Can 2 different sites under different Quality System have a common management review?

#1
Hi!
I currently oversee the QS in 2 sites in 2 different countries. Neither site manufactures and both sites use many of the same procedures (design control, CAPA, management review, internal audit, change control, supplier management...). Each site has their own ISO13485 cert (therefore their own quality manual) with 2 different NBs. Where it is challenging is how to distinguish the scope - recently the roles/responsibilities with the different functions have overlapped. For example, R&D has the same VP who assigns projects to engineers across both sites, regardless of product, and the top leadership is at both sites (some functions are at one site and other functions are at the other site). We can handle this resource sharing with a quality agreement as out-sourced processes so I’ll live with that.

Currently each site has their own management review. However the content of each site’s review is redundant or conflicting or incomplete. So my question is - is it possible to have 1 management review across 2 sites as long as the proper site metrics/attendees are included? That way the management with exec responsibility only attends one review that is comprehensive. Does the management rep have to be physically located at each site (so we would need 2 if combined) or can we just have one (for example, it could be me since I’m over the QS for both sites, even though I’m located at one site)?

I understand the risk of 1 review is exposing more metrics than needed to the other NB, but we can clearly indicate which slides belong to which site. On a side note, we will not be merging the certs under one NB.

Thanks for any input you may have!
Wicker
 
Elsmar Forum Sponsor
#2
Re: Can 2 different sites under different Quality System have a common management rev

Seems like a good idea to me. What's more interesting to me is the frequency and who does most of the talking, the role of the audit findings etc.
 

Ajit Basrur

Staff member
Admin
#3
Re: Can 2 different sites under different Quality System have a common management rev

Wicker,

In your organization, do these individual plants reporting into a Corporate structure (i.e. you)? There is nothing wrong in your approach but would also suggest another approach from my past role.

We had plants across different geographies owning their individual ISO certificate; so these plants used to have their internal management review meetings twice a year; but in addition, we had a Senior Management Review Meeting hosted by Corporate group that additionally, included all plants.
 

somashekar

Staff member
Super Moderator
#4
Re: Can 2 different sites under different Quality System have a common management rev

Hi!
I currently oversee the QS in 2 sites in 2 different countries. Neither site manufactures and both sites use many of the same procedures (design control, CAPA, management review, internal audit, change control, supplier management...). Each site has their own ISO13485 cert (therefore their own quality manual) with 2 different NBs. Where it is challenging is how to distinguish the scope - recently the roles/responsibilities with the different functions have overlapped. For example, R&D has the same VP who assigns projects to engineers across both sites, regardless of product, and the top leadership is at both sites (some functions are at one site and other functions are at the other site). We can handle this resource sharing with a quality agreement as out-sourced processes so I’ll live with that.

Currently each site has their own management review. However the content of each site’s review is redundant or conflicting or incomplete. So my question is - is it possible to have 1 management review across 2 sites as long as the proper site metrics/attendees are included? That way the management with exec responsibility only attends one review that is comprehensive. Does the management rep have to be physically located at each site (so we would need 2 if combined) or can we just have one (for example, it could be me since I’m over the QS for both sites, even though I’m located at one site)?

I understand the risk of 1 review is exposing more metrics than needed to the other NB, but we can clearly indicate which slides belong to which site. On a side note, we will not be merging the certs under one NB.

Thanks for any input you may have!
Wicker
You can have. After all its your management reviewing.
The catch is to understand "Review" and "Record" in its right perspective.
You don't need to have meetings and people attending at a common place and time.
It will do you a lot good if you have records suitably maintained for each of your 2 different site reviews.
Its finally all about Review Inputs... Decisions... and Review Outputs
 
#5
Re: Can 2 different sites under different Quality System have a common management rev

Thanks for the responses. I didn’t think it was an issue but wanted to make sure I wasn’t missing a detail from ISO13485 or CFR or maybe even another reg/standard.

To answer the questions...
We conduct quarterly management reviews.
Yes, each site will have the proper information filed as evidence (presentation, attenddees and minutes). The tricky part is making sure any distinction is made in action items if the action item only pertains to one site.

The 2 sites I mentioned do not have manufacturing - but they have the sub-systems I mentioned. There are manufacturing sites but they have their own management reviews that feed up to corporate.

Thanks again,
 
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