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Is handwashing an oprp?


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#51 Charles.C

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Posted 21 July 2011 - 07:21 PM

Dear Sriram,

I admire yr creativity. :thumbup:
No problem re:delays.

As per GMO, I would suggest that production of the 2 products you mention is ideally physically separated.
Accordingly I will focus on the conceptually more difficult one in the sense that no "elimination” step exists, ie salad, and view it as a separate production.

I think it’s important not to get too confused between the interpretation of hazards and control measures. eg, as GMO again, one (most likely) initial cause of , say E.coli O157 contamination, in this line is the raw material. Subsequent activities are then only capable of preventing its proliferation / cross-contamination to good material etc. So, in addition to the raw material, a specific hazard might be considered as, say, E.coli O157 growth or cross-contamination, a possible cause of the hazard being faulty hygiene practices(and perhaps no "popular" production disinfectant step). A control measure would then be either something additional to the existing hygiene setup or perhaps a correction of the original set of procedures.

I would expect that some (documented) confidence exists that the raw material arrives “free” of “headlined” pathogenic bacteria in view of above. Additionally I believe many production scenarios will include sanitising dip stations strategically located within the production area, ie a routine, additional control.

I would hope that some (validated) reason exists to suspect that the current set of prps are not sufficient to do the required “control” (ie in respect to the acceptable level as mentioned below). Although improvement is always a praiseworthy objective of course :smile: .

The 22000 basic logic/sequence of steps involved is something like –

1. Identify PRPs to create a hygienic environment suitable for the production (7.2)
2. Identify potential hazards and their acceptable levels (7.4.2)
3. Assessment (LO / severity) of all these hazards (7.4.3)
4. For hazards requiring control, select a (combination of) control measures (7.4.4)
5. Validate that the combination of control measures achieves the “acceptable” level.(8.2)
6. Categorise the combination to a HACCP plan or oPRP program.

So what is the Acceptable Level (AL) in the RTE finished product ?

I deduce that E.coli O157 is yr primary example / feared relevant microbiological species, the AL could then be a typical regulatory requirement, eg “not detected in 25g” / appropriate sampling plan (eg 5x25g samples per lot).
Assuming Nos.1-3 > significant hazard and you have proposed a No.4, the standard requires validation as per No.5, eg by a “pilot” study. (logically, one would probably hv done this for the raw material / process steps / original set-up also ?).
Assuming AL validation is acceptable, then proceed to No.6.
I could anticipate that depending on yr chosen methodology, it might be possible to (nominally) get either a CCP or OPRP result.

assuming that a significant risk is concluded, one criterion for determining the standards (self-imposed) choice between ccp/oprp might be based on the ability to define a validatable critical limit.


The microbiological CL you mention is not usually considered a viable practical option although other, faster, criteria might be used if validatable (eg by other scientific evidence / using a set of official procedures / practical result). Additionally, it is a matter of interpretation/opinion but monitoring of most of the types of (handwashing) procedure mentioned would, I think, not usually be considered compatible to the (CCP preferred) requirement of para.7.4.4b. The latter result would then probably lead to an OPRP conclusion although even this still requires “monitoring” of, presumably, a logical target.

As a literature example, I enclose a condensed FAQ reply given for a different but related situation.

Cleaning and disinfection of equipment NEP (or CIP) is it a PRP, an oPRP or CCP in ISO 22000 and why?

ISO 22000 does not predefine PRP, oPRP or CCP, but requires to define in terms of its products, processes and threats to control. It can not therefore be a single answer to this question.

The PRP are by definition to create a "hygienic environment appropriate" - without addressing a specific hazard. ( § 7.2), which sets the requirements for PRP, eg explicitly cleaning and disinfection in the aspects to be taken into account in developing the PRPs. A CIP system (or CIP) can be perfectly described in the PRP of a company.

After the hazard assessment (§ 7.4.3), § 7.4.4 requires that (combinations of) control measures should be selected to ensure control of "significant"hazards. It then applies to a specific hazard (eg. Salmonella) and not a "hygienic environment" generally.
It is conceivable at this stage that the CIP is part of the combination of control measures associated, eg a danger of salmonella in milk consumption for a large dairy.
Then and only then, the control measures of the combination will be assigned to a CCP or oPRP by a convenient and reproducible method.
In this case, given the discontinuous nature of control and monitoring possible, it is likely that the CIP should be allotted to a oPRP rather than a CCP.

