Hey ya'll (gee, can you tell I'm from Bama? :D) 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?

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

http://web.archive.org/web/20050308102851/http://www.iso.org/iso/en/iso9000-14000/iso9000/9001_2000application.html

I hope it helps.

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...

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...

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.

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.

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.

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

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.

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.

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 know this thanks. I still think you're posting in the wrong forum.

I think I am in the correct forum wherein the topic here is about exclusion from validation of processes for production and service provision. And this clause 7.5.2 is common to both ISO 9001:2008 and AS 9100C:2009.

Serggie, I think you are answering your own question!

Clause 7.5.2 refers to a situation where you cannot verify the output of a process by subsequent monitoring and measuring. If you can, this does not apply and can therefore be excluded.

One thought I would offer is that if you are dealing with AS9100, I presume you are involved in aerospace so you are operating in a high risk industry (in terms of the consequence of failure) and to make sure that there are no situations where '... deficiencies become apparent only after the product is in use ...'

In Aerospace, the natural candidates for process validation requirements are the ones, currently listed here (http://www.pri-network.org/Special-Processes.id.858.htm). In your specific case, from a hardware perspective, these (http://www.pri-network.org/Electronics.id.864.htm) are the most likely ones. Additionally, not exactly what you are asking for, but how do you validate the software that is embedded in your product?

The standard states that where the output cannot be verified by subsequent testing, then you must validate the process. So if they cannot, then they must. If they can, then they can exclude it. It is the most common exclusion I see.;)

So if they cannot then they must if they can then they can exclude it. What?:confused:

What?:confused:

See edited version....;)

Stijloor.