Re-validation NCR - In which cases re-validation of processes is required

S

sausan23

Hey everyone,

After API conducted audit, they issued 1 NCR to us regarding re-validation process.

Non conformance/Concern Description
The procedure does not state in which cases re-validation of processes is required.

Can anyone send me sample of re validation procedure plz.

Our score is NDT inspection and thread repair.

Thanks in advance :)
 

kuyakut

Involved In Discussions
Re: Re-validation NCR... PLEASE HELP

Hi,
You can add these in your validation programme procedure
Re-validation is required for crucial equipment and/or for
the following changes and condition;
- Changes to / of the equipment
- Location (Machine / Site)
- Validated controlled process parameters (changes on
non-controlled parameter , revalidation is not required)
- Supplier / Material
- Environment
- Product design changes​
- Negative trend in quality indicators

Kuyakut
 

Eredhel

Quality Manager
I'm becoming more and more familiar with API, could you let us know which section of it they cited the NC to?
 
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