26 replies to this topic

[Lelouch_rayne]

Hi guys,

 

 

I'm quite confused with this whole oPRP thing. Based on my assessment, our process steps which include: pasteurizer and filtration which are necessary during processing did not fall on oPRP category. Because on the following reason:

 

Pasteurizer - used to kill or reduce the number of pathogenic micro organisms but there is still a subsequent step that will address the remaining micro biological hazard.

                   - This step can be also validated and measurable which is against the principle of oPRP (only with acceptable criteria)

 

Filtration  - Based on the severity and likelihood, the hazard address by this step is not significant because we implement preventive maintenance to address the possible hazards.

 

So, my question is, is it possible to have no oPRP on a HACCP plan based on ISO 22000? or are we obliged to really identify at least one oPRP?

 

 

 

Thanks,

 

Joan

[Tony-C]

Hi Mary Joan,

 

We are talking about:

7.4.4 Selection and assessment of control measures

Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall be selected which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels.

In this selection, each of the control measures as described in 7.3.5.2 shall be reviewed with respect to its effectiveness against the identified food safety hazards.

The control measures selected shall be categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan.

 

It is possible not to have OPRP's but more information would be useful such as what is the step after pasteurization that ensures microbiological safety and why you don't think filtration is an OPRP or CCP? For example has any foreign body ever been found in your filter?

 

Kind regards,

 

Tony

[Sam30]

Hi, it is very much possible to not have OPRP in your process, however based on limited information provided it is difficult to judge which category the control would land into. For pasteurization step, its important to consider what is the step down the process flow that can prevent micro contamination apart from pasteurization.

[Lelouch_rayne]

Hi Tony,

 

 

We have UHT treatment after pasteurization to ensure that all surviving pathogens are killed prior filling. For the filtration, the physical hazards it address is not considered significant because we make sure that no hazard will be introduced in the system through established preventive maintenance, pre-operational checklist and inspection of filters prior and after production. So far, we dont have any cases yet that where some hazards are trap in the filter that could pose food safety risk.

[Charles.C]

Hi Joan,

 

I suspect yr OP is also asking the question - "Do auditors expect to see at least one OPRP ?"

 

I fear the answer is likely to be Yes but i am interested to know if any users of FSSC22000 here have been satisfactorily/readily audited with a haccp plan possessing zero oprps ?

 

PS - sorry to expand yr OP.

[Lelouch_rayne]

Hi Charles,

 

 

 

That's why I'm asking as many people as possible. Well, based on the standard, it did not say also that a HACCP Plan should at least contain an oPRP. 

 

My argument is that, the results will still be based on the risk assessment the team conduct. So, if they decided that all hazards can be controlled alone by PRP and CCP, then there's no need for an oPRP. Can the auditor still argue about that?

[AS NUR]

Dear Mary Joan..

 

IMO..   It is possible not to have OPRP's,  You just show your CCP analysis using appropriate tools like decision tree analysis. And you can strengthen your result by laboratory analysis data or other verification data. 

 

Rgds

 

AS Nur

[wasiqualityguru]

system is yours and you have to do hazard analysis and decide on CP, PRP,OPRP , CCP.

 

It all depends on how you have done your hazard analysis. Depending on product nature even you may not have a CCP as well.

 

however , as for as Food safety issues are concerned OPRPs and CCPs are established in general as a result of hazard analysis.

 

Share , if possible , your HA and will comment 

 

Thanks a lot !!!

[sudhakar.moorthy]

Hi Mary Joan,

1. Is it possible to have no oPRP on a HACCP plan, based on ISO 22000 - Yes
2. Your Pasteurization and UHT are a combination of control measures. Will your UHT treatment deliver target results if U don't have a Pasteurization, then it would not be a OPRP.

Is Pasteurization step operationally designed in your processing with defined target levels for food safety, then it would result in an OPRP.


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[dominicjamalmangray]

It is possible to have a system without a OPRP. Remember when you filter your processes through your decision tree it may be very possible that you do not end up with an OPRP or even a CCP depending on the product. Also OPRPs are essential for controlling the likelihood of introducing hazards or the proliferation of a hazard but they do not based on my understanding eliminate or reduce hazards to acceptable levels. Only CCPs do this. For example cold storage is a OPRP for my organization but if you dont define your any control measure coming out of your hazard analysis as controlling the likelihood of introducing a hazard (prevention) then you dont have a OPRP.

 

 

Hope this helps.  

[Charles.C]

It is possible to have a system without a OPRP. Remember when you filter your processes through your decision tree it may be very possible that you do not end up with an OPRP or even a CCP depending on the product. Also OPRPs are essential for controlling the likelihood of introducing hazards or the proliferation of a hazard but they do not based on my understanding eliminate or reduce hazards to acceptable levels. Only CCPs do this. For example cold storage is a OPRP for my organization but if you dont define your any control measure coming out of your hazard analysis as controlling the likelihood of introducing a hazard (prevention) then you dont have a OPRP.

 

 

Hope this helps.  

 

Hi dominicjamalmangray,

 

Thanks for input. I agree with yr opening sentences but not the red-marked section.

 

It is IMO operationally preferable to follow the "Guidance" given in iso22004 which attempts to clarify ambiguities in iso22000. For example see clauses 7.1, 8.2 .

[Tony-C]

Hi dominicjamalmangray,

 

Thanks for input. I agree with yr opening sentences but not the red-marked section.

 

It is IMO operationally preferable to follow the "Guidance" given in iso22004 which attempts to clarify ambiguities in iso22000. For example see clauses 7.1, 8.2 .

