What is Process Capability and How to Measure It?

Toxicology, biological assessments


A famous sports coach once said: “If you are not keeping score, you are just practicing.” The US FDA’s Quality System Regulation says that manufacturers “shall establish and maintain procedures for… verifying the acceptability of process capability and product characteristics.” Folks, that’s asking you to keep score. But regulatory compliance is not the only issue. Any organization that wants to pursue world-class quality should rely on meaningful measures of quality.

Course description

The primary goal of this webinar is to develop a simple flow chart on methods to establish and maintain product and process capability through meaningful measures of quality. Statistically valid techniques and industry best-practices are presented.  US FDA regulatory requirements, ISO 13485 requirements, and the recommendations of a key guidance document developed by the Global Harmonization Task Force (GHTF) will be discussed.  Best practices applied in a wide variety of industry settings will be illustrated.

This fast-paced webinar will cover the details of application without the burden of statistical complexity. Analysis results from popular statistical software programs will be illustrated. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

Course outline

  • Background
    • FDA Regulatory and ISO 13485 Requirements
    • Introduction to Jargon and Commonality Among Measures
    • Capability Study Decision Tree
  • Attribute Data Process Capability Measures
    • Measures of Yield
    • Measures of Defects and Defectives
  • Variable Data Process Capability Measures
    • Process capability measures for Normally distributed data
      • Properties of the Normal distribution
      • Practical ways to determine if data come from a Normal distribution
      • Special Topics:
        • Ppk vs. Cpk
        • Tolerance Intervals
      • Process capability measures for non-Normally distributed data
        • Transformed data
        • Data that cannot be transformed
      • Wrap Up and Q&A
        • Expressing Risk in a Decision
        • Important Considerations for Application
        • Q&A

Learning objectives

At the end of this webinar, participants will be able to:

  • Describe the fundamental purpose of capability measures
  • Select and calculate product or process capability indices for the following types of data:
    • Attribute Data
    • Variable Data That Are:
      • Normally Distributed
      • Not Normally Distributed
    • Decide if variable data come from a Normal distribution
    • Discuss US FDA regulatory and ISO requirements and expectations

Who should attend

The content should have great value to individuals in industry who are involved with: new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; quality control; and regulatory compliance. Through this overview of process capability measures, managers and members of the leadership team would see how value is added to a quality process.


There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our “keep-it-simple” approach.



IndustryCombination products, Medical Device, Pharmaceuticals

Peter L. Knepell