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FSMA Preventative Controls Qualified Individual

FSMA PCQI

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#1 WowQC

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Posted 13 April 2016 - 07:51 PM

Hello everyone,

 

I'm sure I'm joining a large group out there trying to understand the requirements of FSMA. My question at this time relates to the Preventative Controls Qualified Individual. From the FDA website:

 

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.

 

So, is a training course required? Or, is our HACCP Coordinator already sufficiently qualified? We are a small, family owned and operated company. The HACCP Coordinator is one of the owners, was involved in the development of the product, and involved in daily production. We just don't want to spend the time and money on 2.5 days of training if it is not required.

 

We are BRC certified (AA on Issue 7). Our HACCP is already based on a risk analysis format. We are in Canada, but ship into the USA as the importer (the product goes to warehouses, from where it is further shipped to the final customer). I just want to be prepared so we don't have a surprise one day with a truck refused entry at the US border.

 

Also, does anyone know how we would show compliance? Thanks.

 

WowQC


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#2 johntstuart

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Posted 13 April 2016 - 09:33 PM

"Qualified Individual" training must be done separately.  The FDA is requiring that this training be done, regardless of whether or not they are HAACP, BRC, or whatever trained and certified.  The plant must have at least 1 person who is a Qualified Individual, but I would suggest that more would be better.  While it does make provision for people who have become qualified by experience, I would still advise the training.  This is because FSMA required HARPC is not quite the same as HAACP and the differences could trip people up.


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#3 Sandima

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Posted 22 April 2016 - 01:02 PM

A well trained HACCP Coordinator is a long way to being qualified but as Johnstuart said there are some differences that need to be considered.  

 

However, there are many training options out there and more are being developed so a 2.5 day course may not be needed.  You don't provide details on your product and process but industry associations may have information that could help you decide what is needed or offer training.

 

Have a certificate from a course would go a long way to proving compliance but it is really about does your documented plan meet the requirements when someone looks at it.


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#4 Kellio

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Posted 22 April 2016 - 04:23 PM

The PCQI is similar to the GFSI requirement for a person  responsible for the Continual Improvement and Maintenance of the FSMS and QMS.  Under SQF this person is called the SQF Practioner and under BRC and FSSC 22000 is the Technical Manager. FDA does not mandate the training Certification for PCQI as long as the Organization can show the person or the persons overseeing the FSMS and QMS has the training records and documentation required justifying the knowledge of the New Rules. However, It is highly recommended to obtain the PCQI training to understand the Methodology of the HARPC Plan and Records in which FDA will expect the Organization to have.   BRC and FSSC 22000 certifications are the closest standards to meet FSMA requirements.  OPRP's are very similar to the Preventive Controls required for the HARPC Plan.  You may be affected  by the Foreign Supplier Verification Program; therefore, your requirements for BRC such as  Internal Audits, Prerequisites Programs under  21 CFR Sec. 117.0 and HARPC and HACCP Plans will be a big plus.  Record Keeping and Corrective Actions and Preventive Actions Documentation will be a sensitive subject with FDA. Attached you will find the FSPCA Course Manual for Preventive Controls. 

 

I suggest to review the FSMA FSVP Rule and the Third Party Audit Rule.

 

I hope this helps,

 

Kellio

 

Training Resources:

 

http://www.sgs.com/e...aining-services

 

http://www.nsf.org/training-education/

 

http://www.aibonline.org/aibOnline/en/

 

http://www.iit.edu/ifsh/alliance/

 

http://www.alchemysy...ventivecontrol/


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#5 ViandGroup

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Posted 28 April 2016 - 01:08 AM

Most definitely take the 2.5 day class.  Eurofins has several on their schedule.  www.eurofinsus.com


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#6 JtpatT

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Posted 29 July 2016 - 03:38 PM

Hi all,

 

As it is not clear from the replies for wowQC, can anybody who has done the training/ or not going for the training help??

 

We are an SQF level 2 certified plant that exports products to the US, and we are FSMA compliant. Can the SQF practitioner be the PCQI without training? Is the training mandatory?

 

I have seen that the Food Safety Preventive Controls Alliance (FSPCA) has partnered with the FDA to develop course curriculum to meet the “Preventive Control Qualified Individual” requirements and is offered by various consultants and trainers. The training duration is 2.5 -3 days.

 

Other than GFTC, anybody knows other training centres in Toronto?

