Hi all,
Ok this is going to sound dumb, but humor me.
Im having an extremely difficult time finding a clear definition of an "outsourced process." when you look at the regulation, it essentially says an outsourced process is something that's outsourced. Cool, I know what outsourced is, but i dont really know what a process is. I know section 0.3 describes the process approach, but again it doesnt define it well.
Here's the dilemma, we have a particular supplier that we cant figure out whether they are a regular supplier or an outsourced process. it led everyone down the rabbit hole of asking whether each supplier that produces a custom component is doing a "process" of designing and developing that custom item (even if it's based on our own spec that we provide them) or whether they are just supplying a component which is then reviewed in incoming inspections. Ultimately, the end result isnt that different because we have controls on our suppliers, but we just want to make sure we categorize everyone correctly. easy processes like sterilization are fine, and we dont have an issue there. but it's things that are related to components/design/engineering that get complicated.
I would love if someone had a good definition of an "outsourced process" they could share, and also explained how the controls for an outsourced process differ from a similarly situated supplier.
Ok this is going to sound dumb, but humor me.
Im having an extremely difficult time finding a clear definition of an "outsourced process." when you look at the regulation, it essentially says an outsourced process is something that's outsourced. Cool, I know what outsourced is, but i dont really know what a process is. I know section 0.3 describes the process approach, but again it doesnt define it well.
Here's the dilemma, we have a particular supplier that we cant figure out whether they are a regular supplier or an outsourced process. it led everyone down the rabbit hole of asking whether each supplier that produces a custom component is doing a "process" of designing and developing that custom item (even if it's based on our own spec that we provide them) or whether they are just supplying a component which is then reviewed in incoming inspections. Ultimately, the end result isnt that different because we have controls on our suppliers, but we just want to make sure we categorize everyone correctly. easy processes like sterilization are fine, and we dont have an issue there. but it's things that are related to components/design/engineering that get complicated.
I would love if someone had a good definition of an "outsourced process" they could share, and also explained how the controls for an outsourced process differ from a similarly situated supplier.
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