14 replies to this topic

[Rudra]

Dear,

I wish to have an example of a hazards analysis and categorisation of control measures according to requirements of iso 22000.
How shall i evaluate the risk level?

Please help.

A+
Rudra

[George @ Safefood 360°]

Hi Rudra

This is a vast and increasingly important area of food safety management particularly in the light of the latest revisions to GFSI standards which place an almost pathological focus on hazard analysis and risk assessment. It has been made more complex due to the need to risk assess individual management and PRP programs in addition to specific food safety hazards arising from HACCP.

We will be publishing two white papers in the coming two weeks on this very subject which will be available from the IFSQN Newsletter. So subscribe if you have not already and check them out. They will come complete with tools to assist you in conducting the HA's and RA's. The first will focus on microbiological risk assessment and the second will deal with everything else including risk assessment of management and PRP's.


George.

[Charles.C]

Dear,

I wish to have an example of a hazards analysis and categorisation of control measures according to requirements of iso 22000.
How shall i evaluate the risk level?

Please help.

A+
Rudra

Dear Rudra,

This thread was initiated specifically to offer one route for addressing your query(s) -

http://www.ifsqn.com...dpost__p__39585

Rgds / Charles.C

[Tony-C]

Dear,

I wish to have an example of a hazards analysis and categorisation of control measures according to requirements of iso 22000.
How shall i evaluate the risk level?

Please help.

A+
Rudra

Hi Rudra,

Have a look at the examples on the link that Charles has posted. If you want specific examples then let us know your products and an idea of your process.

Kind regards,

Tony

[Rodriguez-Gonzalez]

Thanks for sharing, this will be great, looking forward to it.

I am working in a related project which will be happy to share once I have it completed as well.

Hi Rudra

This is a vast and increasingly important area of food safety management particularly in the light of the latest revisions to GFSI standards which place an almost pathological focus on hazard analysis and risk assessment. It has been made more complex due to the need to risk assess individual management and PRP programs in addition to specific food safety hazards arising from HACCP.

We will be publishing two white papers in the coming two weeks on this very subject which will be available from the IFSQN Newsletter. So subscribe if you have not already and check them out. They will come complete with tools to assist you in conducting the HA's and RA's. The first will focus on microbiological risk assessment and the second will deal with everything else including risk assessment of management and PRP's.


George.

[George @ Safefood 360°]

Thanks for sharing, this will be great, looking forward to it.

I am working in a related project which will be happy to share once I have it completed as well.

Hi Rodriguez Gonzalez. The White Paper on Risk Assessment is now available at the following link


MRA and Tools


The white paper on general risk assessment will be available in the early new year.


George

[Rodriguez-Gonzalez]

Great,

Thanks again,

Hi Rodriguez Gonzalez. The White Paper on Risk Assessment is now available at the following link


MRA and Tools


The white paper on general risk assessment will be available in the early new year.


George

Edited by Rodriguez-Gonzalez, 20 December 2012 - 02:53 PM.

[gelato]

last time I reviewed FSSC2200; HACCP is still consider a basis therefore, walk your analyses thru the decision tree etc determine risks related to Bio, Physical and DChemical. Develop corrective action and verification etc..

[Rodriguez-Gonzalez]

As promised, here is a quick view of a way to setup the risk analysis.

Will be happy to get to the details of the idea with any group interested in advancing the idea.

Attached Files

•  Hazards & Risk Analysis - Example.pdf   454.59KB   228 downloads

Edited by Rodriguez-Gonzalez, 09 January 2013 - 03:44 AM.

[Charles.C]

As promised, here is a quick view of a way to setup the risk analysis.

Will be happy to get to the details of the idea with any group interested in advancing the idea.

Dear Rodriguez-Gonzalez,

Thks for yr post. Interesting document.

The document is rather scarce on explanation? A hazard analysis normally includes control measures, by definition in HACCP i think.

Apologies for my ignorance as to typical RPN risk formats but what is column "n" representing? I am also unclear as to what the top-captioned output material refers to ? (or where it is for that matter ?).
A risk matrix key would hv helped. I think in this case, RPN more simply = RISK for most (LxO) multiplicative HACCP publications.?

I'm also slightly confused as to the Tables text layout. Perhaps "Microbial Pathogens = Bacterial Pathogens ? and other following categories have lost the "Pathogens" altogether ? ( bacterial pathogens may exhibit levels of pathogenicity [severity], eg zero and non-zero regulatory species, but some haccp analysts lump them together for "convenience").
I'm also intrigued as to the nature of the unspecified "Other Biologicals" .