This does illustrate a (positive) type answer to yr (mohanp's) original question although without giving the practical details. :clap:

I would still regard all this manouevering as a last resort compared to retaining everything as a nice, verifiable, PRP though. :smile:

Rgds / Charles.C
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Charles.C


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#52 SriramB

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Posted 22 July 2011 - 05:19 AM

Hi Charles,

Thanks for taking the time to respond in detail.

I think this scenario is unfortunately, typical, in real life e.g. beard masks, etc, where we (QA and Operations) always get into a debate :smile: . We try to work with standard (to please auditors et al), while the end resolution may seem so common sensical that the time spent in following any 'systematic' method becomes unjustifiable to the Operations team.

So it is good to be able to thrash out ideas in this forum, without the pressure of day to day distractions.


From this thread, I take the learning that if we give proper respect to PRPs and do not just concentrate on CCP's then stuff like oPRPs would not exist or be necessary! :smile:

Cheers,

Sriram


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#53 GMO

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Posted 22 July 2011 - 07:42 AM

From this thread, I take the learning that if we give proper respect to PRPs and do not just concentrate on CCP's then stuff like oPRPs would not exist or be necessary! :smile:


Well that's kinda my thinking but I'm not sure everyone agrees...
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#54 Charles.C

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Posted 23 July 2011 - 10:07 AM

Dear Sriram,

As a corollary/extension to previous comments – I suggest a procedure(s) which, for the kind of scenario initially presented, might avoid having to (initially or subsequently) consider the handwashing as an oPRP/CCP. I am not a current user of the standard so no problem if someone wishes to demonstrate that the interpretation is not valid due to my misreading the chronological intricacies of the text.

My (primary) interpretation of yr reservations for the RTE product line discussed (no bacterial elimination step) was that you considered that the implemented prerequisite program of (combined) measures constituting cleaning / sanitising / personnel hygiene functions and other related activities (eg training) might be likely to (cumulatively) fail to prevent significant contamination of the hands of food-handlers and cause pathogenic bacteria being transferred (ultimately) from hand to food product (at one or more unspecified point(s)).

It is true that PRPs are by definition 3.8 applied across the entire production system however variation depending on the “particular product or operational line” is also permitted by virtue of 7.2.2c. This is simple commonsense IMO. It also seems to me that it is a reasonable “stretch” to include particular pathogens within the “product” concept if obliged (?) to declare a specific species. (I certainly doubt that an auditor would nit-pick such manoueverings).

It also appears to me that the initial appraisal (I avoid the taboo word “validation”) of the implementation of the PRPs with respect to the proposed salad production line should hv revealed the (hypothesised) lack of control thereby prompting an appropriate modification of the PRP, ie (with high probability of) removing the risk of a health incident. Ie no significant hazard. :smile:

Alternatively if the oPRP scenario as per my previous post does exist, a review (= update) as per sections 8.4.2 – 8.5.2 will presumably result in same conclusion as preceding paragraph, thereby cancelling the oPRP. (commonsense again!).

The above logic obviously assumes that the original PRP program(s) can be (successfully / verifiably [?]) amended but still nominally categorised as PRP, eg by modifying handcleaning procedure, inserting an additional “around production line” sanitising dip station(s), disposable gloves, retraining of workers, etc.

Rgds / Charles.C


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#55 SriramB

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Posted 25 July 2011 - 07:58 PM

Dear Sriram,


It is true that PRPs are by definition 3.8 applied across the entire production system however variation depending on the “particular product or operational line” is also permitted by virtue of 7.2.2c.

