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a_andhika

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Posted 16 June 2008 - 11:12 AM

Hello Forum..

Need some help about validating the CCP and OPRP... I will have ISO 22000:2005 audit in a few months ahead... And I would have some advice about how to validate my CCP and OPRP... Its quite amusing me...

I'll give you an example, one of my CCP surveillance is Raw Material Sieving. Before we mix the RM, we will sieve it through siever with size 20 mesh. This step will prevent foreign matter (e.g. metal, plastics, wood) contaminate the Finished Products. Since we dont have metal catcher/detector (yet), so this process would be a CCP, coz no other process that may reduce or eliminate the foreign material. So, how do I validate it?

What inside my thought is: we do regular process just as usual, and after we get the Finished Products, we will sieve it by using sieving machine (separated from the mixing machine), with siever size 20 - 40 mesh. If we dont found any foreign material, then tada... my CCP surveillance is validated, and it proven to be effective. Is that OK?

But my companion has another idea. When we validate it, why dont we put foreign matter into the RM (without being noticed by the operator of course), and let the process goes as usual. After that, we will sieve it and the rest will be just same like my thought. Is this thing necesarry? Or just a redudantly thought?

I hope you guys can lend me a help... We're running out of time...


Regards,


Arya


IF
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GMO

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Posted 16 June 2008 - 02:51 PM

I suppose you need to think about what you are trying to stop.

Validation = can it work? Therefore, in this case, can it reduce foreign matter contamination to a safe level?

What is it you find on the sieve? As I don't know your raw material, you should really think to start off with, "is it a real CCP?" If you are regularly finding things on the sieve, what are they? Also what contamination could happen of your starting material? What size would be unacceptable?

Then as your colleague said, you need to know it can remove particles of the size you are concerned about; however you should never deliberately contaminate your food! I would use as validation, the calibration certificate from the manufacturer that the sieve is capable of removing pieces of a certain (specified) size. If you don't have calibration on your sieve, I would get one that does.

I was about to say you need to replace the sieve probably at least once a year rather than get it recalibrated but then I remembered the tendency for the sieves to break which will almost certainly happen sooner. Remember, the sieve breakage is probably more important in terms of preventing foreign bodies than the sieve being in place or not. When it breaks, small pieces can fall off which are not always large enough to be metal detectable. The sieve should be checked regularly (e.g. hourly) for damage and any suspect product put on hold and possibly rejected depending on whether all pieces can be found.

Monitoring I would put in place is an hourly "is the sieve in place and undamaged?" check. Another monitor would be recording findings on the sieve after each shift. That might be as simple as sticking them in a book. Then verification could be through consumer complaints.


Edited by GMO, 16 June 2008 - 02:53 PM.


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Posted 16 June 2008 - 03:52 PM

Hello Forum..

Need some help about validating the CCP and OPRP... I will have ISO 22000:2005 audit in a few months ahead... And I would have some advice about how to validate my CCP and OPRP... Its quite amusing me...

Regards,


Arya

Well, ISO/TS 22004 mentioned this as a good validation activities:

Validation methodology includes, but is not limited to the following:

a) reference to validations carried out by others or historical knowledge. If relying

on validations carried out by others, care should be taken to ensure that the

conditions of intended application are consistent with those identified in the

referenced validations. Generally accepted industrial practices may be used.

b) experimental trials to mimic process conditions. Scaling up laboratory-based

experimental trials in a pilot plant may be required to ensure that the trials properly

reflect actual processing parameters and conditions.

c) collection of biological, chemical, and physical hazard data during normal

operating conditions. These can be carried out through the use of intermediate

and/or finished product sampling and testing based on the use of statistical sampling

plans and validated testing methodology.

d) statistically designed surveys. These are useful for control measures that cannot

otherwise be measured, such as consumer practices related to the storage of

perishable foods).

e) mathematical modelling.

Please check again if that control measure is really a CCP. And remember that the VALIDATION definition for ISO-9000:2005 its different that the definition for ISO-22000:2005.


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Posted 16 June 2008 - 07:21 PM

Good points - in the case of a seive; if they are calibrating it, they are doing test a.

As I kind of put across not very clearly in my previous reply; there are two parts to this, not only are you validating it can do it, but certainly whenever I have conducted a validation exercise, I ensure I can validate the decision making for the critical limits with evidence if available.



