Hazard Analysis for HARPC

Hello, 

I am currently finishing conversions of old HACCP plans to new HARPC plans. In doing some research I have seen contradicting information regarding hazard analysis. Several sources have said when producing a HARPC plan hazards should be evaluated as if no prerequisite programs are in place. For example, if my company has a pre-existing allergen control policy, should I disregard this during my hazard analysis so that every scenario for possible allergen cross-contact is evaluated? I come from a HACCP background, so I remember a time when CCP overload was a big deal. I have this stuck in my head when determining preventive controls, I feel like every processing step has a possible preventive control. When making HARPC plans for your companies, did you end up with a large amount of preventive controls?

Hi Jpainter,

It is inevitable that your food safety plan will be more extensive than a 'traditional HACCP plan': 

© Hazard evaluation.

(1)

(i) The hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.

§117.135   Preventive controls.

(a)

(1) You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.

(2) Preventive controls required by paragraph (a)(1) of this section include:

(i) Controls at critical control points (CCPs), if there are any CCPs; and

(ii) Controls, other than those at CCPs, that are also appropriate for food safety.

Kind regards,

Tony

Hello, 

 

I am currently finishing conversions of old HACCP plans to new HARPC plans. In doing some research I have seen contradicting information regarding hazard analysis. Several sources have said when producing a HARPC plan hazards should be evaluated as if no prerequisite programs are in place. For example, if my company has a pre-existing allergen control policy, should I disregard this during my hazard analysis so that every scenario for possible allergen cross-contact is evaluated? I come from a HACCP background, so I remember a time when CCP overload was a big deal. I have this stuck in my head when determining preventive controls, I feel like every processing step has a possible preventive control. When making HARPC plans for your companies, did you end up with a large amount of preventive controls?

It's an excellent question IMO but I have never so far seen an official answer or example. There was an extended discussion about it on this forum about 4 years ago. No conclusion.

The concept (same time as above) has been discussed (negatively) in the Literature.

IIRC the "official"  FSPCA training text avoids any discussion of the concept.

I gave up on FSMA's other haccp propositions due this, IMO, fundamental aspect.

PS - as I understand the terminology "HARPC" is now obsolete. Not a criticism, just an observation.

Hello, 

 

I am currently finishing conversions of old HACCP plans to new HARPC plans. In doing some research I have seen contradicting information regarding hazard analysis. Several sources have said when producing a HARPC plan hazards should be evaluated as if no prerequisite programs are in place. For example, if my company has a pre-existing allergen control policy, should I disregard this during my hazard analysis so that every scenario for possible allergen cross-contact is evaluated? I come from a HACCP background, so I remember a time when CCP overload was a big deal. I have this stuck in my head when determining preventive controls, I feel like every processing step has a possible preventive control. When making HARPC plans for your companies, did you end up with a large amount of preventive controls?

What I concluded from switching over. You shouldn't disregard your old plans. Our CCPs or PCs stayed pretty much the same when switching over. What was different. I had to show proof that I considered other hazards even if they ended up not being a CCP. For example the spice paprika. The hazard - lead oxide because it has been used as an adulterate for economical gain in the past. I don't have it as a CCP but it is controlled under our supplier program.

Thanks for the info KformIA. To accomplish showing that these hazards were evaluated, did you just add them to your current HACCP plan? I am trying to find a method to combine our current HACCP plans with the requirements from FDA on preventive controls. I am thinking my best bet is to just include these other hazards on my current hazard analysis for the HACCP plans in place. 

Thanks for the info KformIA. To accomplish showing that these hazards were evaluated, did you just add them to your current HACCP plan? I am trying to find a method to combine our current HACCP plans with the requirements from FDA on preventive controls. I am thinking my best bet is to just include these other hazards on my current hazard analysis for the HACCP plans in place. 

I ended up making a new plan. There are some examples out there. One of which you can get from going to the PCQI training. I ended up using the FDA Food Safety Plan Builder off their website. If I did it over again - I would have gone with a more user friendly template. Things are missing from it.

For example the Raw material and packaging material hazard analysis - it was easier to do it as an add on.

Attached is the template I used. I believe I got it from this website and then tweaked it. With FSMA - you do need to consider radiological contaminants.

