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#1 FSSM

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Posted 16 July 2009 - 09:48 PM

Does anybody have idea?

ISO 22000 requires OPRP and CCP to have corrections and corrective actions, in case you find the results of your control measure are not within the acceptable level (taking into account that OPRP does not have CL).

What about PRP?

Allergens (as an example) are considered as PRP in PAS:220:2008, but there is no need to document any correction and corrective actions in case a PRP is not executed as planned.

Obviously, you can apply any corrections and corrective actions for any non-conformity (maybe as result of 7.8), but why it is not required for PRP, documented corrections and corrective actions?

:dunno:

Regards,

FSSM


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#2 Simon

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Posted 17 July 2009 - 07:05 PM

BUMP fo FSSM.


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#3 Charles.C

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Posted 18 July 2009 - 03:51 AM

Dear FSSM,

Allergens (as an example) are considered as PRP in PAS:220:2008, but there is no need to document any correction and corrective actions in case a PRP is not executed as planned.


Have not seen the standard but this seems rather improbable.

I think from memory that ISO 22000 includes this aspect within the requirement for verification of prp.

Hopefully Erasmo, the expert on ISO 22k text, will see this thread :biggrin:

Rgds / Charles.C
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#4 Erasmo

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Posted 18 July 2009 - 11:31 PM

Does anybody have idea?

ISO 22000 requires OPRP and CCP to have corrections and corrective actions, in case you find the results of your control measure are not within the acceptable level (taking into account that OPRP does not have CL).

What about PRP?

Allergens (as an example) are considered as PRP in PAS:220:2008, but there is no need to document any correction and corrective actions in case a PRP is not executed as planned.

Obviously, you can apply any corrections and corrective actions for any non-conformity (maybe as result of 7.8), but why it is not required for PRP, documented corrections and corrective actions?

:dunno:

Regards,

FSSM


Hi FSSM
It will depend on the situation, pls read 8.4.2 - It only stated that the organization has to take ACTIONS if the results of Verification Planning are not acceptable. (7.8 includes the PRP verification).
Saludos.
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#5 FSSM

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Posted 19 July 2009 - 03:41 AM

Thank you Charles.C/Erasmo:

I mean, the requirements for OPRP´s and CCP are basically the same, the only difference is CL for the later. Part of those requirements are corrections and corrective actions. PAS 220:2008 treats allergens as PRP only. Why this PRP or any other wouldn't´ require previously established corrections and corrective actions as OPRP´s or CCP?

Hope you can help me clarify my mind.

Regards,

FSSM


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#6 Tony-C

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Posted 23 July 2009 - 07:28 PM

Why this PRP or any other wouldn't´ require previously established corrections and corrective actions as OPRP´s or CCP?


I don't see a problem with having documented corrective actions. It is not a requirement of the standard, in my interpretation, as PRP's are expected to be reliable and verified.

Regards,

Tony :smile:
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#7 Charles.C

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Posted 23 July 2009 - 08:52 PM

Dear FSSM,

Actually, yr query has come up before here in less exact form and was equally debated (and unresolved :smile: ) regarding the logic. IMO, it is surely highly unlikely (and irresponsible ?) that for many PRPs such as factory water chlorination for example, any deviation from set operational limits would not be required to be documented. And the corrective actions which should follow.

Rgds / Charles.C


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#8 Tony-C

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Posted 25 July 2009 - 06:15 AM

IMO, it is surely highly unlikely (and irresponsible ?) that for many PRPs such as factory water chlorination for example, any deviation from set operational limits would not be required to be documented. And the corrective actions which should follow.
Rgds / Charles.C


I agree with you Charles PRPs and OPRPs seem to be muddled and this is leading to a lot of confusion.

Your example would probably be considered an OPRP under management of supplies.

Regards,

Tony :smile:
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#9 FSSM

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Posted 27 July 2009 - 03:07 PM

Thank you!

I don't see a problem with having documented corrective actions. It is not a requirement of the standard, in my interpretation, as PRP's are expected to be reliable and verified.

Regards,

Tony :smile:


As you say, it´s not a requirement, and I´m surprissed and confused about it. I think the only reason they would not need a documented reaction if out of control, is because they are not a significant food safety hazard.


