15 replies to this topic

[GMO]

I'm trying to do a crash course on ISO because I have an interview in which it will feature heavily but due to all you lovely people, I'm learning more every day and have read a lot about oPRPs.

I've done a lot of HACCP in my time and I have to admit to being a bit of a purist. I hate it when I come across CPs or QPs in a HACCP plan. As far as I'm concerned, the point of HACCP is to keep it simple and focus on the points in your process that are really critical. If you bring in a "point" which isn't classed as "critical", it makes me wonder why it's there?

In a lot of ways it goes against all the HACCP training I've done, it's very different from BRC and it makes me wonder if it works. Sorry to be insulting to the lovely operators where I've worked but many don't have English as a first language and several switch off their brains as soon as they come through the door. I'm all about keeping it simple! (I've just reduced a HACCP from 26 CCPs and 20 CPs to 10 CCPs and have challenged 3 more of them.)

[Penard]

Hello GMO,

A lot of opinions about oPRP have already been given - on IFSQN too; potentially great clue, unfortunately not clear enough to be applied and implemented. From the time being despite of many french and english conversations, international and national legislations, auditors and factories don't agree and have big difficulties to determine clearly oPRP. Perhaps our old Haccp is 'easier' to understand and to apply. I wait for the end of the year to try to know more about it...

Regards,

Emmanuel.

[GMO]

I didn't realise how contentious they are! I think anything which makes HACCP harder to communicate is a bad thing.

[Madam A. D-tor]

Dear GMO and Emmanuel,


Don't think to hard of OPRPs.

Every process with an implemented food safety management system or a quality management system is already operating OPRPs.
In my opinion, OPRPs are those issues that you are already controlling, monitoring and recording, but is not actually a CCP. You might control them for quality reasons, food safety reasons, operational reasons or efficiency reasons. Even the BRC standard includes some OPRPs: all those times that BRC wants us to monitor and record things.

I agree with you, GMO, that some companies name everything CCPs. But most of the time, they do not really understand HACCP. For example the companies that (for food safety reasons) want the doors to be closed and has a CCP on closed doors. Or hand washing, or even a CCP on using the right procedures.

Lets see what OPRPs are in BRC Food (issue 4):

3.11.6
Refrigerated transport incorporates temperature data logging devices which can be interrogated to confirm time/temperature conditions or a system is in place to regularly validate the correct operation of refrigerated equipment.

Comment: temperature during transport is obligatory, but is certainly not always a CCP. So it is then an OPRP?

4.3.2
Where a metal or foreign body detector is required, the company has established and applied the best practice, critical limits for detection, having due regard to the nature of the food, the location of the detector and any other factors influencing the sensitivity of the detector.

Comment: metal or foreign body detector is mostly a CCP in the endproduct lines. How about the detectors in the production lines? Situated before packing, filling or even at the receiving department? These detectors are mostly controlled and monitored exactly like the detectors in the end product lines. These detectors might be a OPRP, if there is also a detector in the end product line. Real case: meat ball production plant. They have a metal detector before the "WOLF", to prevent damage on the machines and a metal detector at the end of the packing lines.

4.4.4
Where packaging materials pose a product safety risk, special handling procedures are in place to prevent product contamination or spoilage. Records are maintained of failures and corrective actions taken.

Comment: ????
I have no examples of these kind of packaging materials. Well, maybe glass bottles. Factories filling glass do have sometimes a CCP on the bottles and sometimes just a general measurement. Could be a really great OPRP.

5.1.3
Where physical and chemical control (including temperature) of the raw materials, intermediate or finished product, processes and/or environment is critical to product safety, legality and quality, this is adequately controlled, monitored and recorded.

Comment: OPRP. --> most of these controls are CCPs. But BRC is saying in this requirement: "if it is not a CCP accoring your assessment, you have to control it anyway" --> OPRP.

5.1.5
In circumstances where temperature and/or time control is critical to product safety, quality attribute or legality, temperature and/or time-recording equipment is linked to a suitable failure alert system, or continuous real-time temperature-recording equipment, linked to an automatic alarm system, is used to monitor at an appropriate frequency the process status.

See comment at 5.1.3.


A case study:
I used to work in a company producing mayonnaise-based salads. The pH of the end product was a CCP. The measuring and adding of organic acids was a CCP, but we were not quite happy with the motivation. If I would do an assessment based on ISO 22000, I would now identify it as a OPRP and would be totally happy with it.