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Posted 16 June 2008 - 09:25 PM

Dear Arya,

Interested to know how you validated the choice of 20 mesh size in the first place.
As far as CCP is concerned, this process looks more like a PRP to me (i22k / 7.2.3.f) ? :whistle:

Rgds / Charles.C


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Charles.C


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Posted 17 June 2008 - 05:35 AM

Dear Arya, Interested to know how you validated the choice of 20 mesh size in the first place. As far as CCP is concerned, this process looks more like a PRP to me (i22k / 7.2.3.f) ? :whistle: Rgds / Charles.C


Dear Forum,

To Charles: Well.. technically no, but practically yes. But before I go on to that part, let me give you the reason: this sieving step is controlling 2 potential hazards, 1st one is to prevent the foreign matter contaminate the product, and 2nd one is to prevent Raw Material that has particle size more than 20 mesh enter the mixing machine. So, the first hazard is categorized as Food Safety Issue, and the 2nd one is Quality Issue. This ambiguity often amusing our consultant too. And this one lead to my another question, does CCP surveillance only for Food Safety purpose, or it may combined with the Quality? BAck to the first line, yes Charles I understand if you consider that as a PRP, because practically we found Material that has problem with it particle size rather than occurrence of foreign matter.

To GMO: Thank you very much for the input. Yes, Im totally agreed that deliberately would be the same thing as criminal.. But, can we consider it effective only based on verifying the product doesnt contaminated after sieving? Still related with Charles's thread, we (HACCP Team) decide that particle that loose on 20 mesh size wont give serious cause to the customer. And in fact, we always found foreign matter that big enough to be detained on the sieve with 20 mesh size.

To Erasmo: I guess the point a) and c) will be very suitable for me. Thank you so much.

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Arya

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Charles.C

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Posted 17 June 2008 - 07:59 AM

Dear Arya,

Interesting comments. Illustrates well the various perceptions of what is a significant hazard, eg where do you prioritise risk probabilities and how. Additionally, do you include legislation into the evaluation ?

Slightly OT, re yr first query, well originally, the US haccp plans included quality / economics of course but they rapidly decided that focussing on the specific “health risk” was a preferred option. This on its own already created a whole menu of sub-interpretations hence the long lists of CCPs in the pioneering published haccp plans. Enter “prerequisites, GMP ++” to reduce the auditor’s workload ( IMsuspiciousO) although with immediate (and unconcluded) debate over the risk of reducing the scope of haccp vision targetted on a full case-by-case evaluation.

GMO already nailed the fundamental first question IMO - risk assessment of yr foreign materials (= metal / glass / bone / wood / plastic / rope ? :smile: ). As discussed in detail in another current thread discussing metal particles, this topic inevitably has its own subjectivities particularly the overlap to legal factors. If yr RMat frequently is full of > 20 mesh (BTW, how big is that, visually obvious ?) chunks of metal (failed supplier control prerequisite?), well maybe, but then you should probably change yr supplier or hv a metal remover already ! ?? Nonetheless, if the (net) risk can be demonstrated as low, surely easier to make it a (routine / just like other similar processors = validation) PRP and avoid the auditor’s automatic scrutiny of yr CCPs.
Or are you short of CCPs ?? :biggrin:

Rgds / Charles.C


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Charles.C


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Posted 17 June 2008 - 08:39 AM

Hello Forum..

Need some help about validating the CCP and OPRP... I will have ISO 22000:2005 audit in a few months ahead... And I would have some advice about how to validate my CCP and OPRP... Its quite amusing me...

I'll give you an example, one of my CCP surveillance is Raw Material Sieving. Before we mix the RM, we will sieve it through siever with size 20 mesh. This step will prevent foreign matter (e.g. metal, plastics, wood) contaminate the Finished Products. Since we dont have metal catcher/detector (yet), so this process would be a CCP, coz no other process that may reduce or eliminate the foreign material. So, how do I validate it?

What inside my thought is: we do regular process just as usual, and after we get the Finished Products, we will sieve it by using sieving machine (separated from the mixing machine), with siever size 20 - 40 mesh. If we dont found any foreign material, then tada... my CCP surveillance is validated, and it proven to be effective. Is that OK?

But my companion has another idea. When we validate it, why dont we put foreign matter into the RM (without being noticed by the operator of course), and let the process goes as usual. After that, we will sieve it and the rest will be just same like my thought. Is this thing necesarry? Or just a redudantly thought?

I hope you guys can lend me a help... We're running out of time...


