Sanofi / Rexam – Medical Device Quality Improvement

Case studies

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Sanofi / Rexam – Medical Device Quality Improvement

Data Analytics with JMP used to successfully tackle ‘rare event’ and complex quality problems with medical devices.

The challenge

Medical devices were produced in large batches on very high volume manufacturing lines. Batches were sampled using a destructive test. Occasionally very low levels of defects (ppm level) were detected. Complete batches of suspect product had to be scrapped. The goal was to better understand the problem and to improve yield and OTIF.

The solution

Rigorous statistical analysis of historic test data (over half a million tests!) to identify possible factors e.g. production lines, products, components and test machines.
Design of Experiments to identify root causes.
Changes to product design, manufacturing conditions, test machine calibration, sampling strategy.

The results

Scrapped batches and major supply chain disruptions were reduced by a factor of 3. Major cost savings and customer confidence was greatly increased.