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#1 QAD_Rebisco

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Posted 04 July 2013 - 09:19 AM

What metal size can the special risk group (infants, surgery patients and the elderly) tolerate? Regulation says that "The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly". Does it mean that even metal dust is not allowed for this special risk group? I need this info since we are applying for HACCP certification. Regulation says that less than 7 mm is allowed as long as we state in our "Sensitive Population" - not suitable for special risk group, but I would not like to do that since I will be stating "For general consumption". Our product is ready-to-eat snack foods.

Pls. help. Thanks

 

 

Regards

 

QAD_Rebisco



#2 SQFconsultant

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Posted 05 July 2013 - 10:56 PM

I have never heard of an "acceptable" metal size in finished product.


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#3 QAD_Rebisco

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Posted 05 July 2013 - 11:34 PM

I have never heard of an "acceptable" metal size in finished product.

Hi!,

I mean, What metal size can the special risk group (infants, surgery patients and the elderly) tolerate?



#4 Charles.C

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Posted 06 July 2013 - 04:14 AM

What metal size can the special risk group (infants, surgery patients and the elderly) tolerate? Regulation says that "The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly". Does it mean that even metal dust is not allowed for this special risk group? I need this info since we are applying for HACCP certification. Regulation says that less than 7 mm is allowed as long as we state in our "Sensitive Population" - not suitable for special risk group, but I would not like to do that since I will be stating "For general consumption". Our product is ready-to-eat snack foods.

Pls. help. Thanks

 

 

Regards

 

QAD_Rebisco

 

Dear QADRebisco,

 

A specific, generally applicable, answer to the question for a lower rejection limit in the OP probably does not exist. A general lower (rejection) answer to yr query based on US approach might be <7mm (see text in the link / example below).

 

The question is not semantically unreasonable but any answer could depend on many factors, eg legislation, operational factors (food matrix, actual situation, etc) and especially as to the interpretation of the word  “acceptable”.

 

Referring to metal contamination of food, here are a few typical examples of  interpretations of “acceptable” which can be found in the literature (various others exist) –

 

(a) Local legislation requires an absence of metal concentration in food products.

 (This obviously requires a further definition / interpretation of “absence” which might come via the options given below, or other literature refs, or self-defined (?)).

 

(b) the food product shall not contain any metallic contamination which is detected by a metal detector. (This obviously requires a further statement as to the  detection level capabilities of the metal detector for a particular food matrix, or as is often the [HACCP] case, ability to detect / reject a standard sized / configuration reference “sample” of  one or more types of metal).

 

(c) The food product shall not be “adulterated”.

This terminology in USA as applied  to metal contamination is summarized  in a well-known  document –

http://www.fda.gov/I...l/ucm074554.htm

 

As you probably know, above is based on a previous US “incident”  study and contains a summary of USFDA interpretations / guidelines which are apparently used  for initiating legal action. No specific lower action limit is given  for “vulnerable” groups (and AFAIK never subsequently elaborated by USFDA in print). Other countries have adopted  their own terminologies / action criteria / categories, eg a  maximum size limit of 2mm is apparently in legislatory use in Belgium within their category system.

 

(d) An example of a general response to the semantic aspect of the problem is this ISO22004 quote -

 

Hazard identification and determination of acceptable levels

 

Where statutory and regulatory authorities have established maximum limits, objectives, targets or end product and/or process criteria for a specific hazard/product combination, the hazard in question automatically becomes relevant for that product.

 

The  “acceptable  level”  means  the  level  of  a  particular  hazard  in  the  end  product  of  the  organization  that  is needed at the next step in the food chain to ensure food safety; it refers to the acceptable level in foods for direct consumption only when the next step is actual consumption. The acceptable level in the end product should be determined through information obtained from one or more of the sources below:

a)   objectives, targets or end product criteria established by statutory and regulatory authorities in the country of sale;

b)   specifications or other information communicated by the organization constituting the subsequent step in the food chain (often the customer), in particular for end products intended for further processing or use other than direct consumption;

c)   the  maximum  levels  found  acceptable  by  the  food  safety  team,  taking  into  account  acceptable  levels agreed  on  with  the  customer  and/or  established  by  law  and,  in  the  absence  thereof,  through  scientific literature and professional experience.

