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Interpretation of 7.4.4 (d) and (g)

oPRP CCP

Best Answer Charles.C, 25 February 2015 - 09:10 AM

Dear maximmon,

 

7.4.4 d talks about the likelihood of failure of control measure but not likelihood of occurence of hazard? My understanding is that if the likelihood of occurence of a hazard is high, then it is more likely to be controlled as CCP.

It is important to follow the sequence of paragraphs in iso22000.

7.4.3 deals primarily with the determination of significant hazards. The decision as to whether a CM is CCP/OPRP remains “open”.

7.4.4 deals with “proposing/evaluating/validating” control measures (CM) which can “handle”  the determined significant hazards. And the categorization of a validatable CM option to CCP/OPRP.

 

 

However, if the control measure is easy to fail, then the hazard will not be securely controlled, we should select another control measure which is stable so that the hazard can be securely controlled. I wonder if this is a selection criterion rather than categorization criterion? I am still stuck at this concept.

 

iso22004 (2005) suggests (not demands) a degree of prioritization (for a CCP) towards elements (abe) within  (a-g). Such an approach typifies Tree methods (eg Procert) although in practice the choice of prioritization varies between authors. In contrast,  Modarres’s method uses equal weighting to obtain an 'average", other variations of Modarres use unequal weights. (Note that iso22004 (2014) may have now added further suggestions, have no idea.)

But in practice  most auditors, so far, typically seem to not care regarding subtleties such as the above. They simply require a “logical” method for section 7.4 which is “relatable” to the iso standard. Note that iso22004 (2005) comments that  it does not really matter if you conclude  CCP or OPRP provided that FS is achieved (ie CM validation regarding achieving  the acceptable level exists)  and monitoring is feasible  within an adequate time frame.

 

                     

For synergistic effects, may I use your yogurt hazard analysis as example. In the "Raw milk inspection and off loading into Raw Milk Silo" step, the control for chemical is a CCP. The score for 7.4.4 (g) was 3, would you kindly help to use this example to explain more on synergistic effects? e.g. what are the pair/group of synergistic control measures relevant to this control measure?

 

TBH, I should have slightly updated the above “CCP”. As per the excel comments, I struggled conceptually regarding this specific CM.  I would now tend to classify it as a PRP (via ISO22002-1) since the result is less likely to be auditor debated.

 

This is an idea of Synergy –

 

A practical illustration of Synergy is here –

http://www.fda.gov/F...P/ucm073110.htm

I wouldn’t worry too much about about this element  unless it’s a well-documented situation.

Regarding the excel yoghurt analysis “(g)”, note that I modified Modarres’s scoring concept, (see the note in sheet 4).

 

The above text illustrates what is IMO a major defect in the iso22000 standard. Section 7.4.4 is highly non-prescriptive other than that the output must be either CCP, OPRP, or go back to square 1. :smile:

IMO the optimum procedure is probably one which (a) suits yr process, (b) takes the least analysis time, © minimizes yr subsequent workload, (d) satisfies the auditor. Not necessarily in that order. :smile:

 

 

Rgds /Charles.C

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#1 maximmon

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Posted 24 February 2015 - 08:52 AM

Hi Everyone!

May I know how to interpret 7.4.4 d) and g)?

I saw some of older posts using a tool such as the scoring sheet posted by Modarres to differentiate oPRPs from CCPs, which is straight forward and easy to use.

 

However for 7.4.4 d, the possibility of failure of control measure. Why the more likely it will fail, the more likely it is a CCP? Shouldn't we choose a more reliable control measure to control a CCP instead of oPRP?

 

For 7.4.4 g, how can I assess/ how to define whether a control measure is more synergistic or less synergistic? Is synergistic effect means I have more than one control measure together to control one hazard? If this is the case, then both control measures are CCP? Would someone kindly offer an example of synergistic effect?

 

Thanks!

Best regards,

Finkoo


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#2 Charles.C

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Posted 24 February 2015 - 10:00 AM

Hi Everyone!

