CAPA effectiveness population — working review
WORKING NOTES — review decisions belong in your controlled records.
Guide: https://seal.run/blueprints/guides/capa-effectiveness-population

Use one action and one preselected effectiveness measure. Keep the original observation plan beside the event and exposure records so the assessment can be reproduced later.

1. Action, outcome and decision rule
Identify the CAPA and implementation evidence. State the event definition, denominator, planned observation window, minimum exposure, acceptance criterion and rule for responding to recurrence. Identify the plan revision agreed before assessment.
Your evidence and observations:
[Not recorded]

2. Eligible records and exclusions
List the before/after run populations, extraction time and source query. Record equipment-specific implementation boundaries, excluded runs and reasons. Resolve duplicate reports of the same event; distinguish event count from the number of affected runs.
Your evidence and observations:
[Not recorded]

3. Reproducible rates
Record each period’s event count and eligible exposure, then divide the combined events by the combined exposure. Preserve missing denominators as unavailable. If event frequency is the measure, multiple distinct events in one run must not be silently reduced to one.
Your evidence and observations:
[Not recorded]

4. Comparable operating conditions
Identify changes in equipment, product mix, operating load or event detection between windows. Explain whether those changes limit the before/after comparison. State what the descriptive rate establishes and what it cannot establish.
Your evidence and observations:
[Not recorded]

5. Assessment against the original plan
State whether the observation is complete and whether the chosen criterion is met. Record remaining exposure, recurrence actions and the responsible reviewer’s next step. Keep a changed observation plan or later assessment identifiable rather than replacing the earlier result.
Your evidence and observations:
[Not recorded]

EVIDENCE NEEDED TO FINISH
Another reviewer can reproduce the numerator, denominator and rate from the retained population and compare the result with the original plan. Observation completeness and effectiveness have separate answers. The illustrative case would still be at 5 events per 100 runs if its next 40 runs had no events, above its stated target of fewer than 4.