10 replies to this topic

[skredsfan]

I'd like to throw a couple of practicle examples of common hazards associated with our process (paperboard packaging). I'll give my interpretation of the hazard classification (prp, oprp,ccp). I'd love to heard from some of you as to whether or not I'm interpreting this correctly.

 

1. A common hazard associated with the receiving of goods & raw materials is foreign material (Nuts, Bolts, Leaks, etc) This would be controlled by our Receiving, Warehousing & Transportation Prerequisite Program as well as our Approved Supplier Prerequisite Program, and would not be considered a significant hazard based on a risk assessment.

               

   Am I correct in the assessment?

 

 2. A common hazard associated with printing is allergens due to graphics control, such as incorrect artwork (mislabled allergens). Normally I would say that this is controlled by our Allergen Management Prerequisite Program, but my new interpretation of PRP's is that they're basic conditions & activities that are necessary to maintain a hygienic environment, which wouldn't make sense in this case. Should our Allergen Management Program just be considered a support program rather than a Prerequisite Program? If I consider this hazard (allergens due to mislabeling) to be significant, then classification of OPRP vs. CCP is the next step (Decision Tree). Here is where I get a bit confused. Questions 1 & 2 of the Pro Cert Decision Tree are easily understandable to me http://www.docstoc.c...0-decision-tree. The answer to Question 1 would be yes and the hazard to be controlled is Allergens due to mislabeling. The answer to Question 2 would be yes and the control measures would be graphics control via overlay checks & first piece approval. Questions 3 states Is the combination of measures specifically established for hazard control? If I answered yes to question 2 and listed my control measures, then how could No even be an option for question 3? Question 4 states Is continuous monitoring possible possible to verify the good functioning of these measures? By continuous, does it mean all of the time such as a metal detector? Would first piece approval and periodic press checks be considered continuous? Lastly if I do classify it as a OPRP, then what do I call it? Allergen Management , Overlay check/First Piece Approval or Simply OPRP #1?

 

 

Sorry for the lengthy questions! This FSSC 22000 stuff is making my head spin!

[Charles.C]

I'd like to throw a couple of practicle examples of common hazards associated with our process (paperboard packaging). I'll give my interpretation of the hazard classification (prp, oprp,ccp). I'd love to heard from some of you as to whether or not I'm interpreting this correctly.

 

1. A common hazard associated with the receiving of goods & raw materials is foreign material (Nuts, Bolts, Leaks, etc) This would be controlled by our Receiving, Warehousing & Transportation Prerequisite Program as well as our Approved Supplier Prerequisite Program, and would not be considered a significant hazard based on a risk assessment.

               

   Am I correct in the assessment?

 

 2. A common hazard associated with printing is allergens due to graphics control, such as incorrect artwork (mislabled allergens). Normally I would say that this is controlled by our Allergen Management Prerequisite Program, but my new interpretation of PRP's is that they're basic conditions & activities that are necessary to maintain a hygienic environment, which wouldn't make sense in this case. Should our Allergen Management Program just be considered a support program rather than a Prerequisite Program? If I consider this hazard (allergens due to mislabeling) to be significant, then classification of OPRP vs. CCP is the next step (Decision Tree). Here is where I get a bit confused. Questions 1 & 2 of the Pro Cert Decision Tree are easily understandable to me http://www.docstoc.c...0-decision-tree. The answer to Question 1 would be yes and the hazard to be controlled is Allergens due to mislabeling. The answer to Question 2 would be yes and the control measures would be graphics control via overlay checks & first piece approval. Questions 3 states Is the combination of measures specifically established for hazard control? If I answered yes to question 2 and listed my control measures, then how could No even be an option for question 3? Question 4 states Is continuous monitoring possible possible to verify the good functioning of these measures? By continuous, does it mean all of the time such as a metal detector? Would first piece approval and periodic press checks be considered continuous? Lastly if I do classify it as a OPRP, then what do I call it? Allergen Management , Overlay check/First Piece Approval or Simply OPRP #1?

 

 

Sorry for the lengthy questions! This FSSC 22000 stuff is making my head spin!

 

Dear skredsfan,

 

I’m not in packaging business but regarding PRPs I would have thought PAS223 (or its ISO equivalent) would be the primary  document to be initially implemented within yr hazard analysis. Are you aware of this publication ? As per the sequence within ISO 22000 standard, this would be prior to involvement with  OPRPs / CCPs.

