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Critical limits for Physical Risks-HACCP


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#1 filipa

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Posted 25 May 2008 - 06:23 PM

Hello, :helpplease:

One question regarding the HACCP Plan:

If we consider a "filter" or a "metal detector" as a CCP, what is the critical limit??
I think I need to have a support (Legislation, FDA....) to explain why I consider that a particle > x mmm is a risk, regarding the food security...

Can anyone help me???

Many thanks,

Filipa


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#2 althene

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Posted 26 May 2008 - 09:39 AM

hi Filipa!

we also identified "some forms of metal: ex. metal strips, nuts and bolts" as Physical Hazards, however we did not consider it as a CCP. The reason is that it is usually controlled by the presence of the metal detector. Control Measures to ensure that the metal detector is working properly has to be in place though (ex. calibration and preventive maintenance)

Metal detector sensitivity has to be talked over with your equipment supplier. They usually set the standards. A Physical Hazard is a hazard that could cause laceration, or choking, if the metal strip would be too thin or too small not to cause such it could be a Physical-Quality Hazard and not a Physical Hazard.

I hope I had somehow answered your question. :biggrin:


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#3 filipa

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Posted 26 May 2008 - 03:54 PM

Hello,

Many thanks for your reply.

We have already a procedure regarding the check of metal detector with 1,5mm Fe; 3,0 mm Non-Fe and 3,0 mm SS.

But, my doubt is regarding the dimension of the foreign bodies that we can consider than can cause injury to the consumer.

I have found in FDA site, the "Compliance Policy Guide 555.425" (http://www.fda.gov/o.../cpg555-425.htm).

After some studies, they conclude that foreign bodies less tha 7 mm rarely cause trauma or serious injury. :thumbup:

So, I think that a critical limit less than 7 mm could be acceptable.

Any comments??

Filipa


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#4 Charles.C

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Posted 26 May 2008 - 03:59 PM

Dear filipa,

Try this -

http://www.fsis.usda...ives/7310.5.pdf

(Above link came via this also interesting article -
http://www.fsis.usda...06-07/index.asp )

There are also published US standards specifying maximum sizes of metal "particles" which are considered as non - hazardous however, as per Althene's comment, the use of a detector limit as CCP crit.limit is the most usual response IMEX.

If you want to see more practical details, check Chap20 in the "Purple" Book here -

http://seafoodhaccp....anuals_pdf.html


Rgds / Charles.C

added - just saw yr post - yes, yr data is an often quoted value but in practice people seem to go to the detector limit

added (2) "oops" :smile: , actually after looking again at ch20, the method tabulated is another variation of that stated in 1st link above ( para A.3) but I think my / Althene's comment is the most usual approach. You can see some examples in the model HACCP plans on the CFIA website if you google a bit. Nonetheless, no reason not to be adventurous if you can validate :biggrin:


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Charles.C


#5 filipa

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Posted 26 May 2008 - 09:42 PM

Hello,

Many thanks for your reply.

I need to read and analyse the documentation...

I'm working in a general review of our HACCP (including the risk assessment), and I have already eliminate some CCP, after the risk assessment.

Perhaps I will wliminate the metal detectors..lol

Regards,

Filipa


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#6 Cathy

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Posted 27 May 2008 - 12:56 AM

There is an older FDA document that identified data indicating foreign objects less than 7 mm rarely cause injury and objects greater than 25mm also do not cause injury. On the small end - the object is likely swallowed. On the large end - it's visible and not even eaten.

Some companies use this to define the hazardous size as anything between 7 and 25mm.

The metal detection systems are set to find and eliminate particles of 7mm or more. When something is found - it is further examined to see if it is a simple case of adulteration or if it is also a food safety hazard.


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Cathy Crawford, HACCP Consulting Group
http://haccpcg.com/

#7 filipa

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Posted 27 May 2008 - 08:41 AM

Hello Cathy,

Many thanks for your comment.

I have already analysed the FDA document, and I think that I can use it to support my critical limits in PCC "metal detection".

Filipa


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#8 Charles.C

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Posted 27 May 2008 - 02:07 PM

Dear All,

Some companies use this to define the hazardous size as anything between 7 and 25mm.


