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GMO

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Posted 08 July 2011 - 06:36 AM

Kex? Oh Kegs!

And I think most people say 'Geordie' Posted Image



Tony-C

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Posted 10 July 2011 - 02:26 PM

Kex? Oh Kegs!

And I think most people say 'Geordie' Posted Image


I don't think they are called that in Sunderland :smile:

Interesting stuff. Having managed 80 production staff on a shift I find the concept of "self-managing teams" a little scary.


Tony-C

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Posted 10 July 2011 - 04:49 PM

Sorry if I've been a bit feisty over the past few days. I think I get a bit fighty when I've had very little sleep for about 3 weeks. Got called into work yesterday (Sunday) as well when my TM is full time and I'm part time. Not impressed. Posted Image


Don't take it out on the forums - find another job :smile:

Also more fact rather than opinion would be good :smile:


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Posted 10 July 2011 - 05:17 PM

Negative:
Have CCTV


+ ve = OPRP ?


GMO

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Posted 10 July 2011 - 07:05 PM

Don't take it out on the forums - find another job :smile:

Also more fact rather than opinion would be good :smile:


Hmm. Thanks. And what do I do about my child? Get a new one?

Whether someone is a PRP or oPRP is a matter of opinion, no?


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Posted 11 July 2011 - 06:43 AM

Hi GMO,

I am inclined to agree with Charles.C where he quotes "

any validated control measure which meets the requirements of the first para.of sec.7.4.4 ( ie enters the 7.4.4 box in the decision tree in ISO 22004) via a valid “logical approach” must yield either a CCP or OPRP."

If the Handwashing activity turns out to be a significant control , in that particular Plant/Product/Process, in such a way that it is removing a 'significant' hazard (CCP); Or at the very least, playing a non-replaceable role of reducing the hazard loading to further controls in the process, then it does merit being treated as an oPRP.

Now, since it is an important control we do need to ensure that it is implemented comprehesively and effectively. If there is no easy solution to monitor this, then that does not allow us to reduce its categorization from being an oPRP.

Rather, we need to find the means to do so.;)

But, as you mention, if the handwashing control has not contributed to product safety (or in the absence of this control) you have not seen any incidents, you probably have other controls which make handwashing redundant... :smile:



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GMO

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Posted 11 July 2011 - 06:51 AM

Hi GMO,

I am inclined to agree with Charles.C where he quotes "

any validated control measure which meets the requirements of the first para.of sec.7.4.4 ( ie enters the 7.4.4 box in the decision tree in ISO 22004) via a valid “logical approach” must yield either a CCP or OPRP."

If the Handwashing activity turns out to be a significant control , in that particular Plant/Product/Process, in such a way that it is removing a 'significant' hazard (CCP); Or at the very least, playing a non-replaceable role of reducing the hazard loading to further controls in the process, then it does merit being treated as an oPRP.

Now, since it is an important control we do need to ensure that it is implemented comprehesively and effectively. If there is no easy solution to monitor this, then that does not allow us to reduce its categorization from being an oPRP.

Rather, we need to find the means to do so.;)

But, as you mention, if the handwashing control has not contributed to product safety (or in the absence of this control) you have not seen any incidents, you probably have other controls which make handwashing redundant... :smile:




You can apply the same logic to glass and hard plastic control, cleaning, pest control, maintenance etc, etc.

My concern is that an explosion in numbers for oPRPs has replaced the HACCP plans with 20 CCPs. Just because something is a 'normal' prerequisite, does not make it any less valuable.

Also oPRP have to be location specific do they not? Handwashing takes place all over the place and on several different kinds of occasions in my plant. If you just make handwashing on entry an oPRP, you then devalue the (more important IMO) handwashing occasions, like handwashing after the toilet, before handling foodstuffs, after handling the bin, after touching the floor, after cleaning, after touching your face, after blowing your nose, etc. etc. By introducing more rigorous controls at one point, you can then devalue the others. Just my opinion on how I would run my plant effectively but you're all welcome to yours (although I'm not apparently allowed to hold opinions nowadays... Posted Image)



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Charles.C

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Posted 11 July 2011 - 08:25 PM

Dear Sriram / GMO,

Of course, one (historically popular) solution to avoid an overwhelming of CCPs/OPRPs is simply to “regulate” the risk analysis. :smile:

In addition, some “interpretations” of the 22000 standard can be found which seem to hv conveniently “modified” the hazard analysis/OPRP/CCP chain thereby potentially reducing the workload although I am uncertain whether that was the original intention. Two examples are shown below, second one is a French modification of the Codex decision tree, quite neat IMO.( I hv approx. translated the details below the figure). Also note the sidebar “cleaning” comment in first one.

