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Advice on Foreign Body Complaint

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Baohan88

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Posted Yesterday, 06:25 AM

Hi everyone, I recently received a customer complaint about a 1 cm metal fragment found in one of our finished products. My investigation revealed the contamination occurred during production due to a loose machine part. Although the operator adjusted the equipment and notified maintenance, they did not stop the line or hold the product. Instead, production continued as usual, even after the malfunction was discovered.
I plan to re-train all production operators on proper procedures when equipment abnormalities occur and also assign an additional supervisor to monitor processes during breakdowns.
Besides training and supervision, I would really appreciate suggestions on additional preventive that can help avoid similar complaints. Do you have any suggestions on improving the escalation process to prevent operators from bypassing critical steps? I would be grateful for any insights you can offer from your experience. Thank you in advance for your help!

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GMO

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Posted Yesterday, 06:43 AM

Before you jump to retraining, was lack of training the problem?

 

I know it sounds stupid but SO often when it comes to an incident people jump to "train" or "brief" their teams rather than understand what went wrong first.

 

I'd use a combination of fishbone and five whys to first understand the issue then go to corrective and preventive actions.

 

So a few questions to ask yourself.

 

Why was the machine part loose?

What processes are in place to prevent the loose machine part?

What PPM does the machine receive? Was that to plan?

What knowledge do the team have on metal hazards and consumer risk?

How was the part repaired when it was found? (As presumably it wasn't just a contaminant linked to one person but also later repaired, probably by someone else.)

How much pressure are the team under to deliver production volumes?

How are people treated if they raise a concern?

Are team members overly reliant on metal detectors?

Does your metal detector detect this contaminant?

 

I'm sure you can think of more. Even if you decide training is the answer, you can then direct it to actual gaps.


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SHQuality

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Posted Yesterday, 09:41 PM

I'm not so sure that the training was the actual root cause that needed addressing.

 

How did this piece of metal make it all the way to the customer?

Don't you have a metal detection system?

If you do have one, do you have records that show it was working correctly at the time of this incident?

 

A working metal detection system would've ejected this product from the line and the first thing I would ask if I was auditing your business or if I was this customer is how this could possibly have happened in the first place.


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GMO

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Posted Today, 04:01 AM

 

A working metal detection system would've ejected this product from the line and the first thing I would ask if I was auditing your business or if I was this customer is how this could possibly have happened in the first place.

 

Depends on if it was a long and thin piece of metal and orientation effects but yes, it's certainly worth looking into why it didn't. If there are issues with sensitivity. If settings have been changed. If timing is set up correctly. Are your failsafes working? Are staff even faking results for tests? (It happens.) Etc.


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