  

Rgds / Charles.C

[skredsfan]

Dear skredsfan,

 

I’m not in packaging business but regarding PRPs I would have thought PAS223 (or its ISO equivalent) would be the primary  document to be initially implemented within yr hazard analysis. Are you aware of this publication ? As per the sequence within ISO 22000 standard, this would be prior to involvement with  OPRPs / CCPs.

  

 

Dear skredsfan,

 

I’m not in packaging business but regarding PRPs I would have thought PAS223 (or its ISO equivalent) would be the primary  document to be initially implemented within yr hazard analysis. Are you aware of this publication ? As per the sequence within ISO 22000 standard, this would be prior to involvement with  OPRPs / CCPs.

  

Rgds / Charles.C

 

 

Rgds / Charles.C

 

Sorry Charles. I should have been more specific! Yes, I'm aware of the PAS-223 Specification. Our Receiving, Warehousing & Transportation program (among others) was implemented prior to us obtaining the PAS 223 Specification. I conducted a gap analysis on our previously implemented programs to the PAS 223 Specification and adjusted the procedures accordingly. The part that is really confusing me is actually determining what an OPRP is? I've read that PRP's are the basic activities & conditions needed to maintain a hygienic environment. If this is true then why does PAS 223 (Prerequisite Programs for packaging manufacturers) contain programs such as purchasing & withdrawal?? Is an OPRP more of a specific activity or point such as CCP's? I'll go back to the allergen management example. Allergen mislabeling due to graphics control is a common hazard associated with printed packaging materials. This is controlled by our Allergen Management Program / PAS223. Where do OPRP's come into play here? As I assess hazards, virtually all of them are contolled by programs within the PAS 223 specification. I would love to see a documented hazard analysis that has examples of a hazards controlled by PRP's, OPRP's as well as CCP's. I had a good understanding of HACCP & the Codex principles before OPRP's were thrown into the mix!

[Charles.C]

Sorry Charles. I should have been more specific! Yes, I'm aware of the PAS-223 Specification. Our Receiving, Warehousing & Transportation program (among others) was implemented prior to us obtaining the PAS 223 Specification. I conducted a gap analysis on our previously implemented programs to the PAS 223 Specification and adjusted the procedures accordingly. The part that is really confusing me is actually determining what an OPRP is? I've read that PRP's are the basic activities & conditions needed to maintain a hygienic environment. If this is true then why does PAS 223 (Prerequisite Programs for packaging manufacturers) contain programs such as purchasing & withdrawal?? Is an OPRP more of a specific activity or point such as CCP's? I'll go back to the allergen management example. Allergen mislabeling due to graphics control is a common hazard associated with printed packaging materials. This is controlled by our Allergen Management Program / PAS223. Where do OPRP's come into play here? As I assess hazards, virtually all of them are contolled by programs within the PAS 223 specification. I would love to see a documented hazard analysis that has examples of a hazards controlled by PRP's, OPRP's as well as CCP's. I had a good understanding of HACCP & the Codex principles before OPRP's were thrown into the mix!

 

 

Dear skredsfan,

 

I would love to see a documented hazard analysis that has examples of a hazards controlled by PRP's, OPRP's as well as CCP's

 

I have to ask another 2 questions –

 

(1)  Are you aware of this thread which  was specifically intended to attempt an answer to the above question ? It is food-based but the conceptual logic is, probably (?), interchangeable if you replace PAS220 by PAS223 (I admit i haven't tried it out for packaging though .

 

http://www.ifsqn.com...o-22000-73-744/

 

 

(2) Have you read iso22004 ? This “clarifies”  OPRP although unfortunately only  by avoiding specificity (have to remember that ISO is a generic-oriented organisation, ie non-prescriptive).

 

Having said this, yr question  mirrors so many old / new threads here and perhaps defines an 8yr failure (and counting) in the iso22000 standard. Maybe the earlier / just released iso guidebooks address(ed) it but I have never seen them evaluated regarding this aspect so probably not ?. The inevitable consequence is that a spectrum of interpretations as to “what is OPRP” exist ranging from the most simple to the somewhat opposite in respect to "necessary associated documentation" and "conceptual" complexity. The range is illustrated in ( at least) 2 very (notoriously) long threads here which everybody is  probably bored with so no need to  restate again.