 

I hope someone can help!

 

Question to WowQC: Did you take the training?
 

 

 

 

 

 

 

 


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#7 dshapos

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Posted 12 August 2016 - 02:03 PM

The FDA worked in collaboration with the public and private sector to form the Food Safety Preventive Controls Alliance (FSPCA).  They in turn developed the only training program recognized as the standard training program to satisfy the requirement for a Preventive Controls Qualified Individual be on site to develop and manage the Food Safety Program required under FSMA

 

Just a small note about the Food Safety Program:  HACCP is the foundation of the program.  From HACCP, the hazard analysis will reveal processes and other areas (such as Supplier Controls) that may not necessarily be a CCP, but will fall under the Preventive Control requirement.  All GFSI companies have a HACCP, so enhancing the HACCP to bring it into compliance with the Preventive Controls requirement under FSMA is not all that difficult. 

 

For smaller companies that may not be GFSI certified and who have not implemented a HACCP plan, this can be a major undertaking to develop.  I would highly recommend that those companies not only take the course but enlist the help of an outside consultant if, after taking the course, still feel they need more guidance to come into compliance under the ruling and have a Food Safety Plan developed and implemented.

 

That said, the FSPCA course, Preventive Controls for Human Food, is the fastest and easiest way to understand the rulings and how to manage the program.  While it is not mandatory, it will be what the FDA uses as the standard with which to evaluate any other claims for qualification.

 

There are numerous sites to take the Preventive Controls for Human Food course (they must be led by a FSPCA trained Lead Instructor and registered with the FSPCA).  As a FSPCA trained Lead Instructor for this course, I would be happy to answer any questions or help you find a course to take.  I can be reached at xxxxxxxxx


Edited by Charles.C, 12 August 2016 - 10:48 PM.
email removed - spam magnet

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#8 dshapos

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Posted 12 August 2016 - 02:07 PM

Hi jtpat,

 

I know of an upcoming course in Mississauga on September 14-16.  It is being offered by SGS 6490 Vipond Dr. You can contact them to register. maryana.glavan@sgs.com


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#9 Charles.C

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Posted 12 August 2016 - 10:24 PM

(slightly OT)

 

Hi dshapos,

 

Have a query regarding terminologies in yr Post 7.

 

You refer to HACCP, GFSI, FSMA.

 

afaik, there are numerous "flavours" of HACCP.

 

GFSI's "HACCP" is, i think, declared to be based on Codex's version of HACCP.

 

Most US interpretations prior to FSMA, I believe, are based on NACMCF's version of HACCP.

 

I had understood that FSMA had invented /nominated HARPC to be their "new" HACCP, eg as per -

 

http://www.foodonlin...-and-harpc-0001

 

But I note that HARPC is not mentioned either in the FSPCA manual or in your Post.

 

Has something changed regarding the implementation of the FSMA "System"  or is my (above) understanding incorrect ?

 

PS - TBH, my initial reading of the nice Chapter 13 on Va/Ve in the FSPCA manual was that it looked to be more aligned to USDA/FSIS than FDA, despite USDA facilities being excluded from FSMA's scope.


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Kind Regards,

 

Charles.C


#10 dshapos

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Posted 15 August 2016 - 06:09 PM

Hi Charles C.

 

The HARPc designation was an early adaptation - since the final rule and the completion of the FSPCA training course, that terminology is not being used by the FDA when referring to the FSMA Food Safety Plan.  In response to your statement about HACCP, yes, GFSI standards follow the Codex.  Under FSMA, the starting foundation of the Food Safety Plan is the HACCP, but you must now include Preventive Controls (some of which are our familiar CCPs) These Preventive controls will be  identified during the hazard analysis as being necessary for food safety. They include, but are not limited to Sanitation, Supplier, Raw Material, etc.  I cannot address your comment regarding the NACMCF as being the foundation of the US HACCP since I have not worked in juice or seafood, which were the categories that previously required a HACCP. 


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#11 Scampi

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Posted 15 August 2016 - 06:34 PM

To the canadian meat folks reading this, the HARPc reads just like out FSEP requirements, FYI.  

 

WOWQC what are you processing?


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#12 Charles.C

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Posted 16 August 2016 - 12:51 AM

Hi dshapos,

 

Appreciate yr comments.

