Validation of Processes - Is Cl 7.5.2 applicable to bricktile firing in an oven?

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arin_23

Re: Is Cl 7.5.2 (validation of processes) applicable to bricktile firing in an oven?

thanks to all of you guys...

actually that was my premise before, we already setup everything. But our CB auditor said it is not enough, we must show other evidence that it is controlled since it is a special process.

But now I am enlightened, thanks a lot.:thanx:

So the final call is you are going with 7.5.2.

I was indisposed for last couple of days. And could not reply to your last post. It was nice to see how Helmut, Harry and Big Jim has arrived at a decision based on the inputs provided by you. There lies the bauty of cove.You are destined to get a good reply against all of your questions.

Happy implementation.

Regards,

Arin
 
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w_grunfeld

Re: Is Cl 7.5.2 (validation of processes) applicable to bricktile firing in an oven?

I know it won't help much with the auditor, but I cast my vote with the others. You have validated the process by fine tuning the "recipe' and demonstarting once that it is "capable" (of producing conforming product). All you have to do is to keep records (as mentioed by others) to monitor that the key process parameters are within spec
 
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mcenyll

Re: Is Cl 7.5.2 (validation of processes) applicable to bricktile firing in an oven?

thanks guys, I might as well be prepared with my answers and evidences during our surveillance audit that we are already controlling our process in accordance with the requirements. I will see how the CB will react next time.:thanks:
 
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