Dear FSSM,

Actually, yr query has come up before here in less exact form and was equally debated (and unresolved :smile: ) regarding the logic. IMO, it is surely highly unlikely (and irresponsible ?) that for many PRPs such as factory water chlorination for example, any deviation from set operational limits would not be required to be documented. And the corrective actions which should follow.

Rgds / Charles.C


I also think documented reaction should be required, but maybe there is something I´m not considering that justifies this way of the standard.

Regards,

FSSM
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#10 Charles.C

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Posted 27 July 2009 - 11:37 PM

I have a simple proposal to resolve these semantic / subjective issues - delete the introduction of the term oprp from the standard at it's upcoming 5yr review. IMO, as currently presented (and attempted to be defended / rationalised in 22004) it can only be described as an insult. It's formulation for the standard was seemingly a last minute compromise and it shows.

Mind you, the audit / consultant companies must be laughing their way to the bank. And equally the same for the originators or PAS xxxx.

Rgds / Charles.C


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Charles.C


#11 Sean Archer

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Posted 24 December 2011 - 08:38 AM

Hello everyone,

Noticed two year old thread about PRP's deficiency action. Writing for the first time in this forum, I just want to share my way of thinking in this respect.

In my opinion, PAS 220 does not limit your way of controlling a specific PRP requirement. Everything depends on your hazard analysis. If you have an allergen that is low risk, then you need to control it by PRP only. In this case you may or may not document corrective actions. However, a PRP plan must at least include monitoring and verification actions.

But if your allergen is moderate or high risk, then you have to apply both PRP and OPRP with the corresponding corrective actions documented. What I understood from the discussion, you have an allergen that is perceived as a high risk ingredient in your factory and you need to have corrective actions documented for this hazard.

I would advise you to show your basic allergen control actions in PRP plan without the corrective action. Then, have a hazard analysis for this allergen and include it in your OPRP with the necessary corrective actions specified.

Kind regards.


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#12 Charles Chew

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Posted 24 December 2011 - 12:52 PM

PAS 220 does not limit your way of controlling a specific PRP requirement

If you have an allergen that is low risk, then you need to control it by PRP only. In this case you may or may not document corrective actions. However, a PRP plan must at least include monitoring and verification actions.

But if your allergen is moderate or high risk, then you have to apply both PRP and OPRP with the corresponding corrective actions documented.


Hi Sean, Definitely on the same page with you. Your approach not only fully support the "expectations" from the effects of suitably designed control measure combination of PRPs and OPRPs but the importance of Hazard Analysis on risk categorization and management. We go further by having an Allergen Layout Plan, Allergen Movements Management, etc. There is indeed a paradigm shift in the handling of Allergen and ID-Preserved Materials
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Cheers,
Charles Chew
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#13 Charles.C

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Posted 25 December 2011 - 10:34 AM

Dear Sean Archer,

Thanks for the (IMO) deceptively simple post.

Perhaps it is necessary to remember that OPRPs are created from PRPs when invoked by the hazard analysis (by def 3.9). (But not exclusively so perhaps?).(alternative transformative approaches also exist)

For example, assume the hazard analysis results in a significant hazard at a specific step which may be (validatably) controlled by a control measure (CM)(or CM program) which is listed within PAS220, ie a PAS-PRP.

The CM may then presumably be (logically) categorised as associated with an OPRP (program) or a CCP (point) ?

If the categorised result is OPRP, no conceptual problem from above analysis.

But what about if CCP ?

Or is the conclusion that a PRP can only be transformed into a OPRP, as per the def. again ?

If so, one might argue that PAS220 is applying a restraint on the classification of the CM although the necessity of corrective action will presumably not be hindered.

(As I understand it, the above result represents a divergence [= "improvement"] from traditional haccp where a defined PRP program would simply maintain its PRP status, independently of the assessed risk value.}(ie less work ;) )


Rgds / Charles.C


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#14 mind over matter

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Posted 25 December 2011 - 12:04 PM

ISO 22000 requires OPRP and CCP to have corrections and corrective actions, in case you find the results of your control measure are not within the acceptable level (taking into account that OPRP does not have CL).

