Compliance is Not Quality

 In Barcode Quality Training

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.

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