Is metal detector or metal detector calibration a CCP?
Please explain what is the correct CCP?
a) Pass through metal detector or
b) Metal detector calibration or
C) Both
Below I have mentioned what I have prepared. Please share comments on that.
CCP 01 - PASS THROUGH METAL DETECTOR
Hazard-Presents of foreign materials such as metal particles etc. .
Control measures- Each and every item pass through the metal detector and records are maintained.
Critical Limit- 3.0 mm ferrous, 3.5 mm stainless (316 grade), 3.5 mm nonferrous
Monitoring
What - Presence of metal particles on product
How - Inspect through a metal detector
Frequency - Each and every pack
Who - Production Supervisor
Correction -Discard the product
Corrective action - Metal detector need to be check with the test pieces. If it is due to metal detector need to be informed to the maintenance and rectify the issue. Segregate the product which present metal and pass the other products. If presence the metal continuously should segregate and discard the batch after identify the root cause.
Verification - Review the metal detector inspection records, metal detector record, Preventive maintenance record and maintenance records by Central QA person. Onsite verification By QAM.
Records - NC records (CC/RCD/20), Corrective action records (CC/RCD/21), metal detector inspection records (CC/RCD/17), metal detector calibration record (CC/RCD/16), Preventive maintenance record (CC/RCD/32)and maintenance records (CC/RCD/33)
Thank you
Savani
Hello,
Please find below my comments:
1. Metal detector is CCP.
2. Calibration of metal detector is a tool to ensure that mechanism of metal (rejection and passing) is already fit, this to be done through internal calibration (Factory team) and / or external calibration (third party company accredited).
3. Depending on the type of your metal detector and your product, provider of this equipment will mention how will you do the checking of the metal detector (monitoring) or you can do it through HACCP plan.
4. For critical limit: you shall mention your references.
5. Validation of metal detector, it would be better to mention it.
Hope that i could help you.
Please explain what is the correct CCP?
a) Pass through metal detector or
b) Metal detector calibration or
C) Both
Below I have mentioned what I have prepared. Please share comments on that.
CCP 01 - PASS THROUGH METAL DETECTOR
Hazard-Presents of foreign materials such as metal particles etc. .
Control measures- Each and every item pass through the metal detector and records are maintained.
Critical Limit- 3.0 mm ferrous, 3.5 mm stainless (316 grade), 3.5 mm nonferrous
Monitoring
What - Presence of metal particles on product
How - Inspect through a metal detector
Frequency - Each and every pack
Who - Production Supervisor
Correction -Discard the product
Corrective action - Metal detector need to be check with the test pieces. If it is due to metal detector need to be informed to the maintenance and rectify the issue. Segregate the product which present metal and pass the other products. If presence the metal continuously should segregate and discard the batch after identify the root cause.
Verification - Review the metal detector inspection records, metal detector record, Preventive maintenance record and maintenance records by Central QA person. Onsite verification By QAM.
Records - NC records (CC/RCD/20), Corrective action records (CC/RCD/21), metal detector inspection records (CC/RCD/17), metal detector calibration record (CC/RCD/16), Preventive maintenance record (CC/RCD/32)and maintenance records (CC/RCD/33)
Thank you
Savani
Hi Savani,
"Calibration" is probably not an appropriate word in CCP context.
Textually an answer/explanation is complicated. It's probably easier to offer a (detailed) example which you can condense if preferred-
CFIA - HACCP Generic Model for Fresh produce, Ready-To-Eat Fresh-Cut Vegetables.pdf 427.08KB 69 downloads
(see pg 23/24)
Your hazard is metal (physical hazard) , your CCP is metal detection. You critical limit is basically NO metal at all ( I don't think you have limits), your monitoring would be checking the metal detector hourly to verify it is working. Validation would be calibrating annually.
Your hazard is metal (physical hazard) , your CCP is metal detection. You critical limit is basically NO metal at all ( I don't think you have limits), your monitoring would be checking the metal detector hourly to verify it is working. Validation would be calibrating annually.
This is accurate except for the critical limit. You have critical limit at 3.0 and 3.5, 3.5. I assume that is the limt at which your detector can detect. Be prepared to explain your reason for these limits. The answer should be better than "its the smallest the detector can detect". Use the 7mm size limit set by FDA (CPG Sec. 555.425 Foods, Adulteration Involving hard or ...). I would call that a justification for detecting those sizes since they are below the FDA hazard.
As far as calibration that should be part of your other calibrations. Do a validation on your metal detector annually. Not just a calibration cert from a thrid-party. Challenge your detector with at least a hundred passes of metal. Document your findings in a report. Calibration and Validation will support your CCP, which in turn verifies it is working as it should. The CCP is the metal detector.
Your hazard is metal (physical hazard) , your CCP is metal detection. You critical limit is basically NO metal at all ( I don't think you have limits), your monitoring would be checking the metal detector hourly to verify it is working. Validation would be calibrating annually.
