Hazard Analysis Step By Step Or In The Final Product

Hello everyboby,

In preparation for ISO 22000 certification, I am trying to develop the tools to conduct the hazard analysis.
I hesitate on the approach to choose:
1 A study step by step with te diagram. There is a risk of repetition when the dangers are common to several stages, resulting in a serious study but a more traditional method
2 hazard analysis in the finished product is quite "attractive" as an approach, because for me it is short but my fear is to miss something even though we reboucle with stages of manufacture.

I'll be interested to hear the opinion of those of you who have opted for the 2nd solution (difficulties encountered, template ...)

Thank you for your help

Virginie

Dear Virginie,

I beg you pardon if I am wrong, but isnt HACCP (as you now, it also includes in ISO 22k) suppose to be a "preventive" rather than "correction"? I guess the 1st approach is much more make any sense for me. Or maybe you can give us another hints, a product description, or process flow diagram perhaps?


Regards,


Arya

PS: Happy Welcome to the club!!

Dear Virginie,

I beg you pardon if I am wrong, but isnt HACCP suppose to be a "preventive" rather than "correction"? I guess the 1st approach is much more mak any sense for me. Or maybe you can give us another hints, a product description, or process flow diagram perhaps?

I agree, I know that some hazards will be generic to each step, you could define these around some generic hazards for example, e.g. Introduction of S. aureus to the product due to insufficient handwashing. That said, even in the example I just gave, that will be more of a significant hazard at a manual reworking process than elsewhere.

For me there's no substitute to a step by step approach. I have heard of people saying at the get go "this is my ownly significant hazard" but I don't think that can work. For one, I think it's good practice to outline at each step which prerequisite is controlling the hazards if that's how they are controlled. I also think it's a good sense check to make sure your prerequisites are really robust enough.

I'm speaking from the position of just having written a HACCP plan from scratch (all 100 pages of HACCP analysis), it is surprising how it doesn't actually take that long to write up, it's the meetings that take forever.

Dear Virginie,

Agree with the previous posts.

Additionally, I rather doubt that the ISO 22000 standard gives you a choice as per yr initial post.
eg section 7.3 such as 7.3.5.1 "flow diagrams shall provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards."

Similarly Fig2 in ISO 22004.

Rgds / Charles.C

Dear All,

Thank for your answers.
I just want give you more information. our products are spirits.
Our process is divided in 3 parts : distillation, ageing and bottling. These activities are in different places
We sell products in bottles.
For us , we consider only physic and chemical hazards
Following me, we have to pay more attention on bottling lines that mean in the final products.

My point of view is to list the hazard in the final product (during the bottling) , establish acceptable level in the final product (§7.4.2.3 of ISO 22000) and study how the others stages (distillation, ageing) contribute to this hazard.

For exemple : pieces of glass
If we have breakage glass in the distillation part it is less dangerous than on the bottling line and we have about 10 filtrations after distillation (the last one is 10µm). The probability to have a significative piece of glass becoming to the distillerie in the bottle is 0.

That why I want to consider hazards only in the final product but in general items : heavy metals, peaces of glaces, chemical hazars du to products use clean vat....

I hope now you understand better my position ,and you could give me your point of view about this approch

Regards

Virginie

IMO.. you have to control hygiene personnel and hygiene room (PRP).. and if in the process that potential to micro (pathogenic) growth, for example during ageing process, and you have to control the temperature to avoid it.. so the ageing process is CCP with micro hazard and temperature ageing is conrol measure...

Dear Virginie,

I think it is possible to conduct hazard analysis in two ways.

(a) Process step wise hazard identificiation - common method used

(b) Hazard wise - Identify the hazards first and all steps where these can occure and define the control measure etc.

Dear Virginie,

Obviously easier to create an example HACCP analysis for the forum to comment on, particularly with regard to pre-requisites, oprps etc but I appreciate you are not there yet.

Nonetheless the principle of prioritising the hazards and their appropriate control actions is the core within the QMS, IMO. A logical way to achieve this and organise the surrounding ancillary functions then has to comply with the ISO textual standard from an auditory point of view.

Well, I am not currently a user of ISO 22000 so cannot speak from direct experience but I believe that some of these requirements are compulsory and some are not. Traditionally, the distinction has been sort of designated in ISO language by the use of “shall” (in the English version anyway). This was the thought behind my previous post. I don’t know how black and white this is in practice. 50/50 maybe ? What do you think ?

In a sense, HACCP has always focussed on the end product although some approaches (eg FSO) are more quantitatively explicit than others and some variables more easily expressed in numbers than others. If you compare the traditional HACCP plans of USA and NZFA, you will see some of the differences. Seems to me that 22004 is pointing to the use of specific targets (7.4.2) but not demanding it absolutely. Anyway, I think there is no need to worry that yr “prior point of view” approach is alarmingly revolutionary.

To be honest, I suspect yr 2nd approach may ultimately “morph” into the first one in order to fit within the standard. A trial example should make things easier to see.

Would like to hear from some (certified) 22000 users regarding the “should”, “shall” aspects. And the rest.

Rgds / Charles.C

I think you can use a stepwise approach still and would have to for the hazard of chemical contamination; for example, presence of methanol in the finished spirit I would say is possible and the likelihood of causing injury to a consumer is probable; hence distillation is certainly a step not to miss out.

How much detail you go into with each step though is up to you. You don't have to describe each metre of pipework but I would expect these key stages to be described in full and hazards considered:

Fermentation
Distillation
Ageing
Filtration (remember the risks of the filters themselves becoming damaged and causing a foreign matter hazard.)
Any processes of bottle washing and checking
Bottle filling
Bottle closing (remember the risks of deliberate contamination in the supply chain)
Any metal detection / x-ray
Casing
Distribution
Any rework / recirculation routes

Just my thoughts but you know your process best!

IMO I think the 'finished product' argument doesn't work because the idea of HACCP is it shouldn't get to the finished product.

Dear Virginie,

So sorry, but I am still disagree with the finished product approach. Taking part of your example the breaking glass, there are several points that Id like to elaborate a bit more:

1. Of course the filtration can solve the glass problems at distillation section, but how about the bottling section? How did you handle the breaking glass at the bottling line?
2. How did you check the glass contamination from each bottles (sampling is no good for me in this case)? Do you have a glass detector after bottling section?
3. I believe, that the filtration section is called as OPRP, and the glass detector (if available) is called as CCP. But if you dont think there will be no glass breaking at the bottling section (the PRP is well organized just like AS Nur said), then I am suppose to think that the filtration section is considered as CCP.
4. I think the checking of heavy metals and glass breakage only act as verification/sampling, and cant replace the monitoring activities.

Please be advise if I was miss in intepreting your problems.


Regards,


Arya