Case Histories
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Case Histories
A Midwest corrugated plant was having a problem with their barcodes. Their verifier was telling them everything was fine, but a customer was complaining.
Their customer was using the corrugated boxes on a sortation line, and their scanners were unable to read some of the ITF14 barcodes.
The Quality Control manager at the corrugated plant felt confident the barcodes were fine—they weren’t getting complaints from other customers, and the scanner in their palletizing area had no problem reading their barcodes.
Digging deeper for clues, one of the technicians said they were sometimes getting varying results from their verifier: sometimes it would report a C grade, sometimes an A, sometimes an F, all on the same barcode and often just a few seconds apart. Could there actually be a problem?
At the plant, we inspected their verifiers—new gun-type portable devices.
The client did not know that their portable verifiers were unable to test accurately for contrast and reflectivity because of the gun-type scanner. This is because a handheld scanner does not scan the barcode at a fixed distance or angle. The reflectance results reported in the verification test are unreliable.
Furthermore, the client was unaware that barcodes printed on corrugated are frequently a D grade due to the low contrast and reflectance characteristics of corrugated material. Their verifiers could not accurately or repeatably test and report for reflectivity and contrast, which are the most important qualities of barcodes.
Inaccurate and non-repeatable contrast and reflectance testing can product verification grates that can be (and usually are) optimistic. When it comes to managing barcode-related risk and liability, a verification report to be neither optimistic nor pessimistic—it must be truthful. Significant liabilities are at stake. Customer confidence and future business depend upon it.
Because the customer had recently acquired these devices, they were able to exchange them for ISO-compliant verifiers. Now they could accurately evaluate their barcodes, and the results were surprising and revealing. Taking tests at various locations throughout the height of the barcodes, they saw that symbol quality varied from bottom to top. This helped them to understand their customer’s inability to successfully scan these symbols.
The customer was using laser scanners, which are relatively unforgiving of poorly grading barcodes. The scanners on their sortation line captured these barcodes in their lowest quality area, at the top of the symbol. Other customers, using newer camera scanners with more vertical redundancy, were more tolerant.
Outcomes: The upgrade to ISO compliant verifiers has stabilized barcode printing operations. Initially their operators were upset to discover that their barcodes are not nearly as good as they thought, but the more reliable symbol quality information has given them improved tools to evaluate and adjust their printing process. They haven’t had a barcode-related customer complaint since acquiring the new equipment.
The client is a supplier of diagnostic test kits for a specific medical condition.
They were concerned about GS1 Healthcare compliance in their number assignment to products, including sale units and shipping containers. Amazingly, they have never had a single, standardized item numbering system. Some of their European distributors assigned some of their numbers, and they weren’t sure whether they had ever been “registered”. Some numbers were from a legacy database they’ve used for years. Other numbers were assigned to products at companies they acquired.
Shipping containers were also confusing to the client because the same product is packaged in several different ways, depending upon the receiving customer. Sometimes the sale unit was packaged in a 12 pack inner carton, then in a 4 pack master carton. At other times, the several different sale units would be bundled together in a sample kit which became a new sale unit, which was then packaged in an 8 pack inner carton and then in a 6 pack master carton. Still other customers required different configurations of packaging, some recurring, some custom. How should these various packaging schemes be numbered and how are all the trading partners made aware of the total system? The client did not have a notification procedure in place.
The client was also confused about which symbology to use at the item level and at the shipping level. They had been using EAN13 on most of their item level packages, but they were not sure that was correct. Some customers had insisted on ITF14’s for certain SKU’s.
Finally, the contact person at the client location was newly appointed to head the labeling department, where some personnel had worked for a number of years, and were familiar with the way things have been done. Whether or not things had been done correctly was unclear.
The goal for this consultation was to get the client ready for implementing EDI in their trading partner relationships, and to be UDI compliant.
The challenge for this and many similar companies is to get all stakeholders up to speed on what is required to make their company compliant. Team members simply did not have the time to read and digest the GS1 documentation, and the team would still need to meet and coalesce their knowledge, ask questions about specific issues concerning them, and establish a foundation of common knowledge and practice for moving forward.
We presented a broad overview of the GS1 Healthcare Standards, with a focus on how they could adapt (or in some cases, replace) their legacy numbering system into a compliant system.
Because the client could only devote limited hours per day to this, we negotiated a series of scheduled webinar encounters over several months of steady dialog with this client.
