33 replies to this topic

[Charles.C]

Dear Caz,

Hi there!

I think that Franco’s earlier succint post #18 gives the best quick answer to yr CCP question but how one meaningfully quantitates a (generic?) critical particle size I hv no idea. The USA 7mm was from memory based on “incident” data. According to a recent thread, another “official” limit of 2mm has apparently been adopted in some countries (I think the poster was from Netherlands). Justification i don't remember (if any).
I also expect it is easy to find USA cases of “voluntary” recalls for contaminants << 2mm, eg baby foods.
(The above is one pragmatic reason for the use of metal detector sensitivities as CLs of course)

Rgds / Charles.C

PS No subsequent metal detectors ? Easy get-out

Or are we talking about stones ? Even more complicated.

[cristaleo]

According to a recent thread, another “official” limit of 2mm has apparently been adopted in some countries (I think the poster was from Netherlands). Justification i don't remember (if any).

Brazil is considering adopting such a small limit. Really don't know on what basis.

[harmsome]

First time posting here.

 

Our product is in powder form and we have a sifter with screen mesh at 70. If we are to set the tailings in our sifter as our CCP, how the we set the limit? 

[Charles.C]

First time posting here.

 

Our product is in powder form and we have a sifter with screen mesh at 70. If we are to set the tailings in our sifter as our CCP, how the we set the limit? 

 

There is no single globally validatable textbook answer to yr query. As is evident from the preceding posts.

 

Yr standard/product/process may be related.

 

Yr local/destination Regulatory requirements may be related.

 

Yr consumer.

 

Answers for CL typically seen in the literature are often one of those mentioned in post 19, ie -

 

Screen
- Size ( will depend on product et al.)
- In good repair (= sieve integrity)
- tailings ( no hazardous findings, specific requirements are product dependent)

 

 

Specific size (typically of hard/sharp material) which is  regarded as "hazardous" / auditorially acceptable could range from >0 up to 7mm if you wish to select from one of USA, Canada,Netherlands norms.

 

70 screen mesh is what diameter ?

[EvaB]

Hello everybody,

 

so far I have understood sieving not to be a CCP, as it is difficult to set exact parameters - at least in our case. We granulate and sieve dehydrated vegetables through square mesh stainless steel sieves.

 

We had the sieving set as an oPRP for this year's FSSC 22000 audit for the first time and the auditor said we should take a second look and check our evaluation. Any product that we sieve that is 6x6 mm and larger could theoretically still have a stone or a piece of hard EVM 7x7 mm and larger, as the diagonal of 6x6 mm is >7 mm. Also, slender pieces can find their way through sieve openings, a slim piece of stalk or stem for example. The critical limit can only ever be set at a size larger than the target product size. Can such a variable be set as a critical limit?

 

Looking forward to receiving some input. Thanks a million!

Eva

[FSQA MKE]

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

The critical limit the auditor is referring to may be "condition" of the sieve. Whether damage is present or not. So inspect sieve for condition prior to production start, at end of production run, and at other pre-determined intervals.

If this is merely a suggestion, kindly nod & agree with the auditor and move on with normal operations.

[Charles.C]

Hello everybody,

 

so far I have understood sieving not to be a CCP, as it is difficult to set exact parameters - at least in our case. We granulate and sieve dehydrated vegetables through square mesh stainless steel sieves.

 

We had the sieving set as an oPRP for this year's FSSC 22000 audit for the first time and the auditor said we should take a second look and check our evaluation. Any product that we sieve that is 6x6 mm and larger could theoretically still have a stone or a piece of hard EVM 7x7 mm and larger, as the diagonal of 6x6 mm is >7 mm. Also, slender pieces can find their way through sieve openings, a slim piece of stalk or stem for example. The critical limit can only ever be set at a size larger than the target product size. Can such a variable be set as a critical limit?

 

Looking forward to receiving some input. Thanks a million!

Eva

 

Hi Eva,

 

IMO the auditor should have elaborated the reason for his request. Or you should have asked.

 

I deduce yr (audited) action limit related to the sieve mesh size. IMEX sieve integrity is a more usual decision criterion which would presumably now compel an OPRP within iso22000:2018. (Can blame iso for this oddity).

 

Choice of mesh size inevitably overlaps the concept of what size constitutes a significant  hazardous foreign body. The latter may depend on yr process, location, product status (eg RTE), intended customer, etc. The many posts in this thread illustrate the potential philosophical complexities involved.

