26 replies to this topic

[Saviour]

Dear Members

I have encoundered a typical case, that I would like to share with you and seek solution .

Situation is like that:
In a food manufacturing unit hazard analysis has been carried out, however as per hazard analysis no CCPs have been identified.

I would like to know:
If this unit is eligible for HACCP certificate?
If YES, under which condition?
If NO, what more need to be done by this unit to achieve the certificate?

Regards
Monika

[a_andhika]

Dear monika,


You may want to visit this topic that started by Charles Chew:

http://www.ifsqn.com...p?showtopic=422


In my opinion, yes technically it can be. But please be aware on how did you determine the CCP. If you have a strong argue to ensure your determination is correct, Im not see any reason to say its an impossible thing.

Do you mind to share us how did you determine your CCP? It would be interesting.


Regards,


Arya

[Biss]

hi,

I agree with arya ...

[Erasmo]

It is possible! Last year, one of my clients get the ISO-22000 certification with no CCP and no OPPRP (only PRP). They manufacture plastic bottles for the food and drink industry.

[Suzuki]

and no OPPRP (only PRP).

I would like to know if the FSMS auditor is registered with IRCA or RABQSA and if so, he must have an engineering background. How can any FSMS Systems have PRPs without the support of OPRPs unless your interpretation of PRP and OPRP had been wrongly understood.

It is absolutely possible not to have a HACCP Plan but other verification activities must exist otherwise the FSM System is incomplete and inadequately supported if implementation data is not in place. This ISO 22000 certification (unless unaccredited) is without any doubt in my mind, flawed!

[Charles.C]

Dear Erasmo / Suzuki,

An intriguing post IMO.

Difficult to make a specific comment without seeing the process but it seems to me that Erasmo’s reported result is simply stating that the process steps were evaluated as containing either no significant hazards or only hazards for which the hazard / appropriate control measures could be regarded as within the list of functions accepted by the standard as (non-oprp) PRPs. This achievement does seem rather remarkable ( = “perfect” process ?) but in principle why not ?

A similar conclusion is also possible using Bennii’s procedure although I personally found the separational logic in step 6.1.4 rather questionable.

A third viewpoint is that it nicely utilises the fuzzy – presentation / ambiguity which (intentionally?) exists in the text of the standard.

Rgds / Charles.C

[Erasmo]

I would like to know if the FSMS auditor is registered with IRCA or RABQSA and if so, he must have an engineering background. How can any FSMS Systems have PRPs without the support of OPRPs unless your interpretation of PRP and OPRP had been wrongly understood.

It is absolutely possible not to have a HACCP Plan but other verification activities must exist otherwise the FSM System is incomplete and inadequately supported if implementation data is not in place. This ISO 22000 certification (unless unaccredited) is without any doubt in my mind, flawed!

Hi Suzuki,

More details about this:

- Lead Auditor: she has a Food Safety Lead Auditor Credential with IRCA (the one that is Pink and yellow). And she has a BSc in Food Science

- Auditor in the ST2 audit was just “provisional auditor” with IRCA

- Consultant: Food Safety Lead Auditor with IRCA and BSc in Food Science

- Tech. Reviewer: FS Lead auditor with IRCA

- Accr. Body: UKAS



The verification planning in this system was totally implemented for: PRP’s, Updating of information, Hazard Levels and others… complying with 7.8, and 8.4.

This is totally possible and this is the best example.

[AS NUR]

as i know.. to make plastic bottles, they use blow molded process... and the contamination can occure during cutting the head of bottle (foreign matter) as hard plastic or metal from cutter.. so.. if this step or the forward step do not controll frequently, the contaminant can ocur in bottle.. IMEX.. in my previous company (food company that use plastic bottle) we using "turn down bottle machine" and "metal trap" to make sure the bottle not contain hard plastic and metal....

It is possible! Last year, one of my clients get the ISO-22000 certification with no CCP and no OPPRP (only PRP). They manufacture plastic bottles for the food and drink industry.

This interesting fact.. that plastic bottle manufacturer don't have any CCP or OPRP and they got ISo 22K ...

Edited by AS NUR, 03 March 2009 - 12:59 AM.

[Erasmo]

IMEX.. in my previous company (food company that use plastic bottle) we using "turn down bottle machine" and "metal trap" to make sure the bottle not contain hard plastic and metal....



This interesting fact.. that plastic bottle manufacturer don't have any CCP or OPRP and they got ISo 22K ...

What is a "turn down bottle machine"?
In this company, they documented in the "intended use (7.3.4)" that the bottle has to be rinsed with water or ionized air with a validated operation by the client to avoid physical contamination. Is that the operation that you mentioned?

