PCHF Rule- "oversight" review of records PCQI
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
It's just a provision to say that if you're at a large company, your designated PCQI doesn't need to do everything. Someone they train to do records review could do so.
It's why all of my SOP's for verification say "QA Manager or designee". :)
I see it as the PCQI does not have to do perform every detailed task, but has to have oversight over whoever is the designee verifying documents. I am sure the PCQI's oversight could be verified by internal audits of the documents the designee is signing off, as opposed to your PCQI also signing the same document (double verifying? they would still be doing all the work so what would be the point?).
Thanks for your answers!
The definition of oversight is not yet clear to me. A "double verifying" would involve a higher effort (time, personnel) and wouldn't be meaningful in this case . Still, I wanted to make sure I'll be on the safe side providing some kind of justification and the proof of training employees on records review and assigned tasks?
The documentation of the "oversight" is such a sticking point, because usually it is called "what was not documented, was not done". I do not know, whether the review of records by the PCQI in the course of the internal audits is sufficient (twice a year)- The PCQI would only sample-proof the documents- would that be enough?
Thanks for your answers!
The definition of oversight is not yet clear to me.
Maybe a better way to describe it would be like management review/commitment in the other FS schemes. While our VP's do not respond and address complaints themselves, they have oversight in that they set the policies that we enforce when addressing, and review the trending data regularly.
With respect to documentation, I would say that the PCQI has a responsibility to establish the standards/policies that the documents are reviewed under, and need to demonstrate that they take steps to ensure those standards are followed. Either by training the staff that performs the review, monitoring data trends (e.g. errors per document), or conducting internal audits like you described.
I interpret "oversight" as in the designated PCQI should have the principal role in monitoring the effectiveness of the food safety plan, which includes how well all the individual verification are functioning etc., but does not necessarily need to perform all of those checks, just know that they are held responsible for them being conducted effectively.