 

If my deduction is correct I suggest to change the action limit.

[EvaB]

Hi Eva,

 

IMO the auditor should have elaborated the reason for his request. Or you should have asked.

 

I deduce yr (audited) action limit related to the sieve mesh size. IMEX sieve integrity is a more usual decision criterion which would presumably now compel an OPRP within iso22000:2018. (Can blame iso for this oddity).

 

Choice of mesh size inevitably overlaps the concept of what size constitutes a significant  hazardous foreign body. The latter may depend on yr process, location, product status (eg RTE), intended customer, etc. The many posts in this thread illustrate the potential philosophical complexities involved.

 

If my deduction is correct I suggest to change the action limit.

 

Thanks Charles!

 

The auditor said he wasn't allowed to advise, so I didn't really feel in a position to question further. 

 

The point of argument was, however, the 7 mm (FDA) critical limit we had set ourselves and the fact that we have products larger than 7 mm for which we cannot then make any guarantees. Also, to go into more detail, I had set the actual action of granulation + the granulation sieve as the oPRP, as any hazardous foreign bodies present would be reduced in size here and stay within the granulation unit until small enough to pass through the granulation sieve. The problem: some of these sieves have openings of 7 mm and larger. I think he meant that the subsequent tumbler screening machine should be the oPRP, if at all. But that poses the same problem for me, hence my initial question . Documented before/after screen checks have been part of our process for years anyway. 

 

What isn't helping is that we brought our HACCP in line with our HARPC this year and the FDA speaks of PCs. We have possilby been much more stringent with ourselves than necessary. 

 

If we change the mode of argument from "critical limit" to "acceptable level of hazard", as mentioned in earlier posts, things relax a little. We also need to re-evaluate how large the risk is in the first place, as we may be making mountains out of molehills. 

 

Thanks for your help and for this forum & platform!!!

 

Stay safe,

Eva

[Charles.C]

Thanks Charles!

 

The auditor said he wasn't allowed to advise, so I didn't really feel in a position to question further. 

 

The point of argument was, however, the 7 mm (FDA) critical limit we had set ourselves and the fact that we have products larger than 7 mm for which we cannot then make any guarantees. Also, to go into more detail, I had set the actual action of granulation + the granulation sieve as the oPRP, as any hazardous foreign bodies present would be reduced in size here and stay within the granulation unit until small enough to pass through the granulation sieve. The problem: some of these sieves have openings of 7 mm and larger. I think he meant that the subsequent tumbler screening machine should be the oPRP, if at all. But that poses the same problem for me, hence my initial question . Documented before/after screen checks have been part of our process for years anyway. 

 

What isn't helping is that we brought our HACCP in line with our HARPC this year and the FDA speaks of PCs. We have possilby been much more stringent with ourselves than necessary. 

 

If we change the mode of argument from "critical limit" to "acceptable level of hazard", as mentioned in earlier posts, things relax a little. We also need to re-evaluate how large the risk is in the first place, as we may be making mountains out of molehills. 

 

Thanks for your help and for this forum & platform!!!

 

Stay safe,

Eva

 

Hi Eva,

 

Thks clarifications.

 

I think there may be some confusion over terminologies in iso22000 standard. And perhaps in correspondences to PCs. For example (iso22000, clause 8.5.4.3) -

 

For each OPRP, a monitoring system shall be established for the control measure or combination of control measure(s) to detect failure to meet the action criterion.

 

( Note CL is no longer an appropriate term)

 

As far as FDA's "7mm" criterion is concerned I suggest you examine (re-examine ?) the fine details in the relevant document which is attached below -

 FDA metal contamination - CPG-Sec.-555.425--Foods--Adulteration-Involving-hard-or-Sharp-Foreign-Objects.pdf   15.08KB   12 downloads

 (IMO, notwithstanding "hazard arguments" usage of a 7mm action criterion/CL is unacceptable in many actual cases simply from a practical POV)(also see the following example)

 

Here is a FDA/haccp plan example illustrating the former's philosophy on metal contamination/detectors which you can compare to yr present situation -

 

 FDA,metal detection CCP.pdf   123.49KB   11 downloads

 

PS - I'm not familiar with PC's requirements  but the details involved are presumably also Regulatory related if in USA.