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2.3.1.4 - Documented Validation of New Equipment

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Kevin Oliphant

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Posted 30 September 2015 - 02:25 PM

During our recent recertification audit we received a minor on clasue 2.3.1.4.  We pack and distribute fresh fruits and vegetables - we really do not have any packaged products or ingredients and on our previous audits all that was required was a raw material spec register for FSC4 and FSC25 along with a commodity list.  We bought a Compac sorting machine and the minor came from not testing, recording trials and validating prior to using it.  The machine was validated at a later time.  The auditor says he is looking for a system to be documented to ensure this does not occur again.  Since we really have no product development, ingredients we have not had to previously write an SOP for this clause.  Does anyone have any suggestions for addressing the possibility we may add new equipment but we are not a processor or preparer of fruits and vegetables so we have no packaged products?



RMAV

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Posted 30 September 2015 - 02:46 PM

Doesn't matter in my opinion.  Do you recall the l.mono on the whole, uncut melons in Colorado?  A scenario much like yours where new equipment was brought in (or modifications done to existing equipment) was not validated or verified. 

 

If you don't validate and verify, people can die.





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