Tools for Improving Failure Analysis Processes

🔍Quality Engineer Part 5: FMEA & Risk Analysis "What's the worst that could happen?" That question right there... is the beginning of FMEA. Failure Modes and Effects Analysis is how engineers, QA, and manufacturing teams predict failures before they happen, assess the risk, and put controls in place. But trust me, it’s not just paperwork. It’s critical thinking, cross-functional collaboration, and risk-based decision-making. Let me give you two examples 👇 ☕ Relatable Life Example You’re making coffee before work. You skip checking the water tank. Boom — no water. Next thing? You’re late, stuck in traffic, angry, and caffeine-deprived. 😤 Your FMEA might look like: Failure Mode: No water in coffee machine Effect: Delayed morning, bad mood, low productivity Severity: 7 Occurrence: 5 (you’ve done it before) Detection: 3 (no alarm on your machine) RPN = 7 × 5 × 3 = 105 Control? ✔ Add checking water to your nightly routine. FMEA is basically engineering-level overthinking with results. 😄 Now lets understand in 🧪 Technical (Pharma) terms: We were introducing a new automated blister packaging line. Before going live, we ran a PFMEA with Quality, Engineering, and Production. We identified failure modes like: Tablet misfeed Foil misalignment Seal integrity failure For each one, we scored: Severity (S) – How bad is the impact? (Patient safety = 9/10) Occurrence (O) – How often could this happen? (Misfeeds = 6/10) Detection (D) – Can we catch it before release? (Cameras = 7/10) 📊 Risk Priority Number (RPN) = S × O × D = 378 That’s high. So we: Added redundant camera systems Improved PM schedule Added auto-reject logic for seal deviation Result: Lower RPN, better control, smoother validation. 💡 Why It Matters FMEA teaches you to: Think ahead Collaborate cross-functionally Prioritize risk Drive process improvement It’s one of those tools that once you learn it, you start seeing it everywhere. 🎓 Want to Learn more on PFMEA from Experts? If you're interested in mastering PFMEA, here is one of the best industry-recognized programs: ✅ ASQ - World Headquarters - PFMEA Training Program 🔗 https://lnkd.in/ehpP3_cR This course is practical, detailed, and align with what the industry expects from process engineers and QA professionals. 💡 Takeaway FMEA isn’t just a form — it’s a way of thinking. If you can understand how and where things go wrong, you’ll always be one step ahead — whether you're on the shop floor or in a boardroom. #FMEA #RiskAnalysis #QualityEngineering #CAPA #Validation #MedicalDevices #PharmaIndustry #ProcessImprovement #LinkedInLearning

Structured Proactive Risk Management and Reactive Investigations - Why FMEA Matters for Complex Issues in Biopharma Quality In biopharma, quality issues can range from routine deviations to highly complex, cross-functional failures. The key to effective resolution lies in choosing the right problem-solving tool for the situation — and applying it with discipline. Commonly used approaches include: • 5 Whys – Quick and effective for straightforward issues • Fishbone (Ishikawa) Diagrams – Help visualize and organize potential causes • Pareto Charts – Identify and prioritize high-impact failure trends • FMEA (Failure Mode and Effects Analysis) – Ideal for complex, interconnected systems While tools like 5 Whys and Fishbone are excellent for direct or localized events, FMEA stands out when the problem spans multiple variables and complex. Take sterility assurance as an example. A sterility failure could involve subtle shifts in cleanroom dynamics, gowning behavior, component prep, or equipment integrity — often with no obvious single point of failure. In these situations, already executed (Proactive) FMEA offers more than a preventive planning tool; it becomes a framework for structured, post-event investigation. ** Revisiting each failure mode from the existing FMEA allows teams to: • Systematically assess known risks • Identify breakdowns in existing controls • Uncover overlooked interactions or changes • Link findings back to risk assessments and lifecycle data This strengthens traceability between proactive risk management and reactive investigations — an inportant tool in quality risk management practices. Thoughts? #Biopharma #QualitySystems #FMEA #RootCauseAnalysis #GMP #SterilityAssurance #RiskManagement #QRM #ProblemSolving #ContinuousImprovement

Because root cause analysis is a waste of time when done wrong... This infographics compares 5 Whys vs Fault Tree Analysis (FTA) vs FMEA/ risk matrix: ✅ Concept 👉 5 Why's: keep asking why until getting to the root cause; 5 whys, on average 👉 FTA: analyze the failure causes from top event to basic characteristics 👉 FMEA: identify ways the product can fail and eliminate or reduce the risk of failure ✅ Approach 👉 5 Why's: top down starting with specific failure 👉 FTA: top down starting with specific failure 👉 FMEA: bottom up covering all potential failures ✅ When to Use 👉 5 Why's: 1️⃣ simple and one-dimensional problems 2️⃣ when skilled and experienced team is available 👉 FTA: 1️⃣ complex situations 2️⃣ the intent is to address a specific problem 👉 FMEA: 1️⃣ complex situations 2️⃣ the intent is to identify all potential failures ❌ Not to Use 👉 5 Why's: 1️⃣ no expert team to answer the whys 2️⃣ if multiple root causes 👉 FTA: 1️⃣ top event is not specific. The more specific the top event, the better results. 👉 FMEA: 1️⃣ quick decisions are required 2️⃣ little experience with FMEA (it will create confusion!) ✅ Step-by-step Approach 👉 5 Why's: 1️⃣ assemble the right team 2️⃣ identify the problem 3️⃣ determine why the problem took place 4️⃣ ask why again 5️⃣ repeat 6️⃣ execute 7️⃣ track the results and adapt/ pivot 👉 Fault Tree Analysis: 1️⃣ define the top event, the failure 2️⃣ identify how the process was working before 3️⃣ list potential causes of the failure 4️⃣ map out the potential causes with the "and" and "or" gates 5️⃣ assign risk and probability to each base event 6️⃣ mitigate risk based on highest risk and probability 👉 FMEA: 1️⃣ determine failure modes 2️⃣ determine effects of failures on customers 3️⃣ identify potential causes 4️⃣ document current controls 5️⃣ define rating scales for severity, occurrence, and detection. 6️⃣ assign ratings per scale 7️⃣ prioritize 8️⃣ define recommended actions 9️⃣ execute Any others aspects to add?