Case Histories

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Case Histories

Case History A: Major Midwest Corrugated Plant

The client company, a major corrugated plant in the Midwest was having a problem with their barcodes. Their portable verifier was telling them everything was fine, but one of their customers was complaining.

Their customer was using their boxes on a sortation line, and the scanners weren’t reading a lot 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 own palletizing area was reading their barcodes no problem.

But one of his technicians mentioned they were sometimes getting widely varying results from their verifier. Sometimes it would return 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?

We met at the client’s plant and inspected their verifiers—several brand new portable verifiers, most of them with the calibration patches and documentation still unopened in the shipping boxes.

The client didn’t know that their portable verifiers were unable to test for contrast or reflectivity because of the gun-type scanning devices. This is because the gun does not scan the barcode at a fixed distance or angle. The reflectance parameters in a normal ANSI/ISO verification test are simply disabled when the gun scanner is plugged in, so the test results simply don’t factor in these attributes.

Furthermore, the client was unaware that barcodes printed on corrugated are almost never better than a D grade due to the poor contrast and reflectance characteristics of corrugated material. In other words their verifiers did not test for the most important qualities of their barcodes.

If contrast and reflectance are not tested as part of barcode verification, the test results can be (and usually are) optimistic. When it comes to managing barcode-related risk and liability, you don’t want a verification report to be optimistic or pessimistic—you want it to be truthful because there can be significant liabilities at stake—you want customers to be satisfied and loyal.

We started by unplugging the gun devices from their verifiers and replacing them with the mouse wands I brought with me. Their ITF14 symbols were achieving a solid D on Symbol Contrast but getting varying results, ranging from A to F on Defects.

Upon visual inspection, we could see that symbol quality varied from bottom to top. This explained the widely varying results with the gun imager. What about their customer’s inability to successfully scan these symbols?

The customer has older laser scanners, which are notoriously unforgiving of symbol defects. The scanners on their sortation line just happen to hit these barcodes in their lowest quality area, near the bottom of the symbol. Newer area imagers would have more vertical redundancy and be more forgiving.

Outcomes: The client has purchased ISO-compliant verifiers that eliminate all the variables and unknowns in their barcode testing. Initially their operators were upset to discover that their barcodes are not nearly as good as they thought, because of the “optimism” of their old, non-compliant verifiers 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.

Case History B: Eastern Medical device company
Case History C: A Healthcare Company

Challenge 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).

What we did… 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 original requirements.

Solution: the cause of the problem was the unreliability of scanners as a gauge of barcode quality, and the solution to the problem was to use ISO compliant verifiers to measure and grade barcode performance.

In our test report, 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 their output and include a copy of their verification report with every order, and we pointed out the wisdom of the healthcare company also using a verifier to corroborate their vendor’s report, since they (our client) ultimately bear the risk and liability if their barcodes fail.

Case History D: A Midwest Flexo Printer Company

The Challenge: A Midwest 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 an existing verifier, they tested the barcode files three times:

  1. at pre-press
  2. at proofing.
  3. 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 problems began. Suddenly pre-press and proofing weren’t always the same and on-press results fluctuated widely. What had happened?

What we did By analyzing the situation, 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.

Conclusion:  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 fingerprint their presses—and the ability to monitor the key metrics during the print run

Case History E: A Pharmaceutical Company

A well known Midwest pharmaceutical company faced a crisis when their most important customer rejected a shipment batch because of label inaccuracy. Beyond the product and credibility loss, the pharmaceutical house faced potential litigation 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 used reliably for many years. Barcode-Test was consulted to determine the cause of label problem and recommend a solution to prevent a future occurrence.

Our label tests revealed a number of problems with the printed barcodes. First, data encoded in the barcodes was incorrectly structured according to the healthcare industry specifications for that type of symbol. Second, the software being utilized in the printing process was producing an illegible product. And Third, the press operators were not properly trained to produce an acceptable barcode for healthcare uses.

The label supplier’s product liability insurance covered the product cost but that didn’t deter the pharmaceutical customer from reaching out to other suppliers for future orders.  In addition, the supplier risked a significant increase in their insurance premiums or even cancellation.  As their customer the pharmaceutical company had done, the supplier looked to Barcode-Test LLC for a solution.

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 the future of healthcare barcoding and how it will be affected by future changes in FDA regulations, now being debated before Congress.

The label supplier now uses Barcode-Test as a sounding board when issues arise with new jobs they are running. Barcode-Test is also assisting the supplier’s Q/C people as they rewrite their quality control policy and procedures manual, 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 and could potentially bring them an additional income stream as they become known for their work in healthcare.

Case History F: A Medical Emergency

(Names have been changed due to ongoing litigation)

Bill and Cindy were expecting the birth of their first child when she slipped and fell at six months.  While she felt fine, being cautious they went to the doctor. He was optimistic but as a precaution sent her to the hospital.

They admitted Cindy and gave her a bar-coded wristband.  The floor nurse came into her room, scanned the wristband and her medical orders, and then gave her medication to make sure she did not go into premature labor.  But the barcode was wrong. A later investigation revealed that instead of being given medication to suspend labor, the drug Cindy was administered caused just the opposite result.

In just a short time Cindy went into labor.    Almost immediately, she was fully dilated and there was nothing the attending physicians could do to stop the delivery.

Three months premature, fighting to breathe through lungs that had not fully developed, Bill and Cindy’s first born had to remain in a major hospital neonatal intensive care unit for three months until they could bring their child 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   Any award moneys will no doubt be paid by the hospital’s insurance as well as the label vendor’s Errors and Omissions policy.

Barcode performance is more than just print quality. As this real and nearly tragic case study demonstrates, sometimes a barcode that scans perfectly (but is incorrect) is a much worse liability 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 redundant safeguards built in to catch such errors at every stage in the process, from number assignment in the database management to label printing and packaging.

When verification is viewed as a post-production function, there is only limited opportunity to catch errors with potentially life-threatening consequences, not to mention huge liability and ramifications for insurance claims and future premiums.

Case History G: Important Partnerships

We have all heard a legion of tales about the importance of barcode verification. Many of the stories follow a similar path: verify and prevent problems—end of story. But in the real world that is not always the end of the story—it often is more interesting than that. Here is one such scenario.

XYZ Labels LLC (not the actual company name) 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 and had a rude awakening with a batch of bad barcodes which they replaced at great expense. The seeds of loss, financial, reputational and self confidence, sprouted a new crop of self-examination and diligence around quality assurance, and the plant manager  led the charge by buying verifiers for each press and training each press operator how to use them. Nothing looked any different from the outside, but over time, management at XYZ Labels LLC noticed that barcode quality was a fluid thing, and the verifiers had given them eyeballs with which they could see when quality was approaching a problem, giving them a heads-up to make adjustments and get 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 disaster. The owner’s phone rang; an unhappy customer told him their barcodes were failing. As his stomach knotted his heart sank: 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, contrite conversation. 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 opined 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 usually go unreported for reasons I do not completely understand: important lessons are learned and relationships are strengthened. This story illustrates how quality is the best protection in a valuable business partnership.

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