is-is-not-scoping
Is/Is-Not Problem Scoping
When to use
Use Is/Is-Not at the start of any quality investigation to precisely define what the problem IS and what it IS NOT. This scoping prevents wasted investigation effort and immediately eliminates hypotheses that cannot explain the observed IS/IS-NOT pattern.
Most effective in 8D D2 (problem description), CAPA scoping, and any situation where the defect is intermittent, batch-specific, or location-specific.
Critical rule — facts only
The IS column contains only documented, measured facts. Hypotheses, assumptions, and opinions belong in the hypothesis list, not in the matrix. If a cell contains an assumption rather than a fact, the entire analysis is compromised.
If data is not yet available: mark the cell as "Unknown — to be investigated" and identify what investigation is needed before proceeding.