Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Register Now- Statistical Process Control within regulated manufacturing
- Common cause versus special cause variation
- Control charts, process capability, and Cpk interpretation
- Sample size and sampling plan justification
- Statistical evidence supporting verification and validation
- Equipment and process performance monitoring
- Trending nonconformances, complaints, and CAPA data
- Early identification of meaningful process changes
Process data becomes useful when teams can distinguish routine variation from meaningful change and determine when the evidence supports action, investigation, or continued monitoring.
This session structures the practical use of statistical controls, process capability, sampling, and trend data to support consistent manufacturing and quality decisions.
The session begins with the practical role of statistical controls in regulated manufacturing, then connects process variation with monitoring, sampling, verification, and validation activities. It progresses into control charts, capability measures, trend analysis, and early process signals, emphasizing how statistical evidence can support routine production and quality system decisions.
John E. Lincoln brings over 40 years of experience across FDA-regulated manufacturing, quality, engineering, validation, and regulatory functions. His work with organizations from startups through Fortune 100 companies includes production and process controls, validation, quality system remediation, and regulatory response, providing practical context for applying statistical evidence to manufacturing and quality decisions.