I don't think you are always required to do both correction and corrective action under ISO 22000. This is how I understand the difference between correction and corrective action.

Correction - action to overcome a nonconformance.
Corrective action - action taken to overcome the CAUSE of a nonconformance.

If I understand/define/differentiate them correctly, then you can do corrective action without correction. For example, your customer sends you a picture showing you the defect (say, a missing hole in a part), and you agree it is a defect. The customer says he is just going scrap the part, or use-as-is, so you never perform correction (putting the missing hole in the part). But you can still do corrective action so that you never send him another part that is missing that hole.




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#15 Sean Archer

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Posted 26 December 2011 - 04:03 PM

For example, assume the hazard analysis results in a significant hazard at a specific step which may be (validatably) controlled by a control measure (CM)(or CM program) which is listed within PAS220, ie a PAS-PRP.

The CM may then presumably be (logically) categorised as associated with an OPRP (program) or a CCP (point) ?


I think, it depends on hazard analysis and assesment of control measures (7.4.4 "Selection and assessment of control measures").

If you have a step which demonstrates a significant risk and you found out that your control measure was listed in PAS220 as a PRP measure, then taking into consideration that you have high food safety risk at this step, you can move the PRP measure to OPRP or CCP plan. However, this is not so easy for:

1. The control measure described in PAS220 must provide measurable results not results subject to personal observations.
2. The control measure described in PAS220 must be applicable within a considerablly short time.

If the categorised result is OPRP, no conceptual problem from above analysis.

But what about if CCP ?

Or is the conclusion that a PRP can only be transformed into a OPRP, as per the def. again ?

If so, one might argue that PAS220 is applying a restraint on the classification of the CM although the necessity of corrective action will presumably not be hindered.


Clause 7.4.4 "Selection and assessment of control measures" does not enforce ones OPRP/CCP decision of control measure. So a control measure defined in PAS220 can be applied as OPRP or CCP control measure provided that one will ensure hazard analysis and the two points above.

(As I understand it, the above result represents a divergence [= "improvement"] from traditional haccp where a defined PRP program would simply maintain its PRP status, independently of the assessed risk value.}(ie less work ;) )

Rgds / Charles.C


I think, this is the main reason why ISO22000 does not detail PRP requirements. If someone cannot validate a control measure that seems reasonable for a specific hazard step, then the control measure can be freely added to PRP. :bye:

Kind regards.
Sean
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#16 Charles.C

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Posted 27 December 2011 - 06:29 AM

Dear Sean Archer,

Thks yr reply. I appreciate yr thoughts.

You may understand my personal interest if you have a look at my recently uploaded (excel) yoghurt hazard analysis and refer my CCP1.
(added - see http://www.ifsqn.com...dpost__p__50651 )

As you noted, the situation partly revolves around the expanding “definition” of a PRP. However, in my own example, seems to me the control measure (CM ) is well-matched to para 7.2.3 (f) in ISO 22000.

1. The control measure described in PAS220 must provide measurable results not results subject to personal observations.
2. The control measure described in PAS220 must be applicable within a considerablly short time


I think "measurable" results does not exclude personal (eg visual) observations (see 7.6.3). The "timely manner ...immediate corrections" of 7.4.4 was from memory sort of compromised to "validatably feasible" after the standard(s) was launched. No argument that continuous monitoring is optimum.

However i agree that, on a case-by-case basis, lack of items 1,2 may create an absence of readily monitorable (or suggestable) critical limits which is a reasonable stipulation for a CCP. The lack may also relate to the feasibility of validation, a necessity for both OPRP/CCP

As it happens both critical limits and validation should be possible in my example.

I am unsure if an OPRP is forbidden to have ( pseudo-critical?) limits? . I think possible although the converse situation was a major motivation for the original introduction of OPRP terminology.

It is also certainly possible to find published examples of OPRPs which are seemingly not PRPs at all, eg specific, localised, process activities acting equivalently to CMs.

I am inclined to the conclusion that def.3.9 is simply inaccurate as written, ie an OPRP does not need to be directly "traceable" to a PRP as implied by 3.9, but can be totally deduced, or not, from para. 7.4.4.

