Barcodes and Package Quality
The lead article in the September 17, 2013 Pharmaceutical Online Newsletter is entitled “Mitigate Risk with Package Quality”. It is an excellent article and makes several cogent points about the importance of package quality. Here are some of those points:
- Quality is the drumbeat for profitability
- A bad package is a serious liability
- At what point does my package stop working?
- When assuring packaging quality, you must understand what quality actually means
The author does a great job of defining and explaining the Six Sigma DMAIC Process which begins with defining what quality means so that it can be measured. These are simple and basic considerations, but not always obvious. This is also true of barcode quality: often the mistakes that degrade barcode quality are simple but not obvious.
Notable to me is the absence of any reference to barcodes as an important part of package quality. The author discusses package quality from the standpoint of protecting the contents, and offers two guiding questions to help define package quality for specific situations. These questions focus on the technical performance of the package as a barrier.
This article was not intended to address the broader issue of package quality from the standpoint of ensuring the contents of the package are accurately identified or get to their intended destination—that is a different concern. And yet, poorly performing barcodes carry significant risk which will increase substantially as barcodes are called upon to support product security systems. Are barcode related risks separate from package quality risks? The technologies are obviously different, the quality issues are different but at the end of the day, risk is risk.
D Quality of the printed barcode is defined as ANSI C or better except for direct printing onto corrugated, in which case the acceptable grade is ANSI D. Data structure and integrity can also be tested by a high quality verifier.
M Measurement is mostly the objective results of an ISO compliant and recently calibrated verifier. Subjective attributes are material handling considerations that verifiers cannot measure: symbol location on the package, truncation, minimum magnification, etc.
A Analysis of archived verification reports with supporting subjective documentation
I Improving the process could mean automating the verification function with inline verifiers, writing all verification data to a spreadsheet or database and integrating machine vision to detect the subjective attributes of the barcode on the package.
C Control of barcode quality comes from identifying and documenting every variable in the process, which includes the graphics design file, configuring the printing device including pigment, substrate, impression pressure and running speed. Documentation of these factors and matching them with the verification report is the foundation or control.
The Six Sigma Process of Quality for barcodes is very different from that for packages; I can see why barcoding was not mentioned in this article. Yet the barcode is an integral part of the package and performs a function that is equally important in a different way.