Regards,


Arya


DEar Arya...

you state the sieve is Control measure of your Hazard (CCP), and you need to validate it... You can do validate by literature background.. if you read FDA doc. (i enclose here).. you can find the foreign materials is dangerous if they have > 7 mm of Dimension.. So if you 20 mesh Sieve can remove the foreign metals, that valid to use sieve as control measure.. and you can monitoring the sieve by visual..

hope make you clear :thumbup:

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a_andhika

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Posted 17 June 2008 - 11:23 AM

Dear Arya, Are you short of CCPs ?? :biggrin: Rgds / Charles.C


Gulp...!! Thats really hit me till sank...!!
Well, frankie speaking... sometimes I feel that way...:p As overall, we already follow the Hazard Analysis, Decision Tree, and I think yes... based on what we get from the Analysis and DT, that step would be a CCP. Because... 1) The severity is high (we found metal and plastics that may harmful). And even the likelihood would be low, we consider it as a significant hazard. As for the probability itself we determine it by count how many case(s) found in a year. 2) Enter the DT... Q2 (or depend on your DT): this step would be able to eliminate/reduce the hazard within the acceptable level. And as I mentioned in my first thread, we dont have any metal detector/catcher (yet)... But even we have, there will be no guarantee for non-metal material. So I think yes, the CCP still goes to the Sieving step.

Actually... what is the philosophy for CCP itself? Because from the way I see, our CCP surveillance is derived from the PRP. Should the CCP surveillance is specially built or siginificantly made to reduce the hazard? Or it may be adapted from our process? This conversation amuse me on one side but gives me light on the other side...:-) And another quiestion, based on GMO's opinion I get that validation should be done regularly... Can we only held it once, then we do regular verification to make sure the steps are well executed.

To AS NUR: thank you very much... Once again, you did my homework:) Still related with Charles's query, the sieve with 20 mesh size has 850 micrometer aperture. Materials that may loose: crystal sugar, crsytal salt, MSG, and other material that has powder or crsytal form. So I think there will be no chance for foreign matter which bigger than 7 mm can't be detained from it.

Regards,


Arya

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Charles.C

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Posted 17 June 2008 - 07:04 PM

Dear Arya,

Although I hate to admit defeat :smile: , If you are in the bread / flour type business, I must admit to seeing various literature validations of yr CCP, eg -



http://www.be-sy.org...CCPanalysis.pdf.

The latter link seems to have much less restrictive sieve sizes than yourself, possibly using the previous 7 mm figure as a guide, though I certainly wouldn't choose that large a number myself.

Rgds/ Charles.C


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Charles.C


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Posted 18 June 2008 - 10:09 AM

you welcome Arya :thumbup:



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Posted 19 June 2008 - 01:15 AM

Dear Arya, Although I hate to admit defeat :smile: , If you are in the bread / flour type business, I must admit to seeing various literature validations of yr CCP, eg - http://www.be-sy.org...CCPanalysis.pdf. The latter link seems to have much less restrictive sieve sizes than yourself, possibly using the previous 7 mm figure as a guide, though I certainly wouldn't choose that large a number myself. Rgds/ Charles.C



Thank you very much for the documents Charles, I am very appreciate it...

Regards,


Arya

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a_andhika

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Posted 30 July 2008 - 04:08 AM

Dear Forum,

Last week I e done with my ISO 22k initial audit. The 2nd stage audit will be held on middle of August. One of my critical finding is, I havent validate one of my CCP. And it happen because the related process/product is very seldom to run. So it was not I wont validate it, but I cant. Ive told the auditor that we will execute the validation as soon as the schedule for related product is plotted. Besides, we already have the validation design, we just wait until the process runs. But they insist to conclude it as a critical finding. :unsure:

My CCP is sortation process. We need to ensure that the sortation process is able to eliminate all foreign material from our fresh Raw Material (meat, fish, chicken). We already set the scheme, that the HACCP Team will verify the after sortation Raw Material, is it still contaminated by foreign matter or no. I guess the auditor didnt have any objection to our method.

My question is, could be CCP or oPRP is havent validate yet, because non-techical thing such like that (have you met some particular case like that)? Or.. do we have to wait until the related process running (which may occur on the next 3-4 months ahead), then we can have the 2nd stage audit? Or... can I use the data from previous production? :helpplease:


Regards,


Arya


Edited by a_andhika, 30 July 2008 - 04:30 AM.

