8 replies to this topic

[nikiforos]

Hello to everyone....

please find below some questions/concerns about hazard analysis (7.4) of ISO22K:

In 7.4.2.1 we have to mention all the possible hazzards that may arise from everywhere (eg. raw materials, proccess, facilities etc.) or only the ones that there is a possibility of presence in the final product (eg. hazard from raw material A might be a pathogen but in the final product eg. yogurt due to its pH (lower than 4,5) and not only is not possible to exist)?

In 7.4.3. the hazard assessment is done per hazard in each process step or for the hazard in the final product?
eg. the possibility of precence of pathogen A in step "storage of raw milk" is high and in step "pasterization of raw milk" is low or the possibility of precence of pathogen A in pasteurized milk (final product) is small due to pasterization and aspectic filling?


Also if the hazard assessment is in every process step that may arise, do i take in consideration the existing control measures or not? In most of the studies that i have seen they use hazard assessment as a screening technique for the control measures.

step: storage of raw milk in a tank
microbiological hazards:
a) growth of possible existing pathogens (if temp is above 6C or storage time is above 48hours) and formation of toxins or spores that could not be eliminated by pasterization
b) contamination with pathogens from equipment, personel etc.

For a)
-process equipment: usage of cooling tank, alarm if temp arise above 6C
-control measures: checking of the temp and time before proceeding to the next step (pasteurization)
Possibitily with the aboves low...without them high......????

For b)
-process equipment: closed circuits, adequate equipment etc.
control measures: cleaning procedures, training of personel etc.....
possibility low....

Could you please comment the aboves?

I am sorry if my english are not very well and i am not sure that i made my point.

[Charles.C]

Dear nikiforos,

It would seem yr initial queries are mainly regarding the traditional haccp analysis as applied to milk production. Not my area but would suggest to look up a generic haccp plan, they certainly exist on the net. (basically haccp is concerned with determining the (significant) hazards which may require control (and the methods) so as to achieve a safe product, this necessitates an initial wide-ranging assessment).

As far as the ISO 22000 standard is concerned, the interpretation of the haccp analysis also overlaps things like oprps which I'm sure you know already. ??

BTW (if not said before), welcome to the forum !

Rgds / Charles.C

[nikiforos]

Dear Charles,

Thank you for your quick responce....

i am aware of OPRPs and CCPs but my questions are targeted in specific paragraphes of ISO22K standard.

In haccp analysis everything is more clear to me....But i dont really get the added value of Hazard Assessment in ISO22K? To get it i think some answers in the above questions with be very helpfull.

Kind regards

[Charles.C]

In 7.4.2.1 we have to mention all the possible hazzards that may arise from everywhere (eg. raw materials, proccess, facilities etc.) or only the ones that there is a possibility of presence in the final product (eg. hazard from raw material A might be a pathogen but in the final product eg. yogurt due to its pH (lower than 4,5) and not only is not possible to exist)?

As per previous post, you first hv to list all possible BCP hazards. Then you carry out hazard analysis to determine the significant ones. This is basic haccp, not introduced by iso 22000, however the use of oprps has somewhat changed the implementation procedure as you probably know already.

In 7.4.3. the hazard assessment is done per hazard in each process step or for the hazard in the final product?
eg. the possibility of precence of pathogen A in step "storage of raw milk" is high and in step "pasterization of raw milk" is low or the possibility of precence of pathogen A in pasteurized milk (final product) is small due to pasterization and aspectic filling?

It's done (ie the risk analysis) for potential hazards associated with each step in relation to their effect on the safety of the finished product.

Also if the hazard assessment is in every process step that may arise, do i take in consideration the existing control measures or not?

Yes, why not ?. They may well be the preferred control measures.

For the next 3 paragraphs, I am not really sure what yr question(s) are. Maybe you will have to be more specific so that milk-related people here can respond.

In haccp analysis everything is more clear to me....But i dont really get the added value of Hazard Assessment in ISO22K?

Very, very, basically, ISO 22000 > ISO Management System + (focus on safety), ie FSMS

The (focus on safety) component is provided by the haccp system (as interpreted by ISO).

These ISO 9000/HACCP/22000 documents might be of some interest to you -

 HACCP___ISO_9000.pdf   248.52KB   84 downloads

 iso_9000_compared_haccp_peters.pdf   38.76KB   70 downloads

 heggum_iso_22000_cheese_.pdf   145.53KB   176 downloads

Rgds / Charles.C

[Tony-C]

Dear Charles,
i am aware of OPRPs and CCPs but my questions are targeted in specific paragraphes of ISO22K standard.

