9 replies to this topic

[Kellio]

Hello Everyone!

 

 

Here is the Course Manual for HARPC or Preventive Control Plan.  FDA New Rules are confusing some what but this attachment may help you to at least see what the are teaching.

 

I hope this helps as some of you may waiting to take the class.

 

Have a Great Day Everyone!!!

 

Kelio

Attached Files

•  FSPCA_PC_Human_Food_Course_Participant_Manual_V1.2_Watermark.pdf   20.82MB   303 downloads

[Fijiball]

Thanks Kellio. This is something new to me but seems interesting.

[sofliz]

Many thanks, Kelio!

[Charles.C]

Hi All,

 

JFI, the relevant website for various other related items is here -

 

http://www.iit.edu/i...materials.shtml

[Maltus]

Somebody at the forum have already got this course?

[JPO]

Somebody at the forum have already got this course?

Yep, went the first 3 days of this week.

 

Absolutely worth your time and effort.  One of my instructors was on the committee that wrote the coursework. 

 

I would hesitate to rely on your "experience, training, and education" to call yourself a PCQI.

 

I'd take the class. 

[Kellio]

Yes, I took it and I was Lucky enough that the instructors were also GFSI Auditors and instructors. It made it such much simpler to compare and understand. FDA could get some pointers from GFSI. It will help if you find instructors that are also GFSI certified especially ISO or BRC. These 2 standards are the closest to meet FSMA requirements. OPRP's are similar to Preventive Controls.

Check this resource:

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

[JPO]

Yes, I took it and I was Lucky enough that the instructors were also GFSI Auditors and instructors. It made it such much simpler to compare and understand. FDA could get some pointers from GFSI. It will help if you find instructors that are also GFSI certified especially ISO or BRC. These 2 standards are the closest to meet FSMA requirements. OPRP's are similar to Preventive Controls.

Check this resource:

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

I agree. 

 

The instructors also went the extra mile with us to compare and contrast the differences and similarities of GFSI based plans (specifically SQF and BRC) and the preventive controls requirements.   

 

They also spent time clarifying the maze that is HARPC/HACCP  (there still is HACCP, HARPC is now more accurately called a Preventive Controls based Food Safety Plan) the rolling of radiation into the "chemical" hazards consideration rather than having it be a separate HACCP hazard category, and the idea that while HACCP is designed to control hazards that you can MEASURE (critical limits, CCP's and all that jazz) the Preventive Controls may be in place to control hazards that don't specifically have a limit or aren't "measurable". 

 

So, as Kellio stated, stuff often handled though oPRP's.

[mgourley]

I would third the recommendation to do the training.

My class was small (8 people) so there was plenty of time for additional questions.

 

Certainly was well worth the time and travel.

 

Marshall

[Charles.C]

I agree. 

 

The instructors also went the extra mile with us to compare and contrast the differences and similarities of GFSI based plans (specifically SQF and BRC) and the preventive controls requirements.   

 

They also spent time clarifying the maze that is HARPC/HACCP  (there still is HACCP, HARPC is now more accurately called a Preventive Controls based Food Safety Plan) the rolling of radiation into the "chemical" hazards consideration rather than having it be a separate HACCP hazard category, and the idea that while HACCP is designed to control hazards that you can MEASURE (critical limits, CCP's and all that jazz) the Preventive Controls may be in place to control hazards that don't specifically have a limit or aren't "measurable". 

 

So, as Kellio stated, stuff often handled though oPRP's.

 

Hi JPO,

 

A few queries below which I have seen elsewhere on the IT but so far without, afai could find, any official answer. No doubt(?) must have come up in yr course -

 

(1) afaik, current haccp plans are typically based on assessing the consumer risk in "digesting" a given food product after (if labelled) following any implicit/explicit preparatory instructions/info.  So what precisely  do FDA mean by "ABSENCE of preventive controls" ? (for example  - is this a limited concept such as  evaluating the consumer risk incurred by a (small?) "failure" in a (presumably) microbiologically satisfactory process step such as a cooking procedure or a gross change such as removing the step altogether (eg a labelling check from an allergen risk POV). Notably  for NRTE (ie 'to be cooked") finished products, does the risk asessment for the hazard analysis exclude the cooking step by the consumer ?)

(2) Is it correct that some harpc Plans are expected to have a lot more significant hazards than typical HACCP plans due to (1) ?

(3) How is the FSMA's PC "System" going to practically interpret the term "significantly minimize" ? (a possibly similar idea was tested ca. 20 years ago for haccp/CCPs and subsequently discarded).

I noted these definitions in the FSPCA manual -

 

Critical limit: the maximum or minimum value, or combination of values, to which any biological, chemical or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process preventive control.

 

Significantly minimize – to reduce to an acceptable level, including to eliminate.

 

There is no definition  of “acceptable level” in the manual.

 

So what does “Significantly minimize” actually mean ? If the "acceptable level" is intended to be identical to that in, say, iso22000/22004, I suggest that the terminology "significantly minimize" is redundant and misleading. Either way there is obviously a fundamental necessity for the former or latter term to be "defined".

 

None of the above aspects afai can see are addressed in the FSPCA Course manual.

 

I can make one comment/opinion regarding oprps. After 10 years, it remains an ISO-screwed-up concept IMO and I doubt that it has delivered any meaningfully  practical  benefits over traditional haccp, other than perhaps to the Consultant Industry. If there are some similarities between oprps and PCs, I fear it's not a good indicator for harpc unless fda have better explanative capabilities than ISO and a zillion other publications.

 

Regarding "measure" there are typically  2 types of measurement - Quantitative and Qualitative.

The significance of "measurement" is contentious, eg -

 

https://www.quora.co...it-doesnt-exist

 

https://newsatjama.j...you-improve-it/

 

PS - added - the NRTE query may be solved via the new section XXVII in Final Rule. Time will tell.

 

PPS - added - "acceptable level" is interpreted on pg 55962 of Final Rule as - "By ‘‘acceptable level,’’ we mean a level that will not cause illness or injury or
result in adulterated food." The text on Pg 55947 of Final Rule implies that it equates to the same "acceptable level" as used in Codex's definition of CCP.

 

P3S - After some thought, i suppose that harpc must use an "absence" card since the haccp PRPs now have to miraculously reappear  after the hazard analysis as Sanitation PCs (just like the Sanitation CCPs of ye old HACCP). So a ton of CCPs  >> a ton of PCs.

Offhand, the logic of, effectively, raising all control measures to pseudo-CCPs seems a somewhat sledgehammer approach if the primary objective is to increase focus on the hazards dominating the recall statistics. I guess the Proof of the Pudding will ....... eating.