5-Why often stops at “operator was not paying attention”, and an 8D report becomes the form a customer insists on. Neither is a flaw in the method; both are flaws in how it is applied. These articles show how far a causal chain has to run before a corrective action can bite, how the VDA structure separates the occurrence chain from the detection chain, and why verification of effectiveness is the step most often missing in practice.
What 9.1.1 and 9.1.3 actually require — four determinations, seven evaluation targets, and not one prescribed metric. Why objectives must be measurable but need not be quantified, and where effectiveness ends and efficiency begins.
Read article →Where the 5-Why method comes from, how a defensible causal chain is actually built, and where the method has documented limits - with three fully worked examples.
Read article →The eight disciplines of the 8D report explained through a running practical example - including their origin, the VDA-specific split of root causes, and whether 8D is actually mandatory.
Read article →Why audit findings stall, which records ISO 9001 requires separately in 9.2.2, 10.2.2 and 8.7.2, where major and minor nonconformity really come from — and what FDA inspection data does and does not prove.
Read article →CAPA is FDA vocabulary from 21 CFR 820.100, not ISO 9001 vocabulary. What clause 10.2 actually requires, why preventive action was deleted in 2015, and how to evidence an effectiveness review.
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