The background for this posting is the UDI rule, but in fact inline barcode verification is recommended by the companies and their representatives who sell it. It may be that in certain supply chains, some trading partners may require 100% inline barcode verification, but it is not a requirement in any business setting including the FDA 820.120 UDI Labelling Verification Requirements.
Considering just the technology itself of inline barcode verification, what are the pros and cons?
- FDA/UDI compliance
- Assurance that every barcode is tested and documented to be compliant
- More efficient and reliable than spot checking
- Saves money
- Controls waste
Additional pros are often expansions of these basic four—attributes such as “control risk, avoid fines, etc.”
- The UDI rule is vague about barcode verification and even more vague—i.e. never mentions—100% inline barcode verification
- Inline verifiers will collect a lot of data that requires archiving if it is to be useful later
- Unmonitored inline verifiers can be significantly less efficient, expensive to operate and wasteful if they frequently detect, back-feed and over-print bad barcodes
Inline Systems Can Promote Waste and Inefficiency
While it might be true that inline verification systems can prevent bad barcodes from escaping and causing harm, they do so at potentially high cost and can, ironically, promote a culture of carelessness.
The claim of FDA/UDI compliance is an overreach. The UDI rule states the following:
If a labeler choses a bar code form of AIDC, the bar code form of the UDI should be tested for print quality. Please refer to the most recent version of the following standards for more information on how to determine the print quality: ISO/IEC 15416 Information technology — Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols; ISO/IEC 15415 Information technology — Automatic identification and data capture techniques — Bar code symbol print quality test specification – Two-dimensional symbols; and ISO/IEC TR 29158 Information technology — Automatic identification and data capture techniques – Direct Part Mark (DPM) Quality Guideline. For linear and 2-D bar codes, labelers should consult the most recent version of the standards listed above, and the guidelines of their FDA-accredited issuing agency, to determine the minimum overall symbol grade based upon ISO/IEC verification processes. For purposes of this draft guidance, we define “overall symbol grade” as the arithmetic mean of the grades of multiple scans of the symbol. The minimum acceptable grade should be satisfied under the expected handling and use life of the device. Labelers should discuss print quality requirements with their FDA-accredited issuing agency.
Barcode verification is obviously a very good idea. Using a scanner to read the barcode is not equivalent to verifying the barcode—in fact it is virtually meaningless.
Except in a few very specific circumstances, inline verifier is similarly meaningless: it fails to deliver on what it promises.