Outsourced processes - Same Company, Different Location

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RosieA

#1
Need an opinion:

In my old company, we outsourced our manufacturing to a third party. We had to change our ISO scope to "management of manufacturing" from "manufacturing".

In my current job we outsource some products to a sister plant in another country. They have their own ISO cert, but use our procedures. I am told by management here to consider them a department not another division. I am responsible for the quality of products coming from that plant.

Do I need to change the scope of my ISO cert to "management of manufacturing" under these circumstances? Is outsourcing to a sister plant where I am responsible for the quality really outsourcing?

Thanks for the feedback....
 
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howste

Thaumaturge
Super Moderator
#2
If I was your registrar auditor and you told me they were considered a department of your organization, I'd ask when I should schedule an audit of them. :vfunny:

I think the key words in your statement above are "some products." If you are still doing some of the manufacturing, leave the scope as it is.

I'm not sure there's enough information to really determine if I'd consider it outsourcing. It might even fall under purchasing if you don't own it until it's sent to you...
 
R

Randy Stewart

#3
I have to agree, if you use the same registrar it will be even easier. But from the information given, leave the scope as it is.
 

RoxaneB

Super Moderator
Super Moderator
#4
Not knowing the commercial aspect to how product is transferred from your sister facility to yours, I'll just mention that within my organization we physically purchase product from our sister companies. This means they are on our Approved Vendor List and subject to Performance Tracking and the repercussions should they drop below the acceptable delivery rating.
 
R

RosieA

#5
Howste, I have to agree on your audit comment. I have been puzzled by the statement that the Mexico plant is a department since I got here 5 weeks ago.

My responsibility for the Mexican operations' quality does not show on paper anywhere, in either a job description or an Org chart. Very odd. I have been told verbally by several managers and the Mexico plant, itself, that this is the case, but no one seems to want to commit that to paper.

It's an odd duck to manage, since I have responsibility but no authority, and an odd duck to understand from a QMS point of view, since they have their own cert.

Every job has its oddities, and this appears to be it for this job! :rolleyes:
 
R

RosieA

#6
RcB, that was my first thought too....

No, I was told, they are not a vendor, they are a department. This whole arrangement is messy.

I can't define them and so I cannot determine how best to respresent them in my quality system.

'Tiz a puzzlement.
 
#7
RosieA said:
Need an opinion:...
Do I need to change the scope of my ISO cert to "management of manufacturing" under these circumstances? Is outsourcing to a sister plant where I am responsible for the quality really outsourcing?

Thanks for the feedback....
My first concern here is whether we are just playing "word games". ISO 9001:2000 makes it relatively clear that outsourced processes are really no different than in-house processes. Whether the sister plant is treated like a vendor, or department, if they perform processes you need, then they can be included. I would draw the line if you “sold” product to them and then “bought” it back (but only if you were not doing this to avoid ISO requirements).

Howste said:
If I was your registrar auditor and you told me they were considered a department of your organization, I'd ask when I should schedule an audit of them.
Interesting....What if it was an outsourced process? Based on 4.1, could the registrar visit the vendor to see how the process is controlled? Hmmmm.......
 

howste

Thaumaturge
Super Moderator
#8
db - I'm sure you realize I said that jokingly. They are outside the scope of their registration, but still need to be accounted for somehow during the audit.

If your site is responsible for the product, then you need to have controls in place to ensure that the product is good. Whether you call it purchasing or outsourced processes, it doesn't matter. They are using your procedures. That could be 7.4.2 purchasing information, or that could be 4.1 control of outsourced processes.

An auditor should look for evidence that the resulting product is good either way. If you don't have it onsite (incoming inspection, etc.), then you need to get it from the other "department" (monitoring and measurement of product).
 
#9
howste said:
db - I'm sure you realize I said that jokingly...
Yes I did, but how you meant it is irrelevant. It triggered my thinking of how some auditors could read it. What you stated in jest could well be a serious statement by someone else. It really makes me wonder how far can an audit go? I was just “supposen” in my mind.
 
R

RosieA

#10
db, I think I can respond to that based on past experience. In one previous job, where the manufacturing was outsourced, the third party had ISO certification, and my Registrar accepted that as proof of an adequate quality system. In another instance, we outsourced our repair operation to an uncertified third party and the Registrar wanted at least one site visit to that location within a 3 year period.

In another job, we outsourced the sterilization of a product and the Registrar insisted on a site visit preassessment of the vendor because they did not yet have 9000 certification. Once they did, the Registrar backed off on visits.

These were two different Registrars, by the way.

So I guess the bottom line is, if the subcontractor has ISO certification, the Registrar doesn't require a visit, if they aren't, they may require a site visit.

My question is really about how my scope statement needs to read, and when is something officially "subcontracted"?
 
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