Hi all,
We have several production facilities covered under one ISO 9000 certificate. The design for our products is done by our company's technology business unit which is a completely separate business unit within our company. For this reason we have always excluded 7.3 from our scope and our auditing company never questioned it.
I should mention that a branch of the 'technology group' resides at one of our sites and services all production sites by providing the product design and technical support.
This year our auditing company assigned us a new auditor, who after auditing some of our production sites (in other words, in the middle of the audit) is saying we cannot exclude 7.3 anymore because its being done right at one of our sites. AND he is adding extra time to our audit schedule in order audit 7.3 (to be done while auditing the site where the technology group also resides).
I can understand saying that we cannot exclude all of 7.3 anymore, though I believe that we should still be able to exclude activities handled by a separate business unit (or at least consider them as "outsourced"). The location of the design function in my opinion is irrelevant, they're just renting space locally.
The part I have a BIG BEEF with is the changing of the audit scope midstream. I believe we should have been told that NEXT time we need to be up to snuff regarding 7.3. Who's right (if anyone)?
I'd *love* to hear if anyone has thoughts on this??
Thanks!
We have several production facilities covered under one ISO 9000 certificate. The design for our products is done by our company's technology business unit which is a completely separate business unit within our company. For this reason we have always excluded 7.3 from our scope and our auditing company never questioned it.
I should mention that a branch of the 'technology group' resides at one of our sites and services all production sites by providing the product design and technical support.
This year our auditing company assigned us a new auditor, who after auditing some of our production sites (in other words, in the middle of the audit) is saying we cannot exclude 7.3 anymore because its being done right at one of our sites. AND he is adding extra time to our audit schedule in order audit 7.3 (to be done while auditing the site where the technology group also resides).
I can understand saying that we cannot exclude all of 7.3 anymore, though I believe that we should still be able to exclude activities handled by a separate business unit (or at least consider them as "outsourced"). The location of the design function in my opinion is irrelevant, they're just renting space locally.
The part I have a BIG BEEF with is the changing of the audit scope midstream. I believe we should have been told that NEXT time we need to be up to snuff regarding 7.3. Who's right (if anyone)?
I'd *love* to hear if anyone has thoughts on this??
Thanks!

Hjilling said it well. Plus, it's really the responsibility of the MR to call management on these things, so as to avoid getting wacked during an audit. The 3rd party did what they should have, even if they did it kinda unilaterally. Don't forget the MR's job is to maintain compliance, so this issue probably should have come up a long time ago. Yeah, the registrars are culpable, but the accreditation authorities issued memoranda a long time ago about the practice of registering organizations to 9002 when they were design responsible (didn't make much impact, did it?
)
Randy does not "bash" people personally, and simply was adding "color" to his post to make a point. We really must have a bit thicker skin when it comes to the give and take of information and ideas in a forum such as this. I'm sure Randy doesn't take your "Too bad you don't understand how a process audit trail can lead to things outside of the scope" comment as a personal affront. Mostly we have fun here, feel strongly about some subjects, make light of others, but all in all, enjoy the interaction.