33 replies to this topic

[Biss]

Dear All,

Whether final stage sieving of powder can be a CCP ? One auditor suggested including the sieving activity as a CCP. If sieving is a CCP, then what is the critical limit ?

Thanks in advance

Biss

[Charles.C]

Dear Biss,

I always thought unlikely for any sieving but a recent thread proved to me otherwise, eg

Although I hate to admit defeat smile.gif , 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.

( http://www.ifsqn.com...?showtopic=9986 )

( from memory these were "initial" sievings, also depends what you mean by "final" i guess )
Rgds / Charles.C

added - the first link above is more "informative" than explicit, the second one includes a "final" product CCP (17.0)

[Biss]

 Book2.xls   21.5KB   571 downloadsDear Charles,

thanks for the feedback.

sample flow chart of our process is attached for bettter clarity.

In your opinion whehter the sieving activity can be a CCP?. as per our current hazard analysis, it is PRP.

But our customer insisted to chage it as a CCP. I am finding it difficult to set the critical limt fo rthe activity.

regards

[MartLgn]

Hi Biss.

By coincidence we are just having a similar discussion about our final screening process. My initial thought was that your auditor was being overcautious and it couldnt possibly be a CCP but as I had a pile of HACCP paperwork in front of me already I took a fresh look at it.

Looking at your process diagram I have to say IMO final sieving is a CCP, it is shown as a process step as oposed to a PRP and there is nothing afterwards to remove foreign bodies from the product (assuming the Quality check is an inspection only) , if you apply that to the CCP determination process ( I used the standard Codex decision tree) then by my reckoning you have yourself a CCP.

I suspect your auditor considers your final sieving to be a process step rather than a PRP, if your product is leaving one piece of equipment then being passed through a sieve and then on to another process like packing then Its a step in the process rather than a PRP which would be more like a programme to inspect the integrity of the sieve and how often it was cleaned.

Yout critical limit could be any foreign particles larger than the aperture size of your sieve.

I'd be interested to see what others think of this?

[Charles.C]

Dear Biss,

Well, in principle it logically depends on yr health risk assessment of course unless you are thinking about including some kind of "regulatory HACCP factor" which can be a very debatable area IMO. Not sure about what exactly the diagram step is achieving in this respect, ie as regards to removing a "significant" health hazard which is "reasonably likely to occur". No doubt you know.

BTW, I once had a process with very similar initial stages to yours and I (zealously) denoted that first "sorting" as a CCP in view of risk to consumer's teeth etc. After many defensive arguments with auditors who claimed that nobody else did it and where was my validation, I admitted defeat and quietly demoted it on the face-saving excuse of sufficient experience having demonstrated a negligible frequency of significant risk. Perhaps you can use this route in reverse to ease yr auditor's concerns (or not as your case may be, eg perhaps Indian teeth are unusually fragile or you think the auditor will accept my earlier link [dubious I'm afraid])

Rgds / Charles.C

added - Another "business" leveraged possibility is that yr customer may have an acceptable (to you) specific validation of his own to possibly justify yr issuing a special version on a one-off basis. In that case yr critical limit would presumably need to be geared to the exact situation. This is perhaps analogous to my industry-specific earlier link but less easy if the customer also requires evidence of satisfactory independent auditing. Interested to know more.

[Biss]

Hi Biss.

By coincidence we are just having a similar discussion about our final screening process. My initial thought was that your auditor was being overcautious and it couldnt possibly be a CCP but as I had a pile of HACCP paperwork in front of me already I took a fresh look at it.

Looking at your process diagram I have to say IMO final sieving is a CCP, it is shown as a process step as oposed to a PRP and there is nothing afterwards to remove foreign bodies from the product (assuming the Quality check is an inspection only) , if you apply that to the CCP determination process ( I used the standard Codex decision tree) then by my reckoning you have yourself a CCP.

I suspect your auditor considers your final sieving to be a process step rather than a PRP, if your product is leaving one piece of equipment then being passed through a sieve and then on to another process like packing then Its a step in the process rather than a PRP which would be more like a programme to inspect the integrity of the sieve and how often it was cleaned.

Yout critical limit could be any foreign particles larger than the aperture size of your sieve.

I'd be interested to see what others think of this?

