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Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.

OOS, OOT, OOC, and OOSC

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

A firm grasp of probability and ongoing re-evaluation are key.

Reducing the Risk in Risk Management

Ensuring compliance though increased statistical knowledge and resources.

Statistics in the Service of Quality

The hardest errors to spot are the ones that don't look like errors at all.

Pitfalls in Statistics

Using risk assessment properly can provide industry with a unique tool for quality control.

The Promise and Threat of Quality Risk Management

Applied statisticians are forever searching for the enemy of quality-variability.

Walk Like a Statistician

To properly inspect based on measurement, a reference standard is crucial for comparison.

Statistical Solutions: Visual Inspection Goes Viral

A history of the selection of the widely used significance level leaves much to be desired.

Statistical Solutions: On the Verge of Significance: Why 5%

A method for determining sample size is finally getting some respect.