PCQI - Independence/who can serve in this role?

Hello -- fairly new member, and my company is have a debate with outside consultation on whether I, as the HARPC/HACCP/Food Safety Plan Team Leader, can also be the PCQI.  They are questioning whether having me in both roles allows for the appropriate independence/checks-and-balances philosophy that the FDA is going for.

Any thoughts?  I can anoint someone else to lead the Food Safety Team, and be the PCQI, but that seems pointless since I will still need to be on the team.

Thanks,

Robyn

Hello!

I don't know for sure, and I hope someone else weighs in if they have a different opinion, but perhaps a good way to alleviate the problem would be to have 2 people with the appropriate training to act as PCQIs.  This would provide a good base for development of the preventative controls plan, and as long as both people are appropriately trained, I cant imagine there would be an issue.  I don't recall seeing a requirement that there is only one PCQI, and I think the argument could be made that the "checks and balances" would be more effective with multiple team members with the same knowledge base.

Hope that helps!

Hello - I just don't have the luxury of two PCQI's (only a very small part of the business is food) -- BUT, you've got me thinking that we could have someone at corporate be sort of a 'regional' PCQI who is involved or provides oversight in some way.

Thanks!

Good morning,

I've been utilizing his great site for year and just recently set up the log in credentials-

My understanding is that the PCQI is the most knowledgeable about food safety and has the oversight of the program development. I would think the FS Team Leader and PCQI is one in the same.

Below is  copied from FSMA FAQ's (Preventative Controls -Question 5)

PC.5 What is a preventive controls qualified individual?
This is a new term in the final rule. A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review. 

Hope this helps

I would strongly suggest that you be the PCQI. The PCQI is not an "auditor" per se, so there is really no conflict to worry about.

That being said, you will need to have someone else properly trained to be a PCQI, at least if you plan on taking any vacation time. :)

Marshall

Thanks to both FSQR Manager and mgourley - I like your answers - since I agree with them!  :)  I will see if I can convince our FS consultant.

Your consultant is just blowing smoke...probably looking for more money.  At any rate, go to the PCQI Certification workshop and make sure it is accredited by the Food Safety Alliance.  This is the only recognized accreditation for PCQI training at this point.  I know NSF offers this, I took it with NSF.  The FSMA preventive controls rule doesn't require having a backup, but that's always nice to have.

While the rule specifically doesn't require someone to go to the outside training for PCQI it is highly recommended.  If you don't do the training for PCQI and call yourself one you will somehow have to show and justify how you believe you are a PCQI which can be a tough sell, especially with the myriad of unknowns in enforcing this rule.

Our outside consultant is saying that the food safety team leader (facility QA supervisor) should be the PCQI as she is the most qualified employee as far as food safety is concerned. I would question your consultant's motives as Ryan M. alluded to- it always seemed pretty clear to me that this was just a new qualification for the person responsible for food safety!

I agree with the statement you can and should have more than one PCQI.  We are SQF Certified so our SQF Practitioners are now PCQI's in addition to our HACCP/Food Safety Plan Coordinators.  I am also getting our QA Managers trained as PCQI's.  If you go to https://www.ifsh.iit.edu/fspca  there is a list of approved classes, as well as there are other companies that are now offering virtual live classes as well.

Hope this helps, another reason you want more than one PCQI, if your only PCQI wins the lottery and leaves you will have a rather large gap to fill and very quickly.