Hi,

thank you very much for the valuable feedback. if we consider the sieving activity as a CCP, then the Hazard to be controlled is foreign particles. I think then the Particles size is the acceptable level of the hazard, not the critical limit. In that case what will be the critical limit ?

[Charles Chew]

Probably the sieve / sifter mesh or micron size to determine what should / should not get through that may be considered both quality (e.g. color ) / food safety concerns (e.g. choking hazard)

[a_andhika]

Hi Biss,

Im so happy to found that someone share the same problem like me . If you dont mind, you can read my topic that mentioned on Charles C's posts (hi there ) . Well, on our system, the critical limit for sieving is: "The Siever Integrity" and "The size of the Siever". If the siever was broken, then it means the critical limit was exceeded, we took the correction by re-sieving the related products. The same correction was prevail on the Size of the Siever. If the size is larger than our standard, then the CCP is exceeded.

FYI, for the validation sake, IMEX, my auditor wants me to validate it by using a smaller aperture size. Because he didnt sure that our siever is able to comprehend all foreign materials, especially the small one. Missfortunately... Humph... I am using the same siever size for my validation (Its fine if some of you say: "how come Arya? "). For another info, my siever size is 20 mesh (about 850 micrometer aperture) and we consider the danger foreign material is having more than 7 mm dimension (based on FDA regulation).

Im widely open for any suggestions or critics if my CCP is considered as "not make any sense" or even "bypassing"

Regards,


Arya

[Charles.C]

Dear Arya / Biss,

As you say, a problem shared is a problem halved. Well, sometimes anyway.

It should be noted that -

(a) Regardless of the FDA 7mm guideline, there are obviously regular withdrawals of food products from the US market seemingly due to risks of “harm” from much smaller sizes of foreign material contamination.

(b) the FDA 7mm compliance document details exceptions and other parameters related to the above 7mm rule eg hard, sharp aspects. See –

http://www.fda.gov/o.../cpg555-425.htm

Other authorities hv “modified” the above guideline for specific situations, eg, 5mm by NZFA –

http://www.nzfsa.gov...t-4/page-03.htm

The second link considers the specific foreign materials involved (shell) to be a “wholesomeness” factor.

This can be the problem with generic-type solutions-validations, they offer valuable options but the final decision has to make HACCP sense for the actual product / process and seemingly increasingly frequently (and arguably ??), also any relevant regulations.

I thought this comment was also of interest (the link also discusses possible “critical limits”) –

Glass fragments can cause injury to the consumer. FDA's Health Hazard Evaluation Board has supported regulatory action against products with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See FDA Compliance Policy Guide #555.425

http://seafood.ucdav.....DA Guidelines

So apparently a 5mm piece of glass is considered (statistically) harmless ? Not to my way of eating thank you!

I'm in no way dismissing the already offered suggestions but still think that need more on the actual situation, eg product / customer / specifications ? More precisely, what is the risk ??

Rgds Charles.C

[a_andhika]

Dear Charles C.,

A very good point of view, indeed. Well, the choosen of 7 mm as a minimum dimension is somehow ridiculous to other people. But, the further question is, how did you prevent the 5 mm objects for being contaminate your foods? If it was a metal substance, the metal catcher was possibly able to accomplished that task (some metal catcher do not able to catch that size of metal). But what about the non-metal substance?

IMO, the sieving is the most possible way. But the problem is, how is the characteristic of our products? For example, my products is a powder form that well passed through 20 mesh (about 0.85 mm aperture). As blink of an eye, it safe for the 7 mm dimension. But a wire with 10 mm length, but with diameter size 0.5 mm, can easily through the siever! That wire only can be detained by 60 mesh siever size. But if I am using 60 mesh size, most of my products will be detained too.

So IMO, if we will use sieving as a preventive purpose, we should look at the characteristics of our products and the threatening foreign material. Frankly speaking, I cannot use a tighter regulation than the FDA, because the consecuence is I will loose most of my products. But I still need to convince my auditor (by hypnotism or voodoo?), that our threatening foreign material is not a kind like wire that I've mentioned on the above. From the historical data, we only found plastics, wood, rubber, that can be detained on 20 mesh siever.