 

 

So any particular HACCP study typically has to make its own “action” decision / critical limits based on factors like above / available choices (possibly local driven).

 

Here is a US  (HACCP) document which  compares  some possible action criteria  where a metal detector may / (may not be) in use.

 

Attached File  Fishery Hazards and Control Guidance 2011.pdf   4.34MB   234 downloads

(See Ch20, Pg 385)

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#5 Charles.C

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Posted 06 July 2013 - 11:37 AM

Dear QADRebisco,

 

(Addendum to previous post).

 

I presume that the “Board / Regulations / target consumer comments” you are referring to in your OP are local legislatory requirements rather than the HACCP Plan itself ?. The (general) statement “less than 7 mm is allowed as long as we state in our "Sensitive Population" - not suitable for special risk group” appears very peculiar to me although I can see the basis of its derivation from link in previous post. (Seems to imply that an unlimited quantity of 6mm metal particles would be OK.?)

 

I found a USFDA inspection report (mc1, attached below) for a manufacturer whose product / HACCP Plan, I deduce, included the “special risk group” as a potential consumer. The Plan probably  used a 7mm rejection criterion. The (extracted) FDA criticism and their suggested correction were -

.

B. Your HACCP plan for seafood salads at the "Vegetable Processing" CCP lists the critical limit of "No metal particles in excess of (b)(4) mm". This critical limit is not adequate to control metal fragments that may cause trauma or serious injury. FDA recommends a critical limit at metal detection of "no detectable metal fragments" because foreign objects that are less than (b)(4) mm may cause trauma or injury to persons in special risk groups, such as infants, surgery patients, and the elderly.

 

 

Attached File  mc1 - metal contamination.pdf   78.39KB   294 downloads

 

As you  can see the objective is nil metal contamination although any metal detector inevitably has some detection limitations. Perhaps this approach / format is usable in yr own case (?).

 

Rgds / Charles.C


Edited by Charles.C, 06 July 2013 - 03:40 PM.
text edited

Kind Regards,

 

Charles.C


#6 QAD_Rebisco

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Posted 11 July 2013 - 12:53 AM

Dear Charles,

 

In our Product Description, we stated in our Intended Use -- For general consumption -. However, during the Stage 1 Audit, the SGS auditor commented that we should define in our hazard analysis the size of the hazard (originally we stated "no metal fragments") since FDA states a maximum of 6.9 mm but gave no tolerance for special risk group. However, our smallest metal test piece is 2.0 mm. If we set "no metal fragments" since ---FDA recommends a critical limit at metal detection of "no detectable metal fragments" because foreign objects that are less than (b)(4) mm may cause trauma or injury to persons in special risk groups, such as infants, surgery patients, and the elderly.--- then what verification can we have to really prove that even metal dust can be intercepted by our MD? I find it confusing. Your feedback would greatly help.

 

Thanks

 

Mel / QAD Rebisco



#7 QAD_Rebisco

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Posted 11 July 2013 - 02:38 AM

Dear Charles,

 

(Addendum to previous post).

 

If we say "no detectable metal fragments" , my interpretation is no metal fragments in a size of metal test piece and above..say we have a 2.0 mm test piece..then there should be no 2.0 mm and above metal fragments. Meaning, it's ok to have a metal fragment less than 2.0 mm since since the Critical Limit states only "no detectable metal fragments" . Then what about the special risk group? Since they cannot tolerate any metal fragments "The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly."

 

Thanks a lot

 

Mel / QAD Rebisco



#8 cazyncymru

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Posted 11 July 2013 - 09:06 AM

Personally, I think that the acceptable metal foreign body size in a product is zero.

 

However, regardless of which system you use, whether it is metal detectors or X-Ray, you will never find a piece of kit that will detect the smallest , tiniest piece of metal, so you have to carry out the magical risk assessment. You would need to establish your customer base, and whether this base consists of any of the vulnerable groups, and then taking into account product size, density, viscosity, particle sizes etc and the sensitivity of your detection equipment and whether this is adequate is a justification you must make. Different manufacturers use different criteria, and who is say who is wrong. I have a supplier who sends me bulk product having passed through a metal detector using test pieces of 5mm (Fe & non-Fe). Yet my finished product passes through a metal detector that is set with test pieces of 2mm (Fe & non-Fe). Which one of us is right? As long as the justification is there. You should also use information supplied to you from the supplier of your metal detectors as part of your validation.

