All use cases

Assess CAPA effectiveness against recurrence.

Compare post-action recurrence with a defined population, exposure measure and effectiveness criteria instead of relying on closure status.

Book a demo
Illustration of a seal examining a circled change in a trace alongside run, sample and procedure records.

You: CAPA-301 is implemented and the event count halved. Did the action work?

neil

The count fell from four events to two, but operating exposure fell from 8,000 to 2,000 hours. The observed rate is 0.5 before and 1 event per 1,000 hours after. The raw count does not support an effectiveness conclusion.

Events per 1,000 hours, not raw count
Events per 1,000 hours, not raw count. Before, After: 0.5, 1. Example records.0.5Before1After

You: Does the higher rate prove the CAPA made things worse?

neil

No. Counts are small, and comparability and uncertainty still need assessment. I would verify event definitions, exposure coverage, implementation timing and the asset population before interpreting a change. Implementation complete and effectiveness demonstrated remain different decisions.

You: Write this up for review, with the sources and the follow-up work we need.

neil

Here is the draft. I have kept the supported finding separate from the open questions, and prepared the evidence requests for the responsible roles.

CAPA-301 exposure-adjusted effectiveness reviewReview draft · source evidence and assessment

CAPA-301 exposure-adjusted effectiveness review

The raw count halves, but recorded operating exposure falls to one quarter of the earlier period. Dividing events by hours yields 0.5 before and 1.0 after per 1,000 hours. This is not evidence of improvement from fewer events alone, nor proof that the action worsened performance. Check population comparability, observation windows and uncertainty before reaching an effectiveness conclusion.

Source evidence and search scope

PRE-301 (Before action); POST-301 (After action); CAPA-301 (Action record)

PRE-301 / Before action

Recorded evidence
4 events in 8,000 operating hours

POST-301 / After action

Recorded evidence
2 events in 2,000 operating hours

CAPA-301 / Action record

Recorded evidence
Implementation complete; effectiveness review open
Inputs needed for your own records
  • CAPA action, implementation evidence and effectiveness plan
  • Comparable events and operating exposure before and after the change
  • Exclusions, related changes and open investigations

The CAPA owner and quality reviewer decide effectiveness. Action completion or a lower raw count is not automatically evidence of improvement.

Fictional source snapshots. No live query, assignment or approval.

Follow-up work and evidence requests2 proposed tasks · not assigned

Evidence to request

Verify the effectiveness population
CAPA owner
Confirm comparable assets, event definitions, implementation boundary and complete operating-hour coverage for both windows.
Assess recurrence with uncertainty
Effectiveness reviewer
Use the pre-agreed measure and reporting window, retain counts with denominators and determine whether additional observation is needed before conclusion.
Example conversation · prepared replies

See this job with your team.

Tell us how your team handles this job today. We’ll walk through the analysis, supporting evidence and review steps in a demo.

Book a demo
What to bring for this job
  • CAPA action, implementation evidence and effectiveness plan
  • Comparable events and operating exposure before and after the change
  • Exclusions, related changes and open investigations

Source access, permissions and permitted actions are agreed for your environment.

Source excerpt

PRE-301

Before action

Recorded evidence
4 events in 8,000 operating hours

Selected fictional record, not a live source-system view.

Browse all use cases