This definitely helps me get going in the right direction, thank you!

Another worked example here -

https://www.ifsqn.co...pc/#entry121389

Jpainter - Attached is a white paper from SafeFood 360 about FSMA and the difference between HACCP and the new plan.

Jpainter - Attached is a white paper from SafeFood 360 about FSMA and the difference between HACCP and the new plan.

Hi KfromiA,

Thks for attachment.

Unfortunately it seems to me to contain a  variety of errors  + some (IMO) debatable content.

(Admittedly it is an attempt to respond to what is already IMO a highly flawed original).

Just for example -

(1) Pages have no numbers on my PC.

(2) Figures partially unreadable after (forced) blow-up.

(3) No specific Example (I think).

(4) Pg 5/23

Operational Prerequisites (oPRPs) - Metal detection, detection & scanning, filtering, sieving
and refrigeration.
•  General Prerequisites (oPRPs) - Cleaning and sanitizing plant, equipment, employee       
facilities, as well as managing calibration, maintenance, personal    hygiene, and               
contamination controls.

 

(typo/s ? - prize for guessing  which one(s) is correct ?)

(oprp seems unrelated to the original FSMA since not in its list of definitions [then again, neither is haccp or Prerequisite])

(5) Pg 4/23

Radiological hazards and economically motivated adulteration are identified as chemical hazards (21 CFR 117.130(b))

 

(text seems to not exist in the original on IT)

(6) Pg 4/23

Haccp is implied  to be reactive whereas harpc is proactive. That's (almost) original !

(7)

Pg 7/23 the terminologies "consumer complaint" and  "product recall" are IMO ambiguous/inappropriate for a safety-intentioned risk matrix even after allowing for "subjectivity"
 

On the other hand I rather liked this paragraph even though there is a somewhat contentious terminology in it ("quality" includes safety ?)(none of quality/adulteration/EMA are  included in FSMA definitions)

21 CFR 117.130(b)(2)(iii) states known or reasonably foreseeable hazards that may occur in food
due to intentional adulteration for economic gain should be considered. Adulteration affects food
quality and product integrity. It is recommended to consider circumstances with a history of adul-
teration for economic gain that could cause illness.

PS - I daresay another list of FSMA/cfr definitions exists since so many seem absent but I couldn't see it.

Hi KfromiA,

 

Thks for attachment.

 

Unfortunately it seems to me to contain a  variety of errors  + some (IMO) debatable content.

 

(Admittedly it is an attempt to respond to what is already IMO a highly flawed original).

 

Just for example -

 

 

(1) Pages have no numbers on my PC.

 

(2) Figures partially unreadable after (forced) blow-up.

 

(3) No specific Example (I think).

 

(4) Pg 5/23

(typo/s ? - prize for guessing  which one(s) is correct ?)

(oprp seems unrelated to the original FSMA since not in its list of definitions [then again, neither is haccp or Prerequisite])

 

(5) Pg 4/23

(text seems to not exist in the original on IT)

 

(6) Pg 4/23

Haccp is implied  to be reactive whereas harpc is proactive. That's (almost) original !

 

(7)

Pg 7/23 the terminologies "consumer complaint" and  "product recall" are IMO ambiguous/inappropriate for a safety-intentioned risk matrix even after allowing for "subjectivity"
 

 

On the other hand I rather liked this paragraph even though there is a somewhat contentious terminology in it ("quality" includes safety ?)(none of quality/adulteration/EMA are  included in FSMA definitions)

 

 

PS - I daresay another list of FSMA/cfr definitions exists since so many seem absent but I couldn't see it.

Thanks Charles. Good to know.

To shed light on this a little bit further, go back to your training on Preventive Controls.  There is an example in Chapter 8 regarding the hazard analysis.  It indicates that if a company has a good maintenance program in place and can demonstrate this, they might elect to indicate foreign objects are not a likely hazard.  So this tells us that FDA may accept the approach of using your pre-requisites in decision making.    

By the way - I suggest not calling it HARPC.  FDA does not use that term.  Also - there is no reason for two plans. Just expand upon your HACCP Plan to include hazards or concepts that may have previously been missed such as radiological hazards, economic fraud and environmental concerns.