DCN or ECN for Initial Release of FMEA & CP and subsequent changes?

[carryn1]

I am new to the FMEA and control plan. My superior requested me to generate and documented the FMEA and CP, but its to use Engineering change notice (ECN) or Document change notice ( DCN) for the inital release and approval ? how about subsequent changes ? DCN or ECN ?

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Raffy]

Hi carryn1,
Welcome to the cove!
In my previous company I work with, we have two change notice just like yours but later on the management team and I decided to use only one type of change notice, ECN.
For Engineering related such as FMEA, we use ECN for all subsequent changes, because in our document ECN will not only mean for Engineering but also for all other documents related to QMS.
Hope this helps.
Best regards,
Raffy

 

[krishkaar]

Engineering change Note is used to refer to all changes which are needed either a specification change from a customer ( say, a revised drawing) or, organisation's own need after a process review.
Another instance could be a corrective/preventive actions arising out of a customer complaint.

ECN always results in an impact analysis to the processes affected by the change needed.

For an ISO/TS system, a re-validation followed by re-PPAP may also arise.

Any ECN prepared will result in impact to several system documents, say e.g FMEA/Control Plan/WI/SOP etc.
As these are controlled documents in a QMS, any change to these documents are addressed through a Document Change Process ensuring a Revision History Record.