13 replies to this topic

[dohh]

Save me from brain damage, please! Tried to translate between 3 languages, still don´t get, what the ... they want from me!?

8.5.2.1 Conduct a hazard analysis based on the preliminary information

 

then 

 

8.5.2.2.1 Identify and document all food safety hazards AND determine acceptable levels WHILE considering intended use, etc.

 

and then

 

8.5.2.3 Conduct a hazard assessment for each identified hazard. 

 

Did I not just do it? And then:

 

8.5.4.1 Establish, implement and maintain a hazard control plan.

Again? The manuals asks for PRPs much earlier. Sounds the same, same, same and SAME to me. Please help with how to approach... Anyone can explain it so that even I understand? Thanks!

[Scampi]

See my comments in red

Save me from brain damage, please! 

 

Tried to translate between 3 languages, still don´t get, what the ... they want from me!?

8.5.2.1 Conduct a hazard analysis based on the preliminary information  Preliminary information---basic ingredients and process flows

 

then 

 

8.5.2.2.1 Identify and document all food safety hazards AND determine acceptable levels WHILE considering intended use, etc. What hazards did you identifiy based on preliminary information  and what are the acceptable levels

 

and then

 

8.5.2.3 Conduct a hazard assessment for each identified hazard.  Lets assume in step 1 you identified cook time as a hazard.........you know that if not cooked long enough you may have a problem---this step is asking you to expand on that hazard.....what are the actual hazards if cook time is not long or hot enough (as an example)   What are all the downstream (and maybe upstream) issues this hazard could create?

 

Did I not just do it? And then:

 

8.5.4.1 Establish, implement and maintain a hazard control plan.   How will you address each hazard from step 3?  this is where you write in your controls (PC or CCP) and insert monitoring and deviation plans

Again? The manuals asks for PRPs much earlier.  Sure PRPs are easier and you can use them IF you have ones that will DIRECTLY control/reduce or eliminate your hazards.   There is NOT prp that DIRECTLY addresses cook time/temp and it's control. The PRPs will address calibration, documentation and hygiene, but not the HAZARD in this scenario

 

These are the steps required for a HACCP plan which is NOT the same as an FDA PRP

 

 

 

Sounds the same, same, same and SAME to me.

Please help with how to approach... Anyone can explain it so that even I understand? Thanks!

 

[Charles.C]

Save me from brain damage, please! 

 

Tried to translate between 3 languages, still don´t get, what the ... they want from me!?

8.5.2.1 Conduct a hazard analysis based on the preliminary information

 

then 

 

8.5.2.2.1 Identify and document all food safety hazards AND determine acceptable levels WHILE considering intended use, etc.

 

and then

 

8.5.2.3 Conduct a hazard assessment for each identified hazard. 

 

Did I not just do it? And then:

 

8.5.4.1 Establish, implement and maintain a hazard control plan.

Again? The manuals asks for PRPs much earlier. 

Sounds the same, same, same and SAME to me.

Please help with how to approach... Anyone can explain it so that even I understand? Thanks!

Hi dohh,

 

it sounds like you are new to "HACCP" in general and particularly the ISO vision of HACCP.

 

Maybe have a look at this fully worked example/thread for previous version of iso22000 (actually fssc22000 but the haccp basic  logics are near identical) -

 

http://www.ifsqn.com...ge-7#entry50651

[dohh]

See my comments in red

I would like to expand what you said about PRP vs oPRP. Let´s take the example of temperature control.

Can it not be reframed as a PRP, if equipment is programmable/automatic? Can it not be reduced to PRP that software is programmed correctly, therefore expected to do the job of temperature control? 

[dohh]

Thanks, this leads me to more confusion:)

I don´t understand the selection of measures part. The example approach in the other thread was very confusing, they used list of almost 150 combinations. 
Shouldn´t these measures be incorporated in PRP/oPRP anyway? 

