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?:o

Thanks a million!:thanx:

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.

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?

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:

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.

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

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.

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

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.

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.

You could always ask for a certificate of compliance. That should work. It would depend on the welding shop and how critical the welds are. Would it be a safety issue? You see what I mean?

MsHeeler

You could always ask for a certificate of compliance. That should work. It would depend on the welding shop and how critical the welds are. Would it be a safety issue? You see what I mean?

MsHeeler

I agree to disagree here. The Certificate of Compliance is just a piece of paper that give the warm fuzzy feeling to the Customer. It would not hold water under a Court of Law, but again, I am not an Attorney.

The criticality of the welds should be the driving force on the validation of the process. Each circumstance is different. We weld parts and assemblies, but we do it under the AWS D17.1:2001 standard. We also have done some Navy work that required us to weld in accordance with NAVSEA. It really depends on the circumstances and the Customer's requirements.

Superchris, about it just being controlling a supplier.

OK, if you say so.

Sometimes controlling suppliers is more involved than other times.

I think that most of your problem is a lack of understanding of what special processes are, why they need to be validated, and how they can be validated. Let me try to explain.

Special processes are those that you cannot tell the quality or outcome from monitoring or measuring. Validation is performed to demonstrate the ability of the process to achieve planned results.

How can you determine if it has the ability to meet planned results if you cannot monitor or measure it?

Let's take the example of a fire sprinkler. You cannot tell if it will work without heating it and setting it off. Once you do that it cannot be sold as it has already been consumed.

Now you can validate it by determining exactly how to build it by building them over and over again and destructively testing them until you determine exactly how to do it so that the results are repeatable. By then you have determine the exact process or "recipe" that can provide repeatability.

Monitoring that process, (the recipe) the exact materials, exact quantities, exact times, exact temperatures, and so on can provide validation of that process.

Another example is welding, the one you are involved with.

Welding is usually validated by certifying the welder. The quality of a weld cannot be determined without destructive testing. The weld is pulled apart to determine if the break forms at the weld or from the parent material. If it pulls from the weld, it was not properly joined. Since you cannot use a weld that was destructively tested, the welder is trained and then he welds samples that are sent to a lab for various testing including destructive testing. If the welds pass, the welder is certified. This is a bit of an oversimplification as it does not cover the extensive training. Also, the certification is specific to the material, thickness, type of joint, and position of weld (gravity effects the weld puddle so overhead, side, and flat are all different).

To control a supplier for special processes can entail confirming that the welder is certified and his certification covers the type of welding you are having performed.

For plating it can be from the supplier certifying that he followed a specific MIL spec (the "recipe").

For either one you may want visit the supplier and confirm that they actually have the ability to perform what you are after.

Big Jim,
That is an excellent explanation of the Validation process. I prefer to use home brewing beer for an example. For some reason it gets peoples attention. :beerdive:

To the original poster, seems you have at least two members that have knowledge of welding. Might be a good source of information? :read:

But you can verify the quality of the beer. You can taste test it.

I agree to disagree here. The Certificate of Compliance is just a piece of paper that give the warm fuzzy feeling to the Customer. It would not hold water under a Court of Law, but again, I am not an Attorney.

The criticality of the welds should be the driving force on the validation of the process. Each circumstance is different. We weld parts and assemblies, but we do it under the AWS D17.1:2001 standard. We also have done some Navy work that required us to weld in accordance with NAVSEA. It really depends on the circumstances and the Customer's requirements.

That sound a lot like what I said with a few flurishes dosen't it? :bonk:

MsHeeler

Correct, however once tasted you cannot sell it. You can sample some of the product to ensure the process worked as expected. However you cannto sell what has been tested.

That sound a lot like what I said with a few flurishes dosen't it? :bonk:

MsHeeler

It was more about the CoC that I disagreed with.

But you can verify the quality of the beer. You can taste test it.

I agree with Big Jim!

Beer (samples) can be tasted, smelled, chemically analyzed, and will not render the product unsellable. Thus the provision for "Special Process Validation" does not apply.

Stijloor.

Can we try to stay on topic please.

I agree with Big Jim!

Beer (samples) can be tasted, smelled, chemically analyzed, and will not render the product unsellable. Thus the provision for "Special Process Validation" does not apply.

Stijloor.

Except for smell, all of those tests are distrcutive in nature. Once tested you cannot sell the sample product. To validate the sprinkler head process you also sample test. Again, a distructive test thus making that head unsellable.

TO make beer you follow a recipe, one that has been worked out by trial and error to ensure the end result is what your after. There is no test to ensure the wort will achieve the final result. Yeast plays a major roll in how the beer tastes and smells. There are thousands upon thousands strains of yeast. You have limited control over the yeast, it is a live organism. You know it thrives on sugars, and thus feed it. Not enough yeast and the beer will not ferment properly, useless product. Too much yeast and you could be looking at a gusher, thus spilling all your product onto teh floor making it useless. During the tail end of boiling the wort you can add in flavor by steeping hops or other adjuncts. However there again is no test you can conduct to ensure how much flavor is being added. Only through the process of trial and error will you arrive at a process that works, and is repeatable.