Another one:
Ready to heat meals. Heating meat products first, assembly the meat products, with the pasta and the sauce, seal the packing and then pasteurizing the product. Heating the meat (and also heating the sauce and pasta) is a OPRP. It has effect on the pasteurisation process, but the pasteurisation process is a CCP.


I dare you all, to discuss these examples and come up with more examples and case studies.

Edited by Madam A. D-tor, 28 March 2008 - 07:58 AM.

[GMO]

Interesting examples - actually had the case with the last meal, however, because we had a generic HACCP (and had to because we made 140 different products) and other products were not pasteurised, the sauce and pasta cooking were still CCPs for other products.

I've had the situation though where I've had metal detectors earlier in the process. Makes more sense to me now. I suppose as well, you don't need to tell your operator "this is an oPRP and this is what that means" if it's only going to confuse them.

I'm always suspicious about the value of this but we dip some produce in a dilute acetic acid solution which reduces micro counts a bit prior to rinsing and then washing in dilute hypo. I suppose that would be an oPRP because not all manufacturers do that and it certainly doesn't cause them major issues but we have lower loading than they do.

[Penard]

Hello Mm A-D Tor,

Very interesting post! I don't know BRC, that's a quite clear explanation. Right as GMO said CCPs are not always well understood, it's no use having 25 CCP for only one product!

Of course it depends on product and Haccp study, but I agree with you concerning 4.3.2 (or just monitoring?), 4.4.4, good and clear oPRPs.

3.11.6, 5.1.3 and 5.1.5 : I think it depends on your product. To me either you have to implement GMP - so it's PRP, or you have to consider risk are too important to not take it into account in your Haccp study. These points are interesting too because they show us how good manufacturing practices of the factory are important to determine then PRP/ oPRP.
It depends on too your country and national legislation and requirements. For instance in France usually temperature belongs to GMP; if there is a food safety risk, it's a CCP (after a Haccp study of course, I briefly give my point of view) because you can comply with all your CCP requirements.

Another example I've heard : usually hygiene is a GMP in food industry. But for very sensitive operation like slicing salmons, hygiene of employees and materials are fundamental. Difficult to have a continuous or from time to time check control - so it can't be a CCP, it could become an oPRP.

Anyway I thank you Mm A-D Tor to share your experience and your point of view about this very difficult - and interesting!- point!

Regards,

Emmanuel.

[Philip.H]

Thank you, Madam A.D-tor

You're input really helped me out. I'm currently look at the haccp study of a hospital kitchen and i was really getting confused with 7.4...

cleaning & desinfection = OPRP
waterquality = OPRP
Temperatureregistration/controle = CCP

but what to do with personal hygiëne? PRP/OPRP
Personal hygiëne is without a doubt a PRP but if you make it a OPRP how do you control that

[Charles.C]

Dear Philip,

If you want an analytical approach to selecting oprps, try searching for Modarres/Bennii's contributions.

However, if I may make a simple offering -

cleaning & desinfection = OPRP
waterquality = OPRP
Temperatureregistration/controle = CCP

If all the above are routine "items" and unless there is something revolutionary about the control of any of them >>> PRPs. Easy solution.

(actually, not quite sure what the last one means, if for a "cooking" is presumably a CCP, otherwise I stick to my comment )

Rgds / Charles.C

[Philip.H]

Indeed, i meant cooking. Waterquality control isn't a routine it happens twice a year and is regulated by belgian law wich is a national interpretation of 98/83/EC and has a washlist of tests

so maybe that's a logical OPRP since its manditory?

[Erasmo]

I'm trying to do a crash course on ISO because I have an interview in which it will feature heavily but due to all you lovely people, I'm learning more every day and have read a lot about oPRPs.

I've done a lot of HACCP in my time and I have to admit to being a bit of a purist. I hate it when I come across CPs or QPs in a HACCP plan. As far as I'm concerned, the point of HACCP is to keep it simple and focus on the points in your process that are really critical. If you bring in a "point" which isn't classed as "critical", it makes me wonder why it's there?

In a lot of ways it goes against all the HACCP training I've done, it's very different from BRC and it makes me wonder if it works. Sorry to be insulting to the lovely operators where I've worked but many don't have English as a first language and several switch off their brains as soon as they come through the door. I'm all about keeping it simple! (I've just reduced a HACCP from 26 CCPs and 20 CPs to 10 CCPs and have challenged 3 more of them.)

