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Shewhart control charts (I-MR / X-bar / R), Nelson rules 1–8, process capability (Cp/Cpk short-term · Pp/Ppk long-term), normality assessment, batch overlay ANOVA, and statistical PPQ readiness. Import from file or deep link; push results to a project.
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20 valid points
PPQ acceptance criteria
CL 100.305 · UCL 103.538 · LCL 97.072 · σ 1.0778✓ Normal (JB p=0.719)
Cp
Short-term (within)
1.55
Cpk
Short-term (within)
1.45
Pp
Long-term (overall)
1.57
Ppk
Long-term (overall)
1.47
Cp/Cpk use within-subgroup σ̂ (chart sigma); Pp/Ppk use overall sample s. Bands: green ≥ 1.33 · amber 1.0–1.33 · red < 1.0. ICH Q10 §3.2.3 / AIAG SPC Manual 2nd ed.
Stage 2 conformance gate — statistical control, capability vs target, tolerance interval, and lot sufficiency.FDA Process Validation Guidance (Jan 2011) §IV · ICH Q10 §3.2 · EU GMP Annex 15 §9
Process in statistical control
No Nelson rule signals on the plotted series.
Capability meets target (Cpk ≥ 1.33)
Cpk 1.45 meets the 1.33 acceptance target.
99/95 tolerance interval inside spec
[96.46, 104.15] vs spec [95, 105] — contained.
Conformance lots (≥ 3)
3 of 3 planned conformance lots represented.
Sufficient data for capability estimate
20 measurements (≥ 20 preferred for a stable estimate).
99% coverage / 95% confidence tolerance interval: [96.46, 104.15] (two-sided normal model, Odeh & Owen tables).
Automated signals — Rules 1–8 (Nelson 1984 / AIAG SPC Manual).
No Nelson rule violations detected for the current chart.