Please correct me, this is how I understand the logical order of the process:

1) Hazard analysis from preliminary information
2) Assessing these hazards, as they are now, by scoring, explaining. Evaluating which hazards are lowered enough with PRPs already. <-- I take the majority of measures from here.
3) The hazards that score above accepted levels, get oPRP or CCP. 
 

Hi dohh,

 

it sounds like you are new to "HACCP" in general and particularly the ISO vision of HACCP.

 

Maybe have a look at this fully worked example/thread for previous version of iso22000 (actually fssc22000 but the haccp basic  logics are near identical) -

 

http://www.ifsqn.com...ge-7#entry50651

[Scampi]

You should NOT end up with a "score" in a hazard analysis. You should only be left with identified hazards that need controlled and then you can decide what is managed with a PRP and what isn't

 

A risk assessment will give you a score and it they are used in very different scenarios

 

Have you taken a HACCP course?  It really sounds like your getting yourself confused because you don't fully understand the fundamentals

 

My suggestion would be to educate yourself first, you'll also notice, I'm not the only one to suggest this as your next step

 

https://www.inspecti...2/1528205368359

[dohh]

Yes, every person has a different reasons to ask. I explain my case a bit, if you are kind enough to give me more advice.

I´m an owner of a quite small company (yet not micro), I know my business through and more. I have built it. No, I have not taken a ISO 22000 course, but I have downloaded quite a lot materials by now. Some of it paid. Even procedure examples, etc. 

I will not build the actual system all by myself, but I want to understand it before I hire someone, as I am extremely skeptical about someone coming from outside and doing it correctly. I want to take part.

So for now, I believe my biggest problem is I don´t understand, in what order I should approach to the system. I believe I do more-or-less understand, what every separate clause means.

Is this a bad place to look for information?: https://www.pqbweb.e...018.php#8.5.1.1
 
8.5.2.2 says to identify FS hazards.
8.5.1.1 said earlier to include FS hazards. How can I include something I haven´t identified yet?

Am I missing something or I can´t approach to it more or less in order?

You may also recommend me a paid material, that gives good overall vision, of what order I should do the things. Of course I have separately most of the documents (Pest control plan, Personal training, HACCP for product etc), but from where to start to structure it by ISO 22000:2018? I get the first clauses, I get confused at 8.5.2.
 
My goal for now, is to get my company de facto close to ISO 22000 compliance, not to certify it yet.
 
Thanks for your time. 

 

You should NOT end up with a "score" in a hazard analysis. You should only be left with identified hazards that need controlled and then you can decide what is managed with a PRP and what isn't
 
A risk assessment will give you a score and it they are used in very different scenarios
 
Have you taken a HACCP course?  It really sounds like your getting yourself confused because you don't fully understand the fundamentals
 
My suggestion would be to educate yourself first, you'll also notice, I'm not the only one to suggest this as your next step
 
https://www.inspecti...2/1528205368359

[Scampi]

This site is a better place to start

 

https://haccpmentor.com/

 

http://www.ccofah.or...ication-course/

 

http://loyalisttrain...ction-to-haccp/

 

https://www.nsfcanad...rolment-courses

 

Starting with ISO 22000 and not HACCP is like learning to downhill ski over moguls before learning to walk

 

You need to master the foundation of HACCP before you even attempt to understand the intricacies of and GFSI plan

 

AND if you want to participate (way to go!) and hire a 3rd party to help, the only way to be sure you don't get hosed, is to have a basic understanding from the ground up

[Charles.C]

Yes, every person has a different reasons to ask. I explain my case a bit, if you are kind enough to give me more advice.

I´m an owner of a quite small company (yet not micro), I know my business through and more. I have built it. No, I have not taken a ISO 22000 course, but I have downloaded quite a lot materials by now. Some of it paid. Even procedure examples, etc. 

I will not build the actual system all by myself, but I want to understand it before I hire someone, as I am extremely skeptical about someone coming from outside and doing it correctly. I want to take part.

So for now, I believe my biggest problem is I don´t understand, in what order I should approach to the system. I believe I do more-or-less understand, what every separate clause means.

