For years, we have beaten the drums about compliance. Our barcode quality training module presses the point: compliance is a two-part discipline that includes ISO print quality and industry standard compliance such as GS1 or HIBC. Rethinking that mantra, I now believe we got that wrong.

Are we splitting hairs? Maybe. We are responding to an entrenched belief system, one that holds that compliance is the gold standard. Compliance is not the gold standard. Compliance does not contain print quality—it assumes it.  Virtually everyone in quality well understands the trap of assumptions.

Hair-splitting or Hair Raising?

Heavily regulated industries are obsessed with compliance. That is a good thing, but not without pitfalls. In barcoding, compliance refers to data structure. A compliant GS1 barcode contains data packets with prefixes that identify the data type and data field characteristics. A GS1 FDA compliant Unique Device Identification (UDI) barcode on a medical device must begin with a 01 prefix, and if it is a Code 128 barcode, it must start with a Function 1 C subset. The first data packet is always the Global Trade Identification Number (GTIN). If there are subsequent data packets, each of this must be properly prefixed, and the data must adhere to type (numerical only or alphanumeric) and field capacity (number of characters). That is compliance. An HIBC FDA compliant UDI barcode will have different data packet prefixes and field characteristics. Compliance is not quality.

Compliance is not Quality

Conceptually, “compliant” sounds all-inclusive. It isn’t. A scanner may not be able to read a compliant barcode even though the data is perfectly prefixed and parsed. Why? Many reasons. The data carrier—the barcode–is a printed image. Data retrieval is an optical event. Unlike human eyes, which perceive the full spectrum of visible color, scanners operate in the red portion of the spectrum. Only certain colors are visible to a scanner. Scanning fails when the barcode or background is an incompatible color. Quality is not compliance.

A scanner captures the data from a 1D barcode based on the reflective differences between narrow and wide bars and spaces. In 2D barcodes, clusters of same-sized elements form those same reflective differences. Excessive ink spread in the print process alters critical reflective differences. Compliant barcodes may or may not be scannable. Compliance is not quality.

Quality is not Compliance

Quality extends beyond print. Lamination over the printed barcodes changes reflectance properties. Compliant and well-printed barcodes can become difficult to scan. Barcodes identify levels of packaging, from individuals, multi-packs and master packages up to and beyond pallets. Each level of package requires a unique barcode. There are many different types of barcodes. In every supply chain, with a specific set of trading partners, it matters what type of barcode identifies your product package. Quality is not compliance.

Compliance is not a super-category encompassing quality. Neither is quality a super-category. Each is important—both are important. Equally.

Comments are welcome. Contact us here.

Recommended Posts

3db Barcode Testimonial

Our company (an advanced software company) recently worked with Barcode Test to source a barcode verifier.  Not long ago, we were awarded a contract requiring products to be marked with IUIDs in accordance with MIL-STD-130.  For that standard, marking labels must pass a verification test that evaluates many variables (contrast, size, clarity, syntax, modularity, and more).  After a thorough search, we reduced our options to a select few.

In our search for a verifier, the Axicon line caught our attention.  Barcode Test is our regional reseller for this product.   From the beginning, they were very prompt with their responses.  We ended up having a quick call with John Nachtrieb to go over our needs.  John was extremely easy to work with and provided a lot of great information.  He was very knowledgeable on the matter and was quick to offer up a demo unit (free of charge).

Upon receiving the demo verifier and testing it, a few questions arose.  John joined a call with us and answered all our questions.  Ultimately, the Axicon verifier wasn’t the best fit for us, so we shipped the demo back.  John was completely understanding.  A few weeks later, Barcode Test reached back out with another possible verifier for us to try.  While they didn’t sell that brand, they just wanted to help us find the best option that met our needs. They even offered to send us the unit that they have in-house to see if it worked to our liking. 

Barcode Test is truly a great company to work with.  Their service and willingness to help the customer are far beyond what you typically get from other companies.  They are experts in barcode quality assurance and seem willing to help in any way they can (even if that means not getting a sale and recommending another option that better fits the customer’s needs).  If anyone is in the market for barcode verification/scanning services or products, I would highly recommend giving Barcode Test a call.

Regards,

Production Manager