I am part of a team implementing ISO22000 at an animal feed ingredients manufacturer.
We have had HACCP successfully implemented and maintained for more than 20 years.
Recently we successfully passed Stage 1 assessment for ISO22000 and are now working towards the Stage 2 assessment.
I have some questions around validation that I am struggling to answer through reading the ISO22000 standard and would welcome other IFSQN colleagues comments on.
We only have 2 CCPs and are confident that we can demonstrate validation of these based on chemical analysis and experimental trial data.
Regarding validation of OPRPs what is the experience of other people when it comes to factors like:-
- Do you have to confirm and provide evidence of validation for every individual OPRP or it is it acceptable to demonstrate that, as per Clause 8.2 "8.2 Validation of control measure combinations", the combination of controls are effective in managing food safety? What type of evidence do people use to demonstrate that a "combination of controls" are effective?
- It is not always possible in some instances to have critical limits based on physical measurement eg temperature, pH etc. If there is a requirement to validate individual OPRPs, how do you validate controls that are procedural eg suppliers satisfactorily complete questionnaire sent to them that covers aspects like HACCP, QMS and food safety management systems?
- Where ISO22000 procedures and control points have been adapted and updated from a HACCP based risk analysis, how can previous successful implementation and maintenance and presumably validation be used to support current day ISO22000 assessment? Can this history of success with HACCP be used in someway to demonstrate validation of ISO22000?
Any comments and views on the above would be most welcome
Thanks,
DP2006
Dear DP,
I can appreciate the probable reason but your queries are somewhat lacking in specific details.
I hope you will shortly get some (optimistic) practical responses. I can add a few generic comments based solely on my interpretation / familiarity of the iso22000/22004 text (both of which have certainly been proven quite “malleable” in practice) –
Do you have to confirm and provide evidence of validation for every individual OPRP or it is it acceptable to demonstrate that, as per Clause 8.2 "8.2 Validation of control measure combinations", the combination of controls are effective in managing food safety? What type of evidence do people use to demonstrate that a "combination of controls" are effective?
It is possible you are (hopefully?) misconstruing the meaning of “combination”. For example iso22004, 7.4.4, 2nd para., note the words “specific” and “each”.
It is also possible that 7.6.3 of iso22004 is implicitly involved if one assumes that, other than terminology, the validation procedure for OPRPs will be equivalent to
CCPs (this is implied in 2nd para of the 3rd section of iso22004, 7.4.4 ).
It is not always possible in some instances to have critical limits based on physical measurement eg temperature, pH etc. If there is a requirement to validate individual OPRPs, how do you validate controls that are procedural eg suppliers satisfactorily complete questionnaire sent to them that covers aspects like HACCP, QMS and food safety management systems?
Your “actual” query appears to be “how do you (directly/indirectly) validate belief/trust?” The trite answers of course are things like - audit and/or certification to standards. If official documentation, presumable auto-validated. It depends.
Debatably, partially answered by iso22000, 7.6.3, last para.
(Some related issues can be equally tricky IMEX, eg items like chemicals in raw material where a chain of primary / secondary / etc suppliers is involved and/or audits / COAs are prohibitively expensive. Never found a perfect solution to some of these, used routes such as the certification option / analysis-lot-coding / compromise / auditor goodwill).
Where ISO22000 procedures and control points have been adapted and updated from a HACCP based risk analysis, how can previous successful implementation and maintenance and presumably validation be used to support current day ISO22000 assessment? Can this history of success with HACCP be used in someway to demonstrate validation of ISO22000
Appears to be conceptually supported by iso22004, 8.2 (a), “historical knowledge”. And possibly some of (b-f) also.
It is clearly also an advantage to minimise one's significant hazards.
Rgds / Charles.C
PS -
(a)I presume yr post was a side-effect of Stage One.IMHO, yr auditor should have clarified some of the above.
(b) I believe some oprp methodologies which further invoke a "managing" viewpoint could generate multiple instances for the same hazard. It is possible in this context that "combination" might have a broader interpretation than my above opinion. Depends on the actual procedure you have chosen. Seems to me that the optimum number is zero, or perhaps 1, so the auditor can tick a box.
© It is probably a waste of yr time to worry too much about the subtleties of the OPRP/CCP aspect because i doubt very much that the auditor will care. My impression is that this portion of the standard simply requires presentation of a logical procedure, eg KISS.