It also appears to me that the initial appraisal (I avoid the taboo word “validation”) of the implementation of the PRPs with respect to the proposed salad production line should hv revealed the (hypothesised) lack of control thereby prompting an appropriate modification of the PRP, ie (with high probability of) removing the risk of a health incident. Ie no significant hazard. :smile:

Rgds / Charles.C



Dear Charles, GMO,

There is an old Indian poem that questions, why a 'people' cannot govern themselves and require a king/government etc to do so. In contemporary, times it looks like , we actively invite governance, regulation and inspection, so really cannot complain that standard writers/ auditors are taking us for a merry old ride..:smile:


It is unfortunately a fact that commonsense does not prevail at all times.

Also, budgetary and resource issues limit the amount and comprehensiveness of due diligence activities, even in 'high risk" situations , leave alone percieved 'commonsense' processes such as PRPs.

I guess, a self aware and competent HACCP team would have an effective PRP set complemented with process specific CCP.


But, tongue in cheek, I have audited HACCP plans which mostly indicate the 'lack of control' of 'Hazards' in a process rather than the other way :off_topic: . Hence, my posts usually are in response to arguments which call on commonsense as a risk analysis aspect. :smile: .


But, I do agree that where the team understands the goal of the standard then , there are simpler ways of achieving it, than having to categorize stuff into CCP/oPRP/PRP!

Thanks,
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#56 Tony-C

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Posted 26 July 2011 - 02:53 AM

I've worked in two ready meals and two sandwich sites. None of them had handwashing as an oPRP.


No surprise BRC certification is prolific throughout the UK
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#57 Tony-C

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Posted 26 July 2011 - 02:56 AM

--------------------------------
Assume we start of with a pie making plant, where end product is well cooked etc...
Now, we want to add a new "salad' packing line, on a small scale. Also assume we plan to pack salad leaves manually by hand.


Salads & Pies - Sounds like one of the wacky ideas my old Sales & Marketing Director would come up with :wacko:
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#58 Tony-C

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Posted 26 July 2011 - 03:03 AM

Cleaning and disinfection of equipment NEP (or CIP) is it a PRP, an oPRP or CCP in ISO 22000 and why?


All dependent on risk and control. For instance when filler hygiene is key to product quality I have it as a CCP.

Edited by Tony-C, 26 July 2011 - 03:05 AM.

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#59 Charles.C

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Posted 26 July 2011 - 03:14 AM

Dear SriramB,

It is unfortunately a fact that commonsense does not prevail at all times.


Very profound. :biggrin:

I admit that I cheerfully inserted the c-e word a few times particularly due to the comment in various publications that use of Decision Trees can lead to illogical conclusions in some cases therefore care is required in implementation. They typically also tend to maximise the total number of (CCPs + oPRPs}(in contrast to the use in traditional HACCP).

In the same vein as yr previous post, while studying the ISO 22000 standard, i frequently run into the (to me) conceptual illogicality that "operational prerequisites are", by name and definition, a (logical?) extension of "prerequisites".
However by (the defined) generation process via 7.4.4, they are clearly never prerequisites with regard to chronology and frequently not with respect to meaning either. :smile: Many authors classify them as "slightly" less "significant" than CCPs (eg the popular analogy to CPs) which is understandable in view of their typical identification processes (ie failed CCPs). However the 22004 standard seems to be strongly opposing such a viewpoint in respect to its emphasis on validation / non-caring of the final distribution of CCPs/oPRPs.

It seems to me that the original reasons for introducing the oPRP concept had value but, as currently implemented, it has more become an inconvenience in the sense of optimally achieving food safety (remember the 2-tiered CCP?). One obvious difference to the development of traditional HACCP is in the (lack of )open availability of practical examples. Thanks ISO. :smile:

Rgds / Charles.C
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#60 color sorter

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Posted 09 August 2011 - 08:06 AM

i don't really know, but thanks for asking. learnt ---- :oops:


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#61 Charles.C

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Posted 09 August 2011 - 11:51 PM

i don't really know, but thanks for asking. learnt ---- :oops:


Dear color sorter,

Welcome to the forum! :welcome:

Very sorry but i have no idea what you are trying to say ? :smile:

Rgds / Charles.C
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#62 zein1

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Posted 13 November 2014 - 08:19 AM

Dear Tony-C,

Nice to break the triolog. :thumbup:

I believe yr detailed analysis of the RTE-handwashing situation should capably discourage anyone from making it an OPRP. :clap:
Personally, it seems to me that for some cases (eg like the current one) it might be simply easier to, quietly, expand one's general interpretation of the PRP so as to allow for any retrospective findings/misgivings (analogous, I think :rolleyes: , to what has historically occurred with allergens in traditional HACCP). (This would equate to an "update" of a significant hazard perhaps ?)

