Do you have to be certified on PCQI to sign off on records in a manufacturing facility?
Do you have to be a certified individual to sign off on records?? based on FDA standards? Is HACCP sufficient?
I'm looking for the CFR and can't find it. Thank you in advanced!
Hi rgomez,
Yes, as per my knowledge no GFSI standard says that you have to have PCQI certified for signing the documents.
HACCP is definitely enough.
Even if we train somebody (delegating duty) to check/verify the records its equally valid. no auditor can challenge you (Keep that record in which you trained that employee to do it).
Thanks
Do you have to be a certified individual to sign off on records?? based on FDA standards? Is HACCP sufficient?
I'm looking for the CFR and can't find it. Thank you in advanced!
If you are a FDA regulated facility, subject to the PC rule in FSMA, then yes, records that deal with Preventive Controls must be reviewed/signed off by a PCQI.
If the record does not support monitoring or verification of a PC, then no.
Marshall
Do you have to be a certified individual to sign off on records?? based on FDA standards? Is HACCP sufficient?
I'm looking for the CFR and can't find it. Thank you in advanced!
Your question is complicated. You technically don't need to take the PCQI course however you do need to show proficiency. See other posts on this forum.
Like mgourly said - FDA records need to be signed off by a PCQI individual.