[ SCENARIO · FREE · DETERMINISTIC ]
Trace a Deviation
You are on the floor when something departs from the approved procedure. Walk it from discovery through containment, investigation, CAPA, and management review — and see whether your record would survive an inspection.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
Something has gone wrong on the line. Your choices decide whether it is handled in a way that protects the patient and holds up to inspection.
A deviation must be contained, recorded, investigated to root cause, corrected and prevented (CAPA), and escalated appropriately. Each decision here has consequences that carry forward.
This is where the state of control is proven or lost in real time — and where an inspector will later pull the thread.
You are a manufacturing operator. Midway through a batch, you notice two similar containers of raw material may have been swapped at the last step.
Nothing here is a trick. Choose what a controlled operation would actually do — the situation will change based on your choice.
You suspect a material mix-up. The batch is still in progress and no one else has noticed.
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across containment · documentation · escalation · ownership — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
WHAT THE CORRECT PATH RESTS ON
The primary sources behind the debriefs. The authoritative text lives at each official source.
- 21 CFR 211.100(b) — deviations from written production procedures recorded and justified ↗
- 21 CFR 211.192 — production record review and investigation of unexplained discrepancies ↗
- EU GMP (EudraLex Volume 4) Chapter 1 — Pharmaceutical Quality System, 1.4(xiv) and 1.8(vii) ↗
- ICH Q10 — Pharmaceutical Quality System, 3.2.2 Corrective Action and Preventive Action (CAPA) System ↗
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →DO IT FOR REAL
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