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Charles.C

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Posted 07 June 2007 - 09:15 AM

Dear All,

I didn't have the courage to put this into the proud I22k forum.

The road to ISO 22000:2005 certification starts with a Food Safety Policy that includes Prerequisite Programs, Good Manufacturing Practices (GMPs) and a subsequent HACCP Plan. In contrast to ISO 9001:2000, validation plays a part prior to verification. Food safety programs require validation of the hazard analysis and subsequent control measures prior to implementation of the policy. Only when all reasonable doubt of hazard introduction has been removed by validating the proposed process should a HACCP plan be implemented.

ISO 22000:2005 also introduces an Operational Prerequisite Program, which covers all facets of the food safety program identified by the hazard analysis that are unique to the organization’s processes and goes beyond the general Prospective Reimbursement Plans (PRPs) established in the beginning.


Actually the intentions of the item are rather good IMO but there are some definitely strange statements in it :smile: .

http://www.tuvameric...ail.cfm?ID=1208

Rgds / Charles.C

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Charles.C


Sankara narayanan

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Posted 07 June 2007 - 06:35 PM

Actually the intentions of the item are rather good IMO but there are some definitely strange statements in it :smile: .

http://www.tuvameric...ail.cfm?ID=1208


Dear Charles,

I went through the thread. I am really confused about some definitions....whether its a joke or something :doh:

Best Regards,

A Sankara Narayanan

A.Sankara Narayanan

Simon

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Posted 07 June 2007 - 07:06 PM

I went through the thread. I am really confused about some definitions....whether its a joke or something :doh:

Sankara, Post the terms and definitions that confuse you and we can pick them apart here. :thumbup:

Regards,
Simon

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Charles.C

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Posted 07 June 2007 - 11:45 PM

Dear Simon,

May I temporarily borrow the opportunity of yr suggestion to enter a minor OT but which can still be considered as “glossary” related?

I have been looking through the chain of threads on ISO 22000 which in many cases indicate IMHO that there remain considerable differences in the interpretation of the basic terms in the standard (this certainly applies to me anyway). I would like to attempt some further clarification if people are not already too bored (I can believe that some of these queries would be un-necessary if the pre-final I22k drafts had been published but such is ISO)

I would like to initially input two comments –

(1) It is my interpretation that the word “Prerequisite” in “Operational Prerequisite” has no particular meaning.
This is in comparison to the word “Prerequisite” in PRP where I think it retains a similar meaning to the traditional HACCP term, ie meaning “some necessary program” that must be implemented before the hazard analysis (although perhaps now with a narrower scope as per the ISO22k standard). In other words, oPRP could just as well be called something like a program to control a significant but “non-critical / sub-critical control point” as concluded from the hazard risk analysis.

(2) The ISO 22k standard has a list of items and activities 7.2.3 (a) – (k) . (the last one, k, allows for amendments I guess.)
It is my interpretation that Items (a) – (j) are intended to be INITIALLY defined as PRPs , ie something coming before the hazard analysis.
I realise that there is flexibility which may allow “elevation” of items like (g) to be also used as an oPRP (or even a CCP) if justifiable by a risk assessment within the hazard analysis (and have validatability etc as required by ISO 22000) but this will come later with the hazard analysis – ie a Post-prerequisite decision (similar to the options illustrated within the “GMPvsCCP” thread).

My (hopefully simple) question to the forum is - do you agree with the underlined interpretations ?

Any comments are appreciated.

Rgds / Charles.C


Kind Regards,

 

Charles.C


Sankara narayanan

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Posted 08 June 2007 - 08:43 AM

Sankara, Post the terms and definitions that confuse you


A few of them in the thread go like this .....

ISO 22000:2005 also introduces an Operational Prerequisite Program, which covers all facets of the food safety program identified by the hazard analysis that are unique to the organization’s processes and goes beyond the general Prospective Reimbursement Plans (PRPs) established in the beginning.

ISO 22000:2005 Terms

Hazard: An agent causing an illness or adverse health affect. Hazard analysis is an industry task, which can vary in complexity depending on the commodity and the identified end user. Hazards are identified by implementation of the HACCP plan and other known and shared industry practices.

