A verification study that will not answer the question asked

A new chemistry analyzer is going in next month to run an FDA-cleared, unmodified enzymatic creatinine method exactly as labeled. A colleague drafts a one-page verification plan: two QC levels, five days, done. The plan does not name a reportable range, does not set an allowable bias limit in writing, and does not say who signs off before the method reports patient results. Someone asks whether this plan is enough, and the honest answer is that nobody can tell yet, because the plan does not say what the laboratory is trying to prove.

The gap is not effort. The gap is that a study plan without a stated intended use, a predefined acceptance criterion, and a named decision-maker cannot be judged pass or fail by anyone reading it later, including an inspector, a new supervisor, or the director who has to sign it.

Close that gap before the first specimen runs, not after a discordant result forces a scramble: a study plan is complete when a stranger could read it, run it, and know exactly what result would have stopped the go-live.