Validation & Reliability — question 9 of 10
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During environmental validation, 1 unit out of 30 fails intermittently at high temperature -- it works fine every time at room temperature. It's not consistently reproducible even at high temp; sometimes it passes there too. How would you approach isolating what's going on, and how would you decide whether this is a marginal design issue, a rare statistical outlier, or a flaw in the test itself?