Attached File  Example 1.doc   104.5KB   66 downloads
Attached File  Example 2a.doc   154.5KB   52 downloads

With respect to handwashing, especially see qu3 of example 2 (effectively offers PRP or OPRP). One conceptual objection to this "zigzag" is that it diminishes one of the original prime motivations for introducing the OPRP concept. C'est la vie, maybe. :smile:

Rgds / Charles.C


Kind Regards,

 

Charles.C


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Posted 12 July 2011 - 03:22 AM

If you just make handwashing on entry an oPRP, you then devalue the (more important IMO) handwashing occasions, like handwashing after the toilet, before handling foodstuffs, after handling the bin, after touching the floor, after cleaning, after touching your face, after blowing your nose, etc. etc. By introducing more rigorous controls at one point, you can then devalue the others.



Just my opinion on how I would run my plant effectively but you're all welcome to yours (although I'm not apparently allowed to hold opinions nowadays... Posted Image)



Dear GMo,

Hear your logic,

Where I am coming from is, ..If handwashing is a critical control in one part of your plant, I would treat it to te level the standard required. Not sure, if we should consider other instances of the control, in less critical roles to influence, the risk analysis process. :smile:

p.s. re opinions, i am luckier as i am still allowed to hold some opinions...as long as they are my wife's...:biggrin:


Charles.C

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Posted 13 July 2011 - 03:31 AM

Dear All,

Just in case some readers of this thread hv not quite been driven to sleep (yet), I would like to add a little clarification to my previous post.

The original question related to whether the traditional PRP of handwashing is (or could be) an OPRP.

For traditional haccp, I noticed this, IMO, very neatly presented comment on the use of PRPs vis-à-vis CCPs which may “explain” the “zigzag” as noted in my previous post –

If a significant hazard that is reasonably likely to occur is identified in the Hazard Analysis, it must be controlled somewhere in the food processing and handling system. Due to the rigorous HACCP requirements for setting appropriate CLs and monitoring, there are certain hazards in certain situations which are more appropriately controlled by prerequisite programs. This has been the subject of some debate and has led to two approaches in dealing with such hazards. While they differ philosophically, the end result of these two approaches is similar.
• Approach A: This approach is used by some HACCP auditors in the regulatory and private sector. It dictates that a hazard deemed significant in the Hazard Analysis must be controlled at a CCP. It then follows that a hazard which is, in fact, managed by a prerequisite program is considered not "reasonably likely to occur" because of the prerequisite program.
• Approach B: In this approach, prevention and control of identified significant hazards can either be at a CCP or through rigorously applied prerequisite programs.

No set number of CCPs is required in HACCP. Rather, CCPs must be determined for each specific food processing and handling system and be appropriate to that specific system. Having too many CCPs could unnecessarily encumber and burden the implementation of the HACCP plan. Conversely, having too few CCPs could jeopardize food safety.
CCPs that involve subjective control measures (e.g., visual parameters, observations) rather than objective control measures (e.g., temperature, time) are difficult to implement and require more creativity with regard to CLs and monitoring procedures. For this reason, many HACCP plans now have fewer CCPs than they did historically, with the emphasis instead being placed on sound, well-conceived, and well-implemented Prerequisite Programs.

( http://edis.ifas.ufl.edu/fs140 )

By the strict text of the original ISO 22000 standard, it seems to me that PRPs utilised as above should simply be re-classified as OPRPs but some users are seemingly “interpreting” differently, presumably with auditorial acceptance. Similarly, the logic path in the decision tree given in my previous post seems flawed to me but I daresay that from the ISO point of view, as long as the proposed methodology is properly presented / validated as producing the desired safety result, all is good.

Whether handwashing is a “significant hazard” can be estimated by something like –

Activity = Handling Food
Hazard = Presence / Transfer of pathogenic bacteria on hands to food, etc (to consumer if end product)
Risk = Likelihood of Occurrence (LO) x Severity of Consequences (S)
Hopefully LO (ie handwashing fails) is usually low, whereas S could theoretically vary from low to high depending on the situation (eg non-RTE to RTE product / legislatory).
Accordingly, Risk = (LxL) to (LxH) = (non-significant) – (??)
Obviously if LO is considered > low, the risk is likely to be considered “significant” >> OPRP (by definition or perhaps equally by lack of a readily monitored critical limit )

Rgds / Charles.C

Kind Regards,

 

Charles.C


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Posted 13 July 2011 - 06:14 AM

Whether handwashing is a “significant hazard” can be estimated by something like –

