Critical & Operational Limits for Metal Detection
I am wondering why we set critical and operational limits for metal detection within our HACCP plans if it is identified as a CCP, wouldn't we want to state that the critical limit is no metal? I am just slightly confused on this as we were asked if metal under those limits set is acceptable for a finished product. I am in a meat processing facility goverened by the USDA.
Thank you for your help!
:happydance: :happydance: :happydance:
https://www.fda.gov/...n/UCM252440.pdf
Perhaps this guidance will help
For meat, the critical limits result in Nothing Being Detected which is not to be confused with zero metal. The guidance explains CCP vs control for the metal detector
https://meathaccp.wi...ective 7310.pdf
I know there are standards in size that are the MAXIMUM (but still very very small) but I cannot locate them........your best bet is to ask your VIC for the sizes to ensure your metal detector is calibrated to that MAXIMUM or smaller
wouldn't we want to state that the critical limit is no metal?
IMO: It is due to the metal detector capability and range.
For example: If you metal detector manufacturer is stating the lowest metal detection possible is 2mm, while you are stating No metal, any metal pieces in the range of 0-1.99mm can put your product out of compliance.
https://www.fda.gov/...n/UCM252440.pdf
Perhaps this guidance will help
For meat, the critical limits result in Nothing Being Detected which is not to be confused with zero metal. The guidance explains CCP vs control for the metal detector
https://meathaccp.wi...ective 7310.pdf
I know there are standards in size that are the MAXIMUM (but still very very small) but I cannot locate them........your best bet is to ask your VIC for the sizes to ensure your metal detector is calibrated to that MAXIMUM or smaller
Thank you for the great information, could you kindly clarify what VIC stands for? I am still struggling with the interpretation of the FSIS Directive, do we basically just have to calibrate our metal detector to the limits set forth with the HACCP Plan and just have scientific justification for the critical limits we determined within the HACCP Plan? Thank you!
Sorry Elsa......VIC in Canada is Veterinarian In Charge.....it's who gets to make the decisions on behalf of the USDA in the US
Yes, you are correct. You need proof that the test bars function (detector is calibrated properly) and that the limits/sizes for the 3 different metals (stainless, ferrous and non ferrous) are based on sound science and/or regulatory standards
So you need to
A) Validate.............that means the metal detector WILL catch any pieces the same size as your test bars or greater under ALL working conditions (more than 1 piece of meat through the detector, piece on it's side so thicker than usual etc) WORST CASE SCENARIO---as long as nothing changes in the plant/type of meat/volume put through in a day this never needs done again....once/year you review the validation to make sure it matches what happens on a day to day basis
B) Verify...........during operations, the test bars are run through the detector to ensure it's functioning properly
C) Monitor..........frequency of verification and by WHOM (don't forget to train them and make a record of the training)
BTW----once you've got a meat plant under your belt, everything else will seem easy peasy!!! pardon the pun, but it's a great way to cut your teeth
In case of MD and Xray the operational limit is at times the "best" condition for your MD to operate.. in example they say the metal detector can detect up to 0.8mm SS however the scenario is it is only the one running among all machine with less traffic and movement to cause any signifcant vibration..if you do it real life production, there will be some interferences along your operation that make your metal detection limit be higher than 0.8mm already.. this limit will be what you need to validate...
as for to calibrate what is in the haccp plan,I think it is the other way around "at first"...you validate your metal detector and the determined limit will be what you will have in the HACCP plan.. it will be hard for you to say in the HACCP plan my limit will be 1.2mm but during validation out of 200 good products it rejects around 60 good products that are without contaminant, then people may question the efficiency of metal detector and will be thinking "my equipment always reject even though it should not".. along this scenario, it will just be one day that they neglect the alarm and real contaminantion may happen..
I am wondering why we set critical and operational limits for metal detection within our HACCP plans if it is identified as a CCP, wouldn't we want to state that the critical limit is no metal? I am just slightly confused on this as we were asked if metal under those limits set is acceptable for a finished product. I am in a meat processing facility goverened by the USDA.
Thank you for your help!
:happydance: :happydance: :happydance:
Hi Elsa,
Just to hopefully summarise/expand the previous posts a little. Details are in various previous threads here.
Any specific limits usually have their own caveats , eg related to target consumer of the particular food category involved (ie risk assessment).
The concept of a (MD) zero limit CCP is obviously wishful thinking from a practical POV. Nonetheless it is a logical, Politically unchallengeable, "Official" response for the uninitiated.
if a CCP is involved some "typical" Regulatory published " limits" are -
USFDA - 7mm (!!!), USDA (FSIS) used to be 2mm, now I believe they have standardised to (perhaps reluctantly) agree with USFDA. Some US Industries may likely go their own merry way, eg "Best Practice", eg Baking Industry.
Canada - 2mm (non-meat IIRC)
A few European Countries - 2mm
Globally many countries have no specific limit and implement typically from Best Practice or Machine Operational Limit, ie approx LOD (limit of detection). Or copy other Countries
Operational limits are typically set outside critical limits so as to avoid failure of the critical limit. This then minimizes headaches such as activating / documenting corrective actions. It's as simple as that. :smile:
PS -- some of the above numbers may not be entirely aligned to previous posts. If so i suggest some further searching.
PPS - just to note that Operational Limit has a more specific meaning in a FSSC22000 context but afaik this is not yr area of interest.
P3S - in addition to the legal interpretation, and as noted above, the practical crunch often comes when you need to validate the sensitivity of the MD.
Dear Elsa,
Just a link to an article to help you further with the determination of the detection limits and to develop your quality system. The detection limit depends on:
- The product
- The type of metal
- False rejections need to be avoided, see above
Yes, the best is that there is no metal at all in the products. So, it can be valuable to see whether there is room for process improvements or to combine the metal detection with other methods, like Xray inspection.
https://qualitic4u.c...n-minimum-size/
Kind regards,
Gerard Heerkens
Good afternoon, Elsa
I just came across this post and I'm not sure if your question has been answered, but I have this link that may be helpful to you.
https://www.fda.gov/...t/ucm074554.pdf
Hope this helps!