Clause 4.1 - What qualifies as an outsourced process? What controls are required?

[Rachel]

Hi everyone,

I'm new to this, so bear with me - this is my first post!

I'm trying to prepare the documentation for our company's switch to ISO 9001:2000. There's a section in clause 4.1 about outsourced processes, saying that where companies outsource processes that affect product conformity, the organization (that's me) has to ensure control over those processes.

Two questions:
1) What qualifies as an outsourced process? If, for example, we receive packaging materials (bottles, tubes, etc.) that are subsequently sent out for printing and then re-received when the printing is done, I think that's an outsourced process - although there's some argument at my end as to whether it is or not.

2) What is "control" over someone else's processes? Is that as simple as dock audits, or is that more like physically going to their site and auditing their process?

Any insight would be appreciated.
Ahhh, the quality manual....

Cheers,
-R.

 

[Rob Nix]

Welcome to the Cove, Rachel!

Outsourced processes are generally processes you would normally do, but may subcontract them when necessary. For example, we sometimes outsource design work, build of some subassemblies, or some painting.

There is sometimes a fine line, and some debate, between outsourced work and purchased product and services.

So, related to your point number 1, if you do not normally do the printing, it is not outsourced, but a purchased service.

Regarding control (point #2), the simple answer is: control outsourced activity exactly as you would internally (even using the same procedures).

I hope this helps.

 

[Craig H.]

Rachel

Let me be the first to welcome you to the Cove!!

OK, unless the printer is another part of your company, and will be covered within the scope of your certificate, then the work is being outsourced.

As far as control goes, it is up to you (and your management) to decide (identify) what is the most effective way for you to control those processes. I would think one would need to include some sort of specification (in the case of printing, maybe with each order, if it changes for each order) for the contractor to start with. Then, unless they are so good that you will allow ship-to-stock, you will need some way to verify their process output.

Do you need to do a site visit? Well, that is up to you, but if their work is important and they are a new supplier, then I would tend to say "yes" - but that is my decision for my situation. You need to decide what your company's comfort level is.

I think the main thing here is that you need to identify the "outsourcing situations" and make a conscious decision how you want to make sure you will get what you need.

Just my 2 cents.

Craig

Ok, not the first to welcome you, but welcome just the same!!

 

[Mike S.]

Welcome Rachel!

ISO says for the purposes of ISO 9001 that "outsource" and "subcontract" mean the same thing but don't really define either further. Regardless of whether you consider it a purchased item or an outsourced/subcontracted item you still need to ensure it is suitable for use/meets spec's. if it can affect the quality of the product or service you are selling to your customer. You can decide how to do that based on the importance of the item, history with the supplier, etc. Whatever level of control gives you the warm-fuzzy feeling that it is okay and your product will therefore be okay is what you should do. In our place that can mean anything from no further inspection because we have a history with the supplier and that product and the importance is low to 100% incoming inspection, and everything in between.

 

[SteelWoman]

We handle this by imposing the same standards on "OSPS' (outside processors/subcontractors) as we do on our vendors. We're a steel processor, so for instance if we buy from USST they have to be at LEAST ISO certified, per our procedures. Well, if we have to send some steel to a sub down the road to get slit for whatever reason, before it goes to the customer, that sub has to be at least ISO certified also.

 

[RoxaneB]

Wow...yet another Canadian...our numbers on here are increasing!

What qualifies as an outsourced process? If, for example, we receive packaging materials (bottles, tubes, etc.) that are subsequently sent out for printing and then re-received when the printing is done, I think that's an outsourced process - although there's some argument at my end as to whether it is or not.

In my opinion, yes, that is an outsourced process. We had a product sent to a Customer who subsequently complained about the product's quality. The documentation of this complaint showed that part of the resolution was having the product sent to another company for rework. Our external auditor deemed this to be outsourcing (and our manual states that we do not outsource) - no finding, however, because a quick investigation showed that the Customer had selected the other company, and not us. Ahhh...loopholes...gotta love 'em!

Basically, our external auditor said that an outsourced process is when we send out our product (at any stage) to have further work done it prior to the Customer accepting it.

What is "control" over someone else's processes? Is that as simple as dock audits, or is that more like physically going to their site and auditing their process?

And as the others have said, the extent of control is up to you. Obviously, it is not always feasible nor practical to station your own personnel at the other company to watch your product being made. Auditing them will work if your organization feels that is a good method to use to establish a baseline of their performance requirements. Inspection processes are also good.

Try a search in the Cove to see what comes up for Supplier Evaluation or Supplier Control.

 

[RosieA]

Hey Rachel, welcome to the Cove

I had some similar questions awhile back and a "neighbor" in the Cove sent me an ISO guidance document on outsourcing that I found helpful. I'll send it to you in a private message.

Simply, I think the ISO guys are most concerned about those outsourced items that have a large effect on your product. The example of outsourcing design work, given by Rob, is a good one. What could possibly effect the quality of your product more painfully than the design process?

My company outsources some of its manufacturing, and that too, has a high impact on the product.

The controls needed for this level of outsourcing are more intense than if you do a smaller impact process like printing, out of house. You'll need contracts spelling out review points, rules, data to be provided, etc. I think you can handle the smaller processes through your usual component supply procedures.

i hope that helps.

 

[Al Dyer]

Welcome,

Is the outsourcing for printing a requirement to meet customer requirements, which would be defined during product realization, or something as simple as having a company logo printed on shipping containers?



Al...

 

[eddie5659]

Hiya

I'm curently doing my first year of my IQA, so getting into the roots of things.

What I can say, is we are a major chemical company (CIBA in case anyone has heard of us). We do a lot of production on site, either in Bradford or worldwide.
Now, we do have one company I know of here, that produces some of our products under our recipes (not bought in products to sell under a new name) and we then export to Germany.
Now, not sure if they compliant as they're only a small company. I'm glad that this thread is here, as I can now mention it to my Quality manager.

However, one company that is a definate outscource (I think) is one we use for repacking of material.

We make chelates (powder) and pack them in 1 tonne containers. Now, as many customers require all sorts of packaging, we then send it to this other company, to repack them. They get sent back to us, and we send them on.

We check what its like before it goes (keep samples), repack it, check the repacked (keep samples) and away it goes.

If we get a complaint, but all samples of that batch were okay (ours and repacked), who gets the blame? Thinking us.

Gonna find out if they're compliant as well, on Monday.

Regards

eddie

 

[Wes Bucey]

Hiya

However, one company that is a definate outscource (I think) is one we use for repacking of material.

We make chelates (powder) and pack them in 1 tonne containers. Now, as many customers require all sorts of packaging, we then send it to this other company, to repack them. They get sent back to us, and we send them on.
Regards

eddie

Forgive my parochialism. Are "tonnes" the British spelling to indicate "metric tons" (i.e. 1,000 kilograms)?