OK, validation is wonderful but IMO, this is a case where commonsense suggests the validation is extremely debatable. :whistle

I would personally consider my sandwich to be significantly hazardous to me if I found a 5mm diameter ball-bearing in it ! Admittedly only one statistic but ........

The fact that I might not be able to sue the restaurant due to the above standard existing is perhaps not HACCP - final despite the FDA having accumulated some helpful epidemiological statistics. IMO ensuring that a metal detector machine's limits are demonstrably within the "usual" range is a more rational choice. So far IMEX, auditor's seem to hv agreed.

Rgds / Charles.C
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Charles.C


#9 GMO

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Posted 27 May 2008 - 03:17 PM

In practice I think you're right but as you are probably only using the sizes you quoted; I've always stated that our critical limit is the largest piece size. Yes I know that's a**e about face but it's also pragmatic. If a stick failed, I would recheck the stock from the last good check, I wouldn't put through a bigger stick and see if that passed!

I would say anything under 6 mm is unlikely to cause a big injury, 25 mm would be likely to cause tooth damage.


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#10 filipa

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Posted 27 May 2008 - 08:35 PM

Hello,

When I put this post, my principal doubt is:

We have already a "Company Standard" where we consider that we not admite a piece with a dimension > 3mm. We teste the metal detector with 1,5mm e 3,0 mm and we consider the largest piece the critical limit.

But, because we are now review the HACCP, and I think that we need to validate, to have a suport, the FDA Guidelines give me one.. But we can consider the critical limit less than 7 mm.

Confused?? :rolleyes:

Filipa


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#11 Biss

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Posted 28 May 2008 - 08:47 AM

Hi all,

please see the critical limits set for the metal detection activity in the attachement.

regards

Biss

Attached Files


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#12 filipa

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Posted 28 May 2008 - 09:48 AM

Hello Biss,

many thanks for your information.
One question: the critical limits that you set are the dimensions of particles that you use to test de metal detector?? (1,o mm Fe; 1,5mm Non-Fe ans 2,0 mm SS)??

Awaiting for your comments,

Regards,
Filipa


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#13 Cathy

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Posted 28 May 2008 - 01:48 PM

I think we need to be careful of why we are naming something a critical limit and in which type of system. I have seen multiple companies who declare one limit as a true food safety hazard, and another limit, a quality critical control point. Oneof the limitationsof HACCP is that it does not address quality concerns. SQF or something like it would come into play here.


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Cathy Crawford, HACCP Consulting Group
http://haccpcg.com/

#14 Biss

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Posted 29 May 2008 - 10:27 AM

Dear Filipa,

yes, you are correct.

regards

Biss


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#15 Erasmo

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Posted 29 May 2008 - 04:27 PM

Hello, :helpplease:

One question regarding the HACCP Plan:

If we consider a "filter" or a "metal detector" as a CCP, what is the critical limit??
I think I need to have a support (Legislation, FDA....) to explain why I consider that a particle > x mmm is a risk, regarding the food security...

Can anyone help me???

Many thanks,

Filipa


Hi,
There is always a confusion with "critical limits" (7.6.3) and "Acceptable levels" (7.4.2). The Critical limits applies for control measures and the Acceptable levels for hazards. I think you are talking about acceptable level of that particular hazard.
The critical limits has to be monitored (7.6.4) and acceptable levels has to be verified (7.8 - d).
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#16 MRios

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Posted 30 January 2009 - 05:44 PM

Thanks everyone for the information on critical limits for physical risks, especially the FDA link.
I work at a flour mill and our CCP is a turbosifter that has 5 mm openings, which means that everything larger than 5 mm is rejected. Because of the equipment´s capacity, this also means that a lot of flour is also sent to the rejection bin. This is later reprocessed. Because a large part of the milling process is sifting (our specification says that 100% of flour goes through a sieve that has 180 microns), any physical risks would be eliminated along the way.
We´d been considering reducing the openings on our turbosifter to 2.0 mm simply because our sister mills all have them that way. However thanks to the info on this forum we´ll keep it as it is.
Just one question: most decision trees for the determination of PCCs say that if the step is set up specifically to reduce / eliminate the risk of a hazard, it is a PCC. In that case, our separator (it eliminates any particles that do not have the size, shape and density of wheat) would be a PCC. However, there are other steps further down the line that eliminate physical hazards.
Opinions, anyone?


