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Do I need a PCQI?

FSMA PCQI

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#1 GrumpyJimmy

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Posted 06 June 2018 - 11:14 AM

Everyone Hi, We are looking to sell a few products over in the USA, either directly, through an agent/broker or distributor 

 

If someone is buying our goods to send to the USA and then sell/distribute the product for themselves, do i need a PCQI? 

 

If we have a distributor operating for us in the USA do we need a PCQI?

 

Basically when does a PCQI come into play?

 

I couldn't find it in previous posts so apologize  if it's a repeat

 

Thanks

J

 

 



#2 jdpaul

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Posted 06 June 2018 - 01:05 PM

A PCQI is just a term used in the FDA jargon; all it means is someone who can be shown to have the experience needed to understand and create a food safety system which includes the Food safety plan and supporting prereq programs. You can justify the PCQI through a widely recognized FSPCA course or through work experience, degree, etc..



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#3 jdpaul

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Posted 06 June 2018 - 01:06 PM

You would have a preventive control qualified individual (PCQI) in your own company if you make product for consumption. Is that you? It just means someone who is able to oversee and implement the food safety system



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#4 SQFconsultant

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Posted 06 June 2018 - 01:19 PM

The DC in the USA will need a designated person and will need to be in compliance with FSMA.


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#5 GrumpyJimmy

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Posted 06 June 2018 - 01:23 PM

You would have a preventive control qualified individual (PCQI) in your own company if you make product for consumption. Is that you? It just means someone who is able to oversee and implement the food safety system

Thanks jdpaul, would that still apply if It wasn't me actually selling it and just supplied it to a company who then sells it in the USA themselves?

 

J



#6 GrumpyJimmy

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Posted 06 June 2018 - 01:25 PM

The DC in the USA will need a designated person and will need to be in compliance with FSMA.

Thanks SQFconsultant, im going to kick myself but what is the DC?

 

Thanks

Jimmy



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#7 SQFconsultant

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Posted 06 June 2018 - 01:38 PM

Distribution Center/Distributor location, etc.

 

No need to kick - when I first started as a food safety auditor years ago I was told I would need to inspect DC's and I sat there and OK, thinking to myself - I better look that one up! LOL


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Glenn Oster
 
 
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Internal Auditor Training/eConsultant/CB/SQF-GAP/PCQI OnlineTraining

 

www.GlennOsterConsulting.com

 

GOC BLOG - They Come for the Children Next - https://bit.ly/36RHMZy

 


#8 GrumpyJimmy

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Posted 06 June 2018 - 01:53 PM

Distribution Center/Distributor location, etc.

 

No need to kick - when I first started as a food safety auditor years ago I was told I would need to inspect DC's and I sat there and OK, thinking to myself - I better look that one up! LOL

Thanks for the info, even with 15 years experience in the UK market i have found myself another 15 years worth of work just working out USA acronym's and FSMA.

 

Another question, would that USA company have to audit us to make sure we are to FDA standards which is fine as we are a grade A BRC site (i will have to extend a few things to comply), would it not be a good idea for me to do the PCQI training also, apart from gaining better knowledge will it be a benefit to the FDA and in-turn ourselves having a PCQI on site? 

 

Thanks

Jimmy



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#9 CHRISTBEARER7

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Posted 06 June 2018 - 06:32 PM

Yes, definitely. It wouldn't hurt especially since FMSA was such a large overhaul of the FDA's Food Safety regulations. It's a great way to review the United State's Food Safety laws.



#10 Ian R

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Posted 06 June 2018 - 07:00 PM

Hi Jimmy

 

I have a client who manufacturers for another company who then sells in the USA.

They have had to appoint a PCQI

In fact for a few months I was the PCQI until we could document the current Technical Manager had sufficient training.

We added the `FSMA module to the BRC audit

 

We have argued, successfully, that completion of the Level 3 Food Safety and Level 3 HACCP accredited courses are sufficient to meet the requirements.

There is an FDA approved specific training course but you have to find some one running it.

 

With regard to being audited, yes that is a real possibility

But it will be an FDA appointed auditor

There is concern that with the growth in businesses taking the FSMA module with their BRC the likelihood of an audit team coming to Europe is increasing.

 

A good guide is the BRC additional module, get a copy from the BRC web site and it is quite a useful guide to achieving basic FSMA compliance

 

But remember Preventative Controls are not always the same as HACCP

 

regards



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#11 ncwingnut

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Posted 08 June 2018 - 12:19 PM

We are a facility that was just audited under the new FSMA Preventive Controls rules by the FDA.  You absolutely have to have a PCQI if you are an FDA company.  The PCQI is required to sign off on all production documentation (batch records, sanitation records) and is to oversee the vendor control programs and recall.  

 

We incorporated all of the preventive control programs into our HACCP plan and this was acceptable by our FDA auditor.  

 

PCQI is not just work experience, you must have a training certificate from a training center.



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#12 jdpaul

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Posted 08 June 2018 - 12:35 PM

We are a facility that was just audited under the new FSMA Preventive Controls rules by the FDA.  You absolutely have to have a PCQI if you are an FDA company.  The PCQI is required to sign off on all production documentation (batch records, sanitation records) and is to oversee the vendor control programs and recall.  