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GMO

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Posted 30 July 2008 - 08:16 AM

Dear Forum,

Last week I e done with my ISO 22k initial audit. The 2nd stage audit will be held on middle of August. One of my critical finding is, I havent validate one of my CCP. And it happen because the related process/product is very seldom to run. So it was not I wont validate it, but I cant. Ive told the auditor that we will execute the validation as soon as the schedule for related product is plotted. Besides, we already have the validation design, we just wait until the process runs. But they insist to conclude it as a critical finding. :unsure:

My CCP is sortation process. We need to ensure that the sortation process is able to eliminate all foreign material from our fresh Raw Material (meat, fish, chicken). We already set the scheme, that the HACCP Team will verify the after sortation Raw Material, is it still contaminated by foreign matter or no. I guess the auditor didnt have any objection to our method.

My question is, could be CCP or oPRP is havent validate yet, because non-techical thing such like that (have you met some particular case like that)? Or.. do we have to wait until the related process running (which may occur on the next 3-4 months ahead), then we can have the 2nd stage audit? Or... can I use the data from previous production? :helpplease:


Regards,


Arya



I don't really understand what your CCP is and I would question if that is a CCP at all from what I am guessing it is but as you have identified it as a CCP, you should validate it before you use it so the fact you haven't run it for a while is not an excuse. You might need to run a trial but that isn't prevented from being done due to the line not running is it?


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Posted 30 July 2008 - 11:12 AM

Dear Arya,

Don't quite understand the process since this step seems required for all raw materials so why not running ? An invisible CCP ? :smile: Some divergences from a stated process flow / HACCP plan are inevitable IMEX but this looks a bit major (CCP!) as the auditor also seemingly concluded.

I suppose you can modify yr risk anlysis if you wish but maybe still need some data to justify the result ?? Really depends on the specific situation, eg scope ?

The conceptual aspect seems related to the previous posts in this thread. As mentioned before, like GMO's comment, I suspect many people would not make this a CCP but yr industry / specific process may be an exception. CCPs work like a bulldog to a bone for auditors since they also need evidence of carrying out prioritised functions in their job, and rightly so of course since you are paying them to do it :biggrin: .

Regardless, very happy to hear yr (modified) risk analysis methodology was accepted ok :thumbup: .

Rgds / Charles.C


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Charles.C


a_andhika

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Posted 31 July 2008 - 01:31 AM

Dear Charles and GMO,

I guess my problem wont be sufficient to be described in one post. So, here is the "chronological" explanation:
1. In our company, we produce 3 kinds/category of product, which is:
a. Spices Flavor
b. Seasoning Powder
c. Meat Extract Flavor
2. Each category has it own oPRP and CCP.
3. From those categories, the Meat Extract Flavor product is still on a development, and therefore it seldom runs.
4. Ive validate the oPRP and CCP on Spices Flavor and Seasoning Powder. Consider it was done.
5. For the Meat Extract, our team decide that "Sortation" process of the fresh RM is considered as CCP. Therefore, we need to validate it, to ensure it effective and so on.
6. As mentioned before, it seldom runs, so we cant validate it yet.

But the idea of trial is giving me a hunch. I do not need to proceed to the next process, just until the sortation step. Consider the fresh material is easily deteriorated, it must be rejected after the trial. So I think I have to calculate the rejection cost too.

Back to my previous question, just asking one more time, can a CCP is not validated yet, because non technical problem such as it very seldom runs? Thank you.

PS to Charles: Thank you. Yup, I dont think they disagree back then. As long as the step still following Food Safety logical, I guess it would be fine for them.

Regards,


Arya


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Charles.C

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Posted 31 July 2008 - 04:07 AM

Dear Arya,

Don’t hv any direct experience of ISO 22000 but if it were BRC, IMEX the answer is yes. But, usually, only if the relevant © process is provably similar to another one where you hv already done an analogous validation so a grouping is possible. Reason is that if you hv many products containing essentially the same basic steps and “equivalent” CCPs but not necessarily running at same time the auditor may (at his discretion) take a “sample” although retaining the missing product in the scope which you submit for certification. Effectively you are getting a certification for a definable “group”, eg raw vegetables. Even so, the auditor will probably require evidence that a stated product / process line actually exists, eg raw material deliveries etc.

But this does not seem to be the case here since the sorting step is only a CCP for the third product. Perhaps it doesn’t exist for other two or for some reason in their case is not significant (eg clean raw material). Still not enough info. to comment :smile: .

The other idea you refer is a challenge test and is acceptable as a validation. Is described in one of the thread links here somewhere.

