There’s one question every audit team asks during a repeat audit: Did you solve the problem? Not the symptom. The root cause. Too many MedTech teams fall into the same traps: ❌ Skipping frontline input ❌ Abandoning follow-through ❌ Using the wrong tool for the issue ❌ Fixing symptoms instead of systems But there’s a fix. Here are 4 proven root cause tools, and when to use each: 1. 5 Whys 👉 Keep asking “why?” until you hit the core issue. Best for: Simple, recurring problems. 2. Fishbone (Ishikawa) 👉 Map causes across methods, materials, manpower, etc. Best for: Complex, cross-functional issues. 3. Fault Tree Analysis (FTA) 👉 Break down failure logic step by step. Best for: System-level breakdowns or safety-critical events. 4. Pareto Principle (80/20 Rule) 👉 Use data to find which few issues cause most failures. ✔ Prioritize audit findings ✔ Focus your RCA where it counts ✔ Guide resource use with impact in mind Best for: Identifying high-impact failure clusters before RCA begins. ✅ A strong RCA is: • Process-focused – not blame-focused • Evidence-based – not guesswork • Collaborative – includes voices from the floor • Actionable – ends in real improvements • Audit-ready – easy to explain and document Because if you want: ➟ Fewer findings ➟ Less CAPA churn ➟ And safer devices You need to solve the right problem. So when the audit team asks, “Did you fix this?” You’ll say, “Yes, and here’s how we know.” ♻️ Find this valuable? Repost for your network. 💡 Follow Bastian Krapinger-Ruether for actionable tips on MedTech compliance and QM. Tired of wasting time on repetitive compliance tasks? DM me to see how AI can automate 70% of your processes, so you can focus on what really matters. | 22 comments on LinkedIn