Hey everyone,
focussing on FSMA requirements, especially on PCHF rule, I have got one question reagarding the requirements applicale to the function of the PCQI.
Response 538 states after assessment of public comments (PCHF): "The rule does not preclude review of records by persons other than the preventive controls qualified individual, provided that the preventive controls qualified individual provides oversight for that review"
What is meant by "oversight"? The review of records on monitoring and corrective actions should be carried out within 7 working days.
On the assumption that an authorized person performs the review of records and signs and dates relevant documents, how is the proof of the oversight by the PCQI intended to be conducted in practice? Is a signature of the PCQI intended as evidence of oversight?
Thanks you for your help in advance!!
Lena