 

To slightly expand haccp history, the FSPCA Manual contains –

 

In the 1970’s, FDA used HACCP principles in the development of low-acid canned food regulations. The US National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the Codex Alimentarious Commission (Codex) published HACCP principles in the 1900s. FDA has HACCP regulations for seafood and juice products; USDA has HACCP regulations for meat and poultry products.

 

In fact Seafood haccp was initially based on “Codex haccp” however after some criticisms from advocates of “NACMCF haccp”  various textual modifications were included (eg Seafood Final Rule).

 

One noticeable difference is that Codex/Seafood haccp/GFSI(i think) makes no use of the term "Control Point" whereas NACMCF/USDA-FSIS(I think) haccp does. But “FSMA-haccp” (F-haccp?)  no idea ?

 

I am rather amazed to learn that the terminology “HARPC” is being (quietly?) dumped after all this time. Admittedly many aspects of F-haccp seem like mixed and regurgitated old-haccp (other than F-PRPS perhaps) but it looked logical to at least give the new F-haccp it’s own official acronym.

 

I had a brief look in the Literature following yr Post and note that "harpc" was still being used in educational mode in March 2016, eg –

 

http://www.foodproce...a-requirements/

 

However I also noticed this interesting May 2016 article (thanks George !) critically discussing various haccp manoueverings within FSMA among which was a section starting –

 

The fact that more recently we are being told to no longer refer to it as HARPC but rather as PCP (Preventative Controls Program).......

 

https://safefood360....accp-and-harpc/

 

Some of the subtleties detailed in 2nd Link were above me but I did get the impression  that the basis/presentation of (ex)-harpc methodology continues to be a contentious issue. I quite liked the PCP acronym above but unfortunately this does not occur in the FSPCA manual so is presumably  unauthorized.

 

So what is the current preferred terminology to reference F-haccp ?  Is it "Preventive Food Safety Plan" (PFSP) as might be inferred from the FSPCA manual ? Seems a bit long-winded.

 

@scampi, i think i recall FSEP started decades before FSMA / ex-harpc ? Hmmm.


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Kind Regards,

 

Charles.C


#13 Scampi

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Posted 16 August 2016 - 05:06 PM

Yes Charles, FSEP has been around for a long time in meat in Canada. It is an easy "guide" to use for PCP as it explains in generality what is required, it speaks in detail from exterior right through to forgeign material and allergen control.

I have attached a link

http://www.inspectio...7674768_eng.pdf


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#14 Charles.C

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Posted 16 August 2016 - 11:44 PM

Yes Charles, FSEP has been around for a long time in meat in Canada. It is an easy "guide" to use for PCP as it explains in generality what is required, it speaks in detail from exterior right through to forgeign material and allergen control.

I have attached a link

http://www.inspectio...7674768_eng.pdf

 

Hi scampi,

 

Thks for the link.

Indeed it is a very comprehensive/integrated FS program and excellently explained.

The CFIA website has always had some of the best examples of haccp plans although they are over-fond of changing their URLs IMO.

I think FSEP is fundamentally more oriented to NACMCF than Codex, positively in respect to PRPs but (IMO) negatively in respect to PCs.

 

The only parts of FSEP I don’t go for are (a) the innovative use of Operational Prerequisite Programs (not to be confused with ISO’s version) and (b) the substantive use of PCs. IMO (a) is superfluous and the content might just as well hv been blended into the PRP section while (b) is (just like ISO’s OPRP) too ambiguous to be a useful part of a haccp plan. I suspect sections (a,b) are specific to the Meat program since I do not recall seeing them developed  in the various example haccp plans available on the CFIA website. Just my opinion. :smile:


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Kind Regards,

 

Charles.C


#15 Apples

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Posted 04 January 2017 - 08:18 PM

There are numerous sites to take the Preventive Controls for Human Food course (they must be led by a FSPCA trained Lead Instructor and registered with the FSPCA).  As a FSPCA trained Lead Instructor for this course, I would be happy to answer any questions or help you find a course to take.  I can be reached at xxxxxxxxx

I realize this is an older thread but I am looking for help finding a course in or near Buffalo and noticed you are from Buffalo.  How can I reach you?


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#16 mgourley

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Posted 04 January 2017 - 10:18 PM

I don't see anything in the Buffalo area, but there is:

 

Long Island in a couple of weeks

 

Cherry Hill, NJ in February

 

Use the Google and search for FSPCA PCQI Training.

 

Marshall


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