Is this a bad place to look for information?: https://www.pqbweb.e...018.php#8.5.1.1
 
8.5.2.2 says to identify FS hazards.
8.5.1.1 said earlier to include FS hazards. How can I include something I haven´t identified yet?

Am I missing something or I can´t approach to it more or less in order?

You may also recommend me a paid material, that gives good overall vision, of what order I should do the things. Of course I have separately most of the documents (Pest control plan, Personal training, HACCP for product etc), but from where to start to structure it by ISO 22000:2018? I get the first clauses, I get confused at 8.5.2.
 
My goal for now, is to get my company de facto close to ISO 22000 compliance, not to certify it yet.
 
Thanks for your time. 

 

Hi dohh,

 

Maybe consider this Package -

 

https://www.ifsqn.co...tion-programmes

 

I do slightly wonder why you selected iso22000 to work with ?.

IMO iso22000  is one of the most complicated of the group  of GFSI-recognised FS Standards due to its own (generic) version of HACCP, ie ISO-HACCP. However, as I understand, it iso22000 (or rather the fssc version of it) is favored  by many large Organisations particularly due its relatively "advanced" Management content ("borrowed" from the ISO Series of Standards).

 

PS - IIRC, ISO themselves also issue some kind of a do-it-yourself publication (see website) for their iso22000 Standard aimed at "small" enterprises.. The ISO Standard ISO22004 is also intended to explain the concepts/requirements utilised by iso22000 however afaik it has not yet been updated since ca 2015, ie prior to issuance of iso22000-2018.

[dohh]

Hi Charles

I chose ISO 22000 because this is kind of minimum that some potential export customers would accept. They prefer BRC or IFS, but as my factory is located in a town, there would be non-resolvable problems with separating the plant physically. (Main entrance opens to street literally). At least that´s how I understood it.

Also if I was able to work by ISO 22000 standards de facto for a while, I could then expand it to FSSC and be accepted by GFSI too.

Thanks for recommendation. I will think about it and maybe buy.

I think too, that ISO 22000 approach to HACCP is difficult to bite, especially if you are not a quality manager. But I think I will go on with it. I kind of like the way HACCP is written into many clauses, I am just confused, in which order to approach. But I am getting there:)

The fact that ISO focuses on management a lot, is attractive to me too. My long term plan is to buy out the other founders and retire from active managing. So having a system, that incorporates management commitment is useful in the scenario, if I should delegate my work one day.
 

Hi dohh,

 

Maybe consider this Package -

 

https://www.ifsqn.co...tion-programmes

 

I do slightly wonder why you selected iso22000 to work with ?.

IMO iso22000  is one of the most complicated of the group  of GFSI-recognised FS Standards due to its own (generic) version of HACCP, ie ISO-HACCP. However, as I understand, it iso22000 (or rather the fssc version of it) is favored  by many large Organisations particularly due its relatively "advanced" Management content ("borrowed" from the ISO Series of Standards).

 

PS - IIRC, ISO themselves also issue some kind of a do-it-yourself publication (see website) for their iso22000 Standard aimed at "small" enterprises.. The ISO Standard ISO22004 is also intended to explain the concepts/requirements utilised by iso22000 however afaik it has not yet been updated since ca 2015, ie prior to issuance of iso22000-2018.

[dohh]

Found an approach, that clarified me a lot: https://www.exaris.f...p-prpo-en.phtml

 

Key moments, that got me so confused before:

 

• "Finally, it is now clearly established that Prerequisite Programs are not (no longer) considered as "control measures" in the strict meaning of ISO 22000:2018." 
• "Then the standard requires hazard analysis (to identify significant hazards) regardless of control measures (which the analysis is specifically intended to determine) but not without considering PRPs !"
• "The oPRP is a “control measure” without an explicit connection to a PRP."