 

Caz x



#9 David Pham

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Posted 11 July 2013 - 12:34 PM

Dear Charles,

 

(Addendum to previous post).

 

If we say "no detectable metal fragments" , my interpretation is no metal fragments in a size of metal test piece and above..say we have a 2.0 mm test piece..then there should be no 2.0 mm and above metal fragments. Meaning, it's ok to have a metal fragment less than 2.0 mm since since the Critical Limit states only "no detectable metal fragments" . Then what about the special risk group? Since they cannot tolerate any metal fragments "The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly."

 

Thanks a lot

 

Mel / QAD Rebisco

Ideally you do not want to have any metal in your product, however if you are detecting 2.0mm test wands then I would say you have done your due diligence. As long as you keep up with your equipment certifications and have all the needed documents to say that you do. 7mm is an industry standard for metal detection however there is no clear definiition on that. The 7mm standard isn't very clear IMO, when you look at it a 7mm piece of wire small gauge wire vs a 7mm ball bearing the damage caused would be much different between the 2. But if you took the 7mm ball bearing and stripped it down to a thin piece of wire you would have a much greater length. Just a thought. At our facility we use 3.0mm test wands and have found pieces much smaller than that, luckly we haven't had any major issues so far. With all the technology today we could use xray technology but even that isn't fool proof.


Edited by David Pham, 11 July 2013 - 12:35 PM.


#10 Charles.C

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Posted 11 July 2013 - 04:41 PM

Dear QADRebisco,

 

I do agree with you that this topic is confusing. Personally I hv never encountered a comment like the one you are mentioning (but I have also never used a critical limit of “nil” contamination either). I  predict that different auditors may have varying interpretations / expectations, possibly  depending on things like the particular food standard involved and perhaps a local consideration. It appears that yr auditor is locked into (an interpretation of) the USFDA viewpoint ? I will attempt to give a pragmatic response rather than a philosophical one.

 

If yr auditor actually required you to nominate a  size of metallic contamination which does not represent a "significant risk " for the “special risk group (SRG)”, I would have challenged this request. AFAIK, it simply does not exist, at least from a USFDA viewpoint anyway. Is it possible that the auditor's comment was incompletely stated / quoted.?

 

I suggest you re-read the (USFDA) Ch 20 I mentioned earlier. Particularly refer to the summarised example  haccp plan (pg 390). IMO this table and the surrounding  text is closely matched to the FDA format I quoted in post #4. It includes verification requirements. Note that the opening page specifically includes SRGs.  It also illustrates  the problem of defining meaningful size tolerances in the current context.

 

Whether this haccp approach would be acceptable to yr auditor I don’t know. I think you are probably going to have to do a little more “pushing” on the auditor :smile: .

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#11 AlexHayes

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Posted 23 July 2014 - 04:05 PM

Hi Charles, 

 

I just read your post. The FDA text you quoted makes mention of "no detectable metal fragments".  -How do you suppose the FDA might react to a an increase in detectability of metal fragments?

 

I'm asking because I work at a startup that is considering developing a detector that could detect 0.2 mm particles. It is not based on inductive coils, which is why we believe we can circumvent current limitations in accuracy. In general we are trying to gather information on metal detection and quality assurance, so any input is appreciated.

 

Cheers,

-Alex



#12 Snookie

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Posted 23 July 2014 - 04:45 PM

Hi Charles, 

 

I just read your post. The FDA text you quoted makes mention of "no detectable metal fragments".  -How do you suppose the FDA might react to a an increase in detectability of metal fragments?

 

I'm asking because I work at a startup that is considering developing a detector that could detect 0.2 mm particles. It is not based on inductive coils, which is why we believe we can circumvent current limitations in accuracy. In general we are trying to gather information on metal detection and quality assurance, so any input is appreciated.

