Hi all,
The company I work for switched from being a captive manufacturer to a contract manufacturer a few years ago. We had to redo most of our QMS system and tbh it's kind of been one of those "update as your learn" kind of situations. I am looking from some outside opinions on this, as this is all still kind of new to everyone in my company and none of us has really seen how others handle it. Most of our business is manufacturing medical devices or PCBAs that go into medical devices, though we do have a few non-medical device/PCBA contracts.
We do not own the designs. For the majority of our product, we create our own documentation as opposed to using documentation provided by the customer. Such as, releasing it under our own assembly# and creating our own drawings, work instructions, etc.
I know customer approval requirements should be generated from contractual agreements/customer requirements.
We tried to 'make it easy' and create a matrix (attached) and defined customer approval requirements universally depending on the type of document that is being updated. There are some mixed feelings about this, with the various departments involved arguing about what is 'required of us' and that some of the requirements are excessive. Some customers are extremely critical and want to give approval on everything, some customers (per the quality agreement) say they want to give approval for everything but then do not respond to approval requests, and some customers just don't seem to care either way. On some changes, the customers have requested to see the associated work instructions, which brings up a lot of proprietary concerns.
How do you manage this at your company?
The company I work for switched from being a captive manufacturer to a contract manufacturer a few years ago. We had to redo most of our QMS system and tbh it's kind of been one of those "update as your learn" kind of situations. I am looking from some outside opinions on this, as this is all still kind of new to everyone in my company and none of us has really seen how others handle it. Most of our business is manufacturing medical devices or PCBAs that go into medical devices, though we do have a few non-medical device/PCBA contracts.
We do not own the designs. For the majority of our product, we create our own documentation as opposed to using documentation provided by the customer. Such as, releasing it under our own assembly# and creating our own drawings, work instructions, etc.
I know customer approval requirements should be generated from contractual agreements/customer requirements.
We tried to 'make it easy' and create a matrix (attached) and defined customer approval requirements universally depending on the type of document that is being updated. There are some mixed feelings about this, with the various departments involved arguing about what is 'required of us' and that some of the requirements are excessive. Some customers are extremely critical and want to give approval on everything, some customers (per the quality agreement) say they want to give approval for everything but then do not respond to approval requests, and some customers just don't seem to care either way. On some changes, the customers have requested to see the associated work instructions, which brings up a lot of proprietary concerns.
How do you manage this at your company?
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