Above was sort of logic i used in yoghurt example but it would be nice to be able to justify it (or not). :smile:

Rgds / Charles.C

PS - I appreciate yr point re flexibility of ISO 22000 but this is what has (partly) contributed to the GFSI problem, hence FSSC. Not really ISO’s fault I suppose, just business driven.

Not sure if PAS220’s additional menu now de facto ISO 22000 "approved" by virtue of later issues in the 22000 series ? (unseen by myself, just speculating).(maybe it depends on 22003).

PPS - Apologies to FSSM, this is all totally OT of course. :oops:
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#17 mind over matter

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Posted 28 December 2011 - 11:48 AM

(As I understand it, the above result represents a divergence [= "improvement"] from traditional haccp where a defined PRP program would simply maintain its PRP status, independently of the assessed risk value.}(ie less work )

Favorite Charles.C

I think a monitoring/tally sheet can be used for tracking PRP deviations. Even under ISO 22000 you don't need a CAR for every nonconformity, the decision about this should be based on the risk involved with the nonconformity. If a system is established that requires a corrective action for every nonconformance, that system is soon bogged down with investigations, corrective action requests, etc. for a large number of "insignificant" happenings. My advice to OP is to save the corrective actions for the "significant" items. Determination of what is significant is entirely up to his/her organization. It can be based on impact to food safety, product quality, customer satisfaction, bottom line, undesirable trends, etc. or anything else that he/she decide. If corrective actions (and all that they entail) are reserved for real problems then they will get the attention and resources that they deserve.

Edited by mind over matter, 28 December 2011 - 11:58 AM.

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#18 Sean Archer

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Posted 28 December 2011 - 01:57 PM

Dear Sean Archer,

Thks yr reply. I appreciate yr thoughts.

You may understand my personal interest if you have a look at my recently uploaded (excel) yoghurt hazard analysis and refer my CCP1.
(added - see http://www.ifsqn.com...dpost__p__50651 )

As you noted, the situation partly revolves around the expanding “definition” of a PRP. However, in my own example, seems to me the control measure (CM ) is well-matched to para 7.2.3 (f) in ISO 22000.

I think "measurable" results does not exclude personal (eg visual) observations (see 7.6.3). The "timely manner ...immediate corrections" of 7.4.4 was from memory sort of compromised to "validatably feasible" after the standard(s) was launched. No argument that continuous monitoring is optimum.

However i agree that, on a case-by-case basis, lack of items 1,2 may create an absence of readily monitorable (or suggestable) critical limits which is a reasonable stipulation for a CCP. The lack may also relate to the feasibility of validation, a necessity for both OPRP/CCP

As it happens both critical limits and validation should be possible in my example.


I have overviewed CCP1 in your yoghurt hazard analysis and want to share my interpretation with you.

The hazard in the step 1C is:
"chemical contamination, eg antibiotic residues in milk unapproved supplier / specification"

The step describes the needs to eliminate hazard that can arise from "antibiotic residues" and "unapproved supplier". But how in general we can rely on a milk sent by a supplier that was not approved? If I were an auditor, I would immediately ask the FST leader: Do you buy raw milk from unapproved suppliers?

Therefore, "unapproved supplier" is not a hazard for this particular example but your choice of doing bussiness.

From a tentative approach in your yoghurt risk analysis, let`s suppose that we have made hazard analysis of this particular milk supplier and concluded that the supplier is capable of providing antibiotics free raw milk with the likelihood of occurence "L" (low) as indicated in your analysis. In that case, the likelihood of occurence of antibiotics in the raw milk shall also be "L" (low) not "M" (moderate).

In most cases, if one is auditing the supplier of main raw material periodically, and ensures that the supplier is capable of providing raw material meeting the raw material specification, then a step associated with this supplier can be OPRP. For this particular yoghurt case, despite we can assign "L" (low) for the likelihood of occurence of antibiotics in the raw milk (since the supplier was assigned "L" (low) too), taking into consideration that the health severety of the hazard is catastrophic, the step can be included in CCP plan.