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#17 aps

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Posted 30 January 2009 - 10:36 PM

We reconise as a company of anything above 2.5mm as a risk to health

We currently have 2 metal detectors which we currently can detect as low as 1.5mm

(1.0mm NF / 1.0mm Ferrous / 1.5mm Stainless)

Hope this helps


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#18 Erasmo

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Posted 04 June 2009 - 01:30 AM

Hello,

Many thanks for your reply.

We have already a procedure regarding the check of metal detector with 1,5mm Fe; 3,0 mm Non-Fe and 3,0 mm SS.

But, my doubt is regarding the dimension of the foreign bodies that we can consider than can cause injury to the consumer.

I have found in FDA site, the "Compliance Policy Guide 555.425" (http://www.fda.gov/o.../cpg555-425.htm).

After some studies, they conclude that foreign bodies less tha 7 mm rarely cause trauma or serious injury. :thumbup:

So, I think that a critical limit less than 7 mm could be acceptable.

Any comments??

Filipa


Hi Filipa,
I have a different opinion. What are you mention is not a critical limit, it is the acceptable level of the hazard.
It is important to read the guide again, because 7 mm is a very large piece (I would aks a food manufacturer to control physical hazards smaller than that). and the guides clearly states: "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."
It is not easy to think that a food product wont be consumed by those groups. it is like design and calculate an important bridge only for compact cars and forget trailers and heavy trucks.

Retailers have differents standars, I hope this metal detector guide could help you.

Saludos.

Attached Files


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#19 GMO

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Posted 04 June 2009 - 05:27 AM

Thanks everyone for the information on critical limits for physical risks, especially the FDA link.
I work at a flour mill and our CCP is a turbosifter that has 5 mm openings, which means that everything larger than 5 mm is rejected. Because of the equipment´s capacity, this also means that a lot of flour is also sent to the rejection bin. This is later reprocessed. Because a large part of the milling process is sifting (our specification says that 100% of flour goes through a sieve that has 180 microns), any physical risks would be eliminated along the way.
We´d been considering reducing the openings on our turbosifter to 2.0 mm simply because our sister mills all have them that way. However thanks to the info on this forum we´ll keep it as it is.
Just one question: most decision trees for the determination of PCCs say that if the step is set up specifically to reduce / eliminate the risk of a hazard, it is a PCC. In that case, our separator (it eliminates any particles that do not have the size, shape and density of wheat) would be a PCC. However, there are other steps further down the line that eliminate physical hazards.
Opinions, anyone?


Ha! I now think I understand oPRPs!!!!! Blimey, it only took finding a situation where a CCP doesn't make sense! Do others agree this should be an oPRP?

It depends on the decision tree you use whether this would drop out as a CCP. IMO a CCP should always be at the last point where the hazard can be controlled unless the earlier step is also required to control the hazard (for example, you might have two cooling stages to control bacillus cereus toxin formation in a post pack pasteurised ready meal for example, where the pasteurisation step is not designed to kill b. cereus spores, once for the original cool and the second for the cool after the pasteurisation. Both would be valid CCPs as if either failed, there would be a hazard of b. cereus toxin which the other CCP could not eliminate.)

Edited by GMO, 04 June 2009 - 05:29 AM.

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#20 Charles.C

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Posted 04 June 2009 - 08:55 AM

Dear All,

I go along with Erasmo’s observations however I think that (though perhaps not for ISO 22000?) the practical situation is that many possible textual styles for controlling the “metal” CCP are being officially used. This is perhaps related to the variety of official definitions of “critical limit”, eg –

(1) National Advisory Committee on Microbiological Criteria for Foods (NACMCF) - One (or more) prescribed tolerances that must be met to ensure that the CCP effectively controls the biological, chemical or physical hazard

(2) Food and Drug Administration (FDA) - A maximum or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce (to an acceptable level) the occurrence of the identified food safety hazard

(3) USDA/Food Safety and Inspection Service (FSIS) - CLs shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirements set forth, are met.