[Just as an example the most simple viewpoint here is exemplified by an oldish post from CharlesChew which is (paraphrasing, apologies to CC) something like – after the hazard analysis, a (relevant) control measure is either a CCP or OPRP. So if it fails the [codex] test for CCP, what can it be other than an OPRP ? This answer maybe ignores  the  subtleties of the intended conceptual theory ( semantics?) in  the 22000 / 22004 standards but seems to be auditorially accepted as  a valid operational solution. Maybe implicitly accepts that the auditorial community don’t really understand what OPRP means also .

Some more detailed solutions are in the 2 threads mentioned above and loads of other places, eg the French Literature (I previously posted one elaborate example in an older thread here)  or perhaps The IFSQN treatment within the commercial package offered here ( this [I understand from posts here] uses a “system” OPRP approach to avoid over-complexity in documentation aspects)]

 

Why does PAS 223 (Prerequisite Programs for packaging manufacturers) contain programs such as purchasing & withdrawal?

 

It is subjective of course (eg see a parallel thread here on SSOPs). See the early PRP literature for other examples. i also find some of the inclusions a little tenuous in respect to maintaining "good hygienic conditions".  I suppose a degree of expansion from GHP to GMP has quietly occurred.

 

This is controlled by our Allergen Management Program / PAS223. Where do OPRP's come into play here?

I guess this was rhetorical? .

 

To summarise, IMO, OPRP is a control measure defined in ISO22000 but  whose interpretation (eg 22004) has chronologically changed since its inception pre-2005. Currently, in the English Literature, it is operationally (ie for auditorial purposes) mostly determined by the methods given in various places in this forum, now particularly via additional use of the PAS-ISO (PRP) documents. Conceptually, it’s up for grabs .

 

Addendum - One perhaps important aspect but normally not discussed is -  

 

How many OPRPs should there be ?

 

This will vary depending on the conceptual approach.

 

In my link given above, there are none. Some people (auditors?) may find this unacceptable. Opinions are welcomed.

 

 Iso 22004 says the question is ultimately (operationally)  irrelevant since can tag (significant) control measures as CCP or OPRP as long as (safety) validation is available. So why bother if  critical limits (or validatable pseudo-equivalent values)  can be given ? Back to Square One. Sighhh.

 

Rgds / Charles.C

[Charles Chew]

Hi skredsfan,

 

Admittedly, its a gray area. IMO, we identify OPRP as a control measure that is essential and implemented in combination with other control measures where a violation does not implicate an immediate food safety risk. Monitoring must be capable and verifiable in determining effectiveness. 

 

There is also always a subsequent process step in eliminating an identified hazard or a capability to reduce the hazard to an acceptable level. Hope this helps. 

[Charles.C]

Hi skredsfan,

 

Admittedly, its a gray area. IMO, we identify OPRP as a control measure that is essential and implemented in combination with other control measures where a violation does not implicate an immediate food safety risk. Monitoring must be capable and verifiable in determining effectiveness. 

 

There is also always a subsequent process step in eliminating an identified hazard or a capability to reduce the hazard to an acceptable level. Hope this helps. 

 

Dear Charles Chew,

 

No argument that it’s a grey area.

And, based on yr current opinions, I would add highly debatable also.

 

Best Rgds / Charles

[Charles.C]

Dear skredsfan,

I would like to add a short addition which amplifies the methodology in the link given in post 4.

A popular word in the context of traditional haccp hazard analyses is “significant”. This is typically used to categorise those (risk-assessed) hazards which are concluded from a hazard analysis as essential (ie necessary) to be controlled with respect to consumer food safety and are outside the scope of system PRPs. The operational decision (eg via risk matrices) on what determines the “significant” is subjective, but that’s another story.

The fundamental 2003 Codex document on haccp has this text (sec.6) –

The haccp team should next conduct a hazard analysis to identify for the haccp plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of the food.

I concluded that the ("identified") hazards resulting (remaining) from the above procedure were those elsewhere typically described as “significant” using the above interpretation.

Iso22000 (7.4.3) has this text –

A hazard assessment shall be conducted to determine, for each food safety hazard identified (see 7.4.2) whether its elimination or reduction to acceptable levels is essential to the production of a safe food, and whether its control is needed to enable the defined acceptable levels to be met.

I concluded that the word “identified” is not being used in the same way in iso22000 as "identify" in codex2003.
I concluded that the hazards resulting (remaining) from the above procedure were those elsewhere typically described as “significant”, again using a similar interpretation as above.

