Using Six Sigma’s five-phase DMAIC (Define, Measure, Analyze, Improve, Control) approach, SECORA has helped a pharmaceutical supplier check ‘black spot’ contamination of its syringes, saving it millions in unnecessary costs and reaffirming its standing as the preferred supplier of choice for quality syringes.
After detecting ‘black spots’ in some of its syringe batches, a European-based pharmaceutical supplier has, with SECORA’s help, moved to zero defect with the hypodermic needles it supplies the health sector, staunching the debilitating costs it was incurring to manage the problem.
The black spots were discovered in the tip of the luer-lock syringe barrels that are used to inject the pre-filled syringe applications of various lifesaving medicines. Sourced from a globally-recognized manufacturer in Germany, the syringe barrels are processed at multiple production sites.
A Taguchi Design of Experiment (DOE) test confirmed that the spots were formed by oil lubricant deposits leaking into the syringe during the manufacturing process.
Although this flaw did not compromise patient safety, to comply with health authority requirements, the pharmaceutical supplier was forced to implement a rigorous screening process to inspect all syringe barrels received, which was costing it millions of Swiss francs each month.
“SECORA was able to pinpoint, contain, resolve, and eliminate this anomaly without disrupting operations. The forensic insights it acquired from its data-driven methodology and structured problem-solving approach successfully addressed FDA concerns, which allowed us to continue business uninterrupted, while guaranteeing ultimate safety to patents,” said the project sponsor.
Having set a defect rate target of 100 ppm (0.001%), the supplier was able to deliver a final process capability of 38 ppm (0.00038%), a dramatic improvement on its initial 100’000 ppm (10%) defect rate.
This falls way below the less than 1% ppm (10 000 ppm) measure that most reputable suppliers typically use to benchmark the quality of their products against.
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Operating globally across the Americas, Europe, Asia and Australia, SECORA helps organizations of 50 to 80 000 employees optimize their efficiency through process streamlining, effective strategy, risk reduction and quality advancement initiatives.
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