Regards,


Arya

[Charles.C]

Dear Arya,

Well, unless you have a classified "high risk" product etc and/or you are perhaps getting 100 incidences / day (?!), it appears to me that -

(Severity x Likelihood of occurrence) >> not significant (esp. if prioritised on the L.o.o.)

It then requires the auditor / customer to justify his disagreement to the risk evaluation or find a mutually acceptable compromise

Rgds / Charles.C

[AS NUR]

Dear Charles C.,

A very good point of view, indeed. Well, the choosen of 7 mm as a minimum dimension is somehow ridiculous to other people. But, the further question is, how did you prevent the 5 mm objects for being contaminate your foods? If it was a metal substance, the metal catcher was possibly able to accomplished that task (some metal catcher do not able to catch that size of metal). But what about the non-metal substance?

IMO, the sieving is the most possible way. But the problem is, how is the characteristic of our products? For example, my products is a powder form that well passed through 20 mesh (about 0.85 mm aperture). As blink of an eye, it safe for the 7 mm dimension. But a wire with 10 mm length, but with diameter size 0.5 mm, can easily through the siever! That wire only can be detained by 60 mesh siever size. But if I am using 60 mesh size, most of my products will be detained too.

So IMO, if we will use sieving as a preventive purpose, we should look at the characteristics of our products and the threatening foreign material. Frankly speaking, I cannot use a tighter regulation than the FDA, because the consecuence is I will loose most of my products. But I still need to convince my auditor (by hypnotism or voodoo?), that our threatening foreign material is not a kind like wire that I've mentioned on the above. From the historical data, we only found plastics, wood, rubber, that can be detained on 20 mesh siever.

Regards,


Arya

Dear Arya...

The best way is preventive action... so. first you have to identified where and how the contamination (Plastic, wood etc) come?... and if the source is Raw material you have concern about supplier assurance on food safety.. or if the source come from your process.. you have to control your process...


In my process... we have sieveter too, to screen any foreign matter.. but we already indetified that the source of foreign matter come from Gasket (sealant)..so we do preventive maintenance to check condition and to make sure theres no broken gasket in our machine...And preventive maintenance is PRP for us and sieveter is not CCP (only OPRP)...

[Raj21]

Hello Forum,

In my opinion,sieving should be a CCP due to the fact that there are no controls in place beyond the sieving operation to take care of physical contaminants, exception being metallic impurities which can be checked with a metal detector.

As mentioned the critical limit can be the integrity of the sieve and it can be monitored at regular specified intervals depending the size,volume & type of the operation.

Prior to arriving at the decision, validation of the sieve size is also a prime requirement.

I would like to know what others think of this.
Regards,
Rajesh.

[Biss]

Hi All,

In our case, I think sieving activity is more like a OPRP. our auditor is more concerned about the integrity check of the sieve before and after every batch. we are using SS sieve so the possibility of failureis very less.

regards

[Ganesh]

Dear Biss,

Having worked in this industry I believe you should have series of sieves of fine size before pulverisation that would take care of physical hazards. If seiving is a CCP then the critical limit would be intactness of the sieve and the sieve size

regards
Ganesh

Edited by Ganesh, 15 August 2008 - 04:23 AM.

[wamamili]

Its quite unfortunate that have joined discussion quite late but its quite interesting, Have never worked with sieves but have experience in haccp. But I look at the whole issue this way. If I were to select sieving as a ccp then I should have the following at hand, hazards not just foreign matter i.e wood, glass, metal etc. are they significant? i.e glass, metal etc critical limit should be zero. Is the mesh used being able to give me recommended final product requirements =0 can I justify???. For monitoring I believe we have glass or metal detectors. Of course one way of validating detectors is by sieving. To me sieving might not be a processing step but I can choose another step where glass or metal is controlled. Am I making stories?

[GMO]

I have included sieves as CCPs in the past as they were sieving a rework process which had some associated hazards. The other reason some sieves might be identified as CCPs is when they break up (especially the Russell vibrating sieve kind) they might introduce metal contamination which cannot be picked up by a metal detector because the sieve wire thickness is below the minimum size of detection. Therefore, your monitoring in such a situation is to check the sieve is intact to check it still can sieve out contaminants but also it's intact so it's not introducing contaminants.

As a result of the above argument; I would always say have a sieve if the HACCP or quality plan demands it but if it doesn't; having a sieve may cause more problems than it solves.

