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Generic Models Defining PRPs and OPRPs (with examples)

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Clemkonan

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Posted 06 November 2010 - 09:45 PM

I have been turning blue in the face ( which is sort of a challenge given my complexion) trying to get a "leg up" on the issue of PRP's vs OPRPs and the merits of having a system where there are no CCP's and no OPRPs.

The solution to me seems obvious , well at least from an educational perspective. Why not post a series of generic models where the experts have gone through the risk assessments for products A, B C and D? For example industry choices could be Dairy, canning, poultry, beverages, water ,etc.

The international members could then respond with their comments especially for folks whose processes are featured they could compare and contrast the published solution with what they had developed in house.

I have found a number of definitions or attempts at defining PRPs and OPRPs however they all tend to omit a a critical component, namely examples. Examples adds clarity, examples is the waterway that allows folks hampered by different perspectives to reach a common Eureka moment .....ah ha I got it!

Alternatively if this is already present in one of your publication then hey point me in that direction , I really look weird wearing a blue hue.

OK sorry for the sick attempt at humor.



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Simon

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Posted 08 November 2010 - 10:53 AM

Hi Clemkonan,

It’s a good idea. I think this is still an area of major confusion and by working through a specific example it is an opportunity for all of us to share and learn and be clear on PRP's vs OPRPs vs CCP's for a distinct product type / process.

If members are interested in participating then we would need to decide on the process; maybe dairy would be a good place to start as I know there are members experienced in this area. We would also need to know how to phrase the question and the starting point / references e.g. flow diagram and to what standard we were working to.

Any interest form members in participating in such a project?

Thanks,
Simon



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Posted 08 November 2010 - 05:20 PM

Dear Clemkonan,

Alternatively if this is already present in one of your publication then hey point me in that direction


Two detailed, multi-step analyses of, respectively, postharvested vegetables / bottling line exist here. First is linked in my post (see FSSM) in your parallel thread. Second within this thread - http://www.ifsqn.com...dpost__p__19765 (see Bennii)

For prps, maybe also see this thread (pre-FSSC maybe) -
http://www.ifsqn.com...dpost__p__32110

There are many other individual examples but I agree they do take some searching. ;)

added - After reading some of these links, you should realise that various (sometimes opposed) interpretations of the requirements of the ISO 22000 / 22004 texts exist. Members here have commented that some auditors will accept some styles, others go for others, some maybe go for all. I guess it’s a seller’s market.

Rgds / Charles.C

PS @Simon, Yes it is an interesting idea. I only wish i knew more about dairy than cow and bottle. :smile:

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Charles.C


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Tony-C

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Posted 10 November 2010 - 03:11 PM

Hi Clemkonan,

It’s a good idea. I think this is still an area of major confusion and by working through a specific example it is an opportunity for all of us to share and learn and be clear on PRP's vs OPRPs vs CCP's for a distinct product type / process.

If members are interested in participating then we would need to decide on the process; maybe dairy would be a good place to start as I know there are members experienced in this area. We would also need to know how to phrase the question and the starting point / references e.g. flow diagram and to what standard we were working to.

Any interest form members in participating in such a project?

Thanks,
Simon


I would be happy to assist. I think we may be able to knock up a basic model with the understanding it would be generic and any assessment of risk needs to take into consideration the extent of control PRP's achieve in individual sites.

Regards,

Tony


Simon

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Posted 18 November 2010 - 10:20 PM

How about doing one for youghurt? Who wants to kick it off? :smile:


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Posted 19 November 2010 - 05:18 AM

How about doing one for youghurt? Who wants to kick it off? :smile:


Some choices:

Is it called yoghurt, yogurt or yoghourt (As Loseley liked to call it)?
Set/Stirred?
Natural/Fruited?
Fresh/Pasteurised? (Hot fill or Aseptic)

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Tony


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Posted 19 November 2010 - 10:09 AM

The simplest, yoghurt. :smile:


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Posted 22 November 2010 - 12:14 PM

I split the process flow diagrams Tony posted into its own topic here - Yoghurt Risk Assessment


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Posted 26 November 2010 - 08:32 AM

Dear All,

I thought it was worthwhile to suggest some comments to Chemkonan’s specific plea. Most of the below exists in different places / forms on this forum already although the opinions given here are obviously my own flavour. The projected yoghurt analysis in a parallel thread ( http://www.ifsqn.com...dpost__p__39585 )will undoubtedly expand / clarify / improve on the comments below (since my primary experience is with traditional haccp and not iso 22000).
IMO, two key generic words with regard to ISO standards including 22000 are Interpretation and Subjective. Not necessarily a criticism, just a warning that consensus answers are, in some places, difficult and variations probably unavoidable.

