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

S

sausan23

#1
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 :)
 
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kuyakut

Involved In Discussions
#2
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
 
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