(1) It seems that having no oPRP's was questioned already by Tony.
Yes but here only as to the interpretation, not, i think, as to any auditorial consequences if absent**. The problem with oprp interpretation is that it has always been a (considerable) matter of opinion. Blame ISO's original text/ambiguity.
(2) Based on the hazard analysis you provided, I agree with Tony that the final pasteurization step will be your CCP (the final step that would likely to addressed your biological hazards). But I'm quite confuse if we make the CCP2 and CCP3 as oPRP's.
At the time of writing (2012), I was able to literature validate either of the 2 ways discussed.I preferred the one shown. (see note 2 in Excel of Post 79/Comments in Post 84).
(3) According to some references, oPRP's are control with only acceptable criteria (e.g. visual detection of sieves. The acceptable criterion is the integrity of the sieve) unlike CCP's that have clear measurable limits (e.g. final heating. This means the limit is ≥ 120°C).
ISO-CCPs may utilise non-numerical critical limits. I think the above may be a misinterpretation of the Standard. IMO It is operationally important to be aware of the haccp nuances given in iso22004 while following the overall step sequence presented in iso22000.
(4) Based on this examples, would pasteurizer contradict such principle if we declare it as oPRP's? Because all the parameters on pasteurizer are measurable and we can established acceptable limit.
See (3).
The decision (for a significant hazard / validatable control measure) should be based on 7.4.4 (a-g) and perhaps as further explained in iso22004.
The extract below (from Praxion) is IMO the best textual explanation I have seen of ISO's intended distinction(s) between CCP and OPRP. (The methodology used in the yoghurt example attempts to utilise/average the (a-g) decision categories shown. Both average-based methods and decision trees involve "logical" interpretations of the iso22000 standard/clause 7.4.4. Both approaches seem to be equally acceptable to auditors).
Consider using your HACCP plan to manage a control measure:
- If strict control must be applied.
- If your control measure is likely to fail in the future.
- If a control failure would have severe consequences.
- If monitoring and rapid corrective action is feasible.
- If your control measure must be able to cope with significant processing variability.
- If your control measure is designed to eliminate or reduce the level of a specific food safety hazard.
- If your control measure's place in the system makes it convenient to make it part of your HACCP plan.
- If a control measure helps to boost the effectiveness of another control measure that is also part of your particular HACCP plan.
If the above conditions do not seem to apply to your specific control measure, consider using an operational prerequisite program (OPRP) to manage it.
Consider using an operational prerequisite program (OPRP) to manage a control measure:
- If strict control is not needed.
- If your control measure is unlikely to fail in the future.
- If a control failure would not have severe consequences.
- If monitoring and rapid corrective action is not feasible.
- If your control measure does not need to be able to cope with significant processing variability.
- If your control measure is not designed to eliminate or reduce the level of a specific food safety hazard.
- If your control measure's place in the system makes it convenient to make it part of your OPRP.
- If a control measure helps to boost the effectiveness of another control measure that is also part of your OPRP.
If the above conditions do not apply to your specific control measure, consider using your HACCP plan to manage it.