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anoordende

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Posted 09 September 2021 - 05:35 PM

This is a discussion I have frequently:

 

The risk matrix (Probability x Impact), regardless of its format, is assessing the risk before PRP's and CCP's are implemented or the remaining risk after these are implemented (which is obviously a Chicken & Egg situation)?

 

A consultant once told me "the remaining risk after all possible measures are implemented". But that sounds like putting the cart before the horse, as the objective of the matrix is to determine the measures.

 

Any thoughts?



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Tony-C

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Posted 10 September 2021 - 02:13 AM

Hi anoordende,
 
I would proceed by noting the control measures but considering the significance of a hazard (probability x severity) without them. Then consider the impact of those control measures on the hazard.
 
Kind regards,
 
Tony


Charles.C

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Posted 10 September 2021 - 02:30 AM

This is a discussion I have frequently:

 

The risk matrix (Probability x Impact), regardless of its format, is assessing the risk before PRP's and CCP's are implemented or the remaining risk after these are implemented (which is obviously a Chicken & Egg situation)?

 

A consultant once told me "the remaining risk after all possible measures are implemented". But that sounds like putting the cart before the horse, as the objective of the matrix is to determine the measures.

 

Any thoughts?

 

As I understand yr query is equivalent to "Should PRPs be derived from the risk result of the hazard analysis or designated in advance.

 

This "before or after topic" has been long argued over in haccp documentation.

 

afaik most traditional, eg Codex-based, HACCP treatises specify the designation of PRPs prior to initiating hazard analyses. Sort of follows from (satisfactory) GMP (a source of many PRPs) being regarded as a necessary precursor to HACCP.

 

IIRC, ISO-HACCP, eg iso22000 standard, assumes same chronological order as Codex.

 

Nonetheless the use of risk assessment to nominate PRPs can certainly be found in some texts also, eg the FSSC 2020 Guidance material for differentiating PRP/CCP/OPRP


Kind Regards,

 

Charles.C


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Tony-C

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Posted 10 September 2021 - 02:43 AM

As I understand yr query is equivalent to "Should PRPs be derived from the risk result of the hazard analysis or designated in advance.

 

This "before or after topic" has been long argued over in haccp documentation.

 

afaik most traditional, eg Codex-based, HACCP treatises specify the designation of PRPs prior to initiating hazard analyses. Sort of follows from (satisfactory) GMP (a source of many PRPs) being regarded as a necessary precursor to HACCP.

 

IIRC, ISO-HACCP, eg iso22000 standard, assumes same chronological order as Codex.

 

Nonetheless the use of risk assessment to nominate PRPs can certainly be found in some texts also, eg the FSSC 2020 Guidance material for differentiating PRP/CCP/OPRP

 

Thank you Charles.

 

Also applicable legislation may need to be considered, for example:

PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
117.130   Hazard analysis. Part c) 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.
 
Kind regards,
 
Tony

Edited by Tony-C, 10 September 2021 - 02:44 AM.


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Charles.C

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Posted 10 September 2021 - 09:28 AM

 

Thank you Charles.

 

Also applicable legislation may need to be considered, for example:

PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
117.130   Hazard analysis. Part c) 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.
 
Kind regards,
 
Tony

 

 

Hi Tony,

 

TBH, since FSMA appeared,  I have studied innumerable articles relating to your quotation but have never succeeded in comprehending the operational meaning/objective/necessity of your underlined phrase (UL). Just for example, does "absence" mean total or a little ? eg consider a cooking step in a process.

 

IMEX virtually all the related publications quietly skip over the UL since (1) the "impact" of the UL as far as final choice of Preventive Controls are concerned appears to be zero, (2) I suspect the respective authors frequently  do not understand the UL's objective either.

 

Above topic, for me, is horribly reminiscent of the OPRP saga whose generated confusion over 13 years (truly unlucky !) has finally resulted in ISO effectively admitting to a terminological fiasco from which they have now retreated with the 2018 issue of iso22000.

 

@ anoordende - risk assessment/risk matrices as utilised in haccp  only represent the simplified tip of an iceberg. I suggest the topic of pre- and post- probabilities is an analogous situation. Bit like Fisher/Bayesian Estimations.


Kind Regards,

 

Charles.C




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