Pairs with the circular root causes guide and the quality-event criterion Root-cause adequacy. Drafts stay in this browser only.
What the coach looks for
- Category labels only (operator error, human error, procedure not followed…)
- CA that is only retrain / remind / be careful — no system change
- Draft too short to explain a mechanism
Green chips mean those patterns didn’t fire — not that your science is correct.
Rewrite drills
Given: “Root cause: Operator error. CA: Operator retrained on SOP-114.”
Root cause: Changeover checklist did not require a second person to verify the product-code field; wrong WIP was staged against an incomplete clearance.
CA: Add independent verification step to the checklist; hold similar changeovers until the revision is effective and trained.
Given: “Root cause: Procedure not followed. CA: Read and understand issued.”
Root cause: SOP allowed two acceptable sample pull times without a decision rule; operators chose the later window under throughput pressure, outside process validation assumptions.
CA: Clarify the single allowed window in the SOP; add a line-clearance question that forces the validated window; assess other lots in the same window.
Given: “Root cause: Equipment failure. CA: Part replaced.”
Root cause: Preventive maintenance interval for seal kit X was extended without a documented risk assessment; seal wear progressed to failure during batch Y.
CA: Restore the PM interval with engineering justification; inspect sister equipment on the extended interval; document impact on open batches.
Given: “Root cause: Human error during data entry. CA: Staff reminded to be careful.”
Root cause: Result transcription required re-keying from the instrument printout into the LIMS with no field check; unit-of-measure fields were adjacent and unlabeled on the paper form.
CA: Redesign the form / add dual entry or electronic capture; short-term: second-person verification of UOM for assays of this type.
Still judgment. Clearing the smell-test is not the same as a true root cause. Evidence, scope, and impact stay with the reviewer. This page never issues PASS / FLAG / REVIEW.