Activity = Handling Food
Hazard = Presence / Transfer of pathogenic bacteria on hands to food, etc (to consumer if end product)
Risk = Likelihood of Occurrence (LO) x Severity of Consequences (S)
Hopefully LO (ie handwashing fails) is usually low, whereas S could theoretically vary from low to high depending on the situation (eg non-RTE to RTE product / legislatory).
Accordingly, Risk = (LxL) to (LxH) = (non-significant) – (??)
Obviously if LO is considered > low, the risk is likely to be considered “significant” >> OPRP (by definition or perhaps equally by lack of a readily monitored critical limit )

Rgds / Charles.C


Hi Charles,

The link and the info is very good for CCP !:smile:

Could you kindly clarify for me, the example you have used, because I was looking at it as follows:

1. First handwashing station at entry to Plant OR in the Toilets etc...


Activity = Handling Food
Hazard = Presence / Transfer of pathogenic bacteria on hands to food, etc (to consumer if end product)


Risk = Likelihood of Occurrence (LO) x Severity of Consequences (S)

LO = probably high as staff member coming in to plant making contact with many surfaces
S = Potential to be high , as pathogenic bacteria could cause fatality.

Control at this point = Handwashing (will reduce the micro load on the hand surface to acceptable levels)

But going through the Decision tree, I would see that there are other controls downstream ( e.g. cooking at high temperatures, more handwashing station before actually getting in contact with product).

As this is not the final control and we have controls of better if not similar effectiveness, i would normally think of this as GMP, PRP.

2. Now assuming, that there is a second handwashing station at entry to a part of the plant where salads are being handled by hand...Here,


Activity = Handling Food
Hazard = Presence / Transfer of pathogenic bacteria on hands to food, etc (to consumer if end product)


Risk = Likelihood of Occurrence (LO) x Severity of Consequences (S)

LO = probably high as staff member may have come in contact with non sterile surface on his way, o
S = Potential to be high , as pathogenic bacteria could cause fatality.

Control at this point = Handwashing (will reduce the micro load on the hand surface to acceptable levels)

In this place, I possibly might find that we have some controls such as keeping the salad cold in the supply chain to prevent micro growth, maybe even some sort of preservatives; but, I would feel that the Handwashing control in this stage is playing a important role where it is reducing the 'Hazard' , i.e. microorganisms transmitted by hand , to a level where the prservatives/ Cold chain are effective.

Hence it becomes more than a good practice but almost an prerequisite for the safety of the salad. As this is specific to the safety of that particular Salad/operation , I would elevate it to an operational Prerequisite.

----

In my team, we are still struggling to get an understanding of the whole concept and most auditors though helpful, seem to be in a similar boat! So, apologies to all for acting like a dog with a bone..:smile: . But would really appreciate any help towards understanding the concept so that I can confidently pass the same to our staff on the shop floor..


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GMO

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Posted 13 July 2011 - 06:14 AM

Solution -> don't use ISO22000 and get rid of oPRPs altogether!

Seriously, I think the 'aim' was to reduce the number of CCPs where there were several 'grey area' ones in your plant, so, for example in a bakery, sieving and baking are obvious oPRPs. The thing is some of the points currently being assigned as oPRPs were perfectly well controlled as PRPs for years without incident. I wonder why we should change?

Also one thing I've just thought of; handwashing is not a process step on any HACCP flow diagram I've ever done as the process steps follow the product. It's a control to help prevent things like staph aureus contamination at points where the food is handled. My understanding of oPRPs is they should be a defined point in the process and handwashing just doesn't tick that box for me.



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Posted 13 July 2011 - 06:56 AM

Solution -> don't use ISO22000 and get rid of oPRPs altogether!

The thing is some of the points currently being assigned as oPRPs were perfectly well controlled as PRPs for years without incident. I wonder why we should change?




:clap: ...

Sympathize totally, GMO,

But help!! We have a mandate from our franchisers to hold ISO22000, so are stuck with it ( well at least....till they tell us to get FSSC :smile: )


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Posted 13 July 2011 - 12:19 PM

Dear Sriram,

Thks yr comments.

The nature of the OPRPs as mentioned in published documents can vary widely. For some examples I suggest the original ISO info. document from Didier Blanc (which I expect you are well-familiar with) which itemises/illustrates some general sources.

I presume this is why operationally (and logically :smile: ), people hv found it easier to focus on (a) deciding whether a hazard represents a significant risk then (b) deciding whether a viable (ie validatable) control measure (CM) is a CCP or not, the latter result then being concluded as corresponding to an OPRP by default.