Risk: The probability of becoming ill by contact with the hazard and the severity of that illness. Risk analysis is a governmental task, which is controlled by the publication of FDA regulations and other state laws. Enforcement of these regulations is through inspections by the FSIS.

Preventive Action is represented by the entire standard. The implementation of a HACCP plan, be it a requirement or not, is a preventive measure to help insure food safety for the consumer. .



Well.......arent they confusing? Or am I a novice still?

Best regards,

A Sankara Narayanan

A.Sankara Narayanan

Charles.C

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Posted 08 June 2007 - 11:13 AM

Dear Sankara,

Novice with certification to ISO 22000, surely impossible ! :biggrin:

First error probably typo by optimistically dreaming secretary.

2nd, 3rd are not really wrong, just incomplete, possibly hoping to scare Customers to come running.

4th one is trying to appeal to a Customer's sense of public responsibity to come walking.

Best Rgds / Charles.C

PS, How about some expert answers to my questions ?


Kind Regards,

 

Charles.C


Gavinova

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Posted 13 June 2007 - 06:02 AM

Charles.C,

I think that your questions could be answered in ISO 22004:2005 clause 7.1

Check it out



Charles.C

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Posted 13 June 2007 - 06:40 AM

Dear Gavinova,

Was that an "Agree" or "Not Agree" ? :biggrin:

Please feel free to be more specific, you can only increase my (the forum) knowledge.

Rgds / Charles.C


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Charles.C


Gavinova

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Posted 13 June 2007 - 07:42 AM

It's an "I'm not sure" :huh:

I think that it is telling us that the development and implementation of PRPs and then OPRPs should come before the HACCP plan. If you don't do it in that order I don't think your HACCP plan will be effective because you cannot accurately do a hazard analysis or your CCP might be affected if an OPRP at another stage of production is identified later.


Edited by Gavinova, 13 June 2007 - 07:58 AM.


Charles.C

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Posted 13 June 2007 - 09:01 AM

Dear Gavinova,

Appreciate yr frankness and yr comments. Will be interesting to see if any more interpretations come in to compare.

Rgds / Charles.C


Kind Regards,

 

Charles.C


Simon

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Posted 14 June 2007 - 08:01 PM

Charles I don't know.
Sankara yes they are crazy.
Everyone is ISO 22000 really this difficult?


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Erasmo

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Posted 16 June 2007 - 01:33 AM

the definitions in the TUV website are from section 3 of the standard with the exception of “Preventive action” and “Risk”.



I think the understanding of the glossary is the key for understand the ISO-22000 standard. This is from ISO/TS 22004:



The concepts of validation, verification and monitoring are often confused.

— Validation is an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures are capable of achieving the intended level of control. (Only before implementation of control measures or after any change [8.2])

— Verification is an assessment carried out during and after the operation, the role of which is to demonstrate that the intended level of control has actually been achieved. (Basically 7.8 and 8.4.1)

— Monitoring is a procedure to detect any failures in the control measure. (only in 7.5 and 7.6.1)





Saludos.



Charles.C

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Posted 16 June 2007 - 10:43 AM

Dear Erasmo,

Good to hear from you again.

Actually when I first read this article I thought it was a machine translation from some other more poetic version of the I22k standard, Spanish maybe?. :biggrin:

“The concepts of validation, verification and monitoring are often confused.”
I agree but I think this is also due to the variety of interpretations / usages which are accepted as OK in different applications. I can give you a list if you wish ? :smile: A related problem IMO is that examples are frequently not offered.

Do you have an opinion on my earlier OT ?

This extract and article offering some interpretations as to various features of ISO 22000 may be helpful (please [anyone] feel free to comment if you don’t agree with the text etc) –

"7.2 PreRequisite Programmes (PRP)
Where Codex only deals with them in generalities, ISO 22000 imposes the selection of adequate programmes of good hygiene practices (GHP or PRP), before proceeding to a HACCP analysis; These PRPs must be established on recognised bases & submitted to verification (§ 7.8 or HACCP step 11 according to Codex).
7.4.4 / 7.5 Operational PRPs
According to Codex – and it is a major deficiency – a « significant » hazard whose control cannot be attributed to a CCP is not made the object of a special surveillance. This leads to aberrations such as the creation of CCPs which are not CCPs, or to apply surveillance to points which are « easy » or « certain » (e.g. pasteurisation for a salmonella in milk…) whereas the same hazard would not result in a surveillance programme for raw milk ; ISO 22000 introduces the notion of operational PRP to cover the « significant » hazards which are not attributed to a HACCP plan (that is to a CCP) ; From then on, the Codex decision tree is no longer adapted, and must be replaced by a reproducible method which allows for the attribution of the surveillance of control measures, either to the HACCP plan or to an operational PRP. "
( http://www.procert.ch/ )

http://www.foodsafet...S3-2006E-LD.pdf


Rgds / Charles.C


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Charles.C


KellyB

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Posted 17 June 2007 - 08:29 AM

Dear all,

It is a must in my country that anyone that wants to be ISO22k certified has to buy the Standard from our National Standardization Organisation. And so we did (all copies are controlled and there is no way to avoid paying 75€ for it). Well.... wait until you see the translation in Greek! :wacko: This document is so confusing that you risk to forget anything you know. So I had to go and buy the English version as well, in order to understand what it is all about. Plus I had an auditor explain quite a few things to me in order to understand the glossary.
I think the bottom line is not to stick on terms but to prepare a system following the common sence. I also think that it can be a lot easier for people who already have a well-organized HACCP system already operating for some time. Then you just make a transition from the one system to the other converting the HACCP plan and validating/verifying the procedures you already have (since they remain the same), adding the details requested by the ISO. I have to add that our auditors said that this is fully accepted and that we are ISO certified since yesterday!
I hope this is understandable and that it will be a little helpful for the rest of you. Anyone interested in the audit procedure, please let me know.
Rgds/Kelly B.


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Simon

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Posted 17 June 2007 - 08:56 PM

Anyone interested in the audit procedure, please let me know.

Yes an overview of the audit procedure would be very helpful to members who are down the certification track. If you can please start it in a new topic Kelly.

Thanks,
Simon

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Charles.C

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Posted 18 June 2007 - 04:49 PM

Dear Kelly,

Once again, Congratulations!. I am impressed that you found the English version reasonably straightforward. :smile:

Then you just make a transition from the one system to the other converting the HACCP plan and validating/verifying the procedures you already have (since they remain the same), adding the details requested by the ISO.


Sounds almost too easy. Don't know exactly what yr process is but may I ask if you ended up with any oPRPs?

Rgds / Charles.C

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KellyB

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Posted 18 June 2007 - 05:48 PM

Hello Charles C.

Thank you for your kind words. The English version of the standard was more understandable, the terminology sounds really strange in Greek.
And to reply to your question: Yes, in fact we did end up with OPRPs. The company I work for deals with import, storage and dirtribution of oriental packaged food. We don't produce-process or re-pack anything. We ended up with 3 OPRPs. As I am out on a seminar combined with a few days' rest (eventually!) I can forward to you all our OPRPs and CCPs (they are all described in a table) after I go back at the office, if you want to take a look at it. I will have to convert it to English but it is not so difficult. The validation/verification part of our procedures and putting them to an overall plan and showing the OPRPs and CCPS and verification was the most difficult thing to do when we were preparing for the audit, if you understand what I mean. The bottom line is that the auditors were quite satisfied from our job (believe me, they did not grant us anything, they were very "by-book" and looked everything in detail). Well, I guess that says it all.
Regards/Kelly B.


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Charles.C

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Posted 18 June 2007 - 06:05 PM

Dear Kelly,

Many thks yr generous offer. Am sure will be of considerable interest ( it might even clarify some of my other queries in this thread ?).

I was also impressed from yr earlier post that apparently auditors in Greece work on Saturday (but presumably Never on Sunday :smile: ). I doubt this is the case in much of Europe.

Rgds / Charles.C


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Charles.C





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