May I know how to interpret 7.4.4 d) and g)?

I saw some of older posts using a tool such as the scoring sheet posted by Modarres to differentiate oPRPs from CCPs, which is straight forward and easy to use.

 

However for 7.4.4 d, the possibility of failure of control measure. Why the more likely it will fail, the more likely it is a CCP? Shouldn't we choose a more reliable control measure to control a CCP instead of oPRP?

 

For 7.4.4 g, how can I assess/ how to define whether a control measure is more synergistic or less synergistic? Is synergistic effect means I have more than one control measure together to control one hazard? If this is the case, then both control measures are CCP? Would someone kindly offer an example of synergistic effect?

 

Thanks!

Best regards,

Finkoo

 

Dear maximmon,
 

 

Consider using an operational prerequisite program (OPRP) to manage a control measure:

 

(1) If strict control is not needed.(a)

(2) If your control measure is unlikely to fail in the future.(d)

(3) If a control failure would not have severe consequences.(e)

(4) If monitoring and rapid corrective action is not feasible.(b)

(5) If your control measure does not need to be able to cope with significant processing variability.(d)

(6) If your control measure is not designed to eliminate or reduce the level of a specific food safety hazard.(f)

(7) If your control measure's place in the system makes it convenient to make it part of your OPRP.©

(8) If a control measure helps to boost the effectiveness of another control measure that is also part of your OPRP.(g)

 

If the above conditions do not apply to your specific control measure, consider using your HACCP plan to manage it.

 

http://www.praxiom.c...rograms (OPRPs)

(IMO, No.7 is evasive, it's typically interpreted similarly to Qu4 in the Codex decision Tree)

 

Regarding yr queries,

 

"More likely to fail" implies maximum need for control >>> CCP

 

Synergy typically is relevant where a single control measure (= "Perfection" >> tends to CCP) is considered  "inadequate" to achieve the desired FS result, ie better or = to the defined "acceptable level" but >1 control measure[CM] together will (ie a "combination of CMs" in the iso22000 terminology) (. Some OPRP/CCP methodologies consider it very important, some not. The relevance may also depend on the process / yr interpretation of OPRP..

 

As long as you can validate the logicality of the methodology you use, the choice is usually up to you. One difference is that Modarres's method gives a kind of (=weighted) / average decision result. Decision Tree methods tend to prioritize within (a-g). Both methods afaik are equally ok with auditors. And a dozen other conceptual variations also. All the methods are subjective, somewhere.

 

The latest revision of iso22004 is supposed to more clearly explain what iso22000 requires. I haven't seen it but i doubt it will make much difference. :smile:

 

Rgds / Charles.C

 

PS - i used Modarres's method in the attachment here -

 

http://www.ifsqn.com...ge-7#entry50651

 

PPS - one comment is that some other methods involve less effort than above, eg Procert's Tree method (probably the simplest implementation) -

 

http://www.ifsqn.com...indpost&p=65180

(continuation from Qu.3 is subjective although consistent with Praxiom extract above)

(element 7.4.4[c] is unaccounted for)(possibly included within preceding Hazard Analysis)

 

or the Coca Cola one here -

http://www.ifsqn.com...indpost&p=36620

(Phraseology IMO attempts to be more explanative than Procert but maintains some interpretive uncertainties)

("necessary" in qu4 may often be interpreted as "possible")

(necessary in qu5 might be better interpreted as "possible") (the latest iso22004 expands on the "no critical limits" aspect)

(qu.2 has some ambiguity regarding "combination")


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Kind Regards,

 

Charles.C


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#3 maximmon

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Posted 25 February 2015 - 04:34 AM

Dear Charles,

7.4.4 d talks about the likelihood of failure of control measure but not likelihood of occurence of hazard? My understanding is that if the likelihood of occurence of a hazard is high, then it is more likely to be controlled as CCP. However, if the control measure is easy to fail, then the hazard will not be securely controlled, we should select another control measure which is stable so that the hazard can be securely controlled. I wonder if this is a selection criterion rather than categorization criterion? I am still stuck at this concept.

