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BRCGS 2.11.1 - Nonconformity

Started by , Jun 05 2023 09:53 AM
4 Replies

NC: Staff at CCP Xray did not take appropriate corrective action when the instrument failed to capture the samples, but let the product through, nor did the instrument's sensitivity be properly adjusted.

 

Can anyone help me take corrective and preventive action?

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Starting with the corrective action, hopefully the material is still in your possession and can be re-run through an equivalent foreign material detector, including all material back to the last acceptable verification of the x-ray device.  Has the detector been adjusted and re-verified yet?

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About corrective action: perform consignment isolation at the time of the previous pass test, modify the machine, adjust the sensitivity, run the test sample, re-scan the suspect shipment.
record : Xray monitoring process tracking form with corrective action taken
Is it okay if I do this?
Firstly you need a containment. Presumably the protect was held and redetected?

Then I’d do a root cause analysis. Talk to your staff. Ask them about what happened? Talk to the equipment suppliers, your team, look at the procedure, is it clear? Were people trained in it? How did you audit it?

If you found the procedure was unclear for example, you might rewrite the procedure and train your staff. That would be your corrective action. Your preventive might be a review of all procedures impacting CCPs with actions as appropriate or it might be a change to your auditing process to have greater independence in it etc.

Or for example you might find the procedure was clear but untrained people were operating the machine. So your corrective may be to train more staff and your preventive could be to change your labour planning to ensure there is always a trained operative planned to work in that area.

The above are just examples. Always always do some root cause analysis l, ideally as a team and then be guided on your actions by where that leads you.
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Hi khanhhuyen,

 

You will need to do a root cause analysis as GMO has stated and as per BRCGS clause 1.1.12 this will be checked at your next audit. Whatever the outcome I would expect to see the following actions.

 

Corrective Action:

Hold and check the product

Investigate the cause of the failure

Fix and validate the metal detector & re-establish verification procedures.

 

Preventive Action

Retrain staff and evaluate the effectiveness at training

Increase service frequency and validation frequency of metal detector

Review procedures

 

Note BRCGS Global Standard for Food Safety Issue 9 Section 4.10 Foreign-body detection and removal equipment, second part of Clause 4.10.1.3:

The site shall establish and implement corrective action and reporting procedures in the event of a failure of the foreign-body detector and/or removal equipment. Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.

 

Kind regards,

 

Tony

 

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