I am unsure if an OPRP is forbidden to have ( pseudo-critical?) limits? . I think possible although the converse situation was a major motivation for the original introduction of OPRP terminology.

It is also certainly possible to find published examples of OPRPs which are seemingly not PRPs at all, eg specific, localised, process activities acting equivalently to CMs.

I am inclined to the conclusion that def.3.9 is simply inaccurate as written, ie an OPRP does not need to be directly "traceable" to a PRP as implied by 3.9, but can be totally deduced, or not, from para. 7.4.4.


Definitely agree with you. As the name suggests, the Operational PRP is something related to the operations in the factory, generally assigned to Control Limits. For example, controlling maximum permissible temperatures in the production line can be a good OPRP if there is any potential of food safety risk.

Kind regards
Sean
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#19 Charles.C

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Posted 29 December 2011 - 04:45 AM

Dear Sean Archer,

Thks yr reply.

IMO, risk matrices are like Mary Poppins, (almost) anything is possible. Subjective is perhaps the polite terminology.

There is a fairly popular view that significant hazards in haccp require a likelihood of occurrence (LKO), at a minimum, to be “reasonably likely to occur”. For example this pictorial extract –

Attached File  significant hazard.png   70.23KB   33 downloads

On such logic, (LxS) is typically non-significant. Hence my “M”. One arguable but quoted definition of “M” is that the user/user's facility has personally experienced one event of the hazard in a stated time frame, eg one month in a year (8% ? :smile: ). But I totally don’t disagree with yr interpretation of “L”, “S” either, there are many, many official 5x5 risk matrices which will agree with you. Just an example of the inherent subjectivity which is possible, especially around the borderlines. And then we might have “Justification Column” methods in Risk Tables, “Regulatory” CCPs, ALOPs, FSOs, Pathogen Reduction Projects. The list is endless. And this is before you consider the blending with, say, different microbiological severities / vulnerable consumers etc etc.

There has been a multi-year case of a Country vs Country row at GATT over the banning of importation of a particular whole fish (hazard of introducing exotic pathogens not then existing in destination) which resulted in teams of national (and co-opted) statistical/fish experts defending the use of their qualitative risk matrices. The blocker won, on a majority verdict, at a massive cost, essentially because no-one could prove that the reality was not subjective and thus allowed a (wide) range of interpretation. The logic arguments ran into a few hundred pages, and a book.

Clearly epidemiological data should be involved also. But this is not always easy to find in the case of such sensitive issues and may still be difficult to apply in a specific situation. Regretfully milk is not my own practical area of expertise so I had to rely on literature publications relating to status/control of milk at reception prior to further processing. The “average” conclusion I inferred from my studies was that antibiotic residues is definitely considered an issue in various geographical areas but apparently less so in others. Very little published data of incident frequencies exists AFAIK (could find). Further input is only too welcome.

Similar issues can occur when one tries to assess the “risk status” of approved suppliers, eg everyone (visibly) knows that severe pathogens are being occasionally found in raw, RTE vegetables with harmful consequences of substantial widespread distribution. So what does a COA actually prove ?? or even a 1 year stack of satisfactory COAs. Then again, one has to start somewhere. I recall (from memory) that Canada once simply defined (for a different product which was to be cooked by consumer) that the possession of a supplier audit / COA for every lot was a minimum acceptable official requirement. Fair enough maybe. So the paperwork becomes the critical limit, at a cost +++. But is such logic statistically defendable ?? Seems to defeat one major analytical reason for HACCP’s elevation in the first place?.

Thks for 1 vote to support my OPRP interpretation. I hv no doubt that there are plenty of dissenters out there also. :biggrin:

