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Modares

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Posted 09 March 2007 - 07:43 PM

In HACCP, we were used of Decision Tree for recognition of CCP's. But now we have to categorize the control measures for management by OPRP or HACCP Plan, now what is the best practical method about "7.4.4 Selection and assesment of control measures"?


Edited by Modares, 09 March 2007 - 07:45 PM.


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Posted 12 March 2007 - 08:42 AM

In HACCP, we were used of Decision Tree for recognition of CCP's. But now we have to categorize the control measures for management by OPRP or HACCP Plan, now what is the best practical method about "7.4.4 Selection and assesment of control measures"?

Any ISO 22000 users out there who can help Modares?

Cheers,
Simon

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Modares

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Posted 19 March 2007 - 06:34 PM

Any ISO 22000 users out there who can help Modares?

Cheers,
Simon


Dear Simon/Users
Is it correct: If all answers to 7 questions about a Control Measure, according to 7.44.a to 7.44.g, were Yes, then that CM should be managed by HACCP Plan? :dunno:

Thanks.

Edited by Modares, 19 March 2007 - 06:38 PM.


Charles.C

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Posted 20 March 2007 - 07:46 AM

Dear Modares,

Nobody's responded yet so -

Actual Iso22k users are (very) free to correct me but I'm afraid the answer is not so black and white (based on the comments in many other threads here which you have hopefully seen already).

You are unlucky in that, I think, there are no detailed examples in the doc. exchange unlike HACCP (copyright / confidentiality limitations probably).

May I suggest this simple, pragmatic start-up option and again, all you genuine users are totally welcome to constructively shoot me down -

(1) Do the HACCP analysis and get the CCPs. Methods / examples are very available and you have to be able to do this as a "personal pre-requisite".

(2) Look at the pre-requisite program which came out of the HACCP analysis, this I suppose gives the non-oprps. If yr HACCP analysis doesn't use a pre-requisite system, consider yr GMP set-up.

(3) Look at the other control measures which you discarded in the HACCP analysis as non (but almost) -CCPs. These are probably oprps.

See if this makes sense as per ISO22000 document and then start filling in the blanks (eg the risk factors).

I looked at this net example to get some thoughts on the philosophy which I suppose all users have seen already -

http://www.nordicinn..._img/heggum.pdf

also a more classic descriptive ref. is -

http://www.foodquali...0012006_SS2.htm
-
added Charles.C/11- 09-2014 - Sorry, above links seem not working now

Rgds / Charles.C


Edited by Charles.C, 11 September 2014 - 04:35 PM.

Kind Regards,

 

Charles.C


Modares

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Posted 20 March 2007 - 07:54 PM

Thanks Dear Charles! :smarty:

...As result: There is no famous method for Control Measure Assessment (like Decision Tree in HACCP), but any logic method could response to ISO 22k-7.4.4 clause? for example can I make a new Decision Tree based on 7.4.4.a to g requirements and use it and show in a CB audit?.... :helpplease:


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Posted 22 May 2007 - 09:41 AM

Hi Modares,

As an auditor, I've faced the same issue during an assessment audit that the organization used the ISO2204 decision tree as basis for categorization of control measures.

In my opinion it is better to have a brainstorming session and considering the factors stated in the section 7.4.4 to establish the case. It can be spiced up by putting the rating against each factor which will help in refining the output of categorization.

For this, the clear 'Yes' or 'No' situation is not possible.

Regards.

Jahanzeb



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Posted 24 November 2008 - 06:05 AM

Hi,
I am erum, anew memmber.

I suggest u to that u can categorize your Control measure by giving them some nummbers if marks are between 10-14 then it could be CCP,if 5-10 then OPRP and if Less than five than PRP's.

Further comments are needed



Charles.C

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Posted 24 November 2008 - 11:05 AM

Dear Erum,

Welcome to the forum ! :welcome:

Yes you are probably correct. In fact Modares proposed a neat, much-developed numerical system in a later thread which is well worth reading but I cannot find it directly. Can try searching for his name if you are interested.

