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Traceability for dressings- Batch Kits


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lavalienteQA

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Posted 19 January 2022 - 05:13 PM

Hi all,

My facility produces dressings into large tanks. Our kitting room prepares each batch and tracks lot codes/weight onto lot sheet. It includes lot-weight-name etc. 

Our kitchen team receives it, who then accounts for ingredients in the kit by looking at each bag of ingredients and verifying ingredients are there. 

My concern is that the bags say weight only- no lots codes directly on the bags. Our kitchen team is trusting that the kitting room actually put noted lot into those bags. There's no further verification of lot codes on the bag, just weight. 

I guess I am seeking guidance if I am just being nitpicky or is this a cause for review?

I come from RTE where all material had everything associated all the way to production.


Edited by sreyes7, 19 January 2022 - 05:15 PM.


kfromNE

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Posted 19 January 2022 - 05:35 PM

Traceability and how precise you are all comes down to - in a recall, how much product would you have to recall and is the company okay with this. Do a mock recall to test the system.


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Scampi

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Posted 19 January 2022 - 07:40 PM

Also ask how month end inventory is done......if they aren't consuming from the correct lots it will show up as a ton of partial units of raw ingredients

 

There's nothing wrong with what they are doing--but as mentioned, the trace exercise will tell you if it's working or not

 

Alternatively, you should watch the kitting room measure out a batch----don't assume that because it's different that it isn't in control or wrong


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lavalienteQA

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Posted 19 January 2022 - 07:50 PM

Thanks @scampi & @kfromNE, great insight!  Our mock is happening February. Meanwhile, I will be observing and getting back with my QAM to ensure compliance.


Edited by sreyes7, 19 January 2022 - 07:51 PM.





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