Rgds / Charles.C

PS after re-reading yr previous post, i realised that my yoghurt presentation is perhaps slightly ambiguous in that (a) my inclusion of "unapproved supplier" was intended to imply a (generic-type) hazard due to an error by the raw material reception team in proceeding to evaluate an undocumented lot, not a policy decision to buy in that way, (b) the hazard of antibiotic residues was not intended to be feasible due to an unapproved supplier (although obviously it could be) but more a reflection of the general (known) situation in the industry, ie typical average level of contamination. The problem then passes as to whether a COA for an approved supplier is accepted as an adequate measure of the safety status of the whole batch or not. In practice any option seems to be acceptable to auditors as long as a choice can be validated for the COAs or respectively for another alternative, ie testing for antibiotic residues at reception. For non-liquid materials which actually do contain pathogens like Salmonella, the sampling aspect of a COA should favour the supplier unless gross contamination has occurred. For liquids / chemical hazards, more chance of homogeneity / fairness I guess. In both cases, validation is presumably workable for a typical n=5 / no detection in 25g samples scenario. By definition this result then matches the iso 22000 requirement of achieving an "acceptable level", regardless of conceptual sampling limitations. (a more meaningful statistical result would demand a much heavier sampling).

added - here are links to a couple of recent articles re. antibiotic residues. Predictably, the % positive detections vary substantially-

http://www.nytimes.c...ess/26milk.html

http://www.arpnjourn...bs_1111_329.pdf


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#20 Tony-C

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Posted 06 January 2012 - 03:59 AM

I have overviewed CCP1 in your yoghurt hazard analysis and want to share my interpretation with you.

The hazard in the step 1C is:
"chemical contamination, eg antibiotic residues in milk unapproved supplier / specification"

The step describes the needs to eliminate hazard that can arise from "antibiotic residues" and "unapproved supplier". But how in general we can rely on a milk sent by a supplier that was not approved? If I were an auditor, I would immediately ask the FST leader: Do you buy raw milk from unapproved suppliers?

Therefore, "unapproved supplier" is not a hazard for this particular example but your choice of doing bussiness.

From a tentative approach in your yoghurt risk analysis, let`s suppose that we have made hazard analysis of this particular milk supplier and concluded that the supplier is capable of providing antibiotics free raw milk with the likelihood of occurence "L" (low) as indicated in your analysis. In that case, the likelihood of occurence of antibiotics in the raw milk shall also be "L" (low) not "M" (moderate).

In most cases, if one is auditing the supplier of main raw material periodically, and ensures that the supplier is capable of providing raw material meeting the raw material specification, then a step associated with this supplier can be OPRP. For this particular yoghurt case, despite we can assign "L" (low) for the likelihood of occurence of antibiotics in the raw milk (since the supplier was assigned "L" (low) too), taking into consideration that the health severety of the hazard is catastrophic, the step can be included in CCP plan.

Kind regards
Sean


From experience approved and unapproved suppliers can get antibiotics in milk. The hazard is the presence of antibiotics and as such it is normal to conduct an antibiotics test prior to accepting a delivery/tanker.

It is likely that the step will be considered an OPRP given that the risk is of starter culture inhibition and controls will be in place later in the process such as acidification rate and final pH.


Regards,

Tony
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#21 Charles.C

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Posted 07 January 2012 - 12:41 PM

From experience approved and unapproved suppliers can get antibiotics in milk. The hazard is the presence of antibiotics and as such it is normal to conduct an antibiotics test prior to accepting a delivery/tanker.

It is likely that the step will be considered an OPRP given that the risk is of starter culture inhibition and controls will be in place later in the process such as acidification rate and final pH.


Regards,

Tony


Dear Tony,

Perhaps reported non-compliance rates to existing, legislatory, health-related standards for antibiotic-related drug residues might be an additional (significant) hazard.

(I appreciate that reported occurrences of manifestations of the hazard are Low/VL on a conventional timescale but it also appears unarguable that the hazard is avoidable. The primary reasons for MRLs appear to be a mixture of [allergenic/increased resistance/cumulative toxicity] fears. Another conundrum for risk matrix exponents.) :biggrin:

Rgds / Charles.C
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Charles.C


#22 Tony-C

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Posted 07 January 2012 - 02:08 PM

Dear Tony,

Perhaps reported non-compliance rates to existing, legislatory, health-related standards for antibiotic-related drug residues might be an additional (significant) hazard.

Rgds / Charles.C


Hi Charles

For dairy products in general maybe but as Sean was specifically asking about Yoghurt I don't think so. Also given the prerequisite of testing bulked milk for antibiotics as an acceptance test I don't see the the hazard you mention as significant.