 

I would agree entirely Charles:

 

From ISO/TS 22004:
7 Guidance on the use of ISO 22000:2005, Clause 7: Planning and realization of safe products
7.1 General
b) operational prerequisite programmes (operational PRPs) that 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

From ISO 22000:
7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall be selected which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels.
In this selection, each of the control measures as described in 7.3.5.2 shall be reviewed with respect to its effectiveness against the identified food safety hazards.
The control measures selected shall be categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan.

 

Kind regards,

 

Tony

[Lelouch_rayne]

It is possible to have a system without a OPRP. Remember when you filter your processes through your decision tree it may be very possible that you do not end up with an OPRP or even a CCP depending on the product. Also OPRPs are essential for controlling the likelihood of introducing hazards or the proliferation of a hazard but they do not based on my understanding eliminate or reduce hazards to acceptable levels. Only CCPs do this. For example cold storage is a OPRP for my organization but if you dont define your any control measure coming out of your hazard analysis as controlling the likelihood of introducing a hazard (prevention) then you dont have a OPRP.

 

 

Hope this helps.  

 

I think this is were all the confusion starts. I saw a decision tree with the same question, if you answer YES then it would likely fall to CCP and if NO then it would be OPRPs. So we concluded that this question refers if the step in question would be LAST step to eliminate or reduce hazards to acceptable levels.

[Lelouch_rayne]

There are process steps that really eliminate and reduce the hazards BUT not to an extent that it would fall to acceptable levels. IMO, only critical steps (or only step to address such hazard) and final steps would likely fall to this categories and therefore would be CCP. 

 

If the step would still address the hazard but not literally that it would fall to acceptable level, then IMO it would be consider as OPRP.

[dominicjamalmangray]

Thanks for the clarification.

[Charles.C]

Hi Joan,

 

As I understand. yr interpretation implies that a control measure/combination for a specific hazard  which is designated as an OPRP may deliver less than the “acceptable level” as  required to be pre-defined by iso22000 to ensure food safety.

 

Such a scheme will logically not comply with  the Validation requirements of clause 8.2  within the context of previous posts. It is analogous to a much earlier (and essentially abandoned) implementation of a 2 level- critical control point scheme (CCP1/CCP2).

 

The rapid release of iso22004, including its oprp/ccp-decision tree/suggested distinction criteria, was an attempt to clarify the global confusion generated by iso22000. Only partially successful, then and now.

 

I suspect that many auditors have long given up trying to assess the basis of an auditee’s  iso-haccp scheme and just look at the output.

[Lelouch_rayne]

Hi Charles,

 

 

Auditors nowadays have their own personal interpretation of each concept, no such thing as realignment. SO in return, 

[Lelouch_rayne]

 What happened? I'm still typing, and it got posted??? 

 

I think I hit the wrong button. 

 

 

Well, going back to the topic, I'm not still familiar with the clause 8.2 and I cant find my ISO manual...

 

I'll be back guys.

[Charles.C]

Hi Joan,

 

This is the overall logic chain.

 

 decision tree.pdf   128.4KB   229 downloads

 

 

 

[Lelouch_rayne]

 

Such a scheme will logically not comply with  the Validation requirements of clause 8.2  within the context of previous posts. It is analogous to a much earlier (and essentially abandoned) implementation of a 2 level- critical control point scheme (CCP1/CCP2).

 

 

Can you please elaborate this statement? I'm quite confused by your point. 

[Charles.C]

Can you please elaborate this statement? I'm quite confused by your point. 

Hi Joan,

 

this is the main part of 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.

 

 

The above implies validation of the item 7.1(b) quoted in Post 12.

 

If that doesn't answer yr query, can you identify which part is causing the confusion ?.

i agree that the whole topic is a maze of convoluted bits and pieces.  It's sad that, afaik, ISO have never published one example of the practical use of their Standard.

[Lelouch_rayne]

 

 

 

I have this idea in my mind but can't still comprehend it, so please bear with me.

 

The above underline word made this thing more confusing. Its like you should treat the control measures as whole thing rather than an individual entity when your validating (as long as they addressed the same food safety hazards). 

 

For instance, I mentioned above that the OPRPs are control measures that can control the hazard but cannot meet the defined acceptable levels because its your CCP who do the job. 

 

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.

[Lelouch_rayne]

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.

[Charles.C]

Hi Joan,

 

i wouldn't worry too much about being confused regarding the oprp topic because i daresay the majority of iso22000 users (and auditors) have shared yr confusion since 2005 but learned to live with it.

 

To illustrate you are far from alone, can see the conversations in this 2014 thread (the white paper available via the OP's link is also well worth reading) -

 

http://www.ifsqn.com...in-food-safety/

 

i hv also attached an iso22000 designer's response to queries on similar topics issued in 2006. IMO this document has more clarity regarding iso's intentions than many of the subsequent publications.

 

 ISO 22000 - concepts and implementation.pdf   275.29KB   226 downloads

[Leila Burin]

Hello, I hope this helps you to defeat from the audiotrs

:):

http://eur-lex.europ...78:FULL&from=ES

 

check p. 30:

"ALTERNATIVE/SIMPLIFIED APPROACH The same approach is used in a simpler way, for example:

 

— Risk levels 1 to 5 instead of 1 to 7 by using 3 instead of 4 subdivisions of the probability and effect (subdivisions 3 and 4 are merged).

— oPRPs are not included when identifying ‘intermediate’ risk, but only differentiation is made between hazards that can be controlled by PRPs only and those requiring a CCP."

 

Personally, I do not agree, but it is up to you...

Best regards,

Leila