Rgds / Charles.C


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Charles.C


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Posted 24 November 2008 - 12:07 PM

Hello everybody :biggrin:
I must admit that 7.4.4 is very difficult to document. It was also disccused by me and my friend few days ago, and we have two different methods.
First one is a tree, but it is important to be elastic when you use it, because you must consider specific conditions of every process. I tanslate it from Polish to English and I hope it's understood :rolleyes: If not I try to explain what the author was thinking about.
The second method is a tabel with answers on all 7 questions. But here also is important to think over all the answers. Once again: I hope you will find out what I wanted to tell you :biggrin:
Best regards
adobrosielska

Attached Files



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Charles.C

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Posted 24 November 2008 - 10:31 PM

Dear Adobrosielska,

Thank you very much for the 2 documents. I presume these are original to you.

I remember seeing trees for PRPs vs CCPs in the early HACCP formats but they were ultimately not considered very suitable (from memory). I guess there should be a risk analysis somewhere in there.

The Table looks like a multiplication version of the one Modares earlier proposed here (additive from memory again). This one is more like an expanded FMEA technique I guess. All the methods are equally subjective I suppose with respect to the numbers. The final formula maybe lost a “G” somewhere ?

Some of the people here seem to have successfully avoided this detailed analysis step (as far as I can deduce) by presenting a “simple” add-on extrapolation from a more conventional HACCP-type risk analysis. Maybe it depends on how nice the auditor is (quality/quantity of the lunch ?) and/or the particular process.

Definitely interesting to know how other people are carrying out this step (or avoiding it).

Rgds / Charles.C


Kind Regards,

 

Charles.C


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Posted 25 November 2008 - 12:34 AM

thansk Adobrosielska.. that great docs ..



a_andhika

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Posted 25 November 2008 - 11:23 AM

Dear Adobrosielska,

Cool documents, another brilliant way to determine CCP and oPRP. But I still wonder about the coefficients, how did you determine it? I mean how many coefficent and what kind of parameter that needed on the decision making? Would you mind to break it down a little bit? And the limit number 1500, how did you determine this?

I remember the decision making from Modares also use certain limit to divide the CCP and oPRP, but I havent get the clear reason why it has to be "that" number. You may love to visit this thread too, Adobrosielska, to get what Charles C. means:

http://www.ifsqn.com...amp;#entry19699


Some of the people here seem to have successfully avoided this detailed analysis step (as far as I can deduce) by presenting a “simple” add-on extrapolation from a more conventional HACCP-type risk analysis. Maybe it depends on how nice the auditor is (quality/quantity of the lunch ?) and/or the particular process. Definitely interesting to know how other people are carrying out this step (or avoiding it). Rgds / Charles.C


Oh dear Charles, Charles... Sceptic as always, huh? Hmm, I dunno bout the "real" standard of hazard analysis, but IMO as long as it suits for your needs, can be used to fully ensure your products is safe, and accountable (especially to the auditor), then why not? I mean why on earth I have to sail across the Africa if I can use the Suez canal? (yes, bad comparison, I know :p )


Regards,


Arya

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Charles.C

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Posted 26 November 2008 - 10:32 PM

Dear Arya,

Sceptic as always, huh?


No,No, on the contrary, more admiring. I always go for simplicity if possible.

Also thank you for doing some thread searching on my behalf.

In case new posters are interested in this topic I hv extracted the major attachments (I think) which hv previously been posted here on this subject and reposted here. If I hv missed any, people are welcome to add. The ones by Modarres and Bennii are of the more "extended" type whereas the Charlorne document gives a shortened approach. I guess the last is more like Arya's technique ??

I haven't posted all the various relevant thread links to save space but if anyone is interested, can add them later.

Attached File  Modarres__first__iso_22000_oprp_ccp.pdf   22.7KB   355 downloads

Attached File  modarres_haccp_iso_22000_risk_matrix_.pdf   24.88KB   334 downloads

Attached File  Bennii_Methodology_for_determination_of_Hazard_Controls__CCP__s_and_oPRP__s.doc   91KB   346 downloads

Attached File  charlorne_iso_22000__Form_7_PRP_oPRP_CCP_worksheet_2.doc   40.5KB   314 downloads

added - I remembered after that there are a few typo errors in some of above so I have added the relevant source thread links where these are hopefully clarified

Relating to Bennii
http://www.ifsqn.com...?showtopic=9053

Relating to Charlorne (and Modarres)
http://www.ifsqn.com...?showtopic=3183

Relating to Modarres
http://www.ifsqn.com...?showtopic=8952

(Sort of) relating to "Arya's Method" :biggrin:
http://www.ifsqn.com...?showtopic=8737
http://www.ifsqn.com...?showtopic=9986

Rgds / Charles.C

Kind Regards,

 

Charles.C


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Erasmo

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Posted 27 November 2008 - 02:12 AM

Dear Adobrosielska,

Thank you very much for the 2 documents. I presume these are original to you.

