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Acceptable Size Limit for Foreign Material?


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#1 kellym

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Posted 18 November 2011 - 07:02 PM

So it says "Reduce to and acceptable limit". What is the acceptable limit? FDA has 7 mm. Does that mean its ok to have a piece of metal smaller than 7mm in your sauce. Now i know that as a qc manager that is a terrible question to ask. But what if you recover a piece of metal that is 99.9% intact and you found it after running 30000 bottles. Are all the bottles scrap? You are 100% sure that any metal that is in the product is very tiny like a grain of sand. What do you do? How do i prove to an auditor?

Thanks

Kelly


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#2 esquef

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Posted 18 November 2011 - 07:50 PM

Hi Kelly,

The FDA guidance is here:

FDA's "Adulteration Involving Hard or Sharp Foreign Objects"

Their range is 7mm - 25mm. The thing is, try arguing this with a customer or auditor. You have to determine what the maximum acceptable size of metal contamination allowed based on risk analyses at each step in you process flow (should be done not just by yourself, but a cross functional HACCP team). There are a lot of variables involved; what's your product, wat's your process flow; how do you control metal (metal detectors, screens/seives, rare earth magnets?), is it a Control Point or Critical Control Point, etc?

Regarding your question about determining corrective action/product disposition after finding a piece of metal after running 30K bottles; assuming it exceeds your critical limit set in your HACCP plan (if the step is a CCP), the action you would take would be dependant on the last time you ran a CCP check and whether or not your CCP is capable of detecting the size of the piece you found

If you find metal in your product that's "very tiny like a grain of sand" I'd have to say that if it's over your maximum critical limit set in your HACCP plan you're going to have trouble. What corrective action was taken? Was questionable product put on hold and was a disposition decision made? If so, by whom? Based on what facts?

If it's below you critical limits how would you even find it (and a peice of metal the size of a grain of sand might get caught by a fine mesh screen, but not likely by a metal detector)? Again, if it's above your set Critical Limit, the response would be the same as the example above.

HACCP is not an easy subject!

Good Luck,
esquef


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#3 Charles.C

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Posted 18 November 2011 - 08:32 PM

Dear kellym,

Actually, 7mm up is perhaps not quite the whole story. have a look at this post -

http://www.ifsqn.com...dpost__p__46636
(re-emphasis of point "d" in previous posted link)

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#4 kellym

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Posted 21 November 2011 - 04:12 PM

Esquef

That is very helpful info. I understand all of what you are saying. Yes HACCP can become stressful. Let me ask the question a little differently just for kicks. Say you find a broken razor blade on your magnet trap. You immediately place all the product on hold from the last good check of the trap. Once you get the razor blade into the lab you find two things. One is that it didnt come from your facility and its origin cannot be diterminded (makes no difference anyway you still found it). Two, you find that it is 99.99% intact. However, you know that the other .001% is in you product and that the .001% is so small that it poses no threat to the public. Can you release the product with the knowledge that there is metal in your product? If so, how do you explain that to the auditor?

Thanks
Kelly



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#5 esquef

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Posted 21 November 2011 - 04:54 PM

Hi Kelly,

Well, first you say that the blade is 99% intact. I'd calculate the probable dimentions of the 1% that's likely in the product. Assuming that it's in the range that the metal could be captured (you haven't stated what your product is; if it's a fine powder andpropduct on Hold could be sifted through a mesh finer than the loose piece, or preferably run through a metal detector). If the piece is found you're in the clear. Write your non-conformance report and release the product on Hold./

If the missing piece is not found and below your detectable Critical Limit, you and your Food Safety Team need to meet and perform a risk analysis to decide on product disposition of what you've put on hold. That's what you would have to show your auditor; the documentation of the meeting and the conclusion from the risk analysis that the loose piece does not pose a food safety threat.

If you're certain that the blade definitely came in through a raw material I'd definitely take a look at all suppliers that provided ingredients for your product run when the blade was found and make sure that they are doing what's necessary to prevent steel knife blades to get through their food safety system. Do they have a HACCP program? What is/are their CCP's that should have caught the blade before it left their facility? Does your Supplier Approval program need to be strengthened?

All of this info should be captured in a non-conformity report, and that could also be shown to the auditor if you feel it would bolster your case about you and your company's committment to your food safety management program.

Regards,
esquef


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#6 kellym

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Posted 21 November 2011 - 05:07 PM

Esquef

The product is a cooked sauce that cannot be reworked. Are there any non conformity reports out there that you would recommend over another?


Again thanks for all of your help.

Kelly


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#7 esquef

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Posted 21 November 2011 - 05:57 PM

So if you have no chance of reworking the product, you and the Food Safety Committee need to make a decision about the disposition of the product on hold.

Here's a very bare bones example of a Non-Conformance Report:


PRODUCT SAFETY NON-CONFORMANCE REPORT




Date __________________ Time _____________



Product ______________________ Formula No. _____________________



Lot No. ___________________________





Location ______________________________________________________________



Type of Incident ________________________________________________________



_______________________________________________________________________



_______________________________________________________________________



Time since last CCP check ____________________________________________________



Report by: _____________________________ ______________________________

Print





Corrective Action(s) Taken _______________________________________________



_______________________________________________________________________.



_______________________________________________________________________.



Preventive Action(s) _____________________________________________________



_______________________________________________________________________



_______________________________________________________________________





Product disposition ______________________________________________________







Approved by: _________________________ _____________________________

QA Manager Production Manager


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