It's only my opinion but I feel it is un-necessary to sub-divide so many items as done here. I prefer the more conventional (?) approach of grouping microbial pathogens into one category with sub-specification of specific hazards as relevant. The present layout is unobjectionable but I suspect will become laborious if done for every process step. The current procedure is tending to the FMEA styling i guess (?), comprehensive but also very "heavy duty".

I would also comment that, AFAIK, for ISO 22000 the specification in the risk analysis of which hazards are controlled by which ISO-defined prerequisite functions is a usual expectation (less so for traditional HACCP).

It's difficult to make specific comments without details on the actual processes 1 and 2 (eg flow charts), specific hazards under discussion, risk assessment methodology, etc.

Offhand the table looks like a summary of some data from a full traditional HACCP hazard analysis for the "processes" 1 and 2.

Since this thread was in ISO22000 context, i am interested how the results within the table were utilised to determine / categorise control measures into CCPs / OPRPs ? (I am guessing [red (80)] > significant hazards ? >>>>> ?)
Perhaps the CCPs are being determined directly from the relative risk values of the hazard analysis.? If so, I anticipate this procedure will be questioned as incomplete by some users of ISO22000 however perhaps i hv misunderstood the info. presented in which case my apologies in advance. Similar comment for OPRPs.

sorry for my confusion and interested in your comments. Thks again for the contribution.

Rgds / Charles.C

PS - side-comment only, it is also conventional to use a slightly different, albeit analogous, hazard analysis procedure for input materials as compared to process steps.

(ADDED LATER) - After some googling, I can add 3 examples of use of RPN given below.

I deduce the risk matrix in RG's post was probably 10x10 with linear score steps (cannot even imagine how individual L,O numbers in the middle are chosen?).

As per attach. gg1 CCPs are determined by hazards with risk scores exceeding an arbitrary cut-off value. A similar idea is used in the matrix in gg3. This procedure is similar to that in traditional haccp.

ISO22000 where OPRPs are an additional possibility to CCPs requires additional evaluation of capabilities of proposed control measures sourced as per preceding paragraph.

I initially assumed that the additional column data shown in RG's post was analogous to the recalculation-after-correction step values as per gg1,gg3 below. This seems possible for "Material" but not for "Process" The meaning of "n" remains a mystery (to me anyway).

When fully applied, a lot more effort seems required in RPN method as compared to typical haccp hazard analysis. Whether any benefit results is unclear. I recall some much older threads on this forum had similar objections.

 gg1 - iso22000 - FMEA (RPN) salmon process.pdf   1.47MB   141 downloads
 gg2 - haccp - Quality - RPN - Cookies Production -.pdf   2.09MB   160 downloads
 gg3 - FMEA (RPN) workplace safety.xls   102KB   125 downloads

[George @ Safefood 360°]

Hi Rodriguez-Gonzalez,

Thank you for posting the hazard-risk analysis model. It is great to see members putting effort into this area which I am a strong advocate of change and improvement. I get where you are going with this model and I see merit in it. The objective is to make what is often a complex activitiy into one that can be conducted across the industry with ease to produce safe food products.


Your model follows the well established convention of hazard identification followed by an assessment of risk based on multiplication of Severity and Occurence. All good so far... It also builds out to define CCP's, critical limits and Reference. The model also draws a more direct link between significance and control. The model is certainly simple in many ways than those currently employed. However, I think Charles has highlighted a number of valid points relating to the model which you might consider in future revisions.

HACCP, Hazard Analysis and Risk Assessment all have common objectives which can be posed in some very simple questions:

1. What hazards potentially exist with this food product?

2. What is the significance of each hazard?

3. Is the significance critical in nature?

4. Can we apply control to the hazard and if so which controls and to which limit(s)

5. Can we validate all this?


Whether we adopt traditional HACCP models or new challanging approaches, IMO the above questions must always be answered (if possible).

The exercise must be step focused. I see you you model accounts for this however it may breakdown when the hazards are applied accross. For example if a specific pathogen is identifed e.g. Salmonella, this may only have significance for one step such as cooking. But does it need to be identified and assessed for each step? As Charles points out it with become somewhat unwieldy and I am not sure will it make it easy to interpret. Also there will be multiple pathogenic hazards for the same step and again the model does not appear to allow for this.

Another area is the development of CCP's. There appears to be no determination of critical points. This for me should not be a major problem but when applied to HACCP is will be a major No-No. It also appears that criticality is based on the sum of the risk values calculated in the workbook and it begs the question - WHY? What is this actually telling us? The sum of all risks in the determination of Critical Control Points does not have any statisical logic. So I would be very careful on this one. CCP's are derived from an understanding of how the hazard is controlled and not the sumation of all risks. I hope you get what I am trying to say here.