Iso22000 subsequently requires (7.4.4) that these (in my interpretation) “significant” hazards are controlled at/by CCPs or OPRPs.

My selection of the "significant" hazards primarily focused on the "process" steps [ie as per the process flowchart] and is probably best oriented to a manufacturing situation. It assumed that the system PRPs satisfactorily control any other, non-process, potentially “significant” hazards, eg hygienic factors from the personnel, environment, equipment. Compliance to the latter is assured by the (on-going) System's Verification process and corrections / re-assessment made if the assumption found lacking.
Usage of PAS compilations for iso PRPs now seems auditorially well established. The PAS scope may overlap some aspects which often appear in a typical process flowchart, eg raw material reception, storage.

The above logic was the basis of the hazard analysis output into the CCP-OPRP portion of the (linked) example in post 4. If my interpretation of “significant” was incorrect, the example will similarly be inaccurate / incomplete.
.
Unfortunately, there are very few (English) published iso22000 examples to compare against. Yay Consultants .

Regarding some of yr other specific queries, I think it is considered critical to organize the PRPs (ie as per PAS) before implementing any Decision trees, etc, otherwise OPRP-CCP confusion is possible (a similar comment is often also applied to Codex Tree). For monitoring, some texts suggest that the categorization will self-determine itself when you consider validation, eg an inadequate frequency will negate validation. (Procert takes an easier viewpoint but which is inevitably arguable).

Sorry, not so short .

Rgds / Charles.C

Edited by Charles.C, 20 May 2013 - 06:43 AM.
clarified some of the text

[skredsfan]

Dear skredsfan,

I would like to add a short addition which amplifies the methodology in the link given in post 4.

A popular word in the context of traditional haccp hazard analyses is “significant”. This is typically used to categorise those (risk-assessed) hazards which are concluded from a hazard analysis as essential (ie necessary) to be controlled with respect to consumer food safety and are outside the scope of system PRPs. The operational decision (eg via risk matrices) on what determines the “significant” is subjective, but that’s another story.

The fundamental 2003 Codex document on haccp has this text (sec.6) –
I concluded that the ("identified") hazards resulting (remaining) from the above procedure were those elsewhere typically described as “significant” using the above interpretation.

Iso22000 (7.4.3) has this text –

I concluded that the word “identified” is not being used in the same way in iso22000 as "identify" in codex2003.
I concluded that the hazards resulting (remaining) from the above procedure were those elsewhere typically described as “significant”, again using a similar interpretation as above.

Iso22000 subsequently requires (7.4.4) that these (in my interpretation) “significant” hazards are controlled at/by CCPs or OPRPs.

My selection of the "significant" hazards primarily focused on the "process" steps [ie as per the process flowchart] and is probably best oriented to a manufacturing situation. It assumed that the system PRPs satisfactorily control any other, non-process, potentially “significant” hazards, eg hygienic factors from the personnel, environment, equipment. Compliance to the latter is assured by the (on-going) System's Verification process and corrections / re-assessment made if the assumption found lacking.
Usage of PAS compilations for iso PRPs now seems auditorially well established. The PAS scope may overlap some aspects which often appear in a typical process flowchart, eg raw material reception, storage.

The above logic was the basis of the hazard analysis output into the CCP-OPRP portion of the (linked) example in post 4. If my interpretation of “significant” was incorrect, the example will similarly be inaccurate / incomplete.
.
Unfortunately, there are very few (English) published iso22000 examples to compare against. Yay Consultants .

Regarding some of yr other specific queries, I think it is considered critical to organize the PRPs (ie as per PAS) before implementing any Decision trees, etc, otherwise OPRP-CCP confusion is possible (a similar comment is often also applied to Codex Tree). For monitoring, some texts suggest that the categorization will self-determine itself when you consider validation, eg an inadequate frequency will negate validation. (Procert takes an easier viewpoint but which is inevitably arguable).

Sorry, not so short .

Rgds / Charles.C

Thanks Charles! My cloudy interpretation of OPRP's is that they relate to significant hazards as well, although I've seen different interpretations. That's what I'm sticking with moving forward. The ISO 22000 explanation is very generic so I'd have to assume that most auditors regularly encounter different interpretations of this.

[skredsfan]

One last thing..If during the hazard analysis/risk assessment, none of the hazards are determined to be significant, I would say the need for OPRP's is non-existent. That is the case for CCP's so am I right in following the same logic for OPRP's? Agree or Disagree?

