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

[Hanr3]

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.

 

[John Broomfield]

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?


Thx again!

Cris

Cris,

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

1. The application of your effective selection (and reselection) criteria including the supplier's ability to validate their welding process;
2. The specification of your requirements to provide evidence of validation in your purchase order (as negotiated with your supplier); and
3. 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.

 

[Caster]

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!

 

[Denis]

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

 

[Luis768]

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.

 

[w_grunfeld]

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

 

[Big Jim]

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?

 

[w_grunfeld]

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.

 

[John Broomfield]

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.

 

[1frenchie]

I think the point of this discussion has been missed.
What is a special process and how are they validated?
For my company we identify the following as special processes: Welding, coating (powder, ecoat, brush,....), plating, casting (AL and FE) all processes, Metton, heat treat,
A formal audit is performed on each of these processes annually by our team. For those suppliers that have a demonstrated history of compliance we reduce the frequency of onsite and allow for self audits to be performed and submitted.
As Willy suggested in his reply, AWS is the guide that should be referenced on all welding processes. Most importantly, although a lot of companies do not do this, is the use of a CWI for daily inspections and annual recert of welders. There are many community colleges that have a CWI onsite that will perform these functions in addition to training a member of your team to perform the daily inspections as confidence and capability increases.