15 replies to this topic

[Tresa]

Hi everyone, I would appreciate your input on how to validate the CCP for Metal detector? (bakery products)

 

 

[Scampi]

This is a great article that will help walk you through the steps

 

https://techni-k.co....ion-validation/

[FSQA MKE]

Tresa,

Metal detection as a CCP is a divisive topic.

I am inclined to ask:

Why is metal detection considered a CCP and not a pre-resquisite program?

[Charles.C]

Hi everyone, I would appreciate your input on how to validate the CCP for Metal detector? (bakery products)

 

Hi Tresa,

 

Did you mean Metal Detector or HACCP CCP-Critical Limit ? There is a difference.

 

Mettler would probably regard the link in Post2 as insufficient if referred to the former, eg -

 

 Mettler - Validation of Metal Detector.pdf   1.39MB   153 downloads

[Ieatcookies]

From my short experience I would say this is a tricky one. I have met the auditors who were happy with the calibration of the equipment. I would also rely on FDA cocking hazard suggestions, and they say it should be smaller than 7mm (i think i got this right), therefore you know your sample pieces should also be below 7mm. 

 

Because on our site we have often product change overs, we grouped the products into categories, and we check our product less often that the changeover takes place (we sometimes have changeovers every 10minutes). so annually we check every product on each programme, we send it placed in various ways on the conveyor and with the sticks in different places. this way we prove that the programmes are set up right. We also send some other bits through the metal detector placed in product in different places (screws, plasters, hair nets, pens). we also test every batch prior issuing to production. 

[Charles.C]

From my short experience I would say this is a tricky one. I have met the auditors who were happy with the calibration of the equipment. I would also rely on FDA cocking hazard suggestions, and they say it should be smaller than 7mm (i think i got this right), therefore you know your sample pieces should also be below 7mm. 

 

Because on our site we have often product change overs, we grouped the products into categories, and we check our product less often that the changeover takes place (we sometimes have changeovers every 10minutes). so annually we check every product on each programme, we send it placed in various ways on the conveyor and with the sticks in different places. this way we prove that the programmes are set up right. We also send some other bits through the metal detector placed in product in different places (screws, plasters, hair nets, pens). we also test every batch prior issuing to production. 

 

Hi Ieatcookies,

 

I have never met an auditor/customer who would accept the "famous" 7mm decision criterion.

 

A close reading of FDA's relevant document demonstrates that this value, albeit scientifically safety supportable, is illusory from an ultimate Product accept/reject POV.

 

I suggest a study of US recalls due metal contamination.

 

PS - auditors who confuse Calibration with Validation should perhaps be regarded as "suspect".

[Scampi]

Canada's choking reference is  2mm, 7mm is actually quite large

 

Health Canada has developed a guidance document for determining the general cleanliness of foods. The document, Guidelines for the General Cleanliness of Food - An Overview includes information on foreign matter associated with objectionable conditions or practices in manufacturing, processing, storing, transporting and handling of food. Health Canada considers 2.0 mm or greater as the threshold size for consideration as a health risk.[1]

[Tresa]

Hi Tresa,

 

Did you mean Metal Detector or HACCP CCP-Critical Limit ? There is a difference.

 

Mettler would probably regard the link in Post2 as insufficient if referred to the former, eg -

 

Mettler - Validation of Metal Detector.pdf

I meant HACCP CCP. our MD is the CCP in our HACCP Plan

[Scampi]

Tresa, has the MD already been validated?  Assuming its not new to your company?

[Charles.C]

I meant HACCP CCP. our MD is the CCP in our HACCP Plan

 

This is typically interpreted as Validation of Critical Limits(s), eg (one of many) -

 

https://www.ifsqn.co...or/#entry174393

Edited by Charles.C, 21 May 2021 - 06:10 PM.
emended

[Tresa]

Tresa, has the MD already been validated?  Assuming its not new to your company?