In haccp analysis everything is more clear to me....But i dont really get the added value of Hazard Assessment in ISO22K?

Hi Nikiforos

Hopefully Charles response has helped with regards to ISO 22000. I think the added value in ISO 22000 is that although a little confusing it does prescribe a structured approach to HACCP analysis and also offers a certification which gives your customers confidence that you are producing a "safe product".

If you have any specific Dairy HACCP questions I can help with those.

Regards,

Tony

[nikiforos]

Dear Charles,

probably i wasn't so clear about my questions. The purpose of them was (for my opinion) to show that for the ISO22K standard the hazard assessment is a *&%$@#%%

Step by step after you have prepared a flow diagramm and you have described the process steps and the control measure it is time to do the hazard identification and the hazard assessment.

Ok, true you describe all the hazards that would come out from every step, raw material, bla bla bla.....

In the hazard assessment if i get it right, you have to describe if each of the aboves hazards is a "real" hazard or not.

To do this the standard guides you not to take in consideration the process steps or the control measures that you have, but only the "nature" of the product. Thats what my examples in dairy process in my first post are trying to show.

A short example (again from dairy but an easy one). Let say you produce sterilized milk and your last step is sterilization. Also lets say that one of the hazards is some non sporoforming and without production of toxins bacteria (eg. listeria monocytogenes). If you take in consideration the process steps (sterilization) then the possibility of this hazard to your final product is very low. So you can come to a conclusion that listeria is not a real hazard for me. True or false?

Thats an example that in the hazard assessment you have to assess the posibility of one hazard independently of the process steps or the control measures....

And of course in this way 99,9% of the hazards that you have identify earlier are "true hazards" and the hazard assessment is a *&@%&^%&.

I hope this time i was more specific.

Kind regards



Dear Tony thanks for you offer to help me. I am sure i ll contact you real soon.

[Tony-C]

A short example (again from dairy but an easy one). Let say you produce sterilized milk and your last step is sterilization. Also lets say that one of the hazards is some non sporoforming and without production of toxins bacteria (eg. listeria monocytogenes). If you take in consideration the process steps (sterilization) then the possibility of this hazard to your final product is very low. So you can come to a conclusion that listeria is not a real hazard for me. True or false?

Hi Nikiforos

I think once you get your head round it the sturcture of ISO 22000 isn't too bad and certainly offers a disciplined methodology.

Your example Listeria is the hazard and your control measure is sterilisation. This is almost certainly a CCP.
I assume that you are sterilising in container, so not so applicable, but with pasteurised milks there would probably be Prerequisite procedures to prevent the
contamination of pasteurised milk such as sanitation.

Regards,

Tony

[nikiforos]

Dear Tony,

i am fully aware about what i am going to do at last....

In almost every study i know the most common practise is to go backwards (meaning i am sure that listeria is a hazard and a CCP so i ll find a way to present it like this)....and if you know well enough what, where and how you have to control a hazard in order to be as secure as possible , everything is fine with me....

As for the example with Listeria, sterilization at the end will be a CCP but i was trying to show that if in the hazard assessment you take into consideration the process steps or the control measures (eg. sterilization) then Listeria will not be a hazard at the first place.

Also i dont get some studies that they use for example the hazard assessment in order to find a way to say that this hazard is below this grade so i ll control it with PRPs (where sth relevant is mentioned in ISO22K?)

Kind regards

[Charles.C]

Dear ni,

If you are claiming that the ISO 22000 standard is a very confusing document, I 1000% agree with you.

Unfortunately, IMHO, this is not unusual for ISO documents.

As per it’s opening, ISO 22000 relies on Codex HACCP for its basic HACCP structure, I suggest that –

ISO 22000 HACCP = (Codex HACCP) + (oprp) + (a re-focusing on control perspective)

Regarding control measures, I think this is the relevant comment in the standard Codex HACCP(para.6, ca. Pg25) –

List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards

(the underline is mine).

Regarding yr comments on “real” hazards, it is, as you hv just noted, perhaps helpful to look at the definition of a CCP, eg - any point in the chain of food production from raw material to finished product where the loss of control could result in an unacceptable food safety risk. (Maybe if L.mono did not exist in the raw material, it would simply be replaced by yet another pathogen? ).

Rgds / Charles.C