 

We incorporated all of the preventive control programs into our HACCP plan and this was acceptable by our FDA auditor.  

 

PCQI is not just work experience, you must have a training certificate from a training center.

 

Hi ncwingnut,

 

if the auditor stated that I would have a lot of push-back based on this:



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#13 jdpaul

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Posted 08 June 2018 - 12:36 PM

ncwingnut,

 

See attached

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#14 CHRISTBEARER7

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Posted 08 June 2018 - 12:52 PM

Very true jdpaul but how does someone prove that they are qualified through job experience without the certificate?

 

I understand the FDA says this and I read that too but I also feel all of us should have that piece of paper that says we are qualified.

 

It's fairly inexpensive to become a PCQI so I would just take the course. It's 2.5 days but well worth be assured the FDA will recognize that you are indeed qualified.

 

I'm not trying to start an argument or debate. This is my personal opinion so please take it or leave.

 

Thanks!

 

Chris



#15 ncwingnut

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Posted 08 June 2018 - 12:56 PM

ncwingnut,

 

See attached

See, any time we tried to bring things up like that she would shut us down.  

 

Just like I tried to explain as the PCQI, I don't have time to sign off on EVERY piece of documentation here.  If I did, I would be spending 10+ hours a day doing nothing but that.  So, I have QI's, as we were told in our training we could have.  Individuals that work under the guidance of the PCQI that are approved to review and sign documentation.  She was here 4 days, plus came back this past tuesday to do closeout meeting.  At least by the end, she said she had asked 3 other co workers about that and found that I was right.  

 

She was not very giving, or willing to double check things, unfortunately.



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#16 jdpaul

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Posted 08 June 2018 - 01:04 PM

ncwingnut, I agree with you. Probably she shut you down because the FDA has not determined what aspects of job experience would qualify that person to be considered a PCQI without taking one of the FDA recognized courses; this is an ongoing debate actually. By the way, ncwingnut, what does your company produce?

 

CHRISTBEARER7, I agree with you as well and I am not opposed to the standardized course; however, as mentioned above the FDA needs to determine what aspects of job experience would qualify someone as a PCQI. I believe job experience certainly can qualify you as a PCQI. I think it would be good to hear what other forum users have experienced from FDA auditors.
 



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#17 ncwingnut

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Posted 08 June 2018 - 03:32 PM

ncwingnut, I agree with you. Probably she shut you down because the FDA has not determined what aspects of job experience would qualify that person to be considered a PCQI without taking one of the FDA recognized courses; this is an ongoing debate actually. By the way, ncwingnut, what does your company produce?

 

She shut me down on the QI, not PCQI.  We didn't challenge the PCQI.  No need since we have 3.  I am the main, 2 others are backup and work in different departments.

We make food flavorings....extracts, powders, etc.  Very low risk.  No finished product sold to public.  Everything is for further processing.



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#18 RMAV

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Posted 08 June 2018 - 07:09 PM

Part of the trouble is FDA investigators do not yet know what enforcement of FSMA looks like in many situations.



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#19 CHRISTBEARER7

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Posted 08 June 2018 - 07:14 PM

For our FDA inspection they said they were here to "educate before they regulate" and only wanted to review and see that we were in the process of meeting the FSMA requirements but did not judge anything yet.



#20 MIguel A. Rodriguez

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Posted 08 June 2018 - 07:33 PM

If you are not the direct importer in USA, then is not necesary to have a PCQI, but your broker, agent or distribuitor will demand you to fulfil with the FSMA requirements, eg. food safety plan, preventive controls, etc.
If your company appears as importer, then is imperative to have a PCQI and you are subjected to inspection. Now, FSMA also specifies that you can be a PCQI without taking the official training under FDA, if you have the expierence, backgrounds and training enough to demonstrate you know all needed to elaborate a food safety plan based on scientific principles. Actually, you can even have an external PCQI to do all the hard work.   


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#21 Charles.C

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Posted 09 June 2018 - 02:14 AM

As a neutral bystander I am getting the impression that this topic has a lot of "nuances" due variations in the specific "trading flowchart" (TF)

 

Accurate answers to the OP may need to be referenced to the actual FSMA text involved ?. (if such exists ?). I presume the requirements are  (hopefully) detailed somewhere in the FSVP regulations.(++ ?)

 

It looks like the answer to OP is driven by the supply of an appropriate  official minimum FSVP response to FDA. The supply appears to be the primary responsibility of whomsoever is officially designated the "importer" ? (not 100% clear in OP). The supply may involve delegated functions, eg provision of HARPC Plan.

 

I assume regarding use of a PCQI that there is a minimum official requirement and optional increases related to obligatory associated documentation requirements, eg HARPC Plan.

 

I suspect a large chunk of the answer for a 1:1 straight-line TF is already within the FSVP threads. But, if above interpretation is correct, the OP possibly needs a little more clarity as to official "importer" :smile:


Kind Regards,

 

Charles.C


#22 jaysoria

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Posted 31 October 2018 - 08:03 PM

I read above every importer should have a PCQI is this necessary even if you are considered a small business? we import from overseas but it comes already packaged and labeled to us.







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