[Suzuki]

This achievement does seem rather remarkable ( = “perfect” process ?) but in principle why not ?

Hi Charles C.
Even for a perfect process you would still need analytical data to prove it. Without OPRP how can you gather these data. I am indeed lost and stunned!

the bottle has to be rinsed with water or ionized air with a validated operation by the client to avoid physical contamination

Hi Erasmo,
There you go! Without data how can you verify / validate the process of rinsing and if this is control point for prevention / elimination / reduction and or even the mere potential risk of other physical contaminations - I think you have just shot yourself on the feet.

Note: There is also the risk of chemical toxic leach during the reisn melting process (resin tolerant temperature etc) and if it is PET (you run the risk of AA migration as well) and the water rinsing needs to be verified as effective while the presence / absence of AA needs to be validated. So how can there not be any OPRPs?

I have checked the IRCA register for Food Auditor - there was only one member
Liliana Jimenez
Certification number: 01184425

If she was not the one auditing this FSMS, I suspect the certification is flawed.

Edited by Suzuki, 03 March 2009 - 06:48 AM.

[a_andhika]

Dear All,

Interesting posts. Although I feel like its going to diverse from the main topic. Should we have a new topic regarding this?

As for my opinion, according the system (which still confusing me), I dont think its impossible thing. I guess it wouldnt be fair to judge the zero determination is not true if we didnt see the whole process, and the determination of CCP /oPRP. Coz it may vary depend on the process/products. Care to elaborate it?


Regards,


Arya

Edited by a_andhika, 03 March 2009 - 06:18 AM.

[Suzuki]

I dont think its impossible thing

didnt see the whole process, and the determination of CCP /oPRP

You do not need to see the process or processes to know that it is impossible not to have an OPRP plan (epsecially when a HACCP Plan does not exist) including even if the entire process was performed by robotics.

The essense of ISO 22K is built around resource planning of PRPs and planning for realization of safe product under the control measures combination of PRPs, OPRPs, CCPs (not in this case) including whatever you need to have as per your hazard analysis. If this is not clarified, there will be a whole lot of confused people out there.

[AS NUR]

What is a "turn down bottle machine"?
In this company, they documented in the "intended use (7.3.4)" that the bottle has to be rinsed with water or ionized air with a validated operation by the client to avoid physical contamination. Is that the operation that you mentioned?

process of at "turn down bottle machine" are :
1. the bottle is rotate until the bottom of bottle in upper side, we using"zigzag"conveyor system,
2.we blow with compressed and dry air, and if any foreign material inside the bottle, they can fall to down and we put bag to collect the foreing matter.
(sorry if my explain not very clear for you..)

We dont rinse with water becaus, the bottle must be dry before filled by product.

[Charles.C]

Dear Suzuki,

I applaud yr determination to achieve a conclusion. I only wish that the designers of the text of ISO 22000 standard had used more prescriptive language to facilitate yr objective.

I offer a minimalist answer regarding the general situation. The specific one is unknown.

Referring to ISO 22004 / 7.1.b – "operational prerequisite programmes (operational prps) that manage those control measures that the hazard analysis identifies as necessary to control hazards to acceptable levels, and which are not otherwise managed by the HACCP plan."

I think it is at least definitive that the hazard analysis (7.4.3 in 22000) precedes the decision regarding any choice of ccps and oprps. I think it is also important to keep reminding oneself that the focus is on safety related parameters.

The associated (and detailed) Para 7.4.3 of ISO 22004 includes the statement that “ the hazard analysis may determine that control of a hazard by the organisation will not be needed”. The immediately following text appears to me to leave the justification / consequence fully open, ie to be decided by the user. I guess this section of the standard was the support for Bennii’s earlier posted procedure.

The above seems to me to support the hypothetical possibility of the posted introduction. I don'tsee how one can make more specific comments without knowing the process. Anyone is totally encouraged to agree / disagree / amplify any of the above.

I can understand the difficulty which faced the ISO 22000 team in that so many possibilities were involved, (perhaps most of all the appropriate use of a new tool,oprp) which required to be addressed plus the whole topic of risk analysis is so continually subjective. Unfortunately, all these options (perhaps inevitably) resulted, IMO, in a very well-intentioned but equally confusing document.

Rgds / Charles.C

PS - I should add that an obvious related question to the present thread is - when is a “control point” an oprp ? for which other threads already exist. I hv deliberately avoided this aspect in above since no process is given and I was trying to simplify my comment as much as I could

[Erasmo]

Hi Charles C.
Even for a perfect process you would still need analytical data to prove it. Without OPRP how can you gather these data. I am indeed lost and stunned!