(4) Codex Alimentarius - A criterion which separates acceptability from unacceptability



Similarly, some USA operational offerings –

(A) USFDA juice regulations (2004)

• 1.2 Metal Fragments
We can recommend several possible ways to establish control measures for metal fragments in juice.
One way involves the use of on-line metal detection equipment. With this method, the equipment continuously monitors the product after the last step at which metal inclusion is reasonably likely to occur (e.g., after bottling and sealing of the juice) at a process step designated for metal detection. The critical limit might be designated as "no metal fragments in the finished product." The following illustrates some of the elements that might be entered into your HACCP plan.
• What is the critical limit? No metal fragments in finished product (Note: FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See also FDA Compliance Policy Guide 555.425).
• What will be monitored? The presence of metal fragments in containers passing the CCP.
• How is monitoring done? By the use of metal detection equipment.
• How often? Continuously. Each container is subjected to detection. We recommend that you confirm that the device is operating correctly at least at the start of each production day.
• Who should perform the monitoring? Monitoring is performed by the equipment itself. We recommend that a check be made at least once per day to ensure that the device is operating correctly.
A second way to control metal fragments involves the use of a separation device such as a screen after the last step at which metal inclusion is reasonably likely to occur, at a process step designated for screening. For this approach (see example HACCP plans for Pasteurized Refrigerated Apple Juice and Not-from-concentrate Orange Juice in section VII):
• The critical limit might be designated as "screen is functional."
• Monitoring may be done by a daily visual check for screen integrity.
• We recommend that verification include periodic calibration testing to ensure that the screen retains its separation capability for metal particles of a specific size. In establishing this size, we recommend that you consider that FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. (See also FDA Compliance Policy Guide 555.425).
A third way to control metal fragments involves visually inspecting equipment for damage or missing parts at process steps such as extraction and grinding, where such damage or loss of parts could lead to metal fragments in your juice. This approach may only be feasible for relatively simple equipment that can be fully inspected visually in a reasonable time period. Under this approach, CCPs might be identified as the fruit grinding and extraction steps in a process. The critical limit might be designated as "no broken or missing metal parts from equipment at the CCPs for metal inclusion." If broken or missing metal parts are observed, the line is stopped, the equipment is repaired and, if necessary, adjusted or modified, and the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step. The following illustrates the elements that might be entered into your HACCP plan.
• What is the critical limit? No broken or missing metal parts from grinding (or extraction) equipment
• What will be monitored? The presence of broken or missing metal parts on or near the grinder
• How is monitoring done? By visual check of the grinder and immediate vicinity for broken or missing metal parts
• How often? Check before starting operations each day, check at least every four hours during operation, check at the end of operations each day, and check whenever there is an equipment or other malfunction that could increase the likelihood that metal inclusion could occur.
• Who will perform the monitoring? Any person who has a thorough understanding of the proper condition of the equipment and surrounding area may perform monitoring.
• If broken or missing metal parts are observed at a CCP, the corrective action procedure would be to stop the line, repair, adjust, and modify the equipment as necessary; the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step.


http://www.fda.gov/F...e/ucm072557.htm

(B) USDA / FSIS (2003)

The HACCP plan is also to have a critical limit, such as having a functional metal detector, calibrated to a specific standard (9 CFR 417.2©(3)).


http://www.fsis.usda...ives/7310.5.htm

© University of Florida

D. Ground Beef
• Hazard: Metal fragments
• Control Measure: Automatic rejection of packaging containing metal fragments of sufficient size to be detected by a metal detection system
• CCP: Metal detector
The CL in this case is open to some discussion. In many HACCP plans (including those under federal regulation [a regulatory CL I suppose]), the CL is defined as the rejection size of the metal detector, and monitoring is continuous by the detector itself. Others may prefer to have an employee monitor the detector on a defined frequency to determine its operation. In this case, it may be more appropriate to indicate that the CL is simply whether the detector is operating (on vs. off), rather than the size exclusion limit of the detector. In both cases, the detector is calibrated as part of HACCP verification.