Well, this is my interpretation: there are only 2 types of control measures; 1) CCP’s and 2) opPRP’s (see 7.4.4 and 8.2). The difference is the CRITICAL LIMITS (see 7.5 and 7.6.1) those are absent in opPRP’s – there is no other difference… both control measures has to be:

1) Monitored

2) Validated, and

3) Verified.

The opPRP’s are control measures with no critical limits identified.



“When you monitor a metal detector, you are not monitored the size of the standard metal sphere,

When you monitor an electronic sniffer, you are not monitoring the concentration of the standardized solution,

When you monitor a x-ray device, you are not monitoring specific defects or foreign material….”



Usually; when a device has to be “challenge” it usually is an opPRP.



When you measure continual variables like temperature in pasteurizers, ozone concentration in water disinfection, chlorine concentration in vegetable disinfection, water or ionized air pressure in bottle rinsers, those king of operations are usually a CCP.

[Charles.C]

Dear All,

@ Philip -

Waterquality control isn't a routine

OK, I appreciate you are not in a factory situation where "routine" is often daily. I guess you are also using municipal (= guaranteed quality = no danger) water. Accordingly, yr minimal evaluation is surely routine for you ?? I note that iso 22000 remarks - when selecting and/or establishing prps, the organisation shall consider and utilise appropriate information ( eg statutory and regulatory requirements ....)

@ Erasmo - I hate to be argumentative ( ) but I really don't agree that PRP can not be called a control measure. This is a quote from one of the formulators of the standard -

 prp___iso22000.jpg   30.56KB   63 downloads

When you measure continual variables like temperature in pasteurizers, ozone concentration in water disinfection, chlorine concentration in vegetable disinfection, water or ionized air pressure in bottle rinsers, those king of operations are usually a CCP.

I can agree with the first one, don't know about the last one, but I think the 2nd / 3rd are prp / oprp respectively - the 2nd if not , then it surely should be . However, I accept that if it can be demonstrated that significant numbers of operators are incapable of controlling these variables, this may offer a justification for lifting their status.

rgds / Charles.C

added - I anticipate some disagreement with my above opinions, accordingly I thought that this extract from an unusually "critical" document on the HACCP subject (though also possibly somewhat biased?) might be of related interest to people (as it was to me) -

In a fresh-cut processing facility bacteria are present on raw and finished product, sometimes in high numbers. Is the presence of bacteria a CCP? Very few kinds of bacteria pose a hazard to humans and those that do are rarely found on fresh-cut produce. So the presence of bacteria, even in high numbers, does not constitute a hazard. Furthermore, it is impossible to accurately monitor bacterial numbers on produce. Variability of bacterial populations in different samples from the same lot, population changes over time, and a delay in getting results from micro tests all make it impossible to realistically monitor bacterial numbers on produce. In fact, total numbers of bacteria on produce have little to do with the safety of that produce. But surely the possible presence of pathogens on fresh-cut produce represents a hazard and there is no kill step to eliminate them should they be present. Such hazards are addressed by preventing contamination by pathogens through GAP's, GMP's and SSOP's. If these programs are functioning properly, contamination of product with pathogens should not happen. Thus, high bacterial numbers may impact product quality, but they will not be a safety issue.

It is time that the produce industry stopped calling GAP or GMP programs in the fields or elsewhere HACCP. It is time to recognize that the heart of food safety begins with the prerequisite programs, GAP, GMP and SSOP. Those systems assure the safety of fresh produce. In a few instances HACCP may also be useful. Resisting mandated HACCP actually misses the point. In most cases HACCP is the wrong program for the produce industry. So let's devote our resources and attention to the prerequisite programs that will actually deliver safe and wholesome food.

http://www.davisfres...cles_haccp.html

[Charles Chew]

@ Erasmo - I hate to be argumentative ( ) but I really don't agree that PRP can not be called a control measure. This is a quote from one of the formulators of the standard -

Absolutely, PRPs are part of a larger combination of control measures within a FSMS

When you measure continual variables like temperature in pasteurizers, ozone concentration in water disinfection, chlorine concentration in vegetable disinfection, water or ionized air pressure in bottle rinsers, those king of operations are usually a CCP.

Not necessarily but the effectiveness of your risk assessment tools, food safety knowledge including your risk assessment criteria would determine the categorization and justificaiton of the identified risks rather than a list of generalised processes since risk containment in food establishments are dynamic in nature.

