering Change Orders are closed after the change has been implemented and the output is validated in the same way as it was in the design and development stage.

Some of the others here may have things to add.
This is one of those areas where documents are confused with processes. Strictly speaking, an ECO is the former and not the latter. In my experience, ECOs are issued after the validation has taken place--it's the end of the process that formally establishes the change as the new configuration.

In various places, there will be different processes and names for the documents. I've seen:
  • ECR (Engineering Change Request), a proposal for an engineering change;
  • ECO (Engineering Change Order) a document that serves as a record of an engineering change;
  • ECN (Engineering Change Notice) Sometimes used as synonymous with ECO but is sometimes a separate document that serves as an announcement or notification of the change.
There's usually not an issue with "closing" an ECO because it's generally a document that serves as formal notification of a configuration change. The change process itself shouldn't be finalized until it's reasonably certain that the change in question was executed effectively.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Good point, Jim. I was thinking of the entire engineering change process - Start to Finish.
 

v9991

Trusted Information Resource
#6
This is one of those areas where documents are confused with processes. Strictly speaking, an ECO is the former and not the latter. In my experience, ECOs are issued after the validation has taken place--it's the end of the process that formally establishes the change as the new configuration.

In various places, there will be different processes and names for the documents. I've seen:
  • ECR (Engineering Change Request), a proposal for an engineering change;
  • ECO (Engineering Change Order) a document that serves as a record of an engineering change;
  • ECN (Engineering Change Notice) Sometimes used as synonymous with ECO but is sometimes a separate document that serves as an announcement or notification of the change.
There's usually not an issue with "closing" an ECO because it's generally a document that serves as formal notification of a configuration change. The change process itself shouldn't be finalized until it's reasonably certain that the change in question was executed effectively.
one clarification in this regard...
we in pharma follow change control(management) procedure;
which essentially is the combination of proposal-justification-evaluation-approval-verification/validation-closure.

1) as explained above, can i consider combination of ECR-ECO-ECN as equivalent to CC?
2) or shall i understand the CC is actually ECR ; and upon approval-validation-verification it shall lead to ECO&ECN?

thank you for clarification.
 
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