Specification limit provenance sheet StatMedAnalysis | 9 November 2026 Use aggregate or synthetic process observations. Use before computing capability. Mark whether a requirement is one-sided or two-sided. Process and measurement unit: ______________________ Reference operating conditions: __________ Limit | Numeric value | Units | Requirement owner/document | Version/date | Applies to Lower | _____________ | _____ | __________________________ | ____________ | __________ Upper | _____________ | _____ | __________________________ | ____________ | __________ Dispersion estimator, sample size and reference interval: ________________________ Stability evidence / distribution check: ________________________________________ 1. Confirm production measurements and requirements use the same scale. 2. Check whether the reference SD represents within-run or longer-term variation. 3. Record the decision maker and what a low capability estimate would trigger. Fictional example: a simulator must return 90–110 units. A stable reference mean of 106 leaves only four units of upper-side clearance. Keep these externally set limits separate from estimated monitoring limits. Completion check: both limit values have a source independent of the observed sample extremes.