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

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  Post Number #1  
Old 21st July 2017, 04:03 AM
sausan23

 
 
Total Posts: 4
Please Help! Re-validation NCR - In which cases re-validation of processes is required

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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  Post Number #2  
Old 21st July 2017, 04:45 AM
kuyakut

 
 
Total Posts: 114
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
  Post Number #3  
Old 21st July 2017, 06:50 AM
sausan23

 
 
Total Posts: 4
Re: Re-validation NCR - In which cases re-validation of processes is required

Thank you so much, i hope they will accept this answer
  Post Number #4  
Old 21st July 2017, 07:34 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,662
Re: Re-validation NCR - In which cases re-validation of processes is required

Quote:
In Reply to Parent Post by sausan23 View Post

<snip> After API conducted audit, they issued 1 NCR to us regarding re-validation process. <snip>
What standard were you being audited to?
  Post Number #5  
Old 21st July 2017, 08:02 AM
sausan23

 
 
Total Posts: 4
Re: Re-validation NCR - In which cases re-validation of processes is required

Quote:
In Reply to Parent Post by Marc View Post

What standard were you being audited to?
Marc,

API Q1, ISO 9001 & API 7-1, 7-2
  Post Number #6  
Old 21st July 2017, 11:52 AM
Eredhel

 
 
Total Posts: 292
Re: Re-validation NCR - In which cases re-validation of processes is required

I'm becoming more and more familiar with API, could you let us know which section of it they cited the NC to?
  Post Number #7  
Old 25th July 2017, 02:12 AM
sausan23

 
 
Total Posts: 4
Re: Re-validation NCR - In which cases re-validation of processes is required

Quote:
In Reply to Parent Post by Eredhel View Post

I'm becoming more and more familiar with API, could you let us know which section of it they cited the NC to?
clause 5.7.1.5f
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