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Judgment & ambiguity · When to act

Post-market surveillance shows a small uptick in one specific failure mode — above baseline, but not yet statistically significant given the volumes. Do you open a formal CAPA now or wait for more data, and what tips you either way?

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Statistical significance is the wrong gate here — it protects me from false positives, but in post-market safety the expensive error is the false negative.

The full answer: structure, worked example, likely follow-up.

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