Unfortunately, the question still arises – which and how many criteria from the standard’s lengthy list are necessary / sufficient to define a CM characterising a CCP ? Only the auditors know the answer to that one. No minimum perhaps? The published lowest I hv seen is 2, ie the Codex tree, and two risk matrix types. Unfortunately many trees are primarily designed to work with production steps so hv some difficulties with peripheral support activities like cleaning etc (not to mention dead-ends in the trees). The layout I attached in previous post illustrates an attempt to present a combined production/surroundings approach but not with total success IMO.

Could you kindly clarify for me, the example you have used, because I was looking at it as follows:


Actually I was simply generalising.

Hence it becomes more than a good practice but almost an prerequisite for the safety of the salad. As this is specific to the safety of that particular Salad/operation , I would elevate it to an operational Prerequisite.


(text amended, misread 1st time :oops: )
Yes, I understand yr point, I think this is analogous to the concept of "Hurdle" control (ie effectively a combined CM) as seen in fresh-produce production. (compare the 1-stage cleaning/listeria comment in the first example of my previous post where the operator is acknowledging that LO is not low)
The snag is particularly as GMO is commenting - if you apply this logic indiscriminately, a horde of oprps will result, albeit maybe lumped together. Nonetheless, it's yr haccp system. And (will be) yr validation ! :smile:
(You can see from the literature that organisations like US-FDA hv refrained from issuing formal haccp plans for vegetables due to the potential complications where a pathogen elimination stage is normally not possible)(other groups hv used multiple oprps).

Frankly, it seems pragmatic to me to (à la GMO) simply ensure / verify that all applied PRPs work satisfactorily until (auditor) proven otherwise. This then mainly leaves the production steps plus possible items like environment temps. I suspect this is what most producers do. :biggrin: (items like the Listeria scenario referred above might be a possible exception if "monitoring" data has inescapable implications)

@GMO, I think one concept of oprps was to enable emphasising/directing existing prp procedure to specific non-production-step hazards such as the listeria example above, ie not necessarily location based although it could be. Another one i saw was failure of a high/low zoning partition with respect to xcontamination. These are typically not amenable to frequent/quantitative monitoring so critical limits are problematic, > enter oprp's non-CL-requirement. ;)
(Some typical CM / source options are summarised in ISO 22004, 7.4.4, first paragraph.)
It is less obvious whether this feature was added so as to further boost the prime concept of re-focussing the haccp treatment towards the control measures. At one stage close to finalising the standard, the idea of oprps was much more oriented towards certain specified, "operational"- traditional prps while "non-operational"-traditional prps became a second group, eg infrastructure ("think" non-moving :rolleyes: ). Not surprisingly this partitioning caused considerable +/- debate. The current setup is probably a "compromise".(worst of both worlds :smile: )

Rgds / Charles.C

PS added - One more practical comment. IMEX, it is customary to not only maintain handwash/glove sanitising dip stations at main entrances to production areas but also to install them at key positions (eg near substantial handling stages) within the production area also. This minimises the possible contamination from random contacts.

Kind Regards,

 

Charles.C


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Posted 14 July 2011 - 02:18 AM

Hi Charles, GMO,

Thanks for your clarifications.

i have to confess, I do not use any other system (other than 1SO22000) as it is a franchiser requirement and do not have the benefit of seeing different tools in play.

I enjoyed your detailed explanations and pointers, and will try to read the Didier Blanc document!

Cheers,

Sriram



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Posted 14 July 2011 - 04:05 PM

Dear SriramB,

I have attached the Didier Blanc reference below. I also enclose a section of the pre-final version of the 22000 standard below for info., can compare with the final format.

Just out of curiosity, did you use the standard Codex Decision Tree in yr own plan to categorise the CCPs / OPRPs or some other procedure ? :smile:

7.2 Prerequisite program(s)
7.2.1 General requirements
The organization shall establish, implement and maintain PRP(s) to assist in the following:
a) controlling the likelihood of introducing food safety hazards to the product through the work environment;
b) controlling biological, chemical and physical contamination of the product(s) including cross contamination between products;
c) controlling food safety hazard(s) levels in the product and product processing environment.
The PRP(s) shall be appropriate to the organizational needs with regard to food safety, be approved by the food safety team, and their relevance and appropriateness for controlling food safety hazards shall be included in the hazard analysis (7.4).
The PRPs consist of two types:
a) infrastructure and maintenance programs (see 7.2.2);
b) operational PRP(s) (see 7.2.3).
When selecting and designing PRP(s), the organization shall consider and utilize appropriate existing information (e.g. regulations, customer requirements, guidelines, Codex principles and codes of practices, national, international or industrial standards) that is relevant for the design of the PRP(s).
NOTE References to documents that include examples of PRPs are provided in Annex C.

