5 replies to this topic

[ahansen27]

Hi ya'll!

I work as a QA Specialist for a CBD manufacturing company. I was recently given a CAPA when i staged two label rolls for production that had different SKUs/Version #s. In addition to my error, both rolls of labels were later verified by our staging personnel (material handler) and the production operator. This resulted in half of the batch being labeled with the incorrect label and having to be reworked.

 

I would like to say the root cause was human error but I feel as though this is not justified as it was missed by multiple people.

 

Verification is an issue we continue to see and we have implemented dual sign offs on almost all steps of production. We have performed additional training and little to no progress is seen in the way of reducing verification errors. 

 

My question is multi faceted:

What are other ways to prevent verification mistakes?

Does human error seem like a justified root cause or is there another path i should explore?

 

Any and all help would be greatly appreciated! Thank you.

[G M]

One of these was outdated, or was it just a case of one of them being entirely wrong for the item?

[Brothbro]

Do you think these verifications would have more success if they were being reviewed by supervisors instead of operators? Another thing to consider is how many things are getting verified in one go. It can be difficult for someone to do a ton of label review all in one check, they're worn out by the end of it. If the review can be split up a bit their eyes are fresher.

 

An alternative in verifications is switching to something computer-assisted. Using an app like RedZone, you can use an iPad to scan the barcode of a label and verify that the correct SKU/UPC is being run for the assigned production run. 

[Scampi]

Add the label to your batch record

 

I'm assuming visually, the labels are all quite similar.  If you're batch record includes a smaller version of the actual label, with check boxes for pertinent values that forces them to slow down and look

 

 

Alternatively-the root cause may very well be that the labels are entirely too similar, and changing art work may be the best preventative action

 

Human error is not a great root cause explanation--particularly if you had made this mistake with CBD vs THC   same product VERY different active ingredient

[ahansen27]

G M: The SKU differed by one letter so it was extremely easy to miss and the label itself looks almost exactly the same except for that one letter. 

 

Brothbro: I work for an extremely small company that is unwilling to invest in an electronic MMR system at this time, hence the continued mistakes. As for the review, it is done maybe 6 times in a ten hour work shift and they are only required to review 1-3 rolls at a time. I do not believe that is contributing to the errors. 

[kingstudruler1]

Whats the difference between the two products?  If your people are missing it, are customers purchasing an item they are not intending?

 

Make the lables more distinguishable?

 

Make people circle/ initial the the distinguishing the areas and attach to docs.  Pilots are / were taught to touch the gauges that they are required to verify.   this helps ensure they look at it purposefully

 

there are online lable verification systems, it  sounds like that is not an option.  

Edited by kingstudruler1, 17 April 2024 - 11:18 PM.