4 replies to this topic

[elaine1980]

Hi All

 

I've had issues this week with the identification of small fragments of metal <5mm size in a batch of dry material that has passed through our 7mm sieve mesh and attached themselves to the bar magnets located below the mesh (magnets not identified as a CCP).  Our CCP to sieve all materials is being correctly followed, the fragments were identified by "chance" as we have magnets fitted, but had this been plastic for example it would probably not have been spotted.  My question is, given that we are successfully sieving to 7mm size and the magnets are picking up the rogue fragments of metal, is it acceptable to continue using the material?  What would a BRC or retailer auditors think of this?  Even as I type this sentence it sounds like a ridiculous question given that the material is clearly contaminated.  However, lead time for replacement stock would mean we would be unable to manufacture any products at our site for 7 days until replacement material is delivered. No alternatives are available and the supplier is unable to reduce lead time any further.  Nightmare!  Currently trying to justify this to myself in order to support the business.

 

p.s thanks in advance for your thoughts!

[cazyncymru]

My first thought is, that your magnets also ought to be a CCP. Otherwise why have you got them? At least it shows their working!

 

What does your supplier spec say for contamination? Do they mention sieving and at what gauge?  Has there been a failure at their end? Or has there been a failure at your plant?

 

How small are the piece that are being detected by the magnet? AS a quick validation, see how small a piece it can pick up. it maybe that you run the plant slower, or recirculate. It's difficult to judge without knowing what you do.

 

It maybe in this instance that all of the metal is being captured by the magnets. Can you sieve through a finer sieve? Have you another batch or day code you can move onto? If your uncomfortable, then reject. Don't forget what a product recall can entail.

 

I'd be on the case of your supplier, wanting a full traceability and why there is contamination in their product and how has it happened.What Corrective Actions are they putting into place. Also, if you can, get someone to audit them. Keep the pressure on them (if it is them!) don't let them become complacent..

 

Cazx

[elaine1980]

Hi Caz

Unfortunately we can't pass through a smaller mesh due to the coarse nature of the material but I have tried, it all just sat on top of the mesh and wouldn't move!! We have metal detection in place but I fear that if there is material passing through the sieve it could be broken up into smaller pieces thus not being picked by the detectors.  I've tried 3 different batch codes and all are contaminated.  I'm onto the supplier and they are reporting to their local authority so they are taking it seriously but since the size of pieces we're finding are all <7mm they are not considering it to be "hazardous".  I'm awaiting their report before I take any further action but yes they do have both sieving and magnets in place at their facility.  My gut tells me to reject the lot and face the issues of zero supply with our MD in the morning.  Take on board your comment about magnets, its part of our sieving CCP to check and report any findings on the magnet bars but we only have magnets on one of our many sieves so I'm trying to justify why it would be a CCP for one line and not for them all but that's just something else I need to establish! 

Thanks again Caz

Elaine

[Munda]

Well! this need to scruitinize the situation therein. But before going further we need to answer the questions like; what is the source of these metals? was magnet put to remove metals or to be like a monitor? if was to remove,what is the monitor for this step? if was the monitor, what is the removal step for metals?

 

If we can have answers for these kind of questions then we will have to know where to start and if the point ought to be ccp.

 

Munda

[Charles.C]

Dear Elaine,

 

We have metal detection in place but I fear that if there is material passing through the sieve it could be broken up into smaller pieces thus not being picked by the detectors.

I am confused regarding yr process. I deduce you have MDs in the line but they not identified as CCPs. Unusual albeit not impossible. Or perhaps the MDs are off-line since you only use them for "Verification".?

 

I also deduce that the MDs are missing contaminants up to 7mm dimension. This is unusually poor sensitivity  IMEX but perhaps you have set the MDs up this way. ?

 

Regardless of USFDA opinions, I think you are very fortunate if yr customer is willing to routinely receive metal contaminants up to 7mm in dimension. Equally interesting to hear the opinion of the Local Authority.

 

I guess BRC's opinion will be prioritised somehow. eg legislatory > int.stds (if any, which for MD debatable) > customer requirements.

 

It is interesting to note from other threads running here the caveats on using the 7mm handout for general usage. Such aspects seem to be conveniently omitted in many discussions. For example, if one refers to more detailed analyses the data seems a little more expressive -
 

FDA Health Hazard Evaluation Board  FDA Health Hazard Evaluation Board conclusions in cases of foreign materials (1972-1997) found that 56% of objects 1- 6 mm might pose a limited acute hazard.

For objects > 6 mm, only 2.9% were judged to present no hazard.

 

Rgds / Charles.C