So we have a custom quantitative, destructive quality test for our Class II device that was originally put in place as a part of design validation but is also used for final inspection of the devices. There is not any type of industry standard or guidelines around this testing. The way that the device is designed, there is really no way for the device to fail this test. The Cpk is approaching 2.0, the 99% lower confidence limit is almost double the failure point, and I have a year’s worth of data and ~20 consecutive lots with nothing near a failure. We would like to remove this testing as lot release but keep it as a part of design validation. I am thinking we could put together a strong, statistically based rationale for why this testing is no longer necessary for lot release. Is there anything I am missing? Are there any other considerations anyone can think of prior to moving forward with this approach? Thanks in advance for any thoughts or advice!