[Franco]

if we consider the sieving activity as a CCP, then the Hazard to be controlled is foreign particles.

Hi Biss,

it's just the other way round: if you evaluate that foreign particles are a significant hazard and the only step in your process to control the hazard on 100% of the product and providing real time reaction is sieving, then sieving is a CCP.

I think then the Particles size is the acceptable level of the hazard, not the critical limit. In that case what will be the critical limit ?[/size][/font]

Hi Biss,

you're right.

The critical limit is a value of a process parameter.

Values lower than the critical limit results in safe food, higher results in unsafe food.

The critical limit could be the mesh number of the sieve, but it seems hard to monitor it and react in real time.

[Charles.C]

Dear Franco (and Biss)

Thks yr perceptive post and very nice to hear from you.

I believe this whole topic is helped / distorted (not really sure which) by all the various chronological variations which hv been placed on the HACCP idea with the intention to make it more general / more logical etc etc. As a result, seems to me that it is often very difficult to state whether a particular viewpoint is correct or not in an absolute sense but at least one needs to try and validate a choice in a manner which is intelligibly transparent to a neutral reader.

For example, here is (I think) one simple route to validation of sieving as a CCP via Codex tree (I personally don't like the tree method very much but it does have its uses ) –
 detector_as_a_codex_ccp.jpg   65.8KB   105 downloads

(detecting foreign bodies in foods / M.Edwards)
For Info, note that the ilsi organisation offer a, perhaps, more “generalised” decision tree procedure than codex –
 ilsi_decision_tree.jpg   33.27KB   92 downloads

(source - International Food Safety Handbook - Kees A. van der Heijden, Sanford Miller)

Regarding critical limits (c.l), the same above initial general comment applies IMO. Control measures as such were sort of under-emphasized in the original haccp works as compared to the ISO 22000 methodology and I won’t create a +/- discussion on that however a lot of thought was still inputted on the c.l. requirements – eg consider this text (Pierson / Corlett 1992) [pre – Codex haccp I guess] –

The decision criteria on the selection of a critical limit should be based on the following considerations –

1.evidence of the existence of a health hazard (eg hazardous metal findings on the final magnet)
2. evidence that a health hazard could develop (eg underprocessing of low-acid canned food)
3. indications that a product was not produced under conditions assuring safety (eg metal detector kick outs)
4. indications that a raw material may affect the safety of the product (eg pesticide audit detects aldicarb at high levels)

And this from same source –

Physical Critical Limits
Identification of physical hazards in a food processing system is straightforward. Any physical matter that is not normally found in a food is considered an adulterant. Those that present a health hazard are physical hazards (p.h.) of concern. Such p.h. would include glass, metal, wood, stones, bones, plastic and employee personal effects. To be hazardous these materials would be of such size and shape that they pose a potential health hazard concern.
Limits on ccps associated with p.hs are the most straightforward. (!!!!). Critical limits on p.hs will be zero or nondetectable. Metal detectors, magnets, screens and sifters can be used to detect most physical hazards. Functioning of this equipment would be such that p.hs would be removed or detected to meet the zero or nondetectable Crit.Limit. The most important function in this area is not in setting the limit, but in assuring proper installation of the equipment in the system, in verifying (validating ???) the calibration of the equipment, in checking of tailings (screens and sifters) for the foreign material, and in maintaining the equipment.
Most (??) manufacturers specify on their purchase orders or their ingredient specs that all product delivered from a supplier must be free of “all forms of foreign and extraneous matter as can be achieved by Good Manufacturing Practices”. The manufacturer should also verify the existence of a supplier haccp program or at a minimum sufficient product protection devices are present, functioning, and properly maintained to prevent physical hazards from contaminating his potential ingredients.

Examples of physical hazard CCPs and the assoc crit.limits are –
Metal detector
- rejection of 3/32” series 400 stainless steel sphere 100% of time (calibration)
- no hazardous metal, ferrous and non-ferrous detectable

Magnet
- no hazardous metal

Screen
- Size ( will depend on product)
- In good repair
- tailings ( no hazardous findings, specific requirements are product dependent)

Some more recent views on crit. limits of above type are here -

 crit.limit_detectors_1.jpg   23.2KB   80 downloads
(The Certified HACCP Auditor Handbook - John G. Surak, Steven Wilson)

The reason for the above "zero" reservation on metal detectors is here –
 crit.limits_detectors_2.jpg   48.32KB   67 downloads
(1st ref.above)

Hopefully the above gives a few more insights into the background of this topic.