Hi Erasmo,
There you go! Without data how can you verify / validate the process of rinsing and if this is control point for prevention / elimination / reduction and or even the mere potential risk of other physical contaminations - I think you have just shot yourself on the feet.

Note: There is also the risk of chemical toxic leach during the reisn melting process (resin tolerant temperature etc) and if it is PET (you run the risk of AA migration as well) and the water rinsing needs to be verified as effective while the presence / absence of AA needs to be validated. So how can there not be any OPRPs?

I have checked the IRCA register for Food Auditor - there was only one member
Liliana Jimenez
Certification number: 01184425

If she was not the one auditing this FSMS, I suspect the certification is flawed.

Hi Suzuki,
It is totally possible not to have validation (pls read ISO/TS-22004), but it is not possible to avoid Verification activities. "verify/validate" Those are not synonims, are very different terms. Also, please check ISO-9000:2005 and ISO-22000:2005 (section 3) and you will see different definition of "validation". This is a common error in food safety systems.
I'm trying to locate a reply from Jacob Færgemand from 2006 (BVQI Denmark A/S member of the ISO/TC 34) because I have ask this same question, and he said that examples like that are totally possible.
Also...:Liliana was the Lead Auditor.

[Erasmo]

The bottle rinsing operation is made by the clients (outside the organization and of course: outside the scope). and this is documented according to 7.3.4 (Intended use).
Also, I have see analysis of the resins (including reclycled resins) and the heavy metals (including lead) are not a problem.
And I have another example: A company that manufactures additives for feed does not have CCP and opPRP also! They have the plan to recieve the stage 1 audit in April...
The produc (this additive) has Organic Certification, it is totally natural (this is a plant extract).
It is totally possible not to have CCP and op PRP's.

[Charles.C]

Dear All,

This discussion seems to verify the weakness of the ISO 22000 text. Now 4 yrs old and we are discussing absolute fundamentals. Of course, one can initially blame the standard’s designers since not one appropriate detailed example was presented at the standard’s inception and, as far as I know, the situation remains the same today. No doubt the fear of people copying any presented format as “authorised” was part of the problem but this seems ultimately self-defeating to me. The intention IMO should be to educate without the user having to lay out further substantial sums of money after having already invested in the standard’s text. Then again, this is ISO after all *sighhhh*.

BTW, it’s rather OT here but the semi-example posted by Bennii for a wine bottling process has a preliminary bottle rinsing step which in her opinion is a CCP. This suggests (for her process) an existing case history of some variations in delivered bottle quality which were considered signifiicant.? [ added - I re-read the previous posts after i wrote this and realised the rinsing step could fit the 7.3.4 comment, so maybe this is a typical product specification requirement to be imposed on the bottle user, ie product is sold "internally 100% as is" which seems remarkably tolerant to me and certainly assists in minimising hazards, rightly or wrongly ].
Unfortunately, although admiring the ingenuity, I find the numerical, non-prioritised, method used for partitioning control measures into an oprp program / CCP program rather unconvincing although I don’t hv a better option to offer [strictly, yet another risk analysis is probably required using the ISO 7.4.4 menu ] . Blame the compromise on the standard again I suppose, any method will probably be no more subjective than the primary risk analysis anyway.

Nonetheless, it's very good that Erasmo has supplied the information to generate this partial thread (and equally to Suzuki for launching his feedback ) (and monika for not complaining on the borrowing of her thread )

Rgds / Charles.C

[Suzuki]

Dear All,

Firstly to Monika for allowing us to borrow her thread for amplyfing a divergence in opinion on a diverted subject. I hope its not taken as hijacking the thread and if so, it was indeed not intended.

Dear Erasmo,

It is totally possible not to have validation (pls read ISO/TS-22004), but it is not possible to avoid Verification activities

I take it you mean to clarify whether avoidance of validation is possible but not verification. Frankly, regardless of ISO 22K or Codex-HACCP, BRC, IFS, etc - validations and verifications are absolutely required to determine the degree of effectiveness of the food safety system including the ability of the food safety system to deliver the FSO consistently. You may say both tasks are unavoidable.

check ISO-9000:2005 and ISO-22000:2005 (section 3) and you will see different definition of "validation". This is a common error in food safety systems.

It is dangerous to compare definition of "validation" as one is a quality management system while the other is a food safety system. In ISO 22K, only the ISO 9K Management Principles are applied while all other food related issues obviously has to meet the requirements of ISO 22K. (Most people have erred and are so wrong to suggest that ISO 22K is equals to ISO 9000 + HACCP. If so, there is then absolutely no need to even consider systems integration. The failure of ISO 15161 integration has taken the entire equation out)

Dear Charles C.

