Step 1 · Analyze
Filter integrity test — max pressure parameter changed during execution
During post-use filter integrity testing on lot G0131A0226BBDS, the Palltronic Flowstar IV reported “Error Maximum Pressure Reached”. The programmed maximum-pressure parameter was changed during execution, outside change management. Found 35 days later through audit-trail review.
G0131A0226BBDS
35 days
08 MAY 2026 → 12 JUN 2026
Audit-trail review
Not caught at execution
The question that decides this case
Impact is reported as two verdicts and never collapsed into one.
Bubble point measured ~5550 mbar against a 3450 mbar minimum. The filter was integral — no product impact. TR-000624
A controlled parameter was altered outside change management and the GMP record obscures the execution issue. DEV-02470 narrative
Collapsing the two verdicts into one is what lets a compliance failure hide behind an intact product. SOP-QM-GEN-000005
Replay warning. Evaluated against the 12JUN2026 snapshot — the date this deviation was actually triaged — this determination is blocked at the impact node: TR-000624 is not effective as of 2026-06-12, so product SISPQ impact is BLOCKED pending an SME-authored controlled assessment. Re-running against today's corpus reproduces a better-informed decision, not the original one.