What are the Barcode Verification Requirements for My Industry?
Here are 9 frequently asked questions about barcode verification.
1. How does an industry know they have to verify barcodes?
There will be an industry committee mandate or a government mandate. The industry will be required to adhere to an application standard, which acts as the barcode guide for each industry.
2. What type of verification requirements does the U.S. Department of Defense have?
UID or IUID is the policy mandated by the U.S. Department of Defense (DOD) that provides the framework to acquire, track, maintain, and deploy assets. It dictates what needs to be marked and registered.
- IUID stands for “Item Unique Identification” and requires that items are registered in the IUID registry and permanently affixed to the assets in the form of a plate or a tag.
- UID stands for “Unique Identification,” which refers to when an asset is physically marked with a DPM barcode.
- MIL-STD-130 specifies text sizes, fonts, formats, location of the marks, size of marks, marking methods, and quality requirements.
Barcodes for the DOD must be permanently capable of withstanding environmental testing and cleaning procedures and have a “B” or higher quality grade via verification. Verifiers establish barcode grades and allow users to keep track of these individual grades.
3. I’ve heard of the military using the AS9132 standard, but what is it for?
AS9132 is a standard that defines barcode marking for the aerospace industry. It was developed by the Society of Automotive Engineers in 2002. It specifies six print quality and technical parameters for Data Matrix symbols that are direct part marked, specifically dot peen marked. The parameters include a quiet zone, symbol contrast, cell size, dot center offset, dot ovality, and angle of distortion.
It’s worth noting that while AS9132 is a method of quality checking dot peen codes that checks the shape of the dots, it does not check the symbol as a whole. For example, the standard does not include a lighting angle specification so results can vary from setup to setup, and it doesn’t check for finder pattern damage or modulation. Because of this, AS9132 is a better tool for monitoring or calibrating the marking settings and needle quality, rather than the readability of the code.
4. What do medical device manufacturers need to do to meet FDA requirements?
The FDA mandates that all medical devices contain a UDI barcode. Unique Device Identifier (UDI) is a system that uses barcodes to identify medical devices throughout distribution and use. The goal of UDIs is to provide a safe and secure global distribution chain.
Devices must be labeled with a barcode that lists a product’s lot number, serial number, and expiration date if applicable. Additionally, the FDA also requires that a portion of the information within each UDI barcode be submitted to its Global Unique Device Identifier Database (GUDID) system. The information required depends on the medical device type.
UDI requirements have resulted in an increased demand for verifiers, especially DPM verifiers. All medical device barcodes need to have a “C” or higher quality grade to meet requirements. The only way to prove the barcode quality grade is with a verifier that indicates how well a barcode can be read.
5. When is the deadline for companies to meet the UDI mandate?
The deadline has been extended to September 24, 2022.
6. What about the pharmaceutical industry? What are their requirements?
In 2004, the FDA issued a new rule requiring certain drugs and biological products labels to have 1D barcodes containing a national drug code (NDC).
In 2015, the Drug Supply Chain Security Act required pharmaceutical products to be marked with a 2D code containing the NDC number, serial number, lot number, and expiration date. Those codes must have a “C” or higher grade in accordance with ISO 15415.
7. What is 21 CFR Part 11 and which industries use it?
In 1997, the FDA issued regulations that established the criteria for acceptance of electronic records and signatures. The rules apply to companies in pharma, medical devices, biotech, biologics developers, and other FDA regulated industries.
These regulations require companies to have a system in place to lock down settings, track user changes, and securely store documents.
8. How do validation protocols fit into all of this?
Validation protocols are designed for pharmaceutical and medical device manufacturers that are bound by FDA regulations. They help ensure the highest quality standards are being met.
Validation protocols check every possible setting combination that a verifier can perform during the testing process. They include hundreds of test barcodes, each designed to test specific operational characteristics of the verifier. Each combination is tested with verification, which documents that the results are as expected.
9. Even if my industry is not required to verify, should I?
Yes, absolutely. There are several reasons to choose verification over barcode quality software, including:
- Validating to an industrywide standard solves potential readability debates between vendors.
- Reports produced by verifiers can be used to prove code quality at the time of marking and that incoming codes are not acceptable.
- Verification guarantees that all barcodes can be decoded by DPM readers and is the best way to confirm proper calibration of laser or dot peen marking machines.
- Verification helps pinpoint when line or machine components fail and ensures that all equipment is performing at the highest efficiency.
- Verifiers feature real-time tracking of when the print or marking quality drops below the user setup threshold.
If you decide to verify, make sure you use an ISO-compliant device. Since the hardware and software setup for verifiers are regulated, the results are more trustworthy. If you only use barcode quality software, the lighting setup can vary from line to line and there is no calibration process. In addition, the algorithms the software uses to establish a grade are unknown because they do not adhere to ISO standards.
10. Where can I find an ISO-compliant barcode verifier?
Cognex offers a range of ISO-compliant barcode verifiers that use high-quality optics, advanced algorithms, and simple software to demonstrate compliance with industry standard guidelines. Check out our family of barcode verifiers here.
In conclusion, if your industry has specific barcode verification requirements, it’s important to be up to date on those regulations by checking your verifiers’ capabilities and ensuring you submit the appropriate information to each agency by the given deadline. Even if your industry is not bound by verification requirements, you may want to consider verification to ensure your barcodes can be decoded properly.