This discussion seems to verify the weakness of the ISO 22000 text.

I agree with you that understanding some of the requirements of ISO 22K can be mind boggling. However, IMO despite the dreadful use of certain technical terminologies, ISO 22K is in mind one of the most powerful food safety systems available today.

Regards
Suzuki

[Saviour]

Dear All

Thanks a lot for all of the above discussion.Definetely this is not a hijacked topic.
This point was boggling me 'what if,' for this simple reason I found the best way to explore this point by posting in this forum, as many of you are expert in this field.


I personaly feel this is possible provided Hazarad analysis is carried out correctly.


Regards
Monika

[Erasmo]

Today, another Organization has received the recommendation for ISO-22000:2005 certification with no CCP and no opPPR implemented. They manufacture feed additives. So, in their hazard analysis, they didn’t find any hazard to be controlled in order to prevent people that consume products like milk, beef, chicken and pork could be harmed because a hazard introduced in the feed additive. Anyway, they identify hazards, but no hazards to be controlled with a “validable” control measure.



There are some organizations in specific sub-sectors in the food chain in where situations like above mentioned are totally possible. Organizations like feed additives, some plastic packaging, pumps manufacturers for the food and beverage industry, some fertilizers, catering equipment manufacturers, pest control services for food plants, some food distribution companies (not frozen or refrigerated products), etc. usually does not have CCP and opPRP.



If you see ISO-22000 (1.- Scope) you will see that the standard is applicable to any organization which are involved in any aspect on the food chain (see also Figure 1). ISO-22000 is not only for food processors.

[Charles.C]

Dear Erasmo,

Interesting. Thks for the update.
I’m not disagreeing with the principle but I suspect this result may often indicate a clever utilisation of subjectivities in the selection of procedures for risk assessment (or specifications / defects perhaps) / choice of oprp. Or by the extensive / generous use of (non-oprp) pre-requisites.

Similarly, one inspector I met stated that anyone who presented him with a (food) HACCP with no CCP always got the immediate response "Where's the metal detector?"

Zero CCP / OPRP also seems to demand an amazingly good record of defects.

Rgds / Charles.C

[S.U.Siddiqui]

Hey there,

Real interesting discussion going on. I would like to participate also. First things first, the answer to the initially asked question. What if in a process there is no CCP?

Ms.Monika was very specific and she was asking about HACCP certification and not ISO22000 certification. So the answer is IT IS IMPOSSIBLE to have a HACCP (Hazard Analysis and Critical Control Point) certification without a CCP (Critical Control Point).

Secondly, I strongly agree with Suzuki and definitely doubt the qualification of Auditor who has accepted a ISO22000 based FSMS having no OPRPs. What a fuss?

If you read introduction section of ISO22000 on page vi para 3 of ISO22000:2005 text it clearly states that:

This international standard combines the following generally recognized key elements to ensure food safety along the food chain, up to the point of final consumption:
- Interactive communication
- System Management
- Prerequisite Programs (Both Operational and Non-operational)
- HACCP Principle

This specifies FOUR MAJOR PILLARS of the food safety management system building. Now how can you EXCLUDE the ISO 22000 requirements mentioned from clause 7.4 to 7.6. Standard requires you to document HACCP plan and uses the words :
"The HACCP Plan shall be documented" it is a MANDATORY document and i dont know which auditor has suggested the client for ISO22000 certification without any DOCUMENTED HACCP Plan.

Stage 1 audit (Document Review) can never be cleared WITHOUT DOCUMENTING HACCP PLAN.

Thirdly, to my dear friend Mr.Erasmo, Sir! clause 7.3.4 requires you to define:
- Intended Use (Purpose for which your product is manufactured)
- Reasonably expected handling of end product (Keep freezed, chilled etc.)
- Any unintended but reasonably expected to occur (The UNINTENDED use which can harm the consumer)

For example, the bottles are produced for filling liquids and not for oral consumption hence this shall be described in the INTENDED USE of bottles. The process of washing, which you have mentioned in INTENDED USE, IMO is totally wrong.

If we consider it correct then no company will develop any control measures for its food product and will communicate to the consumer that our product contains x, y and z hazards, so you shall eliminate them before use. This is not what is required by clause 7.3.4.

Fortunately, standard has mentioned INTENDED USE (7.3.4) before hazard analysis so you cannot break the sequence and say that the user shall wash the bottles to avoid the EXPECTED HAZARDS which are to be analyzed later (7.4).

