Troubleshooting a Challenging Performance Issue

Manufacturing a high volumes, customer-designed, precision optical assembly for an FDA-regulated medical device.

Challenge:

JML Optical was contracted to make in high volumes a customer-designed, precision optical assembly for an FDA-regulated medical device. The assembly met all specifications and passed all in-process quality tests, but JML’s customer was experiencing a high rate of failure during system quality testing. Troubleshooting showed that the system failure was due to optical assembly performance.

Solution:

How the optical assembly caused system test failure was not obvious. JML’s engineering team researched possible reasons including testing methods, material supply chain, fabrication, and assembly processes. A thorough tolerance analysis at the component level showed a clear statistical correlation between the amount of spherical aberration produced by a certain optical surface and the system-level test results.

JML proposed several changes that would address the performance issue. They included:

  • Implement a new component level testing process, focusing on spherical aberration
  • Design a new testing fixture for the assembly and calibrate it to the client’s testing equipment

Results

After implementation of the first two changes above, the passing rate of system-level quality tests increased from 50% to 99%. The customer was able to decrease the acceptance testing rate for JML’s product from 100% to 8%.

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