If the only block to the third product being passed is this CCP, I would consider a pragmatic re-think unless very definite reason for choice.

Still (happily) surprised that you're risk analysis passed (smoothly?) so perhaps you hv a very persuasive ability over auditors so maybe anything possible. Hypnotism ? :clap: :clap:

Interested to hear opinion from any actual ISO 22000 supplicants ?

Rgds / Charles.C


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Posted 31 July 2008 - 05:08 AM

Dear Forum,

My CCP is sortation process. We need to ensure that the sortation process is able to eliminate all foreign material from our fresh Raw Material (meat, fish, chicken). We already set the scheme, that the HACCP Team will verify the after sortation Raw Material, is it still contaminated by foreign matter or no. I guess the auditor didnt have any objection to our method.

My question is, could be CCP or oPRP is havent validate yet, because non-techical thing such like that (have you met some particular case like that)? Or.. do we have to wait until the related process running (which may occur on the next 3-4 months ahead), then we can have the 2nd stage audit? Or... can I use the data from previous production? :helpplease:


Regards,


Arya


Dear Arya..

first i want to say that clausul 7.6.3 in ISO 22000 state : ".... Critical limits shall be established to ensure that the identified acceptable level of the Food safety hazard in the end of product not exceeded".. and " Critical limits based on subjective data (such as visual inspection of product, process, handling, etc) shall be supported by instructions or spesifications and/or educations and training"...

And.. in my opinion sortation process is Subjective process.. so.. to validate you must prove that your instruction or training can eliminate all of foreign matter.. for example you have to define lux meter in sorting area is 500 lux. 500 lux is minimal lighting for checking or inspection area.. thats validate document for process sorting.

or

maybe you have to recheck for :..
1. Is your foreign material is significant HAzard ? you have to check severity and
probability of hazard..
2. is other process that can be removed of foreign material? if yes that sorting process
is not CCP..
3. Is other control for contamination possible ? Such as the Supplier can guarantee that
RM not contain any foreign matter...
( in my Company we using Supplier assurance to minimize contaminaton from RM and
we put as control measure for HAzard from RM.. and to make sure the system we do
Supplier audit.)

hope can help you.... :thumbup:


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Posted 02 August 2008 - 03:18 AM

Still (happily) surprised that you're risk analysis passed (smoothly?) so perhaps you hv a very persuasive ability over auditors so maybe anything possible. Hypnotism ? :clap: :clap:



I'll take that as a compliment, thank you... :whistle:

Dear Charles and AS Nur

The process of Meat Extract however very much different than the other process. We didnt use the fresh RM, and yes, the supplier of the other process is much more credible and trustworthy. Besides, we have other CCP to prevent the presence of foreign material on the other process.

As the sortation itself... It is the only way to prevent adulteration, none of the other process able to do that. But in the worst scenario, if the sortation process is loosen, we "may" able to found foreign material at the other step (or maybe cust. complaints), and thats a sign that our CCP is loosen.

The idea of measuring the lux is good. But since we dont have the lux meter, we just determine the watt capacity needs of our lamps. As far as I am concern, the lux value can be converted into watt.

Thank you once again, I hope the other expertise in this forum would lend me a help too.

Regards,


Arya

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Posted 04 August 2008 - 10:06 AM

Dear Arya...

Dont forget to train your Sorting Operator.. and keep the record.. I remember, during last audit of ISO 22000, the auditor ask me to show what the prove document for Visual inspection activities....

And for lux meter, you can buy... i think thats meter quite cheap.. ± Rp. 2.000.000, -... or you can ask to LAB or Technical equipment Supplier....



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Posted 03 June 2019 - 11:20 AM

DEar Arya...

you state the sieve is Control measure of your Hazard (CCP), and you need to validate it... You can do validate by literature background.. if you read FDA doc. (i enclose here).. you can find the foreign materials is dangerous if they have > 7 mm of Dimension.. So if you 20 mesh Sieve can remove the foreign metals, that valid to use sieve as control measure.. and you can monitoring the sieve by visual..

hope make you clear thumbup.gif

Agree with AS Nur. but if you are determine sieving as CCP then you need to determine critical limits (measurable) based on the FDA Doc which is provided by AS NUR. (attachment). but if you make sieving as an OPRP then you can determine measurable critical limit or observable action criteria. in both the cases you need to validate your control measure/s before implementing.

Validation can be done by checking sieve size at different points of by passing particle size more than critical limit.






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