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Corrective Action if operator forgets to carry out a rejection test?


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maylao123

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Posted 18 October 2019 - 04:48 AM

Hi everyone,

 

Can anyone help to answer what is the corrective action for conduct Metal Detector rejection test at the frequency longer than what's written in the SOP, like it's required every 1 hour, however the operator forget and does it more then 1 hour? 

 

Moreover, for the start up test, can the metal test strips embedded with product be conveyed through the Metal Detector instead of only metal test strips alone?

 

Thanks, 



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Posted 18 October 2019 - 10:25 AM

Maylao123

 

The corrective action is to re put all the product through the metal detector since the last rejection test was done. however in practice some will do the representative  sampling of the product which has not been through the metal detector and if nothing is detected in the sample they will release the whole batch.

 

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Posted 18 October 2019 - 11:10 AM

Go to last good check and re-run everything or if not practical (as one of my clients has done in the past) to re-run, dump.


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Posted 18 October 2019 - 11:40 AM

Hi everyone,

 

Can anyone help to answer what is the corrective action for conduct Metal Detector rejection test at the frequency longer than what's written in the SOP, like it's required every 1 hour, however the operator forget and does it more then 1 hour? 

 

Moreover, for the start up test, can the metal test strips embedded with product be conveyed through the Metal Detector instead of only metal test strips alone?

 

Thanks, 

Maylo,

You can embed the metal test pieces in your product (depends on what type of product you produce), and do not forget to mark the metal embedded product properly to easily identify.

If metal detector is not verified within the time of one hour, then you have to hold the product from the last verification and repass through metal detector.

 

Regards

Mahantesh



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majoy

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Posted 18 October 2019 - 03:38 PM

Hi everyone,

 

Can anyone help to answer what is the corrective action for conduct Metal Detector rejection test at the frequency longer than what's written in the SOP, like it's required every 1 hour, however the operator forget and does it more then 1 hour? 

 

Moreover, for the start up test, can the metal test strips embedded with product be conveyed through the Metal Detector instead of only metal test strips alone?

 

Thanks, 

 

Agree with running all the products made after the last good run, time consuming, but this is how production/management people will learn that Metal detection is not something that they should take lightly.

 

But, in your written procedure, you should have some wiggle room too to conduct the test, say +/- 15 mins, the metal detector test must be carried out. Unless of course you have dedicated personnel doing the metal detector test, then the exact hourly should no longer be missed.

 

So... when you pass the test strip on its own on the metal detector, you're not only checking the working condition of the metal detector but you're also checking the condition of each test strip, that they are actually getting detected by the machine and still has the metal in them. So checking the test strip on its own is a good practice before you embed it on a product.


Edited by majoy, 18 October 2019 - 03:41 PM.

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zanorias

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Posted 18 October 2019 - 05:12 PM

Do you conduct external validation of your detectors? I would recommend a visit from the manufacturers or equivalent to validate your detection against product suitability.

Personally I'm sceptical of a sampling approach to 'check' for foreign body acceptability - metal contamination is often singular i.e. a piece of metal from equipment finds its way into a pouch of product. Hence all pouches need to pass through a working detector, you can't assume that because a sample % is ok that the whole amount is safe.

Also it's worth considering preventive. Why did the tester miss the hour? I've crossed this subject during auditing and always suggest to operators that the SOP is hourly maximum - best to increase frequency if they are finding they can't make the test on the dot for whatever reason. Plus the +/- parameters are often subjective if not defined and risk non-comp from auditor if they judge an excessive delay, plus extra re-work as seen here.



maylao123

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Posted 28 October 2019 - 05:18 AM

Thanks everyone for the advces.



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Posted 28 October 2019 - 05:08 PM

Hi everyone,

 

Can anyone help to answer what is the corrective action for conduct Metal Detector rejection test at the frequency longer than what's written in the SOP, like it's required every 1 hour, however the operator forget and does it more then 1 hour? 

 

Moreover, for the start up test, can the metal test strips embedded with product be conveyed through the Metal Detector instead of only metal test strips alone?

 

Thanks, 

 

More than i hour is somewhat undefined. :smile:

 

Unfortunately sensitivity can vary substantially  with food matrix so some validation is relevant.


Kind Regards,

 

Charles.C





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