[Charles.C]

 

Found an approach, that clarified me a lot: https://www.exaris.f...p-prpo-en.phtml

 

Key moments, that got me so confused before:

 

• "Finally, it is now clearly established that Prerequisite Programs are not (no longer) considered as "control measures" in the strict meaning of ISO 22000:2018." 
• "Then the standard requires hazard analysis (to identify significant hazards) regardless of control measures (which the analysis is specifically intended to determine) but not without considering PRPs !"
• "The oPRP is a “control measure” without an explicit connection to a PRP."

 

 

Yes the link you mention has been previously discussed here. One problem is that some of the interesting opinions quoted above are distinctly debatable. In fact the PRP comment referred above is precisely  opposite to that published (ca 2005) by one of the originators of the Standard.

IIRC this is a French Website.There is a near Encyclopedia of discussion/argumentations over iso22000 in the French Literature, notably regarding OPRP and  afaik, net result = no consensus.

 

A relatively readable discussion over iso-haccp is IMO given in iso22004 (2005). (The later revised version,ca 2015, IIRC, tends to confuse more than illuminate).

 

It is an intrinsic feature of the iso22000 standard that the basic concepts regarding iso-haccp have fundamentally changed since its original draft and up to its current format. Personally I think that OPRP is a redundant concept and preferably abandoned but that would presumably also destroy iso-haccp.

 

PS - Note that fssc (2020) have published a lengthy and quite detailed explanation of changes, concepts in iso22000-2018 (posted elsewhere here). Unfortunately , again IMO, some of the haccp content is internally inconsistent and/or "haccp-illogical".

[dohh]

Very interesting discussion, Charles, thank you!

 

How do you look at this: can one make baking as oPRP?

 

My justification: although it is a temperature-controlled process, normal baking temperatures of low-moisture foods are a huge overkill from in the aspect of pathogen preservation in the product. We speak about programs that operate at least 30 degrees on top of what is needed for killing the pathogens. Also a hypothetical failure, when pathogens could survive because or oven´s malfunction would result in obviously under-baked products.

 

So, could it be solved as a periodic control, if the oven´s thermometers are calibrated? 

[Charles.C]

Very interesting discussion, Charles, thank you!

 

How do you look at this: can one make baking as oPRP?

 

My justification: although it is a temperature-controlled process, normal baking temperatures of low-moisture foods are a huge overkill from in the aspect of pathogen preservation in the product. We speak about programs that operate at least 30 degrees on top of what is needed for killing the pathogens. Also a hypothetical failure, when pathogens could survive because or oven´s malfunction would result in obviously under-baked products.

 

So, could it be solved as a periodic control, if the oven´s thermometers are calibrated? 

 

Hi dohh,

 

^^^(red) - Baking is undeniably a source of frequent haccp debates.

 

JFI I should point out a few initial debating points -

 

(1) Many, but definitely not all, texts consider the baking step as not being associated with any significant hazard. In which case, neither a CCP nor an oprp exist. (The "visibly unbaked" argument was, IIRC, included in a near-final draft of iso22000:2005 but got deleted from the final version for unspecified reasons).

(2) The relevant hazard/CCP reference point is the product core temperature so that above mention of + 30degC (I assume "C") as typical may not always be valid.

(3) Contrary to (1) above, the interpretation of baking as a CCP is supported in FSMA's "HACCP Program" via a specific example in FDA's draft Hazard Analysis / Preventive Controls Guidance. (This analysis rebuts some earlier baking FSMA speculations, eg -

https://www.ift.org/...umns/processing

 

Regardless, i assume for present purposes that the baking step is associated with a significant pathogen hazard, eg Salmonella spp, B.cereus. Accordingly it is necessary to apply a logical decision methodology to determine whether the associated control measure (temp/time) is a CCP or oprp.

 

One possible decision tree (of many) is attached in post linked below (also assuming the additional textual caveats). Alternatively one could apply the more exhaustive excel method given in Post 22 of same thread.

 

https://www.ifsqn.co...18/#entry138212

 

Both decision routes indicated a CCP for me.