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/20050308...o9000-14000/iso9000/9001_2000application.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]

The old "Special Processes" clause?

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]

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 - 2010]

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]

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

 

[JaneB]

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

Serggie, I couldn't even begin to offer any useful advice here because there's just not enough info to make a reasonable decision on & thus respond. I also wonder if this is in the wrong forum - this one's for SERVICE industry topics, yet you keep referring to 'product'. I'd try the 9001 forum instead. And provide more information.

 

[serggie]

Hi Jane! I believe that the term "product" is applicable to both tangible commodities and services knowing that its definition is a result or output of a process after converting all inputs. Refer to ISO 9000:2005.

I am just hoping to get some sensible advices if we can exclude the requirement "validation of processes for production and service provision - clause 7.5.2 of ISO 9001 & AS9100" since we use multiple verification and validation tests to make sure that our end product conforms to all identified requirements. Meaning, we will only install our system/product into the aircraft until we are sure that it serves its purpose and satisfies all the functional requirements from customers. Perhaps, we can say that we don't need to validate the processes for production or service provision since our resulting output can be verified subsequently by constant monitoring and in-service support.