Regards,

Tony
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#23 Sean Archer

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Posted 04 February 2012 - 01:58 PM

Binding allergen control in milk production to the PRP correction/corrective action question since the discussion went far away from the original topic. :smile:

Assuming that you manage your raw milk reception network by
1. Auditing the raw milk supplier "A" once a year and requesting COA every delivery: a PRP measure,
2. Conducting an antibiotics test prior to accepting a delivery/tanker: an OPRP measure.

Let's say, you have a supplier "A" which provides fine quality raw milk and annual audit shows satisfactory results.
However, yesterday the plant lab found that the raw milk tanker #A123 contains allergen which is above the MRL. In this case,

PRP correction: Auditing the raw milk supplier "A" twice a year with focus on supplier's animal management system.
PRP corrective action: Requiring the supplier to send samples to third party labs more frequently for COA verification.

OPRP correction: Rejection of the tanker #A123.
OPRP corrective action: Requiring the supplier "A" to commence corrective action and inform you about results with the relevant records. The action will continue until the supplier "A" shows evidence of conformity. Until that date no raw milk is bought from the supplier "A". The actions will be:
- Revalidating animal management system (animal treatments, used medicals and their doses etc.)
- Revalidating COA (methods, equipment, reagents etc.)

As you noticed PRP correction/corrective actions do not focus on the product rather try to correct supplier's conformity whereas OPRP correction/corrective actions concentrate on supplier's raw milk production system.

Again of my solely point of view...

Kind regards
Sean


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#24 Tony-C

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Posted 05 February 2012 - 07:10 AM

Binding allergen control in milk production to the PRP correction/corrective action question since the discussion went far away from the original topic. :smile:

OPRP corrective action: Requiring the supplier "A" to commence corrective action and inform you about results with the relevant records. The action will continue until the supplier "A" shows evidence of conformity. Until that date no raw milk is bought from the supplier "A". The actions will be:
- Revalidating animal management system (animal treatments, used medicals and their doses etc.)
- Revalidating COA (methods, equipment, reagents etc.)

Kind regards
Sean


Yes - you want the supplier to investigate the incident to determine the cause. Normally this is not down to animal treatment but the management of excluding treated animals from milking until their treatment is finished and milk clear of residues. In this case their system has failed and this is what I would want to look at.

One such corrective action could be positive release of milk at farm prior to collection.

Regards,

Tony

Edited by Tony-C, 05 February 2012 - 07:11 AM.

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#25 Charles.C

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Posted 07 February 2012 - 04:08 PM

Dear Sean,

Since it appears to me that some support is available for all 3 possible categories of the 2nd control measure (CM) referred, I have suggested a generic answer to yr basic question, ie what to do if this CM fails. It appears to me that ISO 22000 attempts to present the requirements in some kind of chronological safety order.

If the CM is a PRP, >>7.8 (inc. 7.2.3, 7.10.3 et al)
If the CM is (applied at) a CCP, >> 7.6.5, 7.10
If the CM is an OPRP, same as CCP, (presumably based on some sort of “OPRP limits” ).
(Note that a rather intriguing conceptual distinction is made [10.1] regarding the follow-up to a failed OPRP as compared to a CCP, although this is not relevant in present example).

All 3 will presumably have potential implication to 8.4.2
Last 2 may have relevance to ISO 22004, 8.2 (esp. last para.) .Frankly, I would probably invent a pseudo-validation so as to include PRP within this comment also, if it were otherwise excluded.

(Of course, ISO 22004 implies that all the OPRP/CCP distinguishing efforts are basically a waste of everybody's time. Probably the next revision will suggest all CMs should be labelled PRPP or PRPR [ primary or retrospective] :biggrin: ).

In the specific example, I would hv thought all 3 options would have the same 1st consequence assuming that the initial results were confirmable, ie batch rejection. Many of the subsequent supplier consequences will IMO, as Tony indicated, depend upon / fall under the category of “root cause”, usually a section of the standard CA form. Plus some kind of version of the American "3 knocks(?)" rule.

I hope the above partially embraces the original thread heading (strictly should hv included PAS220) and yr example. :smile:

Rgds / Charles.C


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Charles.C





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