7.2.2 Infrastructure and maintenance programs
The organization shall establish and maintain the infrastructure needed to achieve conformity to the food safety needs including as applicable
a) lay-out, design and construction of buildings and facilities, including workspace, employee facilities, and associated utilities,
b) supplies of air, water, energy and other utilities,
c) equipment including its preventative maintenance, sanitary design and accessibility for maintenance and cleaning for each unit, and
d) supporting services including waste and sewage disposal.
Verification of the fulfilment of these requirements shall be planned (see 7.8). The infrastructure shall be modified as necessary, taking into account the results of the hazard analysis (7.4) and the capability of the selected control measures to control the identified food safety hazards (see 7.5 and 7.6). Such modifications shall be recorded.

7.2.3 Operational prerequisite programs
The organization shall establish, document, maintain and update operational PRP(s). The stringency of the control measures constituting or included in these programs shall enable the control of identified food safety hazards for as far as these are not controlled by the HACCP plan.
NOTE Clauses 7.4.4 and 7.5 determine the stringency of control measures inherent in the operational PRP(s).
The operational PRP(s) shall be appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled. They shall be implemented across the entire production system, either as programs applying in general or as programs applying for a particular product or operational line. When establishing these programs consideration shall be given but not be limited to
a) personnel hygiene,
b) cleaning and sanitizing,
c) pest control,
d) measures for the prevention of cross contamination,
e) packaging procedures, and
f) management of purchased materials (e.g. raw materials, ingredients, chemicals), supplies (water, air, steam, ice, etc.), disposals (e.g. waste and sewage), and handling of products (e.g. storage and transportation).
The operational PRP(s) shall be documented in instructions and procedures or plans, which specify how the programs are to be operated and shall include the specifications determined in accordance with 7.5.
Control measures managed through operational PRP(s) shall be validated (see 7.4.4 and 8.4).
The operational PRP(s) shall be amended in accordance with 7.7.


http://www.procert.c...lang=en&chap=17

Attached File  ISO 22k 22000 didier blanc - some concepts and terminology.pdf   381.73KB   56 downloads

Rgds / Charles.C

Kind Regards,

 

Charles.C


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Posted 14 July 2011 - 10:12 PM

Dear SriramB,
Just out of curiosity, did you use the standard Codex Decision Tree in yr own plan to categorise the CCPs / OPRPs or some other procedure ? :smile:




Rgds / Charles.C


Many thanks for the texts Charles, This will be my weekend reading :smile: ( My Batman & Hush comic will need to wait...)

We started with the Codex tree, but soon decided to work out some additional steps:

1. We identify the hazards at each step
2. we try to not all the controls - at that step, prior and after
3. we use codex to see if the control at the step is CCP
4. If not we make a 'evaluation' if the control by itself or in conjunction with any other is essential to reduce the hazard. If so, we quickly run through the 7.4 sub clasues a- f to see if it ticks against those. Then we call it oPRP and in the records , we mention the answers to the Dec tree questions as well as the clauses applicable.

5. I made a Dec tree some time back which just forced us to keep looping till all the Codex questions as well as the oPRPR sub clauses '7.4.4a to g' are answered, but lately we seem to use a card with the clauses as an aide memoir, when we brainstorm.


Luckily most auditors are still looking out only for the documented answers to the Codex Tree question - re CCP or Not.; so for the oPRP I normally have to explain the thought process and the alignment to Clause 7.4.4 a-g. At this stage they seem satisfied..:smile:

Cheers,


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Posted 15 July 2011 - 11:28 PM

Dear SrisamB,

Many thks for the info.

Somehow, i get the feeling that you hv a lot of OPRPs :biggrin:

Regarding the previous discussion on "handwashing" it should be interesting to decide what is an "acceptable level" for safety purposes since i hv never seen any of the multitude of swab limits based on APCs etc, correlated to "pathogens".

Rgds / Charles.C


Kind Regards,

 

Charles.C


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Posted 17 July 2011 - 05:03 AM

This is a case where ISO 22000 requirements emphasise the need for control when significant hazards are identified but don’t fit into the HACCP plan. This may be where a control measure controls a significant hazard but is limited in the ability for monitoring for example delivering results within an adequate timeframe. In such situations it may have been that the hazards were marked as controlled by prerequisites and did not receive the attention they deserved. Whereas following ISO 22000 these hazards tend to be categorized as Operational PRPs and there is a requirement to demonstrate documented controls:
- hazard(s) to be controlled
- control measure(s)
- monitoring procedures
- corrections and corrective actions to be taken
- responsibilities and authorities
- record(s) of monitoring.

