[ PRACTISE · 4 OF 5 ]

Practise the judgment, not the vocabulary

Deterministic scenario exercises where your choices change the situation — and a source-linked debrief explains why each one mattered.

13 SCENARIOS PUBLISHED · NO COMPLIANCE VERDICT IS ISSUED BY ANY OF THEM

How to use this library

Pick a scenario for your role, or search for the situation you face, then play it through: your choices change what happens, and the debrief explains why each one mattered.

No scenario issues a compliance verdict, on you or on the situation; that is a decision your organisation makes with evidence SPEQ does not have.

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13 scenarios

Published order

Trace a DeviationYou 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.CONTAINMENT · DOCUMENTATION · ESCALATION · OWNERSHIP

Build a FacilityYou are bringing a new manufacturing facility online. Decide how to scope, verify, and evidence the qualified state — from design through commissioning and qualification to startup.SCOPE · VERIFICATION · EVIDENCE · GOVERNANCE

Clinical Trial Data JourneyFollow trial data from a participant’s source record through the EDC, queries, and database lock. Your choices decide whether the evidence a regulatory approval rests on is credible and defensible.INTEGRITY · TRACEABILITY · TIMELINESS · OVERSIGHT

Investigate an OOS ResultA finished-product assay comes back below specification. Walk it from the bench through the laboratory investigation, hypothesis testing, the full-scale investigation, and batch disposition — and see whether your record would survive an inspection.RIGOR · INTEGRITY · ROOTCAUSE · DISPOSITION

Prepare for a Pre-Approval InspectionYour application is filed and a pre-approval inspection is coming. Walk the site from readiness assessment through data-integrity verification, application conformance, and the inspection itself — and see whether the outcome would be a recommendation for approval.PREPARATION · EVIDENCE · CANDOR · OWNERSHIP

Complaint to CAPAA clinician reports that an infusion pump alarmed and stopped mid-therapy. Take it from complaint intake through investigation, reportability, and the risk file — and see whether the post-market loop actually closes.INVESTIGATION · REPORTABILITY · RISK · SYSTEMIC

A Preventive Control FailsThe thermal-process record for a run sits below its minimum for eleven minutes, and the shift has already moved on. Take it from the monitoring record through disposition, cause, and plan reanalysis.CONTAINMENT · RECORDS · INVESTIGATION · SYSTEMIC

Signal to ActionA report of harm reaches your company by an unexpected route. Decide how it is captured, assessed, reported and escalated — and what to do when the evidence is suggestive but not conclusive.TIMELINESS · ASSESSMENT · GOVERNANCE · EVIDENCE

Validate a SystemA configured LIMS is being implemented to replace paper worksheets. Decide how much validation the risk warrants, what the supplier’s assurance can substitute for, and what to do about an audit trail that does not capture what you assumed.SCOPE · VERIFICATION · DATAINTEGRITY · GOVERNANCE

Cold Chain ExcursionA refrigerated shipment arrives with a temperature excursion on the logger. Decide what happens to the stock, who makes the call, and what the answer rests on — before a customer asks where their order is.ASSESSMENT · CONTROL · EVIDENCE · GOVERNANCE

A PPQ Batch Out of TrendA tablet has been transferred to a new site. The second process performance qualification batch passes every specification but misses the protocol’s own consistency criterion. Decide what the result means, where the explanation lives, and whether the process is ready for market.PROTOCOL · INVESTIGATION · KNOWLEDGE · DECISION

A Critical Supplier Audit FindingAn audit of your active-ingredient supplier finds that its laboratory’s results cannot be trusted, and you have been releasing its material on its certificates. Decide what happens to the lots in quarantine, the product already on the market, and the supplier.CONTAINMENT · ASSURANCE · IMPACT · GOVERNANCE

A Media Fill FailsOne vial out of a routine media fill comes back cloudy. Decide what that single unit means, what happens to the product filled since the last good simulation, where the cause is, and when the line can fill again.RESPONSE · INVESTIGATION · PRODUCTIMPACT · REQUALIFICATION

COMPLETE INDEX — ALL 13 SCENARIO

Role links come from the published scenario-to-role map; each card's dimensions are the ones that scenario declares and scores.

WHAT A SCENARIO IS

A judgment exercise, not a quiz. Each one is deterministic — the same choices always produce the same situation and the same debrief — and each is scored only against the dimensions it declares for itself. No scenario issues a compliance verdict, on you or on the situation, because that is a decision your organisation makes with evidence SPEQ does not have. Every one is free and needs no account.

STATED COVERAGE

These 13 scenarios exercise 33 of the 48 published role maps. They do not yet reach these:

Clinical Sample Manager
Cosmetics Safety Assessor
Excipient Quality Manager
Bioanalytical Laboratory Scientist
Founder or Principal Investigator
Training and Qualification Lead
Regulatory Strategy Lead
Medical Writer
Independent GxP Consultant
Notified Body Auditor
Certification Scheme Manager
Clinical Site Quality Lead
Compounding Pharmacist
Sterile Compounding Technician
Packaging Engineer