A more realistic critical limit would be no detectable metal. This then equates to the LOD for the MD.
metal inclusion.PNG 96.51KB 2 downloads
(ex FDA)
@wtheriot - the reality is rather more complex and overlaps (in the USA) Adulteration.
I suggest very few customers will accept 5mm ball bearings in their product.
BRC consider that "calibration" for a MD has no specific meaning. They recommend use of "Sensitivity".
Ahh, the metal detector question again.
While the FDA guidance for over 7mm detectable is pretty much the only "guidance" provided by the FDA, Charles is completely correct in asking if your customer(s) are OK with having a 5mm chunk of metal in your product.
While the goal is to have zero metal in your product, I'm not aware of any metal detector that will detect, let's say a .5mm test wand. So basically you need to determine what level of risk you are willing to take.
What your Critical Limits are are completely dependent on the sensitivity of your metal detectors and the type of product you produce (and the orientation of those products when they pass through the detector).
In my situation, our detectors for some products are as low as 1.5mm ferrous and as high as 4mm Stainless. It really depends on the density of the product that is passing through the detector and, of course, the sensitivity of the detector.
But to attempt to answer the OP, the CCP is whether or not the detector does in fact do what you say it's supposed to do.
Marshall
Hi,
Since metal detection is a part of your process then CCP is Metal detection and not the calibration of metal detector. The critical limits as you have mention should have supporting data based on which you have set these critical limits for your end products.
Get the test pieces calibrated and verify the metal detection process and document it. As for as i know there is no calibration for metal detector itself but the preventive maintenance and verification is done on regular basis.
Mahantesh
Hi,
Since metal detection is a part of your process then CCP is Metal detection and not the calibration of metal detector. The critical limits as you have mention should have supporting data based on which you have set these critical limits for your end products.
Get the test pieces calibrated and verify the metal detection process and document it. As for as i know there is no calibration for metal detector itself but the preventive maintenance and verification is done on regular basis.
Mahantesh
Actually the test pieces should be certified, eg -
https://www.pharmace...tion-sampl-0001
The potential problems with use of the terminology "calibration" for metal detectors are detailed here -
Actually the test pieces should be certified, eg -
https://www.pharmace...tion-sampl-0001
The potential problems with use of the terminology "calibration" for metal detectors are detailed here -
Yes Charles,
Metal detectors are calibrated in the same way we do daily verification with some preventive maintenance etc, but i dont think we should get it from external agents instead we can do it in-house. But yes the pressure gauges present on the ejector side of metal detector should be calibrated.
And also the test pieces should have NIST standard certificate if not then we can get it calibrated by external agency. This is how we did in my company, we did not have certificate then we got it calibrated by external calibration agency.
Your hazard is metal (physical hazard) , your CCP is metal detection. You critical limit is basically NO metal at all ( I don't think you have limits), your monitoring would be checking the metal detector hourly to verify it is working. Validation would be calibrating annually.
Thanks for you reply. but how we say no metals for critical limits. Because as I know the metal detector can't detect all the metals. It can detect only up to the limits given at the calibration.
Ahh, the metal detector question again.
While the FDA guidance for over 7mm detectable is pretty much the only "guidance" provided by the FDA, Charles is completely correct in asking if your customer(s) are OK with having a 5mm chunk of metal in your product.
While the goal is to have zero metal in your product, I'm not aware of any metal detector that will detect, let's say a .5mm test wand. So basically you need to determine what level of risk you are willing to take.What your Critical Limits are are completely dependent on the sensitivity of your metal detectors and the type of product you produce (and the orientation of those products when they pass through the detector).
In my situation, our detectors for some products are as low as 1.5mm ferrous and as high as 4mm Stainless. It really depends on the density of the product that is passing through the detector and, of course, the sensitivity of the detector.
But to attempt to answer the OP, the CCP is whether or not the detector does in fact do what you say it's supposed to do.
Marshall
Hi Marshall,
The critical limits which I have mentioned above are given by our principles. And we teach the detector daily for above limits. But previous audit one of our auditor comment to put another CCP as "metal detector calibration ". That is my question.
Thank you
Hi Marshall,
The critical limits which I have mentioned above are given by our principles. And we teach the detector daily for above limits. But previous audit one of our auditor comment to put another CCP as "metal detector calibration ". That is my question.
Thank you
Hi Savani,
I anticipate that yr auditor was probably referring to Validation of the Critical Limits but was misunderstood.
Our metal detection is part of the Control of Foreign Materials program, depending on your risk assessment -this will either become a CCP or OPRP. In our case, it is an OPRP, we stated our internal standards. If you assessed that the hazard is high enough to be a CCP, then you must find established or regulatory limits forthe hazard, look to the specific Codex of your product or industry.
Our metal detection is part of the Control of Foreign Materials program, depending on your risk assessment -this will either become a CCP or OPRP. In our case, it is an OPRP, we stated our internal standards. If you assessed that the hazard is high enough to be a CCP, then you must find established or regulatory limits forthe hazard, look to the specific Codex of your product or industry.
OPRP is only meaningful if using ISO-HACCP, not Codex.