Rgds / Charles.C

[Erasmo]

Dear All,

Whether final stage sieving of powder can be a CCP ? One auditor suggested including the sieving activity as a CCP. If sieving is a CCP, then what is the critical limit ?

Thanks in advance

Biss

It is not correct that an auditor "suggest" the selection of control measures. He/She need to be very careful with his/her opinions. But if you need opinions, please consider opPRP - it contains all the elements of one CCP except for the critical limit.... Please remember not to confuse the critical limits with the acceptable levels of a hazard.
Saludos

[Biss]

hi,

thanks for the feedback.
we have included it as a OPRP by checking the integrity of sieve before and after every batch

regards

[AS NUR]

congrats Bss.. the forum can give you the enlightment...hope youi can sucess with the system..and the important think is how to implement and practice your knowledge...

[Abdul Qudoos]

Dear All,

Whether final stage sieving of powder can be a CCP ? One auditor suggested including the sieving activity as a CCP. If sieving is a CCP, then what is the critical limit ?

Thanks in advance

Biss

Greetings to all,

As i explained previously, Sieving may be a CCP in powder formulations, we have kept CCP in powder formulation and everyone agrees, the critical limits are: proper sieving at maximum 4 mm size in diameter of holes and online monitoring (i.e. our internal standard)

The customer requires always 'zero' physical hazard in product.

[cazyncymru]

Good Morning!

I've been reading this topic with particular interest this morning as i have a similar problem.

One of the retailers has asked us to sieve our ingredients prior to blending our base mix. Now all of the ingredients that are in powder form are sieved as part of the supplier criteria. There are some ingredients, such as starches, that cannot be sieved or they would lose their functionality. Also, further ingredients such as diced vegetables are added once the base mix is made (usually dairy based mixes, so ingredients such as mustard, salt and sugars are added to yogurt, sour creams or soft cheeses)

My understanding is, and someone correct me if i'm wrong, is that this cannot be a CCP as we are not eliminating or controlling the risk of foreign bodies from ingredients, as i am adding further ingredients, which to me carry a higher risk, further on in the process. Also, I'm struggling to decide what size mesh i should be using for the powdered ingredients, without these products losing functionality. Ideally all i want is a one size fits all sieve, but i don't think that would go down well as my justification! I know i can say that my suppliers sieve through a 1mm or 2mm sieve, but is that justification enough to say i can use a 2.5mm sieve?

Caz x

Edited by cazyncymru, 25 March 2011 - 09:30 AM.

[GMO]

Good Morning!

I've been reading this topic with particular interest this morning as i have a similar problem.

One of the retailers has asked us to sieve our ingredients prior to blending our base mix. Now all of the ingredients that are in powder form are sieved as part of the supplier criteria. There are some ingredients, such as starches, that cannot be sieved or they would lose their functionality. Also, further ingredients such as diced vegetables are added once the base mix is made (usually dairy based mixes, so ingredients such as mustard, salt and sugars are added to yogurt, sour creams or soft cheeses)

My understanding is, and someone correct me if i'm wrong, is that this cannot be a CCP as we are not eliminating or controlling the risk of foreign bodies from ingredients, as i am adding further ingredients, which to me carry a higher risk, further on in the process. Also, I'm struggling to decide what size mesh i should be using for the powdered ingredients, without these products losing functionality. Ideally all i want is a one size fits all sieve, but i don't think that would go down well as my justification! I know i can say that my suppliers sieve through a 1mm or 2mm sieve, but is that justification enough to say i can use a 2.5mm sieve?

Caz x

I hate it when customers start meddling. Anyway, perhaps you need to think about it the other way. Would a contaminant of 2.5mm be a problem? If not, then a 2.5mm sieve is fine even if it "feels" too big. There are few products which could be metal detected to 2.5mm stainless steel (without using an x-ray anyway) and I would suggest that 2.5mm would be seen as a very tight critical limit for metal detection so I don't see a problem with that for sieving tbh.