14 replies to this topic

[kconf]

Hi all,

Could someone share info on FDA/BRC guidelines for metal detector calibration/certification please? Is it annual or biannual?

[kconf]

Come on experts, I need answers 

[Setanta]

Come on experts, I need answers 

 

 

BRC is not my thing, man!  

[Tony-C]

Come on experts, I need answers 

 

Sorry kconf I was asleep when you posted!    

 

BRCGS does not require annual calibration/certification for metal detectors, I would refer to the manufacturer’s recommendations.

 

See BRCGS Global Standard for Food Safety Issue 9 Clause 4.10.3.3 Documented metal detector and X-ray procedures - Guidance:

 

‘The set-up and design of the operating procedures will need to consider a number of factors, which will affect the sensitivity of the detector and the effectiveness of the rejection mechanisms, including, for example:

• size and type of product – product size and composition can affect the sensitivity of the detector and therefore its ability to identify

• product packaging – product is normally tested in pack, but certain types of packaging will prevent this

• line operating speeds – there must be sufficient time for the detector to identify the presence of a contaminant and the rejection mechanism to accurately and consistently remove the implicated pack from the product flow

• location of the detector – should be risk-assessed to ensure that the placement efficiently and effectively minimises the risk of foreign bodies in the finished product

• customer-specific requirements – some customers have specific requirements relating to detector sensitivity or frequency of tests

• identification of the least sensitive (sometimes referred to as the weakest) part of the detector, to ensure that any contaminated product will still be rejected, even if the contaminant is located at this weakest point.’ 

 

'The frequency of testing must be based on the quantity and type(s) of product. However, the following should be considered: ..... blah, blah etc.'

 

‘The Standard does not require routine calibration of metal detectors beyond the verification/checking activities described in this section. However, planned maintenance or servicing may have value depending on the machine, the manufacturer’s specification, the contract and/or the operating environment.’

 

Kind regards,

 

Tony

[GMO]

Don't forget that original set up would require a level of validation on efficacy and retailer standards often go above and beyond BRCGS.  I also agree with the above that PPM may essentially be the same as that normally considered a revalidation (a term I hate personally) or calibration and the lack of planned maintenance might be an issue without it.

 

Also remember any changes may require some level of revalidation.  So for example, significant formulation changes or relocation of the detector but that shouldn't wait for an annual service if you decide to do that.

 

Where are you based?

[kconf]

Hi GMO. I am in the US. If I do not have a calibration record from manufacturer for beyond 2 years, would I be in trouble? 

 

Btw, you guys rock! All of you. 

[GMO]

Hi GMO. I am in the US. If I do not have a calibration record from manufacturer for beyond 2 years, would I be in trouble? 

 

 

Does your team have sufficient training to be able to service or maintain the machine "in house"?  If so, I think you should be fine.  If not that might be harder.

[kconf]

I don't know about service or maintain. They just know how to use it and what to do if it fails. 

[GMO]

I don't know about service or maintain. They just know how to use it and what to do if it fails. 

 

Then who services and maintains your metal detector?  If it's nobody, then it might be worth bringing in the OEM or a competent expert contractor to do so and as part of that they will issue a service report.

[kconf]

Mettler Toledo does, but it has been 2+ years. I was wondering how long I can go on without being serviced again. 

[GMO]

Might be worth looking back at any manuals or if you don't still have them, search online for the make and model.  It will probably have guidance in there on how often they need to be serviced.  

[jfrey123]

What does your PM program state for the maintenance frequency?  As GMO eluded to, the manufacturer's technical specs for the device probably mention the prescribed maintenance intervals.  Other thing to check are whether the calibration certs you've got from Mettler Toledo have an expiration.

[G M]

Hi GMO. I am in the US. If I do not have a calibration record from manufacturer for beyond 2 years, would I be in trouble? 

 

Btw, you guys rock! All of you. 

 

The interval for service is probably annual according to the technical manual.  If you have the model number you can probably get the documents for it from MT if you can't find them.

 

Beyond that it is mostly up to your own verification and validation programs, which I would guess probably also default to annual service/calibration for most equipment.

 

As far as 'trouble' ~ meh.  It's not great, but if your verification records have been acceptable, and you get the service done or have it scheduled, it shouldn't be more than a minor problem to most auditors.

[kingstudruler1]

Hi GMO. I am in the US. If I do not have a calibration record from manufacturer for beyond 2 years, would I be in trouble? 

 

Btw, you guys rock! All of you. 

 

 

What does your calibration program state you are going to do for the metal detector?

If your metal detector is ccp / pc , what does does the validation of portion of the plan say you are going to do?

 

Most auditors like to see the third party "validation" / "calibratin"  once per year.   Especially true if its a CCP / PC.  However, Ive gotten around in the past.   Ive also seen some very "cheesy" validations / calibrations done by third parties that seem to pass muster.  Depending on location, there may be a local / non equipment MFG that will provide the service.

 

There is value in the annual service / calibrationv/ validation.   Not only do you get the rock solid piece of paper stating that a third party expert has validated the equipment as effective.   They may also give you information such as the the health / strenght of the "head" indicating it may be starting to fail and need replacement, etc .   

 

a few options:

1.  You may be able to "get by" declaring that everything is done in house.   Make sure all your procedures state this.  

2.   Get the third party company onsite  to provide the validation / calibration.  

3.   If you cant get the third party in prior to an audit, enter a non-conformity and get them scheduled.   Add what your are doing in the mean time to ensure MD is functioning properly (reviewing, evaluating, trending MD failures, etc)

[GMO]

 

 

Most auditors like to see the third party "validation" / "calibratin"  once per year.   Especially true if its a CCP / PC.  However, Ive gotten around in the past.   Ive also seen some very "cheesy" validations / calibrations done by third parties that seem to pass muster.  Depending on location, there may be a local / non equipment MFG that will provide the service.

 

There is value in the annual service / calibrationv/ validation.   Not only do you get the rock solid piece of paper stating that a third party expert has validated the equipment as effective.   They may also give you information such as the the health / strenght of the "head" indicating it may be starting to fail and need replacement, etc .   

 

 

I agree.  I am not a fan of people calling it a revalidation or validation.  It's not.  It's a maintenance activity in which there is a verification that the test pieces are still rejected etc but that's no better than normal testing IMO.  The real value is in the maintenance as you say.