An East Coast healthcare company and their label printer were engaged in an argument about the reliability of their barcodes. The healthcare company said they were having problems scanning them; the label printer said the barcodes were fine. Both were using scanners (not verifiers).
The healthcare company contracted with us to settle the argument. We found that while there was room for improvement, overall the barcodes performed satisfactorily, achieving ISO B’s and C’s, which was acceptable to the healthcare company’s requirements.
We determined that the disagreement was based on the unreliability of scanners as a gauge of barcode quality. The solution was to use ISO compliant verifiers to measure and grade barcode performance.
We advised our client, the healthcare company, that neither they nor their label printer had any idea how their barcodes were performing because they were using scanners rather than ISO compliant test devices (verifiers). We recommended that at a minimum the label printer should be required to verify a representative sampling of their output and include a copy of their verification report with every order. We also recommended that the healthcare company acquire and use a verifier to corroborate their vendor’s report, since they ultimately bear the risk and liability if their barcodes fail.
A flexo printer was experiencing a mystery. They had a procedure in place which they had relied upon for years—and for years had no problems. Using a verifier, they tested the barcode files three times:
- at pre-press
- at proofing.
- during the print run (spot check).
Over time, the results were solid and stable. However, when their old verifier was no longer supported by its manufacturer, they upgraded to a new ISO compliant one, and that’s when the apparent problems began. Suddenly pre-press and proofing weren’t always the same and on-press results fluctuated widely. What had happened?
We determined that the problem was that the old verifier was not testing all the ISO parameters—it was ignoring two critical factors which the new technology was testing and reporting. The new test results were the first truly compliant evaluations of their work—and they weren’t quite as good as the printer thought they were.
This situation points out the need to stay on top of new technology. A good tool makes it possible for you to do things a poor tool cannot. An ISO compliant verifier gives a printer “eyeballs” they wouldn’t otherwise have. Because of the new verifier this printer realized for the first time the need to exhaustively benchmark and control the performance their presses. The verifier upgrade gave them the ability to monitor the key quality metrics over time.
A pharmaceutical company faced a crisis when their most important customer rejected a shipment batch, blaming label inaccuracy. Beyond the product and credibility loss, the pharmaceutical house faced a severe liability because it appeared that at least one suspect label had caused a dosing error at a nursing home facility. The labels in question were produced by a supplier of many years. Barcode-Test was consulted to determine the cause of label problem and recommend a solution to prevent a future recurrence.
Verification tests revealed a number of problems with the printed barcodes. Data encoded in the barcodes was incorrectly structured according to the healthcare industry specifications for that type of symbol.
The design software utilized in pre-process was out of date and did not reflect recent changes in the symbol specification.
Finally, the press operators had not been trained to properly use a verifier and interpret the test results with healthcare barcodes.
The label supplier’s product liability insurance covered the quality claim but the customer was reaching out to other suppliers for future orders. In addition, the supplier faced an increase in their insurance premiums or possible cancellation.
We presented a seminar at the label supplier’s facility to the quality team and press operators. Our one-day seminar included a briefing on unique health care bar code specifications and a demonstration of how these symbols must be structured to comply with the requirements of this supply chain. Then we performed a hands-on practicum on the use of barcode verification equipment, including how to interpret the verification test report in order to improve print quality.
Another module focused on appropriate software options for their printing system. The seminar concluded with a lengthy Q&A about healthcare barcoding and the FDA regulations.
The label supplier now uses Barcode-Test as a resource when questions and concerns arise with jobs they are running. Barcode-Test has assisted in updating their quality policy and procedures documentation, so it includes barcode verification. These steps have resulted in an improved relationship with their most important customer, the pharmaceutical company. The label supplier has acknowledged that this incident resulted in an expensive but important education which has made them a better supplier.
Bill and Cindy were expecting the birth of their first child. At the end of her second trimester, Cindy slipped and fell. She felt fine, but out of caution they went to the emergency room at their local hospital. Her doctor had her admitted for observation. A barcoded wristband was placed on her wrist.
A nurse administered medication to prevent premature labor. The barcode on the medication misidentified it. Cindy went into labor and her baby was born, three months premature.
Fighting to breathe through lungs that had not fully developed, Bill and Cindy’s first born spent several months in neonatal intensive care unit. The child survived and was finally brought home.
Faced with crushing debt as a result (and potentially more costs to come), Bill and Cindy were forced to seek litigation against both the hospital and the label vendor.
