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. ## Required Is/Is-Not Checklist ☐ All five dimensions completed — What, Which, Where, When, How many — or marked "Unknown — to be investigated" ☐ IS column contains only documented facts and measured values — no assumptions, no hypotheses ☐ IS NOT column completed for each dimension — this is where hypotheses get eliminated; do not leave blank ☐ Vague IS statements converted to specific facts with numbers (batch, quantity, percentage) ☐ At least three hypotheses generated and tested against the full matrix ☐ Eliminated hypotheses documented with the specific IS/IS-NOT entry that contradicts them ☐ Is/Is-Not output referenced in ...