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How to handle Outsourcing with Same Site - Separate Cert

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cshumway

#1
Since this is my first post (I have been lurking for months) I will introduce myself. I took over as Quality Manager In April of this year after the previous Manager was fired. I have been an ISO 9001:2008 internal Auditor for a couple years but this has been a new ballgame.

We made it through our first external audit with me as Manager and came out with only a couple suggestions! One was that we treat our purchasing and customer service processes as outsourced processes. To explain this is one site with two ISO 9001:2008 certifications. Let's say a Main Plant and a Secondary Plant. I am the Secondary Plant. The Main handles all of the purchasing / customer service. The Main has Divisional Procedures for those departments (Which I reference those in my Quality Manual), the Main also conducts yearly internal audits of these processes and the Secondary also send auditors there yearly. The external auditor goes to the Main every six months and to the Secondary annually.

To treat these as outsourced processes, would it be sufficient to state in my quality manual that these are outsourced, have the audits (internal and external) conducted by the Main plant sent to me for review (as a way to control the process), and stop the Secondary audits of these processes. Also then remove the measurements that the Secondary plant has for these processes. Auditing these processes twice a year feels like we are :deadhorse:


Thanks for the help on this topic and many many many others.
 
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William_55401

#2
Welcome! I think you are on the right track with your plan. The only suggestion I would have is to ensure your site also participates in management review at the Main so you have visibility to how they view the performance of the Purchasing and Customer Service processes that you rely on. This demonstrates a close connection between the sites. Good luck!
 

somashekar

Staff member
Super Moderator
#3
Main or secondary is only for you within your internal management. For the CB, when they audit you, they will simply need to see what controls you exercise on the outsourced entity (The Main) that meets your purchasing requirements.
So all your interactions that you do with the Main in terms of purchasing activity, (evaluation and selection / purchasing communication / supplier corrective actions when necessary / inspection, acceptance of supplied parts) must have your grip and directions that you can demonstrate. These become your live control over purchasing process which is outsourced.
You do not have to audit them, if you do not say that your audit is one of your way to exercise control over the main on purchasing. The main plant being an ISO9001 certified is in itself a good step in right control direction.
Likewise for your customer service also .....
Identify and document what specific controls you have put in place (jointly with the main plant participation) for each of these processes to be working well and good for you. Be able to show / demonstrate these with appropriate records.
The Main has Divisional Procedures for those departments (Which I reference those in my Quality Manual),
Why do you want to do that and complicate your documentation when it does not belong to you. The main plant being ISO9001 assures that they have decent procedures for purchasing and customer service, which you have found good to be outsourcing on them these processes.
The only suggestion I would have is to ensure your site also participates in management review at the Main so you have visibility to how they view the performance of the Purchasing and Customer Service processes that you rely on. This demonstrates a close connection between the sites.
I am not sure if you can get into the management review process of the main plant. But for the controls needed on outsourcing, this may be a far reach and not really needed from your QMS view point.
 
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Big Jim

Super Moderator
#4
I see no benefit to you as a company to treat this as outsourcing. Their may be some benefit to the auditor (easier to audit?).

Unless you see how you can benefit from it, simply remember that suggestions (including observations and opportunities for improvement) and just suggestions. You do not need to respond to them. As a courtesy to the auditor, and showing respect for his ideas, show in a management review that they were discussed but determined that they were of no benefit. Auditors tend to be somewhat offended if you simply ignore their suggestions.

If you see benefit from the suggestions, then by all means see it through.
 
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dksfwmcc

#5
For me the last reply is spot on.

As it is a suggestion stand back & look at how any change will benefit both your (secondary) plant & the company as a whole.

Then either do, or do not do something.

If after careful considerations you are not going to do anything I would strongly advise that you email your auditor with your response explaining why not (as you would do with a minor/major finding). Although not actually required it often shows the auditor you are pro-actively considering their points & not just 'doing nothing as you have not had time' come the next external audit. Thi sapproach tends to make subsequent audits run much more smoothly.
 

somashekar

Staff member
Super Moderator
#6
We made it through our first external audit with me as Manager and came out with only a couple suggestions! One was that we treat our purchasing and customer service processes as outsourced processes.
Dear cshumway ...
Can you tell us here how the external audit of purchasing and customer service processes went about in your first external audit, before the suggestions were made .... ?
 
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cshumway

#7
Firstly I'd like to apologize that it has been months since I looked at the wonderful responses that everyone provided. Please forgive me on the delay, as other duties at work have prevented me from focusing on this. But I will have the focus now..
When the external auditor comes he audits both the main and secondary plants at the same 2 day time frame. The main plant gets audited 2 times a year and the secondary only 1 time. So depending on what he has audited before he will only hit D&D/Purchasing/Customer Service once. When he does audit them he goes in with a general mindset of both plants.

When I took over this system the Secondary and Main had separate procedures for those processes but utilized the same personnel in those departments. So the secondary/main have different ways to handle customer complaints (depending on who takes them) to me there is mass confusion on how to handle certain things that arise.

To handle our joint D&D/Purchasing/Customer Service I could treat them as outsourced, be included in the internal audits/MGMT reviews. The main plant would be responsible for keeping those areas informed about their metrics along with scheduling the internal audits. Currently those processes are audited internally 3 times a year (for really no reason, they don't provide more issues that necessary). I feel like in areas where there is this overlap we should simplify this. But how exactly do I handle it with my secondary (separate cert) site? State in the quality manual that the main plant handles the procedures for these? Or am I again totally off base?
 
S

sadamson

#8
Hi I am in the same predicament.

We are a medical store that procures, stores and distributes products. We are ISO 9001 certified.

We have now outsourced the warehousing and distribution function. Procurement / finance / QA / overall management stays with the store.

My question is how does the outsourcing fit into our QMS.

For example: Document control and SOP's

Do we insist that our current SOP's are to be used and that the outsourced body can modify but that the changes, structure of the documents and the control of such are done through the store management or do we let them have their own system.

My concern with the latter is that there are a lot of interactions between the store and the outsourced body e.g invoices flow between receiving and finance department. To follow the process one would have to look at their SOP up to a certain point and then look at the stores SOP to continue the process of invoice payment.

It may also arise that if the outsourced body makes changes the store may not know and vice verse and soon there would be a bit of a mess. How would we know that they comply with ISO requirements without extensive audits?

Same with training / auditing / corrective action / strategy development etc. Do we insist that the outsourced body fits into our QMS or do we insist that they develop their own QMS?

I would appreciate guidance, thanks.
 
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