I remember seeing trees for PRPs vs CCPs in the early HACCP formats but they were ultimately not considered very suitable (from memory). I guess there should be a risk analysis somewhere in there.

The Table looks like a multiplication version of the one Modares earlier proposed here (additive from memory again). This one is more like an expanded FMEA technique I guess. All the methods are equally subjective I suppose with respect to the numbers. The final formula maybe lost a “G” somewhere ?

Some of the people here seem to have successfully avoided this detailed analysis step (as far as I can deduce) by presenting a “simple” add-on extrapolation from a more conventional HACCP-type risk analysis. Maybe it depends on how nice the auditor is (quality/quantity of the lunch ?) and/or the particular process.

Definitely interesting to know how other people are carrying out this step (or avoiding it).

Rgds / Charles.C


Hi Charles, Adobrosielska (and everyone),

It is a requirement to make a Hazard assessment about severity and probability (7.4.3) but not in all situations that assessment has to be the “key” for the selection (7.4.4). For example… If one of the steps has a high “score” in the assessment or it is categorized with the decision tree as an OPPRP or CCP (the decision trees are only a guideline) and there is no possibility for a good monitoring system and / or there is no feasible for validation, you will receive a Major NC in the stage 1 audit. It is a requirement for CCP and OPPRP to have monitoring system (7.5 & 7.6.4) and validation (8.2).

There is a very good document in the Codex website (CAC/GL 69 – 2008) that explains very well the concept of validation and it uses examples (I’m not agree with one of them).

Saludos from México.


a_andhika

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Posted 27 November 2008 - 11:28 AM

Dear Charles,

Sorry, maybe I am a bit overreacted... :p BTW, I dont remember our exact conversation last time.. But IMO, my CCP determination is somehow "technically" similar like Bennii, well not mention the calculation part.

In our HACCP Plan, firstly we determine the significancy of the hazard by using "Hazard Analysis Table", which evaluating the level of it's probability and severity. If we figure it as non significant one, then it will be controlled by PRP. Then if we figure the hazard as the significant one, then we input the hazard to the Decision Tree (yes, the conventional one). If it was considered as CCP, then it is CCP, but if it doesnt, it considered as controlled by oPRP. I guess "technically" its the same like Bennii who determine the significance first, and then determine the right control measures after that. But yes I admit her method is much more advance than mine.

Honestly, I've just read it, and it clear my wonder about the origin of the "magic" number, extrapolation is a genious way. But Im still wondering about number that resulted from quantifying hazard with combination Low x Low, isnt it suppose to be "1" instead of "2"? Please correct me if I'm wrong. Thanks.

To Erasmo: Hmmm, judging from your posts, its seems you are an expert practise, an auditor or consultant perhaps? BTW, now you mention it. Ive read the Draft of validation from Codex too, its already posted in this forum, but I dunno when and by who..:p May I know which part of example that you dont agreed, and why? And one more question that might be off topic: do we only need validation once in a lifetime (considering that monitoring & verification is enough), or do we need to re-validate it again? And for how long? Thanks.


Regards,


Arya


IF
safety and quality means perfection
AND
nobody's perfect
THEN
why should I bother?

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Erasmo

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Posted 27 November 2008 - 02:18 PM

To Erasmo: Hmmm, judging from your posts, its seems you are an expert practise, an auditor or consultant perhaps? BTW, now you mention it. Ive read the Draft of validation from Codex too, its already posted in this forum, but I dunno when and by who..:p May I know which part of example that you dont agreed, and why? And one more question that might be off topic: do we only need validation once in a lifetime (considering that monitoring & verification is enough), or do we need to re-validate it again? And for how long? Thanks.