Perhaps, yet again, one should mention the potential of gloves. smile.gif



If generally applied, I do agree that this would certainly make life a lot easier.

Unfortunately, as per Tony's comments, I fear the situation is simply not so clear-cut. I hv attached a recent French review (2008) of the ISO 22000 standard, which particularly focuses on the interpretation of OPRP / distinguishing from CCP. (I accept that other localities may not agree however the French/"French-speaking" contribution in “shaping” the standard does seem to be significant)(but relative usage I don’t know).

Anyway, the authors consider the conceptual linkage of OPRP to PRP through the definition 3.9 as "meaningfully" broad, compared to the “step” concept of the CCP (though this was less narrow in some older usages). In respect to distinguishing between CCP and OPRP, the (French) text goes something like –



There is a lot more detail before and after. A look at the decision tree they propose/include illustrates their (logic) opinion. (I hv to say that I am not totally enthusiastic over some of their other comments but that is a different matter smile.gif ).

Generally, it seems to me that the OPRP concept is currently being interpreted in 2 ways depending on the particular situation – (1) as an inevitable consequence of the text in 7.4.4 / “clarified” in ISO 22004 (as yr post, tends to be production step focussed comments [though see 7.4.2.2b]), (2) a more 3.9- definition oriented scenario where the attraction IMO is OPRPs amazing flexibility, for example as used in some of the “minimalised” risk scenarios eg vegetables or the no “proper” critical limit situations (various).
(IMHO, the standard’s OPRP definition is awful, but I am sure it’s ambiguity was totally intentional).

Maybe a compromise result should be the appearance of more “globalised” process charts / an abundance of “2-way-arrows”. I think in truth the original HACCP was supposed to look at everything but ...... biggrin.gif

I can understand why people who implement the standard prefer to (rightly or wrongly) pragmatise . This seemingly well-concurs with auditor expectations (path of least resistance?). I guess auditors rarely encounter the novelty of non-production-step oriented significant hazards. But perhaps they should ? wink.gif

attachicon.gifcontrol programs.pdf
attachicon.giftranslation of non-standard part of decision tree.doc

Rgds / Charles.C

Dear Charles,

Do you have English translation for the attachment which is expressed in French?

Regards,

Zein


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#63 lmugs

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Posted 13 November 2014 - 12:46 PM

I think making it an OPRP is going too far as that should be covered by Personnel hygiene(under PRPs).


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#64 Charles.C

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Posted 13 November 2014 - 09:16 PM

Dear Charles,

Do you have English translation for the attachment which is expressed in French?

Regards,

Zein

 

Dear zein,

 

The French iso22000 exponents have published a vast amount of interesting discussion material on this topic. Mainly parallel to other languages AFAIK. :smile:

 

If tested, you will find that google is approx. 60-70% accurate IMEX. i did make a (google + school French) translation 3 yrs ago and will repost if i can find it in my archives. :smile:

 

The fact is that OPRP (which is a central issue in the document) can be, and has been, interpreted in sooo many ways. And no-one claims (or can prove) that a particular view is a uniquely correct one. This document sort of (ultimately) divides the CCP/OPRP selection based on a prioritization of "conceptual" distinctions. Others tend to use solely qualitative decision criteria based on parts/whole of  7.4.4 (a-g) as in trees. Others use totally numerical bases via 7.4.4 again. Others use mixtures of any of previous or different approaches. All can (somehow) be categorized as "logical" so it then becomes a matter of user choice. I think auditors gave up trying to discriminate a long time ago but you will probably know more than i on that aspect.

 

One practical difference can be that certain routes will generate a lot more total (CCPs + OPRPs) than others.  AFAIK, auditors currently do not discriminate on such a "gross" basis unlike (possibly) traditional haccp. :smile:

 

Rgds / Charles.C


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