The Taktly blog
DMAIC, Lean, Process Improvement, Standard Work, root cause, control plans, CAPAs, MSA, Kaizen. Written for the people who have to explain the fix — not sell the consulting.
If your CAPA's effectiveness check says 'continue to monitor going forward,' you're already on the FDA's audit risk register. Here's why — and exactly what a defensible effectiveness check looks like.
Read the guideMost teams FMEA the failure that caused the deviation. Almost none FMEA the corrective action they're about to ship. Here's why that's how new failures get introduced — and how to score the risk of your own fix.
Read the guideFDA inspectors reject 'operator error' as a terminal root cause in every CAPA they review. Here's why — and the question you ask yourself when the 5-Why chain wants to stop on a person.
Read the guideCapability indices tell you whether a process can hit spec — but only if you compute them on a stable process. Here's what each index means, when to use which, and the rule that keeps capability numbers honest.
Read the guideFDA cites the same patterns in 483 observations every quarter. Here's how to write a response that satisfies the inspector — and the four patterns that draw a Warning Letter when you get them wrong.
Read the guideVSM is the backbone of Lean. Here's what goes on a current-state map, how to spot the 8 wastes, and how to build a credible future state.
Read the guideA control plan isn't a checkbox — it's the document that decides whether your gain holds. Here's the structure that works.
Read the guideA Kaizen event compresses weeks of improvement into one week. Here's the day-by-day structure that works — and the four failure modes that kill most events.
Read the guideMost CAPAs close on paper and recur within a year. Here's why, and the 5 tests a strong CAPA passes before it's declared effective.
Read the guideIf your measurement system is bad, every DMAIC decision after it is wrong. Here's MSA in plain English, Gage R&R when you need it, and Kappa for attribute data.
Read the guideTollgate reviews kill more projects than they save. Here's how to prep so your sponsor signs, not sends you back.
Read the guideSIPOC is the fastest way to scope a process at a high level before you map it in detail. Here's the right way to use it.
Read the guideThe fishbone organizes possible causes across 6 categories. Here's how to use it without turning it into a wall of sticky notes you never revisit.
Read the guide5-Why looks simple and usually fails. Here's the method that works, the common mistakes, and when to use fishbone instead.
Read the guideDMAIC is the 5-phase problem-solving framework at the heart of Six Sigma. Here's what each phase does, what tollgate gates exist between them, and when DMAIC is (and isn't) the right tool.
Read the guideA good problem statement answers 7 questions: what, why, when, where, who, how, how much. Here's how to write one that survives a sponsor review.
Read the guideAn A3 tells the whole story of a problem and its fix on one page. Here are the 7 zones, what goes in each, and the mistakes that kill most A3s.
Read the guideThe three time metrics at the core of Lean. What each one measures, how they relate, and the common mistake that makes teams chase the wrong one.
Read the guideSOPs tell you what to do. Standard Work tells you how to do it, why, and in what sequence — with takt, key points, and quality checks per step. Here's the practitioner distinction.
Read the guideTaktly has four purpose-built workspaces for DMAIC, Lean, Process Improvement, and Standard Work. Free for 14 days. No credit card. Keep every PDF you generate.