Extended Manufacturing Sites - What exactly is "on-site support"?

Paragon468

Registered
Extended manufacturing site(s) receives support only from or through the main manufacturing site (considered on-site support).
This is from Rules 5 Annex 4. What exactly does this mean? Our CB says we don't quality for EMS status because preventative and reactive maintenance activities are carried out at the extended site, even though those processes are managed out of the main site.

1: Are they interpreting this correctly?
2: If they are, how on earth do extended sites operate with no maintenance activities on site?
 

Sebastian

Trusted Information Resource
Let's take example of product design.
This process is not carried out at manufacturing site, but headquarter, which is located e.g. abroad.
It is example of remote supporting function.
Second manufacturing site was established.
Part of current production was transferred from first to second manufacturing site.
Headquarter designed product change affecting one of products made at second manufacturing site.
Now, it's important to follow product design process flow.
Proper sequence is headquarter (product design changed) -> manufacturing site 1 (process design changed)-> manufacturing site 2 (manufacturing changed).
No direct system process interaction between headquarter and manufacturing site 2 is allowed.

Going back to example of maintenance.
No, it's not violating EMS status, that maintenance activities are carried out on EMS, but...
Process partially (Deming's cycle Do and Check) can be made there, but authority and responsibility for "the rest" (Plan and Act) is limited to Top management of manufacturing site 1.
See "Certification rules" Annex 4 - Eligibility for certification structure
Crucial point is "autonomous decision making authority" - it can't be given to personnel specific for extended manufacturing site.

I do not know how did you document it.
From my experience - certification body sometimes have own "add-ons" not based on "rules" and refuse to accept EMS structure.
Then you can't fight this, even auditors being later there to audit, agree with you.
These are internal CB rules, so choice is pay twice for separate certificates or look for another CB.
 
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