BCQuality76
Starting to get Involved
Not sure if this is the right place for this post but the topic that got the discussion going on our end was around QC inspection.
Our parent company is licensing our brand name for a product they have developed and intend to sell in the EU. It is not yet cleared for the US.
They are the legal manufacturer. They will be handling distribution, complaints, post-market, design changes, etc. We will only be processing orders and (at least as long as it is not cleared in the US) will not receive/store/distribute product from out facility.
Our parent company and sister company (yes, it is as much fun as it sounds) requested that we conduct "virtual QC" testing (C of A review or something similar, as we won't have access to the actual product or production records) out of concern for our reputation since our name will be on it. A fair concern, but our QA and RA groups does not feel comfortable with this and are pushing back. We plan to add a blurb to our quality manual that the product, even though we process orders for it, and it has our branding, is not within the scope of our quality system. Should the time come when it is cleared for the US or we begin to assume a distribution role, we would revisit our stance.
We have audited their quality system as a supplier (different project), they've been certified by a notified body, and have been cleared for the EU. Beyond some legal points related to the use of our brand and a quality agreement (in progress), I feel like we've done our due diligence. But this is a new situation for us.
Just wondering if anyone else has been in a similar situation.
Thanks, in advance.
Our parent company is licensing our brand name for a product they have developed and intend to sell in the EU. It is not yet cleared for the US.
They are the legal manufacturer. They will be handling distribution, complaints, post-market, design changes, etc. We will only be processing orders and (at least as long as it is not cleared in the US) will not receive/store/distribute product from out facility.
Our parent company and sister company (yes, it is as much fun as it sounds) requested that we conduct "virtual QC" testing (C of A review or something similar, as we won't have access to the actual product or production records) out of concern for our reputation since our name will be on it. A fair concern, but our QA and RA groups does not feel comfortable with this and are pushing back. We plan to add a blurb to our quality manual that the product, even though we process orders for it, and it has our branding, is not within the scope of our quality system. Should the time come when it is cleared for the US or we begin to assume a distribution role, we would revisit our stance.
We have audited their quality system as a supplier (different project), they've been certified by a notified body, and have been cleared for the EU. Beyond some legal points related to the use of our brand and a quality agreement (in progress), I feel like we've done our due diligence. But this is a new situation for us.
Just wondering if anyone else has been in a similar situation.
Thanks, in advance.
