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Minimum Sample Size To Lock Control Limits? A Capability- and Risk-Based Approach Using PpK and Chi-Square Uncertainty

By

Naveenganesh Muralidharan, Akshay Phulgirkar

21d agoen

Source

bioprocessintl.comMinimum Sample Size To Lock Control Limits? A Capability- and Risk-Based Approach Using PpK and Chi-Square Uncertaintybioprocessintl.com
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When deployed correctly, statistical process control (SPC) reduces deviation burden, strengthens process knowledge, and provides early warning for process drift before specification excursions occur. But how many baseline samples are required before control limits should be locked? The authors share a capability- and risk-based method for baseline sample-size selection that is quantitative and compliant.

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