Free tool · Problem statements
… so your people know what issue they are solving. Six questions — 4W2H — shown on a worked example first. Below, write your own.
Use observable symptom only. This means what you’re saying needs to be specific and verifiable. No assumed causes, no solutions.
GlucoTrack Pro (Model GT-400A) displays “Error E-07” and fails to return a blood glucose reading within 5 seconds, violating PS-2024-041 which requires valid readings under all labeled operating conditions (10–40°C).
Mention the date first observed. If you know, describe whether it’s continuous or intermittent. Use factual time anchors only.
First reported December 3, 2025, with complaints ongoing through January 15, 2026, primarily during morning testing.
If you already know, explain where it occurred AND where it was detected. These may differ, but both matter.
Who found it and what is their role? Was it internal or external? That’s not about blame, more about your detection path.
Patients discovered the issue during routine home use in Northern Europe and Canada, while the post-market surveillance team identified it through distributor call centers.
What was the actual detection method? Link it to the requirement or specification that confirms it’s actually a nonconformity.
The trend was flagged during monthly complaint review; consistent complaint descriptions confirm the deviation against PS-2024-041.
What’s the number of units/users affected, frequency, or boundaries of the problem? You may need to update this over the lifecycle.
Affected units were manufactured August–October 2025 (lots LT-2025-08-017 to LT-2025-10-042; S/N GT4-080100 to GT4-101899) at the Berlin site, with 38 complaints out of ~12,000 active units (0.32%) and 3 cases of delayed insulin dosing documented.
Try it yourself
Pick a real issue and answer the six questions. Everything you type stays in your browser — nothing is sent anywhere. Your draft survives a page refresh.
Your statement
How much easier would your root cause investigation be now?
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