(Hopefully of some iso relevance) -
Just as an example of the possible confusion over oprps, I have enclosed a (partial) “oprp” extract from a generally excellent document on haccp validation to enable a little extended analysis on iso control measures -
oPRPs are identified by the hazard analysis. If a loss of control occurs, actions need to take place to bring the process back into control. However, controlling an oPRP does not prevent or eliminate a food safety hazard or reduce it to an acceptable level. Controlling an oPRP does reduce the likelihood of introducing a food safety hazard or the proliferation of an existing food safety hazard in the products or the processing environment. oPRPs must be validated, verified and monitored to ensure effectiveness of the food safety system.
One might criticize the terminological use in above extract, eg (referring to the red portion), as per iso22004 - 7.1[a], one does not control an oprp, it is more the oprp which “manages” a control measure so as to control a [significant] hazard to an acceptable level. In the minimal limit, an oprp is a single control measure (or a PRP in iso def. )
IMO it is a fact that the concept of “Validation” is used in various ways in both iso22000/22004. As illustrations –
(i) 3.15 validation
(food safety) obtaining evidence that the control measures (3.7) managed by the HACCP plan and by the operational PRPs (3.9) are capable of being effective
(ii) [8.2] Prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15 [!!]) that a)the selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated, and b) the control measures are effective [!!] and capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels.
(a)[7.4.4] Subclause 8.2 of ISO 22000:2005 requires that validation demonstrates that the combination of control measures is capable of achieving the intended level of control.
(b)[7.8] 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.
©[8.2] The validation process provides assurance that the combination will deliver products that meet identified acceptable levels
Regarding extracts (i – c) above, there are possible ambiguities due to terms like “effective”, “intended level of control”, “acceptable level of control”, “in combination”. More precisely –
(i) is rather meaningless unless “effective” is itself defined, eg explained / quantitated. IMO Ambiguous.
(ii) is IMO a clear statement of intent.
(a) is incompatible with (ii) unless “intended” >> “acceptable”. IMO Ambiguous.
(b) is also incompatible with (ii) unless, for a combination, “intended” >> “acceptable”. IMO Ambiguous.
© is compatible with the relevant part of (ii). Probably the most definitive comment in iso22004.
IMO the above implies –
(1) an oprp can consist of a single of multiple control measures.
(2) an oprp consisting of a single control measure may/may not achieve control of a significant hazard to a defined acceptable level, ie it may achieve an “intended” control. However in the latter case the further specification of an appropriate combination of associated control measures so to enable achievance of a defined “acceptable level” for the hazard would presumably be mandatory.
Referring to the initial extract / red text, it is unclear whether a “single” or “multiple” oprp is under consideration. IMO, if a finalized multiple case, the text is incorrect, if a single case it may/may not be correct depending on the stated “intended" control.
Some Decision Trees do use the ability of a control measure to individually achieve control of a significant hazard to a defined acceptable level as a primary criterion to separate a CCP from an oprp (eg “total power” concept). This may have been the implicit intent behind the red text as stated. Or it may simply have been by analogy to the use of the CP terminology. Other trees maybe use a wider blend of parameters from the set in iso22000 / 7.4.4 (a-g) to make conclusions.
Rgds / Charles