[Charles.C]

One last thing..If during the hazard analysis/risk assessment, none of the hazards are determined to be significant, I would say the need for OPRP's is non-existent. That is the case for CCP's so am I right in following the same logic for OPRP's? Agree or Disagree?

 

Dear skredsfan,

 

As per the approach I presented, yes, there would be no hazard analysis output into the final ccp-oprp (validation / categorisation) section.

 

I do recall an earlier thread here commenting that iso 22000 was typically less popular for packaging than other prescriptive standards but I think this was prior to issuance of PAS223 which may have changed things somewhat (?). Perhaps you like to be a pioneer ?

 

The hazard analysis result  obviously depends on the product / process / specific risk criteria implemented. Different viewpoints will give different results (see attachment below for an example if you wish to generate more OPRPs).  AFAIK, iso 22000 auditorially is extremely flexible in this respect, two key words are, I believe, "logical approach" ? However, I suspect most auditors will like to see at least one CCP and one OPRP so they can "tick a box(es)". Perhaps there is a requirement for a (cheap), routinely insertable, auditorially well-acepted OPRP control measure, such as the metal detector CCP in traditional HACCP .

 

Do remember that, AFAIK, none of the haccp packaging presentations here are for iso 22000 (?) although the commercial ISO 22000 system offered on this site does cover packaging manufacture. The few IT resources of published (traditional) haccp packaging plans seem able to occasionally find a few CCPs here and there. In a haccp philosophical context, you might find this old (2004) thread with some packaging orientation still interesting  -

 

http://www.ifsqn.com...ible/#entry1730

 

Maybe an (expanded) iso 22000 thread could be of value but, based on recent thread responses, seems that  few posters on this forum are using the ISO standard. Particularly not in Europe / USA maybe.

 

The haccp (ISO) processes used within the previous Excel document / thread are basically a conventional  haccp format + ISO extensions from other posters, eg Bennii, Modarres, + PAS220 (some explanatory text / data / links are given within the file).  The risk assessment as implemented will always be statistically subjective and can further vary according to user cut-off criteria.

 

You may find this alternative all-in-one iso 22000 tool previously posted here of interest to compare to present text.

 iso 22000 tool.xls   47.5KB   158 downloads

 

Rgds / Charles.C

Edited by Charles.C, 23 May 2013 - 06:15 AM.
more detail added

[skredsfan]

Dear skredsfan,

 

As per the approach I presented, yes, there would be no hazard analysis output into the final ccp-oprp (validation / categorisation) section.

 

I do recall an earlier thread here commenting that iso 22000 was typically less popular for packaging than other prescriptive standards but I think this was prior to issuance of PAS223 which may have changed things somewhat (?). Perhaps you like to be a pioneer ?

 

The hazard analysis result  obviously depends on the product / process / specific risk criteria implemented. Different viewpoints will give different results (see attachment below for an example if you wish to generate more OPRPs).  AFAIK, iso 22000 auditorially is extremely flexible in this respect, two key words are, I believe, "logical approach" ? However, I suspect most auditors will like to see at least one CCP and one OPRP so they can "tick a box(es)". Perhaps there is a requirement for a (cheap), routinely insertable, auditorially well-acepted OPRP control measure, such as the metal detector CCP in traditional HACCP .

 

Do remember that, AFAIK, none of the haccp packaging presentations here are for iso 22000 (?) although the commercial ISO 22000 system offered on this site does cover packaging manufacture. The few IT resources of published (traditional) haccp packaging plans seem able to occasionally find a few CCPs here and there. In a haccp philosophical context, you might find this old (2004) thread with some packaging orientation still interesting  -

 

http://www.ifsqn.com...ible/#entry1730

 

Maybe an (expanded) iso 22000 thread could be of value but, based on recent thread responses, seems that  few posters on this forum are using the ISO standard. Particularly not in Europe / USA maybe.

 

The haccp (ISO) processes used within the previous Excel document / thread are basically a conventional  haccp format + ISO extensions from other posters, eg Bennii, Modarres, + PAS220 (some explanatory text / data / links are given within the file).  The risk assessment as implemented will always be statistically subjective and can further vary according to user cut-off criteria.

 

You may find this alternative all-in-one iso 22000 tool previously posted here of interest to compare to present text.

iso 22000 tool.xls

 

Rgds / Charles.C

 

 

Thanks Charles! Great information! I'll certainly share my FSSC 22000 audit experience, on some of the packaging threads in a couple months.