Use Remote Design Center - How should 7.3 be addressed in Quality Manual?

[AndyN]

Yes, but not at first. Initially we began working with a different Registrar in the USA and this Registrar wanted to do a complete re-audit of the European facility when they are already TS-registered under there own registrar. Well... our friends in Europe weren't happy about that.

And they shouldn't be happy - if the European operation is TS already! THAT's one of the reasons for mutual recognition and accreditation! Your USA based Registrar SHOULD accept the registration!

 

[vanputten]

If it were me, here is how I would structure things. I would say the US location is not design responsible. The sister facility in Europe is design responsible and their TS cert scope says so. I would only have manufacturing in the scope of the US facility TS cert. I would not refer to the European facility as a remote site.

I would do this from a TS cert stand point since the company decided to have multiple TS certs instead of one corporate scheme.

Do you want two facilities with responsibility over design? Does the US facility direct the design group and and tell them what and how to design?

 

[Dan M]

If it were me, here is how I would structure things. I would say the US location is not design responsible. The sister facility in Europe is design responsible and their TS cert scope says so. I would only have manufacturing in the scope of the US facility TS cert. I would not refer to the European facility as a remote site.

I would do this from a TS cert stand point since the company decided to have multiple TS certs instead of one corporate scheme.

Do you want two facilities with responsibility over design? Does the US facility direct the design group and and tell them what and how to design?

According to our registrar's auditor our Company can say throughout the quality manual, especially in section 7.3, that our remote design center in Europe performs these [design] activities. Our scope of registration however, must specify "Design and Manufacture of... etc". He informed us that the only way an organization can state they are not responsible for design is if the Customer is designing the products.

 

[vanputten]

Exactly. From a TS cert standpoint, the sister facility in Europe may be your customer.

Does the US facility direct the design group and and tell them what and how to design?

To approach the TS certification structure by fracturing the organization into multiple, separate cert scopes but then treat all locations as one organization since that what it is outside of the TS certification world, is confusing, ineffective and inefficient. Definition of inputs, outputs, outsourcing, remote supporting sites, customers, suppliers, design responsibility, general responsibility and authority, all get muddied and confusing when an organization has multiple TS certs within the overall organization especially with a design group that is included in multiple certs.