[Erasmo]

Well Charles, the word “control” does not appear in the definition of PRP (3.8) and you can see that word in definitions 3.9 (op PRP) and 3.10 (CCP).

• In section 7.4.4 the only control measures mentioned are CCP and opPRP.
• In section 7.8 c) are mentioned together and separated from PRP’s
• A correction and a corrective action has to be activated when CCP and opPRP are found out of control (7.10.1 and 7.10.2)
• In section 8.2 the only control measures mentioned are CCP and opPRP.
• In section 8.4.2 b) are mentioned together and separated from PRP’s

Definition 3.7 (Control Measure) is adapted from the Codex and that refers to Principle 1 where the Codex mentioned

“Consideration should be given to what control measures, if any exist, can be applied to each Hazard”.

So, it is possible not to have CCP or opPRP in some food operations, but it is a requirement to have al least one PRP (see 7.2.1).



In ISO/TS-22004 the PRP’s are mentioned as Control Measures in section 7.1, but that document is only a guide and I think it creates more confusion… you can see this in section 7.4.4 in ISO/TS-22004:

Categorization of control measures: The organization may focus on having as many of the control measures as possible managed by operational PRPs and only a few managed by the HACCP plan <CCP>, or the opposite.

The PRP’s was not showed as an option in that specific clause.



So, in relation to the categorization of ozone concentration in water disinfection, I’m referring of purified water as a final product. Some water processors monitor the ozone concentration to avoid bacteria in bottled water due to low concentration or to avoid the formation of bromates in bottled water due to high concentration of ozone.

Saludos!

[Erasmo]

More...
Now let’s review some the Codex definitions (Just remember that for the Codex the classification have only two options: CCP or PRP)

Control (verb): To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Monitor: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.



And compare the previous definition with the ISO-22000 definition for Monitoring: (not included in ISO-9000:2005)

Conduct a planned sequence of observations or measurements in order to assess whether control measures are effective. –



The PRP’s are NOT monitored (just verified) (see 7.2)

The opPRP and the CCP’s has to be monitored (see 7.5 and 7.6.1)

So, it seems that PRP are only environmental conditions (see definition 3.8) and no control measures.

[Erasmo]

<A name=OLE_LINK1>Lets review some of the history of the oPRP’s:



I’m going to refer to ISO/DIS 22000 (Draft International Standard from 2004)

You can find a note in for the definition of PRP’s during that stage of the standard:



NOTE 1 Depending on their nature and functions, some PRPs include or constitute control measures, whereas other PRPs constitute procedures and instructions of managerial and/or maintenance character.



That note was removed on the final draft (May 2005) and in the standard (Sept 2005).



More from that draft:



7.2.1 … The PRPs consist of two types:

d) Infrastructure and maintenance programs (see 7.2.2);

e) Operational PRP(s) (see 7.2.3).



That declaration was also removed. oPRP looks more like a CCP (see 7.5 and 7.6.1)



On the same document you can observe this:

7.2.3 Operational prerequisite programs

... 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).

On the final document (Sep. 2005) subsection a) to f) [except (e) that was totally removed] were included in 7.2.3 (PRP’s) probably because those refer to basic activities and conditions and does not associated to specific hazards.

[Charles.C]

Dear Erasmo,

Thks for yr in depth presentations.

I totally agree with you that the wordings (and sometimes concepts) of ISO 22000 clearly changed substantially from the draft to the issued document. In fact, if you study the exhaustive reporting of the “expert” comments on the draft, the indications are that a compromise between strongly held but differing views was made, particularly with respect to items such as you point out in yr post. I suspect that this is one major cause of the confused interpretations of the original standard and the rapid appearance of ISO 22004 as a clarification (= “Guidance on the use of ISO22000” on my copy). This is only an opinion, I have not seen details of the, I’m sure, lengthy (heated?) preliminary correspondences.

I think it is very sad that no representative worked example was included in the standard to illustrate the totally new aspects, eg OPRP, of the standard. The resulting confusion has been well-demonstrated on this forum.

I certainly won't claim to be an expert on the detailed meaning of the standard, far from it ! My comments were a deduction from the regettably few documents I hv seen published in this area, eg this article from one member of the working group responsible for the standard –
 ISO_22000___from_intent_to_implementation.pdf   381.73KB   146 downloads

However it may well be that other accessible interpretations exist ?.

Rgds / Charles.C