 

Cheers,

-Alex

 

FDA will love it...customers will be ecstatic.    Some equipment and processes can generate very small pieces of metals, including shavings that are so small that they are almost imperceptible to the eye.  It is unusual but possible.  The question is.....is it dangerous.  If it is not sharp then perhaps not.  I would guess that most of the type of metal used in the food industry would most likely pass through the intestinal tract fairly quickly with little to no adverse effect. The question is how will it function in real life and what is the cost? 


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#13 AlexHayes

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Posted 23 July 2014 - 05:45 PM

FDA will love it...customers will be ecstatic.    Some equipment and processes can generate very small pieces of metals, including shavings that are so small that they are almost imperceptible to the eye.  It is unusual but possible.  The question is.....is it dangerous.  If it is not sharp then perhaps not.  I would guess that most of the type of metal used in the food industry would most likely pass through the intestinal tract fairly quickly with little to no adverse effect. The question is how will it function in real life and what is the cost? 

 

Hi Snookie,

 

you're right, anything below what current detectors notice passes through the intestinal tract without problems (at least in adults), so the accuracy might only be nice for protecting other production machinery. Some sources say 7mm is medically okay, others only 3mm. Since the current detection limit is 1mm, the medical need should be covered.

 

The weak point is reliability.

I did some research and found many factors that cause metal detectors to pass larger fragments than it should, or for instance wires (If oriented a certain way, sensitivity is low). Also, vibrations are generally a large issue, false calibration, change in temperature, too low or high operating temperature, changes in food throughput, metals in the surrounding. Today I spoke with a company in Switzerland that had a detector waste lots of food because it reacted to a metal plate that someone put nearby. Although the largest issue is probably that the inductive coil technology that they operate difficulties not reacting to food. 

 

We already have initial concepts to sidestep all of the above issues, but still ought to build a prototype (perhaps within 2 or 3 months). 

 

– Oh, and the current detectors have a lower sensitivity to steel, and at the center of the detector.

 

Maybe reliability is the most important argument for going through the trouble of building a different sensor. One of my co-founders recently had some extra crunch in his lunch by two long and thick copper wires ;)

 

 

Regards,

 

 

-Alex

 

 

 

PS: To answer your question about cost: Once they are ready, we might be able to sell them for between $50'000 and $100'000, but that is still very much up in the air. I've heard of sensors being sold for as much as up to $155k, but I'm not sure whether these are only used by a few extremely diligent processing companies. 



#14 Snookie

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Posted 23 July 2014 - 06:10 PM

Hi Snookie,

 

you're right, anything below what current detectors notice passes through the intestinal tract without problems (at least in adults), so the accuracy might only be nice for protecting other production machinery. Some sources say 7mm is medically okay, others only 3mm. Since the current detection limit is 1mm, the medical need should be covered.

 

The weak point is reliability.

I did some research and found many factors that cause metal detectors to pass larger fragments than it should, or for instance wires (If oriented a certain way, sensitivity is low). Also, vibrations are generally a large issue, false calibration, change in temperature, too low or high operating temperature, changes in food throughput, metals in the surrounding. Today I spoke with a company in Switzerland that had a detector waste lots of food because it reacted to a metal plate that someone put nearby. Although the largest issue is probably that the inductive coil technology that they operate difficulties not reacting to food. 

 

We already have initial concepts to sidestep all of the above issues, but still ought to build a prototype (perhaps within 2 or 3 months). 

 

– Oh, and the current detectors have a lower sensitivity to steel, and at the center of the detector.

 

Maybe reliability is the most important argument for going through the trouble of building a different sensor. One of my co-founders recently had some extra crunch in his lunch by two long and thick copper wires ;)

 

 

Regards,

 

 

-Alex

 

 

 

PS: To answer your question about cost: Once they are ready, we might be able to sell them for between $50'000 and $100'000, but that is still very much up in the air. I've heard of sensors being sold for as much as up to $155k, but I'm not sure whether these are only used by a few extremely diligent processing companies. 

 

Size can be a relative issue.  Very often we are testing with very small spheres but wires can get through based on their orientation.  Which is one of the challenges of detectors.  Sadly most people don't understand how detectors work and think if it is metal and the right size the detector will catch it.   Maybe it will, maybe it won't.  Again there are a lot factors that play into whether the metal will impact the field enough to allow the detector to work. 

