W
Wicker
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
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