Process Capability Analysis
and Tolerance Intervals

November 30th, 2021

11:00 AM – 12:00 PM SST

Statistics are one of the most important tools available for the validation of processes and systems. In this webinar we will discuss some of the most useful statistical tools that are commonly used in validation: Process Capability Analysis and Tolerance Intervals.

Process Capability Analysis and Tolerance Intervals allow us to determine how well our manufacturing processes meet critical quality specifications for both normal and non-normal data.  These tools allow us to assess the stability and consistency of our processes. They are useful during the validation of new processes, and the validation of changes to existing processes. Use these tools to make sound statistically-based accept/reject decisions about our validation lots with the desired confidence levels.

Top 10 Reasons to Attend:

  •  Learn to use process capability analysis to determine if your validation lots meet process specifications.
  • Learn the difference between short-term and long-term process capability.
  • Determine when 3 validation lots are sufficient to validate a process, and when do we need more.
  • Learn to calculate the most important process capability indices (CPk, CPm, and others).
  • Learn to use process capability to estimate your process percent defective.
  • Learn to calculate confidence intervals around PPk and CPk to estimate its accuracy.
  • How to calculate the sample size needed to obtain a CPk within a specific statistical confidence level.
  • Learn to use tolerance intervals to make statistically-sound process capability and accept/reject statements about your validation lots.
  • Learn to calculate one-sided and two-sided tolerance intervals for your validation lots.
  • Learn to use tolerance intervals to handle non-normal data.


Raul Soto, MSc, CQE

Senior Principal Software Quality Engineer, Quality Assurance Operations Johnson & Johnson Vision Care, Inc.

Raul Soto is an experienced validation and quality assurance professional with nearly thirty years of experience in the biopharmaceutical, medical devices, and consumer electronics industries. He has led global teams, major computerized systems validation projects, and compliance remediation initiatives in the United States, Europe, and China.