5 replies to this topic

[So_Tired]

Hello all : )

 

HARA Plans - When determining hazard significance using the classic 5x5 Likelihood vs severity matrix:

• Should a significance rating be assigned NOT considering PRP control effect, and then PRP listed, followed by a second significance rating where PRP effect IS considered? 
• OR, should there be only one significance rating including PRP control effect because 2.5.2 says " likelihood of occurrence, considering PRP in the absence of additional control"?

it's late in the day here, and my brain is seeing both sides of the argument and confusing wording.

 

We have only PRP's as control mechanisms (thus far) if it helps.

 

Thanks !

Edited by So_Tired, 23 July 2025 - 04:30 AM.

[Tony-C]

Hi So_Tired,

 

First post I see  

 

I think there is some confusing wording across the standards and in the guidance (with/without etc.)  

 

If in doubt I take the black and white and only this significance assessment from your identified hazards (2.5.1):

2.5.2 The HARA team shall conduct a hazard analysis to identify the significant hazards (i.e., those hazards that are reasonably likely to occur at an unacceptable level), which need to be prevented, eliminated or reduced to acceptable levels.

Consideration shall be given to at least the following:

• likelihood of occurrence, considering prerequisite programs in the absence of additional control

• severity of the outcome.

 

Kind regards,

 

Tony

 

[So_Tired]

Thanks Tony, one significance rating it is!

 

I have seen HACCP plans before where there were 2 assessments for each Hazard, one without controls/PRP (then list control/s /PRP), one with controls/PRP. I guess it allows you to understand the impact of the controls /PRP. Or rather what happens to the hazard rating when the controls/PRP fall over. 

[beautiophile]

My guess is because of the grey area between PRP & controls.

I understand HARA scheme would be:

(1) Process description → (2) PRP design & implementation → (3) Hazard identification → (4) Likelihood & severity evaluation → (5) Additional measures to eliminate risk → (6) Verification of measures.

 

The problem is when a factory starts to operate for the 1st time, the PRP in (2) and the measures against risks in (5) are probably already there (by design and/or by experiences of the owner) before the HARA documentation. The point here is to pick up things in (5) from the existing mixture of (2) & (5) while developing (4). The result of (4) would be a collection of currently effective, modified and new items in (5).

Edited by beautiophile, 25 July 2025 - 01:59 AM.

[GMO]

Traditionally HACCP is applied WITH prerequisites, FSMA based approaches without.  I'm assuming your HARA is based on Codex HACCP originally so I would apply the "generic" prerequisites as a minimum.  You don't want to be referencing handwashing in every step.  As for if you apply more specific prerequisites, there is a get out of gaol free option here which I'm assuming is also present in your HARA in that the first question in all flow diagrams I've used in the last 10 years is "is this already controlled by a prerequisite buddy?" (I'm paraphrasing).

 

But ultimately that means it doesn't matter.

 

After spending (too much) time looking at the different HACCP systems globally, what I would always do nowadays is apply the basics as a baseline, so things like traceability, training, handwashing, personal hygiene etc.  Then only apply prerequisites after the hazard assessment if they're more specific as this assessment determines significance NOT if something is a CCP or oPRP.

 

Sorry my experience is HACCP not HARA so not sure if it's directly applicable but I think you're asking a question which has been going around in HACCP for years.

[So_Tired]

Traditionally HACCP is applied WITH prerequisites, FSMA based approaches without.  I'm assuming your HARA is based on Codex HACCP originally so I would apply the "generic" prerequisites as a minimum.  You don't want to be referencing handwashing in every step.   Yes. Correct. Based on HACCP

As for if you apply more specific prerequisites, there is a get out of gaol free option here which I'm assuming is also present in your HARA in that the first question in all flow diagrams I've used in the last 10 years is "is this already controlled by a prerequisite buddy?" (I'm paraphrasing).Again correct : ) . There should be none or perhaps one in our process that may answer no to that 1st question.

 

But ultimately that means it doesn't matter.

 

After spending (too much) time looking at the different HACCP systems globally, what I would always do nowadays is apply the basics as a baseline, so things like traceability, training, handwashing, personal hygiene etc.  Then only apply prerequisites after the hazard assessment if they're more specific as this assessment determines significance NOT if something is a CCP or oPRP. Correct , further review of hazards deemed significant via decision tree will determine CCP/oPRP

 

Sorry my experience is HACCP not HARA so not sure if it's directly applicable but I think you're asking a question which has been going around in HACCP for years. Crazy thing is...the customers who audit us are unlikely to understand HACCP themselves to this degree ! ( also our plan isn't/ won't be certified).

 

Thanks all, once again : )