Analysis

Open QuestionsURL copied

1. What is the actual regulatory obligation? The system is assumed to operate in a clinical lab context where ISO 15189 or GLP may apply. If either applies, the violation log must be append-only, tamper-evident, and retained for a defined period. Options: (a) confirm no formal standard applies — use any durable storage; (b) confirm ISO 15189 applies — design the log as an immutable audit record from day one. Unblocked by: a single conversation with the lab's quality manager or compliance officer.

2. What is the person attribution mechanism? Wristband RFID is the recommended approach but requires technicians to wear a device during shifts. If this is operationally unacceptable, camera-based person tracking is the fallback but degrades under occlusion. Options: (a) wristband RFID — reliable, minor operational overhead; (b) badge RFID at bench entry points — lower reliability for attribution at the instrument level; (c) camera-only person tracking — no wearable, higher CV complexity. Unblocked by: lab operations team confirming willingness to adopt wristbands.

3. Is there existing camera infrastructure in the lab? The system assumes cameras will be placed strategically. If IP cameras already exist, their coverage, resolution, and network accessibility need assessment. If none exist, camera procurement and mounting are part of the Sensor Edge sprint. Unblocked by: a site survey.

4. What is the target platform for the supervisor phone app? iOS, Android, or both? An existing mobile device management (MDM) profile in the organisation would simplify deployment significantly. If no mobile infrastructure exists, a web-based alert dashboard may be a lower-friction alternative for v1. Unblocked by: IT and operations stakeholder alignment.