http://edis.ifas.ufl.edu/FS141

Quite a range of interpretations ! Would seem that as long as you can validate, the available choice is quite wide. I suppose it’s possible that auditor’s preferences may also have some significance. ;)

Rgds / Charles.C
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Charles.C


#21 a_andhika

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Posted 04 June 2009 - 11:40 AM

Dear Charles C.,

Awesome, as always... The physical risk somehow is the most least discussed but tends to be the most controversial. IMO, we need to look the characteristic of the product and the intended costumer. Honestly, I cant understand a regulation which forbid existence of 6 mm metal, but allowed for glass? Any help for me?

As for the CCP and OPRP, sheeesh, this one also a never ending controversial... Anyway, my question is: If we have siever to catch foreign matters, then after that we have a metal detector, which one is the CCP? IMO, it will goes to the metal detector. But the silly question is, if a metal is detected (which means it quite big enough) on metal detector and considered as hazard, then what about glass and wood? If a metal can loose the siever (fortunately detected in the end), then what about other materials that might loose the siever too? Are they considered as hazard?

Really, I think it was depends on how we define the hazard and validate the CCP or OPRP.


Regards,


Arya


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#22 MRios

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Posted 04 June 2009 - 02:43 PM

Arya, in my humble opinion, I would eliminate the metal detector and use only the sieve as a CCP. Unless of course, the sieve is made out of metal and could fall apart and cause adulteration, but supposedly this would be prevented by checking the sieve regularly and giving it adequate maintenance.
The sieve would be effective in retaining all material (metal, glass, wood, plastic,etc) bigger than the size of its apertures, while the metal detector is only good for, of course, metal. Besides, a sieve prevents adulteration, while a metal detector is causing you to have to reprocess the product. A matter of cost, I think. Or maybe a matter of bias, since we don´t have a metal detector and it would be quite expensive to get one (remodeling the facilities for installation of one would be expensive too).
What about using a magnet as a CCP? What would the corrective action if you found metal pieces from equipment? Stopping the line immediately and putting all the product from the last check until then, on hold? Isn´t the magnet preventing adulteration and therefore guaranteeing that there are no ferrous metal particles in the product?


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#23 a_andhika

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Posted 05 June 2009 - 09:13 AM

Dear MRios,

I beg you dont tease me with your modesty.... The humble is mine...

I am very much agree with you. However, one of our costumer keep insists to demand a metal detector on our site. Even if we declare them that we are fully aware of foreign matters (not only metals), and we manage to prevent it by using siever. But still, metal detector or catcher (I assume same as magnetic trap) is a must for them

Thats why I send my paradoks question to all of you. If we manage to prevent all of the foreign matters, does the metal detector/catcher is still an urge? But what I see from Charles C.'s references, every regulation has it day. Depends on the products, and countries, it may vary. So I guess it somehow make any 'sense' if the spesific control measure has to be doubled like that.


Regards,


Arya


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#24 MRios

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Posted 05 June 2009 - 02:05 PM

Hello Arya!
Clients can be quite a handful sometimes. Maybe they´re thinking that if the sieve falls apart, the metal detector will tell you immediately? provided that the sieve is metallic in the first place.
Could you please help me with my magnet questions? (in my previous post).
By the way, we have a ferrous metal sieve one step above the magnet, so that if the sieve falls apart, we should be able to catch the parts. ;) ;) The sieve is also one of our CCPs.


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#25 a_andhika

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Posted 23 September 2009 - 02:35 PM

Dear MRios,

When I lookin some discussion about metal detector/catcher, it lead me to this thread. And I realize that I haven't answered your question.

If the magnet caught a metal, I guess the corrective action should be inform the supplier about the occurence of metal on their product. Magnet is used to prevent metal contaminate your product, and ensure it safe. So I cant see any reason to hold the previous product, coz you already validate it, and fully assured that there wont be a metal goes through without being catched by the magnet.

And you may consider it as CCP IMO. And the metal siever can be an O-PRP.


Regards,


Arya


Edited by a_andhika, 23 September 2009 - 02:45 PM.

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