As with the sprinkler head example, beer making is done via trial and error. During each stage of the process you can change the final product. Why do you think commercial brewers pay people to taste test beer during each stage of the process. To help contol the final product. There is no magic science test for smell or taste, two of the most important atributes of beer. The final smell and taste of beer is controlled by the process, a process that is determined by trial and error. Hell, there is no garuntee that using the same ingredients will result in the same flavor from one batch to the next.

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

Cris,

The way I see it you have at least three points of control over your welding supplier:


The application of your effective selection (and reselection) criteria including the supplier's ability to validate their welding process;
The specification of your requirements to provide evidence of validation in your purchase order (as negotiated with your supplier); and
Your organization's decision to pay for work that fulfills the purchase order requirements including any specified paperwork.


Being as ISO 9001 is the American Quality Management System Standard you would be within your rights to use it as part of 1 or 2 above without any reference to certification.

Big Jim

Thanks - that is about the nicest explanation of special processes and how to deal with them I have ever seen. Clear, simple, to the point and very well written!

Some of the key aspects in determining any validation work should be drafting up a User Requirement Specification (URS). This URS should detail all the aspects that you require , in this case the welding service from the supplier.

Get the supplier to agree and sign up to this document - it can be discussed and amended by both parties until final agreement is reached.

The URS forms the basis for the acceptance quality and key characteristics, which should form part of the OQ /IQ/PQ stages.

In this instance the key quality characteristics that will form the validation of the process would be (not totally inclusive, but you'll get the idea).

Materials used
Equipment used to perform the welding
Training records of welders
Competence of welders
Drawings
Acceptance criteria - visual and destructive test reports
Customer work instructions (demonstrating adequate control)
Design of the article being welded - engineers report into structure and stresses etc


I could go on , but would need more specific details etc

Hope this helps

We are also making the supervision on welding activities, by otsourcing the process, you only need to make sure that the welding inspector has an external supervision. for example the NDT are made by another company in our case. So if the visual inspector who works for the same company that is making the weldings is not doing his job well, the NDT company will find many mistakes above the normal ratio of rejections. But this is a process that you have to include in your quality manual.

I agree with Big Jim!

Beer (samples) can be tasted, smelled, chemically analyzed, and will not render the product unsellable. Thus the provision for "Special Process Validation" does not apply.

Stijloor.
I am not sure why serious people turn serious questions into jokes.
Beer doesn't have a requirements specification any more than grandma's chocolate cake
On a more serious note, first off welding should be specified on your drawings in terms of an AWS or similar standard.
If that is the case the same standard usually includes a chapter on the process validation or references another standard for it : it includes the welder's certification and that of the process
You may select an outside source that has already been certified by an objective third body or reputable second party (and have cerificates attesting that).
Or select to cerify the supplier yourself-for this you need a checklist drawn up according to the respective weldimg specification and it usually involves welding samples that have to pass certain criteria plus on site auditing of the process (to make sure it is properly controlled)
Once you have that on file, all you need is to control the quality of welds being supplied to you. Depending on the criticality of the weldments this could be as simple as visual inspection and up to radiographic inspection

I am not sure why serious people turn serious questions into jokes.
Beer doesn't have a requirements specification any more than grandma's chocolate cake
On a more serious note, first off welding should be specified on your drawings in terms of an AWS or similar standard.
If that is the case the same standard usually includes a chapter on the process validation or references another standard for it : it includes the welder's certification and that of the process
You may select an outside source that has already been certified by an objective third body or reputable second party (and have cerificates attesting that).
Or select to cerify the supplier yourself-for this you need a checklist drawn up according to the respective weldimg specification and it usually involves welding samples that have to pass certain criteria plus on site auditing of the process (to make sure it is properly controlled)
Once you have that on file, all you need is to control the quality of welds being supplied to you. Depending on the criticality of the weldments this could be as simple as visual inspection and up to radiographic inspection

Wally,

I call on companies in the flavors industries. I can assure you that they are extremely concerned with the consistancy of their flavors. Consistancy is one of the definitions of quality. The flavor company I'm speaking of runs a gas chromatograph analysis followed by an aroma and flavor test by at least three qualified personnel before they ship. There is even more to it, but you get the idea.

Beer companies do indeed check their product for consistancy before they ship it, including taste testing samples. Why would they not want to make sure of the consistancy of their product?

I don't argue that they are not concerned about the consistency of their flavour or that they do not run continuous quality checks, This hower is NOT VALIDATION OF SPECIAL PROCESSES in the ISO sense.
I think it was you or someone else who pointed out that the taste and chemical composition of beer can be inspected 100% after it has been produced -so it is not a "special process" like welding or painting, for which you need destructive tests to fully assess their compliance to specifications.

If you want to reduce the costs of inspecting and testing the product than validate the process so you do not have to waste money verifying the product after it is made.

Better still, design the production process per the requirements of clause 7.3. Invest in preventing defects and nonconformity and reduce the costs of appraisal (sorting good product from bad) and the high costs of failure to meet requirements.

Any organization that relies on checking its products for quality is doomed.

No longer is QC about inspection and testing; it is about controlling processes to result in conforming products.