This is in line with Charles on Approach B:” In this approach, prevention and control of identified significant hazards can either be at a CCP or through rigorously applied prerequisite programs.”

Clearly when vulnerable RTE foods are being handled the Significance of the hazard is High = Likelihood of Occurrence x Severity of Consequences

Now assuming, that there is a handwashing station at entry to a part of the plant where salads are being handled by hand it becomes more than a good practice ………… as this is specific to the safety of that particular operation, I would elevate it to an operational prerequisite.”

I would agree in combination with other control measures such as:
- hourly hand sanitation/washing
- cleaning/sanitation
- autobarrier/handwash entry

So then monitoring procedures also need to be considered such as:
- CCTV
- Supervision
- Hand swabbing
- Hand plates
- Monitor the volume of alcohol-based hand rub used
- Monitor the volume of hand soap used

Plus strategies for successful promotion of hand hygiene:
- Education http://uvblacklights...aining-kit.html
- Routine observation and feedback
- Engineering control - Make hand hygiene possible, easy, and convenient
- Engineering control - Make alcohol-based hand rub available
- Reminders in the workplace
- Administrative sanction/rewarding
- Avoid overcrowding, understaffing, and excessive workload

Ref “Handwashing is not a process step on any HACCP flow diagram I've ever done as the process steps follow the product. It's a control to help prevent things like staph aureus contamination at points where the food is handled. My understanding of oPRPs is they should be a defined point in the process and handwashing just doesn't tick that box for me.”

From my bible of HACCP ‘Codex’ definitions:
Step – A point, procedure, operation or stage in the food chain……….



Charles.C

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Posted 17 July 2011 - 08:41 AM

Dear Tony-C,

Nice to break the triolog. :thumbup:

I believe yr detailed analysis of the RTE-handwashing situation should capably discourage anyone from making it an OPRP. :clap:
Personally, it seems to me that for some cases (eg like the current one) it might be simply easier to, quietly, expand one's general interpretation of the PRP so as to allow for any retrospective findings/misgivings (analogous, I think :rolleyes: , to what has historically occurred with allergens in traditional HACCP). (This would equate to an "update" of a significant hazard perhaps ?)

Perhaps, yet again, one should mention the potential of gloves. :smile:

My understanding of oPRPs is they should be a defined point in the process and handwashing just doesn't tick that box for me.”


If generally applied, I do agree that this would certainly make life a lot easier.

Unfortunately, as per Tony's comments, I fear the situation is simply not so clear-cut. I hv attached a recent French review (2008) of the ISO 22000 standard, which particularly focuses on the interpretation of OPRP / distinguishing from CCP. (I accept that other localities may not agree however the French/"French-speaking" contribution in “shaping” the standard does seem to be significant)(but relative usage I don’t know).

Anyway, the authors consider the conceptual linkage of OPRP to PRP through the definition 3.9 as "meaningfully" broad, compared to the “step” concept of the CCP (though this was less narrow in some older usages). In respect to distinguishing between CCP and OPRP, the (French) text goes something like –

The challenge is to clearly distinguish control measures that are stages in the development of flow of product (filter, magnet, adding additives, heat treatment ...) from those that are not directly integrated into the manufacturing process, but related to it.


There is a lot more detail before and after. A look at the decision tree they propose/include illustrates their (logic) opinion. (I hv to say that I am not totally enthusiastic over some of their other comments but that is a different matter :smile: ).

Generally, it seems to me that the OPRP concept is currently being interpreted in 2 ways depending on the particular situation – (1) as an inevitable consequence of the text in 7.4.4 / “clarified” in ISO 22004 (as yr post, tends to be production step focussed comments [though see 7.4.2.2b]), (2) a more 3.9- definition oriented scenario where the attraction IMO is OPRPs amazing flexibility, for example as used in some of the “minimalised” risk scenarios eg vegetables or the no “proper” critical limit situations (various).
(IMHO, the standard’s OPRP definition is awful, but I am sure it’s ambiguity was totally intentional).

