Clause 7.5.2 (Validation Process)

Dear All,

Am working in Cable Manufacturing Industry.Raw material(copper,Insulating material etc) all test we carriaed out properly calibrated instruments,and while doing in-process in all stage output product we are testing in our lab,final product testing also we are doing.So in all stage we are doing the test and verified the product.Properly doing preventive maintenace for the machines,yearly calibration done for the instruments.Is necessary to do process validation for our company.

 

Hi,
Process validation is necessary when unable to verify the output products.But in every stage like raw material for cable,inprocess cable and final cable we tested and verified in our own lab.so i need to maintain the process validation records or not?

 

Clause 7.5.2 is intended for "special processes".
Note 3 of section 3.4.1 of ISO 9000:2005, i.e. definition of process, mentions "A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is frequently referred to as a “special process”.

From your description of the cable manufacturing processes, IMHO, don't fall on the definition as stated above. I believe you can claim exclusion on 7.5.2 for your cable manufacturing processes.

You can also use the ISO 9001:2008 Guidance on Application where it explained:

Example 8 – Validation of processes

Situation:
A small garment manufacturer carries out cutting work on textiles that are delivered to an internal sewing department for the next phase of the process. The quality of the output of the cutting work can be checked after finalization of the work. It has implemented a QMS and claims conformity to ISO 9001:2008 , with the exclusion of sub-clause 7.5.2 Validation of processes for production and service provision.

Issue(s):
Can the small garment manufacturer exclude sub-clause 7.5.2 Validation processes for production and service provision from its QMS and claim conformity to ISO 9001:2008?

Analysis and conclusion:
The organization is justified in the exclusion of the requirements of sub-clause 7.5.2 Validation of processes for production and service provision since it can inspect the result of the cutting process to determine conformance or nonconformance to specification.​

 

Hi Kavinraj,

I don't see any need to perform a process validation. The only potential requirement for this validation is when your customer(s) requires this validation. However, you could also just come up with a clever way to document the test results in combination with a witness test just before approval.
On the other end you could very well perform an audit every year or so to actually check if all the quality checks are performed during the process.


Good luck