9 replies to this topic

[PollyKBD]

I have a customer asking us to provide scientific justification for metal detection as our CCP. 

This is what they are asking for:

"Do the validation reports appear to support a conclusion for effectiveness of the control measure? (e.g. control, reduce, or eliminate the hazard to the specified Critical Limit; for a consistently safe product; as determined through scientifically designed experimental validation studies which are objectively measured and formally reported with conclusions, evidence from professional bodies, trade associations, scientific literature, regulations, and legislation).

Is a Validation Report attached in the Process Controls section for EACH of the identified Process Preventive Controls and CCP's?"

 

I sent them our annual validation record, which is proof that the metal detector works on each of our products which was not the information they were looking for. They said I must conduct a study to ensure the effectiveness of the control measure.

I reached out the the manufacturer of our metal detector and they did not understand what I was looking for. 

These are the audit criteria the customer referred me to:

"Does validation/scientific justification documentation exist to support adequacy of critical limits or parameters for controlling the significant hazard at each CCP? Is there annual verification performed and documented? Where scientific justification of critical limits or parameters relies upon published, referee journal research publication, regulatory guidance, etc., are the processing critical parameters and prudent matrix adequately represented?"

 

I'm afraid I am with our metal detector manufacturer and really don't understand what they are looking for. I have read some of the other metal detection threads here and felt like the didn't completely address what I needed. Can anyone help, explain, or point me in the right direction? 

Thanks in advance!

~Polly 

[pHruit]

"Does validation/scientific justification documentation exist to support adequacy of critical limits or parameters for controlling the significant hazard at each CCP?

This sentence reads as though they're potentially looking for justification of the limit itself, rather than the functionality of the detector - e.g. if you've validated detection of 2mm Fe, can you prove that a piece smaller than 2mm does not pose a hazard to the consumer.

But that contrasts with this sentence where they appear to be asking if the metal detector achieves what you expect it to, i.e. that they want the validation details you've already sent to them...

"Do the validation reports appear to support a conclusion for effectiveness of the control measure? (e.g. control, reduce, or eliminate the hazard to the specified Critical Limit; for a consistently safe product; as determined through scientifically designed experimental validation studies which are objectively measured and formally reported with conclusions, evidence from professional bodies, trade associations, scientific literature, regulations, and legislation).  

 

I'm not entirely sure how you'd be expected to conduct your own experimental study on whether the critical limits are suitable - I know the food industry gets some bad press but I don't think we'd actually start pushing a range of differently-sized metal fragments into consumers throats to see whether there was any adverse effect!

Have you tried pointing them towards the oft-cited FDA guidance, assuming your critical limits are all below 7mm? (https://www.fda.gov/.../ucm074554.pdf)

 

Tying this together with your own validation report would demonstrate that you can detect metal fragments below x mm (and thus prevent them reaching consumers), and that pieces below this limit do not pose a significant hazard to consumers. .

[Scampi]

This article may be of assistance in preparing your validation study 

http://www.fao.org/i...22/CXG_069e.pdf

 

You should use the FDA (and other government standards) as the basis for your validation. Regulatory standards are based on scientific information and are often quoted in validation studies for any control measure.

 

What you provided your customer with is just the verification that your control measure is working (think monitoring here).................they are asking for PROOF that your controls are SUITABLE for the hazard

 

You do not need to do your own study (unless you are trying to prove something other than the regulatory standards) but you do need to gather and reference scientific proof that metals smaller than your detector is capable of catching, do not pose a hazard to consumers 

[kfromNE]

http://www.aibonline...aldetectors.pdf - this article may help. AIB is a professional body stating that metal detectors are high effective (last paragraph)

 

Another way to validate perhaps - show you've had no recalls due to foreign metal - that would support the effectiveness of the control measure. Justification for the scientific justification for metal detection - present the number of recalls occurred due to metal. This data would come from a government source.

[012117]

Hi, Polly.

 

On top of what was mentioned, does the customer have specific "food safety" limit for the physical hazard? Or are the country they are supplying to have critical limit different to 7mm? If so, you must also show that the equipment you have is able to satisfy their requirement. If they are catering to the same country as your, then reference from FDA will suffice to say that it is considered physical hazard. Unless you identified different hazard in your HACCP or the material you supply have "intrinsic" hazard which is not metal detectable.

 

Like also what attached in the codex (as attached by Scampi), how many passes of the product with contaminant did the manufacturer (MD) made? Is the number statistically sound?