If you will follow the correct sequence of ISO22000 standard you will definitely end up with at least 2 OPRPs and 1 CCP. I suggest you to revise your FSMS or otherwise sooner or later the auditor will change and certification of your client will be in real danger.

Nothing personal, i was just trying to clear the ambiguities regarding ISO22000:2005.

Regards
Siraj

[Erasmo]

I know it is not personal. I like to discuss subjects like this in this forum…



Remember that ISO-22000 is for all organization in the food chain, and sometimes it could be difficult to believe that a factory in the food sector does not have a CCP. In fact, I don’t know any food manufacturing plant without CCP’s or opPRP’s.



Well, let’s review ISO/TS-22004.

1.- In clause 7.4.4 states that it is possible not to have CCP.



2.- In clause 7.6.2 states that CCP’s are those steps where control measures to be managed by the HACCP plan are located. So, if there is no CCP, then it is possible not to have a HACCP plan. I know that is a mandatory document but in those cases, the requirement is not applicable. Similar situations sometimes occur in clauses 4.1 and 7.3.5.1 b) (subcontracted processes) if you don’t have a subcontracted process, you don’t have to documented.



3.- If you see figure 3 (decision tree of ISO/TS-220004) you can see that it its possible not to have CCP and opPRP if all the answers to Question 1 & 2 are NO, then no CCP or opPRP are necessary.



Now, the Codex document:

“Redesign of the operation should be considered if a hazard which must be controlled is identified but no CCPs are found”. So, if there is no identified hazard that should be controlled, then no CCP, then no HACCP plan.



Not all hazards has to be controlled, please read definition 3.9 and 3.10 (opPRP and CCP) in ISO-22000 these are the control measures that specifically controls hazards (eliminates or reduce to an acceptable levels), and if you see the standard clause 7.2, PRP’s are only to assist in controlling hazards (not for controlling them). The word “control” does not appear in definition 3.8.



If you review ISO-DIS-22000 (a draft from 2004) previously opPRP are now PRP’s mentioned in 7.2.3 (those PRP’s were included later in PAS-220), in the Final Draft and in the final document; the opPRP’s are more specific control measures.



Now what you mentioned about intended use: to document further processing is totally adequate, specifically in organizations related with primary producers, feed manufacturers, equipment for food processing, etc.



Sometimes the HACCP plan is confused with the Hazard Analysis (the HACCP plan (as well as the opPRP) are the result of the hazard analysis).



Remember the 3 steps in principle 1:



1.- Identify hazards and acceptable levels of those hazards,

2.- Assess hazards (Severity/Probability) and Hazards that has to be controlled (validated and monitored) (not all hazards has to be controlled)

3.- Categorization of control measures (CCP’s or opPRP’s)



Also, I know a factory that manufactures synthetic corks for wine bottles from virgin resins and approved pigments… they have HACCP implemented according to the Codex and they don’t have any CCP, they received audits from a lot of clients from California and also third party inspections and they don’t have NC notes as a result of those audits.



Going back to the 2 companies ISO-22000 certified:


Two different companies that manufacture two different products in two different places with two different Registrars, different auditors, different technical reviewers… I think is totally possible.

[S.U.Siddiqui]

Fortunately, standard has mentioned INTENDED USE (7.3.4) before hazard analysis so you cannot break the sequence and say that the user shall wash the bottles to avoid the EXPECTED HAZARDS which are to be analyzed later (7.4).

Intended Use is defined BEFORE HAZARD ANALYSIS (7.3- Preliminary Steps to Hazard Analysis) and hence logically you can NEVER discuss any hazard in the Intended Use section.

I havent gone through the ISO/TS 22004 technical guidance document hence can not comment on your references but my personal experience and a bit of common sense suggests that it is merely IMPOSSIBLE to have an FSMS without any OPRP and CCP.

If you revise the hazard analysis and do it on-site (not in a closed meeting room), on basis of factual data, you will definitely end up with more than 1 OPRP and at least 1 CCP.

Regards
Siraj

[kmasan]

It is possible! rLast year, one of my clients get the ISO-22000 certification with no CCP and no OPPRP (only PRP). They manufacture plastic bottles for the food and drink industry.

Hi Sir,
It is interesting. We also manufacturing PET preforms for mineral water companies. Could you give me more input about this. In Plastic manufacturing normally use magnet in line to catpure if any ferrous mateiral in PET raw mateiral. But the frequency and liklihood is very minor or Very Low. Could we take this as a CCP? thanks and regards
K.Masan