Bottom line: #dashboards don’t prevent issues. Decision systems do. Build a defensible ##signal lifecycle and you’ll reduce surprises, improve audit readiness, and protect customers.

#KPIs that drive behavior: Time to detect/triage/escalate/contain, true signal rate, recurrence after closure, traceability completeness (signal → decision → action → evidence).

#Governance makes it real: severity classes + signal strength levels + decision rights + #SLAs (time-to-triage/escalate) + CAPA linkage rules.

Detection without triage = alarm fatigue. Every candidate signal needs an evidence pack: what changed, where, which products/lots/serials, severity indicators, historical analogs.

“Detect” should be hybrid: rules/thresholds (known critical triggers) #statistical shift detection (rate-based, normalized to exposure) text analytics (cluster narratives, anomaly terms)

The target #model is an always-on loop: Ingest → Normalize → Detect → Triage → Escalate → Act → Verify.

Second failure: lag. Monthly/quarterly trending is too slow. Weak signals either strengthen fast or vanish—both require timely decisions.

Why most PMS fails: data silos. Complaints over here, service over there, manufacturing elsewhere, external signals tracked ad hoc. Patterns never meet.

Weak signals are low-frequency, early-stage clues: subtle shifts in complaint #narratives, service notes, returns, or field telemetry—before failure rates spike.

Post-Market #Surveillance has changed. The expectation is early detection of weak safety/quality signals using integrated internal + external data—not periodic reporting.

FDAxRadar™ Quality and Regulatory leaders and practitioners in Drugs, Life Sciences, Food and Medical Devices who need early warning and defensible, citation-backed insight from FDA signals—so decisions accelerate, risk becomes visible sooner, and responses are regulator-ready.

Check out the latest article in my newsletter: New FDA QMSR and the Global Convergence to ISO 13485 / ISO 9001 https://t.co/Edk77gtj6o via @LinkedIn

🚨 It’s official: The Crisis Management Playbook is LIVE! Inside you’ll find: ✔️ Crisis communication templates ✔️ Leadership strategies for uncertainty ✔️ Assessment tools to strengthen readiness https://t.co/sDQ7GpRsL7

"It’s here 🚨 The Crisis Management Playbook is now available! Practical strategies. Templates. Leadership tools. Everything you need to lead with clarity in chaos. 👉 https://t.co/eYPwaRm2Gv #Leadership #CrisisReady"

Servant #leadership is not soft. Done properly, it is high care and high steel: serving people, stewarding power, and raising the bar on performance and ethics. I break down the mindset shifts and a 90-day implementation plan in my latest piece. Read here:

🔟 Governance, purpose & succession Board skills, leadership pipeline, and lived purpose are strategic assets. Treat succession and board refresh as continuous, not episodic. Which 3–5 of these are decisive for your 2026–27 agenda? https://t.co/DpbEGoBWVi

9️⃣ Customer-centric innovation Stop counting pilots. Measure NPS, churn, time-to-value, share of wallet. Design products and journeys for an AI-enabled, always-on customer.

8️⃣ Productivity & capital discipline No priority without funding. No funding without a clear value thesis.

7️⃣ ESG as strategy, not slideware Pick the 2–3 ESG themes that really move risk, cost, or growth.

6️⃣ Cyber, data governance & digital trust Cyber incidents = board events. Integrate cyber, privacy, and AI risk. Test it with full-team simulations, not just PowerPoint.