Validation of Processes for Production and Service Provision - 7.5.2

B

baynoli

Hi everyone,

I just want to clarify on this clause of ISO 9001:2008, I may state the clause "The organization shall validate any processes for production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become
apparent only after the product is in use or the service has been delivered."

Can someone clarify me on this statement "where the resulting output cannot be verified by subsequent monitoring or measurement....."

Say in the production line every output will undergo checking and monitoring....is this what it meant by the standard? and by observation this is mostly the exclusion of most organization.

Hoping someone can enlighten me on this...

thanks everyone.

:):):):):D:D:D
 
Stijloor

Stijloor

Leader
Super Moderator
Re: 7.5.2 Validation of Processes for Production and service provision

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Stijloor.
 
C

csterling

Validation of Processes

Hello to All;

Can any one guide me on the following?

We are a contactract manufacturer and a customer is transfering a process for us to manufacture the device (medical) at our plant. The equipment have being validated and in use for many years (at the customer)...is it necessary or required for us to run a full IQ, OQ and PQ?

I understand that the IQ is a must; but I'm looking my way around to only perform a first article (FAI), testing or capability study to demonstrate that the resulting product at our plant is in compliance to requirements.

Thanks in advanced for all the help.

Regards.
 
A

arios

I would do IQ as a minimum, and depending on the risk and potential effect of the relocation of the equipment would also consider OQ/PQ, if not write a rationale why you don't think it is necessary to do OQ/PQ.

As acceptance criteria would consider at least equivalent, or better performance than before the transfer.
 
R

ravigupt2

Hi,

Clause 7.5.2 says: The processes, where it's output can't be inspected & the defect due to this process is detected at final stage. Then these types of processes should be validated by the organisation.
 
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