Barcode performance is more than just print quality. As this real and nearly tragic case study demonstrates, sometimes an incorrect barcode that scans perfectly is worse than a barcode that doesn’t scan at all. Verification also encompasses validation that the barcode represents an actual entity and the correct item. Mis-identification because of a database error can be averted and a well crafted, carefully executed barcode quality program should have safeguards built in to catch such error, from item number assignment and database management to label printing and packaging.
When verification is a post-production function, there is only limited opportunity to catch errors with potentially life-threatening consequences, huge liability and preventable pain and suffering.
Most stories of bad barcodes and the importance of barcode verification follow a similar path: verify and prevent problems. But not all stories follow this pattern—it often is more interesting than that. Here is one such scenario. The names have been changed to protect identities and reputations.
XYZ Labels did business with a healthcare device manufacturer for many years. The barcoded labels were used on a packaging line. The label printer enjoyed a reputation as a quality shop, a lesson they had learned years earlier, with a batch of bad barcodes which they replaced at great expense. The financial loss and damage to their reputation launched them into a renewed diligence about quality. The plant manager led the charge, installing verifiers for each press and training each press operator how to use them. As time passed, the manager noticed that barcode quality was not a static condition. The verifiers had given them the tools with which they could see when quality was approaching a problem. They gave them the ability to predict a looming problem, to make adjustments and get the process back on track. Their self-confidence was renewed and the program was embraced and formalized into a company-wide policy and procedures document.
Then it happened: another apparent disaster. The owner’s phone rang; an unhappy customer told him their barcodes were failing. How could this have happened? The plant manager was called to the office; the mood in the plant intensified. The documentation was brought out and the procedures were re-examined. Where were the holes? What did they miss? Here is where the story really gets interesting.
They couldn’t find any problems with the job documents or the procedures. Unless somebody was lying—a possibility nobody wanted to even think about—they couldn’t account for the complaint. The procedures had been followed, the verifier re-calibrations were all up-to-date; everything seemed to be working fine. The sales rep was ordered to contact the customer and ask them to send back samples. It was an awkward, humbling request. There was a lot on the line and she had only questions, no answers yet.
The overnight air express packaged arrived early the next morning. The conference room was ready with a verifier and worried plant manager. The first samples were OK—and the next ones too. Another verifier was brought in. Everything was testing fine and matched the archived verification records. The tension mounted as the owner, plant manager and sales rep began to fear that the verifiers were the culprit—how could all of them fail at once? Somebody said that it didn’t make sense—and suddenly it dawned on them all. No, it didn’t make sense: call the customer.
The embarrassed label company owner admitted they had not found a cause of the problem, and diplomatically asked about the customer’s scanners: how old were they? Had they been recently serviced, moved or replaced? Had any changes been made recently? The customer’s impatient tone softened: as a matter of fact, the old laser scanners had been acting erratic lately. The hardware vendor had assured them they would last “forever”. Both sides of the phone conversation breathed a sigh of relief. Apologies were expressed. Life returned to normal.
Stories like this happen all the time. They often go unreported. Important lessons are learned and relationships are strengthened. This story illustrates how quality is the best protection in a valuable business partnership.
Case Study: Print Gain Problems
A packaging designer specified a high-tech look for the rollout of a hot new electronics product. They created a box with black barcodes printed on a crisp white substrate. Visually the barcodes looked great but failed to scan.
Linear and 2D barcodes share a common characteristic: they must have uniform dark and light values with at least a minimum reflective difference
Symbol Contrast is the parameter in the ISO standard that reports this reflective difference, and the verification report showed an ISO 4.0 (A) grade. Why are these symbols failing?
The remainder of the highest detected reflectance value minus the lowest detected reflectance value is the Symbol Contrast value.
Variations in the reflectance values are reported in the ISO parameter Modulation. How could there be reflectance variations in a black barcode on a clean, white substrate?
Print gain is the most common cause.
Print gain is the spreading of the printed image—in this case the black bars in a barcode. When the bars gain or spread, they crowd the spaces between them, making them smaller.
The reflectance value is lowered in spaces squeezed by print gain. The high reflectance value is no longer uniform. Why is this a problem” Barcode scanners decode a barcode by detecting the reflective differences in bar and space patterns. When bars get fatter and spaces get thinner, the reflective differences decrease. If the bars grow excessively, a scanner may incorrectly decode the barcode, or fail to decode it altogether.
Fortunately for the electronics company, this problem was detected before the product rollout. The solution: bar width reduction of the design file. Bar width reduction (BWR) thins the bars so anticipated print gain returns them to their nominal width. This preserves the full reflectance value of the spaces and reassures high scanning rates.
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