I would also suggest that the inclusion of CCP's, limits and references brings this model into the realms of HACCP planning and away from HA/RA. No problem with this but if you want to do this you will have to include all CCP monitoring details for it to be any value to the user, auditor and monitor.

So overall, Rodriguez, I like where you are going, but development is required and Charles's points are important.

P.S. Charles, I suspect the 'n' represents 'up to the total number of unknown steps' as used in the convention for describing the number of samples in a population (SPC).

George

[Charles.C]

Dear George,

Thanks for the (horizontal i presume) pointer.
And your thought-provoking comments.

I now deduce we are entering into this kind of realm -

 ss1 - cumulative RPN.png   279.6KB   38 downloads
 ss2 - cumulative RPN.png   194.37KB   37 downloads

Interesting for sure but regrettably somewhat over my head in the mathematical arena. Reminds me of my first encounter with bacterial posterior probabilities, in a reverse sense.

Awaiting any further comments with interest.

Rgds / Charles

[Rodriguez-Gonzalez]

Thanks for your comments, very useful to review my ideas with experts, I just started to brew a few more.

By no means I am trying to make a complicated model. As a continual improvement facilitator, the idea of this tool is to make it easy to identify the hazards.

As you know in food safety literature risk is considered a scientific word, and there are several guidelines to do scientifically correct risk assessments (especially Microbiological), but because in on our role we are trying to manage a system by including scientifically sound information I have taken the challenge to understand risk management on its fundamentals.

What I showed in the pages before was just a quick description on how it could be done. There are no complicated calculations hidden except for multiplying Severity (S) with Occurrence (O) to get a Risk Priority Number (RPN). I have seen this calculation in FMEA, in H&S guides and ToC studies. The relationship is also used in graphics to demonstrate relative positioning of allergens or foods. From my understanding the trick here is how to determine the scales and to whom it applies (i.e. the individual, the company). I mostly follow SQF guidelines, but I think that they have taken their approach from fundamental knowledge, which is what I continue discovering.

 Hazards list.jpg   115.19KB   47 downloads

 RPN Matrix.jpg   21.84KB   44 downloads

Where I am going with this tool is to make easier the thinking process and analysis of Food > Hazards > Critical Limits > Control Measure(s) > Official Methods of Analysis (Laboratory tests).

As a Food Safety Engineer and Continual Improvement facilitator I am trying to develop tools that will make easier to practitioners to manage and improve their systems. If you are interested in working out something together I will be happy to share more ideas.

Edited by Rodriguez-Gonzalez, 10 January 2013 - 05:56 AM.

[Charles.C]

Dear Rodriguez-Gonzalez,

Thks for the risk matrix and expanded table.

As you can see, your layout has generated substantial interpretative confusion . I am guessing your methodology to determine CCPs will be in a similar style to my previously posted attachment “gg1” but please comment / explain if this is not the case (gg1 itself is rather lacking in haz.analysis details and seems to exclude the final consumption step as a control option.)

Rgds / Charles.C

[Rodriguez-Gonzalez]

Yes, your previously posted paper is a good example of how it could be done. The interesting part is how they look into integrating continual improvement tools and techniques to take the best of both. It seems that the risk analysis in this paper is a bit short in hazards and stronger in root-cause analysis.

My interest is in analyzing the effectiveness of food safety measures. At the beginning I was also wondering if doing a "risk analysis" is going to interfere the way of conducting a proper "Hazard Analysis", but looking to the Codex and NACMCF guidelines the objective of the Hazard Analysis step is to identify Hazards and Control Measures, to then prioritize them based on their severity and occurrence (risk).

I think that identifying hazards is a matter of knowing all the hazards and their association with the food that you are working with. This can be addressed with experience or by researching supporting literature. The trick with the control measures is that they are associated with the cause, so some corrective actions may be more effective than others depending on the particular situation.

In brief, identifying and prioritizing hazards can be as daunting as finding the appropriate control measures, and this may take us away from the objective of being effective. That's why I think that tools that facilitate this type of analysis can be of real help to food safety managers and their food companies. I am thinking that will be better to write a white paper, poster or video on this (whichever is more effective.)



Effective: /ɪˈfɛktɪv/ successful in producing a desired result (oxford dictionary).

Dear Rodriguez-Gonzalez,

Thks for the risk matrix and expanded table.

As you can see, your layout has generated substantial interpretative confusion . I am guessing your methodology to determine CCPs will be in a similar style to my previously posted attachment “gg1” but please comment / explain if this is not the case (gg1 itself is rather lacking in haz.analysis details and seems to exclude the final consumption step as a control option.)

Rgds / Charles.C

Edited by Rodriguez-Gonzalez, 12 January 2013 - 04:02 PM.