Regards,


Arya


Hi Arya,
Yes, I'm an auditor for this standard...
To your first question: The requirement states that you have to validate before the implementation and after a change... the need for re-validation is in th mentioned document:

VII. NEED FOR RE-VALIDATION

There are many changes that could lead to a need to re-validate a control measure or combination of control measures. Examples include:

• System failure: If monitoring or verification identifies failures for which a process deviation cause cannot be identified, re-validation may be needed. Non-compliance with monitoring or verification criteria may indicate a need for a change in the parameters (i.e., the selection and specification of the control measures) on which the design of the food safety control system is based. A system failure may also result from an inadequate hazard analysis and may require re-validation.

• Process changes: The introduction in the food safety control system of a new control measure, technology or a piece of equipment that is likely to have a decisive impact on the control of the hazard may necessitate that the system or parts of it be re-validated. Similarly, changes made in product formulation or the application of current control measures (e.g. time/temperature changes) may result in the need for re-validation of control measures.

• New scientific or regulatory information: Re-validation may be needed if the hazard associated with a food or ingredient changes as a result of (i) higher concentrations of hazards than originally encountered and accounted for in the design, (ii) a change in response of a hazard to control (e.g. adaptation), emergence of a previously unidentified hazard, (iv) new information indicating that the hazard is not being controlled to the level specified (e.g. new epidemiological findings or new validated and internationally accepted analytical technologies ) or (v) a new food safety outcome.


To your second question: I'm not agreeing with the example of the labeling of table eggs... the reason is that I'm not agree with:
-The expected outcome (change in 25% of the understanding in the correct handling)
-In my understanding, this is part of the intended use.

It is totally obvious that if someone get sick for not follow the correct instruction it won’t be a food safety problem by definition:

Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use




If I get a bag of berries and the label stated that you have to washed before consume, I'll do it!



a_andhika

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Posted 28 November 2008 - 10:47 AM

Dear Erasmo,

Thanks for the reply. I am just wondering if there's no irregularity/alteration/changing from the beginning of validation until, let's said it.. 20 years ahead, then it means we do not need to re-validate it right? Coz I didnt see the time term from the CAC GL.

Anyway, its still a proposal, maybe you can send your disagreement to them? IMO, That'll be great :)


Regards,


Arya


IF
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AND
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THEN
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Posted 03 June 2010 - 09:37 AM

Hello everybody Posted Image
I must admit that 7.4.4 is very difficult to document. It was also disccused by me and my friend few days ago, and we have two different methods.
First one is a tree, but it is important to be elastic when you use it, because you must consider specific conditions of every process. I tanslate it from Polish to English and I hope it's understood Posted Image If not I try to explain what the author was thinking about.
The second method is a tabel with answers on all 7 questions. But here also is important to think over all the answers. Once again: I hope you will find out what I wanted to tell you Posted Image
Best regards
adobrosielska



Modarres

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Posted 01 October 2010 - 07:51 PM

Hi every body!

Please tell ur opinions about these 3 attachment methods...

Regards,
Modarres

Attached Files


Best Regards,
Modarres

Charles.C

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Posted 01 October 2010 - 10:29 PM

Dear Modarres,

Quick answer. IMO, it’s a matter of personal choice.

Didn’t do an exhaustive analysis of yr options but I believe I hv seen all these approaches used in different places without rebuttal. Each has subjective components which are debatably incorrect with respect to the ISO 22000 standard. However, IMHO, the ISO 22000 / 22004 series is worded so as to permit many such ambiguities, a feature which is ultimately a significant defect IMO but I expect other people will disagree with me. :smile:

Have you seen this thread where I/other people offer various reviews / analyses of these type of issues –
http://www.ifsqn.com...dpost__p__34239

IMO, it probably makes pragmatic sense to select the simplest auditorially satisfactory solution as can be applied to yr specific requirement. Some practical cases are more easily accommodated than others, for example where universally accepted CCPs like cooking steps are involved. Offhand, none of yr 3 options appears to be significantly simpler to apply than the others ?. :smile:

My personal, preferred semi-generic solution / example format is as presented in this post –

http://www.ifsqn.com...dpost__p__36566

however if a simpler / non-simpler method works for you and is satisfactory to an auditor, it’s ok for me. :smile:

Best Regards / Charles.C


Kind Regards,

 

Charles.C





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