I assume a working knowledge of traditional haccp. If otherwise, could try the concise series of general / introductional documents here – necessarily condensed but nicely presented (as per US styling) IMO.

http://edis.ifas.ufl.edu/topic_haccp

Some distinctions between prps* and oprps*

(A) generality – prps are of a general nature, eg system (facility-environment)-wide application, targeted at non-specific safety hazards, eg pathogenic bacteria, harmful foreign objects. This is analogous to the use of prerequisites in traditional haccp. The 22000 prp definition is well stated IMO. Oprps are explicitly / implicitly specifically targeted ( analogous to ccps in this aspect). The 22000 definition is NOT well stated IMO (perhaps intentionally).
2 examples -
prp – pest control - general protection against (hopefully) all microbiological pathogens in/on the rat, etc. No specific mention of bacterial species (or rat).
oprp – application of a specific cleaning / sanitising procedure to a particular line for RTE food to prevent / eliminate L.monocytogenes. (and conforming B,C, D, E ++)

(B) Set-Up – prps are (optimally) designed and implemented before initiating the “process” although second thoughts are surely inevitable in practice (system validation). CMs for possible oprps / ccps are proposed after doing the hazard analysis. Again, similar to determination of ccps in traditional haccp.
© Intention - Risk aspect – prps are typically regarded as associated with hazards of low risk as a corollary of the definition of a ccp. (this is conceptually debatable but operationally prevalent, if interested see url 2 below). In contrast, since oprps are proposed / justified as essential by the hazard analysis, they (their CMs) are applied to specific, risk-assessed, significant hazards. This also applies to the example referred above.
(D) Validation / verification – due to their lack of specificity, prps are not required to be validated in the 22000 standard, only verified. Oprps must comply with both parameters and their related CMs are required to have this carried out before the categorisation step in 7.4.4. (Some disagreement inevitably exists regarding prp / validation, partially semantic).
(E) Sourcing – IMEX, this is a major area of (particularly oprp) confusion. The sourcing of prps is (minimally) relatively clearly defined as per the 22000 definition plus PAS220. I presume there is no maximum if any proposed CM conforms to the typical prp requirements as above. The situation for oprp IMO is less straightforward and more subjective than prp. This is already evident in its 22000 definition since “likelihood” is a probabilistic word which is freely open to interpretation although the additional word ‘essential” suggests that the probability should presumably be “substantial” (another subjective term!).
Two official complimentary definitions exist of oprp, No.3.9 in 22000 and within para 7.1 in 22004. The latter is important IMO since 3.9 appears to require the oprp to be sourced only from organisation “prps” but this, if my interpretation is correct, was not intended and is clarified / expanded in 22004 and a semi-official publication (I guess) nominally attributable to the iso organisation (Blanc 2006, see later attachment). To condense 22004 (para 7.1.b) – oprps “manage those control measures that the hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are not otherwise managed by the haccp plan.” This plus the Blanc document offers a wide reservoir. The combination of the 2 definitions implies that the CM associated with the oprp may function in more than 1 way, either individually or perhaps as a (implicit / explicit) support to / with other CMs. Either way, the net result of any combination must be to (validatably) achieve control of the specific (significant) hazard, eg as per the above quoted 22004 definition.. In some cases, the validation may require use of an “observation” rather than a conventional numeric value, this was one of the special characteristics of some early oprps.


Regarding the classification of a CM as oprp or ccp, further requirements will apply as indicated in 22000/ 7.4.4 and 22004. Clemkonan seemingly hasn’t got to that question yet so I will stop here. [At least 3 distinct (albeit partially overlapping) procedures seem to be regarded as auditably acceptable – (i) initial use of a modified / non-modified Codex decision tree, (ii) direct use of the paras (a-g) in para 7.4.4 via averaging or yes/no formats, (iii) pre-emptive (2 level) selection from the initial risk assessment.][I daresay there are more]

*Strictly these are managed “programs” and I am talking about the control measure(s) (CM) which is/are the core of the program. I will try to be specific where I feel necessary. Similar comment for ccps although in this case a “step” is equivalent to the “program”.

URL 2 - http://edis.ifas.ufl.edu/fs140

Attached File  iso 22000 -oprp - didier blanc (2006).pdf   381.73KB   232 downloads

Criticisms are welcome, I am sure that people will not agree with some of the above or will know something important to maybe add.

Instead of adding more examples myself, I suggest to Clemkonan that, in addition to Tony’s project, he might consider posting some of his (vexed) CMs with their intended application for people’s comments.

Rgds / Charles.C


Kind Regards,

 

Charles.C


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