Definition Outsourced process - Clear definition - 13485

joemar

Involved In Discussions
#1
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.
 
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Tagin

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#2
ISO 9000:2015 is the normative reference for 13485:
3.4.6
outsource (verb)
make an arrangement where an external organization (3.2.1) performs part of an organization’s
function or process
I think the key is in the bolded part.

I look at it that this way:
  • Consider a SIPOC model of your defined process.
  • Is the supplier providing an Input to that process? Then they are a typical supplier.
  • Is the supplier providing is one or more of the processing steps in the Process (aka Activities) phase? If so, then it is an outsourced process.
 

joemar

Involved In Discussions
#3
ISO 9000:2015 is the normative reference for 13485:


I think the key is in the bolded part.

I look at it that this way:
  • Consider a SIPOC model of your defined process.
  • Is the supplier providing an Input to that process? Then they are a typical supplier.
  • Is the supplier providing is one or more of the processing steps in the Process (aka Activities) phase? If so, then it is an outsourced process.
ok, i hear you and i'll check out the reference, but can you help me understand a situation where you provide a firm a design to build a component, but they need to do some additional engineering to get it to meet their equipment. why isnt the engineering that they do a outsourced process? i know im buying the part, but they arent able to produce it without performing a process (but say, the last supplier was able to produce it per spec).
 

Tagin

Trusted Information Resource
#4
ok, i hear you and i'll check out the reference, but can you help me understand a situation where you provide a firm a design to build a component, but they need to do some additional engineering to get it to meet their equipment. why isnt the engineering that they do a outsourced process? i know im buying the part, but they arent able to produce it without performing a process (but say, the last supplier was able to produce it per spec).
They are doing the engineering for their process, not yours.

You need to look at it in the context of your defined processes. The term 'outsourced' is meaningful only relative to your processes, so you can't remove the context. In other words, you can't outsource a process X if you do not actually have a process X defined as one of your processes or process activities.

In your example, you are providing your supplier a requirement spec (design doc, etc.) and they are providing a component per that spec. What engineering they do internally is all about their processes, it is not part of your organization’s defined processes. With respect to your processes, they are just providing an input.

If you have an engineering process, and then during this process you give the design docs to another company to do further engineering, and then they provide back to you some design changes, analysis, recommendations, etc., and then you perform your final engineering steps, then it would seem to me that what they did is an outsourced process, since they performed some activities that are part of your engineering process.

If we don't make this kind of distinction, then I see how you'd end up with practically everything being an outsourced process.
 

joemar

Involved In Discussions
#6
They are doing the engineering for their process, not yours.

You need to look at it in the context of your defined processes. The term 'outsourced' is meaningful only relative to your processes, so you can't remove the context. In other words, you can't outsource a process X if you do not actually have a process X defined as one of your processes or process activities.

In your example, you are providing your supplier a requirement spec (design doc, etc.) and they are providing a component per that spec. What engineering they do internally is all about their processes, it is not part of your organization’s defined processes. With respect to your processes, they are just providing an input.

If you have an engineering process, and then during this process you give the design docs to another company to do further engineering, and then they provide back to you some design changes, analysis, recommendations, etc., and then you perform your final engineering steps, then it would seem to me that what they did is an outsourced process, since they performed some activities that are part of your engineering process.

If we don't make this kind of distinction, then I see how you'd end up with practically everything being an outsourced process.
Thanks, sometimes you dig in too much and lose sight of the forest.
 
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