CAPA Effectiveness Loop
A marker steps around the corrective-action loop from complaint through root cause to correction, drawing the accent arc behind it until the effectiveness check closes it.
A marker steps around the corrective-action loop from complaint through root cause to correction, drawing the accent arc behind it until the effectiveness check closes it.
One change order at the head of a dependency tree propagates outward, the three directly affected artefacts re-verifying first and the six downstream records following.
Monthly complaints per thousand units rise against a dashed signal threshold, and the last month carries above it, lighting the threshold in the accent.
A baseline rule locks the released design and change requests arrive from the right to stack against it, the queue depth growing while the frozen baseline holds still.
A bound column of design history file record slots fills section by section while the completeness gauge beside it climbs to full.
A shipped cohort holds the affected lot in the accent, each unit recovered in turn and leaving a returned outline behind it while the recall effectiveness bar fills.
Residual risk bars rise to meet their pale initial-risk twins and then fall one by one until every hazard sits beneath the dashed acceptability rule.
A regulatory review clock sweeps its elapsed arc, stops dead at the gate while an information request is open, then resumes from where it stopped and closes.
A candidate device drops gate by gate down a ladder of classification rules and stops at the rule that catches it, filling the matching class band to its full width.
A severity-by-probability grid holds a hazard marker in the unacceptable corner, and as each mitigation lands the marker steps down the dashed track into the acceptable band below the staircase limit.
A stability curve decays across the storage months toward the dashed specification floor while the expiry rule tracks its leading edge to the month they meet.
A trace rule sweeps down a requirements-by-tests matrix, verified cells landing row by row behind it while the coverage gauge on the right climbs to full.
A scan rule crosses the unique device identifier strip and its device, lot, serial and expiry segments resolve one after another against the registry record beneath.
Each user need ties across to its validation run one link at a time and the run's acceptance bar fills behind it, the cycle resting fully validated.
A run of verification readings draws left to right between the dashed lower and upper specification limits, resting on a complete in-spec trace.