Maybe a compromise result should be the appearance of more “globalised” process charts / an abundance of “2-way-arrows”. I think in truth the original HACCP was supposed to look at everything but ...... :biggrin:

I can understand why people who implement the standard prefer to (rightly or wrongly) pragmatise . This seemingly well-concurs with auditor expectations (path of least resistance?). I guess auditors rarely encounter the novelty of non-production-step oriented significant hazards. But perhaps they should ? ;)

Attached File  control programs.pdf   274.85KB   62 downloads
Attached File  translation of non-standard part of decision tree.doc   24KB   51 downloads

Rgds / Charles.C

Kind Regards,

 

Charles.C


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Posted 18 July 2011 - 06:22 AM

This is a case where ISO 22000 requirements emphasise the need for control when significant hazards are identified but don’t fit into the HACCP plan. This may be where a control measure controls a significant hazard but is limited in the ability for monitoring for example delivering results within an adequate timeframe. In such situations it may have been that the hazards were marked as controlled by prerequisites and did not receive the attention they deserved. Whereas following ISO 22000 these hazards tend to be categorized as Operational PRPs and there is a requirement to demonstrate documented controls:
- hazard(s) to be controlled
- control measure(s)
- monitoring procedures
- corrections and corrective actions to be taken
- responsibilities and authorities
- record(s) of monitoring.

This is in line with Charles on Approach B:” In this approach, prevention and control of identified significant hazards can either be at a CCP or through rigorously applied prerequisite programs.”

Clearly when vulnerable RTE foods are being handled the Significance of the hazard is High = Likelihood of Occurrence x Severity of Consequences

Now assuming, that there is a handwashing station at entry to a part of the plant where salads are being handled by hand it becomes more than a good practice ………… as this is specific to the safety of that particular operation, I would elevate it to an operational prerequisite.”

I would agree in combination with other control measures such as:
- hourly hand sanitation/washing
- cleaning/sanitation
- autobarrier/handwash entry

So then monitoring procedures also need to be considered such as:
- CCTV
- Supervision
- Hand swabbing
- Hand plates
- Monitor the volume of alcohol-based hand rub used
- Monitor the volume of hand soap used

Plus strategies for successful promotion of hand hygiene:
- Education http://uvblacklights...aining-kit.html
- Routine observation and feedback
- Engineering control - Make hand hygiene possible, easy, and convenient
- Engineering control - Make alcohol-based hand rub available
- Reminders in the workplace
- Administrative sanction/rewarding
- Avoid overcrowding, understaffing, and excessive workload

Ref “Handwashing is not a process step on any HACCP flow diagram I've ever done as the process steps follow the product. It's a control to help prevent things like staph aureus contamination at points where the food is handled. My understanding of oPRPs is they should be a defined point in the process and handwashing just doesn't tick that box for me.”

From my bible of HACCP ‘Codex’ definitions:
Step – A point, procedure, operation or stage in the food chain……….



Good ideas but I would argue that all of your monitoring suggestions are, in fact, verification, unless CCTV is used for 100% of staff handwashing occasions of course? Or you've invented an instant micro technique which is 100% accurate (ie not ATP) and is used on everyone? Or handwash and santiser volume is checked after every wash? The only method I can see where you can 'monitor' this like a prerequisite is those funky handwashing turnstyle things where it only admits you once you have washed your hands but even then it doesn't ensure that handwashing takes place at other points.

How did we manage before oPRPs existed eh? I've worked in two ready meals and two sandwich sites. None of them had handwashing as an oPRP.




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Posted 18 July 2011 - 09:40 PM

Dear Tony-C,

Nice to break the triolog. :thumbup:

I believe yr detailed analysis of the RTE-handwashing situation should capably discourage anyone from making it an OPRP. :clap:

[
Rgds / Charles.C


Hi Charles, Tony, GMO,

Just to clarify, the detailed RTE would lead to the control 'handwashing' being categorized as what ? CCP/oPRP/PRP ?:smile:

Unfortunately, this is a hypothetical situation for me, so cannot draw from real life experience !

I know that have been chewing this bone for long, so feel free to tell me to move on :smile: ...

Regards,


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Posted 19 July 2011 - 07:44 AM

Dear SriramB,

No problem to discuss, it’s a generally interesting topic (to me anyway :smile: ).

For myself, development of yr query first requires a realistic hypothesis/justification as to why hand-cleanliness might be a significant hazard?. IMO, the existence of a high risk product does not automatically generate a significant risk although I accept that others may not agree or a specific situation may influence the assessment (previously NASA purchasing for one example perhaps :smile: ). (Or perhaps you simply consider that Low(LO) x H > sig.hazard. It is a possibility, and one which should provide a lot more OPRPs/CCPs also ;) )

Rgds / Charles.C

PS assuming that a significant risk is concluded, one criterion for determining the standards (self-imposed) choice between ccp/oprp might be based on the ability to define a validatable critical limit. A more conceptual approach is illustrated in my previous post but whatever route / conclusion is utilised, validation will be required (before the categorisation as per the text/decision tree in ISO 22004.)


Kind Regards,

 

Charles.C


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Posted 21 July 2011 - 06:11 AM

Dear SriramB,

No problem to discuss, it’s a generally interesting topic (to me anyway :smile: ).