 

For the validation study, does it also account the worst case scenario (e.g I used the "maximum" operating speed, overlapping of product, product distance, "worst case" product) etc. As we all know, when the MD manufacturer conducts their test, it is mostly during the "best case" scenario, or when there are less interference to production or around the MD equipment.

[mgourley]

It sounds to me like a bunch of horse poop.
If you are using metal detection, and the metal detector reliably rejects test pieces well below what the FDA "guidance" is, what is the issue?

I'd get a hold of the contact at your customer and ask, specifically, what they want. I'd be willing to bet that the contact has no clue. This sounds to me like boilerplate language that nobody has bothered to bring into the real world.

Marshall

[Charles.C]

I have a customer asking us to provide scientific justification for metal detection as our CCP. 

This is what they are asking for:

"Do the validation reports appear to support a conclusion for effectiveness of the control measure? (e.g. control, reduce, or eliminate the hazard to the specified Critical Limit; for a consistently safe product; as determined through scientifically designed experimental validation studies which are objectively measured and formally reported with conclusions, evidence from professional bodies, trade associations, scientific literature, regulations, and legislation).

Is a Validation Report attached in the Process Controls section for EACH of the identified Process Preventive Controls and CCP's?"

 

I sent them our annual validation record, which is proof that the metal detector works on each of our products which was not the information they were looking for. They said I must conduct a study to ensure the effectiveness of the control measure.

I reached out the the manufacturer of our metal detector and they did not understand what I was looking for. 

These are the audit criteria the customer referred me to:

"Does validation/scientific justification documentation exist to support adequacy of critical limits or parameters for controlling the significant hazard at each CCP? Is there annual verification performed and documented? Where scientific justification of critical limits or parameters relies upon published, referee journal research publication, regulatory guidance, etc., are the processing critical parameters and prudent matrix adequately represented?"

 

I'm afraid I am with our metal detector manufacturer and really don't understand what they are looking for. I have read some of the other metal detection threads here and felt like the didn't completely address what I needed. Can anyone help, explain, or point me in the right direction? 

Thanks in advance!

~Polly 

 

Hi Polly,

 

I suggest you re-read the link in Post 3. And perhaps try this recent thread -

 

https://www.ifsqn.co...or/#entry134357

 

There are many, many discussions here over the interpretation/distinction between Validation and Verification.

 

This extract from the OP sounds (to me and perhaps Codex [but probably not  SQF]) more like the Latter (there is insufficient detail to be certain) ?

 

I sent them our annual validation record, which is proof that the metal detector works on each of our products which was not the information they were looking for. They said I must conduct a study to ensure the effectiveness of the control measure.

 

 

Examples of studies illustrating the Generation of "Validation" documents exist on this Forum. Notably one by Marshall.

 

The subject of choice of  the  XYZmm limit has also been discussed here at length. And summarised recently here -

 

https://www.ifsqn.co...on/#entry133891

[PollyKBD]

Thank you, everyone. I don't disagree that the customer is challenging, to say the least and has had some requests that have me scratching my head, but they are a very reputable retailer and we are grateful to have them as a new customer, even though it has made my job more challenging.  

Hopefully the advice here will guide me to the answer they are looking for and we can satisfactorily meet their requirements.

Thanks again!

[Charles.C]

Thank you, everyone. I don't disagree that the customer is challenging, to say the least and has had some requests that have me scratching my head, but they are a very reputable retailer and we are grateful to have them as a new customer, even though it has made my job more challenging.  

Hopefully the advice here will guide me to the answer they are looking for and we can satisfactorily meet their requirements.

Thanks again!

 

Hi Polly,

 

This elegant approach might be one way to satisfy yr customer -

 

https://www.ifsqn.co...zes/#entry91771

[Mulan1010]

Some scientific articles that might be helpful to support Metal Detection Parameters are the following:

• 7.2 Olson 1998 Review of Hard or Sharp Foreign Objects as Physical Hazards in Food Reg Toxic and Pharm 28 181-189
• Goldman 2002 The Physical Hazards of Foreign Materials - Public Meeting September 24, 2002, Slides 18-19
• FDA CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects, Issued 3/23/1999, Updated 2005-11-29  Pages 1-2  (I think a few links to this have been shared in previous replies.)

You can also use in-house data from SSOP Program, Calibration Program and Customer Complaints (or lack thereof) to help supports the metal detectors are validated and working properly.