 

The prices you listed are hard to judge without all the details.  As someone who thinks metal detectors are interesting (yeah crazy huh) I look forward to hearing more about it. 


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#15 Mike Green

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Posted 23 July 2014 - 08:05 PM

 

 

Does it mean that even metal dust is not allowed for this special risk group?

 

 I think that once you get down below 7mm you may no longer have a significant risk of lacerations or choking-but there are still other potential concerns.......especially with babies and young children

http://www.ncbi.nlm....pubmed/11764847

 

http://cot.food.gov....s/statement.pdf

(Note, added Charles.C,120819, - 2nd link now > general page only.)


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#16 Charles.C

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Posted 24 July 2014 - 03:31 AM

Hi Charles, 

 

I just read your post. The FDA text you quoted makes mention of "no detectable metal fragments".  -How do you suppose the FDA might react to a an increase in detectability of metal fragments?

 

I'm asking because I work at a startup that is considering developing a detector that could detect 0.2 mm particles. It is not based on inductive coils, which is why we believe we can circumvent current limitations in accuracy. In general we are trying to gather information on metal detection and quality assurance, so any input is appreciated.

 

Cheers,

-Alex

 

Dear AlexHayes,

 

The fact is that globally this topic is a minefield of semantics. This was illustrated in my previous post.

 

The (somewhere seen) FDA, validation-verification, logic of "Say what you do" and "do what you say" is IMO in practice  "flexible".

 

It eventually becomes a question of restating "ideal" concepts into a quantitative instrumentation scenario. The elegant published FDA "directive" implicitly accepts that this is an awkward task and tries to cover as many bases as possible, some semi-ambiguously, some more explicitly, eg 7mm etc.

 

The FDA are fortunate that in many "disputable" situations, they can fall back on the existence of the USA concept of adulteration which allows the manufacturer/distributor to pre-emptively recall the product at their own cognizance. It's a very useful leverage.

 

As you imply, detection is inevitably limited by LOD/LOQ factors etc but this aspect is often carefully avoided in regulation land. (There are a few exceptions, Canada is one from memory).

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#17 Charles.C

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Posted 24 July 2014 - 03:42 AM

 I think that once you get down below 7mm you may no longer have a significant risk of lacerations or choking-but there are still other potential concerns.......especially with babies and young children

http://www.ncbi.nlm....pubmed/11764847

 

http://cot.food.gov....s/statement.pdf

Dear Mike Green,

 

Nice to hear from you.

 

Unfortunately, globally, the interpretation/opinions of "metal contamination" vary a lot pro/con USA, or simply disagree. Especially in Europe afaik. (And, i think, UK also), eg post #4

 

Even the USA has some "twists and turns" in practice. In fact if you examine the FDA history  they also seem to have made a few quiet adjustments a while back. The well-known problem of putting "theory" into practice. :smile:

 

Thks for the interesting safety refs although maybe slightly ageing (ca. 2000) ? :smile: . Sadly I think MAFF is now long gone ?

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#18 Mike Green

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Posted 24 July 2014 - 09:58 AM

Dear Mike Green,

 

Nice to hear from you.

 

Unfortunately, globally, the interpretation/opinions of "metal contamination" vary a lot pro/con USA, or simply disagree. Especially in Europe afaik. (And, i think, UK also), eg post #4

 

Even the USA has some "twists and turns" in practice. In fact if you examine the FDA history  they also seem to have made a few quiet adjustments a while back. The well-known problem of putting "theory" into practice. :smile:

 

Thks for the interesting safety refs although maybe slightly ageing (ca. 2000) ? :smile: . Sadly I think MAFF is now long gone ?

 

Rgds / Charles.C

Hi Charles C,

 

It's nice to be back(it's been a while!)

 

I'm not sure why the metal toxicity research seems to have dried up (not sexy enough maybe?!)-a pity because there was some interesting stuff going on (IMO)

 

There are some more recent studies (though some of the reference material quoted therein is still ancient!)

 

eg  http://www.ncbi.nlm....les/PMC2782734/   http://link.springer...2011-012-9551-1

 

Not sure why it doesn't seem to concern 'the powers that be' as much as maybe it used to?

 

Kind Regards

 

Mike


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