For myself, development of yr query first requires a realistic hypothesis/justification as to why hand-cleanliness might be a significant hazard?.

PS assuming that a significant risk is concluded, one criterion for determining the standards (self-imposed) choice between ccp/oprp might be based on the ability to define a validatable critical limit.



Hi Charles,

sorry but I am getting lesser occasions to log in and hence the delay.

I agree that every case will merit different conclusion, but am putting forward an hypothetical situation:

--------------------------------
Assume we start of with a pie making plant, where end product is well cooked etc...
Now, we want to add a new "salad' packing line, on a small scale. Also assume we plan to pack salad leaves manually by hand.
The QA manager believes Gloves give a false sense of cleanliness and prefers to use plain , cleaned hands.

Now, the HACCP team sits to review the line, and the following observations are made:

1. there are known occurences from the market of other brand Salads being withdrawn due to E coli contamination.
2. Ecoli could cause severe and wide spread food safety issues.

Now the salad line is climate controlled and positive air pressure etc. The salad is washed and treated before it comes to packing station. routine tests find that the leaves are clean at this point of the process. these leaves are now packed manually into bags. the bags will be kept cool etc till consumer gets them.

Our only worry is that the manual packing must not introduce any pathogens to the product.

3. Our salad line has a handwashing station at entry and also many other stations e.g. in the cafeteria, toilets etc..
4. The path a employee takes from the Toilet to the salad line is such that, he may touch railings, door handles etc.

We do some tests and find that the railings and door handles, have micro contamination.

5. Operations manager says it is not feasible for him to ensure all possible contact surfaces are kept clean especially in walkways etc..

6. The HACCP team determines that the final handwash station on the actual salad line probably is most suitable for getting the hands clean.

7. The HACCP team also reflects that there are similar final stations in the Pie making line, but the fact that pies are cooked etc, reduces the risk of the living contaminant from passing on to final customer.

8. On the same token, the salad line is susceptible, as the contaminant can pass on to the consumer.

Process Map:

9. now the process flow shows the salad leaves packing as part of the steps, but the handwashing is not indicated as a 'equipment', 'step/ or 'process' which the product ' i.e.' 'Salad' passes through.
10. Indeed , handwashing seems to be included generally under the Hygiene PRP.

11. But the HACCP team decides that the handwashing activity has a greater role to play, in the "Salad" line. it is preventing the fresh contaminantion from Hands , but not used for removal/ mitigation of any contamination already present in the 'Salad'.

12. If this Hand washing was compromised , consumers would very likely fall sick based on other industry experience.
(hence High Probability and also High severity)

13. So, some one says lets make it a critical step... OK, but in theory it is still not part of the 'Product' flow chart. It is a PRP.
14. So, someone else says, lets make this a crucial PRP or an oPRP.

--------------------
Quote"
assuming that a significant risk is concluded, one criterion for determining the standards (self-imposed) choice between ccp/oprp might be based on the ability to define a validatable critical limit. "

Here the critical limit for hazard ( I am taking pathogenic bacteri as the hazard)= 0 numbers pathogenic bacteria on hand

So Operational limit to ensure adequacy of handwashing, hypothetically based on studies, could be (i.e. Operational Control Points) :

1. rinsing hands under water- set time ( indicated by light)
2. Uisng treated soap dispensed in preset quantity ( dosed with flourescent indicator)
3. Scrubbing till Light indicator goes off
4. Rinsing - set time

maybe even,

5. inspecting hand under UV blacklight ( no flouresecence = cleaned hands)
The above procedure could be validated by trials and micro tests.
---------------------------------

In the above case, I would find Handwashing as critical on the specific Salad line compared to other areas.

I would get a validated procedure as it merits being proven effective and measurable.

I would find CCP not the right word as it is not part of product flow.

Maybe oPRP suits as it is part of a PRP but more improtant in context of this line.
------------------

Whew.............. Sorry for inflicting the above on you :smile: , but I am still getting interested in this topic!

Like i said I am not in this industry, so please forgive if I have imagined a completely unfeasible way to produce Salads!:smile:

Regards,


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Posted 21 July 2011 - 10:18 AM

Personally IME in the above scenario if you have raw meat on site a certain very large UK retailer would not accept a salad packing plant as well even in a segregated area because of these risks.

Also you should consider the hygiene of hand contact points for your existing products in your high care area and also consider the risks the salad would bring to the cooked pies (you'd be going from high risk to high care) as I would suggest the E Coli outbreaks in salad are more to do with poor controls of irrigation (and hence E coli being intrinsic to the leaf and not wash off-able) rather than poor hand hygiene of the operators.





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