6 replies to this topic

[dianep1]

I have recieved a non conformace for not validating the metal test pieces/sizes, I am unsure of how I should go about this??
Can anyone help please??

[Charles.C]

Dear dianep1,

Normally yr auditor should tell you what is required. ?

If you purchased them new, with/without a metal detector, they should hv come with a registered manufacturer's certificate.

If otherwise, yr supplier should be able to arrange an appropriate documented performance validation. (Possibly also depending on yr auditor's specific requirements).

Rgds / Charles.C

[Patrick F]

I believe what the auditor is referring to is. The actual size and type of the metal detection test strips or wands. The standard types of test strips/wands are: Ferrous,Non-Ferrous and Stainless steel. Along with that information on each test strip there is usually a size(2.0mm, 4.0mm, 6.0mm etc...). When you generally write it into your program you would outline the type of test strip for example: 2.0mm stainless steel.



I hope that is what you are referring to. Since you were rather vague in the request.

[dianep1]

I believe what the auditor is referring to is. The actual size and type of the metal detection test strips or wands. The standard types of test strips/wands are: Ferrous,Non-Ferrous and Stainless steel. Along with that information on each test strip there is usually a size(2.0mm, 4.0mm, 6.0mm etc...). When you generally write it into your program you would outline the type of test strip for example: 2.0mm stainless steel.



I hope that is what you are referring to. Since you were rather vague in the request.

Sorry............I was!!
She was refering to the sizes we use with our product (which is fried snack foods)!!
I have never validated that they are the correct size/type to use with our product!!

Thanks

[Charles.C]

Dear dianep,

I interpret yr previous post as meaning that you specify a different metal detector sensitivity standard (ie the "MM" number) for the same metallic material, depending on the type of snack food.

IMO that is remarkable. And yr auditor also.

Rgds / Charles.C

[Bradi]

Here in the states, I have learned that having a copy of FDA Compliance Policy Guide #555.425 helps in this discussion. At least for setting the critical limit at 7mm.

I believe this is also tied to the topic of validation vs. verification.


dianep; I struggle with this too. How do I know that my selection of test cards is correct? How do I know that the size of my metal detector opening is the correct size? How do I know that the sensitivity selection is correct? Do I need to have a "Offically Certified" test card in each size and test that against the cards I use on the floor?


Answers anyone?? Plz.

[Erickx]

Here in the states, I have learned that having a copy of FDA Compliance Policy Guide #555.425 helps in this discussion. At least for setting the critical limit at 7mm.

I believe this is also tied to the topic of validation vs. verification.


dianep; I struggle with this too. How do I know that my selection of test cards is correct? How do I know that the size of my metal detector opening is the correct size? How do I know that the sensitivity selection is correct? Do I need to have a "Offically Certified" test card in each size and test that against the cards I use on the floor?


Answers anyone?? Plz.

Hello,


What I did was doing a test on what is achievable with a certain type of metal detector in combination with a certain food product and the smallest type test strips possible.

I wrote a report on that and in the conclusion of the report was that we found 3 test strips (fe /non-fe/SS) which we could work with without having to many false positive rejects. Also mentioned in the report that smaller test strips resulted in many false positive rejects.

Furthermore I referred in this report to a report of the Dutch authorities in which the size of hazardous foreign bodies was discussed.

We have several metal detectors operational over here. In one occasion during an audit i had no test report as mentioned above and got a minor


I also found out that mentioning this report was of great help:

http://www.fda.gov/I...l/ucm074554.htm

Kind regards

Erickx