Exclusion from Validation of Processes for Production and Service Provision?

[SteelWoman]

Hey ya'll (gee, can you tell I'm from Bama? ) I just got a copy of an ISO cert newly issued to one my suppliers of raw material (steel) and noted that they claimed (and apparently got) an exclusion from "Validation of Processes for Production and Service Provision". Hmmm.... I gotta' say this is a first for me - I've never seen/heard of anyone even attempting to justify an exclusion from that clause. Have you? And if so, what was the basis for the argument?

[Rob Nix]

I haven't personally run across it, but see example #8 at the web site below

http://web.archive.org/web/200503081...plication.html

I hope it helps.

[SteelWoman]

Hmmm... thanks for the direction - I read the example and I guess I understand what they're saying, but.... I don't know, maybe this is okay but I've not read any interpretation or guidance or HEARD anything that indicates this clause could really be excluded by anyone. interesting...

[fuzzy]

SteelWoman,

My first post so please excuse...I'm pretty sure this is the 2000 version (7.5.2) of the 1994 clause regarding special processes - my old definition being processes that by their nature can be validated only by destroying the product during the inspection, i.e. welding was the classic example. Hence the list of "arrangements" such as qualified personnel (certified TIG welder), approved equipment (weld unit #7), specific methods (SOP-75-TIG), etc.,etc.

Along the lines of this concept, you would need knowledge of your supplier's processes to know if this exclusion is actually valid in your opinion. Apparently the supplier convinced their registrar...

[Sidney Vianna]

Originally Posted by SteelWoman

Hmmm... thanks for the direction - I read the example and I guess I understand what they're saying, but.... I don't know, maybe this is okay but I've not read any interpretation or guidance or HEARD anything that indicates this clause could really be excluded by anyone. interesting...

In principle, any clause (sub-clause or requirement) within section 7 of ISO 9001 can be considered for exclusion if it does not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

So, if my product realization processes are always able to be monitored by testing or inspecting the (Intermediate and finished) products, then it is perfectly OK to claim an exclusion to 7.5.2.

[John E Hopkinson]

I actually don't audit anyone who does not exclude that clause - most companies can verify the resulting output of the process. The clause says where you cannot validate the item you must validate the process, so if you can validate the item you must do that and not the process.

[Cari Spears]

Originally Posted by Sidney Vianna

So, if my product realization processes are always able to be monitored by testing or inspecting the (Intermediate and finished) products, then it is perfectly OK to claim an exclusion to 7.5.2.

We claim exclusion to this. We just machine and assemble - no special processes.

[serggie]

If we employ a series of verification inspections and validation tests before we install/deliver the final product(s) to customer, can we exclude the requirement validation of processes for production and service provision knowing that we have already identified and corrected mostly the major deficiencies early on? while we are still developing the product? I would appreciate if you can offer some advice. Thanks a lot!

Regards,

Serggie Tabanao