How To Write Engineering Risk Assessments

Here's my cheat sheet for a first-pass quantitative risk assessment. Use this as your “day-one” playbook when leadership says: “Just give us a first pass. How bad could this get?” 1. Frame the business decision - Write one sentence that links the decision to money or mission. Example: “Should we spend $X to prevent a ransomware-driven hospital shutdown?” 2. Break the decision into a risk statement - Identify the chain: Threat → Asset → Effect → Consequence. Capture each link in a short phrase. Example: “Cyber criminal group → business email → data locked → widespread outage” 3. Harvest outside evidence for frequency and magnitude - Where has this, or something close, already happened? Examples: Industry base rates, previous incidents and near misses from your incident response team, analogous incidents in other sectors 4. Fill the gaps with calibrated experts - Run a quick elicitation for frequency and magnitude (5th, 50th, and 95th percentiles). - Weight experts by calibration scores if you have them; use a simple average if you don’t. 5. Assemble priors and simulate - Feed frequencies and losses into a Monte Carlo simulation. Use Excel, Python, R, whatever’s handy. 6. Stress-test the story - Host a 30-minute premortem: “It’s a year from now. The worst happened. What did we miss?” - Adjust inputs or add/modify scenarios, then re-run the analysis. 7. Deliver the first-cut answer - Provide leadership with executive-ready extracts. Examples: Range: “10% chance annual losses exceed $50M.” Sensitivity drivers: Highlight the inputs that most affect tail loss Value of information: Which dataset would shrink uncertainty fastest. Done. You now have a defensible, numbers-based initial assessment. Good enough for a go/no-go decision and a clear roadmap for deeper analysis. This fits on a sticky note. #riskassessment #RiskManagement #cyberrisk

Stop doing risk assessments no one reads. You already have to do one every year—why not make it useful? Most assessments get buried because they’re qualitative, vague, and disconnected from the decisions that actually matter. Here’s the fix: → Upgrade to a semi-quantitative assessment that clearly shows what’s most likely to go wrong—and what it would cost. → Then take your top 3–5 material risks and run a simple quantitative analysis. Think: loss expectancy, downtime thresholds, incident response costs. You don’t need a math degree. You just need better structure, tighter inputs, and a little courage to stop playing the compliance game. Because when done right, that same assessment suddenly becomes: - A tool for executive reporting - A foundation for budget justification - A forcing function for business alignment Risk assessments shouldn’t sit on a shelf. They should drive action.

🔍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