Hello Anon,
Typically for UDI verification there would be two activities or phases which would be viewed. The first is the validation of the process, meaning there would be a large sample or even 100% testing of UDI labels potentially from different products, different types of labels, or different batches to support the UDI verification process functions (validation). The second part would then be routine verification of the UDI which would typically be done through sampling, typically during the labelling and packaging operation or part of the final processing of the medical device. There are some ISO standards such as the ISO 154** standards like ISO 15416 or ISO 15426 which can provide some further information. These standards definitely define the acceptance criteria for bar codes both linear and 2D.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Dec-2022 09:35
From: Anonymous Member
Subject: UDI verification acceptance criteria
This message was posted by a user wishing to remain anonymous
Hello,
What standards/methods are people using to select UDI sample sizes and acceptance criteria on verification? Should we be doing 100% verification or would a sample of each batch be sufficient?
thank you in advance