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
iso 22000 -oprp - didier blanc (2006).pdf 381.73KB
236 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