 

For synergistic effects, may I use your yogurt hazard analysis as example. In the "Raw milk inspection and off loading into Raw Milk Silo" step, the control for chemical is a CCP. The score for 7.4.4 (g) was 3, would you kindly help to use this example to explain more on synergistic effects? e.g. what are the pair/group of synergistic control measures relevant to this control measure?

 

Thanks!

Best regards,

Maximmon


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#4 Charles.C

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Posted 25 February 2015 - 09:10 AM   Best Answer

Dear maximmon,

 

7.4.4 d talks about the likelihood of failure of control measure but not likelihood of occurence of hazard? My understanding is that if the likelihood of occurence of a hazard is high, then it is more likely to be controlled as CCP.

It is important to follow the sequence of paragraphs in iso22000.

7.4.3 deals primarily with the determination of significant hazards. The decision as to whether a CM is CCP/OPRP remains “open”.

7.4.4 deals with “proposing/evaluating/validating” control measures (CM) which can “handle”  the determined significant hazards. And the categorization of a validatable CM option to CCP/OPRP.

 

 

However, if the control measure is easy to fail, then the hazard will not be securely controlled, we should select another control measure which is stable so that the hazard can be securely controlled. I wonder if this is a selection criterion rather than categorization criterion? I am still stuck at this concept.

 

iso22004 (2005) suggests (not demands) a degree of prioritization (for a CCP) towards elements (abe) within  (a-g). Such an approach typifies Tree methods (eg Procert) although in practice the choice of prioritization varies between authors. In contrast,  Modarres’s method uses equal weighting to obtain an 'average", other variations of Modarres use unequal weights. (Note that iso22004 (2014) may have now added further suggestions, have no idea.)

But in practice  most auditors, so far, typically seem to not care regarding subtleties such as the above. They simply require a “logical” method for section 7.4 which is “relatable” to the iso standard. Note that iso22004 (2005) comments that  it does not really matter if you conclude  CCP or OPRP provided that FS is achieved (ie CM validation regarding achieving  the acceptable level exists)  and monitoring is feasible  within an adequate time frame.

 

                     

For synergistic effects, may I use your yogurt hazard analysis as example. In the "Raw milk inspection and off loading into Raw Milk Silo" step, the control for chemical is a CCP. The score for 7.4.4 (g) was 3, would you kindly help to use this example to explain more on synergistic effects? e.g. what are the pair/group of synergistic control measures relevant to this control measure?

 

TBH, I should have slightly updated the above “CCP”. As per the excel comments, I struggled conceptually regarding this specific CM.  I would now tend to classify it as a PRP (via ISO22002-1) since the result is less likely to be auditor debated.

 

This is an idea of Synergy –

Attached File  synergy,pH-Aw.pdf   59.26KB   68 downloads

 

A practical illustration of Synergy is here –

http://www.fda.gov/F...P/ucm073110.htm

I wouldn’t worry too much about about this element  unless it’s a well-documented situation.

Regarding the excel yoghurt analysis “(g)”, note that I modified Modarres’s scoring concept, (see the note in sheet 4).

 

The above text illustrates what is IMO a major defect in the iso22000 standard. Section 7.4.4 is highly non-prescriptive other than that the output must be either CCP, OPRP, or go back to square 1. :smile:

IMO the optimum procedure is probably one which (a) suits yr process, (b) takes the least analysis time, © minimizes yr subsequent workload, (d) satisfies the auditor. Not necessarily in that order. :smile:

 

 

Rgds /Charles.C


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Kind Regards,

 

Charles.C


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#5 maximmon

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Posted 25 February 2015 - 10:10 AM

Dear Charles,

It's clear now :thumbup:

 

Thank you!

 

Best regards,

Maximmon


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