When planning to temporarily transfer work to a location outside the organization’s facilities, does the organization define the process to control and validate the quality of the work?

May be applicable for manufacturing, if certain equipment or facility is not available.
In service Industry cases any idea how to define process for it?

Limited exposure to Aero so I can only respond from a medical (FDA) perspective.

Were we to do that, we would have to use a qualified supplier. One aspect of qualification might be to verify that their quality system meets regulatory or standards requirements. If not, and they could be qualified for other reasons, we might have to supplement the contract to ensure everything was covered.

We are often on the other side of that equation. We are certified to ISO 13485 which allows us to be considered a "qualified" supplier for the services we offer. Often, we can operate directly under our quality system and meet all requirements. However, we also have the ability to operate under the contracting company's quality system; i.e., we would work as extension of their staff. We put this in the contract.

It's not been an issue on the medical side.

Hope that helps.

When planning to temporarily transfer work to a location outside the organization’s facilities, does the organization define the process to control and validate the quality of the work?

May be applicable for manufacturing, if certain equipment or facility is not available.
In service Industry cases any idea how to define process for it?

In other posts you've mentioned work stations. If you moved work stations to another facility, how would you control the process and ensure that it would still be effective?

By the way, in the draft of the new AS9100 they have changed this clause from "Control of work transferred, on a temporary basis, outside the organization’s facilities" to "Control of work transfers" and it now reads:
"The organization shall develop and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another supplier) and verify the quality of the work."

I think this is really the intent of what they meant in the current version.

:topic:
Do you have a copy of AS9100? I notice that every time you post, you are quoting from the checklist, not the standard... :read: