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Methodology for Categorization of Control Measure

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Zeeshan

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Posted 24 May 2010 - 05:45 AM

Dear all!

I am reviewing and re-establishing company's hazard analysis working. During this task, I have re-established the "Methodology for categorization of control measures". Attached is the same. Please have a look and provide your precious feedback and comments to change or improve it further.

Prior thanks.

Attached File  Categorization of CM.pdf   82.96KB   319 downloads

Regards:
Zeeshan.



Charles.C

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Posted 24 May 2010 - 06:53 AM

Dear Zeeshan,

I'm not quite sure if you have been certified to ISO 22000 already ? If so you may know a lot of my comments below already and perhaps not agree (I'm not a user, only an observer) which is fine and I would equally appreciate to know yr disagreements and see yr current procedure. :smile: The following sort of assumes you are still "calculating".

Firstly I would ask if you hv read ISO 22004 ? This details the considerable auditory flexibility for the required methodology in the sense of the required number of parameters, their interpretation and the appropriate relative proportion of CCPs / OPRPs. The precise procedure is undoubtedly up to you plus various of the (a-g) items have variable interpretation, ie if you can convince (validate) the auditor as to yr statement(s) then it should be ok. If you have not seen it already, I suggest you look at the summary of published opinions and previous posts here in this recent thread –

http://www.ifsqn.com...dpost__p__34239

Although it is not definitively stated in the 22004 text, IMO, and based on published examples, the minimum number of defining parameters may well be “1”, ( various peoples’ systems hv certainly been effectively accepted based on “3”) and the maximum is presumably unlimited although only (a-g) are strictly required by ISO 22000.

In yr attachment, it looks to me on a quick view that yr interpretation of some of the items in the ISO 22000 list in 7.4.4 is the reverse of usual. (see the examples in above link, eg Praxiom). The total number of items is probably overkill but if you are happy with that, no problem.

It is always easier to do a test example to see how yr proposal result compares to the traditional (non-oprp) method. As a first approximation, I would suggest that the number of CCPs should not increase although someone may immediately post to show I’m wrong!

Regardless, yr basic method, assuming it is applied on already selected significant hazards is usable IMO. But the details probably need some more thought. Yr minimum score for a CCP is >10 which is only 60% (sorry, 55%!) of the possible maximum, this intuitively seems rather low (try comparing other posted methods)but maybe only reflects yr total number of items (ie a>g = 7 :smile: ).

Again, I think it is important to read ISO 22004 if you haven't yet done so :smile:

Rgds / Charles.C


Kind Regards,

 

Charles.C


Tony-C

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Posted 25 May 2010 - 03:36 AM

Dear all!

I am reviewing and re-establishing company's hazard analysis working. During this task, I have re-established the "Methodology for categorization of control measures". Attached is the same. Please have a look and provide your precious feedback and comments to change or improve it further.

Prior thanks.

Attached File  Categorization of CM.pdf   82.96KB   319 downloads

Regards:
Zeeshan.


Hi Zeeshan,

Whilst I like the idea of your assessment methodology, do you feel it factors in the significance and probability of the hazard occuring enough?

Regards,

Tony


Zeeshan

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Posted 25 May 2010 - 06:22 AM

Dear Charles and Tony!

Thank you for your comments.

Hi Zeeshan,

......do you feel it factors in the significance and probability of the hazard occuring enough?


Sorry Tony, I didn't get your point.......:dunno:.

Regards.
Zeeshan.


Zeeshan

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Posted 26 May 2010 - 10:22 AM

Hi Charles and Tony,

While reading the previous post referenced by Charles, a question comes to my mind.............

"Why none of the expert has followed the exact or somewhat resembling sequence specified by the international standard?"

I have drafted a simple decision tree based on this sequence. Presented for your generous comments!

Attached File  CM categorization.doc   33.5KB   166 downloads

Regards:
Zeeshan.


Edited by Zeeshan, 26 May 2010 - 10:23 AM.


Charles.C

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Posted 26 May 2010 - 04:04 PM

Dear Zeeshan,

You didn’t mention if you are already certified or not.?
You asked why people don’t precisely follow the 22000 standard. Some possible reasons are –

1. Parts of 7.4.4 are ambiguous to some (many?) people.
2. The consequences of an exact adherence to 22000 format for some practical situations are rather unpleasant, eg dozens of OPRPs. I noticed this problem in some published water systems.
3. ISO 22004 offers an excellent justification for alternative options. (have you read it yet?)
4. Auditors are simply not requiring a close match. In fact the expectations seem to vary a lot.

No doubt there are more.

Regarding tree presentations, I hv myself so far sort of interpreted the items in 7.4.4 (a-g) as related to 3 basic factors (somewhat disregarding, but not forgetting, the equally important conceptual features of OPRPs etc). Other people may well disagree, it’s a very flexible / interpretative topic as illustrated by all the posted scoring tables. –

A. The fundamental need for a properly implemented CM. Max need > +CCP
B. The ability / likelihood (AL) of a chosen / analysed / implemented control measure (CM) being optimally "sucessful". So max (AL) > +CCP (this tends to create OPRPs by "default" but the allocation should also make sense within their conceptual definition)
C. Handling a situation where a CCP might hv been considered appropriate but for which no practical critical limits are readily stated.


Obviously many of the items discussed below are not black and white [hence all these discussions :unsure: ], an occurrence which has probably dismayed the 22000 designers. (note to PAS for their next prescriptive category??)

As related to (A-C), I (very approximately) interpret 7.4.4 (a-g) as –

(a) > B. High effectiveness tends to CCP (I suppose "effectiveness" is a theoretical/practical composite as described in 7.4.4 a,b etc of ISO 22004 however achievance of the CCP criteria of def.3.10 is presumably a crucial part of any performance objective target [eg see note3 in above 22004 ref.])
(b) > B. Continuous monitoring (but variously interpreted) tends to CCP
© > B. (variously interpreted) but typically considered as CM required to be in the “best” location, usually nearest the end of the process chain with no subsequent equivalent competitors.
(d) > A. (as I understand it, this is a sort of circular logic). If there was no initial significant chance of a CM failing (inc. due to varying process conditions), no reason to invoke HACCP. So a sig. likelihood tends to CCP. This parameter is coupled to (e) and the pair are a sort of re-iteration of the starting situation.
(e) > A. Linked with (d). (eg Risk = Likelihood x Severity) (in the current application anyway). So max. severity tends to CCP (but not necessarily independently of likelihood of course).
(f) > B. A designed / appropriately deployed CM should be optimum, therefore tends to CCP.
(g) > B. (variously interpreted). One viewpoint is that a single CM which establishes full control is optimum. IMO, take yr pick either way and validate.

From the published / posted items in my previous link, you will see there is general agreement on some of above opinions, disagreement on others. IMO, for several of the contentious items, as long as you can justify yr point of view, it probably doesn’t matter to the auditor (particularly in view of the "clarifications" in ISO 22004 which take precedence over ISO 22000).
I may hv got some of the above wrong, anyone feel free to comment!.
As far as the minimum number of criteria are concerned, this is typically a result of an intuitive prioritisation / weighting within the elements of 7.4.4 (a-g). Some people’s posts here hv implied that “1” was auditorily acceptable for them. The Procert example is the shortest one I think I hv seen published. The justification may relate to the process etc. And the auditor :rolleyes:

So, referring to yr latest tree, on the basis of above logics, I hv some reservations about the interpretation / positioning of the first, second (b), sixth (f) boxes on LHS.
It is also equally important to analyse the steps passed through prior to category 7.4.4 (a) box as illustrated in the Procert flow chart. The details will depend on yr process again.
You may also find that yr specific process is more compatible with the scoring system as in yr previous post. The latter has the advantage (especially using 3-step score) of more easily working with non-black/white situations. The cost may be more work and thinking. As usual, it all depends. (FSSM’s vegetable / excel sheet is an example of the use of scoring options as per his interpretation.)

Hope the above comments are intelligible, the 22000 standard is a classic of unclear statements IMO however I can appreciate that this whole risk topic is very dificult to present in an auditable format so (reluctant) kudos to ISO for at least making the attempt.

Rgds / Charles.C


Kind Regards,

 

Charles.C


Zeeshan

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Posted 27 May 2010 - 07:42 AM

Dear Charles!

Thanks for in depth comments.

We are ISO 22000 certified by SGS and BRC certified by RINA Certification. Unfortunately I have not gone through ISO 22004 standard, however I have planned to purchase it.

To conclude the topic at my side:

Did I understand it correctly, from all the discussions, that if our auditors are happy with the methodology based on sequential questions 7.4.4 (a-g) (pls refer to the decision tree I've posted in last post) then I should better use it neglecting all other theories? OR I should give other theories a try in the name of continual improvement?

Regards:
Zeeshan.


Edited by Zeeshan, 27 May 2010 - 07:42 AM.


Charles.C

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Posted 27 May 2010 - 05:20 PM

Dear Zeeshan,

Well, further comments might depend on yr process but if you are happy with yr current procedure / decision tree and its ability to ensure a safe product as per ISO 22000 plus yr methodology is approved by yr auditors, then it would appear that everybody is satisfied. :smile: Maybe it is more prudent to seek continual improvement elsewhere.

It’s only one opinion of course. I’m sure any additional comments on this dialog would be welcome, particularly by users of ISO 22000 ?

Rgds / Charles.C

Added – Frankly , assuming my comments on yr tree attachment are valid, I’m rather amazed yr auditor(s) did not notice any of my “reservations”. For example the box (b) exit “NO” looks like a simple “typo” error to me. :smile: ?? Similarly, the text in 6th box, perhaps copied from the standard's paragraph "f", does significantly not conform to the ISO definition of a CCP (compare def. 3.10 in ISO 22000 standard.)(hv to say that my own posted tree also contains same debatable text! :oops: )

Added (2) – if you go to this post http://www.ifsqn.com...dpost__p__25674, you will see an example of the “minimum number of criteria” = 1 ( :thumbup: Arya) to which I referred earlier and which was apparently accepted by the auditor. The logic/detail used seems to me rather deficient compared to the full requirement of ISO 22000 7.4.4 (a-g) but the result for a given process with respect to determining the final CCPs may well be identical. A partial justification for this “lean” approach is in ISO 22004 although IMO not quite to the extreme as illustrated by previous link (other people may well disagree!). The related auditorial comments, eg Erasmo, in above referred thread are also interesting to read.

I suspect the reality is that different auditors may be extremely variable in their requirements thanks to the lack of clarity of the relevant ISO standards. It therefore is attractive to seek (ie prioritise) a minimum pragmatic set of criteria both “alignable” to the standard(s) and which can (verifiably / validatably) still achieve the required food safety result for the given process. This thought was related to my comment in first paragraph of this post. In this respect the scoring – type procedure will surely involve more labour but (with the slight exception of setting the subjective numerical CCP/OPRP divisor) offers a more routine / flexible technique.(added - but see this thread also - http://www.ifsqn.com...dpost__p__36438 ) The latter’s attraction may depend on yr process complexity / available manpower / individual taste. In view of the inevitable subjectivities involved, it seems to me that both methodologies are equally acceptable, more a question of different styles, eg conceptual vs numerical. My guess is that most auditors hv a similar view.

A better idea of which is more convenient for your own situation can be obtained by doing a brief comparative trial for yr specific process.


Kind Regards,

 

Charles.C




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