Yes, it is not new. we have Loma who comes once a year to calibrate the MD. I usually reference the the Health Canada consideration of 2.0 mm or greater as the threshold size for consideration as a health risk. but not sure if this is enough or not. I am looking for better/proper way for CCP critical limits Validation.

Edited by Tresa, 21 May 2021 - 06:09 PM.

[Charles.C]

Yes, it is not new. we have Loma who comes once a year to calibrate the MD. I usually reference the the Health Canada consideration of 2.0 mm or greater as the threshold size for consideration as a health risk. but not sure if this is enough or not. I am looking for better/proper way for CCP critical limits Validation.

 

Calibration is not Validation.

 

See -

 

https://www.ifsqn.co...rs/#entry105910

 

PS - You are perhaps extremely fortunate in that Canada is one of the rare Global locations which  has, afaik, established specific  Regulatory Limiits for metallic contamination. (Although I would anticipate that the limits may be instrumentally unachievable for, say SS, if applied to some large  packs).

 

PPS - IIRC, depending on the situation, yr 2.0mm may be 0.0mm)

Edited by Charles.C, 22 May 2021 - 04:43 AM.
added

[Scampi]

Basically, you need to perform destructive testing. Put a tiny ball bearing in various locations in a marked (wrapped) baked good, and then run it through the detector in different orientations. 

Repeat that over and over to ensure it's repeatable. 

 

This procedure should be done on every sku for every test bar.  Then put all that data together, you have now got site specific validation to prove your MD is capable of doing what you've said it can do

 

It will probably take a couple of weeks (unless you can dedicate all your time) to get every possible item/orientation in the MD completed

[Charles.C]

Hi Tresa,

 

Here is one example (but also see my PS/PPS to Post 12) -

 

 Validation MD Critical Limit.pdf   72.54KB   82 downloads

 

(Credit mgourley/Marshall)

Edited by Charles.C, 22 May 2021 - 04:44 AM.
added

[Ieatcookies]

Hi Ieatcookies,

 

I have never met an auditor/customer who would accept the "famous" 7mm decision criterion.

 

A close reading of FDA's relevant document demonstrates that this value, albeit scientifically safety supportable, is illusory from an ultimate Product accept/reject POV.

 

I suggest a study of US recalls due metal contamination.

 

PS - auditors who confuse Calibration with Validation should perhaps be regarded as "suspect".

 

Hi Charles, 

 

I think you have misinterpreted my words. I have never said that 7mm is acceptable and in my short auditing career I challenged 6mm as too large pieces. I referred to FDA as explain why the pieces should not be larger. Yes, smaller sharp pieces also may cause serious issues and should be taken into consideration. 

I do not comment on differences and understanding by auditors between validation and calibration. Our auditors (seeing our validation documents) referred to it as 'best practice'. my understanding is, this was not required, but one step ahead. 

[Charles.C]

Hi Charles, 

 

I think you have misinterpreted my words. I have never said that 7mm is acceptable and in my short auditing career I challenged 6mm as too large pieces. I referred to FDA as explain why the pieces should not be larger. Yes, smaller sharp pieces also may cause serious issues and should be taken into consideration. 

I do not comment on differences and understanding by auditors between validation and calibration. Our auditors (seeing our validation documents) referred to it as 'best practice'. my understanding is, this was not required, but one step ahead. 

 

Hi ILC,

 

Here is one (quoted) suggestion for the potential US consequences of metal contamination -

 

Metal detection is used for both quality and safety reasons. FDA has established guidelines for hard and sharp objects, but the presence of any metal in a food product, even if it’s very small and does not pose a significant safety hazard, renders that product adulterated. In fact, most recalls are initiated because of very small bits of metal or plastic in food.

 

IIRC, the classic FDA response to  "what is the size of acceptable metallic contamination in food ?"  is "Zero". 

 

Although the haccp interpretation  in FDA's Fishery Standard Text is slightly more generous (and operationally ambiguous)  -

 

No detectable metal fragments are in the product that passes through the metal detection or separation device

 

I have always wondered who defines "Best Practice".