Special Process Validation - ISO9001 Clause 7.5.2 - How do I go about it?

S

Superchris

#1
Hi all!

Long time listener first time caller:D

As I'm writing our Quality Manual, I'm wondering how I should cover section 7.5.2. The only "special process" we have is welding and it is out-sourced.
Should I just say that the process is validated through our Supplier qualification-evaluation process?:eek:

Thanks a million!:thanx:
 
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S

SteveK

#2
Re: 7.5.2 : How do I go about it?

Note form my QM might help:

7.5.2

XXXXXX's products involve basic hand assembly operations; all the resulting assemblies and sub-assemblies are monitored or measured throughout the process. As such the resulting output can be verified. This sub-clause can therefore be excluded under Module E for BS EN ISO 9001:2000.

An external auditor (recently) seemed quite happy with this.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Re: 7.5.2 : How do I go about it?

Should I just say that the process is validated through our Supplier qualification-evaluation process?
That would not fly with me. Since you are outsourcing the process, you are still responsible for ensuring that the process is validated and revalidated. What is the criteria for process validation? How do you ensure the supplier has validated the process? Do they have records? Do your purchasing documents clearly stipulate this as a requirement?
 
S

Superchris

#4
Re: 7.5.2 : How do I go about it?

That would not fly with me. Since you are outsourcing the process, you are still responsible for ensuring that the process is validated and revalidated. What is the criteria for process validation? How do you ensure the supplier has validated the process? Do they have records? Do your purchasing documents clearly stipulate this as a requirement?
I would guess that the only way for us to validate the process is by measuring customer complaints related to the welding. Keep in mind that the whole reason we outsource this process is because we do not have the "know how" in house. This is why I think the only real power we have over this process is limited to the selection of the supplier (making sure they have procedures, controls, records, etc. in place)
:confused::(

Thanks again!:thanx:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: 7.5.2 : How do I go about it?

I would guess that the only way for us to validate the process is by measuring customer complaints related to the welding.
That is incorrect. Can you imagine if you were welding high pressure piping in the primary cooling system of a nuclear reactor? Would you wait until you have a "radioactive spill" before you validate that process? Depending on the type of welding you are doing, there could be many different types of validating a process. Pressure containment weldments, structural components welding are critical. Most standards will have criteria for welding process and welder qualification.

On the other hand, some welding processes do not raise to the category of "special process", thus, don't need to be validated at all. There is no one-size-fits-all scenario here.
 
S

Superchris

#6
Re: 7.5.2 : How do I go about it?

On the other hand, some welding processes do not raise to the category of "special process", thus, don't need to be validated at all. There is no one-size-fits-all scenario here.

I think this categorizes my case. :bonk:

By reading other posts, I was under the impression that welding = special process. However you're explanation makes much more sense.

Thanks!
:D
 
H

Hanr3

#7
Since your outsourcing it to the "experts" let them provide the evidence that thier process meets your specs. Ask them to validate thier process and provide evidence that is build is up to spec. If they are a quality shop, they no doubt already ahve controls and records in place, especially if they are ISO Certified.
 
S

Superchris

#8
Since your outsourcing it to the "experts" let them provide the evidence that thier process meets your specs. Ask them to validate thier process and provide evidence that is build is up to spec. If they are a quality shop, they no doubt already ahve controls and records in place, especially if they are ISO Certified.
Sorry to be so hard headed but wouldn't this prove my initial point that the only real power I have over my welding process is in the selection of the supplier?
:frust:

Thx again!

Cris
 
H

Hanr3

#9
Yes and No.
Yes you have control over who the vendor is.
No that is not your only control in the process.

You have product specifics that must be meet. Your vendor is the expert, they will know the questions to ask you about what you expect from them.

Let's say you need a transmission for an old car your going to rebuild.

You can choose 1 of a 1,000 different places to get the tranny. Local salvage yard, dealer, independent shop, Uncle Buck, nieghbor, or some guy you just meet on the web. How do you whittle that list down? Vendor certification process.

Let's say for simplicity sake you decided that I might be the vendor.
I will ask you for the year, make, model, engine, and intended use of the vehicle. Each answer will point me in a different direction. To keep it smiple lets say your vehicle is an old S10 Blazer and the engine is a 4.3L V6, you want an automatic and the truck is a 4x4 used mostly for hunting and winter weather driving. That tells me that your looking for either a 4L60 or 4L60E tranny. If the truck is a '93 or newer your looking for a 4L60E. Pre '93 you will need a 700R4 or 4L60, roughly the same tranny and you wont know the difference once its rebuilt. Being that it will see off-road use I will ask if you plan to tow a trailer? If you have a boat you will pull with it in the summer I will suggest a shift kit, kevlar clutch packs, auxilary tranny cooler, and larger oil pan. Now we can talk price and reliability. You agree and we have a deal. I build the tranny and deliver. What kind of certification would you like me to provide to verify or validate that I build the tranny to your specs? Do you want to inspect the build process? Do you want me to provide checklists or inspection records of the build process?

Sure picking the vendor is part of the process, however the vendor must know the industry and must be able to provide records as needed. In the case of the tranny I could provide you with our test records. The test records are taken as the tranny is being assembled and after final assemble. During assemble we measure things like gaps between cluth packs, verify gaskets are facing the correct direction, we air test each clutch pack prior to the valve body being installed. And Finally we hook the tranny up to a test machine and verify that all pressure readings are within spec, and the tranny shifts as expected.

There is more to it than picking a vendor. You still have to provide them with teh specs they must meet. A good vendor will know the industry and can help you ask the right questions.

One last thing, before you hang the tranny on the engine get a new torque converter, put tranny fluid on teh input gasket before you install teh torque converter, and blow out the tranny cooler lines / tranny cooler so you don't introduce dirt into the clean tranny and destroy it. Failure to do so will violate your warrenty.

I hope that helps.
 
H

Hanr3

#10
Whew!
Allright, now how does all that tie into ISO?

This is what your looking for as an answer correct?
Simple.
7.2.1 Determination of requirements related to the product- should be negotiated between you and the customer.
7.2.2 Review of Requirements Related to the Product- between you and your vendor.
7.3 Design and Development- specifically 7.3.5 and 7.3.6 Verification and Validation. Your vendor must be able to Verify and Validate their proces meets your specs, just as you do for your customer.
7.4 Purchasing ensures you are using an Approved Certifed Vendor.
7.5.3 Identification and Traceability- if you have a return from your customer you must be able to trace the problem, and if that trace leads you back to your vendor then they must be able to trace the problem on their end. You will look for them to do a CAR and replay to you with the root cause which you will use to reply to your customer for your CAR and root cause.
7.4.3 Verification of Product- you will inspect the product to ensure it meets your specs prior to use.
8.2.3 & 8.2.3 Monitoring and Measurement- you will audit your vendor to ensure they are still meeting your expectations. Prior to approving a vendor you should conduct an audit to see how they handle everything I pointed out so far.
and finally.
8.5 CAR's do they have a process in place to address the root cause of problems?

Selecting an approved vendor isn't a quick and simple process in most cases. It can be if they are ISO certified.

Your control of the outside vendor is in more than one section of the ISO Standard, you need to make sure you address it in each section.
 
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