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Exclusion from Validation of Processes for Production and Service Provision?

J

JaneB

#11
#11
serggie said:
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.
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I know this thanks. I still think you're posting in the wrong forum.
 
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S

serggie

#12
#12
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.
 
Colin

Colin

Quite Involved in Discussions
#13
#13
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 ...'
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#14
#14
In Aerospace, the natural candidates for process validation requirements are the ones, currently listed here. In your specific case, from a hardware perspective, these 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?
 
J

John E Hopkinson - 2010

#15
#15
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.;)
 
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D

Diego Cely

#18
#18
actually under this scenario, where your are fabricating the components for your final products, the sub-clause 7.5.2 Validation of processes for production and service provision. cannot be claimed as exclusion
 
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